Q3 2011 Results

44
Q3 2011 RESULTS November 3, 2011

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Q3 2011 Results

Transcript of Q3 2011 Results

Page 1: Q3 2011 Results

Q3 2011 RESULTS

November 3, 2011

Page 2: Q3 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’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

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, 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, 2010.

Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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Agenda

Key Highlights

Christopher A. Viehbacher, Chief Executive Officer

Business Performance

Hanspeter Spek, President, Global Operations

Financial Performance

Jérôme

Contamine, Executive Vice President, Chief Financial Officer

Q&A

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KEY HIGHLIGHTS

Christopher A. Viehbacher

Chief Executive Officer

4

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Total Sales (€m)

Sanofi Demonstrates its Ability to Overcome the Patent Cliff in Q3 2011

€8,753m

Business EPS (€)

€1.79

5

€7,395m€7,779m

€8,349m

Q4 2010 Q1 2011 Q2 2011 Q3 2011

€1.41

€1.66 €1.64

Q4 2010 Q1 2011 Q2 2011 Q3 2011

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Aprovel®

EU

Key Genericized Products(1)

Quarterly Sales (€m)

(1)

Key genericized

products include Lovenox®, Taxotere®, Ambien®, Eloxatin®, Allegra®, Xyzal®, Xatral®

and Nasacort®

in the U.S.  

as well as Taxotere®, Plavix®

and Aprovel®

in Western Europe(2)

Eloxatin®

U.S. market exclusivity expected through August 9, 2012

Patent Cliff Sales Exposure Declines Slightly in Q3 2011 despite Recovery of U.S.

Eloxatin®

Sales

€744m

% of Total Sales 13.7% 12.1% 9.3% 8.5%

Eloxatin®

U.S.: €245m(2)

Lovenox®

U.S. 

Plavix®

EU

€499m

Others

€773m

€945m

€1,072m

Q4 2010 Q1 2011 Q2 2011 Q3 2011

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Growth Platforms and Genzyme Continue to Expand in Q3 2011

€5,996m

% of Total Sales 58.0% 59.2% 65.2% 68.5%

Growth Platforms and Genzyme(1)

Quarterly Sales (€m)

(1)

Growth platforms [Emerging Markets, Diabetes, Vaccines excluding

A/H1N1, CHC, New products (Multaq®

& Jevtana®), Animal Health] and Genzyme

€5,447m

€4,607m€4,563m

Q4 2010 Q1 2011 Q2 2011 Q3 2011

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Growth

Platforms

Sustain

Double-Digit Sales Increase for Three Consecutive Quarters in 2011

Emerging Markets €2,565m, +6.8% excluding A/H1N1 vaccines and Genzyme sales(2)

Consumer Healthcare €665m, +20.3%

Vaccines €1,343m, +19.9% excluding A/H1N1 vaccines(3)

Animal Health €470m, -5.2%

Innovative Products(4)

€111m, +34.5%Diabetes Solutions €1,161m, +12.4%

Growth Platforms : +11.1% in Q3 2011 and +11.9% in first 9M 2011excluding A/H1N1 vaccines and Genzyme sales(1)

Growth is at CER (Constant Exchange Rates)(1)

Q3 2011 Growth

Platforms

sales increased

by +26.5% at

CER including

€33m of A/H1N1 vaccine sales in Q3 2010 and €768m of Genzyme sales in Q3 2011(2)

Q3 2011 Emerging

Markets

sales increased

by +12.0% at

CER including

€117m of Genzyme sales in Q3 2011(3)

Q3 2011 Vaccines sales increased

by +16.7% at

CER when

including

€33m of A/H1N1 vaccine sales in Q3 2010 (4)

Multaq®

and Jevtana®

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Lyxumia® (lixisenatide)(2)

Type 2 diabetes in Oct 2011 in EU

Zaltrap™ (aflibercept)(3)

2L-mCRC in Oct 2011 in the U.S.

Five

NME’s

Recently

Submitted

to Regulatory

Agencies

Kynamro™ (mipomersen)(1)

hoFH

and Severe heFH

in Jul 2011 in EU

Visamerin® / Mulsevo® (semuloparin)–

VTE prevention in chemo-treated patients in Sep 2011 in the U.S. and EU

Aubagio™ (teriflunomide)–

RMS in Aug 2011 in the U.S.

NME: New Molecular EntityhoFH: Homozygous Familial HypercholesterolemiaheFH: Heterozygous Familial Hypercholesterolemia

RMS: Relapsing Forms of Multiple SclerosisVTE: Venous Thrombo

Embolismm‐CRC: Metastatic Colorectal Cancer

(1)

Licensed from Isis Pharmaceuticals(2)

Licensed from Zealand Pharma(3)

Partnership with Regeneron

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Important R&D Milestones

Expected

Shortly

Expected Phase III Study Initiations

sarilumab -

Extension of MOBILITY trial into

Phase III in rheumatoid

arthritis

New formulation of insulin glargine -

Phase III in diabetes

(EDITION)

Anti-PCSK-9 mAb -

Phase III trials in hypercholesterolemia

Expected Headline Data Releases

Zaltrap™ (aflibercept) -

Phase II in 1st

line colorectal cancer (AFFIRM)

Lemtrada™ (alemtuzumab) -

Phase III in RMS (CARE-MS II)

Aubagio™ (teriflunomide) -

Phase III in RMS (TENERE)

Expected Regulatory Submissions

Kynamro™ (mipomersen) in hoFH

in the U.S.

Zaltrap™ (aflibercept) in 2L-mCRC in EU

Lemtrada™ (alemtuzumab) in RMS in the U.S. and EU

Aubagio™ (teriflunomide) in RMS in EU

Q4 2011

Q4 2011

Q4 2011

Q4 2011

Q4 2011

Q1 2012

Q1 2012

Q1 2012

Q2 2012

hoFH: Homozygous Familial Hypercholesterolemiam‐CRC: Metastatic Colorectal CancerRMS: Relapsing forms of Multiple Sclerosis 10

Zaltrap™, Lemtrada™, Aubagio™

and Kynamro™

are 

registered trade names submitted to health authorities 

for investigational agents

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EPS Guidance for FY 2011 Confirmed

YTD September 2011 Q4 2011

Impact of multiple generic entries in H2 2010

Lack of H1N1 vaccines sales in Q1 2011

Loss of exclusivity of Taxotere®

in the U.S. in late Q1 2011

Benefit of Genzyme consolidation only as of Q2 2011

Expected solid overall sales from growth platforms

Low relative quarterly U.S. flu vaccines sales after strong Q3

Expected sales of Genzyme consistent with Q3 2011

2011 Business EPS to be 2 to 5% lower than 2010 Business EPS at CER(1,2)

barring major unforeseen adverse events

(1)

Growth is at CER (Constant Exchange Rates)(2)

FY 2010 Business EPS: €7.06 11

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BUSINESS PERFORMANCE

12

Hanspeter Spek

President, Global Operations

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Key Genericized Products(2)

-€471m●

Taxotere® U.S. & Western EU: -€308m

Lovenox® U.S.: -€108m

Ambien® U.S.: -€98m

Allegra® U.S.: -€38m

Xyzal® U.S.: -€34m

Plavix® Western EU: -€25m

Others(2): -€71m

Eloxatin® U.S.: +€211m(6)

Q3 2011 Sales Variations (€m)

(1)

Growth platforms: Emerging Markets, Diabetes, Vaccines excluding

A/H1N1, CHC, New products (Multaq®

and Jevtana®), Animal Health(2)

Other key genericized

products include  Aprovel®

in Western EU, Nasacort®

and Xatral®

in the U.S.  (3)

Incremental quarterly sales contribution from Emerging Markets excluding other Growth Platforms and Genzyme was €61m(4)

A/H1N1 vaccine sales were €33m in Q3 2010 (5)

Genzyme Q3 2011 sales at 2010 exchange rates(6)

Eloxatin®

U.S. market exclusivity expected through August 9, 2012

Growth Platforms and Genzyme Lead to 10.1% Sales Growth in Q3 2011 despite Generic Competition

Growth Platforms(1)

+ €555m●

Emerging Markets: +€291m(3)

Vaccines w/o A/H1N1(4): +€237m

Diabetes Solutions: +€136m

CHC: +€117m

Innovative Products: +€30m

Animal Health: -€27m

+ €839m(5)

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(1)

World excluding 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)

Genzyme sales in Emerging Markets were €117m in Q3 2011

Sanofi Is Poised

to Continue Solid

Growth

in Emerging Markets

Q3 2011 Emerging Markets(1)

sales of €2,565m, +6.8% at CER without Genzyme or +12.0% at CER with Genzyme(2)

Strong sales in BRIC of €901m, +20.2% at CER without Genzyme

or +24.2% at CER with Genzyme

Eastern Europe & Turkey impacted by cost containment measures and Taxotere®

genericization●

Emerging Markets up

+11.5% at CER outside Eastern Europe and Turkey excluding Genzyme

Emerging Markets Q3 2011 Sales Split 

Growth at CER excluding Genzyme

+12.0%

‐5.4% +17.5%

+3.4%

14

€457m

€631m€649m

€802m

LatinAmerica

EasternEurope &

Turkey

Asia Africa &Middle East

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Sanofi Shows Impressive Double Digit Sales Growth in Diabetes for the Third Consecutive Quarter in 2011

Quarterly Sales (€m)2

Growth at CER€968m

Q3 2011 Diabetes sales of €1,161m, +12.4% at CER ●

[Lantus®

+ Apidra®] up +15.2% at CER in first 9 months of 2011, outpacing competition

Strong Q3 performance of Lantus®

+14.6% in the U.S. due to increased market penetration of SoloSTAR®

(47.2%)

Solid performance in Western Europe of +7.1%

Sustained growth in Emerging Markets with sales up +23.4%

+14.6%+14.5%

+13.2%

+8.8%

+6.7%

+10.6%+10.4%

Q1 2010 Q2 2010 Q3 2010 Q4 2010 Q1 2011 Q2 2011 Q3 2011

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Q3 2009 Q3 2010 Q3 2011

Strong performance with Q3 2011 sales of €665m, +20.3 % at CER(1)

Successful first allergy season of Allegra®

OTC in the U.S.

Sales of €186m in YTD Sep 2011

Strong organic growth at CER of other key CHC brands

Essentiale®: +8.1%; Dorflex®: +11.3%; Lactacyd®: +25.8%; NoSpa®: +28.1%

Sanofi Delivers +20.3% Growth in CHC in Q3 2011

+20.3% at CER

€665m

Quarterly Sales (€m)

(1)

Growth at constant perimeter and exchange rate was +13.8% in Q3 2011

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U.S.

Western

Europe

Solid Q3 sales of €410m, +9.2% at CER●

64.4% of Generics sales in Emerging Markets: €264m, +9.9% at CER

Authorized generics of Ambien®

CR and Taxotere®

in the U.S.

Medley expansion in Latin America

initiated●

+10.5%

at

CER in Brazil

and +37.2% at

CER in LatAm

excluding

Brazil

Launch

of our

authorized

generic

of Lovenox®

in October

in the U.S.

Sanofi Achieves Another Solid Performance in Generics in Q3 2011

€410mQuarterly Sales (€m)

17

Q3 2009 Q3 2010 Q3 2011

Emerging

Markets 

Others

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Cardio-Thrombosis

Leading Brands Generate Annualized ex-U.S. Sales of > €1.8bn in Q3 2011

Q3 2011 presence: ●

€1,738m, +6.5% at CER(1,2)

€554m,

+1.1% at CER outside the U.S.

Q3 2011 sales: ●

€494m,

-12,7% at CER●

€361m,

+9.9% at CER outside the U.S.

(1)

Includes sales consolidated by Bristol‐Myers Squibb(2)

The BMS alliance does not cover rights to Plavix®

in Japan; sales of Plavix®

in Japan are consolidated by Sanofi

Q3 2011 Lovenox®

salesQ3 2011 Plavix®

presence(1,2)

U.S. €133m-42.4%

Emerging Markets€137m +11.6%

Western EU €199m +8.7%

Others €25m +9.5%

U.S. €1,185m+9.0%

Japan + China €234m +22.6%

EU €143m -21.0%

Others €176m +0.8%

69%8%

13%

10% 27%

40%

28%

5%

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Genzyme Driven

by Performance of Key Products in Q3 2011

Q3 2011 sales of €768m, +6.9% at constant rate and perimeter●

Strong

sales of Myozyme®

/ Lumizyme®

of €101m, +27.2%

Cerezyme®

growth still limited by reduced product availability

New Fabrazyme®

plant continues to be on track with internal and regulatory milestones

Solid performance of Renagel®

/ Renvela®

and Synvisc®

franchise

Two regulatory filings submitted: Kynamro™ in EU and Aubagio™

in the U.S.

+7.0%

+27.2%

+6.7%

Others -0.7% +24.9%

+11.3%

&

&

Quarterly Sales Split by Products

Growth at CER

Kynamro™

is the registered name submitted to health authorities for the investigational agent mipomersenAubagio™

is the registered name submitted to health authorities for the investigational agent teriflumomide

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Temporary

Slowdown

of Merial

in Q3 2011 due to "At-Risk"

Generic

Launch

in the U.S. and Strong

Q2 2011

Q3 sales of €470m, -5.2% at CER

Solid sales in Production Animals of €175m, +5.4% at CER

Sales in Companion Animals of €295m impacted by temporary U.S. generic competitor of Frontline®

Plus●

Positive U.S. court ruling barring further sales of Cipla

and Velcera’s

generics

and ordering seizure of U.S. inventory in possession of generic makers

Launch

of Certifect®

in the U.S.

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Early

Shipments

of U.S. Seasonal

Flu

Vaccines Boost Sanofi Pasteur Sales in Q3 2011

€1,343m

+19.9%

at

CER

excludingA/H1N1

Q3 2011 Vaccine sales of €1,343m, +19.9% at CER excluding A/H1N1(1)

Strong seasonal flu sales of €602m, +42.6% at CER excluding A/H1N1 ●

First U.S. doses shipped July 18 and ~90% of doses shipped in Q3 2011

Further differentiation with launch of Fluzone®

Intradermal

in the U.S.

Continued resilience of Menactra®

in Q3 2011: €195m, +10.2% at CER

Strong sales of Pentaxim®

in Emerging Markets: €52.6m,

+18.5% at CER

Vaccines Consolidated Sales (€m)

21(1)

A/H1N1 vaccines sales were €33m in Q3 2010 

Q3 2010 Q3 2011Seasonal Influenza Pandemic InfluenzaPolio/Pertussis/Hib Meningitis/PneumoniaBoosters Travel & EndemicsOther

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FINANCIAL PERFORMANCE

Jérôme

Contamine

Executive Vice President, Chief Financial Officer

22

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€8,753m

€8,339m

Q3 2010 KeyGenericized

Brands

OthersincludingA/H1N1

GrowthPlatforms

Genzyme FX Impact Q3 2011

USD : -€299mVEF : -€42mTRY : -€26m

Others : -€59m

Genzyme Sales Add

to a Stable Base and More than Offset Negative

Fx Impact in Q3 2011 vs. Q3 2010

Q3 2011 sales (€m)

VEF: Venezuelan BolivarTRY: Turkish Lira

+0.0%

+10.1% ‐5.1%

+5.0%‐

€426m

€471 + €555m

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P&L Continues to Reflect

Genzyme Consolidation and Shift in Business Mix in Q3 2011

€m Q3 2011 Q3 2010 % Change

(reported €)

% Change

(CER)

Net sales 8,753 8,339 +5.0% +10.1%

Other

revenues 419 443 -5.4% +2.3%

Cost of sales (2,755) (2,444) +12.7% +17.4%

Gross profit 6,417 6,338 +1.2% +6.7%

R&D (1,221) (1,123) +8.7% +12.8%

SG&A (2,114) (2,004) +5.5% +10.4%

Other current operating income & expenses 40 33 - -

Share of Profit/Loss of associates 276 292 - -

Minority interests (54) (54) - -

Business operating income 3,344 3,482 -4.0% +2.8%

Business operating margin 38.2% 41.8% - -

CER: Constant Exchange Rates 

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Cost

of Sales of 30.9% in first 9M 2011 In-Line with

FY 2011 Estimate

Cost of Sales (%)●

Higher Cost of Sales in Q3 2011 vs. Q3 2010 due to:

Loss of sales of €471m from key genericized

products with relatively low Cost of Sales

Business mix impact from strong vaccines sales

Cost of Sales ratio in 9M 2011 aligned with expected Cost of Sales level for FY 2011

25

2010 2011

31.5%31.0%30.4%

Q1 Q2 Q3 Q4 Q1 Q2 Q3

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2010 2011

Increase

in R&D Expenses

due to the Addition of Genzyme R&D Costs

in Q3 2011

R&D/Sales Ratio (%)●

Q3 2011 R&D expenses of €1,221m, up 12.8% at CER

Addition of €139m of R&D expenses from Genzyme

R&D expenses down 0.8% at CER excluding Genzyme

R&D/Sales ratio slightly down vs. Q2 2011 to 13.9%

26

13.9%14.3%14.1%

Q1 Q2 Q3 Q4 Q1 Q2 Q3

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2010 2011

SG&A Expenses

Excluding

Genzyme

Decline

in Q3 2011

SG&A/Sales Ratio (%)●

Q3 2011 SG&A expenses of €2,114m, up +10.4% at CER

Tight control of SG&A expenses leading to 2% decline excluding Genzyme

SG&A/Sales ratio only slightly up

in Q3 2011 vs. last year reflecting:

Lower ratio of Selling & Marketing Expenses to Sales ratio

Start of implementation of Genzyme synergies

27

24.2%

27.2%24.8%

Q1 Q2 Q3 Q4 Q1 Q2 Q3

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€m Q3 2011 Q3 2010 % Change

(reported €)

% Change

(CER)

Business operating income 3,344 3,482 -4.0% +2.8%

Net financial

expenses (121) (127) - -

Income

tax

expense (825) (883) - -

Effective tax rate -27.5% -28.3% - -

Business net income 2,398 2,472 -3.0% +4.1%

Net margin 27.4% 29.6% - -

Business EPS € 1.79 € 1.89 -5.3% +1.6%

Average number of shares outstanding (in million) 1,339.4 1,304.8 - -

Business Net Income up 4.1% at CER in Q3 2011 After Two Quarters of Declining BNI

CER: constant exchange rates 28

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Net Debt        Jun  30, 2011

Net Cashfrom

OperatingActivities CapEx

Acquisitions& Licensing

ShareRepurchase

RestructuringCosts &Others

Net Debt        Sep 30, 2011

Strong

Free Cash Flow in Q3 2011

- €11,938m- €413m

+ €2,016m

- €57m

+ €3,326m

- €13,231m - €388m

(1)

Represents 10,195,453 shares at an average price of €49.03(2)

Excluding Restructuring Costs(3)

Including €989m Fx

translation effect on Net Debt vs. end of June 2011

(2)

- €1,175m

(3)

Strong Free Cash Flow of €2,913m, up +3.3% in Q3 2011

€500m of opportunistic share repurchases to date in 2011(1)

Low average cost of gross debt of 2.4% in Q3 2011

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Successfully Navigating through the Patent Cliff and Investing in Sustainable Growth in first 9M 2011

Double-digit sales increase of growth platforms(1,2) in first 9M 2011

Significant generic headwind of >€1.7bn in first 9M 2011

On-track to deliver the €2.0bn cost savings objective by end of 2011(3)

Limited erosion of Business EPS of 3.5% at CER w/o A/H1N1 in first 9M 2011

(1)

Excluding Genzyme and A/H1N1 (2)

Growth platforms [Emerging Markets, Diabetes, Vaccines excluding

A/H1N1, CHC, New products (Multaq®

and Jevtana®), Animal Health](3)

Before inflation and tax on a constant structure basis vs. 2008(4)

In Q3 2009, Merial

Joint Venture sales of €443m were not consolidated by Sanofi

With a 50% share of Merial

Joint Venture sales, Sanofi pro forma growth platforms sales would have been €3,911m(5)

Q3 2010 and Q3 2011 sales include 100%  of Merial

sales, respectively €518m and €470m(6)

Q3 2011 includes Genzyme sales of €768m 

Proportion of Sales from

Growth

Platforms

and Genzyme(1)

Q3 2009 Q3 2010 Q3 2011(4) (5) (5, 6)

51.3% 60.2% 68.5%

Page 31: Q3 2011 Results

APPENDICES

R&D Pipeline

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Late Stage Pipeline –

Pharma & Vaccines

N New Molecular Entity

G GenzymeCentral Nervous System

Genetic diseases

OncologyMetabolic Disorders

Vaccines

Internal Medicine

RegistrationPhase III

Biosurgery

* ORIGIN: Evaluation of Lantus®

in reducing cardiovascular morbidity & mortality

iniparib (BSI-201)

squamous

NSCLC

MACI®Cell-based treatment

Articular

cartilage defects

Quadracel®

Diphtheria, tetanus, pertussis

& polio vaccine; 4-6 y of age

Hexaxim®

DTP-HepB-Polio-Hib

vaccine

aflibercept VEGF-Trap

2nd

line mCRC

EU; 1st line mHRPC

otamixaban Direct Xa

inhibitor ACS

Fluzone® QIV IM Quadrivalent

inactivated influenza

vaccine

Plavix®

clopidogrel

bisulfate Stent, Japan

ombrabulin (AVE8062)

Vascular disrupting agent

Sarcoma

Plavix®

clopidogrel

bisulfate PAD, Japan

Dengue Mild-to-severe

dengue fever vaccine

semuloparin (AVE5026)

Indirect Xa/IIa

inhibitor

VTE prevention in cancer patients

Clolar® / Evoltra®

Purine

nucleoside analogAdult acute myeloid leukemia (AML)

Lantus®

insulin glargine

ORIGIN*; Pediatric, EU

DTP-HepB-Polio-Hib Pediatric hexavalent

vaccine

teriflunomide Relapsing forms of multiple sclerosis

(RMS) –

monotherapy, U.S.

teriflunomide Multiple sclerosis

(monotherapy, adjunct therapy & CIS)

lixisenatide (AVE0010)

GLP-1 agonist Type 2 diabetes

Allegra®

fexofenadine

Dry syrup, Japan

mipomersenApolipoprotein

B-100 antisensehoFH

and severe heFH, EU

alemtuzumabAnti-CD52 mAb

Multiple sclerosis

mipomersenApolipoprotein

B-100 antisensehoFH

(U.S.)

sarilumab (SAR153191)

Anti-IL-6R mAb

RA

lixisenatide (AVE0010)

GLP-1 agonist Type 2 diabetes, EU

eliglustat tartrateGlucosylceramide

synthetase

inhibitorGaucher

disease

prochymalMesenchymal

stem cellGraft-versus-host disease

aflibercept VEGF-Trap

2nd

line mCRC, U.S.

N

G

G

G

N

N

N

N

N

N

G

N

G

Thrombosis

N

G

N

32

N

Page 33: Q3 2011 Results

33

Early Stage Pipeline –

Pharma & Vaccines

N New Molecular Entity

G GenzymeCentral Nervous SystemCardiovascularGenetic diseases

OncologyMetabolic Disorders

VaccinesInternal Medicine

Phase II

Ophthalmology

iniparib (BSI-201)

Ovarian cancer, non-squamous

NSCLC, neoadjuvant

breast cancer

FOV1101 FDC prednisolone/ cyclosporine

Allergic conjunctivitis

Multaq®

Antiarrhythmic

agent

Atrial

fibrillation, Japan

aflibercept VEGF-Trap

1st line mCRC

FOV2302 Plasma kallikrein

inhibitor

Retinal vein occlusion induced macular edema

SAR231893 Anti-IL4 mAb

Asthma; Atopic dermatitis

SAR256212 (MM-121)

anti-ErbB3 mAb

Breast cancer

FOV2304 Bradykinin

B1 antagonist

Diabetic macular edema

ferroquine Antimalarial

Malaria

SAR245408 (XL147)

Oral PI3K inhibitor

Endometrial cancer

SAR164877 Anti-NGF mAb

Pain

(on clinical hold)

fresolimumabTGFβ

antagonistFibrosis

SAR245409 (XL765)

Oral dual inhibitor of PI3K & mTOR

Breast cancer

SAR110894 H3 antagonist

Alzheimer's disease

ACAM-Cdiff Clostridium difficile

Toxoid

vaccine

ombrabulin (AVE8062)

Vascular disrupting agent

Ovarian 2nd

line, NSCLC 1st

line

atalurenTranscription modulator

Cystic fibrosis

Rabies mAb

post exposure prophylaxis

SAR302503 JAK-2 inhibitor

Myelofibrosis

SAR236553 (REGN727)

Anti-PCSK-9 mAb

Hypercholesterolemia

Rabies VRVg Purified vero

rabies vaccine

Recombinant human TSH Modified (rhTSH-M)

Goiter

Meninge ACYW conj. 2nd

generation meningococcal

conjugate Infant vaccine

N

N

N

N

N

N

N

N

N

N

N

G N

G N

NG

33

N

Page 34: Q3 2011 Results

34

Early Stage Pipeline –

Pharma & Vaccines

Phase ISAR153192

Anti-DLL4 mAb

Solid tumors

Genz644282 Topoisomerase-1 inhibitor

Solid tumors

Gene therapy (sFLT-01)

Age related Macular Degeneration

(AMD)

SAR114137 Cathepsin

S/K inhibitor

OA pain & Peripheral neuropathic pain

SAR3419 Maytansin-loaded anti-CD19 mAb

B-cell malignancies (NHL, ALL)

Mozobil® (plerixafor)

CXCR4 Antagonist

AML

Gene therapy (AAV-AADC)

Parkinson's disease

SAR411298 FAAH inhibitor

Cancer pain

SAR256212 (MM-121) anti-ErbB3 mAb

Solid tumors, ovarian cancer

GC1008 Anti-TGFβ

mAb

Solid tumors

SAR339658 VLA 2 antagonist

Inflammatory Bowel disease

Rotavirus Live Attenuated Tetravalent

Rotavirus oral vaccine

SAR103168 Multikinase

inhibitor

AML

Oral clofaribine Purine

nucleoside analog

Myelodysplastic

syndrome

SAR113945 IKK-β

inhibitor

Osteoarthritis

Streptococcus pneumonia Meningitis & pneumonia vaccine

SAR650984 Anti-CD38 naked mAb

Hematological malignancies

SAR407899 Rho kinase

inhibitor

Diabetic nephropathy

SAR292833 (GRC15300)

TRPV3 antagonist

Neuropathic pain, osteoarthritic

pain

Pseudomonas aeruginosa Antibody fragment product

Prevention of ventilator-associated pneumonia

SAR302503 (TG101348)

JAK-2 inhibitor

Polycythemia

vera, Incyte

resistant MF

lixisenatide + Lantus®

GLP-1 agonist + insulin glargine

Single pen device / Type 2 diabetes

SAR100842 LPA-1/LPA-3

Internal medicine

Tuberculosis Recombinant subunit vaccine

SAR566658 Maytansin-loaded anti-DS6

DS6 positive solid tumors

SAR101099 Urotensin

II receptor antagonist

Diabetic nephropathy

SAR279356 (F598)

Anti-PNAG mAb

Serious infections

RetinoStat®

Gene therapy

Wet

age-related

macular

degeneration

(AMD)

SAR307746 (REGN910)

Anti-Ang2 mAb

Solid tumors

New formulation Insulin

glargine

Type 1+2 diabetes

SAR97276 Antimalarial

Malaria

StarGen®

Gene therapy

Stargardt

disease

SAR125844 Met kinase

inhibitor

Solid tumors

SAR164653 Cathepsin

A inhibitor

CV-related

complications & deaths

in diabetic

patients

SAR156597 IL4/IL13 Bi-specific

mAb

Idiopathic

Pulmonary

Fibrosis

SAR104772/SAR126119 TAFIa

inhibitor

Acute ischemic stroke

Combinations SAR245408 / MSC1936369B

SAR245409 / MSC1936369B

Acid sphingomyelinase Niemann-Pick type B

N

N

N

N

N

N

N

N

G

G

N

N

G

G

N New Molecular EntityG Genzyme

Central Nervous SystemGenetic diseasesOncology

Metabolic DisordersVaccinesInternal Medicine

Thrombosis

Ophthalmology

N

N

N

N

N

N

N

N

N

N

N

N N

G

G N

NG

34

N

N

Page 35: Q3 2011 Results

35

Phase I Phase II Phase III Registration TOTAL

Oncology 9 4 2 1 16

Metabolic Disorders 3 2 0 2 7

Thrombosis 1 0 1 1 3

Central Nervous System 2 2 0 1 5

Internal Medicine 7 3 2 0 12

Ophthalmology 2 3 0 0 5

Genetic Diseases 3 1 1 0 5

Vaccines 4 4 4 1 13

TOTAL 31 19 10 6

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

50 16NMEs

& Vaccines

53

66

35

Page 36: Q3 2011 Results

36

Anticipated

R&D Newsflow

Q4 2011

Q4 2011

Q4 2011

Q1 2012

Q4 2011

Q4 2011

Q1 2012

Expected

Key Milestones

-

Pharmaceuticals Timing

Regulatory submission of ZaltrapTM in 2nd line mCRC in EU

Phase II results of ZaltrapTM in 1st line mCRC (AFFIRM)

Initiation of Phase III study with new insulin glargine formulation in diabetes (EDITION)

Phase III top-line results of LemtradaTM in multiple sclerosis (CARE-MS II)

Phase III top-line results of AubagioTM in multiple sclerosis (TENERE)

Regulatory submission of KynamroTM in U.S. for hoFH

Regulatory submission of AubagioTM in EU

36

Q1 2012Regulatory submission of LemtradaTM in MS in U.S. and EU

Q2 2012Initiation of Phase III study with anti-PCSK-9 mAb in hypercholesterolemia

Page 37: Q3 2011 Results

37

Anticipated R&D Newsflow

37

Q4 2012

Q4 2011

Q2 2012

Expected

Key Milestones

-

Vaccines

Scientific opinion for HexaximTM issued by EMA

Start of Phase III for Fluzone® QIV ID

Start of Phase III for Vaxigrip® QIV IM

File Submission in US for Fluzone® QIV IM Q3 2012

File Submission in EU for HexaximTM Q3 2012

Timing

Page 38: Q3 2011 Results

APPENDICES

FINANCE

Page 39: Q3 2011 Results

39

Business Net Income Statement -

Q3 2011

*     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 1,339.4 million in the third quarter of 2011 and 1,304.8 million in the third quarter of 2010(1)

In 2010, 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.

Third quarter 2011

Net sales 6,940 6,595 5.2% 1,343 1,226 9.5% 470 518 (9.3%) 8,753 8,339 5.0%Other revenues 406 429 (5.4%) 8 9 (11.1%) 5 5 419 443 (5.4%)Cost of sales (2,094) (1,843) 13.6% (502) (451) 11.3% (159) (150) 6.0% (2,755) (2,444) 12.7%As % of net sales (30.2%) (27.9%) (37.4%) (36.8%) (33,9%) (29.0%) (31.5%) (29.3%)Gross profit 5,252 5,181 1.4% 849 784 8.3% 316 373 (15.3%) 6,417 6,338 1.2%As % of net sales 75.7% 78.6% 63.2% 63.9% 67.2% 72.0% 73.3% 76.0%Research and development expenses (1,031) (954) 8.1% (154) (131) 17.6% (36) (38) (5.3%) (1,221) (1,123) 8.7%As % of net sales (14.9%) (14.5%) (11.5%) (10.7%) (7,7%) (7.3%) (13.9%) (13.5%)Selling and general expenses (1,827) (1,707) 7.0% (140) (144) (2.8%) (147) (153) (3.9%) (2,114) (2,004) 5.5%As % of net sales (26.3%) (25.9%) (10.4%) (11.7%) (31.2%) (29.5%) (24.2%) (24.0%)Other current operating income/expenses (1) 54 2 10 (4) (6) 43 (25) 40 33Share of profit/loss of associates* 269 267 7 25 276 292Net income attributable to non-controlling interests (55) (53) 1 (1) (54) (54)Business operating income 2,607 2,788 (6,5%) 564 544 3.7% 130 175 (25.7%) 43 (25) 3,344 3,482 (4.0%)As % of net sales 37.6% 42.3% 42.0% 44.4% 27.7% 33.8% 38.2% 41.8%Financial income and expenses (121) (127)Income tax expense (825) (883)Tax rate** 27.5% 28.3%

Business net income 2,398 2,472 (3.0%)As % of net sales 27.4% 29.6%Business earnings per share*** (in euros) 1.79 1.89

% changeQ3 2011 Q3 2011 Q3 2010Q3 2010

Pharmaceuticals%

change

Group Total

Millions of euros Q3 2011 Q3 2010 Q3 2010 Q3 2011Q3

2010(1) Q3 2011% change

Other%

change

Vaccines Animal health

Page 40: Q3 2011 Results

40

Nine months 2011

Net sales 20,670 20,071 3.0% 2,651 2,918 (9.2%) 1,560 1,555 0.3% 24,881 24,544 1.4%Other revenues 1,222 1,215 0.6% 18 21 (14.3%) 14 14 1,254 1,250 0.3%Cost of sales (6,167) (5,374) 14.8% (1,052) (1,003) 4.9% (486) (453) 7.3% (7,705) (6,830) 12.8%As % of net sales (29.8%) (26.8%) (39.7%) (34.4%) (31.2%) (29.1%) (30.9%) (27.8%)Gross profit 15,725 15,912 (1.2%) 1,617 1,936 (16.5%) 1,088 1,116 (2.5%) 18 430 18,964 (2.8%)As % of net sales 76.1% 79.3% 61.0% 66.3% 69.7% 71.8% 74.1% 77.3%Research and development expenses (2,994) (2,897) 3.3% (418) (378) 10.6% (106) (113) (6.2%) (3,518) (3,388) 3.8%As % of net sales (14.5%) (14.4%) (15.8%) (13.0%) (6.8%) (7.3%) (14.1%) (13.8%)Selling and general expenses (5,441) (5,080) 7,1% (404) (428) (5,6%) (469) (459) 2,2% (1) (2) (6,315) (5,969) 5.8%As % of net sales (26.3%) (25.3%) (15.2%) (14.6%) (30.1%) (29.5%) (25.4%) (24.3%)Other current operating income/expenses 41 222 1 8 (11) 32 (95) 63 135Share of profit/loss of associates* 828 758 5 17 13 8 846 783Net income attributable to non-controlling interests (191) (203) 1 1 (190) (202)Business operating income 7,968 8,712 (8,5%) 801 1,156 (30,7%) 503 544 (7,5%) 44 (89) 9,316 10,323 (9.8%)As % of net sales 38.5% 43.4% 30.2% 39.6% 32.2% 35.0% 37.4% 42.1%Financial income and expenses (299) (267)Income tax expense (2,299) (2,679)Tax rate** 27.5% 28.3%Business net income 6,718 7,377 (8.9%)As % of net sales 27.0% 30.1%Business earnings per share*** (in euros) 5.09 5.65

Other%

change

Vaccines Animal health Group Total

Millions of euros 9M 2011 9M 2010 9M 2010 9M 20119M

2010(1) 9M 2011% change

% change9M 2011 9M 2011 9M 20109M 2010

Pharmaceuticals%

change

Business Net Income Statement -

YTD Sep 2011

*     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 1,318.9 million in the first 9 months of 2011 and 1,305.5 million in the

first 9 months of 2010(1)

In 2010, 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 41: Q3 2011 Results

41

Reconciliation of Business Net Income to Consolidated Net Income -

Q3 2011

(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. (2)

Of which amortization expense generated by the remeasurement of intangible assets as part of business combinations: €

760 million in the 

third quarter of 2011 and €

831 million in the third 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 1,339.4 million in the third quarter of 2011 and 1,304.8 in the third quarter of 2010.* Property, Plant and Equipment.

Millions of euros Q3 2011 Q3 2010 % changeBusiness net income 2 398 2 472 (3,0%)Amortization of intangible assets (2) (804) (879)

Impairment of intangible assets (7) (171)

Fair value remeasurement of contingent consideration liabilities 233

Expenses arising from the impact of acquisitions on inventories (140) (2)

Restructuring costs (70) (302)

Other gains and losses, and litigation (3)

Discontinuation of depreciation of PP&E* (IFRS5) 19

Tax effect of: 427 478

amortization of intangible assets 354 319 impairment of intangible assets 2 60 fair value remeasurement of contingent consideration liabilities 5 expenses arising on the workdown of acquired inventories 42 restructuring costs 24 104 other gains and losses, and litigation discontinuation of depreciation of PP&E* (IFRS5) (5)

Other tax items

Share of items listed above attributable to non-controlling interests 1

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 2 030 1 609 26,2%

Consolidated earnings per share (4) (in euros) 1,52 1,23 23,6%

Page 42: Q3 2011 Results

42

Reconciliation of Business Net Income to Consolidated Net Income -

YTD Sep 2011

(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. (2)

Of which amortization expense generated by the remeasurement of intangible assets as part of business combinations: €

2,367 million in the 

first 9 months of 2011 and €

2,532 million in the first  9 months 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 1,318.9 million in the first 9 months of 2011 and 1,305.5 in the first 9 months of 2010.* Property, Plant and Equipment.

Millions of euros 9M 2011 9M 2010 % changeBusiness net income 6 718 7 377 (8,9%)Amortization of intangible assets (2) (2 505) (2 681)

Impairment of intangible assets (76) (279)

Fair value remeasurement of contingent consideration liabilities 167

Expenses arising from the impact of acquisitions on inventories (404) (136)

Restructuring costs (537) (492)

Other gains and losses, and litigation (3) (517)

Discontinuation of depreciation of PP&E* (IFRS5) 58

Tax effect of: 1 429 1 203

amortization of intangible assets 913 918 impairment of intangible assets 22 93 fair value remeasurement of contingent consideration liabilities 10 expenses arising on the workdown of acquired inventories 120 43 restructuring costs 174 167 other gains and losses, and litigation 190 discontinuation of depreciation of PP&E* (IFRS5) (18)

Other tax items

Share of items listed above attributable to non-controlling interests 2

Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures (21) (22)

Net income attributable to equity holders of sanofi 4 254 5 030 (15,4%)

Consolidated earnings per share (4) (in euros) 3,23 3,85 (16,1%)

Page 43: Q3 2011 Results

43

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 

separate organizations.

Millions of euros

Net sales 8,753 8,339 24,881 24,544

Other revenues 419 443 1,254 1,250

Cost of sales (2,895) (2,433) (8,109) (6,929)

Gross profit 6,277 6,349 18,026 18,865

Research and development expenses (1,221) (1,120) (3,518) (3,380)

Selling and general expenses (2,114) (2,001) (6,315) (5,956)

Other operating income 90 96 281 339

Other operating expenses (50) (63) (218) (204)

Amortization of intangible assets (804) (879) (2,505) (2,681)

Impairment of intangible assets (7) (171) (76) (279)

Fair value remeasurement of contingent consideration liabilities 233 167

Restructuring costs (70) (302) (537) (492)

Other gains and losses, and litigation (517)

Operating income 2,334 1,909 4,788 6,212

Q3 2010 (1)Q3 2011 9M 2010 (1)9M 2011

Page 44: Q3 2011 Results

44

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 

separate organizations.

Millions of euros

Operating income 2,334 1,909 4,788 6,212

Financial expenses (153) (116) (387) (330)

Financial income 32 (11) 88 63Income before tax and associates and joint ventures 2,213 1,782 4,489 5,945

Income tax expense (398) (405) (870) (1 476)

Share of profit / loss of associates and joint ventures 269 285 825 761

Net income 2,084 1,662 4,444 5,230

Net income attributable to non-controlling interests 54 53 190 200

Net income attributable to equity holders of sanofi 2,030 1,609 4,254 5,030

Average number of shares outstanding (million) 1,339.4 1,304.8 1,318.9 1,305.5

Consolidated earnings per share (in euros) 1.52 1.23 3.23 3.85

Q3 2010 (1)Q3 2011 9M 2010 (1)9M 2011