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Q4 and Full Year 2016 Results
February 8, 2017
2
Forward Looking Statements
This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of
1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include
projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events, operations, services, product development and potential,
and statements regarding future performance. Forward-looking statements are generally identified by the words
“expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which
are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to
differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
These risks and uncertainties include among other things, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the
EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such
product candidates as well as their decisions regarding labelling and other matters that could affect the availability or
commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will
be commercially successful, the future approval and commercial success of therapeutic alternatives, the Company’s
ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with
intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in
exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives
and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in
the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and
“Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year
ended December 31, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to
update or revise any forward-looking information or statements.
3
Agenda
3
Key Highlights
● Olivier Brandicourt - Chief Executive Officer
Update on Consumer Healthcare
● Alan Main - Executive Vice President, Consumer Healthcare
Financial Results
● Jérôme Contamine - Executive Vice President, Chief Financial Officer
Additional Participants for Q&A Session
● Olivier Charmeil - Executive Vice President, General Medicines & Emerging Markets
● Peter Guenter - Executive Vice President, Diabetes & Cardiovascular
● Karen Linehan - Executive Vice President, Legal Affairs and General Counsel
● David Loew - Executive Vice President, Sanofi Pasteur
● David P. Meeker - Executive Vice President, Sanofi Genzyme
● Elias Zerhouni - President, Global R&D
KEY HIGHLIGHTS
4
Olivier Brandicourt
Chief Executive Officer
Company Sales(1) Business EPS(2)
2016 Financial Performance
Stronger than Initial Expectations
FY 2016
€33,821m(3)
FY 2015
€34,060m
5
(1) FY 2015 Company Sales restated to exclude Animal Health Business
(2) FY 2015 and FY 2016 Business EPS include the contribution from Animal Health
(3) FY 2016 Company Sales were €36,529m (+1.8% at CER) including Animal Health (previously referred to as “Aggregate Sales)
(4) Evolution at Constant Exchange Rates (CER)
(5) On a reported basis, FY 2016 sales were down -0.7% and Business EPS was up +0.7%
+1.2%
at CER(4,5)
€5.64
FY 2016FY 2015
€5.68
+4.1%
at CER(4,5)
6
Growth
at CER
All Global Business Units Delivered Growth in Q4 2016
(1) Does not include Emerging Markets sales
(2) Reflecting reclassification of VaxServe from Sales to Other
revenues from Jan 1, 2016
(3) Includes Emerging Markets sales for Diabetes &
Cardiovascular and Specialty Care
(4) Emerging Markets: World excluding U.S., Canada, Western &
Eastern Europe (except Eurasia), Japan, South Korea,
Australia, New Zealand and Puerto Rico
(5) Excluding global Consumer Healthcare sales
(6) Consumer Healthcare includes sales in Emerging Markets
Pictures by Freepik
Q4 2016 Sales by Global Business Unit
Company Sales €8,867m +3.4%
€1,710mDiabetes & Cardiovascular +3.8%
€1,335mSanofi Genzyme (Specialty Care) +12.6%
€1,352mSanofi Pasteur (Vaccines) +3.7%
€3,636mGeneral Medicines & Emerging Markets +0.4%
(3,4,5)
(6)
(1)
(2)
(1)
€834mConsumer Healthcare +2.7%
7
Specialty Care Increased Double Digits and
Consumer Healthcare Returned to Growth
Q4 2016 Sales by Franchise
Developed Markets Emerging Markets
Growth
at CER
Total
Sales GrowthSales
Specialty Care +12.9%€1,569m +14.3%+12.6%€1,335m €234m
Diabetes & Cardiovascular +3.9%€2,076m +4.1%+3.8%€1,710m €366m
Sales Growth
Vaccines +3.7%€1,352m +7.3%+1.4%€831m €521m
Established Rx Products -1.3%€2,568m +0.9%-2.6%€1,622m €946m
Generics +0.2%€468m +5.1%-3.3%€259m €209m
Consumer Healthcare +2.7%€834m -3.2%+7.0%€508m €326m
Q4 2015 Q4 2016
Rare Diseases Multiple Sclerosis Oncology
8
Rare Disease and Multiple Sclerosis Drive Growth in
Specialty Care
● Specialty Care franchise up double digits
in developed and emerging markets in Q4
● Multiple Sclerosis franchise continues to
gain market share
● Aubagio® sales up +34.2% to €367m and
reached 8.8% of U.S. Total Rx share(1)
● Lemtrada® sales up +46.9% to €117m
● Rare Disease franchise grew 9.7% driven
by new patient accruals in developed and
emerging markets
● Dupixent® and Kevzara® U.S. launch
preparation activities ongoing
€661m
€1,569m
€716m
+9.7 % at CER
€484m
+37.1% at CER
Global Specialty Care
Franchise Sales
€353m
(1) IMS NPA TRx data as of Q4 2016
€381m
€369m
-3.9 % at CER
€1,395m
+12.9%
at CER
Specialty Care achieved +17.2% sales growth in 2016
8
Vaccines Growth Driven by Pediatric Combination(1)
Franchise in Q4
9
PPH: Polio, Pertussis, Hib vaccines
(1) Pediatric combination vaccines are referred to as “PPH franchise”
(2) Pediatric combination vaccines including Hexaxim, Pentaxim, Tetraxim
● Vaccines sales up +3.7% at CER in Q4
● PPH franchise +16.5% at CER to €544m
in Q4 2016
● Pentacel® supply improving in the U.S.
● Emerging Markets growth +5.1% despite
continued China weakness
● FY 2016 PPH growth (+12.7%) driven by
AcXim family (+39.2%)
● Flu franchise delivers new record year
● €1,521m, up +16.6% at CER in 2016
● 70m doses shipped in the U.S.
● Dengvaxia®: FY 2016 sales of €55m
Global Growth of AcXim Family(2)
(sales in €m)
2011 2016
€258m €677m
+23%
CAGR
at CER
/
Vaccines delivered +8.8% growth in 2016 driven by Flu and PPH differentiation
10
CHC Business Returned to Growth in Q4 2016
● Developed Markets up +7.0%(1)
● U.S. sales grew +4.6% to €209m
● Europe up +9.5% to €229m helped by
strong cough and cold sales
● Emerging Markets down -3.2%
● Business in Russia starting to recover
● Brazil economic situation remains
challenging
● Boehringer Ingelheim asset swap
completed(3), positioning Sanofi as a
top 3 global CHC player
All Growth at CER and constant structure
(1) Excluding the sales of small divested products in the 2015 base, growth at CER was +8.0%
(2) Excluding the sales of small divested products in the 2015 base, growth at CER was +3.2%
(3) The closing of the disposal of Merial in Mexico and the swap of Merial and CHC in India have been delayed
pending receipt of certain regulatory approvals. The transactions in both countries are expected to close early 2017.
CHC Global Sales Growth at CER
Q1 Q4Q3Q2
-3.1% -4.3% -1.2%
+2.7%
2016
(2)
CHC sales increased +2.7% in 2016 at constant structure and ex-Venezuela
Toujeo® Gains Share in Several Important Markets
While U.S. DCV(1) Environment Remains Challenging
11
● Global Diabetes franchise sales up +1.9%
at CER in Q4 2016 to €1,945m
● Toujeo® up 39.3%(2) sequentially to €238m
● Share gains continue in EU and Japan
● Soliqua™ 100/33 launched in the U.S. and
Suliqua™ approved in EU(3)
● Praluent® sales of €37m in Q4
● Briefing on motion to suspend (stay)
permanent injunction completed
● U.S. CAFC(4) granted expedited briefing
schedule for appeal of District Court rulings
● Product remains available to patients in the
U.S. in both 75/150 mg doses(5)
Market Share(6)
Top EU Countries, Japan and the U.S.
0%
5%
10%
15%
20%
W0 W10 W20 W30 W40 W50 W60 W70 W80 W90
France Germany UK Spain Japan U.S.
(1) Diabetes and Cardiovascular
(2) at Constant Exchange Rate
(3) Approved in Europe under the brand name Suliqua™ in 2 doses
(insulin 100 units/ml with lixisenatide 33 or 50 micrograms/ml)
(4) Court of Appeals for Federal Circuit
(5) Absent a stay, the injunction will take effect in the U.S. on February 21,
2017
(6) Market share of the basal insulin market in international units for
France, Germany, Spain, UK and Japan, in TRx for the U.S.
Week since launch
€3,321m
€2,134m
€782m
€810m
€710m
EUROPE
-1.7%
ASIA
-2.8%
ROW(4)
-11.0%
LATAM
+4.2%
U.S.
Good Growth in Emerging Markets Partially Offset by
China(1) Comparisons in the Quarter(2)
12
Emerging Markets(3) grew +7.0% in 2016 excluding Venezuela
+11.3%
€752m
AMESA(6)
+11.4%
€329m
EURASIA(5)
+8.4%
All Growth at Constant Exchange Rates
(1) As per IMS CHPA (China Hospital Pharmaceutical Audit) Oct-Nov sales
growth in China was +11.9% for Sanofi Pharmaceutical products
(2) Q4 2016 Emerging Markets sales grew +3.5% at CER
(3) World excluding U.S., Canada, Europe, Japan, South Korea, Australia,
New Zealand and Puerto Rico
(4) RoW: Japan, South Korea, Canada, Australia, New Zealand and Puerto
Rico
(5) Eurasia: Russia, Ukraine, Georgia, Belarus, Armenia and Turkey
(6) AMESA: Africa, Middle East and South Asia
13
Building our Immunology Franchise
(1) Brand name has been conditionally approved
(2) Subject to successful FDA pre-license inspection related to Dupixent
(3) Atopic Dermatitis
● First fully human IL-6 mAb for the treatment of moderately to severely active
rheumatoid arthritis
● Recently received first approval in Canada
● Le Trait “fill-finish” plant classified as “acceptable” by FDA based on review of
responses to the FDA 483 as well as proposed corrective actions
● Expect FDA inspection of Le Trait and re-submission of U.S. BLA in Q1 2017(2)
(1)
● Anticipated FDA regulatory decision in AD(3) on March 29th 2017
● Phase 3 in asthma ongoing with FDA regulatory submission expected in Q4 2017
● Phase 3 in nasal polyposis initiated in Q4 2016
● Additional LCM studies to start in 2017, including in pediatric AD and asthma
®
14
Expanding our Late Stage Pipeline with Two Potentially
Differentiated Assets
● Dual SGLT1 and SGLT2 inhibitor
● Phase 3 program in T2D to explore
potential benefit of product profile in:
● Monotherapy
● Addition to OADs(1)
● Addition to basal insulin
● Targets differentiation in T2D:
● In renally impaired patients
● On HbA1C and SBP(2) vs empagliflozin
● Phase 3 initiated in monotherapy and
in addition to metformin in Q4 2016
Sotagliflozin
● Mechanism of action potentially
differentiated by targeting a unique
epitope on CD38 receptor
● Phase 3 program in relapsed-refractory
multiple myeloma in combination with
pom-dex(3,4) initiated in Q4 2016
● Additional clinical trials to be initiated in
multiple myeloma in 2017
● Clinical studies in other potential
oncology indications to start in 2017
Isatuximab
(1) Oral Anti-diabetic agents
(2) Systolic Blood Pressure
(3) Pomalidomide and dexamethasone
(4) Phase 3 trial referred to as ICARIA-MM
15
(1) Compared to FY2016 and barring major unforeseen adverse events
(2) FY 2016 Business EPS of €5.68
(3) Difference between variation on a reported basis and variation at CER
Outlook for 2017
Business EPS
+3% to +4%(3)
based on Dec 2016 average exchange rates
Stable to -3%
at CER(1,2)
FY 2017
FX impact on Business EPS
Guidance based on FY2016 Business EPS of €5.68
CONSUMER HEALTHCARE
16
Alan Main
Executive Vice President - Consumer Healthcare
17
Integration on Track(1) and Unlocking the Potential of the
Iconic BI Brands
17
● Integration on track
● Operating from two geographic hubs
in Paris and Frankfurt
● Regional leadership and global
marketing heads appointed
● Confident in reaching financial
objectives
● Timing of transfer of regional and
local marketing authorizations will
lead to progressive sales recognition
● Sanofi to recognize in “Other
Operating Income” the profit of
products temporarily distributed by BI
until transfers completed in 2017
(1) The closing of the disposal of Merial in Mexico and the swap of Merial and CHC in India have been delayed pending receipt of certain regulatory
approvals. The transactions in both countries are expected to close early 2017.
(2) Nicholas Hall & Company, MAT September 2016
(3) Transaction excludes CHC in China; value of CHC sales in Venezuela have been reduced to nearly zero due to revision of foreign exchange rates
(4) Based on unaudited figures, subject to change
BI Brands Lift Sanofi to Leadership
Position(2) in Attractive Categories
2016 Sales(3) of acquired BI brands
€1.5bn(4)
#1 #2
#3 #6
● Xyzal® offers 24 hour relief to
adults and children with seasonal
and year-round allergies
● Xyzal® adds to Sanofi’s leading
Allergy CHC portfolio (#1 in U.S.)
● Sanofi to leverage its proven
expertise in Rx-to-OTC switches
1818
Xyzal® Approval Broadens OTC Allergy Offering
in Important U.S. Market
Three Rx-to-OTC Switches Build on Success of U.S. CHC Platform
2011 2012 2013 2014 2015 2016 2017e
€549m
U.S. CHC
non-allergy
portfolio
€938m
FINANCIAL RESULTS
Jérôme Contamine
Executive Vice President, Chief Financial Officer
19
Quarterly Company Sales Growth(1,2) Quarterly Business EPS Growth(1)
Q2 2016Q1 2016
Q4 2016
Quarterly Sales Growth Progressively Improved While
Investing Behind R&D and Launches
20
Q3 2016
-0.9%
-0.7%
(1) Growth at Constant Exchange Rates (CER)
(2) Reflect reporting structure changes to exclude Animal Health
(3) On a reported basis, Q4 2016 sales were up +3.3% and Business EPS was down -4.6%
+3.0%
+5.3%
-2.1%
+12.4%
-1.5%
(3)
+3.4%
Q2 2016
Q1 2016
Q4 2016
Q3 2016
(3)
Q4 2016 Business Operating Income grew 3.7% at CER
CER: Constant Exchange Rates
(1) Reflecting reclassification of VaxServe from Net Sales to Other revenues and Animal Health reclassification.
VaxServe sales of non-Company products were €136m in Q4 2015 and €221m in Q4 2016
(2) Effective tax rate excluding Animal Health
21
Business Operating Income Growth Offset
by Higher Tax Rate
€m Q4 2016 Q4 2015
% Change
(reported €)
% Change
(CER)
Net Sales 8,867 8,583 +3.3% +3.4%
Other revenues 310 235 +31.9% +31.1%
Gross Profit 6,221 5,953 +4.5% +4.5%
R&D (1,437) (1,364) +5.4% +4.7%
SG&A (2,603) (2,482) +4.9% +4.8%
Other current operating income & expenses (78) 24 - -
Share of profit/loss of associates 53 31 - -
Minority interests (32) (39) - -
Business Operating Income 2,124 2,123 0.0% +3.7%
Business operating margin 24.0% 24.7% - -
Effective tax rate(2) 24.0% 17.4% - -
Animal Health contribution to BNI 81 17 - -
Total Business Net Income 1,606 1,709 -6.0% -2.9%
Business EPS €1.25 €1.31 -4.6% -1.5%
(1)
Q4 2015 Q4 2016
€4,040m
+4.8% at CER
€3,846m
€1,437m
+4.7% at
CER€1,364m
€2,603m
+4.8% at
CER
€2,482m
R&D
Continued Improvement in Gross Margin;
Opex Growth Lower than our Initial Expectations
22
Operating Expenses
(1) Gross Margin is calculated as the ratio of Gross profit over Company sales
(excluding Other revenues)
Gross Margin Ratio(1)
SG&A
Q3Q2Q1
+0.8%
+1.3%
+0.3%
+0.2%
Q4
2015 2016
72.2%
71.0%
70.4% 70.2%
FY 2016 Gross Margin 71.0% (+0.7%);
Operating Expenses up +2.5% at CER in 2016
23
FX Headwind Eased on Sales but
Remained Challenging on EPS
(1) Main currency impact on Company Sales in FY 2016: Japanese Yen (+€160m); Argentine Peso (-€147m);
Chinese Yuan (-€110m); Mexican Peso (-€94m)
Currency Impact
-2.6%
-€215m
-€0.05
-4.2%
-€353m
-1.0%
-€83m
Q4Q3Q2Q1
-0.1%
-€10m
-€0.02
Q4Q3Q2Q1
-€0.07 +€0.05
-€0.04
-3.8%
-5.0%
-1.2%
-3.1%
Company Sales(1) Business EPS
FY 2016
-€0.19
-3.4%
FY 2016
-€661m
-1.9%
Creating a More Agile Sanofi Through a
Strategic Cost Savings Program
24
2015 2016 2017e 2018e
One-time costs Annual Cost Savings
€1.5bn
● Primary sources of cost savings in
2016/2017:
● Simplification via new GBU structure and
creation of global functions(1)
● Manufacturing operational improvement
and productivity efforts
● Product portfolio streamlining in
Established Products franchise
● Resizing of sales forces to evolving
market dynamics
● Reinvestment decisions scaled to the
needs of the business
On track to deliver at least €1.5bn in cost savings in 2018
Progression of Cost Savings
~€650m
2015 2016 2017e 2018e
(1) Global functions such as SBS (Sanofi Business Services) and Global ITS (Global Information Technology Solutions)
~€1.3bn
Proposal for 23rd Consecutive Increase in Annual Dividend
25
(1) To be submitted for approval by shareholders at the Annual General Meeting on May 10, 2017
(2) Sanofi share price averaged €76.38 during January 2017
● Commitment to progressive dividend
growth remains a key value proposition
to our shareholders
● €0.03 per share increase over 2015
● Implies a dividend yield of 3.9%(2)
2016
€2.96
2015
€2.93
2014
€2.85
2013
€2.80
(1)
Evolution of Dividend
Returning Cash to Shareholders in Anticipation of BI Cash
Received in 2017
26
Share Count (m) 1,309.9 1,301.7
2014 2015
(1)
SBB: Share Buyback
(1) Number of shares outstanding in million on Dec 31st 2014, Dec 31st 2015 and Dec 31st 2016
(2) During the Q3 2016 results, Sanofi announced a €3.5bn share repurchase program expected to be completed by the end of 2017
1,271.9
2016
Evolution of Share Buyback
€2.3bn of €3.5bn share buyback program(2) bought to date
€1,121m
Net SBB
€680m €1,801m
€1,211m
Net SBB
€573m €1,784m
€2,602m
Net SBB
€306m €2,908m
Issuance Buyback Issuance Buyback Issuance Buyback
Sanofi Exceeded its Key 2016 Financial Objectives
Gross Margin
OpEx Growth Rate at CER
Tax Rate
Business EPS Guidance at CER
Dividend growth
Broadly stable
Progressive
~ +4.5%
24-25%
68-69%
27
+4.1%
3 cent increase
+2.7%(2)
23.9%(3)
70.7%(1)
Initial Objectives
Results including
Animal Health
(1) Gross Margin: 71.0% excluding Animal Health
(2) Operating Expenses: +2.5% excluding Animal Health
(3) Tax rate: 23.3% excluding Animal Health
CLOSING REMARKS
28
Olivier Brandicourt
Chief Executive Officer
29
Q&A SESSION
30
APPENDICES
R&D Pipeline
R&D Pipeline – Pharma & Vaccines
Phase I Phase II Phase III Registration
(1) Approved in 14 countries to date
(2) Approved in 27 countries as of end December 2016
(3) Previously referred as Niemann Pick type B
31
N New Molecular Entity
Infectious Diseases
Oncology
Immuno-inflammation
Diabetes Solutions
Rare Disease
Vaccines
MS, Neuro, Ophthalmology
Cardiovascular & metabolism
GZ402668
GLD52 (anti-CD52 mAb)
Relapsing multiple sclerosis
N GZ389988
TRKA antagonist
Osteoarthritis
N
SAR425899
GLP-1R/GCGR dual agonist
Type 2 diabetes
N
SAR438335
GLP-1R/GIPR dual agonist
Type 2 diabetes
N
SAR566658
Maytansin-loaded anti-CA6 mAb
Solid tumors
N
SAR408701
Maytansin-loaded anti-CEACAM5 mAb
Solid tumors
N
SAR428926
Maytansin loaded anti-Lamp1 mAb
Cancer
N
SAR247799
S1P1 agonist
cardiovascular indication
N
SAR439152
Myosin inhibitor
Hypertrophic cardiomyopathy
N
SAR407899
rho kinase
Microvascular angina
N GZ402666
neoGAA
Pompe Disease
N
fitusiran (ALN-AT3)
siRNA targeting Anti-Thrombin
Hemophilia
N
UshStat®
Myosin 7A gene therapy
Usher syndrome 1B
N
SAR228810
Anti-protofibrillar AB mAb
Alzheimer’s disease
N
Herpes Simplex Virus Type 2
HSV-2 vaccine
dupilumab
Anti-IL4Rα mAb
Eosinophilic oesophagitis
SAR156597
IL4/IL13 Bi-specific mAb
IPF / Systemic Scleroderma
N
SAR100842
LPA1 receptor antagonist
Systemic sclerosis
N
efpeglenatiden
Long-acting GLP-1 receptor agonist
Type 2 diabetes
N
sarilumab
Anti-IL6R mAb
Uveitis
isatuximab
Anti-CD38 naked mAb
Relapsed Refractory Multiple Myeloma
N
SAR439684
PD-1 inhibitor
Advanced CSCC (Skin cancer)
N
olipudase alfa
rhASM Deficiency
Acid Sphingomyelinase Deficiency(3)
N
GZ402671
Oral GCS inhibitor
Fabry Disease, Gaucher Type 3,
Gaucher related Parkinson’s Disease
N
SAR422459
ABCA4 gene therapy
Stargardt disease
N
Combination
ferroquine / OZ439
Antimalarial
N
Rabies VRVg
Purified vero rabies vaccine
Tuberculosis
Recombinant subunit vaccine
Fluzone® QIV HD
Quadrivalent inactivated
influenza vaccine - High dose
SAR342434
insulin lispro
Type 1+2 diabetes
N
sotagliflozin n
Oral SGLT-1&2 inhibitor
Type 1 & Type 2 diabetes
N
patisiran (ALN-TTR02)
siRNA inhibitor targeting TTR
Familial amyloidotic polyneuropathy
N
Clostridium difficile
Toxoid vaccine
VaxiGrip® QIV IM
Quadrivalent inactivated
influenza vaccine (6-35 months)
Pediatric pentavalent vaccine
DTP-Polio-Hib
Japan
Men Quad TT
2nd generation meningococcal
ACYW conjugate vaccine
sarilumab
Anti-IL6R mAb
Rheumatoid arthritis, U.S., EU
N
Dupixent
Anti-IL4Rα mAb
Atopic dermatitis, U.S., EU
N
Dengvaxia®(1)
Mild-to-severe
dengue fever vaccine
PR5i
DTP-HepB-Polio-Hib
Pediatric hexav. vaccine, U.S
VaxiGrip® QIV IM(2)
Quadrivalent inactivated
influenza vaccine (3 years+)
SAR440340
Anti-IL33 mAb
Asthma & COPD
N dupilumab
Anti-IL4Rα mAb
Asthma, Nasal Polyposis
SAR439794
TLR4 agonist
Peanut allergy
N SAR341402
Rapid acting insulin
Diabetes
N
Adacel+
Tdap booster
Shan 6
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine
HIV
Viral vector prime & rgp120 boost
vaccine
Zika
Inactivated Zika vaccine
Respiratory syncytial virus
Infants
32
Phase I Phase II Phase III Registration TOTAL
Oncology 3 1 1 0 5
Diabetes 2 2 1 1 6
Cardiovascular Diseases 2 2 0 0 4
Immuno-inflammation 2 2 0 2 6
Infectious Diseases 0 1 0 0 1
Rare Diseases 1 2 2 0 5
Multiple Sclerosis,
Neurology, Ophthalmology
3 1 0 0 4
Vaccines 3 4 3 3 13
TOTAL 16 15 7 6
R&D Pipeline Summary Table(1)
31 13 NMEs & Vaccines
44
32
31
(1) Excluding life cycle management programs
Expected Regulatory Decisions Q1 Q2 Q3 Q4
● Dengvaxia® in endemic countries
● Suliqua® in Diabetes (EU)
● Dupixent®(1) in Atopic Dermatitis (U.S.) 
● Kevzara® in Rheumatoid Arthritis (U.S.) 
● Kevzara® in Rheumatoid Arthritis (EU)
Expected Regulatory Submissions Q1 Q2 Q3 Q4
● Kevzara® in Rheumatoid Arthritis (U.S.) 
● Dupixent®(1) in Atopic Dermatitis (Japan) 
● dupilumab in Asthma in Adult patients (U.S.) 
Expected Phase III / IIIb Topline Data Q1 Q2 Q3 Q4
● patisiran in Familial amyloidotic polyneuropathy 
● dupilumab in Asthma in Adult patients 
Expected Phase III Starts Q1 Q2 Q3 Q4
● dupilumab in Asthma in patients aged 6-11 year-old 
● fitusiran (ALN-AT3) in Hemophilia 
● Dupixent®(1) AD in 6-11 and 12-17 year-old
● efpeglenatide in type-2 diabetes 
33
Expected 2017 Late-Stage Pipeline Events
(1) The European Medicines Agency (EMA) and FDA have conditionally accepted Dupixent® as the trade name for dupilumab..
34
Expected R&D Milestones in 2017
34
Products Expected milestones Timing
Dengvaxia® Regulatory decisions in endemic countries Throughout 2017
Kevzara®(1) U.S. regulatory resubmission in Rheumatoid Arthritis Q1 2017
Dupixent®(1) Japan regulatory submission in Atopic Dermatitis Q1 2017
Dupixent®(1) U.S. regulatory decision in Atopic Dermatitis Q1 2017
dupilumab Start of Phase 3 trial in Asthma in 6-11 year-olds Q2 2017
fitusiran Start of Phase 3 trial in Hemophilia Q2 2017
Kevzara®(1) U.S. regulatory decision in Rheumatoid Arthritis Q2 2017
Dupixent®(1) Start of Phase 3 trial in Atopic Dermatitis in 12-17 year-olds Q2 2017
Dupixent®(1) Start of Phase 3 trial in Atopic Dermatitis in 6-11 year-olds Q3 2017
patisiran Phase 3 results in Familial amyloidotic polyneuropathy Q3 2017
Fluzone QIV HD Start of Phase 3 trial Q3 2017
VaxiGrip® QIV IM (6-35 months) EU regulatory submission Q3 2017
dupilumab Phase 3 results in Asthma in Adult patients Q4 2017
dupilumab U.S. regulatory submission in Asthma in Adult patients Q4 2017
efpeglenatide Start of Phase 3 trial in type-2 Diabetes 2017
isatuximab Start of additional Phase 3 trials in Multiple Myeloma 2017
(1) Name received conditional approval
APPENDICES
FINANCE
35
Net Debt
Dec 31, 2016
Other
-€1,453m
Dividends
-€3,759m
Acquisitions,
Licensing, Net
of Disposals
-€936m
Net Share
Repurchase
-€2,602m
CapEx
-€1,486m
Net Cash from
Operating
Activities
Net Debt
Dec 31, 2015
36
(1)
(2)
€7,254m
€8,206m
€9,284m
(4) (1)
FCF
€7,798m
(3)
FCF: Free Cash Flow
(1) Including derivatives related to the financial debt +€152m at
December 31st 2015 and +€100m at December 31st 2016
(2) Excluding Restructuring costs
(3) Including Hanmi Pharmaceuticals of €400m, Onduo of
€165m, Regeneron anti-dilutive share purchase of €115m
and Bayer Contingent consideration of €137m
(4) Other including Restructuring costs and Fx impact
Net Debt
36
Net Debt Evolution in 2016
2017 Business EPS Currency Sensitivity
Currency Exposure on Q4 2016 Sales Currency Average Rates
2017 Currency Sensitivity
37
Q4 2015 Q4 2016 % change
EUR/USD 1.09 1.08 -1.5%
EUR/JPY 132.93 117.92 -11.3%
EUR/CNY 7.00 7.38 +5.5%
EUR/BRL 4.21 3.55 -15.7%
EUR/RUB 72.37 67.99 -6.0%
Currency Variation Business EPS Sensitivity
U.S. Dollar - 0.05 USD/EUR + EUR 0.13
Japanese Yen + 5 JPY/EUR - EUR 0.02
Chinese Yuan + 0.2 CNY/EUR - EUR 0.02
Brazilian Real + 0.4 BRL/EUR - EUR 0.02
Russian Ruble + 10 RUB/EUR - EUR 0.03
€
21.9%
US $
38.2%Chinese Yuan
5.3%
Japanese
Yen
4.5%
Brazilian Real
2.5%
Mexican Peso
2.4%
Russian
Ruble
1.9%
British £
1.7%
Australian $
1.4%
Canadian $
1.4%
Others
18.8%
38
Business Net Income Statement
*** Net of tax.
*** Determined on the basis of Business income before tax, associates and non-controlling interests (excluding Animal Health business).
*** Based on an average number of shares outstanding of 1,282.9 million in the fourth quarter of 2016 and 1,304.9 million in the fourth quarter of 2015.
(1) As per a change in accounting presentation, VaxServe sales of non-Sanofi products are reported in Other revenues from 2016 onwards. Prior period Net sales and Other
revenues have been represented accordingly.
Fourth-quarter 2016 Pharmaceuticals Vaccines Others Total Group
€ million Q4 2016 Q4 2015 Change Q4 2016 Q4 2015 Change Q4 2016 Q4 2015 Q4 2016 Q4 2015 Change
Net sales 7,515 7,277 3.3% 1,352 1,306 3.5% 8,867 8,583 3.3%
Other revenues (1)
83 91 (8.8%) 227 144 57.6% 310 235 31.9%
Cost of Sales (2,210) (2,195) 0.7% (746) (670) 11.3% (2,956) (2,865) 3.2%
As % of net sales (29.4%) (30.2%) (55.2%) (51.3%) (33.3%) (33.4%)
Gross Profit 5,388 5,173 4.2% 833 780 6.8% 6,221 5,953 4.5%
As % of net sales 71.7% 71.1% 61.6% 59.7% 70.2% 69.4%
Research and development expenses (1,292) (1,214) 6.4% (145) (150) (3.3%) (1,437) (1,364) 5.4%
As % of net sales (17.2%) (16.7%) (10.7%) (11.5%) (16.2%) (15.9%)
Selling and general expenses (2,401) (2,276) 5.5% (202) (206) (1.9%) (2,603) (2,482) 4.9%
As % of net sales (31.9%) (31.3%) (14.9%) (15.8%) (29.4%) (28.9%)
Other operating income/expenses (28) 46 (14) 25 (36) (47) (78) 24
Share of profit/loss of associates* and joint-ventures 41 28 12 3 53 31
Net income attributable to non controlling interests (31) (39) (1) - (32) (39)
Business operating income 1,677 1,718 (2.4%) 483 452 6.9% (36) (47) 2,124 2,123 0.0%
As % of net sales 22.3% 23.6% 35.7% 34.6% 24.0% 24.7%
Financial income & expenses (125) (73)
Income tax expenses (474) (358)
Tax rate** 24.0% 17.4%
Business net income excl. Animal Health business 1,525 1,692 (9.9%)
As % of net sales 17.2% 19.7%
Business net income of Animal Health business 81 17 376.5%
Business net income 1,606 1,709 (6.0%)
Business earnings / share
excluding Animal Health business (in €)***
1.19 1.30 (8.5%)
Business earnings / share (in €)*** 1.25 1.31 (4.6%)
39
Business Net Income Statement
*** Net of tax.
*** Determined on the basis of Business income before tax, associates and non-controlling interests (excluding Animal Health business).
*** Based on an average number of shares outstanding of 1,286,6 million in 2016 and 1,306.2 million in 2015.
(1) As per a change in accounting presentation, VaxServe sales of non-Sanofi products are reported in Other revenues from 2016 onwards. Prior period Net sales and Other
revenues have been represented accordingly.
2016 Pharmaceuticals Vaccines Others Total Group
€ million 2016 2015 Change 2016 2015 Change 2016 2015 2016 2015 Change
Net sales 29,244 29,799 (1.9%) 4,577 4,261 7.4% 33,821 34,060 (0.7%)
Other revenues (1)
274 288 (4.9%) 613 513 19.5% 887 801 10.7%
Cost of Sales (8,349) (8,788) (5.0%) (2,353) (2,131) 10.4% (10,702) (10,919) (2.0%)
As % of net sales (28.5%) (29.5%) (51.4%) (50.0%) (31.6%) (32.1%)
Gross Profit 21,169 21,299 (0.6%) 2,837 2,643 7.3% 24,006 23,942 0.3%
As % of net sales 72.4% 71.5% 62.0% 62.0% 71.0% 70.3%
Research and development expenses (4,618) (4,530) 1.9% (554) (552) 0.4% (5,172) (5,082) 1.8%
As % of net sales (15.8%) (15.2%) (12.1%) (13.0%) (15.3%) (14.9%)
Selling and general expenses (8,743) (8,656) 1.0% (743) (726) 2.3% (9,486) (9,382) 1.1%
As % of net sales (29.9%) (29.0%) (16.2%) (17.0%) (28.0%) (27.5%)
Other operating income/expenses (1) (121) (14) 27 (112) (114) (127) (208)
Share of profit/loss of associates* and joint-ventures 129 146 48 23 177 169
Net income attributable to non controlling interests (112) (125) (1) (1) (113) (126)
Business operating income 7,824 8,013 (2.4%) 1,573 1,414 11.2% (112) (114) 9,285 9,313 (0.3%)
As % of net sales 26.8% 26.9% 34.4% 33.2% 27.5% 27.3%
Financial income & expenses (399) (381)
Income tax expenses (2,054) (1,929)
Tax rate** 23.3% 21.7%
Business net income excl. Animal Health business 6,832 7,003 (2.4%)
As % of net sales 20.2% 20.6%
Business net income of Animal Health business 476 368 29.3%
Business net income 7,308 7,371 (0.9%)
Business earnings / share
excluding Animal Health business (in €)***
5.31 5.36 (0.9%)
Business earnings / share (in €)*** 5.68 5.64 0.7%
Reconciliation of Business Net Income to Consolidated
Net Income Attributable to Equity Holders of Sanofi
40
(1) Animal Health business reported separately in accordance with IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations).
(2) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €374 million in the fourth quarter of 2016
and €423 million in the fourth quarter of 2015.
(3) Gain on Sanofi Pasteur MSD investment in associates and joint-ventures upon termination of the joint-venture.
(4) This lines includes the impact on deferred tax assets and liabilities coming from the reconciliation items (in particular amortization and impairment of intangible assets and
restructuring costs) following the change in tax rates, mainly in France (28% standard rate effective as of January 1, 2020).
(5) Includes the following items: impact of the elimination of depreciation and impairment of Property, Plant & Equipment from the IFRS 5 application date, impact of the
amortization and impairment of intangible assets until IFRS 5 application date, costs incurred as a result of the divestment as well as tax effect of these items.
(6) Includes the following items: impact of the discontinuation of the equity accounting of the Sanofi Pasteur MSD business net income since the announcement by Sanofi and
Merck of their intent to end their joint vaccine operations in Europe.
(7) Based on an average number of shares outstanding of 1,282.9 million in the fourth quarter of 2016 and 1,304.9 million in the fourth quarter of 2015.
€ million Q4 2016(1)
Q4 2015(1)
Change
Business net income 1,606 1,709 (6.0%)
Amortization of intangible assets (2)
(412) (695)
Impairment of intangible assets (119) (533)
Fair value remeasurement of contingent consideration liabilities (41) (108)
Restructuring costs and similar items (189) (359)
Impairment loss on Alnylam investment (296) -
Other gains and losses, and litigation (3)
211 -
Tax effect of items listed above (4)
: 95 601
Amortization of intangible assets 197 256
Impairment of intangible assets 24 175
Fair value remeasurement of contingent consideration liabilities 1 46
Restructuring costs and similar items (139) 124
Other tax effects 12 -
Other tax items - -
Share of items listed above attributable to non-controlling interests 11 20
Restructuring costs of associates and joint-ventures, and expenses arising from the
impact of acquisitions on associates and joint-ventures
(9) (59)
Animal Health items (5)
(63) (242)
Other Sanofi Pasteur MSD items (6)
(4) -
Net income attributable to equity holders of Sanofi 790 334 136.5%
IFRS earnings per share (7)
(in euros) 0.62 0.26
Reconciliation of Business Net Income to Consolidated
Net Income Attributable to Equity Holders of Sanofi
41
(1) Animal Health business reported separately in accordance with IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations).
(2) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €1,550 million in 2016 and €1,770
million in 2015.
(3) Gain on Sanofi Pasteur MSD investment in associates and joint-ventures upon termination of the joint-venture.
(4) This lines includes the impact on deferred tax assets and liabilities coming from the reconciliation items (in particular amortization and impairment of intangible assets and
restructuring costs) following the change in tax rates, mainly in France (28% standard rate effective as of January 1, 2020) and in Japan.
(5) Includes the following items: impact of the elimination of depreciation and impairment of Property, Plant & Equipment from IFRS 5 application date, impact of the
amortization and impairment of intangible assets until IFRS 5 application date, costs incurred as a result of the divestment as well as tax effect of these items.
(6) Includes the following items: impact of the discontinuation of the equity accounting of the Sanofi Pasteur MSD business net income since the announcement by Sanofi and
Merck of their intent to end their joint vaccine operations in Europe.
(7) Based on an average number of shares outstanding of 1,286.6 million in 2016 and 1,306.2 million in 2015.
€ million 2016(1)
2015(1)
Change
Business net income 7,308 7,371 (0.9%)
Amortization of intangible assets (2)
(1,692) (2,137)
Impairment of intangible assets (192) (767)
Fair value remeasurement of contingent consideration liabilities (135) 53
Restructuring costs and similar items (879) (795)
Impairment loss on Alnylam investment (457) -
Other gains and losses, and litigation (3)
211 -
Tax effect of items listed above (4)
: 841 1,331
Amortization of intangible assets 647 757
Impairment of intangible assets 47 262
Fair value remeasurement of contingent consideration liabilities 24 39
Restructuring costs and similar items 95 273
Other tax effects 28 -
Other tax items (113) (111)
Share of items listed above attributable to non-controlling interests 22 25
Restructuring costs of associates and joint-ventures, and expenses arising from the
impact of acquisitions on associates and joint-ventures
9 (191)
Animal Health items (5)
(162) (492)
Other Sanofi Pasteur MSD items (6)
(52) -
Net income attributable to equity holders of Sanofi 4,709 4,287 9.8%
IFRS earnings per share (7)
(in euros) 3.66 3.28
42
Consolidated Income Statements
(1) Animal Health business reported on a single line in the consolidated income statements in accordance with IFRS 5 (Non-current held for sale and discontinued operations).
(2) As per a change in accounting presentation, VaxServe sales of non-Sanofi products are reported in Other revenues from 2016 onwards. Prior period Net sales and Other
revenues have been restated accordingly.
€ million Q4 2016 (1) Q4 2015 (1)(2) 2016 (1) 2015 (1)(2)
Net sales 8,867 8,583 33,821 34,060
Other revenues 310 235 887 801
Cost of sales (2,956) (2,865) (10,702) (10,919)
Gross profit 6,221 5,953 24,006 23,942
Research and development expenses (1,437) (1,364) (5,172) (5,082)
Selling and general expenses (2,603) (2,482) (9,486) (9,382)
Other operating income 56 145 355 254
Other operating expenses (134) (121) (482) (462)
Amortization of intangible assets (412) (695) (1,692) (2,137)
Impairment of intangible assets (119) (533) (192) (767)
Fair value remeasurement of contingent consideration liabilities (41) (108) (135) 53
Restructuring costs and similar items (189) (359) (879) (795)
Other gains and losses, and litigation 211 - 211 -
Operating income 1,553 436 6,534 5,624
Financial expenses (422) (172) (924) (559)
Financial income 1 99 68 178
Income before tax and associates and joint-ventures 1,132 363 5,678 5,243
Income tax expense (369) 243 (1,326) (709)
Share of profit / loss of associates and joint-ventures 30 (28) 134 (22)
Net income excluding the held for exchange Animal Health business 793 578 4,486 4,512
Net income from the held for exchange Animal Health business 18 (225) 314 (124)
Net income 811 353 4,800 4,388
Net income attributable to non-controlling interests 21 19 91 101
Net income attributable to equity holders of Sanofi 790 334 4,709 4,287
Average number of shares outstanding (million) 1,282.9 1,304.9 1,286.6 1,306.2
Earnings per share excluding the held for exchange Animal Health business (in euros) 0.60 0.43 3.42 3.38
IFRS earnings per share (in euros) 0.62 0.26 3.66 3.28
43
Animal Health Segment Results
€ million
Q4 2016 Q4 2015 Change 2016 2015 Change
Net sales 599 559 7.2% 2,708 2,515 7.7%
Other revenues 12 9 33.3% 39 41 (4.9%)
Cost of sales (230) (217) 6.0% (937) (885) 5.9%
As % of net sales (38.4%) (38.8%) (34.6%) (35.2%)
Gross profit 381 351 8.5% 1,810 1,671 8.3%
As % of net sales 63.6% 62.8% 66.8% 66.4%
Research and development expenses (56) (51) 9.8% (191) (177) 7.9%
As % of net sales (9.3%) (9.1%) (7.1%) (7.0%)
Selling and general expenses (225) (218) 3.2% (899) (865) 3.9%
As % of net sales (37.6%) (39.0%) (33.2%) (34.4%)
Other operating income/expenses 2 (4) (14) 5
Share of profit/loss of associates(1)
and joint-ventures - - 1 1
Business operating income 102 78 30.8% 707 635 11.3%
As % of net sales 17.0% 14.0% 26.1% 25.2%
(1) Net of tax
44
Change in Net Debt
(1) Excluding restructuring costs and similar items
€ million 2016 2015
Business net income 7,308 7,371
Depreciation, amortization and impairment of property, plant and equipment and software 1,355 1,333
Net gains and losses on disposals of non-current assets, net of tax (33) (137)
Other non-cash items 44 (19)
Operating cash flow before changes in working capital (1)
8,674 8,548
Changes in working capital (1)
610 1,048
Acquisitions of property, plant and equipment and software (1,486) (1,464)
Free cash flow (1)
7,798 8,132
Acquisitions of intangible assets excluding software (716) (1,559)
Acquisitions of investments including assumed debt (534) (365)
Restructuring costs and similar items paid (729) (682)
Proceeds from disposals of property, plant and equipment, intangibles, and other
non-current assets, net of tax 314 208
Issuance of Sanofi shares 306 573
Dividends paid to shareholders of Sanofi (3,759) (3,694)
Acquisition of treasury shares (2,908) (1,784)
Disposals of treasury shares, net of tax - 1
Transactions with non-controlling interests including dividends (31) (25)
Foreign exchange impact (192) (768)
Other items (501) (120)
Change in net debt (952) (83)
45
Simplified Consolidated Balance Sheet
ASSETS
€ million
Dec 31,
2016
Dec 31,
2015
LIABILITIES & EQUITY
€ million
Dec 31,
2016
Dec 31,
2015
Equity attributable to equity holders of Sanofi 57,554 58,049
Equity attributable to non-controlling interests 170 161
Total equity 57,724 58,210
Long-term debt 16,815 13,118
Property, plant and equipment 10,019 9,943
Non-current liabilities related to business
combinations and to non-controlling interests
1,378 1,121
Intangible assets (including goodwill) 51,166 51,583 Provisions and other non-current liabilities 8,834 9,169
Non-current financial assets and investments in
associates and deferred tax assets
10,379 10,115 Deferred tax liabilities 2,292 2,895
Non-current assets 71,564 71,641 Non-current liabilities 29,319 26,303
Accounts payable and other current liabilities 14,472 13,259
Inventories, accounts receivable and other
current assets
16,414 15,780
Current liabilities related to business combinations
and to non-controlling interests
198 130
Cash and cash equivalents 10,273 9,148 Short-term debt and current portion of long-term debt 1,764 3,436
Current assets 26,687 24,928 Current liabilities 16,434 16,825
Assets held for sale or exchange 6,421 5,752
Liabilities related to assets held for sale or
exchange
1,195 983
TOTAL ASSETS 104,672 102,321 TOTAL LIABILITIES & EQUITY 104,672 102,321

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Annual Results 2016

  • 1. Q4 and Full Year 2016 Results February 8, 2017
  • 2. 2 Forward Looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Company’s ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
  • 3. 3 Agenda 3 Key Highlights ● Olivier Brandicourt - Chief Executive Officer Update on Consumer Healthcare ● Alan Main - Executive Vice President, Consumer Healthcare Financial Results ● Jérôme Contamine - Executive Vice President, Chief Financial Officer Additional Participants for Q&A Session ● Olivier Charmeil - Executive Vice President, General Medicines & Emerging Markets ● Peter Guenter - Executive Vice President, Diabetes & Cardiovascular ● Karen Linehan - Executive Vice President, Legal Affairs and General Counsel ● David Loew - Executive Vice President, Sanofi Pasteur ● David P. Meeker - Executive Vice President, Sanofi Genzyme ● Elias Zerhouni - President, Global R&D
  • 5. Company Sales(1) Business EPS(2) 2016 Financial Performance Stronger than Initial Expectations FY 2016 €33,821m(3) FY 2015 €34,060m 5 (1) FY 2015 Company Sales restated to exclude Animal Health Business (2) FY 2015 and FY 2016 Business EPS include the contribution from Animal Health (3) FY 2016 Company Sales were €36,529m (+1.8% at CER) including Animal Health (previously referred to as “Aggregate Sales) (4) Evolution at Constant Exchange Rates (CER) (5) On a reported basis, FY 2016 sales were down -0.7% and Business EPS was up +0.7% +1.2% at CER(4,5) €5.64 FY 2016FY 2015 €5.68 +4.1% at CER(4,5)
  • 6. 6 Growth at CER All Global Business Units Delivered Growth in Q4 2016 (1) Does not include Emerging Markets sales (2) Reflecting reclassification of VaxServe from Sales to Other revenues from Jan 1, 2016 (3) Includes Emerging Markets sales for Diabetes & Cardiovascular and Specialty Care (4) Emerging Markets: World excluding U.S., Canada, Western & Eastern Europe (except Eurasia), Japan, South Korea, Australia, New Zealand and Puerto Rico (5) Excluding global Consumer Healthcare sales (6) Consumer Healthcare includes sales in Emerging Markets Pictures by Freepik Q4 2016 Sales by Global Business Unit Company Sales €8,867m +3.4% €1,710mDiabetes & Cardiovascular +3.8% €1,335mSanofi Genzyme (Specialty Care) +12.6% €1,352mSanofi Pasteur (Vaccines) +3.7% €3,636mGeneral Medicines & Emerging Markets +0.4% (3,4,5) (6) (1) (2) (1) €834mConsumer Healthcare +2.7%
  • 7. 7 Specialty Care Increased Double Digits and Consumer Healthcare Returned to Growth Q4 2016 Sales by Franchise Developed Markets Emerging Markets Growth at CER Total Sales GrowthSales Specialty Care +12.9%€1,569m +14.3%+12.6%€1,335m €234m Diabetes & Cardiovascular +3.9%€2,076m +4.1%+3.8%€1,710m €366m Sales Growth Vaccines +3.7%€1,352m +7.3%+1.4%€831m €521m Established Rx Products -1.3%€2,568m +0.9%-2.6%€1,622m €946m Generics +0.2%€468m +5.1%-3.3%€259m €209m Consumer Healthcare +2.7%€834m -3.2%+7.0%€508m €326m
  • 8. Q4 2015 Q4 2016 Rare Diseases Multiple Sclerosis Oncology 8 Rare Disease and Multiple Sclerosis Drive Growth in Specialty Care ● Specialty Care franchise up double digits in developed and emerging markets in Q4 ● Multiple Sclerosis franchise continues to gain market share ● Aubagio® sales up +34.2% to €367m and reached 8.8% of U.S. Total Rx share(1) ● Lemtrada® sales up +46.9% to €117m ● Rare Disease franchise grew 9.7% driven by new patient accruals in developed and emerging markets ● Dupixent® and Kevzara® U.S. launch preparation activities ongoing €661m €1,569m €716m +9.7 % at CER €484m +37.1% at CER Global Specialty Care Franchise Sales €353m (1) IMS NPA TRx data as of Q4 2016 €381m €369m -3.9 % at CER €1,395m +12.9% at CER Specialty Care achieved +17.2% sales growth in 2016 8
  • 9. Vaccines Growth Driven by Pediatric Combination(1) Franchise in Q4 9 PPH: Polio, Pertussis, Hib vaccines (1) Pediatric combination vaccines are referred to as “PPH franchise” (2) Pediatric combination vaccines including Hexaxim, Pentaxim, Tetraxim ● Vaccines sales up +3.7% at CER in Q4 ● PPH franchise +16.5% at CER to €544m in Q4 2016 ● Pentacel® supply improving in the U.S. ● Emerging Markets growth +5.1% despite continued China weakness ● FY 2016 PPH growth (+12.7%) driven by AcXim family (+39.2%) ● Flu franchise delivers new record year ● €1,521m, up +16.6% at CER in 2016 ● 70m doses shipped in the U.S. ● Dengvaxia®: FY 2016 sales of €55m Global Growth of AcXim Family(2) (sales in €m) 2011 2016 €258m €677m +23% CAGR at CER / Vaccines delivered +8.8% growth in 2016 driven by Flu and PPH differentiation
  • 10. 10 CHC Business Returned to Growth in Q4 2016 ● Developed Markets up +7.0%(1) ● U.S. sales grew +4.6% to €209m ● Europe up +9.5% to €229m helped by strong cough and cold sales ● Emerging Markets down -3.2% ● Business in Russia starting to recover ● Brazil economic situation remains challenging ● Boehringer Ingelheim asset swap completed(3), positioning Sanofi as a top 3 global CHC player All Growth at CER and constant structure (1) Excluding the sales of small divested products in the 2015 base, growth at CER was +8.0% (2) Excluding the sales of small divested products in the 2015 base, growth at CER was +3.2% (3) The closing of the disposal of Merial in Mexico and the swap of Merial and CHC in India have been delayed pending receipt of certain regulatory approvals. The transactions in both countries are expected to close early 2017. CHC Global Sales Growth at CER Q1 Q4Q3Q2 -3.1% -4.3% -1.2% +2.7% 2016 (2) CHC sales increased +2.7% in 2016 at constant structure and ex-Venezuela
  • 11. Toujeo® Gains Share in Several Important Markets While U.S. DCV(1) Environment Remains Challenging 11 ● Global Diabetes franchise sales up +1.9% at CER in Q4 2016 to €1,945m ● Toujeo® up 39.3%(2) sequentially to €238m ● Share gains continue in EU and Japan ● Soliqua™ 100/33 launched in the U.S. and Suliqua™ approved in EU(3) ● Praluent® sales of €37m in Q4 ● Briefing on motion to suspend (stay) permanent injunction completed ● U.S. CAFC(4) granted expedited briefing schedule for appeal of District Court rulings ● Product remains available to patients in the U.S. in both 75/150 mg doses(5) Market Share(6) Top EU Countries, Japan and the U.S. 0% 5% 10% 15% 20% W0 W10 W20 W30 W40 W50 W60 W70 W80 W90 France Germany UK Spain Japan U.S. (1) Diabetes and Cardiovascular (2) at Constant Exchange Rate (3) Approved in Europe under the brand name Suliqua™ in 2 doses (insulin 100 units/ml with lixisenatide 33 or 50 micrograms/ml) (4) Court of Appeals for Federal Circuit (5) Absent a stay, the injunction will take effect in the U.S. on February 21, 2017 (6) Market share of the basal insulin market in international units for France, Germany, Spain, UK and Japan, in TRx for the U.S. Week since launch
  • 12. €3,321m €2,134m €782m €810m €710m EUROPE -1.7% ASIA -2.8% ROW(4) -11.0% LATAM +4.2% U.S. Good Growth in Emerging Markets Partially Offset by China(1) Comparisons in the Quarter(2) 12 Emerging Markets(3) grew +7.0% in 2016 excluding Venezuela +11.3% €752m AMESA(6) +11.4% €329m EURASIA(5) +8.4% All Growth at Constant Exchange Rates (1) As per IMS CHPA (China Hospital Pharmaceutical Audit) Oct-Nov sales growth in China was +11.9% for Sanofi Pharmaceutical products (2) Q4 2016 Emerging Markets sales grew +3.5% at CER (3) World excluding U.S., Canada, Europe, Japan, South Korea, Australia, New Zealand and Puerto Rico (4) RoW: Japan, South Korea, Canada, Australia, New Zealand and Puerto Rico (5) Eurasia: Russia, Ukraine, Georgia, Belarus, Armenia and Turkey (6) AMESA: Africa, Middle East and South Asia
  • 13. 13 Building our Immunology Franchise (1) Brand name has been conditionally approved (2) Subject to successful FDA pre-license inspection related to Dupixent (3) Atopic Dermatitis ● First fully human IL-6 mAb for the treatment of moderately to severely active rheumatoid arthritis ● Recently received first approval in Canada ● Le Trait “fill-finish” plant classified as “acceptable” by FDA based on review of responses to the FDA 483 as well as proposed corrective actions ● Expect FDA inspection of Le Trait and re-submission of U.S. BLA in Q1 2017(2) (1) ● Anticipated FDA regulatory decision in AD(3) on March 29th 2017 ● Phase 3 in asthma ongoing with FDA regulatory submission expected in Q4 2017 ● Phase 3 in nasal polyposis initiated in Q4 2016 ● Additional LCM studies to start in 2017, including in pediatric AD and asthma ®
  • 14. 14 Expanding our Late Stage Pipeline with Two Potentially Differentiated Assets ● Dual SGLT1 and SGLT2 inhibitor ● Phase 3 program in T2D to explore potential benefit of product profile in: ● Monotherapy ● Addition to OADs(1) ● Addition to basal insulin ● Targets differentiation in T2D: ● In renally impaired patients ● On HbA1C and SBP(2) vs empagliflozin ● Phase 3 initiated in monotherapy and in addition to metformin in Q4 2016 Sotagliflozin ● Mechanism of action potentially differentiated by targeting a unique epitope on CD38 receptor ● Phase 3 program in relapsed-refractory multiple myeloma in combination with pom-dex(3,4) initiated in Q4 2016 ● Additional clinical trials to be initiated in multiple myeloma in 2017 ● Clinical studies in other potential oncology indications to start in 2017 Isatuximab (1) Oral Anti-diabetic agents (2) Systolic Blood Pressure (3) Pomalidomide and dexamethasone (4) Phase 3 trial referred to as ICARIA-MM
  • 15. 15 (1) Compared to FY2016 and barring major unforeseen adverse events (2) FY 2016 Business EPS of €5.68 (3) Difference between variation on a reported basis and variation at CER Outlook for 2017 Business EPS +3% to +4%(3) based on Dec 2016 average exchange rates Stable to -3% at CER(1,2) FY 2017 FX impact on Business EPS Guidance based on FY2016 Business EPS of €5.68
  • 16. CONSUMER HEALTHCARE 16 Alan Main Executive Vice President - Consumer Healthcare
  • 17. 17 Integration on Track(1) and Unlocking the Potential of the Iconic BI Brands 17 ● Integration on track ● Operating from two geographic hubs in Paris and Frankfurt ● Regional leadership and global marketing heads appointed ● Confident in reaching financial objectives ● Timing of transfer of regional and local marketing authorizations will lead to progressive sales recognition ● Sanofi to recognize in “Other Operating Income” the profit of products temporarily distributed by BI until transfers completed in 2017 (1) The closing of the disposal of Merial in Mexico and the swap of Merial and CHC in India have been delayed pending receipt of certain regulatory approvals. The transactions in both countries are expected to close early 2017. (2) Nicholas Hall & Company, MAT September 2016 (3) Transaction excludes CHC in China; value of CHC sales in Venezuela have been reduced to nearly zero due to revision of foreign exchange rates (4) Based on unaudited figures, subject to change BI Brands Lift Sanofi to Leadership Position(2) in Attractive Categories 2016 Sales(3) of acquired BI brands €1.5bn(4) #1 #2 #3 #6
  • 18. ● Xyzal® offers 24 hour relief to adults and children with seasonal and year-round allergies ● Xyzal® adds to Sanofi’s leading Allergy CHC portfolio (#1 in U.S.) ● Sanofi to leverage its proven expertise in Rx-to-OTC switches 1818 Xyzal® Approval Broadens OTC Allergy Offering in Important U.S. Market Three Rx-to-OTC Switches Build on Success of U.S. CHC Platform 2011 2012 2013 2014 2015 2016 2017e €549m U.S. CHC non-allergy portfolio €938m
  • 19. FINANCIAL RESULTS Jérôme Contamine Executive Vice President, Chief Financial Officer 19
  • 20. Quarterly Company Sales Growth(1,2) Quarterly Business EPS Growth(1) Q2 2016Q1 2016 Q4 2016 Quarterly Sales Growth Progressively Improved While Investing Behind R&D and Launches 20 Q3 2016 -0.9% -0.7% (1) Growth at Constant Exchange Rates (CER) (2) Reflect reporting structure changes to exclude Animal Health (3) On a reported basis, Q4 2016 sales were up +3.3% and Business EPS was down -4.6% +3.0% +5.3% -2.1% +12.4% -1.5% (3) +3.4% Q2 2016 Q1 2016 Q4 2016 Q3 2016 (3) Q4 2016 Business Operating Income grew 3.7% at CER
  • 21. CER: Constant Exchange Rates (1) Reflecting reclassification of VaxServe from Net Sales to Other revenues and Animal Health reclassification. VaxServe sales of non-Company products were €136m in Q4 2015 and €221m in Q4 2016 (2) Effective tax rate excluding Animal Health 21 Business Operating Income Growth Offset by Higher Tax Rate €m Q4 2016 Q4 2015 % Change (reported €) % Change (CER) Net Sales 8,867 8,583 +3.3% +3.4% Other revenues 310 235 +31.9% +31.1% Gross Profit 6,221 5,953 +4.5% +4.5% R&D (1,437) (1,364) +5.4% +4.7% SG&A (2,603) (2,482) +4.9% +4.8% Other current operating income & expenses (78) 24 - - Share of profit/loss of associates 53 31 - - Minority interests (32) (39) - - Business Operating Income 2,124 2,123 0.0% +3.7% Business operating margin 24.0% 24.7% - - Effective tax rate(2) 24.0% 17.4% - - Animal Health contribution to BNI 81 17 - - Total Business Net Income 1,606 1,709 -6.0% -2.9% Business EPS €1.25 €1.31 -4.6% -1.5% (1)
  • 22. Q4 2015 Q4 2016 €4,040m +4.8% at CER €3,846m €1,437m +4.7% at CER€1,364m €2,603m +4.8% at CER €2,482m R&D Continued Improvement in Gross Margin; Opex Growth Lower than our Initial Expectations 22 Operating Expenses (1) Gross Margin is calculated as the ratio of Gross profit over Company sales (excluding Other revenues) Gross Margin Ratio(1) SG&A Q3Q2Q1 +0.8% +1.3% +0.3% +0.2% Q4 2015 2016 72.2% 71.0% 70.4% 70.2% FY 2016 Gross Margin 71.0% (+0.7%); Operating Expenses up +2.5% at CER in 2016
  • 23. 23 FX Headwind Eased on Sales but Remained Challenging on EPS (1) Main currency impact on Company Sales in FY 2016: Japanese Yen (+€160m); Argentine Peso (-€147m); Chinese Yuan (-€110m); Mexican Peso (-€94m) Currency Impact -2.6% -€215m -€0.05 -4.2% -€353m -1.0% -€83m Q4Q3Q2Q1 -0.1% -€10m -€0.02 Q4Q3Q2Q1 -€0.07 +€0.05 -€0.04 -3.8% -5.0% -1.2% -3.1% Company Sales(1) Business EPS FY 2016 -€0.19 -3.4% FY 2016 -€661m -1.9%
  • 24. Creating a More Agile Sanofi Through a Strategic Cost Savings Program 24 2015 2016 2017e 2018e One-time costs Annual Cost Savings €1.5bn ● Primary sources of cost savings in 2016/2017: ● Simplification via new GBU structure and creation of global functions(1) ● Manufacturing operational improvement and productivity efforts ● Product portfolio streamlining in Established Products franchise ● Resizing of sales forces to evolving market dynamics ● Reinvestment decisions scaled to the needs of the business On track to deliver at least €1.5bn in cost savings in 2018 Progression of Cost Savings ~€650m 2015 2016 2017e 2018e (1) Global functions such as SBS (Sanofi Business Services) and Global ITS (Global Information Technology Solutions) ~€1.3bn
  • 25. Proposal for 23rd Consecutive Increase in Annual Dividend 25 (1) To be submitted for approval by shareholders at the Annual General Meeting on May 10, 2017 (2) Sanofi share price averaged €76.38 during January 2017 ● Commitment to progressive dividend growth remains a key value proposition to our shareholders ● €0.03 per share increase over 2015 ● Implies a dividend yield of 3.9%(2) 2016 €2.96 2015 €2.93 2014 €2.85 2013 €2.80 (1) Evolution of Dividend
  • 26. Returning Cash to Shareholders in Anticipation of BI Cash Received in 2017 26 Share Count (m) 1,309.9 1,301.7 2014 2015 (1) SBB: Share Buyback (1) Number of shares outstanding in million on Dec 31st 2014, Dec 31st 2015 and Dec 31st 2016 (2) During the Q3 2016 results, Sanofi announced a €3.5bn share repurchase program expected to be completed by the end of 2017 1,271.9 2016 Evolution of Share Buyback €2.3bn of €3.5bn share buyback program(2) bought to date €1,121m Net SBB €680m €1,801m €1,211m Net SBB €573m €1,784m €2,602m Net SBB €306m €2,908m Issuance Buyback Issuance Buyback Issuance Buyback
  • 27. Sanofi Exceeded its Key 2016 Financial Objectives Gross Margin OpEx Growth Rate at CER Tax Rate Business EPS Guidance at CER Dividend growth Broadly stable Progressive ~ +4.5% 24-25% 68-69% 27 +4.1% 3 cent increase +2.7%(2) 23.9%(3) 70.7%(1) Initial Objectives Results including Animal Health (1) Gross Margin: 71.0% excluding Animal Health (2) Operating Expenses: +2.5% excluding Animal Health (3) Tax rate: 23.3% excluding Animal Health
  • 31. R&D Pipeline – Pharma & Vaccines Phase I Phase II Phase III Registration (1) Approved in 14 countries to date (2) Approved in 27 countries as of end December 2016 (3) Previously referred as Niemann Pick type B 31 N New Molecular Entity Infectious Diseases Oncology Immuno-inflammation Diabetes Solutions Rare Disease Vaccines MS, Neuro, Ophthalmology Cardiovascular & metabolism GZ402668 GLD52 (anti-CD52 mAb) Relapsing multiple sclerosis N GZ389988 TRKA antagonist Osteoarthritis N SAR425899 GLP-1R/GCGR dual agonist Type 2 diabetes N SAR438335 GLP-1R/GIPR dual agonist Type 2 diabetes N SAR566658 Maytansin-loaded anti-CA6 mAb Solid tumors N SAR408701 Maytansin-loaded anti-CEACAM5 mAb Solid tumors N SAR428926 Maytansin loaded anti-Lamp1 mAb Cancer N SAR247799 S1P1 agonist cardiovascular indication N SAR439152 Myosin inhibitor Hypertrophic cardiomyopathy N SAR407899 rho kinase Microvascular angina N GZ402666 neoGAA Pompe Disease N fitusiran (ALN-AT3) siRNA targeting Anti-Thrombin Hemophilia N UshStat® Myosin 7A gene therapy Usher syndrome 1B N SAR228810 Anti-protofibrillar AB mAb Alzheimer’s disease N Herpes Simplex Virus Type 2 HSV-2 vaccine dupilumab Anti-IL4Rα mAb Eosinophilic oesophagitis SAR156597 IL4/IL13 Bi-specific mAb IPF / Systemic Scleroderma N SAR100842 LPA1 receptor antagonist Systemic sclerosis N efpeglenatiden Long-acting GLP-1 receptor agonist Type 2 diabetes N sarilumab Anti-IL6R mAb Uveitis isatuximab Anti-CD38 naked mAb Relapsed Refractory Multiple Myeloma N SAR439684 PD-1 inhibitor Advanced CSCC (Skin cancer) N olipudase alfa rhASM Deficiency Acid Sphingomyelinase Deficiency(3) N GZ402671 Oral GCS inhibitor Fabry Disease, Gaucher Type 3, Gaucher related Parkinson’s Disease N SAR422459 ABCA4 gene therapy Stargardt disease N Combination ferroquine / OZ439 Antimalarial N Rabies VRVg Purified vero rabies vaccine Tuberculosis Recombinant subunit vaccine Fluzone® QIV HD Quadrivalent inactivated influenza vaccine - High dose SAR342434 insulin lispro Type 1+2 diabetes N sotagliflozin n Oral SGLT-1&2 inhibitor Type 1 & Type 2 diabetes N patisiran (ALN-TTR02) siRNA inhibitor targeting TTR Familial amyloidotic polyneuropathy N Clostridium difficile Toxoid vaccine VaxiGrip® QIV IM Quadrivalent inactivated influenza vaccine (6-35 months) Pediatric pentavalent vaccine DTP-Polio-Hib Japan Men Quad TT 2nd generation meningococcal ACYW conjugate vaccine sarilumab Anti-IL6R mAb Rheumatoid arthritis, U.S., EU N Dupixent Anti-IL4Rα mAb Atopic dermatitis, U.S., EU N Dengvaxia®(1) Mild-to-severe dengue fever vaccine PR5i DTP-HepB-Polio-Hib Pediatric hexav. vaccine, U.S VaxiGrip® QIV IM(2) Quadrivalent inactivated influenza vaccine (3 years+) SAR440340 Anti-IL33 mAb Asthma & COPD N dupilumab Anti-IL4Rα mAb Asthma, Nasal Polyposis SAR439794 TLR4 agonist Peanut allergy N SAR341402 Rapid acting insulin Diabetes N Adacel+ Tdap booster Shan 6 DTP-HepB-Polio-Hib Pediatric hexavalent vaccine HIV Viral vector prime & rgp120 boost vaccine Zika Inactivated Zika vaccine Respiratory syncytial virus Infants
  • 32. 32 Phase I Phase II Phase III Registration TOTAL Oncology 3 1 1 0 5 Diabetes 2 2 1 1 6 Cardiovascular Diseases 2 2 0 0 4 Immuno-inflammation 2 2 0 2 6 Infectious Diseases 0 1 0 0 1 Rare Diseases 1 2 2 0 5 Multiple Sclerosis, Neurology, Ophthalmology 3 1 0 0 4 Vaccines 3 4 3 3 13 TOTAL 16 15 7 6 R&D Pipeline Summary Table(1) 31 13 NMEs & Vaccines 44 32 31 (1) Excluding life cycle management programs
  • 33. Expected Regulatory Decisions Q1 Q2 Q3 Q4 ● Dengvaxia® in endemic countries ● Suliqua® in Diabetes (EU) ● Dupixent®(1) in Atopic Dermatitis (U.S.)  ● Kevzara® in Rheumatoid Arthritis (U.S.)  ● Kevzara® in Rheumatoid Arthritis (EU) Expected Regulatory Submissions Q1 Q2 Q3 Q4 ● Kevzara® in Rheumatoid Arthritis (U.S.)  ● Dupixent®(1) in Atopic Dermatitis (Japan)  ● dupilumab in Asthma in Adult patients (U.S.)  Expected Phase III / IIIb Topline Data Q1 Q2 Q3 Q4 ● patisiran in Familial amyloidotic polyneuropathy  ● dupilumab in Asthma in Adult patients  Expected Phase III Starts Q1 Q2 Q3 Q4 ● dupilumab in Asthma in patients aged 6-11 year-old  ● fitusiran (ALN-AT3) in Hemophilia  ● Dupixent®(1) AD in 6-11 and 12-17 year-old ● efpeglenatide in type-2 diabetes  33 Expected 2017 Late-Stage Pipeline Events (1) The European Medicines Agency (EMA) and FDA have conditionally accepted Dupixent® as the trade name for dupilumab..
  • 34. 34 Expected R&D Milestones in 2017 34 Products Expected milestones Timing Dengvaxia® Regulatory decisions in endemic countries Throughout 2017 Kevzara®(1) U.S. regulatory resubmission in Rheumatoid Arthritis Q1 2017 Dupixent®(1) Japan regulatory submission in Atopic Dermatitis Q1 2017 Dupixent®(1) U.S. regulatory decision in Atopic Dermatitis Q1 2017 dupilumab Start of Phase 3 trial in Asthma in 6-11 year-olds Q2 2017 fitusiran Start of Phase 3 trial in Hemophilia Q2 2017 Kevzara®(1) U.S. regulatory decision in Rheumatoid Arthritis Q2 2017 Dupixent®(1) Start of Phase 3 trial in Atopic Dermatitis in 12-17 year-olds Q2 2017 Dupixent®(1) Start of Phase 3 trial in Atopic Dermatitis in 6-11 year-olds Q3 2017 patisiran Phase 3 results in Familial amyloidotic polyneuropathy Q3 2017 Fluzone QIV HD Start of Phase 3 trial Q3 2017 VaxiGrip® QIV IM (6-35 months) EU regulatory submission Q3 2017 dupilumab Phase 3 results in Asthma in Adult patients Q4 2017 dupilumab U.S. regulatory submission in Asthma in Adult patients Q4 2017 efpeglenatide Start of Phase 3 trial in type-2 Diabetes 2017 isatuximab Start of additional Phase 3 trials in Multiple Myeloma 2017 (1) Name received conditional approval
  • 36. Net Debt Dec 31, 2016 Other -€1,453m Dividends -€3,759m Acquisitions, Licensing, Net of Disposals -€936m Net Share Repurchase -€2,602m CapEx -€1,486m Net Cash from Operating Activities Net Debt Dec 31, 2015 36 (1) (2) €7,254m €8,206m €9,284m (4) (1) FCF €7,798m (3) FCF: Free Cash Flow (1) Including derivatives related to the financial debt +€152m at December 31st 2015 and +€100m at December 31st 2016 (2) Excluding Restructuring costs (3) Including Hanmi Pharmaceuticals of €400m, Onduo of €165m, Regeneron anti-dilutive share purchase of €115m and Bayer Contingent consideration of €137m (4) Other including Restructuring costs and Fx impact Net Debt 36 Net Debt Evolution in 2016
  • 37. 2017 Business EPS Currency Sensitivity Currency Exposure on Q4 2016 Sales Currency Average Rates 2017 Currency Sensitivity 37 Q4 2015 Q4 2016 % change EUR/USD 1.09 1.08 -1.5% EUR/JPY 132.93 117.92 -11.3% EUR/CNY 7.00 7.38 +5.5% EUR/BRL 4.21 3.55 -15.7% EUR/RUB 72.37 67.99 -6.0% Currency Variation Business EPS Sensitivity U.S. Dollar - 0.05 USD/EUR + EUR 0.13 Japanese Yen + 5 JPY/EUR - EUR 0.02 Chinese Yuan + 0.2 CNY/EUR - EUR 0.02 Brazilian Real + 0.4 BRL/EUR - EUR 0.02 Russian Ruble + 10 RUB/EUR - EUR 0.03 € 21.9% US $ 38.2%Chinese Yuan 5.3% Japanese Yen 4.5% Brazilian Real 2.5% Mexican Peso 2.4% Russian Ruble 1.9% British £ 1.7% Australian $ 1.4% Canadian $ 1.4% Others 18.8%
  • 38. 38 Business Net Income Statement *** Net of tax. *** Determined on the basis of Business income before tax, associates and non-controlling interests (excluding Animal Health business). *** Based on an average number of shares outstanding of 1,282.9 million in the fourth quarter of 2016 and 1,304.9 million in the fourth quarter of 2015. (1) As per a change in accounting presentation, VaxServe sales of non-Sanofi products are reported in Other revenues from 2016 onwards. Prior period Net sales and Other revenues have been represented accordingly. Fourth-quarter 2016 Pharmaceuticals Vaccines Others Total Group € million Q4 2016 Q4 2015 Change Q4 2016 Q4 2015 Change Q4 2016 Q4 2015 Q4 2016 Q4 2015 Change Net sales 7,515 7,277 3.3% 1,352 1,306 3.5% 8,867 8,583 3.3% Other revenues (1) 83 91 (8.8%) 227 144 57.6% 310 235 31.9% Cost of Sales (2,210) (2,195) 0.7% (746) (670) 11.3% (2,956) (2,865) 3.2% As % of net sales (29.4%) (30.2%) (55.2%) (51.3%) (33.3%) (33.4%) Gross Profit 5,388 5,173 4.2% 833 780 6.8% 6,221 5,953 4.5% As % of net sales 71.7% 71.1% 61.6% 59.7% 70.2% 69.4% Research and development expenses (1,292) (1,214) 6.4% (145) (150) (3.3%) (1,437) (1,364) 5.4% As % of net sales (17.2%) (16.7%) (10.7%) (11.5%) (16.2%) (15.9%) Selling and general expenses (2,401) (2,276) 5.5% (202) (206) (1.9%) (2,603) (2,482) 4.9% As % of net sales (31.9%) (31.3%) (14.9%) (15.8%) (29.4%) (28.9%) Other operating income/expenses (28) 46 (14) 25 (36) (47) (78) 24 Share of profit/loss of associates* and joint-ventures 41 28 12 3 53 31 Net income attributable to non controlling interests (31) (39) (1) - (32) (39) Business operating income 1,677 1,718 (2.4%) 483 452 6.9% (36) (47) 2,124 2,123 0.0% As % of net sales 22.3% 23.6% 35.7% 34.6% 24.0% 24.7% Financial income & expenses (125) (73) Income tax expenses (474) (358) Tax rate** 24.0% 17.4% Business net income excl. Animal Health business 1,525 1,692 (9.9%) As % of net sales 17.2% 19.7% Business net income of Animal Health business 81 17 376.5% Business net income 1,606 1,709 (6.0%) Business earnings / share excluding Animal Health business (in €)*** 1.19 1.30 (8.5%) Business earnings / share (in €)*** 1.25 1.31 (4.6%)
  • 39. 39 Business Net Income Statement *** Net of tax. *** Determined on the basis of Business income before tax, associates and non-controlling interests (excluding Animal Health business). *** Based on an average number of shares outstanding of 1,286,6 million in 2016 and 1,306.2 million in 2015. (1) As per a change in accounting presentation, VaxServe sales of non-Sanofi products are reported in Other revenues from 2016 onwards. Prior period Net sales and Other revenues have been represented accordingly. 2016 Pharmaceuticals Vaccines Others Total Group € million 2016 2015 Change 2016 2015 Change 2016 2015 2016 2015 Change Net sales 29,244 29,799 (1.9%) 4,577 4,261 7.4% 33,821 34,060 (0.7%) Other revenues (1) 274 288 (4.9%) 613 513 19.5% 887 801 10.7% Cost of Sales (8,349) (8,788) (5.0%) (2,353) (2,131) 10.4% (10,702) (10,919) (2.0%) As % of net sales (28.5%) (29.5%) (51.4%) (50.0%) (31.6%) (32.1%) Gross Profit 21,169 21,299 (0.6%) 2,837 2,643 7.3% 24,006 23,942 0.3% As % of net sales 72.4% 71.5% 62.0% 62.0% 71.0% 70.3% Research and development expenses (4,618) (4,530) 1.9% (554) (552) 0.4% (5,172) (5,082) 1.8% As % of net sales (15.8%) (15.2%) (12.1%) (13.0%) (15.3%) (14.9%) Selling and general expenses (8,743) (8,656) 1.0% (743) (726) 2.3% (9,486) (9,382) 1.1% As % of net sales (29.9%) (29.0%) (16.2%) (17.0%) (28.0%) (27.5%) Other operating income/expenses (1) (121) (14) 27 (112) (114) (127) (208) Share of profit/loss of associates* and joint-ventures 129 146 48 23 177 169 Net income attributable to non controlling interests (112) (125) (1) (1) (113) (126) Business operating income 7,824 8,013 (2.4%) 1,573 1,414 11.2% (112) (114) 9,285 9,313 (0.3%) As % of net sales 26.8% 26.9% 34.4% 33.2% 27.5% 27.3% Financial income & expenses (399) (381) Income tax expenses (2,054) (1,929) Tax rate** 23.3% 21.7% Business net income excl. Animal Health business 6,832 7,003 (2.4%) As % of net sales 20.2% 20.6% Business net income of Animal Health business 476 368 29.3% Business net income 7,308 7,371 (0.9%) Business earnings / share excluding Animal Health business (in €)*** 5.31 5.36 (0.9%) Business earnings / share (in €)*** 5.68 5.64 0.7%
  • 40. Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi 40 (1) Animal Health business reported separately in accordance with IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations). (2) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €374 million in the fourth quarter of 2016 and €423 million in the fourth quarter of 2015. (3) Gain on Sanofi Pasteur MSD investment in associates and joint-ventures upon termination of the joint-venture. (4) This lines includes the impact on deferred tax assets and liabilities coming from the reconciliation items (in particular amortization and impairment of intangible assets and restructuring costs) following the change in tax rates, mainly in France (28% standard rate effective as of January 1, 2020). (5) Includes the following items: impact of the elimination of depreciation and impairment of Property, Plant & Equipment from the IFRS 5 application date, impact of the amortization and impairment of intangible assets until IFRS 5 application date, costs incurred as a result of the divestment as well as tax effect of these items. (6) Includes the following items: impact of the discontinuation of the equity accounting of the Sanofi Pasteur MSD business net income since the announcement by Sanofi and Merck of their intent to end their joint vaccine operations in Europe. (7) Based on an average number of shares outstanding of 1,282.9 million in the fourth quarter of 2016 and 1,304.9 million in the fourth quarter of 2015. € million Q4 2016(1) Q4 2015(1) Change Business net income 1,606 1,709 (6.0%) Amortization of intangible assets (2) (412) (695) Impairment of intangible assets (119) (533) Fair value remeasurement of contingent consideration liabilities (41) (108) Restructuring costs and similar items (189) (359) Impairment loss on Alnylam investment (296) - Other gains and losses, and litigation (3) 211 - Tax effect of items listed above (4) : 95 601 Amortization of intangible assets 197 256 Impairment of intangible assets 24 175 Fair value remeasurement of contingent consideration liabilities 1 46 Restructuring costs and similar items (139) 124 Other tax effects 12 - Other tax items - - Share of items listed above attributable to non-controlling interests 11 20 Restructuring costs of associates and joint-ventures, and expenses arising from the impact of acquisitions on associates and joint-ventures (9) (59) Animal Health items (5) (63) (242) Other Sanofi Pasteur MSD items (6) (4) - Net income attributable to equity holders of Sanofi 790 334 136.5% IFRS earnings per share (7) (in euros) 0.62 0.26
  • 41. Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi 41 (1) Animal Health business reported separately in accordance with IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations). (2) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €1,550 million in 2016 and €1,770 million in 2015. (3) Gain on Sanofi Pasteur MSD investment in associates and joint-ventures upon termination of the joint-venture. (4) This lines includes the impact on deferred tax assets and liabilities coming from the reconciliation items (in particular amortization and impairment of intangible assets and restructuring costs) following the change in tax rates, mainly in France (28% standard rate effective as of January 1, 2020) and in Japan. (5) Includes the following items: impact of the elimination of depreciation and impairment of Property, Plant & Equipment from IFRS 5 application date, impact of the amortization and impairment of intangible assets until IFRS 5 application date, costs incurred as a result of the divestment as well as tax effect of these items. (6) Includes the following items: impact of the discontinuation of the equity accounting of the Sanofi Pasteur MSD business net income since the announcement by Sanofi and Merck of their intent to end their joint vaccine operations in Europe. (7) Based on an average number of shares outstanding of 1,286.6 million in 2016 and 1,306.2 million in 2015. € million 2016(1) 2015(1) Change Business net income 7,308 7,371 (0.9%) Amortization of intangible assets (2) (1,692) (2,137) Impairment of intangible assets (192) (767) Fair value remeasurement of contingent consideration liabilities (135) 53 Restructuring costs and similar items (879) (795) Impairment loss on Alnylam investment (457) - Other gains and losses, and litigation (3) 211 - Tax effect of items listed above (4) : 841 1,331 Amortization of intangible assets 647 757 Impairment of intangible assets 47 262 Fair value remeasurement of contingent consideration liabilities 24 39 Restructuring costs and similar items 95 273 Other tax effects 28 - Other tax items (113) (111) Share of items listed above attributable to non-controlling interests 22 25 Restructuring costs of associates and joint-ventures, and expenses arising from the impact of acquisitions on associates and joint-ventures 9 (191) Animal Health items (5) (162) (492) Other Sanofi Pasteur MSD items (6) (52) - Net income attributable to equity holders of Sanofi 4,709 4,287 9.8% IFRS earnings per share (7) (in euros) 3.66 3.28
  • 42. 42 Consolidated Income Statements (1) Animal Health business reported on a single line in the consolidated income statements in accordance with IFRS 5 (Non-current held for sale and discontinued operations). (2) As per a change in accounting presentation, VaxServe sales of non-Sanofi products are reported in Other revenues from 2016 onwards. Prior period Net sales and Other revenues have been restated accordingly. € million Q4 2016 (1) Q4 2015 (1)(2) 2016 (1) 2015 (1)(2) Net sales 8,867 8,583 33,821 34,060 Other revenues 310 235 887 801 Cost of sales (2,956) (2,865) (10,702) (10,919) Gross profit 6,221 5,953 24,006 23,942 Research and development expenses (1,437) (1,364) (5,172) (5,082) Selling and general expenses (2,603) (2,482) (9,486) (9,382) Other operating income 56 145 355 254 Other operating expenses (134) (121) (482) (462) Amortization of intangible assets (412) (695) (1,692) (2,137) Impairment of intangible assets (119) (533) (192) (767) Fair value remeasurement of contingent consideration liabilities (41) (108) (135) 53 Restructuring costs and similar items (189) (359) (879) (795) Other gains and losses, and litigation 211 - 211 - Operating income 1,553 436 6,534 5,624 Financial expenses (422) (172) (924) (559) Financial income 1 99 68 178 Income before tax and associates and joint-ventures 1,132 363 5,678 5,243 Income tax expense (369) 243 (1,326) (709) Share of profit / loss of associates and joint-ventures 30 (28) 134 (22) Net income excluding the held for exchange Animal Health business 793 578 4,486 4,512 Net income from the held for exchange Animal Health business 18 (225) 314 (124) Net income 811 353 4,800 4,388 Net income attributable to non-controlling interests 21 19 91 101 Net income attributable to equity holders of Sanofi 790 334 4,709 4,287 Average number of shares outstanding (million) 1,282.9 1,304.9 1,286.6 1,306.2 Earnings per share excluding the held for exchange Animal Health business (in euros) 0.60 0.43 3.42 3.38 IFRS earnings per share (in euros) 0.62 0.26 3.66 3.28
  • 43. 43 Animal Health Segment Results € million Q4 2016 Q4 2015 Change 2016 2015 Change Net sales 599 559 7.2% 2,708 2,515 7.7% Other revenues 12 9 33.3% 39 41 (4.9%) Cost of sales (230) (217) 6.0% (937) (885) 5.9% As % of net sales (38.4%) (38.8%) (34.6%) (35.2%) Gross profit 381 351 8.5% 1,810 1,671 8.3% As % of net sales 63.6% 62.8% 66.8% 66.4% Research and development expenses (56) (51) 9.8% (191) (177) 7.9% As % of net sales (9.3%) (9.1%) (7.1%) (7.0%) Selling and general expenses (225) (218) 3.2% (899) (865) 3.9% As % of net sales (37.6%) (39.0%) (33.2%) (34.4%) Other operating income/expenses 2 (4) (14) 5 Share of profit/loss of associates(1) and joint-ventures - - 1 1 Business operating income 102 78 30.8% 707 635 11.3% As % of net sales 17.0% 14.0% 26.1% 25.2% (1) Net of tax
  • 44. 44 Change in Net Debt (1) Excluding restructuring costs and similar items € million 2016 2015 Business net income 7,308 7,371 Depreciation, amortization and impairment of property, plant and equipment and software 1,355 1,333 Net gains and losses on disposals of non-current assets, net of tax (33) (137) Other non-cash items 44 (19) Operating cash flow before changes in working capital (1) 8,674 8,548 Changes in working capital (1) 610 1,048 Acquisitions of property, plant and equipment and software (1,486) (1,464) Free cash flow (1) 7,798 8,132 Acquisitions of intangible assets excluding software (716) (1,559) Acquisitions of investments including assumed debt (534) (365) Restructuring costs and similar items paid (729) (682) Proceeds from disposals of property, plant and equipment, intangibles, and other non-current assets, net of tax 314 208 Issuance of Sanofi shares 306 573 Dividends paid to shareholders of Sanofi (3,759) (3,694) Acquisition of treasury shares (2,908) (1,784) Disposals of treasury shares, net of tax - 1 Transactions with non-controlling interests including dividends (31) (25) Foreign exchange impact (192) (768) Other items (501) (120) Change in net debt (952) (83)
  • 45. 45 Simplified Consolidated Balance Sheet ASSETS € million Dec 31, 2016 Dec 31, 2015 LIABILITIES & EQUITY € million Dec 31, 2016 Dec 31, 2015 Equity attributable to equity holders of Sanofi 57,554 58,049 Equity attributable to non-controlling interests 170 161 Total equity 57,724 58,210 Long-term debt 16,815 13,118 Property, plant and equipment 10,019 9,943 Non-current liabilities related to business combinations and to non-controlling interests 1,378 1,121 Intangible assets (including goodwill) 51,166 51,583 Provisions and other non-current liabilities 8,834 9,169 Non-current financial assets and investments in associates and deferred tax assets 10,379 10,115 Deferred tax liabilities 2,292 2,895 Non-current assets 71,564 71,641 Non-current liabilities 29,319 26,303 Accounts payable and other current liabilities 14,472 13,259 Inventories, accounts receivable and other current assets 16,414 15,780 Current liabilities related to business combinations and to non-controlling interests 198 130 Cash and cash equivalents 10,273 9,148 Short-term debt and current portion of long-term debt 1,764 3,436 Current assets 26,687 24,928 Current liabilities 16,434 16,825 Assets held for sale or exchange 6,421 5,752 Liabilities related to assets held for sale or exchange 1,195 983 TOTAL ASSETS 104,672 102,321 TOTAL LIABILITIES & EQUITY 104,672 102,321