BTG Regulatory News (BTG)

BTG plc: Interim Management Statement

London, UK, 16 July 2013: BTG plc (LSE: BTG), the specialist healthcare company, today announces its interim management statement for the period from 1 April 2013 to 15 July 2013.

During the period, the Group successfully completed the important strategic acquisitions of the Targeted Therapies division of Nordion, Inc. and EKOS Corporation. Once integrated with BTG's existing operations, the addition of these businesses, which are focused on two fast-growth segments of interventional oncology and interventional vascular, will provide BTG with a powerful platform in the interventional medicine sector, with the potential to generate over $1bn in annual revenues by 2021.

In connection with the acquisitions, on 23 May 2013 the Group raised gross proceeds of £106.3 million through a placing of 32.2 million new ordinary shares in the Company at a price of 330 pence per share.

Trading overall has been in line with the Board's expectations. Full year revenue, excluding any impact from the recent acquisitions, is anticipated to be in the range of £235m to £245m as per the guidance issued on 20 May 2013. Guidance will be updated to include the effects of recent acquisitions in due course.

The Group has also made good operational progress. In April 2013, a New Drug Application for Varisolve® (PEM), under development for treating moderate to severe varicose veins, was accepted for full review by the US Food and Drug Administration (FDA), which aims to complete its review by 4 December 2013. Commercial planning is advanced and BTG anticipates a US launch during H1 2014.

During the period, Biocompatibles, Inc. voluntarily stopped the manufacture and distribution of brachytherapy products made at the site in Oxford, CT, USA following receipt of a warning letter from the FDA citing concerns relating to process validations, data analysis, complaint investigations and environmental controls at the facility. We are working to identify and implement processes and procedures to address these concerns. In the year ended 31 March 2013, the brachytherapy business generated revenues of £7.3m and a profit before tax of less than £1.0m.

In June 2013, BTG's licensee Genzyme, a Sanofi company, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for approval of Lemtrada™ (alemtuzumab) for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical or imaging features. A decision by the US FDA is anticipated by the end of 2013; BTG will receive a royalty on all global sales of Lemtrada™ following marketing approvals.

Louise Makin, Chief Executive Officer, commented: "We are very pleased with the strategic and operational progress made in the period. The business is at an exciting stage in its development, and we are focused on executing the significant growth opportunities we now have. We are also delighted that our shareholders supported our recent capital raise to enable us to make both strategic acquisitions."

BTG's Annual General Meeting takes place at 10.30am today at the offices of Stephenson Harwood LLP, 1 Finsbury Circus, London EC2M 7SH.

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About BTG

BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and varicose veins. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG please visit our website at www.btgplc.com.