2013 - jp morgan hc
DESCRIPTION
2013 - Jp Morgan HCTRANSCRIPT
JP Morgan Healthcare ConferenceDr. Elias Zerhouni, President – Global R&D
San Francisco, January 8, 2013
2
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 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, andstatements 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 believesthat 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 andgenerally beyond the control of Sanofi, that could cause actual results and developments to differ materially from thoseexpressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertaintiesinclude 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 toapprove any drug, device or biological application that may be filed for any such product candidates as well as theirdecisions regarding labeling and other matters that could affect the availability or commercial potential of such productcandidates, the absence of guarantee that the product candidates if approved will be commercially successful, the futureapproval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growthopportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies andsubsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in thepublic filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "CautionaryStatement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise anyforward-looking information or statements.
33
Repositioning Sanofi for Sustainable Growth
2005-2008 2009-2012 2013+
Focusing on Rx Blockbusters Transforming Generating
Sustainable Growth• Investing in growth platforms• Increasing diversification• Managing patent cliff
• Growing recurring sales• Improving risk profile
• Blockbuster drugs• Patents challenged• R&D setbacks
Growth Platforms Sales(2)
(€m and % of Total Sales)
Q2 Q1 Q2 Q3
€6,412m
€5,381m
Over 70% of Sales from Growth Platforms and Limited Sales Exposure to Patent Cliff(1) as of Q3 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
Q2 Q1 Q2 Q3
4.4%of Total Sales
€813m€399m
Key Genericized Products Sales(1)
(€m and % of Total Sales)
€752m
€5,753m
70.9%of Total Sales
€3,339m
€2,207m
20122009 20122009
Executing Successful Strategy to Reposition Sanofi
Deliversustainable growth
and generate improved
shareholder returnsAdapt structure for futurechallenges and opportunities3
Pursue external growth opportunities2
Increase innovation in R&D1
55
PDUFA Date: Jan 29, 2013(1)TM
hoFH in the U.S
EC Decision: Q1 2013FDA Decision on File Acceptance: Q1 2013Type 2 Diabetes
®
Multiple Regulatory Milestones Expected in Next Three Months
hoFH: Homozygous Familial HypercholesterolemiaEC: European CommissionDTP-HepB-Polio-Hib: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus type b
6
Lyxumia®, Kynamro™ and Lemtrada™ are registered trade names submitted to health authorities for investigational agentsZaltrap® is developed in collaboration with Regeneron, Kynamro™ with Isis Pharmaceuticals and Lyxumia® is in-licensed from Zealand PharmaGenzyme is developing Lemtrada™ in MS in collaboration with Bayer HealthCare
PDUFA: Prescription Drug User Fee Act CHMP: Committee for Medicinal Products for Human Use
Expected Milestones
EC Decision: Q1 2013
Products
® MetastaticColorectal Cancer
Targeted Indications
FDA Decision on File Acceptance: Q1 2013CHMP Opinion: Q2 2013
Relapsing Forms ofMultiple Sclerosis
CHMP Opinion: Q1 2013Relapsing Forms ofMultiple Sclerosis
®
(1) On October 18th 2012, an FDA AdCom recommended Kynamro™ for hoFH
DTP-HepB-Polio-Hib CHMP Opinion: Q1 2013New 6-in-1
Paediatric Vaccine
77
Focusing R&D on High-Value Projects in Key Therapeutic Areas
1 Diabetes
2 Oncology
3 Multiple Sclerosis and Rare Diseases
4 Cardio-Metabolic Diseases
5 Immunology
6 Vaccines
Broadening our Diabetes Platform with New Patient-Focused Solutions
8
® ● Once-daily and pronounced PPG lowering effect
● Use on top of basal insulin
● ELIXA: CV outcome study ongoing
Lyxumia® is the proprietary name submitted to the EMA for the company’s investigational GLP-1 RA lixisenatide. The proprietary name for lixisenatidein 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
● 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 Sanofi’s insulin portfolio in India and possibly other Emerging Markets
NEWINSULIN GLARGINE
FORMULATION
Key Facts about MST2D Patients Treated with Basal Insulin(1) (worldwide)
On basal insulinOn basal insulinwith controlledfasting glucosebut A1c >7%
4 millionon other
basal insulins(2)
4 millionon Lantus®
4 million
Lyxumia® is the proprietary name submitted to the EMA for the company’s 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.
T2D – Type 2 Diabetes A1C – HbA1c or Glycated hemoglobin (1) Adapted from IMS data (2) Includes all types of basal insulins
Clinical Development Designed to Support Use in Combination with Basal Insulin
®
9
MonoMono Japan
Monotherapy
Placebo-controlledin OAD failure
M (metformin)
F1 (metformin)
M Asia (metformin)
S (sulfonylurea)
P (pioglitazone)
X vs. exenatideActive-controlled
L Asia
L Placebo-controlled on top of
basal insulin Duo 1
Phase III Program
Next step: to develop a combination of Lantus® and Lyxumia®
10
Broad Phase III Program Evaluating Potential Clinical Benefitsof Improved PK/PD Profile of New Glargine Formulation
● Two Phase III trials in T2D high-dose insulin users(1)
● 1,600 patients● Headline results expected in Q2 2013
● Second set of Phase III studies started in H2 2012(1)
● Two new studies also initiated in Japan (JPI and JPII)
EDITION IT2D PatientsBasal Bolus
EDITION IIT2D PatientsBasal + OAD
OAD – Oral anti-diabetic drugs (1) EDITION I, II, III, IV, JPI, JPII - ClinicalTrials.gov Identifier: NCT 1499082, 01499095, 01676220 & 01683266, 01689129 & 01689142
New Insulin Glargine Formulation Depot formation after subcutaneous injection
Schematic illustration
Lantus® New Glargine Formulation
10
EDITION IIIT2D PatientsInsulin Naïve
EDITION IVT1D Patients
Basal
1111
Focusing R&D on High-Value Projects in Key Therapeutic Areas
1 Diabetes
2 Oncology
3 Multiple Sclerosis and Rare Diseases
4 Cardio-Metabolic Diseases
5 Immunology
6 Vaccines
U.S. Launch On Track and EU Roll Out Imminent
12
Zaltrap® is developed in collaboration with Regeneron(1) Van Cutsem, et al. JCO Oct 1, 2012:3499-3506;
● 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
VEGF: Vascular endothelial growth factor FOLFIRI: FOL (folinic acid), F (fluorouracil) and IRI (irinotecan)mCRC: Metastatic colorectal cancer
● 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
● Two Phase II studies ongoing● Polycythemia vera● Myelofibrosis patients previously
treated with ruxolitinib
% patients with ≥35% reductionin spleen volume from baseline
JAK2 inhibitor - Addressing Treatment Gaps for Patients with Debilitating Hematologic Malignancies
13
SAR302503 - Phase II trial
1414
1 Diabetes
2 Oncology
3 Multiple Sclerosis and Rare Diseases
4 Cardio-Metabolic Diseases
5 Immunology
6 Vaccines
Focusing R&D on High-Value Projects in Key Therapeutic Areas
15
Global MS Market - Significant and Expected to Grow
Key Facts about MS
● ~2.1m patients worldwide(1)
● Prevalent in young women (~2:1 female/male ratio)
● Life expectancy 5-10 years lower than unaffected people
● A major impact on family, social and professional life
● Symptoms include fatigue, weakness, walking and balance difficulties, vision problems
Multiple Sclerosis
(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
Multiple Sclerosis Market Global Sales(2,3)
CAGR >6%
2011 2016e
U.S.
ROW
56%
54%
44%46%
$12.5bn
$17.8bn
Key Facts about MSMS Therapies
Global MS Market - Still Dominated by ABCRE Products
16(1) ABCRE stands for Avonex®, Betaseron®/Betaferon®, Copaxone®, Rebif® and Extavia®
(2) Reported sales of ABCRE products plus Tysabri®, and Gilenya® in 2011
● “ABCRE” products(1) represented 84% of the global MS market in value in 2011
● Moderate efficacy and patients continue to relapse on therapy
● Require frequent injections
● Latest entrants represent treatment alternatives
● Drives the benefit vs. risk discussion
$3,884m31%
$2,686m21%
$1,553m12%
$494m4%
$2,350m19%
$1,511m12%
2011 Sales and Market Share in Value(2)
$154m1%
All trademarks are the property of their respective owners
17
An Exciting Oral Treatment for Relapsing MS
17
(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(5) TEMSO and TOWER; Aubagio® 7mg tablets are also available in the U.S.
● Aubagio® 14mg is the only oral MS drug to significantly delay disability progressionin 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 TOWER STUDYReduction in Progression of
Disability(2)
Placebo
-29.8%(3)p=0.0279(4)
Aubagio®
14mgPlacebo Aubagio®
14mg
0.273
0.1580.202 0.197
-31.5%(3)p=0.0442(4)
Reduction in Progression of Disability(2)
n=370n=363 n=359 n=388
TEMSO STUDY TOWER STUDYAnnualized Relapse Rate(1)
Placebo
- 31.5%p=0.0005
Aubagio®
14mg
n=370
Placebo Aubagio®
14mg
0.539
0.3190.369
0.501
n=363 n=359 n=388
Annualized Relapse Rate(1)
- 36.3%p=0.0001
®
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).
Only Therapy(1) Slowing Accumulation of Disability Sustained for 6 Months vs. Active Comparator
3 months
Active Comparators
Placebo
6 monthsEDSS
HigherHurdle
18
EDSS: Expended Disability Status Scale (1) Investigational compound(2) Based on CARE-MS II
HigherHurdle
(2)
For Illustrative Purposes
19
Rebif®
- 55%p<0.0001
n=426
0.39
0.26
0.18
0.52
n=187 n=376 n=202
Lemtrada™Rebif® Lemtrada™
- 49%p<0.0001
CARE-MS I CARE-MS IIAnnualized Relapse Rate Annualized Relapse Rate
Significantly More Effective at Reducing ARR in Pivotal Trials(1) with Unique Dosing Regimen
ARR: Annualized Relapse Rate (1) CARE-MS I and CARE-MS II were both head-to-head trials comparing Lemtrada™ versus Rebif®
Eliglustat(1) - A Novel Oral Therapy in Gaucher Disease
● Potent, novel substrate inhibitor
● Oral therapy ● Eliminating challenges of infusions
● 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
● ENCORE Phase III results (vs. Cerezyme®) expected in early 2013
20(1) Eliglustat tartrate is an investigational drug(2) Secondary endpoints included improvements in hemoglobin levels and platelet levels, as well as liver volumes
+2%
-28%
Placebo
Eliglustat
30%Absolute Difference
Change in Spleen Volume(% change at 9 months)
2121
1 Diabetes
2 Oncology
3 Multiple Sclerosis and Rare Diseases
4 Cardio-Metabolic Diseases
5 Immunology
6 Vaccines
Focusing R&D on High-Value Projects in Key Therapeutic Areas
PCSK9 mAb: First in Class and Targeting Unmet Needs in Hypercholesterolemia
22
LDL-C Change from baseline (Phase II)(2,4,5)
SAR236553 / REGN727 is developed in collaboration with Regeneron PCSK9: proprotein convertase subtilisin/kexin type 9, an enzyme that can contribute to elevated LDL-C levels through degradation of LDL-C receptorsCHD – Coronary Heart Disease(1) Cohen JC. N Engl J Med 2006;354(12):1264-72(2) McKenney, et al JACC published online March 28 2012(3) Roth et al JACC Volume 59, Issue 13, Supplement, 27 March 2012, E1620(4) Patients with primary hypercholesterolemia receiving stable atorvastatin therapy; change from baseline to week 12(5) LS mean (SE), using LOCF method* P<0.0001 for % change SAR236553 vs. placebo
● 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
-80
-70
-60
-50
-40
-30
-20
-10
0BASELINE WEEK 2 WEEK 4 WEEK 6 WEEK 8 WEEK 10 WEEK 12
SAR236553 100 mg Q2W PlaceboSAR236553 50 mg Q2W SAR236553 150 mg Q2W
∆ - 64.2%
∆ - 5.1%
∆ - 39.6%
∆ - 72.4%
Decrease in LDL-C shown is at week 12.
~21m patients globallyestimated not at goal for LDL-C(1)
(mainly at high cardiovascular risk)
Sanofi Recently Started the First EverPhase 3 Program for an Anti-PCSK9 mAb
23
● 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
● Creation of a PCSK9 Development & Launch Unit
(1) Adapted from Decision Resources 2008, Decision Resources 2010 and CVReg 2011(2) heFH: Heterozygous Familial Hypercholesterolemia
Target Population
Statin Intolerant
heFH (2)
SecondaryPrevention
PrimaryPrevention
SAR236553 / REGN727 is developed in collaboration with Regeneron
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)
● Phase III TAO study ongoing with results expected in Q2 2013
(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
TAO Study
Moderate-to-high risk NSTE-ACS with planned early invasive strategy (n=13,220)
Primary endpoint:Death/Myocardial Infarction @ day 7
OtamixabanRegimen 2(n=1,969)
OtamixabanRegimen 1(n=1,969)
UFH + Eptifibatide(n=1,969)
R
24
Sponsor-blinded interim analysis
2525
1 Diabetes
2 Oncology
3 Multiple Sclerosis and Rare Diseases
4 Cardio-Metabolic Diseases
5 Immunology
6 Vaccines
Focusing R&D on High-Value Projects in Key Therapeutic Areas
Sarilumab (Anti IL-6R mAb): Addressing an Unmet Needin Rheumatoid Arthritis
● ~1/3 of RA patients treated with anti-TNFα do not respond to therapy
● Sarilumab is a fully human, high affinity, IL-6R mAb administered subcutaneously in combinationwith methotrexate● Positive Phase II with meaningful
improvements in signs & symptoms of moderate-to-severe RA
● 2 pivotal Phase III trials ongoing● SARIL-RA-MOBILITY fully enrolled
● SARIL-RA-TARGET recruiting
● New studies to start in H1 2013
MOBILITY Trial (Phase IIb Results)
Sarilumab is developed in collaboration with RegeneronRA – Rheumatoid Arthritis IL-6R – Interleukin-6 receptorACR – American College Of Rheumatology (ACR) Scoring System
200 mg q2w
17.3*
40.4*
65.4
150 mg q2w
11.8
35.3
66.7
Placebo
1.9
15.4
46.2
ACR70ACR50ACR20
* p<0.01 versus placebo (only unadjusted p-values <0.01 are considered statistically significant)
ACR response at week 12 (%)
A&R 2011; 63; suppl.10:4041
26
● Fully human monoclonal antibody binding to IL-4Rα● Targeting the common IL-4Rα
subunit ● Dual IL-4/IL-13 cytokine antagonism
with a single agent
● Positive proof of concept datafor asthma and atopic dermatitis to be submitted for presentationat medical conferences in 2013
● Phase 2b initiation in both indications expected mid-year
27Anti IL-4Rα mAb is developed in collaboration with Regeneron
IL-4
IL-4R c
Type IReceptor
Type IIReceptor
IL-13
IL-4R IL-13R1
or
IL-4 IL-13Dominant (some overlapping) functions in :
• Initiated and drives TH2 differentiation
• Activation and growth of B cells
• Class switching to IgE and IgG1a
• Recruitment of eosinophils
• Airway hyper responsiveness (AHR)
• Goblet cell hyperplasia• Tissue remodeling• Fibrosis • Regulation of
gastrointestinal parasite expulsion
Anti IL-4Rα mAb: Targeting Asthma and Atopic Dermatitis
28
An Innovative Productwith a Breakthrough Design(1)
(1) Sanofi U.S. licensed the North American commercialization rights to the epinephrine auto-injector from Intelliject, Inc.,(2) Source: 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Practice Parameters (3) Source: Mylan Form 10-K for the period ending Dec 31, 2011 and Mylan Investor Day on Feb 21, 2012(4) IMS MAT sales through July 2012
● Nearly 6 million people in the U.S. may be at risk for anaphylaxis(2)
● One main U.S. competitor with >95% market share(3): EpiPen®
from Mylan ● Estimated U.S. sales of $570m(4)
● Auvi-Q™ offers a unique compact size and shape● Audio and visual cues guide users
through the injection process
● Retractable needle mechanism
● U.S. launch planned in Q1 2013
2929
1 Diabetes
2 Oncology
3 Multiple Sclerosis and Rare Diseases
4 Cardio-Metabolic Diseases
5 Immunology
6 Vaccines
Focusing R&D on High-Value Projects in Key Therapeutic Areas
30
Dengue Vaccine: Addressing a Growing Global Threat
First Efficacy Results
● Phase IIb results in ~4,000 patients recently published in the Lancet
● Effective against DENV 1, 3 and 4 (in the range of 60% to 90%), with only DENV 2 appearing to be resistant
● Safe and well-tolerated
Significant Disease Burden
● Estimated 220m dengue infections worldwide per year
● 2m cases of Hemorrhagic Fever
● >500,000 hospitalizations and >20,000 deaths / year
● Dengue: a public health priority in Asia and Latin America
30
Ambitious Phase III Program
● Global Phase III program ongoing
● Large scale studies in LatAm and Asia
● 31,000 children and adolescents
● Results expected in 2014
C. Diff Toxoid Vaccine: Preventing Primary Symptomatic Clostridium Difficile Infections (CDI)
31
● 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)
● Multinational Phase III trial planned to start in Q3 2013● Case driven study
● Lot consistency trial to follow
● Fast Track Development Program designation granted by CBER
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
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
● Targeted patients at high risk of CDI:● Elderly with antibiotic use, planned at-risk
admissions to hospital and long-term care facilities residents
FY 2008 FY 2009 FY 2010 FY 2011 9M 2012
14.1%
Maintaining Rigorous Control of R&D Expenses
32
● 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
● R&D/Sales ratio down 0.6 points in 9M 2012 vs. 9M 2011 (13.5% vs. 14.1%)
32
R&D/Sales Ratio (%)
14.4%13.5%
16.6%15.6%
Strengthening the R&D Leadership Team with New Talent
Philip Just LarsenDiabetes - Head of Research & Early Development
Jay Edelberg Head of PCSK9 Launch Unit
Gary Nabel SVP, Chief Scientific Officer Chairman of the Strategic Development and Scientific Advisory Council
Andrew PlumpDeputy of President R&D VP Research and Translational Medicine
33
Rodger Novak VP for Infectious diseases
Victoria Richon Oncology - Head of Research & Early Development
Eckhard Leifke Diabetes - Head of Development
Philippe Monteyne VP Head of R&D France
North America
hub
Boston hub
France hub Germany
hubAsia hub
Tokyo
Shanghai
Beijing
Ensuring R&D Contributes to Sanofi’s Success
GlobalR&D
Goals
Create an efficient global R&D organization Maximize synergies and convergence around Hub modelLeverage economies of scale Improve R&D cost structure
Focus on high-value projects Execute on late-stage projectsGuide early-stage portfolio prioritization utilizing medical value
and translational medicine
Establish new models of external innovationEnhance the value of external opportunities and partnershipsAccelerate science by establishing creative and adapted models
with partners across the healthcare ecosystem
34
APPENDICES
R&D Pipeline
35
36
Late Stage Pipeline – Pharma & Vaccines
eliglustat tartrateGlucosylceramide synthetase inhibitor
Gaucher disease
otamixabanDirect Xa inhibitor
ACS
Quadracel®Diphtheria, tetanus, pertussis& polio vaccine; 4-6 y of age
Hexaxim™ / New hexavalent vaccineDTP-HepB-Polio-Hib vaccine
iniparib (BSI-201)Squamous NSCLC (1L)
Insulin glargineNew formulation
Type 1+2 diabetes
VaxiGrip® QIV IMQuadrivalent inactivated
influenza vaccine
Fluzone® QIV IMQuadrivalent inactivated
influenza vaccine
SAR302503 (TG101348)JAK-2 inhibitor
Myelofibrosis (1L)
mipomersenApolipoprotein B-100 antisense
Severe HeFH, U.S.
DengueMild-to-severe
dengue fever vaccine
Aubagio® (teriflunomide)Relapsing forms of Multiple sclerosis
(RMS) – Monotherapy, EU
Jevtana® (cabazitaxel) Metastatic prostate cancer (1L)
SAR236553Anti-PCSK-9 mAb
Hypercholesterolemia
DTP-HepB-Polio-HibPediatric 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 IDQuadrivalent inactivated
influenza vaccine Intradermal
Allegra®
fexofenadineDry syrup, Japan
MACI®Cell-based treatment
Articular cartilage defects
mipomersenApolipoprotein B-100 antisenseHoFH and severe HeFH in EU;
HoFH in U.S.
lixisenatideGLP-1 agonist
Type 2 diabetes, EU, Japan, U.S.
Zaltrap® (aflibercept)VEGF-Trap
2nd line mCRC, EU
RegistrationPhase III
N
N
N
N
N
36
N
N
NN
N New Molecular EntityCentral Nervous System
Rare Diseases
OncologyMetabolic Disorders
VaccinesInternal Medicine
Biosurgery
Thrombosis
AgingOphthalmology
N
Early Stage Pipeline – Pharma & Vaccines
iniparib (BSI-201)Platinum-resistant ovarian cancer (2L)
FOV1101FDC prednisolone/cyclosporine
Allergic conjunctivitis
SAR231893Anti-IL4 mAb
Asthma; Atopic dermatitis
SAR3419Maytansin-loaded anti-CD19 mAb
B-cell malignancies refractory/relapsed (NHL, ALL)
SAR292833 (GRC15300)TRPV3 antagonist
Neuropathic pain, osteoarthritic pain
ferroquineAntimalarial
Malaria
SAR256212 (MM121) anti-ErbB3 mAb
Breast cancer (2L, 3L)
SAR110894H3 antagonist
Alzheimer's disease
fresolimumabTGFβ antagonist
Fibrosis
SAR245408 (XL147)Oral PI3K inhibitor
Breast cancer
SAR113945IKK-β inhibitorOsteoarthritis
SAR97276Antimalarial
Malaria
SAR245409 (XL765)Oral dual inhibitor of PI3K & mTOR
Non-Hodgkin lymphoma
Meninge ACYW conj.2nd generation meningococcal
Conjugate infant vaccine
SAR279356 (F598)Anti-PNAG mAb
Serious infections
SAR302503 (TG101348)JAK-2 inhibitor
Polycythemia vera (2L)Incyte (ruxolitinib) resistant/intolerant MF
ACAM-CdiffClostridium difficile
Toxoid vaccine
SAR339658VLA 2 antagonist
Inflammatory bowel disease
Jevtana® (cabazitaxel) Small cell lung cancer (2L)
Rabies VRVgPurified vero rabies vaccine
SAR156597IL4/IL13 Bi-specific mAb
Idiopathic pulmonary fibrosis
Phase II
N
N
N
N
N
N
N
N
N N
N
N
3737
N New Molecular EntityCentral Nervous System
Rare Diseases
OncologyMetabolic Disorders
VaccinesInternal Medicine
Biosurgery
Thrombosis
AgingOphthalmology
N
N
N
38
Early Stage Pipeline – Pharma & Vaccines
SAR153192Anti-DLL4 mAb
Solid tumors
SAR126119TAFIa inhibitor
Acute ischemic stroke
SAR252067Anti-LIGHT mAb
Crohn’s disease & Ulcerative colitis
RotavirusLive Attenuated Tetravalent
Rotavirus oral vaccine
GZ402674Non-camptothecin topo1 inhibitor
Solid tumors
SAR127963P75 receptor antagonist
Trauma brain injury
SAR100842LPA-1/LPA-3
Skin manifestation of scleroderma
Streptococcus pneumoniaMeningitis & pneumonia vaccine
SAR650984Anti-CD38 naked mAb
Hematological malignancies
GZ404477(AAV-hAADC)Gene therapy
Parkinson's disease
SAR113244Anti-CXCRS mAb
Systemic lupus erythematosus
Pseudomonas aeruginosaAntibody fragment product
Prevention of ventilator-associated pneumonia
SAR566658Maytansin-loaded anti-DS6 mAb
DS6 positive solid tumors
SAR391786Rehabilitation post orthopedic surgery
SAR407899Rho kinase inhibitor
Diabetic nephropathy
Tuberculosis Recombinant subunit vaccine
SAR307746Anti-Ang2 mAb
Solid tumors
SAR228810Anti-protofibrillar AB mAb
Alzheimer’s disease
lixisenatide + Lantus®
GLP-1 agonist + insulin glargineFix-Flex / Type 2 diabetes
RetinoStat®
Gene therapy Wet age-related macular degeneration (AMD)
SAR125844C-Met kinase inhibitor
Solid tumors
SAR399063DHA-GLP + vit DPre-sarcopenia
SAR164653Cathepsin A inhibitor
CV-related complications & deaths in diabetic patients
StarGen®
Gene therapyStargardt disease
CombinationsSAR245409 / MSC1936369B
SAR245408/SAR256212 (MM121)Solid tumors
SAR404460DHA-GPL + Vit DPre-sarcopenia
GZ402665(rhASM)
Niemann-Pick type B
GZ402663 (sFLT-01)Gene therapy
Age-related macular degeneration(AMD)
SAR405838 (MI-773)HDM2 / p53 antagonist
Solid tumors and hematological malignancies
GZ402671GCS InhibitorFabry Disease
UshStat®
Gene therapyUsher syndrome 1B
SAR260301PI3K β selective
PTEN – Deficient tumors
Phase IN
N
N
N
N
N N
N N
N
N N N
38
NN
N
N
N
N
N New Molecular EntityCentral Nervous System
Rare Diseases
OncologyMetabolic Disorders
VaccinesInternal Medicine
Biosurgery
Thrombosis
AgingOphthalmology
N
N
N
N
N
N
N
39
Phase I Phase II Phase III Registration TOTAL
Oncology 8 4 2 0 14
Metabolic Disorders 2 0 1 2 5
Thrombosis 1 0 1 0 2
Central Nervous System 2 0 0 2 4
Internal Medicine 3 7 1 0 11
Ophthalmology 4 1 0 0 5
Genetic Diseases 2 0 1 0 3
Aging 4 3 0 0 7
Vaccines 4 3 5 2 14
TOTAL 30 18 11 6
R&D Pipeline Summary TableNew Molecular Entities (NMEs) and Vaccines
48 17NMEs & Vaccines
65
39
51
40
Expected R&D Milestones – Pharmaceuticals
40
Product Event TimingZaltrap® (aflibercept) Expected EC approval in 2nd line mCRC in EU Q1 2013
Lyxumia® (lixisenatide) Expected EC approval in type 2 diabetes in EU Q1 2013
Lyxumia® (lixisenatide) Expected FDA file acceptance in type 2 diabetes in U.S. Q1 2013
AubagioTM (teriflunomide) Expected CHMP decision in RMS in EU Q1 2013
Kynamro™ (mipomersen) Expected FDA decision in hoFH in the U.S. Q1 2013
eliglustat tartrate Phase III headline results in Gaucher disease (ENCORE) Q1 2013
Lemtrada™ (alemtuzumab) Expected CHMP decision in RMS in EU Q2 2013
iniparib Phase III headline results in 1st line squamous NSCLC Q2 2013
otamixaban Phase III headline results in ACS Q2 2013
JAK2 inhibitor Phase III headline results in myelofibrosis Q2 2013
Insulin glargine (new formulation) First Phase III headline results in diabetes Q2 2013
41
Expected R&D Milestones – Vaccines
41
Product Event TimingVaxigrip® QIV IM Expected submission of regulatory file in EU Q1 2013
6-in-1 paediatric vaccine Expected CHMP opinion in EU Q1 2013
Fluzone® QIV IM Expected FDA decision in the U.S. Q2 2013
C. Diff vaccine Expected start of Phase III study Q3 2013