Sanofi (Incorporated as a société anonyme in France)

Transcription

1 FOURTH SUPPLEMENT DATED 23 JANUARY 2017 TO THE BASE PROSPECTUS DATED 24 MARCH 2016 Sanofi (Incorporated as a société anonyme in France) 20,000,000,000 Euro Medium Term Note Programme This fourth supplement (the Supplement ) constitutes a supplement to and must be read in conjunction with the base prospectus dated 24 March 2016 which received visa no from the AMF, as supplemented by the first supplement to the base prospectus dated 28 June 2016 which received visa no , by the second supplement to the base prospectus dated 5 September 2016 which received visa no and by the third supplement to the base prospectus dated 21 November 2016 which received visa no (together, the Base Prospectus ) prepared in connection with the 20,000,000,000 Euro Medium Term Note Programme (the Programme ) established by Sanofi (the Issuer ) Terms defined in the Base Prospectus have the same meaning when used in this Supplement Application has been made to the AMF, as competent authority pursuant to Article of its Réglement Général implementing Directive 2003/71/EC (as amended, the Prospectus Directive ) to approve this Supplement The Issuer declares that, having taken all reasonable care to ensure that such is the case, the information contained in this Supplement with respect to the Issuer, and to the Issuer and its subsidiaries taken as a whole (the Group ) is, to the best of its knowledge, in accordance with the facts as at the date of this Supplement and contains no omission likely to affect its import The Issuer accepts responsibility accordingly This Supplement has been prepared pursuant to Article 161 of the Prospectus Directive and Article of the Réglement Général of the AMF for the purposes of: A amending the terms and conditions set out on pages 57 to 84 of the Base Prospectus in order to exclude the application of Article 1195 of the French code civil; and B amending the Recent Developments section of the Base Prospectus (page 89) A copy of the document herein incorporated by reference and a copy of this Supplement can be obtained from the registered office of the Issuer as set out at the end of the Base Prospectus and at the office of the Fiscal Agent, as described on page 109 of the Base Prospectus A copy of such document incorporated by reference as well as a copy of this Supplement are also available on the website of the Issuer, wwwsanoficom, and a copy of this Supplement is available on the website of the AMF, wwwamf-franceorg To the extent that there is any inconsistency between (a) any statement included or incorporated by reference in this Supplement and (b) any statement included or incorporated by reference in the Base Prospectus, the statements in (a) above will prevail Save as disclosed in this Supplement, there has been no significant new factor, material mistake or inaccuracy relating to information included in the Base Prospectus since the publication thereof which is capable of affecting the assessment of Notes to be issued under the Programme To the extent applicable, and provided that the conditions of Article I of the Réglement Général of the AMF are fulfilled, investors who have already agreed to purchase or subscribe for Notes to be issued under the Programme before this Supplement is published, have the right, according to Article II of the Réglement Général of the AMF, to withdraw their acceptance by no later than 25 January 2017 (included)

2 TABLE OF CONTENTS TERMS AND CONDITIONS OF THE NOTES 3 BUSINESS OF SANOFI 4 PERSONS RESPONSIBLE FOR THE PROSPECTUS SUPPLEMENT 6 2

3 TERMS AND CONDITIONS OF THE NOTES The "Terms and Conditions of the Notes" (pages 57-84) are amended by adding the following new Condition: 18 ARTICLE 1195 OF THE CODE CIVIL NOT TO APPLY Article 1195 of the French code civil shall not apply to or in connection with any Notes or any Conditions thereof as supplemented or amended from time to time 3

4 BUSINESS OF SANOFI RECENT DEVELOPMENTS The "Recent Developments" section of the Base Prospectus (page 89) is amended to include the following paragraphs before the "Recent Developments Issue of US commercial paper" paragraph: On November 21, 2016 Sanofi announced that the US Food and Drug Administration (FDA) approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/ml for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide* On December 8, 2016 Sanofi and Regeneron Pharmaceuticals, Inc announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy The investigational biologic therapy Dupixent inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response, which is believed to be a major driver in the pathogenesis of the disease On January 2, 2017 Sanofi and Boehringer Ingelheim confirmed that the strategic transaction signed in June 2016, which consists of an exchange of Sanofi s animal health business (Merial) and Boehringer Ingelheim s consumer healthcare (CHC) business, was successfully closed in most markets on January 1st 2017 On January 2, 2017 Sanofi and its vaccines global business unit Sanofi Pasteur confirmed the end of their vaccine joint-venture with MSD (known as Merck & Co Inc, in the United States and Canada), Sanofi Pasteur MSD (SPMSD) Sanofi Pasteur and MSD will separately pursue their own vaccine strategies in Europe, integrating their respective European vaccines business into their operations The change in operations took effect January 1, 2017 On January 5, 2017 Sanofi and Regeneron Pharmaceuticals, Inc announced that they will appeal the injunction granted by the US District Court for the District of Delaware preventing the marketing, selling or manufacturing of Praluent in the US during the term of two Amgen patents The companies believe Amgen s asserted patent claims are invalid and will also appeal a prior jury verdict upholding the validity of those patents The court delayed imposition of the injunction for 30 days to allow Sanofi and Regeneron to file a motion for a suspension (stay) of this injunction during the appeal process On January 9, 2017 the US District Court denied Sanofi and Regeneron motion to suspend the injunction and has delayed imposing the injunction for an extra 15 days for a total of 45 days from January 5 Sanofi and Regeneron filed an appeal to the US Court of Appeals for the Federal Circuit on January 12 and filed a motion to suspend the injunction in the Federal Circuit on January 13 Praluent continues to be available to patients at this time On January 18, 2017 Sanofi announced today that the European Commission has granted marketing authorization in Europe for SuliquaTM, the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes Suliqua is authorized for use in combination with metformin to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin 4

5 The "Recent Developments Issue of US commercial paper" paragraph of the Base Prospectus (page 89) is hereby deleted and replaced in its entirety by the following: As at December 31 st, 2016, there was no US commercial paper of Sanofi outstanding An aggregate amount of US $ 500 million of US commercial paper has been issued by Sanofi since January 1 st, 2017 The total aggregate amount of US commercial paper outstanding as at January 20 th, 2017 was US $ 500 million 5

6 PERSONS RESPONSIBLE FOR THE PROSPECTUS SUPPLEMENT In the name of the Issuer To the best of the knowledge of the Issuer (having taken all reasonable care to ensure that such is the case), the information contained or incorporated by reference in this Supplement is in accordance with the facts and does not omit anything likely to affect the import of such information Sanofi 54, rue La Boétie Paris France Duly represented by Olivier Klaric, Senior Vice President Financing and Treasury Signed in Paris Dated 23 January 2017 In accordance with Articles L412-1 and L621-8 of the Code monétaire et financier and with the General Regulations (Règlement Général) of the Autorité des marchés financiers (AMF), in particular Articles to , the AMF has granted to this Supplement the visa no on 23 January 2017 The Base Prospectus, as supplemented by this Supplement may only be used for the purposes of a financial transaction if completed by Final Terms This Supplement was prepared by the Issuer and its signatories assume responsibility for it In accordance with Article L I of the Code monétaire et financier, the visa was granted following an examination by the AMF of "whether the document is complete and comprehensible, and whether the information it contains is coherent" It does not imply that the AMF approves the opportunity of the transaction or has verified the accounting and financial data set out herein The visa has been granted subject to the publication of Final Terms in accordance with Article of the AMF General Regulations, setting out the terms of the securities to be issued 6