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/

Interims Tues 27 Feb 18

Half year results
HIGHLIGHTS
§ Adjusted gross profit up 10% driven by strong performance by Commercial Medicines and two months contribution from Quantum Pharma plc ('Quantum')
§ Adjusted EPS up 13% to 21.2p (2016: 18.8p)
§ Strong cash flow performance with cash generated from operations of £34.3m (2016: £7.7m)
§ Interim dividend increased 10% to 1.76p (2016: 1.6p)
§ All products across Commercial Medicines portfolio performing strongly
§ Good growth in Africa and Asia Pacific region
§ Acquisition of Quantum adds complementary capability in Unlicensed Medicines and provides pipeline of products and in-house development capabilities
§ Unlicensed Medicines capability and geographical footprint further enhanced by acquisition of IMMC in Japan

28 Feb
Peel Hunt
1,350.00
Buy

Clinigen and Jazz Pharma initiate MA programme
RNS
RNS Number : 0522I
Clinigen Group plc
19 March 2018

RNS Reach
19 March 2018


Clinigen appointed by Jazz Pharmaceuticals to manage Managed Access Program for Vyxeos® (CPX-351) outside the United States
Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global pharmaceutical and services company, has been appointed by Jazz Pharmaceuticals plc (NASDAQ: JAZZ, 'Jazz') to distribute Vyxeos® (daunorubicin and cytarabine) liposome for injection via a Managed Access Program ('MAP') outside the United States.
This MAP is for the treatment of adults aged 60-75 with newly-diagnosed, therapy-related, acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos® is a dual-drug liposomal encapsulation of daunorubicin and cytarabine combined in a 1:5 molar ratio respectively.
Initially, the program is being launched in the United Kingdom, Ireland, Germany, Poland, Belgium, Switzerland, Portugal, Spain and Canada.
In August 2017, the U.S. Food and Drug Administration ('FDA') approved Vyxeos® liposome for injection for the treatment of adults with newly-diagnosed t-AML or AML-MRC. Vyxeos® is not approved for use outside of the U.S.
AML is a rapidly progressing and life-threatening blood cancer that starts from young white blood cells called granulocytes or monocytes which build up in the bone marrow - the soft inner part of the bones where new blood cells are made. It is relatively rare with approximately 21,000 people in the United States and 19,000 in the European Union diagnosed each year.1 However, it is the most common type of acute (aggressive) leukemia in adults with variable treatment options and outcomes depending on the subtype of AML and the age of the patient. It has one of the lowest survival rates of all types of leukemia.
John Lagus, Head of Managed Access, Clinigen, said:
"There is a huge unmet need for adults with AML where treatment options to date have been very few. Vyxeos® provides the first FDA approved chemotherapy treatment for patients with certain types of high-risk AML in more than 40 years."

09:20 23/05/2018
Broker Forecast - Berenberg issues a broker note on Clinigen Group
Berenberg today reaffirms its buy investment rating on Clinigen Group (LON:CLIN) and cut its price target to 1160p (from 1220p). Story provided by StockMarketWire.com Broker Forecasts data provided by www.sharesmagazine.co.uk

Extended partnership agreement signed with BMS
RNS
RNS Number : 7396P
Clinigen Group plc
31 May 2018

RNS Reach
31 May 2018

Clinigen and Bristol-Myers Squibb sign extended partnership agreement in South Africa
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has signed a commercial agreement with Bristol-Myers Squibb ('BMS') in South Africa. The agreement covers BMS' South African portfolio of products for an initial period of five years.
Clinigen's Commercial Medicines business operation will provide access for patients in South Africa for the BMS products. Clinigen will provide local regulatory expertise, supply and distribution infrastructure and experience in managing licensed medicines in the region. The agreement will lead to the transfer of Marketing Authorisations (product registration certificates) from BMS to Clinigen, which will likely be completed in the first half of 2019.
In the Africa and Asia Pacific region, Clinigen has 192 actively marketed specialist pharmaceutical and medical technology licensed products, including both branded and generic products. This agreement with Bristol-Myers Squibb will complement the Group's growing basket of essential medicine on offer to healthcare providers and their patients in the region.
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"This agreement demonstrates the long and successful relationship we have built with BMS, which began with providing access to BMS' unlicensed products globally, and has grown with Clinigen's expansion into important future growth markets.

"Clinigen is increasingly becoming the partner of choice for pharmaceutical companies to license and distribute their products. This agreement shows that our strategy for Commercial Medicines of adding regional commercial agreements to our existing portfolio of global products, a key strategic priority for the Group, is working."

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10:20 31/05/2018
Broker Forecast - Numis issues a broker note on Clinigen Group
Numis today upgrades its investment rating on Clinigen Group (LON:CLIN) to buy (from add). Story provided by StockMarketWire.com Broker Forecasts data provided by www.sharesmagazine.co.uk

Year end trading update
RNS
RNS Number : 7933U
Clinigen Group plc
17 July 2018

17 July 2018

Year end trading update

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, today provides an unaudited trading update for the year ended 30 June 2018.

The Group has had a strong year, combining a good financial performance with excellent progress on delivering the Group's strategy. The Board expects results to be in line with current market expectations and the Group is well positioned to drive further growth across all parts of the business in the year ahead.

Revenues increased by around 26% on a reported basis and by around 27% on a constant currency basis* compared to last year. This is higher than the growth in gross profit due primarily to an increased level of pass through costs within the early access part of Unlicensed Medicines. Gross profit** increased by around 14% on a reported basis and by around 16% on a constant currency basis*. Following tight cost control and benefits obtained from the integration of the acquisitions, EBITDA growth is expected to increase at a higher rate than gross profit.

Commercial Medicines continued to deliver excellent growth with the Group continuing to realise the benefits of its expanding geographical presence. The performance in Clinical Trial Services ('CTS') and Unlicensed Medicines strengthened in the second half with the latter benefiting from a number of new early access programs starting. Integration of Quantum is going to plan with the unlicensed to licensed portfolio performing well.

In addition, today the Group announced it has acquired from Novartis the global rights outside the United States to Proleukin®. Proleukin® is indicated for use in metastatic renal cell carcinoma, as well as for metastatic melanoma in certain markets and is a good fit with the Group's current Commercial Medicines portfolio of products in the oncology and infectious disease therapy areas - see separate press release.

Shaun Chilton, Group Chief Executive Officer of Clinigen, said:

"This year has demonstrated the strength and diversity of the Group's portfolio. Our largest business operation, Commercial Medicines, has had an excellent year more than offsetting weakness in CTS.

"I am particularly pleased with the performance from our acquisitions in the year, Quantum and IMMC, and the performance in the Africa and Asia Pacific region.

"With a strong balance sheet and cash generative business model, our strategy remains to drive growth across our portfolio organically, by making acquisitions and through geographic expansion."

* Constant currency is growth applying prior period's actual exchange rate to this period's result.
** Gross profit growth rates exclude the release of the fair valuation on inventory from business acquisitions.


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Clinigen acquires global rights to Imukin
RNS
RNS Number : 6382V
Clinigen Group plc
25 July 2018

RNS Reach
25 July 2018

Clinigen acquires global rights to Imukin®
from Horizon Pharma
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has acquired the global rights to Imukin® (recombinant human interferon gamma-1b) from Horizon Pharma plc ('Horizon'). Horizon will retain the rights to Actimmune® (recombinant human interferon gamma-1b) in the US, Canada and Japan.
Imukin® is licensed in 19 countries globally to reduce the frequency of serious infections in patients with Chronic Granulomatous Disease (CGD) and for the treatment of Severe Malignant Osteopetrosis (SMO), both considered rare conditions.
Clinigen will revitalise Imukin® by working with healthcare professionals to ensure its benefits to patients are well understood. The Group will also make the medicine available to those who need it through the Group's global distribution network for both licensed and unlicensed supply.
Imukin® is the second global acquisition of a biologic by Clinigen following the acquisition of the global rights (outside the US) of Proleukin® from Novartis on 17 July 2018.
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"Imukin® strengthens our commercial offering and represents a good strategic fit with our medicines portfolio growth strategy focused on products in oncology and rare diseases."
David Bryant, Chief Business Officer, Clinigen, said:
"Our second acquisition in recent weeks delivers on our long term strategy of acquiring global rights to assets with the aim of revitalising and returning them back to the broadest possible access."

1 Aug
Peel Hunt
N/A
Buy

Clinigen acquires iQone Healthcare Holding
RNS
RNS Number : 0824C
Clinigen Group plc
26 September 2018

27 September 2018

Clinigen acquires Swiss based iQone Healthcare Holding
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has agreed to acquire iQone Healthcare Holding ('iQone'), a privately owned Swiss based speciality pharmaceutical business for an initial consideration of €7.5 million (£6.7 million) on a cash free, debt free basis.
iQone is based near Geneva with operations across Europe. It has medical and commercial operations in France, Germany, Italy, Spain and Switzerland. Its team has extensive experience in the set up and delivery of both Managed Access Programs and commercial solutions across Europe.
iQone adds capability to Clinigen's Unlicensed and Commercial divisions, whilst also offering the Group a platform to support and expand its activities in mainland Europe. It also provides iQone with resources and access to an extensive customer and product base to accelerate its growth.
Clinigen is acquiring iQone on a cash free, debt free basis for a total initial consideration of €7.5 million, made up of €5.0m in cash and €2.5m in new Clinigen shares, with an additional potential deferred consideration based on the achievement of certain future EBITDA targets.
The Group has also published today its year end results and announced that it is acquiring CSM - see separate announcements.
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"Expanding our geographical footprint to support our activities in mainland Europe is a key benefit of this acquisition, along with the additional services it will offer our customers in Unlicensed Medicines. It also has the potential to drive growth in our owned Commercial Medicines portfolio.
"This acquisition coincides with our Full Year Results and the strategic acquisition of CSM, both announced earlier this morning. Today sees a significant strengthening in the Clinigen offering both through an increased global footprint, particularly in Europe, and across each of our three business divisions."
Laurent Massuyeau, Chief Executive Officer, iQone, said:
"We explored multiple strategic options which would allow iQone to grow and fulfil its potential. Clinigen is a recognised industry leader across the unlicensed and licensed medicine sectors. As both our companies share a common vision, we believe that being part of the Clinigen Group provides a compelling strategic fit and a strong growth potential."

Consideration detail
The €2.5m of initial share consideration will be satisfied through the issuance of 241,744 new Ordinary Shares in Clinigen (the "New Ordinary Shares") at an issue price of 925.13 pence per share. Application will be made to the London Stock Exchange for the New Ordinary Shares to be admitted to trading on AIM ("Admission"). It is expected that Admission will occur at 8:00 a.m. on 9 October 2018. Completion of the acquisition is expected to take place on or about 9 October 2018. The Ordinary Shares will rank pari passu with the Group's existing ordinary shares in issue.
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Proactive investor - Clinigen Group set for 77% upside according to RBC Capital
Share
15:21 15 Oct 2018
The company's prospects are boosted by recent acquisitions, and, according to RBC,more deals may follow.


Capital Network report here
RBC has a 1,470p price target
Clinigen Group PLC (LON:CLIN) shares could see some 77% upside to the current price, that’s according to RBC Capital, which rates the London listed life science company as a ‘top pick’.
RBC has a 1,470p price target, compared to the current price of around 830.3p.







“We believe acquisitions have positioned Clinigen as the No. 1 player in the ‘ethical’ supply of medications and, alongside existing products, this should lead to strong cash flow generation over the coming 5 years,” RBC analyst Nick Keher said in a note.
“With management aiming to double the number of products under its control and with the business model enhancing its product acquisition pipeline, we see this goal as likely.
READ: Clinigen raises £80mln to fund two new acquisitions
“We see further product acquisitions enhancing margins and promoting even faster earnings growth.”
Keher highlighted that further acquisitions are likely due to the company’s growing cash position and its desire to build a portfolio of ten products – and, such deals would represent a potential value catalyst for Clinigen shares.
Other possible catalysts identified by RBC include programme wins in the group’s Unlicensed Medicines division and/or upgrades created by the Quantum Pharma and CSM acquisitions.
“Clinigen trades at a material discount to its peer group but we think this discount will unwind as organic growth rates improve in FY19E,” the analyst said.
He added: “Our upside scenario values Clinigen at 1740p per share and is based upon the successful integration of recent acquisitions plus a return to growth of the CST and Unlicensed Medicines business, leading to forecast certainty and potential earnings upgrades.
“In such a scenario, we think Clinigen would hold a premium rating (c25x EPS) which we would apply to our FY20E estimates.”

In the Sunday Mail today -

THE SUNDAY TIMES
AIM-listed Clinigen specialises in supplying drugs to patients who cannot get access to them through normal channels, says Sarah Meddings in The Sunday Times Inside the City column.
Acting as a middleman, it can send a medicine that has been approved for use somewhere in the world to somewhere it has yet to get the green light — and add a mark-up for its trouble.
Demand for its services is set to surge in the next decade as patients, often in emerging markets, become more aware of the availability of life-saving treatments in different parts of the world and demand their doctor supplies them.
Since it listed on AIM in 2012, it has bought rival Idis in 2015 for £225million and Link Healthcare in the same year for £100million. In recent weeks, it returned to the acquisition trail, agreeing in September to buy CSM, a European specialist in packaging, labelling, warehousing and distribution. A second smaller deal to buy iQone, which specialises in oncology, for €7.5million (£6.6million), brought with it scientific expertise.
With increasing fears that a no-deal Brexit could cause chaos among medicine makers, Clinigen has been extremely smart. Shares have been volatile since the CSM deal was announced on September 26, falling 11.1 per cent the first day to 830p.
However, they have recovered to 902.5p, valuing the company at £1.2billion. And at 13 times expected full-year earnings, Clinigen is viewed as undervalued by analysts.
Verdict: Buy

Half Year trading update
RNS
RNS Number : 0648N
Clinigen Group plc
15 January 2019

15 January 2019

Half Year trading update

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, today provides an unaudited trading update for the six months ended 31 December 2018.

Revenues increased by around 24% on a reported basis and by around 25% on a constant currency basis* compared to last year. Gross profit** increased by around 25% on a reported basis and by around 27% on a constant currency basis* in line with the Board's expectations.

The Group completed two corporate acquisitions, CSM and iQone, in October 2018 and two product acquisitions, Proleukin® and Imukin®, in July 2018. Both of the acquired businesses have performed well.

Shaun Chilton, Group Chief Executive Officer of Clinigen, said:

"The Unlicensed Medicines portfolio performed well as anticipated, starting a number of new programs, and we have diversified our Commercial Medicines portfolio with the purchase of two specialty medicines. We are already seeing the operational benefit of combining CTS with the clinical trial capabilities of the recently acquired CSM, which when combined with iQone, also acquired in October 2018, enhance our European and US infrastructure for the benefit of all our businesses.

"We are well positioned to deliver another good year of progress."

The Group expects to publish its interim results for the six months ended 31 December 2018 on Wednesday 27 February 2019.

* Constant currency is growth applying prior period's actual exchange rate to this period's result.
** Gross profit growth rates exclude the release of the fair valuation on inventory from business acquisitions.

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