Preliminary Results for the Year Ended 30 September 2003

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Jan 21, 2004

GW Pharmaceuticals plc, the company which develops a range of new medicines based on cannabis and other controlled drugs, announces its preliminary results for the year ended 30 September 2003.

Highlights

  • Regulatory dossier for Sativex® submitted to the UK authorities in March 2003
  • Sativex regulatory assessment process well advanced. Completion expected during the second quarter of 2004.
  • Production, supply chain and marketing teams prepared for launch of Sativex
  • Marketing arrangements signed with Bayer in UK and Canada providing GW with total potential milestone payments in excess of £30m as well as a significant share of long term product sales revenues
  • Bayer extend option to licence Sativex in Europe, Australia and New Zealand into 2004
  • £19m net raised from share placing in June 2003
  • Five Phase III clinical trials recruiting as planned and due to report in 2004
  • Net loss of £8.1m (2002: £11.2m) in line with expectations
  • Cash and short term deposits of £32.0m at year end (2002: £20.2m)

Dr Geoffrey Guy, Executive Chairman, commented: “Having filed the UK regulatory submission for Sativex in March 2003, the application is now well advanced towards achieving the critical milestone of regulatory approval. The final stages in the regulatory process are underway; the timing of completion of this process is a matter of scheduling within the regulatory agency and is currently expected to occur during the second quarter of 2004.

“GW and Bayer are working very closely together to prepare for the anticipated launch of Sativex and we expect to be able to move swiftly towards market launch following a successful approval. The Bayer agreement, together with a successful institutional share placing undertaken last summer, has significantly enhanced the Group’s financial position.

“We anticipate that 2004 will see the regulatory approval and launch of Sativex. Achievement of this milestone would represent a transformation for GW as a pharmaceutical company and provide validation for the future therapeutic and market opportunities in our product pipeline. We have every reason to be extremely excited about the year ahead.”

A presentation for analysts is taking place today at 09.30 at Weber Shandwick Square Mile, Fox Court, 14 Gray’s Inn Road, London WC1. An audio webcast of the presentation will be available on this website. Access the webcast here.

Enquiries:

GW Pharmaceuticals plc

(21/01/04) 020 7067 0700

Dr Geoffrey Guy, Chairman

(Thereafter) 01980 557000

Justin Gover, Managing Director

Weber Shandwick Square Mile

020 7067 0700

Kevin Smith

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