BUSINESS AND TRADING UPDATE


14th January 2021

Continued growth in Alkindi sales despite impact of Covid-19 on hospital visits and new launches Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, today provides a business and unaudited trading update for the six months ended 31 December 2020.

Financial highlights

Revenue

  • Alkindi® (hydrocortisone granules in capsules for opening) 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)

  • 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)

    • Continued growth in UK and Germany, with sales increasing by over 20% despite the impact of the Covid-19 pandemic on patients’ ability to visit hospitals and, consequently, physicians’ ability to switch these patients to Alkindi®

    • Modest growth from new territories where Alkindi® was launched during the period reflecting the curtailment of impactful in-country launches due to the pandemic

    • Sales growth in core commercial markets offset by timing of bulk sales to Nordic partner, Frost Pharma, with sales into the Nordic region for the six months ended 31 December 2020 £207k lower than the prior period

Cash

  • Cash and cash equivalents at 31 December 2020: £20,344k (31 December 2019: £4,625k; year ended 30 June 2020: £15,434k)

  • Placing and Open Offer completed in October 2020 raising £9.8m before expenses, to fund development of DITEST™ and other pipeline opportunities

  • R&D tax credit of £1.2m received in November 2020

  • Cash resources expected to fund Group to profitability, based on current plans and assumptions

Operational highlights 

  • Alkindi® approved in Israel, Australia and the US (as Alkindi® Sprinkle)

  • Alkindi® progress outside of core territories highlights long-term potential

    • Product launch by Eton Pharmaceuticals (Eton) in the US in November 2020

    • Marketing Authorisation Application submission in Switzerland by EffRx Pharmaceuticals

    • Consilient Health marketing and distribution agreement in Benelux countries

  • Chronocort® (modified release hydrocortisone) Day 120 responses submitted on time to the European Medicines Agency; Chronocort® remains on track for anticipated Committee for Medicinal Products for Human Use recommendation in Q1 2021

  • Post period end:

    • Distribution agreement with Er-Kim for Alkindi® and Chronocort® in Turkey and extension of Eton US licensing arrangements for Alkindi® Sprinkle to add Canada, with further distribution and licensing partnerships anticipated in Q1 2021

Martin Whitaker, Chief Executive Officer of Diurnal, commented:

“Diurnal is pleased that Alkindi® revenues have continued to grow despite the significant challenges in access to hospitals due to Covid-19 pandemic restrictions, impacting both patients and our commercial team. The trajectory of Alkindi® growth in the second half of the financial year, and hence our full year product sales, will be dependent on when the pandemic restrictions are eased; however, we expect as a minimum to maintain reasonable growth in our core commercial markets and believe, once the pandemic has eased, growth will significantly accelerate. We are also pleased with the continued geographic expansion for Alkindi®, highlighting the value for patients across the globe, and look forward to announcing further partnerships in due course. “We are now preparing for the anticipated approval of Chronocort® in the first quarter of 2021 and the subsequent commercial launch and roll-out, as we progress our European cortisol deficiency franchise towards profitability.”

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: Rupert Dearden

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-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

Date of Preparation: January 2021     Code: CORP-GB-0093www.diurnal.co.uk

View pdf document: Business and trading update

Diurnal Limited (Company Number: 05237326) is registered in England & Wales. Registered office: Cardiff Medicentre, Heath Park, Cardiff CF14 4UJ, UK.