Full Year Results for the year ended 30 June 2021
Results for the year ended 30 June 2021
Significant progress made during the year with two major regulatory approvals
Alkindi® growth of 18% in core markets despite continued impact of Covid-19 on hospital visits
Post-period, launch of Efmody® in Europe, Diurnal’s second product on the market following Alkindi®
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its audited results for the year ended 30 June 2021.
Operational highlights (including post-period):
Approved products:
Alkindi® (hydrocortisone granules in capsules for opening)·
Continued rollout of Alkindi® across Europe with growth in UK, Germany and Italy, despite the impact of Covid-19 on patients’ ability to visit hospitals and physicians’ ability to switch patients to Alkindi®
Alkindi Sprinkle® approved by the US Food and Drug Administration (FDA) and subsequent launch in the US by Eton Pharmaceuticals (Eton) in November 2020.
Signed distribution agreements to expand the future availability of Alkindi® in Benelux, Switzerland, Turkey and China.
Further Alkindi® regulatory approvals in Australia and Israel.
Efmody® (modified-release hydrocortisone)
Approval of Efmody® as treatment of congenital adrenal hyperplasia (CAH) in adults and adolescents aged 12 years and over.
Efmody® commercial roll-out initiated in September 2021 with launches in Germany, Austria and Great Britain.
Successful completion of Special Protocol Assessment (SPA) with the FDA for the pivotal Efmody® US Phase 3 study in CAH; study due to commence in Q4 2021.
Publication of Efmody® European Phase 3 pivotal trial and extension study data in the Journal of Clinical Endocrinology and Metabolism (JCEM).
Signed further distribution agreements for Efmody® in Benelux, Nordic countries, Turkey, Romania, and Bulgaria.
Development products:
DITEST™ (native oral testosterone formulation)
Positive meeting with the FDA confirming abbreviated 505(b)(2) development pathway, with potential to be the first effective oral native testosterone treatment in an estimated $5.0bn global market.
Financial overview
Total revenues for the year were £4,371k (2020: £6,313k), comprising Alkindi® product sales of £2,267k (2020: £2,390k) and licensing income of £2,104k (2020: £3,923k), with lower Alkindi® product sales predominantly due to lower sales to the Company’s Nordic distribution partner.
Continued growth of Alkindi® sales in core commercial markets of the UK, Germany, Italy and Austria, with proforma sales increasing by 18% in these countries despite the impact of the Covid-19 pandemic.
Operating loss for the year was £11,600k (2020: £5,392k), reflecting pre-launch commercialisation expenditure for Efmody® and the increase in Research and Development (R&D) expenditure for the set-up costs of upcoming key studies for Efmody® and DITEST™.
Cash and cash equivalents were £34,037k (2020: £15,434k), reflecting the completion of two oversubscribed Placing and Open Offers during the year, raising a total of £28,762k after expenses, to open up new markets and indications for Efmody® and to further develop DITEST™ and other early-stage pipeline opportunities.
Diurnal expects its cash resources to take its core commercial European cortisol deficiency franchise through to profitability based upon current plans and assumptions, including expectations regarding the timing of product approvals and sales projections.
Financial year end to be changed to 31 December, with next statutory reporting due for the 18 month period to 31 December 2022.
Martin Whitaker, CEO of Diurnal, commented:
“Over the past year, Diurnal has continued to make significant progress in its ambition towards becoming a world-leading endocrinology company. We continued to roll-out Alkindi® across Europe and secured FDA approval for the product, which was subsequently launched in the US by our partner Eton. Another key milestone was the approval of our second product, Efmody®, in Europe. The launch is progressing well and we expect to realise synergies in the utilisation of our existing European commercial infrastructure and supply chain from Alkindi® which we anticipate to lead to the rapid uptake of Efmody® as a new treatment option available for patients suffering from CAH as the launch gains momentum."
“In our pipeline, we are excited to progress our development strategy for Efmody® in the US, as well as the clinical development of DITEST™, with an IND application expected to be filed later this year. We continue to believe that Diurnal is well positioned with sufficient cash resources to take our core commercial European cortisol deficiency franchise through to profitability and look forward to reporting on further operational and commercial progress in this current financial period.”
Martin Whitaker, Chief Executive Officer, and Richard Bungay, Chief Financial Officer, will provide a live presentation relating to the Company’s financial results today via the Investor Meeting Company platform at 11:00 BST.
The online presentation is open to all existing and potential shareholders. Investors can sign up to Investor Meet Company for free and interested parties can register to attend the presentation via the following link: https://www.investormeetcompany.com/diurnal-group-plc/register-investor.
In the audited results for the year ended 30 June 2021:
"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 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 Sole 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
Simon Conway
Victoria Foster Mitchell
Alex Davis
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
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.
To continue reading the full press release please click here