2015/11 - meet sanofi management
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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.
MEET SANOFI Management
2015-2020 ROADMAP
Olivier BrandicourtChief Executive Officer
4
Agenda
Our vision for Sanofi
Sanofi’s path to success
Delivering performance
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
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
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
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
9
Agenda
Sanofi’s path to success
Delivering performance
Our vision for Sanofi
We Have Four Strategic Priorities
10
Reshapethe portfolio
Deliveroutstanding
launches
Simplify the organization
Sustaininnovation
in R&D
1 2 3
4
● 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
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
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)
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
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
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
● 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
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
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
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
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
● 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
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
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
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
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
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%
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
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
● 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
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
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
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
Simplify the Organization
34
4
Create one
Sanoficulture
Reshapethe plant network
Move to Global Business
Unit organization
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)
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
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
38
Agenda
Sanofi’s path to success
Delivering performance
Our vision for Sanofi
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
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
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
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
MEET SANOFI Management
P&L RATIOS& CAPITAL ALLOCATION
Jérôme ContamineExecutive Vice President, Chief Financial Officer
44
Agenda
P&L ratios
Capital allocation
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
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%
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
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
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)
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
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
52
Agenda
P&L ratios
Capital allocation
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
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
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
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)
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
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)
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
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
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
62
Agenda
Executing a clear R&D strategy
Next wave of innovation
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
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
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
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
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
68
Agenda
Executing a clear R&D strategy
Next wave of innovation
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
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
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
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
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
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.
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
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)
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
● 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
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
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
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
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
83
Agenda
Sanofi’s global diabetes leadership
A broad and growing portfolio
Significant unmet medical needs
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%
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
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%)
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
88
Agenda
Sanofi’s global diabetes leadership
A broad and growing portfolio
Significant unmet medical needs
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
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
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%
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®
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
94
Agenda
Sanofi’s global diabetes leadership
A broad and growing portfolio
Significant unmet medical needs
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
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
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
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
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®
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
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
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
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
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
®
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
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
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
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
109
Agenda
Significant unmet need and cost burden
Strong and differentiated product profile
Initial uptake gradual as expected
Upcoming milestones and future opportunity
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
111
Agenda
Significant unmet need and cost burden
Strong and differentiated product profile
Initial uptake gradual as expected
Upcoming milestones and future opportunity
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
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
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
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
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
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
118
Agenda
Significant unmet need and cost burden
Strong and differentiated product profile
Initial uptake gradual as expected
Upcoming milestones and future opportunity
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
● 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
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
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
123
Agenda
Significant unmet need and cost burden
Strong and differentiated product profile
Initial uptake gradual as expected
Upcoming milestones and future opportunity
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)
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
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
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
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
129
Agenda
Genzyme: a success story
Rare Diseases: an untapped opportunity
Multiple Sclerosis: a fast-growing player
Inspired by the Potential to Improve Patients' Lives
130
Milena , Argentina
Gaucher DiseaseDean , Australia
Multiple Sclerosis
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%
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
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
134
Agenda
Genzyme: a success story
Rare Diseases: an untapped opportunity
Multiple Sclerosis: a fast-growing player
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
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
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)
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
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
● 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
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
● 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
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
144
Agenda
Genzyme: a success story
Rare Diseases: an untapped opportunity
Multiple Sclerosis: a fast-growing player
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
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%
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
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
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
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
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.
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
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
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
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
156
Agenda
The Vaccines market
Sanofi Pasteur growth perspectives
A balanced R&D pipeline
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”
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
● 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
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
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
162
Agenda
The Vaccines market
Sanofi Pasteur growth perspectives
A balanced R&D pipeline
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
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
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
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
® ®
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
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
● 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
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
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
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
173
Agenda
The Vaccines market
Sanofi Pasteur growth perspectives
A balanced R&D pipeline
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
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
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
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
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
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
180
Agenda
Consumer Healthcare
Emerging Markets
Established Products
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
+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)
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%
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)
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
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
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
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
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…
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
191
Agenda
Consumer Healthcare
Emerging Markets
Established Products
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
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
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.
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
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
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
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
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
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
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
202
Agenda
Consumer Healthcare
Emerging Markets
Established Products
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
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
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%)
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)
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
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)
MEET SANOFI Management
APPENDIX
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
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