Posted on Monday, 21/Dec/2015 Posted by michelle

Diurnal, the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has today published its Admission Document following a successful £30 million fundraising and has applied for the Admission of its entire issued and to be issued share capital to AIM, a market operated by London Stock Exchange plc (“AIM”) (“Admission”). Admission is expected to occur on Thursday, 24th December 2015, under the ticker symbol “DNL”. The nominated adviser and broker to the Company is Numis Securities Limited (“Numis”).

The Company has conditionally raised approximately £30 million (£28.4 million net of expenses) by way of a placing of new ordinary shares of 5 pence each in the Company (the “Shares”) at 144 pence per Share (the “Placing Price”) to institutional and other investors (the “Placing”) and through IP2IPO Limited (a subsidiary of IP Group plc) (“IP2IPO”) making a convertible loan available to it. Pursuant to the Placing, the Company will issue 17,603,759 Shares, raising gross proceeds for the Company of approximately £25.3 million. A total of 52,210,759 Shares will be in issue immediately following Admission, giving a market capitalisation of approximately £75.2 million at the Placing Price. In addition to the Placing, IP2IPO is providing approximately £4.7 million to the Company by way of a five year, interest-free, unsecured convertible loan, convertible at the Placing Price.

Existing shareholders, IP Group plc (through certain subsidiaries) and Finance Wales plc (through certain funds managed by it), supported the transaction, alongside other UK and international institutional and other investors. 

Dr Martin Whitaker, CEO of Diurnal, commented:

We are delighted to have been able to complete our IPO successfully. The new funds will allow us to accelerate the development of our two leading product candidates which are in, or expected to commence shortly, late-stage clinical development targeting diseases of cortisol deficiency; Chronocort®, to be used for Congenital Adrenal Hyperplasia (“CAH”) in adults, and Infacort®, to be used for Adrenal Insufficiency (“AI”), including CAH in children. Our lead product candidate, Infacort®, is anticipated to receive its first regulatory approval in Europe in the third quarter of 2017.

“Our vision is to become the world’s leading endocrinology specialty pharma company targeting under-served patient needs in chronic hormonal diseases. We have identified a number of such needs which we estimate represent a combined market opportunity of more than $11 billion. As potential prescribing endocrinologists for our products are predominantly concentrated in specialist centres throughout Europe and the US, we believe there is significant opportunity, at the right time, to build a cost-effective, focused sales and marketing operation. This should enable us to maximise the value from our product candidates, once approved, and create a base for further growth through in-licensing.

“We are excited to be entering this new chapter in Diurnal’s evolution. This IPO is a major milestone for the Company which would not have been possible without the hard work of our employees. We also wish to thank our existing investors for their continuing support and welcome our new shareholders.” 

Highlights

- Diurnal is a specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases which the Company believes are currently not met satisfactorily by existing treatments

- The Company has identified a number of specialist endocrinology market opportunities in Europe and the US that are together estimated to be worth more than $11 billion per annum

- Diurnal’s principal product candidates, Infacort® and Chronocort®, are either in, or expected to commence Phase III clinical trials shortly. Infacort® is currently undergoing a Phase III clinical trial in Europe and Chronocort® is expected to commence a Phase III clinical trial in Europe in Q1 2016

- These product candidates are initially targeting indications with an estimated global addressable market potential of $0.5 billion, rising to $3.4 billion with anticipated line extensions in new indications

- If approved, Infacort® has the potential to be the first licensed treatment in Europe for Adrenal Insufficiency (including Congenital Adrenal Hyperplasia) specifically designed for use in children under six years of age

- Infacort® is currently in a Phase III clinical trial in Europe; Diurnal anticipates market authorisation in Q3 2017

- Chronocort® has the potential to be the first product candidate for adults with Congenital Adrenal Hyperplasia to mimic the natural cortisol circadian rhythm, therefore improving disease control

- Diurnal’s products are based on established active pharmaceutical ingredients with no requirement for pre-clinical toxicology and they are therefore associated with a low relative safety risk

- The target network of prescribers practising in specialist endocrinology centres in Europe and the US is concentrated within specialist centres. Therefore, the Directors believe that only a modest direct sales and marketing capacity will be required to market its lead product candidates, and that this can be constructed and operated cost-effectively in a financially viable manner

- Diurnal’s lead product candidates have the potential to be granted market and data exclusivity on approval (although this cannot be guaranteed), with Infacort® and Chronocort® benefiting from Orphan Drug Designations in the United States and Chronocort® benefiting from two Orphan Drug Designations in Europe. Diurnal also intends to apply for a paediatric use marketing authorisation for Infacort® in Europe. Diurnal’s product candidates also benefit from a number of granted or pending patents in key jurisdictions

- Diurnal has an experienced board and has built a management team with significant experience in clinical development, regulatory issues and marketing and sales, and will seek to supplement it as its operations mature and new skills and expertise are required

- Diurnal plans to use its cortisol replacement offering to build a strong platform in under-served diseases of the adrenal gland from which it will expand into disease areas such as those associated with the thyroid, gonads and pituitary

- Diurnal has realistic opportunities to add further revenue growth over the longer-term via its strong early-stage product pipeline, and is exploring opportunities to in-license or acquire products to sell through its specialist sales force once established 

Please further information, please visit www.diurnal.co.uk or contact:

Diurnal Group PLC 
+44 (0)20 3727 1000
Martin Whitaker, CEO
Ian Ardill, CFO

Numis Securities Ltd
+44 (0)20 7260 1000
Nominated Adviser: Michael Meade, Freddie Barnfield, Paul Gillam
Corporate Broking: James Black

FTI Consulting
+44 (0)20 3737 1000
Simon Conway
Victoria Foster Mitchell

IMPORTANT NOTICE

This announcement does not constitute an offer to sell, or the solicitation of an offer to acquire or subscribe for, Shares in any jurisdiction where such offer or solicitation is unlawful or would impose any unfulfilled registration, qualification, publication or approval requirements on the Company or Numis. The offer and sale of Shares has not been and will not be registered under the applicable securities laws of Canada, Australia, Japan, New Zealand or the Republic of South Africa. Subject to certain exemptions, the Shares may not be offered to or sold within Canada, Australia, Japan, New Zealand or the Republic of South Africa or to any national, resident or citizen of Canada, Australia, Japan, New Zealand or the Republic of South Africa.

The Shares have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the “US Securities Act”), or the securities laws of any other jurisdiction of the United States. The Shares may not be offered or sold, directly or indirectly, in or into the United States (except pursuant to an exemption from, or a transaction not subject to, the registration requirements of the US Securities Act). No public offering of the Shares is being made in the United States. The Shares are being offered and sold only outside the United States in “offshore transactions” within the meaning of, and in reliance on, Regulation S under the US Securities Act (“Regulation S”).

The Shares have not been approved or disapproved by the United States Securities and Exchange Commission, any state securities commission in the United States or any other regulatory authority in the United States, nor have any of the foregoing authorities passed on or endorsed the merits of the Placing or the accuracy or adequacy of the information contained in this announcement. Any representation to the contrary is a criminal offence in the United States.

The distribution of this announcement outside the UK may be restricted by law. No action has been taken by the Company or Numis that would permit a public offer of Shares in any jurisdiction outside the UK or possession of this announcement where action for that purpose is required. Persons outside the UK who come into possession of this announcement should inform themselves about the distribution of this announcement in their particular jurisdiction. Failure to comply with those restrictions may constitute a violation of the securities laws of such jurisdiction.

This announcement is directed only at persons whose ordinary activities involve them in acquiring, holding, managing and disposing of investments (as principal or agent) for the purposes of their business and who have professional experience in matters relating to investments and are: (i) if in a member state of the European Economic Area, qualified investors within the meaning of article 2(1)(e) of the Prospectus Directive ("Qualified Investors"); or (ii) if in the United Kingdom, Qualified Investors and fall within: (a) article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"); or (b) article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the Order (all such persons together being referred to as "Relevant Persons"). The term "Prospectus Directive" means Directive 2003/71/EC as amended and includes any relevant implementing measures in each member state of the European Economic Area.

This announcement must not be acted on or relied on by persons who are not Relevant Persons. Persons distributing this announcement must satisfy themselves that it is lawful to do so. Any investment or investment activity to which this announcement relates is available only to Relevant Persons and will be engaged in only with Relevant Persons. This announcement does not itself constitute an offer for sale or subscription of any securities in the Company.

Numis Securities Limited ("Numis') is authorised and regulated in the United Kingdom by the Financial Conduct Authority ("FCA') and is advising the Company and no one else in connection with the placing and the Company's admission to AIM ("Admission') (whether or not a recipient of this announcement), and is acting exclusively for the Company as nominated adviser and broker for the purpose of the AIM Rules for Companies.

Numis will not be responsible to any person other than the Company for providing the protections afforded to its customers, nor for providing advice in relation to the placing and Admission or the contents of this announcement. In particular, the information contained in this announcement has been prepared solely for the purposes of the placing and Admission and is not intended to inform or be relied upon by any subsequent purchasers of ordinary shares (whether on or off exchange) and accordingly no duty of care is accepted in relation to them. Without limiting the statutory rights of any person to whom this announcement is issued, no representation or warranty, express or implied, is made by Numis as to the contents of this announcement. No liability whatsoever is accepted by Numis for the accuracy of any information or opinions contained in this announcement, for which the directors of the Company are solely responsible, or for the omission of any information from this announcement for which it is not responsible. 

FORWARD-LOOKING STATEMENTS

This announcement contains forward looking statements relating to the Company's future prospects, developments and strategies, which have been made after due and careful enquiry and are based on the directors of the Company's current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Forward-looking statements are identified by their use of terms and phrases such as "believe", "could", "envisage", "estimate", "intend", "may", "plan", "will" or the negative of those, variations or comparable expressions, including references to assumptions. 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.

The price of shares and any income expected from them may go down as well as up and investors may not get back the full amount invested upon disposal of the shares. Past performance is no guide to future performance, and persons needing advice should consult an independent financial adviser.

Neither the content of the Company's website nor any website accessible by hyperlinks on the Company's website is incorporated in, or forms part of, this announcement.