DNL.L Regulatory News (DNL)

28 July 2021

Diurnal Group plc

("Diurnal" or the "Company")

Business and trading update

Alkindi® growth of 18% in core markets despite continued impact of Covid-19 on hospital visits

Efmody® European commercial preparations well-progressed with first market launch in Q3 2021

Efmody® US Phase 3 CAH study on track to commence in Q4 2021

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 year ended 30 June 2021.

Financial highlights

Revenue

· Proforma Alkindi® (hydrocortisone granules in capsules for opening) product sales for the year ended 30 June 2021 of £2,455k (year ended 30 June 2020: proforma sales of £2,286k) represent year-on-year growth of 7%:

· Product sales of Alkindi® of £2,351k for the year ended 30 June 2021 on a statutory reporting basis include a retrospective price adjustment of £104k. This relates to sales to Diurnal's Nordic distribution partner which were originally recorded by Diurnal in the year ended 30 June 2020. Had this deduction been recorded in the year ended 30 June 2020, proforma product sales would have been £2,455k for the year ended 30 June 2021 and £2,286k for the year ended 30 June 2020.

· Continued growth in core commercial markets (UK, Germany, Italy and Austria) with proforma sales increasing by 18% despite the impact of the Covid-19 pandemic on patients' ability to visit hospitals and, consequently, physicians' ability to switch these patients to Alkindi®.

· Majority of new-borns in core commercial markets with congenital adrenal hyperplasia (CAH) now believed to be treated with Alkindi®.

· Sales in other markets decreased by 21%, primarily due to timing of bulk sales to Nordic partner, with proforma sales into the Nordic region for the year £349k lower year-on-year.

· Alkindi® sales growth expected to accelerate with lifting of Covid-19 restrictions.

· Milestone and licensing income for the year ended 30 June 2021 of £2,103k includes a total of $2,750k in signature fees and milestone payments from Citrine Medicine relating to the licensing deals for Alkindi® and Efmody® in China. Milestone and licensing income of £3,923k for the year ended 30 June 2020 comprised the $5,000k signature fee relating to the US licensing deal with Eton Pharmaceuticals for Alkindi®.

· Total revenues of £4,454k (year ended 30 June 2020: £6,313k), comprising Alkindi® product sales of £2,351k (year ended 30 June 2020: £2,390k) and licensing income of £2,103k (year ended 30 June 2020: £3,923k).

Cash

· Cash and cash equivalents at 30 June 2021: £34,037k (30 June 2020: £15,434k).

· Completion of two Placing and Open Offers during the year, raising a total of £30.5m before expenses, to open up new markets and indications for Efmody® and to develop DITEST™ and other early-stage pipeline opportunities.

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

· Diurnal and Eton Pharmaceuticals are also awaiting confirmation of Orphan Drug Status of Alkindi® Sprinkle from the FDA, which will trigger a $2,500k milestone payment to Diurnal.

Operational highlights

· Approval of Efmody® (modified release hydrocortisone) for the treatment of adults and adolescent patients with CAH in the European Economic Area (EEA) and Great Britain; preparations well-progressed for timely commercial launches from Q3 2021.

· Successful completion of Special Protocol Assessment with the US FDA for the Efmody® Phase 3 pivotal study in CAH, due to commence in Q4 2021; trial to be conducted in US and international centres including Japan, where the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has agreed this study can act as the registration study for Efmody® in Japan.

· Approval of Alkindi® Sprinkle in the US with subsequent launch by Diurnal's partner, Eton Pharmaceuticals.

· Further global expansion of Diurnal's cortisol deficiency franchise during the year including licensing and distribution deals covering China, Turkey, Canada and European markets outside of Diurnal's core commercial territories.

Martin Whitaker, Chief Executive Officer of Diurnal, commented: 

"We are pleased to be able to show continued growth of Alkindi® revenues in our core commercial markets, despite the continued challenges in accessing hospitals due to Covid-19 pandemic restrictions that are impacting both patients and our commercial team. Physician feedback indicates that the majority of new-born patients in these core markets now begin treatment with Alkindi®. As pandemic restrictions begin to ease, we expect to accelerate Alkindi® revenue growth as older patients can return to clinics and be initiated on this drug.

"The recent approvals for Efmody® in adult and adolescent CAH will enable our commercial organisation to focus on both adult and paediatric endocrinologists, providing significant synergies with the continued promotion of Alkindi®. We are now preparing for the commercial launch of Efmody® in the third quarter of 2021 which will catalyse the progression of our European cortisol deficiency franchise towards profitability.

"We are also pleased with the continued geographic expansion for Alkindi® and Efmody® and look forward to working with our partners to bring these treatments to patients across the globe."

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 Article 7 of Regulation (EU) 596/2014 (MAR).

Notes to Editors

About Alkindi® (hydrocortisone granules in capsules for opening)

Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenal insufficiency (AI). Alkindi® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children.

About Efmody® (hydrocortisone modified-release hard capsules)

Efmody® is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody® has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US.

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.

For further information about Diurnal, please visit www.diurnal.co.uk

Date of Preparation: July 2021 Code: CORP-GB-0145