Vectura Group Plc Annual Report and Accounts 2017 Annual Report and Accounts 2017 Accounts and Report Annual
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TRANSFORMING THE LIVES OF AIRWAYS DISEASE PATIENTS Vectura Group plc Vectura Group plc Annual Report and Accounts 2017 Annual Report and Accounts 2017 FAVORITE™ inhalation Our proprietary FAVORITE™ breath controlled nebulised technology, developed to improve effectiveness of inhaled drugs and deliver better clinical outcomes and shorter treatment times ASTHMA Asthma is one of the most common non-communicable diseases.1 Asthma is a chronic, reversible disease that inflames and narrows airways in the lungs, causing wheezing, chest tightness and coughing.2 Not all asthma is the same and severe asthma can have a number of underlying causes.3 Triggers4 Dust mites Pets Sulphites in Infections, such Physical activity, foods and drinks as colds including exercise Symptoms Prevalence • Recurring attacks of breathlessness and wheezing that • Asthma is a significant health burden of considerable vary in severity and frequency from person to person5 and growing significance with increasing urbanisation7 • Asthma attacks – a sudden worsening of symptoms, • Estimated 10m adults under the age of 45 affected in Europe9 can be unpredictable and 18.4m adults in the US9 • During an asthma attack, the lining of the bronchial • Prevalence continues to increase and it is estimated that tubes swell, causing the airways to narrow and by 2025 asthma will affect more than 400m people globally10 6 reducing the flow of air into and out of the lungs • Asthma affects people of all ages but most frequently begins in childhood11 14% of the world’s children experience asthma symptoms12 Impact 40–50% • Patients with uncontrolled asthma are significantly of patients are not well controlled14; poor more likely to suffer from poor outcomes and adherence to treatment and device user errors contribute to lack of control 15 medical emergencies • Asthma caused 383,000 deaths in 201513 By 2025 the total asthma market is expected to be worth over $17bn16 1 Latest WHO estimates, released in December 2016, 9 2014; 12; 24: 14009; Centers for Disease, Control and Prevention (CDC). Respiratory & Allergies. www.who.int/mediacentre/factsheets/fs307/en/ [Last accessed March 2018]. Available from: www.cdc.gov/nchs/fastsats/asthma.htm [Last accessed March 2018]. 2 National Heart, Lung and Blood Institute. What is asthma? Available from 10 WHO (2007) Global surveillance, prevention and control of chronic respiratory diseases: www.nhlbi.nih.gov/health-topics/asthma [Last accessed March 2018]. a comprehensive approach/Jean Bousquet and Nikolai Khaltaev. 3 Walford HH, Doherty TA. Diagnosis and management of eosinophilic asthma: a US perspective. 11 National Heart, Lung and Blood Institute. What is asthma? Available from J Asthma Allergy. 2014; 7; 53–65. www.nhlbi.nih.gov/health-topics/asthma [Last accessed March 2018]. 4 www.asthma.org.uk/advice/triggers/ [Last accessed March 2018]. 12 www.globalasthmareport.org/burden/burden.php [Last accessed March 2018]. 5 Latest WHO estimates, released in December 2016, 13 Latest WHO estimates, released in December 2016, www.who.int/mediacentre/factsheets/fs307/en/ [Last accessed March 2018]. www.who.int/mediacentre/factsheets/fs307/en/ [Last accessed March 2018]. 6 Latest WHO estimates, released in December 2016, www.who.int/mediacentre/factsheets/ 14 Adelphi DSP. fs307/en/ [Last accessed March 2018]. 15 IMS, CRITIKAL publication 2017. 7 www.globalasthmareport.org/burden/burden.php [Last accessed March 2018]. 16 Decision Resources Pharmacor Asthma (March 2017). 8 www.europeanlung.org/en/lung-disease-and-information/lung-diseases/adult-asthma [Last accessed March 2018]. COPD Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease that is characterised by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. COPD is not curable, but treatment can relieve symptoms, improve quality of life and reduce the risk of death.1 2 Risk factors Smoking (no. 1) Second hand or Exposure to indoor Occupational Frequent lower passive exposure air pollution exposure to dusts respiratory to smoke and chemicals infections 3 Symptoms Prevalence • Chronic and progressive shortness of breath • COPD is currently the fourth leading cause of death in the US4 and the World Health Organization (WHO) • Cough and mucus production predicts that COPD will be the third leading cause of • Wheezing and chest tightness death worldwide by 20305 • Infection-driven exacerbation of symptoms often • Currently the disease is largely hidden, with a large speeds up decline of lung function number of patients undiagnosed6 • Unexplained weight loss • General fatigue Approximately 330m people globally living with COPD7 8 Impact 9 out of 10 • Significant impact on daily activities and patients reported an inability to maintain quality of life their lifestyle following the onset of COPD • Estimated one in five sufferers give up work due By 2025 the total COPD market is expected to their disease to be worth over • Six out of ten patients reported feeling concern about their future earning potential as a 9 consequence of COPD $19bn 1 World Health Organization, COPD factsheet, www.who.int/mediacentre/factsheets/fs315/en/ 5 World Health Organization, COPD, www.who.int/respiratory/copd/burden/en/ [Last accessed March 2018]. [Last accessed March 2018]. 2 World Health Organization, COPD factsheet, www.who.int/mediacentre/factsheets/fs315/en/ 6 Changing the burden of COPD mortality, David M Mannino1 and Victor A Kiri, [Last accessed March 2018]. International Journal of COPD 2006:1(3) 219–233. 3 COPD foundation, www.copdfoundation.org/What-is-COPD/Understanding-COPD/What-is-COPD 7 Vos T, et al. Lancet 2012;380:2163–96. [Last accessed March 2018]. 8 COPD Uncovered, www.copdfoundation.org/pdfs/COPD-Uncovered-Report-2011 4 Changing the burden of COPD mortality, David M Mannino and Victor A Kiri, International Journal [Last accessed March 2018]. of COPD 2006:1(3) 219–233. 9 Decision Resources Pharmacor COPD (October 2016). An industry-leading inhaled airways disease-focused business with uniquely integrated formulation, device and development capabilities Strategic report Governance Financial statements 2 About us 70 Corporate governance 110 Independent auditor’s report 4 Operational and financial highlights Introduction from the Chairman 117 Consolidated income statement 6 Our integrated approach 72 Board of Directors 118 Consolidated statement of other 8 Chairman’s statement 74 Executive leadership team comprehensive income 10 Chief executive’s statement 76 Corporate governance report 119 Consolidated balance sheet 13 Markets 79 Nomination Committee report 120 Consolidated statement of changes 16 Business model 80 Audit Committee report in equity 18 Our uniquely integrated formulation, 84 Remuneration Committee report 121 Consolidated cash flow statement device and development capabilities 86 Remuneration report 122 Notes to the consolidated 24 Our strategy 105 Directors’ report – additional disclosures financial statements 34 Our in-market products 108 Directors’ responsibilities statement 151 Company balance sheet 38 Refocused R&D investment and pipeline 152 Company statement of changes in equity 46 Key performance indicators 153 Notes to the Company financial statements 48 Risk management and principal risks 156 Shareholder information 55 Viability statement 56 Financial review 64 Corporate responsibility For more information visit: www.vectura.com @vecturagroup TRANSFORMING THE LIVES OF AIRWAYS DISEASE PATIENTS STRATEGIC REPORT STRATEGIC Vectura develops products that help patients with airways diseases to live better lives Airways diseases is an umbrella term covering diseases of the airways including asthma, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis, cystic fibrosis and respiratory syncytial virus Every day hundreds of millions of people suffer from these conditions, severely impacting their quality of life Every year, millions of people die from airways-related conditions The number of people suffering from airways-related diseases is expected to grow by over 100m in the next six years alone The airways diseases market is currently valued at $40bn and is expected to grow in value to $56bn by 2025 The complexity of developing inhaled products provides a significant opportunity for a limited number of companies with proven expertise We aim to transform the lives of airways disease patients by enhancing the delivery and performance of inhaled products and through the development of high-quality generic alternatives to branded therapies. 7m+ patients treated with Vectura technologies in 20171 Breelib™ CASE STUDY Commercial validation of our FAVORITE™ technology Read more on page 23 1 Approximation based on 2017 IMS unit sales for marketed inhaled products, assuming 60% compliance. Annual Report and Accounts 2017 Vectura Group plc 1 ABOUT US We develop products that help patients with airways diseases to live better lives Our vision is clear… to be the industry-leading inhaled-drug device development specialist, transforming the lives of airways disease patients Our differentiated capabilities are validated through our extensive collaboration and licensing arrangements and through our future pipeline 20 partnered on-market revenue-generating products Extensive pipeline in key Asthma and COPD growth classes, untapped generics and fast growing specialist segments Strong underlying revenue base – key growth