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DNL Diurnal Group Plc

27.30
0.00 (0.00%)
24 Apr 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Diurnal Group Plc LSE:DNL London Ordinary Share GB00BDB6Q760 ORD GBP0.05
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 27.30 0.00 01:00:00
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

Diurnal Group PLC Final Results June 2016 (2788M)

12/10/2016 7:00am

UK Regulatory


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TIDMDNL

RNS Number : 2788M

Diurnal Group PLC

12 October 2016

12 October 2016

Diurnal Group plc

("Diurnal" or the "Company")

Results for the year ended 30 June 2016

Significant progress towards becoming a revenue generating endocrinology specialty pharmaceutical company

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its results for the year ended 30 June 2016.

Operational highlights

-- Primary endpoint met in European pivotal study of Infacort(R) in paediatric Adrenal Insufficiency; regulatory filing anticipated by the end of 2016.

-- First patient treated in the Group's European Phase III trial of Chronocort(R) in Congenital Adrenal Hyperplasia.

-- First patient treated in the Group's European open-label safety extension studies of Infacort(R) in paediatric Adrenal Insufficiency and Chronocort(R) in Congenital Adrenal Hyperplasia.

-- Initial Public Offering on the Alternative Investment Market ("AIM") of the London Stock Exchange in December 2015, raising GBP30m before expenses.

-- Strengthening of the Board with the appointment of Peter Allen as Non-executive Chairman and John Goddard as Non-executive Director.

Financial overview

-- Operating loss of GBP7.0m (2015 13 months: GBP3.0m) reflecting investment in increased clinical and development activities together with investment in overheads to support the anticipated growth and development of the business and including GBP1.5m of one-off, share option related and non-cash expenses.

-- Held to maturity financial assets, cash and cash equivalents at 30 June 2016 of GBP30.1m (2015: GBP6.1m) following the successful AIM IPO and fundraising.

   --      Net assets of GBP25.9m (2015: GBP6.0m). 
   --      Net cash used in operating activities was GBP5.1m (2015 13 months: GBP2.9m). 

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

"This financial year has been transformational as we executed our Initial Public Offering on AIM, providing the Group with the capital to accelerate product development to bring our novel products to market. Despite the distraction of the IPO, the Group's late-stage products, Infacort(R) and Chronocort(R) , continue to progress according to plan in Europe and we are working with the US Food and Drug Administration to design the optimal clinical pathway towards regulatory approval in the US. Diurnal expects to receive its first market authorisation in late 2017 and is well positioned to initiate commercialisation activities towards building a proprietary endocrinology franchise."

In the Results for the year ended 30 June 2016:

   --      "bn", "m" and "k" represent billion, million and thousand respectively 
   --      "Group" is the Company and its subsidiary undertaking, Diurnal Limited 
 
 For further information, please visit www.diurnal.co.uk 
  or contact: 
 
                                           +44 (0)20 3727 
 Diurnal Group plc                          1000 
 Martin Whitaker, CEO 
 Ian Ardill, CFO 
 
 Numis Securities Ltd (Nominated           +44 (0)20 7260 
  Adviser)                                  1000 
 Nominated Adviser: Michael Meade, 
  Freddie Barnfield, Paul Gillam 
 Corporate Broking: James Black 
 
                                           +44 (0)20 3727 
 FTI Consulting                             1000 
 Simon Conway 
 Victoria Foster Mitchell 
 

Notes to Editors

About Diurnal

Diurnal is a clinical stage specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases which the Company believes are currently not satisfactorily met by existing treatments. It has identified a number of specialist endocrinology market opportunities in Europe and the US that are together estimated to be worth more than $11bn per annum.

On its admission to AIM in December 2015, the Company raised GBP30 million by way of a placing of new ordinary shares and a convertible loan. The new funds will accelerate the development of two leading product candidates which are in, or expected to commence shortly, Phase III clinical trials, targeting diseases of cortisol deficiency; Chronocort(R) , to be used for Congenital Adrenal Hyperplasia ("CAH") in adults, and Infacort(R) , to be used for Adrenal Insufficiency ("AI"), including CAH in children. The lead product candidate, Infacort(R) , is anticipated to receive its first regulatory approval in Europe towards the end of 2017.

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.

Chairman's Statement

I am pleased to provide my inaugural Chairman's statement and the first for Diurnal Group plc as a public company. This financial year has been transformational as we executed our Initial Public Offering (IPO), providing the Group with the capital to accelerate product development to bring our novel products to market. I am excited to be part of Diurnal with its entrepreneurial and patient-centric approach, combined with its international network of experts, which have enabled the development of a balanced late-stage portfolio of prospects and provide a solid platform from which we can confidently build a proprietary endocrinology franchise.

Diurnal aims to develop and commercialise products to address unmet patient needs in chronic endocrine (hormonal) diseases, typically where there is either no licensed medicine or where current treatment does not sufficiently improve the patients' health. Diurnal has identified a number of such needs within the field of endocrinology, which the Group believes represent a multi-billion dollar combined market opportunity. The Group intends to address these market opportunities through the development of its late-stage pipeline, by finalising its commercialisation plans in Europe, to be followed by the US, through development of its early-stage pipeline and, longer-term, through in-licensing and acquisitions.

In December 2015, Diurnal successfully completed an IPO on AIM, raising GBP30m from new and existing long-term investors. These monies enable the Group to continue to pursue its vision of becoming a world-leading endocrinology speciality pharmaceutical group.

In the near term, funding from the IPO allows Diurnal to maintain the momentum behind its late-stage development programmes for treatments targeting indications of cortisol deficiency. Cortisol is an essential hormone for health in regulating metabolism, growth, fertility and the response to stress. It is Diurnal's ambition to develop a product franchise that can treat patients with all forms of cortisol deficiency. Diurnal anticipates its first market authorisation in Europe towards the end of 2017.

I am pleased with the significant clinical development progress in the Group's late-stage pipeline products during the year, with Chronocort(R) commencing a pivotal Phase III clinical trial in Europe and Infacort(R) reporting positive headline data from a pivotal Phase III clinical trial also in Europe. Infacort(R) has the potential to be the first licensed treatment in Europe for Adrenal Insufficiency (AI) (including Congenital Adrenal Hypoplasia (CAH)) specifically designed for use in children under six years of age. Chronocort(R) has the potential to be the first product candidate for adults with CAH to mimic the natural cortisol circadian rhythm, therefore improving disease control. In the US, Infacort(R) and Chronocort(R) are expected to commence Phase III clinical development in 2017.

During the period, Diurnal enhanced its Board with the appointment of John Goddard as Non-executive Director and Chairman of the Audit Committee. John's extensive financial, accounting, strategic planning and business development experience in the global pharmaceuticals industry will be invaluable as we embark on our next stage of growth.

Diurnal also continues to develop its earlier-stage pipeline, with the Group obtaining the rights to the orphan drug designation for an oligonucleotide therapy for the potential treatment of Cushing's Disease (cortisol excess) in May 2016. In addition, Diurnal's oral native testosterone product is scheduled to enter human clinical trials imminently.

The Board will continue to monitor the potential effects of the 23 June 2016 UK referendum result on the Group's business and, in particular, any impact on the regulatory framework for pharmaceutical product development, approval and commercialisation.

I would like to thank our employees for their continued support and hard work in driving the Company's progress towards commercialising the Group's first products. Despite the distraction of the IPO, the Group's late-stage products, Infacort(R) and Chronocort(R) , continue to progress according to plan in Europe and we are working with the US Food and Drug Administration (FDA) to design the optimal clinical pathway towards regulatory approval in the US. I would also like to thank my fellow Board members for the progress made this year in formulating the foundations of a strategy that will ensure continued and sustainable growth from our pipeline. Finally, I would like to thank our shareholders for their continued support as Diurnal aims to make a real difference to patients currently without effective treatment options for chronic endocrine diseases.

Operational Review

The financial year to June 2016 has seen significant transformation in our aspiration to become a revenue generating endocrinology specialty pharmaceutical company. We successfully completed a GBP30m Initial Public Offering (IPO) on AIM in December 2015, providing the Group with the resources to develop our novel, high quality, patent protected products by focussing on completing the development of Infacort(R) in Europe and the US; obtaining market authorisation in Europe for Infacort(R) and generating first revenues; completing the development of Chronocort(R) in Europe and commencing development in the US; and commencing the construction of Diurnal's commercial capability in Europe.

As a quoted company, the IPO on AIM also provides additional currency for future development by providing potential access to development capital to progress its current and future pipeline and enabling it to expand within its chosen specialist endocrine therapy areas.

Significant clinical progress towards building a proprietary endocrinology franchise

Infacort(R)

Infacort(R) is Diurnal's most clinically advanced product and is the first preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from adrenal insufficiency (AI), including the related disease, Congenital Adrenal Hyperplasia (CAH). Currently there is no licensed hydrocortisone preparation in Europe or the US specifically designed to treat these young patients. Infacort(R) is on target to be the first pharmaceutically defined dose and consistent formulation of hydrocortisone designed specifically for children. The patented, immediate-release oral product has been designed to meet the dosing needs of children and is manufactured using commercially proven technology in paediatric acceptable doses in order to give maximum flexibility to clinicians in tailoring treatment to children as they develop and grow. Currently, pharmacists often compound (grind) hydrocortisone tablets to a fine powder and reconstitute it in individual capsules or sachets to achieve the lower doses required for children. Compounding is not a licensed method of producing medicines; it can be highly variable and may result in inaccurate dosing to patients.

Post year and ahead of schedule in July 2016, Diurnal announced positive headline data from the pivotal Phase III clinical trial for Infacort(R) in Europe for paediatric AI. AI (and CAH) is identified as a rare disease in Europe where there are estimated to be approximately 4,000 sufferers younger than the age of six. Left untreated, the disease is associated with significant morbidity.

The Phase III study was designed in agreement with the European Medicines Agency (EMA) and conducted in a total of 24 subjects before their sixth birthday, requiring replacement therapy for AI due to CAH, primary adrenal failure or hypopituitarism. Comprehensive analysis of the results confirms that the study met its primary endpoint, demonstrating a statistically significant (p<0.0001) increase in cortisol values following administration of Infacort(R) compared to the pre-dose values. No serious adverse events were reported.

In March 2016, the first patient was treated in the Group's European open-label safety extension trial of long term safety and biochemical disease control of Infacort(R) in neonates, infants and children with CAH and AI, previously enrolled in the Group's pivotal Infacort(R) Phase III registration trial.

Chronocort(R)

Diurnal announced that the first patient was dosed with its second late-stage product, Chronocort(R) , in the pivotal Phase III clinical trial in Europe for adults with CAH in February 2016. Chronocort provides a drug release profile that the Group believes mimics the body's natural cortisol circadian rhythm, which current therapy is unable to replicate, and will improve disease control for adults with CAH. Clinical data have shown that approximately two thirds of CAH patients are estimated to have poor disease control. CAH sufferers, even if treated, remain at risk of death through an adrenal crisis, suffer from high morbidity and a poor quality of life. The condition is estimated to affect approximately 51,000 patients in Europe and 20,000 patients in the US, with approximately 405,000 patients in the rest of the world.

The Phase III trial is designed to study up to 110 patients in an open-label six month protocol. Enrolled patients currently treated with a single or combination of generic steroids (standard-of-care) will be randomised to Chronocort(R) on a twice daily "toothbrush" regimen or will continue on their standard-of-care regimen. Following discussions with the EMA, the primary endpoint of the trial is the control of androgens (sex hormones) on the same or lower total daily dose of steroid when treated with Chronocort(R) compared to standard-of-care treatment. This primary endpoint is identical to the previous successful Phase II clinical trial for Chronocort(R) for which data were released in 2014. Secondary endpoints will include an assessment of fatigue levels and the relative effect of Chronocort(R) on body mass index and bone turnover, all of which are indicative of clinical benefits. The trial is scheduled to complete in early 2018, implying a potential market authorisation in Europe could be forthcoming around the end of 2018.

In August 2016, the first patient was treated in the Group's European open-label safety extension trial of long term safety, efficacy and tolerability of Chronocort(R) in patients with CAH, previously enrolled in the Group's pivotal Chronocort(R) Phase III registration trial.

During the period, Diurnal extended its existing Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH), Maryland, US until June 2021. The extension will support the Phase III clinical trial of Chronocort(R) for the treatment of CAH in both the US and Europe. Diurnal successfully collaborated with the NIH to complete the Phase II clinical trial of Chronocort(R) .

Prelaunch activities

The EMA has already approved a Paediatric Investigation Plan (PIP) for Infacort(R) , setting out the regulatory pathway to market authorisation via the Paediatric Use Marketing Authorisation (PUMA) route, affording 10 years data exclusivity from the date of market authorisation. Diurnal is on track to submit this regulatory dossier to the EMA around the end of 2016. If approved, Infacort(R) has the potential to be the first licensed treatment in Europe for AI (including CAH) specifically designed for use in children. Diurnal anticipates market authorisation in late 2017 and is developing launch plans to ensure a prompt market introduction in the event that the product receives approval.

Extensive patent protection

Diurnal continues to protect its product candidates through an extensive patent portfolio, benefitting from a number of granted or pending patents in key jurisdictions. During the period, Chronocort(R) was granted orphan drug designation in the treatment of AI by the US Food and Drug Administration (FDA) in September 2015. This is further to Chronocort(R) 's orphan drug designation for the treatment of CAH, granted by the FDA in March 2015 and Infacort(R) 's orphan drug designation in the treatment of paediatric AI, granted by the FDA in May 2015. These orphan drug designations, together with the PUMA, mean Infacort(R) and Chronocort(R) have the potential to be granted market and data exclusivity for 10 years in Europe and seven years in the US post market authorisation.

Early-stage pipeline

Diurnal plans to use its cortisol replacement offering to build a strong platform in underserved diseases of cortisol deficiency and then expand into endocrine disease areas such as those associated with the thyroid, gonads and pituitary. Continued product development is expected to come from Chronocort(R) line extensions aiming to address additional cortisol deficiency indication(s) and from the Group's earlier-stage pipeline of endocrinology product candidates. These earlier-stage candidates currently include a native oral testosterone for the treatment of male hypogonadism; and Tri4Combi(TM), a novel formulation to treat hypothyroidism. Diurnal has successfully completed in vivo pre-clinical studies of its native oral testosterone replacement and expects to initiate a proof-of-concept study in human hypogonadal patients imminently.

Diurnal demonstrated its ability to identify potential endocrine therapies with one such pipeline acquisition during the period with the Group obtaining the rights, from the University of Sheffield (UK), to the orphan drug designation for an oligonucleotide therapy for the potential treatment of Cushing's Disease (cortisol excess). Cushing's Disease is often treated by the same clinicians that treat diseases of cortisol deficiency, thereby leveraging Diurnal's network in line with the Group's commercialisation strategy.

Outlook

Diurnal is well positioned to develop its late-stage pipeline to market authorisation and initiate commercialisation activities towards building a proprietary endocrinology franchise.

In Europe, Infacort(R) has the potential to be the first licensed treatment for AI (including CAH) specifically designed for use in children under six years of age. Following a full evaluation of the Phase III data, Diurnal is on track to submit a regulatory dossier to the EMA around the end of 2016 and is optimistic that it may receive market authorisation in late 2017. Prelaunch planning is underway to effect a rapid transition to a commercial organisation. In the US, following FDA feedback, Diurnal will be commencing the US registration programme for Infacort(R) in 2017 and anticipates market authorisation in the US in 2019 (previously the end of 2018).

Chronocort(R) has the potential to be the first product candidate for adults with CAH to mimic the natural cortisol circadian rhythm, therefore improving disease control. In Europe, Diurnal expects to report headline data from the Phase III clinical trial in Europe for adults with CAH in early 2018, implying a potential market authorisation in Europe could be forthcoming around the end of 2018. In the US, the Group continues its dialogue with the FDA on the Phase III clinical trial design and expects to have an update in early 2017, with the intention to commence the study later that year and anticipates market authorisation in the US in 2021 (previously the end of 2020).

Financial Review

Operating income and expenses

Operating expenses are in a growth phase, reflecting the increased clinical and development activities together with investment in overheads including headcount and business infrastructure to support the anticipated growth and development of the business in the coming periods.

Research and development expenditure for the year was GBP3.9m (13 months 2015: GBP2.2m). Of this GBP1.7m increase in expenditure, GBP0.2m was as a result of the first time accounting for share options and a further GBP0.3m was as a result of the creation of a national insurance accrual for historical share option awards. Expenditure on product development and clinical costs increased in the period as the Group's Chronocort(R) product entered a Phase III clinical trial in Europe and prepared for a US trial and its native oral testosterone product prepared to commence its human proof-of-concept trial in hypogonadal patients. Staff related expenditure also increased as a result of the implementation of a new remuneration policy.

Administrative expenses for the year were GBP3.1m (13 months 2015: GBP1.0m). Of this GBP2.1m increase in expenditure, GBP0.6m was the one-off IPO costs, GBP0.3m was as a result of the first time accounting for share options and a further GBP0.1m was as a result of the creation of a national insurance accrual for historical share option awards. The remaining increase resulted from the appointment of new staff, the implementation of a new remuneration policy and public company costs. In addition to the IPO costs of GBP0.6m (13 months 2015: GBPnil), a further GBP0.8m (13 months 2015: GBPnil) of fees paid in connection with the fundraising are shown as a deduction from share premium and GBP59k and GBP28k have been charged against the convertible loan liability and its equity component respectively.

Operating income in the prior period represents funds receivable from a European Commission grant supporting the European development of the Group's Infacort(R) product.

Operating loss

Operating loss for the period increased to GBP7.0m (13 months 2015: GBP3.0m).

Financial income and expense

Financial income in the period was GBP63k (13 months 2015: GBP8k), due to the higher average cash balances during the year, after the IPO fundraising and convertible loan financing. Financial expense for the period was GBP133k (13 months 2015: GBP41k), being the financial expense of the convertible loan. No interest is payable in cash on this loan, the financial expense representing the effective interest required under accounting standards to charge the transaction costs and equity element of the loan to the income statement over the term of the loan. The Group had interest bearing convertible loans outstanding for two months of the comparative period, before they were converted into equity, whilst the new convertible loan was outstanding for over six months of the 2015/16 financial year.

Loss on ordinary activities before tax

Loss before tax for the period was GBP7.1m (13 months 2015: GBP3.0m).

Tax

The Group has not recognised any deferred tax assets in respect of trading losses arising in either the current financial period or accumulated losses in previous financial years. The tax credits recognised in the financial periods ended 30 June 2016 and 2015 represent the receipt of Research & Development tax credits relating to their respective prior periods' activities.

Earnings per share

Loss per share was 15.0 pence (13 months 2015: 8.5 pence). Loss per share has increased due to the higher operating costs explained above.

Cash flow

Net cash used in operating activities was GBP5.1m (13 months 2015: GBP2.9m), driven by the increased loss for the period. Net cash used in investing activities was GBP14.0m (13 months 2015: GBPnil) being the investment of funds into one year cash deposits. Net cash generated by financing was GBP29.1m (13 months 2015: GBP8.0m) reflecting the net proceeds of the issue of shares in the IPO of GBP24.5m (13 months 2015: GBP8.0m from a private fundraising) together with GBP4.6m (13 months 2015: GBPnil) of funds received from the convertible loan.

Balance sheet

Total assets increased to GBP30.7m (2015: GBP6.5m), reflecting the increase in cash and cash equivalents arising from the issue of ordinary shares and the convertible loan, offset by the operating cash outflow for the period. Held to maturity financial assets were GBP14.0m (2015: GBPnil) and cash and cash equivalents were GBP16.1m (2015: GBP6.1m). Total liabilities increased to GBP4.7m (2015: GBP0.4m), reflecting the GBP3.2m liability component of the convertible loan (2015: GBP24k of other loans), together with trade and other payables of GBP1.5m (2015: GBP0.4m), which increased due to accruals for clinical costs, bonuses and employer's national insurance on non-tax beneficial share options. Net assets were GBP25.9m (2015: GBP6.0m).

Comparative information

The Group has applied the principles of reverse acquisition accounting under IFRS 3 'Business Combinations' in the presentation of consolidated shareholders' equity for comparative periods. These comparative periods show the results of the accounting acquirer (Diurnal Limited) along with the share capital structure of the parent company (Diurnal Group plc). As a result, the consolidated share capital and share premium presented for comparative periods is that which was in existence immediately following the share for share exchange which occurred on 1 December 2015, and which is explained further in note 2 to the financial statements.

Consolidated income statement

for the year ended 30 June 2016

 
                                        12 months   13 months 
                                            ended       ended 
                                           30 Jun      30 Jun 
                                             2016        2015 
                                 Note      GBP000      GBP000 
 
 Research and development 
  expenditure                     4       (3,886)     (2,227) 
 Administrative expenses          4       (3,106)     (1,000) 
 Other operating income                         -         241 
 Operating loss                           (6,992)     (2,986) 
 Financial income                 5            63           8 
 Financial expense                6         (133)        (41) 
 Loss before tax                          (7,062)     (3,019) 
 Taxation                         7           491          81 
 Loss for the period                      (6,571)     (2,938) 
                                       ----------  ---------- 
 
 Basic and diluted loss 
  per share (pence per share)     8        (15.0)       (8.5) 
                                       ----------  ---------- 
 

All activities relate to continuing operations.

Consolidated statement of comprehensive income

for the year ended 30 June 2016

 
                          12 months   13 months 
                              ended       ended 
                             30 Jun      30 Jun 
                               2016        2015 
                             GBP000      GBP000 
 
 Loss for the period        (6,571)     (2,938) 
                         ----------  ---------- 
 

Consolidated balance sheet

as at 30 June 2016

 
                                            2016      2015 
                                  Note    GBP000    GBP000 
 
 Non-current assets 
 Intangible assets                             6        10 
 Property, plant and equipment                 3         5 
                                               9        15 
                                        --------  -------- 
 Current assets 
 Trade and other receivables                 530       376 
 Held to maturity financial 
  assets                           9      14,000         - 
 Cash and cash equivalents         10     16,114     6,073 
                                          30,644     6,449 
                                        --------  -------- 
 
 Total assets                             30,653     6,464 
                                        --------  -------- 
 
 Current liabilities 
 Loans and borrowings              11          -      (24) 
 Trade and other payables                (1,480)     (399) 
                                         (1,480)     (423) 
                                        --------  -------- 
 Non-current liabilities 
 Loans and borrowings              11    (3,239)         - 
                                         (3,239)         - 
                                        --------  -------- 
 
 Total liabilities                       (4,719)     (423) 
                                        --------  -------- 
 
 Net assets                               25,934     6,041 
                                        --------  -------- 
 
 Equity 
 Share capital                     12      2,610    15,351 
 Share premium                            23,632         - 
 Consolidation reserve                   (2,943)   (2,943) 
 Other reserve                             1,458         - 
 Retained earnings                         1,177   (6,367) 
 Total equity                             25,934     6,041 
                                        --------  -------- 
 

Consolidated statement of changes in equity

for the year ended 30 June 2016

 
                              Share      Share   Consolidation      Other    Retained 
                            Capital    Premium         Reserve    Reserve    Earnings     Total 
                             GBP000     GBP000          GBP000     GBP000      GBP000    GBP000 
 
 Balance at 
  27 May 2014                15,351          -        (11,824)          -     (3,849)     (322) 
 
 Loss for the 
  period and 
  total comprehensive 
  loss for the 
  period                          -          -               -          -     (2,938)   (2,938) 
                          ---------  ---------  --------------  ---------  ----------  -------- 
 Equity settled 
  share based 
  payment transactions            -          -               -          -          20        20 
 Reduction 
  of Capital                      -          -               -          -         400       400 
 Contributions 
  by owners                       -          -           8,881          -           -     8,881 
 Total transactions 
  with owners 
  recorded directly 
  in equity                       -          -           8,881          -         420     9,301 
                          ---------  ---------  --------------  ---------  ----------  -------- 
 
 Balance at 
  30 June 2015               15,351          -         (2,943)          -     (6,367)     6,041 
 
 Loss for the 
  period and 
  total comprehensive 
  loss for the 
  period                          -          -               -          -     (6,571)   (6,571) 
                          ---------  ---------  --------------  ---------  ----------  -------- 
 Equity settled 
  share based 
  payment transactions            -          -               -          -         490       490 
 Reduction 
  of Capital               (12,107)          -               -          -      12,107         - 
 Issue of shares 
  for cash                      884     24,465               -          -           -    25,349 
 Costs charged 
  against share 
  premium                         -      (833)               -          -           -     (833) 
 Equity component 
  of convertible 
  loan                            -          -               -      1,486           -     1,486 
 Issue expenses 
  of convertible 
  loan                            -          -               -       (28)           -      (28) 
 Repurchase 
  of deferred 
  shares                    (1,518)          -               -          -       1,518         - 
 Total transactions 
  with owners 
  recorded directly 
  in equity                (12,741)     23,632               -      1,458      14,115    26,464 
                          ---------  ---------  --------------  ---------  ----------  -------- 
 
 Balance at 
  30 June 2016                2,610     23,632         (2,943)      1,458       1,177    25,934 
                          ---------  ---------  --------------  ---------  ----------  -------- 
 

Loss for the period is the only constituent of total comprehensive loss for each period so the period amounts are shown in the same line in the consolidated statement of changes in equity.

Consolidated cash flow statement

for the year ended 30 June 2016

 
                                           12 months   13 months 
                                               ended       ended 
                                              30 Jun      30 Jun 
                                                2016        2015 
                                    Note      GBP000      GBP000 
 
 Cash flows from operating 
  activities 
 Loss for the period                         (6,571)     (2,938) 
 Adjustments for : 
 Depreciation, amortisation 
  and impairment                                   6           7 
 Share-based payment                             490          20 
 Financial income                    5          (63)         (8) 
 Finance expenses                    6           133          41 
 Taxation                            7         (491)        (81) 
 Increase in trade and other 
  receivables                                  (135)       (261) 
 Increase in trade and other 
  payables                                     1,081         284 
 Cash flow used in operations                (5,550)     (2,936) 
 Interest paid                                     -         (1) 
 Tax received                        7           491          81 
 Net cash used in operating 
  activities                                 (5,059)     (2,856) 
                                          ----------  ---------- 
 
 Cash flows from investing 
  activities 
 Additions of property, plant 
  and equipment                                    -         (5) 
 Purchases of held to maturity 
  financial assets                          (14,000)           - 
 Interest received                                44           8 
 Net cash (used in)/from 
  investing activities                      (13,956)           3 
                                          ----------  ---------- 
 
 Cash flows from financing 
  activities 
 Net proceeds from issue 
  of share capital                            24,516       8,000 
 Repayment of borrowings                        (24)        (25) 
 Net proceeds from issue 
  of borrowings                                4,564           - 
 Net cash generated by financing 
  activities                                  29,056       7,975 
                                          ----------  ---------- 
 
 Net increase in cash and 
  cash equivalents                            10,041       5,122 
 Cash and cash equivalents 
  at the start of the period                   6,073         951 
 Cash and cash equivalents 
  at the end of the period                    16,114       6,073 
                                          ----------  ---------- 
 

Notes to the consolidated financial statements

   1          General information 

Diurnal Group plc ('the Company') and its subsidiary (together 'the Group') are a clinical stage specialty pharmaceutical business targeting patient needs in chronic endocrine (hormonal) diseases which the Company believes are currently not met satisfactorily by existing treatments. It has identified a number of specialist endocrinology market opportunities in Europe and the US that are together estimated to be worth more than $11bn per annum.

The Company is a public limited company incorporated and domiciled in the UK. Its registered number is 09846650. The address of its registered office is Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ and its primary and sole listing is on the Alternative Investments Market (AIM). The Company was incorporated as Project Dime Limited on 28 October 2015 and reregistered as a public company and changed its name to Diurnal Group plc on 4 December 2015.

On 21 December 2015 the Company published its AIM Admission Document following its successful GBP30m fundraising. Its ordinary shares of 5 pence each were admitted to trading on the AIM market on 24 December 2015.

The Company issued 17,603,759 shares at a price of GBP1.44 per share to raise GBP25.3m before expenses and received GBP4.7m before expenses under a convertible loan from IP2IPO Limited, one of its shareholders. Total expenses of the IPO and fundraising were GBP1.5m, of which GBP0.8m were directly attributable to the issue of the new shares and have been charged to the Share Premium account. GBP59k and GBP28k have been charged against the convertible loan liability and its equity component respectively. The balance of GBP0.6m has been charged to the Consolidated Income Statement and included within administrative expenses in the period ended 30 June 2016.

To facilitate the IPO, the Company was incorporated on 28 October 2015 and acquired the entire issued share capital of Diurnal Limited under a share for share exchange on 1 December 2015. The Company has applied the principles of reverse acquisition accounting in the preparation of the consolidated financial information.

   2          Basis of preparation 
   2.1        Basis of preparation 

The financial information set out above does not constitute the company's statutory accounts for the years ended 30 June 2016 or 2015 but is derived from those accounts. Statutory accounts for 2015 have been delivered to the registrar of companies (being those of Diurnal Limited prior to the incorporation of Diurnal Group plc), and those for 2016 will be delivered in due course. The auditor has reported on those accounts; their reports were (i) unqualified, (ii) did not include a reference to any matters to which the auditor drew attention by way of emphasis without qualifying their report and (iii) did not contain a statement under section 498 (2) or (3) of the Companies Act 2006.

The financial information has been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union, IFRIC interpretations and the Companies Act 2006. The financial information contained in these financial statements have been prepared under the historical cost convention, and on a going concern basis.

The accounting policies used in the financial information are consistent with those set out in the AIM Admission document dated 21 December 2015. The following Adopted IFRSs have been issued but have not been applied by the Group in these financial statements. Their adoption is not expected to have a material effect on the financial statements unless otherwise indicated:

   --      IFRS 9 Financial Instruments (effective date to be confirmed). 
   --      IFRS 14 Regulatory Deferral Accounts (effective date to be confirmed). 
   --      IFRS 15 Revenue from Contract with Customers (effective date to be confirmed). 

-- Clarification of Acceptable Methods of Depreciation and Amortisation - Amendments to IAS 16 and IAS 38 (effective date to be confirmed).

-- Equity Method in Separate Financial Statements - Amendments to IAS 27 (effective date to be confirmed).

   --      Annual Improvements to IFRSs - 2012-2014 Cycle (effective date to be confirmed). 
   --      Disclosure Initiative - Amendments to IAS 1 (effective date to be confirmed). 

The preparation of financial information in conformity with IFRS requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Although these estimates are based on management's best knowledge of the amount, event or actions, actual events ultimately may differ from those estimates.

   2.2        Summary of impact of Group restructure and Initial Public Offering 

On 24 December 2015, the Company listed its shares on AIM. In preparation for this Initial Public Offering ('IPO') the Group was restructured. The restructure has impacted a number of the current year and comparative primary financial statements and notes.

For the consolidated financial statements of the Group, prepared under IFRS, the principles of reverse acquisition accounting under IFRS 3 'Business Combinations' have been applied. The steps to restructure the Group had the effect of Diurnal Group plc being inserted above Diurnal Limited as the holder of the Diurnal Limited share capital.

By applying the principles of reverse acquisition accounting, the Group is presented as if Diurnal Group plc has always owned Diurnal Limited. The comparative Income Statement and Balance Sheet are presented in line with the previously presented Diurnal Limited position. The comparative and current year consolidated reserves of the Group are adjusted to reflect the statutory share capital and share premium of Diurnal Group plc as if it had always existed, adjusted for movements in the underlying Diurnal Limited share capital and reserves until the share for share exchange.

The steps taken to restructure the Group are explained in more detail in the Group Reorganisation section below. The impact on the primary consolidated financial statements is as follows:

-- Equity reflects the capital structure of Diurnal Group plc. As part of the restructuring of the Group and the IPO, a number of shares in Diurnal Group plc were issued in exchange for cash. The premium arising on the issue of shares is allocated to share premium.

-- A consolidation reserve was created and reflects the difference between the Diurnal Group plc reserves at the balance sheet date as reflected in the opening reserves at the start of the comparative period (28 May 2014) and the equity of Diurnal Limited at the same date.

Fees associated with the IPO are allocated to share premium and the Consolidated Income Statement depending on the nature of the costs.

Group reorganisation

Prior to IPO the Group undertook a reorganisation in preparation for the transaction.

The effect of this reorganisation was to insert a new ultimate parent company, Diurnal Group plc, into the Group. This company acquired the entire issued share capital of Diurnal Limited, as summarised below.

Diurnal Group plc became the ultimate parent company of the Group by acquiring Diurnal Limited in exchange for the issue of new shares.

The key steps of the process were as follows:

   --      On incorporation on 28 October 2015, 1 Ordinary share of GBP1 was allotted and issued. 
   --      On 1 December 2015, a number of further changes to the share capital occurred: 

- a share subdivision whereby the ordinary share of GBP1 each was subdivided into 2 Ordinary shares of 50 pence each;

- in accordance with the terms of a share for share exchange agreement, the allotment and issue of 30,267,498 ordinary shares of 50 pence each and 4,395,000 B shares of 5 pence each in consideration for the entire issued share capital of Diurnal Limited. Following the conclusion of this share for share exchange, which involved nil cash consideration, Diurnal Limited became a wholly owned subsidiary undertaking of the Company;

   -       the nominal value of the 30,267,498 ordinary shares of 50 pence were reduced to 10 pence. 

-- On 23 December 2015, 83,038 ordinary shares of 10 pence each were allotted and issued to the Enterprise Investment Scheme investors participating in the IPO placing of shares.

-- On 24 December, 30,350,538 ordinary shares of 10 pence each were subdivided and reclassified into 30,350,538 ordinary shares of 5 pence each and 30,350,538 deferred share of 5 pence each. Thereafter, a number of further changes to the share capital occurred, which were conditional upon and immediately prior to admission of the Company's shares to trading on AIM and simultaneous with each other:

- the conversion of 4,339,500 B shares of 5 pence each into 4,339,500 ordinary shares of 5 pence each;

- the reduction of the Company's share capital by GBP1,517,526.90 representing the aggregate nominal value of the 30,350,538 deferred share of 5 pence each, as a result of the transfer of the deferred shares to the Company for nil consideration and their subsequent cancellation;

- the allotment and issue of 17,520,721 ordinary shares of 5 pence each to investors participating in the IPO placing of shares.

   3          Segmental information 

The Board regularly reviews the Company's performance and balance sheet position for its operations and receives financial information for the group as a whole. As a consequence the Group has one reportable segment, which is Clinical Development. Segmental profit is measured at operating loss level, as shown on the face of the Income Statement. As there is only one reportable segment whose losses, expenses, assets, liabilities and cash flows are measured and reported on a basis consistent with the financial statements, no additional numerical disclosures are necessary.

   4          One-off, share option related and non-cash items 

A number of one-off, share option related and non-cash items, totalling GBP1.5m, are analysed in the following table:

 
                                         12 months   13 months 
                                             ended       ended 
                                            30 Jun      30 Jun 
                                              2016        2015 
                                            GBP000      GBP000 
 
 Research and development expenditure 
 IFRS2 equity settled share based 
  payment transactions - non-cash              188           - 
 Employer NIC provision on unapproved 
  share options - initial recognition 
  of historical liability                      258           - 
                                               446           - 
                                        ----------  ---------- 
 
 Administrative expenses 
 Expenses of the initial public 
  offering - one-off                           623           - 
 IFRS2 equity settled share based 
  payment transactions - non-cash              302          20 
 Employer NIC provision on unapproved 
  share options - initial recognition 
  of historical liability                      119           - 
                                             1,044          20 
                                        ----------  ---------- 
 
   5          Finance income 
 
                                   12 months   13 months 
                                       ended       ended 
                                      30 Jun      30 Jun 
                                        2016        2015 
                                      GBP000      GBP000 
 
 Interest receivable on cash 
  and cash equivalents and term 
  deposits                                63           8 
 Total finance income                     63           8 
                                  ----------  ---------- 
 
   6          Finance expenses 
 
                                          12 months   13 months 
                                              ended       ended 
                                             30 Jun      30 Jun 
                                               2016        2015 
                                             GBP000      GBP000 
 
 Total interest payable on loans                133           1 
 Total interest expenses on financial 
  liabilities measured at amortised 
  cost                                            -          34 
 Total fair value losses on derivative 
  financial liabilities                           -           6 
 Total finance expense                          133          41 
                                         ----------  ---------- 
 
   7          Taxation 
 
                                     12 months   13 months 
                                         ended       ended 
                                        30 Jun      30 Jun 
                                          2016        2015 
                                        GBP000      GBP000 
 
 Current tax 
 - current year                          (491)        (81) 
 Tax credit charge for the period        (491)        (81) 
                                    ----------  ---------- 
 

The tax credits assessed for the periods ended 30 June 2015 and 2016 relate entirely to R&D tax credit relief.

Reconciliation of total tax expense:

 
                                          12 months   13 months 
                                              ended       ended 
                                             30 Jun      30 Jun 
                                               2016        2015 
                                             GBP000      GBP000 
 
 The tax assessed for the year 
  varies from the small company 
  rate of corporation tax as explained 
  below 
 Loss on ordinary activities 
  before tax                                (7,062)     (3,019) 
                                         ----------  ---------- 
 
 Tax at the standard rate of 
  UK corporation tax rate of 20% 
  (2014/15: 20%)                            (1,412)       (604) 
 Research and development tax 
  credit                                      (491)        (81) 
 Non-deductible expenses                        104          41 
 Current year losses for which 
  no deferred tax asset was recognised        1,308         563 
 Tax credit for the period                    (491)        (81) 
                                         ----------  ---------- 
 

The company has approximately GBP11.8m of trading losses carried forward at 30 June 2016 (2015: approximately GBP5.3m) for which no deferred tax asset has been recognised due to the uncertainty of availability of future taxable profits. The estimated value of the deferred tax asset not recognised, measured at a standard tax rate of 20% is GBP2.4m (2015: GBP1.1m at 20%).

A reduction in the UK corporation tax rate from 21% to 20% (effective from 1 April 2015) was substantively enacted on 2 July 2013. Further reductions from 20% to 19% from 1 April 2017 and 18% from 1 April 2020 were substantively enacted on 26 October 2015.

   8          Loss per share 
 
                                      12 months   13 months 
                                          ended       ended 
                                         30 Jun      30 Jun 
                                           2016        2015 
 
 Loss for the period (GBP000)           (6,571)     (2,938) 
 Weighted average number of shares 
  (000)                                  43,746      34,607 
 
 Basic and diluted loss per share 
  (pence per share)                      (15.0)       (8.5) 
                                     ----------  ---------- 
 

The diluted loss per share is identical to the basic loss per share in all periods, as potentially dilutive shares are not treated as such since they would reduce the loss per share.

   9          Held to maturity financial assets 
 
                        2016       2015 
                      GBP000     GBP000 
 
 Bank term deposits   14,000          - 
                     -------    ------- 
 

The effective interest rate on bank deposits was 1.05% and these deposits had a weighted average maturity of 11 months. The Group's treasury policy requires that deposits are held with financial institutions having a minimum credit rating of A- (from Moody's S&P or Fitch), that individual counterparty exposure is no more than GBP8m and that the maximum term is 12 months. The Group's deposits are in line with this policy.

   10         Cash and cash equivalents 
 
                               2016     2015 
                             GBP000   GBP000 
 
 Cash at bank and on hand    16,114    6,073 
                            -------  ------- 
 

The Group holds its cash and cash equivalents with its clearing bank and in a AAA rated Liquidity fund providing same day access to its cash. The Group's treasury policy is summarised in Note 19. Although the Liquidity fund balance exceeds the GBP8m counterparty limit, the Board is satisfied that the individual counterparty risk within the fund is significantly below this amount.

   11         Loans and borrowings 
 
                                       2016     2015 
                                     GBP000   GBP000 
 
 Current loans and borrowings 
 Other current loans                      -       24 
                                    -------  ------- 
 
 Non-current loans and borrowings 
 Convertible Loans                    3,239        - 
                                    -------  ------- 
 
 Total loans and borrowings           3,239       24 
                                    -------  ------- 
 

IP Group convertible loan

On 24 December 2015 the Company received GBP4.7m from IP2IPO Limited, a wholly owned subsidiary of IP Group plc under a convertible loan agreement. The convertible loan facility is interest-free and unsecured with a maturity date of 24 December 2020 (or such other date as the parties may agree) at which point the Company may either repay the principal amount outstanding in full or convert such amount into non-voting shares at a lower nominal value to that of the Ordinary Shares to ensure that IP2IPO Limited did not have control of the Company. IP2IPO Limited may convert the principal outstanding in whole or in parts exceeding GBP0.1m into ordinary shares calculated at the IPO share price of GBP1.44 per share conditional on it not having control of the Company resulting from the conversion.

The convertible loan note is a compound financial instrument containing a host financial liability and an equity component as there is a contractual obligation to deliver a fixed number of shares at the IPO price if the loan note is converted.

At 30 June 2016, the amount outstanding comprised:

 
                                          2016       2015 
                                        GBP000     GBP000 
 
 Face value of convertible loan 
  issued on 24 December 2015             4,651          - 
 Equity Component                      (1,486)          - 
 Issue costs relating to the 
  liability element                       (59)          - 
 Liability component on initial 
  recognition at 31 December 2015        3,106          - 
 Accrued interest                          133          - 
 Liability component at 31 December 
  2015                                   3,239          - 
 Less amount included in current 
  liabilities                                -          - 
 Included in non-current liabilities     3,239          - 
                                      --------    ------- 
 
   12         Share capital 
 
                                    2016     2015 
                                  GBP000   GBP000 
 
 52,210,759 ordinary shares of 
  GBP0.05 each                     2,610        - 
 30,267,498 ordinary shares of 
  GBP0.50 each                         -   15,134 
 4,339,500 B shares of GBP0.05 
  each                                 -      217 
                                   2,610   15,351 
                                 -------  ------- 
 

The Group has applied the principles of reverse acquisition accounting under IFRS 3 'Business Combinations' in the presentation of consolidated shareholders' equity for comparative periods. These comparative periods show the results of the accounting acquirer (Diurnal Limited) along with the share capital structure of the parent company (Diurnal Group plc). As a result, the consolidated share capital and share premium presented for comparative periods is that which was in existence immediately following the share for share exchange which occurred on 1 December 2015, and which is explained further in note 2.

 
                                  Number        Number         Number 
                             of Ordinary          of B    of Deferred      Total 
                                  Shares        Shares         Shares     GBP000 
 
 At 28 October 2015 
  on incorporation                     1             -              -          - 
 Share subdivision 
  on 1 December 2015                   1             -              -          - 
 Issued on 1 December 
  2015                        30,267,498     4,339,500              -     15,351 
 Share capital reduction 
  on 1 December 2015                   -             -              -   (12,107) 
 Issued on 23 December 
  2015                            83,038             -              -          8 
 Share split on 24 
  December 2015                        -             -     30,350,538          - 
 Conversion of B 
  shares on 24 December 
  2015                         4,339,500   (4,339,500)              -          - 
 Cancellation of 
  Deferred shares 
  on 24 December 2015                  -             -   (30,350,538)    (1,518) 
 Issued on 24 December 
  2015                        17,520,721             -              -        876 
 At 31 December 2015: 
  Ordinary shares 
  of 5 pence each             52,210,759             -              -      2,610 
                           -------------  ------------  -------------  --------- 
 

The changes in the share capital are described in Note 2.

This information is provided by RNS

The company news service from the London Stock Exchange

END

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