REGISTRATION DOCUMENT 2017 Sommaire
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REGISTRATION DOCUMENT 2017 sommaire Interview with History 4 Yves L’Épine, Chief Executive Officer 2 Key figures 6 1 4 THE GUERBET GROUP 9 MANAGEMENT REPORT 55 1.1 History of the Company 9 4.1 Analysis of the Group’s activity and results 55 1.2 Mission and ambition 10 4.2 Major events since the start of 2018 58 1.3 Main consolidated data 10 4.3 Information about internal control 59 1.4 Overview of activities 11 4.4 Risk management and risk factors 60 1.5 Industrial and logistics activity 17 4.5 Other legal information 64 1.6 Research and Development 18 1.7 The Group’s governance structure at December 31, 2017 22 5 CORPORATE SOCIAL RESPONSIBILITY 69 2 Employee information 70 CORPORATE GOVERNANCE 27 5.1 5.2 Environmental information 76 2.1 Report of the Board of Directors on 5.3 Social information 80 corporate governance 27 5.4 Report by one of the Statutory Auditors, 2.2 Board of Directors 27 designated as an independent third-party, 2.3 General Management 38 on the consolidated human resources, 2.4 Compensation of company officers 38 environmental and social information 2.5 Agreements referred to in Article L. 225- included in the management report 82 37-4-2° of the French Commercial Code 45 2.6 Provisions in the articles of association 6 relating to General Meetings of Shareholders 46 FINANCIAL STATEMENTS 2.7 Deviations from the recommendations for the composition of the Board of AND RELATED NOTES 85 Directors and the Committees 47 6.1 Consolidated financial statements and notes 86 2.8 Other information from the corporate 6.2 Statutory Auditors’ report on the governance report contained in other consolidated financial statements 120 sections of the Registration Document 48 6.3 Annual financial statements and notes 124 6.4 Statutory Auditors’ report on the financial 3 statements 144 GUERBET AND ITS SHAREHOLDERS 49 6.5 Statutory Auditors’ special report on regulated commitments and agreements 147 3.1 Guerbet shares 49 3.2 Dividend paid over three years 50 3.3 Share ownership structure 50 7 3.4 Shareholder Agreement and collective GENERAL MEETING share lock-in commitments 51 OF MAY 25, 2018 149 3.5 Control mechanisms provided for in a 7.1 Agenda 149 potential employee shareholding system, 7.2 Draft resolutions 151 when control rights are not exercised by the employees 52 8 3.6 Threshold crossings 52 ADDITIONAL INFORMATION 161 Transactions performed by executive 3.7 8.1 Person responsible for the accuracy officers and similar individuals 52 of the Registration Document 161 Transactions performed by employees 3.8 8.2 Statutory Auditors 161 excluding company officers 52 8.3 Share capital 162 Limiting the risk of undue control 3.9 8.4 Public access to this document 162 by the majority Shareholder 54 8.5 General information about the Company 163 The Board of Directors’ powers to issue 3.10 8.6 Articles of association (excerpts) 163 and buy back shares 54 8.7 2018 Financial calendar 164 Summary of granted authorizations that 3.11 8.8 Concordance tables 165 may potentially impact the share capital 54 3.12 Provisions in the articles of association relating to the shares 54 Registration Document 2017 Including the Annual Financial Report Unofficial translation of the French language “Document de Référence 2017” of Guerbet, for information purposes only. This Registration Document was filed with the Autorité des marchés financiers or AMF (French Financial Markets Authority) on April 25, 2018, in compliance with Article 212-13 of its General Regulation. It can be used in connection with a financial transaction if it is accompanied by a securities note approved by the AMF. This Document was prepared by the issuer, and its signatories are liable for its content. In accordance with article 28 of European Regulation 809/2004 of April 29, 2004, readers are invited to refer to previous Registration Documents regarding certain information: 1. the Management Report of the Board of Directors, the consolidated financial statements and the report of the Statutory Auditors on the consolidated financial statements for the fiscal year ended December 31, 2016, included in the Registration Document filed with the AMF on April 5, 2017 under number D.17-0323; 2. the Management Report of the Board of Directors, the consolidated financial statements and the report of the Statutory Auditors on the consolidated financial statements for the fiscal year ended December 31, 2015, included in the Registration Document filed with the AMF on April 21, 2016, under number D.16-0378. A French Limited Company (société anonyme) governed by a Board of Directors with a share capital of €12,563,358 Registered Office: 15, rue des Vanesses 93420 Villepinte Bobigny Trade and Companies Register No. 308 491 521 Guerbet Registration Document 2017 1 Interview with Yves L’Épine, Chief Executive Officer 2017 confirmed the importance of Interventional Imaging for the Group’s development, alongside Diagnostic Imaging Yves L’Épine Chief Executive Officer ¢ Two years after the acquisition of CMDS, what progress made with image-guided in situ treatments (Interventional synergies are already visible? Imaging unit). The Group’s attractiveness for new talent has improved significantly on the international scene; through this successful CMDS was acquired barely two and a half years ago, and its integration, Guerbet has shown that it can combine organic growth integration into Guerbet has fundamentally changed our Group. It and growth via acquisitions. has strengthened it by adding to its range of contrast media, now well balanced with strong brands in slide X-ray imaging (Optiray®, Xenetix®) and MRI (Dotarem®), by allowing it to significantly expand ¢ How is Guerbet positioned in an MRI market marked its range of injectors and associated medical devices, by increasing its by the arrival of new generics? commercial footprint through several new affiliates and by providing The MRI segment, where Guerbet is world number 2, saw many it with plants in the United States and Ireland complementing its own events in 2017. This year, it will need to keep navigating between production facilities to meet global demand. tailwinds and headwinds. We were facing a difficult integration due to a combination of Since 2017, we have seen the introduction of a new generic in the several failure risk factors: acquisition of a company of similar size market. While Dotarem® has already faced local generic competition to ours, with declining assets, with a very different culture from for several years now, limited to a few countries in Europe and Asia, a ours, all to be handled by teams that had never been involved in new generic product was registered in 2017 in most European Union an integration process. The result is very satisfying: we are ahead countries and several Asian countries. Most of them began marketing of our value creation roadmap. Our aim was to capture more than the generic in 2017, with no significant impact on the first half of the 80% of synergies over three years, and we are already close. This year but with a slowdown in Dotarem® sales over the second half. shows the strong commitment of the employees, and I wish to pay Despite this, our growth remains strong: above 10% this year. tribute to them. The Group is now resolutely international (its sales outside France represent more than 80% of total business), and this Tailwinds are driving our flagship product, as several health agencies development has further strengthened the Group worldwide, including – in Europe, Japan, the United States and Canada – are recommending in France. We have succeeded in establishing a new common culture that, within gadolinium-based contrast media, radiologists distinguish around our primary mission of improving patient prognosis thanks between linear products and macrocyclical products according to to earlier, more precise diagnosis (Diagnostic Imaging unit) and the their safety profile, with a preference for macrocyclical products. Our 2 Guerbet Registration Document 2017 www.guerbet.com Dotarem® product, remains, nevertheless, the leader in macrocyclic ¢ How is Guerbet positioned with regard to digital products, considered to be the most stable. At the European level, development in radiology? following the decision of the EMA(1), the European Commission decided to suspend the use of non-specific linear products in human body Digital technology and artificial intelligence will transform medical imaging. In Japan, the PMDA(2) issued an order recommending the imaging profoundly by allowing quantitative data to be interpreted use of secondary linear products when macrocyclic products are not for better characterization of tissues and pathologies. Guerbet is suitable or available. Lastly, in the United States, the FDA(3) issued new particularly attentive to these developments and recruited a Chief safety measures in favor of macrocyclic products, forcing companies Digital Officer in September 2017. We are exploiting all our strengths selling MRI contrast media in the US market to change their labeling to seize any new opportunities that arise and to confirm our status as from the start of 2018. a medical imaging expert. ¢ ¢ What will be the consequence of these two trends for And how important is Interventional Imaging’s role? Guerbet? Very important! Our strategy to strengthen Interventional Imaging has already been in place for several years and is continuing. Our Lipiodol® The long-term result of these two trends is not clear yet, but they and Patent Blue V products are recognized as gold standards: the first are not preventing our double-digit growth in this segment for now. in transarterial chemoembolization of liver cancers and the second We have prepared an industrial plan to significantly increase our in the detection of sentinel nodes in breast cancer.