2013 - Jp Morgan HC

JP Morgan Healthcare ConferenceDr. Elias Zerhouni, President – Global R&D

San Francisco, January 8, 2013

2

Forward Looking Statements

This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995,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, andstatements regarding future performance. Forward-looking statements are generally identified by the words "expects","anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believesthat the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict andgenerally beyond the control of Sanofi, that could cause actual results and developments to differ materially from thoseexpressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertaintiesinclude 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 the EMA, regarding whether and when toapprove any drug, device or biological application that may be filed for any such product candidates as well as theirdecisions regarding labeling and other matters that could affect the availability or commercial potential of such productcandidates, the absence of guarantee that the product candidates if approved will be commercially successful, the futureapproval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growthopportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies andsubsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in thepublic filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "CautionaryStatement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise anyforward-looking information or statements.

33

Repositioning Sanofi for Sustainable Growth

2005-2008 2009-2012 2013+

Focusing on Rx Blockbusters Transforming Generating

Sustainable Growth• Investing in growth platforms• Increasing diversification• Managing patent cliff

• Growing recurring sales• Improving risk profile

• Blockbuster drugs• Patents challenged• R&D setbacks

Growth Platforms Sales(2)

(€m and % of Total Sales)

Q2 Q1 Q2 Q3

€6,412m

€5,381m

Over 70% of Sales from Growth Platforms and Limited Sales Exposure to Patent Cliff(1) as of Q3 2012

(1) Key genericized products include Lovenox® U.S., Plavix® Western EU, Taxotere® Western EU & U.S., Eloxatin® U.S., Ambien® family U.S., Allegra® U.S., Aprovel® Western EU, Xyzal® U.S., Xatral® U.S., Nasacort® U.S. and BMS Alliance (active ingredients of Plavix® and Avapro® sold to BMS)

(2) Growth Platforms include Emerging Markets, Diabetes Solutions, Vaccines, Consumer Health Care, Animal Health, New Genzyme (Rare Diseases and Multiple Sclerosis) and Innovative Products (new product launches which do not belong to the Growth Platforms listed above: Multaq®, Jevtana®, Mozobil® and Zaltrap®) 4

Q2 Q1 Q2 Q3

4.4%of Total Sales

€813m€399m

Key Genericized Products Sales(1)

(€m and % of Total Sales)

€752m

€5,753m

70.9%of Total Sales

€3,339m

€2,207m

20122009 20122009

Executing Successful Strategy to Reposition Sanofi

Deliversustainable growth

and generate improved

shareholder returnsAdapt structure for futurechallenges and opportunities3

Pursue external growth opportunities2

Increase innovation in R&D1

55

PDUFA Date: Jan 29, 2013(1)TM

hoFH in the U.S

EC Decision: Q1 2013FDA Decision on File Acceptance: Q1 2013Type 2 Diabetes

®

Multiple Regulatory Milestones Expected in Next Three Months

hoFH: Homozygous Familial HypercholesterolemiaEC: European CommissionDTP-HepB-Polio-Hib: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus type b

6

Lyxumia®, Kynamro™ and Lemtrada™ are registered trade names submitted to health authorities for investigational agentsZaltrap® is developed in collaboration with Regeneron, Kynamro™ with Isis Pharmaceuticals and Lyxumia® is in-licensed from Zealand PharmaGenzyme is developing Lemtrada™ in MS in collaboration with Bayer HealthCare

PDUFA: Prescription Drug User Fee Act CHMP: Committee for Medicinal Products for Human Use

Expected Milestones

EC Decision: Q1 2013

Products

® MetastaticColorectal Cancer

Targeted Indications

FDA Decision on File Acceptance: Q1 2013CHMP Opinion: Q2 2013

Relapsing Forms ofMultiple Sclerosis

CHMP Opinion: Q1 2013Relapsing Forms ofMultiple Sclerosis

®

(1) On October 18th 2012, an FDA AdCom recommended Kynamro™ for hoFH

DTP-HepB-Polio-Hib CHMP Opinion: Q1 2013New 6-in-1

Paediatric Vaccine

77

Focusing R&D on High-Value Projects in Key Therapeutic Areas

1 Diabetes

2 Oncology

3 Multiple Sclerosis and Rare Diseases

4 Cardio-Metabolic Diseases

5 Immunology

6 Vaccines

Broadening our Diabetes Platform with New Patient-Focused Solutions

8

® ● Once-daily and pronounced PPG lowering effect

● Use on top of basal insulin

● ELIXA: CV outcome study ongoing

Lyxumia® is the proprietary name submitted to the EMA for the company’s investigational GLP-1 RA lixisenatide. The proprietary name for lixisenatidein the U.S. is under consideration. Lixisenatide is not currently approved or licensed anywhere in the world.Lixisenatide was in-licensed from Zealand Pharma A/S. PPG: postprandial glucose PK/PD – Pharmacokinetic/Pharmacodynamic TD1 and TD2: Type 1 and Type 2 diabetes(1) EDITION I, II, III, IV, JPI, JPII - ClinicalTrials.gov Identifier: NCT 1499082, 01499095, 01676220 & 01683266, 01689129 & 01689142

● Unique flat PK/PD profile and lower injection volume

● EDITION program: six Phase III trials currently ongoing in T1D and T2D(1)

● First state-of-the art reusable insulin pen, manufactured by a global company in India

● For use with Sanofi’s insulin portfolio in India and possibly other Emerging Markets

NEWINSULIN GLARGINE

FORMULATION

Key Facts about MST2D Patients Treated with Basal Insulin(1) (worldwide)

On basal insulinOn basal insulinwith controlledfasting glucosebut A1c >7%

4 millionon other

basal insulins(2)

4 millionon Lantus®

4 million

Lyxumia® is the proprietary name submitted to the EMA for the company’s investigational GLP-1 RA lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration. Lixisenatide is not currently approved or licensed anywhere in the world.

T2D – Type 2 Diabetes A1C – HbA1c or Glycated hemoglobin (1) Adapted from IMS data (2) Includes all types of basal insulins

Clinical Development Designed to Support Use in Combination with Basal Insulin

®

9

MonoMono Japan

Monotherapy

Placebo-controlledin OAD failure

M (metformin)

F1 (metformin)

M Asia (metformin)

S (sulfonylurea)

P (pioglitazone)

X vs. exenatideActive-controlled

L Asia

L Placebo-controlled on top of

basal insulin Duo 1

Phase III Program

Next step: to develop a combination of Lantus® and Lyxumia®

10

Broad Phase III Program Evaluating Potential Clinical Benefitsof Improved PK/PD Profile of New Glargine Formulation

● Two Phase III trials in T2D high-dose insulin users(1)

● 1,600 patients● Headline results expected in Q2 2013

● Second set of Phase III studies started in H2 2012(1)

● Two new studies also initiated in Japan (JPI and JPII)

EDITION IT2D PatientsBasal Bolus

EDITION IIT2D PatientsBasal + OAD

OAD – Oral anti-diabetic drugs (1) EDITION I, II, III, IV, JPI, JPII - ClinicalTrials.gov Identifier: NCT 1499082, 01499095, 01676220 & 01683266, 01689129 & 01689142

New Insulin Glargine Formulation Depot formation after subcutaneous injection

Schematic illustration

Lantus® New Glargine Formulation

10

EDITION IIIT2D PatientsInsulin Naïve

EDITION IVT1D Patients

Basal

1111


1 Diabetes

2 Oncology



5 Immunology

6 Vaccines

U.S. Launch On Track and EU Roll Out Imminent

12

Zaltrap® is developed in collaboration with Regeneron(1) Van Cutsem, et al. JCO Oct 1, 2012:3499-3506;

● A novel VEGF trap acting on multiple angiogenic targets

● Indicated in combination with FOLFIRI in mCRC patients resistant to or progressing on an oxaliplatin-containing regimen

● Significant improvement in Overall Survival demonstrated in the VELOUR study(1)

● European launch roll out expected to start as of Q1 2013

VEGF: Vascular endothelial growth factor FOLFIRI: FOL (folinic acid), F (fluorouracil) and IRI (irinotecan)mCRC: Metastatic colorectal cancer

● Novel selective JAK2 inhibitor

● Promising Phase II response rate in patients with myelofibrosis (MF)

● Phase III in MF (JAKARTA)● Two doses (400 mg and 500 mg)

selected● Enrollment completed● Headline results in Q2 2013

● Two Phase II studies ongoing● Polycythemia vera● Myelofibrosis patients previously

treated with ruxolitinib

% patients with ≥35% reductionin spleen volume from baseline

JAK2 inhibitor - Addressing Treatment Gaps for Patients with Debilitating Hematologic Malignancies

13

SAR302503 - Phase II trial

1414

1 Diabetes

2 Oncology



5 Immunology

6 Vaccines


15

Global MS Market - Significant and Expected to Grow

Key Facts about MS

● ~2.1m patients worldwide(1)

● Prevalent in young women (~2:1 female/male ratio)

● Life expectancy 5-10 years lower than unaffected people

● A major impact on family, social and professional life

● Symptoms include fatigue, weakness, walking and balance difficulties, vision problems

Multiple Sclerosis

(1) National Multiple Sclerosis Society(2) 2011: Reported sales of Copaxone®, Avonex®, Rebif®, Betaseron/Betaferon®, Extavia®, Tysabri®, and Gilenya®

(3) 2016e: Adapted from Evaluate Pharma report - December 2011

Multiple Sclerosis Market Global Sales(2,3)

CAGR >6%

2011 2016e

U.S.

ROW

56%

54%

44%46%

$12.5bn

$17.8bn

Key Facts about MSMS Therapies

Global MS Market - Still Dominated by ABCRE Products

16(1) ABCRE stands for Avonex®, Betaseron®/Betaferon®, Copaxone®, Rebif® and Extavia®

(2) Reported sales of ABCRE products plus Tysabri®, and Gilenya® in 2011

● “ABCRE” products(1) represented 84% of the global MS market in value in 2011

● Moderate efficacy and patients continue to relapse on therapy

● Require frequent injections

● Latest entrants represent treatment alternatives

● Drives the benefit vs. risk discussion

$3,884m31%

$2,686m21%

$1,553m12%

$494m4%

$2,350m19%

$1,511m12%

2011 Sales and Market Share in Value(2)

$154m1%

All trademarks are the property of their respective owners

17

An Exciting Oral Treatment for Relapsing MS

17

(1) Adjusted for Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment into account(2) At Week 108(3) Derived using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates(4) Derived from log-rank test with stratification of EDSS strata at baseline and region(5) TEMSO and TOWER; Aubagio® 7mg tablets are also available in the U.S.

● Aubagio® 14mg is the only oral MS drug to significantly delay disability progressionin two Phase III trials(5)

● Aubagio® 14mg provided statistically significant reduction in Annualized Relapse Rate● Convenience of OD oral administration to avoid the burden of regular injections● Encouraging Rx launch trends in the U.S. tracking ahead of fingolimod

TEMSO STUDY TOWER STUDYReduction in Progression of

Disability(2)

Placebo

-29.8%(3)p=0.0279(4)

Aubagio®

14mgPlacebo Aubagio®

14mg

0.273

0.1580.202 0.197

-31.5%(3)p=0.0442(4)

Reduction in Progression of Disability(2)

n=370n=363 n=359 n=388

TEMSO STUDY TOWER STUDYAnnualized Relapse Rate(1)

Placebo

- 31.5%p=0.0005

Aubagio®

14mg

n=370

Placebo Aubagio®

14mg

0.539

0.3190.369

0.501

n=363 n=359 n=388

Annualized Relapse Rate(1)

- 36.3%p=0.0001

®

The most frequent adverse reactions for AUBAGIO® in the placebo-controlled studies were ALT increased, alopecia, diarrhea, influenza, nausea, and paresthesia. The AUBAGIO® label includes a boxed warning citing the risk of hepatotoxicity and teratogenicity (based on animal data).

Only Therapy(1) Slowing Accumulation of Disability Sustained for 6 Months vs. Active Comparator

3 months

Active Comparators

Placebo

6 monthsEDSS

HigherHurdle

18

EDSS: Expended Disability Status Scale (1) Investigational compound(2) Based on CARE-MS II

HigherHurdle

(2)

For Illustrative Purposes

19

Rebif®

- 55%p<0.0001

n=426

0.39

0.26

0.18

0.52

n=187 n=376 n=202

Lemtrada™Rebif® Lemtrada™

- 49%p<0.0001

CARE-MS I CARE-MS IIAnnualized Relapse Rate Annualized Relapse Rate

Significantly More Effective at Reducing ARR in Pivotal Trials(1) with Unique Dosing Regimen

ARR: Annualized Relapse Rate (1) CARE-MS I and CARE-MS II were both head-to-head trials comparing Lemtrada™ versus Rebif®

Eliglustat(1) - A Novel Oral Therapy in Gaucher Disease

● Potent, novel substrate inhibitor

● Oral therapy ● Eliminating challenges of infusions

● Positive results from ENGAGE, first Phase III study (vs. placebo)● Primary endpoint and all secondary

endpoints met(2)

● Well tolerated with no serious adverse events reported in the primary analysis period

● ENCORE Phase III results (vs. Cerezyme®) expected in early 2013

20(1) Eliglustat tartrate is an investigational drug(2) Secondary endpoints included improvements in hemoglobin levels and platelet levels, as well as liver volumes

+2%

-28%

Placebo

Eliglustat

30%Absolute Difference

Change in Spleen Volume(% change at 9 months)

2121

1 Diabetes

2 Oncology



5 Immunology

6 Vaccines


PCSK9 mAb: First in Class and Targeting Unmet Needs in Hypercholesterolemia

22

LDL-C Change from baseline (Phase II)(2,4,5)

SAR236553 / REGN727 is developed in collaboration with Regeneron PCSK9: proprotein convertase subtilisin/kexin type 9, an enzyme that can contribute to elevated LDL-C levels through degradation of LDL-C receptorsCHD – Coronary Heart Disease(1) Cohen JC. N Engl J Med 2006;354(12):1264-72(2) McKenney, et al JACC published online March 28 2012(3) Roth et al JACC Volume 59, Issue 13, Supplement, 27 March 2012, E1620(4) Patients with primary hypercholesterolemia receiving stable atorvastatin therapy; change from baseline to week 12(5) LS mean (SE), using LOCF method* P<0.0001 for % change SAR236553 vs. placebo

● First-in-class fully-human antibody targeting PCSK9

● Landmark study demonstrated that when PCSK9 is disabled, cholesterol and risk of CHD are greatly lowered(1)

● Phase II data(2,3)

● Significantly reduced mean LDL-C by 40% to 72% over 8 to 12 weeks in patients with elevated LDL-C in patients on stable dose of statins

● Most common TEAE: mild injection site reaction

-80

-70

-60

-50

-40

-30

-20

-10

0BASELINE WEEK 2 WEEK 4 WEEK 6 WEEK 8 WEEK 10 WEEK 12

SAR236553 100 mg Q2W PlaceboSAR236553 50 mg Q2W SAR236553 150 mg Q2W

∆ - 64.2%

∆ - 5.1%

∆ - 39.6%

∆ - 72.4%

Decrease in LDL-C shown is at week 12.

~21m patients globallyestimated not at goal for LDL-C(1)

(mainly at high cardiovascular risk)

Sanofi Recently Started the First EverPhase 3 Program for an Anti-PCSK9 mAb

23

● ODYSSEY: a large global Phase 3 clinical program evaluating the safety and efficacy of SAR236553 ● 22,000 patients, including those with

elevated cardiovascular risk, intolerant to statins or patients with FH

● Injected subcutaneously as one single injection every two weeks

● Evaluating a 1mL auto-injector for both Q2W doses, 75mg and 150mg

● Creation of a PCSK9 Development & Launch Unit

(1) Adapted from Decision Resources 2008, Decision Resources 2010 and CVReg 2011(2) heFH: Heterozygous Familial Hypercholesterolemia

Target Population

Statin Intolerant

heFH (2)

SecondaryPrevention

PrimaryPrevention

SAR236553 / REGN727 is developed in collaboration with Regeneron

Otamixaban: Providing Superior Outcomes while Simplifying Treatment during Interventional Procedures

● Despite current therapies, death, MI, and readmission rates remain high

● Otamixaban is the first IV direct and selective factor Xa inhibitor with quick onset/offset

● 27% to 42% risk reduction in ACS complications including death and MI in Phase Il(1)

● Phase III TAO study ongoing with results expected in Q2 2013

(1) The Lancet, Volume 374, Issue 9692, Pages 762 - 764, 5 September 2009 NSTE-ACS – Non-ST-Elevation Acute Coronary Syndrome, MI – Myocardial Infarction, UFH – Unfractionated Heparin

TAO Study

Moderate-to-high risk NSTE-ACS with planned early invasive strategy (n=13,220)

Primary endpoint:Death/Myocardial Infarction @ day 7

OtamixabanRegimen 2(n=1,969)

OtamixabanRegimen 1(n=1,969)

UFH + Eptifibatide(n=1,969)

R

24

Sponsor-blinded interim analysis

2525

1 Diabetes

2 Oncology



5 Immunology

6 Vaccines


Sarilumab (Anti IL-6R mAb): Addressing an Unmet Needin Rheumatoid Arthritis

● ~1/3 of RA patients treated with anti-TNFα do not respond to therapy

● Sarilumab is a fully human, high affinity, IL-6R mAb administered subcutaneously in combinationwith methotrexate● Positive Phase II with meaningful

improvements in signs & symptoms of moderate-to-severe RA

● 2 pivotal Phase III trials ongoing● SARIL-RA-MOBILITY fully enrolled

● SARIL-RA-TARGET recruiting

● New studies to start in H1 2013

MOBILITY Trial (Phase IIb Results)

Sarilumab is developed in collaboration with RegeneronRA – Rheumatoid Arthritis IL-6R – Interleukin-6 receptorACR – American College Of Rheumatology (ACR) Scoring System

200 mg q2w

17.3*

40.4*

65.4

150 mg q2w

11.8

35.3

66.7

Placebo

1.9

15.4

46.2

ACR70ACR50ACR20

* p<0.01 versus placebo (only unadjusted p-values <0.01 are considered statistically significant)

ACR response at week 12 (%)

A&R 2011; 63; suppl.10:4041

26

● 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

● Positive proof of concept datafor asthma and atopic dermatitis to be submitted for presentationat medical conferences in 2013

● Phase 2b initiation in both indications expected mid-year

27Anti IL-4Rα mAb is developed in collaboration with Regeneron

IL-4

IL-4R c

Type IReceptor

Type IIReceptor

IL-13

IL-4R IL-13R1

or

IL-4 IL-13Dominant (some overlapping) functions in :

• Initiated and drives TH2 differentiation

• Activation and growth of B cells

• Class switching to IgE and IgG1a

• Recruitment of eosinophils

• Airway hyper responsiveness (AHR)

• Goblet cell hyperplasia• Tissue remodeling• Fibrosis • Regulation of

gastrointestinal parasite expulsion

Anti IL-4Rα mAb: Targeting Asthma and Atopic Dermatitis

28

An Innovative Productwith a Breakthrough Design(1)

(1) Sanofi U.S. licensed the North American commercialization rights to the epinephrine auto-injector from Intelliject, Inc.,(2) Source: 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Practice Parameters (3) Source: Mylan Form 10-K for the period ending Dec 31, 2011 and Mylan Investor Day on Feb 21, 2012(4) IMS MAT sales through July 2012

● Nearly 6 million people in the U.S. may be at risk for anaphylaxis(2)

● One main U.S. competitor with >95% market share(3): EpiPen®

from Mylan ● Estimated U.S. sales of $570m(4)

● Auvi-Q™ offers a unique compact size and shape● Audio and visual cues guide users

through the injection process

● Retractable needle mechanism

● U.S. launch planned in Q1 2013

2929

1 Diabetes

2 Oncology



5 Immunology

6 Vaccines


30

Dengue Vaccine: Addressing a Growing Global Threat

First Efficacy Results

● Phase IIb results in ~4,000 patients recently published in the Lancet

● Effective against DENV 1, 3 and 4 (in the range of 60% to 90%), with only DENV 2 appearing to be resistant

● Safe and well-tolerated

Significant Disease Burden

● Estimated 220m dengue infections worldwide per year

● 2m cases of Hemorrhagic Fever

● >500,000 hospitalizations and >20,000 deaths / year

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

30

Ambitious Phase III Program

● Global Phase III program ongoing

● Large scale studies in LatAm and Asia

● 31,000 children and adolescents

● Results expected in 2014

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

31

● 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)

● Multinational Phase III trial planned to start in Q3 2013● Case driven study

● Lot consistency trial to follow

● Fast Track Development Program designation granted by CBER

CBER – Center for Biologics Evaluation and Research (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

CDI – A Growing Healthcare Problem

● Most common cause of health care 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

FY 2008 FY 2009 FY 2010 FY 2011 9M 2012

14.1%

Maintaining Rigorous Control of R&D Expenses

32

● R&D expenses of €4,811m in 2011

● R&D spend of €3,564 million in 9M 2012, down 6.0% at CER and with Genzyme proforma reflecting:● Good internal cost management

● Ongoing transforming initiatives

● R&D/Sales ratio down 0.6 points in 9M 2012 vs. 9M 2011 (13.5% vs. 14.1%)

32

R&D/Sales Ratio (%)

14.4%13.5%

16.6%15.6%

Strengthening the R&D Leadership Team with New Talent

Philip Just LarsenDiabetes - Head of Research & Early Development

Jay Edelberg Head of PCSK9 Launch Unit

Gary Nabel SVP, Chief Scientific Officer Chairman of the Strategic Development and Scientific Advisory Council

Andrew PlumpDeputy of President R&D VP Research and Translational Medicine

33

Rodger Novak VP for Infectious diseases

Victoria Richon Oncology - Head of Research & Early Development

Eckhard Leifke Diabetes - Head of Development

Philippe Monteyne VP Head of R&D France

North America

hub

Boston hub

France hub Germany

hubAsia hub

Tokyo

Shanghai

Beijing

Ensuring R&D Contributes to Sanofi’s Success

GlobalR&D

Goals

Create an efficient global R&D organization Maximize synergies and convergence around Hub modelLeverage economies of scale Improve R&D cost structure

Focus on high-value projects Execute on late-stage projectsGuide early-stage portfolio prioritization utilizing medical value

and translational medicine

Establish new models of external innovationEnhance the value of external opportunities and partnershipsAccelerate science by establishing creative and adapted models

with partners across the healthcare ecosystem

34

APPENDICES

R&D Pipeline

35

36

Late Stage Pipeline – Pharma & Vaccines

eliglustat tartrateGlucosylceramide synthetase inhibitor

Gaucher disease

otamixabanDirect Xa inhibitor

ACS

Quadracel®Diphtheria, tetanus, pertussis& polio vaccine; 4-6 y of age

Hexaxim™ / New hexavalent vaccineDTP-HepB-Polio-Hib vaccine

iniparib (BSI-201)Squamous NSCLC (1L)

Insulin glargineNew formulation

Type 1+2 diabetes

VaxiGrip® QIV IMQuadrivalent inactivated

influenza vaccine

Fluzone® QIV IMQuadrivalent inactivated

influenza vaccine

SAR302503 (TG101348)JAK-2 inhibitor

Myelofibrosis (1L)

mipomersenApolipoprotein B-100 antisense

Severe HeFH, U.S.

DengueMild-to-severe

dengue fever vaccine

Aubagio® (teriflunomide)Relapsing forms of Multiple sclerosis

(RMS) – Monotherapy, EU

Jevtana® (cabazitaxel) Metastatic prostate cancer (1L)

SAR236553Anti-PCSK-9 mAb

Hypercholesterolemia

DTP-HepB-Polio-HibPediatric hexavalent vaccine

alemtuzumab Anti-CD52 mAb

Multiple sclerosis, EU, U.S.

SYNVISC-ONE®

Medical device Pain in hip OA

sarilumab (SAR153191)Anti-IL-6R mAb

Rheumatoid arthritis

Fluzone® QIV IDQuadrivalent inactivated

influenza vaccine Intradermal

Allegra®

fexofenadineDry syrup, Japan

MACI®Cell-based treatment

Articular cartilage defects

mipomersenApolipoprotein B-100 antisenseHoFH and severe HeFH in EU;

HoFH in U.S.

lixisenatideGLP-1 agonist

Type 2 diabetes, EU, Japan, U.S.

Zaltrap® (aflibercept)VEGF-Trap

2nd line mCRC, EU

RegistrationPhase III

N

N

N

N

N

36

N

N

NN

N New Molecular EntityCentral Nervous System

Rare Diseases

OncologyMetabolic Disorders

VaccinesInternal Medicine

Biosurgery

Thrombosis

AgingOphthalmology

N

Early Stage Pipeline – Pharma & Vaccines

iniparib (BSI-201)Platinum-resistant ovarian cancer (2L)

FOV1101FDC prednisolone/cyclosporine

Allergic conjunctivitis

SAR231893Anti-IL4 mAb

Asthma; Atopic dermatitis

SAR3419Maytansin-loaded anti-CD19 mAb

B-cell malignancies refractory/relapsed (NHL, ALL)

SAR292833 (GRC15300)TRPV3 antagonist

Neuropathic pain, osteoarthritic pain

ferroquineAntimalarial

Malaria

SAR256212 (MM121) anti-ErbB3 mAb

Breast cancer (2L, 3L)

SAR110894H3 antagonist

Alzheimer's disease

fresolimumabTGFβ antagonist

Fibrosis

SAR245408 (XL147)Oral PI3K inhibitor

Breast cancer

SAR113945IKK-β inhibitorOsteoarthritis

SAR97276Antimalarial

Malaria

SAR245409 (XL765)Oral dual inhibitor of PI3K & mTOR

Non-Hodgkin lymphoma

Meninge ACYW conj.2nd generation meningococcal

Conjugate infant vaccine

SAR279356 (F598)Anti-PNAG mAb

Serious infections

SAR302503 (TG101348)JAK-2 inhibitor

Polycythemia vera (2L)Incyte (ruxolitinib) resistant/intolerant MF

ACAM-CdiffClostridium difficile

Toxoid vaccine

SAR339658VLA 2 antagonist

Inflammatory bowel disease

Jevtana® (cabazitaxel) Small cell lung cancer (2L)

Rabies VRVgPurified vero rabies vaccine

SAR156597IL4/IL13 Bi-specific mAb

Idiopathic pulmonary fibrosis

Phase II

N

N

N

N

N

N

N

N

N N

N

N

3737


Rare Diseases



Biosurgery

Thrombosis

AgingOphthalmology

N

N

N

38

Early Stage Pipeline – Pharma & Vaccines

SAR153192Anti-DLL4 mAb

Solid tumors

SAR126119TAFIa inhibitor

Acute ischemic stroke

SAR252067Anti-LIGHT mAb

Crohn’s disease & Ulcerative colitis

RotavirusLive Attenuated Tetravalent

Rotavirus oral vaccine

GZ402674Non-camptothecin topo1 inhibitor

Solid tumors

SAR127963P75 receptor antagonist

Trauma brain injury

SAR100842LPA-1/LPA-3

Skin manifestation of scleroderma

Streptococcus pneumoniaMeningitis & pneumonia vaccine

SAR650984Anti-CD38 naked mAb

Hematological malignancies

GZ404477(AAV-hAADC)Gene therapy

Parkinson's disease

SAR113244Anti-CXCRS mAb

Systemic lupus erythematosus

Pseudomonas aeruginosaAntibody fragment product

Prevention of ventilator-associated pneumonia

SAR566658Maytansin-loaded anti-DS6 mAb

DS6 positive solid tumors

SAR391786Rehabilitation post orthopedic surgery

SAR407899Rho kinase inhibitor

Diabetic nephropathy

Tuberculosis Recombinant subunit vaccine

SAR307746Anti-Ang2 mAb

Solid tumors

SAR228810Anti-protofibrillar AB mAb

Alzheimer’s disease

lixisenatide + Lantus®

GLP-1 agonist + insulin glargineFix-Flex / Type 2 diabetes

RetinoStat®

Gene therapy Wet age-related macular degeneration (AMD)

SAR125844C-Met kinase inhibitor

Solid tumors

SAR399063DHA-GLP + vit DPre-sarcopenia

SAR164653Cathepsin A inhibitor

CV-related complications & deaths in diabetic patients

StarGen®

Gene therapyStargardt disease

CombinationsSAR245409 / MSC1936369B

SAR245408/SAR256212 (MM121)Solid tumors

SAR404460DHA-GPL + Vit DPre-sarcopenia

GZ402665(rhASM)

Niemann-Pick type B

GZ402663 (sFLT-01)Gene therapy

Age-related macular degeneration(AMD)

SAR405838 (MI-773)HDM2 / p53 antagonist

Solid tumors and hematological malignancies

GZ402671GCS InhibitorFabry Disease

UshStat®

Gene therapyUsher syndrome 1B

SAR260301PI3K β selective

PTEN – Deficient tumors

Phase IN

N

N

N

N

N N

N N

N

N N N

38

NN

N

N

N

N


Rare Diseases



Biosurgery

Thrombosis

AgingOphthalmology

N

N

N

N

N

N

N

39

Phase I Phase II Phase III Registration TOTAL

Oncology 8 4 2 0 14

Metabolic Disorders 2 0 1 2 5

Thrombosis 1 0 1 0 2

Central Nervous System 2 0 0 2 4

Internal Medicine 3 7 1 0 11

Ophthalmology 4 1 0 0 5

Genetic Diseases 2 0 1 0 3

Aging 4 3 0 0 7

Vaccines 4 3 5 2 14

TOTAL 30 18 11 6

R&D Pipeline Summary TableNew Molecular Entities (NMEs) and Vaccines

48 17NMEs & Vaccines

65

39

51

40

Expected R&D Milestones – Pharmaceuticals

40

Product Event TimingZaltrap® (aflibercept) Expected EC approval in 2nd line mCRC in EU Q1 2013

Lyxumia® (lixisenatide) Expected EC approval in type 2 diabetes in EU Q1 2013

Lyxumia® (lixisenatide) Expected FDA file acceptance in type 2 diabetes in U.S. Q1 2013

AubagioTM (teriflunomide) Expected CHMP decision in RMS in EU Q1 2013

Kynamro™ (mipomersen) Expected FDA decision in hoFH in the U.S. Q1 2013

eliglustat tartrate Phase III headline results in Gaucher disease (ENCORE) Q1 2013

Lemtrada™ (alemtuzumab) Expected CHMP decision in RMS in EU Q2 2013

iniparib Phase III headline results in 1st line squamous NSCLC Q2 2013

otamixaban Phase III headline results in ACS Q2 2013

JAK2 inhibitor Phase III headline results in myelofibrosis Q2 2013

Insulin glargine (new formulation) First Phase III headline results in diabetes Q2 2013

41

Expected R&D Milestones – Vaccines

41

Product Event TimingVaxigrip® QIV IM Expected submission of regulatory file in EU Q1 2013

6-in-1 paediatric vaccine Expected CHMP opinion in EU Q1 2013

Fluzone® QIV IM Expected FDA decision in the U.S. Q2 2013

C. Diff vaccine Expected start of Phase III study Q3 2013

2013 - Jp Morgan HC

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