Tuesday, September 25, 2012 - 01:00

Clinigen Group plc, the global specialty pharmaceuticals and pharmaceutical services business,announces the commencement of dealings in its Ordinary Shares on AIM at 8.00am today under the ticker code CLIN and the ISIN number: GB00B89J2419.

**NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF IRELAND, THE REPUBLIC OF SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE OR PUBLICATION WOULD BE UNLAWFUL**

This announcement is an advertisement and not a prospectus or an admission document and does not constitute an offer to subscribe for or purchase any securities or a recommendation regarding any securities. Copies of the admission document (“Admission Document”) which has been published by Clinigen Group plc (”Clinigen” or the ”Company”) in connection with the institutional placing of ordinary shares in the Company (”Placing”) and admission of the ordinary shares in the Company (“Ordinary Shares”) to trading on AIM (“Admission”) will be available during normal business hours on any weekday (except Saturdays, Sundays and public holidays) from the registered office of the Company and at the offices of Numis Securities Limited at The London Stock Exchange Building, 10 Paternoster Square, London EC4M 7LT for a period of at least one month from the date of this announcement. 

25 September 2012

 

Placing statistics

Placing Price: 164p per share

Number of Ordinary Shares in issue immediately following the Placing: 82,555,585

Market Capitalisation at the Placing Price: £135.4 million

Number of new Ordinary Shares placed on behalf of the Company: 6,097,561 shares

Number of Ordinary Shares sold by existing Shareholders*: 24,402,439

Total number of Placing Shares*: 30,500,000 

Placing Shares as a percentage of the issued share capital immediately following the Placing*: 36.9 %

Gross proceeds of the Placing: £50 million

Estimated net proceeds of the Placing receivable by the Company: £6.6 million

Estimated net proceeds of the Placing receivable by the selling Shareholders*: £38.5 million

*Note: Does not include any Ordinary Shares which may be sold pursuant to the over-allotment option granted by certain Selling Shareholders to Numis under which such selling Shareholders may be required to sell up to 3,050,000 additional Ordinary Shares at the Placing Price. 

Peter George, Chief Executive Officer, said:

“I am delighted that Clinigen has today joined AIM. This is an exciting day for Clinigen, and one which we believe will be critical for the development of the business. The funds raised will enable us to maintain our strong international growth record by providing a solid platform to continue to develop both organically and through acquisition of new pharmaceutical products. Our underlying principle remains to get ‘the right drug to the right patient at the right time’.” 

About Clinigen

Clinigen is headquartered in the UK, with offices in the US and Japan. Formed in 2010 it comprises two divisions – Services and Products. Within the Services division, there are two operations: ClinigenCTS, which offers Clinical Trial Supply services, and ClinigenGAP, which offers Global Access Program (“GAP”) services. The Products division owns and supplies Foscavir® (a hospital-only drug which is used in the treatment of cytomegalovirus and which was acquired from AstraZeneca in 2010) and intends to acquire, and grow sales of, additional niche hospital-only drugs.

Taking into account both sales of Foscavir® and the GAP programs currently within the Services division, Clinigen manages the supply of drugs into a total of 53 countries. These drugs are used in therapeutic areas of leukaemia (and other oncology), haematology, transplantation, anti-infective, pain management, gastrointestinal and hospital and critical care, as well as orphan diseases.  Clinigen helps patients around the world with unmet medical needs by supplying their pharmacist or physician with the drugs these patients require.

- Ends -

For further information, please contact:

Clinigen Group plc

Tel: +44 (0) 1283 495 010

Peter George, CEO
Robin Sibson, CFO

College Hill

Tel: +44 (0) 20 7457 2020

Adrian Duffield / Melanie Toyne-Sewell / Nicole Yost / Jayne Crook

Clinigen@collegehill.com

Numis Securities Limited

Tel: +44 (0) 20 7260 1000

Michael Meade / Nick Westlake / Freddie Barnfield (Nominated Adviser)
David Poutney / James Black (Corporate Broking)

The distribution of this announcement and other information in connection with Admission and the Placing may be restricted by law in certain jurisdictions and persons into whose possession this announcement or any document or other information referred to herein may come should inform themselves about, and observe, any such restrictions. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction. Neither this announcement nor any copy of it may be made or transmitted into the United States of America or its territories or possessions, nor may it be made or transmitted into Australia, Canada, Japan, the Republic of Ireland or the Republic of South Africa or to any persons in any of those jurisdictions. Any failure to comply with such restriction may constitute a violation of United States of America, Australian, Canadian, Japanese, Irish or South African securities laws. 

The Shares referred to in this announcement may not be offered or sold in or into the United States unless registered under the US Securities Act of 1933, as amended (the "US Securities Act") or offered in a transaction exempt from, or not subject to, the registration requirements of the US Securities Act. The offer, and sale or subscription, of Shares referred to herein has not been and will not be registered under the US Securities Act or under the applicable securities laws of Australia, Canada, Japan, the Republic of Ireland or the Republic of South Africa and, subject to certain exceptions, the Shares referred to herein may not be offered or sold in or within the United States of America, Australia, Canada, Japan, the Republic of Ireland, or the Republic of South Africa or to, or for the account or benefit of, any national, resident or citizen of the United States of America, Australia, Canada, Japan, the Republic of Ireland or the Republic of South Africa. In particular, this announcement is not an offe sale of, or solicitation to purchase or subscribe for, any securities in the United States of America.

This announcement does not constitute or form part of, and should not be construed as, an offer for sale or subscription or solicitation of or invitation to make any offer to buy or subscribe for any securities, and neither this announcement nor any part of it shall form the basis of or be relied on in connection with or act as an inducement to enter into any contract or commitment whatsoever. 

This announcement may include statements that are, or may be deemed to be, “forward-looking statements”. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “plans”, “projects”, “anticipates”, “expects”, “intends”, “may”, “will” or “should” or, in each case, their negative or other variations or comparable terminology, including references to assumptions, or by discussions of strategy, plans, objectives, goals, future events or intentions. Forward-looking statements may and often do differ materially from actual results. Any forward-looking statements reflect Clinigen’s current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to Clinigen’s business, results of operations, financial position, liquidity, prospects, growth and strategies. Forward-looking statements speak only as of the date they are made.

Neither Numis Securities Limited, nor any of its directors, officers, employees, advisers or agents, accepts any responsibility or liability whatsoever for, or makes any representation or warranty, express or implied, as to the truth, accuracy or completeness of the information in this announcement (or whether any information has been omitted from this announcement) or of any other information relating to the Company, its subsidiaries or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this announcement or its contents, or otherwise arising in connection herewith.

Both Clinigen Group plc and Numis Securities Limited expressly disclaim any obligation or undertaking to update, review or revise any forward-looking statement contained in this announcement (other than as required by the AIM Rules or by the rules of any other applicable securities regulatory authority) whether as a result of new information, future developments or otherwise. 

Numis Securities Limited, which is authorised and regulated in the United Kingdom by the Financial Services Authority, is acting exclusively for Clinigen Group plc and no-one else in connection with the Placing and Admission. Numis will not regard any other person as its client in relation to the matters described in this announcement and will not be responsible to anyone other than Clinigen Group plc for providing the protections afforded to its clients, nor for providing advice in relation to the Placing and Admission, the contents of this announcement or any transaction, arrangement or other matter referred to herein.

BACKGROUND INFORMATION

Introduction and business overview

Overview

Clinigen is a fast-growing, global specialty pharmaceuticals and pharmaceutical services business dedicated to serving patients, the medical community and the healthcare industry. The Group currently employs 78 people across its operations and has a head office and newly fitted-out, bespoke, MHRA approved warehouse and distribution hub in Burton-on-Trent, UK, with further offices in Philadelphia, US and Tokyo, Japan.

Clinigen generated sales of £82.1 million and EBITDA of £17.3 million in the year ended 30 June 2012, representing increases of 135 per cent. and 109 per cent. respectively on the prior financial year. Over the period from 1 July 2010 to 30 June 2012, revenues have shown a compound annual growth rate (“CAGR”) of 97 per cent. and EBITDA a CAGR of 215 per cent.

The Clinigen Group was formed in 2010 and comprises two divisions – Services and Products. Within the Services division, there are two businesses: ClinigenCTS, which offers Clinical Trial Supply (“CTS”) services, and ClinigenGAP, which offers Global Access Program (“GAP”) services. The Products division (“Clinigen Products”) owns and supplies Foscavir® (a hospital-only drug which is used in the treatment of Cytomegalovirus or CMV and which was acquired in 2010) and intends to acquire, and grow sales of, additional niche, hospital-only drugs. Taking into account both sales of Foscavir® and the GAP programs currently within the Services division, the Group manages the supply of drugs into a total of 53 countries. These drugs are used in the therapeutic areas of leukaemia (and other areas of oncology), haematology, transplantation, anti-infective, pain management, gastrointestinal and hospital and critical care, as well as orphan diseases. Through the Products division and the GAP Business, Clinigen helps patients around the world with unmet medical needs by supplying their pharmacist or physician with the drugs these patients require.

Services division

The Services division comprises two separate businesses:

ClinigenCTS creates innovative customer solutions for the global sourcing and supply of comparator drugs, as well as other support drugs needed for the well-being of patients in clinical studies.

ClinigenGAP creates global tailored solutions that provide for patients access, via their clinicians, to unlicensed drugs through various permitted named patient programs, including compassionate use, commercial access and early access programs, as well as access through mature product access programs to licensed drugs that are in the process of being withdrawn from the market.

Products division

Clinigen Products is focussed on the acquisition, development, registration, marketing and commercialisation of niche, hospital-only drugs in Clinigen’s targeted therapeutic areas. In identifying potential acquisitions, the Group looks for opportunities to extend product life, seeks new indication opportunities, extend geographical sales footprint, review pricing opportunities and generally rejuvenate product performance. Clinigen Products is building on the success of its first such drug, Foscavir®, which was acquired from AstraZeneca in 2010. The value of annual global sales of Foscavir® has grown more than four-fold under Clinigen’s management.

The Products division also aims, through in-licensing of drugs, to be the preferred partner for pharmaceutical and biotechnology companies which are seeking to maximise product and commercial opportunities.

Clinigen Products is currently exploring a number of acquisition opportunities, five of which are at a reasonably advanced stage.

Synergies

Clinigen has a unique, global service and product offering, with activities that function synergistically.

Customers requiring the services of ClinigenCTS when conducting clinical trials may also require:

  • the services offered by ClinigenGAP to manage patients’ ongoing care after the data gathering phase of a clinical trial has finished, or
  • distribution of a new drug before it is fully licensed globally, or
  • distribution to countries in which it does not intend, for commercial reasons, to seek a Marketing Authorisation.

Similarly, a customer using ClinigenGAP for a drug withdrawal programme may consider the Group’s Products division to be an appropriate party to which it may divest or out-license that drug.

Strategy

The Company’s strategy, in place since the formation of the Clinigen Group in 2010, is to:

  • focus on and globalise the Group’s specialist services in clinical trial supply;
  • develop into a leading provider of global early access programs and mature product access programs;
  • acquire and revitalise drugs that have reached the end of their lifecycle with their current owner; and
  • combine drug management and supply capabilities within Clinigen Products and ClinigenGAP with the specialist service of clinical trial drug supply in ClinigenCTS, thereby exploiting the synergies across the Group’s different businesses.

Sales model

A key element of Clinigen’s expertise is its ability in its Products division and in ClinigenGAP to stimulate demand through its work with Key Opinion Leader networks, rather than through a hospital-focussed sales force (which represents an expensive investment for many specialty pharmaceutical companies). The products which Clinigen supplies (whether on its own account or on behalf of customers) are for hospital only use or prescription. Clinigen is able to stimulate prescriber usage in its targeted therapeutic areas by working with KOLs, who then, in turn, influence other prescribers to follow their clinical practice. Direct marketing or selling of unlicensed medicines is not permitted.

ClinigenCTS, through a small and focussed team, engages in direct sales and marketing activity, concentrating on those pharmaceutical and biopharmaceutical companies in Europe and the USA engaged in R&D.

Operations

Group sales and marketing are underpinned by a central operating platform which delivers a shared logistics and distribution centre, a global hub and spoke distribution network, supply chain management, regulatory, pharmacovigilance and quality management systems and multi-lingual customer services (13 languages), as well as support services such as information technology, human resources and finance.

Key Competitive Strengths

  • Unique business model: Clinigen’s business model incorporates a unique combination of the following features:
  • Solely dedicated to clinical trial drug supply: ClinigenCTS is the only global supplier of drugs used for clinical trial purposes that does not engage in any wholesaling activity, thus ensuring no risk of seepage of surplus drugs into the grey market.- Managing licensed and unlicensed supply: Clinigen manages drug supply globally on both a licensed and an unlicensed basis.
  • Global presence: From its creation in 2010, the Clinigen Group has operated globally, as distinct to most of its competitors, who are country or region specific.
  • KOL network: Clinigen targets hospital-only products which can be commercialised by informing prescribers about them through therapeutic KOLs and lead clinicians. As a result, Clinigen requires no direct hospital-focussed sales force within the ClinigenGAP or the Products division.
  • Track record of strong, profitable growth: The Company is a profitable and cash-generative business with impressive CAGRs in sales and EBITDA.
  • Track record of revitalising an acquired pharmaceutical product on a global basis: Clinigen has successfully transformed the performance of the acquired drug Foscavir®.
  • Broad client base: Clinigen has a diversified blue chip client base of global pharmaceutical and biotechnology companies, including 13 of the top 20 pharmaceutical companies by sales revenue.
  • Experienced and committed management team: Clinigen has a highly experienced management team, with a proven track record in driving organic growth, in building pharmaceutical businesses and in integrating acquisitions, and who retain significant personal shareholding interests in the Company.
  • Focussed approach to product acquisitions: Clinigen adopts a rigorous and analytical approach in the identification of acquisition candidates.
  • Managing supply chain: Clinigen has strong supplier relationships, which enable it to maintain a short supply chain, and operates its own global hub and spoke distribution network, which ensures full control of supply.
  • Central operations: Clinigen gains significant cost efficiency and synergies by having a centralised operational platform.
  • Technical and regulatory competencies: Clinigen maintains strong regulatory, pharmacovigilance and quality management systems as well as employing its own in-house Qualified Person, which provides a major differentiator over many of the competitors to the Services division.

Information on the Directors

Peter Allen, Non-Executive Chairman

Peter joined Clinigen as Non-Executive Chairman in August 2012. He has experience as chairman, CEO and CFO of several publicly quoted companies. Peter is currently chairman of Chroma Therapeutics Limited, ProStrakan plc and Future plc and a non-executive director of Oxford Nanopore Technologies Limited and TMO Renewables Limited. He was until recently chairman of Proximagen Neuroscience plc and has held executive positions with a number of companies, including Celltech Group plc, Abacus Group plc and ProStrakan Group plc.

Peter George, Chief Executive Officer

Peter joined the Clinigen Group when it formed in June 2010. Prior to joining the Group he was CEO at Penn Pharma, having led a £67 million management buy-out of the company in 2007. He was previously an executive VP for Wolters Kluwer Health with responsibility for the Europe and Asia Pacific regions. Peter was formerly chief operating officer of Unilabs Clinical Trials International Limited. Prior to this he was head of Clinical Pathology in the Oxford region of the NHS. Peter is a qualified Clinical Biochemist and Immunologist and a former Fellow of the Institute of Biomedical Sciences. He holds masters degrees in Clinical Biochemistry and Immunology and an Executive Masters in Business from Kelloggs School of Management at Northwestern University, Chicago. Peter is also a director of PharmaPatents Global.

Robin Sibson, Chief Financial Officer

Robin joined ADL Healthcare Limited, a company owned by Andrew Leaver (the founder of the Clinigen Group), in 2003. He has over 30 years of experience in the pharmaceutical industry and has been a finance director for the last 15 years. Before this Robin was finance director of BASF’s UK Pharmaceuticals, sales and R&D divisions for six years. Robin was finance director at Boots UK Pharmaceutical business and led the integration following its sale to BASF, as well as the subsequent integration of BASF’s UK Pharmaceutical business into Abbot Laboratories. Robin is a Chartered Management Accountant (ACMA).

John Hartup, Non-Executive Director

John joined the Company in May 2011 and was appointed to the Board in August 2012. He has over 30 years experience as a corporate lawyer dealing with corporate finance and commercial contract issues across a number of industries. He was a managing partner at Ricksons LLP and subsequently became a partner at DWF LLP upon that firm’s acquisition of Ricksons. John is also a non-executive director of Mitre Group Limited, Ellis Pharmaceutical Limited and Creo Pharmaceutical Limited.

Ian Nicholson, Non-Executive Director

Ian was appointed as a Non-Executive Director in September 2012. He was chief executive of Chroma Therapeutics Limited, a drug discovery and development company from 2004 until July 2012. He is chairman of Bioventix Ltd, a diagnostics company, and a non-executive director of Consort Medical plc, an international medical devices company. He is also a non-executive director of Symphogen A/S, an antibody therapeutics company. From 2000 to 2004 Ian was senior vice president, business development at Celltech Group plc, then the UK's largest biotechnology company. He has extensive experience in licensing, mergers and acquisitions and market development in the UK, Europe and the US. Ian is also a member of the Investment Committee of the recently created £50 million Cancer Research UK Pioneer Fund.

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