Diurnal Group PLC – Interim Results

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. 

Highlights:

• 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 

Alkindi^® (hydrocortisone granules in capsules for opening)

• 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
• 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)

• 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.“