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Annual Report 2015 2 Biocartis Annual Report 2015 2 Sooner “or later, we are all patients.” RUDI PAUWELS, FOUNDER AND CEO BIOCARTIS 2015 Highlights 05 4. Remuneration report 76 76 Interview Biocartis Chairman Rudi Mariën 07 4.1. Remuneration policy and CEO & Founder Rudi Pauwels​​ 4.2. Remuneration of Directors 76 Disclaimer and other information​​​​​​ 09 4.3. Remuneration of members of the 77 executive team 80 1. Business section 10 4.4. Relative weighting of each component of the remuneration 1.1. About Biocartis Group 12 4.5. Characteristics of the stock options 80 1.2. Risks related to our business​​​​​ 18 4.6. Changes to the remuneration policy 82 1.3. Review 2015​​​​​​​ 25 4.7. Remuneration policy for the next two 83 1.4. Biocartis as an organisation​​​​​ 35 financial years (2016-2017) 3 1.5. Activities 39 4.8. Main contractual conditions 83 2. The Biocartis share 52 5. Consolidated annual accounts 86 2.1. Outstanding shares and share capital 52 5.1. Consolidated financial statements as of 86 and for the years ended 31 December 2.2. Share performance​​​​​​ 53 2015 and 2014 2.3. Trading volume 53 5.2. Notes to the consolidated financial 91 2.4. Shareholders 54 statements 2.5. Analyst coverage 56 2.6. Financial calendar 56 6. Statutory Annual Accounts 140 6.1. Abbreviated statutory annual accounts 140 2.7. Investor relation details 56 6.2. Activity Biocartis Group NV 140 6.3. Income statement and balance sheet 140 3. Corporate Governance 60 Biocartis Group NV 3.1. Introduction 60 6.4. Discussion of statutory accounts 141 3.2. Internal & External control 61 6.5. Appropriation of results 143 3.3. Protection schemes 63 6.6. Going concern valuation rules 143 3.4. Board of Directors 66 3.5. Committees of the board of directors 69 7. Statutory Auditor’s Report 144 3.6. Other information 70 7.1. Statutory Auditor’s Report 144 3.7. Executive management 72 7.2. Disclosure Audit fees 145 3.8. Share ownership of the members of the 73 executive management team 8. Glossary 146 ANNUAL REPORT 2015 Innovative molecular diagnostics 4 company Biocartis provides next generation diagnostic solutions aimed at improving clinical practice for the COMMITTED TO ESTABLISH A benefit of patients, clinicians, payers and the industry. NEW GOLD STANDARD IN Biocartis’ proprietary MDx Idylla™ platform is a DIAGNOSTIC TESTING WITH fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers ITS UNIQUE PROPRIETARY accurate, highly reliable molecular information from virtually any biological sample, in virtually any setting, MOLECULAR DIAGNOSTICS allowing fast and effective treatment selection and treatment progress monitoring. PLATFORM IDYLLA™ Biocartis’ solutions focus on addressing unmet needs in oncology and infectious diseases. Listed on Euronext Commercialising an Headquartered in Focused on oncology and Brussels since April 2015, unique proprietary MDx Belgium (Mechelen) infectious diseases ticker BCART platform Idylla™ 2015 highlights Idylla™ instrument and console instrumentation outsourced Management team strengthened 278 employees, 25 nationalities balanced gender diversity 52% Covering over 55 men and 48% women 5 countries worldwide Biocartis’ DNA reinforced: 5 new collaborations employee campaign signed to accelerate ‘Sense, Think, Share, Do’ menu development EUR 15m operating income EUR 115m gross proceeds IPO MDx EUR 104.1m year-end cash position Installed base of 165 Idylla™ instruments 4 new tests launched 5 assays on the market in 15 months’ time ANNUAL REPORT 2015 6 “WE PRESENT TO YOU OUR VERY FIRST ANNUAL REPORT AS A LISTED COMPANY. IN THIS REPORT, WE WANT TO TAKE YOU ON “ BOARD IN OUR JOURNEY TOWARDS FASTER, HIGHLY ACCURATE DIAGNOSTICS, CLOSER TO THE POINT OF IMPACT AND UPDATE YOU ON OUR ACHIEVEMENTS FOR 2015.” RUDI PAUWELS, BIOCARTIS CEO & FOUNDER Chairman and CEO reflections and outlook BIOCARTIS CHAIRMAN RUDI MARIËN AND CEO & FOUNDER RUDI PAUWELS LOOK BACK ON 2015 AND REFLECT ON THE CHALLENGES AND OPPORTUNITIES THAT LIE AHEAD ased on Biocartis’ nature as What did the IPO mean for driven by an increased need an innovative commercial Biocartis? for accurate measurements via stage molecular diagnostics Rudi Mariën: “The first year-half near-patient molecular testing. (MDx) company providing of 2015 was marked by our 6.5x Budgetary pressure on healthcare 7 Bnext generation diagnostic solutions, systems worldwide, calls for tools oversubscribed successful (IPO, we have a specific role in developing in which Biocartis raised gross that provide accurate diagnosis universally accessible, sustainable proceeds of EUR 115m. It was and enable improved treatments, healthcare on a global scale. As the largest Life Sciences capital resulting in optimal use of such, we aim to create value for markets transaction in 2015 on healthcare resources. These trends our shareholders and for society, the European markets, and ranks require fast and accurate sample- by growing our Idylla™ installed amongst the 10 largest IPOs over to-result testing solutions such as base and expanding our menu of the last 10 years on Euronext Idylla™.” tests. Therefore, in addition to the Brussels, underpinning the financial information, we decided strong belief of institutional and What were major achievements to include some key sustainability/ retail investors in the potential in 2015? ESG (environmental, social and of Biocartis. Our IPO attracted a Rudi Pauwels: “I am pleased to governance) information in this wide interest from a mix of long- state that we exceeded our growth report, based on some guiding term, specialist investors across target for 2015 by adding 83 principles of the international continental Europe, the UK and the Idylla™ instruments to our installed sustainability reporting guidelines, US. base, bringing it to 165. This is the the Global Reporting Initiative (GRI) result of, amongst others, great G4 Guidelines The IPO was a logical next step for Biocartis to further finance the work from our sales and marketing 2015 was a successful year for commercialising of our Idylla™ team. They realised an impressive Biocartis during which we significantly molecular diagnostics platform. expansion of our commercial executed upon our strategy to We are very pleased with the footprint. We are now covering establish a new gold standard for proceeds that we raised as it puts more than 55 countries worldwide.” diagnostic testing by launching four the company in a solid position to “Next to commercial success, new tests and growing our installed execute our business plan.” our efforts to increase our menu base to over 160 Idylla™ instruments. of tests bore fruit as well: we Furthermore, we strengthened our Rudi Pauwels: “We experience an successfully launched four new financial position, following, amongst increasing positive momentum tests in 2015. In June 2015 we others, our Initial Public Offering (IPO) around our Idylla™ platform, launched the world’s first fully in April 2015.” ANNUAL REPORT 2015 automated CE-IVD KRAS test on commercial and for routine use to match novel menu expansion we also guidelines that is capable of strengthened our senior detecting an extended panel of management team in view 21 KRAS mutations with high of the next critical steps sensitivity, in an unprecedented Biocartis has to take in timeframe of approximately two becoming a world leader hours. In November 2015, we in molecular diagnostics. introduced our very first infectious In September 2015, Hilde disease test to the market, the Windels (our former CFO) Idylla™ Respiratory (IFV-RSV) was appointed Deputy Panel, developed by Janssen CEO and Ewoud Welten, Diagnostics (Johnson & Johnson). bringing in extensive This test is able to detect various experience as a corporate strains of Influenza Virus (IFV) and financier in healthcare, 8 Respiratory Syncytial Virus (RSV).” “THE STATE-OF-THE-ART PERFORMANCE joined as CFO.” “In December 2015, the launch of OF IDYLLA™ HAS NOT GONE UNNOTICED What do you expect for the Idylla™ ctBRAF Mutation Assay IN THE MARKET”. 2016? (RUO1), the world’s first and only RUDI MARIËN, BIOCARTIS CHAIRMAN fully automated liquid biopsy assay Rudi Pauwels: “We are which allows for diagnostic testing looking forward to 2016 as based on circulating tumour (ct) we aim to have our core DNA fragments in the blood, was with at least four new tests and to menu for oncology on the market a true milestone on its own. At the expand our installed base of Idylla™ by the end of the year. We expect same time, we also launched the instruments to over 300 by the end this to be an important driver in Idylla™ NRAS-BRAF-EGFR S492R of 2016.” the further growth of our installed Mutation Assay that together with base. Furthermore, we have Rudi Mariën: “Our outlook for the Idylla™ KRAS Mutation Test high expectations for one of our 2016 underlines our ambition and enables a complete RAS analysis on biomarkers which are relevant for confidence in the future, as we a same-day basis, reducing anxiety new and booming treatments such focus on becoming a global leading for the affected patients and their player in molecular diagnostics relatives and opening up the route as immuno-oncology, requiring fast that generates significant returns towards faster treatment selection.” and accurate MDx. for shareholders by providing Rudi Mariën: “The state-of-the-art Also in infectious diseases, the innovative, personalised healthcare performance of Idylla™ has not unique Idylla™ multiplexing solutions which will make a real gone unnoticed in the market. capacity, allowing simultaneous difference to the lives of patients.” In 2015, Biocartis signed five detection of one or more new collaborations with leading biomarkers in one single sample, healthcare industry players, among is opening promising doors. The which Merck and Amgen, who are Ebola, MERS and more recently recognising the unique benefits the Zika outbreak show that our Rudi Mariën, Chairman of our Idylla™ technology. Our world needs better and earlier partnership strategy is essential for disease detection and surveillance accelerated test development and solutions.
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