2. Forward Looking Statements
2
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.
3. Agenda
3
2015 Financial Performance
Jérôme Contamine, Executive Vice President, Chief Financial Officer
Introduction & Governance
Serge Weinberg, Chairman of the Board of Directors
Compensation Policy
Patrick Kron, Chairman of the Compensation Committee
Progress in Research & Development
Elias Zerhouni, President, Global R&D
Questions & Answers
Vote on the Resolutions
Perspectives
Olivier Brandicourt, Chief Executive Officer
5. An Independent, Diversified and Renewed Board
5
14 Directors
Current Board Composition
● A majority of independent Directors
(11 out of 14)
● 5 non-French Directors (31%)
● No over-boarding, for increased
attendance and involvement
13 Directors
Proposed Board Composition
● A gradual and controlled renewal
● International
● Widely independent (10 out of 13)
● Gender-balanced (46% of women)
● A smaller Board
● Expertise in the scientific and
pharmaceutical field:
Diane Souza and Thomas Südhof
6. An Active and Engaged Board
6
In 2015:
High attendance
rate from
Directors
>91%
● Increased activity: 11 meetings
● Strategic review
● Presentations by key Group managers on their
Business Units
● Review of proposed acquisitions, disposals
and collaborations
● Transitional period for the office of
Chief Executive Officer
7. Four Specialist Committees
7
Audit
Committee
Attendance rate
96%
Compensation
Committee
Attendance rate
100%
● Chairman: Robert Castaigne
● 3 financial experts
● 3 independent members out of 4
● 6 meetings in 2015
● 3 independent members out of 4
● 6 meetings in 2015
● The main activities of this Committee will be
presented by Patrick Kron
● Regular reviews: main risks which may have
an impact on financial statements
● Specific reviews: notably progress reports on
acquisitions, R&D agreements and update on
compliance programs
8. Four Specialist Committees (cont’d)
8
Appointments
and Governance
Committee
Attendance rate
100%
Strategy
Committee
Attendance rate
92%
● 4 independent members out of 4
● 6 meetings in 2015
● Appointment of the new Chief Executive Officer
● Setting of a framework for the review
of the succession plan
● Evaluation of the work of the Board and
its Committees
● 4 independent members out of 6
● 5 meetings in 2015
● Reviews of activities, in particular of new
product launches
● Strategic review and prospects
● Review of proposed R&D collaborations,
acquisitions and partnerships
9. Sanofi Share Performance vs. CAC 40 and Pharmaceutical
Sector from January 2015
9
€50
€55
€60
€65
€70
€75
€80
€85
€90
€95
€100
€105
- 4.8%
CAC 40
+ 4.0%
US Pharma
+ 5.7%
EU Pharma
- 4.2%
Source : Bloomberg (31/12/2014 - 02/05/2016)
EU Pharma = 7 pharmaceutical companies; US Pharma = 6 pharmaceutical companies
10. Sanofi Share Performance vs. Pharma Company Peers from
January 2015
10Source: Bloomberg (12/31/2014 - 05/02/2016)
-4.8%
11. 11
The Dividend Is a Core Part of our Value Proposition to
Shareholders
(1) Submitted for approval by shareholders at the Annual General Meeting on May 4, 2016
Evolution of Dividend
2014
€2.85
2013
€2.80
2012
€2.77
2011
€2.65
2015
€2.93(1)
● Proposed dividend of €2.93 per share for 2015 financial year(1)
● 22nd consecutive year of dividend increase
12. 7.1%
12.6%
13.6%
29.4%
9.1%
5.9%
7.8%
An International and Diversified Shareholder Base(1)
12
United States
France
Institutional
investors
75.6%
UK
Other EU countires
Asia
Germany
Switzerland
Canada
Rest of the world
L’Oréal
Individual Shareholders
Employees
1,305,696,759
shares
0.3% Treasury
Miscellaneous
7.2%
2.5%
3.5% 1.3%
1.4%
1.8%
3.7%
(1) Shareholder structure as of December 31, 2015, source: NASDAQ Corporate Solutions
12
13. Strengthen Employee Share Ownership
13(1) At December 31, 2015
Sanofi Wants to Strengthen
Employee Share Ownership
● 21st resolution adopted by
Shareholders at the General
Meeting of May 4, 2015
● To be implemented in
June 2016
● More than 80 countries
participating
4 plans since 2005
● >2 million shares subscribed
● >1.5 million shares subscribed
Global share plan awarding 20 restricted shares
to each Group employee
● >2.1 million restricted shares allocated
● >1.6 million shares subscribed
1.3%(1)
of Sanofi
share capital
is held by
employees
Action
2005
Action
2007
Share
2010
Action
2013
13
14. Compensation Policy
Chairman of the Committee since March 3, 2016,
succeeding Jean-René Fourtou
Patrick Kron
Chairman of the Compensation Committee*
15. Composition of the Compensation Committee
15
● Patrick Kron,
Chairman of the Committee
since March 3, 2016
● Claudie Haigneré
● Christian Mulliez
● Jean-René Fourtou
Chairman of the Committee
until March 3, 2016
In accordance
with the
AFEP-MEDEF
Code,
more than half
the members are
independent
(3 out of 4)
The Compensation Committee is composed of:
16. Compensation Policy for the Chairman of the Board
16
● No Directors’ attendance fee
● No annual variable compensation
● No equity compensation
● No compensation payable upon
termination of office
● No pension entitlement
● Annual fixed compensation
(gross amount)
● No adjustment in spite of the
temporary combining of the
offices of Chairman of the Board
and Chief Executive Officer for
five months
17. Elements of Compensation of Serge Weinberg in 2015
17
Amounts due Comments
Fixed compensation €700,000
Fixed compensation unchanged
since his appointment as Chairman
of the Board on May 17, 2010
€8,218 Company car
Total €708,218
18. Compensation Policy for the Chief Executive Officer
18
● Annual fixed compensation
(gross amount)
● Annual variable compensation
(gross amount)
● Equity compensation
● Options to subscribe for shares
● Performance shares
● No Directors’ attendance fee
● Compensation payable upon
termination of office
● Severance benefit
● Top-up pension plan
● Non-compete undertaking
19. Elements of Compensation of Olivier Brandicourt in 2015
19
Amounts due Comments
Fixed compensation €895,455
€1,200,000 pro rated with his presence
within the Group
Variable compensation €1,491,300
Between 0% and 250% of his fixed
compensation
Target: 150% of his fixed compensation
Vesting: 165.7% of his fixed
compensation
Options
220,000 options to
subscribe for
shares
Exercise price: €89.38
Performance shares
45,000
performance shares
20. Equity Compensation of Olivier Brandicourt in 2015
● 220,000 options to
subscribe for shares
● 45,000 performance
shares
● Performance conditions measured
over 3 years
● 3 performance criteria
● Business net income (50%)
● Return on assets (30%)
● Total shareholder return (20%)
2015 Plan Conditions
2015 Grant
20
21. 21
Indemnification of Elements Lost by Olivier Brandicourt
Amounts due Comments
Exceptional
compensation 2015
€2,000,000 Upon his taking up office
Exceptional
compensation 2016
€2,000,000
In January 2016 and subject to a condition of
continued employment
Performance shares 66,000 shares
Performance shares granted in 2015 with a
3-year vesting period and subject to performance
conditions
Pension plan
Attribution of ten years’ service
subject to his presence within the Group
at the time of retirement
23. (1) Including Sanofi’s Animal Health business, Merial. Following the announcement of exclusive negotiations with Boehringer Ingelheim and as an IFRS presentation requirement for discontinued
operations, Net Income for Merial will be reported on a separate line
(2) CER: Constant Exchange Rates. On a reported basis, 2015 aggregate sales were up 9.7% and Business EPS was up 8.5%
Aggregate Group Sales(1) Business EPS
8 075 M€
9 378 M€
FX Impact FY 2015Incremental
Sales at CER
FY 2014
2015 Business EPS Up 8.5% on a Reported Basis
and Stable at CER
23
+€2,549m
+€738m
+2.2%
at CER(2)
€33,770m
€37,057m
FY 2015FX ImpactFY 2014
5,20 €
Stable
at CER(2)€5.20
€5.64
+€0.44
24. Genzyme, Vaccines and Animal Health Drove Sales Growth
in 2015
24
CER: Constant Exchange Rates
(1) FY 2015 sales of Pharmaceuticals include €9m of Praluent®
Genzyme
Consumer Healthcare
Oncology
Diabetes
Established Products
% of Sales
9.9%
4.1%
20.5%
9.4%
31.3%
Animal Health
Vaccines12.8%
6.8%
Pharmaceuticals(1)
80.4%
Generics5.2%
Growth at CER
€3,664m
€3,492m
€1,504m
€7,580m
€11,633m
+29.5%
+2.8%
-1.9%
-6.8%
-2.3%
€2,515m
€4,743m
+10.8%
+7.3%
€29,799m +0.8%
€1,917m +7.6%
25. Balanced Geographical Sales Split in 2015
with Leadership Position in Emerging Markets
32.4%
36.2%
21.7%
9.7%
Emerging Markets Total Sales
by Region
25
+4.0% +5.4% +6.8%Growth at CER +13.2%
€3,732m
€3,305m
€2,429m €2,319m
Asia Latin America Eastern Europe,
Russia & Turkey
Africa & Middle
East
Emerging
Markets(1)
€12,014m
+7.8%
at CER
U.S.
€13,406m
-1.0% at CER
Western EU
€8,026m
+0.9% at CER
RoW(2)
€3,611m
-2.5% at CER
Evolution of FY 2015 aggregate sales at CER (constant exchange rates)
(1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, the Netherlands, Austria, Switzerland, Sweden, Ireland,
Finland, Norway, Iceland, Denmark), Japan, South Korea, Australia, and New Zealand
(2) RoW: Japan, South Korea, Canada, Australia, and New Zealand
26. Solid Financial Performance in 2015
26
€m FY 2015(1) FY 2014(1)
% Change
(reported €)
% Change
(CER)
Aggregate Group sales 37,057 33,770 +9.7% +2.2%
Aggregate Other revenues 360 339 +6.2% -4.7%
Aggregate Gross profit 25,613 23,080 +11.0% +2.0%
Aggregate R&D (5,259) (4,824) +9.0% +1.8%
Aggregate SG&A (10,247) (8,991) +14.0% +6.0%
Aggregate Business operating income 9,948 9,449 +5.3% -2.9%
Effective tax rate 23.0% 24.0% - -
Business net income 7,371 6,847 +7.7% -0.9%
CER: Constant Exchange Rates
(1) Including Sanofi’s Animal Health business, Merial. Following the announcement of exclusive negotiations with Boehringer Ingelheim and as an IFRS presentation
requirement for discontinued operations, Net Income for Merial will be reported on a separate line
27. Increasing Investments in R&D and New Product Launches
27
20152014 20152014
R&D Expenses
(€m)
SG&A Expenses
(€m)
14.2%
of sales
27.7%
of sales
€10,247m
€5,259m
€4,824m
€8,991m
26.6%
of sales
14.3%
of sales
69.1%
20152014
68.3%
Aggregate Gross Margin
(%)
+1.8%
at CER(1)
+6.0%
at CER(2)
CER: Constant Exchange Rates
(1) +9.0% on a reported basis
(2) +14.0% on a reported basis
28. Consolidated Net Income(1)
28
€m 2015(2) 2014(2) % change
(reported €)
Business net income 7,371 6,847 7.7%
Amortization of intangible assets (2,137) (2,081)
Impairment of intangible assets (767) 31
Fair value remeasurement of contingent consideration liabilities 53 (303)
Restructuring costs (795) (404)
Other gains and losses, and litigation - 35
Additional yearly expense related to U.S. Branded Prescription Drug Fee(3) - (116)
Tax effect of items listed above 1,331 928
Other tax items (111) (110)
Restructuring costs of associates and joint ventures, expenses arising from the impact of
acquisitions on associates and joint ventures, and share of items listed above attributable to
non-controlling interests
(166) (191)
Animal Health items (492) (246)
Net income attributable to equity holders of Sanofi 4,287 4,390 -2.3%
(1) Attributable to equity holders of Sanofi
(2) Animal Health reported separately in accordance with IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations)
(3) Annual fee related to 2013 sales following the final IRS regulation issued in July 2014 that has changed the timing of liability recognition and leads to a one-time “double” expense in the year of 2014
29. €7.7bn
€6.0bn
€7.2bn €7.3bn
2012 2013 2014 2015
€7.4bn
€6.5bn
€7.2bn
€8.1bn
+12.2%
2012 2013 2014 2015
Strong Free Cash Flow and Low Debt
29
Free Cash Flow(1)
● Strong long-term credit ratings (Moody’s A1; S&P AA)
● Average cost of borrowings(2)
: 1.6%
Net Debt
(1) Free Cash Flow after change in working capital and after CapEx
(2) Borrowing includes bonds denominated in € and U.S.$ and U.S. Commercial Paper drawings post swap into €
30. Capital Investments Grew by 19.7% in 2015
Reflecting Expansion in Biologic Products
30
2015
€1.5bn
2014
€1.2bn
Industrial
Affairs R&D
Support
Functions
Genzyme,
Vaccines &
Animal Health(1)
Pharmaceutical
Operations
In 2016, capital expenditure is expected to reach €1.8bn
Capital Expenditure Evolution and Breakdown in 2015
9%
7%
12%
7%
65%
(1) Excluding Industrial Affairs
31. Strong Balance Sheet
31
December 31, 2015
ASSETS
LIABILITIES & EQUITY
Net Debt (A-B) 7.3
In €bn
Change vs.
December 31, 2014
-2.1
Intangible assets
Other non-current assets
WCR
Net cash (B)
Equity attributable
Provisions and other
non-current liabilities
Financial debt (A)(1)
Assets held for sale
or exchange
Liabilities related to assets
held for sale or exchange
-0.1
-2.2
+5.8
+1.8
+1.9
-1.6
+1.0
+1.9
51.6
20.1
2.2
5.8
9.1
58.2
13.2
1.0
16.4
+0.1
(1) Including interest rate and currency derivatives used to hedge debt
32. Stable
to slightly growing
Progressive
Mid-single digit
Around 69%
Stable
€0.08 increase(1)
+4.5%
69.1%
Objectives Results
Sanofi Delivered on its 2015 Financial Objectives
32
Gross Margin
OpEx Growth Rate at CER
Business EPS Guidance at CER
Dividend Growth
(1) Proposed dividend of €2.93 per share for 2015 financial year
33. ● SANOFI IR: Mobile application dedicated to
Sanofi’s financial news
● New section dedicated to individual shareholders
● Available in the App Store and on Google Play
● Publications for individual shareholders
● Shareholder Handbook
● Letter to Shareholders
● Fact Sheet
● A rich and useful Website
● With a dedicated section for individual shareholders
www.sanofi.com/shareholders
Regular Information for our Shareholders
33
34. Meetings with Shareholders Around France
Individual Shareholder Committee
● 4 meetings in 2015
● Visit of Frankfurt industrial site
● Insulin production, SoloStar® and Toujeo® pen
assembly line
● Meetings with Serge Weinberg,
Olivier Brandicourt and Jérôme Contamine
Meetings with Shareholders
● 8 meetings in France in 2016
● March 14: Lyon
● March 21: Nantes
● May 24: Aix en Provence
● June 27: Biarritz
● September 12: Bordeaux
● September 29: Nice
● November 28: Tours
● December 8: Reims
● 7 meetings with wealth managers
● Actionaria shareholder exhibition
● November 18-19: Paris
34
Biarritz
36. Challenges for the Pharmaceutical Industry,
Opportunities for Sanofi
36
Participate in the evolution of medicine
Contribute to advancing healthcare throughout the world
● In the context of growing population with increasing life expectancy
Anticipate the transformation of the pharmaceutical
industry
37. 2015 - A Year of Transformation with Significant Achievements
37
3 launches of major products – Toujeo®, Praluent® and Dengvaxia®
3 submissions for regulatory review(1)
Significant R&D alliances in Oncology and Diabetes(2)
Key first transaction announced in Consumer Healthcare(3)
New organizational model in place to drive focus and simplification
2020 strategic roadmap to create long term value
(1) LixiLan, combination of insulin glargine and lixisenatide (U.S.), sarilumab (U.S.) and lixisenatide (U.S.)
(2) BioNTech, Evotec, Hanmi, Innate Pharma, Lexicon Pharmaceuticals, Regeneron and Verily (formerly Google Life Sciences),
(3) December 15, 2015 press release: Sanofi and Boehringer Ingelheim enter exclusive negotiations on business swap: subject to execution of a definitive agreement and regulatory approvals
39. Reshape the Portfolio Focused on Human Health
● Multiple Sclerosis(1)
● Oncology(1)
● Immunology(1)
● Consumer
Healthcare(2)
● Animal Health
● Generics(2)
in Europe
● Diabetes/
Cardiovascular
● Vaccines
● Rare Diseases(1)
● Emerging
Markets(2)
Explore strategic
options
Sustain
leadership
Build competitive
positions
1
39
A B C
(1) Will be part of Specialty Care Global Business Unit
(2) Will be part of General Medicines and Emerging Markets Global Business Unit
40. (1) Excluding CHC in China
(2) Exclusive negotiations announced on December 15, 2015; following consultations with the relevant social bodies and subject to appropriate regulatory approvals
Planned Swap of Sanofi Animal Health Business and
Boehringer Ingelheim (BI) Consumer Healthcare Business(1)
1
BI Consumer Healthcare
Objective:
Close of
potential transaction
by year-end(2)
40
Sanofi Animal Health
41. Sanofi Would Become Global Leader in Consumer Healthcare
10 key brands of Sanofi:
~50% of sales in 2015
7 key brands of Boehringer
Ingelheim: >60% of sales in 2015
Strengthening in
priority categories(1)
• Digestive Health: #1
• Feminine Care: #1
• Pain Care: #2
• Allergy Solutions: #3
• VMS(2): #3
• Cough & Cold Care: #6
(1) As per Sanofi definition; combined wolrdwide sales; source: Nicholas Hall & Company FY 2014
(2) Vitamins, Minerals and Supplements
1
41
43. Six Major Launches of Key Products
LixiLan, dupilumab and sarilumab have not yet been commercialized
(1) LixiLan is a project name and is not the intended brand name for the combination of insulin glargine and lixisenatide
2
43
(1)
44. Launch of New Insulin Toujeo® Is on Track
● Global Toujeo® sales progressing
● Rapid market access obtained
in the U.S.(1)
● Launched globally
in over 20 countries
(1) As of January 1, 2016, 86% of commercial and 91% of Medicare lives covered
Ex U.S.
U.S.
2015 Global Toujeo® Sales of
€164m
44
€7m
€13m
€46m
€98m
Q1 2015 Q2 2015 Q3 2015 Q4 2015
2
45. Praluent®, Available for Hypercholesterolemic Patients on the
U.S. Market since July 2015
● More than 170 million patients covered for a potential treatment
with Praluent® in the United States(1)
● Reimbursement discussions initiated in Europe
● Cardiovascular outcomes study ongoing
● 2nd interim analysis results potentially in H2 2016(2)
Praluent® is developed and commercialized in collaboration with Regeneron
(1) >170m Commercial and Medicare lives now covered
(2) Odyssey Outcomes : Second interim analysis for futility and overwhelming efficacy potentially in H2 2016 when 75% of the targeted number of primary events have occurred 45
2
46. Sanofi Pasteur Launches First Ever Vaccine for the Prevention
of Dengue
(1) The Mexican Federal Commission for the Protection against Sanitary Risks, Philippines' Food and Drug Administration, Brazilian regulatory authorities ANVISA and El Salvador Dirección Nacional de
Medicamentos approved Dengvaxia®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue virus serotypes in individuals from 9-45 years of age living in endemic areas
● Submission of regulatory file in 20 endemic countries
of Asia and Latin America
● 4 approvals granted(1):
Mexico, the Philippines, Brazil and El Salvador
● First doses shipped and launch of public dengue immunization
program in the Philippines
● Preparing for future launches
● Recommended in endemic countries by Strategic Advisory
Group of Experts on Immunization convened by the World
Health Organization
46
2
47. Important Launches in the Next 12 Months
47
Dupilumab and sarilumab are developed in collaboration with Regeneron: dupilumab = IL4Rα – Interleukin-4 alpha receptor in atopic dermatitis, asthma, nasal polyposis,
eosinophilic oesophagitis; sarilumab : Interleukin-6 receptor: contributes to the inflammatory mechanism of rheumatoid arthritis
LixiLan is a project name and is not the intended brand name for the combination of insulin glargine and lixisenatide
(1) Glycosylated hemoglobin (HbA1c) tests show what a person's average blood glucose level was for the 3 months before the test. This can help determine the risk of complications over the long term.
Proof-of-concept study (323 patients): a 24-week randomized, open-label, trial comparing the efficacy and safety of insulin glargine/lixisenatide fixed ratio once-daily combination versus insulin glargine, in
type 2 diabetes inadequately controlled with metformin
● Potential new treatment
for patients suffering from
moderate to severe atopic
dermatitis
● Multiple indications
● U.S. submission in atopic
dermatitis planned for
third quarter 2016
Immunology
● Potential new option for
patients with rheumatoid
arthritis
● Important unmet needs
despite existing treatments
● U.S. regulatory decision
expected in fourth quarter
2016
Immunology
● Fixed ratio combination
of two active components to
improve care of people with
type 2 diabetes
● More patients with
HbA1c <7%(1)
● U.S. FDA advisory
committee on May 25, 2016
2
49. Innovation in R&D to Ensure Future Growth3
49
Translational Medicine
Open Innovation
Ambition to increase
annual R&D investments
up to €6bn
by 2020
Concentration of resources
on most
promising projects
52. New Organization for Greater Efficiency
Sanofi
Pasteur
(Vaccines)
Sanofi
Genzyme
(Specialty Care)
Merial
(Animal Health)
Diabetes &
Cardiovascular
General Medicines &
Emerging Markets
4
52
Research &
Development
Industrial
Affairs
Finance
Human
Resources
Business
Development
& Strategy
External Affairs
Medical
Legal
5 Global Business Units(1)
Globalized Functions
=
Accountability, efficiency
& excellence
(1) Definitive implementation of the new structure is subject to mandatory labor consultations
53. Targeting Cost Savings of €1.5bn by 2018 Largely Reinvested
to Support Growth(1)
(1) At CER, before inflation and tax on a constant structure basis and by 2018
● Significant investments required to launch
biologics and to support growing businesses
● Sanofi aims to generate cost savings
of €1.5bn by 2018 to:
● Balance the need for increased resources
● Partly offset reduced diabetes sales expectations
4
53
54. A Strong Presence in France
~25% of global
headcount
Headquarters
in Paris
Strong activity in
research and
production on more
than 40 sites
~40% of global
R&D budget
Paris Neuville sur Saône Strasbourg
54
55. Our Social, Environmental and Community Responsibilities
● Expanding access to healthcare
300 programs over 15 years
190 million beneficiaries
Sanofi Espoir Foundation
Partnerships: Bill & Melinda Gates Foundation
Samu Social in France
● Fighting against counterfeiting and providing
quality medicines worldwide
● Reducing our environmental footprint
55
56. Encouraging First Quarter 2016 Sales Given High Base for
Comparison
56
Aggregate Group Sales Business EPS
Q1 2016Incremental
EPS at CER
+€0.07
Q1 2015 FX Impact
-€0.05
(1) Reflecting reclassification of VaxServe from Sales to Other revenues
(2) On a reported basis, Q1 2016 Aggregate Sales were down -1.9% and Business EPS was up +1.5%
+5.3%
at CER(2)
Q1 2015 FX Impact
-€228m
+€61m
Incremental
Sales at CER
Q1 2016
+0.7%
at CER(2)
€8,710m
€8,543m €1.32
€1.34
(1)
Aggregate Group Sales +3.0% at CER excluding Venezuela
57. Outlook for 2016
5757
Business EPS
Growth
Estimated FX Impact on
Business EPS
Broadly stable at CER(1,2)
FY 2016
57
Around -3%(3)
based on March 2016 average exchange rates
(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
58. Objectives for 2015-2020(1)
58
2015 2020
Expected sales CAGR of +3% to +4%
beginning in 2018
Business EPS expected
to grow faster than sales
(1) Based on current group structure and at CER
60. Significant R&D Turnaround since 2012
60
2012 2015
Quality over Quantity(1)
79 projects 44 projects
Prioritization Unprioritized Tiering system
Biologics(2) 58% 85%
R&D Budget ~14% of sales ~14% of sales
Launches 3 launches since 2008(3) 9 launches since 2012(4)
(1) From first in human to approval
(2) Peptide, protein, nucleic acid based molecular entities and vaccines
(3) From beginning of 2008 to end of 2011: Pentacel® (2008), Multaq® (2009), Jevtana® (2010)
(4) Toujeo®, Cerdelga®, Lemtrada®, Aubagio®, Zaltrap®, Kynamro®, Hexaxim®, Fluzone® Quadrivalent, Praluent®
61. Expected Regulatory Decisions Q1 Q2 Q3 Q4
● Toujeo® in Diabetes (U.S. & EU)
● Praluent® in Hypercholesterolemia (U.S. & EU)
● Dengvaxia® in endemic countries
Expected Regulatory Submissions Q1 Q2 Q3 Q4
● Lixisenatide in Diabetes (U.S.)
● LixiLan in Diabetes (U.S. & E.U.)
● Sarilumab in Rheumatoid Arthritis (U.S.)
Expected Headline Phase III Data Releases Q1 Q2 Q3 Q4
● Lixisenatide ELIXA CV outcome study in Diabetes
● LixiLan in Diabetes
● Sarilumab in Rheumatoid Arthritis
Expected Phase III Start Q1 Q2 Q3 Q4
● Dupilumab in Asthma
Major Progress Achieved in 2015
61
62. Many Milestones Ahead in 2016
62
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 Cutaneous Squamous Cell Carcinoma(2)
● Fitusiran in Hemophilia
● Efpeglenatide in Diabetes
● Sotagliflozin in Diabetes
● Isatuximab in Multiple Myeloma
(1) Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred potentially in H2 2016
(2) Pivotal phase II/III trial
63. Dupilumab: New Innovative Investigational Agent with Positive
Phase III Results in Atopic Dermatitis
Dupilumab is an investigational agent under clinical development and its safety and efficacy has not been fully evaluated by any Regulatory Authority
Dupilumab is developed in collaboration with Regeneron / IL4Rα – Interleukin-4 alpha receptor
(1) For illustration only. While these pictures are from the Phase IIb clinical trial, individual results may vary
(2) See press release of April 1, 2016
(3) Most frequently Treatment Emergent Adverse Events include serious and severe infections, injection site reactions and conjunctivitis 63
● Atopic dermatitis – severe form of eczema,
is a type of inflammation of the skin, resulting in
itchy, red, swollen, and cracked skin
● Results of Phase III studies SOLO 1 and 2(2)
● 36% to 38% of treated patients achieved clearing
or near-clearing of skin lesions
● Percent improvement in EASI from baseline was
67% to 72%(3)
● Results of Phase III study CHRONOS expected
in second quarter 2016
Images of a patient before and after
dupilumab therapy in Phase II trial
(Individual results may vary)(1)
64. Sarilumab: New Investigational Product Being Evaluated
for Patients with Moderate to Severe Rheumatoid Arthritis
Sarilumab is developed in collaboration with Regeneron / IL6R – recepteur Interleukin-6
(1) Not included in the initial BLA filed with FDA
(2) Marketed by AbbVie as HUMIRA®
(3) See press release of March 11, 2016
(4) Most frequently Treatment Emergent Adverse Events include serious infections, injection site erythema and neutropenia 64
Immunology
● Rheumatoid Arthritis: autoimmune disease
causing inflammation in joints that can cause
physical disabilities
● Sarilumab: inhibitor of IL6 receptor being
evaluated for subcutaneous administration every
two weeks
● Results of comparative MONARCH study(1)
● Superiority of sarilumab over adalimumab(2)
in monotherapy (DAS28-ESR: improvement in signs
and symptoms of active rheumatoid arthritis) in
patients who were inadequate responders to,
intolerant of, or inappropriate candidates for
methotrexate(3,4)
65. 65
Three Filings Are Being Evaluated
Regulatory decision
in the United States
expected in
August 2016(2)
Regulatory filings
in Europe expected
in March 2016
Type 2 Diabetes Rheumatoid Arthritis
Regulatory decision
in the United States
expected in
July 2016(1)
Regulatory decision
in the United States
expected in
fourth quarter 2016(3)
Regulatory filings
in Europe expected
in third quarter 2016
lixisenatide
Type 2 Diabetes
Sarilumab is developed in collaboration with Regeneron
(1) Sanofi announced that the U.S. FDA accepted the lixisenatide NDA for review on September 29, 2015; lixisenatide was approved for treatment of Type 2 Diabetes in Europe in February 2013
(2) Sanofi announced that the U.S. FDA accepted the LixiLan NDA for review on February 22, 2016
(3) Sanofi and Regeneron announced that the U.S. FDA accepted the sarilumab BLA for review on January 8, 2016
66. (1) Phase II/III pivotal study
Seven New Products Expected to Enter Phase III in 2016
66
Expected Phase III Starts Q2 Q3 Q4
● Olipudase alfa(1) Niemann Pick type B Disease
● NeoGAA Pompe Disease
● PD-1 Inhibitor(1) Cutaneous Squamous Cell Carcinoma
● Fitusiran Hemophilia
● Efpeglenatide Diabetes
● Sotagliflozin Diabetes
● Isatuximab Multiple Myeloma
67. Olipudase Alfa: An Investigational Treatment
for Niemann-Pick Disease Type B
(1) The Breakthrough Therapy designation is supported by data from a completed Phase 1b study. The data on repeat-dose safety, pharmacodynamics, and exploratory efficacy support continued
development for the investigational use in nonneurological manifestations of ASMD 67
Niemann-Pick disease
type B
● Serious and
life-threatening disorder
characterized by fat
deposits in spleen and
liver
● Non-neurological
manifestations of Acid
Sphingomyelinase
Deficiency (ASMD)
Olipudase alfa
● Investigational
enzyme replacement
therapy
● Supplementing the
defective or deficient
native enzyme
R&D Milestones
● Granted
“Breakthrough
Therapy” designation
by FDA(1)
● Start of pivotal
Phase II/III study
expected in second
quarter 2016
68. Neo GAA: Investigational Second Generation Therapy
for Pompe Disease
68
Pompe Disease
● Progressive, debilitating
and often fatal
neuromuscular disease
● Genetic deficiency or
dysfunction of the
lysosomal enzyme acid
alpha-glucosidase (GAA)
● 50,000 people affected
worldwide
Neo GAA
● Investigational novel
enzyme replacement
therapy
● Favorable safety
profile
R&D Milestones
● Encouraging results
of Phase I/II clinical
study
● Start of Phase III
study expected in
second quarter 2016
69. Alnylam Collaboration Provides Access to Unique Rare Genetic
Disease Therapies, Notably Fitusiran(1)
69
TTR: transthyretin is the disease-causing protein in TTR-mediated amyloidosis; AT: antithrombin is a key endogenous anticoagulant
(1) Sanofi has exclusive territory rights for the ALN-TTR programs outside North America and Western Europe
patisiran
RNAi therapeutic targeting
transthyretin (TTR)
Phase III ongoing
in TTR Amyloidosis - Familial
Amyloidotic Polyneuropathy
revusiran
RNAi therapeutic targeting
transthyretin (TTR)
Phase III ongoing
in TTR Amyloidosis - Familial
Amyloidotic Cardiomyopathy
fitusiran
RNAi therapeutic targeting
antithrombin (AT)
Phase III trials in severe hemophilia
A and B patients planned to start in
third quarter 2016
70. Strengthening our R&D Portfolio in Diabetes
with Two In-Licensing Agreements
70
In Phase III in type 1
diabetes
Start of Phase III in type 2
diabetes expected in
fourth quarter 2016
Sotagliflozin
Dual SGLT1 and SGLT2 inhibitor(1)
● Limiting meal time glucose absorption
and increasing renal glucose excretion
● Favorable safety profile
Efpeglenatide
Long acting GLP-1(2)
● Diabetes/Obesity
● Weekly/monthly administration
Start of Phase III in type 2
diabetes expected in
fourth quarter 2016
(1) Sodium-glucose cotransporter type 1 and 2
(2) LAPS CA-Exendin-4 analog
71. New Strategic Alliance with Regeneron to Develop
Cancer Treatments in Emerging Field of Immuno-Oncology
71
● Establish Sanofi’s presence in cancer immunotherapy,
a rapidly growing and attractive segment of oncology
● Expand oncology pipeline, developing potentially best-in-class
new antibodies and novel combination therapies
● Enable development of multiple assets in Immuno-Oncology
● PD-1 Inhibitor: start of pivotal Phase II/III study in
Cutaneous Squamous Cell Carcinoma in second quarter 2016
72. Further Expanding the R&D Pipeline Is a Key Strategic Priority
72
Phase I Phase II Phase III Registration
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
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 Ab
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
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
N
N
N
N
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
N
N
N
N
N
N
Immunology
Infectious Diseases
Neurodegenerative Diseases
Ophthalmology
Multiple Sclerosis
N New Molecular Entity
Rare Diseases
Oncology
Diabetes
Vaccines
Cardiovascular Diseases
(1) Approved in Brazil, Mexico, the Philippines and El Salvador