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Q2 2014 RESULTS July 31, 2014

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Q2 2014 Results by Sanofi

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Page 1: Q2 2014 Results by Sanofi

Q2 2014 RESULTS July 31, 2014

Page 2: Q2 2014 Results by Sanofi

2

Forward Looking Statements

This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of

1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include

projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and

expectations with respect to future financial results, events, operations, services, product development and potential,

and statements regarding future performance. Forward-looking statements are generally identified by the words

"expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's

management believes that the expectations reflected in such forward-looking statements are reasonable, investors are

cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which

are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to

differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.

These risks and uncertainties include among other things, the uncertainties inherent in research and development,

future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the

EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such

product candidates as well as their decisions regarding labeling and other matters that could affect the availability or

commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will

be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability

to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost

containment policies and subsequent changes thereto, the average number of shares outstanding as well as those

discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under

"Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form

20-F for the year ended December 31, 2013. Other than as required by applicable law, Sanofi does not undertake any

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

Page 3: Q2 2014 Results by Sanofi

3 3

Agenda

Key Highlights

● Christopher A. Viehbacher, Chief Executive Officer

Financial Performance

● Jérôme Contamine, Executive Vice President, Chief Financial Officer

Conclusion

● Christopher A. Viehbacher, Chief Executive Officer

Q&A

Page 4: Q2 2014 Results by Sanofi

KEY HIGHLIGHTS

4

Christopher A. Viehbacher

Chief Executive Officer

Page 5: Q2 2014 Results by Sanofi

● Net sales up +6.4% at CER and Business EPS up +13.4% at CER

● Free Cash Flow up +33% in H1 2014

● €3.7bn dividend payment and €1.1bn share buyback

● 76.3% of Group sales

● Solid execution in Emerging Markets

● Merial back to growth

● 3 significant regulatory reviews ongoing

● 4 major projects with Phase IIb/III readouts

● 2 new important collaborations

Sanofi Delivered Solid Results in Q2 2014

5

3

2

1 Solid financial performance

Strong performance

of Growth Platforms

Significant progress

in late stage pipeline

FCF: Free Cash Flow

(1) Excluding Generics in Brazil, Q2 2014 sales were up +3.9% at CER

(2) Dividend payment of €3,676m on full-year 2013 results made in Q2 2014

(3) As of July 15th 2014, Sanofi bought back shares for €1,100m in YTD 2014

(1)

(3) (2)

Page 6: Q2 2014 Results by Sanofi

Q2 2014

-€0.10

FX Impact Incremental

EPS at CER Q2 2013

+€0.15

Net Sales(1) Business EPS(1)

Solid Q2 2014 Financial Performance Reflects

Consistent Execution of our Growth Strategy

6

(1) On a reported basis, Q2 2014 sales were up +0.9% and Business EPS was up +4.5%

(2) With retroactive application of IFRIC21

+13.4% at CER(1)

Incremental

Sales at CER Q2 2014 Q2 2013 FX Impact

+€515m -€443m

+6.4% at CER(1)

€8,003m €8,075m

€1.12

€1.17

(2)

1

(2)

Page 7: Q2 2014 Results by Sanofi

2014 Business EPS Guidance Adjusted Slightly Upwards

7 (1) FY 2013 Business EPS of €5.05 with retroactive application of IFRIC21

7

Given our financial performance in H1 2014 and

despite increasing U.S. competitive pressure at the payor level,

2014 business EPS is expected to be

between 6% to 8% higher than 2013 at CER(1),

barring major unforeseen adverse events

1

FY 2014 Guidance

Page 8: Q2 2014 Results by Sanofi

Evolution of Share Buyback(1,2)

8

SBB: Share Buyback

(1) As of July 15th 2014, YTD 2014 share buyback of €1,100m and YTD 2014 proceeds from share issuance of €252m

(2) Number of shares outstanding in million on Dec 31st 2012, Dec 31st 2013 and June 30th 2014

€646m

€1,100m

€252m

€823m

€1,641m

€1,004m

2012

Sanofi Increased Buyback Activity in H1 2014

2013 YTD 2014

€177m Net SBB

€637m Net SBB

€848m Net SBB

Share count (m) 1,323.2 1,320.7 1,312.1

1

Issuance Issuance Issuance Buyback Buyback Buyback

Page 9: Q2 2014 Results by Sanofi

Quarterly Sales Growth from Growth Platforms(1)

+6.2%

Q1 2013

+8.6%

Q4 2012

+11.5%

Q3 2012

+6.4%

Q2 2012

+7.6%

Q1 2012

+5.7%

Q4 2013

+10.0%

Q3 2013 Q2 2013

+5.5%

+7.9%

Q1 2014 Q2 2014

+10.7%

(1) Growth at CER. Q1 2012 growth restated for Genzyme Q1 2011 (€396m)

(2) Growth at CER including Generics in Brazil was +2.5% in Q2 2013 and +14.5% in Q2 2014 9

Growth Platforms Show Consistent Strong Performance

Demonstrating the Value of our Business Model

(2)

(2)

+5% at CER

+10% at CER

2

% of Group sales 63.2% 76.3%

Page 10: Q2 2014 Results by Sanofi

+9.2% Consumer Healthcare(3)

€816m

Vaccines -4.2% €718m

Genzyme(4)

Growth Platforms Grew +14.5%(1) in Q2 2014

Reaching 76.3% of Sales

10

(1) Excluding Generics in Brazil, Growth Platforms grew +10.7% in Q2 2014 and +9.0% in H1 2014 at CER

(2) Excluding Generics in Brazil, Emerging Markets grew +8.6% in Q2 2014 and +6.5% in H1 2014 at CER

(3) Some products recorded in prescription pharmaceuticals in 2013 were transferred as Consumer Healthcare products and totaled €73m in Q2 2013

Including this category change, sales of Consumer Healthcare grew +20.2% in Q2 2014 and +19.4% in H1 2014 at CER

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

(5) Includes products launched since 2009 which do not belong to the Growth Platforms listed above: Multaq®, Jevtana®, Auvi-Q™, Mozobil® and Zaltrap®

+16.2%

-0.4%

+29.1%

+6.2%

Other Innovative Products(5) €189m +13.3%

+16.5%

Diabetes Solutions €1,788m

Animal Health

€643m

Emerging Markets(2) €2,855m

€537m

Q2 2014 Growth at CER

2

-4.2%

H1 2014 Growth at CER

+9.3%

+14.7%

-2.2%

+25.4%

+2.2%

+17.8%

+11.0%

Page 11: Q2 2014 Results by Sanofi

H1 2014 Geographic Sales Mix

(1) World excluding U.S., 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) Pharmaceuticals sales growth at CER was +2.2% in Africa & Middle East, +4.3% in Eastern Europe, Russia & Turkey, +10.6% in Asia and

+18.2% in Latin America excluding Generics in Brazil in H1 2014

Solid Sales Performance in Emerging Markets in H1 2014

as Operational Issues from 2013 Have Been Addressed

Emerging Markets €5,445m

U.S. €4,984m

Western EU €3,906m

RoW €1,582m

34.2%

31.3%

24.5%

10.0%

11

(1)

€1,006m

€1,239m

€1,519m €1,618m

Africa & MiddleEast

Eastern Europe,Russia & Turkey

Asia Latin America

+8.5%

+4.7% +5.4% +14.6% Growth at CER

-1.5%

-7.4%

-0.7%

+11.0%

2

Emerging Markets Total Sales by Region

excluding Brazil Generics

(2)

Page 12: Q2 2014 Results by Sanofi

Merial Returned to Growth in Q2 2014

12

● Successful launch of NexGard®

● First soft, beef-flavored chew treating

fleas and ticks for dogs in the U.S.

● €58m sales in H1 2014

● Frontline® family sales stabilized

in Q2 2014

● Start of flea and tick season not

disrupted by weather conditions

except in Northern U.S.

● Effective investment in ad campaign

reinforcing strong Frontline® brand

2

Q2 Q1 Q4 Q3

-3.1%

-5.7% -6.3%

2013

Merial Sales Growth at CER

-6.4%

-1.6%

+6.2%

Q2 Q1

2014

Page 13: Q2 2014 Results by Sanofi

● Filed in the U.S. and EU

in Q2 2014 and recently

in Japan

● Regulatory decisions for

marketing authorization

in the U.S. and EU

anticipated in H1 2015

Three New Medicines Under Regulatory Review

with the Potential to Meaningfully Improve Patient Lives

13

● U.S. and EU regulatory

reviews ongoing

● Regulatory decisions

expected in Q3 and Q4

2014, respectively

● NDA submitted in Japan

in June, 2014

● sBLA resubmission

accepted for review

by FDA in May 2014

● FDA action expected

in Q4 2014

● New dedicated salesforce

being recruited

3

Three major new drug approvals expected over the next 12 months

Page 14: Q2 2014 Results by Sanofi

14

● Primary efficacy endpoint met in all 9 trials(1)

● LDL reduction consistent with previous trials

● Generally well tolerated in the 9 ODYSSEY trials(2)

● Lower rate of adjudicated major CV events(3, 4)

observed in a post-hoc analysis of ODYSSEY

LONG TERM (p-value <0.05)

● Potential to demonstrate CV benefit being

prospectively assessed in an 18,000-patient

ODYSSEY OUTCOMES trial

● U.S. and EU regulatory submissions expected

by end of 2014

Alirocumab is developed in collaboration with Regeneron

(1) The nine trials included ODYSSEY LONG TERM, FH I, FH II, HIGH FH, COMBO I, COMBO II, OPTIONS I, OPTIONS II and ALTERNATIVE

(2) The most common adverse events were nasopharyngitis and upper respiratory tract infections, which were generally balanced between treatment

groups. Injection site reactions occurred more often in the alirocumab group compared to placebo. Serious adverse events and deaths were generally

balanced between treatment groups as were other key adverse events including musculoskeletal, neurocognitive and liver-related events.

(3) Major CV events included cardiac death, myocardial infarction, stroke, and unstable angina requiring hospitalization

(4) Based on a pre-specified interim safety analysis performed when all patients reached one year and approximately 25% of patients reached 18 months

of treatment in the ongoing ODYSSEY LONG TERM trial with 2,341 patients at high or very high cardiovascular (CV) risk

Positive Top-Line Results across 9 Phase III Trials

of Alirocumab in People with Hypercholesterolemia 3

Page 15: Q2 2014 Results by Sanofi

15

Sarilumab and dupilumab are developed in collaboration with Regeneron

NEJM: New England Journal of Medicine

(1) The measured efficacy of the vaccine is consistent across countries and appears to vary by dengue serotype (between 34.7% and 72.4%) and by age

(2) Mean % change in EASI score from baseline to Week 16 / Clearing or near-clearing of skin lesions, measured by an investigator's global assessment

(IGA) score of 0 or 1 / Mean reduction in itching measured by the pruritus numerical-rating scale (NRS) score

(3) Improvement in signs and symptoms of RA / Improvement in physical function / Inhibition of progression of structural damage

Strong Late Stage Pipeline of Biologics Demonstrates

the Shift of our Portfolio towards Innovative Products 3

● First Phase III published in

The Lancet

● 56.5% reduction in

symptomatic dengue(1)

● 88.5% reduction of

haemorrhagic fever

● 67.2% reduction in

hospitalization

Dengue Vaccine

● Detailed data from positive

Phase III MOBILITY trial

presented at EULAR

● Statistically significant

improvements

in all three co-primary

endpoints(3)

Sarilumab Rheumatoid Arthritis

● Strong Phase IIa data

published in the NEJM

● Positive Phase IIb top-line

results

● Statistically significant and

dose-dependent

improvements in all key

efficacy measures(2)

Atopic Dermatitis

Page 16: Q2 2014 Results by Sanofi

Two New Collaborations Signed in Q2 2014

Strengthening our CHC and Diabetes Growth Platforms

16

● Licensing agreement with Lilly

● Opportunity to switch Cialis® from Rx to OTC in the U.S., Europe,

Canada and Australia(1)

● Ambition to transform how this important medicine for erectile

dysfunction (ED) is offered to millions of men in the world

● Global strategic alliance(2) in diabetes structured as open-innovation model

● Initial focus on novel drug-device combinations and care management

● Objective to improve adherence, simplify insulin treatment and help patients

better manage their condition

3

(1) Subject to Sanofi's receipt of all necessary regulatory approvals

(2) Implementation of the alliance is subject to the negotiation and execution of a definitive agreement between the companies

Page 17: Q2 2014 Results by Sanofi

Strong Innovation Momentum Expected to Be Maintained

in H2 2014

17

2014

Expected Regulatory Decisions Q3 Q4

● Cerdelga™ (eliglustat) in Gaucher disease (U.S.)

● Lemtrada™ (alemtuzumab) in Multiple Sclerosis (U.S.)

● Cerdelga™ (eliglustat) in Gaucher disease (EU)

● Fluzone® QIV Intradermal (U.S.)

Expected Regulatory Submissions Q3 Q4

● PR5i 6-in-1 pediatric vaccine (U.S.)

● Alirocumab in Hypercholesterolemia (U.S. & EU)

Expected Headline Phase III Data Releases Q3 Q4

● Alirocumab in Hypercholesterolemia (9 ODYSSEY trials)

● Dengue vaccine 2nd Phase III trial in Latin America

Expected Phase III Starts Q3 Q4

● Dupilumab in Atopic Dermatitis

● Rotavirus vaccine

● Insulin lispro in Diabetes

3

Page 18: Q2 2014 Results by Sanofi

Sanofi to Organize an IR Thematic Seminar

on New Medicines and Vaccines

18

3

● Discussing the market opportunity for key pipeline projects

● Emphasizing the shift of our portfolio to biologics

● Presenting further progress of our innovative R&D assets

IR Thematic

Seminar

on New

Medicines

Thursday November 20th, 2014 in Genzyme HQ - Cambridge, MA

Page 19: Q2 2014 Results by Sanofi

FINANCIAL PERFORMANCE

Jérôme Contamine

Executive Vice President, Chief Financial Officer

19

Page 20: Q2 2014 Results by Sanofi

Net Sales(1) Business EPS

20

FX Impact in Q2 2014 Was Comparable to Q1 2014

and In Line with our Expectations

(1) Main currency impact on sales in Q2 2014: U.S. Dollar (-€129m); Brazilian Real (-€48m); Japanese Yen (-€39m); Russian Ruble (-€33m);

Argentine Peso (-€32m); Turkish Lira (-€23m), Canadian Dollar (-€15m) and Australian Dollar (-€14m)

(2) Difference between variation on reported basis and variation at constant exchange rates

Quarterly Currency Impact

-2.5%

-€212m

-4.4%

-€0.08

-3.5%

-€305m

2013

-€0.08

-5.5%

-7.3%

-€662m -€0.17

-10.2%

Q4 Q3 Q2 Q1

-7.3%

-€627m

2014

Q1

-€0.16

-13.7%

-6.2%

-€497m -9.1%

-€0.11

Assuming June exchange rates remain stable in H2 2014,

negative FX impact on full-year Business EPS would be ~5%(2)

Q2

-5.5%

-€443m

2013

Q4 Q3 Q2 Q1

2014

Q1 Q2

-8.9%

-€0.10

Page 21: Q2 2014 Results by Sanofi

(1) With the retroactive application of IAS19R

(2) Includes a payment of €62m before tax resulting from the return of U.S. rights for Eligard® to TOLMAR Pharmaceuticals

(3) Includes a payment of €165m before tax associated to the sale of U.S. tail products to Covis Pharmaceuticals 21

BOI Increased Faster than Sales in Q2 2014

€m Q2 2014 Q2 2013 % Change (reported €)

% Change (CER)

Net sales 8,075 8,003 +0.9% +6.4%

Other revenues 71 83 -14.5% -12.0%

Cost of sales (2,608) (2,670) -2.3% +2.2%

Gross profit 5,538 5,416 +2.3% +8.2%

R&D (1,188) (1,185) +0.3% +3.2%

SG&A (2,255) (2,306) -2.2% +2.6%

Other current operating income & expenses 54 141 - -

Share of Profit/Loss of associates 26 3 - -

Minority interests (30) (45) - -

Business operating income 2,145 2,024 +6.0% +15.0%

Business operating margin 26.6% 25.3% - -

CER: Constant Exchange Rates

(1)

(2) (3)

Page 22: Q2 2014 Results by Sanofi

Improvement in Gross Margin in Q2 2014 vs. Q2 2013

● Cost of Sales (CoS) in Q2 2014:

€2,608m, up +2.2% at CER

● CoS ratio down 1 percentage point

in Q2 2014 vs. Q2 2013

● Reflecting recovery of Generics

in Brazil and higher margin from

Genzyme

● Slight negative mix impact from

Vaccines and Animal Health

● Unfavorable currency variations

22

Gross Margin (%)

Q1 Q2 Q3 Q4 Q1 Q2

2013 2014

69.0% 69.6% 67.7% 67.0% 66.8% 68.6%

Page 23: Q2 2014 Results by Sanofi

Q1 Q2 Q3 Q4 Q1 Q2

R&D Expenses Slightly Increased in Q2 2014

Despite Significant Investment in Phase III Trials

23

● Q2 2014 R&D expenses of

€1,188m, up +3.2% at CER

● Slight increase in R&D spend in line

with guidance

● Higher spend in three large

development programs for mAbs

(alirocumab, sarilumab, dupilumab)

● More than offsetting internal costs

savings

23

R&D Expenses (€m)

€1,188m €1,185m

(1) With retroactive application of IFRIC21

(1)

2013 2014

Page 24: Q2 2014 Results by Sanofi

Lower SG&A to Sales Ratio in Q2 2014 vs. Q2 2013

24

● Q2 2014 SG&A expenses of

€2,255m, up +2.6% at CER

● Lower increase in SG&A than Sales

● Modest SG&A increase driven

by investment in product launches

● NexGard™, Nasacort® OTC and

Genzyme MS franchise

24

SG&A Expenses (€m)

Q1 Q2 Q3 Q4 Q1 Q2

€2,255m €2,306m (1)

(1) With retroactive application of IFRIC21

2013 2014

Page 25: Q2 2014 Results by Sanofi

CER: Constant Exchange Rates

25

€m Q2 2014 Q2 2013 % Change (reported €)

% Change (CER)

Business operating income 2,145 2,024 +6.0% +15.0%

Net financial expenses (94) (137) - -

Income tax expense (514) (408) - -

Effective tax rate -25.0% -21.2% - -

Business net income 1,537 1,479 +3.9% +13.0%

Net margin 19.0% 18.5% - -

Business EPS €1.17 €1.12 +4.5% +13.4%

Average number of shares outstanding (m) 1,314.5 1,325.7 - -

Strong Business EPS Growth of +10% in H1 2014

25 (1) With the retroactive application of IFRIC21

(2) Included a capital gain of €31m before tax resulting from the sale of several financial investments

(1)

(2)

Page 26: Q2 2014 Results by Sanofi

-€0.06

-5.4%

Disposals &

Capital Gains

-€0.05

-4.5%

Brazil

Generics

€0.16

+14.3%

Business

EPS Q2 2013

Reported

€1.12

€1.27

Business

EPS Q2 2014

Reported

Fx

€1.17

Organic

Growth

-€0.10

-8.9%

€0.10

+8.9%

Tax Rate Business

EPS Q2 2014

@ CER

26

Business EPS (in €)

Business EPS Organic Growth Larger than Sales Growth

in Q2 2014

Page 27: Q2 2014 Results by Sanofi

Net Debt (in €m)

Dividend

€487m

Other Net Debt

Jun 30, 2014

€3,676m

Acquisitions,

Licensing, Net

of Disposals

€1,608m

Share

Repurchase

€1,010m

Proceeds

from Issuance

of Shares

€240m

CapEx

€529m

Net Cash from

Operating

Activities

Net Debt

Dec 31, 2013

Free Cash Flow (FCF) Increased by 33% in H1 2014

27

(1)

(2)

€6,043m

€10,194m

€2,919m

(4) (1)

FCF

€2,390m

FCF: Free Cash Flow

(1) Including derivatives related to the financial debt +€290m at December 31st 2013 and +€296m at June 30th 2014

(2) Excluding Restructuring costs

(3) Including €1,050m in Regeneron and €530m in Alnylam

(4) Other including Restructuring costs

(3)

Page 28: Q2 2014 Results by Sanofi

CONCLUSION

28

Christopher A. Viehbacher

Chief Executive Officer

Page 29: Q2 2014 Results by Sanofi

Solid H1 Performance Reflects Consistent Execution

of our Growth Strategy

Over 75% of sales now being generated by Growth Platforms

Business EPS guidance for 2014 adjusted slightly upwards

Late stage pipeline moving to launch execution

Expected new medicine launches to further redefine Sanofi

as a biopharmaceutical leader

29

Page 30: Q2 2014 Results by Sanofi

APPENDICES

R&D Pipeline

30

Page 31: Q2 2014 Results by Sanofi

31

Late Stage Pipeline – Pharma & Vaccines

LixiLan lixisenatide + insulin glargine

Fixed-Ratio / Type 2 diabetes

alirocumab Anti-PCSK-9 mAb

Hypercholesterolemia

Toujeo® (U300)

Insulin glargine

Type 1+2 diabetes, U.S., EU

Lyxumia® (lixisenatide)

GLP-1 agonist

Type 2 diabetes, U.S.

Kynamro® (mipomersen)

Apolipoprotein B-100 antisense

Severe HeFH, U.S.

Lemtrada™ (alemtuzumab)

Anti-CD52 mAb

Multiple sclerosis, U.S.

sarilumab Anti-IL-6R mAb

Rheumatoid arthritis

Dengue Mild-to-severe

dengue fever vaccine

Cerdelga™ (eliglustat tartrate)

Glucosylceramide synthetase inhibitor

Gaucher disease, U.S., EU

patisiran SAR438037 mRNA inhibitor

Familial amyloid polyneuropathy

Clostridium difficile Toxoid vaccine

Quadracel® Diphtheria, tetanus, pertussis

& polio vaccine; 4-6 y of age

Jevtana® (cabazitaxel)

Metastatic prostate cancer (1L)

PR5i DTP-HepB-Polio-Hib

Pediatric hexavalent vaccine

Fluzone® QIV ID Quadrivalent inactivated

influenza vaccine intradermal

SYNVISC-ONE®

Medical device

Pain in hip OA

VaxiGrip® QIV IM Quadrivalent inactivated

influenza vaccine

N

31

N

N

N

N New Molecular Entity Immune Mediated Diseases

Rare Diseases

Oncology

Diabetes Solutions

Vaccines

Infectious Diseases

Cardiovascular / Renal

Diseases

Age Related Degenerative

Diseases

Ophthalmology

Biosurgery

N

Phase III Registration

N

Page 32: Q2 2014 Results by Sanofi

Early Stage Pipeline – Pharma & Vaccines

dupilumab Anti-IL4Rα mAb

Atopic dermatitis; Asthma; Nasal polyposis

SAR391786 GDF8 mAb

Sarcopenia

Rotavirus Live attenuated tetravalent

Rotavirus oral vaccine

SAR339658 Anti-VLA 2 mAb

Multiple sclerosis

SAR650984 Anti-CD38 naked mAb

Multiple myeloma

Rabies VRVg Purified vero rabies vaccine

SAR156597 IL4/IL13 Bi-specific mAb

Idiopathic pulmonary fibrosis

SAR3419 Maytansin-loaded anti-CD19 mAb

B-cell refractory/relapsed malignancies

Meningitis ACYW conj. 2nd generation meningococcal

conjugate infant vaccine

SAR438714 (ALN-TTRsc)

RNAi

Familial amyloid cardiomyopathy

Combination

SAR245409 (XL765) / MSC1936369B Oral dual inhibitor of PI3K & mTOR / pimasertib

Ovarian cancer

Tuberculosis Recombinant subunit vaccine

sarilumab Anti-IL-6R mAb

Uveitis

Combination

ferroquine / OZ439 Antimalarial

Malaria

fresolimumab TGFβ antagonist

Focal segmental glomerulosclerosis

SAR279356 (F598)

Anti-PNAG mAb

Serious infections

Phase II

N

N

N

N

N N

32

N

32

N

N New Molecular Entity Immune Mediated Diseases

Rare Diseases

Oncology

Diabetes Solutions

Vaccines

Infectious Diseases

Cardiovascular / Renal

Diseases

Age Related Degenerative

Diseases

Ophthalmology

Biosurgery

N

N

N

Page 33: Q2 2014 Results by Sanofi

Early Stage Pipeline – Pharma & Vaccines

SAR405838 (MI-773)

HDM2 / p53 antagonist

Solid tumors

SAR113244 Anti-CXCR5 mAb

Systemic lupus erythematosus

GZ402663 (sFLT-01)

Gene therapy Age-related macular degeneration (AMD)

Streptococcus pneumonia Meningitis & pneumonia vaccine

SAR566658

Maytansin-loaded anti-CA6 mAb

Solid tumors

SAR252067 Anti-LIGHT mAb

Crohn’s disease

StarGen® Gene therapy

Stargardt disease

Herpes Simplex Virus Type 2 HSV-2 vaccine

SAR125844

C-MET kinase inhibitor

Solid tumors

SAR228810 Anti-protofibrillar AB mAb

Alzheimer’s disease

UshStat® Gene therapy

Usher syndrome 1B

SAR260301 PI3K β selective inhibitor

PTEN – Deficient tumors

SAR425899 GLP-1 / GCGR agonist

Diabetes

GZ402665 (rhASM)

Niemann-Pick type B

SAR307746 Anti-ANG2 mAb

Solid tumors

SAR342434 Insulin Lispro

Diabetes

GZ402671 Oral GCS Inhibitor

Fabry Disease

SAR245408 (XL147)

Oral PI3K inhibitor

Solid tumors

SAR438584 Undisclosed target

GZ402666 neo GAA

Pompe Disease

Combination

SAR405838 / MSC1936369B Solid tumors

Phase I

N

N

N

N

N

N

N

N

N N

N N

33 33

N

N

N New Molecular Entity Immune Mediated Diseases

Rare Diseases

Oncology

Diabetes Solutions

Vaccines

Infectious Diseases

Cardiovascular / Renal

Diseases

Age Related Degenerative

Diseases

Ophthalmology

Biosurgery

N

N

N

Page 34: Q2 2014 Results by Sanofi

34

Phase I Phase II Phase III Registration TOTAL

Oncology 6 3 0 0 9

Diabetes Solutions 1 0 1 1 3

Cardiovascular / Renal

Diseases 0 1 1 0 2

Immune Mediated

Diseases 2 3 1 0 6

Infectious Diseases 0 2 0 0 2

Ophthalmology 3 0 0 0 3

Rare Diseases 3 1 1 1 6

Age Related

Degenerative Diseases 1 1 0 0 2

Vaccines 2 4 4 2 12

TOTAL 19(2) 15 8 4

R&D Pipeline Summary Table(1)

34 12 NMEs & Vaccines

46

34

34(2)

(1) Excluding life cycle management programs

(2) Includes 1 Phase I project addressing an undisclosed target

Page 35: Q2 2014 Results by Sanofi

35

Expected R&D Milestones in H2 2014 / H1 2015

35

Product Event Timing

Cerdelga™ (eliglustat tartrate) Expected U.S. regulatory decision in Gaucher disease Q3 2014

Dengue vaccine Expected 2nd Phase III results (Latin America) Q3 2014

PR5i (DTP-HepB-Polio-Hib) Expected U.S. regulatory submission Q3 2014

Dupilumab (anti-IL4Rα mAb) Expected start of Phase III trial in Atopic Dermatitis H2 2014

New Insulin Lispro (SAR342434) Expected start of Phase III trial in Diabetes H2 2014

Lemtrada™ (alemtuzumab) Expected U.S. regulatory decision in Multiple Sclerosis Q4 2014

Cerdelga™ (eliglustat tartrate) Expected EU regulatory decision in Gaucher disease Q4 2014

Alirocumab (anti-PCSK9 mAb) Expected U.S. and EU regulatory submissions in Hypercholesterolemia Q4 2014

Fluzone® QIV ID Expected U.S. regulatory decision Q4 2014

Rotavirus vaccine Expected start of Phase III trial Q4 2014

Fluzone® High Dose Expected U.S. label upgrade Q4 2014

Dengue vaccine Expected regulatory submission in priority countries Q1 2015

Dupilumab (anti-IL4Rα mAb) Expected Phase IIb top-line results in Asthma Q1 2015

Lyxumia® (lixisenatide) Expected ELIXA CV outcome trial top-line results H1 2015

Toujeo® (U300) Expected U.S. and EU regulatory decisions in Diabetes H1 2015

Page 36: Q2 2014 Results by Sanofi

APPENDICES

FINANCE

36

Page 37: Q2 2014 Results by Sanofi

37

Business Net Income Statement

Second quarter 2014

Net sales 8,075 8,003 0.9% 6,820 6,714 1.6% 718 760 (5.5%) 537 529 1.5%

Other revenues 71 83 (14.5%) 58 72 (19.4%) 7 5 40.0% 6 6 - - -

Cost of sales (2,608) (2,670) (2.3%) (2,058) (2,140) (3.8%) (350) (350) - (200) (180) 11.1% - -

As % of net sales (32.3%) (33.4%) (30.2%) (31.9%) (48.8%) (46.1%) (37,2%) (34.0%)

Gross profit 5,538 5,416 2.3% 4,820 4,646 3.7% 375 415 (9.6%) 343 355 (3.4%)

As % of net sales 68.6% 67.7% 70.7% 69.2% 52.2% 54.6% 63.9% 67.1%

Research and development

expenses (1,188) (1,185) 0.3% (1,030) (1,018) 1.2% (123) (121) 1.7% (35) (46) (23.9%) - -

As % of net sales (14.7%) (14.8%) (15.1%) (15.2%) (17.1%) (15.9%) (6.5%) (8.7%)

Selling and general

expenses (2,255) (2,306) (2.2%) (1,930) (1,965) (1.8%) (142) (160) (11.3%) (183) (181) 1.1% - -

As % of net sales (27.9%) (28.8%) (28.3%) (29.3%) (19.8%) (21.1%) (34.1%) (34.2%)

Other current operating

income/expenses 54 141 42 100 3 5 11 - (2) 36

Share of profit/loss of

associates* 26 3 25 8 1 (3) - (2) - -

Net income attributable to

non-controlling interests (30) (45) (30) (45) - - - - - -

Business operating

income 2,145 2,024 6.0% 1,897 1,726 9.9% 114 136 (16.2%) 136 126 7.9% (2) 36

As % of net sales 26.6% 25.3% 27.8% 25.7% 15.9% 17.9% 25.3% 23.8%

Financial income and

expenses(94) (137)

Income tax expense (514) (408)

Tax rate** 25.0% 21.2%

Business net income 1,537 1,479 3.9%

As % of net sales 19.0% 18.5%

Business earnings per

share*** (in euros)1.17 1.12 4.5%

(1) Including impact of transition to IFRIC 21.

* 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 1,314.5 million in the second quarter of 2014 and 1,325.7 million in the second quarter of 2013.

Q2 2013 (1)€ million Q2 2014 Q2 2013

(1) change Q2 2014 change Q2 2014 Q2 2013 (1)change Q2 2014 Q2 2013

(1) change Q2 2014 Q2 2013 (1)

OtherGroup Total Pharmaceuticals Vaccines Animal health

* 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 1,314.5 million in the second quarter of 2014 and 1,325.7 million in the second quarter of 2013

(1) Including impact of transition to IFRIC 21

Page 38: Q2 2014 Results by Sanofi

Business Net Income Statement

38

First-half 2014

Net sales 15,917 16,062 (0.9%) 13,517 13,522 - 1,346 1,457 (7.6%) 1,054 1,083 (2.7%)

Other revenues 154 181 (14.9%) 126 155 (18.7%) 14 12 16.7% 14 14 -

Cost of sales (5,124) (5,215) (1.7%) (4,046) (4,174) (3.1%) (700) (695) 0.7% (378) (346) 9.2%

As % of net sales (32.2%) (32.5%) (29.9%) (30.9%) (52.0%) (47.7%) (35.8%) (32.0%)

Gross profit 10,947 11,028 (0.7%) 9,597 9,503 1.0% 660 774 (14.7%) 690 751 (8.1%)

As % of net sales 68.8% 68.7% 71.0% 70.3% 49.0% 53.1% 65.5% 69.3%

Research and development

expenses (2,327) (2,342) (0.6%) (2,025) (2,008) 0.8% (230) (249) (7.6%) (72) (85) (15.3%)

As % of net sales (14.6%) (14.6%) (15.0%) (14.8%) (17.1%) (17.1%) (6.8%) (7.8%)

Selling and general

expenses (4,333) (4,446) (2.5%) (3,721) (3,801) (2.1%) (271) (301) (10.0%) (341) (344) (0.9%)

As % of net sales (27.2%) (27.7%) (27.5%) (28.1%) (20.1%) (20.7%) (32.4%) (31.8%)

Other current operating

income/expenses 29 170 19 130 1 7 17 (1) (8) 34

Share of profit/loss of

associates* 39 21 33 27 6 (4) - (2)

Net income attributable to

non-controlling interests (65) (86) (65) (86)

Business operating

income 4,290 4,345 (1.3%) 3,838 3,765 1.9% 166 227 (26.9%) 294 319 (7.8%) (8) 34

As % of net sales 27.0% 27.1% 28.4% 27.8% 12.3% 15.6% 27.9% 29.5%

Financial income and

expenses(170) (277)

Income tax expense (1,036) (991)

Tax rate** 25.0% 24.0%

Business net income 3,084 3,077 0.2%

As % of net sales 19.4% 19.2%

Business earnings per

share*** (in euros)2.34 2.32 0.9%

(1) Including impact of transition to IFRIC 21.

* 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 1,317.2 million in the f irst semester of 2014 and 1,323.9 million in the f irst semester of 2013.

6M 2013 (1) 6M 2014 6M 2013

(1)

Other

6M 2013 (1) change 6M 2014 6M 2013

(1)6M 2014 change change

Group Total Pharmaceuticals Vaccines Animal health

€ million 6M 2014 6M 2013 (1) change 6M 2014

* 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 1,317.2 million in the first semester of 2014 and 1,323.9 million in the semester of 2013

(1) Including impact of transition to IFRIC 21

Page 39: Q2 2014 Results by Sanofi

39 39

Reconciliation of Business Net Income to Consolidated

Net Income Attributable to Equity Holders of Sanofi

(1) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €601 million

in the second quarter of 2014 and €740 million in the second quarter of 2013

(2) Tax on dividends paid to shareholders of Sanofi

(3) Based on an average number of shares outstanding of 1,314.5 million in the second quarter of 2014 and 1,325.7 in the second quarter of 2013

(4) Impact of transition to IFRIC 21

€ million Q2 2014 Q2 2013(4)

Change

Business net income 1,537 1,479 3.9%

Amortization of intangible assets(1)

(624) (768)

Impairment of intangible assets (71) (430)

Fair value remeasurement of contingent consideration liabilities (124) (76)

Expenses arising from the impact of acquisitions on inventories - (3)

Restructuring costs (84) (105)

Tax effect of items listed above: 274 469

Amortization of intangible assets 207 231

Impairment of intangible assets 25 180

Fair value remeasurement of contingent consideration liabilities 13 16

Expenses arising from the impact of acquisitions on inventories - 1

Other gains and losses, and litigation - -

Restructuring costs 29 41

Other tax items

(2)

(110)

(109)

Share of items listed above attributable to non-controlling interests

3 1

Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures

(24) (10)

Net income attributable to equity holders of Sanofi 777 448 73.4%

Consolidated earnings per share(3)

(in euros) 0.59 0.34

Page 40: Q2 2014 Results by Sanofi

40 40

Reconciliation of Business Net Income to Consolidated

Net Income Attributable to Equity Holders of Sanofi

(1) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €1,258 million in

the first semester of 2014 and €1,489 million in the first semester of 2013

(2) Tax on dividends paid to shareholders of Sanofi

(3) Based on an average number of shares outstanding of 1,317.2 million in the first semester of 2014 and 1,323.9 million in the first semester of 2013

(4) Impact of transition to IFRIC 21

€ million H1 2014 H1 2013(4)

Change

Business net income 3,084 3,077 0.2%

Amortization of intangible assets(1)

(1,301) (1,543)

Impairment of intangible assets (74) (440)

Fair value remeasurement of contingent consideration liabilities (132) (117)

Expenses arising from the impact of acquisitions on inventories - (6)

Restructuring costs (135) (159)

Other gains and losses, and litigation 35 -

Tax effect of items listed above: 522 749

Amortization of intangible assets 451 490

Impairment of intangible assets 26 180

Fair value remeasurement of contingent consideration liabilities 14 20

Expenses arising from the impact of acquisitions on inventories - 2

Other gains and losses, and litigation (13) -

Restructuring costs 44 57

Other tax items

(2)

(110) (109)

Share of items listed above attributable to non-controlling interests

4 2

Restructuring costs of associates and joint ventures. and expenses arising from the impact of acquisitions on associates and joint ventures

(32) (17)

Net income attributable to equity holders of Sanofi 1,861 1,437 29.5%

Consolidated earnings per share(3)

(in euros) 1.41 1.09

Page 41: Q2 2014 Results by Sanofi

41 41

Consolidated Income Statements

(1) Including impact of transition to IFRIC 21

(2) In 2014, including a tax on dividends paid to shareholders of Sanofi: (110) M€ compared to (109) M€ in 2013

€ million Q2 2014 Q2 2013(1)

H1 2014 H1 2013(1)

Net sales 8,075 8,003 15,917 16,062

Other revenues 71 83 154 181

Cost of sales (2,608) (2,673) (5,124) (5,221)

Gross profit 5,538 5,413 10,947 11,022

Research and development expenses (1,188) (1,185) (2,327) (2,342)

Selling and general expenses (2,255) (2,306) (4,333) (4,446)

Other operating income 106 276 116 347

Other operating expenses (52) (135) (87) (177)

Amortization of intangible assets (624) (768) (1,301) (1,543)

Impairment of intangible assets (71) (430) (74) (440)

Fair value remeasurement of contingent consideration liabilities (124) (76) (132) (117)

Restructuring costs (84) (105) (135) (159)

Operating income 1,246 684 2,674 2,145

Financial expense (145) (154) (292) (311)

Financial income 51 17 157 34

Income before tax and associates and joint ventures 1,152 547 2,539 1,868

Income tax expense(2)

(350) (48) (624) (351)

Share of profit/loss of associates and joint ventures 2 (7) 7 4

Net income 804 492 1,922 1,521

Net income attributable to non-controlling interests 27 44 61 84

Net income attributable to equity holders of Sanofi 777 448 1,861 1,437

Average number of shares outstanding (million) 1,314.5 1,325.7 1,317.2 1,323.9

Earnings per share (in euros) 0.59 0.34 1.41 1.09

Page 42: Q2 2014 Results by Sanofi

42 42

Cash Flow Statements

(1) Including impact of transition to IFRIC 21

(2) Excluding restructuring costs

€ million H1 2014 H1 2013(1)

Business net income 3,084 3,077

Depreciation amortization and impairment of property. plant and equipment and software 582 594

Net gains and losses on disposals of non-current assets, net of tax (97) (154)

Other non-cash items (98) (277)

Operating cash flow before changes in working capital (2)

3,471 3,240

Changes in working capital (2)

(552) (859)

Acquisitions of property, plant and equipment and software (529) (586)

Free cash flow (2)

2,390 1,795

Acquisitions of intangibles, excluding software (108) (142)

Acquisitions of investments, including assumed debt (2)

(1,679) (273)

Restructuring costs paid (382) (325)

Proceeds from disposals of property, plant and equipment, intangibles, and other non-current assets. net of tax

179 266

Issuance of Sanofi shares 240 741

Dividends paid to shareholders of Sanofi (3,676) (3,638)

Acquisition of treasury shares (1,010) (890)

Disposals of treasury shares, net of tax - 2

Transactions with non-controlling interests including dividends (6) (10)

Foreign exchange impact (37) 17

Other items (62) 4

Change in net debt (4,151) (2,453)

Page 43: Q2 2014 Results by Sanofi

43 43

Balance Sheets

(1) Including impact of transition to IFRIC 21

ASSETS € million

06/30/14 12/31/13(1)

LIABILITIES € million

06/30/14 12/31/13(1)

Property, plant and equipment 10,090 10,182 Equity attributable to equity-holders of sanofi

51,637 56,904

Intangible assets (including goodwill) 51,675 52,529 Equity attributable to non-controlling interests

130 129

Non-current financial assets, investments in associates, and deferred tax assets

8,568 9,418 Total equity 51,767 57,033

Long-term debt 10,113 10,414

Non-current liabilities related to business combinations and to non-controlling interests

974 884

Non-current assets 70,333 72,129 Provisions and other non-current liabilities

9,066 8,735

Deferred tax liabilities 4,600 5,060

Inventories, accounts receivable and other current assets

16,063 15,655 Non-current liabilities 24,753 25,093

Cash and cash equivalents 4,306 8,257 Accounts payable and other current liabilities

9,408 9,728

Current liabilities related to business combinations and to non-controlling interests

109 24

Short-term debt and current portion of long-term debt

4,683 4,176

Current assets 20,369 23,912 Current liabilities 14,200 13,928

Assets held for sale or exchange 18 14 Liabilities related to assets held for sale or exchange

- 1

Total ASSETS 90,720 96,055 Total LIABILITIES & EQUITY 90,720 96,055

Page 44: Q2 2014 Results by Sanofi

Business EPS Currency Sensitivity

€ 25.0%

US $ 32.6%

Japanese Yen 5.6%

£ 2.2%

Australian $ 1.5%

Canadian $ 1.5%

Brazilian Real 4.5%

Chinese Yuan 4.3%

Russian Ruble 2.5%

Others 19%

Mexican Peso 1.7%

Currency Exposure on Q2 2014 Sales Currency Average Rates

2014 Currency Sensitivity

44

● 1% variation in €/$ corresponds to an impact of 0.5% on 2014 Business EPS

● 1% variation in €/Yen corresponds to an impact of 0.1% on 2014 Business EPS

Q2’13 Q2’14 % change

€/$ 1.31 1.37 4.6%

€/Yen 129.02 140.03 8.5%

€/Real 2.70 3.06 13.3%

€/Ruble 41.38 47.96 15.9%