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BTG Plc Annual Report and Accounts 2018 BTG Plc Annual Report and Accounts 2018

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BTG Plc Annual Report and Accounts 2018 BTG Plc Annual Report and Accounts 2018 BTG plc Annual Report and Accounts Accounts and plc Annual Report BTG BTG plc Annual Report and Accounts 2018 2018 Imagine where we can go. At BTG, we are focused on bringing to market innovative products in specialist areas of medicine to better serve doctors and patients. Our growing portfolio of image-guided minimally invasive Interventional Medicine products is designed to advance the treatment of cancer, severe blood clots, varicose veins and severe emphysema. We also provide Pharmaceuticals that counteract certain snake venoms and toxicities associated with some heart and cancer medications. Strategic Report 04 Chairman’s introduction 06 CEO’s Strategic report 08 Market overview 10 Our business model 12 Our strategic priorities 14 Performance 28 Group financial review Governance 38 Corporate Governance report 38 Letter from the Chairman 40 Board of Directors 42 Leadership 52 Effectiveness 54 Accountability (including Audit Committee report and risk) 68 Relations with shareholders 69 Remuneration 95 Directors’ report 98 Statement of directors’ responsibilities in respect of the Annual Report 2018 and the financial statements Financials 100 Independent auditor’s report to the members of BTG plc only 108 Consolidated income statement 109 Consolidated statement of comprehensive loss/income 110 Consolidated statement of financial position 111 Consolidated statement of cash flows 112 Consolidated statement of changes in equity 113 Notes to the consolidated financial statements 154 Company financial statements Statement of financial position 155 Statement of cash flows 156 Statement of changes in equity 157 Notes to the Company financial statements 161 Five-year financial record 164 Shareholder information Overview Creating value today... Establishing leadership positions in attractive markets The role of Interventional Medicine is expanding. Advances in imaging and device technology mean that more diseases can now be treated in minimally invasive procedures. Short hospital stays and low rates of treatment complication benefit patients and healthcare providers. BTG focuses on market segments where there are large patient populations with high unmet need. We provide leading-edge interventional therapies, and we invest in activities to expand their use and to enable our customers to treat more patients. Our Pharmaceuticals business provides antidote products for conditions where there are limited or no existing treatment options. We continue to invest in product and data enhancements to ensure optimal outcomes for patients. Business units Stage Therapies Patient populations† High-growth Interventional Oncology businesses Embolic and drug-eluting beads, and radioactive microspheres to c. 325,000 treat tumours in the liver annual patients Cryoablation technology to treat worldwide solid tumours Interventional Vascular Ultrasonic catheter drug delivery device for treating severe blood clots c. 2-3m Anchoring catheters and microcatheters annual patients Interventional used to cross complex lesions and worldwide Medicine arterial blockages Early-stage Varithena® products Injectable microfoam that reduces the c. 800,000 symptoms and improves the appearance annual GSV of varicose veins procedures in the US PneumRx® Coil Implantable metal coils designed >4m to improve lung function in certain annual severe emphysema patients with severe emphysema patients worldwide Established CroFab®/DigiFab®/ cash generation Voraxaze® >10,000 Pharmaceuticals Antidote products for treating snakebite patients treated envenomation, and toxicity from annually overexposure to certain medicines Zytiga®/Two-part hip cup Licensing Royalties relating to products subject to BTG intellectual property and licence agreements † Company estimates. To learn more about our products go to pages 14 to 23. Building a scalable growth platform Overview 1,600 1,200 800 Strategic Report 400 Average number of employees number of Average 0 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 We have built our business through acquisition and organic development, and we now have a scalable platform for sustained growth. With each acquired business we have added capability as well as products, development programmes and technology platforms. We have also invested in our company infrastructure to ensure we have the right skills and experience across the business to be leaders in our field. As we have grown, successfully integrating businesses and people, we have maintained Governance a consistent company culture centred on putting our customers and their patients first. Delivering a good underlying financial performance Revenue £620.5m +9% (+10% CER1) Adjusted operating profit2 IFRS operating loss Financials £152.7m +18% (+20% CER) (£102.8m) n/m Adjusted basic EPS2 IFRS basic EPS 32.9p +42% 3.9p (55%) Free cash flow2 IFRS cash from operating activities £109.3m +69% £120.7m +63% 1. Constant exchange rate ('CER') growth is computed by restating 2017/18 results using 2016/17 foreign exchange rates for the relevant period. 2. Adjusted operating profit, Adjusted basic EPS and free cash flow are not prepared in accordance with IFRS. For definition see page 34. BTG plc Annual Report and Accounts 2018 01 Overview …while investing to ensure growth over the long term 1 Innovation and development Investing in our technology platforms to expand our portfolio and enable our customers to treat more patients. Our goal is to bring to market differentiated products with the characteristics that meet the needs of customers, patients and payers. We invest in product innovation and clinical studies, to develop new products from our current technology platforms and to expand the use of our products to new patient populations and therapy areas. Smart access Local delivery Liver Neuro Existing and Enhanced safety Kidney Vascular Healthcare potential therapy Value for money Lung Prostate themes area targets Precision Bone Pain medicine BTG Patient friendly Interventional Medicine Radiation Technology Embolisation platforms Ablation Coil and foam technology Enhanced drug activity TheraSphere® STOP-HCC and EPOCH clinical trials to expand use Liver in HCC and mCRC Lung PneumRx® Coils ELEVATE study to support market adoption Exploring how BTG products may be synergistic to immuno- Immuno-oncology oncology therapies Developing other treatment approaches to supplement Solid tumours chemoembolisation, radiation therapy and cryoablation Vascular Developing products for tougher obstructions and smaller vessels 02 BTG plc Annual Report and Accounts 2018 2 Commercial and Progress with liver cancer geographic expansion therapy in Asia, Europe Making our products available and Latin America to patients around the world. Overview During the year, the first patients were treated with TheraSphere® in Latin BTG is a global business with direct commercial America, Taiwan and Israel, and the operations in the US and major European markets. We supplement our direct sales first patients in Europe were treated activities with partnerships to ensure our with the novel radiopaque chemo- products are available worldwide. embolising bead, DC Bead LUMI™. We are investing in clinical and regulatory development activities to gain approvals to market our products in new geographies, and to secure appropriate reimbursement. We are also building our commercial and medical capabilities to support our growth Strategic Report in new territories, including China and other Asian markets, where we see significant future growth opportunities. 3 Acquisitions Roxwood Medical Sourcing leading-edge acquisition external innovation. Governance In October 2017, BTG acquired In parallel with our organic innovation and Roxwood Medical, an innovative development programmes, we will continue provider of advanced cardiovascular to seek opportunities to expand our portfolio specialty catheters used in the and pipeline through acquisitions. treatment of patients with severe We look for differentiated products and coronary and peripheral artery disease. technology platforms that will enhance our customer offering and help us develop and maintain leadership positions in our chosen therapy areas. This gives us confidence we can continue to create long-term value through disciplined allocation of capital to sourcing Financials external technologies and investing behind them. BTG plc Annual Report and Accounts 2018 03 Overview Chairman’s introduction Creating value through leadership in Interventional Medicine Our vision is to be a global leader in Interventional Medicine. This drives our growth strategy to expand our portfolio of minimally invasive products through organic development and acquisitions, and to invest in activities that support sustained product growth. Our Interventional Oncology and Interventional Vascular businesses are performing well. We were pleased to add Roxwood Medical’s specialty catheters into the Interventional Vascular portfolio in October 2017. The earlier-stage assets, Varithena® and the PneumRx® Coils, continue to progress towards key milestones. The fact that the market for the Coils is taking longer to develop than expected, has resulted in an impairment charge of approximately £145m in our results for the year, and we took the decision to reduce costs and to focus on activities to build long-term value. The Pharmaceuticals business has delivered another good performance and continues to generate significant cash that is available for reinvestment. All rights to Vistogard® were returned to Wellstat Therapeutics Corporation
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