BTG Plc Annual Report Annual Plc BTG and Accounts 2014 Imagine Where We Can Go
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BTG plc Annual Report and Accounts 2014 BTG plc Annual Report and Accounts 2014 Imagine where we can go. Introduction BTG is a growing international specialist healthcare company. We develop innovative products in specialist areas of medicine where current treatment options are limited. Our products advance the treatment of people with liver cancer, blood clots and varicose veins, and of people who need antidotes if they are overexposed to certain medications or toxins. Inspired by patient need, we are investing to expand our portfolio with products that address today’s healthcare challenges. Partnership and innovation are at the heart of our approach. By delivering products that improve patient treatment, and that are valued by clinicians and payers, we will grow our business sustainably and will deliver significant value to all our stakeholders. Imagine where we can go. Find out more online www.btgplc.com Strategic report Our performance 02 An overview of our performance Group overview 04 this year, our business model, Chairman’s statement 06 our objectives and the principal risks Chief Executive’s review 08 we face, accompanied by relevant Our objectives 10 performance and operating information. Focus on Interventional Medicine: Vascular 14 Focus on Interventional Medicine: Oncology 16 Our business model 18 Read more page 03 Corporate citizenship 22 Market overview 24 Financial review 26 Risk management and principal risks 30 Governance Board of Directors 36 The Board of Directors and our Corporate governance report 38 approach to corporate governance Audit Committee report 46 and remuneration. Nomination Committee report 50 Directors’ remuneration report 51 Directors’ report 69 Statement of directors’ responsibilities 71 Read more page 35 Independent auditor’s report 72 Strategic report Strategic report Financials Consolidated income statement 76 Financial statements, notes Consolidated statement of comprehensive income 77 and other key data. Consolidated statement of financial position 78 Consolidated statement of cash flows 79 Consolidated statement of changes in equity 80 Read more page 75 Notes to the consolidated financial statements 81 Company statement of financial position 117 Company statement of cash flows 118 Company statement of changes in equity 118 Notes to the Company financial statements 119 Shareholder information 124 Cautionary statement and Trademarks 125 Our business model elopment produ We create value by acquiring, developing Dev cts and commercialising innovative ht Ac sig qu s i e products that meet the needs of in re i r t & i e l i L m d specialist physicians and their patients. e b e o t v a a s e p r u l n o a C i p c n d g n a a n s See page 18 d s g Core e r c o o w C purpose r t o p e h m r l u m t a c n e a r r f e ci u t a n In li a se M t Fin en ancial managem BTG plc Annual Report and Accounts 2014 01 Our performance Overview 2013/14 was a transformational year for BTG. We acquired TheraSphere®, a localised radiation treatment for liver tumours, and EKOS Corporation, which makes advanced treatments for blood clots. We also gained US approval for Varithena™, a new treatment for varicose veins. We now have a leading international portfolio with the vision to build a $1bn+ Interventional Medicine business by 2021. With the continued strong financial underpin from our Specialty Pharmaceuticals and Licensing businesses, we are able to implement the planned investments to deliver our growth targets, while seeking to further expand our portfolio through acquisition. Summary of financial performance Revenue Profit before tax 2013/14 2013/14 £290.5m £33.3m 2012/13 £233.7m 2012/13 £24.1m Change: +24% Change: +38% Contribution1 Cash and cash equivalents 2013/14 2013/14 £111.5m £38.2m 2012/13 £108.5m 2012/13 £158.7m Change: +3% Change: -76% 1 Contribution is gross profit less selling, general and administrative (SG&A) costs. See page 26 02 Strategic report The Strategic report explains in detail how we have performed this year. It provides a review of the business and a comprehensive analysis of our performance. It describes the key performance indicators we use to monitor the progress we have made, a description of the principal risks and uncertainties facing the Company, and potential future developments. This report is intended to provide shareholders with a better understanding of the Company, of its position in the markets within which it operates, Strategic report and of its prospects. Strategic report Our performance 02 Group overview 04 Chairman’s statement 06 Chief Executive’s review 08 Our objectives 10 Focus on Interventional Medicine: Vascular 14 Focus on Interventional Medicine: Oncology 16 Our business model 18 Corporate citizenship 22 Market overview 24 Financial review 26 Risk management and principal risks 30 BTG plc Annual Report and Accounts 2014 03 Group overview Our business We operate in three business segments: Interventional Medicine (oncology and vascular products), Specialty Pharmaceuticals (antidote products) and Licensing (royalties from licensed assets). Interventional Medicine Revenue split Interventional medicine aims to deliver treatments precisely to where they are £33.4m needed in the body in order to seek to Beads improve efficacy and reduce side effects. £24.7m This is a fast-growing area of medicine, ® driven by demand for better treatments TheraSphere and outcomes, by advances in imaging £20.3m techniques and product innovation. EkoSonic® BTG focuses on growing market £0.7m segments and patient populations that Brachytherapy are poorly served by current approaches. Our existing portfolio comprises products to treat people with liver tumours, blood clots and varicose veins. Interventional oncology Interventional vascular LC Bead®, DC Bead®, Bead Block® EkoSonic® Embolisation and drug-eluting Ultrasonic catheter devices that accelerate the beads that are used in the treatment penetration of thrombolytic agents into blood of a number of solid tumours including clots, to aid lysis (clot dissolution) performance. hepatocellular carcinoma (HCC, a primary liver cancer), liver metastases from colorectal cancer, and other cancers. TheraSphere® Varithena™ (polidocanol injectable foam) 1% A targeted liver cancer therapy that An engineered injectable foam product approved consists of millions of tiny radioactive in the US in November 2013 for the treatment glass microspheres that are delivered of patients with symptoms and appearance directly to liver tumours and used of incompetent veins and visible varicosities to treat patients with unresectable of the great saphenous vein (GSV) system. HCC and, outside the US, all types of liver tumours. 04 Group revenue £290.5m Contribution £111.5m £79.1m Interventional £13.8m Medicine Interventional Medicine £102.3m Specialty £58.7m Pharmaceuticals Specialty Pharmaceuticals £109.1m Licensing £39.0m Licensing Specialty Pharmaceuticals Revenue split Our Specialty Pharmaceuticals business focuses on antidote products that are £62.7m used in hospital emergency rooms and CroFab® intensive care units. The products £27.3m typically address conditions with small ® patient populations for which there are DigiFab limited or no existing treatment options. £12.0m ® Voraxaze 1 Strategic report £0.3m Uridine triacetate 1 Product not yet approved in any territory; revenue is from named patient sales where permitted. CroFab® Crotalidae Polyvalent DigiFab® Digoxin Immune Fab (Ovine) Immune Fab (Ovine) A polyclonal antibody treatment for patients with A polyclonal antibody treatment for life-threatening or potentially life-threatening the management of patients with digoxin2 toxicity or overdose. Clinically proven to North American pit viper envenomation. effectively clear digoxin from the body. Clinically proven to effectively address envenomation progression. Voraxaze® (glucarpidase) Uridine triacetate A recombinant enzyme used for A pharmaceutical product under development treatment of toxic plasma methotrexate2 with partner Wellstat Therapeutics Corporation concentrations (>1 micromole per litre) as a potential treatment for overexposure to in patients with delayed methotrexate 5-fluorouracil (5-FU)2. clearance due to impaired renal function. 2 Methotrexate and 5-FU are chemotherapies used to treat different types of cancer. Digoxin is a commonly used heart medication. Licensing Revenue split The Licensing business generates royalties from technologies that have £83.8m been licensed to others. This is no longer Zytiga® a core strategy but this business is expected to continue to deliver revenues £13.0m beyond 2020. Two-Part Hip Cup The major contributor to royalty revenues £12.3m is Johnson & Johnson’s Zytiga® Others (abiraterone acetate). This treatment for men with advanced prostate cancer is available in more than 80 countries. BTG plc Annual Report and Accounts 2014 05 Chairman’s statement We have delivered a strong financial performance, expanded our portfolio of marketed products and development opportunities and enhanced our organisational capacity and capabilities to enable the business to continue to deliver sustainable growth. “ We have had an exceptional year, transforming our business and becoming a leading player in interventional medicine.” Garry Watts Chairman 06 Performance against corporate Governance objectives Our business operates in highly regulated Our corporate objectives focus on our markets, requiring that the Board has a financial performance, delivering products continuous focus on good governance and for our customers,