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GW Pharmaceuticals Preliminary Results for 2012

Porton Down, UK, 28 November 2012: GW Pharmaceuticals plc (AIM: GWP, “GW” or “the Group”), the specialty pharmaceutical company focused on cannabinoid science, announces its preliminary results for the year ended 30 September 2012.

COMMERCIAL: Sativex in-market sales growth follows new country launches

  • Sativex® in-market net sales by partners grow to £10.0m (2011: £5.3m), reflecting 108% volume growth
  • Positive reimbursement decision received in Germany
  • A total of 22 countries have now approved/recommended approval for Sativex o 12 new European launches being planned from early 2013 onwards, including Italy o Regulatory submissions underway in a further eight countries
  • New post-approval data in Germany and UK show positive clinical benefits of Sativex for patients and their carers, as well as the potential to yield cost savings for healthcare systems
  • Milestone payment of €11.9m (£9.8m) received from Almirall, and extension of Almirall’s Sativex commercial rights to Mexico

SATIVEX R&D: Sativex Phase III cancer trial programme – initial US target indication

  • Three Sativex Phase III cancer pain trials ongoing – trials fully funded by US partner, Otsuka

PIPELINE R&D: Positive Phase II diabetes data highlights breadth of clinical activity

  • Positive preliminary data reported today from a Phase IIa  exploratory clinical trial of the novel cannabinoid medicine GWP42004 in type-2 diabetes (see separate announcement)
  • Phase IIa trial of novel cannabinoid medicine GWP42003 in ulcerative colitis is on-going and due to complete in mid-2013
  • Additional product candidates earmarked for entry to the clinic in 2013: Phase Ib/IIa trial in glioma in planning for 2013. Lead drug candidate GWP42006 identified in pre-clinical epilepsy programme and set to enter Phase I trial in 2013

FINANCIALS: Revenue growth and net cash inflow provides strong balance sheet to support R&D investment to maximise pipeline value

  • Total revenue increased to £33.1m (2011: £29.6m), principally reflecting increased R&D fees and milestone payments. GW Sativex sales of £2.5m (2011: £4.4m) in line with guidance
  • Net profit before tax of £1.2m (2011: £2.5m)
  • Cash and short term deposits at 30 September 2012 increased to £29.3m (30 September 2012: £28.3m)

Dr Geoffrey Guy, GW’s Chairman, said, “GW has made strong progress in 2012. We are pleased with the growth of Sativex in-market sales and look forward to further launches in up to 12 countries in Europe next year. In addition, we are now undertaking our largest ever clinical programme to expand the market opportunity for Sativex beyond multiple sclerosis to cancer pain.  This programme comprises three global Phase III cancer pain trials and is fully funded by our partner, Otsuka. Importantly, success in this indication is intended to lead to our first commercial launch in the U.S. market. Our strong financial position allows us to invest in advancing our product pipeline and we are encouraged by the positive data reported today from our first Phase II trial for GWP42004, a novel cannabinoid drug candidate, in type 2 diabetes. We look forward to progressing this and other early stage clinical programmes in 2013.”

An analyst presentation is being held today at 9.30am at FTI Consulting, Holborn Gate, 26 Southampton Buildings, London WC2A 1PB.  Please contact Natalie Garland-Collins at FTI Consulting on +44 20 7269 7121 for details. An audio webcast of the presentation will be available on GW’s website at later this afternoon.