general meeting 2016
TRANSCRIPT
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.
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
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
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
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
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
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
Sanofi Share Performance vs. Pharma Company Peers from January 2015
10 Source: Bloomberg (12/31/2014 - 05/02/2016)
-4.8%
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
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
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
Compensation Policy
Chairman of the Committee since March 3, 2016, succeeding Jean-René Fourtou
Patrick Kron
Chairman of the Compensation Committee*
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:
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
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
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
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
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
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
(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 2015 Incremental 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 2015 FX Impact FY 2014
5,20 €
Stable at CER(2) €5.20
€5.64 +€0.44
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
Vaccines 12.8%
6.8%
Pharmaceuticals(1) 80.4%
Generics 5.2%
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%
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 & MiddleEast
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
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
Increasing Investments in R&D and New Product Launches
27
2015 2014 2015 2014
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%
2015 2014
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
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
€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 €
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
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
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
● 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
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
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
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
Reshape the portfolio
Deliver outstanding
launches
Strengthen innovation
in R&D
New organization for
greater efficiency
Four Strategic Priorities
1
2
3
4
38
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
(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
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
Reshape the portfolio
Deliver outstanding
launches
Strengthen innovation
in R&D
New organization
for greater efficiency
Four Strategic Priorities
42
1
2
3
4
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)
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
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
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
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
Reshape the portfolio
Deliver outstanding
launches
Strengthen innovation
in R&D
New organization for
greater efficiency
Four Strategic Priorities
1
2
3
4
48
Innovation in R&D to Ensure Future Growth 3
49
Translational Medicine
Open Innovation
Ambition to increase annual R&D investments
up to €6bn by 2020
Concentration of resources
on most promising projects
Reshape the portfolio
Deliver outstanding
launches
Strengthen innovation
in R&D
New organization for
greater efficiency
Four Strategic Priorities
1
2
3
4
51
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
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
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
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
Encouraging First Quarter 2016 Sales Given High Base for Comparison
56
Aggregate Group Sales Business EPS
Q1 2016 Incremental 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
Outlook for 2016
57 57
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
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
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®
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
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
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)
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)
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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
(1) Phase II/III pivotal study
Seven New Products Expected to Enter Phase III in 2016
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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
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
Neo GAA: Investigational Second Generation Therapy for Pompe Disease
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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
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
Strengthening our R&D Portfolio in Diabetes with Two In-Licensing Agreements
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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
New Strategic Alliance with Regeneron to Develop Cancer Treatments in Emerging Field of Immuno-Oncology
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● 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
Further Expanding the R&D Pipeline Is a Key Strategic Priority
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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