Financial Highlights
• Revenues in line with expectations, down 2.9m (10%) to £25.5m (H1 2008: £28.4m); H1 2008 included £2.9m non-recurring manufacturing revenue
• Pre-exceptional operating profit of £4.9m (H1 2008: loss of £1.6m), resulting from reduced Flutiform™ R&D costs and cost savings
• Net loss of £6.1m (H1 2008: loss of £6.8m) post exceptional income of £0.5m (H1 2008: charge of £3.4m)
• £6.6m of 6% 2024 convertible bonds converted into ordinary shares in first half of 2009, strengthening Group balance sheet
• Cash and undrawn facilities of £23.8m at 30 June 2009 (31 December 2008: £37.5m)
• £5.0m net cash inflow in July 2009 from termination agreements with Novartis and subcontractor related to Foradil® Certihaler®
Operating Highlights
• Flutiform™ accepted for review by US FDA; meeting to determine how to address potential review issues to be held shortly
• Flutiform™ development remains on track in EU and Japan - EU filing for Flutiform™ still expected Q1 2010
• Lodotra™ launched in Germany for treatment of rheumatoid arthritis-related stiffness
o Mundipharma distribution agreement signed by partner Nitec for rest of Europe
o FDA filing planned Q2 2010
• Significant price increases negotiated for several manufactured products
• Restructuring of French and Swiss operations, reducing annual costs by approx. £2.0m.
• Dr Thomas Werner appointed to Board on retirement of Dr Jerry Karabelas
Commenting on the results, Ken Cunningham, Chief Executive Officer, said: “SkyePharma made good progress on a number of fronts during the first half of 2009, with Flutiform™ accepted for review by the FDA in the US. Although some potential review issues have been raised by the FDA we are aiming to address these as quickly as possible and we remain confident in the potential for Flutiform™ in the US and other key markets. Lodotra™ was launched in Germany for the treatment of rheumatoid arthritis-related morning stiffness and subsequently approved in other major European markets. The Company also significantly reduced its cost base through the reorganisation of manufacturing operations in France and research and development operations in Switzerland, resulting in annualised savings of around £2.0 million. We also successfully negotiated some substantial price increases for manufactured products and a £5.0 million cash settlement on the termination of agreements related to the Foradil® Certihaler®. The Company is now actively seeking partners for the SkyeHaler™ DPI.
“Trading for the second half of 2009 is expected to remain in line with the Board’s expectations, with overall revenues similar to those reported in the first half. The second half year will benefit from the cost reductions already implemented and the continuing effect of price increases for certain manufactured products negotiated in the first six months. We will continue to control cash tightly to ensure that the cash position remains sufficient to enable the Company to achieve sustainable profitability.”
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Group has twelve approved products in the areas of oral, inhalation and topical delivery. The Group’s products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com.
• Revenues in line with expectations, down 2.9m (10%) to £25.5m (H1 2008: £28.4m); H1 2008 included £2.9m non-recurring manufacturing revenue
• Pre-exceptional operating profit of £4.9m (H1 2008: loss of £1.6m), resulting from reduced Flutiform™ R&D costs and cost savings
• Net loss of £6.1m (H1 2008: loss of £6.8m) post exceptional income of £0.5m (H1 2008: charge of £3.4m)
• £6.6m of 6% 2024 convertible bonds converted into ordinary shares in first half of 2009, strengthening Group balance sheet
• Cash and undrawn facilities of £23.8m at 30 June 2009 (31 December 2008: £37.5m)
• £5.0m net cash inflow in July 2009 from termination agreements with Novartis and subcontractor related to Foradil® Certihaler®
Operating Highlights
• Flutiform™ accepted for review by US FDA; meeting to determine how to address potential review issues to be held shortly
• Flutiform™ development remains on track in EU and Japan - EU filing for Flutiform™ still expected Q1 2010
• Lodotra™ launched in Germany for treatment of rheumatoid arthritis-related stiffness
o Mundipharma distribution agreement signed by partner Nitec for rest of Europe
o FDA filing planned Q2 2010
• Significant price increases negotiated for several manufactured products
• Restructuring of French and Swiss operations, reducing annual costs by approx. £2.0m.
• Dr Thomas Werner appointed to Board on retirement of Dr Jerry Karabelas
Commenting on the results, Ken Cunningham, Chief Executive Officer, said: “SkyePharma made good progress on a number of fronts during the first half of 2009, with Flutiform™ accepted for review by the FDA in the US. Although some potential review issues have been raised by the FDA we are aiming to address these as quickly as possible and we remain confident in the potential for Flutiform™ in the US and other key markets. Lodotra™ was launched in Germany for the treatment of rheumatoid arthritis-related morning stiffness and subsequently approved in other major European markets. The Company also significantly reduced its cost base through the reorganisation of manufacturing operations in France and research and development operations in Switzerland, resulting in annualised savings of around £2.0 million. We also successfully negotiated some substantial price increases for manufactured products and a £5.0 million cash settlement on the termination of agreements related to the Foradil® Certihaler®. The Company is now actively seeking partners for the SkyeHaler™ DPI.
“Trading for the second half of 2009 is expected to remain in line with the Board’s expectations, with overall revenues similar to those reported in the first half. The second half year will benefit from the cost reductions already implemented and the continuing effect of price increases for certain manufactured products negotiated in the first six months. We will continue to control cash tightly to ensure that the cash position remains sufficient to enable the Company to achieve sustainable profitability.”
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Group has twelve approved products in the areas of oral, inhalation and topical delivery. The Group’s products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com.
