The document summarizes Olivier Brandicourt's presentation at the JP Morgan Healthcare Conference on January 12, 2016. Some key points from the presentation include:
- Sanofi outlined four strategic priorities to drive future success - reshaping the portfolio, delivering outstanding launches, simplifying the organization, and sustaining innovation in R&D.
- Sanofi entered exclusive negotiations with Boehringer Ingelheim for a potential business swap that would make Sanofi a global leader in consumer healthcare and Boehringer Ingelheim the second largest animal health company.
- Sanofi highlighted plans to focus resources on key therapeutic areas and launch several major new products, with an expectation of €12-
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2016/01 - JP Morgan HC Conference
1. JP Morgan Healthcare Conference
Olivier Brandicourt – Chief Executive Officer
San Francisco - January 12, 2016
2. 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 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 initiatives 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, 2014. Other than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or statements.
3. Key Accomplishments Since April 2015
On Our Way to Future Success
3
(1) LixiLan (U.S.), sarilumab (U.S.) and lixisenatide (U.S.)
(2) BioNTech, Evotec, Google Life Sciences, Hanmi, Lexicon Pharmacuticals, Voyager Therapeutics and Regeneron
(3) December 15, 2015 press release: Sanofi and Boehringer Ingelheim enter exclusive negotiations on business swap : Sanofi would
become a global leader in Consumer Healthcare and Boehringer Ingelheim would become second largest Animal Health company
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3 launches of major products – Toujeo®, Praluent® and Dengvaxia®
3 submissions for regulatory review(1)
Accelerated BD(2) activities and strategic alliance in Immuno-oncology
Key first transaction announced to reshape the portfolio(3)
New organizational model to drive focus and simplification
2015-2020 strategic roadmap to create long term value
4. We Have Four Strategic Priorities
4
Reshape
the portfolio
Deliver
outstanding
launches
Simplify the organization
Sustain
innovation
in R&D
1 2 3
4
5. ● Multiple Sclerosis(1)
● Oncology(1)
● Immunology(1)
● Consumer
Healthcare(2)
● Animal Health
● Generics(2)
in Europe
● Diabetes/CV
● Vaccines
● Rare Diseases(1)
● Emerging Markets(2)
Reshape the Portfolio
5
1
Explore strategic
options
CA
Sustain
leadership
Build competitive
positions
B
(1) Will be part of Specialty Care Global Business Unit
(2) Will be part of General Medicines and Emerging Markets Global Business Unit
6. Sanofi and Boehringer Ingelheim Enter Exclusive
Negotiations on Business Swap
6
Potential exchange of Sanofi Animal Health (Merial)
and Boehringer Ingelheim (BI) CHC businesses
● Enterprise value:
● Merial: €11.4bn
● BI CHC: €6.7bn
● Gross cash payment from BI to Sanofi of €4.7bn
(1) Following consultations with the relevant social bodies and subject to appropriate regulatory approvals
(2) Taking into account the anticipated CHC results, share buybacks and potential synergies
BI CHC:
7 core brands
Expected CHC
pro forma sales of
~€5.1bn
in 2015e
Sanofi would
become a
Leading
player in CHC
Goal is to close the potential transaction in Q4 2016(1)
● Sanofi intends to use a portion of the net proceeds of the
transaction to repurchase shares
● The overall transaction is expected to be business EPS neutral
in 2017 and accretive in subsequent years(2)
>60%
of sales
7. 7
4.6%
4.6%
4.4%
4.3%
3.4%
2.5%
2.1%
1.1%
1.0%
71.9%
Other
Global Categories(2) Segment Size
in €bn
Sanofi +
BI CHC
VMS(3) 27.6 #3
Cough & Cold Care 17.2 #6
Digestive health 14.4 #1
Pain Care 13.2 #2
Allergy Solutions 3.1 #3
Feminine Care 0.8 #1
Combined Worldwide CHC
Market Share(1)
Combined Worldwide CHC Sales
- Priority Categories(4)
(pro forma)
Sanofi to Become a Global Leader in CHC
(1) Nicholas Hall & Company, MAT Q3 2015
(2) As per Sanofi definition
(3) Vitamins, Minerals and Supplements
(4) Source: Nicholas Hall & Company, FY 2014
Taisho
Reckitt Benckiser
Pfizer
J&J
GSK
Takeda
P&G
Bayer
+
8. 8
Committed to Diabetes and Cardiovascular Diseases
1 Develop the
insulin franchise
4
3
Lead the market shift to managing
diabetes outcomes
A
Google
Life Sciences
2
Strengthen the pipeline through external
opportunities and ambitious research
Transform the management of
hypercholesterolemia
Ambition to grow Diabetes franchise beginning in 2019(1)
Praluent® multi-blockbuster potential(2)
(1) Diabetes sales are expected to decline at an average annualized rate of -4% to -8% at CER over 2015-2018
(2) As of December 31, 2015, Sell-side analyst consensus for Praluent in 2020 per Vara is € 3,063m
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LixiLan filed in the U.S.
with PRV
Lexicon and Hanmi deals
closed
Significant U.S. market
access achieved
9. 9
Strengthening our R&D Portfolio in Diabetes
with Two In-Licensing Agreements
A
(1) SGLT2 (sodium-glucose cotransporter type 2) is a transporter responsible for most of the glucose reabsorption performed by the kidney
SGLT1 (sodium-glucose cotransporter type 1) is a transporter responsible for glucose and galactose absorption in the gastrointestinal tract,
and to a lesser extent than SGLT2, glucose reabsorption in the kidney
(2) Subject to customary closing conditions
(3) LAPS CA-Exendin-4 analog
T1DM: Diabetes mellitus type 1
Sotagliflozin - Phase II in T2 Diabetes
Phase III in T1 Diabetes
● Dual SGLT1 and SGLT2 inhibitor(1)
● Limiting meal time glucose absorption and
increasing renal glucose excretion
● Oral administration
● Adjunct therapy
to insulin
in T1DM
● Favorable
safety profile
Immunology
Efpeglenatide – Phase II
● Long acting GLP-1(3)
● Diabetes/Obesity
● Weekly/monthly administration
LAPS Insulin 115 (HM12470) – Phase I
● Long acting insulin
● Less side-effects (hypoglycemia, obesity)
● Weekly administration
LAPS Insulin Combo – Pre-clinical
● Long acting insulin + efpeglenatide combination
● Weekly administration
(2)
10. Growing Faster than Market in Vaccines
10
A
Further develop strong vaccine brands
● Flu vaccines
● Pediatric combinations
● Adult boosters
Successfully launch Dengvaxia®
Expand our manufacturing
capacity
Deliver novel high-value
vaccines e.g. C. diff vaccine
2015e2014
€4.0bn
2020e
Pediatric
& boosters
Flu
Dengue
~75%
of
sales
Projected Sanofi Pasteur Sales
1
2
3
4
High
single digit
sales CAGR
at CER
11. Sustaining Leadership in Rare Diseases
11
A
● Sustain market share through patient-centered approach,
product differentiation and market access
● Grow market through patient screening and manufacturing expansion
● Advance internal and partnered novel pipeline
Sales CAGR for Rare Diseases expected at high single digit at CER over 2015-2020
1
2
3
Undiagnosed(1)
Undiagnosed(1)
Undiagnosed(1)
(1) Genzyme internal analysis. Include China and India
12. Retaining #1 Position in Emerging Markets
through Greater Focus
12
Leader in Emerging Markets(1)
● Increase focus on priority countries/regions
● Prioritize resource allocation
● Adapt industrial footprint
● Redefine scope to exclude Eastern Europe(1)
● Win the emerging middle class
● Innovate specifically for Emerging Markets
● Optimize trade and channel management
#3 in China
#1 in Brazil
#2 in Russia
#4 in India
#2 in Mexico
A
A top 3 MNC player in BRIC-M
1
2
3
4
MNC: Multinational corporation
(1) World excluding U.S., Canada, Western & Eastern Europe (except Russia, Ukraine, Georgia, Belarus and Armenia),
Japan, South Korea, Australia, New Zealand and Puerto Rico
13. Growing our Multiple Sclerosis Franchise
13
● Successfully complete global
launches of Aubagio® and Lemtrada®
● Expand LCM activities to maximize
support to existing products
● Reinforce presence in “high efficacy”
category
● Enter the neuroprotection/
remyelination segment
B
Q1
2013
Q2
2013
Q3
2013
Q4
2013
Q1
2014
Q2
2014
Q3
2014
Q4
2014
Q1
2015
Q2
2015
Q3
2015
Série2
Série1
Multiple Sclerosis Franchise
Reported sales (€m)
€923m
®
1
2
3
4
Ambition to double the size of the MS franchise from 2015 to 2020
LCM: Life Cycle Management
14. Rebuilding a Competitive Position in Oncology
14
● Maximize clinical assets, particularly isatuximab
(anti-CD38 mAb) and Antibody-Drug Conjugates
● Build a transformative pipeline
● Immuno-oncology collaboration with Regeneron
● Collaboration with BioNTech on mRNA therapeutics
● Rebuild critical mass
Oncology Opportunity
Largest therapeutic area
for pharmaceuticals
Strong growth driven
by unmet need and
groundbreaking science
B
1
2
3
ADCs: Antibody-Drug Conjugates
15. Sarilumab and Dupilumab Represent Cornerstones
of a New Immunology Franchise
15
● Multi-disease, best in class drug
targeting Th2 pathway
● Breakthrough treatment for
atopic dermatitis
● Further opportunities in asthma
and nasal polyposis
● Multi-blockbuster potential
across key indications
● FDA submission
in AD planned for
Q3 2016
Immunology
B
● Entering an €18bn RA market
where unmet need is still high
● IL-6 class >€1bn in sales and
growing >20%
● Aim to be preferred 2nd line for
TNF-IR patients and preferred
monotherapy
● Goal to differentiate through
dosing, bone impact
● Filed with FDA
in Q4 2015
RA: Rheumatoid Arthritis TNF-IR: TNF inadequate responders AD: Atopic Dermatitis
16. 16
Focus on 6 Products … … and Excel in Execution
New GBU organization
with clear accountability,
P&L ownership and life cycle
management to focus on:
● Delivering differentiated
products rapidly
● Shaping the market
● Securing market access
● Driving uptake
Deliver Outstanding Launches2
Expected combined peak sales of €12bn to €14bn(1)
(1) At CER, non-risk adjusted sales projections through 2025
17. Global Roll-out Underway for Three Major Products
● Rapid market access
obtained in the U.S.(1)
● Showing early promise
in key markets
● U.S. uptake trending
favorably compared to
diabetes analogues(2)
● Launched globally
in 20 countries
● Now accessible on
formularies covering
~150m patients
in the U.S.
● Only PCSK9 inhibitor
preferred across
UnitedHealth Group
formularies
● ODYSSEY OUTCOMES
interim efficacy analysis
expected in H2 2016(3)
● First ever dengue
vaccine
● Priority introduction in
large endemic countries
● Approvals recently
granted in Mexico, the
Philippines and Brazil(4)
● Submitted in over 20
countries
17
Praluent® is developed and commercialized in collaboration with Regeneron
(1) As of January 1, 2016, 86% of commercial and 91% of Medicare lives covered
(2) Toujeo® analogues include: Bydureon® (AstraZeneca), Farxiga® (AstraZeneca), Invokana® (J&J), Levemir® (Novo Nordisk),
Tanzeum® (GlaxoSmithKline), Tresiba® (Novo Nordisk) and Trulicity® (Eli Lilly)
(3) Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred
(4) The Mexican Federal Commission for the Protection against Sanitary Risks, Philippines' Food and Drug Administration and Brazilian
regulatory authorities ANVISA approved Dengvaxia®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue
virus serotypes in individuals from 9-45 years of age living in endemic areas.
18. 18
N New Molecular Entity
Immunology
Rare Diseases
Oncology
Diabetes
Vaccines
Infectious Diseases
Cardiovascular Diseases
Neurodegenerative Diseases
Ophthalmology
Multiple Sclerosis
GZ402668
GLD52 (anti-CD52 mAb)
Relapsing multiple sclerosis
GZ402666
neo GAA
Pompe Disease
SAR113244
Anti-CXCR5 mAb
Systemic lupus erythematosus
SAR339375
Anti-miR21 RNA
Alport syndrome
GZ389988
TRKA antagonist
Osteoarthritis
SAR439774 (ALN-AT3)
siRNA targeting Anti-Thrombin
Haemophilia
SAR425899
GLP-1R/GCGR dual agonist
Diabetes
SAR228810
Anti-protofibrillar AB mAb
Alzheimer’s disease
SAR438335
GLP-1R/GIPR dual agonist
Diabetes
SAR422459
ABCA4 gene therapy
Stargardt disease
SAR566658
Maytansin-loaded anti-CA6 mAb
Solid tumors
UshStat®
Myosin 7A gene therapy
Usher syndrome 1B
SAR408701
Anti-CEACAM5 ADC
Solid tumors
SAR366234
EP2 receptor agonist
Elevated intraocular pressure
SAR439684
PD-1 inhibitor
Cancer
Streptococcus pneumonia
Meningitis & pneumonia vaccine
SAR428926
LAMP-1 inhibitor
Cancer
Herpes Simplex Virus Type 2
HSV-2 vaccine
SAR439152
Myosin inhibitor
Hypertrophic cardiomyopathy
Phase I
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
dupilumab
Anti-IL4Rα mAb
Nasal polyposis;
Eosinophilic oesophagitis
GZ402671
Oral GCS Inhibitor
Fabry Disease
SAR156597
IL4/IL13 Bi-specific Ab
Idiopathic pulmonary fibrosis
olipudase alfa
rhASM
Niemann-Pick type B
sarilumab
Anti-IL6R mAb
Uveitis
Rabies VRVg
Purified vero rabies vaccine
Combination
ferroquine / OZ439
Antimalarial
Meningitis ACYW conj.
2nd generation meningococcal
conjugate infant vaccine
isatuximab
Anti-CD38 naked mAb
Multiple myeloma
Tuberculosis
Recombinant subunit vaccine
Fluzone® QIV HD
Quadrivalent inactivated
influenza vaccine - High dose
Phase II
N
N
N N
N
LixiLan
lixisenatide + insulin glargine
Fixed-Ratio / Type 2 diabetes
SAR342434
insulin lispro
Type 1+2 diabetes
sarilumab
Anti-IL6R mAb
Rheumatoid arthritis, EU
dupilumab
Anti-IL4Rα mAb
Atopic dermatitis, Asthma
patisiran (ALN-TTR02)
siRNA inhibitor targeting TTR
Familial amyloidotic polyneuropathy
revusiran (ALN-TTRsc)
siRNA inhibitor targeting TTR
Familial amyloidotic cardiomyopathy
Jevtana®
cabazitaxel
Metastatic prostate cancer (1L)
Clostridium difficile
Toxoid vaccine
Rotavirus
Live attenuated tetravalent
Rotavirus oral vaccine
VaxiGrip® QIV IM
Quadrivalent inactivated
influenza vaccine (3-36 months)
Phase III
N
N
N
N
N
Registration
lixisenatide
GLP-1 agonist
Type 2 diabetes, U.S.
sarilumab
Anti-IL6R mAb
Rheumatoid arthritis, U.S.
Dengvaxia®
Mild-to-severe
dengue fever vaccine
PR5I
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine, U.S.,
EU
VaxiGrip® QIV IM
Quadrivalent inactivated
influenza vaccine (3 years+)
N
N
3 Sustain Innovation in R&D(1)
(1) Pipeline chart as of November 6, 2015
19. Diabetes
Vaccines
Rare Diseases
1
2
3
4
19
Isatuximab - Multiple Myeloma
Immuno-oncology - Various oncology indications
5
6
7
(1) Patisiran, revusiran and ALN-AT3 developed in collaboration with Alnylam
Potentially Transformative Drugs in Earlier Stages
of Development
Selected R&D Assets
Oncology
Immunology
8
Olipudase alfa - Niemann-Pick type B
Patisiran(1)
- Familial Amyloidotic Polyneuropathy
Revusiran(1)
- Familial Amyloidotic Cardiomyopathy
Dual agonists - Type 2 Diabetes
C. difficile vaccine - Nosocomial infections
IL4/IL13 Bi-specific Ab - Idiopathic Pulmonary Fibrosis
ALN-AT3(1)
- Haemophilia
NeoGAA - Pompe9
10
20. 20
Key R&D Milestones Expected in 2016
20
Expected Regulatory Decisions Q1 Q2 Q3 Q4
● Lixisenatide in Diabetes (U.S.)
● LixiLan in Diabetes (U.S.)
● Sarilumab in Rheumatoid Arthritis (U.S.)
Expected Regulatory Submissions Q1 Q2 Q3 Q4
● LixiLan in Diabetes (E.U.)
● Dupilumab in Atopic Dermatitis (U.S.)
Expected Phase III / IIIb Data Q1 Q2 Q3 Q4
● Dupilumab in Atopic Dermatitis
● Insulin lispro in Diabetes (SORELLA )
● Sarilumab in Rheumatoid Arthritis (MONARCH)
● Praluent® ODYSSEY OUTCOMES interim analysis(1)
Expected Phase III Starts Q1 Q2 Q3 Q4
● Olipudase alfa in Niemann Pick type B(2)
● NeoGAA in Pompe
● Fitusiran in Hemophilia
● Efpeglenatide in Diabetes
● Sotagliflozin in Diabetes
● Isatuximab in Multiple Myeloma
(1) Interim analysis for futility when ~50% of events have occurred; second interim analysis for futility and overwhelming efficacy when ~75% of
events have occurred in H2 2016
(2) Pivotal phase II/III trial
22. The Roadmap for Sanofi
22
● Invest for the future
● Refocus the portfolio
● Execute launches
● Reinforce pipeline through
business development
● Simplify the organization
● Accelerate growth
from priority launches
● Continue to build scale
in priority businesses
● Capture margin
improvement
1
2
2018-20
Accelerate
growth
2015-17
Reshape
Sanofi