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Pioneering Diagnostics Contents 2016 REGISTRATION DOCUMENT AND ANNUAL FINANCIAL REPORT PIONEERING DIAGNOSTICS CONTENTS Who are we? 2 1 bioMérieux, pioneering diagnostics 5 Comments on the financial year 127 to serve public health 13 5.1 Selected financial information 128 1.1 History and development of bioMérieux 14 5.2 Operating and financial review 129 1.2 Business overview 5.3 Capital resources 135 of bioMérieux’s activities 17 5.4 Significant change in financial 1.3 bioMérieux’s strategy 34 or trading position 135 1.4 Organisational structure 36 5.5 Investments 136 1.5 Quality systems and 5.6 Overview and current trends applicable regulations 38 and objectives 137 1.6 Research & development, patents and licenses 41 Financial statements 139 1.7 Property, plant and equipment 46 6 6.1 Consolidated financial statements 140 6.2 Parent company financial statements 197 2 Risk factors 51 2.1 Risks relative to the activities 52 2.2 Industrial and environmental risks 7 Information on the Company 2.3 Regulatory and legal risks and its share capital 231 2.4 Market risks and financial risks 7.1 General information on the Company 232 2.5 Insurance and risk management 7.2 Articles of incorporation and bylaws 232 2.6 Administrative, legal and arbitration 7.3 Share capital 234 procedures 7.4 Main shareholders 238 7.5 Provisions delaying a change of control 243 Corporate Social Responsibility 65 3 7.6 Dividend policy 243 3.1 Corporate Social Responsibility: at the heart of bioMérieux’s concerns 66 7.7 Main related-party transactions 244 3.2 Social responsibility 70 7.8 Material contracts 249 3.3 Labour relations 74 3.4 Environmental responsibility 83 8 Additional information 251 3.5 Methodology – indicator scope 90 8.1 Persons responsible 3.6 Report by the independent third party for the Registration Document 252 on the consolidated environmental, 8.2 Responsible for auditing labour-related and social information 92 the financial statements 252 8.3 Documents on display 253 Corporate governance 95 8.4 2017 Provisional investor calendar 254 4 4.1 Administrative, management and supervisory 8.5 Concordance tables 255 bodies and senior management 96 8.6 Glossaries 261 4.2 Board practices 102 4.3 Directors compensation and benefits 114 Items in the annual financial report are identified in the contents using the AFR symbol. AFR REFERENCE DOCUMENT 2016 including the Annual Financial Report French joint stock company (société anonyme) with share capital of €12,029,370 Registered office: Marcy l’Étoile (69280) Registered in Lyon, France under number 673 620 399 The French version of this Registration Document (document de référence) was filed with the French financial markets authority (Autorité des marchés financiers – AMF) on March 15, 2017 in accordance with article 212-13 of the AMF’s General Regulation This document may be used in support of a financial transaction if it is accompanied by an offering circular (note d’opération) approved by the AMF. This document was drawn up by the issuer and its signatories assume responsibility for its content. bioMérieux • 2016 Registration Document and Annual Financial Report | 1 WHO ARE WE? BIOMÉRIEUX, A FAMILY COMMITMENT TO THE FIGHT AGAINST INFECTIOUS DISEASES bioMérieux is a family-owned company created in 1963. Its expertise and its commitment to expand the frontiers of knowledge in biology are grounded in an entrepreneurial adventure that has been ongoing for more than one century. bioMérieux is first and foremost a human and scientific adventure that began more than 50 years ago, yet its roots reach back to the tradition of Louis Pasteur and the fight against infectious diseases. In 1897, Marcel Mérieux, who had studied with Pasteur, founded a laboratory in Lyon where he developed the first anti-tetanus sera. He called it Institut Mérieux, and from the outset began to lay the groundwork for a bio-industrial edifice that would leave its mark on vaccinology and the diagnosis of infectious diseases worldwide. Under the direction of his son, Dr. Charles Mérieux, and later his grandson, Alain Mérieux, Institut Mérieux grew to become world leader in human and veterinary vaccines. The Institute gave rise to companies that rank today as major players in public health, such as Sanofi Pasteur and Merial. In 1994, Alain Mérieux shifted his focus from the vaccines activity to concentrate on the family holding and its diagnostics and immunotherapy businesses, including bioMérieux. Alexandre Mérieux, the great-grandson of Marcel, has taken over the management of bioMérieux since 2014. AN INSTITUT MÉRIEUX COMPANY Americas bioMérieux is 59% owned by Institut Mérieux. Within * the scope of a global, long-term vision, Institut Mérieux 42% contributes its experience in industrial biology to 19% ** improving medicine and public health across the globe. To fight against infectious diseases and cancers, it designs and develops new approaches in the fields of diagnostics, immunotherapy, food safety, and nutrition. Its three bio-industrial companies, bioMérieux, Transgene and Mérieux NutriSciences, working closely with its entities devoted to innovation, including Mérieux Développement and ABL Inc., have contributed to major advances in medicine and public health. Institut Mérieux employs over 15,000 people worldwide. It is present in over 40 countries. 2 | bioMérieux • 2016 Registration Document and Annual Financial Report Nearly 10,000 employees; bioMérieux is present in more than 150 countries through 42 subsidiaries and a network of distributors; 90% of international sales ; 19 bio-industrial sites and 20 R&D centres worldwide A GLOBAL PLAYER IN THE FIELD OF IN VITRO DIAGNOSTICS North America 35%* 20.6%** Asia EMEA Pacific 41% * 17% * Europe 2.7% ** 6.3% ** Latin Middle East- Africa America 7% * 12.2 %** Headquarters Subsidiaries Bio-industrial sites R&D centres * Percentage of bioMérieux 2016 total sales.. ** Year-on-year, at constant exchange rates and scope of consolidation. bioMérieux • 2016 Registration Document and Annual Financial Report | 3 WHO ARE WE? THE CRUCIAL ROLE OF DIAGNOSTICS IN SERVING PUBLIC HEALTH As an essential link in the healthcare chain, diagnostics are a fundamental source of medical, economic and social value. Between 60% and 70% of healthcare decisions are based on diagnostic test results(1). bioMérieux, a major player of in vitro diagnostics and world leader in clinical microbiology and industrial microbiological control, contributes to the quality of patient care and the safety of consumers. bioMérieux develops and produces in vitro diagnostic solutions (instruments, reagents and software) for private and hospital laboratories, mainly for the diagnosis of infectious diseases. The results obtained from samples taken from the patient (blood, urine, stool, cerebrospinal fluid, saliva, etc.) provide the clinician with information to help in decision-making. For 25 years, bioMérieux has also been putting its expertise in clinical applications to the service of industrial microbiological control, helping manage the risks of contamination of food products, pharmaceuticals or cosmetics throughout the production chain. 50 YEARS OF MERGERS/ACQUISITIONS (M&A) AND PARTNERSHIPS An original innovation model based on partnerships with international research and joint research units: a multidisciplinary approach to develop the diagnostic solutions of tomorrow. 1986 2001 API Systems, France Organon Teknika, Netherlands 1988 2004 2004 VITEK (McDonnel Douglas), US Initial public Bacterial Barcodes, US offering 2007 Biomedics, Spain BTF, Australia API® VITEK® VIDAS® BacT/ALERT® DiversiLAB® 4 | bioMérieux • 2016 Registration Document and Annual Financial Report For improved patient care Diagnostic tests have a major influence on the quality of patient care, as well as on early diagnosis: ● For screening in the context of the prevention of certain diseases. ● For early diagnosis, that is, at the early stages of a disease when symptoms are still very mild . ● For diagnosis and prognosis, particularly in the case of infectious diseases, in order to identify the causative pathogen and the antimicrobial resistance profile. ● For therapeutic decisions and treatment monitoring. How diagnostics benefit healthcare systems Spending on medical biology represents only between 2% and 3% of healthcare expenditures(2) This cost is limited when weighed against the medical value of diagnostics and the savings it can generate – both by reducing over-prescription of treatments and by shortening the onset of care and the length of hospital stays. Diagnostics is also a valuable instrument of healthcare policy, in particular for epidemiological monitoring and control. Microbiology applications in industrial production Microbiological control tests make it possible to meet the quality demands of the agri-food, pharmaceutical and cosmetic industries. Performed along the entire production chain and for the environmental control of production zones, such tests ensure product sterility, the absence of disease-causing bacteria and the enumeration of bacterial flora that indicate the quality of food products. HOMME Veterinary applications: a continuum from animals to humans ANIMAL The “One Health” concept, an integrated approach advocated by international organisations, is ENVIRONNEMENT based on the principle of the continuum between animals and humans when it comes to the transmission of infectious agents and antimicrobial resistance. Since 2011, bioMérieux has ALIMENTATION provided its microbiology expertise to professionals of animal health, in particular to make
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