Skyepharma PLC: Preliminary Results

Published: Mar 23, 2011

SkyePharma PLC (LSE: SKP), LONDON, ENGLAND, 23 March 2011 -- Financial Summary

- Trading in line with Board’s expectations - revenues up 4% to £58.1m (2009: £55.9m), benefiting from non-recurring manufacturing revenues

- Pre-exceptional operating profit up to £15.3m (2009: £15.1m)

- Profit after tax of £6.3 million (2009: loss of £1.4 million)

- Pre-exceptional EBITDA £18.6m (2009: £18.6m)

- Sufficient cash generated to cover all operating and finance costs, with net cash and undrawn facilities of £29.7m at 31 December 2010 (2009: £29.3.m)

Operating Summary

- Flutiform™ European Marketing Authorisation Application under review, preparations for potential 2011 launch progressing according to plan

- Development of Flutiform™ in Japan on track with recruitment for Phase III studies underway; Kyorin aims to file Japanese NDA by end of March 2013

- Lodotra® - launched in Italy in Q1 2011; Horizon intends to submit US NDA for Lodotra® in H2 2011

- Primary endpoints met in Phase II study of SKP-1041 for sleep maintenance

- Proof of concept study for SKP-1052 in diabetes care commenced in Q1 2011

- Pacira Pharmaceuticals filed US NDA for EXPAREL™ Sept. 2010; PDUFA date 28 July 2011

- Additional strenghtening of Business Development capacity to identify new drug delivery projects; several feasibility studies initiated funded by partners

- Dr Axel Müller appointed CEO effective 23 August 2010

Commenting on the results, Dr. Axel Müller, Chief Executive Officer, said:

“SkyePharma had a solid financial performance during 2010, finishing the year with liquidity of £29.7 million, compared with £29.3 million at the end of 2009.

“Flutiform™ remains an important potential value driver for the business and we are working with our partner Mundipharma to prepare for its launch, subject to approval, in Europe later this year. Phase III studies are now underway in Japan, a large and under-served market in the treatment of asthma. We are seeing solid progress in the rest of our pipeline in significant areas including insomnia and diabetes and with external projects such as EXPAREL™, which could be approved in the US later this year. The quality of our drug delivery technology is being demonstrated every day in our broad portfolio of marketed products and we are accelerating our efforts to identify new partnerships, with a number of feasibility studies underway financed by partners.”

The results presentation has been published on the Company’s website and a webcast of the analysts’ conference will be available later today.

For further information please contact:

SkyePharma PLC

Axel Müller, Chief Executive Officer +44 207 881 0524 Peter Grant, Chief Financial Officer

Singer Capital Markets Limited Shaun Dobson / Claes Spång +44 203 205 7500

Financial Dynamics Jonathan Birt /Sue Quigley +44 207 831 3113

About SkyePharma PLC

Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage. 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

Mo Noonan Senior Manager Financial Dynamics Holborn Gate, 26 Southampton Buildings London, WC2A 1PB D +44 (0)20 7269 7116 M +44 (0)7876 444 977

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