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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 2021 (the "Period") and follows the publication of a trading update on 26 January 2022 .

Operational highlights

Commercial products

• Alkindi^® (hydrocortisone granules in capsules for opening)
  • Alkindi^® approved in Switzerland by SwissMedic
  • US partner Eton Pharmaceuticals announced co-promotion for Alkindi Sprinkle^® in US with Tolmar Pharmaceuticals
• Efmody^® (modified-release hydrocortisone)
  • Initial commercial launches in Germany, UK and Austria
  • Post-Period end, following an announcement by the Scottish Medicines Consortium (SMC) that Efmody^® was not recommended for automatic reimbursement within NHS Scotland, Diurnal will generate further clinical and health-economic data to support a re-submission to the SMC at the earliest possible opportunity
  • Post-Period end, reimbursement approved in Norway
• Continued expansion of the Company's global footprint through distribution agreement with ExCEEd Orphan for Alkindi^® and Efmody^® in Central and Eastern Europe (CEE) countries

Development products

• DNL-0200 (modified-release hydrocortisone - previously referred to as Chronocort^®)
  • Agreement of Special Protocol Assessment (SPA) for DNL-0200 US Phase 3 study (CONnECT) in congenital adrenal hyperplasia (CAH) with the US Food and Drug Administration (FDA)
  • Agreement with Japanese Pharmaceuticals and Medical Devices Agency (PMDA) that CONnECT study can act as the registration study for DNL-0200 in Japan
  • First sites opened for recruitment in the US for the CONnECT study
  • First sites opened for recruitment for CHAMPAIN study (European Phase 2 trial of DNL-0200 in adrenal insufficiency (AI)), with first patient dosed post-Period end, and headline data expected around the end of 2022
• DNL-0300 (native oral testosterone formulation)
  • Post-Period end, submission of Investigational New Drug (IND) application for next stage of clinical development; feedback received from FDA expected to facilitate study commencement following requested protocol amendments

Financial highlights

• Total revenue for the Period increased to £2.13m, representing year-on-year growth of 75% (six months ended 31 December 2020: £1.21m)
• Alkindi^® product sales (including royalties) for the Period increased to £1.74m, representing year-on-year growth of 46% (six months ended 31 December 2020: £1.19m)
  • Continued growth achieved in core markets (UK, Germany, Italy and Austria) with sales of £1.28m for the Period (six months ended 31 December 2020: £0.92m), an increase of 39% year-on-year despite the continued impact of the Covid-19 pandemic on patients' ability to visit hospitals and consequently physicians' ability to switch these patients to Alkindi^®
• Efmody^® initial product sales for the Period of £0.39m (six months ended 31 December 2020: £nil) were in line with the Company's expectations, reflecting sales in the initial launch markets of Germany, UK and Austria since the first pricing approvals in September 2021
• Operating loss for the Period of £9.20m (six months ended 31 December 2020: £5.26m), reflecting increased investment in the product pipeline and preparations for the anticipated Efmody^® launches across Europe
• Cash and cash equivalents as at 31 December 2021: £24.36m (as at 30 June 2021: £34.04m), including R&D tax credit of £1.51m received in December 2021.
• The Company's initial assessment of the impact of the recent SMC decision is that, despite continued strong growth (expected to be in excess of 100% for the 12-month period ended 30 June 2022), near-term sales expectations for Efmody^® are unlikely to be met and that further funding will be required to reach profitability. The Board remains confident that Efmody^® can become a profitable franchise but, based on current resource allocation, this will depend on approval of the drug in the treatment of adrenal insufficiency (AI) in 2024. To accelerate near-term Efmody^® uptake and sales growth, the Company will be reallocating resources towards key territories with immediate effect. The impact of this on Efmody^® sales and the extent of further financing for the Company to reach profitability will be assessed over the coming months. In parallel, the Company is exploring financing options, including non-dilutive funding.

Corporate highlights

• Appointment of Anders Härfstrand as Chairman and Jean-Michel Cosséry and Deborah Jorn as Non-Executive Directors, each bringing significant commercial experience to the Board

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

"Diurnal has continued to make incremental progress during the Period in making Alkindi^® available to patients around the world. We   are pleased with Alkindi^®'s growth in revenues, despite the continued impact of pandemic-related restrictions in Europe and look forward to this growth accelerating as hospitals begin to return to normal. Further growth is expected from launches of Alkindi^® by our partners in new markets over the coming period and we look forward to continuing to expand our commercial footprint through further distribution agreements.

"In early March 2022, we were disappointed to receive the SMC decision not to recommend Efmody^® for automatic reimbursement in Scotland, which will impact near-term revenues in the UK. Looking forward, our near-term focus is on the continued commercial roll-out of Efmody^® for CAH in other major European territories and ensuring the Company has adequate resources to maximise the commercial opportunity. In the longer-term, we are focused on the generation of new clinical data from the CHAMPAIN and CONnECT studies, which we believe will highlight the value and benefits of physiological cortisol replacement with Efmody^® in both CAH and AI globally and provide additional data for continued reimbursement discussions in Europe"

Diurnal plans to hold its R&D Day for analysts and institutional investors on 7 September 2022, having re-scheduled the event from February 2022. The R&D Day will be held in-person at FTI Consulting, 200 Aldersgate, Aldersgate Street, London, EC1A 4HD, with the option to attend virtually. To register to attend in person, or to receive a link to the webcast, please contact [email protected] .

As reported at the Company's results for the year ended 30 June 2021 on 14 September 2021, Diurnal's financial year end has been changed to 31 December, with the next statutory reporting due for the 18-month period to 31 December 2022.

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 is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions.

This announcement contains inside information for the purposes of the UK Market Abuse Regulation (UK 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 Corporate Broker)	+44 (0)20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden
Stifel Nicolaus Europe Limited (Joint Corporate Broker)	+44 (0) 20 7710 7600
Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea, William Palmer-Brown Corporate Broking: Nick Adams, Nick Harland
FTI Consulting (Media and Investor Relations)	+44 (0)20 3727 1000
Simon Conway Victoria Foster Mitchell Alex Davis

 

Notes to Editors

About Diurnal Group plc

Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.