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Q3 2015 RESULTS October 29, 2015

Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

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Page 1: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Q3 2015 RESULTSOctober 29, 2015

Page 2: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

2

Forward Looking Statements

This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of1995, as amended. Forward-looking statements are statements that are not historical facts. These statements includeprojections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions andexpectations with respect to future financial results, events, operations, services, product development and potential,and statements regarding future performance. Forward-looking statements are generally identified by the words"expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi'smanagement believes that the expectations reflected in such forward-looking statements are reasonable, investors arecautioned that forward-looking information and statements are subject to various risks and uncertainties, many of whichare difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments todiffer materially from those expressed in, or implied or projected by, the forward-looking information and statements.These risks and uncertainties include among other things, the uncertainties inherent in research and development,future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or theEMA, regarding whether and when to approve any drug, device or biological application that may be filed for any suchproduct candidates as well as their decisions regarding labeling and other matters that could affect the availability orcommercial potential of such product candidates, the absence of guarantee that the product candidates if approved willbe commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's abilityto benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of costcontainment policies and subsequent changes thereto, the average number of shares outstanding as well as thosediscussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under"Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form20-F for the year ended December 31, 2014. Other than as required by applicable law, Sanofi does not undertake anyobligation to update or revise any forward-looking information or statements.

Page 3: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

KEY HIGHLIGHTS

3

Olivier Brandicourt

Chief Executive Officer

Page 4: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments to Drive Future Growth

4

Deliveringsolid sales growth

Posting steady financial results

Bringinginnovative medicines

to market

NDA: New Drug Application GBUs: Global Business Units (1) On a reported basis, Q3 2015 sales were up +9.2% (2) On a reported basis, Q3 2015 Business EPS was up +9.5%(3) In particular Aubagio®, NexGard®, Lemtrada® and Toujeo®

(4) Scheduled to be effective January 1, 2016

Buildinga sustainablepath forward

11

22

33

44

● Higher OpEx, as expected, driven by investment in launches● Business EPS up +6.1% at CER(2)

● Sales up +3.4% at CER(1) despite Diabetes sales erosionin the U.S.

● Growing contribution from new products(3)

● Praluent® launched in the U.S. and EMA approval granted● NDA for lixisenatide accepted for review by FDA

● Plans for implementation of Global Business Unit structure and globalization of functions on track(4)

Page 5: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Q3 2015FX Impact

+€0.05

Incremental EPS at CER

+€0.09

Q3 2014

Net Sales Business EPS

Solid Top and Bottom Lines Growth in Q3 2015

5(1) On a reported basis, Q3 2015 sales were up +9.2% and Business EPS was up +9.5%

+6.1%at CER(1)

FX Impact Q3 2015

+€508m

Incremental Sales at CER

+€302m

Q3 2014

+3.4%at CER(1)

€8,781m

€9,591m

€1.47

€1.61

Page 6: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

6

Q3 2015 Sales by Business Areas

(1) Q3 2015 sales were up +3.4% at CER and +9.2% on a reported basis(2) Q3 2015 sales excluding Diabetes were €7,739m, up +6.0% at CER; YTD Sep 2015 sales excluding Diabetes were €22,102m, up +5.8% at CER(3) Sales of Pharmaceuticals include €4m of Praluent®

Growth at CER

Genzyme

Generics

Consumer Healthcare

Diabetes

Oncology

€923m

€452m

€814m

€1,852m

€376m

+32.7%

+6.7%

+3.2%

-6.6%

+5.4%

Broad-based Sales Growth Continues in Q3 2015(1,2)

% of Sales

9.6%

8.5%

19.3%

4.7%

3.9%

Animal Health

Vaccines

€607m

€1,717m

+9.3%

+5.5%17.9%

6.3%

Pharmaceuticals(3) €7,267m +2.6%75.8%

Established Products €2,846m +0.1%29.8%

Q3 2015 sales growth excluding Diabetes of +6.0% at CER

Page 7: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Diabetes Performance in Q3 2015 ReflectsLower U.S. Sales of Lantus® than Expected

7

(1) Diabetes sales in the U.S. declined by 12.0% at CER in Q1 2015 and by 14.0% at CER in Q2 2015(2) U.S. Lantus® sales were €997m down -19.6% at CER in Q3 2015(3) Diabetes sales in Western EU were €296m, down -0.3% at CER, in Q3 2015(4) Diabetes sales in Emerging Markets were €373m, up +15.5% in Q3 2015

Global diabetes sales expected to be down between 6% and 7% at CER in 2015

● U.S. Lantus® sales(2) impacted by: ● Higher discounts as compared to last year ● Slower than expected U.S. basal market ● Higher than expected proportion of sales to U.S.

government channels (e.g. Medicaid)

● Successfully defending U.S. glargine TRx share post Toujeo® launch

● Stable diabetes sales in Western EU(3) given biosimilar glargine entry in some countries

● Sustained double-digit diabetes sales growth in Emerging Markets(4)

Q3 2015 Diabetes Salesby Geography (€m)

Global Diabetes Sales:€1,852m, -6.6% at CER

Ex-U.S. €777m

+8.1% at CERU.S.(1)

€1,075m-16.4% at CER

42.0%58.0%

Page 8: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Global Roll-out Underway and Showing Early Promise in Key Markets

8

0%

1%

2%

3%

4%

5%

6%

7%

8%

1 3 5 7 9 11 13 15 17 19 21 23 250%

10%

20%

30%

40%

50%

60%

1 3 5 7 9 11 13 15 17 19 21 23 25 27

Weekly NBRx Sharewithin Basal Market(1)

Lantus®

49.8%

Levemir®

26.8%

NPH9.4%

Weekly Sell Out Share (in Units/Packs)within Basal Market(2)

6.8%

(1) Basal market includes Toujeo®, Lantus®, Levemir® (a Novo Nordisk brand) and NPH - Source: IMS Weekly Data week of April 3 - week of Oct 9, 2015(2) Insight Health Germany (Retail Apo-Weekly-Pharma) – All data including parallel trade; Toujeo® week of May 5 - Oct 20, 2015;

Tresiba® week of April 29 - Oct 14, 2014

Weeks from Toujeo® Launch Weeks from Launch

3.6%Tresiba®

Additional launches in Q3 in Japan, Canada, U.K. and other EU countries

14.0%

Page 9: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Genzyme Delivers Strong Q3 2015 with MS Franchise Continuing to More than Double vs. Q3 2014

● Strong MS sales in Q3 2015 ● Aubagio® reaching €225m● Lemtrada® at €68m, sequentially up +24.0%

at CER from previous quarter● ECTRIMS data presentations support value

proposition of MS products: Aubagio® favorable impact on brain atrophy(1)

Lemtrada® effect maintained over 5 years(2)

● Sustained Rare Diseases sales growth driven by continued new patient accrual● Double digit growth of Gaucher franchise, Fabry and

Pompe brands(3)

9

Genzyme Quarterly Sales

Q3 2014 Q3 2015

€923m+32.7% at CER

€293m+120.2%at CER

€119m

€649m

MS: Multiple Sclerosis(1) Additional MRI data on brain atrophy from Phase III TEMSO study, Press release October 7th 2015(2) CARE-MS I&II 5-year extension study, Press release October 8th 2015(3) Gaucher franchise (Cerezyme®+Cerdelga®) sales were €207m, up +14.3% at CER, while

Fabrazyme and Myozyme were €147m and €162m respectively, up +18.1% at CER and +10.9% at CER

Rare Disease

Multiple Sclerosis

€630m+13.0%at CER€530m

Page 10: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Vaccines Showed Good Sales Growth in Q3 2015

10

Q3 2015

€1,717m+5.5% at CER

Q3 2014

€1,451m

Other

Adult BoostersTravel/Endemic

Polio/Pertussis/HibInfluenza Vaccines

Meningitis/Pneumo

(2)

(1) U.S. flu vaccines sales were €576m in Q3 2015, up 8.3% at CER(2) Includes VaxServe, a U.S. healthcare supplier serving primary care physician offices, community immunization providers,

immunizing pharmacies, travel clinics and corporations

● Stable flu vaccines sales of €736m (+0.3% at CER) in Q3 2015 ● Solid U.S. performance(1), partially offset by

delayed supply in Western EU and Mexico

● PPH sales up +17.8% at CER driven by strong delivery pattern in China

● Menactra® sales up +17.8% at CER as a result of U.S. public sector purchases

● Dengue vaccine launch preparation on track● 1st license anticipated before year-end● 1st wave of launches in endemic countries

planned for 2016

Sanofi Pasteur Quarterly Sales

On track to deliver >65m doses of Flu vaccine in the U.S. in 2015

Page 11: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Sixth Consecutive Quarter of Growth at Merial Driven by Strong Performance in Pets

11

● Q3 2015 sales of €607m, up +9.3% at CER

● Companion Animals sales of €401m, up +13.6% at CER● NexGard® U.S. advertising campaign

leads to strong performance in Q3 2015

● Production Animals segment sales of €206m, up +2.5% at CER

Q32013

Q42013

Q12014

Q22014

Q32014

Q42014

Q12015

Q22015

Q32015

-6.3%-6.4%

-1.6%

+12.7%

+6.2%

+11.5%

+13.5%+14.2%

+9.3%

Quarterly Sales Growthat CER

Page 12: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

(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(3) At constant exchange rate

Double Digit Growth in Emerging Marketsand Low Single Digit Growth in the U.S. in Q3 2015

29.9%

40.5%

20.7%8.9%

12

(1)

€964m

€697m€587m €562m

Asia Latin America Eastern Europe,Russia & Turkey

Africa & MiddleEast

+7.0% +6.0% +11.4%Growth at CER +17.8%

Emerging Markets Sales by Region

Emerging Markets €2,871m+11.4%

at CERU.S.

€3,888m+2.3% at CER

Western EU€1,988m

-1.8% at CER

RoW€844m

-4.5% at CER

(2)

Q3 2015 Sales by Geography (€m)

(3)

Page 13: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Early Launch Progress Encouraging with Gradual Uptake(1) Consistent with Expectations

● U.S. comprehensive support hub tracking in line with expectations● Over 4,000 prescribers

● Preferred Tier 2 formulary position granted by ESI (parity for both PCSK9 brands)● Formulary status at CVS

and UHC pending

● Near-term expansion opportunities: Driving awareness and adoption Gaining greater U.S. market access

13

Launches in first EU countries underway

UHC: United Healthcare(1) Initial U.S. sales were €4m in Q3 2015

75 mg/1 mL pen 150 mg/1 mL pen

Both doses available in a single-dose, 1-mL, prefilled pen and prefilled syringe

Dosage and Administration Options

150 mgQ2W

Available in 2 Doses

Increaseif needed

Recommendedstarting dose

75 mgQ2W

Page 14: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

New Launches More than Offset Lantus® Sales Declinein YTD Sep 2015

14

YTD Sep 2015

FXOthers Q3 2015 at CER

Lantus®LaunchesYTD Sep 2014

+€566m-€332m

+€647m

+€2,200m

(1)

(1) Includes Aubagio®, Lemtrada®, Cerdelga®, Toujeo®, Afrezza®, Praluent®, NexGard®

+3.6%at CER

€27,779m

€24,698m

YTD Sep 2015 Sales

€25,579m

+12.5%reported

Page 15: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

15

U.S. (Q4 2015)EU (Q3 2016)

Regulatory Submissions for Two High Potential Products Expected by Year End

1

Key Regulatory Submissions

Rheumatoid Arthritis

U.S. (Q4 2015)EU (Q1 2016)

2

Diabetes

sarilumab

Page 16: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

FINANCIAL RESULTS

Jérôme Contamine

Executive Vice President, Chief Financial Officer

16

Page 17: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Net Sales(1,2) Business EPS(1,2)

17

FX Tailwind Easing Due to Emerging Market Currenciesin Q3 2015

(1) Main currency impact on sales in Q3 2015: U.S. Dollar (+€621m); Chinese Yuan (+€79m); Brazilian Real (-€82m); Venezuelan Bolivar Forte (-€81m); Russian Ruble (-€62m)

(2) Q3 2015 Fx impact without Venezuela on Sales +€589m (+6.7ppt) and Business EPS +€0.15 (+10.3ppt)

Quarterly Currency Impact

-1.0%-€81m

+9.9%+€782m

Q2 2015Q3 2014

Q4 2014 Q1 2015

+2.7%+€229m

-€0.03

-2.2%

+1.5%+€0.02

+10.2%+€0.12

Q3 2015

+11.2%+€910m +15.4%

+€0.18

+5.8%+€508m

+3.4%+€0.05

Q2 2015Q3 2014

Q4 2014 Q1 2015 Q3 2015

Page 18: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

CER: Constant Exchange Rates(1) Includes a foreign exchange loss of €137m on Venezuela 18

Q3 2015 Business Operating Income Stable at CER Given Investments to Drive Future Growth

€m Q3 2015 Q3 2014% Change

(reported €)% Change

(CER)

Net sales 9,591 8,781 +9.2% +3.4%

Other revenues 89 87 +2.3% -8.0%

Cost of sales (2,998) (2,864) +4.7% +2.0%

Gross profit 6,682 6,004 +11.3% +4.0%

R&D (1,355) (1,146) +18.2% +9.9%

SG&A (2,461) (2,193) +12.2% +6.2%

Other current operating income & expenses (136) 39 - -

Share of Profit/Loss of associates 78 43 - -

Minority interests (25) (31) - -

Business operating income 2,783 2,716 +2.5% -0.4%

Business operating margin 29.0% 30.9% - -

(1)

Page 19: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

19

€m Q3 2015 Q3 2014% Change

(reported €)% Change

(CER)

Business operating income 2,783 2,716 +2.5% -0.4%

Net financial expenses (105) (139) - -

Income tax expense (582) (642) - -

Effective tax rate -22.2% -25.0% - -

Business net income 2,096 1,935 +8.3% +5.0%

Net margin 21.9% 22.0% - -

Business EPS €1.61 €1.47 +9.5% +6.1%

Average number of shares outstanding (m) 1,305.5 1,313.0 - -

Mid-Single Digit Business Net Income Growth at CER in Q3 2015 Resulting from Lower Tax Rate

19CER: Constant Exchange Rates

Page 20: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Gross Margin Consistent with FY 2015 Expectations

● Cost of Sales (CoS) of €2,998m in Q3 2015, up +2.0% at CER

● Gross margin of 69.7% in Q3 2015 reflecting 1.3 pt increase over Q3 2014: ● Positive impact from MS franchise and

Vaccines more than offsetting negative impact of Diabetes U.S. and Plavix® LoEin Japan

● Favorable FX impact (1.0 pt)

20

Gross Margin (%)

Q12014

Q22014

Q32014

Q42014

Q12015

Q22015

Q32015

69.7%68.4%

Gross Margin expected to be around 69% in 2015

Page 21: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

OpEx Up +5.0% at CER in YTD Sep 2015 as Expected

2121

Q12014

Q22014

Q32014

Q42014

Q12015

Q22015

Q32015

€3,816m

€3,339m

Operating Expenses (€m)

€1,355m

€1,146m

€2,461m€2,193m

Targeting mid-single digit OpEx growth at CER in 2015

● Q3 2015 OpEx of €3,816m, up +7.5% at CER

● R&D expenses of €1,355m (14.1% of sales), up +9.9% at CER, driven by dupilumab, ODYSSEY CVOT study and immuno-oncology

● SG&A expenses of €2,461m (25.7% of sales), up +6.2% at CER, mainly due to Toujeo® DTC, Praluent®

launch, support to MS brands as well as Animal Health

SG&A

R&D

Page 22: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Over €5bn of Free Cash Flow Generated in YTD Q3 2015

22

Net Debt (€m)

Acquisitions, Licensing, Net of Disposals

€3,694m

€1,383m

Share Repurchase

Proceeds from Issuance

of Shares

€552m

CapEx

€1,009m

Net Cash from Operating Activities

Net Debt Dec 31, 2014

Other

€1,182m

Net Debt Sep 30, 2015

Dividend

€1,481m

(1)

(2)

€7,171m€9,354m€6,014m

(4) (1)

FCF€5,005m

FCF: Free Cash Flow(1) Including derivatives related to the financial debt +€302m at December 31st 2014 and +€302m at September 30th 2015(2) Excluding Restructuring costs(3) Including Regeneron immuno-oncology collaboration of €584m and Caprelsa® rights of €149m(4) Other including Restructuring costs and Fx impact

(3)

Page 23: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Business EPS Growth

Between +6% and +8%(3)

Stable to slightly growing at CER(1,2)

23

(1) Barring major unforeseen adverse events(2) FY 2014 Business EPS of €5.20(3) Difference between variation on a reported basis and variation at CER, when applying September

2015 average exchange rates to the remaining quarter of the year and including Venezuela impact

Outlook for 2015 Reaffirmed

FY 2015

FX impact on Business EPS

Page 24: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

APPENDICES

R&D Pipeline

24

Page 25: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

25

Late Stage Pipeline – Pharma & Vaccines

LixiLanlixisenatide + insulin glargineFixed-Ratio / Type 2 diabetes

patisiran (ALN-TTR02)siRNA inhibitor targeting TTR

Familial amyloidotic polyneuropathy

Clostridium difficileToxoid vaccine

lixisenatideGLP-1 agonist

Type 2 diabetes, U.S.

SAR342434insulin lispro

Type 1+2 diabetes

revusiran (ALN-TTRsc)siRNA inhibitor targeting TTR

Familial amyloidotic cardiomyopathy

RotavirusLive attenuated tetravalent

Rotavirus oral vaccine

DengueMild-to-severe

dengue fever vaccine

sarilumab(Anti-IL6R mAb)

Rheumatoid arthritis

Jevtana®

cabazitaxelMetastatic prostate cancer (1L)

VaxiGrip® QIV IM Quadrivalent inactivated

influenza vaccine (3-36 months)

PR5iDTP-HepB-Polio-Hib

Pediatric hexavalent vaccine, U.S., EU

dupilumabAnti-IL4Rα mAb

Atopic dermatitis, Asthma

VaxiGrip® QIV IM Quadrivalent inactivated

influenza vaccine (3 years+)

25

N

N

N New Molecular Entity

Immunology

Rare Diseases

OncologyDiabetes

Vaccines

Infectious DiseasesCardiovascular DiseasesNeuro-degenerative Diseases

Ophthalmology

Phase III Registration

N

N

NN

N

Multiple Sclerosis

Page 26: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Early Stage Pipeline – Pharma & Vaccines

dupilumabAnti-IL4Rα mAbNasal polyposis;

Eosinophilic oesophagitis

isatuximabAnti-CD38 naked mAb

Multiple myeloma

Rabies VRVgPurified vero rabies vaccine

SAR156597IL4/IL13 Bi-specific mAb

Idiopathic pulmonary fibrosis

GZ402671Oral GCS Inhibitor

Fabry Disease

Meningitis ACYW conj.2nd generation meningococcal

conjugate infant vaccine

sarilumabAnti-IL6R mAb

Uveitis

olipudase alfarhASM

Niemann-Pick type B

Tuberculosis Recombinant subunit vaccine

Combinationferroquine / OZ439

Antimalarial

Fluzone® QIV HD Quadrivalent inactivated

influenza vaccine - High dose

Phase II

N

N

2626

N

N

N

N New Molecular Entity

Immunology

Rare Diseases

OncologyDiabetes

Vaccines

Infectious DiseasesCardiovascular DiseasesNeuro-degenerative Diseases

Ophthalmology

Multiple Sclerosis

Page 27: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Early Stage Pipeline – Pharma & Vaccines

GZ402668GLD52 (anti-CD52 mAb)

Relapsing multiple sclerosis

SAR566658Maytansin-loaded anti-CA6 mAb

Solid tumors

GZ402666neo GAA

Pompe Disease

SAR422459ABCA4 gene therapy

Stargardt disease

SAR113244Anti-CXCR5 mAb

Systemic lupus erythematosus

SAR408701Anti-CEACAM5 ADC

Solid tumors

GZ389988TRKA antagonist

Osteoarthritis

UshStat®

Myosin 7A gene therapyUsher syndrome 1B

SAR228810Anti-protofibrillar AB mAb

Alzheimer’s disease

SAR439684PD-1 inhibitor

Cancer

SAR339375Anti-miR21 RNAAlport syndrome

SAR366234EP2 receptor agonist

Elevated intraocular pressure

SAR425899GLP-1R/GCGR dual agonist

Diabetes

SAR428926LAMP-1 inhibitor

Cancer

SAR439774ALN-AT3

Haemophilia

Streptococcus pneumoniaMeningitis & pneumonia vaccine

SAR438335GLP-1R/GIPR dual agonist

Diabetes

SAR439152Myosin inhibitor

Hypertrophic cardiomyopathy

Herpes Simplex Virus Type 2HSV-2 vaccine

Phase I

N

N

N

NN

NN

N

27

N

N

N

N

N

N

N

N

N

N New Molecular Entity

Immunology

Rare Diseases

OncologyDiabetes

Vaccines

Infectious DiseasesCardiovascular DiseasesNeuro-degenerative Diseases

Ophthalmology

Multiple Sclerosis

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28

Phase I Phase II Phase III Registration TOTAL

Oncology 4 1 0 0 5

Diabetes Solutions 2 0 2 1 5

Cardiovascular / Renal Diseases 1 0 0 0 1

Immune Mediated Diseases 2 1 2 0 5

Infectious Diseases 0 1 0 0 1

Ophthalmology 3 0 0 0 3

Rare Diseases 4 2 2 0 8

Age Related Degenerative Diseases 1 0 0 0 1

Vaccines 2 4 3 3 12

TOTAL 19 9 9 4

R&D Pipeline Summary Table(1)

28 13 NMEs & Vaccines

41

28

29

(1) Excluding life cycle management programs

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29

Expected R&D Milestones

29

Product Event Timing

Dengue vaccine Expected regulatory decision in endemic countries Q4 2015

sarilumab Expected U.S. regulatory submission in Rheumatoid Arthritis Q4 2015

LixiLan Expected U.S. regulatory submission in Diabetes Q4 2015

PR5i vaccine (DTP-HepB-Polio-Hib) Expected CBER decision on the extended review timeline Q4 2015

LixiLan Expected EU regulatory submission in Diabetes Q1 2016

dupilumab Expected Phase III top line results in Atopic Dermatitis Q1 2016

PR5i vaccine (DTP-HepB-Polio-Hib) Expected EU regulatory decision Q2 2016

Meningitis ACYW conj. vaccine Expected start of Phase III trial Q2 2016

Rotavirus vaccine Expected regulatory submission in India Q2 2016

Insulin lispro Expected Phase III top line results in Diabetes Q2 2016

lixisenatide Expected U.S. regulatory decision Q3 2016

dupilumab Expected U.S. regulatory submission in Atopic Dermatitis Q3 2016

sarilumab Expected MONARCH Phase III results in Rheumatoid Arthritis Q3 2016

Page 30: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

APPENDICES

FINANCE

30

Page 31: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

Business EPS Currency Sensitivity

Currency Exposure on Q3 2015 Sales Currency Average Rates

2015 Currency Sensitivity

31

Q3 2014 Q3 2015 % change

EUR/USD 1.33 1.11 -16.5%

EUR/JPY 137.74 135.89 -1.3%

EUR/CNY 8.17 7.01 -14.2%

EUR/RUB 48,08 70,46 +46.6%

Currency Variation Business EPS Sensitivity

U.S. Dollar -0.05 USD/EUR +EUR 0.10Japanese Yen +5 JPY/EUR -EUR 0.03Russian Ruble +10 RUB/EUR -EUR 0.06

€21.4%

US $41.5%

Japanese Yen4.5%

Bristish £2.1%

Australian $1.4%

Canadian $1.5%

Brazilian Real2.7%

Chinese Yuan5.9%

Russian Ruble1.4%

Others16.2%

Mexican Peso1.4%

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32

Business Net Income Statement

Third quarter 2015

Net sales 9,591 8,781 9.2% 7,267 6,815 6.6% 1,717 1,451 18.3% 607 515 17.9% - -Other revenues 89 87 2.3% 68 69 (1.4%) 9 9 - 12 9 33.3% - - Cost of sales (2,998) (2,864) 4.7% (2,151) (2,036) 5.6% (635) (629) 1.0% (212) (199) 6.5% - - As % of net sales (31.3%) (32.6%) (29.6%) (29.9%) (37.0%) (43.3%) (34.9%) (38.6%)

Gross profit 6,682 6,004 11.3% 5,184 4,848 6.9% 1,091 831 31.3% 407 325 25.2% - -As % of net sales 69.7% 68.4% 71.3% 71.1% 63.5% 57.3% 67.1% 63.1%Research and development expenses

(1,355) (1,146) 18.2% (1,173) (987) 18.8% (140) (121) 15.7% (42) (38) 10.5% - -

As % of net sales (14.1%) (13.1%) (16.1%) (14.5%) (8.2%) (8.3%) (6.9%) (7.4%) Selling and general expenses

(2,461) (2,193) 12.2% (2,070) (1,859) 11.4% (176) (170) 3.5% (215) (164) 31.1% - -

As % of net sales (25.7%) (25.0%) (28.5%) (27.3%) (10.3%) (11.7%) (35.4%) (31.8%) Other current operating income/expenses

(136) 39 (128) 57 - 2 4 1 (12) (21)

Share of profit/loss of associates* 78 43 57 22 20 21 1 - - -

Net income attributable to non-controlling interests

(25) (31) (24) (31) (1) - - - - -

Business operating income 2,783 2,716 2.5% 1,846 2,050 (10.0%) 794 563 41.0% 155 124 25.0% (12) (21)

As % of net sales 29.0% 30.9% 25.4% 30.1% 46.2% 38.8% 25.5% 24.1% Financial income and expenses

(105) (139)

Income tax expense (582) (642)

Tax rate** 22.2% 25.0%

Business net income 2,096 1,935 8.3%As % of net sales 21.9% 22.0%

Business earnings per share*** (in euros)

1.61 1.47 9.5%

Q3 2014€ million Q3 2015 Q3 2014 change Q3 2015 change Q3 2015 Q3 2014change Q3 2015 Q3 2014 change Q3 2015 Q3 2014

OtherGroup Total Pharmaceuticals Vaccines Animal health

(1) Net of tax(2) Determined on the basis of Business income before tax, associates and non-controlling interests(3) Based on an average number of shares outstanding of 1,305.5 million in the third quarter of 2015 and 1,313.0 million in the third quarter of 2014

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33

Business Net Income Statement

Nine months 2015

Net sales 27,779 24,698 12.5% 22,522 20,332 10.8% 3,301 2,797 18.0% 1,956 1,569 24.7% - -Other revenues 252 241 4.6% 197 195 1.0% 23 23 - 32 23 39.1% - -Cost of sales (8,722) (7,988) 9.2% (6,593) (6,082) 8.4% (1,461) (1,329) 9.9% (668) (577) 15.8% - -As % of net sales (31.4%) (32.4%) (29.3%) (29.9%) (44.3%) (47.5%) (34.2%) (36.8%)

Gross profit 19,309 16,951 13.9% 16,126 14,445 11.6% 1,863 1,491 24.9% 1,320 1,015 30.0% - -As % of net sales 69.5% 68.6% 71.6% 71.0% 56.4% 53.3% 67.5% 64.7%Research and development expenses

(3,844) (3,473) 10.7% (3,316) (3,012) 10.1% (402) (351) 14.5% (126) (110) 14.5% - -

As % of net sales (13.8%) (14.1%) (14.7%) (14.8%) (12.2%) (12.5%) (6.4%) (7.0%) Selling and general expenses

(7,547) (6,526) 15.6% (6,380) (5,580) 14.3% (520) (441) 17.9% (647) (505) 28.1% - -

As % of net sales (27.2%) (26.4%) (28.3%) (27.4%) (15.8%) (15.8%) (33.1%) (32.2%) Other current operating income/expenses

(223) 68 (167) 76 2 3 9 18 (67) (29)

Share of profit/loss of associates* 139 82 118 55 20 27 1 - - -

Net income attributable to non-controlling interests

(87) (96) (86) (96) (1) - - - - -

Business operating income 7,747 7,006 10.6% 6,295 5,888 6.9% 962 729 32.0% 557 418 33.3% (67) (29)

As % of net sales 27.9% 28.4% 28.0% 29.0% 29.1% 26.1% 28.5% 26.6%Financial income and expenses

(314) (309)

Income tax expense (1,771) (1,678)

Tax rate** 24.0%) 25.0%

Business net income 5,662 5,019 12.8%As % of net sales 20.4% 20.3%

Business earnings per share*** (in euros)

4.33 3.81 13.6%

9M 2014 9M 2015 9M 2014

Other

9M 2014 change 9M 2015 9M 20149M 2015 change change

Group Total Pharmaceuticals Vaccines Animal health

€ million 9M 2015 9M 2014 change 9M 2015

(1) Net of tax(2) Determined on the basis of Business income before tax, associates and non-controlling interests(3) Based on an average number of shares outstanding of 1,306.6 million in the first nine months of 2015 and 1,315.8 million in the first nine months of 2014

Page 34: Q3 2015 Results - Sanofi · 10/29/2015  · Q3 2015 RESULTS October 29, 2015. 2 Forward Looking Statements ... Sanofi Grew Sales and Business EPS in Q3 2015 while Accelerating Investments

34

Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi

€ million Q3 2015 Q3 2014 Change

Business net income 2,096 1,935 8.3%

Amortization of intangible assets(1) (598) (561)

Impairment of intangible assets (209) (35)

Fair value remeasurement of contingent consideration liabilities 90 (45)

Restructuring costs (58) (163)

Other gains and losses, and litigation - -

Additional yearly expense related to US Branded Prescription Drug Fee (2) - (116)

Tax effect of: 310 261

amortization of intangib le assets 210 188 impairment of intangib le assets 77 13 fair value remeasurement of contingent consideration liab ilities 8 5 other gains and losses, and litigation - - restructuring costs 15 55

Other tax items - -

Share of items listed above attributable to non-controlling interests 2 -

Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures

(5) (86)

IFRS net income reported (3) 1,628 1,190 36.8%

Consolidated earnings per share(4) (in euros) 1.25 0.91

(1) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €560 million in the third quarter of 2015 and €540 million in the third quarter of 2014

(2) 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

(3) Net income attributable to equity holders of Sanofi(4) Based on an average number of shares outstanding of 1,305.5 million in the third quarter of 2015 and 1,313.0 million in the third quarter of 2014

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3535

Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi

€ million 9M 2015 9M 2014 Change

Business net income 5,662 5,019 12.8%

Amortization of intangible assets(1) (1,827) (1,862)

Impairment of intangible assets (237) (109)

Fair value remeasurement of contingent consideration liabilities 161 (177)

Restructuring costs (439) (298)

Other gains and losses, and litigation (2) - 35

Additional expense related to US Branded Prescription Drug Fee (3) - (116)

Tax effect of: 871 783

amortization of intangib le assets 641 639 impairment of intangib le assets 87 39 fair value remeasurement of contingent consideration liab ilities (7) 19 other gains and losses, and litigation - (13) restructuring 150 99

Other tax items(4) (111) (110)

Share of items listed above attributable to non-controlling interests 5 4

Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures

(132) (118)

IFRS net income reported(5) 3,953 3,051 29.6%

Consolidated earnings per share(6) (in euros) 3.03 2.32

(1) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €1,732 million in the first nine months of 2015 and €1,798 million in the first nine months of 2014

(2) Day one profit on Alnylam shares presented in financial result(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(4) Tax on dividends paid to shareholders of Sanofi(5) Net income attributable to equity holders of Sanofi(6) Based on an average number of shares outstanding of 1,306.6 million in the first nine months of 2015 and 1,315.8 million in the first nine months

of 2014

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3636

Consolidated Income Statements

€ million

Net sales 9,591 8,781 27,779 24,698Other revenues 89 87 252 241

Cost of sales (2,998) (2,864) (8,722) (7,988)

Gross profit 6,682 6,004 19,309 16,951Research and development expenses (1,355) (1,146) (3,844) (3,473)

Selling and general expenses (2,461) (2,309) (7,547) (6,642)

Other operating income (108) 47 (25) 163

Other operating expenses (28) (8) (198) (95)

Amortization of intangible assets (598) (561) (1,827) (1,862)

Impairment of intangible assets (209) (35) (237) (109)

Fair value remeasurement of contingent consideration liabilities 90 (45) 161 (177)

Restructuring costs (58) (163) (439) (298)

Operating income 1,955 1,784 5,353 4,458Financial expenses (127) (154) (394) (446)

Financial income 22 15 80 172

Income before tax and associates and joint ventures 1,850 1,645 5,039 4,184

Income tax expense(1) (272) (381) (1,011) (1,005)

Share of profit / loss of associates and joint ventures 73 (43) 7 (36)

Net income 1,651 1,221 4,035 3,143Net income attributable to non-controlling interests 23 31 82 92

Net income attributable to equity holders of Sanofi 1,628 1,190 3,953 3,051

Average number of shares outstanding (million) 1,305.5 1,313.0 1,306.6 1,315.8

Consolidated earnings per share (in euros) 1.25 0.91 3.03 2.32

Q3 2014Q3 2015 9M 2015 9M 2014

(1) In 2015, including a tax on dividends paid to shareholders of Sanofi: (111) M€ compared to (110) M€ in 2014