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Q1 2016 RESULTS April 29, 2016
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Forward Looking Statements
This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of
1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include
projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events, operations, services, product development and potential,
and statements regarding future performance. Forward-looking statements are generally identified by the words
"expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's
management believes that the expectations reflected in such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which
are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to
differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
These risks and uncertainties include among other things, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the
EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such
product candidates as well as their decisions regarding labeling and other matters that could affect the availability or
commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will
be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability
to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost
containment 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.
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Agenda
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Q1 2016 Key Highlights
● Olivier Brandicourt - Chief Executive Officer
Q1 2016 Financial Results
● Jérôme Contamine - Executive Vice President, Chief Financial Officer
Q&A Session
● Olivier Charmeil - Executive Vice President, Sanofi Pasteur
● Peter Guenter - Executive Vice President, General Medicines & Emerging Markets
● Carsten Hellmann - Executive Vice President, Merial
● David P. Meeker - Executive Vice President, Sanofi Genzyme
● Pascale Witz - Executive Vice President, Diabetes & Cardiovascular
● Elias Zerhouni - President, Global R&D
Q1 2016 KEY HIGHLIGHTS
4
Olivier Brandicourt
Chief Executive Officer
● Toujeo® continues to capture TRx share in the U.S. reaching 5.0%(4)
● Progressive launch of Praluent® while awaiting outcomes data
● SAGE recommends Dengvaxia® use in endemic countries to WHO First public immunization program launched in the Philippines
Launches
Q1 2016 – Progressing on our 2020 Roadmap
5
RA: Rheumatoid Arthritis / AD: Atopic Dermatitis
(1) On a reported basis, Q1 2016 Aggregate Sales were down -1.9%
(2) On a reported basis, Q1 2016 Business EPS was up +1.5%
(3) Subject to regulatory clearances
(4) IMS data as of April 1st 2016
(5) LixiLan is a project name and is not the intended brand name for the combination of insulin glargine and lixisenatide
● Exclusive Boehringer Ingelheim asset swap expected to be signed mid-year and closed by year-end(3)
● Sanofi Pasteur targeting to manage European vaccine portfolio independently by year-end
Portfolio
● Aggregate Sales reached €8,543m (after VaxServe reclassification), up +0.7% or +3.0% excluding Venezuela at CER(1)
● Solid Business EPS growth of +5.3% at CER(2) to €1.34
Financial Results
● Sarilumab monotherapy showed superior efficacy vs. adalimumab in RA
● Dupilumab met primary endpoints in 2 Phase III studies in AD
● LixiLan(5) combination submitted to EMA
Innovation
3
1
2
4
Q1 2016 Incremental
EPS at CER
+€0.07
Q1 2015 FX Impact
-€0.05
Aggregate Group Sales Business EPS
As Expected, Aggregate Sales Up Slightly in Q1 2016
Given High Base for Comparison in Venezuela & Japan
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(1) Including Merial
(2) Reflecting reclassification of VaxServe from Sales to Other revenues
(3) On a reported basis, Q1 2016 Aggregate Sales were down -1.9% and Business EPS was up +1.5%
+5.3% at CER(3)
Q1 2015 FX Impact
-€228m
+€61m
Incremental
Sales at CER Q1 2016
+0.7% at CER(3)
€8,710m
€8,543m €1.32
€1.34
(2)
Aggregate Group Sales +3.0% at CER excluding Venezuela
(1)
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Growth
at CER
New Organization by Global Business Unit
in Place as of January 1st 2016
(1) Does not include Emerging Markets sales
(2) Includes Emerging Markets sales for Diabetes & Cardiovascular and Sanofi Genzyme
(3) Emerging Markets: World excluding U.S., Canada, Western & Eastern Europe (except Eurasia), Japan,
South Korea, Australia, New Zealand and Puerto Rico
(4) Excluding Venezuela: -0.3% at CER
(5) Reflecting reclassification of VaxServe from Sales to Other revenues from Jan 1, 2016. Pictures by Freepik
Q1 2016 Aggregate Sales by Global Business Unit
Group Aggregate Sales €8,543m
+0.7%
€760m
Animal Health
+17.5%
€1,499m
Diabetes & Cardiovascular -5.8% (1)
€1,169m
Sanofi Genzyme +20.5% (1)
€4,490m
General Medicines & Emerging Markets -4.3% (4) (2,3)
€625m
Vaccines
+8.2% (5)
8
Q1 2016 Sales Up 3% excluding Venezuela at CER
Driven by Specialty Care, Vaccines and Animal Health
(1) Excluding Venezuela sales were up +12.3% at CER
(2) Excluding Plavix® in Japan, sales were down -6.3% at CER
(3) Excluding Venezuela sales were up +8.8% at CER
(4) Excluding Venezuela sales were up +3.8% at CER
Q1 2016 Aggregate Sales by Franchise
Developed Markets Emerging Markets
Growth
at CER
Total
Sales Growth Sales
Animal Health
+17.5% €760m +37.5% +13.0% €612m €148m
Specialty Care +18.4% €1,371m
+9.3% +20.5% €1,169m
€202m
Diabetes & Cardiovascular -3.5% €1,832m
+6.7% -5.8% €1,499m
€333m
Sales Growth
Vaccines
+8.2% €625m
+37.0% -8.1% €347m
€278m
Established Rx Products -8.2% €2,591m
-2.1% -11.5% €1,667m
€924m
Generics +3.3% €459m 0.0% +6.0% €282m €177m
Consumer Healthcare -3.1% €905m
-9.9% +1.5% €594m
€311m
(1)
(3)
(4)
(6)
(5) Excluding Venezuela sales were up +7.1% at CER
(6) Reflecting reclassification of VaxServe from Sales to Other revenues from Jan 1, 2016
(7) Excluding Pentacel® in the U.S., sales were up +9.3% at CER
(5)
(2)
(7)
Q1 2015 Q1 2016
Other
Rare Disease Franchise Shows High-Single Digit Growth
in Q1 2016
● Comparable franchise growth
in Developed and Emerging Markets
(+8.5% / +8.3% at CER, respectively)
● Sales split Developed / Emerging: 83% / 17%
● Growth driven by patient accruals
● Gaucher franchise grew +10.1% at CER
● Market share of 73% in value(1)
● Cerdelga® sales in the U.S. almost double(2)
● Fabrazyme® sales up +6.4% at CER
following strong Q4 2015(3)
● Myozyme® / Lumizyme® sales up +8.3% at
CER
€646m +8.5% at CER
€613m
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&
€182m
€23m
€166m
€149m
€126m
(1) Cerezyme® + Cerdelga® value share is 73% based on Q1 2016 reported sales by Sanofi and Shire
(2) Cerdelga® sales were €23m in Q1 2016 and €10m in Q1 2015
(3) Fabrazyme® Q4 2015 sales were up +20.3% at CER
Global Rare Diseases Sales
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Multiple Sclerosis Franchise Continues to Deliver
Strong Growth in Q1 2016
● Aubagio® continues to expand oral
segment with sales up +64.1% at CER
● Remains fastest growing oral MS drug
● Sales now annualizing at more than €1bn
● U.S. weekly TRx share increased
to 7.2%(1)
● Progressively overcoming barriers to
Lemtrada® use with sales more than
doubling in Q1 2016
● Lemtrada® demonstrated significant slow
down in brain volume loss at 3 years and
increase in retinal nerve fiber layer
thickness over 2 years(2)
€243m
Q1 2015 Q1 2016
€208m
€367m +76.9% at CER
€88m +134.2% at CER
€279m +64.1% at CER
(1) IMS data for the week ending April 1st 2016
(2) Presentation at American Academy of Neurology Annual Meeting 2016
Global Multiple Sclerosis Sales
Vaccines Franchise Up 8.2% at CER in Q1 2016
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PPH: Polio, Pertussis, Hib vaccines
(1) After VaxServe reclassification from the Sales P&L line to the Other revenues P&L line from January 1, 2016.
VaxServe sales from third parties were €100m in Q1 2015
(2) Strategic Advisory Group of Experts on Immunization to the World Health Organization
● PPH vaccines up +6.0% at CER
● Strong sales in Emerging Markets driven
by Hexaxim®
● Low U.S. sales given expected
Pentacel® supply constraint
● Menactra® performance more than offsets
softness in Booster vaccine
● Menactra® sales up +29.9%
● Adult boosters decline -15.8% due to
Adacel® buying pattern in the U.S.
● First sales of Dengvaxia® of €19m
● SAGE(2) recommends use
in endemic countries to WHO
● Dossier submitted to EMA
Sanofi Pasteur Sales
Q1 2016
€625m
Q1 2015
€597m
Other
Dengvaxia®
Travel/Endemic
Adult Boosters
Meningitis/Pneumo
Polio/Pertussis/Hib
Influenza Vaccines
(1)
+8.2% at CER
(1)
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Diabetes Franchise Reflected Lower U.S. Glargine(1)
Average Net Price, Moderated by Growth in EU and China
● Sales of €1,734m, down -4.5%(2) at CER
● U.S. sales down by -11.1% reflecting
expected lower Glargine average net price
● Europe up +4.0% despite biosimilar
competition
● Emerging Markets up +12.0%(3) excluding
Venezuela
● Glargine TRx U.S. market share relatively
stable year over year at 68.4%(4)
● Toujeo® expected to be launched in over
40 countries by end 2016
● LixiLan(5) and lixisenatide FDA Advisory
Committee scheduled for May 25th 2016 Q1 2015 Q1 2016
Other
€1,734m -4.5% at CER
(1) Lantus® and Toujeo®
(2) Diabetes sales declined by -3.6% when excluding Venezuela
(3) Diabetes sales in Emerging Markets increased by +6.4% when including Venezuela
(4) IMS Rapid weekly as of April 1st 2016, -0.4% vs same period in 2015
(5) LixiLan is a project name and is not the intended brand name for the combination of insulin glargine and lixisenatide
(6) Includes Apidra®, Amaryl®, Insuman®, Lyxumia® and Blood Glucose Monitoring
€1,837m
(6)
Global Diabetes Sales
13 Praluent® is developed and commercialized in collaboration with Regeneron
Progressive Launch Underway
Awaiting Outcomes Study Results
● Q1 2016 sales of €12m reflecting current
payer restrictions limiting uptake
● ODYSSEY OUTCOMES first interim data
analysis for futility conducted and study
continues
● Second interim analysis for futility and
overwhelming efficacy potentially in H2 2016
when 75% of the targeted number of primary
events have occurred
● 300mg monthly dosing expected to be filed
with FDA in Q2 2016
● Sanofi and Regeneron strongly disagree
with U.S. jury verdict in ongoing patent
litigation and will appeal
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CHC Franchise Grows by +4.1%
Excluding Venezuela Impact and at Constant Structure(1)
● Strong U.S. performance up +7.7% at CER driven by Allegra®, Nasacort® and Gold Bond®
● Europe declines -7.3% at CER due to Doliprane® price cuts and mild winter
● Emerging Markets were up +3.8% at CER excluding Venezuela(2)
(1) Excluding minor divestments
(2) Including Venezuela sales were down -9.9% at CER
(3) Subject to regulatory clearances
CHC Franchise Global Sales
Fx Impact Q1 2016 Organic
Growth
Q1 2015
Adjusted Base
Venezuela &
Minor
Divestments
-€67m
Q1 2015
€979m
€912m
+€37m -€44m
€905m
+4.1% at CER
CHC asset swap on track for signing in mid 2016 and closing by end 2016(3)
+15.6%
CER: Constant Exchange Rates
(1) World excluding U.S., Canada, Europe, Japan, South Korea, Australia, New Zealand and Puerto Rico
(2) RoW: Japan, South Korea, Canada, Australia, New Zealand and Puerto Rico
(3) Eurasia: Russia, Ukraine, Georgia, Belarus, Armenia and Turkey
Sanofi Continues to Show a Balanced Geographic Profile
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Q1 2016 Aggregate Group Sales by Geography (€m)
27.8%
34.7%
27.8%
9.7% (1)
€833m
€571m
€259m
€668m
Asia AfricaMiddle East
and South Asia
Latin America Eurasia
Growth at CER
Emerging Markets Sales by Region
Emerging
Markets
€2,373m +4.2% at CER
or
+13.1% at CER
excluding
Venezuela U.S.
€2,966m +1.5% at CER
Europe
€2,372m +1.7% at CER
RoW
€832m -13.3% at CER
(2)
Growth at CER
excluding Venezuela
+9.9% -14.9%
+11.0%
+11.8%
(3)
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Expected Regulatory Decisions Q1 Q2 Q3 Q4
● Dengvaxia® in endemic countries
● Lixisenatide in Diabetes (U.S.)
● LixiLan in Diabetes (U.S.)
● Sarilumab in Rheumatoid Arthritis (U.S.)
Expected Regulatory Submissions Q1 Q2 Q3 Q4
● LixiLan in Diabetes (E.U.)
● Dupilumab in Atopic Dermatitis (U.S.)
● Sarilumab in Rheumatoid Arthritis (EU)
Expected Phase III / IIIb Topline Data Q1 Q2 Q3 Q4
● Dupilumab in Atopic Dermatitis (SOLO 1 & 2 / CHRONOS)
● Sarilumab in Rheumatoid Arthritis (MONARCH)
● Insulin lispro in Diabetes (SORELLA)
● Praluent® ODYSSEY OUTCOMES 2nd interim analysis(1)
Expected Phase III Starts Q1 Q2 Q3 Q4
● Olipudase alfa in Niemann Pick type B(2)
● NeoGAA in Pompe
● PD-1 Inhibitor in CSCC(3) pivotal Phase II
● Fitusiran in Hemophilia
● Efpeglenatide in Diabetes
● Sotagliflozin in Diabetes
● Isatuximab in Multiple Myeloma
Seven Registrational Studies Expected to Start in 2016
(1) Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred in H2 2016
(2) Pivotal phase II/III trial
(3) Cutaneous Squamous Cell Carcinoma
First Fully-Human, Subcutaneously
Delivered IL-6R Antibody Studied in RA
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● Sarilumab efficacy/safety results in moderate to
severe RA patients
● Sarilumab 200mg Q2W + MTX(1) in MTX-
inadequate responders showed 91% inhibition of
structural damage
● Sarilumab + MTX in anti-TNFα-inadequate
responders showed consistent impact on
symptoms and physical functioning
● Most frequently reported TEAE(2) include serious
infections, injection site erythema and neutropenia
● Sarilumab monotherapy shows superior efficacy
vs. adalimumab(3)
● Two subcutaneous doses evaluated: 150mg and
200mg Q2W
U.S. regulatory decision expected in early Q4 2016
Sarilumab is developed in collaboration with Regeneron
RA: Rheumatoid Arthritis
Sarilumab is an investigational agent under clinical development and its safety
and efficacy has not been fully evaluated by any Regulatory Authority
(1) Methotrexate
(2) Treatment Emergent Adverse Events
(3) Not included in the initial BLA filed with FDA
First IL-4/IL-13 Receptor Antibody to
Show Positive Phase III Results in AD
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● Dupilumab Phase IIb data in Atopic Dermatitis
published in The Lancet
● Dupilumab 300mg QW / Q2W demonstrated the
following in SOLO 1 and 2 Phase III trials(3)
● 37-36% / 38-36% of patients achieved clearing or
near-clearing (IGA 0 or 1) of skin lesions at week 16
● 72-69% / 72- 67% improvement in EASI(2)
● CHRONOS Phase III results expected in Q2 2016
● European pivotal study initiated in Q1 2016
(CAFE)
● Phase III study in Asthma ongoing
Dupilumab is developed in collaboration with Regeneron
AD: Atopic Dermatitis
Dupilumab is an investigational agent under clinical development and its safety
and efficacy has not been fully evaluated by any Regulatory AuthorityThe
SOLO 1 , SOLO 2, CHRONOS and CAFE trials are part of the LIBERTY AD
clinical trial program
U.S. submission in AD planned for Q3 2016
IGA score 4
(1) For illustration only. While these pictures are from the Phase IIb
clinical trial, individual results may vary
(2) Eczema Area and Severity Index
(3) Most frequently Treatment Emergent Adverse Events include
serious and severe infections, injection site reactions and
conjunctivitis
AFTER BEFORE (1) (1)
Images of a patient before and after
dupilumab therapy in Phase IIb trial (Individual results did vary)
IGA score 0
FINANCIAL RESULTS
Jérôme Contamine
Executive Vice President, Chief Financial Officer
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20
FX Headwind on Top and Bottom Line in Q1 2016
(1) Main currency impact on sales in Q1 2016: Brazilian Real (-€70.3m), Argentine Peso (-€39.6m),
South African Rand (-€20.4m), Turkish New Lira (-€19.7m), Russian Ruble (-€18.9m) and
Mexican Peso (-€18.9m); U.S. Dollar (+€50.6m) , Japanese Yen (+€22.2m)
(2) Excluding Vaxserve in Aggregate Sales
(3) Adverse impact of Venezuela on Q1 2016 Business EPS was €0.09, which includes €197m lower sales vs Q1 2015
and €102m Fx loss recorded in Other operating income P&L line
+9.8%
+€764m
+11.1%
+€888m
+5.6%
+€487m
-2.6%
-€228m
Q1 2016
Q1 2015 Q2 2015 Q3 2015 Q4 2015
+3.7%
+€332m
Q1 2016
Q1 2015 Q2 2015 Q3 2015 Q4 2015
+10.2%
+€0.12
+15.4%
+€0.18
+€0.05
+3.4%
+7.1%
+€0.10
-3.8%
-€0.05
Currency Impact
Aggregate Group Sales(1,2) Business EPS
Currency impact excluding Venezuela(3)
CER: Constant Exchange Rates
(1) Reflecting reclassification of VaxServe from Sales to Other revenues. VaxServe sales of non-Group products were €100m in Q1 2015
and €83m in Q1 2016
(2) Includes an indemnity amount of €192m pursuant to a final arbitration as consequence of a contractual dispute
and an Fx loss of €102m in Venezuela 21
Aggregate BOI Increased +3.0% at CER in Q1 2016
€m Q1 2016 Q1 2015 % Change
(reported €)
% Change (CER)
Aggregate Group sales 8,543 8,710 -1.9% +0.7%
Aggregate Other revenues 155 180 -13.9% -15.0%
Aggregate Cost of sales (2,693) (2,786) -3.3% -0.1%
Aggregate Gross profit 6,005 6,104 -1.6% +0.6%
Aggregate R&D (1,278) (1,199) +6.6% +6.5%
Aggregate SG&A (2,418) (2,438) -0.8% +1.3%
Aggregate Other current operating income & expenses 79 (67) - -
Aggregate Share of profit/loss of associates 23 31 - -
Aggregate Minority interests (27) (33) - -
Aggregate Business operating income 2,384 2,398 -0.6% +3.0%
Aggregate Business operating margin 27.9% 27.5% - -
(1)
(2)
22
€m Q1 2016 Q1 2015 % Change
(reported €)
% Change (CER)
Aggregate Business operating income 2,384 2,398 -0.6% +3.0%
Aggregate Net financial expenses (118) (97) - -
Income tax expense (544) (575) - -
Effective tax rate 24.0% 25.0% - -
Business net income 1,722 1,726 -0.2% +3.5%
Net margin 20.2% 19.8% - -
Business EPS €1.34 €1.32 +1.5% +5.3%
Average number of shares outstanding (m) 1,288.4 1,308.4 - -
A Good Start to 2016 with Mid-Single Digit Growth
of Business EPS at CER
22 CER: Constant Exchange Rates
(1) Number of shares outstanding on March 31st, 2016: 1,286.7m
(1)
Stable Gross Margin Ratio in Q1 2016
● Stable Cost of Sales (CoS) of
€2,693m in Q1 2016
● Gross margin of 70.3% in Q1 2016
reflects:
● Positive impact from Specialty Care
franchise and Vaccines more than
offsetting the impact from lower Glargine
average net price in the U.S. and Plavix®
LoE(2) in Japan
● Slight positive currency impact
23
Q1 Q2 Q3 Q4 Q1
2015 2016
70.3% 70.1%
Aggregate Gross Margin(1)
Gross Margin is calculated as the ratio of Aggregate Gross profit over Aggregate Group sales (excluding Aggregate Other revenues)
(1) Historical values adjusted for VaxServe reclassification
(2) Loss of Exclusivity
70.4% 70.7% 69.0%
Limited OpEx Growth Mostly Driven by R&D in Q1 2016
24
● Q1 2016 OpEx of €3,696m, up
+3.0% at CER
● R&D expenses of €1,278m up 6.5%
at CER mainly due to:
● Immuno-Oncology activities
● Dupilumab Phase III program
● SG&A expenses of €2,418m,
slightly up (+1.3% at CER) showing:
● Reallocation of resources behind key
products launches
● Lower G&A expenses
24
Q1 Q2 Q3 Q4 Q1
€3,696m €3,637m
2015 2016
€1,278m €1,199m
€2,418m €2,438m
R&D
SG&A
Operating Expenses
Share Repurchase
-€1,403m
CapEx
-€325m
Net Cash from
Operating
Activities
Net Debt
Dec 31, 2015
Net Debt
Mar 31, 2016
Other
-€569m
Acquisitions,
Licensing, Net
of Disposals
-€25m
€1.4bn of Share Repurchase Completed in Q1 2016
25
(1)
(2)
€7,254m
€8,373m
€1,203m
(4) (1)
FCF
€878m
(3)
FCF: Free Cash Flow
(1) Including derivatives related to the financial debt +€152m at December 31st 2015 and +€196m at March 31st 2016
(2) Excluding Restructuring costs
(3) Including Hanmi Pharmaceuticals of €400m, Verily JV of €165m and Regeneron anti-dilutive share purchase of €94m
(4) Other including Restructuring costs and Fx impact
Net Debt
25
26
(1) Barring major unforeseen adverse events
(2) FY 2015 Business EPS of €5.64
(3) Difference between variation on a reported basis and variation at CER when applying March 2016 average exchange rates
to the remaining quarters of the year
Confirmed 2016 Business EPS Growth at CER
Business EPS Growth
Around -3%(3)
based on March 2016 average exchange rates
Broadly stable at CER(1,2)
FY 2016
FX impact on Business EPS
CLOSING REMARKS
27
Olivier Brandicourt
Chief Executive Officer
28
Delivering on our Strategic Priorities
● Solid financial results in Q1 2016
● Reshaping the portfolio
● CHC/Animal Health asset swap
● End joint Vaccines operations in Europe
● Focus on execution of launches
● New wave of innovation with seven pivotal trials
expected to start in 2016
1
2
3
4
29
Q&A SESSION
30
APPENDICES
R&D Pipeline
Immunology
Infectious Diseases
Neurodegenerative Diseases
Ophthalmology
Multiple Sclerosis
R&D Pipeline – Pharma & Vaccines
GZ402668 GLD52 (anti-CD52 mAb)
Relapsing multiple sclerosis
GZ402666 neoGAA
Pompe Disease
GZ389988 TRKA antagonist
Osteoarthritis
SAR339375 Anti-miR21 RNA
Alport syndrome
SAR425899 GLP-1R/GCGR dual agonist
Type 2 diabetes
fitusiran (ALN-AT3)
siRNA targeting Anti-Thrombin
Hemophilia
SAR438335 GLP-1R/GIPR dual agonist
Type 2 diabetes
UshStat® Myosin 7A gene therapy
Usher syndrome 1B
SAR438544 Stable glucagon analog
Diabetes
SAR228810 Anti-protofibrillar AB mAb
Alzheimer’s disease
SAR440067 (LAPS Insulin 115)nn
Long acting insulin analog
Type 2 diabetes
SAR439152 Myosin inhibitor
Hypertrophic cardiomyopathy
SAR566658
Maytansin-loaded anti-CA6 mAb
Solid tumors
SAR407899 rho kinase
Microvascular angina
SAR408701 Anti-CEACAM5 ADC
Solid tumors
SAR366234 EP2 receptor agonist
Elevated intraocular pressure
SAR439684 PD-1 inhibitor
Cancer
Streptococcus pneumonia Meningitis & pneumonia vaccine
SAR428926 LAMP-1 inhibitor
Cancer
Herpes Simplex Virus Type 2 HSV-2 vaccine
Phase I
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
dupilumab Anti-IL4Rα mAb Nasal polyposis;
Eosinophilic oesophagitis
olipudase alfa rhASM
Niemann-Pick type B
SAR156597 IL4/IL13 Bi-specific mAb
Idiopathic pulmonary fibrosis
GZ402671 Oral GCS inhibitor
Fabry Disease
SAR100842 LPA1 receptor antagonist
Scleroderma
SAR422459 ABCA4 gene therapy
Stargardt disease
SAR439954 (sotagliflozin)
Oral SGLT-1&2 inhibitor
Type 2 diabetes
Combination
ferroquine / OZ439
Antimalarial
SAR439977 (efpeglenatide)n Long-acting GLP-1 receptor agonist
Type 2 diabetes
Rabies VRVg Purified vero rabies vaccine
sarilumab Anti-IL6R mAb
Uveitis
Tuberculosis Recombinant subunit vaccine
isatuximab Anti-CD38 naked mAb
Multiple myeloma
Fluzone® QIV HD Quadrivalent inactivated
influenza vaccine - High dose
Phase II N
N
N N
N
SAR342434 insulin lispro
Type 1+2 diabetes
SAR439954 (sotagliflozin) n
Oral SGLT-1&2 inhibitor
Type 1 diabetes
sarilumab Anti-IL6R mAb
Rheumatoid arthritis, EU
dupilumab Anti-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® cabazitaxel
Metastatic prostate cancer (1L)
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
Phase III
N
N
N
N
Registration
lixisenatide
GLP-1 agonist
Type 2 diabetes, U.S.
LixiLan Fixed-Ratio insulin glargine+lixisenatide
Type 2 diabetes, U.S., EU
sarilumab Anti-IL6R mAb
Rheumatoid arthritis, U.S.
Dengvaxia®(1) Mild-to-severe
dengue fever vaccine
PR5i DTP-HepB-Polio-Hib
Pediatric hexav. vaccine, U.S.
VaxiGrip® QIV IM Quadrivalent inactivated
influenza vaccine (3 years+)
N
N
N
N
(1) Approved in Brazil, Mexico, the Philippines and El Salvador 31
N
N
N
N New Molecular Entity
Rare Diseases
Oncology
Diabetes
Vaccines
Cardiovascular Diseases N
N
N
32
Phase I Phase II Phase III Registration TOTAL
Oncology 4 1 0 0 5
Diabetes 4 1 2 2 9
Cardiovascular Diseases 2 0 0 0 2
Immune Mediated
Diseases 1 2 1 1 5
Infectious Diseases 0 1 0 0 1
Ophthalmology 1 0 0 0 1
Rare Diseases 4 3 2 0 9
Multiple Sclerosis 1 0 0 0 1
Neurodegenerative
Diseases 1 0 0 0 1
Vaccines 2 3 4 3 12
TOTAL 20
11 9 6
R&D Pipeline Summary Table(1)
31 15 NMEs & Vaccines
46
32
34
(1) Excluding life cycle management programs
33
Expected R&D Milestones (1/2)
33
Product Event Timing
Dengvaxia® Expected regulatory decision in endemic countries Throughout 2016
Lixisenatide and LixiLan FDA Advisory Committee May 25, 2016
Men Quad TT Expected start of Phase III trial Q2 2016
insulin lispro Expected SORELLA Phase III top line results in Diabetes Q2 2016
dupilumab Expected CHRONOS Phase III interim results in Atopic Dermatitis Q2 2016
NeoGAA (GZ402666) Expected start of Phase III trial in Pompe Disease Q2 2016
olipudase alfa Expected start of pivotal Phase II/III trial in Niemann Pick type B Q2 2016
SAR439684 (PD-1 Inhibitor) Expected start of pivotal Phase II trial in Cutaneous Squamous Cell Carcinoma Q2 2016
sarilumab Expected EU regulatory submission in Rheumatoid Arthritis Q3 2016
Lixisenatide Expected U.S. regulatory decision in Type 2 Diabetes Q3 2016
LixiLan Expected U.S. regulatory decision in Type 2 Diabetes Q3 2016
dupilumab Expected U.S. regulatory submission in Atopic Dermatitis Q3 2016
fitusiran Expected start of Phase III trial in Hemophilia Q3 2016
34
Expected R&D Milestones (2/2)
34
Product Event Timing
Praluent® Expected results of ODYSSEY OUTCOMES 2nd interim analysis(1) H2 2016
sarilumab Expected U.S. regulatory decision in Rheumatoid Arthritis Q4 2016
VaxiGrip® QIV IM (3 years+) Expected EU regulatory decision Q4 2016
sotagliflozin Expected start of Phase III trial in Type 2 Diabetes Q4 2016
efpeglenatide Expected start of Phase III trial in Type 2 Diabetes Q4 2016
isatuximab (anti-CD38) Expected start of Phase III trial in Multiple Myeloma Q4 2016
(1) 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
APPENDICES
FINANCE
35
Business EPS Currency Sensitivity
Currency Exposure on Q1 2016 Sales Currency Average Rates
2016 - Currency Sensitivity
36
Q1 2015 Q1 2016 % change
EUR/USD 1.13 1.10 -2.2%
EUR/JPY 134.19 127.02 -5.3%
EUR/CNY 7.03 7.21 +2.6%
EUR/BRL 3.22 4.31 +33.7%
EUR/RUB 71.09 82.47 +16.0%
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 0.01
Russian Ruble +10 RUB/EUR -EUR 0.04
€ 24.9%
US $ 35.9%
Chinese Yuan 5.9%
Japanese Yen 5.0%
Brazilian Real 2.5%
British £ 1.9%
Australian $ 1.5%
Canadian $ 1.4%
Russian Ruble 1.3%
Mexican Peso 1.2%
Others 18.5%
2016 - Headwinds and Tailwinds
● Residual impact of Plavix® generic erosion in Japan
● Biosimilar insulin glargine launched in Japan & EU in H2 2015
● Potential generic competition for Renagel®/Renvela® in the U.S. and Lovenox® in the EU
● Launch expenses for Toujeo®, Praluent®, Dengvaxia®, LixiLan(1) and sarilumab
● Immuno-Oncology related expenses
● Low tax rate in H2 2015 creating unfavorable base for comparison
37 37
Headwinds
● Easier base for comparison for Diabetes and Venezuela(2) in H2 2016
● Stronger Vaccines outlook in H2 2016
● Q4 2015 negatively impacted by Auvi-Q® and Afrezza®
Tailwinds
(1) LixiLan is a project name and is not the intended brand name for the combination of insulin glargine and lixisenatide
(2) €200m sales in Q2 2015 and €56m in H2 2015
38
Q1 2016 - Business Net Income Statement
First quarter 2016 Pharmaceuticals Vaccines Others Total Group Animal Health(1) Total: aggregate basis(4)
€ million Q1 2016 Q1 2015 Change Q1 2016 Q1 2015(3) Change Q1 2016 Q1 2015 Q1 2016 Q1 2015 Q1 2016 Q1 2015 Change Q1 2016 Q1 2015 Change
Net sales 7,158 7,455 (4.0%) 625 597 4.7% 7,783 8,052 760 658 15.5% 8,543 8,710 (1.9%)
Other revenues 54 62 (12.9%) 91 106 (14.2%) 145 168 10 12 (16.7%) 155 180 (13.9%)
Cost of sales (2,097) (2,190) (4.2%) (350) (376) (6.9%) (2,447) (2,566) (246) (220) 11.8% (2,693) (2,786) (3.3%)
As % of net sales (29.3%) (29.4%) (56.0%) (63.0%) (31.4%) (31.9%) (32.4%) (33.4%) (31.5%) (32.0%)
Gross profit 5,115 5,327 (4.0%) 366 327 11.9% 5,481 5,654 524 450 16.4% 6,005 6,104 (1.6%)
As % of net sales 71.5% 71.5% 58.6% 54.8% 70.4% 70.2% 68.9% 68.4% 70.3% 70.1%
Research and development
expenses (1,108) (1,039) 6.6% (127) (120) 5.8% (1,235) (1,159) (43) (40) 7.5% (1,278) (1,199) 6.6%
As % of net sales (15.5%) (13.9%)
(20.3%) (20.1%) (15.9%) (14.4%) (5.7%) (6.1%) (15.0%) (13.8%)
Selling and general expenses (2,046) (2,094) (2.3%) (166) (156) 6.4% (2,212) (2,250) (206) (188) 9.6% (2,418) (2,438) (0.8%)
As % of net sales (28.6%) (28.1%) (26.6%) (26.1%) (28.4%) (27.9%) (27.1%) (28.6%) (28.3%) (28.0%)
Other current operating
income/expenses 107 (28) 1 (14) (40) 93 (67) (14) 79 (67)
Share of profit/loss of
associates* and joint ventures 16 32 7 (1) 23 31 - 23 31
Net income attributable to
non-controlling interests (27) (33) - (27) (33) - (27) (33)
Business operating income 2,057 2,165 (5.0%) 80 51 56.9% (14) (40) 2,123 2,176 261 222 17.6% 2,384 2,398 (0.6%)
As % of net sales 28.7% 29.0% 12.8% 8.5% 27.3% 27.0% 34.3% 33.7% 27.9% 27.5%
Financial income and
expenses(2) (118) (97)
Income tax expense(2) (544) (575)
Tax rate** 24.0% 25.0%
Business net income 1,722 1,726 (0.2%)
As % of net sales 20.2% 19.8%
Business earnings per
share*** (in euros) 1.34 1.32 1.5%
* Net of tax
** Determined on the basis of Business income before tax, associates and non-controlling interests.
*** Based on an average number of shares outstanding of 1,288.4 million in the first quarter of 2016 and 1,308.4 million in the first quarter of 2015.
(1) Pursuant to IFRS5 presentation requirement as "discontinued operations”, Animal Health business net result is reported on the single income statement line Net income from the held-for-exchange
Animal Health business for 2015 and prior years. Until the closing of the transaction, Animal Health remains an operating segment of the Group
(2) Including Animal Health business which is reported on a single line in the consolidated income statements in accordance with IFRS5 (Non-Current Held for Sale and Discontinued Operations)
(3) As per a change in accounting presentation, Vaxserve sales of non Group products are reported in Other revenues from 2016 onwards. Prior period Net sales and Other revenues have been restated
accordingly. .
(4) Aggregate amount including Animal Health business
Q1 2016 - Reconciliation of Business Net Income to
Consolidated Net Income Attributable to Equity Holders of Sanofi
39
(1) Animal Health 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: €410 million in the first quarter of 2016 and
€471 million in the first quarter of 2015
(3) Includes the following items: Impact of the discontinuation of depreciation and impairment of Property, Plant & Equipment starting at IFRS 5 application (Non-current held for
sale and discontinued operations), impact of the amortization and impairment of intangible assets until IFRS 5 application, costs incurred as a result of the divestment as well
as tax effect of these items, and outside basis deferred tax impact
(4) Based on an average number of shares outstanding of 1,288.4 million in the first quarter of 2016 and 1,308.4 million in the first quarter of 2015
€ million Q1 2016(1) Q1 2015 (1) Change
Business net income 1,722 1,726 (0.2%)
Amortization of intangible assets(2) (444) (499)
Impairment of intangible assets - (27)
Fair value remeasurement of contingent consideration liabilities (29) 1
Restructuring costs (500) (353)
Tax effect of items listed above: 338 312
Amortization of intangible assets 156 174
Impairment of intangible assets - 10
Fair value remeasurement of contingent consideration liabilities 11 7
Other gains and losses, and litigation - -
Restructuring costs 171 121
Share of items listed above attributable to non-controlling interests 1 1
Restructuring costs of associates and joint ventures, and expenses arising from the
impact of acquisitions on associates and joint ventures 70 (62)
Animal Health items(3) (71) (76)
Net income attributable to equity holders of Sanofi 1,087 1,023 6.3%
Consolidated earnings per share(4) (in euros) 0.84 0.78
40
Q1 2016 - Consolidated Income Statements
(1) Including Animal Health business which is reported on a single line in the consolidated income statements in accordance with IFRS5
(Non-Current Held for Sale and Discontinued Operations).
(2) As per a change in accounting presentation, Vaxserve sales of non-Group products are reported in Other revenues from 2016 onwards. Prior period Net sales and Other
revenues have been restated accordingly. .
€ million Q1 2016(1) Q1 2015(1)(2)
Net sales 7,783 8,052
Other revenues 145 168
Cost of sales (2,447) (2,566)
Gross profit 5,481 5,654
Research and development expenses (1,235) (1,159)
Selling and general expenses (2,212) (2,250)
Other operating income 217 34
Other operating expenses (124) (101)
Amortization of intangible assets (444) (499)
Impairment of intangible assets - (27)
Fair value remeasurement of contingent consideration liabilities (29) 1
Restructuring costs (500) (353)
Operating income 1,154 1,300
Financial expenses (129) (131)
Financial income 12 36
Income before tax and associates and joint ventures 1,037 1,205
Income tax expense (117) (184)
Share of profit/loss of associates and joint ventures 93 (31)
Net income excluding the held for exchange Animal Health business 1,013 990
Net income from the held for exchange Animal Health business 100 65
Net income 1,113 1,055
Net income attributable to non-controlling interests 26 32
Net income attributable to equity holders of Sanofi 1,087 1,023
Average number of shares outstanding (million) 1,288.4 1,308.4
Earnings per share (in euros) excluding the held for exchange Animal Health business 0.77 0.73
Earnings per share (in euros) 0.84 0.78
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