Clinigen: Unaudited Preliminary Results Announcement For Year Ended 30 June 2015

Great Strides Made in Strategic Priorities, with Underlying EBITDA up 20%

BURTON-ON-TRENT, England--(BUSINESS WIRE)--Clinigen Group plc (AIM:CLIN, ‘Clinigen’, or the ‘Group’), the global specialty pharmaceuticals business, has today published its full year results for the 12 months ended 30 June 2015.

“With Idis, we are now the market leader in the $5+ billion unlicensed medicine supply sector and in the $2 billion clinical trial supply market. The addition of Link will substantially increase our international footprint into the Asia, Africa and Australasia region.”

The Group has also announced today a proposed acquisition of Link Healthcare (‘Link’) to strengthen Clinigen’s global footprint in Asia, Africa and Australasia, for an initial consideration of £44.5m (rising to a maximum of £100m if performance milestones over two years are achieved) – see separate release.

Financial highlights

• Revenues increased by 45% to £184.4m (2014: £126.6m)
• Gross profit increased 30%, mainly driven by 25% growth in Clinigen Specialty Pharmaceuticals (SP) gross profits and the acquisition of Idis Group Holdings Limited (‘Idis’) in April 2015
• Underlying EBITDA up 20% to £32.3m (2014: £26.8m)
• Adjusted underlying earnings per share¹ up 14% to 28.0 pence (2014: 24.5 pence), reported earnings per share at 6.0 pence (2014: 19.6 pence) are after one off acquisition costs and post-acquisition restructuring cost
• Final dividend 2.3 pence per share proposed; total dividend 3.4 pence per share (2014: 3.1 pence per share), up 10%

¹ The adjusted earnings per share is based on underlying profit after tax adjusted for amortization and associated tax for the year and the weighted average number of shares of 87,242,269

Business highlights

• Acquisition of Idis in April 2015 established the Group’s international market leader status in both unlicensed ethical supply of medicines and in clinical trials supply as well as providing commercialization opportunities for SP.
• Clinigen Clinical Trial Services (CTS): strong US performance and increase in customers to 85 (2014: 73). Developing new Expanded Value Services; ‘Just in Time’ smarter supply and labelling and direct to site services
• Idis Managed Access (MA) (includes Clinigen Global Access Programs): increase in deliveries of innovative early stage medicines to 418,000 units via 62,000 shipments (2014: 263,000 units from 40,000 shipments) with 99 products under active management
• Idis Global Access (GA): new business unit created from acquisition of Idis. Combined with the proposed acquisition of Link Healthcare, this provides Clinigen with a significant potential to shape the ethical on-demand unlicensed supply market and drug shortages market, estimated at $5bn.
• Clinigen Specialty Pharmaceuticals (SP): acquisition of fifth product, oncology support, Ethyol® (amifostine), widens portfolio and dilutes dependency on Foscavir; lifting of EMA Article 31 referral in place on Cardioxane remains on track.

Peter George, Chief Executive Officer, Clinigen, said

“Strategically, we have made great strides in progressing our two priorities – the continued revitalization of our speciality products portfolio and the strengthening of our global capabilities. We have also had a very strong financial performance reflecting our strengthening international position in growing markets.

“Our newer assets - Cardioxane, Savene and Ethyol - are all progressing to plan with the lifting of the EMA Article 31 referral on track.

“The addition of Idis in April, the strategic alliance with Cumberland in the US and today’s proposed acquisition of Link, have and will transform our international reach and capabilities, and will continue to accelerate our growth.

“With Idis, we are now the market leader in the $5+ billion unlicensed medicine supply sector and in the $2 billion clinical trial supply market. The addition of Link will substantially increase our international footprint into the Asia, Africa and Australasia region.

“Looking forward, the integration of Idis is progressing well and trading is in line with the Board’s expectations at this early stage of the year. The Board remains confident about the outlook for the full year.”

-Ends-

Analyst briefing will be held at 8:30am on Tuesday, 22 September 2015 at the offices of Instinctif Partners, 65 Gresham Street, London EC2V 7NQ.

An audio replay file will be made available shortly afterwards via the Group’s website: www.clinigengroup.com.

To see a recorded message from Peter George describing the impact of the Link proposed acquisition, see https://vimeo.com/139592580.

For the full release, please visit the Group website at www.clinigengroup.com.

About Clinigen Group

Clinigen Group is a global pharmaceutical and services company with a unique combination of businesses dedicated to delivering the right drug to the right patient at the right time. The Group consists of four synergistic businesses that provide medicines to patients with unmet medical need; through Clinigen CTS we manage the supply of commercial medicines for clinical trials, through Idis Managed Access we run early access programs for our own and other companies’ portfolios, our Idis Global Access team works directly with healthcare providers to enable ethical compliant access to unlicensed medicines, and through Clinigen SP, we market our own portfolio of niche commercial products.

We are global leaders in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need.

For more information, please visit www.clinigengroup.com.

Forward-looking statement

This announcement contains certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of Clinigen Group plc (‘Clinigen’). These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors which could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Recipients are cautioned not to place undue reliance on any forward-looking statements contained herein.