Download - 2012 - BofA Merill Lynch HC Conference
BofA-Merrill Lynch Healthcare Conference
Dr. Elias Zerhouni, President - Global R&D
London, September 12th, 2012
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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, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Growth Platforms Accounted for 64.9% of Group Sales and Grew by +7.6% in Q2 2012
5 (1) New Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises (2) Multaq®, Jevtana® and Mozobil®
+13.7%
+3.0%
+11.3%
+9.1%
+9.1%
Innovative Products(2) €152m +4.5%
+9.8%
Vaccines €783m
Diabetes Solutions €1,436m
Consumer Health Care €738m
Animal Health €576m
Emerging Markets €2,823m
New Genzyme(1) €434m
Growth at CER
Executing Successful Strategy to Reposition Sanofi
Deliver sustainable growth
and generate improved
shareholder returns Adapt structure for future challenges and opportunities 3
Pursue external growth opportunities 2
Increase innovation in R&D 1
6 6
Multiple Regulatory Milestones Expected in H2 2012
hoFH: Homozygous Familial Hypercholesterolemia heFH: Heterozygous Familial Hypercholesterolemia 7
Zaltrap®, Kynamro™, Aubagio®, Lyxumia® 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
PDUFA: Prescription Drug User Fee Act CHMP: Committee for Medicinal Products for Human Use
Expected Milestones
FDA Approval on Aug 4th 2012 CHMP Opinion: Q4 2012
CHMP Opinion: Q4 2012 FDA Submission: Dec 2012
FDA Re-Submission as soon as possible CHMP Opinion: Q2 2013
Relapsing Forms of Multiple Sclerosis
PDUFA Date: Sep 12th 2012 CHMP Opinion: Q1 2013
Relapsing Forms of Multiple Sclerosis
Metastatic Colorectal Cancer
Type 2 Diabetes
CHMP Opinion: Q4 2012 PDUFA Date: Jan 29th 2013
hoFH/severe heFH in EU and hoFH in the U.S
Products Targeted Indications
®
®
®
TM
Now Available in the U.S.
8 (1) Van Cutsem, et al. Ann Oncol. 2011;22(suppl 5). Abstract O-0024 and presentation at: ESMO 13th WCGIC.
June 22-25, 2011; Barcelona, Spain.
Key Facts about MS
● 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)
Oncology
Only Therapy(1) Slowing Accumulation of Disability Sustained for 6 months vs. Active Comparator
3 month
Active Comparators
Placebo
6 month EDSS
Higher Hurdle
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(1) Investigational compound (2) Based on CARE-MS II
Higher Hurdle
(2)
For Illustrative Purposes
Typical Threshold for Approval
A GLP-1 Agonist for A1c Control with a Unique Biological Profile
Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is currently not approved or licensed anywhere in the world. Lixisenatide was in-licensed from Zealand Pharma A/S. (1) Except for the device intended for Japan (2 steps to maintenance dose with one pen) 16
Pronounced effect on postprandial glucose (PPG) levels
Favorable safety profile with low risk of hypoglycemic events
Once-daily injection, simple 1 step to maintenance dose, 1 pen per dose(1)
A Unique Profile:
®
T2D Patients Treated with Basal Insulin(1) (worldwide)
On basal insulin On basal insulin with controlled fasting
glucose control but A1c >7%
4 million on other
basal insulins(2)
4 million on Lantus®
4 million
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
®
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Mono Mono Japan
Monotherapy
Placebo-controlled in OAD failure
M (metformin)
F1 (metformin)
M Asia (metformin)
S (sulfonylurea)
P (pioglitazone)
X vs. exenatide Active-controlled
L Asia
L Placebo-controlled on top of
basal insulin Duo 1
Phase III Program
Fix-Flex Device Has Been Developed for Joint Administration of Lantus® and Lyxumia®
● Convenience of a single injection per day coupled with possibility to adjust Lantus® dose
● Entering phases for industrialization, validation, usability and manufacturing
● Device expected to be available mid-2013 for Phase III initiation
+ ®
Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is currently not approved or licensed anywhere in the world. 18
New Glargine Formulation with Unique Pharmacokinetics
● New glargine formulation: ● Unique flat PK/PD profile ● Lower injection volume
● Phase III trials ongoing in T2D high-dose insulin users(1)
● Targeting ~1,600 patients
● Second set of studies recently started
EDITION I T2D Patients Basal Bolus
EDITION II T2D Patients Basal + OAD
PK/PD – Pharmacokinetic/Pharmacodynamic OAD – Oral anti-diabetic drugs (1) ClinicalTrials.gov Identifier: NCT1499082 & NCT01499095
New Insulin Glargine Formulation Depot formation after subcutaneous injection
Schematic illustration
Lantus® New Glargine Formulation
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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
Otamixaban Regimen 2 (n=1,969)
Otamixaban Regimen 1 (n=1,969)
UFH + Eptifibatide (n=1,969)
R
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Sponsor-blinded interim analysis
Eliglustat: a Novel Oral Therapy in Gaucher Disease(1)
● Potent, novel substrate inhibitor
● Convenience of oral therapy ● Eliminating challenges of
infusing patients
● Clinical profile expected to be similar to Cerezyme®
● 4-year Phase II data at WORLD congress in February 2012
● Phase III trials fully recruited
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(1) Investigational drug (2) Patient from Phase II clinical trial WORLD – World Organization of Research on Lysosomal Diseases
December 2006 pre-treatment (18 years)
December 2009 3 years post treatment (21 years)(2)
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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
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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
Ensuring R&D Contributes to Sanofi’s Success
Global R&D
Goals
An efficient global R&D organization Maximize synergies and convergence around Hub model Exploit economies of scale Improve R&D cost structure
Focus on high-value projects
Execute on late-stage projects Medical value and translational feasibility to guide early-stage
portfolio prioritization
Establish new models of external innovation Enhance the value of external opportunities and partnerships Create open and creative models with partners across the
healthcare ecosystem
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APPENDICES R&D Pipeline
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Late Stage Pipeline – Pharma & Vaccines
eliglustat tartrate Glucosylceramide synthetase inhibitor
Gaucher disease
otamixaban Direct Xa inhibitor
ACS
Quadracel® Diphtheria, tetanus, pertussis & polio vaccine; 4-6 y of age
Hexaxim® DTP-HepB-Polio-Hib vaccine
iniparib (BSI-201)
squamous NSCLC (1L)
lixisenatide (AVE0010) GLP-1 agonist
Type 2 diabetes, U.S.
Fluzone® QIV IM Quadrivalent inactivated
influenza vaccines
Plavix® clopidogrel bisulfate PAD, STEMI, Japan
ombrabulin (AVE8062) Vascular disrupting agent
Soft tissue sarcoma (2L/3L)
New formulation Insulin glargine
Type 1+2 diabetes
VaxiGrip® QIV IM Quadrivalent inactivated
influenza vaccines
teriflunomide Relapsing forms of multiple sclerosis
(RMS) – monotherapy, U.S. / EU
SAR302503 (TG101348) JAK-2 inhibitor
Myelofibrosis (1L)
mipomersen Apolipoprotein B-100 antisense
Severe HeFH, U.S.
alemtuzumab Anti-CD52 mAb
Multiple sclerosis, U.S. / EU
Jevtana®
Cabazitaxel Metastatic prostate cancer (1L)
SAR236553 Anti-PCSK-9 mAb
Hypercholesterolemia
Allegra® fexofenadine
Dry syrup, Japan
SYNVISC-ONE™
Medical device Pain in hip OA
sarilumab (SAR153191) Anti-IL-6R mAb
RA
mipomersen Apolipoprotein B-100 antisense HoFH and severe HeFH in EU;
HoFH in U.S.
MACI®
Cell-based treatment Articular cartilage defects
Dengue Mild-to-severe
dengue fever vaccine
lixisenatide (AVE0010) GLP-1 agonist
Type 2 diabetes, EU / Japan
teriflunomide Multiple sclerosis
(adjunct therapy & CIS)
DTP-HepB-Polio-Hib Pediatric hexavalent vaccine
aflibercept VEGF-Trap
2nd line mCRC, U.S. / EU
Registration Phase III
N
N
N N
N
N
N
N
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N
N N
N
N New Molecular Entity Central Nervous System
Genetic diseases
Oncology Metabolic Disorders
Vaccines Internal Medicine
Biosurgery
Thrombosis
Aging Ophthalmology
Status as of July 26, 2012
Early Stage Pipeline – Pharma & Vaccines
iniparib (BSI-201)
Ovarian cancer (2L)
FOV1101 FDC prednisolone/cyclosporine
Allergic conjunctivitis
SAR231893 Anti-IL4 mAb
Asthma; Atopic dermatitis
SAR3419 Maytansin-loaded anti-CD19 mAb
B-cell malignancies refractory/relapsed (DLBCL, ALL)
safotibant (FOV2304) Bradykinin B1 antagonist Diabetic macular edema
ferroquine Antimalarial
Malaria
SAR256212 (MM121) anti-ErbB3 mAb
Breast cancer (2L, 3L)
SAR110894 H3 antagonist
Alzheimer's disease
fresolimumab TGFβ antagonist
Fibrosis
SAR245408 (XL147) Oral PI3K inhibitor
Endometrial cancer (1L)
SAR113945 IKK-β inhibitor Osteoarthritis
SAR97276 Antimalarial
Malaria
SAR245409 (XL765) Oral dual inhibitor of PI3K & mTOR
Breast cancer (1L)
SAR292833 (GRC15300) TRPV3 antagonist
Neuropathic pain, osteoarthritic pain
SAR279356 (F598) Anti-PNAG mAb Serious infections
ombrabulin (AVE8062) Vascular disrupting agent
Ovarian cancer (2L)
ACAM-Cdiff Clostridium difficile
Toxoid vaccine
SAR302503 (TG101348) JAK-2 inhibitor
Polycythemia vera (2L) Incyte (ruxolitinib) resistant/intolerant MF
Rabies VRVg Purified vero rabies vaccine
Jevtana®
Cabazitaxel, Microtubule inhibitor Small cell lung cancer (2L)
Meninge ACYW conj. 2nd generation meningococcal
Conjugate infant vaccine
Phase II
N
N
N
N
N
N
N
N
N
N
N N
N N
30 30
N New Molecular Entity Central Nervous System
Genetic diseases
Oncology Metabolic Disorders
Vaccines Internal Medicine
Biosurgery
Thrombosis
Aging Ophthalmology
Status as of July 26, 2012
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Early Stage Pipeline – Pharma & Vaccines
SAR153192 Anti-DLL4 mAb
Solid tumors
SAR405838 (MI-773) MDM2 / p53 antagonist
Solid tumors and hematological malignancies
SAR252067 Anti-LIGHT mAb
Crohn’s disease & Ulcerative colitis
Rotavirus Live Attenuated Tetravalent
Rotavirus oral vaccine
GZ402674 Non-camptothecin topo1 inhibitor
Solid tumors
SAR127963 P75 receptor antagonist
Trauma brain injury
SAR339658 VLA 2 antagonist
Inflammatory Bowel disease
Streptococcus pneumonia Meningitis & pneumonia vaccine
SAR650984 Anti-CD38 naked mAb
Hematological malignancies
GZ404477 (AAV-hAADC) Gene therapy
Parkinson's disease
SAR100842 LPA-1/LPA-3
Skin manifestation of scleroderma
Pseudomonas aeruginosa Antibody fragment product
Prevention of ventilator-associated pneumonia
SAR566658 Maytansin-loaded anti-DS6 mAb
DS6 positive solid tumors
SAR391786 Rehabilitation post orthopedic surgery
SAR156597 IL4/IL13 Bi-specific mAb
Idiopathic Pulmonary Fibrosis
Tuberculosis Recombinant subunit vaccine
SAR307746 Anti-Ang2 mAb
Solid tumors
SAR228810 Anti-protofibrillar AB mAb
Alzheimer’s disease
SAR407899 Rho kinase inhibitor
Diabetic nephropathy
RetinoStat® Gene therapy
Wet age-related macular degeneration (AMD)
SAR125844 C-Met kinase inhibitor
Solid tumors
SAR399063 DHA-GLP + vit D Pre-sarcopenia
lixisenatide + Lantus® GLP-1 agonist + insulin glargine
Fix-Flex / Type 2 diabetes
StarGen® Gene therapy
Stargardt disease
Combinations SAR245409 / MSC1936369B
SAR245408/SAR256212 (MM121) Solid tumors
SAR404460 DHA-GPL + Vit D Pre-sarcopenia
SAR164653 Cathepsin A inhibitor
CV-related complications & deaths in diabetic patients
GZ402663 (sFLT-01) Gene therapy
Age related Macular Degeneration (AMD)
SAR393590 (Oral clofaribine) DNA synthesis inhibitor
Hematological malignancies
GZ402665 (rhASM)
Niemann-Pick type B
SAR126119 TAFIa inhibitor
Acute ischemic stroke
UshStat® Gene therapy
Usher syndrome 1B
Jevtana®
Cabazitaxel, Microtubule inhibitor Gastric cancer (2L)
Phase I N
N
N
N
N
N
N
N
N
N
N
N
N N
N
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N
N
N
N
N
N
N New Molecular Entity Central Nervous System
Genetic diseases
Oncology Metabolic Disorders
Vaccines Internal Medicine
Biosurgery
Thrombosis
Aging Ophthalmology
N
N N
N
Status as of July 26, 2012
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Expected R&D Milestones – Vaccines
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Product Event Timing Shan5® Start of Phase III study Q3 2012
Fluzone® QIV IM Submission of regulatory file in the U.S. Q3 2012
HexaximTM Submission of regulatory file in EU Q3 2012
Fluzone® QIV ID Start of Phase III study Q4 2012
Vaxigrip® QIV IM Submission of regulatory file in EU Q1 2013
Fluzone® QIV IM Expected licensure in the U.S. Q2 2013
HexaximTM Expected licensure in EU and international countries Q2 2013