You are on page 1of 41

JP Morgan Healthcare Conference

Dr. Elias Zerhouni, President Global R&D


San Francisco, January 8, 2013

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 include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations 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's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forwardlooking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ 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 the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed 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 Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Repositioning Sanofi for Sustainable Growth

2005-2008

2009-2012

2013+

Focusing on Rx Blockbusters
Blockbuster drugs Patents challenged R&D setbacks

Transforming
Investing in growth platforms Increasing diversification Managing patent cliff

Generating Sustainable Growth


Growing recurring sales Improving risk profile

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

Growth Platforms Sales


(m and % of Total Sales)

(2)

6,412m
5,753m 5,381m

3,339m 2,207m

70.9%
of Total Sales

4.4%
of Total Sales 813m 752m

399m
Q3 Q2 Q1 Q2 Q3

Q2

Q1

Q2

2009

2012

2009

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

Executing Successful Strategy to Reposition Sanofi

Increase innovation in R&D

Pursue external growth opportunities Adapt structure for future challenges and opportunities

Deliver sustainable growth and generate improved shareholder returns

5 5

Multiple Regulatory Milestones Expected in Next Three Months


Products

Targeted Indications
Metastatic Colorectal Cancer Relapsing Forms of Multiple Sclerosis Relapsing Forms of Multiple Sclerosis

Expected Milestones
EC Decision: Q1 2013

CHMP Opinion: Q1 2013 FDA Decision on File Acceptance: Q1 2013 CHMP Opinion: Q2 2013 EC Decision: Q1 2013 FDA Decision on File Acceptance: Q1 2013 PDUFA Date: Jan 29, 2013(1)

Type 2 Diabetes
TM

hoFH in the U.S

New 6-in-1 Paediatric Vaccine

DTP-HepB-Polio-Hib

CHMP Opinion: Q1 2013

(1) On October 18th 2012, an FDA AdCom recommended Kynamro for hoFH Lyxumia, Kynamro and Lemtrada are registered trade names submitted to health authorities for investigational agents Zaltrap is developed in collaboration with Regeneron, Kynamro with Isis Pharmaceuticals and Lyxumia is in-licensed from Zealand Pharma Genzyme is developing Lemtrada in MS in collaboration with Bayer HealthCare PDUFA: Prescription Drug User Fee Act hoFH: Homozygous Familial Hypercholesterolemia CHMP: Committee for Medicinal Products for Human Use EC: European Commission DTP-HepB-Polio-Hib: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus type b 6

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

1 2 3 4 5 6

Diabetes Oncology Multiple Sclerosis and Rare Diseases Cardio-Metabolic Diseases Immunology Vaccines

Broadening our Diabetes Platform with New Patient-Focused Solutions


Once-daily and pronounced PPG lowering effect Use on top of basal insulin ELIXA: CV outcome study ongoing NEW
INSULIN GLARGINE FORMULATION

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 Sanofis insulin portfolio in India and possibly other Emerging Markets

Lyxumia is the proprietary name submitted to the EMA for the companys 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. 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

Clinical Development Designed to Support Use in Combination with Basal Insulin


T2D Patients Treated Key Facts about MS (1)

Phase III Program


Monotherapy Mono Mono Japan F1 (metformin) S (sulfonylurea) M (metformin) P (pioglitazone) M Asia (metformin) Active-controlled X vs. exenatide

with Basal Insulin

(worldwide)

On basal insulin

Placebo-controlled in OAD failure

On basal insulin with controlled fasting glucose but A1c >7%

4 million
on Lantus

4 million 4 million
on other basal insulins(2)

Placebo-controlled on top of basal insulin

L L Asia Duo 1

Next step: to develop a combination of Lantus and Lyxumia


Lyxumia is the proprietary name submitted to the EMA for the companys 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 (1) Adapted from IMS data A1C HbA1c or Glycated hemoglobin (2) Includes all types of basal insulins 9

Broad Phase III Program Evaluating Potential Clinical Benefits of Improved PK/PD Profile of New Glargine Formulation
New Insulin Glargine Formulation
Depot formation after subcutaneous injection

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


1,600 patients Headline results expected in Q2 2013


EDITION I T2D Patients Basal Bolus EDITION II T2D Patients Basal + OAD

Lantus

New Glargine Formulation

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


EDITION III T2D Patients Insulin Nave EDITION IV T1D Patients Basal
Schematic illustration

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

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

10

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

1 2 3 4 5 6

Diabetes Oncology Multiple Sclerosis and Rare Diseases Cardio-Metabolic Diseases Immunology Vaccines

11

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

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

Zaltrap is developed in collaboration with Regeneron (1) Van Cutsem, et al. JCO Oct 1, 2012:3499-3506; VEGF: Vascular endothelial growth factor FOLFIRI: FOL (folinic acid), F (fluorouracil) and IRI (irinotecan) mCRC: Metastatic colorectal cancer 12

JAK2 inhibitor - Addressing Treatment Gaps for Patients with Debilitating Hematologic Malignancies
% patients with 35% reduction in spleen volume from baseline
SAR302503 - Phase II trial

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

13

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

1 2 3 4 5 6

Diabetes Oncology Multiple Sclerosis and Rare Diseases Cardio-Metabolic Diseases Immunology Vaccines

14

Global MS Market - Significant and Expected to Grow

Key FactsSclerosis about MS Multiple


~2.1m patients worldwide(1)
Prevalent in young women (~2:1 female/male ratio) Life expectancy 5-10 years lower than unaffected people

Multiple Sclerosis Market Global Sales(2,3)


CAGR >6% $17.8bn

$12.5bn U.S. 56%

A major impact on family, social and professional life


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

54%

ROW

44% 2011

46% 2016e

(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

15

Global MS Market - Still Dominated by ABCRE Products

Key Facts about MS MS Therapies


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

2011 Sales and Market Share in Value(2)

$3,884m 31% $1,553m 12%

$2,350m 19%

Latest entrants represent treatment alternatives


Drives the benefit vs. risk discussion

$2,686m 21% $1,511m 12% $494m 4%

$154m 1%

All trademarks are the property of their respective owners (1) ABCRE stands for Avonex, Betaseron/Betaferon, Copaxone, Rebif and Extavia (2) Reported sales of ABCRE products plus Tysabri, and Gilenya in 2011

16

An Exciting Oral Treatment for Relapsing MS

Aubagio 14mg is the only oral MS drug to significantly delay disability progression in 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
Annualized Relapse Rate(1)

TOWER STUDY
Annualized Relapse Rate(1)

TEMSO STUDY
Reduction in Progression of Disability(2)

TOWER STUDY
Reduction in Progression of Disability(2)

- 31.5%
0.539
p=0.0005

0.501

- 36.3%
p=0.0001

-29.8%(3)
0.273
p=0.0279(4)

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

0.369

0.319

0.202

0.197 0.158

n=363 Placebo

n=359 Aubagio
14mg

n=388 Placebo

n=370 Aubagio
14mg

n=363 Placebo

n=359 Aubagio
14mg

n=388 Placebo

n=370 Aubagio
14mg

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). (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 17 (5) TEMSO and TOWER; Aubagio 7mg tablets are also available in the U.S.

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

For Illustrative Purposes

(2)

Active Comparators


Higher Hurdle

Placebo

3 months

EDSS

6 months

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

18

Significantly More Effective at Reducing ARR in Pivotal Trials(1) with Unique Dosing Regimen
CARE-MS I
Annualized Relapse Rate

CARE-MS II
Annualized Relapse Rate

- 49% - 55%
p<0.0001

0.52

p<0.0001

0.39 0.26 0.18

n=187 Rebif

n=376 Lemtrada

n=202 Rebif

n=426 Lemtrada

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

19

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

Potent, novel substrate inhibitor Oral therapy


Eliminating challenges of infusions

Change in Spleen Volume


(% change at 9 months)

+2%
Placebo

Eliglustat

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

30%
Absolute Difference

ENCORE Phase III results (vs. Cerezyme) expected in early 2013 -28%

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

20

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

1 2 3 4 5 6

Diabetes Oncology Multiple Sclerosis and Rare Diseases Cardio-Metabolic Diseases Immunology Vaccines

21

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

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
0 -10 -20 -30 -40 -50 -60 -70 -80

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


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

- 5.1%

- 39.6%

- 64.2%

- 72.4%

SAR236553 100 mg Q2W SAR236553 50 mg Q2W

Placebo SAR236553 150 mg Q2W

Decrease in LDL-C shown is at week 12.


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 receptors CHD 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

22

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

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

Target Population
~21m patients globally estimated not at goal for LDL-C(1)
(mainly at high cardiovascular risk)

Secondary Prevention

Primary Prevention

Creation of a PCSK9 Development & Launch Unit

heFH (2) Statin Intolerant

SAR236553 / REGN727 is developed in collaboration with Regeneron (1) Adapted from Decision Resources 2008, Decision Resources 2010 and CVReg 2011 (2) heFH: Heterozygous Familial Hypercholesterolemia

23

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)

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

Phase III TAO study ongoing with results expected in Q2 2013

Otamixaban Regimen 1 (n=1,969)

Otamixaban Regimen 2 (n=1,969)

UFH + Eptifibatide (n=1,969)

Sponsor-blinded interim analysis

Primary endpoint: Death/Myocardial Infarction @ day 7

(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

24

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

1 2 3 4 5 6

Diabetes Oncology Multiple Sclerosis and Rare Diseases Cardio-Metabolic Diseases Immunology Vaccines

25

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


~1/3 of RA patients treated with anti-TNF do not respond to therapy Sarilumab is a fully human, high affinity, IL-6R mAb administered subcutaneously in combination with methotrexate
Positive Phase II with meaningful improvements in signs & symptoms of moderate-to-severe RA

MOBILITY Trial (Phase IIb Results)


ACR response at week 12 (%)
66.7 65.4
ACR20 ACR50 ACR70

46.2 35.3

40.4*

15.4 1.9 Placebo

2 pivotal Phase III trials ongoing


SARIL-RA-MOBILITY fully enrolled SARIL-RA-TARGET recruiting

11.8

17.3*

150 mg q2w

200 mg q2w

New studies to start in H1 2013

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

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

Sarilumab is developed in collaboration with Regeneron RA Rheumatoid Arthritis IL-6R Interleukin-6 receptor ACR American College Of Rheumatology (ACR) Scoring System

26

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

Fully human monoclonal antibody binding to IL-4R


Targeting the common IL-4R subunit Dual IL-4/IL-13 cytokine antagonism with a single agent

IL-4 or

IL-13

IL-4R
Type I Receptor

IL-4R Type II Receptor

IL-13R1

Positive proof of concept data for asthma and atopic dermatitis to be submitted for presentation at medical conferences in 2013 Phase 2b initiation in both indications expected mid-year

IL-4
Initiated and drives TH2 differentiation Activation and growth of B cells Class switching to IgE and IgG1a Recruitment of eosinophils

IL-13
Airway hyper responsiveness (AHR) Goblet cell hyperplasia Tissue remodeling Fibrosis Regulation of gastrointestinal parasite expulsion

Dominant (some overlapping) functions in :

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

An Innovative Product with a Breakthrough Design(1)


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

(1) (2) (3) (4)

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

28

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

1 2 3 4 5 6

Diabetes Oncology Multiple Sclerosis and Rare Diseases Cardio-Metabolic Diseases Immunology Vaccines

29

Dengue Vaccine: Addressing a Growing Global Threat

Significant Disease Burden


Estimated 220m dengue infections worldwide per year
2m cases of Hemorrhagic Fever >500,000 hospitalizations and >20,000 deaths / year

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

Ambitious Phase III Program


Global Phase III program ongoing
Large scale studies in LatAm and Asia 31,000 children and adolescents

Dengue: a public health priority in Asia and Latin America

Results expected in 2014

30 30

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

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

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

Targeted patients at high risk of CDI:


Elderly with antibiotic use, planned at-risk admissions to hospital and long-term care facilities residents

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

31

Maintaining Rigorous Control of R&D Expenses

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
16.6%

R&D/Sales Ratio (%)

15.6%

14.1%

14.4%

13.5%

R&D/Sales ratio down 0.6 points in 9M 2012 vs. 9M 2011 (13.5% vs. 14.1%)
FY 2008 FY 2009 FY 2010 FY 2011 9M 2012

32

Strengthening the R&D Leadership Team with New Talent


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

Jay Edelberg
Head of PCSK9 Launch Unit
NorthBoston America hub hub France hub Germany
hub

Andrew Plump
Deputy of President R&D VP Research and Translational Medicine
Beijing Tokyo

Asia Shanghai hub

Philippe Monteyne
VP Head of R&D France

Eckhard Leifke
Diabetes - Head of Development

Victoria Richon
Oncology - Head of Research & Early Development

Philip Just Larsen


Diabetes - Head of Research & Early Development

Rodger Novak
VP for Infectious diseases
33

Ensuring R&D Contributes to Sanofis Success

Create an efficient global R&D organization


Maximize synergies and convergence around Hub model Leverage economies of scale Improve R&D cost structure

Global R&D Goals

Focus on high-value projects


Execute on late-stage projects Guide early-stage portfolio prioritization utilizing medical value and translational medicine

Establish new models of external innovation


Enhance the value of external opportunities and partnerships Accelerate science by establishing creative and adapted models with partners across the healthcare ecosystem

34

APPENDICES R&D Pipeline

35

Late Stage Pipeline Pharma & Vaccines


Phase III
eliglustat tartrate
N

Registration
N

otamixaban
Direct Xa inhibitor ACS

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

Glucosylceramide synthetase inhibitor Gaucher disease

Hexaxim / New hexavalent vaccine


DTP-HepB-Polio-Hib vaccine

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

Insulin glargine
New formulation Type 1+2 diabetes

VaxiGrip QIV IM
Quadrivalent inactivated influenza vaccine

Quadrivalent inactivated influenza vaccine N Aubagio (teriflunomide) Relapsing forms of Multiple sclerosis (RMS) Monotherapy, EU

Fluzone QIV IM

SAR302503 (TG101348)
JAK-2 inhibitor Myelofibrosis (1L)

mipomersen
Apolipoprotein B-100 antisense Severe HeFH, U.S.

Dengue
Mild-to-severe dengue fever vaccine N

Jevtana (cabazitaxel)
Metastatic prostate cancer (1L)

SAR236553
Anti-PCSK-9 mAb Hypercholesterolemia

DTP-HepB-Polio-Hib
Pediatric 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

Quadrivalent inactivated influenza vaccine Intradermal

Fluzone QIV ID

Allegra
fexofenadine Dry syrup, Japan

MACI
Cell-based treatment Articular cartilage defects

mipomersen
Apolipoprotein B-100 antisense HoFH and severe HeFH in EU; HoFH in U.S.

lixisenatide
GLP-1 agonist Type 2 diabetes, EU, Japan, U.S.

Zaltrap (aflibercept)
VEGF-Trap 2nd line mCRC, EU

New Molecular Entity Ophthalmology

Oncology Metabolic Disorders Rare Diseases

Thrombosis Central Nervous System Biosurgery

Vaccines Internal Medicine Aging 36

Early Stage Pipeline Pharma & Vaccines


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

FOV1101
FDC prednisolone/cyclosporine Allergic conjunctivitis

SAR231893
Anti-IL4 mAb Asthma; Atopic dermatitis

SAR3419 N Maytansin-loaded anti-CD19 mAb B-cell malignancies refractory/relapsed (NHL, ALL) SAR256212 (MM121)
anti-ErbB3 mAb Breast cancer (2L, 3L) N

SAR292833 (GRC15300)
TRPV3 antagonist Neuropathic pain, osteoarthritic pain

ferroquine
Antimalarial Malaria

H3 antagonist Alzheimer's disease N

SAR110894

fresolimumab
TGF antagonist Fibrosis

SAR245408 (XL147)
Oral PI3K inhibitor Breast cancer

SAR113945
IKK- inhibitor Osteoarthritis

SAR97276
Antimalarial Malaria

N 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-Cdiff
Clostridium difficile Toxoid vaccine

SAR339658
VLA 2 antagonist Inflammatory bowel disease

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

Rabies VRVg
Purified vero rabies vaccine

SAR156597
IL4/IL13 Bi-specific mAb Idiopathic pulmonary fibrosis

New Molecular Entity Ophthalmology

Oncology Metabolic Disorders Rare Diseases

Thrombosis Central Nervous System Biosurgery

Vaccines Internal Medicine Aging 37

Early Stage Pipeline Pharma & Vaccines


Phase I
SAR153192
Anti-DLL4 mAb Solid tumors N N N

SAR126119
TAFIa inhibitor Acute ischemic stroke

SAR252067
Anti-LIGHT mAb Crohns disease & Ulcerative colitis

Rotavirus
Live Attenuated Tetravalent Rotavirus oral vaccine

GZ402674
Non-camptothecin topo1 inhibitor Solid tumors

SAR127963
P75 receptor antagonist Trauma brain injury

SAR100842
LPA-1/LPA-3 Skin manifestation of scleroderma

Streptococcus pneumonia
Meningitis & pneumonia vaccine

SAR650984
Anti-CD38 naked mAb Hematological malignancies

GZ404477
(AAV-hAADC) Gene therapy Parkinson's disease

SAR113244
Anti-CXCRS mAb Systemic lupus erythematosus

Pseudomonas aeruginosa
Antibody fragment product
Prevention of ventilator-associated pneumonia

SAR566658
Maytansin-loaded anti-DS6 mAb DS6 positive solid tumors

SAR391786

SAR407899
Rho kinase inhibitor Diabetic nephropathy

Tuberculosis
Recombinant subunit vaccine

Rehabilitation post orthopedic surgery N

SAR307746
Anti-Ang2 mAb Solid tumors

SAR228810
Anti-protofibrillar AB mAb Alzheimers disease

lixisenatide + Lantus
GLP-1 agonist + insulin glargine Fix-Flex / Type 2 diabetes

RetinoStat
Gene therapy

Wet age-related macular degeneration (AMD)

SAR125844 C-Met kinase inhibitor


Solid tumors

SAR399063
DHA-GLP + vit D Pre-sarcopenia

SAR164653
Cathepsin A inhibitor CV-related complications & deaths in diabetic patients

StarGen
Gene therapy Stargardt disease

Combinations
SAR245409 / MSC1936369B SAR245408/SAR256212 (MM121) Solid tumors

SAR404460
DHA-GPL + Vit D Pre-sarcopenia N

GZ402665 (rhASM)
Niemann-Pick type B

GZ402663 (sFLT-01)
Gene therapy Age-related macular degeneration (AMD)

SAR405838 (MI-773) HDM2 / p53 antagonist SAR260301


PI3K selective PTEN Deficient tumors

GZ402671
GCS Inhibitor Fabry Disease

UshStat
Gene therapy Usher syndrome 1B

Solid tumors and hematological malignancies

New Molecular Entity Ophthalmology

Oncology Metabolic Disorders Rare Diseases

Thrombosis Central Nervous System Biosurgery

Vaccines Internal Medicine Aging

38

R&D Pipeline Summary Table


New Molecular Entities (NMEs) and Vaccines

Phase I Oncology Metabolic Disorders Thrombosis Central Nervous System Internal Medicine Ophthalmology Genetic Diseases Aging Vaccines TOTAL 8 2 1 2 3 4 2 4 4

Phase II 4 0 0 0 7 1 0 3 3

Phase III 2 1 1 0 1 0 1 0 5

Registration 0 2 0 2 0 0 0 0 2

TOTAL

14 5 2 4 11 5 3 7

51

14

30 48

18

11 17

65
NMEs&Vaccines
39

Expected R&D Milestones Pharmaceuticals


Product
Zaltrap (aflibercept) Lyxumia (lixisenatide) Lyxumia (lixisenatide) AubagioTM (teriflunomide) Kynamro (mipomersen) eliglustat tartrate Lemtrada (alemtuzumab) iniparib otamixaban JAK2 inhibitor Insulin glargine (new formulation)

Event
Expected EC approval in 2nd line mCRC in EU Expected EC approval in type 2 diabetes in EU Expected FDA file acceptance in type 2 diabetes in U.S. Expected CHMP decision in RMS in EU Expected FDA decision in hoFH in the U.S. Phase III headline results in Gaucher disease (ENCORE) Expected CHMP decision in RMS in EU Phase III headline results in 1st line squamous NSCLC Phase III headline results in ACS Phase III headline results in myelofibrosis First Phase III headline results in diabetes

Timing
Q1 2013 Q1 2013 Q1 2013 Q1 2013 Q1 2013 Q1 2013 Q2 2013 Q2 2013 Q2 2013 Q2 2013 Q2 2013

40

Expected R&D Milestones Vaccines


Product
Vaxigrip QIV IM 6-in-1 paediatric vaccine Fluzone QIV IM C. Diff vaccine

Event
Expected submission of regulatory file in EU Expected CHMP opinion in EU Expected FDA decision in the U.S. Expected start of Phase III study

Timing
Q1 2013 Q1 2013 Q2 2013 Q3 2013

41