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QUARTERLY RESULTS April 28, 2011 Q1 2011

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Quaterly Results 2011

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Page 1: Q1 2011 Results

QUARTERLY RESULTS

April 28, 2011

Q1 2011

Page 2: Q1 2011 Results

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‐aventis’

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‐aventis, 

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

labelling 

and 

other

matters

that

could

affect 

the 

availability

or 

commercial 

potential

of 

such

products

candidates, 

the 

absence 

of 

guarantee

that

the 

products

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 as well

as those 

discussed 

or 

identified 

in 

the 

public 

filings 

with 

the 

SEC 

and 

the 

AMF 

made 

by 

sanofi‐aventis, 

including 

those 

listed 

under 

“Risk 

Factors”

and 

“Cautionary 

Statement 

Regarding 

Forward‐Looking 

Statements”

in 

sanofi‐aventis’

annual 

report 

on 

Form 

20‐F 

for 

the 

year ended December 31, 2010.

Other than as required by applicable law, sanofi‐aventis does not undertake any obligation to update 

or revise any forward‐looking information or statements.

Page 3: Q1 2011 Results

3

Key Highlights

Christopher A. Viehbacher, Chief Executive Officer

Business Performance

Hanspeter Spek, President, Global Operations

Olivier Charmeil, Senior Vice President, Vaccines

R&D Update

Dr. Elias Zerhouni, President, Global Research & Development

Financial Performance

Jérôme

Contamine, Executive Vice President, Chief Financial Officer

Q&A Session

Agenda

Page 4: Q1 2011 Results

Key Highlights

Christopher A. Viehbacher

Chief Executive Officer

Page 5: Q1 2011 Results

5

Q1 2011 ‐

Solid

Underlying

Sales Performance

Q1 2011 sales reached  €7,779m

Q1 2010 sales included €413m of A/H1N1 vaccine sales

Excluding A/H1N1, Q1 2011  sales growth was:

+0.1%

at

CER(1)

€7,485m€7,107m

Q1 2009 Q1 2010 Q1 2011

Total Sales (€m)

€7,898m

A/H1N1

€413m

(1)

Growth is at CER (Constant Exchange Rates) vs. Q1 2010(2)

In Q1 2009, Merial

Joint Venture sales of €521m were not consolidated by sanofi‐aventis

With  a 50% share of Merial

Joint Venture sales, sanofi‐aventis pro forma

sales would be €7,367m(3)

Q1 2010 and Q1 2011 sales include 100%  of Merial

sales of €513m and €594m, respectively 

€7,779m

(3)

(2)

Page 6: Q1 2011 Results

6

Q1 2011 sales of key  genericized

products reduced 

by >€1bn

vs. Q1 2009:

Lovenox®

U.S.

Plavix®

Western EU 

Taxotere®

Western EU & U.S. 

Eloxatin®

U.S.(1)

Ambien CR®

U.S. 

Allegra®

U.S.

Aprovel®

Western EU 

Others(2)

€1,488m

€2,014m

Q1 2009 Q1 2010 Q1 2011

Key Genericized

Products Sales (€m)

(1)

Generic makers (Teva, Fresenius Kabi

(formerly Dabur), Sandoz, Mayne/Hospira, MN/Par, Actavis

and Sun) have been required to cease selling 

in the U.S. since June 30, 2010 but litigation continues.(2)

Other genericized

products include Xyzal®, Xatral®

and Nasacort®

in the U.S.

Q1 2011 ‐

Getting through the Patent Cliff

€945m

Page 7: Q1 2011 Results

7

Sales from growth platforms  represented 59.2%

of total 

sales

in Q1 2011 vs. 42.2% in Q1 2009

An increase

of >€1.3bn vs.  Q1 2009 pro forma

sales(2)

Excluding A/H1N1, our growth  platforms grew in Q1 2011 by 

+15.5%

at

CER(1)

€4,262m

€3,002m

Q1 2009 Q1 2010 Q1 2011

Growth Platforms Sales (€m)€4,607m

€3,849m

A/H1N1

€413m

(1)

Growth is at CER (Constant Exchange Rates) vs. Q1 2010(2)

In Q1 2009, Merial

Joint Venture sales of €521m were not consolidated by sanofi‐aventis

With  a 50% share of Merial

Joint Venture sales, sanofi‐aventis pro forma

growth platforms sales would be €3,262m(3)

Q1 2010 and Q1 2011 sales include 100%  of Merial

sales, respectively €513m and €594m

(2)

Q1 2011 ‐

Strong Performance from Growth Platforms 

(3)

Page 8: Q1 2011 Results

8

Q1 2011 ‐

Resilient

EPS despite

Generic

Headwind

Q1 2011 Business EPS was €1.66

€0.20

of Q1 2010 Business EPS  was related

to A/H1N1 vaccine 

sales

Excluding A/H1N1, Q1 2011  Business EPS was 6.0%

lower

at

CER(1)

€1.66

Q1 2010 Q1 2011

Business EPS (€m)€1.86

€0.20 €1.66

(1)

Growth is at CER (Constant Exchange Rates) vs. Q1 2010. Q1 2011 Business EPS excluding A/H1N1 vaccine sales was flat on a reported basis

Page 9: Q1 2011 Results

9

Merial

A Fully

Owned

Consolidated

Growth

Platform

#3

Animal Health player(1)

with sales of €2bn(2)

#1

in Companion Animals and Parasiticides(1)

Double‐digit growth in Emerging Markets

High operating margin(3)

Opportunity for synergies

New innovative brands, geographic expansion  and bolt‐on acquisitions to drive future growth

(1)

Vetnosis

2010 Annual Report(2)

FY 2010 Sales: €1,983m(3)

FY 2010 Business Operating Margin: 31.3%

Key Brands

Page 10: Q1 2011 Results

10Genzyme

A New Platform for Sustainable

Growth with

Near

Term

Value Drivers

Business EPS accretion expected already in 2011

Cost of financing <2%

before tax in 2011 

Integration

progressing well

Manufacturing

recovery on‐track

Remediation plan submitted to FDA 

All fill & finish activities in Allston to be

completed by target date of August 2011

Pre‐launch activities for  LemtradaTM

(alemtuzumab)

in

MS

Detailed identification of synergies

ongoing

Preliminary R&D

portfolio review conducted

#1Delivering high value

products

Page 11: Q1 2011 Results

11

Multiple Milestones

over the Next

12 Months

2011

Q2 Q3 Q4

Phase III data of 

Zaltrap®

(aflibercept)

in 2nd line mCRC

Launch of Jevtana®

in 

2nd line mHRPC

in EU 

Phase III data of 

lixisenatide

in T2 DM

Phase III results of 

semuloparin

in VTE 

prevention in cancer 

patients

Launch of Certifect®

for dogs

in the U.S.

Phase III top‐line results 

of LemtradaTM

in MS 

(CARE‐MS 1)

Regulatory submission 

of teriflunomide

in U.S.

Further Phase III data 

of lixisenatide

in T2 DM 

Regulatory submission 

of mipomersen

in EU 

for hoFH

and severe heFH

Regulatory submission 

of HexaximTM

for 

Emerging Markets

Exit fill/finish at Allston 

Landing

facility for ex‐US

IR thematic

seminar

on Strategy

& Outlook

Phase III top‐line results 

of LemtradaTM

in MS 

(CARE‐MS 2)

Regulatory submission 

of lixisenatide

in EU

Phase III top‐line results 

of teriflunomide

in MS 

(TENERE)

Regulatory submission 

of mipomersen

in U.S. 

for hoFH

Start of Phase III for 

Anti‐IL‐6 Receptor mAb

in RA and AS

Regulatory decision on 

Framingham

plant for 

Fabrazyme®

Q1

Regulatory filings of 

LemtradaTM

in MS

Regulatory submission of 

teriflunomide

in EU

Start of Phase III for 

anti‐PCSK9 mAb

in 

hypercholesterolemia

2012

Targeted

Dates for Selected

Upcoming

Milestones

mHRPC: metastatic Hormone Refractory Prostate Cancer

T2 DM ‐

Type 2 Diabetes Mellitus        VTE ‐

Venous Thrombo‐Embolism

mCRC: metastatic Colorectal Cancer 

MS: Multiple Sclerosis        RA: Rheumatoid Arthritis

AS: Ankylosing

SpondylitisFH: Familial Hypercholesterolemia

EM: Emerging Markets

Page 12: Q1 2011 Results

12

Outlook for 2011 

The lack

of A/H1N1 vaccine

sales only

affects Q1 2011

Currently in the U.S., there is no generic of Eloxatin®

on the market(1)

and 

only one generic of Lovenox®

On April 8, 2011, sanofi‐aventis announced

the closing

of the Genzyme

acquisition and integration

decisions

will

be

announced

before

summer

2011

FY 2011 outlook

will

be

revised

at

half‐year

results

(1)

Generic makers (Teva, Fresenius Kabi

(formerly Dabur), Sandoz, Mayne/Hospira, MN/Par, Actavis

and Sun) have been required to cease selling 

in the U.S. since June 30, 2010 but litigation continues.

Page 13: Q1 2011 Results

Business Performance

Hanspeter Spek

President, Global Operations

Olivier Charmeil Senior Vice President, Vaccines

Page 14: Q1 2011 Results

14

Q1 2011 Group Sales (€m)

€7,898m

Q1 2010 KeyGenericizedProducts

GrowthPlatforms

Others Q1 2011

Growth Platforms ‐

Delivering +15.5% at CER (excluding A/H1N1)

(1)

Key genericized

products include Lovenox®, Taxotere®, Ambien CR®, Eloxatine®, Allegra®, Xyzal®, Xatral®

and Nasacort®

in the U.S.  

as well as Taxotere®, Plavix®

and Aprovel®

in Western Europe(2)

Growth platforms: Emerging Markets, Diabetes, Vaccines excluding

A/H1N1, CHC,  New products (Multaq®

and Jevtana®) and Animal Health

Q1 2011 sales: €7,779m,  almost stable

Non‐recurring €413m  sales of A/H1N1

vaccine

in Q1 2010

Growth platforms

more  than compensated for 

the impact of key  genericized

products

(2)

(1)

‐€569m

A/H1N1

€413m +€595m

‐€21m

Fx

€289m

€7,779m

Page 15: Q1 2011 Results

15

28.9%

12.5%

27.8%

Emerging Markets

Western 

Europe

USA

RoW(3)

(1)

World less North America (USA, Canada), Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg,

Portugal, Holland, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark), Japan, Australia and New Zealand(2)

Emerging markets sales growth including A/H1N1 sales of €355m in Q1 2010 was +1.0% on a reported basis or ‐2.6% at CER(3)

RoW: Japan, Australia, New Zealand, Canada

30.7%

Emerging Markets ‐

Expanding our Leadership

Q1 2011 sales in Emerging  Markets(1): €2,386m, +14.6%

at CER excluding A/H1N1(2)

Emerging Markets sales exceed  the U.S. and Western Europe

All growth platforms delivered  double‐digit

growth in EM

Cardio‐thrombosis

franchise  continues to grow: +10.4%

at CER

Q1 2011 Sales Breakdown

Page 16: Q1 2011 Results

16

An Update on the Situation in Japan

All employees

safe

and secure

Medicines

and monetary

donations from company

and employees

to support aid

relief efforts

Kawagoe factory

and distribution centers unaffected

No stock‐out situation

Solid Q1 2011 sales: €665m, +13.7%

at  CER despite crisis situation

Allegra®

: +41.1%

Plavix®

: +28.8%

Myslee®

: +14.7%

Lantus®

: +34.8%

Earthquake

-

March 11, 2011

Sanofi‐aventis headquarters, 

manufacturing

and R&D sites

(1)

Growth at constant exchange rates (CER)

Page 17: Q1 2011 Results

17

Diabetes ‐

Back to Double‐Digit Growth in Q1 2011

Q1 2010 Q1 2011

(1)

Growth at constant exchange rates (CER)

U.S.

Emerging

Markets

Western EU

Others

+14.7%

+1.2%

+31.4%

+19.1%

Q1 Sales(1)

Q1 2011 sales: €925m, +13.2% at CER

Reacceleration of growth in the  U.S. following increase in Share  of Voice

Stable EU sales: volume growth  counter‐balanced price cuts

Launch of BGStar®

and i‐BGStar® in Germany (April)

and France 

(May)

Page 18: Q1 2011 Results

18

New Products

€111m in Q1 2011

Q1 2011 sales: €48m

54% share of U.S. patients in 2L mHRPC(1)

EC approval on March 18, 2011

Launch

in Germany in April 

Most EU countries expected to launch

before the end of 2011

Q1 Sales (€m)

®

24

63

48

Q1 2010 Q1 2011

Q1 2011 sales: €63m

Revised label

Two

new major

U.S. Managed

Care wins

with

Tier

2 unrestricted

status(2)

On‐going EMA benefit/risk assessment

®

(1)

IntrinsiQ

Research Diag

Drug LOT ‐

Feb 2011(2)

United Healthcare Medicare and Commercial

€111m

Page 19: Q1 2011 Results

19

Consumer Health

Care ‐

Doubled

Sales in only

2 Years

€339m

€491m

Q1 2009 Q1 2010 Q1 2011

Q1

Sales (€m)

Q1 2011 sales: €712m, +40.3%

at CER

CHC

driven by organic  growth(1)

and acquisitions  in the U.S. and China

Allegra®

OTC successfully  launched in the U.S. in March

Q1 2011 sales: €80m

Outselling Zyrtec

OTC as early 

as week 2(2)

Already our #1

OTC brand

Leveraging the acquisition of  Chattem

(1)

Growth at constant perimeter and exchange rate was +23.0% in Q1 2011(2)

Nielsen Food, Drug and Mass excluding Walmart

(represents 54% of All Outlets) through 3/19/11

€712m

Page 20: Q1 2011 Results

20

Q1 2009 Q1 2010 Q1 2011

Generics

An Additional

Key Growth

Driver

Q1 2011 sales: €414m, +16.9% at

CER

Authorized

generics

of Ambien®

CR and Taxotere®

launched

in the U.S.

: 3rd

largest

player(1) and among

fastest

growing

generic

companies

in Europe

: leader in Brazil(2)

and  expanding

in Latin America

Q1 Sales (€m)€414m

(1)

Adapted from IMS MIDAS Feb 2011(2)

IMS MIDAS

U.S.

Emerging

Markets

Western

Europe

Others

€343m

€93m

Page 21: Q1 2011 Results

21

Animal Health

Strong

Growth

in Q1 2011

Q1 2011 sales: €594m, +11.5%

at CER

sales up +15.1%(1)

Emerging Markets sales up +24.7%(1)

driving growth in 

Avian segment

Expected launch of new combination  product in Q2 2011 in the U.S.

eliminates fleas and ticks 

within 24h on dogs

Equine

3.0%

Avian

11.3%

Swine

3.0%

Pets

66.1%Ruminant

10.9%

VPH(2)

5.7%

Q1 2011 Sales Breakdown

Europe

29.8%

Emerging

Markets 

19.5%

U.S.

43.6%

RoW

7.1%

(1)

Growth at constant exchange rates (CER)(2)

VPH: Veterinary Public Health

Page 22: Q1 2011 Results

22

Q1 2011 Sales: €602m, +9.6%

at  CER excluding A/H1N1(1)

Strong Emerging Markets sales of  €282m,

+37.1% at

CER excluding 

A/H1N1, driven by:

Record seasonal flu campaign

Solid growth of                                

Good performance of                          and                        in the U.S.     

FDA approval granted for  for

infants and toddlers                      

(1)

Q1 2011 sales decreased

by ‐38.3% at

constant exchange rates when

including

€413m of A/H1N1 vaccine sales in Q1 2010 

Q1 2010 Q1 2011

Polio/Pertussis/Hib Seasonal InfluenzaMeningitis/Pneumonia BoostersTravel & Endemics OtherPandemic Influenza

Vaccines ‐

Good Start to the Year

Vaccines Consolidated Sales (€m)

A/H1N1

€413m €602m

Page 23: Q1 2011 Results

R&D Highlights

Dr. Elias Zerhouni

President, Global Research & Development

Page 24: Q1 2011 Results

24

DISCOVERYVEGF Trap

VEGFR1

VEGFR2 Fc

IgG

DISCOVERYVEGF Trap

VEGFR1

VEGFR2 Fc

IgG

Bound

VEGF

VEGF Trap

ZALTRAP®

(aflibercept): a novel anti‐angiogenic

agent

ZALTRAP®

(aflibercept)

VEGF Trap(1,2): a fusion protein blocking VEGF, 

a well‐validated anti‐angiogenic

approach

: positive Phase III results in 

2L‐mCRC with OS primary endpoint met(3,4)

Regulatory filings expected in H2 2011

: accrual completed in Phase III 

trial in 1L‐mHRPC(5)

Final results expected in mid 2012

AFFIRM: final analysis of Phase II trial 

in 1L‐mCRC expected in H2 2011 

(1)

Partnership

with

Regeneron(2)

VEGF: Vascular Endothelial Growth Factor (3)

mCRC: metastatic

Colorectal Cancer(4)

OS: Overall

Survival(5)

mHRPC: metastatic

Hormone Resistant

Prostate Cancer

Page 25: Q1 2011 Results

25

Lixisenatide(1)

: A GLP‐1 Tailored for PCPs(2)

(1)

In‐licensed

from

Zealand

Pharma(2)

PCPs: Primary

Care Physisians(3)

PPG ‐

Prandial Plasma Glucose

Opportunity to expand GLP‐1 market 

Benefits of lixisenatide: 

Effective reduction of HbA1C and PPG(3)

Low incidence of hypoglycemia

Weight loss 

Ease of use (once‐daily injection, 

simple titration and device) 

Expected compelling value proposition

Planned submissions in EU in H2 2011

and the U.S. in H2 2012

lixisenatide

GetGoa

l Mono

HbA1c

change from baseline (%)

‐0.2

‐0.4

‐0.6

0.4

0.2

0

‐0.8

‐1.0

GetGoa

l‐L Asia

lixisenatide

(2‐step titration)

lixisenatide

(1‐step titration)

GetGoa

l‐X

GetGoa

l‐S

Page 26: Q1 2011 Results

26

Teriflunomide: A Potential First‐Line Oral DMT in RMS

(1) Results presented at 2010 ECTRIMS congress(2) Adjusted for Expanded Disability Status Scale score strata at baseline and takes duration of treatment into accountRMS ‐

Relapsing Multiple Sclerosis        ARR ‐

Annualized Relapse Rate       IFN ß

Interferon‐beta        RRR ‐

Relative risk reduction       

HRR ‐

hazard ratio reduction

New disease modifying therapy

2‐year placebo‐controlled study 

(TEMSO) completed(1)

2nd

placebo‐controlled study 

(TOWER) fully recruited

Comparative study vs. IFN‐β

1a 

(TENERE) fully recruited 

Phase III adjunctive therapy 

to IFN‐β

(TERACLES) ongoing

Planned submissions in the U.S. 

in Q3 2011

and EU in Q1 2012

teriflunomide

0 0,1 0,2 0,3 0,4 0,5 0,6

T. 14 mg

T. 7 mg

Placebo

TEMSO: Reduction in Adjusted(2)

AAR

RRR: 31.2%p=0.0002

RRR: 31.5%p=0.0005

0 12 24 36 48 60 72 84 96 1080%

20%

10%

HRR: 23.7%p=0.0835

HRR: 29.8%p=0.0279

30%PlaceboT. 7 mgT. 14 mg

Week

TEMSO: Reduction in Disability Progression (%)

Page 27: Q1 2011 Results

27

: A Promising New Therapy for MS

Potential for alemtuzumab

in MS: 

Strong efficacy shown in Phase II(1)

65% of patients free from clinically 

active disease at 5 years

Improvement in disability

Convenient dosing

Manageable safety and tolerability 

profile 

Planned U.S. and EU filings in early 2012

Fast track status granted by the FDA

(1)

Results from CAMMS223 Phase II trial

CARE‐MS I CARE‐MS II

Patients 581 840

Study 

Duration

2 years 2 years

Patient

Population

Treatment

naïve

Treatment 

experienced

Treatment

Arms

Alemtuzumab

vs. IFNβ

1aAlemtuzumab

vs. IFNβ

1a

Co‐primary 

Outcomes

Relapse RateDisability

Progression

Relapse RateDisability

Progression

Data Timing Early Q3 2011 Q4 2011

Page 28: Q1 2011 Results

Financial Performance

Jérôme Contamine

Executive

Vice President, Chief

Financial Officer

Page 29: Q1 2011 Results

29

Resilient

Sales Performance in Q1 2011 

(1)

Organic sales growth is on a constant structure and exchange rate basis

7,7797,385

+289‐38

+513+43

7,898

‐413

Q1 2010Reported

Merial Q1 2010Pro Forma

A/H1N1 OrganicGrowth

Change inStructure

FX Impact Q1 2011

‐1.5%

Chattem

: +36

USD: +61

YEN: +78

BRL: +26

AUD: +22

CNY: +14

Others: +88

Q1 2011 sales (€m)

+0.1%

(1)

Page 30: Q1 2011 Results

30Solid

Business Operating Income

Excluding

Impact  of A/H1N1 sales and Copaxone®

payment

in Q1 2010

€m Q1 2011 Q1 2010 % Change

(reported €)

% Change

(CER)

Net sales 7,779 7,898 ‐1.5% ‐5.2%

Other

revenues 413 395 +5.1% +1.5%

Cost of sales (2,362) (2,177) +8.5% +5.6%

Gross profit 5,830 6,116 ‐4.7% ‐8.2%

R&D (1,100) (1,146) ‐4.0% ‐6.0%

SG&A (1,933) (1,840) +5.1% +1.7%

Other current operating income & expenses 16 75 ‐ ‐

Share of Profit/Loss of associates 292 243 ‐ ‐

Minority interests (78) (78) ‐ ‐

Business operating income 3,027 3,370 ‐10.2% ‐15.5%

Business operating margin 38.9% 42.7% ‐ ‐

CER: constant exchange rates 

Page 31: Q1 2011 Results

31As Expected, Further

Generic

Competition Leads

to Slight

Increase

in CoS

in Q1 2011 

Higher Cost of Sales (2.8 ppt)

in Q1 2011 

vs. Q1 2010 due to:

Key genericized

products

A/H1N1 vaccines

Cost of raw heparin

Quarterly Cost of Sales ratio aligned with 

expected level for FY 2011

Cost of Sales (%)

27.6%

30.4%

Q1 2010 Q2 2010 Q3 2010 Q4 2010 Q1 2011

Page 32: Q1 2011 Results

32

Sustained

Control of R&D Expenses

in Q1 2011

R&D/Sales Ratio (%)

14.5%14.1%

Q1 2010 Q2 2010 Q3 2010 Q4 2010 Q1 2011

Q1 2011 R&D expenses of €1,100m, 

down ‐6.0%(1) driven by: 

Lower Internal R&D spend

R&D/Sales ratio reduced to 14.1%

(1)

Reduction at constant exchange rates (CER)

Page 33: Q1 2011 Results

33Slight

Increase

in SG&A to Sales Ratio in Q1 2011 Excluding A/H1N1 

SG&A/Sales Ratio (%)

Q1 2011 SG&A expenses of €1,933m, 

up +1.7%(1)

SG&A/Sales ratio relatively stable

in Q1 

2011 vs. Q1 2010 excluding A/H1N1 (24.4%) 

reflecting:

SG&A decrease in EU

given ongoing new 

organizational model

for Commercial 

Operations

Strong SG&A decrease in the U.S.

partially 

offset by investment in Allegra®

OTC, 

increased promotional spend on Lantus®

as well as the impact of the excise fee

Flat G&A

expenses

Continued investment in Emerging Markets

(1)

Growth at constant exchange rates (CER)

23.3%24.8%

Q1 2010 Q2 2010 Q3 2010 Q4 2010 Q1 2011

Page 34: Q1 2011 Results

34

€m Q1 2011 Q1 2010 % Change

(reported €)

% Change

(CER)

Business operating income 3,027 3,370 ‐10.2% ‐15.5%

Net financial

expenses (78) (45) ‐ ‐

Income

tax

expense (779) (898) ‐ ‐

Effective tax rate ‐28.5% ‐28.4% ‐ ‐

Business net income 2,170 2,427 ‐10.6% ‐16.1%

Net margin 27.9% 30.7% ‐ ‐

Business EPS € 1.66 € 1.86 ‐10.8% ‐16.1%

Resilient Business EPS in Q1 2011

CER: constant exchange rates 

Excluding A/H1N1 vaccine sales, Q1 2011 Business EPS growth was flat

on a 

reported basis or down 6.0%

at CER

Page 35: Q1 2011 Results

35

Underlying

Net Profit Growth

of +10.5% in Q1 2011

2 170

2,427

Q1 2010 A/H1N1 Key GenericizedProducts

Copaxone andOthers

Underlying NetProfit Gain

FX Impact Q1 2011

Q1 2011 Business Net Income (€m)

-10.9%

-13.0%

+10.5%

+5.5%

-2.7%

(1)

Key genericized

products include Lovenox®, Taxotere®, Ambien CR®, Eloxatine®, Allegra®, Xyzal®, Xatral®

and Nasacort®

in the U.S.  

as well as Taxotere®, Plavix®

and Aprovel®

in Western Europe

®(1)

Page 36: Q1 2011 Results

36Stable FCF despite

Lack

of A/H1N1 in Q1 2011 and Net Debt

Free Status

at

the End of Q1 2011

-1 750

-1 250

-750

-250

250

750

Net Debt                    Dec  31, 2010

Net Cash fromOperatingActivities CapEx

Acquisitions &Licensing

Restructuring           Costs & Others

Net Debt                    Mar 31, 2011

€m

+16

‐340

+2,346

‐382

Change in 

Net Debt

+1,593

FCF +2,006(1)

‐31

(1)

FCF: Free Cash Flow before restructuring costs(2)

Includes €336m for BMP Sunstone acquisition(3)

Includes €162m of restructuring costs

‐1,577

(3)(2)

Page 37: Q1 2011 Results

37

Investing in Sustainable Growth 

Strong double‐digit

sales growth of our growth platforms(1)

On‐track to deliver cost savings

of €2.0bn by end of 2011(2)

Limited erosion of Business EPS excluding impact of A/H1N1 and Copaxone®

Strong free cash flow

generation lead to net

debt free status at the end of March 

before Genzyme

acquisition

(1)

Emerging Markets, Diabetes Brands, Vaccines (excluding A/H1N1 sales), Consumer Health Care, New Products and Animal Health(2)

Before inflation and tax on a constant structure basis vs. 2008(3)

In Q1 2009, Merial

Joint Venture sales of €521m were not consolidated by sanofi‐aventis

With  a 50% share of Merial

Joint Venture sales, sanofi‐aventis pro forma growth platforms sales would be €3,262m(4)

Q1 2010 and Q1 2011 sales include 100%  of Merial

sales, respectively €513m and €594m

Proportion of Sales from

Growth

Platforms(1)

Q1 2009

42.2%

Q1 2010

51.4%

Q1 2011

59.2%

(3) (4) (4)

Page 38: Q1 2011 Results

Appendices

R&D

Page 39: Q1 2011 Results

39

Late Stage Pipeline –

Pharma & Vaccines

N New Molecular Entity

G GenzymeCentral Nervous SystemCardiovascularGenetic diseases

OncologyMetabolic Disorders

Thrombosis VaccinesInternal Medecine

Fluzone®

ID

Seasonal influenza vaccine

Intradermal micro‐injection, U.S.

Plavix®

clopidogrel

bisulfate 

Atrial

fibrillation, U.S.; Pediatric, EU; 

Stent, Japan

DTP‐HepB‐Polio‐Hib

Pediatric hexavalent

vaccine

Dengue

Mild‐to‐severe 

dengue fever vaccine

Fluzone®

QIV

Quadrivalent inactivated influenza

vaccine

Hexaxim™

DTP‐HepB‐Polio‐Hib vaccine

Quadracel®

Diphtheria, tetanus, pertussis

& polio vaccine; 4‐6 y of age

Plavix®

clopidogrel bisulfate 

PAD, Japan

semuloparin

(AVE5026)

Indirect Xa/IIa

inhibitor

VTE prevention in cancer patients

otamixaban

Direct Xa

inhibitor 

ACS

Allegra®

fexofenadine

Dry syrup, Japan

teriflunomide

Multiple

sclerosis 

(monotherapy, adjunct therapy & CIS)

Multaq®

dronedarone

Permanent atrial

fibrillation

lixisenatide

(AVE0010)

GLP‐1 agonist 

Type 2 diabetes

Lantus®

insulin glargine

ORIGIN*; Pediatric, EU

ombrabulin

(AVE8062)

Vascular disrupting agent

Sarcoma

Zaltrap®

(aflibercept)

(VEGF‐Trap)

2nd

line mCRC;

1st

line mHRPC

iniparib

(BSI‐201)

mTNBC; squamous

LC

N

N N

N

N

Registrationeliglustat

tartrateGlucosylceramide

synthetase

inhibitorGaucher

disease

LemtradaTM

(alemtuzumab)Anti‐CD52 mAbMultiple sclerosis

prochymalMesenchymal

stem cellGraft‐versus‐host disease

Clolar®

/ Evoltra®Purine

analogueAdult acute myeloid leukemia (AML)

mipomersenApolipoprotein

B‐100 antisensehoFH; severe heFH

N

N

Phase III

G

G

G

G

Recombinant human 

TSH

Modified (rhTSH‐M)Goiter

G

G

G N

N

atalurenTranscription modulator

Cystic fibrosis

NG

N

MACI®Cell‐based treatment

Articular

cartilage defects

Biosurgery

* ORIGIN: Evaluation of Lantus®

in reducing cardiovascular morbidity & mortality

Page 40: Q1 2011 Results

40

Early Stage Pipeline –

Pharma & Vaccines

Multaq®

Antiarrhythmic

agent

Atrial

fibrillation Japan

celivarone

Antiarrhythmic

agent

Ventricular arrhythmia

SAR110894

H3 antagonist

Alzheimer's disease

SAR164877

Anti‐NGF mAb

Pain

(on clinical hold)

FOV2304

Bradykinin

B1 antagonist

Diabetic macular edema

FOV2302

Plasma kallikrein

inhibitor

Retinal vein occlusion induced 

macular edema

FOV1101

FDC prednisolone/ cyclosporine 

Allergic conjunctivitis

Meninge

ACYW conj. 

2nd

generation meningococcal

conjugate Infant vaccine

Rabies VRVg

Purified vero

rabies vaccine

Rabies

mAb

post exposure prophylaxis

SAR153191

Anti‐IL‐6R mAb

RA ; Ankylosing

spondylitis

ferroquine

Antimalarial

Malaria

SAR231893

Anti‐IL4 mAb

Asthma;

Atopic dermatitis

SAR236553 (RENG727)

Anti‐PCSK‐9 mAb

Hypercholesterolemia

SAR245409

(XL765)

Oral dual inhibitor of PI3K & mTOR

Cancer

SAR245408 (XL147)

Oral PI3K inhibitor

Endometrial  cancer

SAR256212

(MM‐121)

anti‐ErbB3 mAb

Breast cancer

Zaltrap®

(aflibercept)

VEGF‐Trap 

1st line colorectal cancer

iniparib

(BSI‐201)

Ovarian cancer, non‐squamous

NSCLC, 

neoadjuvant

breast cancer

N N

N

N

N

N

N

N

N

N

N

N

N

Acid sphingomyelinaseNiemann‐Pick type B

N

Gene therapy

(AAV‐AADC)Parkinson's disease

fresolimumab

(GC1008)TGFβ

antagonistFibrosis

N

G

G

G

Phase II

Central Nervous SystemCardiovascularGenetic diseases

OncologyMetabolic Disorders

Ophthalmology Vaccines

Internal Medecine

N

ACAM‐Cdiff

Clostridium difficile

Toxoid

vaccine

N New Molecular Entity

G Genzyme

Page 41: Q1 2011 Results

41

Early Stage Pipeline –

Pharma & Vaccines

Tuberculosis 

Recombinant subunit vaccine

Pseudomonas aeruginosa

Antibody fragment product 

Prevention of

ventilator‐associated pneumonia

Streptococcus pneumonia

Meningitis & pneumonia vaccine

Rotavirus

Live Attenuated Tetravalent 

Rotavirus oral vaccine

SAR411298

FAAH inhibitor

Cancer pain

SAR152954

H3 antagonist

Sleep disorders

SAR114137

Cathepsin

S/K inhibitor

OA pain & 

Peripheral neuropathic pain1

RetinoStat®

Gene therapy

Wet

age‐related

macular

degeneration

(AMD) 

SAR292833 (GRC15300)

TRPV3 antagonist

Neuropathic pain, osteoarthritic

pain

SAR650984                               Anti‐CD38 naked mAb

Hematological malignancies

SAR 156597

IL4/IL13 Bi‐specific

mAb

Idiopathic

Pulmonary

Fibrosis

SAR104772

TAFIa

inhibitor

Acute ischemic stroke

SAR97276

Antimalarial

Malaria

SAR100842

LPA‐1/LPA‐3

Internal medicine

SAR113945

IKK‐β

inhibitor

Osteoarthritis

SAR302532 (RENG846)

Internal medicine

SAR101099

Urotensin

II receptor antagonist

Diabetic nephropathy

lixisenatide

+ Lantus®

GLP‐1 agonist + insulin glargine

Type 2 diabetes

SAR 307746 (REGN 910)

Anti‐Ang2 mAb

Cancer

SAR566658                               

Maytansin‐loaded anti‐DS6

Solid tumors

SAR302503 (TG101348)

JAK‐2 inhibitor

Myelofibrosis, refractory polycythemia

SAR103168

Multikinase

inhibitor

AML

SAR256212

(MM‐121)

anti‐ErbB3 mAb

Solid tumors, ovarian cancer

SAR3419

Maytansin‐loaded anti‐CD19 mAb

non‐Hodgkin’s lymphoma

SAR153192

Anti‐DLL4 mAb

Cancer

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

Thrombosis

Genz644282Topoisomerase‐1 inhibitor

Solid tumors

N

Mozobil®

(plerixafor)

CXCR4 Antagonist

Tumor Sensitization

tasidotin

GC1008 topoisomerase

inhibitor

tubulin

binding agent

Melanoma

N

Oral clofaribinePurine

analogueMyelodysplastic

syndromes

Gene therapy

(sFLT‐01)Age related Macular Degeneration

(AMD)

N

G

G

G

G

GSAR279356 (F598)

Anti‐PNAG mAb

Serious infections

Phase I

SAR 3077646 (REGN 910)Anti‐Ang2 mAb

Cancer

N

N

N

Central Nervous SystemGenetic diseases

OncologyMetabolic Disorders

Ophthalmology VaccinesInternal Medecine

N New Molecular Entity

G Genzyme

Page 42: Q1 2011 Results

42R&D Pipeline Summary Table New Molecular Entities and Vaccines

40211Metabolic Disorders     

30201Thrombosis

10010Cardiovascular

150339Oncology

40031Ophthalmology

70223Central Nervous System

64

14

11

1

1

0

162027TOTAL

544Vaccines

047Internal Medicine

TOTAL

Registration

Phase III

Phase II

Phase I

47 17

New Molecular Entities

& Vaccines

50

50221Genetic Diseases

Page 43: Q1 2011 Results

43

Expected

regulatory

submission

of mipomersen

in U.S. for hoFH

Phase III top‐line results

of LemtradaTM

in multiple sclerosis

(CARE‐MS 2)

Anticipated

R&D Newsflow

H2 2011Phase II results

of Zaltrap®

in 1st line mCRC

(AFFIRM)

Q1 2012Expected

regulatory

submission

of teriflunomide

in EU

Q4 2011Phase III top‐line results

of teriflunomide

in multiple sclerosis

(TENERE)

Q4 2011Expected

regulatory

submission

of lixisenatide

in EU

Q2 2011Phase II interim analysis

of iniparib

in Ovarian

Cancer 

Q2 2011Phase III results

of semuloparin

in VTE prevention

in cancer patients

(SAVE ONCO)

Q2 & Q3 2011Lixisenatide in Type 2 diabetes

Further

Phase III data presentation

Mid

2011Phase III interim

analysis

of Zaltrap®

in 1st

line mHRPC

(VENICE)

Q3 2011Expected

regulatory

submission

of teriflunomide

in U.S.

Key Milestones

Pharmaceuticals Timing

H2 2011

Q4 2011

Q1 2012Expected

regulatory

submission

of LemtradaTM

in MS

H2 2011Expected regulatory submission of Zaltrap®

in 2nd

line

mCRC

in U.S. and EU

Early

Q3 2011Expected

regulatory

submission

of mipomersen

in EU for hoFH

and severe

heFH

Early

Q3 2011Phase III top‐line results

of LemtradaTM

in multiple sclerosis

(CARE‐MS 1)

Page 44: Q1 2011 Results

44

Anticipated R&D Newsflow

Key Milestones ‐

Vaccines TimingExpected

regulatory decision on Fluzone®

ID in US Q2 2011

Start of Phase III efficacy trial for Dengue Vaccine in Asia Pacific and Latin America Q2 2011

Expected regulatory submission of HexaximTM

for Emerging Markets Q3 2011

Start of Phase III for IMOJEVTM

in India Q3 2011

Page 45: Q1 2011 Results

Appendices

Finance

Page 46: Q1 2011 Results

46

Business Net Income Statement

*     Net of tax**   Determined on the basis of Business income before tax, associates, and non‐controlling interests*** Based on an average number of shares outstanding of 1,305.2 million in the first quarter of 2011 and 1,307.3 million in the first quarter of 2010

(1) The results of operations of the Merial business previously presented as “held‐for‐exchange”

were reclassified and included in income from continuing 

operations  in accordance with

IFRS5 §36, following the announcement to maintain Merial and Intervet/Schering‐Plough as two separate organizations. 

First-quarter 2011 Pharmaceuticals Vaccines Animal health Other Group Total

Millions of euros Q1 2011 Q1 2010 % change Q1 2011 Q1 2010 % change Q1 2011 Q1 2010(1) % change Q1 2011 Q1 2010 Q1 2011 Q1 2010 % change

Net sales 6,583 6,441 +2.2% 602 944 (36.2%) 594 513 +15.8% 7,779 7,898 (1.5%)

Other revenues 404 385 +4.9% 5 5 4 5 (20.0%) 413 395 +4.6%

Cost of sales (1,927) (1,725) +11.7% (268) (300) (10.7%) (167) (152) +9.9% (2,362) (2,177) +8.5%

As % of net sales (29.3%) (26.8%) (44.5%) (31.8%) (28.1%) (29.6%) (30.4%) (27.6%)

Gross profit 5,060 5,101 (0.8%) 339 649 (47.8%) 431 366 +17.8% 5,830 6,116 (4.7%)

As % of net sales 76.9% 79.2% 56.3% 68.8% 72.6% 71.3% 74.9% 77.4% Research and development expenses (940) (993) (5.3%) (125) (117) +6.8% (35) (36) (2.8%) (1,100) (1,146) (4.0%)

As % of net sales

(14.3%)

(15.4%)

(20.8%)

(12.4%)

(5.9%) (7.0%)

(14.1%)

(14.5%)

Selling and general expenses (1,645) (1,565) +5.1% (127) (136) (6.6%) (161) (139) 15.8% (1,933) (1,840) +5.1%

As % of net sales

(25.0%)

(24.3%)

(21.1%)

(14.4%)

(27.1%) (27.1%)

(24.8%)

(23.3%)

Other current operating income/expenses 62 101 1 (2) (17) 5 (30) (29) 16 75

Share of profit/loss of associates* 283 236 (4) (1) 13 8 292 243

Net income attributable to non-controlling interests (78) (78) (78) (78)

Business operating income 2,742 2,802 (2.1%) 84 393 (78.6%) 218 196 11.2% (17) (21) 3,027 3,370 (10.2%)

As % of net sales 41.7% 43.5% 14.0% 41.6% 36.7% 38.2% 38.9% 42.7% Financial income and expenses

(78) (45)

Income tax expense (779) (898)

Tax rate** 28.5% 28.4%

Business net income 2,170 2,427 (10.6%)

As % of net sales 27.9% 30.7%

Business earnings per share*** (in euros) 1.66 1.86 (10.8%)

Page 47: Q1 2011 Results

47Reconciliation of Business Net Income to Net Income  attributable to Equity Holders of sanofi‐aventis

(1) The results of operations of the Merial business previously presented as “held‐for‐exchange”

were reclassified and included in income from continuingoperations in accordance with IFRS5 §36, following the announcement to maintain Merial and Intervet/Schering‐Plough as two separate organizations.(2) Of which amortization expense generated by the remeasurement of intangible assets as part of business combinations: €

686 million in the first quarter 

of 2011

and €

801 million in the first quarter of 2010. (3) In 2011:

“Catch up”

in respect of 2009 and 2010 depreciation and amortization expense on PP&E* and intangible assets of Merial, previously classified 

as “Assets

held for sale or exchange”

(IFRS5 §27).(4)

Based on an average number of shares outstanding of 1,305.2 million in the first quarter of 2011 and 1,307.3 in the first quarter of 2010.* Property, Plant and Equipment..

Millions of euros Q1 2011 Q1 2010(1) % change

Business net income 2,170 2,427 (10.6%)

Amortization of intangible assets(2) (736) (848) Impairment of intangible assets (32)

Fair value remeasurement of contingent consideration liabilities (46)

Expenses arising from the impact of acquisitions on inventories (2) (62)

Restructuring costs (122) (167) Other gains and losses, and litigation(3) (517) Discontinuation of depreciation of PP&E* (IFRS5) 18

Tax effect of 510 349 Amortization of intangible assets 263 282 Impairment of intangible assets 10 Expenses arising on the workdown of acquired inventories 17

Restructuring costs 42 56 Other gains and losses, and litigation 195 Discontinuation of depreciation of PP&E * (IFRS5) (6)

Other tax items 4 Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures

(7) (7)

Net income attributable to equity holders of sanofi-aventis 1,218 1,714 (28.9%)

Consolidated earnings per share(4) (in euros) 0.93 1.31 (29.0%)

Page 48: Q1 2011 Results

48

Consolidated Income Statements

Millions of euros  Q1 2011  Q1 2010(1) 

Net sales  7,779  7,898 

Other revenues  413  395 

Cost of sales  (2,364)  (2,227) 

Gross profit  5,828  6,066 

Research and development expenses  (1,100)  (1,143) 

Selling and general expenses  (1,933)  (1,837) 

Other operating income  118  152 

Other operating expenses  (102)  (77) 

Amortization of intangible assets  (736)  (848) 

Impairment of intangible assets  (32)   

Fair value remeasurement of contingent consideration liabilities 

(46)   

Restructuring costs  (122)  (167) 

Other gains and losses, and litigation  (517)   

Operating income  1,358  2,146 

(1)

The results of operations of the Merial business previously presented as “held‐for‐exchange”

were reclassified and included in income from continuing

operations in accordance with IFRS5 §36, following the announcement to maintain Merial and Intervet‐Schering Plough as two separate organizations.

Page 49: Q1 2011 Results

49

Consolidated Income Statements

(1) The results of operations of the Merial business previously presented as “held‐for‐exchange”

were reclassified and included in income from continuing operations in accordance with IFRS5 §36, following the announcement to maintain Merial and Intervet/Schering‐Plough as two separateorganizations.

(2)

Based on an average number of shares outstanding of 1,305.2 million in the first quarter of 2011 and 1,307.3 million in the first quarter of 2010.

Millions of euros  Q1 2011  Q1 2010(1) 

Operating income  1,358  2,146 

Financial expenses  (101)  (103) 

Financial income  23  58 

Income before tax and associates and joint ventures 

1,280  2,101 

Income tax expenses  (269)  (545) 

Share of profit/loss of associates and joint ventures 

285  236 

Net income   1,296  1,792 

Net income attributable to non‐controlling interests 

78  78 

Net income attributable to equity holders of sanofi‐aventis   

1,218  1,714 

Average number of shares outstanding (million)  1,305.2  1,307.3 

Earnings per share(2) (in euros)  0.93  1.31