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Building Global Momentum in Drug Delivery

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Building Global Momentum in Drug Delivery Skyepharma Annual Report and Accounts for the year ended 31 December 2013 SKYEPHARMA plc Annual report and accounts for the year Ended 31 December 2013 Annual report Building global momentum in drug delivery Skyepharma AR2013.indd 3 28/03/2014 17:58:12 23122.04 28 March 2014 5:45 PM PROOF 15 Welcome to Skyepharma Skyepharma’s mission is to apply its proven scientific expertise and proprietary drug delivery technology to develop oral and inhalation pharmaceutical products which provide benefits to patients, meet market needs and create value for the Group’s stakeholders. Innovative oral and inhalation pharmaceutical products: Inhalation product development Skyepharma’s inhalation product development team in Switzerland has a proven track record of successful development of inhaled products from initial concept to development and regulatory approval, commercial manufacture and product supply. This reputation was further strengthened by the approval and subsequent launch of flutiform® in multiple territories including in Europe and Japan. Oral drug delivery Skyepharma’s oral drug delivery expertise extends from formulation to process development and scale-up, and from technology transfer and regulatory affairs to commercial manufacture. We combine our breadth and depth of expertise with our range of proprietary technologies to control when and how orally administered drugs are delivered into the body. For more information on Our Products see page 06 Skyepharma’s range of services Pre-clinical Phase I Phase II Phase III Pre-approval Post-approval Pre-formulation, Optimise Pilot scale Commercial Commercial Commercial formulation, product for manufacturing, scale capacity support, development early clinical further process/ manufacturing, industrialisation, capacity and candidate trials product work final product/ launch readiness evolution, selection process life cycle characterisation management Chemistry, manufacturing and control (CMC) Regulatory/clinical development Supply Chain development Skyepharma AR2013.indd 4 28/03/2014 17:58:13 23122.04 28 March 2014 5:45 PM PROOF 15 Skyepharma PLC Annual Report and Accounts for the year ended 31 December 2013 01 Strategic Report Our Business 2013 Highlights 02 Chairman’s Statement 03 Our Business Model 04 Market Overview 05 Marketed Products 06 Our Business Our Performance Operating Review 08 Key Performance Indicators 20 Financial Review 22 Risk Management and Internal Control 28 Corporate Social Responsibility 35 Our Governance Directors and Officers 38 Report of the Directors 40 Corporate Governance Report 43 Remuneration Report 50 Look out for these icons: Statement of Directors’ Responsibilities 70 See more information See more information within Our Business within Our Performance Financial Statements See more information See more information Independent Auditor’s Report 72 within Our Governance within Financial Statements Consolidated Income Statement 75 Consolidated Statement of Other Comprehensive Income/(Expense) 76 Consolidated Balance Sheet 77 Company Balance Sheet 78 www.skyepharma.com Consolidated Statements of Changes in Equity 79 Company Statements of Changes in Equity 80 Consolidated Cash Flow Statement 81 Notes to the Consolidated Cash Flow Statement 82 Company Cash Flow Statement 83 Notes to the Accounts 84 Glossary 131 Shareholder Information 133 Advisers 134 Skyepharma AR2013.indd 1 28/03/2014 17:58:17 23122.04 28 March 2014 5:45 PM PROOF 15 02 Skyepharma PLC www.skyepharma.com Annual Report and Accounts for the year ended 31 December 2013 Stock Code: SKP STRATEGIC REPORT STRATEGIC REVIEW 2013 Highlights Positive Momentum Total Revenues R&D Expenditure Pre-exceptional Operating Profit £62.6m £10.8m £13.6m (2012: £49.9m) (2012: £11.9m) (2012: £12.6m) Net 2013 £62.6m 2013 £0.5m £10.8m 2013 £13.6m Gross 2012 £49.9m 2012 £2.4m £11.9m (restated) 2012 £12.6m 2011 £55.2m 2011 £8.0m £16.8m 2011 £11.9m Cash and Facilities Cash Flow £17.3m £0.1m (2012: £17.2m) (2012: £1.2m) Operational cash flow 14.2 2013 £17.3m Net Capex (3.4) Debt repaid (7.1) 2012 £17.2m Interest paid (3.7) Other 0.1 2011 £16.0m For more information on Financial Statements see page 22 • Substantial progress with flutiform®: — Growth of in-market sales in Germany, UK and the Netherlands, following launch in 2012 — Further launches in Japan, Italy and 10 other countries — Substantial growth in supply revenues • Significant revenue-generating potential from third-party products: — Strong growth of sales of Pacira’s product, EXPAREL® — Approval and launches in the United States and Japan of GSK’s products Relvar® Ellipta®/Breo® Ellipta® — Approval of GSK’s products Relvar® Ellipta® in Europe and Anoro™ Elllipta™ in the United States • Renewal of lease of Lyon Facility to June 2016 • Post year-end: flutiform® launched in France, the Czech Republic and South Korea, and approved in Spain • Planned implementation of a £112m capital raising to pay off bond debt and increase the Group’s capacity to strengthen the product pipeline Relvar® Ellipta® launched in Japan Timeline of key events Anoro™ flutiform® Ellipta™ Mundipharma launched approved in announced in Japan U.S. initiation of Full-scale European Breo® Andrew Renewal of launch of flutiform® trial for use of Ellipta® Derodra lease of Lyon ® RAYOS® in launched flutiform for launched in appointed Facility to the U.S. in Italy COPD U.S. as CFO June 2016 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Skyepharma AR2013.indd 2 28/03/2014 17:58:18 23122.04 28 March 2014 5:45 PM PROOF 15 Skyepharma PLC Annual Report and Accounts for the year ended 31 December 2013 03 Chairman’s Statement On 28 March 2014 the Board approved the announcement of a Firm Placing and Placing and Open Offer (“Capital Raising”) to raise £112 million, which will enable the Group to pay off the bond debt and increase our capacity to invest more in research and development and leverage our expertise, technologies and reputation to strengthen the product pipeline. A key part of our continued success is our ability to attract and retain the best people. I am particularly pleased that we Our Business were able to welcome Andrew Derodra as Chief Financial Officer in November 2013. His broad industrial and commercial experience at companies including Tate & Lyle, SABMiller, Diageo and British Airways will be invaluable as we seek to Positioned for future growth make the most of our capabilities and target future growth. 2013 was another year of good progress for the Group and We were deeply saddened that our Senior Independent we were able to build on the momentum of newly-approved Non-Executive Director and Audit Committee Chairman, Alan and launched products across our oral and respiratory Bray, passed away in February 2014, following a sudden and portfolios. unexpectedly severe recurrence of a previous illness. Alan Our business strategy is based on two highly joined the Board of Skyepharma in September 2004 and complementary approaches – generating new product ideas had chaired the Audit Committee since shortly after that. He through to proof of concept, which we can out-license to was a very diligent, reliable and conscientious Board member partners and using our in-house expertise and technologies and he played a key role in steering the Company to the to help other companies develop their own concepts. strengthened position it is in today. He will be deeply missed by his fellow Board members and everyone at Skyepharma. Our novel respiratory combination product flutiform® demonstrated the full range of Skyepharma’s capabilities, As Alan Bray had been on the Board for 9 years, a process from initial concept and formulation working with our partners, was already underway to recruit a successor and, in to the full development and regulatory approval and the March 2014, we were pleased to welcome John Biles as management of the global supply chain. flutiform® continues Non-Executive Director, Chairman of the Audit Committee to forge ahead and by 27 March 2014 now has approvals and a member of the Remuneration and Nomination and in 28 countries, including most of Europe as well as Japan, Governance Committees. At the same time, Jean-Charles the world’s second-largest pharmaceutical market. Already Tschudin took over the role of Senior Independent Director. launched in 19 countries, we look forward to further approvals The Board continues to assess the strategy and risks of the and launches over the coming months and years. business. Following changes in UK corporate governance The Group’s cash-generating potential was further boosted in requirements, you will find that our Annual Report includes 2013 by the progress of three products where Skyepharma additional information about the work of both our Board technology is used or where Skyepharma was involved in committees and the business to ensure that risks are the initial development. GSK’s respiratory products Relvar® properly identified, evaluated, and mitigated or controlled Ellipta®/Breo® Ellipta® and Anoro™ Ellipta™, all of which use where possible. technology licensed from Skyepharma, gained approvals in We are proud of the quality and dedication of our workforce key markets during 2013 and the Group is entitled to royalty and I would like to take this opportunity to thank the payments on net sales. Also, the long-acting analgesic, employees of the Group for their commitment and hard EXPAREL®, a product of our former Injectable Business, on work in ensuring the continued success of Skyepharma. which we are entitled to milestones and a share of net sales, continues to grow rapidly in the United States. I would also like to thank you, our shareholders, for your continued support as we strive to build on the platform for With sales of flutiform® growing in multiple markets and a growth that has been created over the past few years. strengthening financial position, we are now well placed to focus our resources and efforts on identifying new opportunities Frank Condella in both the oral and respiratory markets.
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