Porton Down, UK, 25 November 2009: GW Pharmaceuticals plc (AIM: GWP), the developer and manufacturer of a range of new cannabinoid medicines, including Sativex®, announces its preliminary results for the year ended 30 September 2009.
OPERATIONAL HIGHLIGHTS
• Positive results in Sativex Phase III MS spasticity trial and long term randomised withdrawal study
• Sativex MS spasticity European regulatory submission filed with outcome expected H1 2010
• Sativex European launch preparations well underway
o Marketing teams at partners, Bayer and Almirall, preparing for launch
o Sativex manufacturing process brought in-house, thereby securing control over full supply chain
o GW commercial manufacturing licence granted by regulatory authorities
• Sativex Phase IIb/III cancer pain trial, funded by Otsuka as part of the US development programme, completed recruitment (announced today), due to report results in Spring 2010
• Sativex MS spasticity regulatory submission filed in Canada with outcome expected H2 2010
• Highly promising product pipeline in cancer, epilepsy and psychiatric illness emerging under the GW-Otsuka cannabinoid research collaboration
• GW Metabolic Research Laboratory established. Phase II trial on novel cannabinoid medicine for the treatment of dyslipidaemia in Type II diabetes patients due to commence Q2 2010
FINANCIAL HIGHLIGHTS
• Net profit after tax for the year of £1.5m (2008: £8.2m loss)
• Turnover increased to £24.1m (2008: £11.8m) reflecting revenue growth from milestone income, Otsuka alliance and Sativex sales
• Cash and short term deposits at 30 September 2009 increased to £20.6m (2008: £14.1m)
Dr Geoffrey Guy, GW’s Chairman, said: “During 2009, we have delivered our maiden full year profit, doubled turnover and improved our cash position. We also reported positive Phase III data for Sativex in MS spasticity and regulatory submissions are now underway in both Europe and Canada. In addition, we have made good progress with our US cancer pain programme and in advancing the product pipeline in exciting new areas.
“We are currently working with our marketing partners towards the first major commercial launch of Sativex. With this landmark event and further material clinical data due next year, I believe that 2010 will see GW complete the transition into a commercial stage pharmaceutical business with excellent growth prospects.”
An analyst presentation of the interim results is being held today at 09.30 at Financial Dynamics, Holborn Gate, 26 Southampton Buildings, London WC2A 1PB. Please contact Juliet Edwards at Financial Dynamics on +44 20 7269 7125 for details. An audio webcast of the presentation will be available on GW’s website at www.gwpharm.com later this afternoon.
