Posted on Monday, 20/Mar/2017 Posted by mike

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 2016.

Operational highlights

  • Primary endpoint met in European Phase III Infacort® registration trial in paediatric adrenal insufficiency (“AI”)
  • Infacort® paediatric use marketing authorisation (PUMA) submitted to EMA
  • Significant progress in the European Phase III trial of Chronocort® in congenital adrenal hyperplasia (“CAH”), with over 50% of patients enrolled
  • First patients dosed in European follow-on study of the Phase III Infacort® registration trial in paediatric AI and the European follow-on study of the Phase III Chronocort® registration trial in adult CAH
  • Development of the Company’s European commercial organisation instigated through the appointment of Ashfield to support sales and medical infrastructure and Sharp to bring expertise to Infacort® supply chain
  • Initiation of Named Patient Access Programme for Infacort® and Chronocort® with Clinigen, following the period end
  • First patient dosed with novel oral testosterone therapy in study evaluating pharmacokinetics, safety and tolerability in male patients with hypogonadism
  • Strengthened the Board with the appointment of Richard Bungay as Chief Financial Officer, following the period end

Financial overview

  • Operating loss of £5.7m (H1 2015/16: £3.5m) reflecting increased investment in clinical and development activities, build out of commercial organisation and investment in overheads to support the anticipated growth and development of the business
  • Held-to-maturity financial assets, cash and cash equivalents at 31 December 2016 of £25.6m (31 Dec 2015: £33.1m)
  • Net cash used in operating activities was £4.5m (H1 2015/16: £2.0m), in line with the Board’s expectations
  • Net assets of £20.6m (31 Dec 2015: £28.6m)

Martin Whitaker, PhD, Chief Executive Officer of Diurnal, commented:

“During 2016, the Company continued to deliver on key milestones as we progressed towards our ambition of becoming a world leading specialty pharma company in endocrinology. The successful completion of the registration study for Infacort® in Europe was a key inflection point for the Company during the year. We have now begun to build out of our European commercial organisation that will allow us to market Infacort®, our first product, directly to specialist prescribers in major European markets following its anticipated market authorisation towards the end of 2017. We believe that this infrastructure will also make Diurnal an attractive licensing partner for third parties focused in the endocrinology space who do not have European commercial operations. In the US, we continued to progress Infacort® and Chronocort® and expect to commence pivotal clinical programmes in the second half of 2017.”

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 undertaking, Diurnal Limited

Date of preparation 17th March 2017 Ref: CORP-EU-0005

For further information, please visit www.diurnal.co.uk or contact:

Diurnal Group plc  +44 (0)20 3727 1000

Martin Whitaker, CEO

Richard Bungay, CFO

Numis Securities Ltd (Nominated Adviser and Joint Broker)  +44 (0)20 7260 1000 

Nominated Adviser: Michael Meade, Freddie Barnfield, Paul Gillam

Corporate Broking: James Black

Panmure Gordon (UK) Limited (Joint Broker)  +44 (0) 20 7886 2500

Corporate Finance: Freddy Crossley, Duncan Monteith

Corporate Broking: Tom Salvesen

FTI Consulting  +44 (0)20 3727 1000

Simon Conway

Victoria Foster Mitchell

Notes to Editors

About Diurnal 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 the orphan diseases 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 2016