2015/11 - meet sanofi management

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Page 1: 2015/11 - Meet Sanofi Management

MEET SANOFI Management

Page 2: 2015/11 - Meet Sanofi Management

2

Forward Looking Statements

This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of1995, as amended. Forward-looking statements are statements that are not historical facts. These statements includeprojections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions andexpectations 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'smanagement believes that the expectations reflected in such forward-looking statements are reasonable, investors arecautioned that forward-looking information and statements are subject to various risks and uncertainties, many of whichare difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments todiffer 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 theEMA, regarding whether and when to approve any drug, device or biological application that may be filed for any suchproduct candidates as well as their decisions regarding labeling and other matters that could affect the availability orcommercial potential of such product candidates, the absence of guarantee that the product candidates if approved willbe commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's abilityto benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of costcontainment initiatives and subsequent changes thereto, the average number of shares outstanding as well as thosediscussed 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 Form20-F for the year ended December 31, 2014. Other than as required by applicable law, Sanofi does not undertake anyobligation to update or revise any forward-looking information or statements.

Page 3: 2015/11 - Meet Sanofi Management

MEET SANOFI Management

2015-2020 ROADMAP

Olivier BrandicourtChief Executive Officer

Page 4: 2015/11 - Meet Sanofi Management

4

Agenda

Our vision for Sanofi

Sanofi’s path to success

Delivering performance

Page 5: 2015/11 - Meet Sanofi Management

Many Elements Point towards a Favorable Outlook for the Healthcare Industry despite Multiple Challenges

5

Growing and aging population

Unmet medical needs remain high

Improved R&D productivity across the industry

Exciting time scientifically

Rising middle class in Emerging Markets

Empowered patients

Affordability is a key concern globally

Price pressure from payers in developed markets

Biosimilar threat and risk of interchangeability

Slowdown in economic growth in Emerging Markets

More focused competitors building leadership positions

ChallengesOpportunities

Page 6: 2015/11 - Meet Sanofi Management

6

Sanofi Has Important Strengths to Build On in this Changing Environment

Launchinga strong setof products

across multiple TAsLeading

positions in Diabetes, Vaccines,

Rare Diseases, Emerging Markets

Record of building leading

brands: Lantus®, Fluzone®,

Cerezyme®

Successful in sourcing external

innovation: Regeneron,

Alnylam, Voyager

Strong skills for managing

maturebusinesses

Making credible entry in new TAs

e.g. Multiple Sclerosis

TA: Therapeutic Areas

Page 7: 2015/11 - Meet Sanofi Management

7

Sanofi Also Has Challenges to Address in Order to Succeed

Pressure on margins

Broad portfolio

Lantus® loss of exclusivity

Limited breadth of pipeline

Complexity

1

2

3

4

5

Page 8: 2015/11 - Meet Sanofi Management

A New Strategic Direction for Sanofi Is Needed to Change our Growth Trajectory

8

Sanofi is a global healthcare company focused on disease prevention and treatment

● DIVERSIFIED in Pharmaceuticals, Vaccines and Consumer Healthcare

● FOCUSED on 5 GBUs(1)

● INNOVATIVE to sustain long term growth

● SIMPLIFIED as an organization

(1) Diabetes/Cardiovascular, General Medicines and Emerging Markets, Specialty Care, Vaccines, Animal Health

Our Vision for Sanofi

Page 9: 2015/11 - Meet Sanofi Management

9

Agenda

Sanofi’s path to success

Delivering performance

Our vision for Sanofi

Page 10: 2015/11 - Meet Sanofi Management

We Have Four Strategic Priorities

10

Reshapethe portfolio

Deliveroutstanding

launches

Simplify the organization

Sustaininnovation

in R&D

1 2 3

4

Page 11: 2015/11 - Meet Sanofi Management

● Multiple Sclerosis(1)

● Oncology(1)

● Immunology(1)

● Consumer Healthcare(2)

● Animal Health

● Generics(2)

in Europe

● Diabetes/CV

● Vaccines

● Rare Diseases(1)

● Emerging Markets(2)

Reshape the Portfolio

11

1

Explore strategic optionsCA Sustain

leadershipBuild competitive positionsB

(1) Will be part of Specialty Care Global Business Unit(2) Will be part of General Medicines and Emerging Markets Global Business Unit

Page 12: 2015/11 - Meet Sanofi Management

12

Committed to Diabetes and Cardiovascular Diseases

1 Develop the insulin franchise

4

3 Lead the market shift to managing diabetes outcomes

A

GoogleLife Sciences

2 Strengthen the pipeline through external opportunities and ambitious research

Transform the management of hypercholesterolemia

Ambition to grow Diabetes franchise beginning in 2019(1)

Praluent® multi-blockbuster potential

(1) Diabetes sales are expected to decline at an average annualized rate of -4% to -8% at CER over 2015-2018Icons designed by Freepik

Page 13: 2015/11 - Meet Sanofi Management

13

Strengthening our R&D Portfolio in Diabetes with Two In-Licensing Agreements

A

(1) SGLT2 (sodium-glucose cotransporter type 2) is a transporter responsible for most of the glucose reabsorption performed by the kidneySGLT1 (sodium-glucose cotransporter type 1) is a transporter responsible for glucose and galactose absorption in the gastrointestinal tract, and to a lesser extent than SGLT2, glucose reabsorption in the kidney

(2) Subject to customary closing conditions(3) LAPS CA-Exendin-4 analog

T1DM: Diabetes mellitus type 1

Sotagliflozin - Phase II in T2 DiabetesPhase III in T1 Diabetes

● Dual SGLT1 and SGLT2 inhibitor(1)

● Limiting meal time glucose absorption and increasing renal glucose excretion

● Oral administration

● Adjunct therapy to insulin in T1DM

● Favorable safety profile

Immunology

Efpeglenatide – Phase II● Long acting GLP-1(3)

● Diabetes/Obesity

● Weekly/monthly administration

LAPS Insulin 115 (HM12470) – Phase I● Long acting insulin

● Less side-effects (hypoglycemia, obesity)

● Weekly administration

LAPS Insulin Combo – Pre-clinical● Long acting insulin + efpeglenatide combination

● Weekly administration

(2)

Page 14: 2015/11 - Meet Sanofi Management

Growing Faster than Market in Vaccines

14

A

Further develop strong vaccine brands● Flu vaccines● Pediatric combinations● Adult boosters

Successfully launch Dengvaxia®

Expand our manufacturing capacity

Deliver novel high-valuevaccines e.g. C. diff vaccine

2015e2014

€4.0bn

2020e

Pediatric& boosters

Flu

Dengue ~75% of

sales

Projected Sanofi Pasteur Sales

~€4.7bn

1

2

3

4

High single digitsales CAGR

at CER

Page 15: 2015/11 - Meet Sanofi Management

Sustaining Leadership in Rare Diseases

15

A

● Sustain market share through patient-centered approach, product differentiation and market access

● Grow market through patient screening and manufacturing expansion

● Advance internal and partnered novel pipeline

Sales CAGR for Rare Diseases expected at high single digit at CER over 2015-2020

1

2

3

Undiagnosed(1) Undiagnosed(1)

Undiagnosed(1)

(1) Genzyme internal analysis. Include China and India

Page 16: 2015/11 - Meet Sanofi Management

Retaining #1 Position in Emerging Markets through Greater Focus

16

Leader in Emerging Markets

● Increase focus on priority countries/regions

● Prioritize resource allocation

● Adapt industrial footprint

● Redefine scope to exclude Eastern Europe(1)

● Win the emerging middle class

● Innovate specifically for Emerging Markets

● Optimize trade and channel management

#3 in China

#1 in Brazil

#2 in Russia

#4 in India

#2 in Mexico

A

EM sales ~€10.8bn in 2015e~29% of Group sales(1)

A top 3 MNC player in BRIC-M

1

2

3

4

MNC: Multinational corporation (1) World excluding U.S., Canada, Western & Eastern Europe (except Russia, Ukraine, Georgia, Belarus and Armenia),

Japan, South Korea, Australia, New Zealand and Puerto Rico

Page 17: 2015/11 - Meet Sanofi Management

● Multiple Sclerosis(1)

● Oncology(1)

● Immunology(1)

● Consumer Healthcare(2)

● Animal Health

● Generics(2)

in Europe

● Diabetes/CV

● Vaccines

● Rare Diseases(1)

● Emerging Markets(2)

Reshape the Portfolio

17

1

Explore strategic optionsCA Sustain

leadershipBuild competitive positionsB

(1) Will be part of Specialty Care Global Business Unit(2) Will be part of General Medicines and Emerging Markets Global Business Unit

Page 18: 2015/11 - Meet Sanofi Management

Growing our Multiple Sclerosis Franchise

18

● Successfully complete global launches of Aubagio® and Lemtrada®

● Expand LCM activities to maximize support to existing products

● Reinforce presence in “high efficacy” category

● Enter the neuroprotection/ remyelination segment

B

Q12013

Q22013

Q32013

Q42013

Q12014

Q22014

Q32014

Q42014

Q12015

Q22015

Q32015

Série2Série1

Multiple Sclerosis FranchiseReported sales (€m)

€923m

®

1

2

3

4

Ambition to double the size of the MS franchise from 2015 to 2020

LCM: Life Cycle Management

Page 19: 2015/11 - Meet Sanofi Management

Rebuilding a Competitive Position in Oncology

19

● Maximize clinical assets, particularly isatuximab(anti-CD38 mAb) and Antibody-Drug Conjugates

● Build a transformative pipeline ● Immuno-oncology collaboration with Regeneron● Collaboration with BioNTech on mRNA therapeutics

● Rebuild critical mass

Oncology Opportunity

Largest therapeutic area for pharmaceuticals

Strong growth drivenby unmet need and

groundbreaking science

B

1

2

3

ADCs: Antibody-Drug Conjugates

Page 20: 2015/11 - Meet Sanofi Management

Sarilumab and Dupilumab Represent Cornerstones of a New Immunology Franchise

20

● Multi-disease, best in class drug targeting Th2 pathway

● Breakthrough treatment for atopic dermatitis

● Further opportunities in asthma and nasal polyposis

● Multi-blockbuster potential across key indications

● FDA submission in AD planned forQ3 2016

Immunology

B

● Entering an €18bn RA market where unmet need is still high● IL-6 class >€1bn in sales and

growing >20%

● Aim to be preferred 2nd line for TNF-IR patients and preferred monotherapy

● Goal to differentiate through dosing, bone impact

● Recently submittedto FDA

RA: Rheumatoid Arthritis TNF-IR: TNF inadequate responders AD: Atopic Dermatitis

Page 21: 2015/11 - Meet Sanofi Management

ShapeNew

Categories

Prepare the potential Rx-to-OTC switch of Cialis®

Maximize ExistingBrands

Manage with speed, agility and consumer focus

1

2

Build Scale in a Fragmented CHC Market

21(1) Nicholas Hall & Company, FY 2014

B

Ranked #5 in the~€100bn OTC Market(1)

3.2%

Taisho

Reckitt Benckiser

Pfizer

J&J

GSKBayer

TakedaBoehringer IngelheimP&G

Other

Build Scale through Bolt-on

Acquisitions

Reach critical scale in key countries and priority categories

3

Page 22: 2015/11 - Meet Sanofi Management

● Multiple Sclerosis(1)

● Oncology(1)

● Immunology(1)

● Consumer Healthcare(2)

● Animal Health

● Generics(2)

in Europe

● Diabetes/CV

● Vaccines

● Rare Diseases(1)

● Emerging Markets(2)

Reshape the Portfolio

22

1

Explore strategic optionsCA Sustain

leadershipBuild competitive positionsB

(1) Will be part of Specialty Care Global Business Unit(2) Will be part of General Medicines and Emerging Markets Global Business Unit

Page 23: 2015/11 - Meet Sanofi Management

Explore Strategic Options for Two Businesses

23

C

● 2015e sales >€2.4bn● Successful return to growth

(YTD +12.4% at CER)● One of the most profitable AH

companies● Ranks #1 in companion

animals and #4 overall● But limited synergies

with otherbusinessesin Sanofi

Merial Generics in Europe

● 2015e sales ~€1bn(1)

● Above average profitability of Generics businesses

● Ranked #5 in Europe, few geographic synergies (limited US presence)

● But consolidating market and increased complexity (biosimilars, differentiated Gx)

23AH: Animal Health(1) Western and Eastern Europe

Page 24: 2015/11 - Meet Sanofi Management

24

2014-2020: Up to 18 Launches Planned

Deliver Outstanding Launches

(U.S.)(U.S.)

patisiran

PR5IVaccine

VaccineShan5

insulinlispro

RotavirusVaccine

Launched Feb 2014 - Feb 2015

Other upcoming launchesFocus on Six Launches

2

isatuximab

Page 25: 2015/11 - Meet Sanofi Management

Greater Focus on Six Major Launchesthrough GBU Structure

25

Focus on 6 Products … … and Excel in Execution

New GBU organization with clear accountability, P&L ownership and life cycle management to focus on:

● Delivering differentiated products rapidly

● Shaping the market

● Securing market access

● Driving uptake

Page 26: 2015/11 - Meet Sanofi Management

Sanofi Expects its Six Major Launches to Generate Substantial Combined Sales

26(1) At CER, non-risk adjusted sales projections through 2025

Expected

combined peak sales

of €12bn to €14bn(1)

Sales Potential of Six Key Products

Page 27: 2015/11 - Meet Sanofi Management

0%

10%

20%

30%

40%

50%

60%

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29

Global Roll-out Underway and Showing Early Promise in Key Markets

27

0%

1%

2%

3%

4%

5%

6%

7%

8%

1 3 5 7 9 11 13 15 17 19 21 23 25

Weekly NBRx Sharewithin Basal Market(1)

Lantus®

50.9%

Levemir®

26.3%

NPH9.0%

Weekly Sell Out Share (in Units/Packs)within Basal Market(2)

7.1%

Levemir® and Tresiba® are Novo Nordisk brands(1) Basal market includes Toujeo®, Lantus®, Levemir® and NPH - Source: IMS Weekly - Data week of April 3 - week of Oct 16, 2015(2) Insight Health Germany (Retail Apo-Weekly-Pharma) – All data including parallel trade; Toujeo® week of May 5 - Oct 27, 2015;

Tresiba® week of April 29 - Oct 21, 2014

Weeks from Toujeo® Launch Weeks from Launch

3.8%Tresiba®

Additional launches in Q3 in Japan, Canada, U.K. and other EU countries

13.7%

Page 28: 2015/11 - Meet Sanofi Management

Investing in a Broad LCM Program to Expand the Evidence Base

28

Real Life Study ProgramEstablish the Value of Toujeo®

in Real World Clinical Practice

Committed to a Phase IIIb/IV Program to Be Submitted to

Health Authorities

● To enhance U.S. label

● To get deeper competitive data

● Start planned for 2016, data from 2017-to-2018

New Pen Device under Development

● Higher single maximum daily dose and greater capacity

● Initial results expected in 2017, extended follow-up findings in 2018

LCM: Life Cycle Management

Page 29: 2015/11 - Meet Sanofi Management

Transforming the Managementof Hypercholesterolemia

29

75 mg/1 mL pen 150 mg/1 mL pen

Building awareness & education

Executing centralized patient initiation & distribution model in the U.S.

Gaining U.S. market access

Driving appropriate use & adherence

2015Launch Focus

Gradual Uptake Expected

● EU top 5 launches planned in Q4 2015 and 2016

● ODYSSEY OUTCOMES interim efficacy analysis(1) expected in H2 2016

● ODYSSEY OUTCOMES study completion expected in late 2017

● Real world and life cycle studies to support market access and value for sub-populations

2016 - 2017Future Opportunity

Expansion and Acceleration

Praluent® is developed and commercialized in collaboration with Regeneron(1) Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred

Page 30: 2015/11 - Meet Sanofi Management

● About half of the world’s population lives in dengue endemic regions(2)

● Recommended for the prevention of dengue disease in individuals 9 years and older living in endemic areas(3)

● Pooled efficacy data demonstrate(3)

● 65.5% protection against all 4 dengue serotypes● 93.2% prevention against severe dengue● 80.8% prevention of hospitalization due to dengue

● Potential to reduce disease burden by about 50% within 5 years if 20% of a country population is vaccinated in endemic countries(4,5)

(1) Under regulatory review in major endemic countries in Asia and South America(2) WHO, 2015, Dengue Fact Sheet(3) Follow-up to 25 months post dose-1; Study population aged 9 to 16 years of age. Hadinegoro SR. et al. NEJM, 2015

Safety analyses showed similar reporting rates between the vaccine and control groups during clinical studies (4) Coudeville L et al. ASVAC 2015(5) Coudeville L et al. SLIPE 2015(6) Bhatt, 2013, Nature

30

The First Ever Dengue Vaccine(1)

Make dengue the next vaccine-preventable disease

Global Evidence ConsensusRisk & Burden of Dengue - 2010(5)

Completeabsence

Completepresence

Page 31: 2015/11 - Meet Sanofi Management

31

An Investigational Agent Combining Insulin Glargine with Lixisenatide in a Daily Injection

FPG + PPG control

Statistically significant A1c reduction versus components

More patients with A1c <7%

Weight neutral versus insulin glargine

Reduced nausea versus lixisenatide alone

No additional incidence of hypos vs. basal

Fixed Ratio Combinationof Two Active ComponentsSingle Once Daily Injection =

Expected key regulatory submissions: U.S. Q4 2015 & EU Q1 2016

PPG: Post-Prandial GlucoseFPG: Fasting Plasma Glucose

Page 32: 2015/11 - Meet Sanofi Management

Sustain Innovation in R&D

32

● Sustain leadership: Diabetes/CV, Vaccines, Rare Diseases

● Build competitive positions: Oncology, MS, Immunology

● Invest opportunistically: Neurodegeneration/pain, Infectious Diseases and Ophthalmology

Continue to strengthen R&D pipelineA

C

D

B

Deliver a Balanced Pipeline… … Focused on GBU Priorities

3

Increasing annual R&D investments up to €6bnby 2020 while maintaining financial discipline

Foster existing R&D collaborations (REGN, ALNY)

Increase capacity for external innovation

Implement the R&D 2.0 model

Page 33: 2015/11 - Meet Sanofi Management

Further Expanding the R&D Pipeline Is a Key Objective for the Next Phase

GZ402668GLD52 (anti-CD52 mAb)

Relapsing multiple sclerosis

GZ402666neo GAA

Pompe Disease

SAR113244Anti-CXCR5 mAb

Systemic lupus erythematosus

SAR339375Anti-miR21 RNAAlport syndrome

GZ389988TRKA antagonist

Osteoarthritis

SAR439774 (ALN-AT3)siRNA targeting Anti-Thrombin

Haemophilia

SAR425899GLP-1R/GCGR dual agonist

Diabetes

SAR228810Anti-protofibrillar AB mAb

Alzheimer’s disease

SAR438335GLP-1R/GIPR dual agonist

Diabetes

SAR422459ABCA4 gene therapy

Stargardt disease

SAR566658Maytansin-loaded anti-CA6 mAb

Solid tumors

UshStat®

Myosin 7A gene therapyUsher syndrome 1B

SAR408701Anti-CEACAM5 ADC

Solid tumors

SAR366234EP2 receptor agonist

Elevated intraocular pressure

SAR439684PD-1 inhibitor

Cancer

Streptococcus pneumoniaMeningitis & pneumonia vaccine

SAR428926LAMP-1 inhibitor

Cancer

Herpes Simplex Virus Type 2HSV-2 vaccine

SAR439152Myosin inhibitor

Hypertrophic cardiomyopathy

Phase I

N

N

N

33

N

N

N

N

N

N

N

N

N

N

N

N

N

N

dupilumabAnti-IL4Rα mAbNasal polyposis;

Eosinophilic oesophagitis

GZ402671Oral GCS Inhibitor

Fabry Disease

SAR156597IL4/IL13 Bi-specific Ab

Idiopathic pulmonary fibrosis

olipudase alfarhASM

Niemann-Pick type B

sarilumabAnti-IL6R mAb

Uveitis

Rabies VRVgPurified vero rabies vaccine

Combinationferroquine / OZ439

Antimalarial

Meningitis ACYW conj.2nd generation meningococcal

conjugate infant vaccine

isatuximabAnti-CD38 naked mAb

Multiple myeloma

Tuberculosis Recombinant subunit vaccine

Fluzone® QIV HD Quadrivalent inactivated

influenza vaccine - High dose

Phase IIN

N

N N

N

LixiLanlixisenatide + insulin glargineFixed-Ratio / Type 2 diabetes

SAR342434insulin lispro

Type 1+2 diabetes

sarilumab Anti-IL6R mAb

Rheumatoid arthritis, EU

dupilumabAnti-IL4Rα mAb

Atopic dermatitis, Asthma

patisiran (ALN-TTR02)siRNA inhibitor targeting TTR

Familial amyloidotic polyneuropathy

revusiran (ALN-TTRsc)siRNA inhibitor targeting TTR

Familial amyloidotic cardiomyopathy

Jevtana®

cabazitaxelMetastatic prostate cancer (1L)

Clostridium difficileToxoid vaccine

RotavirusLive attenuated tetravalent

Rotavirus oral vaccine

VaxiGrip® QIV IM Quadrivalent inactivated

influenza vaccine (3-36 months)

Phase III

N

N

N

N

N

RegistrationlixisenatideGLP-1 agonist

Type 2 diabetes, U.S.

sarilumab Anti-IL6R mAb

Rheumatoid arthritis, U.S.

Dengvaxia®

Mild-to-severe dengue fever vaccine

PR5IDTP-HepB-Polio-Hib

Pediatric hexavalent vaccine, U.S., EU

VaxiGrip® QIV IM Quadrivalent inactivated

influenza vaccine (3 years+)

N

N New Molecular Entity

Immunology

Rare Diseases

Oncology

Diabetes

Vaccines

Infectious Diseases

Cardiovascular Diseases

Neurodegenerative Diseases

Ophthalmology

Multiple Sclerosis

N

Page 34: 2015/11 - Meet Sanofi Management

Simplify the Organization

34

4

Create one

Sanoficulture

Reshapethe plant network

Move to Global Business

Unit organization

Page 35: 2015/11 - Meet Sanofi Management

Diabetes Cardiovascular

Diabetes & Cardiovascular

P. Witz

Rare diseases Multiple

Sclerosis Oncology Immunology

SanofiGenzyme

(Specialty Care)

D. Meeker

CHC Established

products Generics

General Medicines &

Emerging Markets

P. Guenter

SanofiPasteur

(Vaccines)

O. Charmeil

Merial(Animal Health)

C. Hellmann

Human vaccines

Animal Health products

Emerging Markets(1)

&

A New Organizational Model Is a Necessary Step to Drive Focus and Simplification

35

(1) All pharmaceutical businesses in Emerging Markets to report to General Medicine & Emerging Markets GBU(2) Global functions include Research & Development, Industrial Affairs, Finance, Human Resources, Business Development & Strategy,

External Affairs, Information Systems, Medical, Legal, Compliance, Procurement (not an exhaustive list of functions)(3) The process of legal and social consultation will be followed as required

Similar to R&D and Industrial Affairs, all functions will be globalized(2)

New organization implemented beginning in January 2016(3)

Page 36: 2015/11 - Meet Sanofi Management

36

Reshaping Sanofi’s Plant Network

● Continue to reshape plant network to match business evolution

● Implement a more focused approachin Emerging Markets

● Improve competitiveness

● Simplify product lines

● Invest in biologics in support of launches and growth

1

2

70

52

2008 2015Achieved Restructuring

102

Investments/ Transfers

6 -26

Acquisitions

Merial PharmaceuticalsGenzyme Sanofi Pasteur

Industrial Footprint Evolution# of sites

Page 37: 2015/11 - Meet Sanofi Management

Targeting Cost Savings of €1.5bn by 2018Largely Reinvested to Support Growth(1,2)

37(1) The €1.5bn cost savings are at CER, before inflation and tax on a constant structure basis and by 2018.(2) The majority of these savings will be reinvested to launch biologics and to support growing businesses

● Significant investments required to launch biologics and to support growing businesses

● To balance the need for increased resources and to partly offset reduced diabetes sales expectations, Sanofi aims to generate cost savingsof €1.5bn by 2018

● 2/3 to come from simplificationof the organization worldwide and from a more focused portfolio

50% of savings from Gross Margin

50% of savings from SG&A

● 1/3 to come from investment prioritization

Source of cost savings

Page 38: 2015/11 - Meet Sanofi Management

38

Agenda

Sanofi’s path to success

Delivering performance

Our vision for Sanofi

Page 39: 2015/11 - Meet Sanofi Management

The Roadmap for Sanofi

39

● Invest for the future● Refocus the portfolio● Execute launches● Reinforce pipeline through

business development● Simplify the organization

● Accelerate growthfrom priority launches

● Continue to build scale in priority businesses

● Capture margin improvement

11

22

2018-20

Accelerategrowth

2015-17

ReshapeSanofi

Page 40: 2015/11 - Meet Sanofi Management

40(1) Based on current group structure and at CER

Projected Evolution of Sanofi Sales over 2015-2020(1)

Diabetes & Cardiovascular

SanofiGenzyme

(Specialty Care)

General Medicines &

Emerging Markets

SanofiPasteur

(Vaccines)

Merial(Animal Health)

2020 Sales broadly in line

with 2015 Sales

Low single digit Sales CAGR

Double digit Sales CAGR

High single digit Sales CAGR

High single digit Sales CAGR

Expected sales CAGR of +3% to +4% over 2015-2020(1)

Expected mid-single digit sales CAGR between 2018 and 2020(1)

Business EPS expected to grow faster than sales beginning in 2018

Objectives for the 2015-2020 Roadmap

Page 41: 2015/11 - Meet Sanofi Management

41

Deploying Capital Effectively to Create Long Term Value

Balanced Capital Allocation Strategy to Support Growth and Returns

(1) After R&D investments

Prioritiesfor Free

Cash FlowUse(1) Dividend

Organic investment

Stock repurchase

Acquisitions

1

2

3

4

Page 42: 2015/11 - Meet Sanofi Management

By Delivering on Those Targets, We Will Create an EvenStronger Company Positioned for Accelerated Growth

● Diversified, but with a refocused portfolio

● Streamlined, accountable organization with high quality teams

● Innovation driven, to improve lives of millions of people

● Clear measures of success for launches

● Enhanced growth profile through disciplined M&A

● Sustainable growth and shareholder returns

42

Page 43: 2015/11 - Meet Sanofi Management

MEET SANOFI Management

P&L RATIOS& CAPITAL ALLOCATION

Jérôme ContamineExecutive Vice President, Chief Financial Officer

Page 44: 2015/11 - Meet Sanofi Management

44

Agenda

P&L ratios

Capital allocation

Page 45: 2015/11 - Meet Sanofi Management

Sanofi Is Investing in its Future while Responding to Reduced Diabetes Expectations

● 2015-2020 sales CAGR of 3% to 4%(1)

● 2015-18 profitability impacted by:

● Investment in new product launches and R&D pipeline

● Reduced diabetes expectations (CAGR -4% to -8% over 2015-2018)

● Intensified cost savings (€1.5bn) by 2018 from business simplification and investment prioritization, largely reinvested to support future growth

● Beginning in 2018, Business EPS expected to grow faster than sales

45

1

2

(1) Based on current group structure and at CER

2018-20

Accelerategrowth

2015-17

ReshapeSanofi

Page 46: 2015/11 - Meet Sanofi Management

46(1) At CER

Gross Margin in 2018 Should Reach at Least 2015 Level(1)

despite Expected HeadwindsILLUSTRATIVE

Manufacturing PerformanceImproved over 2013-2015e

Savings Planned toAccelerate over 2015e-2018e

FX 2015e

~69%

Industrial performance

2013 Price & Mix

67.7%

Product line

optimization

2018eIndustrial performance

Biologics industrial

investment

~69%

Price & Mix2015e

Evolution of Gross Margin (%) ≥69%

Page 47: 2015/11 - Meet Sanofi Management

7.7

We have keptR&D expenditures stable…

47

2011 2012 20142013

€4.8bn €4.9bn €4.8bn €4.8bn

14.4% 14.1% 14.5% 14.3%R&Dto sales

ratio

Sanofi Has Increased R&D Productivity while Keeping R&D Expenditures Relatively Stable over Last 5 Years

… and alignedthe R&D to sales ratio by activity

(2015e)

Animal Health

Vaccines

~7%

~12%

Pharmaceuticals ~15%

2015e

~€5.3bn

Page 48: 2015/11 - Meet Sanofi Management

48

Range of 15% to 15.5%

Going forward, we expect a slight increase

in R&D to sales ratio

2012-2015e 2016e-2018e

Range of 14% to 14.5%

Increased R&D Investment to Fuel Long Term Growth

Invest in medical and LCM support for launches● Toujeo® / Praluent® / Dengvaxia®

Advance late-stage pipeline development● dupilumab / C. diff / isatuximab / sarilumab / LixiLan

Accelerate early-stage development● New immuno-oncology collaboration with Regeneron

Expand open innovation model● Finance development of future external projects

1

2

3

4

LCM: Life Cycle Management(1) At CER and comparable structure

Increasing annual R&D investments up to €6bnby 2020 while maintaining financial discipline

Page 49: 2015/11 - Meet Sanofi Management

49

SG&A ratio is expected to remain stable despite wave of new launches(1)

Similarlevel

2015e 2016e-2018e

Range of27.5% to 28%

Sanofi has one of the lowestSG&A ratios(2)

Roche 23%

Merck 26%

Sanofi 27%Pfizer 28%

Abbvie 29%

J&J 30%

Novartis 30%

BMS 30%

Novo Nordisk 30%

Abbott 30%

GSK 31%

Eli Lilly 33%

AstraZeneca 39%

(1) At CER and comparable structure(2) Source: Published 2014 financial results - Sanofi analysis

SG&A to Sales Ratio Expected to Remain Stable over 2015-2018(1)

Page 50: 2015/11 - Meet Sanofi Management

Structuring a Global Cross Functional Organization(Sanofi Business Services) and Globalizing the IT Function

50

One Sanofi Business ServicesOrganization (SBS)

● Consolidation of the core process delivery activities of:

● Some support functions (HR, Finance)

● Some expertise functions (Procurement, Real Estate, Facility Management)

● Provide best-in-class service delivery and customer partnering

● Standardization & consolidation leading to end-to-end process across Sanofi

● Globalization of the IT function to drive synergies

● Business applications simplification program

● Implementation of Service Management approach

● Aims to drive a competitive level of IT run cost

● Cutting-edge cloud strategy

One Global Information SolutionsPlatform

Page 51: 2015/11 - Meet Sanofi Management

Accelerated Growth over 2018-2020

51

● Mid-single digit sales CAGR● Growing sales contribution from launches● Increased share of Specialty Care and Vaccines● Rebalanced portfolio of General Medicines with

lower exposure to EP in mature markets● Business EPS growing faster than sales

despite growing payouts to partners

EP: Established Products

11

22

2018-20

Accelerategrowth

Page 52: 2015/11 - Meet Sanofi Management

52

Agenda

P&L ratios

Capital allocation

Page 53: 2015/11 - Meet Sanofi Management

53

Deploying Capital Effectively to Create Long Term Value

Balanced Capital Allocation Strategy to Support Growth and Returns

(1) After R&D investments

Prioritiesfor Free

Cash FlowUse(1) Dividend

Organic investment

Stock repurchase

Acquisitions

1

2

3

4

Page 54: 2015/11 - Meet Sanofi Management

54

Investing to Expand Biologic Manufacturing Capabilities

Keeping tight control on CapEx(1)…

1

Investing between €1.8bn and 1.9bn annually in CapEx over 2016-2018

…while investing in biologic capabilities

2015e

~€1.5bn

2014

€1.2bn

2013

€1.2bn

2012

€1.4bn

Animal HealthVaccines

GenzymePharma (w/o Genzyme)

(1) CapEx w/o Product Acquisition

~€1.5bn

2014

€1.2bn

2013

€1.2bn

2012

€1.4bn

2015e

Injectables + Biologics + Vaccines + GenzymeOthers

Page 55: 2015/11 - Meet Sanofi Management

55

€8.4bn€7.4bn

€6.5bn€7.2bn

~€6.5bn

2011 2012 2013 2014 2015e

Strong Balance Sheet and Free Cash Flow2

Net Debt

● Strong long-term credit ratings (Moody’s A1; S&P AA) ● Current average cost of borrowings(2): 1.6%

(1) Free Cash Flow after change in working capital and before CapEx(2) Borrowing includes bonds denominated in € and U.S.$ and U.S. Commercial Paper drawings post swap into €

Free Cash Flow(1)

€10.9bn

€7.7bn

€6.0bn€7.2bn

€8.5bn to

€9.0bn

2011 2012 2013 2014 2015e

Page 56: 2015/11 - Meet Sanofi Management

56

Sanofi Has Shown Financial Discipline in M&A Deals2

Value(€m)

EPS accretion

Value creation

Buildcritical mass

Strengthenpipeline

Strong player in Animal Health $4.0bn

Strong CHC platform to launch Rx-to-OTC switches in the U.S.

$1.9bn

Leading biotech with unique expertise in

Rare Diseases$20.1bn

Strategic antibody & immuno-oncology

collaborations

22.2% stakevalued at

€12.1bn(3)

Strategic alliance onRNAi therapeutics

11.9% stakevalued at

€850m(3)

(1) IRR (Internal Rate of Return) significantly exceeded WACC(2) Book value of €2,167m in Regeneron and Investments of €721m in Alnylam(3) Market value as of November 2, 2015

(1)

(1)

(1)

(2)

(2)

Page 57: 2015/11 - Meet Sanofi Management

57

Seek Opportunities to Enhance Growth Profile through Targeted M&A2

M&A Scope

● Business development opportunities boosting our growth profile and offering synergies

● Focus on transactions driving value creation

Financial Criteria

● Maintain rigorous metrics

● Key performance indicators include: ● IRR● CFROI● ROA● EPS accretion

Priority Areas

● Reinforcing priority businesses

● Businesses with portfolio or geographic complementarities

● R&D collaborations expanding our pipeline

IRR: Internal Rate of ReturnCFROI: Cash Flow ROIROA: Return on Assets

Page 58: 2015/11 - Meet Sanofi Management

Evolution of Dividend

58

● Consistent history of dividend payment● 21st consecutive year of dividend

increase in 2014

● Solid dividend yield

● Strong payout ratio

● Maintain progressive growth of dividend

Progressive Dividend Growth3

2011

€2.77

€2.40€2.50

2012 2014

€2.65

2013

€2.80

2009

€2.85

2010

(1) 2014 dividend paid in 2015

(1)

Page 59: 2015/11 - Meet Sanofi Management

59

Stock Repurchases Primarily to Absorb Dilution4

Share Buyback (€bn)

2015e

2014

~€1.5bn

€1.8bn

2013 €1.6bn

2012 €0.8bn

2011 €1.1bn

Share buyback expected to be used to tackle dilution over time

~€6.8bnover 5 years

Page 60: 2015/11 - Meet Sanofi Management

Conclusion

● Balancing investment in Sanofi's future with responseto reduced diabetes expectations

● Simplification and savings to result in €1.5bn of cost reduction by 2018, largely reinvested

● Profitability to reflect net investment phase 2016-2017 with margin expansion expected to begin in 2018

● Capital allocation optimized to support shareholderreturns (steady dividend growth) and to enhanceoverall growth profile (disciplined M&A)

60

11

22

33

44

Page 61: 2015/11 - Meet Sanofi Management

MEET SANOFI Management

SUSTAINING INNOVATION IN R&D

Elias Zerhouni, MDPresident, Global R&D

Jorge InsuastySenior Vice President, Development

Philip LarsenDiabetes - Head of Research & Early Development

Mike PanzaraVice President, Multiple Sclerosis and Neurology, Genzyme

Seng ChengVice President, Head of R&D for Rare Diseases

Christian AntoniVice President, Head Development Immunology & InflammationGary Nabel

Senior Vice President, Chief Scientific Officer

Page 62: 2015/11 - Meet Sanofi Management

62

Agenda

Executing a clear R&D strategy

Next wave of innovation

Page 63: 2015/11 - Meet Sanofi Management

Significant R&D Turnaround since 2012

(1) From first in human to approval(2) Peptide, protein, nucleic acid based molecular entities and vaccines(3) From beginning of 2008 to end of 2011: Pentacel® (2008), Multaq® (2009), Jevtana® (2010) (4) Toujeo®, Afrezza®, Cerdelga®, Lemtrada®, Aubagio®, Zaltrap®, Kynamro®, Hexaxim®, Fluzone® Quadrivalent, Praluent®

2012 2015

Quality over Quantity(1) 79 projects 44 projects

Prioritization Unprioritized Tiering system

Biologics(2) 58% 85%

External Innovation >65% >65%

Early Development Fast to Market Fast to Proof of Concept

Cycle Times Slower than industry median

Faster than industry median

R&D Budget ~14% of sales ~14% of sales

Launches 3 launches since 2008(3) 10 launches since 2012(4)

63

Page 64: 2015/11 - Meet Sanofi Management

The Two Pillars of Our Research Strategy

Translational Medicine

Open Innovation

Deep efforts in a concentrated number

of projects

Adapting technology to the disease, not the reverse

64

Page 65: 2015/11 - Meet Sanofi Management

65

Continue to strengthen R&D pipelineA

C

D

B

Deliver a Balanced Pipeline… … Focused on GBU Priorities

Sustain Innovation in R&D over 2015-2020

Foster existing R&D collaborations (REGN, ALNY)

Increase capacity for external innovation

Implement the R&D 2.0 model

Increasing annual R&D investments up to €6bnby 2020 while maintaining financial discipline

● Sustain leadership: Diabetes/CV, Vaccines, Rare Diseases

● Build competitive positions: Oncology, MS, Immunology

● Invest opportunistically: Neurodegeneration/pain, Infectious Diseases and Ophthalmology

Page 66: 2015/11 - Meet Sanofi Management

0-2 years 5+ years3-5 years

TIME to Clinical Proof of Concept

ConsolidationSupport actively our GBUs and their competitive positioning

INN

OVA

TIO

N

TransformationalEnter novel and emerging scientific opportunities with breakthrough potential

Expansion Develop next generation products for each GBU

40%

40%

20%

Our Focus Today is on Building a Strong Follow-on Portfolio to Mature in 2015-2020

66

ILLUSTRATIVE

Page 67: 2015/11 - Meet Sanofi Management

Further Expanding the R&D Pipeline Is a Key Objective for the Next Phase

67

N New Molecular Entity

Immunology

Rare Diseases

Oncology

Diabetes

Vaccines

Infectious Diseases

Cardiovascular Diseases

Neurodegenerative Diseases

Ophthalmology

Multiple Sclerosis

GZ402668GLD52 (anti-CD52 mAb)

Relapsing multiple sclerosis

GZ402666neo GAA

Pompe Disease

SAR113244Anti-CXCR5 mAb

Systemic lupus erythematosus

SAR339375Anti-miR21 RNAAlport syndrome

GZ389988TRKA antagonist

Osteoarthritis

SAR439774 (ALN-AT3)siRNA targeting Anti-Thrombin

Haemophilia

SAR425899GLP-1R/GCGR dual agonist

Diabetes

SAR228810Anti-protofibrillar AB mAb

Alzheimer’s disease

SAR438335GLP-1R/GIPR dual agonist

Diabetes

SAR422459ABCA4 gene therapy

Stargardt disease

SAR566658Maytansin-loaded anti-CA6 mAb

Solid tumors

UshStat®

Myosin 7A gene therapyUsher syndrome 1B

SAR408701Anti-CEACAM5 ADC

Solid tumors

SAR366234EP2 receptor agonist

Elevated intraocular pressure

SAR439684PD-1 inhibitor

Cancer

Streptococcus pneumoniaMeningitis & pneumonia vaccine

SAR428926LAMP-1 inhibitor

Cancer

Herpes Simplex Virus Type 2HSV-2 vaccine

SAR439152Myosin inhibitor

Hypertrophic cardiomyopathy

Phase I

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

dupilumabAnti-IL4Rα mAbNasal polyposis;

Eosinophilic oesophagitis

GZ402671Oral GCS Inhibitor

Fabry Disease

SAR156597IL4/IL13 Bi-specific Ab

Idiopathic pulmonary fibrosis

olipudase alfarhASM

Niemann-Pick type B

sarilumabAnti-IL6R mAb

Uveitis

Rabies VRVgPurified vero rabies vaccine

Combinationferroquine / OZ439

Antimalarial

Meningitis ACYW conj.2nd generation meningococcal

conjugate infant vaccine

isatuximabAnti-CD38 naked mAb

Multiple myeloma

Tuberculosis Recombinant subunit vaccine

Fluzone® QIV HD Quadrivalent inactivated

influenza vaccine - High dose

Phase IIN

N

N N

N

LixiLanlixisenatide + insulin glargineFixed-Ratio / Type 2 diabetes

SAR342434insulin lispro

Type 1+2 diabetes

sarilumab Anti-IL6R mAb

Rheumatoid arthritis, EU

dupilumabAnti-IL4Rα mAb

Atopic dermatitis, Asthma

patisiran (ALN-TTR02)siRNA inhibitor targeting TTR

Familial amyloidotic polyneuropathy

revusiran (ALN-TTRsc)siRNA inhibitor targeting TTR

Familial amyloidotic cardiomyopathy

Jevtana®

cabazitaxelMetastatic prostate cancer (1L)

Clostridium difficileToxoid vaccine

RotavirusLive attenuated tetravalent

Rotavirus oral vaccine

VaxiGrip® QIV IM Quadrivalent inactivated

influenza vaccine (3-36 months)

Phase III

N

N

N

N

N

RegistrationlixisenatideGLP-1 agonist

Type 2 diabetes, U.S.

sarilumab Anti-IL6R mAb

Rheumatoid arthritis, U.S.

Dengvaxia®

Mild-to-severe dengue fever vaccine

PR5IDTP-HepB-Polio-Hib

Pediatric hexavalent vaccine, U.S., EU

VaxiGrip® QIV IM Quadrivalent inactivated

influenza vaccine (3 years+)

N

N

Page 68: 2015/11 - Meet Sanofi Management

68

Agenda

Executing a clear R&D strategy

Next wave of innovation

Page 69: 2015/11 - Meet Sanofi Management

Diabetes

Vaccines

Rare Diseases

1

2

3

4

69

Isatuximab - Multiple Myeloma

Immuno-oncology - Various oncology indications

5

6

7

9

(1) Patisiran, revusiran and ALN-AT3 developed in collaboration with Alnylam

Potentially Transformative Drugs in Earlier Stages of Development

Selected R&D Assets

Oncology

Immunology

8

Olipudase alfa - Niemann-Pick type B

Patisiran(1) - Familial Amyloidotic Polyneuropathy

Revusiran(1) - Familial Amyloidotic Cardiomyopathy

Dual agonists - Type 2 Diabetes

C. difficile vaccine - Nosocomial infections

IL4/IL13 Bi-specific Ab - Idiopathic Pulmonary Fibrosis

ALN-AT3(1) - Haemophilia

Page 70: 2015/11 - Meet Sanofi Management

MTD: Maximum Tolerated Dose(1) Patients on monotherapy study had a median of 4 prior lines of treatment and all patients received IMiD and a proteasome inhibitor; Majority (66%)

received pomalidomide or carfilzomib(2) Patients in combination study had median of 7 prior lines of treatment (74% refractory to prior Revlimid/dexamethasone and 81% refractory to IMiDs)

HDeckert, et al. Clin Cancer Res 2014;20:4574–83. MOA: Mechanisms of action(3) 52% of the patients experienced IARs with 3% of patients with IARs of grade 3/ 4. Pre-treatment prophylaxis used for all patients.

70

● Multiple Myeloma remains incurable

● 50,000 patients are diagnosed annually in the U.S. and Europe

● Encouraging efficacy in heavily pre-treated myeloma patients(1)

● Targets unique epitope possibly differentiating MoA(2)

● Manageable safety profile

● MTD not reached in single agent and combination

● Infusion reactions mainly cycles 1 & 2 and majority are Grade 1-2(3)

● No overlapping toxicity in combination with Revlimid®

● Monotherapy dose ranging study completed

Anti-CD38 (isatuximab): a Significant Opportunity to Potentially Address an Unmet Need in Multiple Myeloma

1

Page 71: 2015/11 - Meet Sanofi Management

71

New Strategic Alliance with Regeneron to Develop Cancer Treatments in Emerging Field of IO

Establish Sanofi’s presence in cancer immunotherapy, a rapidly growing and attractive segment of oncology Significant unmet needs remain despite advances shown with checkpoint

inhibitors

PD-1: Programmed death protein 1 LAG-3: Lymphocyte activation gene 3 IO: Immuno-Oncology(1) Including bi-specifics/multi-specifics antibodies(2) REGN2810

2

Entering Immuno-Oncology

1

2

3

Expand oncology pipeline, developing potentially best-in-class new antibodies(1) and novel combination therapies Alliance includes PD-1(2) in Phase I and a portfolio of antibodies, including

GITR and LAG3, with the first of these entering Phase I in 2016

Enable development of multiple assets in a fast-evolving IO space with a scale and focus beyond our existing discovery agreement

Page 72: 2015/11 - Meet Sanofi Management

IL4/IL13 Bi-specific Ab: Sanofi

IL4/IL13 Bi-specific Antibody (Ab): Demonstrated Biological Activity and Encouraging Safety Data

● Idiopathic Pulmonary Fibrosis (IPF) is a severe & rare(1) chronic lung disease with significant unmet need

● 5-year survival rate of 20%, comparable tolung cancer

● Unlike dupilumab which blocks the IL4 receptor, the IL4/IL13 bispecific Ab binds to the IL4 and IL13 cytokines

● Dose-dependent decrease of TARC-CCL17 biomarker, confirming IL4/IL13 target engagement

● Safe and well tolerated in Phase I study(2)

● Administered subcutaneously

● Phase II PoC trial started in May 2015

72

Blocks IL4 and IL13 cytokines

CH3CH3 CH2

CH2

CH1CH1

Ck

Ck

VH2

VH2VL2

VL2 VL1VH1

VH1VL1

Disulfide bond

G4S(2) linker

(GGGGSGGGGS)

Anti-IL-13

Fv position 1Anti-IL-4

Fv position 2

CH3CH3 CH2

CH2

CH1CH1

Ck

Ck

VH2

VH2VL2

VL2 VL1VH1

VH1VL1

Disulfide bond

G4S(2) linker

(GGGGSGGGGS)

Anti-IL-13

Fv position 1Anti-IL-4

Fv position 2

CH3CH3

CH2CH2

CH1CH1

Ck

Ck

VH2

VH2VL2

VL2VL1VH1

VH1VL1

Disulfid

e bon

d

G4S(2

) link

er

(GGGGSGGGGS)

Anti-IL-

13

Fv p

ositio

n 1

Anti-IL

-4

Fv pos

ition

2

CH3CH3

CH2CH2

CH1CH1

Ck

Ck

VH2

VH2VL2

VL2VL1VH1

VH1VL1

Disulfid

e bon

d

G4S(2

) link

er

(GGGGSGGGGS)

Anti-IL-

13

Fv p

ositio

n 1

Anti-IL

-4

Fv pos

ition

2

BLOCK BLOCK BLOCK

IL4 IL13

(1) Estimated prevalence: ~115,000(2) Phase I study in healthy subjects (n=36) and Idiopathic Pulmonary Fibrosis patients (n=18)

3

Phase II study completion expected in H2 2017

Page 73: 2015/11 - Meet Sanofi Management

C. difficile Vaccine Targeting a High Risk Population of 10 to 15 Million Elderly People in the U.S. Alone

● 660 volunteers aged 40-75 years at risk of C. difficile infections were included in a 2-stage Phase II trial ● Stage 1: dose ranging(1)

● Stage 2: selection of vaccination schedule(2)

● Candidate vaccine generated an immune response against both C. diff toxins A and B

● Neutralizing antibodies were comparable across ages including elderly

● Adverse reactions were generally mild and of short duration

● Objective is to assess efficacy, safety and immunogenicity in preventing the onset of symptomatic PCR-confirmed primary CDI cases

● 3 injections at 0, 7, and 30 days● Up to 15,000 adults to be enrolled –

1/3 already included● CDI case-driven study● Initiated in Q3 2013 and projected to take

4.5-5 years to complete

Fast Track Development Program designation granted by CBER(3)

PCR – Polymerase chain reaction(1) & (2) de Bruyn G et al. Poster presentations at 24th annual meeting of the European Congress of Clinical Microbiology and Infectious

Disease (ECCMID), May 2014(3) CBER: Center for Biologics Evaluation and Research

Phase II successfully completed Multinational Phase III ongoing

73

4

Page 74: 2015/11 - Meet Sanofi Management

Olipudase alfa – A Promising Investigational Treatment for Niemann Pick type B

● Niemann Pick is a serious LSD(1)

characterized by fat deposits in spleen and liver and respiratory problems

● Estimated incidence for Niemann Pick is 0.4 to 0.6 in 100,000 newborns(2)

● Olipudase alfa is a recombinant form of human ASM(3) developed as an ERT(4)

● Positive efficacy response in Phase Ibon pulmonary function, liver volume and spleen volume(5)

● Pivotal Phase II/III trial expected to start by the end of 2015

● FDA granted Breakthrough Therapy Designation in May 2015

74

5

Therapeutic Approach

Phosphorylcholine Ceramide

Sphingosine

Acid-Ceramidase

Intended result:Reverse and prevent somatic disease

if treatment begins early

Target the underlying metabolic defectby replacing the missing enzyme

Olipudasealfa

Olipudasealfa

Sphingomyelin

(1) LSD: lysosomal storage disorder(2) Meikle, P.J.,J.J. Hopwood, et al. (1999). “Prevalence of lysosomal storage disorders.” JAMA 281(3):249-254 ; Pinto, R., C. Caseiro, et al. (2004).

“Prevalence of lysosomal storage diseases in Portugal.” Eur J Hum Genet 12(2):97-92; Poorthuis, B.J., R.A. Wevers, et al. (1999). “The frequency of lysosomal storage diseases in The Netherlands.” Hum Genet105(1-2):151-156; Poupetova, H.,J.Levinova, et al. (2010). “the birth prevalence of lysosomal storage disorders in the Czech Republic: comparison with data in different populations.” J Inherit Metab Dis.

(3) ASM: acid sphingomyelinase (4) ERT: Enzyme Replacement Therapy (5) Study findings showed that the dose escalation regimen was well tolerated. No serious or severe adverse events or deaths were reported.

Page 75: 2015/11 - Meet Sanofi Management

Collaboration Provides Access to Unique RNAi Opportunities

● ~50,000 patients worldwide● FAP and FAC are the two predominant forms● Liver transplantation is often required early and

TTR stabilizers provide modest benefit

● Autosomal dominant with >100 defined mutations● Misfolds and forms amyloid deposits in nerves, heart,

other tissues

Progressive, debilitating monogenic

disease

Mutant transthyretin (TTR)

is genetic cause

RNAiis a potentially transformative

therapy

● Knockdown disease causing protein● Aim to halt progression, possibly achieve regression

Transthyretin-Mediated Amyloidosis (ATTR) Program

FAP: Familial amyloidotic polyneurapthyFAC: Familial amyloidotic cardiomyopathy 75

Page 76: 2015/11 - Meet Sanofi Management

Patisiran: Familial AmyloidoticPolyneuropathy

Patisiran: an Investigational IV Administered RNAiTherapeutic to Treat the FAP Form of ATTR

● Positive Phase II results in FA

● Statistically significant, dose dependent TTR knockdown of up to 96%(1)

● Phase II Open-Label Extension (OLE) ongoing

● APOLLO Phase III trial ongoing

● FDA submission targeted for 2017

76

Dose Response and Durationof TTR Knockdown

FAP: Familial amyloidotic polyneurapthyATTR: Transthyretin (TTR)-mediated amyloidosis(1) Generally well tolerated in FAP patients out to nearly two years, with minimal drug-related adverse events reported.

The most common drug-related or possibly drug-related adverse events were flushing (25.9%) and infusion-related reactions (18.5%), which were both mild in severity and did not result in any discontinuations.

(2) Excludes post-day 28 data from one patient that experienced drug extravasation during second infusion

% Mean Serum TTR KnockdownRelative to Baseline (SEM) - n=29

Days Since First Visit

Cohort 0.30 mg/kg q3w

Cohorts 0.01-0.30 mg/kg q4w

6

Patisiran Treatment Groups

0.01 mg/kg q4w (n=4)0.05 mg/kg q4w (n=3)0.15 mg/kg q4w (n=3)0.30 mg/kg q4w (n=6)(2)

0.30 mg/kg q3w (n=12)

Page 77: 2015/11 - Meet Sanofi Management

Revusiran: Familial AmyloidoticCardiomyopathy

● Positive Phase II results in TTR cardiac amyloidosis patients(1)

● Phase II Open Label Extension (OLE) ongoing

● Subcutaneous administration

● Phase III ENDEAVOUR trial ongoing

77

Rapid, Dose-dependent, Consistent, Durable Knockdown of Serum TTR of Up to 95%

Mean (SEM) % Serum TTRKnockdown Relative to Baseline

Study Day

Placebo(N=6)2.5 mg/kg MAD(N=3) 5.0 mg/kg MAD(N=3)

7.5 mg/kg MAD(N=6) 10.0 mg/kg MAD(N=3)

Revusiran Dose Group

ALN-TTRsc qd x5; qw x5

Dose Level[mg/kg]

Mean % kd (SD)

2.5 58.2 (11.1)

5 87.5 (7.2)

7.5 87.9 (1.2)

10 92.4 (1.5)

7 Revusiran: an Investigational Subcutaneously Administered RNAi Therapeutic to Treat the FAC Form of ATTR

FAC: Familial amyloidotic cardiomyopathyATTR: Transthyretin (TTR)-mediated amyloidosis(1) Generally well tolerated in the majority of ATTR cardiac amyloidosis patients.

Serious adverse events (SAEs) were observed in 8 patients (32%), including one death due to infiltrative cardiomyopathy; none of the SAEs were deemed to be related to study drug. The majority of the adverse events (AEs) were mild or moderate in severity; injection site reactions (ISRs) were reported in 11 patients (44%). As previously reported, 3 patients discontinued due to recurrent localized reactions at the injection site or a diffuse rash; no further discontinuations due to ISRs have occurred

Page 78: 2015/11 - Meet Sanofi Management

● Antithrombin (AT) is a key endogenousanticoagulant● Inactivates Factor Xa and thrombin

● Attenuates thrombin generation

● Expressed in liver; circulates in plasma

● Human AT deficiency associated with increased thrombin generation

● Subcutaneous ALN-AT3 aimed at correcting coagulation defects by knockdown of AT ● Currently in Phase I in

moderate-to-severehemophilia

ALN-AT3: an Investigational RNAi Therapeutic Targeting Antithrombin

ATFIX

FVIII

FIXa

FVIIa FVIIFVIIIa

FVa FV

FX

FXa

Fibrinogen Fibrin

ThrombinProthrombin

Blood clot

Intrinsic system Extrinsic system

Hemophilia B

Hemophilia A

FVIII

FIXAT

78

Coagulation Cascade

Phase III planned to start in mid-2016

8

Page 79: 2015/11 - Meet Sanofi Management

Dual Agonists for GLP-1 and Glucagon/GIP Receptors

79

● Novel synthetic peptidic molecules developed in-house

● Expected benefit is blood glucose control with superior weight loss over pure GLP-1 receptor agonists

● Phase I study of dual GLP-1/Glucagon agonist in healthy volunteers recently completed

● Phase I study of dual GLP-1/GIP agonist recently started

● Of particular interest in overweight to obese people with T2D● 60% of the T2D population

-1.4%-1.2% HbA1c vs. Placebo

0

2

4

6

8

10

Day ‐4

Day 28

Sanofi dualAgonist 4 µg/kg

Liraglutide40 µg/kg Placebo

‐7‐6‐5‐4‐3‐2‐10123

0 5 10 15 20 25 30Study days

GLP-1/Glucagon Dual AgonistGlucose Control Similar to Liraglutide - Animal Data(1)

GLP-1/Glucagon Dual AgonistBody Weight Loss Superior to Liraglutide (~5%) - Animal Data(1)

Sanofi dual agonist 4 µg/kg

Liraglutide40 µg/kg

Placebo%

Bod

y w

eigh

tlos

s(c

ompa

red

to d

ay-5

) H

bA1c

(%)

(1) 4 week study in obese, diabetic non-human primates comparing 4 µg/kg Sanofi dual agonist with 40 µg/kg liraglutideand vehicle (2-step uptitration to reach maintenance dose on day 6), data on file

9

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80

Significant R&D Milestones Expected in the Next Year

80

Expected Regulatory Decisions Q4 2015 Q1 2016 Q2 2016 Q3 2016● Dengvaxia® in Endemic Countries

● Lixisenatide in Diabetes (U.S.)

Expected Regulatory Submissions Q4 2015 Q1 2016 Q2 2016 Q3 2016● Sarilumab in Rheumatoid Arthritis (U.S.)

● LixiLan in Diabetes (U.S.)

● LixiLan in Diabetes (E.U.)

● Rotavirus vaccine (India)

● Dupilumab in Atopic Dermatitis (U.S.)

Expected Headline Phase III Data Releases Q4 2015 Q1 2016 Q2 2016 Q3 2016● Dupilumab in Atopic Dermatitis

● Insulin lispro in Diabetes

● Sarilumab in Rheumatoid Arthritis (MONARCH)

Expected Phase III Starts Q4 2015 Q1 2016 Q2 2016 Q3 2016● Meningitis ACYW conj. vaccine

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81

Transforming the Lives of Patients by Delivering Innovative Therapies

Significant pipeline turnaround since 2012

Translational Medicine and Open Innovation

Increase R&D investments while maintaining financial discipline

Consolidate / Expand / Transform

Implementation of the R&D 2.0 model and alignment with future GBUs

Wave of potentially transformative drugs in earlier stages of development

1

2

3

4

Page 82: 2015/11 - Meet Sanofi Management

MEET SANOFI Management

DIABETES

Pascale WitzExecutive Vice President, Diabetes & Cardiovascular

Pierre ChancelSenior Vice President, Diabetes

Andrew PurcellVice President and Head, U.S. Diabetes Business Unit

Riccardo Perfetti, MDSenior Medical Officer, Diabetes

Page 83: 2015/11 - Meet Sanofi Management

83

Agenda

Sanofi’s global diabetes leadership

A broad and growing portfolio

Significant unmet medical needs

Page 84: 2015/11 - Meet Sanofi Management

North Americaand CaribbeanEurope

Western Pacific

South andCentral AmericaSouth East Asia

Middle East andNorth AfricaAfrica

2014

Diabetes is a Huge and Growing Global Challenge(1)

84(1) International Diabetes Federation Diabetes Atlas 6th Edition revision 2014

2035

WORLD

387mPrevalence:

8.3%

Number of People Living with Diabetes Expected to Increase by 53% between 2014 and 2035

46.3%undiagnosed

WORLD

592m53%

North America and Caribbean 30%Europe 33%

Western Pacific 46%

South and Central America 55%South East Asia 64%

Middle East and North Africa 85%Africa 93%

Page 85: 2015/11 - Meet Sanofi Management

1 healthcare $ in 9

is spent on diabetes

77% of people with diabetes live in low- and middle-income countries

Every 7 seconds1 person dies from diabetes

● 4.9m deaths in 2014● 50% of deaths under 60 years of age

● Intersects with all dimensions of development

● In 2014 diabetes expenditure reached $612bn

● 11% of worldwide healthcare expenditure

Diabetes Is a Human and Economic Burden

Diabetes Costs to Society Are High and Escalating(1)

85(1) International Diabetes Federation Diabetes Atlas 6th Edition revision 2014Icons designed by Freepik

Page 86: 2015/11 - Meet Sanofi Management

Diabetes Patients in the U.S. (Random Sample)

Despite Treatment, Many Patients with Diabetes Are Still not at A1c Goal(1)

86

47% 47%

53% 53%

2013(437)

2013(2215)

T1D Patients T2D Patients

A1c: glycated haemoglobin(1) Adelphi Real World Diabetes Disease Specific Program (DSP) X, 2013Base: U.S. diabetic patients where doctor has stated most recent A1c (random sample) All patients are treated patients and must be on an OAD, GLP-1 or insulin

Uncontrolled (A1c >7%)

Controlled (A1c ≤7%)

Page 87: 2015/11 - Meet Sanofi Management

Inappropriate Diabetes Management Leads to Costly Consequences

87

Microvascular Complications

● Diabetic Retinopathy

● Diabetic Nephropathy

● Diabetic Neuropathy

(1) Endocrinol Metab Clin 1996;25:243 - 254 (DCC Trial)(2) Diabetes Care Publish Ahead of Print, published online March 6, 2013

Risk of Complications and A1c(1)

25% to 45% of diabetes-attributed medical expendituresspent treating complications of diabetes(2)

A1c (%)

Relative Risk in %

1

3

5

7

9

11

13

15

6 7 8 9 10 11 12

RetinopathyNephropathy

MicroalbuminuriaNeuropathy

Macrovascular Complications

● Stroke

● Heart Disease

● Peripheral VascularDisease

Page 88: 2015/11 - Meet Sanofi Management

88

Agenda

Sanofi’s global diabetes leadership

A broad and growing portfolio

Significant unmet medical needs

Page 89: 2015/11 - Meet Sanofi Management

A Sizeable Presence in Diabetes Built on Lantus®, our Insulin Flagship Brand

Global diabetes sales expected to decline at an average annualizedrate of between 4% and 8% at CER over the period of 2015-2018

Sanofi Global Diabetes Sales

89

2012 2013 2014 2015e

€5,782m+16.7% at CER

€6,568m+18.7% at CER

€7,273m+12.1% at CER

-6% to -7%at CER

Page 90: 2015/11 - Meet Sanofi Management

Global Diabetes Sales Account for 20% of Group Sales in the First 9 Months of 2015

20.4%79.6%

57%

43%

U.S. ex U.S.

DiabetesSales

€5,677m-4.6%

Total Group Sales excluding Diabetes€22,102 m+5.8%

YTD Sep 2015 Diabetes Sales by Geographies (in €m)

€2,417m+9.5%

€3,260m-14.2%

Western Europe: +3.5%

Emerging Markets: +17.0%

RoW: +2.6%

Sales Growth at CER

Regional Sales Growth at CER

90

Page 91: 2015/11 - Meet Sanofi Management

48.0%

32.6%

19.3%

Basal Insulins Constitute the Leading Insulin Segment Across All Geographies

91

June MAT 2015 Insulin Market Breakdown by Insulin Type (Value)(1)

Market Share (%)U.S.

Emerging Markets

38%+ 10%

(1) Market share data from Source IMS Health MIDAS MAT June 2015 – Copyright 2015 – All rights reservedNote: IMS data is based on list prices and does not take account of privately-negotiated discounts and rebates

Western Europe

Japan/Can/Aus/NZPremix

BasalSAI

49.3%35.8%

14.8%

43.5%

37.1%

19.4%

54.0%36.5%

9.5%

Page 92: 2015/11 - Meet Sanofi Management

64.4%13.1%

9.6%12.9%

70.5%

25.5%

Toujeo®

0.2%3.8%

56.4%

13.9%1.4%

28.3%

61.4%23.3%

3.9%

11.4%

June MAT 2015 Basal Insulin Market Breakdown by Brand (Value)(1)

Market Share (%)

Sanofi Has Leading Positions in the Basal Market in All Geographies

92Levemir® and Tresiba® are Novo Nordisk brands(1) Market share data from Source IMS Health MIDAS MAT June 2015 – Copyright 2015 – All rights reserved

U.S.

Emerging Markets

Western Europe

Japan/Can/Aus/NZNPH

Lantus®

Levemir®

Tresiba®

Toujeo®

Page 93: 2015/11 - Meet Sanofi Management

31%

43%46%

37%

23% 20%

0%

10%

20%

30%

40%

50%

2004 YTD June 2015

% of sales Basal Premix SAI

Insulin Market by Insulin Type (Value)

Basal Insulin Now the Gold Standard in Emerging Markets and Sanofi Is Leading the Basal Segment

93

Emerging Market Share (%)

Emerging Markets: World excluding the U.S. and Canada, Western Europe, Japan, Korea, Australia and New ZealandSource: Market share data from Source IMS Health MIDAS Q2/2015 – Copyright 2015 – All rights reservedSAI – Short acting insulin

Focusing on expanding access to Lantus® in Emerging Markets

Page 94: 2015/11 - Meet Sanofi Management

94

Agenda

Sanofi’s global diabetes leadership

A broad and growing portfolio

Significant unmet medical needs

Page 95: 2015/11 - Meet Sanofi Management

95

Broadening our Portfolio to Sustain a Leadership Position in Diabetes

1 Establish next generation of basal insulins

2 Innovate with a new combination of basal insulin and GLP-1

4 Lead market shift to data analytics and population outcome care standards through Google collaboration

3 Expand access to Lantus® in Emerging Marketswhile managing Lantus® LoE(1) in mature markets

5 Strengthen pipeline through external opportunities and ambitious research

(1) LoE: Loss of exclusivity

GoogleLife Sciences

Page 96: 2015/11 - Meet Sanofi Management

A Compelling Value Proposition

(1) Toujeo® Prescribing Information, February 2015

Introducing, from the Makers of Lantus®

Toujeo® – Designed and Developed to Be a New Basal Insulin Option(1)

Unmet needs

Micro-precipitate

Stable Activity Profile

Proven Efficacy

Predictable Safety

Toujeo®

SoloStar®Toujeo®

COACH

1 2 3

96

Page 97: 2015/11 - Meet Sanofi Management

0

2000

4000

6000

8000

10000

12000

14000

16000

0%

10%

20%

30%

40%

50%

60%

Basal Market NBRx Shares(2)

week of April 3 - week of Oct 16, 2015

Lantus®

50.9%

Share (%)

Encouraging U.S. Launch Metrics

(1) IMS Weekly Data(2) Basal market includes Toujeo®, Lantus®, Levemir® (Novo Nordisk) and NPH - Source: IMS Weekly Data(3) Toujeo® analogues include: Bydureon® (AstraZeneca), Invokana® (J&J), Farxiga® (AstraZeneca), Trulicity® (Eli Lilly), Tanzeum® (GlaxoSmithKline)

and Levemir® (Novo Nordisk)97

Toujeo® TRx, NRx & NBRx Volume(1)

week of April 3 - week of Oct 23, 2015

9,037NRx

Rx (absolute)

Cumulative TRx 205,299

15,511TRx

13.7%

Levemir®

26.3%5,717NBRx

Cumulative NBRx91,838

NPH9.0%

Toujeo® uptake trending favorably compared to diabetes analogues(3)

Cumulative NRx 134,476

Page 98: 2015/11 - Meet Sanofi Management

Rapid Market Access Obtained in the U.S.

98

Toujeo® Market Accessas of October 1, 2015

% Lives Covered

17%

69%

0%

20%

40%

60%

80%

100%

Commercial Medicare

Tier 2 Tier 2

Tier 3

91%86%

● Parity pricing with Lantus® helped secure rapid and comparable access

● Broad Medicare access achieved ahead of standard timelines

● Focused pull-through efforts in place

Page 99: 2015/11 - Meet Sanofi Management

0%

1%

2%

3%

4%

5%

6%

7%

8%

-6%

-4%

-2%

0%

2%

4%

6%

8%

Germany Showing the Way for Other EU Launches

99

Levemir® and Tresiba® are Novo Nordisk brands(1) Insight Health Germany (Retail Apo-Weekly-Pharma) – All data including parallel trade(2) Toujeo® week of May 5 - Oct 27, 2015; Tresiba® week of April 29 - Oct 21, 2014(3) In July 2015 Novo Nordisk announced that the company decided to cease distribution of Tresiba® in Germany at the end of September 2015 following

a negative outcome of price negotiations with the GKV-Spitzenverband, the German national association of statutory health insurance funds

Weekly Evolution of Sell Out Datawithin Basal Market(1)

% Market Share Delta Developmentvs. May 5, 2015 in Units (Packs)

Toujeo® Weekly Sell Out Data within Basal Market(1,2)

% Market Share in Units (Packs)

21.3%

53.0%

% MS in Basal

Market

Win/Loss in percentage

points6.0%

-4.0%

Toujeo®

Launch on May 5, 2015

Levemir® + Tresiba®

Lantus® + Toujeo®

7.1%

Tresiba®

3.8%

Tresiba®

Ceased Distribution

in Oct 2015(3)

Tresiba®Toujeo®

Page 100: 2015/11 - Meet Sanofi Management

EM andRest of World

Global Launch Continues in EU, EM and RoW

100(1) The brandname of Toujeo® in Japan is Lantus® XR: launched in September 2015

H2 2015 2016

EuropeItaly

France

Spain

UK Czech Rep.

Finland

Australia BrazilS. Korea MexicoCanada SwitzerlandJapan(1)

Belgium GreeceNorway

IrelandAustria Sweden Poland

Page 101: 2015/11 - Meet Sanofi Management

Real-Life Study Program to Expand the Evidence Base

● Insulin-naïve T2D patients (U.S.)

● Target enrolment: 3,270● Primary endpoint:

composite endpoint (A1c+hypo) according to the HEDIS criteria

● Insulin-naïve T2D patients (EU)

● Target enrolment: 800● Primary endpoint:

A1c changes

● T2D patients uncontrolled on basal insulin (EU)

● Target enrolment: 600● Primary endpoint:

A1c changes

HEDIS – Healthcare Effectiveness Data and Information Set 101

Initial results expected in 2017, extended follow-up findings in 2018

Study Program to Investigate Patient Experience, Clinical Effectiveness and Health Resource Utilization in People with Type 2 Diabetes

>4,500 adults with T2D from the U.S. and Europe

Page 102: 2015/11 - Meet Sanofi Management

102

An Investigational Agent Combining Insulin Glargine with Lixisenatide in a Daily Injection

FPG + PPG control

Statistically significant A1c reduction versus components

More patients with A1c <7%

Weight neutral versus insulin glargine

Reduced nausea versus lixisenatide alone

No additional incidence of hypos vs. basal

Fixed Ratio Combinationof Two Active ComponentsSingle Once Daily Injection =

Expected key regulatory submissions: U.S. Q4 2015 & EU Q1 2016

PPG: Post-Prandial GlucoseFPG: Fasting Plasma Glucose

Page 103: 2015/11 - Meet Sanofi Management

Significant Opportunity in Type 2 Diabetes Supported by Two Positive Phase III Studies

103

Patients Uncontrolledwith Basal Therapy:

~4m

Patients Not at Target

on OAD:~5.5m

1st injectable drug

Basal intensification

Two Well Defined U.S. T2D Patient Populations for LixiLan

Positive Top-line Results in Two Pivotal Phase III Studies

OAD: Oral anti-diabetic

Met HbA1c primary endpoints compared to insulin glargine and compared to lixisenatide

Regulatory submission expected in the U.S. in December 2015 and EU in Q1 2016

LixiLan-O study in patients insufficiently controlled on OADs

LixiLan-L study in patients not at goal on basal insulin

Page 104: 2015/11 - Meet Sanofi Management

Important Options for Prandial Diabetes Treatment

104

● Once-daily prandial GLP-1 for Type 2 Diabetes(1)

● Positive ELIXA study results demonstrated CV safety(2)

● More pronounced PPG-lowering compared to liraglutide(3)

● U.S. regulatory decision expected in Q3 2016

● Approved in over 50 countries worldwide

(1) GLP-1 RA: glucagon-like peptide-1 receptor agonist (2) ELIXA evaluated CV outcomes in Type 2 Diabetes patients after Acute Coronary Syndrome during treatment with lixisenatide(3) PPG (post-prandial glucose) lowering effect evaluated after a test-meal - Meier JJ et al, 2014 ADA, Poster 1017-P(4) Apidra® is for adults with type 2 diabetes or adults and children (4 years and older) with type 1 diabetes to improve blood sugar control

● A rapid acting, mealtime, injectable insulin for Type 1 and Type 2 Diabetes(4)

● Available in SoloSTAR® pen

● Strong double-digit YTD Sep 2015 growth in Emerging Markets

● U.S. performance in YTD Sep 2015 was driven by lower demand that was partially offset by price increases

®

Page 105: 2015/11 - Meet Sanofi Management

Innovative Treatment Option for Diabetes

Continued Focus on Gaining Market Access, Building Awareness and Appropriate Usage

A rapid-acting inhaled insulin

Fast absorption rate and short duration of action(1)

An innovative device

105

U.S. Launch in Feb 2015

● Time needed for Afrezza® to demonstrate its potential● Gradual market access● FDA requirements for starting patients on Afrezza®

● Novel mode of administration and innovative nature of the product

● DTC advertising campaign and expanded number of physician targets for sales force

● Commercial focus on ~1.1m uncontrolled basal insulin intensification patients(2,3,4)

(1) Despite the fast absorption of insulin (PK) from Afrezza®, the onset of activity (PD) was comparable to insulin lispro(2) Uncontrolled basal Insulin or Basal ± GLP1 ± OAD patients (A1c >7%)(3) Adelphi Real World: Diabetes DSP 9 (2012), Data on File. US Data(4) Excludes patients for whom Afrezza® is contraindicated

Page 106: 2015/11 - Meet Sanofi Management

Diabetes Integrated Care: Significant Potential to Improve Patients’ Lives

● Leader in the technology space● Data analytics and integration of

information silos● Smart delivery and sensor devices● Miniaturization

● Leader in insulin management ● Deep clinical and medical expertise ● Regulatory and market access● Leading portfolio of pharmaceuticals

Significantcost savings

Betterpatient &providerengage-

ment

Leveraging Complementary Strengths to Establish New Standards for Diabetes Care

106

Improved clinical

outcomes

Real-timemonitoring

& care

GoogleLife Sciences

Page 107: 2015/11 - Meet Sanofi Management

107

2000basal insulin

2004rapid-acting injectable

insulin

2014rapid-acting

inhaled insulin

®

2015new basal

insulin

2016+basal insulin

and GLP-1 RA combination(2)

2013once-daily GLP-1 RA(1)

(1) Lyxumia® approved for treatment of Type 2 Diabetes in Europe in February 2013; U.S. regulatory decision expected in Q3 2016

(2) LixiLan regulatory submission expected in the U.S. in December 2015 and EU in Q1 2016

A Broad and Growing Diabetes Portfolio

Page 108: 2015/11 - Meet Sanofi Management

MEET SANOFI Management

PRALUENT®

Pascale WitzExecutive Vice President, Diabetes & Cardiovascular

Ophra RebièreVice President, General Manager, Brand Team Leader Praluent®

Victoria CareyVice President, Head of U.S. Alirocumab Commercial

Praluent® is developed and commercialized in collaboration with Regeneron

Page 109: 2015/11 - Meet Sanofi Management

109

Agenda

Significant unmet need and cost burden

Strong and differentiated product profile

Initial uptake gradual as expected

Upcoming milestones and future opportunity

Page 110: 2015/11 - Meet Sanofi Management

Cardiovascular Disease Is a Major Health and Economic Burden with Uncontrolled LDL-C Being a Key Risk Factor

110

ACS: Acute Coronary Syndrome(1) CDC and Prevention. Heart Disease Facts. Available from http://www.cdc.gov/heartdisease/facts.htm. Last accessed 29 April 2015(2) Go AS, Mozaffarian D, Roger VL, et al. Circulation. 2014;129(3): e28-e292(3) Zhao Z, Winget M. Economic burden of illness of acute coronary syndromes: medical and productivity costs. BMC Health Serv Res. 2011;11:35(4) 2016 estimates for U.S., EU Top 5 and Japan; U.S. NHANES, Market Scan, IMS and Sanofi estimates; includes HeFH and primary and secondary prevention(5) Costs based insurance claims data; Long term care (e.g. rehab, nursing home) and indirect costs (e.g. lost productivity) are not included; the estimated

one-year cost of an ACS among working-age Americans (direct and indirect) $50,000 - $119,000(6) Inflation adjusted to 2007; OSullivan AK. Pharmacoeconomics. 2011;29(8):693-704.(7) Inflation adjusted to 2004; Smolderen KG, et al. Eur J Vasc Endovasc Surg 2012;43:198e207.

#1Cause of death

worldwide(1)

claims more lives than all forms of cancer combined

Estimated cost of CV disease

management(2,3)

includes health expenditures and lost

productivity

Estimated cost of an ACS event(5)

Patients at high CV risk fail to reach

LDL-C goals(4)

high cholesterol is a key risk factor for

CV disease

24million

$315billion

$34,200(6)

direct costs

€196billion

€4,400-€6,000(7)

direct costs

Page 111: 2015/11 - Meet Sanofi Management

111

Agenda

Significant unmet need and cost burden

Strong and differentiated product profile

Initial uptake gradual as expected

Upcoming milestones and future opportunity

Page 112: 2015/11 - Meet Sanofi Management

112

Significant and Consistent LDL-C Reduction in Five Double-Blind, Placebo-Controlled Trials(1)

Praluent® is developed and commercialized in collaboration with Regeneron*p<0.0001; ASCVD: Clinical Atherosclerotic Cardiovascular Disease; HeFH: Heterozygous Familial Hypercholesterolemia(1) Praluent® data from U.S. FDA Prescribing Information(2) Criteria-based up-titration to 150 mg Q2W at week 12 for patients who did not achieve their pre-specified target LDL-C at week 8(3) LDL-C mean % change from baseline; 24 week (primary endpoint)(4) In the LONG TERM study, 18% of patients had HeFH

-44%*

-2%

COMBO I Study (n=316)(3)

Majority Clinical ASCVD Patients

Praluent®

75 mg/150 mgQ2W + statin

Placebo + statin

0%

-58%*

+1%

LONG TERM Study (n=2,341)(3)

Majority Clinical ASCVD Patients(4)

Praluent®

150 mgQ2W + statin

Placebo + statin

0%

+7%

-47%*

FH I & FHII Studies (n=735)(3)

Majority HeFH and/or Clinical ASCVD Patients

Praluent®

75 mg/150 mgQ2W + statin

Placebo + statin

0%

-43%*-7%

High FH Study (n=107)(3)

Majority HeFH and/or Clinical ASCVD Patients

Praluent®

150 mgQ2W + statin

Placebo + statin

0%

75 mg Up-Titration Regimen(2) Started and Maintained on 150 mg

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113

Praluent® is developed and commercialized in collaboration with Regeneron(1) In the pooled analysis of 6 studies with alirocumab 75mg Q2W on background statin (FH1, FH2, Combo 1, Combo 2, Option 1 and Option 2), 73.7% of

patients achieved LDL-C<70 or <100 mg/dL (depending on CV risk) at Week 8, and did not require up-titration(2) IMS NPA Rapid Weekly(3) ODYSSEY clinical trials using the auto-injector included: High FH, Mono and Alternative, FH1, FH2, Combo 1, Combo 2, Option 1 and Option 2(4) Material developed according to European Medicines Agency Summary of Product Characteristics (SmPC)

Effective LDL-C Reduction on Lower Dose with Auto-Injector Available for Both Doses at Launch

Over 70% of Patients Using Lower 75mg Dose Reached LDL-C Goal in

ODYSSEY Clinical Trials(1)

● 95% of dispensed prescriptions in the U.S. for lower 75mg dose(2)

75 mg/1 mL pen 150 mg/1 mL pen

Both doses available in a single-dose, 1-mL, auto-injector pen and prefilled syringe

(4)

High Injection Acceptance by Patients Supported by Auto-Injector in

ODYSSEY Clinical Trials(3)

● Single 1mL dosage forms for subcutaneous self-injection at home

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114

Approved in the U.S. and EU in High CV Risk Hypercholesterolemic Patients(1)

Approved in EU on September 25, 2015

Indicated in adults with primary hypercholesterolemia (HeFHand non-familial) or mixed dyslipidaemia, as an adjunct to diet in patients unable to reach their LDL-C goals with a maximally-tolerated statin and patients who are statin intolerant, or for whom a statin is contraindicated

FDA approval granted on July 24, 2015

Indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL cholesterol(LDL-C)

Praluent® is developed and commercialized in collaboration with Regeneron(1) The effect of Praluent® on CV morbidity and mortality has not been determined

Page 115: 2015/11 - Meet Sanofi Management

U.S. Label Criteria Represent 90% of Patients in the ODYSSEY Clinical Trial Population(1)

115

Praluent® is developed and commercialized in collaboration with Regeneron(1) Based on five double-blind, placebo-controlled studies that are included in the label(2) Non-heterozygous FH based on AHA/ACC Guidelines, Stone et al.

54% withClinical Atherosclerotic

Cardiovascular Disease (ASCVD)(2)

Defined as any of the following diagnoses: ● Acute coronary syndromes● History including

● Myocardial infarction● Stable or unstable angina● Coronary or other arterial

revascularization● Stroke/transient ischemic stroke

● Peripheral arterial disease presumed to be of atherosclerotic origin

Diagnosed using Simon Broome or Dutch Lipid Networking criteria including:● Cholesterol levels● Physical manifestations● Family history● Genetic testing

36% with Heterozygous Familial

Hypercholesterolemia (HeFH)

90% of ODYSSEY population

Page 116: 2015/11 - Meet Sanofi Management

HeFH Patients(~0.5m)

● Well defined population● Diagnosed with HeFH

(~0.1m)

Eligible U.S. Hypercholesterolemic Patient Population Comprised of Three Segments

116

Praluent® is developed and commercialized in collaboration with RegeneronASCVD: Clinical Atherosclerotic Cardiovascular Disease; HeFH: Heterozygous Familial HypercholesterolemiaCHD: Coronary Heart Disease; ACS: Acute Coronary Syndrome; PAD: Peripheral Artery DiseaseSource: US NHANES, Market Scan – US inputs (estimated 2016 population)Icons designed by Freepik

Addressable patient population could increase based on CV outcome data in late 2017

ASCVD Patients

Recent Event(~1.3m)

● Event in last 12 months

Prior Event(~9.2m)

● Event 13+ months● CHD + ACS (6.9m)● Stroke (1.4m)● PAD (1.0m)

Heterogeneous population

High riskTreatment engaged

populationUnderdiagnosed population

Page 117: 2015/11 - Meet Sanofi Management

Treatment Population in the U.S. Influenced by Many Factors

117Praluent® is developed and commercialized in collaboration with Regeneron

Factors Influencing U.S. Praluent® Treatment Population

Utilization of Existing Medicines

● Optimizing use of statin and other lipid-lowering therapies

Patient, Physician, Access Considerations

● Awareness

● Adoption

● Willingness to inject

● Market access gained

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118

Agenda

Significant unmet need and cost burden

Strong and differentiated product profile

Initial uptake gradual as expected

Upcoming milestones and future opportunity

Page 119: 2015/11 - Meet Sanofi Management

Early Success with U.S. Payer Access

● Praluent® offers significant medical value to patients and payers● Projected to be cost-effective based

on standard QALY model analyses(1)

● Average WAC for Praluent® is $40 per day or $14,600 per year

● Actual patient and payer cost is lower● Patient assistance and bridge

reimbursement programs● Commercial plan rebates● Mandated government payer rebates

119

Praluent® is developed and commercialized in collaboration with RegeneronQALY: Quality-Adjusted Life YearsWAC: Wholesaler Acquisition Cost(1) Based on internal models

● Preferred Tier 2 formulary position granted by ESI

● Parity access for both PCSK9 brands

● 30m commercial formulary lives directly managed by ESI

● Additional 50m lives utilize ESI to model and support customer formulary

● Formulary status at CVS and UnitedHealthcare pending

Page 120: 2015/11 - Meet Sanofi Management

● Copay support(commercial)

● Patient Assistance Program (uninsured)

● Copay foundation referrals

● Praluent® free of charge during coverage appeals

● Benefits investigations

● Prior authorization assistance

● Appeals support

● Payer information

● Coverage exception support

120

Comprehensive Support for U.S.Patients and Prescribers

MyPraluent™ Assists with:

Coverage

Cost(1)

ObtainingPraluent® (alirocumab)

Clinical Support

Adherence

● Specialty pharmacy coordination● Home delivery● In-store pick up

● On-call nurses

● Patient self-injection training

● Adverse event reporting

● Product and disease information

● Information on diet and lifestyle changes

● Injection reminders

● Refill reminders

● Adherence education

Praluent® is developed and commercialized in collaboration with Regeneron(1) Subject to program requirements

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121

U.S. Comprehensive Support HubTracking Ahead of Expectations

● Majority of patients enrolled by specialists● Around 5,000 prescribers

● Benefits investigation requires at least one month● More time required for Medicare

Part D plans

● Efficient patient referral to specialty pharmacy or patient assistance programs

Enrollments by Specialty (%)

PCP/NP/Other

Specialists

73% 27%

Praluent® is developed and commercialized in collaboration with Regeneron

Page 122: 2015/11 - Meet Sanofi Management

U.S. Launch Gradual as Market Accessand Awareness Accelerate

● Specialty pharmacy dispensing expected to accelerate● Bolus of adjudicated patients awaiting

coverage decisions

● Weekly IMS NPA prescription data under-reports underlying demand● Product samples and reimbursement

bridge program not captured● Express Scripts specialty pharmacy (Accredo)

blocked Praluent® prescription data prior to October 9, 2015

● Does not capture non-retail prescriptions0

20

40

60

80

100

120

Praluent®

NRx Volumeweek of Aug 7 - week of Oct 23, 2015

NRxCumulative NRx 628

NRx (absolute)

Praluent® is developed and commercialized in collaboration with RegeneronSource: IMS NPA Rapid Weekly 122

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123

Agenda

Significant unmet need and cost burden

Strong and differentiated product profile

Initial uptake gradual as expected

Upcoming milestones and future opportunity

Page 124: 2015/11 - Meet Sanofi Management

ODYSSEY OUTCOMES Expected to Be Fully Enrolled by Q4 2015

Praluent® is developed and commercialized in collaboration with Regeneron(1) Rationale and design in Schwartz GG et al. Am Heart J 2014;0:1-8.e1.(2) High intensity statin therapy include atorvastatin 40/80mg or rosuvastatin 20/40mg(3) Patients can also qualify with apoB>80mg/dL or non-HDL-C > 100 mg/dL(4) The effect of Praluent® on morbidity and mortality has not yet been determined. Primary endpoint is a composite endpoint of coronary heart disease

death, non-fatal myocardial infarction, fatal and non-fatal ischemic stroke, and unstable angina requiring hospitalization124

N=9,000

Run-in periodRandomization

4-52 weeksafter index event

Screening visit:Initiate high dose statin therapy(2)

Double-blind treatment period (minimum of 2 years)

Qualifying visit: LDL-C must be >70mg/dl(3)

R

Patients with recent ACS>40 years of

age Praluent® 75mg SC Q2WUp-titration at Week 12 if needed

Placebo SC Q2W

N=9,000+ Diet (NCEP ATP III TLC or equivalent diet)

Continued high dose statin

Primary Endpoint(4)

A composite of major CV endpoints

ODYSSEY OUTCOMES Clinical Trial Design(1)

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125

ODYSSEY OUTCOMES Second Interim Analysis Expected in H2 2016

● ODYSSEY OUTCOMES trial design published in Nov 2014(1,2)

● Two interim analyses planned prior to study completion in late 2017

● 90% power to detect an expected 15% hazard reduction in the primary endpoint

● DSMB will conduct two interim analyses to assess safety and efficacy● Interim analysis for futility when ~50% of events have

occurred● Second interim analysis for futility and overwhelming efficacy

when ~75% of events have occurred in H2 2016

Praluent® is developed and commercialized in collaboration with RegeneronDSMB: Data Safety Monitoring Board(1) Rationale and design in Schwartz GG et al. Am Heart J 2014;0:1-8.e1.(2) Assumptions include the incidence of a primary endpoint event in the placebo group, 1% of patients lost to follow-up

through 24 months, a median LDL-C at baseline of 90 mg/dL, and a 50% reduction of LDL-C from baseline with Praluent® treatment

Page 126: 2015/11 - Meet Sanofi Management

Global Launch Outside U.S. Ongoing

126

H2 2015 2016

JapanCanada

Italy Spain France

EU 5

Rest of World

Germany UK

Praluent® is developed and commercialized in collaboration with Regeneron

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Leadership in the PCSK9 Market

127

2015Launch Focus

Gradual Uptake Expected

2016-2017Future Opportunity

Expansion and Acceleration

Praluent® is developed and commercialized in collaboration with Regeneron(1) Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred

Building awareness & education

Executing centralized patient initiation & distribution model in the U.S.

Gaining U.S. market access

Driving appropriate use & adherence

● EU top 5 launches planned in Q4 2015 and 2016

● ODYSSEY OUTCOMES interim efficacy analysis(1) expected in H2 2016

● ODYSSEY OUTCOMES study completion expected in late 2017

● Real world and life cycle studies to support market access and value for sub-populations

Page 128: 2015/11 - Meet Sanofi Management

MEET SANOFI Management

RARE DISEASES & MULTIPLE SCLEROSIS

David Meeker, MDExecutive Vice President, CEO Genzyme

Richard PetersSenior Vice President, Head of Rare Diseases

Bill SiboldSenior Vice President, Head of Multiple Sclerosis

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129

Agenda

Genzyme: a success story

Rare Diseases: an untapped opportunity

Multiple Sclerosis: a fast-growing player

Page 130: 2015/11 - Meet Sanofi Management

Inspired by the Potential to Improve Patients' Lives

130

Milena , Argentina

Gaucher DiseaseDean , Australia

Multiple Sclerosis

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131

● Strong historic growth: >25% per year over 2012-2015

● Leading position in Rare Diseases

● Growing presence in Multiple Sclerosis

● Around 10% of Sanofi sales(1)

● Proven ability to execute in specialized disease areas

● Historic supply chain issues successfully addressed

(1) Calculated using YTD Q3 2015 sales

2012-2015

Genzyme Has Delivered Strong Growth since 2012

~€1bn

~€3.5bn

2015e

€1,785m

~€2.5bn

2014

€2,604m

2013

€2,142m

2012

MultipleSclerosis

RareDiseases

+24.3%Growthat CER +25.9%+16.9%

Annual Sales

>+25%

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132

A Successful Model for Productive R&D Collaborations

132

● World-class RNAi therapeutic technology

● Focus on genetic diseases with a clear translational model for RNA interference

● $875m invested in equity, upfront and milestone payments and R&D costs

● Opt-in rights exercised for two Phase III candidates (patisiran, revusiran) and one Phase I program (ALN-AT3)

● Novel adeno-associated virus (AAV) gene therapy platform

● Targeting rare CNS disorders● e.g.: Huntington’s and Parkinson’s

disease, Friedreich’s ataxia

● $100m upfront commitment and up to $745m in milestones

Recent Collaborations(1,2)

(1) Expansion of the Alnylam collaboration was announced in Jan 2014 (2) Collaboration with Voyager was announced in Feb 2015

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133

2015-2020

Rare Diseases and MS Will Remain Key Growth Drivers

>€2.0bn

2020e

>€6.0bn

~€3.5bn

2015e

>€4.0bn

MultipleSclerosis

~1/3

RareDiseases

~2/3

Annual Sales (€m)

● Solid growth expected from 2015 to 2020 despite increasing competition and pricing pressure

● Rare diseases and MS eachexpected to contribute strongly

● Growth driven mostly by increasedpenetration of existing brands

● New launches expected to drive growth beyond 2020

Significant improvement in BOI margin expected over 2015-2020

Lowdouble digitsales CAGR

at CER

BOI: Business Operating Income

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134

Agenda

Genzyme: a success story

Rare Diseases: an untapped opportunity

Multiple Sclerosis: a fast-growing player

Page 135: 2015/11 - Meet Sanofi Management

Fabry ~90%

Diagnosed Total Treated

GenzymeTreated

3,2006,00010,000

Pompe ~95%

Diagnosed Total Treated

GenzymeTreated

2,4002,5003,000

Gaucher ~80%

Diagnosed Total Treated

GenzymeTreated

5,0007,00010,000

Niemann-Pick (A&B)~95%

Diagnosed Total Treated

GenzymeTreated

1,300

Majority of Rare Disease Patients Are Still Undiagnosed(1)

~50,000

>100,000

(1) Genzyme internal analysis - Includes China and India

~50,00020,000

135

Page 136: 2015/11 - Meet Sanofi Management

Clear Strategies to Sustain Leadership in Rare Diseases

● Focus on hematologists

● Apply proven screening protocols

● Facilitate access

● Optimize launch of Cerdelga®

● Focus primarily on nephrologists

● Map family trees

● Develop oral GCS Inhibitor

● Focus on neurologists and neuromuscular specialists

● Perform testing of high risk patients

● Developneo-GAA(1)

Gaucher Fabry Pompe

Largest opportunity lies in undiagnosed and diagnosed/untreated

136(1) Modified recombinant human GAA (acid alpha-glucosidase) harboring synthetic oligosaccharide ligands

Page 137: 2015/11 - Meet Sanofi Management

Rare Diseases Franchise Sustained Leadership(1)

in YTD Sep 2015

137

Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015

Others

Fabrazyme

Myozyme

Cerdelga

Cerezyme

Genzyme Rare Disease Sales (€m)

€630m+13.0% at CER

€530m

€147m

€189m

€114m

€162m

(1) Cerezyme® + Cerdelga® value share is 74% and Fabrazyme® value share is 59% based on Q3 2015 reported sales by Sanofi and Shire(2) Cerdelga® sales were €18m in Q3 2015

(2)

&

Others

€2,137m (+11.2% at CER)

€1,890m(+12.6% at CER)

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138

● Encouraging performance in first year after U.S. launch

● Almost 1/3 of Genzyme’s Gaucher portfolio in the U.S.

● U.S. Gaucher market share of 17%

● 60% of patients new to Genzyme

● Genzyme Gaucher patient share estimated at 60% in the U.S.versus 52% a year prior

● Available in 8 countries by end of 2015

● 2015 sales expected to exceed €60m

● 14 additional countries expected in 2016

Genzyme Leading Innovation in GaucherDisease with Cerezyme® and Now Cerdelga®

Potential to grow Gaucher market and expand Genzyme Gaucher franchise to >€1bn

Page 139: 2015/11 - Meet Sanofi Management

GZ402666Neo GAA

Pompe Disease

Olipudase alfarhASM

Niemann-Pick type B

Patisiran(2) (ALN-TTR02)siRNA targeting TTR

Familial amyloidotic polyneuropathy

SAR439774 (ALN-AT3)(1)

siRNA targeting Anti-ThrombinHaemophilia

GZ402671Oral GCS Inhibitor

Fabry Disease

Revusiran(3) (ALN-TTRsc)siRNA targeting TTR

Familial amyloidotic cardiomyopathy

Phase I

139139

Phase II Phase III

Genzyme Alnylam

A Solid Rare Diseases R&D Pipeline

(1) Genzyme recently opted into ALN-AT3 in territories outside of North America and Western Europe, retaining its opt-in right to North America and Western Europe. Specifically, Genzyme has the right to either co-develop and co-promote ALN-AT3 in Alnylam's territory or to maintain its ROW rights for ALN-AT3 and obtain a global license to ALN-AS1 in acute hepatic porphyrias. Genzyme will exercise this selection right upon completion of PoC for ALN-AS1, which is expected to occur in 2016

(2) Genzyme territories include Japan, APAC, Latam and Eastern Europe(3) Genzyme territories include Japan, APAC, Latam and Eastern Europe with co-develop/co-promotion right in U.S. and

Western Europe

Page 140: 2015/11 - Meet Sanofi Management

● Niemann-Pick is a serious lysosomal storage disorder, characterized by fat deposits in spleen and liver

● Patient identification uses established diagnosis algorithm for Gaucher

● 3.8% of patients tested positive for Niemann-Pick after testing negativefor Gaucher

Gaucher Hematology Campaign

Niemann-Pick Patient Diagnosis

Addressing Niemann-Pick type B with Olipudase alfa(1), an Enzyme Replacement Therapy Currently in Phase II

Therapeutic Approach

Phosphorylcholine Ceramide

Sphingosine

Acid-Ceramidase

Intended result:Reverse and prevent somatic disease

if treatment begins early

Target the underlying metabolic defectby replacing the missing enzyme

Olipudasealfa

Olipudasealfa

140

Sphingomyelin

(1) Recombinant form of human acid sphingomyelinase (ASM) developed as an enzyme replacement therapy

FDA Breakthrough Therapy Designation granted in May 2015

Page 141: 2015/11 - Meet Sanofi Management

Hemophilia: a $10bn Market Set to Face Substantial Changes

141(1) World Federation of Hemophilia Annual Global Survey 2014(2) World Federation of Hemophilia Guidelines for the management of hemophilia. (http://www1.wfh.org/publications/files/pdf-1472.pdf)

● Inhibitors

● Overcome anti-factor antibodies

● 15-25 bleeds/year; >5 in-hospital days/year

● ~ 3,500 patients

● Prophylaxis

● Goal of therapy for all patients(2)

● Only 42-48% of patients receive prophylactic therapy

● Recessive X-linked monogenic disease

● Hemophilia A: loss of function in Factor VIII

● ~140,000 patients

● Hemophilia B: loss of function in Factor IX

● ~28,000 patients

Hemophilia(1) Unmet Medical Need(1)

Therapy with better benefit/risk profile is needed

Page 142: 2015/11 - Meet Sanofi Management

● Antithrombin (AT) is a key endogenousanticoagulant● Inactivates Factor Xa and thrombin

● Attenuates thrombin generation

● Expressed in liver; circulates in plasma

● Human AT deficiency associated with increased thrombin generation

● Subcutaneous ALN-AT3 aimed at correcting coagulation defects by knockdown of AT ● Currently in Phase I in

moderate-to-severehemophilia

ALN-AT3: an Investigational RNAi Therapeutic Targeting Antithrombin

ATFIX

FVIII

FIXa

FVIIa FVIIFVIIIa

FVa FV

FX

FXa

Fibrinogen Fibrin

ThrombinProthrombin

Blood clot

Intrinsic system Extrinsic system

Hemophilia B

Hemophilia A

FVIII

FIXAT

142

Coagulation Cascade

Phase III planned to start in mid-2016

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143

Genzyme Is the Long-Established Leader and Innovator in the Rare Diseases Area

Rare diseases sales have grown by +12% CAGR since 2012.Drivers to sustain growth in this category are:

● Accelerate systematic patient identification initiatives

● Continue leadership in patient advocacy through genuine commitment

● Focus lifecycle and business development efforts in areas of expertise and strengths to leverage synergies

● Advance internal and partnered novel pipeline

1

2

3

4

2020 Rare Diseases sales expected to exceed €4bn

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144

Agenda

Genzyme: a success story

Rare Diseases: an untapped opportunity

Multiple Sclerosis: a fast-growing player

Page 145: 2015/11 - Meet Sanofi Management

42 years-old 52 years-old

Brain MRI Reveals Significant Progressionof Atrophy over 10 Years(1)

145(1) Courtesy of Beth Fisher and Rick Rudick Cleveland Clinic

Despite Increased Treatment Options,Significant Unmet Needs Remain in Multiple Sclerosis

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146

A Large and Growing Global MS Market

(1) Reported sales of Copaxone® (Teva), Avonex® (Biogen), Rebif® (Merck Serono), Betaseron/Betaferon® (Bayer), Extavia® (Novartis), Tysabri® (Biogen) and Gilenya® (Novartis) for 2014 sales converted using €/$ of 1.3 and 2020e Genzyme estimates

Multiple Sclerosis Market Global Sales(1)

2020e

ROW

€14.3bn ~€22.6bn

~35%~65%

3 oral brands

5 injectable interferon beta brands

2 injectable glatiramer acetate brands including a generic

2 intravenous drugs

+8%CAGR

An Increasingly CompetitiveTherapeutic Area

2014

U.S.

~37%~63%

Page 147: 2015/11 - Meet Sanofi Management

Multiple Sclerosis Franchise Sales Annualizing Over €1bn(1)

147

Genzyme Multiple Sclerosis Sales

Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015

Série2

Série1

€293m

€68m

€225m

(1) Multiplying Q3 2015 sales of €293m by four provides a hypothetical annual run rate of over €1bn sales

®

€168m €467m €761m

Page 148: 2015/11 - Meet Sanofi Management

148

37.5%62.5% OralTherapies

Injectable Therapies

Making Steady TRx Share Gains

Aubagio® Has Become the Fastest Growing Oral MS Drug this Year(1)

Oral Therapies Have Gained Significant Market Share(1)

(1) IMS U.S. - Week of October 23, 2015

Tecfidera®

21.1%

0%

5%

10%

15%

20%

25%

Gilenya®

10.3%

6.2%

U.S. Weekly TRx Share

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149

A Successsful New Global Campaign

● Approved in more than 50 countries

● >40,000 people treated with Aubagio®

worldwide

● Only oral MS treatment to significantly reduce the risk of SAD in 2 Phase III studies in RMS(1) (TEMSO and TOWER)

● Positive data in early MS(2) (TOPIC)

● New analysis of MRI data showing significant reductions in brain volume loss

● Favorable tolerability, once daily dosing

SAD: sustained accumulation of disability (1) AUBAGIO® (teriflunomide) is effective across key measures of disease activity: sustained disability

progression (14 mg only), annualized relapse rate, and MRI activity. Common side effects with AUBAGIO led to treatment discontinuation rates ≤3.3% in clinical trials.

(2) Patients with a first clinical event consistent with MS

Page 150: 2015/11 - Meet Sanofi Management

Significantly Reduced Brain Volume Lossin Relapsing Multiple Sclerosis(1)

RR: Releapse Rate(1) SIENA analysis of the TEMSO MRI dataset presented at ECTRIMS 2015

-0.61

-1.29

-0.39

-0.9

Year 1 Year 2

Med

ian

% C

hang

e fro

m B

asel

ine

Placebo

Teriflunomide 14 mg

RR: 36.9%p=0.0001

N=276 N=263

RR: 30.6%p=0.0001

N=234 N=235

Annualized Percentage Changein Brain Volume(1)

● An immunomodulatoryDisease Modifying Treatment (DMT) with demonstrated efficacy on:

Relapse rate

Disability progression

MRI activity

Brain volume loss(1)

150

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151

Potential to Transform MS Patients’ Lives

● Approved in more than 40 countries

● Extensive clinical development program with 5,400 patient-years of follow-up

● Durable improvements in relapse, disability, and MRI outcomes over 5 years in active RRMS demonstrated in CARE-MS I and II extension studies

No retreatment with Lemtrada® after the initial 2 courses in the core studies for most patients through Year 5

(1) The most common side effects of Lemtrada® are rash, headache, thyroid disorder, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, fungal infection, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting. Other serious side effects associated with Lemtrada® include autoimmune thyroid disease, autoimmune cytopenias, infections and pneumonitis.

(2) Label includes a boxed warning noting a risk of serious, sometimes fatal autoimmune conditions, serious and lifethreateninginfusion reactions and noting Lemtrada® may cause an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders. Lemtrada® is contraindicated in patients with HlV infection.

Page 152: 2015/11 - Meet Sanofi Management

Core Study Extension Study

Durable Clinical Efficacy Through 5 Years

● 68% of patients did not receive additional Lemtrada® treatment during the four years following the initial two courses of treatment (Months 0 and 12)

● 80% of patients were free from 6-month disability progression through Year 5

● The median yearly brain volume loss was -0.20% or less in Year 3, 4 and 5 of the extension study, lower than what was observed during the two-year pivotal study

No. ofPatients 376 349 342 340 349

(Month24‒60)

Annualized Relapse Rate (ARR)(95% CI)

CARE-MS I Study AssessmentsThrough 5 Years

(1) Study in treatment-naive patients with active relapsing-remitting multiple sclerosis 152

0.18 0.190.14 0.15 0.16

0,0

0,2

0,4

0,6

0,8

1,0

Years 0–2 Year 3 Year 4 Year 5 Year 3–5

1.0

0.8

0.6

0.4

0.2

0.0

Page 153: 2015/11 - Meet Sanofi Management

Key Drivers Q3 Q4

HCP Materials & Programs Package Insert Incorporating Brand Messaging

Consumer Materials X

Patient Acquisition/Digital/REMS Monitoring Website X Full Site w/Videos

Reimbursement Misc. J Q-Code

Overcoming Barriers in the U.S. in Q4 2015

153

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154

Our Strategy to Grow our Multiple Sclerosis Franchise

● Successfully complete global launches of Aubagio® and Lemtrada®

● Expand LCM activities to maximally support existing products

● Develop Lemtrada® for subcutaneous use

● Run a PoC study in Progressive MS with Lemtrada®

● Reinforce presence in high efficacy segment

● Advance GLD52, a next generation anti-CD52 mAb, through Phase I

● Enter into the neuroprotection / remyelination segment

● Six programs currently in research

1

2

3

4

Ambition to double the size of the MS franchise sales from 2015 to 2020 to >€2bn

Page 155: 2015/11 - Meet Sanofi Management

MEET SANOFI Management

VACCINES

Olivier CharmeilExecutive Vice President, Vaccines

Damian BragaSenior Vice President, Commercial Operations

Guillaume LeroyVice President, Dengue Company

John ShiverSenior Vice President, R&D

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156

Agenda

The Vaccines market

Sanofi Pasteur growth perspectives

A balanced R&D pipeline

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157

Immunization Is One of the Most Successful and Cost-effective Health Interventions

A successful vaccination program adds more than 1% to a country GDP(4)

Vaccination is rivalled only by clean water for reducing mortality rates and improving lives(1)

Childhood vaccination in U.S. has prevented more than 100m serious cases of infectious disease since 1924(2)

~6m lives saved every year by vaccines (= 10 lives per minute)(3)

€1bn saved annually from eradication of smallpox(5)

(1) http://www.who.int/bulletin/volumes/86/2/07-040089/en/(2) Panhuis WG et al. N Engl J Med 2013; 369:2152-2158(3) Ehreth J. The global value of vaccination. Vaccine 2003; 21: 596-600(4) David E. Bloom DE. Valuing Vaccination. Presentation at Fondation Mérieux, Jan 19, 2015(5) http://www.who.int/mediacentre/news/notes/2010/smallpox_20100517/en/

Vision: “A world in which no one suffers or dies from a vaccine preventable disease”

Page 158: 2015/11 - Meet Sanofi Management

A Concentrated Market with Sanofi Pasteur Ranking #1(1)

in Several Areas

Others

2014 World Vaccine Market Sales(2)

~€21bn

19%GSK

MerckPfizer

158

(1) Sanofi Pasteur internal analysis(2) Sanofi Pasteur sales includes 50% of Sanofi Pasteur MSD JV sales (excludes supply sales from Sanofi Pasteur to JV); 50% of JV

sales added to Merck sales. GSK = GSK + Novartis (excluding Flu vaccines); CSL = CSL + Novartis Flu (market view pro forma)(3) Include VaxServe sales (€314m in 2014). VaxServe is a Sanofi Pasteur company that supplies vaccines in the U.S.

Sanofi Pasteur Sales in 2014 €3,974m

Travel andOther Endemic

Others(3) 437

377

Adult boosters 398

Meningitis 430

Polio, Pertussis& Hib 1,154

Flu 1,178 #1

#2

#1

#3

CSL

#1

Page 159: 2015/11 - Meet Sanofi Management

● Continuously increasing GMP standards for batch releaseby Health Authorities

● Market access often requires local manufacturing

● Very high level of expertise required in industrial processes which often cannot be automated

● Need to continually adapt production process to satisfy evolving regulatory demand

● Much longer product life cycle than pharmaceuticals● Incremental innovation provides high added-value

differentiation in the marketplace

A Complex Industry Where We Have to Deliver on Three Fronts

Complex Biological Processes

Highly Regulated Business

High CapExRequirements

159GMP – Good manufacturing practices

Page 160: 2015/11 - Meet Sanofi Management

160

Evolving Immunization Policies Are Creating Significant Growth Opportunities

160

Level of coverage

Market maturity IPV acP/Hib Flu Ped Flu Rotavirus

Mature

Ongoing modernization

Under-developed

Status of Immunization Schedules

IPV– Inactivated polio vaccine acP – Acellular Pertussis Hib – Haemophilus influenzae type b Ped – Pediatric

Projected Market Trends

% of Birth Cohortin 2020

9%

19%

72%

Sales Growth CAGR

2015-2020

3%

6%

10%

% of Sales in 2020

60%

23%

17%

Source: Sanofi Pasteur internal estimates based on various sources

Page 161: 2015/11 - Meet Sanofi Management

161161

~5%CAGR

2015e 2020e

Projected Market Growth(1) Projected Industry Growth Drivers

1 Launch of innovative vaccines to prevent diseases with unmet need

2 Reach target immunization coverage rates in mature markets

3 Pricing improvement driven by more innovative vaccines

4 Modernization of immunization schedule in middle income countries

2015-2020

Strong Visibility as Mid-Single Digit Growth Sustainable

(1) Internal estimates

~€25bn

5 Growing middle class in Emerging Markets

Page 162: 2015/11 - Meet Sanofi Management

162

Agenda

The Vaccines market

Sanofi Pasteur growth perspectives

A balanced R&D pipeline

Page 163: 2015/11 - Meet Sanofi Management

2015e20142013

€4.0bn

2020e

163

Pediatric& boosters

Flu

Dengue~75%

of sales

Projected Sanofi Pasteur Sales

€3.7bn

~€4.7bn

1 Further develop strong vaccine brandsa) in pediatric combinationsb) in adult boostersc) in flu vaccines

2 Successfully launch Dengvaxia®

3 Expand our manufacturing capacity

4 Deliver novel high-valuevaccines e.g. C. diff vaccine

2015-2020

Sanofi Pasteur Expected to Outperform Market Growth

abc

High single digitsales CAGR

at CER

Page 164: 2015/11 - Meet Sanofi Management

Modern Pediatric Combination Vaccines Will Fuel Growth

164

acP – Acellular Pertussis wcP – Whole cell Pertussis IPV– Inactivated polio vaccine (1) Routine pediatric vaccination in infants and children(2) World Market Analysis (Sanofi Pasteur), 2013

Primary Vaccination Series(1) in Public Markets Are Still wcP-based in Many

Countries(2)

wcP usersacP users

Projected Drivers for Pediatric Combination Vaccines

● Global polio eradication initiative and IPV roll-out expected to facilitate switch to acP combos● Preference for IPV-containing acP

combination vaccines driven by their convenience, immunogenicity and safety profile

● acP expected to represent over 1/3 of all combos in revenues by 2020

● Expansion of penta- and hexavalent combos

1a

wcP GAVI

Acellular Pertussis Whole cell Pertussis

Page 165: 2015/11 - Meet Sanofi Management

UNICEFGAVI

Middle Income & Emerging Markets

ChinaBrazil

MexicoRSAetc.

165

Our Portfolio of Pediatric Combination Vaccines Well Suited to Global Immunization Calendar Modernization

165

Pediatric combination vaccines sales are expected to grow double-digit CAGR over 2015-2020

Primary Series - Infants and Children

Mature Markets

U.S.Western Europe

aCel & aXim Product Families(acP-based)

Shan5™(wcP-based)

PR5I(1)

1a

(1) U.S. and EU regulatory review ongoing. Collaboration with Merck & CoaXim products also distributed in Western Europe

TM

Page 166: 2015/11 - Meet Sanofi Management

Projected Drivers for Public Booster Market

● Even where Tdap vaccines have been introduced, coverage remains relatively low

● Resurgence of pertussis calls for more robust control measures

● Td Tdap replacement for routine immunization

Boosters Demand Expected to Grow in Untapped New Markets

Booster Markets in 2015(1)

Tdap No Tdap

Tdap: Tetanus, diphtheria and pertussis(1) Sanofi estimates based on various sources 166

1b

Launch of Adacel® and Adacel Polio® expected in 50 new markets over the next 5 years

TetanusDiphteria

acellular Pertussis

TetanusDiphteria

® ®

Page 167: 2015/11 - Meet Sanofi Management

Flu Vaccines: High Disease Burden and Low Vaccine Coverage Generate Growth Opportunities

167

(1) 17 key countries: Argentina, Australia, Brazil, Canada, Chile, China, France, Germany, Italy, Japan, Mexico, Russia, RSA, South Korea, Spain, UK, U.S(2) WHO Fact sheet on influenza, N°211, March 2014(3) Molinari N.-A.M. et al. Vaccine 25 (2007) 5086–5096

.

1c

Estimated Vaccination Coverage Rates (VCR) Still Below Target

Key selected countries(1) VCR still below WHO and EU targets of 75%

U.S. VCR still below CDC target of 90%

75% threshold

90% threshold

320m

140m

100m

44m

30m

10m

Not Vaccinated

Vaccinated

Population aged over 65 years

(in million people)

100%

0%

Imm

uniz

atio

n R

ate

(%) High Disease

Burden of Flu(2,3)

● 1 billion cases/year

● 300,000-500,000 deaths/year

● €10-17bn/year in healthcare cost in U.S. alone

Page 168: 2015/11 - Meet Sanofi Management

Sanofi Pasteur Flu Growth Drivers

● Differentiation with Fluzone® HD● Superior efficacy(1) and significant

reduction in flu-related hospital admissions(2) in people aged 65+

● U.S. introduction of Fluzone® HD QIV expected by 2020

● Market expansion and conversion to quadrivalent flu vaccines (QIV)● U.S. switch to QIV almost complete● Progressive switch in RoW expected

to start in 2017 ● Global switch expected to be completed

by end of 2020

Sanofi Pasteur Well Positioned with a Leading Flu Vaccines Franchise

Projected Flu Vaccines(3) Sales Mix Evolution

Quadrivalent

2015 2020

2015 2020

168

(1) DiazGranados CA et al. N Engl J Med 2014; 371:635-645(2) Izurieta HS et al. Lancet Infect Dis 2015; 15: 293–300(3) Intramuscular flu vaccines

1c

Fluzone® U.S.

Vaxigrip® RoW

Page 169: 2015/11 - Meet Sanofi Management

● About half of the world’s population lives in dengue endemic regions(2)

● Recommended for the prevention of dengue disease in individuals 9 years and older living in endemic areas(3)

● Pooled efficacy data demonstrate(3)

● 65.5% protection against all 4 dengue serotypes● 93.2% prevention against severe dengue● 80.8% prevention of hospitalization due to dengue

● 70% to 90% of dengue cases are reported in children aged 10+ in given endemic countries(4)

● Potential to reduce disease burden by about 50% within 5 years if 20% of a country population is vaccinated in endemic countries(5,6)

(1) Under regulatory review in major endemic countries in Asia and South America(2) WHO, 2015, Dengue Fact Sheet(3) Follow-up to 25 months post dose-1; Study population aged 9 to 16 years of age. Hadinegoro SR. et al. NEJM, 2015

Safety analyses showed similar reporting rates between the vaccine and control groups during clinical studies (4) Observed in Thailand, Indonesia and Colombia, Mexico, Brazil and Malaysia over the last 5 years - Jackson N. et al « Recent scientific and clinical

advances in Sanofi Pasteur’s Dengue Vaccine Program » ASTMH 64th Annual Meeting October 25-29, 2015. Philadelphia, USA(5) Coudeville L et al. ASVAC 2015 (5) Coudeville L et al. SLIPE 2015 (6) Bhatt, 2013, Nature

169

Make dengue the next vaccine-preventable disease

Global Evidence ConsensusRisk & Burden of Dengue - 2010(6)

Completeabsence

Completepresence

The First Ever Dengue Vaccine(1)2

169

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Rapid Uptake to Generate Public Health Impact and Return on Investment

170

Launch2016

Implement catch-up 2017-20

2

Pre-launch2015

● Expand “catch-up” program and reach peak sales

● Prepare launch in 2nd & 3rd wave of countries

● Implementation of post-licensure studies to measure effectiveness and impact of first programs

● Adapt production capacity

● Launch in 1st wave of endemic countries

● Start public vaccination including catch up in high endemic countries

● Launch supported by current production capacity

● File submitted in 20 endemic countries by year end

● First doses available for delivery before of end 2015

Page 171: 2015/11 - Meet Sanofi Management

Policy Designed to Maximize Impactin Public Markets

171

2

Broader Vaccination Program Leads to Higher Impact on

Disease Burden(1,2)

Setting a Pricing Policy Linked to Impact

on Disease Outcomes

● Assessing vaccination impact at the population level through modeling

● Direct and indirect protection● Vaccine efficacy and disease epidemiology

● Program-based pricing policy● Maximize public health impact● Equitable policy

(1) Dengue Modeling Consortium ASTMH [2014](2) SP model ASVAC, SLIPE, ASTMH [2015]

Number of age groups vaccinated

0%

-70%

Variabilitiesfrom one country to another

% Reduction of diseaseover 10 years at the population level Average price per dose

Number of age groups vaccinated

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172

Expand Vaccine Production Capacity to Ensure Sustainability of Supply

172

Neuville sur Saône

Marcyl’Etoile

Val-de-Reuil

Pilar

Rockville

Swiftwater

Toronto

Canton

ShanthaHyderadad

Shenzhen

Ocoyoacac

Industrial Sites

● Supply increase ● Invest in new capacity and

upgrade existing footprint● Improve process robustness

● Optimization● Simplify product portfolio● Harmonize antigens

● Quality performance● Setting the new standard for

quality in vaccine industry

Major Initiatives

Projected cumulative CapEx of around €1bn over the next three years

1

2

3

3

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173

Agenda

The Vaccines market

Sanofi Pasteur growth perspectives

A balanced R&D pipeline

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174

A Balanced Pipeline with New Targets and LCMProjects

174

LCM – Life Cycle ManagementPCV – Pneumococcal conjugate vaccineHSV – Herpes simplex virus

● Enhance current vaccines to improve efficacy (e.g. Flu QIV, Flu HD, PR5I)

● Defend key franchises from competitor LCM activity(e.g. 2nd generation meningitis ACYW conj. vaccine)

● Access new markets(e.g. pediatric combos in Japan)

● Improve production processes

Strategic Life Cycle Management

● Advance internal R&D programs (e.g. Rotavirus)

● Establish collaborations on external programs(e.g. SK Chemical Co. for PCV development)

Fill Portfolio Gap

4

● Address unmet medical need through innovative vaccine development(e.g. dengue, tuberculosis)

● Develop new vaccine segments(e.g. nosocomial infections withC. difficile vaccine)

● Introduce new modalities(e.g. HSV therapeutic vaccines)

First in Class Novel Vaccines

Page 175: 2015/11 - Meet Sanofi Management

Robust Sanofi Pasteur R&D Pipeline

Herpes Simplex Virus Type 2HSV-2 vaccine

Meningitis ACYW conj.2nd generation meningococcal

conjugate infant vaccine

VaxiGrip® QIV IM Quadrivalent inactivated

influenza vaccine (3-36 months)

VaxiGrip® QIV IM Quadrivalent inactivated

influenza vaccine (3 years+)

Streptococcus pneumoniaMeningitis & pneumonia vaccine

Rabies VRVgPurified vero rabies vaccine

Clostridium difficile Toxoid vaccine

Dengvaxia®

Mild-to-severe dengue fever vaccine

Fluzone® QIV HD Quadrivalent inactivated influenza

vaccine – High dose

RotavirusLive attenuated tetravalent

Rotavirus oral vaccine

PR5IDTP-HepB-Polio-Hib

Pediatric hexavalent vaccine, U.S., EU

Tuberculosis Recombinant subunit vaccine

Phase I

175

Phase II Phase III Registration

New entities/modalities Portfolio expansion Strategic LCM

Several exciting targets in early stage development

4

Universal flu and new manufacturing technologies

New targets: Respiratory syncytial virus (RSV), Cytomegalovirus (CMV), Staph. Aureus, PCV

PCV – Pneumococcal conjugate vaccine

Page 176: 2015/11 - Meet Sanofi Management

176

Population at risk of CDI~50 million adults (U.S.)(2)

● All adults aged 65+

● Some 64 and under with chronic comorbidities requiring frequent/prolonged antibioticuse or hospitalization

● Adults with elective surgeries

● Long-term care/nursing home residents

~10-15 million adultsat high risk(3)

CDI: Clostidium difficile infection(1) Sources: Lessa FC., N Engl J Med 2015;372:825-34, Kwon et al., Infect Dis Clin N Am 29 (2015) 123–134, and HCUP Projections Report # 2012-01(2) CDI incidence >0.63%/ year (3) CDI incidence >1.5%/year

Rising Medical Need to Fight Clostridium difficile Infection

4

Objectives are to protect individuals from a potentially life threatening infection, stop vicious cycle of recurrences and reduce transmission to other at-risk individuals

● ~450,000 cases and 29,000 deaths

● Hospitalization rates more than doubled in the U.S. between 2001 and 2010

● Increasingly reported in community and nursing homes settings

● Sub-optimal current treatments and high rates of recurrence

● Healthcare costs of $5.9bn for acute care facilities only

High Disease Burden of CDI(1)

Potential target populationfor first C. diff vaccine

Page 177: 2015/11 - Meet Sanofi Management

C. difficile Candidate Vaccine to Address High Unmet Medical Need

● 660 volunteers aged 40-75 years at risk of C. difficile infections were included in a 2-stage Phase II trial ● Stage 1: dose ranging(1)

● Stage 2: selection of vaccination schedule(2)

● Candidate vaccine generated an immune response against both C. diff toxins A and B

● Neutralizing antibodies were comparable across ages including elderly

● Adverse reactions were generally mild and of short duration

● Objective is to assess efficacy, safety and immunogenicity in preventing the onset of symptomatic PCR-confirmed primary CDI cases

● 3 injections at 0, 7, and 30 days● Up to 15,000 adults to be enrolled –

1/3 already included● CDI case-driven study● Initiated in Q3 2013 and projected to take

4.5-5 years to complete

Fast Track Development Program designation granted by CBER

PCR – Polymerase chain reaction CDI – Clostidium difficile infection(1) & (2) de Bruyn G et al. Poster presentations at 24th annual meeting of the European Congress of Clinical Microbiology and Infectious Disease (ECCMID), May 2014

Phase II successfully completed Multinational Phase III ongoing

4

177

Page 178: 2015/11 - Meet Sanofi Management

Sanofi Pasteur Well Positioned for Sustainable and Profitable Growth

● Sanofi Pasteur expects to grow faster than the vaccines market with three main drivers

● Widespread adoption of pediatric combination vaccines and adult boosters

● Expansion of our differentiated offering for flu vaccines to new markets

● Successfully launch the first ever dengue vaccine

● Operating margin expected to improve significantly over 2015-2020

● Product mix evolution

● Further improvement in industrial operations

178

1

2

3

Page 179: 2015/11 - Meet Sanofi Management

MEET SANOFI Management

CONSUMER HEALTHCAREEMERGING MARKETS

Peter GuenterExecutive Vice President, Global Commercial Operations

Jean-Luc LowinskiSenior Vice President, Asia region

Vincent WarnerySenior Vice President, Global CHC Division

ESTABLISHED PRODUCTS

Page 180: 2015/11 - Meet Sanofi Management

180

Agenda

Consumer Healthcare

Emerging Markets

Established Products

Page 181: 2015/11 - Meet Sanofi Management

Sanofi Is the Healthcare Leader in Emerging Markets

181

Leader in Emerging Markets

Sales of ~€12bn in 2015e(1)

>1/3 of Group Sales generated in Emerging Markets in 9M 2015(1)

Commercial footprint in ~160 countries

Lantus® leads paradigm shift tobasal insulin in Emerging Markets(2)

#1

€12bn

32%

160

Top

4.1%

3.9%

3.6%

2.5%

2.4%

2.4%

2.3%

2.1%

1.6%

1.6%

Top 10 Players in Emerging Markets(3)

(1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, the Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark), Japan, Australia, and New Zealand (excl. South Korea from Jan 1st 2015)

(2) Lantus® reached value market share of 56.4% in Emerging Markets, IMS MIDAS MAT June 2015 (3) Market share of total market without vaccines, IMS MIDAS MAT Q2 2015

Page 182: 2015/11 - Meet Sanofi Management

+10.4%+9.9%

(1) World excluding U.S., Canada, Western Europe, Japan, Australia, and New Zealand (excl. South Korea from Jan 1st 2015)(2) Including Brazil generics (excluding Brazil generics, Emerging Markets grew +8.6% in Q2 2014 at CER)(3) Including Brazil generics (excluding Brazil generics growth of Emerging Markets in Q2 2013 was +5.3%)(4) Including Brazil generics (excluding Brazil generics growth of Emerging Markets in FY 2013 was +7.1%)(5) Including Brazil generics (excluding Brazil generics, Emerging Markets grew +6.5% in FY 2014 at CER and +7.6% in Q4 2014 at CER)

Steady Growth Trajectory Despite Economic Slowdown and Volatility in Emerging Markets

182

+5% at CER

+9% at CER

% of Group sales 31.9% (FY2012)

32.1%(9M2015)

+9.8%

+6.8% +6.8% +6.5%

+2.8%

-2.3%

+7.5%

+5.5%

+16.5%(2)

+7.6% +7.9% +7.3%

8.3% 4.4%(4) 9.3%(5) +8.7%

Quarterly Sales Growth in Emerging Markets(1)

+11.4%

(3)

Page 183: 2015/11 - Meet Sanofi Management

Stable Sales Mix Across Emerging Market(1) Regions

(1) World excluding U.S., Canada, Western Europe, Japan, Australia, and New Zealand (excl. South Korea from Q1 ‘15)(2) Including Brazil generics (excluding Brazil generics growth of Emerging Markets in FY2013 was +7.1% at CER)(3) Including Brazil generics (excluding Brazil generics, Emerging Markets grew +6.5% in FY 2014 at CER)(4) Including Brazil generics (excluding Generics in Brazil, LatAm grew 7.4% in FY 2013 at CER)(5) Including Brazil generics (excluding Generics in Brazil, LatAm grew +10.8% in FY 2014 at CER)

Significant Contribution from All Regions Due to Well Balanced Geographical Sales Mix in Emerging Markets

183

20122011 2013 2014

Africa & Middle East

Eastern Europe, Russia & Turkey

Asia

Latin America

€2,095m+2.5%

€2,541m+5.0%

€3,205m+6.3%

€3,363m+21.1%(5)

€2,099m+9.1%

€2,673m+2.2%

€3,040m+10.1%

€3,013m-1.5%(4)

€2,019m+10.2%

€2,721m+2.1%

€2,841m+10.1%

€3,435m+11.3%

€1,821m+9.2%

€2,666m+3.7%

€2,416m+16.6%

€3,111m+11.8%

+9.3%(3)Sales growth at CER +4.4%(2)+8.3%

2015 YTD

+8.7%

€1,694m+7.7%

€1,789m+5.8%

€2,747m+12.1%

€2,525m+7.1%

Page 184: 2015/11 - Meet Sanofi Management

Growth in EM(2) not Dependent on Individual Country Performance

Broad Presence Outside of BRIC-M(1) to Capture Growth in Other Strategically Important Priority Countries

184

BRIC-M(1)

countries,€4,693m

41%

18 countries with sales of >€100m,

€3,990m 36%

Sanofi Sales in Emerging Markets in 2014€11,347m, +9.3%

(1) BRIC-M – Brazil, Russia, India, China, Mexico(2) Emerging Markets - World excluding U.S., Canada, Western Europe, Japan, Australia, and New Zealand (3) IMS MIDAS MAT Q2 2015 (Leading positions in 18 countries applies to total market in these countries)(4) MNC - Multinational Companies

Others,€2,664m

23%

A top 3 player among MNC(4) peers in BRIC-M

markets(3)

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185

Sanofi in China – A Strong and Growing Contributor to EM Sales Despite Market Slowdown

€11,347m

11%

China (as % of EM sales)

Other Emerging Markets

20142012

China Is the Largest Contributorto EM Sales, €1,603m in 2014,

4.7% of Total Group Sales

2013

13% 14%

(1) IMS CHPA 2015 M8(2) MNC - Multinational Companies

+2.0%

+7.6%

+9.1%

+1.4%

+9.8%

-1.1%

+8.7%

+0.9%

-6.7%

-12.7%

Sanofi China Has Outperformedthe Market and its MNC

Peers in Recent Quarters(1,2)

Sanofi Ranked #3 in China among its MNC Peers(1,2)

Sales in China in RMB millionand growth in % (YTD Aug 2015)

MNCs

Market

Growth in %

Total Pharmaceuticals Market Growth +5.8%, YTD August 2015

Sales of Sanofi in China reached €1,614m, +16.7% for the first 9 months 2015

Page 186: 2015/11 - Meet Sanofi Management

Expand geographically

Enhancecore business

Continue to drive innovation

186

3 Growth Pillars for Sanofi in China

Enablers for Sustainable Growth

A Comprehensive Strategy for Sustainable Growth in China

Innovation● New product launches &

customize products for China’s needs

Geographical expansion into the County Market● Expand patient reach

Plavix® & Low-cost model● Support evolution to

volume

Diabetes● Gain leadership through

treatment paradigm shift towards basal insulin● Lantus® is the leading

insulin brand in key cities(1)

Operating modelCompliance & Sustainability

PeopleEngagement & Development

Drive Efficiency & ProductivityCommercial excellence

Market accessStrengthen capability

(1) IMS CHPA July 2015Icons designed by Freepik

Page 187: 2015/11 - Meet Sanofi Management

2019e2014

Superior Growth Contribution from Emerging Markets Expected during 2014-2019…

Mature Markets

Emerging Markets

187

Emerging Markets

Mature Markets

Emerging Markets Expected to Grow Faster than Mature Markets(1)

(1) IMS Market Prognosis 2014-2019 (at constant exchange rates)

>6bn people

Aging population

Rapidly emerging middle classMiddle and Affluent Consumers to represent ~50% of EM population in 2025

Improved access to medicines

Increasing healthcare spend as % of GDP

Mega Trends Remain Compelling

CAGR+8%

CAGR+5%

$993m

$1,330m

Page 188: 2015/11 - Meet Sanofi Management

Challenges to Business Model in EMDrivers of Historic Performance

…but the Evolution of Emerging Markets Requires an Adjustment of our Existing Business Model

188

● Strong heritage and broad product portfolio of value brands

● Bolt-on acquisitions and local collaborations

● Industrial footprint

● ‘First-mover’ advantage

● Maintaining a commercial presence during political instability

● Economic slowdown

● Intensified pricing pressure

● Increased competition from local and regional players

● Consolidation and professionalization in the trade channel

● New middle class demands adaptation of product portfolio

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189

Strategic Priorities to Address Changing Dynamics in Emerging Markets

#1in Emerging

Markets

‘Win’ Emerging Middle Class ● Adapt portfolio and expand coverage

Optimize Trade and Channel Management● Distribution, New Channels, Point of Sale

~160countries

Innovate for Emerging Markets● Address unmet medical needs specific for EMs

…and DifferentiateMarket Approach

by Country

1

2

3

4

Pursue External Growth Opportunities● M&A and collaborations

5

Build Priority Clusters with Countries of Strategic Importance…

Page 190: 2015/11 - Meet Sanofi Management

SustainableProfitability

Sustainoperating margin~37% in 2014(1)

Market Access

Growth driven by volume

PriorityCountries

Maintain toplinegrowth rate in EM

by investing in priority countries

190

Key Success Factors to Reinforce Sanofi’s Leadership in Emerging Markets 2015-2020

#1in Emerging

Markets

(1) Business Operating Margin in Emerging Markets excluding central administrative and R&D costs in 2014Icons designed by Freepik

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191

Agenda

Consumer Healthcare

Emerging Markets

Established Products

Page 192: 2015/11 - Meet Sanofi Management

Ranked #5 in the~€100bn OTC Market(1)

192

Sanofi Is a Leading Player in the Fragmented Global OTC Market and Growing Faster than its Competitors

(1) Nicholas Hall & Company, FY2014, organic growth at CER

3.2%

Taisho

Reckitt Benckiser

Pfizer

J&J

GSKBayer

TakedaBoehringer IngelheimP&GOther

Sanofi Has Outgrown the Marketin Recent Years(1)

P&G

J&J

Taisho

Bayer

Boehringer

Takeda

Pfizer

Reckitt Benckiser

7.4%

Growth in %, 2010-2014 CAGR

OTC Market Growth: 4.1%

6.2%

4.5%

4.0%

3.9%

3.8%

3.1%

-0.7%

-2.1%

0.0%GSK

A top rank despite recent industry consolidation among peers

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193

A Focus on Key Brands in Priority Categories and a Strong Regional Presence

● Sales of €3,337m in 2014, +6.8% at CER(1)

● Leading positions in Priority Categories● 8 brands with >€100m sales in 2014

● Top 10 Sanofi CHC countries generate >70% of sales

● Strong footprint in Emerging Markets● ~50/50 sales split between Emerging and Mature Markets

● 21% of sales in the U.S. OTC market

(1) Several products previously recorded in prescription pharmaceuticals were transferred to Consumer Healthcare products in 2013. Including the category changes (€273 million in 2013), CHC sales grew 16.5% in 2014

Page 194: 2015/11 - Meet Sanofi Management

194

Priority Categories Drive Growth at Sanofi CHC

(1) Nicholas Hall & Company, FY2014(2) Growth in % at CER(3) Excluding the category change, -4.5% in 2014(4) Excluding the category change, +6.0% in 2014(5) Gold Bond® in the U.S. (not part of Global Categories) is 8th Sanofi CHC brand >€100m

Sanofi CHCPriority

Categories

Marketshare in

category(1)

Globalrank in

category(1)

Growth of category(1)

Top 10 brands by sales in 2014(2)

generate >50% of CHC sales(5)

15.6% #2 28.9%

12.6% #1 6.3%

4.0% #3 6.1%

2.3% #3 7.1%

6.4% #3 4.5%

€104m, +5.7%

€156m, +24.6%€235m, +27.1%(4) €98m, +9.6%

€88m, +17.9%

€310m, +7.2% €109m, +6.0% €90m, +6.5%

€350m, +37.1%(3) €114m, n.m.

Page 195: 2015/11 - Meet Sanofi Management

1

2

3

3 Growth Axes For Continued Growth in CHC

195

Maximize Potential of Existing Brands

Shape New Categories

Gain Scale through Bolt-on Acquisitions

● Consumer-driveninnovations

● Unique business model● Geographic expansion

● Realize global & regional switch opportunities

● Leverage consumer trends & preferences

● Reach critical scale inkey countries

● Optimize portfolio in priority categories

CHC Vision2020

195

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Maximizing Brand Equity through Consumer-Driven Innovations

(1) Celtipharm, INN prescription tracking, 2015(2) Awareness Tracking Ipsos 2014 (October 2014)(3) Pharmatrend MAT Aug 2015(4) Nielsen xAOC; 52wk ending 08/29/15(5) TENS - Transcutaneous Electrical Nerve Stimulation 196

1

● An iconic brand in France● #1 most prescribed medicine(1)

● 93% brand awareness(2)

● >280m units sold(3)

● Adding a strong OTC range to Doliprane®’s established Rx portfolio:● Expanding the strong portfolio of OTC products

in acute pain; launched in France in November ‘15 ● Preserving Doliprane® for HCPs as the preferred

prescription choice in chronic pain

● A brand success story in pain relief● >$100m retail sales in the U.S. after acquiring the

brand with $8m sales in 1991(4)

● From topical IcyHot® products to a ‘Smart Relief’ device technology● Introducing IcyHot® Smart Relief TENS(5) therapy

● Launched in 2014, ‘Smart Relief’ sales have been 100% incremental to IcyHot® brand

Page 197: 2015/11 - Meet Sanofi Management

Consumer

Physician Pharmacy

The Power of a Pharmaceutical Company’s Medical Expertise Combined with a Consumer Culture

Example of Allegra® promotion mix in 3 markets

Maximizing Brand Equity through a Tailored OTC Business Model Coupled with Medical Expertise

197

1

Page 198: 2015/11 - Meet Sanofi Management

A Track Record of Commercial Success with 2 of the Top-9 U.S. Switches since 2000

Mucinex ClaritinZyrtec Prilosec OTC

Miralax Nexium 24HR

Plan B

2014 Sales (€m) of Top Brands Switched from Rx since 2000 in the U.S.(1)

20112002 20072004 2014200620022008 2014Switch date:

(1) N. Hall DB6198

483● 2 Rx-to-OTC switches have

driven growth of Sanofi CHC in the U.S.

● Allegra® and Nasacort® are now leading brands in the CHC Allergy category

● Sanofi positioned to be a preferred switch partner in the industry

2

Page 199: 2015/11 - Meet Sanofi Management

The Successes of Allegra® and Nasacort® Bode Well for a Major Switch Opportunity in a New Category

● Licensing agreement with Lilly signed in Q2 2014

● Opportunity to switch Cialis® in the U.S., Europe, Canada and Australia(1)

● Ambition to transform how this erectile dysfunction medicine is offered to millions of men in the world

(1) Subject to Sanofi's receipt of all necessary regulatory approvals199

Developing additional consumer-centric offerings across new CHC categories

Switchdate2014Switch

date2011Acquired

March 2010

199

2

Page 200: 2015/11 - Meet Sanofi Management

Chattem Aquisition Was the Foundation of Our Success in the U.S. CHC Market

200

GSK

PrestigeP&GJ&JBayerChurch

& DwightPfizerReckittChattem

5-year Retail Sales Growth Rate CAGR (2011-2015)(1)

(1) Nielsen xAOC; 52wk ending 08/29/15

● Acquired in 2010 by Sanofi● Tailored integration and preservation

of company values & capabilities

● In 2015, the fastest growing OTC company by retail sales(1) in the U.S.● >$1.3bn in retail sales in 2015● 6 brands with sales >$100m

Reaching critical scale in key CHC countries is a #1 priority

200

3

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201

Well Positioned for Continued Above-Market Growth in CHC

U.S.

Latin America

EU

Asia & Australia

CEE

Fostering continuous innovation to address unmet consumer needs

Leveraging medical, scientific & quality heritage

Commitment to improve consumer access to efficacious and safe treatments via Rx-to-OTC switches and other category shaping initiatives

Geographic build-up to attain critical mass in key markets

Resource allocation to further improve profitability

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202

Agenda

Consumer Healthcare

Emerging Markets

Established Products

Page 203: 2015/11 - Meet Sanofi Management

2014 Sales by Business Segments(1)

Sales of Established Products Reached €11bn and Represented 1/3 of Total Group Sales in 2014

203

PharmaceuticalsVaccines

AnimalHealth

Established Products

Other

● 2014 EP sales of €11,300m, -6.7% at CER

● 41% of Pharmaceuticals sales in 2014

● Global presence

● High volume portfolio

● Size reflects strategic importance for Sanofi

Established Products

Pharmaceuticals€27,720m, +4.4%

€37,770m, +4.9%

(1) Growth at CER

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204

Future GBU Organization to Put Focus on Established Products (EP)

● EP portfolio includes● Off-patent Rx brands ● Brands close to loss of exclusivity● Select non-genericized brands

(e.g. Synvisc® in biosurgery)

● EP value proposition:● Highly recognized medical value brands● Well established experience among

physicians and patients

● Slower sales erosion in recent years largely helped by Emerging Markets

€11,300m€12,446m

€14,058m

Sales of Established Products (in €m)

Mature Markets

Emerging Markets

~€11,700m

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205

Established Products Returned to Growth in the First 9 Months 2015 Driven by Emerging Markets(1)

YTD 2015 Sales of Established Products by Geographies (in €m)

+5.4%+16.5%+9.0%Growth at CER +2.7%

EP Sales in Emerging Markets by Region

(1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, the Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark), Japan, South Korea, Australia, and New Zealand

Emerging Markets €3,476m

+8.3% at CER

MatureMarkets €5,462m

-3.8% at CER

EP Sales in YTD 2015 €8,938m, +0.6% at CER

61% 39%

Eastern Europe, Russia & Turkey

Strong growth of Established Products in EM accelerated in Q3 2015 (+11%)

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A Diverse Portfolio of Strong Medical Value Brands in Large Therapeutic Classes

2%3%

6%

9%

9%10%

13%

23%25%

Antibiotics UrologyAntiarrhythmics RenalCNS Anti-inflammatoriesHypertension AnticoagulentsAntiplatelets

206(1) Breakdown of first 66% of Established Products sales

Business Characteristics of EP

Sanofi’s historical flagship products in large therapeutic categories● Cardiology, CNS, Anti-inflammatory

Addressing fundamental medical needs with high quality medicines● Targeted promotion

Strong influence of dispenser (Physician, Pharmacist)● Substitutability

Sales by Therapeutic Class in 2014(1)

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Established Products Sales Concentrated on Top 10 Brands

207

Top 10 Established Products in 2014 Sales Growth %

(at CER)% of sales

in EM

€1,862m +4.7% 46.2%

€1,699m +2.1% 34.4%

€727m -16.6% 56.3%

€684m -8.7% 10.1%

€395m +0.5% 61.5%

€352m -4.6% 11.1%

€306m -18.4% 20.6%

€290m +7.8% 3.1%

€281m -5.9% 52.3%

€192m -48.3% 2.6%

● Most of EP top 10 brands exposed to generic competition in 2014● Plavix® in Japan and Renagel®

in EU in 2015

● Top 10 products generated 60% of EP sales in 2014● Significant differences in

regional sales profile between Mature and Emerging Markets

● Focus: New organizational structure in Global Business Unit to capture market opportunities

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Innovative and Focused Approach to Capture Market Opportunities and Reinvigorate EP Growth

208

● Building on brand equity and established medical value‒ e.g. Lovenox®, Synvisc®, Renvela®

‒ Expansion in segments where medical value (e.g. Sevelamer)

● Portfolio reinforcement and geographic expansion‒ e.g. L-Thyroxin expansion

● Multi-channel management‒ Very selective, external partner if needed

Mature Markets Emerging Markets● Building on brand equity and

established medical value‒ e.g. Plavix®, Aprovel®, CNS‒ Access and medical education

● Innovation adapted to EM and geographic expansion‒ e.g. Aprovasc®

GrowthOpportunities

for EstablishedProducts

Continuous Margin ImprovementTrade and channel management – (account management, point of sale, joint business planning)

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MEET SANOFI Management

APPENDIX

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GBU Sales in 2014

210

FY 2014 net sales (€ million) Total Total Established Rx Products(1) 11,010Consumer Healthcare 3,337Generics 1,805Total Emerging Markets(9) Diabetes&Cardiovascular 1,169Total Emerging Markets(9) Sanofi Genzyme 777

GBU General Medecines & Emerging Markets(9) 18,098Total Oncology(2) 1,039Total MS(3) 456Total Rare Diseases(4) 1,733

GBU Sanofi Genzyme(10) 3,228Total Diabetes(5) 6,109Total Cardiovascular(6) 285

GBU Diabetes & Cardiovascular(10) 6,394

Total Pharmaceuticals 27,720

GBU Vaccines(7) 3,974GBU Animal Health(8) 2,076Total Group 33,770

(1) Including Plavix, Lovenox, Renagel / Renvela, Aprovel, Allegra, Myslee / Ambien / Stilnox, Synvisc / Synvisc One, Depakine, Tritace, Lasix, Targocid, Orudis, Cordarone, Xatral and Other Rx Drugs

(2) Including Taxotere, Jevtana, Eloxatine, Thymoglobulin, Mozobil, Zaltrap and Other Oncology(3) Including Aubagio and Lemtrada(4) Including Cerezyme, Cerdelga, Myozyme, Fabrazyme, Aldurazyme and Other Rare Diseases products(5) Including Lantus, Apidra, Amaryl, Insuman, Lyxumia, Afrezza, Toujeo and Other Diabetes(6) Including Praluent and Multaq(7) Including Polio / Pertussis / Hib, Adult Booster Vaccines, Meningitis/Pneumonia, Influenza Vaccines, Travel & Other Endemics Vaccines and Other

Vaccines(8) Including Fipronil products, Vaccines, Avermectin products and Others(9) Emerging Markets is defined by world excluding U.S., Canada, Western & Eastern Europe (except Russia, Ukraine, Georgia, Belarus, Armenia and

Turkey), Japan, South Korea, Australia, New Zealand and Puerto Rico(10) Excluding Emerging Markets