##### Table of Contents

 

 

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**
 
**

**FORM 20-F**

**
 
**

**(Mark One)**

 

**OR**

**For the fiscal year ended December 31, 2011**

**OR**

**OR**

Date of event requiring this shell company report . . . . . . . . . . . . . . . . . . . 

**For the transition period from              to            **

**Commission File Number: 001-31368**

**
 
**

**Sanofi**

(Exact name of registrant as specified in its charter) 

**N/A**

(Translation of registrant’s name into English) 

**France**

(Jurisdiction of incorporation or organization) 

**54, Rue La Boétie, 75008 Paris, France**

(Address of principal executive offices) 

**
 
**

**Karen Linehan, Senior Vice President Legal Affairs and General Counsel**

**54, Rue La Boétie, 75008 Paris, France. Fax: 011 + 33 1 53 77 43 03. Tel: 011 + 33 1 53 77 40 00**

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person) 

**
 
**

**Securitiesregistered or to be registered pursuant to Section 12(b) of the Act:**

**Securities registered pursuant to Section 12(g) of the Act:**None****

**The number of outstanding shares of each of the issuer’s classes of capital or**

**common stock as of December 31, 2011 was:**

Ordinary shares:    1,340,918,811 

**Indicate by check mark ifthe registrant is a well-known seasoned issuer, as defined in Rule 405**

**of the Securities Act.**

YES  x    NO   ̈. 

**If this report is an annual or transition report, indicate by check markif the registrant is not**

**required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of1934.**

YES   ̈    NO  x. 

**Indicate by check mark whether the registrant (1) hasfiled all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has beensubject to such filing requirements for the past 90 days.**

Yes  x    No   ̈

**Indicate by check mark whether the registrant hassubmitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for suchshorter period that the registrant was required to submit and post such files).**

Yes  x    No   ̈

**Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer”in Rule 12b-2 of the Exchange Act. (Check one):**

**Indicate by check mark which basis of accounting the registrant has used to prepare thefinancial statements included in this filing:**

U.S.GAAP   ̈    International Financial Reporting Standards as issued by the International Accounting StandardsBoard  x        Other   ̈

**If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item theregistrant has elected to follow.**

Item 17   ̈        Item 18   ̈

**If this is an annual report, indicate by check mark whether theregistrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).**

YES   ̈        NO  x. 

 

 

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**PRESENTATION OF FINANCIAL AND OTHER INFORMATION**

 

The consolidated financial statements contained in thisannual report on Form 20-F have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and with IFRS as adopted by the European Union, as ofDecember 31, 2011. 

 

 

 

Unless the context requires otherwise, the terms“Sanofi,” the “Company,” the “Group,” “we,” “our” or “us” refer to Sanofi and its consolidated subsidiaries. 

 

All references herein to “United States” or“U.S.” are to the United States of America, references to “dollars” or “$” are to the currency of the United States, references to “France” are to the Republic of France, and references to “euro” and“€” are to the currency of the European Union member states (including France) participating in the European Monetary Union. 

 

Brand names appearing in this annual report are trademarks of Sanofi and/or its affiliates, with the exception of: 

 
 • 
trademarks used or that may be or have been used under license by Sanofi and/or its affiliates, such as Actonel® trademark of Warner Chilcott; AvilomicsTM a trademark of Avila Therapeutics Inc.;BiTE® a trademark of Micromet Inc., Copaxone® a trademark of Teva Pharmaceuticals Industries, Cortizone-10® a trademark of Johnson & Johnson (except in the United-States where it is a trademark of the Group); Dynamic Electrochemistry® a trademark of AgaMatrix Inc.; epiCardTM (e-cue) a trademark of Intelliject;Gardasil® a trademark of Merck & Co.; Hyalgan® a trademark of Fidia Farmeceutici S.p.A, under license agreement in the United States; Leukine® a trademark of Alcafleu;Mutagrip® a trademark of Institut Pasteur; Optinate® a trademark of Warner Chilcott on certain geographical areas and of Shionogi Pharma Inc. in the United States; PancréateTM a trademark of CureDM; Prevelle® a trademark of Mentor Worldwide LLC USA; RetinoStat® a trademark of Oxford Biomedica; andRotaTeq® a trademark of Merck & Co.; 

 
 • 
trademarks sold by Sanofi and/or its affiliates to a third party, such as Altace® a trademark of King Pharmaceuticals in the United States; Benzaclin® a trademark of Valeant in the United States and Canada, Carac® a trademark of Valeant in the United States; DDAVP® a trademark of Ferring (except in the United States where it is a trademark of the Group); Lactacyd® a trademark of GSK in certain countries;Liberty®, LibertyLink® and StarLink® trademarks ofBayer; Maalox® a trademark of Novartis in the United States, Canada and Puerto Rico; and Sculptra® a trademark of Valeant; and, 

 
 • 
other third party trademarks such as Acrel® a trademark of Warner Chilcott;ACT® a trademark of Johnson & Johnson on certain geographical areas (except the United States and othercountries where it is a trademark of Signal Investment); Aspirine®, Cipro®, Advantage® and Advantix® trademarks ofBayer; Eprinex® a trademark of Merck & Co. in certain countries; HumaneeredTM a trademark of KaloBios Pharmaceuticals; IC31® a trademark of Intercell;iPhone® a trademark of Apple Inc.; LentiVector® and RetinoStat® trademarks ofOxford BioMedica; LibertasTM a trademark of Apotex in the United States and of International Contraceptive &SRH Marketing Limited in the United Kingdom; Mediator® a trademark of Biofarma; PetArmor® a trademark of Velcera, Inc.; Rotarix® a trademark of GSK; Sklice® atrademark of Topaz Pharmaceuticals LLC; Trajenta® a trademark of Boehringer Ingelheim; Unisom® a trademark of Johnson & Johnson on certain geographical areas (except the United States where it is a trademarkof Signal Investment); and Xyzal® a trademark of GSK in certain countries and of UCB Farchim SA in some others.

 

Not alltrademarks related to investigational agents have been authorized as of the date of this annual report by the relevant health authorities; for instance Lyxumia® and AubagioTM trade nameshave not been approved by the FDA. 

 

 

 

The data relative to market shares and ranking information for pharmaceutical products presented in particular in “Item 4.Information on the Company — B. Business Overview — Markets — Marketing and distribution” are based on sales data from IMS Health MIDAS (IMS), retail and hospital, for calendar year 2011, in constant euros (unless otherwiseindicated). 

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While we believe that the IMS sales data we present below are generally useful comparativeindicators for our industry, they may not precisely match the sales figures published by the companies that sell the products (including our company and other pharmaceutical companies). In particular, the rules used by IMS to attribute the sales ofa product covered by an alliance or license agreement do not always exactly match the rules of the agreement. 

 

In order to allow a reconciliation with our basis of consolidation as defined in “Item 5. Operating and Financial Review andProspects — Presentation of Net Sales,” IMS data shown in the present document have been adjusted and include: 

 
 (i)sales as published by IMS excluding Sanofi sales generated by the vaccines business, equating to the scope of our pharmaceutical operations; 
 
 (ii)IMS sales of products sold under alliance or license agreements which we recognize in our consolidated net sales but which are not attributed to us in the reportspublished by IMS; and 
 
 (iii)adjustments related to the exclusion of IMS sales for products which we do not recognize in our consolidated net sales but which are attributed to us by IMS.
 

Data relative to market shares andranking information presented herein for our vaccines business are based on internal estimates unless stated otherwise. 

 

 

 

Product indications described in this annual report are composite summaries of the major indications approved in the product’sprincipal markets. Not all indications are necessarily available in each of the markets in which the products are approved. The summaries presented herein for the purpose of financial reporting do not substitute for careful consideration of the fulllabeling approved in each market. 

 

 

 

**CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS**

 

This annual report contains forward-looking statements. Wemay also make written or oral forward-looking statements in our periodic reports to the Securities and Exchange Commission on Form 6-K, in our annual report to shareholders, in our offering circulars and prospectuses, in press releases and otherwritten materials and in oral statements made by our officers, directors or employees to third parties. Examples of such forward-looking statements include: 

 
 • 
projections of operating revenues, net income, business net income, earnings per share, business earnings per share, capital expenditures, costsavings, restructuring costs, positive or negative synergies, dividends, capital structure or other financial items or ratios; 

 
 • 
statements of our profit forecasts, trends, plans, objectives or goals, including those relating to products, clinical trials, regulatory approvals andcompetition; and 

 
 • 
statements about our future events and economic performance or that of France, the United States or any other countries in which we operate.

 

This information is based ondata, assumptions and estimates considered as reasonable by the Company as at the date of this annual report and undue reliance should not be placed on such statements. 

 

Words such as “believe,” “anticipate,”“plan,” “expect,” “intend,” “target,” “estimate,” “project,” “predict,” “forecast,” “guideline,” “should” and similar expressions are intended toidentify forward-looking statements but are not the exclusive means of identifying such statements. 

 

Forward-looking statements involve inherent, known and unknown, risks and uncertainties associated with the regulatory, economic, financial and competitive environment, and other factors that could causefuture results and objectives to differ materially from those expressed or implied in the forward-looking statements. The list below indicates some of the risk factors faced by the Company: 

 
 • 
“we rely on our patents and proprietary rights to provide exclusive rights to market certain of our products, and if such patents and other rightswere limited or circumvented, our financial results could be materially and adversely affected”; 

Table of Contents • 
“product liability claims could adversely affect our business, results of operations and financial condition”; 

 
 • 
“changes in the laws or regulations that apply to us could affect the Group’s business, results of operations and financial condition”;

 
 • 
“generic versions of some of our products may be approved for sale in one or more of their major markets”; 

 
 • 
“our long-term objectives may not be fully realized”; 

 
 • 
“we may fail to adequately renew our product portfolio whether through our own research and development or through acquisitions and strategicalliances”; 

 
 • 
“we may lose market share to competing remedies or generic brands if they are perceived to be equivalent or superior products”;

 
 • 
“the diversification of the Group’s business exposes us to additional risks”; 

 
 • 
“our products and manufacturing facilities are subject to significant government regulations and approvals, which are often costly and couldresult in adverse consequences to our business if we fail to comply with the regulations or maintain the approvals”; 

 
 • 
“we incurred substantial debt in connection with the acquisition of Genzyme which may limit our business flexibility compared to some of ourpeers”; 

 
 • 
“we face uncertainties over the pricing and reimbursement of pharmaceutical products”; 

 
 • 
“the ongoing slowdown of global economic growth and the financial crisis could have negative consequences for our business”;

 
 • 
“the manufacture of our products is technically complex, and supply interruptions, product recalls or inventory losses caused by unforeseen eventsmay reduce sales, adversely affect our operating results and financial condition and delay the launch of new products”; and 

 
 • 
risks related to financial markets. 

 

We caution you that the foregoing list of risk factors is not exclusive and a number of important factors, discussed under “Item 3.Key Information — D. Risk Factors” below, could affect the future results and cause actual results to differ materially from those contained in any forward-looking statements. Additional risks, not currently known or considered immaterialby the Group, may have the same unfavorable effect and investors may lose all or part of their investment. 

 

Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation toupdate them in light of new information or future developments. 

Table of Contents
**TABLE OF CONTENTS**

 

**Part I**
   
Item 1.
 
Identity of Directors, Senior Management and Advisers
  
1

Item 2.
 
Offer Statistics and Expected Timetable
  
1

Item 3.
 
Key Information
  
1
 
A. Selected Financial Data
  
1
 
B. Capitalization and Indebtedness
  
3
 
C. Reasons for Offer and Use of Proceeds
  
3
 
D. Risk Factors
  
4

Item 4.
 
Information on the Company
  
19
 
A. History and Development of the Company
  
20
 
B. Business Overview
  
21
 
C. Organizational Structure
  
82
 
D. Property, Plant and Equipment
  
83

Item 4A.
 
Unresolved Staff Comments
  
87

Item 5.
 
Operating and Financial Review and Prospects
  
88

Item 6.
 
Directors, Senior Management and Employees
  
142
 
A. Directors and Senior Management
  
142
 
B. Compensation
  
156
 
C. Board Practices
  
168
 
D. Employees
  
173
 
E. Share Ownership
  
177

Item 7.
 
Major Shareholders and Related Party Transactions
  
182
 
A. Major Shareholders
  
182
 
B. Related Party Transactions
  
184
 
C. Interests of Experts and Counsel
  
185

Item 8.
 
Financial Information
  
186
 
A. Consolidated Financial Statements and Other Financial Information
  
186
 
B. Significant Changes
  
190

Item 9.
 
The Offer and Listing
  
191
 
A. Offer and Listing Details
  
191
 
B. Plan of Distribution
  
192
 
C. Markets
  
192
 
D. Selling Shareholders
  
192
 
E. Dilution
  
192
 
F. Expenses of the Issue
  
192

Item 10.
 
Additional Information
  
193
 
A. Share Capital
  
193
 
B. Memorandum and Articles of Association
  
193
 
C. Material Contracts
  
209
 
D. Exchange Controls
  
211
 
E. Taxation
  
211
 
F. Dividends and Paying Agents
  
216
 
G. Statement by Experts
  
216
 
H. Documents on Display
  
216
 
I. Subsidiary Information
  
216

Item 11.
 
Quantitative and Qualitative Disclosures about Market Risk
  
217

Item 12.
 
Description of Securities other than Equity Securities
  
222

**Part II**
   
Item 13.
 
Defaults, Dividend Arrearages and Delinquencies
  
230

Item 14.
 
Material Modifications to the Rights of Security Holders
  
230

Item 15.
 
Controls and Procedures
  
230

Item 16.
 
[Reserved]
  
230

Item 16A.
 
Audit Committee Financial Expert
  
230

Item 16B.
 
Code of Ethics
  
231

Item 16C.
 
Principal Accountants’ Fees and Services
  
231

Item 16D.
 
Exemptions from the Listing Standards for Audit Committees
  
231

Item 16E.
 
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
  
231

Item 16F.
 
Change in Registrant’s Certifying Accountant
  
231

Item 16G.
 
Corporate Governance
  
231

Item 16H.
 
Mine Safety Disclosure
  
232

**Part III**
   
Item 17.
 
Financial Statements
  
233

Item 18.
 
Financial Statements
  
233

Item 19.
 
Exhibits
  
233

Table of Contents
**PART I**

 

**Item 1. Identity of Directors, SeniorManagement and Advisers**

 

N/A 

 

**Item 2. Offer Statistics and ExpectedTimetable**

 

N/A 

 

**Item 3. Key Information**

 

***A. Selected Financial Data***

 

**SUMMARY OF SELECTED FINANCIAL DATA**

 

The tables below set forth selectedconsolidated financial data for Sanofi. These financial data are derived from the Sanofi consolidated financial statements. The Sanofi consolidated financial statements for the years ended December 31, 2011, 2010 and 2009 are included inItem 18 of this annual report. 

 

Theconsolidated financial statements of Sanofi for the years ended December 31, 2011, 2010 and 2009 have been prepared in compliance with IFRS issued by the International Accounting Standards Board (IASB) and with IFRS adopted by the EuropeanUnion as of December 31, 2011. The term “IFRS” refers collectively to international accounting and financial reporting standards (IAS and IFRS) and to interpretations of the interpretations committees (SIC and IFRIC) mandatorilyapplicable as of December 31, 2011. 

 

Sanofireports its financial results in euros. 

 
1 

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**SELECTED CONDENSED FINANCIAL INFORMATION**

 
    **As of and for the year ended December 31,** *(€ million, except per share data)*  **2011**   **2010**   **2009**   **2008**   **2007** 
**IFRS Income statement data(a)**
        
Net sales
   33,389     32,367     29,785     27,568     28,052  
Gross profit
   24,156     24,638     23,125     21,480     21,636  
Operating income
   5,731     6,535     6,435     4,394     5,911  
Net income attributable to equity holders of Sanofi
   5,693     5,467     5,265     3,851     5,263  
**Basic earnings per share (€) (a)/(b) :**
        
Net income attributable to equity holders of Sanofi
   4.31     4.19     4.03     2.94     3.91  
**Diluted earnings per share (€) (a)/(c) :**
        
Net income attributable to equity holders of Sanofi
   4.29     4.18     4.03     2.94     3.89  
**IFRS Balance sheet data**
        
Goodwill and other intangible assets
   61,718     44,411     43,480     43,423     46,381  
Total assets
   100,165     85,264     80,251     71,987     71,914  
Outstanding share capital
   2,647     2,610     2,618     2,611     2,657  
Equity attributable to equity holders of Sanofi
   56,219     53,097     48,322     44,866     44,542  
Long term debt
   12,499     6,695     5,961     4,173     3,734  
Cash dividend paid per share (€) (d)
   2.65 (e)    2.50     2.40     2.20     2.07  
Cash dividend paid per share ($) (d)(f)
   3.43 (e)    3.34     3.46     3.06     3.02  
 

 
*(a)*
*Theresults of operations of Merial, for 2010 and 2009, previously reported as held-for-exchange, have been reclassified and included in net income of continuing in accordance with IFRS 5.36., following the announcement that Merial andIntervet/Schering-Plough are to be maintained as two separate businesses operating independently.*
*(b) *
*Based on the weighted average number of shares outstanding in each period used tocompute basic earnings per share, equal to 1,321.7 million shares in 2011, 1,305.3 million shares in 2010, 1,305.9 million shares in 2009, 1,309.3 million shares in 2008, and 1,346.9 million shares in 2007.*
*(c) *
*Based on the weighted average in each period of the number of shares outstandingplus stock options and restricted shares with a potentially dilutive effect; i.e., 1,326.7 million shares in 2011, 1,308.2 million shares in 2010, 1,307.4 million shares in 2009, 1,310.9 million shares in 2008, and1,353.9 million shares in 2007.*
*(d) *
*Each American Depositary Share, or ADS, represents one half of one share.*
*(e) *
*Dividends for 2011 will be proposed for approval at the annual general meetingscheduled for May 4, 2012.*
*(f) *
*Based on the relevant year-end exchange rate.*

 
2 

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**SELECTED EXCHANGE RATE INFORMATION**

 

The following table sets forth, for the periods and datesindicated, certain information concerning the exchange rates for the euro from 2007 through March 2012 expressed in U.S. dollars per euro. The information concerning the U.S. dollar exchange rate is based on the noon buying rate in New York City forcable transfers in foreign currencies as certified for customs purposes by the Federal Reserve Bank of New York (the “Noon Buying Rate”). We provide the exchange rates below solely for your convenience. We do not represent that euros were,could have been, or could be, converted into U.S. dollars at these rates or at any other rate. For information regarding the effect of currency fluctuations on our results of operations, see “Item 5. Operating and Financial Review andProspects” and “Item 11. Quantitative and Qualitative Disclosures about Market Risk.” 

 
    **Period-**