Posted on Thursday, 28/Mar/2019 Posted by michelle

Strong launches for Alkindi® in Germany and UK with further launches planned for 2019

Company on track for two major regulatory filings during 2019

Continued progress in emerging early-stage pipeline

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 2018 (the “Period”). 

Operational highlights (during the Period and post the Period end)

• Alkindi® (hydrocortisone granules in capsules for opening)
o Launch of Alkindi® in the UK as the first specifically developed and licensed replacement therapy of paediatric adrenal insufficiency and positive Scottish Medicines Consortium pricing and reimbursement decision
o Confirmation of the current clinical and regulatory path for Alkindi® with the US FDA, facilitating NDA submission in Q4 2019
 Partnering discussions for Alkindi® in the US initiated following confirmation of regulatory path

 Chronocort® (modified release hydrocortisone)
o Completion of European Phase 3 study in congenital adrenal hyperplasia, the largest ever treatment study in this disease, and subsequent announcement of headline data:
 Study missed primary endpoint of superiority of Chronocort® to conventional therapy in control of androgens (17-OHP) over the 24-hour period
 Chronocort achieved significantly better control of androgens (17-OHP) in the period 07:00-15:00
 Chronocort® achieved 24-hour control on a lower overall dose of glucocorticoid with fewer patients requiring rescue therapy (sick day rules)
 Scientific Advice sought from European Medicines Agency with a view to filing a Marketing Authorisation Application in Q4 2019

Financial overview
• Alkindi® revenues of £186k (H1 2017/18: £nil) following initial launches, in Germany and UK, in line with Board’s expectations; continued progress post-Period end with sales for the two months ended 28 February 2019 of £190k
• Operating loss of £9.7m (H1 2017/18: £7.7m) reflecting increased investment in clinical development activities 
• Held-to-maturity financial assets, cash and cash equivalents at 31 December 2018 of £6.9m (31 December 2017: £14.0m); 30 June 2018 of £17.3m

Martin Whitaker, PhD, Chief Executive Officer of Diurnal, commented:
“The Company has made excellent progress with Alkindi® with sales performance in line with the Board’s expectations, following successful launches in the UK and Germany, and with continued growth after the Period end. Further Alkindi® launches are planned for 2019 in Europe. We have also clarified the US regulatory path for Alkindi®, facilitating the Company’s first New Drug Application to the US Food and Drug Administration in Q4 2019.

Despite the initially disappointing top-line analysis of data from the Chronocort® European Phase 3 study in CAH, following further in depth analysis of the study results we continue to believe that Chronocort® represents a valuable treatment option for patients based on multiple important clinical parameters. We have requested Scientific Advice from the EMA in order to clarify the regulatory path for a potential Marketing Authorisation Application (MAA) and we expect to receive this advice in Q2 2019. If the EMA agrees that our existing clinical data could support a regulatory submission, Diurnal anticipates filing an MAA for Chronocort® in Q4 2019.”

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 B.V.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

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 Group plc
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: Interim results for the six months ended 31 December 2018

 

Date of Preparation: March 2019             Code: CH EU-GB-0027