Q1 2012 Results

45
Q1 2012 RESULTS April 27 th , 2012

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Q1 2012 Results

Transcript of Q1 2012 Results

Page 1: Q1 2012 Results

Q1 2012 RESULTS

April 27th, 2012

Page 2: Q1 2012 Results

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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, 2011. 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

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€1.66

Q1 2011 Q1 2012

Total Sales (€m)

2012 - A Good Start to the Year

€7,779m

Q1 2011 Q1 2012

Business EPS (€)

€1.85

5

€8,511m

+7.2% at CER

+7.0% at CER

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2012 - Entering Final Phase of the Patent Cliff(1)

6

Q32008

Q42008

Q12009

Q22009

Q32009

Q42009

Q12010

Q22010

Q32010

Q42010

Q12011

Q22011

Q32011

Q42011

Q12012

Q22012

Q32012

Q42012

Key Genericized Products(1) - Quarterly Sales (€m)

€813m

€2,207m

(1) The patent cliff is the effect of the loss of exclusivity of key genericized products. Key genericized products include Lovenox® U.S., Plavix® Western EU, Taxotere® Western EU & U.S., Eloxatin® U.S., Ambien® family U.S., Allegra® U.S., Aprovel® Western EU, Xyzal® U.S., Xatral® U.S., Nasacort® U.S. and BMS Alliance (active ingredients of Plavix® and Avapro® sold to BMS)

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2011

The Most Significant Headwind from the Patent Cliff in 2012 Will Impact Earnings but Not Sales

Evolution of Group "Other Revenues"

Evolution of Group “Income from Associates"

(1) Avapro® on March 30, 2012 and Plavix® on May 17, 2012

2012e 2011 2012e

€1,669m

Loss of Exclusivity of Plavix® and Avapro® in the U.S.(1)

- 54% - 62%

€1,102m Expected Impact on

2012 Business Net Income ~ €1.4bn

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Growth Platforms Accounted for 63.2% of Sales in Q1 2012

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Growth is at CER (Constant Exchange Rates) (1) With Genzyme pro forma in Q1 2011, Emerging Market sales grew by 5,6%, and by 7,9% excluding vaccines (2) New Genzyme perimeter include Rare Diseases and Multiple Sclerosis franchises (3) Change on a constant structure basis and at constant exchange rates (4) Multaq®, Jevtana®, and Mozobil®

+14.4%

+11.4%

-0.2%

-5.4%

+13.7%(3)

Innovative Products(4) €139m +6.3%(3)

+9.9%(1)

Consumer Health Care €805m

Diabetes Solutions €1,311m

Vaccines €617m

Animal Health €578m

Emerging Markets €2,624m

New Genzyme(2) €400m

Growth at CER

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€81m

€30m

€94m

€139m

€93m

€47m

€112m

€149m

Genzyme Rare Diseases On Track

Quarterly Sales(1) (€m)

● Q1 2012 Genzyme rare diseases sales reached €400m, +13.7%(1,2)

● Framingham plant granted EMA and FDA approvals in January 2012

● U.S. patients and most severely affected EU patients moved to full Fabrazyme® dose starting March 2012

● Complete return to normal supply levels of Fabrazyme® starting this quarter

● Phase 3 studies of eliglustat in Gaucher disease fully enrolled

& Others

(1) Genzyme sales are consolidated since April 1, 2011 (2) Change on a constant structure basis and at constant exchange rates

Other Rare Diseases products

Q1 2012

Q1 2011

Q1 2012

Q1 2011

Q1 2012

Q1 2011

Q1 2012

Q1 2011

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Significant Pipeline Progress over Last 9 Months

Kynamro™ (mipomersen) – hoFH and severe heFH in Jul 2011 in EU and hoFH in Mar 2012 in the U.S.

Aubagio™ (teriflunomide) – RMS in Aug 2011 in the U.S. and Feb 2012 in EU

Lyxumia® (lixisenatide) – Type 2 diabetes in Oct 2011 in EU

Zaltrap® (aflibercept) – 2L-mCRC in Dec 2011 in EU and Feb 2012 in the U.S.

hoFH: Homozygous Familial Hypercholesterolemia heFH: Heterozygous Familial Hypercholesterolemia VTE: Venous Thrombo Embolism

RMS: Relapsing Forms of Multiple Sclerosis mCRC: Metastatic Colorectal Cancer

Visamerin® / Mulsevo® (semuloparin) – VTE prevention in chemo-treated patients in Sep 2011 in the U.S. and EU

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Five new molecular entities submitted in last 9 months:

Kynamro™, Aubagio™, Visamerin® / Mulsevo®, Lyxumia® and Zaltrap® are registered trade names submitted to health authorities for investigational agents

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Zaltrap® aflibercept

● First in class agent addressing unmet needs in hypercholesterolemia

● Very encouraging Phase II data

Phase III program targeted to start in Q2 2012

New Data on Exciting R&D Assets in Q1 2012

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Anti-PCSK9 mAb(1)

● Significant efficacy in RMS(2) with convenient annual dosing, and favorable benefit/risk balance in clinical studies

FDA & EMA submissions expected in Q2 2012

(1) Partnership with Regeneron (2) RMS: Relapsing Forms of Multiple Sclerosis Lemtrada is a trade name submitted to health authorities for the investigational agent alemtuzumab in Multiple Sclerosis

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

3 month

Active Comparators

Placebo

6 month EDSS

Higher Hurdle

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(1) Investigational compound (2) Based on CARE-MS II

Higher Hurdle

(2)

For Illustrative Purposes

Typical Threshold for Approval

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13 Coles A ECTRIMS 2011; platform presentation

CARE-MS I - Strong Effect on Relapse

Proportion of Relapse-Free Patients at Year 2

59%

78%

Lemtrada™ 12 mg/day Rebif®

HR 0.45 P<0.001

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CARE-MS II - Reversing Disability in Some Patients

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Mean EDSS Change from Baseline

p<0.0001

0.24 p=0.0064

‒0.17 p=0.0044

Rebif®

Lemtrada™ 12 mg/day

EDSS: Expanded Disability Status Score Cohen J AAN 2012; platform presentation

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Key R&D Milestones for the Remainder of 2012

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Lemtrada™, Aubagio™ and Lyxumia® are registered trade names submitted to health authorities for investigational agents

2012 Expected Regulatory Submissions Q2 Q3 Q4 ● Lemtrada™ (alemtuzumab) in RMS(1) in the U.S. and EU ● Lyxumia® (lixisenatide) in Type 2 diabetes in the U.S.(2) Expected Headline Data Releases

● Lantus® - ORIGIN study results ● Lantus® - Retrospective cohort studies results ● Aubagio™ (teriflunomide) – TOWER headline Phase III results in RMS

● Dengue vaccine - Phase IIb efficacy results Expected Phase III Study Initiations

● Anti-PCSK-9 mAb - Phase III program in hypercholesterolemia ● Sarilumab (Anti-IL-6R mAb) - Second Phase III trial

(1) RMS: Relapsing Forms of Multiple Sclerosis (2) Partnership with Zealand Pharma (3) Mid year 2012

(3)

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BUSINESS PERFORMANCE

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Hanspeter Spek President, Global Operations

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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

Double Digit Growth in Key Emerging Markets in Q1 2012

● Q1 2012 Emerging Markets(1) sales of €2,624m, up +9.9% at CER

● Strong sales in BRIC of €917m, +16.5% at CER

Emerging Markets Q1 2012 Sales Split (Growth at CER)

+16.0%

+11.7% +2.1%

+8.1%

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Impressive Double Digit Growth in Diabetes Sustained for Five Consecutive Quarters

Quarterly Sales (€m) ● Q1 2012 Diabetes sales of €1,311m, +17.8% or +14.4% at CER

● Strong performance of Lantus®, up +17.2% at CER ● SoloSTAR® accounted for 51.1% of

quarterly sales in the U.S. ● Solid performance in Western Europe

of +8.0% at CER ● Strong growth in Emerging Markets

with sales up +32.4% at CER

● Results of ORIGIN outcome study and two retrospective cohort studies to be presented at ADA in June Q1

10Q111

Q112

Q210

Q211

Q212

Q310

Q311

Q312

Q410

Q411

Q412

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€1,118m

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Q1 2012 - Good Quarter for Oncology

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● Q1 2012 Oncology sales of €741m, +16.7% or +12.8% at CER ● Sales of Jevtana® reached €54m,

up +10.4% at CER ● Taxotere® sales of €150m despite loss

of exclusivity in the U.S. and EU ● Sales of €133m from ex-Genzyme

oncology brands, up +8.4%(1)

● Zaltrap® (aflibercept) granted Priority Review by the FDA ● First anti-angiogenic agent to

demonstrate a survival advantage in mCRC patients previously treated with oxaliplatin(2,3)

Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012

Oncology Others Eloxatin

Quarterly Sales (€m)

€741m

51.8%

48.2%

(1) Change on a constant structure basis and at constant exchange rates (2) m-CRC – Metastatic Colorectal Cancer (3) When combined with FOLFIRI (irinotecan-5-fluorouracil-leucovorin) - Phase III VELOUR study (4) Eloxatin® U.S. market exclusivity expected through August 9, 2012

® (4)

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Q1 2010 Q1 2011 Q1 2012

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Flagship Brands Continue to Grow in Key Geographies outside the U.S. in Q1 2012

Quarterly Sales (€m)

€404m

Quarterly Sales (€m)

€359m

Q1 2010 Q1 2011 Q1 2012

Emerging Markets Japan Ex-US

€168m +11.9%

at CER

€191m +5.2% at CER

+11.9% at CER

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€711m

€491m

€339m

Q1 2009 Q1 2010 Q1 2011 Q1 2012

● Strong Q1 2012 sales of €805m, +13.1% or +11.4 % at CER

● Good start of 2nd year for Allegra® OTC in the U.S. with sales of €87m, +5.0% at CER

● Strong performance in Emerging Markets, up +21.9% at CER ● Double digit growth of Dorflex®,

Lactacyd®, Maalox®, NoSpa® and Enterogermina®

● Contribution of BMP Sunstone in China and Universal Medicare in India(1)

Record Consumer Health Care Sales in Q1 2012

€805m

Quarterly Sales (€m)

USA

Emerging Markets

Western Europe

Others

+4.3%

+3.6%

+21.9%

+1.8%

(1) CHC Sales from BMP Sunstone in China and Universal Medicare in India were €22m in Q1 2012

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● Q1 2012 sales of €617m, +2.5% or -0.2% at CER

● Strong sales in mature markets

● Solid performance of Pentacel® and Menactra® in the U.S.

● Emerging markets impacted by supply phasing issues

● Seasonal flu sales down -15.6% at CER due to timing of Southern Hemisphere (SH) campaign

● Strong flu season expected in H1 2012 in Southern Hemisphere

● Good performance of SPMSD JV(1)

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Sanofi Pasteur Growth in Q1 2012 Impacted by Timing of Seasonal Flu Campaign in Emerging Markets

€371m +11.2%

at CER

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Quarterly Sales (€m)

Q1 2011 Q1 2012 Q1 2011 Q1 2012

Mature Markets Emerging Markets

-13.1% at CER

€246m

(1) Sales from SPMSD, the JV with Merck & Co in Europe, are not consolidated by Sanofi Pasteur

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Merial Sales In-Line with Expected Quarterly Phasing in Q1 2012

● Solid Q1 2012 sales of €578m, but performance impacted by tough comparable (-2.7% or -5.4% at CER)

● Return to growth expected for the remainder of 2012

● Companion Animals sales of €398m (-6.1% at CER)

● Strong Frontline® buying pattern in U.S. veterinary channels in Q1 2011

● Production Animals sales of €180m -3.7% at CER or +5,4% at CER excluding FMD and BTV vaccines sales(1)

● Newport acquisition to enlarge presence in Swine market(2)

Q12010

Q22010

Q32010

Q42010

Q12011

Q22011

Q32011

Q42011

Q12012

Quarterly Sales (€m)

(1) Q1 2011 benefited from one-off sales of Foot-and-mouth and Bluetongue vaccines sales (2) Newport sales were not consolidated by Merial in Q1 2012

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FINANCIAL PERFORMANCE

Jérôme Contamine

Executive Vice President, Chief Financial Officer

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€8,511m

€7,779m

8,349

Q1 2011 KeyGenericized

Products

OthersincludingCopaxone

and Dermik

GrowthPlatforms

Genzyme FX Impact Q1 2012

USD : +€110mJPY : +€51mCNY : +€22mOthers : +€4m

Growth Platforms and Genzyme More than Offset Impact of Key Genericized Products in Q1 2012

Q1 2012 sales (€m)

(1) Sales impact from end of Copaxone® agreement and Dermik disposal: -€131m (2) JPY: Japanese Yen; CNY: Chinese Yuan (3) Genzyme pro forma Q1 2011

+9.4% + €187m

- €235m

+ €287m - €240m

® (1)

(2) (2)

+ €733m

(3)

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BOI Double Digit Growth in Q1 2012 Reflects Genzyme Consolidation and Cost Savings

€m Q1 2012 Q1 2011 % Change (reported €)

% Change (CER)

Net sales 8,511 7,779 +9.4% +7.0%

Other revenues 426 413 +3.1% -0.5%

Cost of sales (2,613) (2,362) +10.6% +9.5%

Gross profit 6,324 5,830 +8.5% +5.5%

R&D (1,176) (1,100) +6.9% +5.2%

SG&A (2,121) (1,933) +9.7% +7.4%

Other current operating income & expenses 147 16 - -

Share of Profit/Loss of associates 297 292 - -

Non controlling interests (54) (78) - -

Business operating income 3,417 3,027 +12.9% +8.9%

Business operating margin 40.1% 38.9% - -

CER: Constant Exchange Rates

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Cost of Sales Ratio Improved in Q1 2012

Cost of Sales (%)

Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012

● Q1 2012 Cost of Sales of €2,613m

● Cost of Sales ratio improvement reflecting:

● Positive impact from productivity improvements and reduced cost of crude heparin

● Negative impact from loss of sales from key genericized products(1), in particular Taxotere® in the U.S.

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32.0% 31.5% 31.0% 30.7% 30.4%

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

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Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012

13.9%

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R&D to Sales Ratio Down in Q1 2012

● Q1 2012 R&D expenses of €1,176m

● R&D spend in line with quarterly average of last 2 years

● Integration of Genzyme R&D

● Ongoing transforming initiatives

● R&D/Sales ratio down 0.7 point vs. Q1 2010

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R&D/Sales Ratio (%)

15.2% 13.8% 14.1% 14.3%

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Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012

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SG&A to Sales Ratio Stable in Q1 2012

SG&A/Sales Ratio (%) ● Q1 2012 SG&A expenses of €2,121m, up +7.4% at CER

● SG&A expenses down 4.9% with Genzyme pro forma

● SG&A/Sales ratio stable vs. Q1 2011 reflecting:

● Tight control of SG&A expense

● Genzyme synergies

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24.2% 26.1% 24.9% 24.8%

27.2%

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€m Q1 2012 Q1 2011 % Change (reported €)

% Change (CER)

Business operating income 3,417 3,027 +12.9% +8.9%

Net financial expenses (119) (78) - -

Income tax expense (856) (779) - -

Effective tax rate -28.0% -28.5% - -

Business net income 2,442 2,170 +12.5% +8.4%

Net margin 28.7% 27.9% - -

Business EPS € 1.85 € 1.66 +11.4% +7.2%

Average number of shares outstanding (in million) 1,321.2 1,305.2 - -

Business Net Income up 12.5% in Q1 2012

30 CER: Constant Exchange Rates

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Net Debt Mar 31, 2012

Restructuring Costs & Others

+295

Dividend & Share

Repurchase

-104

CapEx

-404

Net Debt Dec 31, 2011

Acquisitions & Licensing

-360

Net Cash from Operating Activities

31

Strong Free Cash Flow Generated in Q1 2012

+ €2,016m

(2) (3)

● Strong Free Cash Flow of €2,467m, up +23.0% in Q1 2012

● €404m of opportunistic share repurchases in Q1 2012(1)

● Net debt reduced by €2,254m in Q1 2012

● Gearing of 14.9% by end of March 2012

In €m

-10,859

-8,605

FCF 2,467

(1) Represents 7,137,719 shares at an average price of €56.67 (2) Excluding Restructuring Costs (3) Including derivatives related to the financial debt: €456m at Dec 31, 2011 and €503m at Mar 31, 2012

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Continued Strong Execution of Strategy in Q1 2012

Good performance from growth platforms

Positive contribution from Genzyme integration

Significant progress on late stage pipeline

Sustained cost control

Guidance for FY 2012 reaffirmed

1

2

3

4

32

5

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APPENDICES R&D Pipeline

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Late Stage Pipeline – Pharma & Vaccines

N New Molecular Entity Central Nervous System

Genetic diseases

Oncology Metabolic Disorders

Vaccines Internal Medicine

Registration Phase III

Biosurgery

* ORIGIN: Evaluation of Lantus® in reducing cardiovascular morbidity & mortality

eliglustat tartrate Glucosylceramide synthetase inhibitor

Gaucher disease

SYNVISC-ONE™

Medical device Pain in hip OA

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

Hexaxim® DTP-HepB-Polio-Hib vaccine

iniparib (BSI-201)

squamous NSCLC (1L)

MACI®

Cell-based treatment Articular cartilage defects

Fluzone® QIV IM Quadrivalent inactivated

influenza vaccines

Plavix® clopidogrel bisulfate PAD, STEMI, Japan

ombrabulin (AVE8062) Vascular disrupting agent

Soft tissue sarcoma (2L/3L)

otamixaban Direct Xa inhibitor

ACS

VaxiGrip® QIV IM Quadrivalent inactivated

influenza vaccines

teriflunomide Relapsing forms of multiple sclerosis

(RMS) – monotherapy, U.S. / EU

Clolar® / Evoltra®

DNA synthesis inhibitor Adult acute myeloid leukemia (AML) (1L)

Lantus® insulin glargine

ORIGIN*

Dengue Mild-to-severe

dengue fever vaccine

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

HoFH in US

SAR302503 (TG101348) JAK-2 inhibitor

Myelofibrosis (1L)

lixisenatide (AVE0010) GLP-1 agonist

Type 2 diabetes, U.S.

DTP-HepB-Polio-Hib Pediatric hexavalent vaccine

lixisenatide (AVE0010) GLP-1 agonist

Type 2 diabetes, EU

Jevtana®

Cabazitaxel Metastatic prostate cancer (1L)

New formulation Insulin glargine

Type 1+2 diabetes

sarilumab (SAR153191) Anti-IL-6R mAb

RA

Lantus® insulin glargine Pediatric, EU

teriflunomide Multiple sclerosis

(adjunct therapy & CIS)

mipomersen Apolipoprotein B-100 antisense

Severe HeFH (U.S.)

Allegra® fexofenadine

Dry syrup, Japan

semuloparin (AVE5026) Indirect Xa/IIa inhibitor

VTE prevention in cancer patients

alemtuzumab Anti-CD52 mAb

Multiple sclerosis

aflibercept VEGF-Trap

2nd line mCRC, U.S. / EU

N

N

N N N

N

N

Thrombosis

N

N

34

N N

Aging

Ophthalmology

N

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Early Stage Pipeline – Pharma & Vaccines

Phase II iniparib (BSI-201)

Ovarian cancer (2L)

FOV1101 FDC prednisolone/cyclosporine

Allergic conjunctivitis

SAR231893 Anti-IL4 mAb

Asthma; Atopic dermatitis

SAR3419 Maytansin-loaded anti-CD19 mAb

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

safotibant (FOV2304) Bradykinin B1 antagonist Diabetic macular edema

ferroquine Antimalarial

Malaria

SAR256212 (MM121) anti-ErbB3 mAb

Breast cancer (2L, 3L)

SAR110894 H3 antagonist

Alzheimer's disease

fresolimumab TGFβ antagonist

Fibrosis

SAR245408 (XL147) Oral PI3K inhibitor

Endometrial cancer (1L)

SAR113945 IKK-β inhibitor Osteoarthritis

SAR97276 Antimalarial

Malaria

SAR245409 (XL765) Oral dual inhibitor of PI3K & mTOR

Breast cancer (1L)

SAR292833 (GRC15300) TRPV3 antagonist

Neuropathic pain, osteoarthritic pain

SAR279356 (F598) Anti-PNAG mAb Serious infections

ombrabulin (AVE8062) Vascular disrupting agent

Ovarian cancer (2L), NSCLC (1L)

ACAM-Cdiff Clostridium difficile

Toxoid vaccine

SAR236553 Anti-PCSK-9 mAb

Hypercholesterolemia

SAR302503 (TG101348) JAK-2 inhibitor

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

Rabies VRVg Purified vero rabies vaccine

Jevtana®

Cabazitaxel, Microtubule inhibitor Small cell lung cancer (2L)

Meninge ACYW conj. 2nd generation meningococcal

Conjugate infant vaccine

N

N

N

N

N

N

N

N

N

N

35

N

N N

N

N New Molecular Entity Central Nervous System

Genetic diseases

Oncology Metabolic Disorders

Vaccines Internal Medicine

Biosurgery

Thrombosis

Aging

N

Ophthalmology

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Early Stage Pipeline – Pharma & Vaccines

Phase I SAR153192

Anti-DLL4 mAb Solid tumors

Jevtana®

Cabazitaxel, Microtubule inhibitor Gastric cancer (2L)

SAR402665 (rhASM)

Niemann-Pick type B

Rotavirus Live Attenuated Tetravalent

Rotavirus oral vaccine

SAR402674 (Genz644282) Non-camptothecin topo1 inhibitor

Solid tumors

SAR127963 P75 receptor antagonist

Trauma brain injury

SAR339658 VLA 2 antagonist

Inflammatory Bowel disease

Streptococcus pneumonia Meningitis & pneumonia vaccine

SAR650984 Anti-CD38 naked mAb

Hematological malignancies

SAR404477 (AAV-hAADC) Gene therapy

Parkinson's disease

SAR100842 LPA-1/LPA-3

Skin manifestation of scleroderma

Pseudomonas aeruginosa Antibody fragment product

Prevention of ventilator-associated pneumonia

SAR566658 Maytansin-loaded anti-DS6 mAb

DS6 positive solid tumors

SAR126119 TAFIa inhibitor

Acute ischemic stroke

SAR156597 IL4/IL13 Bi-specific mAb

Idiopathic Pulmonary Fibrosis

Tuberculosis Recombinant subunit vaccine

SAR307746 Anti-Ang2 mAb

Solid tumors

SAR391786 Rehabilitation post orthopedic surgery

SAR407899 Rho kinase inhibitor

Diabetic nephropathy

RetinoStat® Gene therapy

Wet age-related macular degeneration (AMD)

SAR125844 C-Met kinase inhibitor

Solid tumors

SAR228810 Anti-protofibrillar AB mAb

Alzheimer’s disease

lixisenatide + Lantus® GLP-1 agonist + insulin glargine

Single pen device / Type 2 diabetes

StarGen® Gene therapy

Stargardt disease

Combinations SAR245409 / MSC1936369B

SAR245408/SAR256212 (MM121) SAR245408/MSC1936369B

Solid tumors

SAR399063 DHA-GLP + vit D Pre-sarcopenia

SAR164653 Cathepsin A inhibitor

CV-related complications & deaths in diabetic patients

SAR402663 (sFLT-01) Gene therapy

Age related Macular Degeneration (AMD)

SAR393590 (Oral clofaribine) DNA synthesis inhibitor

Hematological malignancies

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

36

N

N

N New Molecular Entity Central Nervous System

Genetic diseases

Oncology Metabolic Disorders

Vaccines Internal Medicine

Biosurgery

Thrombosis

Aging

N

N

N

N

Ophthalmology

Page 37: Q1 2012 Results

37

Phase I Phase II Phase III Registration TOTAL

Oncology 6 4 3 2 15

Metabolic Disorders 2 1 0 2 5

Thrombosis 1 0 1 0 2

Central Nervous System 2 0 1 1 4

Internal Medicine 3 5 1 0 9

Ophthalmology 3 2 0 0 5

Genetic Diseases 1 0 1 0 2

Aging 3 3 0 0 6

Vaccines 4 3 5 1 13

TOTAL 25 18 12 6

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

43 18 NMEs & Vaccines

61

37

48

Page 38: Q1 2012 Results

38

Expected R&D Milestones – Pharmaceuticals

38

Product Event Timing

LemtradaTM Regulatory submission in RMS in EU and U.S. Q2 2012

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

Lantus® ORIGIN Phase III results Q2 2012

AubagioTM TOWER headline Phase III results in RMS Mid year 2012

AubagioTM Expected approval in RMS in U.S. Q3 2012

Zaltrap® Expected approval in 2nd line mCRC in U.S. Q3 2012

KynamroTM Expected approval in hoFH and severe heFH in EU Q3 2012

Visamerin®/Mulsevo® Expected approval in VTE prevention in cancer patients in U.S. and EU Q3 2012

ombrabulin Phase III results in sarcoma Q3 2012

MACI® Regulatory submission in articular cartilage defects in EU Q3 2012

Page 39: Q1 2012 Results

39

Expected R&D Milestones – Pharmaceuticals

39

Product Event Timing

Lyxumia® Expected approval in type 2 diabetes in EU Q4 2012

Zaltrap® Expected approval in 2nd line mCRC in EU Q4 2012

Lyxumia® Regulatory submission in type 2 diabetes in U.S. Q4 2012

sarilumab Additional Phase III in rheumatoid arthritis Q4 2012

iniparib Phase II results in 2nd line ovarian platinum resistant cancer Q1 2013

SAR110894 Phase II results in Alzheimer’s disease Q1 2013

Page 40: Q1 2012 Results

40

Expected R&D Milestones – Vaccines

40

Product Event Timing

HexaximTM Scientific opinion issued by EMA Q2 2012

Shan5® Start Phase III clinical study Q2 2012

Fluzone® QIV IM File submission in U.S. Q3 2012

Rotavirus Start Phase I clinical study Q3 2012

HexaximTM File submission in EU Q3 2012

Dengue vaccine First efficacy results from Phase IIb Q3 2012

Fluzone® QIV ID Start of Phase III Q4 2012

Vaxigrip® QIV IM File submission Q1 2013

HPV Start Phase I clinical study Q1 2013

Page 41: Q1 2012 Results

APPENDICES FINANCE

41

Page 42: Q1 2012 Results

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 1,321.2 million in the first quarter of 2012 and 1,305.2 million in the first quarter of 2011

First quarter 2012

Net sales 7,316 6,583 11.1% 617 602 2.5% 578 594 (2.7%) 8,511 7,779 9.4%Other revenues 412 404 2.0% 5 5 9 4 125.0% 426 413 3.1%Cost of sales (2,182) (1,927) 13.2% (263) (268) (1.9%) (168) (167) 0.6% (2,613) (2,362) 10.6%As % of net sales (29.8%) (29.3%) (42.6%) (44.5%) (29.1%) (28.1%) (30.7%) (30.4%)Gross profit 5,546 5,060 9.6% 359 339 5.9% 419 431 (2.8%) 6,324 5,830 8.5%As % of net sales 75.8% 76.9% 58.2% 56.3% 72.5% 72.6% 74.3% 74.9%Research and development expenses (994) (940) 5.7% (141) (125) 12.8% (41) (35) 17.1% (1,176) (1,100) 6.9%As % of net sales (13.6%) (14.3%) (22.9%) (20.8%) (7.1%) (5.9%) (13.8%) (14.1%)Selling and general expenses (1,824) (1,645) 10.9% (130) (127) 2.4% (167) (161) 3.7% (2,121) (1,933) 9.7%As % of net sales (24.9%) (25.0%) (21.1%) (21.1%) (28.9%) (27.1%) (24.9%) (24.8%)Other current operating income/expenses 144 62 (1) 1 1 (17) 3 (30) 147 16Share of profit/loss of associates* 302 283 (5) (4) 13 297 292Net income attributable to non-controlling interests (55) (78) 1 (54) (78)Business operating income 3,119 2,742 13.7% 82 84 (2.4%) 213 218 (2.3%) 3 (17) 3,417 3,027 12.9%

As % of net sales 42.6% 41.7% 13.3% 14.0% 36.9% 36.7% 40.1% 38.9%Financial income and expenses (119) (78)

Income tax expense (856) (779)

Tax rate** 28.0% 28.5%Business net income 2,442 2,170 12.5%As % of net sales 28.7% 27.9%Business earnings per share*** (in euros) 1.85 1.66 11.4%

Group Total

Millions of euros Q1 2012 Q1 2011 Q1 2011 Q1 2012 Q1 2011 % changeQ1 2012 Q1 2012 Q1 2011Q1 2011

Pharmaceuticals

% change

Vaccines Animal health Other

% change Q1 2012% change

Page 43: Q1 2012 Results

43 43

Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of sanofi

Millions of euros Q1 2012 Q1 2011 % changeBusiness net income 2,442 2,170 12.5%Amortization of intangible assets (1) (833) (736)

Impairment of intangible assets (1) (32)

Fair value remeasurement of contingent consideration liabilities (33) (46)

Expenses arising from the impact of acquisitions on inventories (14) (2)

Restructuring costs (87) (122)

Other gains and losses, and litigation (517)

Tax effect of: 360 510

amortization of intangible assets 332 263 impairment of intangible assets 10 fair value remeasurement of contingent consideration liabilities 2 expenses arising on the workdown of acquired inventories 4 restructuring costs 22 42 other gains and losses, and litigation 195

Other (7) (7)

Net income attributable to equity holders of sanofi 1,827 1,218 50.0%Consolidated earnings per share(2) (in euros) 1.38 0.93 48.4%

Page 44: Q1 2012 Results

Consolidated Income Statements

€ million

Net sales 8,511 7,779

Other revenues 426 413

Cost of sales (2,627) (2,364)

Gross profit 6,310 5,828

Research and development expenses (1,176) (1,100)

Selling and general expenses (2,121) (1,933)

Other operating income 206 118

Other operating expenses (59) (102)

Amortization of intangible assets (833) (736)

Impairment of intangible assets (1) (32)

Fair value remeasurement of contingent consideration liabilities (33) (46)

Restructuring costs (87) (122)

Other gains and losses, and litigation (517)

Operating income 2,206 1,358

Q1 2011Q1 2012

Page 45: Q1 2012 Results

Consolidated Income Statements

€ million

Operating income 2,206 1,358

Financial expenses (139) (101)

Financial income 20 23Income before tax and associates and joint ventures 2,087 1,280

Income tax expense (496) (269)Share of profit / loss of associates and joint ventures 289 285

Net income 1,880 1,296

Net income attributable to non-controlling interests 53 78

Net income attributable to equity holders of sanofi 1,827 1,218

Average number of shares outstanding (million) 1 321.2 1 305.2

Consolidated earnings per share (in euros) 1.38 0.93

Q1 2011Q1 2012