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JP Morgan Healthcare Conference Christopher A. Viehbacher, Chief Executive Officer San Francisco, January 14, 2014

2014/01 - JP Morgan HC

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Page 1: 2014/01 - JP Morgan HC

JP Morgan Healthcare ConferenceChristopher A. Viehbacher, Chief Executive Officer

San Francisco, January 14, 2014

Page 2: 2014/01 - JP Morgan HC

2

Forward Looking Statements

This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of1995, as amended. Forward-looking statements are statements that are not historical facts. These statements includeprojections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions andexpectations with respect to future financial results, events, operations, services, product development and potential,and statements regarding future performance. Forward-looking statements are generally identified by the words"expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi'smanagement believes that the expectations reflected in such forward-looking statements are reasonable, investors arecautioned that forward-looking information and statements are subject to various risks and uncertainties, many of whichare difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments todiffer materially from those expressed in, or implied or projected by, the forward-looking information and statements.These risks and uncertainties include among other things, the uncertainties inherent in research and development,future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or theEMA, regarding whether and when to approve any drug, device or biological application that may be filed for any suchproduct candidates as well as their decisions regarding labeling and other matters that could affect the availability orcommercial potential of such product candidates, the absence of guarantee that the product candidates if approved willbe commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's abilityto benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of costcontainment policies and subsequent changes thereto, the average number of shares outstanding, as well as thosediscussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under"Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake anyobligation to update or revise any forward-looking information or statements.

Page 3: 2014/01 - JP Morgan HC

The Opportunity with Sanofi

Sanofi has transformed into a company positioned for sustainable growth through its Growth Platforms(1) and has a robust late-stage pipelineof new biologics

3(1) Growth Platforms include Emerging Markets, Diabetes Solutions, Vaccines, Consumer Healthcare, Animal Health, Genzyme & Other Innovative

Products. In Q3 2013, sales from Growth Platforms accounted for 74.7% of Group sales

Page 4: 2014/01 - JP Morgan HC

44

Focusing on Growth Platforms and New Products

Emerging Markets1

Diabetes Solutions2

Consumer Healthcare4

Animal Health6

Vaccines3

Genzyme5

Other Innovative Products7

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A commercial presence in a large number of Emerging

Markets

Sanofi’s Scorecard in Emerging Markets

Number onecompany in Emerging

Markets by market share

A top position in most of the fast growing economies

One of the biggest sales

forces in Emerging Markets

An historical presence

and diversified product portfolio

A widenetwork of

industrial sites across

Emerging Markets

#1with

5.7% marketshare(1)

#1in BRIC

and non-BRIC

47/53sales split

between Growth platforms

and Other products

~23,000sales

representatives

37industrial

sites

~100countries with

commercialpresence

(1) IMS MIDAS MAT Q3 20135

Sanofi Is Poised to Capture Growthin Fast Growing Markets

Page 6: 2014/01 - JP Morgan HC

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Quarterly Sales (€m)

€968m

€1,279m

Lantus® Is The Basal Insulin of Reference Worldwide

€1,456m

● Diabetes worldwide prevalence: 382m(1)

● 46% undiagnosed● Almost half live in just three countries

(China, India, U.S.)

● Lantus®: prescribers’ first choice for insulin therapy● >10 years of broad clinical experience● >8m Lantus® patients worldwide

● ORIGIN results on Lantus® CV safety recently integrated into product label

● State-of-the-art, easy-to-use and affordable insulin pens

(1) IDF Diabetes Atlas 2013 - 6th Edition

Page 7: 2014/01 - JP Morgan HC

0 6 12 18 24 30 36

0

5

10

15

20

25

30

LLOQ 5.02 µU.mL-1

SC INJECTION

INSU

LIN

- µU

.mL-1

TIME - hour

U100 0.4 U.kg-1

U300 0.4 U.kg-1

LOESS 0.15

0 6 12 18 24 30 36

0

1

2

3

4

5DOSE 0.4 U.kg-1

U300 U100

GIR

- m

g.kg

-1.m

in-1

TIME - hour

U300: Striving to Further Enhance the Value of Current Basal Insulin

7

Expected regulatory submission in H1 2014 in U.S. and EU

Dahmen R et al, ADA 2013, abstract no. 113-OR. Euglycemic clamp study in T1D in steady state

U300

Lantus®

U300

Lantus®

Flatter PK Profile More Prolonged PD ProfileSerum Insulin Glargine Concentration Glucose Infusion Rate

Page 8: 2014/01 - JP Morgan HC

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● Key benefits of Lyxumia® complementing basal insulin

● Pronounced post-prandial glucose (PPG) lowering effect

● Beneficial effect on body weight

● Limited risk of hypoglycemia

● Indicated in EU for combination use with OADs and basal insulin

● Commercially available in Germany, UK, Spain, Japan and Mexico

● FDA submission expected in 2015 after completion of ELIXA CV outcome trial

Lyxumia® Is an Add-On Therapy for Patientson Basal Insulin

Lyxumia® is the proprietary name approved by the EMA for lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration. In the U.S.; lixisenatide is currently under review by the FDA. Lixisenatide was in-licensed from Zealand Pharma A/S.

Lyxumia®

Easy-to-Use Once-Daily Prandial GLP-1

First 2 weeks of therapy

Remainder of therapy

Lyxumia®

10 µg OD SC

Lyxumia®

20 µg OD SC

OD: Once-daily SC: Subcutaneous

Page 9: 2014/01 - JP Morgan HC

Combining Insulin Glargine with Lixisenatide in One Single Daily Injection (LixiLan)

● Opportunities in patients not at target on OADs and basal insulin

● Phase II Proof-of-concept study completed(1)

● Phase III expected to start in Q1 2014

● Potential to be the first combinationof Basal Insulin + GLP-1 in one daily injection in the U.S

(1) Full data to be submitted for publication in a medical journal 9

Page 10: 2014/01 - JP Morgan HC

(1) Pentacel®, Adacel® and Daptacel®

Vaccines Have Dealt Effectively with Production Shortfalls to Allow a Return to Growth in 2014

1010

● Differentiated flu vaccines have invigorated sales

● Hexyon® rolling out in Europe and strong Pentaxim® uptake in Emerging Markets

● Shan 5® WHO prequalification expected in H1 2014

● Toronto production issues under control and volumes of Pertussis-containing vaccines(1) recovering

Differentiated Vaccines Allow for the “Right Dose, Right Patient” Approach

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Dengue Vaccine: Addressing a Growing Global Threat

Significant Disease Burden(1)

● 2.5bn people at risk

● Estimated 100m dengue infections worldwide per year ● 500,000 people with severe dengue requiring

hospitalization● 2.5% of people with severe dengue die

● Dengue is a public health priority in Asia and Latin America

● Dengue is under-reported and thus the burden is likely underestimated(2)

11

Ambitious Development Program

● Phase IIb results in ~4,000 children recently published in the Lancet(3)

● Efficacy confirmed against DENV 1, 3 and 4 (in the range of 60% to 90%), and inconclusive against DENV 2

● Safe and well-tolerated

● Global Phase III program ongoing ● Large scale studies in Asia and Latin

America ● 31,000 children and adolescents

● Results expected in H2 2014

(1) Dengue and severe dengue; WHO Fact Sheet No. 117 updated Sep. 2013 http://www.who.int/mediacentre/factsheets/fs117/en/index.html

(2) Bhatt S et al. Nature. 2013 Apr 25;496(7446):504-7.(3) Sabchareon A et al. Lancet. 2012 Nov 3;380(9853):1559-67.

Page 12: 2014/01 - JP Morgan HC

CDI – A Growing Healthcare Problem

● Most common cause of healthcare associated infections in developed countries(2)

● In the U.S. alone, a significant burden(3)

● ~28,000 deaths and up to 450,000 hospital admissions

● Associated cost of care: up to $3.4bn

● Targeted patients at high risk of CDI:● Elderly with antibiotic use, planned

at-risk admissions to hospital and long-term care facilities residents

C. Diff Toxoid Vaccine: Preventing Primary Symptomatic Clostridium Difficile Infections (CDI)

12

● Candidate vaccine shown to be safe and immunogenic in Phase I(1)

and Phase II trials● Broad functional antibody responses

to both toxins (A and B)

● Cdiffense multinational Phase III trial started in Q3 2013● Case driven study

● Up to 15,000 adults to be included

● Fast Track Development Program designation granted by CBER

CBER – Center for Biologics Evaluation and Research within FDA (1) Greenberg R, Vaccine, March 2012(2) He M, Nature Genetics, December 2012, and Miller BA, Control Hosp Epidemiol, April 2011(3) CDC Morbidity and Mortality Weekly Report, March 2012

Page 13: 2014/01 - JP Morgan HC

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Sanofi Is the World’s Third Largest CHC Player

● Double digit growth of Top 4 brands● Allegra®, Doliprane®, Enterogermina®

and Essentiale®

● Re-introduction of Rolaids® in the U.S. in Sep 2013

● Nasacort® Allergy 24HR approved by FDA in Oct 2013 for OTC use● First and only nasal spray in its class

to be available without a prescription

● Creation of a Global Consumer Healthcare Division

(1) In 9M 2013. Nicholas Hall & Company

1. J&J 2. BAYER3.4. PFIZER 5. NOVARTIS6. GSK7. RECKITT BENCKISER8. BOEHRINGER INGELHEIM9. TAKEDA 10. TAISHO

4.2%3.4%3.1%3.0%2.9%2.6%2.5%1.5%1.3%1.3%

Top 10 OTC in Market Share(1)

Page 14: 2014/01 - JP Morgan HC

14

Genzyme Rare Disease Products Are a Major Growth Driver for Sanofi

● Rebuilding our leadership position in Rare Diseases ● Cerezyme®: #1 therapy for Gaucher

disease● Fabrazyme®: #1 position reached in

just four quarters once supply restored● Myozyme®: the only approved therapy

for Pompe disease

● Start of clinical development on the next generation ERT for Pompe disease and a small molecule for Fabry disease

52%value share in 9M 2013(1)

for Fabry disease

73%value share in 9M 2013(1)

for Gaucher disease

(1) Based on 9M 2013 reported sales by Sanofi and Shire

Page 15: 2014/01 - JP Morgan HC

Cerdelga™ (eliglustat) - A Novel Investigational Oral Therapy to Expand our Gaucher Franchise

● Oral therapy eliminating infusion challenges

● Largest ever clinical program in Gaucher: ~400 adults in 29 countries● Phase III studies included patients just

starting treatment (ENGAGE) and patients switching from ERT (ENCORE)

● All primary/secondary endpoints met in Phase III studies

● Non-inferiority criteria to Cerezyme® met (ENCORE)

● Regulatory review ongoing by EMA and FDA● Priority review granted in the U.S.

ERT : Enzyme Replacement Therapy

+2%

-28%

Placebo

Eliglustat

30%Absolute Difference

ENGAGE - Change in Spleen Volume(% change at 9 months)

15

Potential to grow market and build Genzyme share further

p<0.0001

Page 16: 2014/01 - JP Morgan HC

16

Genzyme’s Commitment and Leadership in Rare Diseases Increases through Expansion of Alnylam Collaboration

This transaction has been approved by the boards of both companies, and is subject to customary closing conditions and clearances under the Hart-Scott Rodino Antitrust Improvements Act

● Alnylam’s world-class RNAi technology to provide a platform for sustained drug development for rare genetic diseases for Genzyme

● Focus is on genetically defined diseases with a clear translational model for RNA interference

● Genzyme becomes major Alnylam shareholder through $700 million equity investment

Program Rights(subject to opt-in)

PC P1 P2 P3

Patisiran (TTR‐FAP) in expanded territory

AS1 (Hepatic Porphyria)

TTRsc (FAC)

Unnamed

AT3 (Hemophilia)

TTR-FAP: Transthyretin-Familial Amyloïd PolyneuropathyFAC: Familial Amyloïd Cardiomyopathy

Page 17: 2014/01 - JP Morgan HC

(1) Evaluate Pharma July 2013(2) Oral category includes Aubagio®, Gilenya®, Tecfidera®, laquinimod, 2nd Gen S1Ps(3) Intravenous category includes Tysabri®, Lemtrada®, ocrelizumab, daclizumab(4) Injectable category includes Avonex®, Betaseron/Betaferon®, Copaxone®, Rebif®, Extavia®, Plegridy™

Global MS Market - Significant and Growing Market Oral and IV Therapies Expected to Grow

59%

0%

15%

30%

45%

60%

75%

90%

2012 2017e

MS Market Evolution(1,2,3,4)

(% market share)

Injectables

Intravenous

Orals

~€11bn >€14bn

● Oral therapy(2) share projected to increase four-fold to nearly 40% of the MS market by 2017 driven by new entrants

● Intravenous therapies(3) expected to approach 20% of the market

● Injectable therapies(4) (ABCRE’s) projected to decline by roughly half of current usage by 2017

17

Page 18: 2014/01 - JP Morgan HC

1818(1) New Active Substance (NAS) status granted in Europe in Jun 2013Lemtrada™ is developed in collaboration with Bayer HealthCare

Genzyme Is Well Positioned to Enter the €11bnGlobal MS Market with a Franchise Approach

● U.S. sales of €97m in 9M 2013 ● EMA approval granted in Aug 2013(1)

● EU launch rollout started in Q4 2013● Strong launch in Germany and other

EU launch countries

● Regulatory approvals granted in EU, Canada and Australia ● EU launch rollout started in Q4 2013 ● Complete response letter received from FDA in late Dec 2013

● Genzyme plans to appeal the agency’s decision● CVR milestone of U.S. approval by March 31, 2014 will not be met

Aubagio®: Quarterly Sales

Q4 2012 Q2 2013Q1 2013

€7m

€20m

€33m

€44m

Q3 2013

Page 19: 2014/01 - JP Morgan HC

19

Merial Gearing Up to Launch the Next Generation of Flea and Tick Control for Pets

9M Sales (€m)● Companion Animals performance

impacted by relatively weak flea and tick season and more competition to Frontline®

● Regulatory approvals recently granted for NexGard® for dogs in the U.S. and Broadline® for cats in EU

● 10 significant new products potentially launched over next 3 years evenly split between companion and production animals

€1,560m

2011 2012 2013

€1,673m €1,541m

Page 20: 2014/01 - JP Morgan HC

Alirocumab: Fully-Human PCSK9 mAbTargeting Unmet Needs in Hypercholesterolemia

20

Alirocumab is developed in collaboration with RegeneronPCSK9: proprotein convertase subtilisin/kexin type 9, an enzyme that can contribute to elevated LDL-C levels through degradation of LDL-C receptorsLDL-C : Low Density Lipoprotein-Cholesterol(1) From all Phase III studies except OUTCOMES, CHOICE 1, and CHOICE 2(2) ODYSSEY MONO is the first study to report data from the Phase III ODYSSEY program

● Global Phase III ODYSSEY program ongoing with 14 clinical studies underway

● Data from Phase III program expected in mid 2014 through Q3 2014(1)

● Initial regulatory submission based on LDL-C planned for early 2015 outside the U.S.● U.S. regulatory submission

in 2015

- 15.6%

- 47.2%

ezetimibe

alirocumab

p<0.0001

ODYSSEY MONO(2) - Mean LDL-C change(at week 24)

Page 21: 2014/01 - JP Morgan HC

Sarilumab: Significant Opportunity for IL-6R Inhibition in Rheumatoid Arthritis (RA)

● Fully human, high affinity, IL-6R mAb administered subcutaneously

● Positive results from SARIL-RA-MOBILITY, first Phase III trial in moderate-to-severe RA(1)

● Additional Phase III data expected in 2015

● Ongoing Phase III studies are: COMPARE, TARGET, ASCERTAIN, EXTEND

● Regulatory submission roll-out expected to start in 2015

SARIL-RA-MOBILITY (Phase III Results)

ACR – American College Of Rheumatology (ACR) Scoring SystemIL-6R – Interleukin-6 receptorSarilumab is developed in collaboration with Regeneron(1) Clinically relevant and statistically significant improvements in both sarilumab groups compared to placebo in all three co-primary endpoints:

ACR 20, Improvement of physical function and Inhibition of progression of structural damage

Sarilumab200 mg + MTX

25.0*

46.0*

66.0*

Sarilumab150 mg + MTX

20.0*

37.0*

58.0*

Placebo + MTX

7.0

17.0

33.0

ACR70ACR50ACR20**

* p<0.0001 versus placebo** Primary endpoint

Improvement in Signs & Symptoms at Week 24ACR Response (% of Patients)

21

Page 22: 2014/01 - JP Morgan HC

● Fully human monoclonal antibody binding to IL-4Rα● Targeting the common IL-4Rα subunit ● Dual IL-4/IL-13 cytokine antagonism

with a single agent

● Atopic Dermatitis● Phase IIa data to be presented at

AAAAI in Q1 2014● Phase IIb data expected in Q2 2014● Plan to initiate Phase III trial in 2014

● Asthma● Phase IIa data published in NEJM● Phase IIb ongoing

● Phase IIa ongoing in Nasal polyposis

22Dupilumab is developed in collaboration with RegeneronAAAAI:American Academy of Allergy, Asthma & Immunology

IL-4

IL-4R c

Type IReceptor

Type IIReceptor

IL-13

IL-4R IL-13R1

or

Dupilumab: Targeting Atopic Dermatitis (AD), Asthmaand Nasal Polyposis

Atopic Dermatitis

Page 23: 2014/01 - JP Morgan HC

Sanofi’s Growth Profile Expected to Emerge in Q4 2013

● In 2014, Sanofi will continue to demonstrate strong performance of Growth Platforms, launch new products and reinforce pre-launch efforts for late-stage projects

● Growth Platforms now account for 72% of sales(1) and Sanofi has returned to sales growth since September 2013(2)

● New product launches are underway or imminent in all of Sanofi's businesses and several high potential R&D projects progressed in 2013

● The creation of Growth Platforms and the evolution of our R&D pipelinehave effectively transformed Sanofi into a major biopharmaceutical player

(1) 72.4% in 9M 2013 (2) Sales growth of +6.1% in September 2013 at constant exchange rates and constant structure basis 23