Posted on Thursday, 20/Sep/2018 Posted by admin

A transformational year as the Group reports first commercial revenues

Further key clinical and regulatory milestones expected in the next 12 months

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its audited results for the year ended 30 June 2018. 

Operational highlights
• Grant of a paediatric use marketing authorisation (PUMA) by the European Commission for Alkindi® (hydrocortisone granules in capsules for opening) as replacement therapy of adrenal insufficiency (AI) in infants, children and adolescents (from birth to < 18 years old) 
• First launch of Alkindi® in Germany as replacement therapy of paediatric AI 
• Completion of patient recruitment for the European Phase III trial of Chronocort® (modified-release hydrocortisone) in congenital adrenal hyperplasia (CAH)
o Headline data expected during early Q4 2018
• Grant of first US patent for Chronocort® and grant of first Japanese patents for Alkindi® and Chronocort®
• Marketing and distribution agreement with Emerge Health for Alkindi® and Chronocort® in Australia and New Zealand executed

Financial overview
• Successful completion of £10.5m placing with institutional and private investors to fund further development of Diurnal’s late-stage pipeline
• First commercial revenues recorded for the period from launch in May 2018
• Operating loss of £16.8m (2016/17: £12.1m) reflecting increased investment in clinical and development activities and build-out of commercial organisation
• Held to maturity financial assets, cash and cash equivalents at 30 June 2018 of £17.3m (30 June 2017: £19.9m)
• Net cash used in operating activities was £12.8m (2016/17: £10.5m), in line with the Board’s expectations

Post-period highlights
• Treatment phase of European Phase III trial of Chronocort® in CAH completed

Martin Whitaker, PhD, Chief Executive Officer of Diurnal, commented:
“Diurnal has had a transformational year, with the approval of our first product, Alkindi®, and delivery of our first commercial revenues following its launch in Germany in May 2018. We have also made excellent progress with our late-stage pipeline, in particular the completion of recruitment and treatment in our Chronocort® European Phase III study, which is expected to report headline data in Q4 2018, and with the establishment of a clear regulatory path in the US. With a number of key clinical and regulatory milestones due in the next 12 months, we believe that Diurnal is entering a very exciting period as it executes its strategy to become a world-leading, endocrinology focused speciality pharmaceutical company.”

This announcement contains insider information for the purposes of Article 7 of Regulatory (EU) No596/2014.

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 +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 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: Results for the year ended 30 June 2018