Vectura Group Plc Annual Report and Accounts 2018 Our Vision Is to Transform Patients’ Lives Through Enhanced Inhaled Drug Delivery STRATEGIC REPORT Investment Case
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Vectura Group plc Transforming the lives of airways disease patients A nnual Reportnnual and Accounts 2018 Vectura Group plc Annual Report and Accounts 2018 Our vision is to transform patients’ lives through enhanced inhaled drug delivery STRATEGIC REPORT Investment case Sustained revenue growth and REPORT STRATEGIC consistent cash generation with significant pipeline potential STRATEGIC REPORT 01 Investment case 1 2 02 Highlights 04 At a glance Differentiated inhalation In-market product 06 Business model development capabilities cash flow generation 08 Chairman’s statement 10 Chief Executive’s statement + Read about our business model + Read about our in-market products 14 Markets on page 6 on page 32 18 Capabilities 22 Our strategy 28 Research and development 31 Our devices 32 Inhaled in-market 35 Non-inhaled in-market 36 Inhaled generics 3 4 38 Vectura enhanced therapies 40 Key performance indicators Focused R&D strategy with Focus on Operational 42 Risk management and principal risks pipeline progression and Excellence 50 Viability statement partnering potential 51 Financial review + Read about our R&D on page 28 58 Sustainability + Read about our pipeline on page 5 GOVERNANCE 65 Introduction from the Chairman 66 Board of Directors 68 Executive Leadership Team 69 Corporate governance report 73 Nomination Committee report 75 Audit Committee report 5 79 Remuneration Committee report Strong cash flow generation 82 Remuneration at a glance 84 Remuneration report and capital discipline 104 Directors’ report – additional disclosures + Read more in the Financial review 107 Directors’ responsibilities statement on page 51 FINANCIAL STATEMENTS 109 Independent auditor’s report 118 Consolidated income statement 119 Consolidated statement of other comprehensive income 120 Consolidated balance sheet 121 Consolidated statement of changes in equity 122 Consolidated cash flow statement 123 Notes to the consolidated financial statements For more information visit 153 Company balance sheet www.vectura.com 154 Company statement of changes @vecturagroup in equity 155 Notes to the Company financial statements 159 Glossary 160 Shareholder information Annual Report and Accounts 2018 Vectura Group plc 01 STRATEGIC REPORT Highlights Strong 2018 financial and operational performance Financial highlights • Full year reported revenue of £160.5m, +8.4% • Inhaled portfolio revenues of £131.1m, +15.0% • Strong flutiform® performance with Vectura revenues of £79.6m, +13.7%, driven by strong product supply revenues, +17.0% • Generic GSK Ellipta® deal signed with Hikma, £6.6m revenue recognised in 2018 • R&D costs of £55.5m at the lower end of the guidance range, reflecting refocused portfolio prioritisation and Paul Fry initiatives to transform R&D productivity Chief Financial Officer • Adjusted EBITDA of £39.0m, up 51.2%, driven by revenue growth, improved gross margin, lower R&D costs and productivity improvements • Operating loss of £105.4m, after ongoing amortisation and Our full-year results for 2018 exceptional items, impacted by £39.8m intangible asset demonstrate strong cash impairment following the discontinuation of the VR475 programme, as previously communicated generation and adjusted • Strong cash generation from operations, up 30.5% to EBITDA growth. £35.1m. Closing cash and cash equivalents of £108.2m, share buyback of £13.8m also completed in the year + Read more in our Financial review on page 51 Reported revenue Reported operating loss Adjusted EBITDA1 £m £m £m £160.5m £105.4m £39.0m +8.4% -9.6% +51.2% 12 months to 31/12/18 12 months to 31/12/18 12 months to 31/12/18 160.5 (105.4) 39.0 12 months to 31/12/17 12 months to 31/12/17 12 months to 31/12/17 148.0 (96.2) 25.8 Basic EPS Cash and cash equivalents 1 Adjusted EBITDA is a non-IFRS measure which is calculated as operating loss, adding back amortisation p £m and impairment, depreciation, share-based payments and exceptional items. A reconciliation of operating loss to adjusted EBITDA is presented in note 9 to the (13.2)p £108.2m financial statements. -4.8% +4.3% 12 months to 31/12/18 As at 31/12/18 (13.2) 108.2 12 months to 31/12/17 As at 31/12/17 (12.6) 103.7 02 Vectura Group plc Annual Report and Accounts 2018 STRATEGIC REPORT STRATEGIC Operational highlights • Positive progression and expansion of inhaled generics pipeline • VR315 repeat clinical trial on track to enable Hikma Pharmaceuticals (“Hikma”) to resubmit data in 2019, supporting potential launch in 2020 • Largest product agreement deal in Vectura’s history signed with Hikma for the global development of generic versions of GSK’s Ellipta® portfolio, up to $80m in future milestones plus a share of distributable net profit, up to a mid-teen percentage James Ward-Lilley Chief Executive Officer • VR2081 development continues with first clinical trial batches delivered to Sandoz • Growing clinical evidence supports the expansion of Vectura’s enhanced nebulised portfolio Focused execution of the Group’s • As previously reported, the VR475 Phase III study did not strategy resulted in strong meet the challenging primary endpoint of reduction in exacerbations in a severe adolescent and adult asthma financial and operational population. Secondary data support differentiated performance in 2018. performance versus conventional nebuliser and further validates confidence in the platform and symptom relief endpoints for VR647 • Two positive studies for VR647 (US) in children completed; results support Phase III development and partnering progression • Commenced development of three new nebulised therapies, targeting niche or orphan disease segments • Operational Excellence driving improved performance and creating additional capacity • Significant progress in R&D transformation, focused partner and alliance management and supply chain initiatives contributing to strong adjusted EBITDA performance and creating additional capacity for new nebulised pipeline projects Annual Report and Accounts 2018 Vectura Group plc 03 STRATEGIC REPORT At a glance An industry-leading inhaled airways disease-focused business Vectura is an industry-leading inhaled product formulation, device design and development business offering a uniquely integrated 450+ inhaled drug delivery platform. We develop inhalation products to Employees help patients suffering from airways diseases. Vectura’s strategy is to maximise the value of differentiated inhaled formulation, device and development capabilities through partnering c.200 complex inhaled generics and the enhanced delivery of existing molecules. Experienced scientists in our clinical, regulatory, formulation and device teams 15m+ Our target number of patients using products utilising Vectura’s Intellectual Property (IP) by 2025 (from 9m in 2018). Source: Management approximation based on 60% compliance applied to IQVIA SMART MIDAS units. Our locations Corporate office London, UK Development sites Chippenham and Cambridge, UK Muttenz, Switzerland Gauting, Germany Oral manufacturing site Lyon, France 04 Vectura Group plc Annual Report and Accounts 2018 A pipeline focused on inhaled REPORT STRATEGIC generic and nebulised therapies INHALED IN-MARKET INHALED VECTURA ENHANCED OTHER PARTNERED PRODUCTS GENERICS THERAPIES PRODUCTS 10 8 5 1 VR315 (Hikma) Asthma/COPD (US) flutiform® AB-rated substitutable generic (Mundipharma Int. and Kyorin) Ellipta® portfolio (Hikma)3 Asthma flutiform® k-haler® AB-rated substitutable generic breath-actuated, Ellipta® portfolio (Hikma)3 (Mundipharma Int.) Asthma (EU) AB-rated substitutable Vectura Enhanced Therapies Ultibro® (Novartis) generic Ellipta® portfolio Cardiopulmonary Vascular COPD (Global) (Hikma)3 Disease Seebri® (Novartis) VR730 (Hikma) Vectura Enhanced Therapies COPD (Global) Asthma/COPD (US) Cystic Fibrosis Vectura Enhanced Therapies Breelib™ (Bayer) VR506 (Hikma) Post-transplant immune PAH (EU & RoW, ex. US) Asthma (US) compromised patients AirFluSal® Forspiro® (Sandoz) VR2081 (Sandoz) VR647 (US) Asthma/COPD Asthma/COPD (US) Paediatric Asthma (EU & RoW, ex. US) Ellipta® Portfolio VR632 (Sandoz) VR736 (Ventaleon) QVM149 (Novartis) (4 Products1) (GSK) (Global) Asthma/COPD (EU)2 Severe Influenza (Global) Asthma (EU, RoW) 1 Vectura has IP in four Ellipta® products: Breo®, Anoro®, Trelegy® and Incruse®. 2 Approved in EU; launches are imminent. 3 Progressing at least three of a possible five generic GSK Ellipta® assets. + Read about our products and portfolio from page 30 Our partners Annual Report and Accounts 2018 Vectura Group plc 05 STRATEGIC REPORT Business model Proven capabilities to transform patients’ lives and create shareholder value Inhaled market opportunity es and relation ourc ship Res s Device Formulation Range of devices to Optimising drug address differing and excipients to drug delivery deliver required characteristics and clinical profile patient needs Development In-house expertise in support of the development process from early stage through to approval and launch + Read more about our capabilities on pages 18 to 21 Priority investment focus and partnering Strong cash flow generation Value creation for shareholders and others 06 Vectura Group plc Annual Report and Accounts 2018 Inhaled market opportunity REPORT STRATEGIC The inhaled market is large and diverse, with respiratory disease a major segment. There are high barriers to entry for companies focused on delivering complex inhaled generics and enhanced versions of known molecules. Vectura’s capabilities, expertise and experience position us to have a significant impact on patients’ lives and