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Alkindi® sales grow while new deals enable further geographic expansion; EMA approval of second drug, Chronocort®, expected in Q1 2021

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 2020 (the "Period") and follows publication of a trading update on 14 January 2021 .

Operational highlights

• Alkindi® (hydrocortisone granules in capsules for opening)
  • Alkindi® Sprinkle approved in the US with subsequent launch by partner Eton Pharmaceuticals ("Eton") in late 2020
  • Further Alkindi® approvals in Australia and Israel
• Chronocort® (modified-release hydrocortisone)
  • Chronocort® Day 120 responses submitted on time to the European Medicines Agency (EMA); remains on track for anticipated Committee for Medicinal Products for Human Use (CHMP) recommendation in Q1 2021
  • Continued progress in both Europe and US post-period end:
    • Received and replied to Chronocort® Day 180 questions from EMA
    • Chronocort® marketing authorisation application (MAA) submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in parallel with EMA review
    • Commencement of market access activities for Chronocort® in its target European markets, with the first commercial launch scheduled for Q3 2021
    • Positive Type A meeting with US Food and Drug Administration (FDA) to agree Chronocort® US development programme
• DITEST™ (native oral testosterone formulation)
  • Positive meeting with the US FDA confirming abbreviated 505(b)(2) development pathway, with potential to be the first effective oral native testosterone treatment in an estimated $4.8bn global market
• Continued expansion of global footprint post-period end:
  • Extension of Eton US licensing arrangement for Alkindi® Sprinkle to add Canada
  • Distribution agreement with Er-Kim for Alkindi® and Chronocort® in Turkey
  • Licensing agreement with Citrine Medicine for Alkindi® in China; $0.5m non-refundable cash payment received and up to $12.75m additional cash payments upon achieving certain regulatory and sales milestones
  • Distribution agreement with Consilient Health in the Nordics for Chronocort®

Financial highlights

• As previously announced, Alkindi® product sales for the six months ended 31 December 2020 increased to £1,191k, representing year-on-year growth of 4% (six months ended 31 December 2019: £1,147k; year ended 30 June 2020: £2,390k) and total revenue for the six months ended 31 December 2020, including licensing income, was £1,214k, representing year-on-year growth of 6% (six months ended 31 December 2019: £1,147k; year ended 30 June 2020: £6,313k)
  • The roll-out of Alkindi® in all markets was significantly impacted by Covid-19 restrictions and patients' ability to visit hospitals and, consequently, physicians' ability to switch these patients to Alkindi®. Despite these restrictions, Alkindi® revenues grew by over 20% in the UK and Germany
• Operating loss for the six months ended 31 December 2020 of £5,262k, increased 15% year-on-year (six months ended 31 December 2019: £4,575k), reflecting increased investment in the product pipeline and preparations for anticipated Chronocort® European launch
• Cash and cash equivalents at 31 December 2020: £20,344k (year ended 30 June 2020: £15,434k)
  • Placing and Open Offer completed in October 2020 raising £9.8m before expenses, primarily to fund development of DITEST™ and other pipeline opportunities

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

"Diurnal has continued to make excellent progress during the Period in making Alkindi® available to patients around the world. Notably, Alkindi® Sprinkle received regulatory approval in the US and was subsequently launched there by our partner, Eton. W e are pleased with the growth in Alkindi® revenues, despite previously highlighted pandemic-related restrictions in Europe, and look forward to this growth accelerating, especially when pandemic restrictions begin to lift."

"Looking forward, our commercial focus is now on preparation for the anticipated approval and initial launches of Chronocort® in congenital adrenal hyperplasia during 2021, to significantly expand our European cortisol deficiency franchise, towards profitability. Separately, we continue to make good progress in development activities with Chronocort® in the US and Japan, as well as potential indication expansion into adrenal insufficiency. In addition, we are preparing for the next phase of development of DITEST™ in the US as an innovative, testosterone-based, potential treatment for hypogonadism and this is a major commercial opportunity within our pipeline of products."

In the Interim Results:

• "bn", "m" and "k" represent billion, 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	Tel: +44 (0)20 3727 1000
Martin Whitaker, Chief Executive Officer Richard Bungay, Chief Financial Officer
Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker)	Tel: +44 (0)20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden
FTI Consulting (Media and Investor Relations)	Tel: +44 (0)20 3727 1000
Simon Conway Victoria Foster Mitchell

Notes to Editors

About Diurnal Group plc

Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing hormone therapeutics for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. 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

Read the full announcement.