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Creating Excellence and Innovation Multiple Delivery Technologies

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Creating Excellence and Innovation Multiple Delivery Technologies HEAD OFFICE SKYEPHARMA PLC 46–48 grOSVENOR GARDENS LoNDON SW1W 0EB REGISTERED NO: 107582 TELEPHONE: +44 (0)207 881 0524 FAX: +44 (0)207 881 1199 email: [email protected] MULTIPLE www.skyepharma.com DELIVERY TECHNOLOGIES ANNU A L REPO R T A N D ACCOUNTS FO D ACCOUNTS CREATING EXCELLENCE AND INNOVATION R THE YE AR EN D E D 31 D ECEMBE R ENHANCING 2010 QUALITY OF LIFE FOR PATIENTS ANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2010 ADVISERS AUDItoRS ADR DEPOSITARY SkyePharma PLC Ernst & Young LLP Bank of New York Mellon Apex Plaza 101 Barclay Stret SKYEPHarma’s missiON IS TO BECOME Reading New York NY 10286 ONE OF THE WOrld’s leading RG1 1YE USA SPECIALITY DRUG DELIVERY COMPANIES, SOLICItoRS REGISTRARS Fasken Martineau LLP Capita Registrars POWERED THROUGH EXCELLENCE IN ITS 17 Hanover Square The Registry London 34 Beckenham Road ORAL AND INHALATION TECHNOLOGIES. W1S 1HU Beckenham Kent SKYEPHARMA STRIVES TO DELIVER Clifford Chance LLP BR3 4TU CLINICAL BENEFITS FOR PATIENTS 10 Upper Bank Street London Telephone: 0871 664 0300 BY USING ITS MULTIPLE DELIVERY E14 5JJ (Calls cost 10 pence per minute plus network extras) (from outside the UK: +44 (0) 20 8639 3399) TECHNOLOGIES TO CREATE CORPORATE BROKER & FINANCIAL ADVISER ENHANCED VERSIONS OF EXISTING Singer Capital Markets Ltd Lines are open Monday – Friday 8:30 a.m. – 5:30 p.m. One Hanover Street Facsimile: +44 (0) 20 8639 2220 PHARMACEUTICAL PRODUCTS. London Email: [email protected] W1S 1YZ Website:www.capitaregistrars.com Capita Share Portal: www.capitashareportal.com BANKERS OUR BUSINESS FINANCIAL STATEMENTS HSBC Bank plc Highlights/Key Events 01 Independent Auditors’ Report 56 Group Overview 02 Consolidated Income Statement 58 70 Pall Mall Marketed Products 08 Consolidated Statement of Comprehensive London OUR PERFORMANCE Income/(Expense) 59 SW1 5EZ Chairman’s Statement 10 Consolidated Balance Sheet 60 Business Review 12 Company Balance Sheet 61 Financial Review 20 Consolidated Statements of Changes in Equity 62 OUR GOVERNANCE Company Statements of Changes in Equity 63 Directors and Officers 26 Consolidated Cash Flow Statement 64 Report of the Directors 28 Notes to the Consolidated Cash Flow Corporate Social Responsibility 33 Statement 65 Corporate Governance 35 Company Cash Flow Statement 66 Remuneration Report 44 Notes to the Accounts 67 The Statement of Directors’ Responsibilities 54 Glossary of Terms 111 Shareholder Information 114 Advisers IBC OUR BUSINESS OUR PERFORMANCE OUR GOVERNANCE FINANCIAL STATEMENTS HIGHLIGHTS TOTAL REVENUES (£M) R&D EXPENDITURE (£M) GROSS NET +20% +45% 70 62.2 35 55.9 58.1 60 30 25.1 50 25 23.5 19.6 Gross 40 20 30 15 +4% 17.1 Net 20 10 14.9 10.3 10 5 0 0 2008 2009 2010 CASH FLOW (£M) PRE-EXCEPTIONAL OPERATING PROFIT (£M) 16 15.1 15.3 14 Operational 12 cash flow 26.0 10 8 10.9 6 4 Capex (4.2) 2 +1% 0 2008 2009 2010 Debt repaid (10.3) CASH & FACILITIES (£M) Net interest (11.5) 38.0 40 35 29.3 29.7 30 25 Other 1.9 20 15 10 5 -15.0 -10.0 -5.0 0.0 5.0 10.0 15.0 20.0 25.0 30.0 0 2008 2009 2010 KEY EVENTS l Flutiform™ l EXPAREL™ U.S. NDA filed Q3 2010 l MAA filed in March 2010 l Somnus Phase II study met l Launch preparations continue primary endpoints for H2 2011 l Proof-of-principle commenced l Japan Phase III studies on SKP-1052 for diabetes commenced Q4 2010 l Liquidity at 31 December 2010 l Discussion on Latin America was £29.7 million partnership continues Stock Code: SKP 01 20064.04 29/03/2011 Proof 15 SkyePharma PLC ANNUAL REPORT AND ACCOUNTS 2010 GROUP OVERVIEW VALUE PROPOSITION MULTIPLE DELIVERY TECHNOLOGIES CREATING EXCELLENCE & INNOVATION PARTNERING WITH PHARMACEUTICALS ENHANCING QUALITY OF LIFE FOR PATIENTS 02 www.skyepharma.com 20064.04 29/03/2011 Proof 15 OUR BUSINESS OUR PERFORMANCE OUR GOVERNANCE FINANCIAL STATEMENTS VALUE PROPOSITION OWN PRODUCTS PARTNERs’ PRODUCTS In house development of Apply SkyePharma own product concepts technology to partners’ products Flutiform™ Triglide™ Xatral® OD/Uroxatral® SKP-1041 (zaleplon) Paxil CR™ T 2010 EUROPEAN SKP-1052 Requip® XL RESPIRATORY MARKET FAC Sular™ worth ¤6.1 billion* OUR BUSINESS PROPOSITION IN-HOUSE PRODUCT DEVELOPMENT CONTRACT DEVELOPMENT SkyePharma develops new products using its proprietary SkyePharma is a specialist in drug delivery and is available to technologies to the proof of concept stage and then seeks to be engaged by other pharmaceutical companies to develop out-license the concept to a development partner which will fund products. SkyePharma offers a full range of contract development the remaining development. In return SkyePharma will receive capabilities including formulation, device development, scale up milestones and royalties on the development and sales. and production, regulatory affairs and clinical development. ENHANCING EXISTING PHARMACEUTICALS MANUFACTURING Through strategic partnerships, SkyePharma applies its proprietary SkyePharma provides general and specialised manufacturing technologies to existing products to enhance their effectiveness. facilities at its plant in Lyon, France. The Group also has In return for this the Group receives milestones and royalties on considerable experience of transferring and scaling up development and sales of the products. manufacturing to third party plants. REVENUE BY INCOME STREAM REVENUE BY LOCATION OF CUSTOMER 3% 5% 39% 15% n Signing and milestone 14% n UK payments £2.8m £1.6m n Rest of Europe 15% n Contract research and £38.3m development revenue n North America £8.6m £8.7m n Royalties n Rest of World £25.0m £8.3m n Manufacturing and distribution revenues 43% £22.9m 66% * Source IMS Stock Code: SKP 03 20064.04 29/03/2011 Proof 15 SkyePharma PLC ANNUAL REPORT AND ACCOUNTS 2010 GROUP OVERVIEW RESEARCH AND DEVELOPMENT AND MANUFACTURING DEVELOPMENT AND COMMERCIAL PRODUCTION RANGE OF PROPRIETARY TECHNOLOGIES FULL SERVICE SOLUTION PROVIDER SOLID DOSE FORM MANUFACTURING Serves the pharmaceutical industry by providing support in bringing high quality drugs to market fast and profitably; Flexibly spans all areas from product innovation to drug development; Employs highly skilled and experienced people. 04 www.skyepharma.com 20064.04 29/03/2011 Proof 15 OUR BUSINESS OUR PERFORMANCE OUR GOVERNANCE FINANCIAL STATEMENTS SUMMARY GROUP STRUCTURE SkyePharma PLC England Parent company (London) SkyePharma AG Jagotec AG SkyePharma Production SAS Switzerland Switzerland France Research and Development Exploitation of Intellectual Manufacturing (Muttenz) Property (Muttenz) (Lyon) RESEARCH AND DEVELOPMENT MANUFACTURING FACILITIES SkyePharma’s research and development facility is based in SkyePharma operates a fully integrated multilevel manufacturing Muttenz, near Basel, Switzerland employing approximately 100 facility in Lyon, France, employing approximately 90 staff. As staff. The majority of these are scientists who are specialists in drug well as standard manufacturing, the facility offers a number of delivery technologies coming from a number of different countries specialised capabilities, including: around the world. Their skills are combined in order to provide innovative research and development services to develop new l Wet and dry granulation – 600 litre (solvent) and 1,200 litre lines technologies and apply them to development projects. l Tablet coating l Tableting/capsule filling SkyePharma has the capability and expertise to provide a full l Dry Powder Inhaler filling and packaging line range of services to its oral and inhalation contract development l High pressure homogenisation partners including: This facility is approved by both the US FDA (inspected 2010) and l Formulation EMA (AFSSAPS inspection 2009). l Device development and commercialisation l Device scale up and production l Analytical development and method transfer l Process scale up and technology transfer PICTURED: SkyPharma’s manufacturing facility in Lyon, France with approximately l Pilot manufacturing and scale up 22,000 sq. m. of floor space. l Project management l Regulatory affairs l Clinical development The site covers approximately 5,000 square metres over two buildings, and includes laboratories and an approved cGMP pilot manufacturing facility. A successful pre-approval inspection at the site took place in 2009. T £23.5 MILLION SPENT ON RESEARCH AND FAC DEVELOPMENT IN 2010 Stock Code: SKP 05 20064.04 29/03/2011 Proof 15 SkyePharma PLC ANNUAL REPORT AND ACCOUNTS 2010 GROUP OVERVIEW OUR TECHNOLOGIES INNOVATION IN ORAL AND INHALATION TECHNOLOGIES ORAL TECHNOLOGIES ORAL SOLUBILISATION TECHNOLOGIES INHALATION TECHNOLOGIES Drug delivery technologies to deliver clinical benefits; Technological solutions to formulation and targeted delivery challenges; Generation of new product concepts. 06 www.skyepharma.com 20064.04 29/03/2011 Proof 15 OUR BUSINESS OUR PERFORMANCE OUR GOVERNANCE FINANCIAL STATEMENTS ORAL TECHNOLOGIES DISSOCUBES™ DissoCubes™ are crystalline nanoparticles of active substance obtained GEOCLOCK™ by a liquid state high energy process using a high pressure piston gap homogeniser to reduce the drug particle size in the presence of surface Combining formulation skills with controlled modifiers that associate at the freshly generated drug interface. manufacturing processes, SkyePharma has developed a novel oral drug delivery DissoCubes™ and IDD® technologies are technologies of choice for technology, Geoclock™, which allows the molecules with oral bioavailability issues and/or requiring rapid preparation of chronotherapy-focused press- onset of absorption. coated tablets. Beside the oral route, these technologies may have applications in Geoclock™ tablets have an active drug other fields such as inhaled formulations, injectable, ophthalmic in an inner layer (core) and an outer and topical products. tablet layer consisting of a mixture of hydrophobic and waxy material in SOLID LIPID NANOPARTICLES (SLN™) order to obtain a pH-independent SLN™ are nanoparticles of drug solid lipid solutions taking lag time prior to core drug delivery advantage of their small size and the presence of lipids to promote at a predetermined release rate. This drug absorption by the gastrointestinal tract. dry coating approach is designed to allow the timed release of the active core.
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