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Benefits Skills Innovation elivering elivering Skills D D Innovation 21121-04 28/3/2012 Proof 11 elivering D Benefits for the year ended 31 December 2011 SkyePharma PLC Annual Report and Accounts SkyePharma ANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2011 SkyePharma’s mission is to become a leading speciality drug delivery company, powered through excellence in its oral and inhalation technologies and expertise. SkyePharma strives to deliver clinical benefits for patients by using its multiple drug delivery technologies to create enhanced versions of pharmaceutical products. Read more online at www.skyepharma.com Our Business Financial Statements Highlights/Key Events 01 Independent Auditor’s Report 57 Business Model 02 Consolidated Income Statement 59 Group Overview 04 Consolidated Statement of Marketed Products 10 Comprehensive Income/(Expense) 60 Consolidated Balance Sheet 61 Our Performance Company Balance Sheet 62 Chairman’s Statement 12 Consolidated Statements of Changes in Equity 63 Business Review 14 Company Statements of Financial Review 22 Changes in Equity 64 Consolidated Cash Flow Statement 65 Our Governance Notes to the Consolidated Directors and Officers 30 Cash Flow Statement 66 Report of the Directors 32 Company Cash Flow Statement 67 Corporate Social Responsibility 36 Notes to the Accounts 68 Corporate Governance 38 Glossary of Terms 108 Remuneration Report 46 Shareholder Information 111 The Statement of Directors’ Advisers 112 Responsibilities 55 DELIVERING MULTIPLE TECHNOLOGIES DELIVERING MULTIPLE TECHNOLOGIES DELIVERING MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATIONCREATING EXCELLENCE AND INNOVATIONCREATING EXCELLENCE AND INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS ENHANCING QUALITY OF LIFE FOR PATIENTS ENHANCING QUALITY OF LIFE FOR PATIENTS DELIVERING MULTIPLE TECHNOLOGIES DELIVERING MULTIPLE TECHNOLOGIES DELIVERING MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATIONCREATING EXCELLENCE AND INNOVATIONCREATING EXCELLENCE AND INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS ENHANCING QUALITY OF LIFE FOR PATIENTS ENHANCING QUALITY OF LIFE FOR PATIENTS 21121-04 28/3/2012 Proof 11 HIGHLIGHTS Financial Highlights Total Revenues (£m) 70 55.9 55.2 60 50 58.1 40 Key Events 30 20 10 0 ❯❯Flutiform™ 2009 2010 2011 ❯❯Arbitration process for European approval expected to conclude later this year ❯❯Filing in Japan expected during Kyorin’s R&D Expenditure (£m) fiscal year ending 31 March 2013 35 ❯❯ 30 Licensed to Sanofi for Mexico, Central 23.5 25 19.6 and South America 20 16.8 Gross 15 10.3 ® 10 14.9 ❯❯Lodotra NDA accepted by U.S. FDA for Net 5 8.0 0 review, PDUFA date 26 July 2012 2009 2010 2011 ❯❯EXPAREL™ NDA approved by U.S. FDA, launch anticipated Q2, 2012 ❯❯Proof of concept study for SKP-1052 Pre-exceptional Operating Profit (£m) completed 35 30 ❯❯Manufacturing alliance formed with 25 20 15.1 Aenova 15 11.9 10 15.3 ❯❯Swiss operations reorganised to reduce 5 0 cost base by approximately £1.6 million 2009 2010 2011 in 2012 ❯❯ Peter Grant appointed CEO in January Cash & Facilities (£m) 2012 35 29.3 30 25 29.7 20 16.0 15 10 5 0 2009 2010 2011 Cash Flow (£m) Operational cash flow 12.3 Capex (2.6) Debt repaid (12.3) Net interest (11.3) Other DELIVERING MULTIPLE TECHNOLOGIES DELIVERING0.2 MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATION CREATING-15.0 -10. EXCELLENCE0 -5.0 0 5.0 10.0 15.0 20.0 25.0 30.AND0 INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS ENHANCING QUALITY OF LIFE FOR PATIENTS ENHANCING QUALITY OF LIFE FOR PATIENTS DELIVERING MULTIPLE TECHNOLOGIES DELIVERING MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATION CREATING EXCELLENCE AND INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS ENHANCING QUALITY OF LIFE FOR PATIENTS ENHANCING QUALITY OF LIFE FOR PATIENTS www.skyepharma.com Stock code: SKP 01 21121-04 28/3/2012 Proof 11 OUR BUSINESS MODEL DELIVERING MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS DELIVERING MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS DELIVERING In-house Development Product Partner Development Funding the remaining Development of development new products to ‘proof of concept stage’ Enhancing Existing Assets AND KNOW-HOW Pharmaceuticals Strategic partnerships enhancing existing ❯❯❯Multiple Patented Drug products to make them more effective Delivery Technologies: ❯❯❯Oral Technologies Work funded by partner ❯ ❯❯Solubilisation Technologies ❯ ❯❯Inhalation Technologies ❯❯ ❯❯Scientists and highly skilled employees from around the world specialising in ‘drug delivery’ technologies Contract ❯❯ ❯❯Specialised research and Development development facility in Switzerland Engaging with other pharmaceutical companies to develop products ❯❯ ❯❯Oral manufacturing business in Work funded by third party. Royalties due if products France leased to the Aenova Group utilise SkyePharma proprietary technology Supply Chain Management General and specialised supply chain services including manufacturing facilities. The group also has considerable experience of transferring and scaling up manufacturing to third party plants Read more online at www.skyepharma.com 02 SkyePharma PLC Annual Report and Accounts 2011 21121-04 28/3/2012 Proof 11 DELIVERING MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS DELIVERING MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS DELIVERING O Approval Sales of UR B Licensed USINESS Products Through Partner Milestone Payments, Royalties and Manufacturing Revenues Approval Sales of Licensed Products Through REVENUE Partner Further investment to enhance the quality of life for patients Milestone Payments and Royalties Provide shareholder value Royalties and Contract Development Revenues Manufacturing Revenues www.skyepharma.com Stock code: SKP 03 21121-04 28/3/2012 Proof 11 GROUP OVERVIEW VALUE PROPOSITION DELIVERING MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS DELIVERING MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS DELIVERING ❯❯Multiple❯ Delivery Value Proposition Technologies In-house product development Contract development ❯❯Creating Excellence SkyePharma develops new products using its SkyePharma is a specialist in inhalation drug & Innovation proprietary technologies to the proof of delivery and is available to be engaged by concept stage and then seeks to out-license other pharmaceutical companies to develop the concept to a development partner who inhalation products. SkyePharma offers a full ❯❯Strategic❯ Partnering will fund the remaining development. In range of contract development capabilities for Development return SkyePharma typically receives royalties including formulation, device development, and milestones on the development and scale up and production, regulatory affairs ❯❯Enhancing❯ Quality sales. SkyePharma has sub-contract and clinical development. of Life for Patients arrangements for manufacturing with production facilities in Lyon, France, and Supply chain management Sanofi at Holmes Chapel in the UK. SkyePharma provides expertise in supply chain management including general and Enhancing existing pharmaceuticals specialised manufacturing facilities at its Through strategic partnerships, SkyePharma leased plant in Lyon, France and inhalation applies its proprietary technologies and supply chain management at Muttenz in expertise to existing products to enhance Switzerland. The Group also has considerable their effectiveness. In return for this the experience of transferring and scaling up Group typically receives milestones and manufacturing to third party plants. royalties on development and sales of the products. Revenue by Income Stream Revenue by Location of Customer 32% 17% 1% 25% 16% 46% 11% 12% 40% Manufacturing and distribution UK £17.9m £9.2m Signing and milestone payments Rest of Europe £6.1m £25.4m Royalties Rest of World £22.1m £6.9m Contract research and development revenue North America £8.8m £13.7m Other revenue £0.3m £16.0 million ACT liquidity at 31 December 2011 F 04 SkyePharma PLC Annual Report and Accounts 2011 21121-04 28/3/2012 Proof 11 DELIVERING MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS DELIVERING MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS DELIVERING O UR B USINESS Delivering Benefits www.skyepharma.com Stock code: SKP 05 21121-04 28/3/2012 Proof 11 GROUP OVERVIEW RESEARCH, DEVELOPMENT AND MANUFACTURING DELIVERING MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS DELIVERING MULTIPLE TECHNOLOGIES CREATING EXCELLENCE AND INNOVATION ENHANCING QUALITY OF LIFE FOR PATIENTS DELIVERING Research and Development Manufacturing Facilities Development SkyePharma’s research and development SkyePharma has created an alliance with facility is based in Muttenz, near Basel, Aenova which has leased the Group's & Commercial Switzerland employing approximately 80 manufacturing facility in Lyon, France. The staff. The majority of these are scientists who facility is used to scale up and manufacture a Production are specialists in drug delivery technologies variety of products for both SkyePharma and coming from a number of different countries Aenova. As well as standard manufacturing, ❯❯Range❯ Of Proprietary around the world. Their skills are combined the facility offers a number of specialised
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