Interim Results for the Twelve Months Ended 30 June 2022
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its results for the twelve months ended 30 June 2022 (the “Period”) and following the publication of a trading update on 26 July 2022.
Operational highlights (including post-period):
● Proposed acquisition by Neurocrine Biosciences, Inc. (“Neurocrine”)
o On 30 August 2022, Diurnal announced the terms of a recommended cash acquisition pursuant to which Neurocrine intends to acquire the entire issued and to be issued ordinary share capital of Diurnal
o The acquisition is currently expected to complete during late October or early November 2022, subject to satisfaction or (where applicable) waiver of the conditions to the acquisition
● Commercial products
o 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
▪ Distribution agreement with Vector Pharma for named patient sales of Alkindi® covering Middle East and North Africa
o Efmody® (hydrocortisone modified-release hard capsules)
▪ Initial commercial launches in Germany, UK, Austria and the Netherlands
▪ Reimbursement approval in Norway
▪ Post-Period end, agreed reimbursement in Italy, with launch planned for September 2022
▪ Company to generate further clinical and health-economic data to support a re-submission to the Scottish Medicines Consortium (SMC) at the earliest possible opportunity following announcement that Efmody® was not recommended for automatic reimbursement within NHS Scotland
▪ Extension of existing Alkindi® distribution and marketing agreement with EffRx for Alkindi® in Switzerland to cover Efmody ®
o Expansion of global footprint for Alkindi® and Efmody ® through a new distribution agreement with ExCEEd Orphan for Central Eastern European (CEE) countries and an extension of the existing distribution agreement with Er-Kim covering Greece, Cyprus and Malta
● Development products
o DNL-0200 (hydrocortisone modified-release hard capsules – previously referred to as Chronocort®, commercialised as Efmody® in Europe)
▪ 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 patients dosed in the CONnECT study with headline data expected in 2024
▪ First patient dosed in the CHAMPAIN study (European Phase 2 trial of DNL-0200 in adrenal insufficiency (AI)), with headline data now expected in Q1 2023
o DNL-0300 (native oral testosterone formulation – previously referred to as DITEST™)
▪ Submission of Investigational New Drug (IND) application and subsequent feedback received from the FDA enabling finalisation of protocol for multiple ascending dose (MAD) Phase I study
● Product sales (including royalties) for the Period increased to £4.62m, representing year-on-year growth of 104% (twelve months ended 30 June 2021: £2.27m)
o Alkindi® product sales (including royalties) for the Period increased to £3.65m, representing year-on-year growth of 61% (twelve months ended 30 June 2021: £2.27m)
o Efmody® initial product sales for the Period of £0.97m (twelve months ended 30 June 2021: £nil)
o Total revenues for the Period of £4.68m, reflecting licensing income of £0.06m (twelve months ended 30 June 2021: total revenues of £4.37m, reflecting licensing income of £2.10m)
● Operating loss for the Period of £18.96m (twelve months ended 30 June 2021: £11.60m), reflecting increased investment in the product pipeline and the commercial roll-out of Efmody® across Europe
● Cash and cash equivalents at 30 June 2022: £16.49m (30 June 2021: £34.04m)
● As a result of the slower Efmody® sales growth expected following the SMC decision in March 2022, the Company has previously indicated that it will require further financing to reach profitability.
● Appointment of Anders Härfstrand as Chairman and Jean-Michel Cosséry and Deborah Jorn as Non-Executive Directors in November 2021, each bringing significant commercial experience to the Board
● Appointment of Richard Bungay as Interim Chief Executive Officer following the departure of Martin Whitaker as Chief Executive Officer
Richard Bungay, Interim Chief Executive Officer of Diurnal, commented:
“Despite a number of challenges during the Period, we are pleased that Efmody® revenues are currently in line with our expectations in Germany, our first major launch market, and that Alkindi® growth has resumed following a reduction in pandemic-related restrictions.”
“Our near-term focus is the commercial roll-out of Efmody® in those European territories where we have been able to secure reimbursement based on our current clinical data. In the longer-term, the Company will continue to drive the momentum of Alkindi®, and focus on the generation of new clinical data from the CHAMPAIN and CONnECT studies, which we believe will provide additional data to support continued Efmody® reimbursement discussions in Europe.”
As previously reported, 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 is included to allow informed investment decisions.
This announcement contains inside information for the purposes of the UK Market Abuse Regulation (UK MAR).
Diurnal Group plc +44 (0)20 3727 1000
Richard Bungay, Interim Chief Executive Officer
Mike Scott, Interim Chief Financial Officer
Panmure Gordon (UK) Limited (Nominated Adviser and Corporate Broker) +44 (0) 20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: Rupert Dearden
FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000
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.
Forward looking statements
Certain information contained in this announcement, including any information as to the Group’s strategy, plans or future financial or operating performance, constitutes “forward-looking statements”. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “projects”, “expects”, “intends”, “aims”, “plans”, “predicts”, “may”, “will”, “seeks” “could” “targets” “assumes” “positioned” or “should” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors concerning, among other things, the Group’s results of operations, financial condition, prospects, growth, strategies and the industries in which the Group operates. The directors of the Company believe that the expectations reflected in these statements are reasonable but may be affected by a number of variables which could cause actual results or trends to differ materially. Each forward-looking statement speaks only as of the date of the particular statement.
By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future or are beyond the Group’s control. Forward-looking statements are not guarantees of future performance. Even if the Group’s actual results of operations, financial condition and the development of the industries in which the Group operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in subsequent periods.
Date of Preparation: September 2022 Code: CORP-GLO-0041