Q1 2013 RESULTS May 2, 2013
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Forward Looking Statements
This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies 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, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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Agenda
Key Highlights
● Christopher A. Viehbacher, Chief Executive Officer
Business Performance
● Hanspeter Spek, President, Global Operations
Financial Performance
● Jérôme Contamine, Executive Vice President, Chief Financial Officer
Q&A
KEY HIGHLIGHTS
Christopher A. Viehbacher
Chief Executive Officer
4
Key Genericized Products Represented Only ~€260m of Sales for a Second Quarter in a Row
Q1 2013
€259m
Q4 2012
€257m
Q3 2012
€399m
Q2 2012
€752m
Q1 2012
€813m
5
One quarter to go before the impact of Key Genericized Products(1) becomes minimal
Key Genericized Products(1) - Quarterly Sales (€m)
(1) Key genericized products include Lovenox® U.S., Plavix® Western EU, Taxotere® Western EU & U.S., Eloxatin® U.S., Ambien® family U.S., Allegra® U.S., Aprovel® Western EU, Xyzal® U.S., Xatral® U.S., Nasacort® U.S. and BMS Alliance (active ingredients of Plavix® and Avapro® sold to BMS)
3.2% of sales
Growth Platforms Grew by +8.6% in Q1 2013 and Reached 71% of Sales
6 (1) Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises (2) Includes new product launches which do not belong to the other Growth Platforms listed above: Multaq®, Jevtana®, Mozobil®, Zaltrap® and Auvi-Q™
+19.6%
+3.1%
+15.9%
-3.1%
+25.5%
Other Innovative Products(2) €157m +13.7%
+6.5%
Consumer Healthcare
€811m
Diabetes Solutions €1,542m
Vaccines €697m
Animal Health €554m
Emerging Markets €2,719m
Genzyme(1) €493m
Q1 2013 growth at CER
Q1 2013 Sales Were Affected by U.S. Loss of Exclusivity of Eloxatin® in August 2012 and by FX Fluctuations(1)
€9,040m
Q4 2012
€8,526m
Q3 2012 Q2 2012
€8,870m
Q1 2012
€8,511m
Q1 2013
€8,059m
Sales
7
(1) Reported sales of Eloxatin® in the U.S. were €321m in Q1 2012 but only €8m in Q1 2013. (2) On a reported basis, sales in Q1 2013 were down -5.3%.
The negative currency impact in Q1 2013 was €212m.
-2.8% at CER(2)
Q1 2013 Q1 2012 Q1 2012
8
"Other Revenues" "Income from Associates"
(1) Avapro® on March 30, 2012 and Plavix® on May 17, 2012 (2) At constant exchange rates
Q1 2013
€426m
Loss of Exclusivity of Plavix® & Avapro® in the U.S.(1)
€297m Impact on Q1 2013
Business Net Income:
€562m(2) €98m €18m
Residual impact(2) on BNI of Plavix® & Avapro® U.S. LoE expected to be around €240m in Q2 2013
The Loss of U.S. Exclusivity of Plavix® and Avapro® Impacted Business EPS by €0.42 in Q1 2013
Q1 2013
€1.22
Q4 2012 Q2 2012
€1.17
€1.46
Q3 2012 Q1 2012
€1.67 €1.83
As Anticipated, Q1 2013 Business EPS Was Better than Q4 2012 Trough
Business EPS
9
-29.0% at CER(2)
(1) With the retroactive application of IAS19R (2) On a reported basis, Q1 2013 EPS was down -33.3%
Sanofi expects to resume Business EPS growth in H2 2013
(1) (1) (1) (1)
® Type 2 Diabetes EU roll-out starting in late March 2013
Recent Regulatory Approvals Have Resulted in Six New Product Launches
10 Zaltrap® is developed in collaboration with Regeneron, Kynamro™ with Isis Pharmaceuticals and Lyxumia® is in-licensed from Zealand Pharma. Sanofi U.S. licensed the North American commercialization rights to AUVI-Q™ from Intelliject Inc.
Launch Status Products ® Metastatic
Colorectal Cancer
Indications
Launched in the U.S. in August 2012 EU roll-out starting in late March 2013
Relapsing Forms of Multiple Sclerosis
® Launched in the U.S. in October 2012
Launched in the U.S. in January 2013 Life-Threatening Allergic Reactions
Prevention of Poliomyelitis Launched in Japan in September 2012
Homozygous Familial Hypercholesterolemia Launched in the U.S. in late March 2013
Several Important Study Releases and Regulatory Milestones Achieved in the Last 4 Months
11
Clinical Data Releases
● Eliglustat tartrate - Phase III in Gaucher disease (ENCORE)
● Dupilumab - PoC in Atopic Dermatitis and Severe Asthma
● Lemtrada™ - Phase III in MS (1-year Extension of CARE-MS Program)
● Aubagio® - Phase III in Clinically Isolated Syndrome (TOPIC)
Regulatory Milestones
● Lemtrada™ FDA file acceptance in MS
● Aubagio® positive CHMP opinion in MS
● Lyxumia® FDA file acceptance in type II diabetes
● Hexyon® /Hexacima® EC approval (DTaP-IPV-Hib-HepB vaccine)
● Quadrivalent Influenza Vaccine accepted for review in EU
Lemtrada™ is the registered trade name for alemtuzumab in MS submitted to health authorities. Lemtrada™ is developed in collaboration with Bayer HealthCare
Additional Phase III Trial Readouts and Regulatory Decisions Expected Throughout 2013
12
2013 Expected Headline Phase III Data Releases Q2 Q3 Q4 ● New insulin glargine formulation in Diabetes (EDITION I & II) ● Otamixaban in Acute Coronary Syndrome (TAO) ● JAK2 inhibitor in Myelofibrosis (JAKARTA) ● Iniparib in Squamous Non Small Cell Lung Cancer ● Alirocumab (Anti-PCSK9) in Hypercholesterolemia (ODYSSEY Mono) Expected Regulatory Milestones Q2 Q3 Q4 ● Fluzone® Quadrivalent IM FDA decision in the U.S. ● Lemtrada™ CHMP opinion in Multiple Sclerosis in EU ● Lemtrada™ FDA decision in Multiple Sclerosis in the U.S.
● Eliglustat regulatory submission in the U.S. and EU in Gaucher disease
Composition of the Executive Committee as of July 1st, 2013
Karen Linehan Executive VP Legal Affairs & General Counsel
Christopher A. Viehbacher Chief Executive Officer
Jérôme Contamine Executive VP Chief Financial Officer
Elias Zerhouni President Global R&D
Olivier Charmeil Executive VP Vaccines
Peter Guenter Executive VP Global Commercial Operations
Roberto Pucci Executive VP Human Resources
Philippe Luscan Executive VP Industrial Affairs
David-Alexandre Gros Executive VP Chief Strategy Officer
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Pascale Witz Executive VP Global Divisions & Strategic Commercial Development
BUSINESS PERFORMANCE
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Hanspeter Spek President, Global Operations
(1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Holland, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark), Japan, Australia and New Zealand
Emerging Markets Represented >1/3 of Total Sales and Delivered Solid Sales Growth in Q1 2013
● Q1 2013 Emerging Markets sales of €2,719m, up +6.5% at CER ● Strong growth in Diabetes, Vaccines and Genzyme ● Lower sales of Generics and Oncology products
● BRIC sales of €975m, up +10.7% at CER
33.7%
29.0%
24.8%
12.5%
15
(1)
+4.7% +11.9% -0.2% +11.7% Growth at CER
Q1 2013 Sales (€m)
16
Double-Digit Growth of our Diabetes Franchise for Nine Consecutive Quarters
Quarterly Sales (€m)
16
€1,338m
● Q1 2013 Diabetes sales of €1,542m, up +19.6% at CER
● Strong performance of Lantus®, up +21.3% at CER ● SoloSTAR® accounted for 57.0% of
U.S. sales (vs. 51.1% in Q1 2012)
● Strong growth in Emerging Markets with sales up +19.9% at CER
● Recovery of Apidra® continues, up +30.8% at CER
● Lyxumia® launched in Germany and the UK in March 2013
17
Consumer Healthcare Showed Steady Performance Except in China in Q1 2013
€199m
Q1 2013 Sales (€m) ● Q1 2013 sales of €811m, up +3.1% at CER ● Double-digit sales growth of several
leading brands (Doliprane®, Dorflex®, Enterogermina®)
● Lower sales in China due to reduced trade inventory levels and ongoing rationalization of distributors
● Allegra® OTC sales of €99m, up +6.3% at CER driven by recent launch in Japan ● New Allegra® anti-itch cream
introduced in the U.S. in April
€177m
€368m
€67m
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Merial Performance Reflected Lower Sales of Frontline® in Q1 2013
Q12011
Q22011
Q32011
Q42011
Q12012
Q22012
Q32012
Q42012
Q12013
Quarterly Sales (€m) ● Q1 2013 sales of €554m, down -3.1% at CER
● Companion Animals sales of €374m, down -5.3% at CER ● Frontline® impacted by unfavorable
weather conditions, increased competition and weak economic environment in Europe
● Strong sales of Heartgard® benefiting from competitor supply issue
● Production Animals sales of €180m, up +1.6% at CER
€554m
€47m
€112m
€149m
€92m€116m
€171m
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Genzyme Rare Diseases Growth Accelerated in Q1 2013
&
Q1 2013
Q1 2012
Q1 2013
Q1 2012
Q1 2013
Q1 2012
● Q1 2013 Rare Disease sales of €473m, up +20.5% at CER driven by supply recovery and growing number of patients on therapy
● Fabrazyme® sales reached €92m doubling in the U.S. as well as in Western Europe
● Myozyme® grew +4.5% at CER to €116m
● Cerezyme® sales increased +16.8% at CER to €171m driven by strong growth in Emerging Markets and the U.S.
Quarterly Sales (€m)
http://www.fabrazyme.com/default.asp
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(1) IMS Weekly Total Prescriptions (2) Based on data collected at Genzyme's MS One to One™ Patient and Provider Support Center, Sep 2012-Jan 2013 (3) NAS: New Active Substance (4) Clinical results for 14 mg dose; CDMS = Clinically Definite Multiple Sclerosis
®
● Aubagio® Q1 2013 sales of €20m
● Encouraging U.S. launch trends(1,2) ● TRx broadly tracking Gilenya®
● >83% of patients switched to AUBAGIO® were most recently on IFN-beta or Copaxone®
● Positive CHMP opinion granted in March 2013 ● Request for CHMP re-examination of
NAS designation filed(3)
● Ongoing regulatory review of Lemtrada™ in EU and the U.S.
A Promising Entry in the Large MS Market
Lemtrada™ is the registered trade name for alemtuzumab in MS submitted to health authorities Lemtrada™ is developed in collaboration with Bayer HealthCare
RELAPSE 31%
DISABILITY 30%
TEMSO(4)
TOWER(4)
TOPIC(4)
RELAPSE 36%
DISABILITY 31%
REDUCTION IN RISK OF CONVERSION TO CDMS 43%
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Q1 2013
€697m
Q1 2012
€617m
Other Meningitis/Pneumo Travel/Endemic
Influenza Vaccines Adult Boosters Polio/Pertussis/Hib
+15.9% at CER
Quarterly Sales (€m)
Vaccines Deliver a Strong First Quarter
● Q1 2013 sales of €697m, up +15.9% at CER
● PPH sales of €270m, +15.9% at CER driven by favorable phasing of Pentaxim® rollout in China and IPV campaign in Japan
● Influenza sales of €119m, +34.8% at CER from successful SH campaign and late U.S. sales
● Solid sales of Menactra® in the U.S. and LatAm (€67m, +19.6% at CER)
● Pentacel® progressive recovery expected to begin as of mid-2013 in the U.S.
(1) Includes VaxServe, a U.S. healthcare supplier serving primary care physician offices, community immunization providers, immunizing pharmacies, travel clinics and corporations.
SH: Southern Hemisphere
(1)
FINANCIAL PERFORMANCE
Jérôme Contamine
Executive Vice President, Chief Financial Officer
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€212m
Q1 2013 FX Impact Growth Platforms
€464m
Copaxone and Others
-€151m
Key Genericized
Products
-€553m
Q1 2012
€8,511m
As Expected, Q1 2013 Sales Were Impacted by the Residual Effect of the Patent Cliff and by FX
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(1) Key genericized products include Lovenox® U.S., Plavix® Western EU, Taxotere® Western EU & U.S., Eloxatin® U.S., Ambien® family U.S., Allegra® U.S., Aprovel® Western EU, Xyzal® U.S., Xatral® U.S., Nasacort® U.S. and BMS Alliance (active ingredients of Plavix® and Avapro® sold to BMS)
(2) Emerging Markets, Diabetes Solutions, Vaccines, Consumer Healthcare, Animal Health, Genzyme and Other Innovative Products
Q1 2013 Sales (€m)
(1)
(2)
€8,059m
®
Q3 2012 Q2 2012 Q1 2012 Q4 2012 Q1 2013
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Q1 2013 Performance Impacted by Unfavorable Currency Headwind in Japan and Latin America
Currency impact on sales in Q1 2013: JPY / Japanese Yen (-€113.7m); BRL / Brazilian Real (-€36.0m) ; VEF / Venezuelan Bolivar (-€14.3m); USD / US Dollar (-€14.2m); ZAR / South African Rand (-€9.8m)
Quarterly Currency Impact (in % change)
Q1 2012 Q1 2013 Q4 2012 Q3 2012 Q2 2012
+2.4%
+5.8%
+4.0%
+8.0%
€486m
€187m
€235m
€120m
+6.4% €561m
+8.2% €277m
Sales Business Operating Income
+1.9% €166m
+2.1% €61m
-2.5% -€212m -4.5%
-€154m
25
Q1 2013 Reflects the Impact of Plavix®/Avapro® U.S. LoE but also Illustrates Good Cost Control
€m Q1 2013 Q1 2012 % Change (reported €) % Change
(CER)
Net sales 8,059 8,511 -5.3% -2.8%
Other revenues 98 426 -77.0% -76.5%
Cost of sales (2,536) (2,608) -2.8% -1.1%
Gross profit 5,621 6,329 -11.2% -8.5%
R&D (1,155) (1,172) -1.5% -0.6%
SG&A (2,129) (2,116) +0.6% +2.7%
Other current operating income & expenses 30 157 - -
Share of Profit/Loss of associates 18 297 - -
Minority interests (41) (54) - -
Business operating income 2,344 3,441 -31.9% -27.4%
Business operating margin 29.1% 40.4% - -
CER: Constant Exchange Rates LoE: Loss of Exclusivity (1) With the retroactive application of IAS19R
(1)
Q1 2013 CoS Ratio Slightly Better than FY 2012 Average(1)
● Slightly lower Cost of Sales (CoS) in Q1 2013: €2,536m, down -1.1% at CER
● CoS ratio slightly up in Q1 2013 vs. Q1 2012 reflecting: ● Loss of sales from Key Genericized
Products with relatively low CoS ● Relatively higher vaccines sales
in Emerging Markets and from VaxServe(1)
● Unfavourable currency impact
26
Cost of Sales (%)
2012 2013
31.5% 30.6%
(1) FY 2012 CoS ratio was 31.7% (2) VaxServe, a Sanofi Pasteur company, is a U.S. healthcare supplier serving primary care physician
offices, community immunization providers, immunizing pharmacies, travel clinics and corporations
Rigorous Control of R&D Expenses While Significantly Investing in Phase III Trials
27
● Q1 2013 R&D expenses of €1,155m, down -0.6% at CER reflecting: ● Ongoing multiple Phase III trials
(e.g. alirocumab, new insulin glargine formulation, JAK2, sarilumab)
● Lower expenses in research and medical affairs
● Quarterly R&D spend in line with guidance
27
R&D Expenses (€m)
2012 2013
€1,155m €1,172m
Increase in SG&A Expenses in Q1 2013 Driven by New Product Launch Costs
28
● Q1 2013 SG&A expenses of €2,129m, up +2.7% at CER reflecting:
● Sales & Marketing investment in product launches (e.g. Genzyme MS)
● Tight control of G&A expenses down -4.8% at CER
● Lower SG&A spend in Europe
28
SG&A Expenses (€m)
2012 2013
€2,129m €2,116m
29
€m Q1 2013 Q1 2012 % Change (reported €) % Change
(CER)
Business operating income 2,344 3,441 -31.9% -27.4%
Net financial expenses (140) (169) - -
Income tax expense (591) (848) - -
Effective tax rate -26.5% -28.0% - -
Business net income 1,613 2,424 -33.5% -28.8%
Net margin 20.0% 28.5% - -
Business EPS(2) €1.22 €1.83 -33.3% -29.0%
Average number of shares outstanding (m) 1,322.2 1,321.2 - -
As Expected, Q1 2013 Business EPS Reflected the Residual Impact of the Patent Cliff(1)
29
(1) With the retroactive application of IAS19R (2) Business EPS was down -7.8% at CER in Q1 2013 excluding Plavix® and Avapro®
Loss of Exclusivity in the U.S. - Avapro® on March 30, 2012 and Plavix® on May 17, 2012
CER: Constant Exchange Rates
(1)
Net Debt Mar 31, 2013
Other
-133
Share Repurchase
-401
Acquisitions & Licensing
-345
CapEx
- 301
Net Cash from Operating Activities
Net Debt Dec 31, 2012
Free Cash Flow Affected by U.S. Loss of Exclusivity of Plavix® and Avapro®
30
(1)
(2)
-7,719 -7,440
FCF +1,158
+1,459
(1)
Q1 2013 (€m)
(3)
(1) Including derivatives related to the financial debt €431m at Dec 31, 2012 and €420m at Mar 31, 2013 (2) Excluding restructuring costs (3) “Other” include €204m of restructuring costs
Net debt decreased by €279m in Q1 2013
Sanofi Expects to Resume Growth in H2 2013
Solid performance of our Growth Platforms representing 71% of sales
As expected, Q1 2013 Business EPS impacted by exclusivity losses in prior year
Continued good cost control illustrated by Q1 2013 OpEx
Guidance for FY 2013 reaffirmed
Significant newsflow related to late stage R&D pipeline
1
2
3
4
31
5
APPENDICES R&D Pipeline
32
33
Late Stage Pipeline – Pharma & Vaccines
eliglustat tartrate Glucosylceramide synthetase inhibitor
Gaucher disease
Insulin glargine New formulation
Type 1+2 diabetes
Quadracel® Diphtheria, tetanus, pertussis & polio vaccine; 4-6 y of age
Fluzone® QIV IM Quadrivalent inactivated
influenza vaccine
iniparib (BSI-201) Squamous NSCLC (1L)
otamixaban Direct Xa inhibitor
ACS
Dengue Mild-to-severe
dengue fever vaccine
VaxiGrip® QIV IM Quadrivalent inactivated
influenza vaccine
SAR302503 (TG101348) JAK-2 inhibitor
Myelofibrosis (1L)
Kynamro™ (mipomersen) Apolipoprotein B-100 antisense
Severe HeFH, U.S.
DTP-HepB-Polio-Hib (PR5I) Pediatric hexavalent vaccine
Aubagio® (teriflunomide) Relapsing forms of Multiple sclerosis
(RMS) – Monotherapy, EU
Jevtana® (cabazitaxel) Metastatic prostate cancer (1L)
alirocumab (SAR236553) Anti-PCSK-9 mAb
Hypercholesterolemia
Fluzone® QIV ID Quadrivalent inactivated
influenza vaccine intradermal
Lemtrada™ (alemtuzumab) Anti-CD52 mAb
Multiple sclerosis, EU, U.S.
SYNVISC-ONE® Medical device Pain in hip OA
sarilumab (SAR153191) Anti-IL-6R mAb
Rheumatoid arthritis
SAR399063 DHA-GLP + vit D Pre-sarcopenia
Lyxumia® (lixisenatide) GLP-1 agonist
Type 2 diabetes, U.S., Japan
MACI® Cell-based treatment
Articular cartilage defects
Registration Phase III
N N
N
N
N
33
N
N
N New Molecular Entity Immune Mediated Diseases
Rare Diseases
Oncology Diabetes Solutions
Vaccines
Infectious Diseases
Cardiovascular Diseases
Age Related Degenerative Diseases
Ophthalmology
N
Biosurgery
N
Early Stage Pipeline – Pharma & Vaccines
iniparib (BSI-201) Platinum-resistant ovarian cancer (2L)
Metastatic triple negative breast cancer (mTNBC)
FOV1101 FDC prednisolone/cyclosporine
Allergic conjunctivitis
fresolumimab TGFβ antagonist
Fibrosis
SAR3419 Maytansin-loaded anti-CD19 mAb
B-cell malignancies refractory/relapsed (NHL, ALL)
SAR292833 (GRC15300) TRPV3 antagonist
Neuropathic pain, osteoarthritic pain
SAR279356 (F598) Anti-PNAG mAb Serious infections
SAR256212 (MM121) anti-ErbB3 mAb
Breast cancer (2L, 3L)
SAR110894 H3 antagonist
Alzheimer's disease
ferroquine Antimalarial
Malaria
SAR245408 (XL147) Oral PI3K inhibitor
Breast cancer
SAR113945 IKK-β inhibitor Osteoarthritis
SAR97276 Antimalarial
Malaria
SAR245409 (XL765) Oral dual inhibitor of PI3K & mTOR
Non-Hodgkin lymphoma
Meninge ACYW conj. 2nd generation meningococcal
conjugate infant vaccine
dupilumab (SAR231893) Anti-IL4Rα mAb
Asthma; Atopic dermatitis
SAR302503 (TG101348) JAK-2 inhibitor
Polycythemia vera (2L) Ruxolitinib resistant/intolerant MF
ACAM-Cdiff Clostridium difficile
Toxoid vaccine
SAR339658 VLA 2 antagonist
Inflammatory bowel disease
Jevtana® (cabazitaxel) Small cell lung cancer (2L)
Rabies VRVg Purified vero rabies vaccine
SAR156597 IL4/IL13 Bi-specific mAb
Idiopathic pulmonary fibrosis
lixisenatide + Lantus® GLP-1 agonist + insulin glargine
Fixed-Ratio / Type 2 diabetes
Rotavirus Live attenuated tetravalent
Rotavirus oral vaccine
SAR100842 LPA-1/LPA-3
Skin manifestation of scleroderma
Phase II
N
N
N
N
N
N
N
N
N N
N
N
34
N
N
N
34
N New Molecular Entity Immune Mediated Diseases
Rare Diseases
Oncology Diabetes Solutions
Vaccines
Infectious Diseases
Cardiovascular Diseases
Age Related Degenerative Diseases
Ophthalmology
Biosurgery
N
Early Stage Pipeline – Pharma & Vaccines
SAR153192 Anti-DLL4 mAb
Solid tumors
SAR260301 PI3K β selective
PTEN – Deficient tumors
SAR252067 Anti-LIGHT mAb
Crohn’s disease & Ulcerative colitis
Streptococcus pneumonia Meningitis & pneumonia vaccine
GZ402674 Non-camptothecin topo1 inhibitor
Solid tumors
SAR405838 (MI-773) HDM2 / p53 antagonist
Solid tumors
SAR113244 Anti-CXCRS mAb
Systemic lupus erythematosus
Pseudomonas aeruginosa Antibody fragment product
Prevention of ventilator-associated pneumonia
SAR650984 Anti-CD38 naked mAb
Hematological malignancies
GZ404477 (AAV-hAADC) Gene therapy
Parkinson's disease
SAR127963 P75 receptor antagonist
Trauma brain injury
Tuberculosis Recombinant subunit vaccine
SAR566658 Maytansin-loaded anti-CA6 mAb
Solid tumors
SAR391786 Rehabilitation post orthopedic surgery
SAR126119 TAFIa inhibitor
Acute ischemic stroke
RetinoStat® Gene therapy
Wet age-related macular degeneration (AMD)
SAR307746 Anti-ANG2 mAb
Solid tumors
SAR228810 Anti-protofibrillar AB mAb
Alzheimer’s disease
SAR407899 Rho kinase inhibitor
Pulmonary hypertension
StarGen® Gene therapy
Stargardt disease
SAR125844 C-MET kinase inhibitor
Solid tumors
SAR404460 DHA-GPL + Vit D Pre-sarcopenia
GZ402665 (rhASM)
Niemann-Pick type B
GZ402663 (sFLT-01) Gene therapy
Age-related macular degeneration (AMD)
Combinations SAR245409 / MSC1936369B
SAR245408/SAR256212 (MM121) Solid tumors
lixisenatide + Lantus® GLP-1 agonist + insulin glargine
Fix-Flex / Type 2 diabetes
GZ402671 GCS Inhibitor Fabry Disease
UshStat® Gene therapy
Usher syndrome 1B
Phase I N
N
N
N
N
N
N
N N N N
N N
N
N
N
N
N
N
N
N
N
35 35
N New Molecular Entity Immune Mediated Diseases
Rare Diseases
Oncology Diabetes Solutions
Vaccines
Infectious Diseases
Cardiovascular Diseases
Age Related Degenerative Diseases
Ophthalmology
Biosurgery
N
36
Phase I Phase II Phase III Registration TOTAL
Oncology 8 4 2 0 14
Diabetes Solutions 0 0 0 1 1
Cardiovascular Diseases 3 1 2 0 6
Immune Mediated Diseases 2 4 1 2 9
Infectious Diseases 0 3 0 0 3
Ophthalmology 4 1 0 0 5
Rare Diseases 2 0 1 0 3
Age Related Degenerative Diseases 4 3 1 0 8
Vaccines 3 4 4 2 13
TOTAL 26 20 11 5
R&D Pipeline Summary Table(1)
46 16 NMEs & Vaccines
62
36
49
(1) Excluding life cycle management programs
37
Expected R&D Milestones
37
Product Event Timing Lemtrada™ (alemtuzumab) Expected CHMP decision in RMS in EU Q2 2013
Sarilumab Start of additional Phase III studies (COMPARE and ASCERTAIN) in RA Q2 2013
New insulin glargine formulation First Phase III headline results in diabetes (EDITION I & II) Q2 2013
Otamixaban Phase III headline results in ACS Q2 2013
JAK2 inhibitor Phase III headline results in Myelofibrosis Q2 2013
Iniparib Phase III headline results in 1st line Squamous NSCLC Q2 2013
Fluzone® Quadrivalent IM Expected FDA decision in the U.S. Q2 2013
Aubagio® (teriflunomide) Expected CHMP reexamination of NAS status in EU Mid-year
Dupilumab (anti IL-4Rα mAb) Expected start of Phase IIb studies in Asthma and Atopic Dermatitis Mid-year
Alirocumab (anti PCSK9 mAb) First Phase III headline results in Hypercholesterolemia Q3 2013
C. Diff vaccine Expected start of Phase III program Q3 2013
Eliglustat Expected U.S. and EU regulatory submissions in Gaucher disease Q4 2013
Lemtrada™ (alemtuzumab) Expected FDA decision in RMS in the U.S. H2 2013
APPENDICES FINANCE
38
Business Net Income Statement
First quarter
Net sales 8,059 8,511 (5.3%) 6,808 7,316 (6.9%) 697 617 13.0% 554 578 (4.2%)Other revenues 98 426 (77.0%) 83 412 (79.9%) 7 5 40.0% 8 9 (11.1%)Cost of sales (2,536) (2,608) (2.8%) (2,025) (2,178) (7.0%) (345) (262) 31.7% (166) (168) (1.2%)As % of net sales (31.5%) (30.6%) (29.7%) (29.8%) (49.5%) (42.5%) (29.9%) (29.1%)Gross profit 5,621 6,329 (11.2%) 4,866 5,550 (12.3%) 359 360 (0.3%) 396 419 (5.5%)As % of net sales 69.7% 74.4% 71.5% 75.9% 51.5% 58.3% 71.5% 72.5%Research and development expenses
(1,155) (1,172) (1.5%) (988) (990) (0.2%) (128) (141) (9.2%) (39) (41) (4.9%)
As % of net sales (14.3%) (13.8%) (14.5%) (13.5%) (18.4%) (22.9%) (7.0%) (7.1%)Selling and general expenses
(2,129) (2,116) 0.6% (1,828) (1,819) 0.5% (139) (130) 6.9% (162) (167) (3.0%)
As % of net sales (26.4%) (24.9%) (26.9%) (24.9%) (19.9%) (21.1%) (29.3%) (28.9%)Other current operating income/expenses
30 157 31 152 2 (1) 1 (2) 4
Share of profit/loss of associates*
18 297 19 302 (1) (5)
Net income attributable to non-controlling interests
(41) (54) (41) (55)
Business operating income 2,344 3,441 (31.9%) 2,059 3,140 (34.4%) 93 84 10.7% 194 213 (8.9%) (2) 4
As % of net sales 29.1% 40.4% 30.2% 42.9% 13.3% 13.6% 35.0% 36.9%Financial income and expenses (140) (169)
Income tax expense (591) (848)
Tax rate** 26.5% 28.0%Business net income 1,613 2,424 (33.5%)As % of net sales 20.0% 28.5%Business earnings per share*** (in euros)
1.22 1.83 (33.3%)
Group Total
€ million Q1 2013 Q1 2012(1) Q1 2012(1) Q1 2013 Q1 2012(1) Q1 2013change
Pharmaceuticals
change
OtherVaccines Animal health
Q1 2012(1)change change Q1 2013Q1 2013 Q1 2012(1)
(1) Including impact of transition to IAS19R * Net of tax ** Determined on the basis of Business income before tax, associates, and non-controlling interests *** Based on an average number of shares outstanding of 1,322.2 million in the first quarter of 2013 and 1,321.2 million in the first quarter of 2012 39
40 40
Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi
€ million Q1 2013 Q1 2012(1) change
Business net income 1,613 2,424 (33.5%)Amortization of intangible assets (775) (833)
Impairment of intangible assets (10) (1)
Fair value remeasurement of contingent consideration liabilities (41) (33)
Expenses arising from the impact of acquisitions on inventories (3) (14)
Restructuring costs (54) (87)
Tax effect of: 280 360
amortization of intangib le assets 259 332 fair value remeasurement of contingent consideration liab ilities 4 2 expenses arising from the impact of acquisitions on inventories 1 4 restructuring costs 16 22
Other tax items
Share of items listed above attributable to non-controlling interests 1 1
Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures
(7) (8)
Net income attributable to equity holders of Sanofi 1,004 1,809 (44.5%)Consolidated earnings per share (in euros) 0.76 1.37 (44.5%)
(1) Including impact of transition to IAS19R
Consolidated Income Statement
€ million
Net sales 8,059 8,511
Other revenues 98 426
Cost of sales (2,539) (2,622)
Gross profit 5,618 6,315
Research and development expenses (1,155) (1,172)
Selling and general expenses (2,129) (2,116)
Other operating income 71 206
Other operating expenses (41) (49)
Amortization of intangible assets (775) (833)
Impairment of intangible assets (10) (1)
Fair value remeasurement of contingent consideration liabilities (41) (33)
Restructuring costs (54) (87)
Other gains and losses, and litigation
Operating income 1,484 2,230
Financial expenses (157) (189)
Financial income 17 20
Income before tax and associates and joint ventures 1,344 2,061
Income tax expense (311) (488)
Share of profit / loss of associates and joint ventures 11 289
Net income 1,044 1,862
Net income attributable to non-controlling interests 40 53
Net income attributable to equity holders of Sanofi 1,004 1,809
Average number of shares outstanding (million) 1,322.2 1,321.2
Consolidated earnings per share (in euros) 0.76 1.37
Q1 2012(1)Q1 2013
41 (1) Including impact of transition to IAS19R
Q1 2013 RESULTSForward Looking StatementsAgendaDiapositive numéro 4Key Genericized Products Represented Only ~€260m�of Sales for a Second Quarter in a RowGrowth Platforms Grew by +8.6% in Q1 2013�and Reached 71% of SalesQ1 2013 Sales Were Affected by U.S. Loss of Exclusivity �of Eloxatin® in August 2012 and by FX Fluctuations(1)The Loss of U.S. Exclusivity of Plavix® and Avapro® Impacted Business EPS by €0.42 in Q1 2013As Anticipated, Q1 2013 Business EPS Was Better �than Q4 2012 TroughRecent Regulatory Approvals Have Resulted �in Six New Product LaunchesSeveral Important Study Releases and Regulatory Milestones Achieved in the Last 4 MonthsAdditional Phase III Trial Readouts and Regulatory Decisions Expected Throughout 2013Diapositive numéro 13Diapositive numéro 14Diapositive numéro 15Double-Digit Growth of our Diabetes Franchise �for Nine Consecutive QuartersDiapositive numéro 17Merial Performance Reflected Lower Sales of Frontline® �in Q1 2013Diapositive numéro 19Diapositive numéro 20Diapositive numéro 21Diapositive numéro 22As Expected, Q1 2013 Sales Were Impacted �by the Residual Effect of the Patent Cliff and by FXQ1 2013 Performance Impacted by Unfavorable Currency Headwind in Japan and Latin AmericaQ1 2013 Reflects the Impact of Plavix®/Avapro® U.S. LoE �but also Illustrates Good Cost ControlQ1 2013 CoS Ratio Slightly Better than FY 2012 Average(1)Rigorous Control of R&D Expenses While Significantly Investing in Phase III TrialsIncrease in SG&A Expenses in Q1 2013�Driven by New Product Launch CostsAs Expected, Q1 2013 Business EPS Reflected the Residual Impact of the Patent Cliff(1)Free Cash Flow Affected by U.S. Loss of Exclusivity �of Plavix® and Avapro®Sanofi Expects to Resume Growth in H2 2013Diapositive numéro 32Late Stage Pipeline – Pharma & VaccinesEarly Stage Pipeline – Pharma & VaccinesEarly Stage Pipeline – Pharma & VaccinesR&D Pipeline Summary Table(1)Expected R&D MilestonesDiapositive numéro 38Business Net Income StatementReconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of SanofiConsolidated Income Statement