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/

11 Jul Numis 650.00 Buy

year end trading update

RNS


RNS Number : 1683N

Clinigen Group plc

24 July 2014






Year end trading update

Profit growth strong; underlying EBITDA up at least 17%

Burton-on-Trent, UK - 24 July 2014 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the specialty global pharmaceutical company, today provides the following trading update for the year ended 30 June 2014.

Highlights

· Like for like revenues* on a constant currency basis up in excess of 7% on prior year and reported revenues not less than £126m.

· Gross margins increased to over 30% delivering growth in excess of 17% on prior year.

· Underlying EBITDA up at least 17% on prior year.

· Closing net cash position of £5.3m; combined with the borrowing facility of £35m, provides opportunity for continued expansion.

· Significant growth in GAP; good new business pipelines for both GAP and CTS.

· Acquisition of Savene complements Cardioxane, and strengthens dexrazoxane market position for SP.

* Like for like sales represent revenues adjusted for Foscavir stock fill (£3m) in FY13.

Group performance

Clinigen continues to drive strong organic growth, demonstrated by in excess of 50% growth in GAP revenues, greater than 10% growth in SP revenues and revenues up more than 11% in H2 on H1 in CTS. This, combined with improved gross margins and lower than expected administrative costs, has resulted in over 17% growth in underlying EBITDA.

Foscavir in-market sales are matching the global growth of the transplant market. The integration of two new products during FY14, Cardioxane and Savene, is running to plan and they are expected to complete their transition to Clinigen during FY15. Both of these brands are formulated from the active ingredient dexrazoxane, and going forward Clinigen's revitalization opportunities are enhanced by acquiring both of these products.

The Group continues to have strong cashflows, which this year have funded the acquisition of Savene and the second staged payment for Cardioxane. The closing net cash position combined with the bank facility provides funding for further product acquisitions.

Peter George, Chief Executive Officer, Clinigen said,

"This has been another great year for Clinigen. All three operating businesses have contributed to a strong trading performance and we have seen good organic growth, especially in GAP. We're particularly pleased with the increased gross margins and, yet again, the excellent growth of EBITDA.

"We are also seeing good acquisition and complementary product opportunities for SP, which supports our strategy to focus on niche, hospital-only, specialty pharmaceutical products. This strategy plays well in the current environment where big pharmaceutical companies are looking to divest more mature products.

"At this early stage, we are confident of another strong year ahead and we remain on track to be the leading provider of CTS and GAP services."



Operational businesses

· CTS

CTS continues to be the main revenue generator of the Group albeit the revenues are lumpy. Revenues in FY14 will be lower than the prior year due to the previously explained anti-viral studies in FY13 which were not repeated this year.

A recent market research report estimates the clinical trial supply market to be $1.5-2.0bn globally, with spend on individual clinical trial comparators ranging from $200K to $20m. Clinigen is in a good position, with its regulatory and global distribution expertise, to target this large market. The goal for the Group is to become the global leader in clinical trial supply and continued growth is supported by the division's strong sales pipeline.

· GAP

GAP continues to be the fastest growing Clinigen business. A measure that reflects this significant growth is the number of drug units delivered, which has increased to 58,000 in FY14 from 31,000 in the prior year.

As previously announced, H1FY14 saw the winding down of one large high revenue, lower margin program which has not been replicated in the second half of the year. Despite this, GAP has maintained its gross profits.

Clinigen GAP's growing reputation in the delivery of global access programs places it in a strong position to increase market share in the outsourced global access market, estimated to be in excess of $500m. This position is reflected in the division's robust new business pipeline.

· SP

Revenues have been boosted as a result of a full year's ownership of Cardioxane and a small contribution from newly acquired Savene in the final quarter of this year. SP remains the largest contributor to the Group's gross profits.

Foscavir continues to be a reliable generator of revenue and profits. Year on year revenues and volumes were impacted last year by stock fills and this year by new bulk supply distribution agreements, which benefit cashflow but mean actual sales do not accurately reflect in-market sales. For the full year results, the Group will report on underlying in-market sales which are expected to reflect the growth of the transplant treatment area. There has also been improvement in the average selling price of Foscavir.

Under the agreement for Cardioxane with Novartis, sales are not recognized at the market value until the Marketing Authorization (MA) for the specific territory has been transferred. All MAs for Cardioxane have now been transferred, apart from Latam and South Korea which are on schedule. The integration of Savene into the operational business also remains on track. More detail on the revitalization plans for these two dexrazoxane products will be provided at the full year results.

The lifting of the suspension on the European Marketing Authorisation for the antibiotic Vibativ, in March 2014, was an important milestone in the development of the European launch of the product. This launch is now anticipated to be October/November this year following unforeseen delays in product availability and sensitivity testing.

Overall, Clinigen continues to deliver on its objective of building its specialty pharmaceutical portfolio and is on track to have ten products over the next four to five years.



The information contained in this statement has not been audited and may be subject to further review. The Group expects to publish its final results for the year to 30 June 2014 on Wednesday 24 September 2014.



-Ends-

UPDATE - Clinigen Group sees opportunities arising from sector consolidation

By John Harrington

July 24 2014, 11:42am
UPDATE - Clinigen Group sees opportunities arising from sector consolidation

---ADDS CHIEF EXECUTIVE'S COMMENTS AND SHARE PRICE---

Speciality pharmaceutical company Clinigen (LON:CLIN) saw strong profits growth last year, with all three divisions pitching in.

Though it is early days, management is confident of another strong year this time round as it strives to become the leading global clinical trial supply (CTS) and global access programmes (GAP) company.

For the group as a whole, like-for-like (LFL) revenues on a constant currency basis in the year to 30 June are likely to be up by at least 7% year-on-year once the numbers are totted up, with reported revenues set to come in at £126mln or higher.

Gross margins during the year increased to more than 30%, delivering growth in excess of 17% on the previous year, while underlying earnings (EBITDA) were up at least 17% on the previous year.

The CTS division continues to be the main generator of revenue. This is the division that sources and supplies comparator drugs and medicines to the big pharmaceutical and contract research firms when those firms are carrying out their all-important clinical trials.

CTS revenues in fiscal 2014 (FY14) were lower than they were in FY13, as per the previously explained situation with anti-viral studies in FY13 that were not repeated in the fiscal year just finished.

The GAP division 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 continues to be the fastest growing part of the business, and despite the winding down of one large high revenue, lower margin programme in the first half of the financial year, GAP maintained its gross profits, and has a robust new business pipeline.

The third leg of the business is Specialty Pharmaceuticals (SP), where the company has been bedding down the Cardioxane acquisition and integrating the recently acquired Savene unit. SP remains the largest contributor to group profits, Clinigen revealed.

Overall, Clinigen continues to deliver on its objective of building its specialty pharmaceutical portfolio and is on track to have ten products over the next four to five years.

“We have seen good organic growth, especially in GAP. We're particularly pleased with the increased gross margins and, yet again, the excellent growth of EBITDA,” said Clinigen’s chief executive officer, Peter George.

A lot of trading updates from companies recently have grumbled about the strength of sterling, and with just 5% of its revenues derived from the UK, Clinigen is exposed to currency fluctuations, particularly in respect of sterling’s performance against the euro, the US dollar, the Swiss franc and the Japanese yen.

George was sanguine about sterling’s strength, however, saying the effect has not been huge – it’s lopped a couple of million off the top line – and it has not affected EBITDA, he told Proactive Investors.

The group ended the financial year with cash of £5.3mln, plus it has a borrowing facility of £35mln, thus providing plenty of firepower for continued expansion, particularly if the recent wave of consolidation in the pharmaceuticals sector leads to companies pruning their portfolios.

“I love it when big pharma goes into mergers & acquisitions mode,” George revealed. “The merged companies outsource more, they often have duplicate products in their portfolio, or they review what they’ve got.”

Unfortunately, while recent mergers might eventually see some interesting drugs come up for grabs, in George’s experience it won’t be for 12 to 18 months, as the merged companies go into a kind of stasis, with no one quite sure who is responsible for making the decisions.

“Once they work out who is entitled to make the decisions, you get a burst of activity, with the new decision makers determined to make their mark,” George suggested, adding that if the Shire/AbbVie merger goes through, he expects some interesting drugs to become available for purchase.

Shares in Clinigen rose 11.25p to 406p on the trading update before drifting back to 387.48p at midday.

Clinigen: N+1 Singer initiates with a target price of 439p and a buy recommendation.

MIDAS SHARE TIPS: Drugs firm Clinigen comes off boil but has right chemistry to be a winner

By Joanne Hart, Financial Mail On Sunday

Published: 22:21, 16 August 2014 | Updated: 22:46, 16 August 2014


Speciality drugs group Clinigen was founded in 2010 and within two years, it had joined AIM with a stock market value of £135million. The shares, which floated at 164p, became a market favourite and by the start of this year they had risen to more than 625p.


Since then, the stock has almost halved to 3833⁄4p. At this level, it offers real potential.


Chief executive Peter George is fiercely ambitious and has a welldefined growth plan for the business over the next three to five years. A biochemist turned entrepreneur, George spent many years working in private equity, delivering top results for demanding paymasters. He now intends to continue in that vein on AIM.


Niche: Clinigen has targeted one drug at patients receiving bone marrow transplants



The company has three divisions. It runs drug-testing programmes for large pharmaceutical groups. It acquires highly specialised medicines, with the aim of doubling their sales. And under its global access programme, it makes drugs available to patients when they have been extensively tested but have yet to receive regulatory approval.


Clinical testing of new drugs has traditionally been carried out by pharmaceutical groups themselves. Regulators need to know that a new product really is an improvement on existing treatments so new drugs are tested against market leaders. Testing conditions need to be rigorous, however, to ensure that true comparisons are made – otherwise the trial becomes invalid.




Hundreds of millions of pounds are wasted every year in clinical trials because conditions are subsequently deemed to have been sub-optimal, but Clinigen can help to cut this figure. It takes considerable care with procedures and sourcing to ensure that trials are acceptable and its testing division has increased turnover from £4million in 2010 to more than £80million.



Revenues can fluctuate from year to year. In 2013, for example, a single trial produced revenues of £24million, but larger trials often have lower profit margins than smaller ones, so profits have been growing steadily and George expects to double the size of the division by 2019.


Clinigen has also started to acquire niche drugs that have been neglected by their previous owners. The company then tries to revitalise the products by working out which patients might benefit most from them. The first drug it bought, Foscavir, was being offered to patients who had been diagnosed as HIV positive, but Clinigen realised that it would be far more helpful for those receiving bone marrow transplants, and sales have soared from £4.5 million in 2010 to more than £20 million. The company has four niche drugs today, but intends to take that up to ten over the next five years.


Clinigen’s global access programme, which makes drugs available before they are licensed, is the fastest growing division in the group. It can take years for regulators to approve new drugs, particularly in Europe, where governments are trying to cut public sector costs. In Greece, Spain and Italy, for example, very few new drugs have been licensed since the financial crisis, as health services face growing pressure to keep the lid on spending.


This can be hugely frustrating for patients – highlighted in this country by the recent outcry over the £90,000 breast cancer drug Kadcyla, which was deemed too expensive to be approved.


However, patients can access these drugs through schemes like Clinigen’s. The company cannot promote medicines that have not been approved, but top doctors, many of whom will have been involved in testing the products, already know of their existence and can apply to Clinigen for supplies.


Some pharmaceutical groups interact directly with the medical profession. Many prefer to take a step back so they are not accused of active promotion. Clinigen supplies 30 such medicines to 85 countries, including Britain, and George is keen to triple the business by 2019, making it the number one player worldwide.


Results for the year to June will be released at the end of September and are expected to show profits rising 19 per cent to £23.5million with a further increase to almost £27million forecast for 2015. Unusually for a small biotech business, Clinigen pays a dividend, which is poised to increase 15 per cent to 3p this year and a further 10 per cent to 3.3p next year.


Midas verdict: Clinigen came to the stock market in a blaze of glory and suffered at the hands of a merciless City earlier this year when it said that growth would not be quite as racy as analysts had hoped for. However, the underlying business has sound, long-term prospects and the shares offer good value at 3833⁄4p. Buy.


Traded on: AIM Ticker: CLIN

Another oncology treatment added from AstraZeneca. Investec out yesterday with buy, tp 497p and Numis today, tp 650p

Share price is waking up finally.

CLIN, RNS out today new drug. Now with the SP off the high of the day is an opportunity to jump abroad. Just bought.

CLINIGEN GROUP BROKER VIEWS

Date Broker Recommendation Price Old target price New target price Notes
20 Aug Investec Buy 429.50 497.00 512.00 Reiterates
20 Aug Numis Buy 429.50 650.00 650.00 Reiterates
20 Aug N+1 Singer Buy 429.50 439.00 439.00 Reiterates

@360 seems to be support?

360ish yep, unless 'I should have gone to specsavers'.

And Peel Hunt today 710p. I'm seeing consensus tp 577p

Been well oversold throughout the year I reckon.

Clinigen Acquires Ethyol

RNS


RNS Number : 5595P

Clinigen Group plc

20 August 2014








Clinigen Group Further Strengthens Oncology Support Portfolio with Acquisition of Ethyol® (amifostine), from AstraZeneca

Clinigen Specialty Pharmaceuticals division expands to five products

Burton-on-Trent, UK - 20 August 2014 - Clinigen Group plc ('Clinigen' or the 'Group') (LSE: CLIN) (AIM: CLIN) the specialty global pharmaceutical company today announces the acquisition of the global rights to the oncology support therapy, Ethyol® (amifostine) from AstraZeneca.

Ethyol is a cytoprotective drug indicated as an adjuvant therapy to reduce the incidence of xerostomia (dry mouth) as a side-effect in patients undergoing post-operative radiation treatment for head and neck cancer. It also reduces the cumulative renal toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer.

In 1995, the US Food and Drug Administration (FDA) granted Ethyol a New Drug Application ('NDA') and in 2013, Ethyol revenue was approximately $4.9million.

This is the second product Clinigen has acquired from AstraZeneca (the first being the anti-viral Foscavir® in 2010), and the Group's third oncology support product adding to Cardioxane® and Savene® bringing the Specialty Pharmaceuticals portfolio to five products in total.

Under the terms of the agreement, Clinigen will assume full responsibility for the distribution of the product with immediate effect. AstraZeneca, working closely with Clinigen, will continue to manufacture the product whilst the NDA and Investigational New Drug ('IND') authorizations are transferred and the technical transfer to a third party manufacturer is completed. The acquisition will be paid for in milestone related stage payments linked to the transfer of manufacturing. The financial terms of the agreement are not disclosed.

Peter George, Chief Executive Officer, Clinigen Group, said: "I am very pleased to be working with the AstraZeneca team again. In acquiring Ethyol, as well as bringing our total number of products to five, we now have a portfolio of three oncology support products, adding to Cardioxane® and Savene®. This acquisition is in line with our stated strategy of acquiring niche, hospital-only therapies which have the potential to save and improve the lives of critically ill patients. Ethyol was originally identified through our acquisition database of large pharma product candidates as a very good fit for Clinigen's business model; whilst it was one of the original 12 targets and took some time to close, it is further evidence that the Clinigen model works."

- Ends -

Clinigen - Acquisition
Today (2014-08-20 11:23:08)Print this Article
by James Faulkner

Clinigen (CLIN), the specialty pharmaceuticals and services company, has announced the acquisition of the global rights to the oncology support therapy, Ethyol (amifostine) from AstraZeneca. Ethyol is a cytoprotective (cell protecting) drug indicated as an adjuvant therapy (i.e. one that modifies the effects of other agents) to reduce the incidence of xerostomia (dry mouth) as a side-effect in patients undergoing post-operative radiation treatment for head and neck cancer.

It also reduces the cumulative renal (kidney) toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer. In 2013, Ethyol revenue was approximately $4.9 million.

Under the terms of the agreement, Clinigen will assume full responsibility for the distribution of the product with immediate effect. AstraZeneca, working closely with Clinigen, will continue to manufacture the product whilst the NDA and Investigational New Drug (IND) authorisations are transferred and the technical transfer to a third party manufacturer is completed. The acquisition will be paid for in milestone related stage payments linked to the transfer of manufacturing. The financial terms of the agreement were not disclosed.

Assessment...

We see it as a positive that Clinigen continues to reduce its reliance on its Foscavir product, especially given the recent weakness seen in this area. Ethyol is the second product Clinigen has acquired from AstraZeneca (the first being the anti-viral Foscavir in 2010), and the group's third oncology support product adding to Cardioxane and Savene bringing the Specialty Pharmaceuticals portfolio to five products in total.

Although we are disappointed by the lack of financial details in today's announcement, if Clinigen can come anywhere close to replicating the success of Foscavir with Ethyol shareholders could see decent returns. Clinigen acquired Foscavir for £9.15 million - a price to sales ratio of 2 times - from AstraZeneca in early 2010. Through its local knowledge and global reach Clinigen has successfully increased pricing around threefold in most countries, has sought (and started to receive) additional regulatory approvals, and is broadening the product's geographic footprint. Sales have grown rapidly from £4.6 million in 2009 to £21.7 million in FY2012.

We retain our belief that Clinigen has a unique combination of businesses that delivers a whole greater than the sum of the parts, which sets it in good stead to realise its ambition of becoming the number one global provider of CTS and GAP services and a major global specialty pharmaceutical company. Furthermore, the cash generative nature of the business means that acquisitions, for the most part, should be able to be funded internally from cashflow.

Valuation...

House broker Numis has noted the potential for "over 100% upside to its 5-year forecasts", should the company meet its stated ambition to become the market leader in both CTS and GAP through organic growth, and to add a further 5-7 specialty pharmaceutical (SP) products over the next 3-5 years (it has now added two since we tipped the shares in April 2013). In this context, we believe the current rating of c.15.1 times 2015 consensus forecast earnings looks like good value, especially when one factors in the rapid earnings growth anticipated over the foreseeable future (PEG <1).

Key risks include further margin erosion, acquisition risks and revenue visibility. We believe recent share price weakness has been overdone, and that the current valuation is well underpinned by the combination of a strong and unique business model, rapid earnings growth and upgrade potential. We therefore keep our stance at 'buy', at 415p.

Clinigen cancer drug acquisition keeps plan on track
Pharmaceutical company Clinigen (CLINC) has added to its cancer care portfolio after the purchase of a chemotherapy drug from AstraZeneca.

Peel Hunt analyst Stefan Hamill retained a ‘buy’ recommendation and increased the target price from 690p to 710p following the purchase of the drug, which reduces the side effects of chemotherapy. Shares jumped 3.7% yesterday on the news to 416.1p.

‘Clinigen’s acquisitions of Ethyol from AstraZeneca fits well into the portfolio, bringing its cancer supportive care portfolio to three and its total portfolio to five products, representing further execution of the plan laid out at initial public offering, when it had just one,’ he said.

‘We factor in modest numbers for Ethyol in advance of an update on the portfolio strategy at the prelims, seeing 3% earnings per share accretion from full year 2016, and moving our valuation up to 710p.’

Clinigen Group: N+1 Singer ups target price from 439p to 488p and keeps a buy recommendation.

2 Sep Oriel... 650.00 Buy

Looks ready to break that 450p level tomorrow!

Could well be tipped this weekend by SCSW, they should have something to say about the new drug.