Preliminary Results for the Year Ended 30 September 2006
Preliminary Results for the Year Ended 30 September 2006
30 January 2007
Porton Down, UK, 30 January 2007: 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 2006.
Operational Highlights
- Sativex regulatory submission filed in four European countries for the relief of Spasticity in Multiple Sclerosis
- European (ex-UK) licence agreement signed with Almirall, including £12m signature fee. Launch preparations now underway
- Sativex regulatory submission filed in Canada to extend approval to the treatment of Cancer Pain
- FDA permitted Sativex to enter directly into US Phase III trials in Cancer Pain, allowing late stage US development to commence during 2007
- US Sativex licensing discussions progressing on track
- Further encouraging data from Phase III trials in MS Spasticity and Neuropathic Pain
- Phase III MS Neuropathic Pain trial recruiting on track
Financial Highlights
- Balance sheet strengthened with net cash inflow for the year of £6.8m. Significant inflows include Almirall signature fee and £8.1m US equity financing
- Cash and short term deposits at 30 September 2006 of £19.9m, ahead of guidance
- Revenues of £1.98m, including £1.35m relating to commercial sales of Sativex. £12m Almirall signature fee to be recognised as revenue over 15 years
- Net loss of £11.9m, in line with expectation
Dr Geoffrey Guy, Executive Chairman of GW, said:
“During 2006, GW made good progress in advancing the clinical and regulatory programme for Sativex in all its target indications. Having achieved approval in Canada in 2005, this year we filed regulatory submissions in four European countries for MS Spasticity and also sought to further expand the Canadian licence though a filing in Cancer Pain. In the United States, we received permission from the FDA to enter directly into late stage development. We also saw further encouraging Phase III data showing that Sativex produces improvements over and above current treatments that are highly meaningful to the everyday lives of patients.
“We look forward to an exciting 2007 in which we will seek to sign a US license agreement, commence late stage US trials, progress the ongoing regulatory submission in Europe, expand our existing market in Canada, and advance early stage cannabinoid research programmes. With Sativex continuing to show great promise and significant potential newsflow anticipated this year, GW continues to make strong progress.”
An analyst presentation of the preliminary results is being held today at 09.30 at Financial Dynamics, Holborn Gate, 26 Southampton Buildings, London WC2A 1PB. Please contact Gemma Cross Brown at Financial Dynamics on +44 20 7269 7125 for details. An audio webcast of the presentation will be available on the investor relations section of GW’s website at www.gwpharm.com later this afternoon.
Enquiries:
GW Pharmaceuticals plc (30/01/07) + 44 20 7831 3113
Dr Geoffrey Guy, Executive Chairman (Thereafter) + 44 1980 557000
Justin Gover, Managing Director
Financial Dynamics + 44 20 7831 3113
David Yates / Nicola Daley
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