Porton Down, UK, 22 May 2012: GW Pharmaceuticals plc (AIM: GWP, “GW” or “the Group”), the specialty pharmaceutical company focused on cannabinoid science, announces its interim results for the six months ended 31 March 2012.
COMMERCIAL: STRONG PROGRESS
Sativex® in-market sales grow to £5.4m (H1 2011: £1.9m). Fourteen additional European country launches being planned from the end of 2012 onwards
Sativex European Mutual Recognition Procedure regulatory submission closes successfully with all ten countries recommending approval. A total of twenty one countries have now approved/recommended approval for Sativex
Almirall licence agreement amended to include new milestone payment of €11.9m (£9.8m), received in May (after period end), and expanded Sativex commercial rights to Mexico
R&D: SIGNIFICANT CLINICAL ACTIVITY
Two pivotal Sativex Phase III cancer pain trials recruiting on track. Third Phase III cancer pain trial now underway (see separate release today)
Three Phase IIa clinical trials of novel cannabinoid medicines (GWP42003 and GWP42004) in diabetes/metabolic disease ongoing. First two trials fully recruited
Phase IIa clinical trial of novel cannabinoid medicine (GWP42003) in ulcerative colitis commenced
Initial clinical trial in glioma now in planning. Lead drug candidate GWP42006 identified in pre-clinical epilepsy programme
FINANCIALS: ROBUST FINANCIAL POSITION
Total revenue of £11.1m (H1 2011: £16.6m, including £5.1m milestone payments). GW Sativex sales of £1.7m (H1 2011: £1.9m)
Net loss before tax of £4.1m in line with expectations (H1 2011: £3.1m profit)
Cash and short term deposits at 31 March 2012 of £26.2m (31 March 2011: £28.3m). Additional £9.8m milestone payment received in May, to be recognised as revenue in H2
Dr Geoffrey Guy, GW’s Chairman, said, “GW has made excellent progress in the first half of 2012. In- market sales of Sativex show strong growth and, with launches being planned in fourteen additional European countries, we expect this sales growth to continue. The market opportunity for Sativex is being expanded through three Sativex Phase III cancer pain trials, which constitute the largest clinical programme ever undertaken by GW and which are fully funded by our partner Otsuka. Success with these trials would provide an opportunity to enter the important US market as well as significantly expand the market for Sativex in the rest of the world. In addition, with four Phase II trials now underway for novel cannabinoid drug candidates and further trials in planning, we are making significant steps towards realising the value of our cannabinoid pipeline. The company is underpinned by a strong financial position and we look forward to continued progress in the second half of the year.”
An analyst presentation is being held today at 9.30am at FTI Consulting, Holborn Gate, 26 Southampton Buildings, London WC2A 1PB. Please contact Jennifer Alves at FTI Consulting on +44 20 7269 7176 for details.
Please click here to download the full release as a PDF
Enquiries:
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GW Pharmaceuticals plc |
(22/05/12) + 44 20 7831 3113 |
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Dr Geoffrey Guy, Chairman |
(Thereafter) + 44 1980 557000 |
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Justin Gover, Managing Director |
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FTI Consulting |
+ 44 20 7831 3113 |
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Ben Atwell / Simon Conway / John Dineen |
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Peel Hunt LLP |
+44 (0)20 7418 8900 |
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James Steel / Vijay Barathan |