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Building on the successful launch of Alkindi®

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 2019.

Operational highlights

Alkindi®

• Successful launch of Alkindi® in the UK as the first specifically developed and licensed replacement therapy for paediatric adrenal insufficiency
• Alkindi® pricing agreed in Germany, Italy, Austria, Sweden, Norway, Denmark and Iceland
• Confirmation of the current clinical and regulatory path for Alkindi® in the US with the US Food and Drug Administration, facilitating a New Drug Application (NDA) submission in Q4 2019
• Progress in the rest of world with Alkindi® Marketing Authorisation Application (MAA) submission in Israel and grant of Orphan Drug Designation in Australia

Chronocort®

• MAA submission is on track for Q4 2019: confirmation of the current clinical and regulatory path for Chronocort® by the European Medicines Agency (EMA) following completion of European Phase 3 study
  • Pivotal study in congenital adrenal hyperplasia, the largest ever interventional study in this disease completed
    • 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 the same or lower overall dose of glucocorticoid with fewer patients requiring rescue therapy (sick day rules)
  • Scientific Advice from the EMA confirmed no additional clinical studies required

Financial overview

• Alkindi® revenues reached over £1 million during the financial year
• Successful completion of a £5.9 million Placing and Open Offer with institutional and private investors to fund further development of Diurnal's late-stage pipeline and commercial roll-out
• Reduced operating loss of £14.5m (2018: £16.8m), reflecting completion of the Chronocort European Phase 3 study, implementation of cost-saving measures and increase in revenues
• Cash and cash equivalents at 30 June 2019 of £9.1m (30 June 2018: £17.3m)
• Net cash used in operating activities was £13.7m (2018: £12.8m), in line with the Board's expectations

Post-period highlights

• Successful launch of Alkindi® in Sweden and Denmark
• Submission of MAA for Alkindi® in Australia following the grant of Orphan Drug Designation
• Investment in enhanced capsuling capability for Alkindi® and Chronocort® agreed with manufacturing partner, Glatt Pharmaceutical Services

Martin Whitaker, CEO of Diurnal, commented: 

"Diurnal continues to execute on delivering its vision of becoming a world leading endocrinology specialty pharma company. During the year, we made substantial operational and commercial progress, overcoming significant challenges, and remain in a strong position.  

"Alkindi®, our first commercialised product, demonstrated strong market uptake, which we believe validates our strategy of focusing on the treatment of underserved chronic endocrine diseases, as well as our expertise in developing, registering and commercialising high-quality products. Importantly, we have also built a valuable sales infrastructure in Europe for Alkindi®, which we can use to commercialise future products including Chronocort®.  As further testament to the expert team at Diurnal, we are pleased that following our detailed analysis of data from our Phase 3 clinical programme of Chronocort® in Europe and our discussion with the EMA, the product remains on track for submission of an MAA in Q4 2019.

"Additionally, as we look ahead, we expect further country launches in Europe for Alkindi® during H2 2019, along with a planned NDA submission of the product in the US during Q4 2019. Diurnal has received strong interest in Alkindi® and Chronocort® for the US and we are progressing with licensing discussions."

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 (Media and Investor Relations)	+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

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