2013 - bofa merrill lynch healthcare conference

34
BofA MERRILL LYNCH HEALTHCARE CONFERENCE Dr. Paul Chew, SVP, Chief Medical Officer / Head of Global Medical Affairs May 14, 2013

Upload: sanofi

Post on 14-Jun-2015

749 views

Category:

Education


10 download

DESCRIPTION

Dr. Paul Chew, SVP, Chief Medical Officer / Head of Global Medical Affairs (May 14, 2013)

TRANSCRIPT

Page 1: 2013 - BofA Merrill Lynch Healthcare Conference

BofA MERRILL LYNCH HEALTHCARE CONFERENCE Dr. Paul Chew,

SVP, Chief Medical Officer / Head of Global Medical Affairs

May 14, 2013

Page 2: 2013 - BofA Merrill Lynch Healthcare Conference

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 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 forward-looking 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, 2012. Other than as required by applicable law, Sanofi does not undertake any

obligation to update or revise any forward-looking information or statements.

Page 3: 2013 - BofA Merrill Lynch Healthcare Conference

3 3

Building a Company with Sustainable Growth

2009-2012

Transforming while

managing the cliff

• Investing in growth platforms

• Increasing diversification

• Disciplined cost management

2013+

Generating

sustainable growth

• Growing recurring sales

• Launching innovative drugs

• Optimizing capital allocation

2005-2008

Focusing on

Rx blockbusters

• Blockbuster drugs

• Patents challenged

• R&D setbacks

Page 4: 2013 - BofA Merrill Lynch Healthcare Conference

Growth Platforms Grew by +8.6% in Q1 2013

and Reached 71% of Sales

4

(1) Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises

(2) Includes new product launches which do not belong to the other Growth Platforms listed above: Multaq®, Jevtana®, Mozobil®, Zaltrap® and Auvi-Q™

+19.6%

+3.1%

+15.9%

-3.1%

+25.5%

Other Innovative Products(2) €157m +13.7%

+6.5%

Consumer Healthcare

€811m

Diabetes Solutions €1,542m

Vaccines €697m

Animal Health €554m

Emerging Markets €2,719m

Genzyme(1) €493m

Q1 2013 growth at CER

Page 5: 2013 - BofA Merrill Lynch Healthcare Conference

Q1 2013 Sales Were Affected by U.S. Loss of Exclusivity

of Eloxatin® in August 2012 and by FX Fluctuations

€9,040m

Q4 2012

€8,526m

Q3 2012 Q2 2012

€8,870m

Q1 2012

€8,511m

Q1 2013

€8,059m

Sales

5

(1) Reported sales of Eloxatin® in the U.S. were €321m in Q1 2012 but only €8m in Q1 2013.

(2) On a reported basis, sales in Q1 2013 were down -5.3%.

The negative currency impact in Q1 2013 was €212m.

-2.8%

at CER(1)

Page 6: 2013 - BofA Merrill Lynch Healthcare Conference

Q1 2013

€1.22

Q4 2012 Q2 2012

€1.17

€1.46

Q3 2012 Q1 2012

€1.67

€1.83

As Anticipated, Q1 2013 Business EPS Was Better

than Q4 2012 Trough

Business EPS

6

-29.0% at CER(2)

(1) With the retroactive application of IAS19R

(2) On a reported basis, Q1 2013 EPS was down -33.3%

Sanofi expects to resume Business EPS growth in H2 2013

(1) (1) (1) (1)

Page 7: 2013 - BofA Merrill Lynch Healthcare Conference

Executing a Successful Strategy

Deliver sustainable

long-term growth

and maximize

shareholder returns Seize value-enhancing growth

opportunities 3

1

7

Adapt structure for future

challenges and opportunities 4

Bring innovative products to market

2

7

Grow a global healthcare leader

with synergistic platforms

Page 8: 2013 - BofA Merrill Lynch Healthcare Conference

®

Type 2 Diabetes EU roll-out started in late March 2013

Recent Regulatory Approvals Have Resulted

in Six New Product Launches

8

Zaltrap® is developed in collaboration with Regeneron, Kynamro™ with Isis Pharmaceuticals and Lyxumia® is in-licensed

from Zealand Pharma. Sanofi U.S. licensed the North American commercialization rights to AUVI-Q™ from Intelliject Inc.

Launch Status Products

®

Metastatic

Colorectal Cancer

Indications

Launched in the U.S. in August 2012

EU roll-out started in late March 2013

Relapsing Forms

of Multiple Sclerosis

®

Launched in the U.S. in October 2012

Launched in the U.S. in January 2013 Life-Threatening Allergic

Reactions

Prevention of Poliomyelitis Launched in Japan in September 2012

Homozygous Familial

Hypercholesterolemia Launched in the U.S. in late March 2013

Page 9: 2013 - BofA Merrill Lynch Healthcare Conference

Several Important Study Releases and Regulatory

Milestones Achieved in the Last 4 Months

9

Clinical Data Releases

● Eliglustat tartrate - Phase III in Gaucher disease (ENCORE)

● Dupilumab - PoC in Atopic Dermatitis and Severe Asthma

● Lemtrada™ - Phase III in MS (1-year Extension of CARE-MS Program)

● Aubagio® - Phase III in Clinically Isolated Syndrome (TOPIC)

Regulatory Milestones

● Lemtrada™ FDA file acceptance in MS

● Aubagio® positive CHMP opinion in MS and request for CHMP re-examination of NAS designation filed

● Lyxumia®

FDA file acceptance in type II diabetes

● Hexyon®

/Hexacima®

EC approval (DTaP-IPV-Hib-HepB vaccine)

● Quadrivalent Influenza Vaccine accepted for review in EU

Lemtrada™ is the registered trade name for alemtuzumab in MS submitted to health authorities.

Lemtrada™ is developed in collaboration with Bayer HealthCare

Page 10: 2013 - BofA Merrill Lynch Healthcare Conference

Additional Phase III Trial Readouts and Regulatory

Decisions Expected Throughout 2013

10

2013

Expected Headline Phase III Data Releases Q2 Q3 Q4

● New insulin glargine formulation in Diabetes (EDITION I & II)

● Otamixaban in Acute Coronary Syndrome (TAO)

● JAK2 inhibitor in Myelofibrosis (JAKARTA)

● Iniparib in Squamous Non Small Cell Lung Cancer

● Alirocumab (Anti-PCSK9) in Hypercholesterolemia (ODYSSEY Mono)

Expected Regulatory Milestones Q2 Q3 Q4

● Fluzone® Quadrivalent IM FDA decision in the U.S.

● Lemtrada™ CHMP opinion in Multiple Sclerosis in EU

● Lemtrada™ FDA decision in Multiple Sclerosis in the U.S.

● Eliglustat regulatory submission in the U.S. and EU in Gaucher disease

Page 11: 2013 - BofA Merrill Lynch Healthcare Conference

11 11

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

Page 12: 2013 - BofA Merrill Lynch Healthcare Conference

Broadening our Diabetes Platform with New

Patient-Focused Solutions

12

® ● Once-daily and pronounced PPG lowering effect

● Use on top of basal insulin

● ELIXA: CV outcome study ongoing

Lyxumia® is the proprietary name approved by the EMA for ixisenatide. The proprietary name for lixisenatide

in the U.S. is under consideration. The U.S. FDA file acceptance occurred in February 2013. 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

● Evaluating potential clinical benefits of improved PK/PD

profile and lower injection volume

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

● In order to complete its portfolio of insulin products,

the Group initiated a biosimilar program

● Two projects in Phase I clinical development

NEW INSULIN GLARGINE

FORMULATION

Insulin

Biosimilar

Program

Page 13: 2013 - BofA Merrill Lynch Healthcare Conference

The proprietary name for lixisenatide in the U.S. is under consideration. Lixisenatide was in-licensed from Zealand Pharma A/S.

A1C – HbA1c or Glycated hemoglobin

(1) Adapted from IMS data

Now Approved in Europe

for the Treatment of Type 2 Diabetes

®

13

● ~4m patients worldwide on basal insulin with controlled fasting glucose

but with A1c >7%(1)

● Pronounced post-prandial glucose lowering effect of Lyxumia®

● Clinical development designed to support use on top of basal insulin

● cardiovascular outcomes study ongoing

● FDA file accepted in February 2013

● Launched in Germany and the UK

in March 2013

First Once-a-Day Prandial GLP-1 Receptor Agonist

Page 14: 2013 - BofA Merrill Lynch Healthcare Conference

Key Facts about MS T2D Patients Treated

with Basal Insulin(1) (worldwide)

On basal insulin

On basal insulin

with controlled

fasting glucose

but A1c >7%

4 million on other

basal insulins(2)

4 million on 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.

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

®

14

Mono

Mono Japan Monotherapy

Placebo-controlled

in OAD failure M (metformin)

F1 (metformin)

M Asia (metformin)

S (sulfonylurea)

P (pioglitazone)

X vs. exenatide Active-controlled

L Asia

L Placebo-controlled

on top of

basal insulin Duo 1

Phase III Program

Currently Developing a Combination of Lantus® and Lyxumia®

Page 15: 2013 - BofA Merrill Lynch Healthcare Conference

15

Broad Phase III Program Evaluating Potential Clinical Benefits

of Improved PK/PD Profile of New Glargine Formulation

EDITION I

T2D Patients

Basal Bolus

EDITION II

T2D Patients

Basal + OAD

PK/PD – Pharmacokinetic/Pharmacodynamic T1D and T2D: Type 1 and Type 2 diabetes 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

15

EDITION III

T2D Patients

Insulin Naïve

EDITION IV

T1D Patients

Basal

● Two Phase III trials in T2D high-dose

insulin users(1)

● EDITION I results to be presented at

the ADA in June 2013

● EDITION II headline results to be

communicated at the same time

● Second set of four Phase III studies

started in H2 2012(1)

● Two new studies also initiated in Japan

(JPI and JPII)

Page 16: 2013 - BofA Merrill Lynch Healthcare Conference

16 16

1 Diabetes

2 Oncology

3 Multiple Sclerosis and Rare Diseases

4 Cardio-Metabolic Diseases

5 Immunology

6 Vaccines

Focusing R&D on High-Value Projects

in Key Therapeutic Areas

Page 17: 2013 - BofA Merrill Lynch Healthcare Conference

● 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% reduction

in spleen volume from baseline

JAK2 Inhibitor - Addressing Treatment Gaps for Patients

with Debilitating Hematologic Malignancies

SAR302503 - Phase II trial

17

Page 18: 2013 - BofA Merrill Lynch Healthcare Conference

18 18

1 Diabetes

2 Oncology

3 Multiple Sclerosis and Rare Diseases

4 Cardio-Metabolic Diseases

5 Immunology

6 Vaccines

Focusing R&D on High-Value Projects

in Key Therapeutic Areas

Page 19: 2013 - BofA Merrill Lynch Healthcare Conference

Key Facts about MS MS Therapies

Global MS Market - Still Dominated by ABCRE Products

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

(2) Reported sales of ABCRE products plus Tysabri®, and Gilenya® in 2012

● A $13.8bn market in 2012 growing

at a high single digit rate

● “ABCRE” products(1) represented

~80% of the global MS market in

value in 2012

● Moderate efficacy and patients

continue to relapse on therapy

● Require frequent injections

● Latest oral entrants represent new

treatment alternatives

$3,996m

29%

$2,913m

21%

$1,569m

11% $2,339m

17%

$1,630m

12%

2012 Sales and

Market Share in Value(2)

$1,195m

9%

$159m

1%

All trademarks are the property of their respective owners

Page 20: 2013 - BofA Merrill Lynch Healthcare Conference

20 20

(1) IMS Weekly Total Prescriptions

(2) Based on data collected at Genzyme's MS One to One™ Patient and Provider Support Center, Sep 2012-Jan 2013

(3) NAS: New Active Substance

(4) Clinical results for 14 mg dose; 7mg tablets are also available; CDMS = Clinically Definite Multiple Sclerosis

®

● Aubagio® Q1 2013 sales of €20m

● Encouraging U.S. launch trends(1,2)

● >83% of patients switched to

AUBAGIO® were most recently

on IFN-beta or Copaxone®

● Positive CHMP opinion granted in

March 2013

● Request for CHMP re-examination of

NAS designation filed(3)

● Ongoing regulatory review of

Lemtrada™ in EU and the U.S.

A Promising Entry in the Large MS Market

Lemtrada™ is the registered trade name for alemtuzumab in MS submitted to health authorities

Lemtrada™ is developed in collaboration with Bayer HealthCare

RELAPSE

31%

DISABILITY 30%

TEMSO(4)

TOWER(4)

TOPIC(4)

RELAPSE 36%

DISABILITY 31%

REDUCTION IN RISK OF

CONVERSION TO CDMS 43%

Page 21: 2013 - BofA Merrill Lynch Healthcare Conference

21 21

®

Reduction in Progression of Disability

CARE-MS I CARE-MS II

Annualized Relapse Rate

● Significant efficacy results vs Rebif®

● Significantly reduced ARR in two

studies

● Reduction of risk of six-month

sustained accumulation of disability

● Safety profile generally managed with

monthly monitoring and conventional

therapies

● Infusion-associated reactions(2)

● Infections more common in Lemtrada™

patients(3)

● Autoimmune events (thyroid disorders,

ITP and neuropathies) detected via

monitoring and generally managed

using conventional therapies

● Unique annual dosing

Significant Efficacy vs. Active Comparator(1)

Lemtrada™ is not yet commercially marketed

ARR: Annualized Relapse Rate ITP: Idiopathic Thrombocytopenic Purpura

CARE-MS I and CARE-MS II were both head-to-head trials comparing Lemtrada™ versus Rebif®

(1) Based on CARE-MS II study

(2) Infusion-associated reactions were most common AE and were effectively managed with standard therapies

(3) Risk of infections higher with Lemtrada™ and majority were mild to moderate

Page 22: 2013 - BofA Merrill Lynch Healthcare Conference

ENGAGE ENCORE

Patients 40 160

Study Duration 9 months 12 months

Patient

Population

Treatment

naïve

Stabilized on

ERT treatment

Treatment

Arms

eliglustat

vs. placebo

eliglustat

vs. Cerezyme®

Primary endpoint

met

Secondary endpoints

met

22

Phase III

Registration Trials

Eliglustat(1)

- A Novel Oral Therapy in Gaucher Disease

● Innovative substrate inhibitor

● Oral therapy

● Eliminating challenges of infusions

● Positive phase III results

● ENGAGE(2): 30% absolute difference

in spleen volume vs. placebo

● ENCORE(3): non-inferiority efficacy

criteria vs. Cerezyme met

● No serious adverse events reported

in the primary analysis period

(1) Eliglustat tartrate is an investigational drug and not yet approved

(2) Primary endpoint was change in spleen volume. Secondary endpoints included improvements in hemoglobin levels, platelet levels and

liver volume. Absolute difference in spleen volume p<0.0001.

(3) Primary endpoint was stability of all composite endpoints for spleen volume, hemoglobin levels, platelet counts, and liver volumes.

Secondary endpoints included stability criteria for the individual components of the composite endpoints including spleen volume,

hemoglobin levels, platelet levels and liver volume

Page 23: 2013 - BofA Merrill Lynch Healthcare Conference

23 23

1 Diabetes

2 Oncology

3 Multiple Sclerosis and Rare Diseases

4 Cardio-Metabolic Diseases

5 Immunology

6 Vaccines

Focusing R&D on High-Value Projects

in Key Therapeutic Areas

Page 24: 2013 - BofA Merrill Lynch Healthcare Conference

Alirocumab: First in Class and Targeting Unmet Needs

in Hypercholesterolemia

24

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 receptors

CHD – Coronary Heart Disease LDL-C : Low Density Lipoprotein-Cholesterol TEAE : Treatment-Emergent Adverse Event

(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 on stable dose

of statins

● Most common TEAE: mild

injection site reaction

-80

-70

-60

-50

-40

-30

-20

-10

0

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

SAR236553 100 mg Q2W Placebo

SAR236553 50 mg Q2W SAR236553 150 mg Q2W

∆ - 64.2%

∆ - 5.1%

∆ - 39.6%

∆ - 72.4%

Decrease in LDL-C shown is at week 12.

Page 25: 2013 - BofA Merrill Lynch Healthcare Conference

~21m patients globally

estimated not at goal for LDL-C(1) (mainly at high cardiovascular risk)

Sanofi Commenced the First Phase III

Program for an Anti-PCSK9 mAb

25

● ODYSSEY: a large global Phase III

clinical program evaluating the

safety and efficacy of alirocumab

● 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

● PCSK9 Development & Launch Unit

created

● Phase III ODYSSEY Mono data

expected in Q3 2013

(1) Adapted from Decision Resources 2008, Decision Resources 2010 and CVReg 2011

(2) heFH: Heterozygous Familial Hypercholesterolemia

Target Population

Statin Intolerant

heFH(2)

Secondary Prevention

Primary Prevention

SAR236553 / REGN727 is developed in collaboration with Regeneron

Page 26: 2013 - BofA Merrill Lynch Healthcare Conference

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

Otamixaban

Regimen 2

(n=1,969)

Otamixaban

Regimen 1

(n=1,969)

UFH +

Eptifibatide

(n=1,969)

R

26

Sponsor-blinded

interim analysis

Page 27: 2013 - BofA Merrill Lynch Healthcare Conference

27 27

1 Diabetes

2 Oncology

3 Multiple Sclerosis and Rare Diseases

4 Cardio-Metabolic Diseases

5 Immunology

6 Vaccines

Focusing R&D on High-Value Projects

in Key Therapeutic Areas

Page 28: 2013 - BofA Merrill Lynch Healthcare Conference

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

in 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 combination

with 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 Q2 2013

MOBILITY Trial (Phase IIb Results)

Sarilumab is developed in collaboration with Regeneron

RA – Rheumatoid Arthritis

IL-6R – Interleukin-6 receptor

ACR – 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

ACR70

ACR50

ACR20

* 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

28

Page 29: 2013 - BofA Merrill Lynch Healthcare Conference

● 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 data

for asthma and atopic dermatitis

to be submitted for presentation

at medical conferences in 2013

● Phase IIb initiation in both

indications expected mid-year

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

IL-4

IL-4R c

Type I

Receptor

Type II

Receptor

IL-13

IL-4R IL-13R1

or

IL-4 IL-13

Dominant (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

29

Page 30: 2013 - BofA Merrill Lynch Healthcare Conference

Launching the First and Only

Voice-Guided Epinephrine Auto-Injector(1)

(1) Sanofi U.S. licensed the North American commercialization rights to the epinephrine auto-injector from Intelliject, Inc.,

(2) 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Practice Parameters

(3) IMS MAT Data Dec 2012

(4) Mylan Form 10-K for the period ending Dec 31, 2011 and Mylan Investor Day on Feb 21, 2012

● Up to 6 million people in the U.S.

may be at risk for anaphylaxis(2)

● Epinephrine auto-injector market

estimated at $665m in 2012(3)

● One main U.S. competitor with >95%

market share(4): EpiPen® from Mylan

● Auvi-Q™ offers a unique compact

size and shape

● Audio and visual cues guide users

through the injection process

● Retractable needle mechanism

● Launched in the U.S. and Canada

in Jan 2013

30

Page 31: 2013 - BofA Merrill Lynch Healthcare Conference

31 31

1 Diabetes

2 Oncology

3 Multiple Sclerosis and Rare Diseases

4 Cardio-Metabolic Diseases

5 Immunology

6 Vaccines

Focusing R&D on High-Value Projects

in Key Therapeutic Areas

Page 32: 2013 - BofA Merrill Lynch Healthcare Conference

32

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

32

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

Page 33: 2013 - BofA Merrill Lynch Healthcare Conference

FY 2008 FY 2009 FY 2010 FY 2011 FY 2012

14.1%

Maintaining Rigorous Control of R&D Expenses While

Investing Significantly in Phase III Trials

33

● R&D expenses of €4,922m in 2012,

down -1.0% at CER or -3.6% at

CER with Genzyme pro forma

reflecting:

● Good internal cost management

● Ongoing transforming initiatives

● Start of multiple Phase III trials (e.g.

alirocumab, new insulin glargine

formulation, sarilumab, JAK2)

● R&D/Sales ratio down 0.3 points

in 2012 vs. 2011

33

R&D/Sales Ratio (%)

14.4% 14.1%

16.6% 15.6%

Page 34: 2013 - BofA Merrill Lynch Healthcare Conference

Ensuring R&D Contributes to Sanofi’s Success

Global

R&D

Goals

Create an efficient global R&D organization Maximize synergies and convergence around Hub model

Leverage economies of scale

Improve R&D cost structure

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