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 forwardlooking 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, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
2005-2008
2009-2012
2013+
Focusing on Rx Blockbusters
Blockbuster drugs Patents challenged R&D setbacks
Transforming
Investing in growth platforms Increasing diversification Managing patent cliff
Over 70% of Sales from Growth Platforms and Limited Sales Exposure to Patent Cliff(1) as of Q3 2012
Key Genericized Products Sales
(m and % of Total Sales)
(1)
(2)
6,412m
5,753m 5,381m
3,339m 2,207m
70.9%
of Total Sales
4.4%
of Total Sales 813m 752m
399m
Q3 Q2 Q1 Q2 Q3
Q2
Q1
Q2
2009
2012
2009
2012
(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) Growth Platforms include Emerging Markets, Diabetes Solutions, Vaccines, Consumer Health Care, Animal Health, New Genzyme (Rare Diseases and Multiple Sclerosis) and Innovative Products (new product launches which do not belong to the Growth Platforms listed above: Multaq, Jevtana, Mozobil and Zaltrap) 4
Pursue external growth opportunities Adapt structure for future challenges and opportunities
5 5
Targeted Indications
Metastatic Colorectal Cancer Relapsing Forms of Multiple Sclerosis Relapsing Forms of Multiple Sclerosis
Expected Milestones
EC Decision: Q1 2013
CHMP Opinion: Q1 2013 FDA Decision on File Acceptance: Q1 2013 CHMP Opinion: Q2 2013 EC Decision: Q1 2013 FDA Decision on File Acceptance: Q1 2013 PDUFA Date: Jan 29, 2013(1)
Type 2 Diabetes
TM
DTP-HepB-Polio-Hib
(1) On October 18th 2012, an FDA AdCom recommended Kynamro for hoFH Lyxumia, Kynamro and Lemtrada are registered trade names submitted to health authorities for investigational agents Zaltrap is developed in collaboration with Regeneron, Kynamro with Isis Pharmaceuticals and Lyxumia is in-licensed from Zealand Pharma Genzyme is developing Lemtrada in MS in collaboration with Bayer HealthCare PDUFA: Prescription Drug User Fee Act hoFH: Homozygous Familial Hypercholesterolemia CHMP: Committee for Medicinal Products for Human Use EC: European Commission DTP-HepB-Polio-Hib: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus type b 6
1 2 3 4 5 6
Diabetes Oncology Multiple Sclerosis and Rare Diseases Cardio-Metabolic Diseases Immunology Vaccines
Unique flat PK/PD profile and lower injection volume EDITION program: six Phase III trials currently ongoing in T1D and T2D(1) First state-of-the art reusable insulin pen, manufactured by a global company in India For use with Sanofis insulin portfolio in India and possibly other Emerging Markets
Lyxumia is the proprietary name submitted to the EMA for the companys investigational GLP-1 RA lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration. Lixisenatide is not currently approved or licensed anywhere in the world. Lixisenatide was in-licensed from Zealand Pharma A/S. PPG: postprandial glucose PK/PD Pharmacokinetic/Pharmacodynamic TD1 and TD2: Type 1 and Type 2 diabetes (1) EDITION I, II, III, IV, JPI, JPII - ClinicalTrials.gov Identifier: NCT 1499082, 01499095, 01676220 & 01683266, 01689129 & 01689142
(worldwide)
On basal insulin
4 million
on Lantus
4 million 4 million
on other basal insulins(2)
L L Asia Duo 1
Broad Phase III Program Evaluating Potential Clinical Benefits of Improved PK/PD Profile of New Glargine Formulation
New Insulin Glargine Formulation
Depot formation after subcutaneous injection
Lantus
OAD Oral anti-diabetic drugs (1) EDITION I, II, III, IV, JPI, JPII - ClinicalTrials.gov Identifier: NCT 1499082, 01499095, 01676220 & 01683266, 01689129 & 01689142
10
1 2 3 4 5 6
Diabetes Oncology Multiple Sclerosis and Rare Diseases Cardio-Metabolic Diseases Immunology Vaccines
11
A novel VEGF trap acting on multiple angiogenic targets Indicated in combination with FOLFIRI in mCRC patients resistant to or progressing on an oxaliplatin-containing regimen Significant improvement in Overall Survival demonstrated in the VELOUR study(1) European launch roll out expected to start as of Q1 2013
Zaltrap is developed in collaboration with Regeneron (1) Van Cutsem, et al. JCO Oct 1, 2012:3499-3506; VEGF: Vascular endothelial growth factor FOLFIRI: FOL (folinic acid), F (fluorouracil) and IRI (irinotecan) mCRC: Metastatic colorectal cancer 12
JAK2 inhibitor - Addressing Treatment Gaps for Patients with Debilitating Hematologic Malignancies
% patients with 35% reduction in spleen volume from baseline
SAR302503 - Phase II trial
Novel selective JAK2 inhibitor Promising Phase II response rate in patients with myelofibrosis (MF) Phase III in MF (JAKARTA)
Two doses (400 mg and 500 mg) selected Enrollment completed Headline results in Q2 2013
13
1 2 3 4 5 6
Diabetes Oncology Multiple Sclerosis and Rare Diseases Cardio-Metabolic Diseases Immunology Vaccines
14
54%
ROW
44% 2011
46% 2016e
(1) National Multiple Sclerosis Society (2) 2011: Reported sales of Copaxone, Avonex, Rebif, Betaseron/Betaferon, Extavia, Tysabri, and Gilenya (3) 2016e: Adapted from Evaluate Pharma report - December 2011
15
$2,350m 19%
$154m 1%
All trademarks are the property of their respective owners (1) ABCRE stands for Avonex, Betaseron/Betaferon, Copaxone, Rebif and Extavia (2) Reported sales of ABCRE products plus Tysabri, and Gilenya in 2011
16
Aubagio 14mg is the only oral MS drug to significantly delay disability progression in two Phase III trials(5) Aubagio 14mg provided statistically significant reduction in Annualized Relapse Rate Convenience of OD oral administration to avoid the burden of regular injections Encouraging Rx launch trends in the U.S. tracking ahead of fingolimod
TEMSO STUDY
Annualized Relapse Rate(1)
TOWER STUDY
Annualized Relapse Rate(1)
TEMSO STUDY
Reduction in Progression of Disability(2)
TOWER STUDY
Reduction in Progression of Disability(2)
- 31.5%
0.539
p=0.0005
0.501
- 36.3%
p=0.0001
-29.8%(3)
0.273
p=0.0279(4)
-31.5%(3)
p=0.0442(4)
0.369
0.319
0.202
0.197 0.158
n=363 Placebo
n=359 Aubagio
14mg
n=388 Placebo
n=370 Aubagio
14mg
n=363 Placebo
n=359 Aubagio
14mg
n=388 Placebo
n=370 Aubagio
14mg
The most frequent adverse reactions for AUBAGIO in the placebo-controlled studies were ALT increased, alopecia, diarrhea, influenza, nausea, and paresthesia. The AUBAGIO label includes a boxed warning citing the risk of hepatotoxicity and teratogenicity (based on animal data). (1) Adjusted for Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment into account (2) At Week 108 (3) Derived using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates (4) Derived from log-rank test with stratification of EDSS strata at baseline and region 17 (5) TEMSO and TOWER; Aubagio 7mg tablets are also available in the U.S.
Only Therapy(1) Slowing Accumulation of Disability Sustained for 6 Months vs. Active Comparator
Higher Hurdle
(2)
Active Comparators
Higher Hurdle
Placebo
3 months
EDSS
6 months
EDSS: Expended Disability Status Scale (1) Investigational compound (2) Based on CARE-MS II
18
Significantly More Effective at Reducing ARR in Pivotal Trials(1) with Unique Dosing Regimen
CARE-MS I
Annualized Relapse Rate
CARE-MS II
Annualized Relapse Rate
- 49% - 55%
p<0.0001
0.52
p<0.0001
n=187 Rebif
n=376 Lemtrada
n=202 Rebif
n=426 Lemtrada
ARR: Annualized Relapse Rate (1) CARE-MS I and CARE-MS II were both head-to-head trials comparing Lemtrada versus Rebif
19
+2%
Placebo
Eliglustat
Positive results from ENGAGE, first Phase III study (vs. placebo)
Primary endpoint and all secondary endpoints met(2) Well tolerated with no serious adverse events reported in the primary analysis period
30%
Absolute Difference
ENCORE Phase III results (vs. Cerezyme) expected in early 2013 -28%
(1) Eliglustat tartrate is an investigational drug (2) Secondary endpoints included improvements in hemoglobin levels and platelet levels, as well as liver volumes
20
1 2 3 4 5 6
Diabetes Oncology Multiple Sclerosis and Rare Diseases Cardio-Metabolic Diseases Immunology Vaccines
21
First-in-class fully-human antibody targeting PCSK9 Landmark study demonstrated that when PCSK9 is disabled, cholesterol and risk of CHD are greatly lowered(1) Phase II data(2,3)
Significantly reduced mean LDL-C by 40% to 72% over 8 to 12 weeks in patients with elevated LDL-C in patients on stable dose of statins Most common TEAE: mild injection site reaction
0 -10 -20 -30 -40 -50 -60 -70 -80
- 5.1%
- 39.6%
- 64.2%
- 72.4%
22
Sanofi Recently Started the First Ever Phase 3 Program for an Anti-PCSK9 mAb
ODYSSEY: a large global Phase 3 clinical program evaluating the safety and efficacy of SAR236553
22,000 patients, including those with elevated cardiovascular risk, intolerant to statins or patients with FH Injected subcutaneously as one single injection every two weeks Evaluating a 1mL auto-injector for both Q2W doses, 75mg and 150mg
Target Population
~21m patients globally estimated not at goal for LDL-C(1)
(mainly at high cardiovascular risk)
Secondary Prevention
Primary Prevention
SAR236553 / REGN727 is developed in collaboration with Regeneron (1) Adapted from Decision Resources 2008, Decision Resources 2010 and CVReg 2011 (2) heFH: Heterozygous Familial Hypercholesterolemia
23
Otamixaban: Providing Superior Outcomes while Simplifying Treatment during Interventional Procedures
Despite current therapies, death, MI, and readmission rates remain high Otamixaban is the first IV direct and selective factor Xa inhibitor with quick onset/offset
27% to 42% risk reduction in ACS complications including death and MI in Phase Il(1)
TAO Study
Moderate-to-high risk NSTE-ACS with planned early invasive strategy (n=13,220)
(1) The Lancet, Volume 374, Issue 9692, Pages 762 - 764, 5 September 2009 NSTE-ACS Non-ST-Elevation Acute Coronary Syndrome, MI Myocardial Infarction, UFH Unfractionated Heparin
24
1 2 3 4 5 6
Diabetes Oncology Multiple Sclerosis and Rare Diseases Cardio-Metabolic Diseases Immunology Vaccines
25
46.2 35.3
40.4*
11.8
17.3*
150 mg q2w
200 mg q2w
* p<0.01 versus placebo (only unadjusted p-values <0.01 are considered statistically significant)
Sarilumab is developed in collaboration with Regeneron RA Rheumatoid Arthritis IL-6R Interleukin-6 receptor ACR American College Of Rheumatology (ACR) Scoring System
26
IL-4 or
IL-13
IL-4R
Type I Receptor
IL-13R1
Positive proof of concept data for asthma and atopic dermatitis to be submitted for presentation at medical conferences in 2013 Phase 2b initiation in both indications expected mid-year
IL-4
Initiated and drives TH2 differentiation Activation and growth of B cells Class switching to IgE and IgG1a Recruitment of eosinophils
IL-13
Airway hyper responsiveness (AHR) Goblet cell hyperplasia Tissue remodeling Fibrosis Regulation of gastrointestinal parasite expulsion
Sanofi U.S. licensed the North American commercialization rights to the epinephrine auto-injector from Intelliject, Inc., Source: 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Practice Parameters Source: Mylan Form 10-K for the period ending Dec 31, 2011 and Mylan Investor Day on Feb 21, 2012 IMS MAT sales through July 2012
28
1 2 3 4 5 6
Diabetes Oncology Multiple Sclerosis and Rare Diseases Cardio-Metabolic Diseases Immunology Vaccines
29
30 30
C. Diff Toxoid Vaccine: Preventing Primary Symptomatic Clostridium Difficile Infections (CDI)
Candidate vaccine shown to be safe and immunogenic in Phase I(1) and Phase II trials
Broad functional antibody responses to both toxins (A and B)
CDI A Growing Healthcare Problem Most common cause of health care associated infections in developed countries(2) In the U.S. alone, a significant burden(3)
~28,000 deaths and up to 450,000 hospital admissions Associated cost of care: up to $3.4bn
CBER Center for Biologics Evaluation and Research (1) Greenberg R, Vaccine, March 2012 (2) He M, Nature Genetics, December 2012, and Miller BA, Control Hosp Epidemiol, April 2011 (3) CDC Morbidity and Mortality Weekly Report, March 2012
31
R&D expenses of 4,811m in 2011 R&D spend of 3,564 million in 9M 2012, down 6.0% at CER and with Genzyme proforma reflecting:
Good internal cost management Ongoing transforming initiatives
16.6%
15.6%
14.1%
14.4%
13.5%
R&D/Sales ratio down 0.6 points in 9M 2012 vs. 9M 2011 (13.5% vs. 14.1%)
FY 2008 FY 2009 FY 2010 FY 2011 9M 2012
32
Jay Edelberg
Head of PCSK9 Launch Unit
NorthBoston America hub hub France hub Germany
hub
Andrew Plump
Deputy of President R&D VP Research and Translational Medicine
Beijing Tokyo
Philippe Monteyne
VP Head of R&D France
Eckhard Leifke
Diabetes - Head of Development
Victoria Richon
Oncology - Head of Research & Early Development
Rodger Novak
VP for Infectious diseases
33
34
35
Registration
N
otamixaban
Direct Xa inhibitor ACS
Quadracel
Diphtheria, tetanus, pertussis & polio vaccine; 4-6 y of age
iniparib (BSI-201)
Squamous NSCLC (1L)
Insulin glargine
New formulation Type 1+2 diabetes
VaxiGrip QIV IM
Quadrivalent inactivated influenza vaccine
Quadrivalent inactivated influenza vaccine N Aubagio (teriflunomide) Relapsing forms of Multiple sclerosis (RMS) Monotherapy, EU
Fluzone QIV IM
SAR302503 (TG101348)
JAK-2 inhibitor Myelofibrosis (1L)
mipomersen
Apolipoprotein B-100 antisense Severe HeFH, U.S.
Dengue
Mild-to-severe dengue fever vaccine N
Jevtana (cabazitaxel)
Metastatic prostate cancer (1L)
SAR236553
Anti-PCSK-9 mAb Hypercholesterolemia
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine
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
Fluzone QIV ID
Allegra
fexofenadine Dry syrup, Japan
MACI
Cell-based treatment Articular cartilage defects
mipomersen
Apolipoprotein B-100 antisense HoFH and severe HeFH in EU; HoFH in U.S.
lixisenatide
GLP-1 agonist Type 2 diabetes, EU, Japan, U.S.
Zaltrap (aflibercept)
VEGF-Trap 2nd line mCRC, EU
FOV1101
FDC prednisolone/cyclosporine Allergic conjunctivitis
SAR231893
Anti-IL4 mAb Asthma; Atopic dermatitis
SAR3419 N Maytansin-loaded anti-CD19 mAb B-cell malignancies refractory/relapsed (NHL, ALL) SAR256212 (MM121)
anti-ErbB3 mAb Breast cancer (2L, 3L) N
SAR292833 (GRC15300)
TRPV3 antagonist Neuropathic pain, osteoarthritic pain
ferroquine
Antimalarial Malaria
SAR110894
fresolimumab
TGF antagonist Fibrosis
SAR245408 (XL147)
Oral PI3K inhibitor Breast cancer
SAR113945
IKK- inhibitor Osteoarthritis
SAR97276
Antimalarial Malaria
N SAR245409 (XL765) Oral dual inhibitor of PI3K & mTOR Non-Hodgkin lymphoma
SAR279356 (F598)
Anti-PNAG mAb Serious infections
SAR302503 (TG101348)
JAK-2 inhibitor Polycythemia vera (2L) Incyte (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
SAR126119
TAFIa inhibitor Acute ischemic stroke
SAR252067
Anti-LIGHT mAb Crohns disease & Ulcerative colitis
Rotavirus
Live Attenuated Tetravalent Rotavirus oral vaccine
GZ402674
Non-camptothecin topo1 inhibitor Solid tumors
SAR127963
P75 receptor antagonist Trauma brain injury
SAR100842
LPA-1/LPA-3 Skin manifestation of scleroderma
Streptococcus pneumonia
Meningitis & pneumonia vaccine
SAR650984
Anti-CD38 naked mAb Hematological malignancies
GZ404477
(AAV-hAADC) Gene therapy Parkinson's disease
SAR113244
Anti-CXCRS mAb Systemic lupus erythematosus
Pseudomonas aeruginosa
Antibody fragment product
Prevention of ventilator-associated pneumonia
SAR566658
Maytansin-loaded anti-DS6 mAb DS6 positive solid tumors
SAR391786
SAR407899
Rho kinase inhibitor Diabetic nephropathy
Tuberculosis
Recombinant subunit vaccine
SAR307746
Anti-Ang2 mAb Solid tumors
SAR228810
Anti-protofibrillar AB mAb Alzheimers disease
lixisenatide + Lantus
GLP-1 agonist + insulin glargine Fix-Flex / Type 2 diabetes
RetinoStat
Gene therapy
SAR399063
DHA-GLP + vit D Pre-sarcopenia
SAR164653
Cathepsin A inhibitor CV-related complications & deaths in diabetic patients
StarGen
Gene therapy Stargardt disease
Combinations
SAR245409 / MSC1936369B SAR245408/SAR256212 (MM121) Solid tumors
SAR404460
DHA-GPL + Vit D Pre-sarcopenia N
GZ402665 (rhASM)
Niemann-Pick type B
GZ402663 (sFLT-01)
Gene therapy Age-related macular degeneration (AMD)
GZ402671
GCS Inhibitor Fabry Disease
UshStat
Gene therapy Usher syndrome 1B
38
Phase I Oncology Metabolic Disorders Thrombosis Central Nervous System Internal Medicine Ophthalmology Genetic Diseases Aging Vaccines TOTAL 8 2 1 2 3 4 2 4 4
Phase II 4 0 0 0 7 1 0 3 3
Phase III 2 1 1 0 1 0 1 0 5
Registration 0 2 0 2 0 0 0 0 2
TOTAL
14 5 2 4 11 5 3 7
51
14
30 48
18
11 17
65
NMEs&Vaccines
39
Event
Expected EC approval in 2nd line mCRC in EU Expected EC approval in type 2 diabetes in EU Expected FDA file acceptance in type 2 diabetes in U.S. Expected CHMP decision in RMS in EU Expected FDA decision in hoFH in the U.S. Phase III headline results in Gaucher disease (ENCORE) Expected CHMP decision in RMS in EU Phase III headline results in 1st line squamous NSCLC Phase III headline results in ACS Phase III headline results in myelofibrosis First Phase III headline results in diabetes
Timing
Q1 2013 Q1 2013 Q1 2013 Q1 2013 Q1 2013 Q1 2013 Q2 2013 Q2 2013 Q2 2013 Q2 2013 Q2 2013
40
Event
Expected submission of regulatory file in EU Expected CHMP opinion in EU Expected FDA decision in the U.S. Expected start of Phase III study
Timing
Q1 2013 Q1 2013 Q2 2013 Q3 2013
41