Posted on Wednesday, 12/Oct/2016 Posted by michelle

 Significant progress towards becoming a revenue generating endocrinology specialty pharmaceutical company

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its results for the year ended 30 June 2016.  

Operational highlights

  • Primary endpoint met in European pivotal study of Infacort® in paediatric Adrenal Insufficiency; regulatory filing anticipated by the end of 2016.
  • First patient treated in the Group’s European Phase III trial of Chronocort® in Congenital Adrenal Hyperplasia.
  • First patient treated in the Group’s European open-label safety extension studies of Infacort® in paediatric Adrenal Insufficiency and Chronocort® in Congenital Adrenal Hyperplasia.
  • Initial Public Offering on the Alternative Investment Market (“AIM”) of the London Stock Exchange in December 2015, raising £30m before expenses.
  • Strengthening of the Board with the appointment of Peter Allen as Non-executive Chairman and John Goddard as Non-executive Director.


Financial overview

  • Operating loss of £7.0m (2015 13 months: £3.0m) reflecting investment in increased clinical and development activities together with investment in overheads to support the anticipated growth and development of the business and including £1.5m of one-off, share option related and non-cash expenses.
  • Held to maturity financial assets, cash and cash equivalents at 30 June 2016 of £30.1m (2015: £6.1m) following the successful AIM IPO and fundraising.
  • Net assets of £25.9m (2015: £6.0m).
  • Net cash used in operating activities was £5.1m (2015 13 months: £2.9m).

 

Martin Whitaker, PhD, Chief Executive Officer of Diurnal, commented:
“This financial year has been transformational as we executed our Initial Public Offering on AIM, providing the Group with the capital to accelerate product development to bring our novel products to market.  Despite the distraction of the IPO, the Group’s late-stage products, Infacort® and Chronocort®, continue to progress according to plan in Europe and we are working with the US Food and Drug Administration to design the optimal clinical pathway towards regulatory approval in the US.  Diurnal expects to receive its first market authorisation in late 2017 and is well positioned to initiate commercialisation activities towards building a proprietary endocrinology franchise.”  
 
 
In the Results for the year ended 30 June 2016:
•     “bn”, “m” and “k” represent billion, million and thousand respectively
•    “Group” is the Company and its subsidiary undertaking, Diurnal Limited

For further information, please visit www.diurnal.co.uk or contact:
   
Diurnal Group plc     
Martin Whitaker, CEO    
Ian Ardill, CFO    

Tel: +44 (0)20 3727 1000
    
Numis Securities Ltd (Nominated Adviser)    
Nominated Adviser: Michael Meade, Freddie Barnfield,  Paul Gillam    
Corporate Broking: James Black    

Tel: +44 (0)20 7260 1000
    
FTI Consulting     
Simon Conway    
Victoria Foster Mitchell

Tel: +44 (0)20 3727 1000   

 

Notes to Editors

About Diurnal
Diurnal is a clinical stage specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases which the Company believes are currently not satisfactorily met by existing treatments. It has identified a number of specialist endocrinology market opportunities in Europe and the US that are together estimated to be worth more than $11bn per annum.

On its admission to AIM in December 2015, the Company raised £30 million by way of a placing of new ordinary shares and a convertible loan.  The new funds will accelerate the development of two leading product candidates which are in, or expected to commence shortly, Phase III clinical trials, targeting diseases of cortisol deficiency; Chronocort®, to be used for Congenital Adrenal Hyperplasia (“CAH”) in adults, and Infacort®, to be used for Adrenal Insufficiency (“AI”), including CAH in children. The lead product candidate, Infacort®, is anticipated to receive its first regulatory approval in Europe towards the end of 2017.

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 2016.