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DOCUMENT D'enregistrement UNIVERSEL 2019 Incluant Le Rapport Financier Annuel Sommaire AVERTISSEMENT AU LECTEUR I ABRÉVIATIONS II PRÉSENTATION DE SANOFI 1RESPONSABILITÉ SOCIALE, 317 ENVIRONNEMENTALE 1 4 ET SOCIÉTALE 1.1. Principales informations relatives 2 4.1. Déclaration de performance extra- 318 à la Société financière et plan de vigilance 1.2. Gouvernement d’entreprise 9 4.2. Détail des enjeux et des risques 321 4.3. Autres éléments relatifs au plan de 366 vigilance 4.4. La contribution de Sanofi aux objectifs de 366 développement durable 4.5 Note méthodologique sur le reporting des 368 données 4.6 Rapport de l'organisme tiers indépendant 372 ACTIVITÉ DE SANOFI 83 SANOFI ET SES 377 2 5 ACTIONNAIRES 2.1. Historique et évolution de la société 84 5.1. Sanofi en Bourse 378 2.2. Présentation de l’activité de Sanofi 85 5.2. L’information aux Actionnaires 382 2.3. Organisation de l’entreprise 117 2.4. Investissements - Principaux 118 établissements 2.5. Litiges 121 2.6. Événements Récents 123 RAPPORT DE GESTION, ÉTATS 125 PERSONNES RESPONSABLES, 385 FINANCIERS ET ATTESTATION ET TABLES 3 INFORMATIONS FINANCIÈRES 6 DE CONCORDANCE COMPLÉMENTAIRES 3.1. Rapport de gestion relatif à l’exercice 2019 126 6.1. Personne responsable du document 386 d'enregistrement universel 3.2. Rapport de la direction de Sanofi sur le 171 6.2. Attestation du responsable du document 386 contrôle interne relatif à l’information d'enregistrement universel contenant un financière rapport financier annuel 3.3. États financiers consolidés de Sanofi 172 6.3. Personnes responsables du contrôle des 386 Comptes 3.4. Comptes annuels de la Société Sanofi 283 6.4. Tables de concordance 386 DOCUMENT D'ENREGISTREMENT UNIVERSEL 2019 incluant le rapport financier annuel Le document d’enregistrement universel a été déposé le 5 mars auprès de l’AMF, en sa qualité d’autorité compétente au titre du règlement (UE) 2017/1129, sans approbation préalable conformément à l’article 9 dudit règlement. Le document d’enregistrement universel peut être utilisé aux fins d'une offre au public de titres financiers ou de l’admission de titres financiers à la négociation sur un marché réglementé s'il est complété par une note d’opération et le cas échéant, un résumé et tous les amendements apportés au document d’enregistrement universel. L’ensemble alors formé est approuvé par l’AMF conformément au règlement (UE) 2017/1129. Avertissement au lecteur Déclarations prospectives Le présent document et les documents qui y sont incorporés par référence contiennent des déclarations prospectives. Ces déclarations prospectives concernent notamment : les projections concernant les résultats opérationnels des activités, le résultat net, le résultat net des activités, le bénéfice net par action, le bénéfice net des activités par action, les investissements, les réductions de coûts, les coûts de restructuration, les synergies positives ou négatives, les dividendes, la structure capitalistique, les autres rubriques financières et ratios ; les déclarations sur les prévisions, tendances, projets, objectifs ou buts, et notamment ceux relatifs aux produits, aux tests cliniques, aux autorisations administratives et à la concurrence ; et les déclarations relatives aux événements et performances futures ou à la croissance économique de la France, des États-Unis d’Amérique ou d’un quelconque autre pays dans lequel Sanofi est présente. Ces informations sont fondées sur des données, des hypothèses et des estimations considérées comme raisonnables par le Groupe à la date du présent document d'enregistrement universel et ne doivent pas être interprétées comme des garanties que les faits et données énoncés se produiront. Ces informations sont parfois identifiées par l’utilisation des termes à caractère prospectif tels que « croire », « anticiper », « prévoir », « s’attendre à », « avoir l’intention de », « viser », « estimer », « projeter », « prédire », « planifier », « devoir », ou le cas échéant toute autre expression similaire. Ces termes ne constituent en aucun cas l’unique moyen d’identifier de telles déclarations. Les déclarations prospectives peuvent être affectées par des risques connus et inconnus, des incertitudes liées notamment à l’environnement réglementaire, économique, financier et concurrentiel, et d’autres facteurs pouvant donner lieu à un écart significatif entre les résultats réels ou les objectifs de Sanofi et ceux indiqués ou induits dans ces déclarations. Les facteurs de risque susceptibles d’influer sur les activités du Groupe sont décrits dans la section « 3.1.9. Facteurs de risque » du rapport de gestion, figurant au chapitre 3 du présent document d'enregistrement universel. La réalisation de tout ou partie de ces risques est susceptible d’avoir un effet défavorable sur les activités, les résultats, la situation financière ou les objectifs du Groupe. Par ailleurs, d’autres risques, non identifiés ou considérés comme non significatifs par le Groupe pourraient avoir le même effet défavorable et les investisseurs pourraient perdre tout ou partie de leur investissement. Les déclarations prospectives sont données uniquement à la date du présent document d'enregistrement universel. Sanofi ne prend aucun engagement de publier des mises à jour de ces informations et déclarations prospectives, ni des hypothèses sur lesquelles elles sont basées, à l’exception de toute réglementation qui lui serait applicable, notamment les articles 223-1 et suivants du règlement général de l’Autorité des marchés financiers. Noms de marques À la date du présent document d'enregistrement universel, les noms de marques suivies du symbole « ® » (registered) ou « ™ » (trademark) mentionnées dans ce document sont des marques appartenant à Sanofi et/ou ses filiales, à l’exception : des marques qui sont prises en licence par Sanofi et/ou par ses filiales, telles que Actonel®, marque détenue par Actavis ; Aldurazyme® marque détenue par la JV Biomarin/Genzyme LLC ; Cialis® OTC, marque détenue par Eli Lilly ; Libtayo®, marque détenue par Regeneron aux États-Unis ; Leukine®, marque détenue par Alcafleu ; UshStat®, marque détenue par Oxford Biomedica ; Vaxelis® marque détenue par MCM Vaccine Co (USA) et MCM Vaccine B.V. (Netherlands) et Zaltrap®, marque détenue par Regeneron aux États-Unis ; des marques cédées à des tiers par Sanofi et/ou par ses filiales, comme Altace®, marque cédée à King Pharmaceuticals aux États-Unis ; Hyalgan®, marque cédée à Fidia Farmaceutici S.p.A. ; LibertyLink® Rice 601, LibertyLink® Rice 604 et StarLink®, marques cédées à Bayer ; des marques appartenant à des tiers, telles que Basaglar® et Humalog®, marques détenues par Eli Lilly ; Eylea®, marque appartenant à Regeneron ; Insulia®, marque cédée à Voluntis ; Kyprolis®, marque appartenant à Onyx Pharmaceuticals Inc. ; Revlimid® marque appartenant à Celgene Corporation ; Velcade®, marque appartenant à Millenium Pharmaceuticals Inc ; et Zantac®, marque appartenant à Glaxo Group Limited. Les marques relatives à des produits en développement n’ont pas toutes été autorisées à la date de ce document par les autorités de santé compétentes . Sources des positions concurrentielles Les informations fournies pour des produits pharmaceutiques notamment à la section « 2.2.6. Marchés - 1. Marketing et distribution » sur les parts de marché et les classements sont fondées principalement sur les données de vente hors ventes des vaccins (ville et hôpital) publiées par IQUIA, en cumul mobile annuel à septembre 2019, en euro constant (sauf mention contraire) , et complétés par des données d’autres sources nationales. Indications thérapeutiques Les indications thérapeutiques décrites dans le rapport financier pour chaque produit sont le résumé des principales indications approuvées sur les principaux marchés. Ces indications ne sont pas nécessairement toutes disponibles sur tous les marchés sur lesquels les produits sont approuvés. Les résumés des indications thérapeutiques présentés dans le rapport financier ne se substituent en aucun cas à un examen attentif des mentions légales complètes disponibles dans chaque pays où le produit est approuvé. I SANOFI / DOCUMENT D'ENREGISTREMENT UNIVERSEL 2019 Abréviations Abréviations utilisées dans le document d'enregistrement universel (2019) ADR American Depositary Receipt (certificat américain représentatif d’actions) ADS American Depositary Share AFEP Association française des entreprises privées AMF Autorité des marchés financiers AMM Autorisation de mise sur le marché ANDA Abbreviated New Drug Application (demande abrégée d’approbation de nouveau médicament) ANSM Agence Nationale de Sécurité du Médicament et des produits de santé BCE Banque centrale européenne BLA Biologic License Application (demande de licence de produit biologique) BMS Bristol-Myers Squibb BNPA Bénéfice net par action BPC Bonnes Pratiques Cliniques BPD Bonnes Pratiques de Distribution BPF Bonnes Pratiques de Fabrication BPL Bonnes Pratiques de Laboratoire BPPV Bonnes Pratiques de PharmacoVigilance BRIC-M Brésil, Russie, Inde, Chine et Mexique CEPS Comité Économique des Produits de Santé CGMP Current Good Manufacturing Practice (Bonnes pratiques courantes de fabrication) CHC Consumer Healthcare (Santé Grand Public) CHMP Comité des médicaments à usage humain COSO Committee of Sponsoring Organizations of the Treadway Commission COVALIS Comité interne de prévention des risques pour la santé (Comité des Valeurs Limites Internes Sanofi) CVMP Comité des médicaments à usage vétérinaire CVR Contingent value right (Certificat de valeur conditionnelle) ECHA European Chemicals Agency (Agence européenne des produits chimiques) ECOVAL Comité
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