Annual Report 2020

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Annual Report 2020 PART 1 INTRODUCTION ANNUAL REPORT 2020 BIOCARTIS ANNUAL REPORT 2020 1 2 PART 1 INTRODUCTION CONTENTS PART 1 / INTRODUCTION 1. Message from the chairman and CEO 2. Who we are 3. Strategy PART 2 / PERFORMANCE 2020 1. Key achievements in 2020 2. Business review 2020 3. Impact of COVID-19 PART 3 / NON-FINANCIAL REPORT 2020 1. Sustainability 2. Risks related to our business 3. Corporate governance report PART 4 / FINANCIAL REPORT 2020 1. Consolidated annual accounts 2020 & Statutory annual accounts 2020 2. Auditor’s report PART 5 / GLOSSARY & BIBLIOGRAPHY BIOCARTIS ANNUAL REPORT 2020 3 BIOCARTIS ANNUAL REPORT 2020 PART 1 INTRODUCTION 4 PART 1 INTRODUCTION BIOCARTIS' MISSION IS TO OFFER RAPID & EASY MOLECULAR DIAGNOSTICS SOLUTIONS AIMED AT ENABLING FASTER & MORE ACCURATE TREATMENT DECISIONS FOR PATIENTS ACROSS THE GLOBE IdyllaTM A revolutionary, fully automated system that makes molecular testing convenient and exceptionally fast. Suitable for any lab. BIOCARTIS ANNUAL REPORT 2020 5 ABOUT THIS REPORT The board of directors of Biocartis Group NV (the ‘Company’) is responsible for the contents of this document and declares that, having taken all reasonable care to ensure that such is the case, the information contained in this Biocartis annual report 2020 is, to the best of its knowledge, in accordance with the facts, contains no omissions likely to affect it materially and contains the NOTHING IS SIMPLE required information in accordance with applicable Belgian Law. In IN ONCOLOGY. accordance with Article 3:32 of the Belgian Code of Companies and Associations, the annual reports on the statutory and consolidated NOTHING annual accounts have been combined. In defining its initial sustainability disclosures, Biocartis has taken BUT into account the Sustainable Development Goals1 (SDG) and the Global Reporting Initiative (GRI) guidelines2. The SDG framework THIS. includes 17 goals which were developed by the United Nations Development Program in January 2016 and are considered to be the guiding universal sustainability framework. The GRI guidelines represent the global reference for sustainability reporting3. The SDG framework places more emphasis on how corporations organize and manage their activities to contribute to a more sustainable world, whereas the GRI framework focuses mainly on how to report on a company’s impact. The chapter ‘sustainability’ in this report provides information on how sustainability is embedded in Biocartis’ core activities, as well as how Biocartis acts responsibly as a company with the social and environmental resources it uses. According to Belgian law, Biocartis must publish its annual report in Dutch. Biocartis also provides an English version. In case of difference in interpretation, the English version shall prevail. An electronic version of the annual report 2020 is available on www. biocartis.com under ‘investors’. Other information on the website of Biocartis or on other websites is not a part of this annual report. The annual report reflects the performance and results of Biocartis in the period between 1 January 2020 and 31 December 2020. An overview of the securities legislation and listed company reporting requirements can be found on the Belgian Financial Authorities’ website, www.fsma.be. ABOUT BIOCARTIS Biocartis Group NV is a limited liability company organized under the laws of Belgium and has its registered office at Generaal de Wittelaan 11 B, 2800 Mechelen, Belgium. Throughout this report, the term ‘Biocartis NV’ refers to the Belgian subsidiary on a standalone basis and references to ‘the Group’ or ‘Biocartis’ include Biocartis Group NV together with its subsidiaries. 6 PART 1 INTRODUCTION FORWARD-LOOKING STATEMENT Certain statements, beliefs and opinions in this report or activities will continue in the future. In addition, even are forward-looking, which reflect the Company’s or, as if actual results or developments are consistent with the appropriate, the Company directors’ or managements’ forward-looking statements contained in this report, those current expectations and projections concerning future results or developments may not be indicative of results or events such as the Company’s results of operations, developments in future periods. As a result, the Company financial condition, liquidity, performance, prospects, expressly disclaims any obligation or undertaking to release growth, strategies and the industry in which the Company any updates or revisions to any forward-looking statements operates. By their nature, forward-looking statements in this report as a result of any change in expectations or any involve a number of risks, uncertainties, assumptions and change in events, conditions, assumptions or circumstances other factors that could cause actual results or events to on which these forward-looking statements are based, differ materially from those expressed or implied by the except if specifically required to do so by law or regulation. forward-looking statements. These risks, uncertainties, Neither the Company nor its advisers or representatives assumptions and factors could adversely affect the outcome nor any of its subsidiary undertakings or any such person’s and financial effects of the plans and events described officers or employees guarantees that the assumptions herein. A multitude of factors including, but not limited to, underlying such forward-looking statements are free from changes in demand, competition and technology, can cause errors nor does either accept any responsibility for the future actual events, performance or results to differ significantly accuracy of the forward-looking statements contained from any anticipated development. Forward-looking in this report or the actual occurrence of the forecasted statements contained in this report regarding past trends developments. You should not place undue reliance on or activities are not guarantees of future performance and forward-looking statements, which speak only as of the date should not be taken as a representation that such trends of this report. USE OF THE IDYLLA™ TRADEMARK, LOGO AND PRODUCT LABELING Biocartis and Idylla™ are registered trademarks in Europe, such restrictions. Biocartis takes no responsibility for any the United States and other countries. The Biocartis violation of any such restrictions by any person. This report trademark and logo and the Idylla™ trademark and logo does not constitute an offer or invitation for the sale or are used trademarks owned by Biocartis. Please refer purchase of securities in any jurisdiction. No securities to the product labeling for applicable intended uses of Biocartis may be offered or sold in the United States for each individual Biocartis product. This report is not of America absent registration with the United States for distribution, directly or indirectly, in any jurisdiction Securities and Exchange Commission or an exemption where to do so would be unlawful. Any persons reading from registration under the U.S. Securities Act of 1933, as this report should inform themselves of and observe any amended. RESPONSIBILITY STATEMENT The undersigned hereby declare that to the best of their the consolidation, and b) the annual report gives a true and knowledge: a) the annual accounts, which have been drawn fair view of the development and results of the business and up in accordance with the applicable accounting standards, the position of the Company and the companies included in give a true and fair view of the net equity, financial position the consolidation, as well as a description of the main risks and results of the Company and the companies included in and uncertainties they are confronted with. HERMAN VERRELST CHRISTIAN REINAUDO CHIEF EXECUTIVE OFFICER CHAIRMAN OF THE BOARD OF DIRECTORS BIOCARTIS ANNUAL REPORT 2020 7 1.1 MESSAGE FROM THE CHAIRMAN AND THE CEO CONTINUED GROWTH THROUGH AGILITY AND RESILIENCE IN PANDEMIC TIMES Despite the global pandemic we grew commercial cartridge volumes by 31% and placed 335 new Idylla™ instruments. We delivered on our pre-pandemic outlook in unprecedented market circumstances: global lock-down measures significantly restricted access to hospitals throughout almost the entire year and severely hampered our sales activities. Nevertheless, oncology volumes continued to grow and our newly developed “2020 was an extraordinary year, to say the Idylla™ SARS-CoV-2 Test kept us on track. In the US, least. The pandemic deprioritized and disrupted we tripled commercial cartridge volumes compared to cancer care globally. Patient access to hospitals 2019. In Europe, sales volumes remained very resilient was significantly restricted throughout almost throughout the entire year. In distributor markets, that were particularly hit by the pandemic, we also managed the entire year and customer prospection was to grow cartridge volumes, except in those countries severely hampered. Nevertheless, we showed where the pandemic impact was compounded by a resilience and delivered on our pre-pandemic significant weakening of the local currency versus the outlook. Oncology volumes continued to grow, euro. Overall, we came out of this pandemic year in a mostly in the US, but also in Europe, and the position of strength thanks to our agility and resilience versatility of Idylla™ allowed the rapid rollout of as an organization, and as a team. a pandemic response test menu that alleviated the pressure on oncology testing volumes. STRATEGIC EXPANSION INTO Furthermore, we continued to expand our global INFECTIOUS DISEASES WITH
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