Dealings in Clinigen shares are expected to commence on AIM at 8.00am on Tuesday 25 September 2012, under the ticker symbol CLIN





Clinigen is a rapidly-growing specialty pharmaceutical and services company, with one clear aim: to deliver the right drug to the right patient at the right time.




To achieve our aim, we have built a group of complementary businesses which can operate efficiently in a complex global regulatory environment and which can ensure that precious medicines are delivered securely and effectively, wherever they are needed. Through three businesses, Clinigen SP, Clinigen GAP, and Clinigen CTS, we acquire, license and revitalise niche, hospital-only critical care medicines, and source and supply our own and other pharmaceutical companies’ products, whether to meet unmet medical needs or for use in clinical trials.





Clinigen Clinical Trials Supply (CTS):

We use our global expertise, systems and relationships to source and manage the supply of commercial medicines to pharmaceutical companies for use exclusively in clinical trials. This requires excellent knowledge of the global pharmaceutical market, the regulatory processes and customs authorities of countries all over the world, along with a high tech supply chain with guaranteed quality and safety standards that can deliver swiftly.

Clinigen Global Access Programs (GAP):

On behalf of pharmaceutical and biotech companies, we manage essential programs that provide access to critical medicines for physicians and their patients all over the world. But what is a Global Access Program? Known by many terms from ‘expanded access’ and ‘named patient’ to ‘compassionate use’ and ‘early access’, a global access program enables physicians to access treatments that are not available in their own country for patients with an unmet medical need. Wherever they are, we can deliver treatments quickly, efficiently and, most importantly, ethically.

Clinigen Specialty Pharmaceuticals (SP):

We acquire niche medicines that don’t fit into the portfolio of larger pharmaceutical companies. These are typically hospital-only treatments for rare or life-threatening diseases, and we specialise in revitalising them – finding new treatment areas; new markets where we can get them licensed; or, potentially, new formulations. All the while, we’re ensuring that patients already using the medicine continue to get the treatment they need, while the company whose product we have acquired can feel confident that its reputation is being well looked after.

We are currently 100+ people, headquartered in Burton-on-Trent in the UK, with facilities in Philadelphia, US, and Tokyo, Japan, and an office in London. With a customer services team who speak over 19 languages between them, our clients from all over the world find us easy to do business with, while doctors and pharmacists find us a valuable source of information about how to access the medicines they need for their patients.




http://www.clinigen.co.uk/

Organizational Changes to Scale up for Growth

RNS


RNS Number : 8587I

Clinigen Group plc

09 July 2013








Clinigen Group Makes Organizational Changes to Scale-up
for Future Business Growth

Burton-on-Trent, UK - 9 July 2013 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN) today announced that it has made organizational changes to prepare and support the Group to scale-up in line with its five year growth strategy and support recent organic growth and the integration of two new products in the Specialty Pharmaceuticals business.

Under the new structure, Shaun Chilton, formerly the Chief Operating Officer in charge of the Clinigen CTS (Clinical Trial Supply) and Clinigen GAP operational businesses, has been appointed Chief Operating Officer for the Group and will add management of the Specialty Pharmaceutical business to his responsibilities. He will be supported in this role by the appointment of new Senior Vice Presidents to run each of these three operating businesses.

Clinigen GAP (Global Access Programs) will be led by Mark Corbett, formerly Vice President of GAP. Lorann Morse will become Senior Vice President of Clinigen CTS (Clinical Trial Supply) having joined Clinigen from Myoderm where she was Director of Client Services. She will be based in Philadelphia and brings valuable regional expertise and insight to the CTS business. David Bryant will move from his role as Business Development Director to head up Clinigen SP (Specialty Pharmaceuticals). Anton Jenkins, previously COO of Clinigen SP, has been appointed to Business Development Director, performing a key role that is focused on the further in-licensing and acquisition of new products.

Peter George, Chief Executive Officer, Clinigen Group said, "Over the past three years, we have seen significant organic growth of CTS and GAP and the expansion of our product portfolio with the acquisition of Cardioxane from Novartis and in-licensing of VIBATIV from Theravance. Now is a logical time for us to ensure we have the right infrastructure and people in place to be able to scale-up further for future growth and achieve our ambitious plans. I am extremely happy with these appointments; we have high quality people running our operational businesses with a wealth of sector experience."

- Ends -

Clinigen reveals AIM success story is primed for further growth
By Proactive Investors July 09 2013, 8:24am
Clinigen (LON:CLIN) was unique for an AIM float. When it came to the market last September it was not only the first pharmaceutical IPO in almost five years, but it was profitable and cash generative. It is also now a dividend payer. Chief executive officer Peter George and chief financial officer Robin Sibson reveal how this drug sector hybrid will continue on its exponential growth trajectory.


http://www.proactiveinvestors.co.uk/companies/stocktube/2091/clinigen-reveals-aim-success-story-is-primed-for-further-growth--2091.html

Appointment of Executive Director

RNS


RNS Number : 1068J

Clinigen Group plc

11 July 2013






Group COO joins the Clinigen Board

Burton-on-Trent, UK - 11 July 2013 - Clinigen Group plc ("Clinigen" or the "Company") (AIM: CLIN) is pleased to announce the appointment of Shaun Edward Chilton (45) to the Board of Directors with effect from 11 July 2013.

Shaun Chilton has been employed by the Group since January 2012 as Chief Operating Officer and is a director of Clinigen CTS Limited and Clinigen CTS Inc., subsidiary companies of Clinigen Group plc. He will now join the Board of Clinigen Group plc as an Executive Director. Before joining Clinigen, he was the President within KnowledgePoint360 Group, a global pharmaceutical information and services operation.

He has over 20 years' commercial, strategic and operational experience in senior leadership positions in product- and service-oriented businesses within the pharmaceutical industry. He has a proven track record of creating and successfully driving business strategies delivering substantial sales, profit and market share growth in a number of international businesses; driving business transformation / change programmes and building, developing and coaching highly motivated, professional multidisciplinary teams.

Peter George, Group Chief Executive Officer said, "Since joining the Group in 2012 Shaun Chilton has been instrumental in driving the business forward, particularly in the CTS business which has grown substantially. His operational and strategic experience will be an asset to the Board as we continue to grow the business."

Shaun holds 607,600 Ordinary Shares of 0.1 pence each in the Company ("Ordinary Shares"), representing 0.74% of the Company's issued share capital. He has share options over a further 412,778 Ordinary Shares, representing 0.5% of the Company's issued share capital.

There is no further information required to be disclosed pursuant to paragraph (g) of Schedule 2 of the AIM Rules.

- Ends -

Clinigen: Profitable and cash generative; in fact a real rarity for the junior market
By Ian Lyall July 12 2013, 10:10am Opening bell: Clinigen team gather at the LSE for the company's stock market debut last September.Opening bell: Clinigen team gather at the LSE for the company's stock market debut last September.

Clinigen (LON:CLIN) was unique for an AIM float. When it came to the market last September it was both profitable and cash generative. In February it announced it would begin paying a dividend, marking it out as a real rarity of the junior market.

The suspicion at the launch of the flotation (done at 164p a share) was that Clinigen might have been dressed for market to give founder and former chairman Andrew Leaver an exit.

Part of this is true; Leaver was able to realise some of his investment (though he still holds around 30% of the speciality pharma and pharmaceutical services group).

However, Clinigen’s performance since listing suggests only a fraction of its full potential has been tapped, leaving plenty on the table for new investors.

This has begun to be reflected in the share price, which is now hovering around the 300p mark and should be seen in the full-year results if, as expected, they match analysts’ forecasts.

“What we have done since the IPO is demonstrated organic growth is quite strong,” chief executive (CEO) Peter George told Proactive Investors.

“We looked at the private equity route, but we didn't want to burden the company with too much debt.

“If we had burdened it with debt then cash would have gone to service debt rather than investing in the future products.”

Clinigen is a three-wheeled hybrid of a business that is unique, not just on AIM and in the UK, but across the world.

But the business model works and has synergies that will be the catalyst for growth for some years to come.

The first wheel, which generates around 65% of revenues, is Clinical Trials Supply (CTS).

Big pharma and the large contract research firms, when carrying out clinical studies on new blockbuster treatments, require comparator drugs and medicines that ensure patient safety. Clinigen sources and supplies these products.

The second business, Global Access Programs (GAP), is described by CEO George as the “glue in the middle” of Clinigen. By this he means it binds CTS with the speciality pharma arm.

GAP provides access to drugs that are still in clinical trials but are showing encouraging signs of efficacy to patients who are very ill and not responding to current treatments.

It will also supply life-saving products in markets where a company doesn’t have a presence but where there is demand, or where a treatment has been discontinued but is still relied on by certain patients.

All of these sound like niche areas, but with an international network, GAP generates significant, high margin sales.

Just as CTS’s role of supplier to big pharma creates opportunities for the GAP business, so GAP has been key to identifying potential drugs for its speciality pharma arm.

“The last two opportunities came from our access programme business,” said George.

In March, the group bought cancer support product Cardioxane for US$33mln from Novartis, and the plan is to revitalise this product with the aim of doubling sales. The company also in-licensed the rights to anti-bacterial VIBATIV in Europe, which it plans to launch Q1 2014.

Privately, George and the team will be hoping to weave the same magic they have with Foscavir, an anti-viral and the company’s first drug.

Bought from AstraZeneca three years ago, its sales have jumped from £4.5mln to £22mln under Clinigen’s ownership.

This is due in no small part to Clinigen’s ability to sell Foscavir into markets where it isn’t currently licensed, as well as those where it is, and demonstrates just how potent the firm’s international network is.

Cash generative and with a £20mln revolving credit facility, the group has the financial headroom to make further acquisitions. However, chief financial officer (CFO) Robin Sibson said the group might also consider issuing equity if the right opportunity came along.

However, the group has some very specific criteria a candidate drug must have before is added to the Clinigen medicine cabinet, reveals George.

“We acquire drugs that are hospital-only and that are in niche areas; at the moment we are targeting oncology, infectious disease and haematology,” he said.

“I think we have gone beyond the proof of concept that was Foscavir and we are now driving growth.”

For the CTS business the story is a very different one. “I’m not interested in buying market share in services,” says George.

“It is about what you do better than your competitors and gaining market share. All three bits of the business have very good organic growth potential. There’s a lot of value in focusing the growth on the higher margin end.”

For CTS, there is plenty more headroom for expansion as it currently has relationships with just 26 of the top 100 pharma companies, and it has demonstrated its potential by expanding turnover from £16mln to £80mln in just two years.

In GAP, it has relationships with 10-11 companies with the “potential for lots of organic growth there”, adds George.

“We have been spending our time in the last nine months ensuring this business has scalability to take advantage of the huge growth opportunities,” adds CFO Sibson.

“We have been investing in the management team and ensuring we have the structures that enable us to cope as we grow. This goes for the distribution network, too.

“We think we have de-risked the business a lot by making it more scalable, global and spreading our risks around lots of different pharma companies.”

The City broker Investec is predicting pre-tax profits will be £18.8mln in the year just ended, up from £16.9mln, rising to £24.4mln in 2014 and then to £28.1mln.

Analyst Nicholas Keher said: “We think Clinigen has a broad range of organic growth opportunities and a business model set up to maximise value from recycling cash from lower-margin divisions into higher margin activities.

“There are risks, but management appear aware of these and, on balance, we believe the shares are too cheap when looking into full-year 2014 and beyond.”

CEO George adds: “Even during a financial year where we had the IPO we have still delivered significant organic growth and we will be in line with market expectations.

“It has been an interesting year. Talk about learning on your feet; but it has been fascinating.”

INVESTMENT EXTRA: Clinigen paying dividend less than a year after AIM float

By Ian Lyall

PUBLISHED: 21:55, 12 July 2013 | UPDATED: 21:55, 12 July 2013



Opening bell: The Clinigen team at last September's market debut


Niche pharmaceutical stock Clinigen was unique for an AIM float. When it came to the market last September it was both profitable and cash generative. In February, it announced it would begin paying a dividend, marking it out as a real rarity of the junior market.


The suspicion at listing was that Clinigen might have been dressed for market to give founder and former chairman Andrew Leaver an exit.


Part of this is true: Leaver was able to realise some of his investment (though he still holds around 30 per cent of the speciality pharma and pharmaceutical services group). However, Clinigen’s performance since listing suggests only a fraction of its full potential has been tapped – leaving plenty on the table for new investors.

This has begun to be reflected in the share price, which has advanced from 164p on listing to 320p. The financial results, meanwhile, should reveal that the group is positively thriving as a quoted company.


‘What we have done since the IPO is demonstrated organic growth is quite strong,’ said chief executive Peter George.


‘We looked at the private equity route, but we didn’t want to burden the company with too much debt. If we had burdened it with debt then cash would have gone to service debt rather than investing in the future products.’


Clinigen is a three-wheeled hybrid of a business that is unique not just on AIM and in the UK, but across the world.


But the model works and has synergies that will be the catalyst for growth for some years to come.


The first wheel, which generates around 65 per cent of revenues, is Clinical Trials Supply (CTS).


Big pharma and the large contract research firms, when carrying out clinical studies on their latest new blockbusters treatments, require comparator drugs and medicines that ensure patient safety. Clinigen sources and supplies these products. The second business, Global Access Programs (GAP), is described by CEO George as the ‘glue in the middle’ of Clinigen. By this he means it binds CTS with the speciality pharma arm.

GAP provides patients who are very ill and not responding to current treatments with access to drugs that are still in clinical trials but are showing encouraging signs of efficacy.


It will also supply lifesaving products in markets where a company does not have a presence but where there is demand, or where a treatment has been discontinued but is still relied on by certain patients.


All of these sound like niche areas, but with an international network, GAP generates significant, high-margin sales.


Just as CTS’s role of supplier to big pharma creates opportunities for the GAP business, so GAP has been key to identifying potential acquisition targets for its speciality pharma arm.


Earlier this year it bought a cancer drug for £22m and in-licensed an anti-bacterial to go with an anti-viral it bought three years ago. Sales of the latter have jumped from £4.5m to £22m under Clinigen’s ownership and George and the team will be hoping to repeat the trick with the two new products.


The City broker Investec is predicting pre-tax profits will be £18.8m in the year just ended, up from £16.9m, rising to £24.4m in 2014 and then to £28.1m.


Analyst Nicholas Keher said: ‘We think Clinigen has a broad range of organic growth opportunities and a business model set up to maximise value from recycling cash from lower-margin divisions into higher-margin activities.


‘There are risks, but management appear aware of these and, on balance, we believe the shares are too cheap when looking into full-year 2014 and beyond.’


OUR VERDICT: Trading at 12 times 2014 earnings the shares offer decent value, particularly if Clinigen can increase the sales and profitability of its two newly acquired drugs.


Definitely worth a look, but set a stop loss at around 260p.

Clinigen Group PLC (CLIN:LSE) set a new high during today's trading session when it reached 333.00. Since the IPO on Sep 25, 2012, the share price is up 89.20%.

Pre-Close Trading Update

RNS


RNS Number : 0870K

Clinigen Group plc

25 July 2013






Clinigen Group plc

Pre-Close Trading Update

Burton-on-Trent, UK - 25 July 2013 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the global specialty pharmaceuticals and services company, today announces its pre-close trading update for the year ended 30 June 2013.

During the second half of the year, Clinigen continued to perform strongly across its three operational businesses, Clinical Trials Supply (CTS), Global Access Programs (GAP) and Specialty Pharmaceuticals (SP). Overall, the Board expects revenue and gross profits to show significant organic growth over prior year and to be slightly ahead of market expectations. Administrative costs have been lower than expected which has led to a further positive impact on underlying EBITDA.

CTS continues to be the main revenue generator with significant growth year on year. The most significant percentage growth was in the GAP business, where full year sales will be more than six times higher on a like-for-like basis. The SP business continues to show organic growth from sales of Foscavir. Significantly , however, we expanded the SP portfolio, through acquisition, from one to three products with the benefits of these acquisitions expected to be felt next year and beyond . The $33m acquisition of Cardioxane (dexrazoxane) from Novartis in March 2013, did, however, make a small contribution to profits in the final quarter of this year.

The Group is in a good position to continue its strategy of acquiring niche, hospital-only products into the SP business with available cash funds and a bank facility.

Peter George, Chief Executive Officer of Clinigen said:

"Since we listed last September, the Group has been transformed by a combination of continued global expansion, strong organic growth and the acquisition of two new products for the Specialty Pharmaceuticals portfolio. We have re-organised the senior management and continue to invest in the infrastructure to scale-up for our next stage of growth."

The Group expects to publish its final results for the year to 30 June 2013 on Wednesday 25 September 2013.

25 Jul Numis 430.00 Buy

Clinigen Group PLC (CLIN:LSE) set a new high during today's trading session when it reached 355.00. Since the IPO on Sep 25, 2012, the share price is up 93.18%.

Clinigen Group marching at the double - worth watching


http://www.proactiveinvestors.co.uk/companies/news/59434/clinigen-group-marching-at-the-double-59434.html

Investment summary: Impressive update

http://www.edisoninvestmentresearch.com/researchreports/ClinigenQV2607013.pdf

Yesterday’s pre-close trading update from Clinigen (LON:CLIN) had brokers queuing up to praise the fast-growing speciality pharmaceuticals firm.

Management indicated revenue and gross profits for the year just finished should show significant organic growth year-on-year, coming in slightly ahead of market expectations. Administrative costs have been lower than expected which has led to a further positive impact on underlying earnings (EBITDA).

That prompted City broker Investec to admit its earnings forecast for this year might be a bit below par.

“It appears Clinigen has delivered organic growth slightly ahead of our estimates and with lower operating costs, we expect profits will be some 10% ahead of our FY13E forecasts,” Investec said in a ‘buy’ note.

At the time of its interim results the company said the division's margins were down to 13% from 17% the year before, but management is confident of reaching a gross profit margin of 15%, according to Investec, while house broker Numis expects margins to have recovered by the end of the current financial year.

Numis has bumped up its full-year revenue estimates for 2013 and 2014 for the Clinical Trials Supply business by 3%.

The performance of the Global Access Programs (GAP) division seems to have caught Investec on the hop, with growth well ahead of the broker’s forecasts. It is not expecting a six-fold increase in GAP’s revenue every year, however.

“We understand that one or two of the division’s high profile contracts have reached peak potential ahead of our expectations, hence we do not see all the outperformance flowing into FY14E,” the broker said.




http://www.proactiveinvestors.co.uk/columns/broker-spotlight/13673/broker-round-up-ii-noricum-gold-clinigen-green-dragon-gas-13673.html

Clinigen to Manage Third Access program for BTG

RNS


RNS Number : 5245K

Clinigen Group plc

31 July 2013










Clinigen Group to Manage Third Access Program for BTG

Supplying Potentially Life-Saving Oncology Antidote in 37 European Countries

Burton-on-Trent, UK - 31 July 2013 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN) today announced that Clinigen Global Access Programs ('Clinigen GAP') has extended its existing distribution agreement with Protherics Medicines Development Ltd, a BTG International group company ('BTG'), to exclusively manage a named patient program in 37 European Countries for uridine triacetate for use as an antidote to overexposure to the chemotherapy drug 5-fluorouracil ('5-FU'). Wellstat Therapeutics Corporation ('Wellstat') is seeking approval in the US and Europe for its investigational drug, uridine triacetate, and granted named patient supply rights to BTG in the 37 European Countries in 2012. Uridine triacetate is the third product that BTG has placed under Clinigen GAP's management.

Under the named patient program, uridine triacetate will be available for healthcare professionals to treat patients who are overexposed to the widely-used cancer chemotherapy 5-FU due to dosing errors, an inability to breakdown 5-FU normally, and other forms of impaired clearance. According to data from the European Medicines Agency ('EMEA') the number of patients in the European Union affected by a 5-FU overdose each year is over 10,0001. Uridine triacetate has orphan drug designation from the EMEA and the US Food and Drug Administration ('FDA').

Although uridine triacetate is not yet approved in Europe, this program operates within regulatory compliant mechanisms to allow healthcare professionals to prescribe uridine triacetate to individual named patients. Clinigen will provide access to uridine triacetate 24 hours a day, 7 days a week.

Mark Corbett, Senior Vice President, Clinigen GAP said, "We are pleased to be extending our current agreement with BTG to add a third program to the portfolio already handled by Clinigen. We are committed to ensuring that our bespoke access program delivers uridine triacetate to health care professionals for their patients within a critical time period. 5-FU overexposure is an important unmet medical need and making available the supply of uridine triacetate on a named patient basis will provide healthcare professionals access to this investigational antidote to treat patients."


1European Medicines Agency (2009). Public summary of positive opinion for orphan designation of 2', 3', 5'-tri-O-acetyluridine for the treatment of 5-fluorouracil overdose. EMEA/COMP/231352/2009

- Ends -

1 Aug Investec 313.00 Hold

A buy in this weeks IC - Burton-on-Trent based specialist medicines supplier Clinigen (CLIN) looks to be performing well after the company reported that it looks on course to beat forecasts for earnings this year. Clinigen reports its full year results on Wednesday 25 Sept 2013. The run should continue with the first substantial contributions from acquired products.

Up 10.36% - Clinigen Group PLC (CLIN:LSE) set a new high during today's trading session when it reached 396.75. Since the IPO on Sep 25, 2012, the share price is up 125.43%.

A buy in this weeks shares mag - House broker Numis reckons Clinigen can spend £40m on acquisitions over the next year. The shares deserve their high rating - trading on 19.4 times forecast earnings for 2013 - because of growth momentum, management expertise and market opportunities.

Notice of Results

RNS


RNS Number : 3324N

Clinigen Group plc

06 September 2013






Clinigen Group plc

Notification of Full Year Results Date

Burton-on-Trent, UK - 6 September 2013 - Clinigen Group plc (AIM: CLIN), the global specialty pharmaceuticals and services company, will announce its full year results for the period ended 30 June 2013 on Wednesday, 25 September 2013.

A group analyst briefing will be held at 09:30am GMT on Wednesday, 25 September 2013 at the Group's London offices at 1 King Street, London EC2V 8AU. Analysts who wish to participate should either contact Claire Dickinson on +44 (0)20 7457 2020 or email Clinigen@CollegeHill.com to register.

- Ends -

Clinigen Group PLC




Clinigen Group plc is a fast-growing specialty global pharmaceuticals and services business, dedicated to serving patients, the medical community and the healthcare industry to supply critical life saving treatment. With offices in the UK, US and Japan, Clinigen is focused on delivering the right drug to the right patient at the right...



Clinigen seals epilepsy drug deal with Eisai
By Jamie Nimmo September 09 2013, 7:38am Epilepsy is a common neurological condition that causes seizuresEpilepsy is a common neurological condition that causes seizures

AIM-listed pharma company Clinigen (LON:CLIN) has unveiled a deal with Eisai that will see it manage an access programme for its anti-epilepsy drug Fycompa in Germany.

The agreement will mean an uninterrupted supply of the drug at no cost to the German healthcare system following the temporary suspension of commercial distribution in the country.

The programme will be managed by Clinigen GAP (Clinigen Global Access Programs) and will begin when stocks of the drug run out in Germany, which is not expected to happen until the end of this calendar year.

Fycompa is the only drug approved in Europe for countering the effects of epilepsy, a common neurological condition that causes seizures.

Chief executive Peter George said: “We look forward to assisting in the provision of continued access to Fycompa in Germany and are pleased with the confidence entrusted in us by Eisai.

“As a specialist provider of global access programmes we have the experience and expertise to deliver this bespoke access programme within Germany.”

He added: “This programme represents the addition of another major pharmaceutical company to our expanding client base.”

In Shares this week - Clinigen is in good health, better than expected results on the way a year after aim listing.

On the year to the day it joined Aim (25 Sept) the group will report sales and growth profits that could well exceed expectations, owing to robust organic growth and lower than expected costs. The market is looking for sales of £120.6 m and £20.8m pre-tax profit, double that achieved last year. It will also declare its maiden dividend of 1.8p per share, equivalent to a 0.5% yield.