LONDON, ENGLAND, 21 March 2013 – Skyepharma PLC (LSE: SKP), the expert oral and inhalation drug delivery company, today reports its annual results for the year ended 31 December 2012.
• Revenues in line with Board expectations at £49.9m (2011: £55.2m), down 10% primarily due to lower royalties in 2012 and higher sales in 2011 from manufacturing initial flutiform® launch stock
• Pre-exceptional operating profit slightly ahead of market expectations at £12.6m (2011: £11.9m), reflecting reduced investment in R&D and cost savings
• Pre-exceptional EBITDA of £15.6m (2011: £14.6m)
• Total net loss after tax from continuing operations and discontinued operations of £4.4m (2011: £1.6m)
o Net loss reflects exceptional finance charge of £15.4m from the Bond Restructuring
• Cash and cash equivalents of £16.4m at 31 December 2012 (2011: £15.2m)
• Debt restructured, aligning repayment obligations with the Group’s forecast cash generative potential
• Positive EC decision in favour of granting marketing authorisations/approvals for flutiform® led to:
o Subsequent launches in 8 European countries, and approvals in 10 additional countries to date
o €8.0m (£6.3 m) in related milestones received in October 2012
• Regulatory filing of flutiform® with the Japanese authorities in September 2012
• RAYOS® (known as LODOTRA® outside the U.S.) launched in the U.S. in December 2012; also approved in Australia, New Zealand and South Korea
• Approval and launch of GSK’s products, Paxil CR™ and Requip® Once-a-day, in Japan
• U.S. launch of EXPAREL® in April 2012 triggered milestone of U.S.$10m (£6.2m) and receipt of initial share of net sales from Pacira Pharmaceuticals, Inc
• Additional contract development services provided to RespiVert
• Two GSK pipeline products incorporating the Group’s technology filed in major markets during 2012
• Reorganisation of Swiss operations in January 2012 to improve competitiveness and cost base
• Receipt of U.S.$8.0m (£5.0m) settlement with AstraZeneca in relation to the Pulmicort pMDI termination
• Peter Grant appointed Chief Executive Officer in January 2012
Commenting on the results, Peter Grant, Chief Executive Officer, said:
“2012 has been a transformational year for Skyepharma. We saw five major regional product launches alongside a restructuring of the Group’s debt to better align repayment obligations with Skyepharma’s forecast cash generative potential. After a long and complex development programme, flutiform gained regulatory approval in Europe and resulted in several launches, including the UK and Germany. flutiform has also been filed in Japan. These developments represent significant further validation of the Group’s proprietary respiratory technology and expertise in a complex treatment area.
“The approval and launch of RAYOS in the U.S. is another milestone for the Group, being the first approval and launch in the United States of a product using Skyepharma’s unique Geoclock™ chronotechnology. Our revenues will benefit from the approvals and launches of GSK’s products Paxil CR and Requip Once-a-day in Japan and EXPAREL in the U.S., for which we received a $10 million launch milestone from Pacira earlier in the year.
“The combination of several product approvals and a much improved capital structure significantly improves the Group’s outlook and sets the stage for future growth.”
The results presentation has been published on the Company’s website and a webcast of the analysts’ results presentation will be available later today.
For further information please contact:
Peter Grant, Chief Executive Officer +44 207 881 0524
Shaun Dobson/Jennifer Wyllie +44 207 496 3000
Julia Phillips/Susan Stuart +44 207 831 3113
About Skyepharma PLC
Skyepharma combines proven scientific expertise with validated proprietary drug delivery technologies to develop innovative oral and inhalation pharmaceutical products. The Group receives revenues from 13 marketed products in the areas of inhalation, oral, topical and injectable drug delivery as well as generating income from the development of further products and technology licenses. The products developed by the Group are marketed throughout the world by big pharma as well as speciality pharmaceutical companies. For more information, visit www.skyepharma.com