SlideShare a Scribd company logo
1
Vaccines
Investor Event
Part 2
Leading with innovation
December 1st, 2021
Vaccines Investor Event | Agenda
Q&A session
Thomas Triomphe Head of Vaccines GBU
Paul Hudson Chief Executive Officer
Thomas Triomphe Head of Vaccines GBU
Bill Averbeck Head of Influenza Franchise
Kimberly Tutwiler Head of RSV Franchise
Q&A session
Frank DeRosa Head of Research for mRNA CoE
Jean-François Toussaint
Thomas Grenier
Head of Vaccines R&D
Head of Franchises & Product Strategy
Conclusion
Growing current
business
Leading with
innovation
Introduction
We Play to Win
Winning in Influenza
All infant protection
against RSV
Unlocking the potential of
mRNA
Broadening the pipeline to
address unmet needs
Building an innovative & diversified pipeline Jean-François Toussaint Head of Vaccines R&D
CoE: Center of Excellence
2
Jean-François Toussaint
Building an innovative &
diversified pipeline
Head of Vaccines Research
& Development
Building an innovative and diversified pipeline to deliver
sustainable growth
4
Opening a new chapter at Sanofi Vaccines,
expanding to new disease areas
Rejuvenated pipeline, with
10 new development
candidates by 2025
(of which 6 mRNAs)
Focused on
first-in-class / best-in-class
R&D objectives
Leveraging state of the art immunology &
antigen design
Selecting the best technology platform for
each target
Broadening our pipeline & opening new areas for growth
5
Expanding research on additional vaccines candidates against chronic diseases
<
• Fluzone HD
pediatric
• Influenza QIV
mRNA
• Next-Gen Flu
vaccines
• PCV21
<
• Chlamydia
• Acne
<
• MenB
• MenPenta
• RSV toddler
• RSV older adults
& respiratory
combo
Influenza Pneumo New frontiers
Meningitis RSV
Deepen our leadership in existing franchises New Growth Areas
= New
RSV: Respiratory syncytial virus PCV: Pneumococcal conjugate vaccine HD: High-Dose QIV: Quadrivalent influenza vaccine
Innovation addressing a large part of the population
6
Influenza
Meningitis
New frontiers
RSV
Adolescents
Young adults(2) Adults(3) Older adults(4)
Pneumo
–
RSV older adults
& combos
Influenza QIV & Next-Gen Flu vaccine
MenB & MenPenta
RSV toddler
Pneumococcal Pneumococcal
Chlamydia
Acne
–
Pediatric
Children(1)
–
1.9bn
Ex-U.S.
61m
U.S.
1.2bn
Ex-U.S.
44m
U.S.
3.7bn
Ex-U.S.
171m
U.S.
0.7bn
Ex-U.S.
55m
U.S.
Population
(1) 0 – 14 years old (2) 15 – 24 years old (3) 25 – 65 years old (4) 65+ years old
Source: Population estimates, The World Bank
We added mRNA to our state of the art toolbox
7
We select the best platform for each target
Established platforms mRNA & LNP platforms
• Broad range of antigen
targets
• Viral & bacterial
• Protein & polysaccharide
• Proven efficacy across
multiple diseases &
populations
• Proven tolerability from
babies to older adults
• Restricted to protein-based
antigens
• Particularly well suited for
(respiratory) viral
pathogens
• Fast to clinic & low CMC
costs
• Potential to facilitate multi-
component vaccines
Subunit
Vaccine
Inactivated
(killed)
Vaccine
Glyco-
Conjugate
Vaccine
Viral
Vector
Vaccines
Monoclonal
Antibodies
mRNA
Vaccine
Adjuvant

n
Θ
Live
Attenuated
Vaccine
Lipid
Nanoparticle
CMC: Chemistry, manufacturing & controls
Frank DeRosa
Unlocking the potential
of mRNA
Head of Research mRNA CoE
CoE: Center of Excellence
9
Sanofi mRNA Center of Excellence
A biotech environment with Sanofi’s powerhouse
• 400 dedicated employees in the U.S.
(Cambridge) and France (Lyon)
• Positive clinical results from COVID-19 and
influenza monovalent mRNA candidates
• Pivot to modified mRNA achieved; clinical trials
planned to start in 2022
• Expansion of proprietary database ongoing
internally & with partnerships
mRNA Center of Excellence
Moving fast beyond 1st generation mRNA
• Deep vaccine & antigen design expertise
• Well-established development platforms
• Expertise in running clinical trials
• Global manufacturing scale
• Strong mRNA & LNP know-how
• Proprietary algorithms & large LNP database
• Large scale material production capabilities
LNP: Lipid nanoparticles
First clinical trial with our proprietary mRNA & LNP platform
Optimized unmodified mRNA
encoding prefusion full-length
SARS-CoV-2 spike protein
Proprietary LNP with
customized composition
and ratio
mRNA 7.5µg
36
Days
21
0
Unmodified mRNA & proprietary LNP,
using COVID-19 as a reference antigen
Phase I design
mRNA 15µg
mRNA 45µg
Control group (saline)
Screening
10
LNP: Lipid nanoparticles
Platform potential confirmed by positive interim results
Pseudovirus nAb to D614G 14 days post-dose 2
(SARS-CoV-2 seronegative participants, n=41)
GMT ratio
Vaccinated /
Convalescent
100% seroconversion for all doses ≥ 15µg Tolerability profile in line with other unmodified
mRNA COVID-19 vaccines
1.0
0.6
0.8
7.5µg 15µg 45µg
1.1
Open label sentinels
Human Conv. 7.5µg 45µg
15µg
Dose 1 n=45 Dose 2 b=44
Open label sentinels
Grade 3 adverse events
11
22%
18%
59%
18%
60%
50%
Seroconversion
(≥4-fold increase)
91% 100% 100%
N/A
GMT: Geometric mean titer
Source: Data on file
Progressing to clinic with influenza
12
n=30
mRNA 7.5µg ; LNP #1
29
Days
1
Unmodified mRNA & proprietary LNPs,
for monovalent influenza vaccine
Phase I design
mRNA 15µg ; LNP #1
mRNA 45µg ; LNP #2
n=40
Control - monovalent Rec HA 45 µg
(= Flublok concentration)
mRNA 45µg ; LNP #1
mRNA 15µg ; LNP #2
mRNA 7.5µg ; LNP #2 n=30
n=30
n=30
n=30
n=30
Optimized unmodified mRNA
encoding for the hemagglutinin
protein of the A/H3N2 strain
Two proprietary LNP
options with customized
composition and ratio
9
Screening
LNP: Lipid nanoparticles
First evidence that mRNA could work for influenza,
pending improved reactogenicity
13
9.5
3.1
7.5μg 15μg 45μg
3.7
2.9
4.5
20.5
12.4
LNP #1 LNP #2
40%
7.5μg
22%
15μg 45μg
10%
20%
30%
89%
7%
LNP #2
LNP #1
Sanofi’s mRNA monovalent Flu
Immunogenicity Reactogenicity(2)
GMT ratio
Sanofi’s mRNA monovalent Flu
LNP # 2 identified as a promising candidate for influenza vaccine
Rec. HA Rec. HA
Seroconversion(1)
30% 70% 44% 90% 40% 100% 73%
Rec. HA: Recombinant HA HA: Hemagglutinin GMT: Geometric mean titer
(1) Seroconversion: proportion of participants with D01 < 10 (1/dil) and post-titer >=40 (1/dil) or D01 >=10 (1/dil) and post-titer >= 4-fold increase (2) Grade 3 solicited reactions
Source: Data on file
Successfully pivoted to modified mRNA
14
Dose 3
Dose 2 Dose 1
0 28 42 56 0 28 42 56
0 28 42
Switch to modified mRNA achieved
Unmodified mRNA 1-N-MEΨ modified mRNA
mRNA-HA dose mRNA-HA dose
1/40 1/40
HAI
Titer
(Log10)
Similar immunogenicity with modified mRNA in NHP
Dose 2 Dose 1
0 28 42 56 0 28 42 56 0 28 42 56
Dose 3
56
• Pre-clinical data generated in multiple
animal models
• GMP material produced
• On track to start clinical trials in influenza
• H1 2022 for monovalent
• H2 2022 for quadrivalent
1
0
2
3
4
5
2
0
1
3
4
5
First clinical data with modified mRNA expected in 2022
GMP: Good manufacturing practices NHP: Non-human primate
Note: Study conducted in NHP with escalating two doses schedule (Day 0 and Day 28) - mRNA encoding for Flu Hemagglutinin Source: Data on file
Biomarkers show clear path to reduce reactogenicity
with modified mRNA and optimized LNPs
15
1
10
100
1,000
10,000
Mod.
Un.Mod. Ø Ø
Un.Mod. Un. Ø
10
1,000
1
100
Mod.
Un. Mod. Ø
Ø
Un.
Mod. Un.
Ø
IFN𝛼2
LNP #1 LNP #2 LNP #3
Proprietary ex-vivo MIMIC
System® assay enabling
evaluation of immune
responses
LNP #1 LNP #2 LNP #3
MCP-3
Modified mRNA & LNP optimization expected to reduce reactogenicity in the clinic
LNP: Lipid nanoparticles Ø: no mRNA MIMIC: Modular Immune in vitro Construct
Note: IFN𝛼2 and MCP-3 presumed biomarkers of reactogenicity
Source: Data on file
Overcoming mRNA thermostability challenges
16
Ready to go with lyophilized
Stability of lyophilized mRNA
drug product achieved
Development of fully liquid
formulation underway
0
0 6
3
50
75
9 12
25
100
Change
in
%
mRNA
Integrity
Liquid LNP (2-8oC)
Months 0
75
25
50
100
W1
In
vivo
potency
in
mice
(%)
W9
W3 W18 W25
Liquid stabilized prototype
LNP (2-8oC)
Classical LNP
Proprietary lyophilized LNP
(2-8oC)
Storage at 4°C is needed for
vaccines outside pandemic
1
12
48
Hexaxim
Fluzone HD
Shelf life at 2-8°C in the
registered product labels
(months)
mRNA based
COVID-19
vaccine
Note: Fluzone HD: Egg-based influenza vaccine Hexaxim: 6-in-1 combination pediatric vaccine
Source: Data on file
Breaking barriers to unlock mRNA potential
17
Duration of
expression
Reactogenicity
Thermostability
Immunogenicity
Targeting
Applicable to
pandemic market
Required profile for
general vaccine markets
Optimal profile for
therapeutics
High High High
Tolerability profile in line with
established vaccines
Tolerability profile in line with
established vaccines
Lyophilized
or 9 – 12 months fully liquid
Lyophilized
or 9 – 12 months fully liquid
Extended half-life
Moderate to high
~1 month shelf life (2-8°C)
1 – 3 days 1 – 3 days
- - Efficient cell & organ specificity
1st gen mRNA 2nd gen mRNA 3rd gen mRNA
18
Jean-François
Toussaint
Head of Vaccines
Research
& Development
Thomas Grenier
Head of Franchises &
Product Strategy
Broadening the pipeline
to address unmet needs
82%
18%
Influenza: further raising the bar
19
€6.7bn
2020
Market overview
Standard dose vaccines
• Accelerated mRNA QIV Influenza
development
• Raising the bar further with Next-Gen Flu
• Machine Learning for better strain selection
• Expanding on neuraminidase to induce
greater protection
Sanofi strategy to keep winning in flu
Differentiated vaccines
QIV: Quadrivalent influenza vaccine
Source: Sanofi published sales and market estimates at 2020 exchange rate
First milestone achieved for Sanofi mRNA QIV
20
• Optimized modified mRNA sequence
• Encoding for 4 HA proteins
• Optimized LNP to reduce reactogenicity
0
8
2
4
6
10
12
14
16
Log2 HA titers at Day 42(1)
B Victoria B Yamagata
H1N1 H3N2
Average
QIV HA mRNA QIV Recombinant Protein
Pre-clinical data generated with unmodified mRNA Pivoted to modified for final candidate
LNP: Lipid nanoparticles HA: Hemagglutinin
(1) Immunogenicity response in ferrets Source: Data on file
Influenza mRNA QIV development with objective to
demonstrate Protection Beyond Flu
21
• Two age cohorts (18-64yo & 65yo+)
• Dose-selection trial
• Comparison against standard of care
• Quadrivalent vaccine based on WHO
selected strains
• Comparison to standard of care
Selection of final composition
for each population
Registration trial designed to
demonstrate vaccine efficacy & build
safety database
Phase I/II – Targeted initiation in 2022 Phase III – Targeted Initiation in 2023
WHO: World Health Organization
Later strain selection not the solution for improved efficacy
22
Vaccine administration Influenza season
0.0
0.6
0.2
0.4
0.8
1.0
2013-06
2015-03
2013-08
Example of 2014-2015 season (H3N2 late mismatch)(3)
2013-07
2013-09
2013-10
2013-11
2013-12
2014-01
2014-02
2015-02
2014-03
2014-04
2014-05
2014-06
2014-09
2014-07
2014-08
2014-10
2014-11
2014-12
2015-01
2015-04
2015-05
Current WHO selection
Shift in strain dynamic can occur late in season
Only 2 out of past 10 years with strain mismatch
Vaccine strain to predominant
circulating strain similarity(1, 2)
Predominant strain
in adults ≥ 65yo(1)
A/H3N2 (80.4%)
A/H3N2 (87.0%)
A/H3N2 (90.6%)
A/H1N1 (71.0%)
A/H3N2 (86.4%)
A/H1N1 (57.2%)
A/H1N1 (48.4%)
A/H3N2 (79.0%)
A/H3N2 (69.4%)
A/H3N2 (53.3%)
2010-11
2011-12
2014-15
2019-20
2012-13
2013-14
2015-16
2016-17
2017-18
2018-19
Season
97%
82%
100%
100%
19%
100%
97%
93%
11%
54%
(1) Adapted from Lee J, Lam J, Shin T, et al. Vaccine 2021 for season 2010-11 to 2018-19 data and from CDC FluView Summary ending July 25, 2020 for season 2019-20 data;
Determined using national CDC viral surveillance data on adults 65 years of age and older (2) Antigenic Similarity of Reference Vaccine Strain to Predominant Circulating Strain based on
CDC data on viral antigenic characterization comparing reference vaccine strains to circulating viruses; mismatched seasons includes seasons of antigenic mismatch (2009–10, 2014–15,
2018–19) as well as seasons where egg-adapted vaccine strains may have affected vaccine effectiveness (2012–13, 2016–17, 2017–18) (3) GISAID data analysis
81
66
79
62
54
35 36
43
Striving for better strain selection with Machine Learning
23
Higher seroconversion for ML-selected antigens(1)
Antigens selected for cross-clade protection
ML selected antigens showed greater breadth in Phase I translational study
66
28
ML - 4
WHO strain ML - 1 ML - 3
ML - 2
% subjects seroconverting to ≥ 5 out of 6 H3 strains
% subjects seroconverting to 6 out of 6 H3 strains
SoC
*Line represents
antibody response
after vaccination >
SoC(2)
3C.2
3C.3
ML-2
Read-out
Other
PC: Principal component SoC: Standard of care ML: Machine learning
(1) Immunogenicity was assessed via a panel of 6 antigenically distinct influenza viruses from both 3C.2 and 3C.3 clades, isolated in 2016 and 2017; n=30 participants per arm (healthy
adults aged 18-30) (2) Statistical significance ratio of 1.35x
Exploring the potential of neuraminidase to further build
Protection Beyond Flu
24
Fluzone SD/Fluzone HD already increase
anti-NA titers(1)
Exploring combined HA + NA multivalent vaccines
Response in ferrets of multivalent protein and mRNA vaccines
6%
13%
24%
31%
N2
N1
Fluzone SD
Fluzone HD
HA
Response
(2)
Log2
HA
titers
2
14
12
0
4
8
6
10
14
8
0
2
10
6
4
12
NA
Response
(3)
Log2
NA
titers
B Victoria B Yamagata
H1N1 H3N2
Multivalent Recombinant Protein Multivalent mRNA rHA Average
NA: Neuraminidase HA: Hemagglutinin rHA: recombinant Hemagglutinin
(1) Defined as ≥2-fold increase in enzyme-linked lectin assay; Graph shows proportion of subjects developing increase in anti-NA titers (2) Microneutralization assay
(3) NA inhibition assay Source: Cate, Thomas R et al. Vaccine (2010); data on file
31%
13%
56%
Respiratory Syncytial Virus: protection across all age groups
25
€8bn
2030
Market overview
Nirsevimab: best-in-class mAb for
All Infant Protection in first season
Best-in-class protection for all ages
<1 year old
1 - 5 years old
65+ years old
RSV toddler: first-in-class Live
Attenuated Virus vaccine for second
season onwards
RSV older adults: initiating standalone
mRNA vaccine, and paving the way for
respiratory combos in older adults
mAb: monoclonal antibody
Source: Sanofi forecast
RSV burden does not stop after the first season
• Excellent safety profile
• Efficacy against medically-
attended upper and lower
respiratory tract infections
RSV toddler vaccine target profile
~905k
~1,500k
1 to 4 years
U.S. RSV-related
hospital admissions(1)
~39k
~18k
<1 year
1 to 4 years
<1 year
U.S. RSV-related
outpatient visits(2)
Note: Internal analysis based on following studies and World Bank 2020 demographic data (1) Rha B, Curns AT, Lively JY, et al. Respiratory Syncytial Virus-Associated Hospitalizations
Among Young Children: 2015-2016. Pediatrics. 2020 (2) Emergency and Pediatric practices RSV-related outpatients estimate - Hall CB, Weinberg GA, Iwane MK, et al. The burden of
respiratory syncytial virus infection in young children. N Engl J Med. 2009
26
FiC RSV toddler vaccine designed by reverse genetics
27
Ongoing Phase I/II in U.S. and Latin America (n=360 participants) – read-out expected in 2022
Deletion of NS2
• Improved immunogenicity
• Improved safety
Deletion of 1313 with
I1314L as stabilizer
Virus
Epithelial cells
NS1 NS2 N P M SH G F M2 L
NS2
• Improved safety
FiC: First-in-class
Source: Data on file
Clinical data shows evidence of efficacy by reducing
medically attended acute respiratory illnesses
28
∆NS2 vaccine candidate selected for further
development
Evidence of efficacy(1) for both upper
and lower respiratory tract infections
0
1
2
3
4
5
6
7
8
Log
10
copies
per
mL
0
1
2
3
4
5
6
7
8
9
10
11
PRNT
60
(1/
log
2
)
0
20
40
60
80
100
% VE, N=80
Upper and lower
respiratory tract
infections
Lower
respiratory
tract infections
Neutralization titer Vaccine shedding by PCR
∆ M2-2 Candidates ∆ NS2 ∆ M2-2 Candidates ∆ NS2
VE: vaccine efficacy PRNT: plaque reduction neutralizing titer PCR: polymerase chain reaction
(1) Efficacy measured and displayed across all candidates and not just ∆NS2; p<0.05 significance for VE was observed for Upper and lower respiratory tract infections, however the
Placebo group was small with 62 subjects of which 11 experienced RSV-related medically attended acute respiratory Illness (18%) Source: Ruth Karron et al; Am J Respir Crit Care
Med 2021
RSV in older adults: addressing a large burden
29
• Initiating standalone RSV mRNA vaccine to
address high burden of disease in older adults
• Low variability of RSV may allow for multiyear
protection
Estimated U.S.
hospitalizations
amid 65yo+
Estimated U.S.
outpatient acute
infection amid 65yo+
Virus
evolution
RSV 105k(2)
1,041k(1) Low
Influenza 204k(3)
1,808k(1) High
HMPV
PIV 82k(2)
329k(1)
88k(2)
603k(1)
Low
Low Opportunity for RSV-based combos
• Cumulated burden of RSV and HMPV comparable
to Influenza
• Potential for additional convenience and cost-
effectiveness benefits
HMPV: Human metapneumovirus PIV: Parainfluenza viruses
(1) Estimate based on World Bank 2020 demographic data and on following study: Jackson ML, Starita L, Kiniry E, et al.. Clin Infect Dis. 2021 (2) Estimate based on World Bank 2020
demographic data and on following study: Sieling, William D et al. “Comparative incidence and burden of respiratory viruses associated with hospitalization in adults in New York
City.” Influenza and other respiratory viruses vol. 15,5, 2021 (3) CDC data, 2018-2019 flu season
Best-in-class RSV antigen through innovative design
30
RSV F antigen designed
to focus on potent site 0
Improved immunogenicity
over competing antigens
Neutralization
titer
-1
Proven potency in mRNA format
Competitive
Elisa
-
Log
2
IT
50
Log2
RSV
MN
titer
-1
0
2
8
4
6
Wild type
RSV F
FD3
RSV
candidate
Site 0
(Nirsevimab)
Site 1
.
Site 2
(Synagis)
8
12
4
16
D0 D28 D56 D0 D28 D56
mRNA Recombinant protein
Site potency
104
101
102
103
Post-F
Trimer
FD3
RSV
candidate
DS-Cav1
Trimer
Initiating Phase I with modified mRNA in 2022
P = 0.0003
P = 0.02
Source: Data on file
State of the art HMPV antigen candidate identified
31
Cutting edge antigen design Proven potency in mRNA format
Sanofi proprietary mAb
focused on most potent
site (Site 0)
HMPV F
Gen1(1) preF
protein
Gen3 preF
protein
Gen2 preF
protein
Log2 HMPV MN titer-1
16
8
4
12
4.5-fold
2.9-fold
Gen1 preF
protein
Gen3 preF
mRNA
Log2 HMPV MN titer-1
8
4
12
16
D0 D28 D56 D0 D28 D56
Initiation of Phase I with RSV older adults combo planned for 2023
mAb: monoclonal antibody HMPV: Human metapneumovirus
Note: Figure is from manuscript in preparation through SP/UT collaboration. SP innovation
(1) Gen1 was unstable, necessitating next generation designs Source: Data on file
Pneumococcal: more serotypes for better protection
32
Large established market
79%
6%
15%
Prevnar (PCV13)
Synflorix (PCV10)
PPV Vx
€6.2bn
2020
• Synergy with pediatric and older
adult portfolio
• State of the art formulation
expertise with multi-valent vaccines
• Partnership with SK Bioscience
• Complementary capabilities
• Investment and risk sharing
Strong fit with existing franchises
Source: Pfizer, GSK, Merck 2020 Annual Reports
Raising the bar with PCV21 candidate
33
Addition of 9N serotype allowing for ~5-7% pts gain in IPD coverage
1 4 5 6B 7F 9V 14 18C 19F 23F 3 6A 19A 22F 33F 8 10A 11A 12F 15B 9N 17F 20 2
5.2%
U.S. 2018(1) EU 2018(2)
26.1%
14.2%
14.0%
6.7%
38.9%
27.5%
29.0%
9.0%
29.3%
IPD coverage in all ages by serotype (%)
Serotype composition per vaccine
NVT/NT
PCV20 non-PCV15
PCV15 non-PCV13
PCV21 non-PCV20
PCV13
Pfizer Prevnar 20
Launch phase in the U.S.
Merck PCV15
Launch phase in the U.S.
Pfizer Prevnar 13
Sanofi PCV21
NVT: Non-vaccine type NT: Non-typable IPD: Invasive pneumococcal disease
(1) All age groups - ABC data 2018. Metcalf et al. Clin Infect Dis. 2021 Jun 15;72(12):e948-e956
(2) All age groups - https://atlas.ecdc.europa.eu/public/index.aspx?Dataset=27&HealthTopic=40
Extensive Phase II program across all age groups
34
Read-out in all 3 populations expected end of 2022; Phase III initiation planned in 2023
Adult ≥ 50 years old
n=750
Toddler
n=140
Infant Primary
n=700
• Subjects naïve to prior PCV
vaccination
• 3 PCV21 formulations vs.
PCV13 & Pneumovax23
• Booster dose for toddlers having
received 3 doses of PCV13
• 3 PCV21 formulations vs.
PCV13
• 2-4-6 months primary series &
booster dose
• 3 PCV21 formulations vs.
PCV13
NCT04398706: Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants. (Sanofi, phase 2 trial,
PSK00008, n = 840, recruiting, estimated study completion date July 2023) NCT04583618: Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years (Sanofi phase 2
trial PSK00009, n = 750; Estimated study completion data Jan 2022)
48%
34%
8%
10%
Meningitis: Strengthening our leadership
35
€2.4bn
2020
• Established leader with Menactra in the U.S.
• MenQuadfi as a new standard in MenACWY,
with superior serotype C response to ease
market conversion to quadrivalent
• Aiming for competitive MenB with broader
strain coverage & longer duration of protection
• Paving the way for best-in-class MenPenta
in fully liquid format
MenC
MenACWY
MenB
Other
Market overview
Source: Sanofi estimates
MenQuadfi as a new standard in MenACWY
36
Broadest age
indication
U.S. ≥2 yo 2 months to 55 yo Not registered
EU ≥12 months old ≥2 yo(2) ≥6 weeks
Int'l ≥12 months old ≥2 yo ≥6 weeks
MenQuadfi
Sanofi (ACWY)
Menveo
GSK (ACWY)
Nimenrix
Pfizer (ACWY)
(1)
≥6 weeks
as of 2025
Enhanced immunogenicity,
with superiority against MenC
in toddlers
Fully liquid quadrivalent
(1) Submission for a liquid form announced in Q3 2021
(2) Indications as of 2 months old in some countries (using US file)
MenQuadfi is the first & only ACWY vaccine to demonstrate
superior immune response against serogroup C
37
Paving the way for MenPenta
515
32 227
Human complement SBA GMTs at D30
(hSBA GMTs)
2,143
315
1,624
Rabbit complement SBA GMTs at D30
(rSBA GMTs)
Enabling switch from MenC to MenACWY without compromising on serotype C
ACWY ACWY C only ACWY ACWY C only
Nimenrix®
(N=211)
NeisVac-C®
(N=216)
MenQuadfi
(N=214)
Nimenrix®
(N=210)
NeisVac-C®
(N=215)
MenQuadfi
(N=213)
SBA: Serum bactericidal assay - Per-protocol analysis set GMT: Geometric mean titer
Source: Knuf et al, (2021): Meningococcal serogroup C (MenC) immune response of a novel tetanus toxoid conjugate quadrivalent meningococcal vaccine (MenACYW-TT) compared to a
quadrivalent (MCV4-TT) or monovalent (MenC-TT) meningococcal vaccine in healthy meningococcal vaccine-naïve toddlers
Novel MenB vaccine aiming for increased protection
38
MenB Phase II read-out expected in 2022 – MenPenta Phase I initiation in 2023
Non-Lipidated fHBP A+B
• Two fHBP covering all MenB strains
• Non-lipidated formulation allowing for better safety
NadA
• Increasing strain coverage
Outer Membrane Vesicle
• Increasing strain coverage
• Potential adjuvant effect
MenB antigen formulation
ST-32
ST-269
ST-213
ST-35
ST-11
ST-461
ST-103
MenB IMD
isolates by
prevalent clonal
complex
4/4
ST-41/44
3/4
4/4
1/3
2/2 2/2
1/2
1/1 1/1
1/1
2/2
1/2
1/2
1/1
1/1
1/1
3/3
3/3
1/1
1/1
1/1
3/3
3/3
2/3
Broader coverage of MenB strains(1)
Sanofi
Pfizer
GSK
IMD: Invasive meningococcal disease fHBP: Factor H binding protein NadA: Neisserial adhesin A
(1) Pre-clinical assessment of Serum Bactericidal Antibodies (SBA) against MenB IMD isolates; 18 strains identified as relevant with 1 secondary strain not tested in the preclinical study
(not suitable with Research hSBA assay) Source: Pre-clinical study in animal model: Assessment of Serum Bactericidal Antibodies against an epidemiology relevant panel of MenB
invasive clinical isolates build by key Reference Laboratories & Representative of current MenB molecular epidemiology
Pioneering science to open new growth areas
39
>€2bn
(peak)
Market overview (estimate)
Chlamydia
Acne
• Chlamydia: tackling the most common
infectious cause of female infertility
• Acne: first immunotherapy to treat acne
Delivering first-in-class vaccines
Source: Sanofi forecasts
Chlamydia: a silent cause of infertility in women
40
Annual U.S. incidence in women
~800k non-diagnosed
~300k PID cases
~2m infections
~20k
cases of
infertility
per year
• 69% of estimated annual cases amid
young women aged 24 years old or less
• Undiagnosed cases can lead to severe
complications, particularly in women
• Pelvic Inflammatory Cases
• Tubal infertility
• Ectopic pregnancy
• Chronic pelvic pain
Overwhelming burden in young women
PID: Pelvic inflammatory disease
Source: Multiple sources for estimate reconstitution: CDC - Sexually Transmitted Disease Surveillance, 2019 & Chlamydia Fact Sheet, 2018; Land JA, Van Bergen JE, Morré SA, Postma
MJ, Hum Reprod. Update, 2010; Price MJ, Ades AE, De Angelis D, et al. Am J Epidemiol., 2013 ; Heisterberg L. Obstet Gynecol., 1993; Ades AE, Price MJ, Kounali D, et al. Am J
Epidemiol., 2017; World Bank demographic data 2020
Chlamydia: mRNA best-suited platform to deliver desired
immune response
41
mRNA-based multi-component vaccine Phase I launch expected in 2023
Selecting additional antigens to prevent
Chlamydia entry in endocervical cells
Optimized antigen for strong CD4 T-cells
response(1)
3000
0
1000
2000
Antigen6
Antigen2
Antigen3
Antigen4
Antigen1
Antigen5
rAntigen+
adjuvant
IFN-γ SFC/10(6) splenocytes
mRNA
without antigens with antigens
Chlamydia infected cells (in red)(2)
(1) Superior IFN-γ producing T cell with mRNA vs adjuvanted rAntigen (2) High throughput screening of neutralizing IgG and real time monitoring of infection kinetics in endocervical cell
line with genetically engineered Chlamydia t. strains Source: Data on file
Acne: a stigmatizing condition
42
• Significant psychological impact
• Current SoC (oral isotretinoin) with severe side
effects
• Significant out-of-pocket expenses ($360-$720(2) /
year in the U.S.)
• P. acnes bacterium also associated with several
conditions beyond acne:
• Other dermatological conditions(3)
• Medical device-related infections(4)
• Prostatic inflammation thought to contribute to prostate
cancer(5)
Mild acne
Severe
acne
Moderate
acne
~140m
worldwide
cases(1)
~90m
worldwide
cases(1)
(1) Source: IHME. GBD Results Tool; http://ghdx.healthdata.org/gbd-results-tool (2) Sanofi internal analysis (3) Bojar and Holland, 2004; Kurokawa et al., 2009; Barnard et al., 2016
(4) Piper KE et al, J Clin Microbiol. 2009;47(6):1878-1884; Niazi SA et al, Clin Oral Investig. 2016;20(8):2149-2160 (5) Cohen RJ et al, J Urol. 2005;173(6):1969-1974
Immune system plays a significant role in moderate-to-
severe acne
43
Vaccine solution as a first immunotherapy to safely treat moderate-to-severe acne
<10k elements secreted by S. epidermidis
TLRs (Toll-like receptors)
Cutibacterium acnes
Staphylococcus epidermidis
Staphylococcus aureus
C. acnes phylotype Origimm's antigens
IA1 +++
IA2 +++
IB ++
IC +++
II ++
III (+)
Origimm‘s antigen induce a functional immune
response against C. acnes virulent strains
Opsonophagocytic killing by antigen
specific mouse sera
Skin dysbiosis (acne patients) Skin homeostasis (healthy)
Epidermis
Dermis
Hypodermis
◌ Keratinocytes
◌ Sebocytes
◌ Keratinocytes
C. acnes
Virulence factors
Immune cells
Inflammation
Immune cells
AMPs
Bacterial proliferation
1
2
AMPs: Antimicrobial peptides PSMs: Phenol-soluble modulins Esp: Endopeptidase serine protease FFAs: Free Fatty Acids
Source: Adapted from Fournière M et al., Microorganisms 2020
Building an industry leading pipeline in Vaccines
44
Pre-clinical Phase I & II Phase III
SP0273
Influenza monovalent vaccine mRNA
Fluzone® HD - SP0178
Pediatric flu
SP0218
Yellow fever vaccine
SP0202
Pneumococcal
SP0230
Meningitis B
nirsevimab
Respiratory Syncytial Virus
SP0253
Recombinant COVID-19
VerorabVax® (VRVg)
Rabies
Influenza QIV mRNA
RSV older adults combo
mRNA
MenPenta
RSV older adults mRNA
• Target to advance 10 clinical
candidates by 2025, incl. 6
mRNA vaccines
• Opportunity to be first-in-class
and lead in several new
therapeutic fields
• Right mix between LCM,
proven targets and
breakthrough vaccines
Future mRNA targets to be
announced
Next-Gen Flu vaccine
Acne
Chlamydia mRNA
SP0125
Respiratory syncytial virus (toddlers)
Pandemic Influenza
Lifecycle management
First-in-class
Funded by BARDA
LCM: Lifecycle management
SP0148 HSV Type 2 vaccine not indicated above; as it will be discontinued after Phase I completion
SP0273 monovalent mRNA Influenza vaccine will be discontinued after Phase I completion
Opening a new chapter for Sanofi Vaccines R&D
45
Epidemic
2
Endemic diseases
1
Chronic diseases
3
Thomas Triomphe
Conclusion
Head of Vaccines GBU
Our ambition in Vaccines
47
Continued strong growth
driven by four core franchises:
Influenza, Meningitis, PPH &
Boosters, RSV
More than doubling Vaccine sales by 2030(1)
Unlocking the potential of
mRNA in Vaccines with
Next-Generation platform
Building an industry
leading pipeline to
address unmet needs
(1) Vs. 2018, risk adjusted, internal estimate
Q&A session| Leading with innovation
Jean-François
Toussaint
Head of Vaccines R&D
Frank DeRosa
Head of Research for
mRNA CoE
Thomas Grenier
Head of Franchises &
Product Strategy
Thomas Triomphe
Head of Vaccines GBU
Jon Heinrichs
Head of R&D RSV
Franchise

More Related Content

What's hot

McKinsey European consumer sentiment survey: How current events are shaping U...
McKinsey European consumer sentiment survey: How current events are shaping U...McKinsey European consumer sentiment survey: How current events are shaping U...
McKinsey European consumer sentiment survey: How current events are shaping U...
McKinsey on Marketing & Sales
 
All about Covid-19 Vaccine Development
All about Covid-19 Vaccine DevelopmentAll about Covid-19 Vaccine Development
All about Covid-19 Vaccine Development
Shivam Parmar
 
Epi program (blood)
Epi program (blood)Epi program (blood)
Epi program (blood)
Dr.Muhammad Omer
 
Paediatric immunization
Paediatric immunizationPaediatric immunization
Paediatric immunization
Chacha Piru
 
Covid 19 Vaccines
Covid 19 VaccinesCovid 19 Vaccines
Covid 19 Vaccines
Azeem Majeed
 
Covid vaccine
Covid vaccineCovid vaccine
Covid vaccine
MonikaSkarbek
 
Covid 19 vaccine
Covid 19 vaccineCovid 19 vaccine
Covid 19 vaccine
Dr. Ravi Prakash
 
COVID-19 Vaccine: Answers to Your Questions
COVID-19 Vaccine: Answers to Your QuestionsCOVID-19 Vaccine: Answers to Your Questions
COVID-19 Vaccine: Answers to Your Questions
CHC Connecticut
 
IMPACT OF COVID19 IN MENTAL HEALTH
IMPACT OF COVID19 IN MENTAL HEALTHIMPACT OF COVID19 IN MENTAL HEALTH
IMPACT OF COVID19 IN MENTAL HEALTH
dr shaliya james
 
McKinsey Survey: Japanese consumer sentiment during the coronavirus crisis
McKinsey Survey: Japanese consumer sentiment during the coronavirus crisisMcKinsey Survey: Japanese consumer sentiment during the coronavirus crisis
McKinsey Survey: Japanese consumer sentiment during the coronavirus crisis
McKinsey on Marketing & Sales
 
Varicela
VaricelaVaricela
Immunisation
ImmunisationImmunisation
Immunisation
shivakumar chawan
 
Choosing a pneumococcal vaccine - wisely.. Prevenar in Indian context
Choosing a pneumococcal vaccine - wisely.. Prevenar in Indian contextChoosing a pneumococcal vaccine - wisely.. Prevenar in Indian context
Choosing a pneumococcal vaccine - wisely.. Prevenar in Indian context
Gaurav Gupta
 
Covid- 19 Vaccines
Covid- 19 VaccinesCovid- 19 Vaccines
Covid- 19 Vaccines
SanjanaDey5
 
vaccine pcv rota.pptx
vaccine pcv rota.pptxvaccine pcv rota.pptx
vaccine pcv rota.pptx
PrashantKoirala12
 
Newer vaccine
Newer vaccineNewer vaccine
Newer vaccine
Dr Bushra Jabeen
 
Covid 19.ppt
Covid 19.pptCovid 19.ppt
Covid 19.ppt
Ali Al Mousawi
 
Rota virus vaccine
Rota virus vaccineRota virus vaccine
Rota virus vaccine
swati shikha
 
WHO COVID-19 Guidelines
WHO COVID-19 GuidelinesWHO COVID-19 Guidelines
WHO COVID-19 Guidelines
Henrique Diez Botelho
 
Top 10 practical questions about Flu Vaccine in India!
Top 10 practical questions about Flu Vaccine in India!Top 10 practical questions about Flu Vaccine in India!
Top 10 practical questions about Flu Vaccine in India!
Gaurav Gupta
 

What's hot (20)

McKinsey European consumer sentiment survey: How current events are shaping U...
McKinsey European consumer sentiment survey: How current events are shaping U...McKinsey European consumer sentiment survey: How current events are shaping U...
McKinsey European consumer sentiment survey: How current events are shaping U...
 
All about Covid-19 Vaccine Development
All about Covid-19 Vaccine DevelopmentAll about Covid-19 Vaccine Development
All about Covid-19 Vaccine Development
 
Epi program (blood)
Epi program (blood)Epi program (blood)
Epi program (blood)
 
Paediatric immunization
Paediatric immunizationPaediatric immunization
Paediatric immunization
 
Covid 19 Vaccines
Covid 19 VaccinesCovid 19 Vaccines
Covid 19 Vaccines
 
Covid vaccine
Covid vaccineCovid vaccine
Covid vaccine
 
Covid 19 vaccine
Covid 19 vaccineCovid 19 vaccine
Covid 19 vaccine
 
COVID-19 Vaccine: Answers to Your Questions
COVID-19 Vaccine: Answers to Your QuestionsCOVID-19 Vaccine: Answers to Your Questions
COVID-19 Vaccine: Answers to Your Questions
 
IMPACT OF COVID19 IN MENTAL HEALTH
IMPACT OF COVID19 IN MENTAL HEALTHIMPACT OF COVID19 IN MENTAL HEALTH
IMPACT OF COVID19 IN MENTAL HEALTH
 
McKinsey Survey: Japanese consumer sentiment during the coronavirus crisis
McKinsey Survey: Japanese consumer sentiment during the coronavirus crisisMcKinsey Survey: Japanese consumer sentiment during the coronavirus crisis
McKinsey Survey: Japanese consumer sentiment during the coronavirus crisis
 
Varicela
VaricelaVaricela
Varicela
 
Immunisation
ImmunisationImmunisation
Immunisation
 
Choosing a pneumococcal vaccine - wisely.. Prevenar in Indian context
Choosing a pneumococcal vaccine - wisely.. Prevenar in Indian contextChoosing a pneumococcal vaccine - wisely.. Prevenar in Indian context
Choosing a pneumococcal vaccine - wisely.. Prevenar in Indian context
 
Covid- 19 Vaccines
Covid- 19 VaccinesCovid- 19 Vaccines
Covid- 19 Vaccines
 
vaccine pcv rota.pptx
vaccine pcv rota.pptxvaccine pcv rota.pptx
vaccine pcv rota.pptx
 
Newer vaccine
Newer vaccineNewer vaccine
Newer vaccine
 
Covid 19.ppt
Covid 19.pptCovid 19.ppt
Covid 19.ppt
 
Rota virus vaccine
Rota virus vaccineRota virus vaccine
Rota virus vaccine
 
WHO COVID-19 Guidelines
WHO COVID-19 GuidelinesWHO COVID-19 Guidelines
WHO COVID-19 Guidelines
 
Top 10 practical questions about Flu Vaccine in India!
Top 10 practical questions about Flu Vaccine in India!Top 10 practical questions about Flu Vaccine in India!
Top 10 practical questions about Flu Vaccine in India!
 

Similar to Presentation Part 2 – Leading with innovation

Katie Flanagan - Malaria vaccines current status and challenges
Katie Flanagan - Malaria vaccines current status and challengesKatie Flanagan - Malaria vaccines current status and challenges
Katie Flanagan - Malaria vaccines current status and challenges
WAidid
 
Platform Technologies to Accelerate Novel Vaccine Development and Manufacturing
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingPlatform Technologies to Accelerate Novel Vaccine Development and Manufacturing
Platform Technologies to Accelerate Novel Vaccine Development and Manufacturing
MilliporeSigma
 
Platform Technologies to Accelerate Novel Vaccine Development and Manufacturing
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingPlatform Technologies to Accelerate Novel Vaccine Development and Manufacturing
Platform Technologies to Accelerate Novel Vaccine Development and Manufacturing
Merck Life Sciences
 
Molnupiravir Medical Presentation - 25th Jan'22.pptx
Molnupiravir Medical Presentation - 25th Jan'22.pptxMolnupiravir Medical Presentation - 25th Jan'22.pptx
Molnupiravir Medical Presentation - 25th Jan'22.pptx
madhu790094
 
Dr Mark Alderson @ MRF's Meningitis and Septicaemia 2019
Dr Mark Alderson @ MRF's Meningitis and Septicaemia 2019Dr Mark Alderson @ MRF's Meningitis and Septicaemia 2019
Dr Mark Alderson @ MRF's Meningitis and Septicaemia 2019
Meningitis Research Foundation
 
ultra lecture 5 molecular 2023 pptx.pptx
ultra lecture 5 molecular 2023 pptx.pptxultra lecture 5 molecular 2023 pptx.pptx
ultra lecture 5 molecular 2023 pptx.pptx
MedicalSuperintenden19
 
Foot and Mouth Disese control strategies
Foot and Mouth Disese control strategiesFoot and Mouth Disese control strategies
Foot and Mouth Disese control strategies
ubio Biotechnology Systems Pvt Ltd
 
Current status of Malaria vaccine (Nov 2016)
Current status of Malaria vaccine (Nov 2016)Current status of Malaria vaccine (Nov 2016)
Current status of Malaria vaccine (Nov 2016)
Pranav Sopory
 
Hiv virus
Hiv virusHiv virus
Hiv virus
RomaChougale
 
COVID Testing and ICMR strategy and vaccines
COVID Testing and ICMR strategy and vaccinesCOVID Testing and ICMR strategy and vaccines
COVID Testing and ICMR strategy and vaccines
RishikaThakur9
 
what is new in prevention, diagnosis and treatment of tuberculosis tb short.pptx
what is new in prevention, diagnosis and treatment of tuberculosis tb short.pptxwhat is new in prevention, diagnosis and treatment of tuberculosis tb short.pptx
what is new in prevention, diagnosis and treatment of tuberculosis tb short.pptx
PathKind Labs
 
Moderna mRNA Vaccines: from Concept to Clinic
Moderna mRNA Vaccines: from Concept to ClinicModerna mRNA Vaccines: from Concept to Clinic
Moderna mRNA Vaccines: from Concept to Clinic
ModernaTherapeutics1
 
New Vaccines in the immediate pipeline - Slideset by Professor Susanna Esposito
New Vaccines in the immediate pipeline - Slideset by Professor Susanna EspositoNew Vaccines in the immediate pipeline - Slideset by Professor Susanna Esposito
New Vaccines in the immediate pipeline - Slideset by Professor Susanna Esposito
WAidid
 
Clinical Trials: Phase 1/2 Highlights
Clinical Trials: Phase 1/2 HighlightsClinical Trials: Phase 1/2 Highlights
Clinical Trials: Phase 1/2 Highlights
Kumaraguru Veerasamy
 
RSV f vaccine in women of childbearing age, Journal of Infectious disease
RSV f vaccine in women of childbearing age, Journal of Infectious diseaseRSV f vaccine in women of childbearing age, Journal of Infectious disease
RSV f vaccine in women of childbearing age, Journal of Infectious disease
Khushboo Gandhi
 
Cheryl Davis PowerPoint Presentation.pptx
Cheryl Davis PowerPoint Presentation.pptxCheryl Davis PowerPoint Presentation.pptx
Cheryl Davis PowerPoint Presentation.pptx
WeldonFultz1
 
Essential information on covid 19 vaccinations
Essential information on covid 19 vaccinationsEssential information on covid 19 vaccinations
Essential information on covid 19 vaccinations
PathKind Labs
 
Dr. Mike Roof - Current status - "State of the Union" - PRRS vaccine research
Dr. Mike Roof - Current status - "State of the Union" - PRRS vaccine researchDr. Mike Roof - Current status - "State of the Union" - PRRS vaccine research
Dr. Mike Roof - Current status - "State of the Union" - PRRS vaccine research
John Blue
 
Target Validation Academy Of Medical Sciences 1 Dec 2006
Target Validation   Academy Of Medical Sciences 1 Dec 2006Target Validation   Academy Of Medical Sciences 1 Dec 2006
Target Validation Academy Of Medical Sciences 1 Dec 2006
Mike Romanos
 
Cancer vaccine from mice to humans
Cancer vaccine from mice to humansCancer vaccine from mice to humans
Cancer vaccine from mice to humans
Houssein A Sater
 

Similar to Presentation Part 2 – Leading with innovation (20)

Katie Flanagan - Malaria vaccines current status and challenges
Katie Flanagan - Malaria vaccines current status and challengesKatie Flanagan - Malaria vaccines current status and challenges
Katie Flanagan - Malaria vaccines current status and challenges
 
Platform Technologies to Accelerate Novel Vaccine Development and Manufacturing
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingPlatform Technologies to Accelerate Novel Vaccine Development and Manufacturing
Platform Technologies to Accelerate Novel Vaccine Development and Manufacturing
 
Platform Technologies to Accelerate Novel Vaccine Development and Manufacturing
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingPlatform Technologies to Accelerate Novel Vaccine Development and Manufacturing
Platform Technologies to Accelerate Novel Vaccine Development and Manufacturing
 
Molnupiravir Medical Presentation - 25th Jan'22.pptx
Molnupiravir Medical Presentation - 25th Jan'22.pptxMolnupiravir Medical Presentation - 25th Jan'22.pptx
Molnupiravir Medical Presentation - 25th Jan'22.pptx
 
Dr Mark Alderson @ MRF's Meningitis and Septicaemia 2019
Dr Mark Alderson @ MRF's Meningitis and Septicaemia 2019Dr Mark Alderson @ MRF's Meningitis and Septicaemia 2019
Dr Mark Alderson @ MRF's Meningitis and Septicaemia 2019
 
ultra lecture 5 molecular 2023 pptx.pptx
ultra lecture 5 molecular 2023 pptx.pptxultra lecture 5 molecular 2023 pptx.pptx
ultra lecture 5 molecular 2023 pptx.pptx
 
Foot and Mouth Disese control strategies
Foot and Mouth Disese control strategiesFoot and Mouth Disese control strategies
Foot and Mouth Disese control strategies
 
Current status of Malaria vaccine (Nov 2016)
Current status of Malaria vaccine (Nov 2016)Current status of Malaria vaccine (Nov 2016)
Current status of Malaria vaccine (Nov 2016)
 
Hiv virus
Hiv virusHiv virus
Hiv virus
 
COVID Testing and ICMR strategy and vaccines
COVID Testing and ICMR strategy and vaccinesCOVID Testing and ICMR strategy and vaccines
COVID Testing and ICMR strategy and vaccines
 
what is new in prevention, diagnosis and treatment of tuberculosis tb short.pptx
what is new in prevention, diagnosis and treatment of tuberculosis tb short.pptxwhat is new in prevention, diagnosis and treatment of tuberculosis tb short.pptx
what is new in prevention, diagnosis and treatment of tuberculosis tb short.pptx
 
Moderna mRNA Vaccines: from Concept to Clinic
Moderna mRNA Vaccines: from Concept to ClinicModerna mRNA Vaccines: from Concept to Clinic
Moderna mRNA Vaccines: from Concept to Clinic
 
New Vaccines in the immediate pipeline - Slideset by Professor Susanna Esposito
New Vaccines in the immediate pipeline - Slideset by Professor Susanna EspositoNew Vaccines in the immediate pipeline - Slideset by Professor Susanna Esposito
New Vaccines in the immediate pipeline - Slideset by Professor Susanna Esposito
 
Clinical Trials: Phase 1/2 Highlights
Clinical Trials: Phase 1/2 HighlightsClinical Trials: Phase 1/2 Highlights
Clinical Trials: Phase 1/2 Highlights
 
RSV f vaccine in women of childbearing age, Journal of Infectious disease
RSV f vaccine in women of childbearing age, Journal of Infectious diseaseRSV f vaccine in women of childbearing age, Journal of Infectious disease
RSV f vaccine in women of childbearing age, Journal of Infectious disease
 
Cheryl Davis PowerPoint Presentation.pptx
Cheryl Davis PowerPoint Presentation.pptxCheryl Davis PowerPoint Presentation.pptx
Cheryl Davis PowerPoint Presentation.pptx
 
Essential information on covid 19 vaccinations
Essential information on covid 19 vaccinationsEssential information on covid 19 vaccinations
Essential information on covid 19 vaccinations
 
Dr. Mike Roof - Current status - "State of the Union" - PRRS vaccine research
Dr. Mike Roof - Current status - "State of the Union" - PRRS vaccine researchDr. Mike Roof - Current status - "State of the Union" - PRRS vaccine research
Dr. Mike Roof - Current status - "State of the Union" - PRRS vaccine research
 
Target Validation Academy Of Medical Sciences 1 Dec 2006
Target Validation   Academy Of Medical Sciences 1 Dec 2006Target Validation   Academy Of Medical Sciences 1 Dec 2006
Target Validation Academy Of Medical Sciences 1 Dec 2006
 
Cancer vaccine from mice to humans
Cancer vaccine from mice to humansCancer vaccine from mice to humans
Cancer vaccine from mice to humans
 

More from Sanofi

Fourth quarter and full year 2023 results
Fourth quarter and full year 2023 resultsFourth quarter and full year 2023 results
Fourth quarter and full year 2023 results
Sanofi
 
Third quarter 2023 Results
Third quarter 2023 ResultsThird quarter 2023 Results
Third quarter 2023 Results
Sanofi
 
Q2 2023 results highlights
Q2 2023 results highlightsQ2 2023 results highlights
Q2 2023 results highlights
Sanofi
 
Q2 2023 results highlights
Q2 2023 results highlightsQ2 2023 results highlights
Q2 2023 results highlights
Sanofi
 
Q2 2023 results highlights
Q2 2023 results highlightsQ2 2023 results highlights
Q2 2023 results highlights
Sanofi
 
Q1 2023 results highlights
Q1 2023 results highlightsQ1 2023 results highlights
Q1 2023 results highlights
Sanofi
 
First quarter 2023 results
First quarter 2023 resultsFirst quarter 2023 results
First quarter 2023 results
Sanofi
 
Q1 2023 results highlights
Q1 2023 results highlightsQ1 2023 results highlights
Q1 2023 results highlights
Sanofi
 
2022 full-year results highlights
2022 full-year results highlights2022 full-year results highlights
2022 full-year results highlights
Sanofi
 
L’essentiel des résultats annuels 2022
L’essentiel des résultats annuels 2022 L’essentiel des résultats annuels 2022
L’essentiel des résultats annuels 2022
Sanofi
 
Presentation of the Q3 2022 Results
Presentation of the Q3 2022 ResultsPresentation of the Q3 2022 Results
Presentation of the Q3 2022 Results
Sanofi
 
Q3 2022 Results
Q3 2022 ResultsQ3 2022 Results
Q3 2022 Results
Sanofi
 
Résultats financiers du 3e trimestre 2022
Résultats financiers du 3e trimestre 2022Résultats financiers du 3e trimestre 2022
Résultats financiers du 3e trimestre 2022
Sanofi
 
Second quarter 2022 results
Second quarter 2022 results Second quarter 2022 results
Second quarter 2022 results
Sanofi
 
Q1 First quarter results
Q1 First quarter resultsQ1 First quarter results
Q1 First quarter results
Sanofi
 
Résultats du premier trimestre 2022
Résultats du premier trimestre 2022Résultats du premier trimestre 2022
Résultats du premier trimestre 2022
Sanofi
 
First quarter 2022 results
First quarter 2022 resultsFirst quarter 2022 results
First quarter 2022 results
Sanofi
 
Q4 and Full Year Results 2021
Q4 and Full Year Results 2021Q4 and Full Year Results 2021
Q4 and Full Year Results 2021
Sanofi
 
Sanofi Q4 2021 Final Financial Results
Sanofi Q4 2021 Final Financial ResultsSanofi Q4 2021 Final Financial Results
Sanofi Q4 2021 Final Financial Results
Sanofi
 
Q3 2021 Financial Results
Q3 2021 Financial ResultsQ3 2021 Financial Results
Q3 2021 Financial Results
Sanofi
 

More from Sanofi (20)

Fourth quarter and full year 2023 results
Fourth quarter and full year 2023 resultsFourth quarter and full year 2023 results
Fourth quarter and full year 2023 results
 
Third quarter 2023 Results
Third quarter 2023 ResultsThird quarter 2023 Results
Third quarter 2023 Results
 
Q2 2023 results highlights
Q2 2023 results highlightsQ2 2023 results highlights
Q2 2023 results highlights
 
Q2 2023 results highlights
Q2 2023 results highlightsQ2 2023 results highlights
Q2 2023 results highlights
 
Q2 2023 results highlights
Q2 2023 results highlightsQ2 2023 results highlights
Q2 2023 results highlights
 
Q1 2023 results highlights
Q1 2023 results highlightsQ1 2023 results highlights
Q1 2023 results highlights
 
First quarter 2023 results
First quarter 2023 resultsFirst quarter 2023 results
First quarter 2023 results
 
Q1 2023 results highlights
Q1 2023 results highlightsQ1 2023 results highlights
Q1 2023 results highlights
 
2022 full-year results highlights
2022 full-year results highlights2022 full-year results highlights
2022 full-year results highlights
 
L’essentiel des résultats annuels 2022
L’essentiel des résultats annuels 2022 L’essentiel des résultats annuels 2022
L’essentiel des résultats annuels 2022
 
Presentation of the Q3 2022 Results
Presentation of the Q3 2022 ResultsPresentation of the Q3 2022 Results
Presentation of the Q3 2022 Results
 
Q3 2022 Results
Q3 2022 ResultsQ3 2022 Results
Q3 2022 Results
 
Résultats financiers du 3e trimestre 2022
Résultats financiers du 3e trimestre 2022Résultats financiers du 3e trimestre 2022
Résultats financiers du 3e trimestre 2022
 
Second quarter 2022 results
Second quarter 2022 results Second quarter 2022 results
Second quarter 2022 results
 
Q1 First quarter results
Q1 First quarter resultsQ1 First quarter results
Q1 First quarter results
 
Résultats du premier trimestre 2022
Résultats du premier trimestre 2022Résultats du premier trimestre 2022
Résultats du premier trimestre 2022
 
First quarter 2022 results
First quarter 2022 resultsFirst quarter 2022 results
First quarter 2022 results
 
Q4 and Full Year Results 2021
Q4 and Full Year Results 2021Q4 and Full Year Results 2021
Q4 and Full Year Results 2021
 
Sanofi Q4 2021 Final Financial Results
Sanofi Q4 2021 Final Financial ResultsSanofi Q4 2021 Final Financial Results
Sanofi Q4 2021 Final Financial Results
 
Q3 2021 Financial Results
Q3 2021 Financial ResultsQ3 2021 Financial Results
Q3 2021 Financial Results
 

Recently uploaded

Domestic investment in pension schemes - a good thing?
Domestic investment in pension schemes - a good thing?Domestic investment in pension schemes - a good thing?
Domestic investment in pension schemes - a good thing?
Henry Tapper
 
Can I sell my hamster kombat tokens Now! (latest update - 2024)
Can I sell my hamster kombat tokens Now! (latest update - 2024)Can I sell my hamster kombat tokens Now! (latest update - 2024)
Can I sell my hamster kombat tokens Now! (latest update - 2024)
CRYPTO SPACE 🪙
 
how to sell hamster kombat tokens before mainnet launch.
how to sell hamster kombat tokens before mainnet launch.how to sell hamster kombat tokens before mainnet launch.
how to sell hamster kombat tokens before mainnet launch.
CRYPTO SPACE 🪙
 
When will I be able to sell my Tapswap token's?
When will I be able to sell my Tapswap token's?When will I be able to sell my Tapswap token's?
When will I be able to sell my Tapswap token's?
CRYPTO SPACE 🪙
 
Is it possible to sell hamster kombat tokens?
Is it possible to sell hamster kombat tokens?Is it possible to sell hamster kombat tokens?
Is it possible to sell hamster kombat tokens?
CRYPTO SPACE 🪙
 
Is hamster kombat currency tradable? If yes How!
Is hamster kombat currency tradable? If yes How!Is hamster kombat currency tradable? If yes How!
Is hamster kombat currency tradable? If yes How!
CRYPTO SPACE 🪙
 
Monthly Economic Monitoring of Ukraine No.234, July 2024
Monthly Economic Monitoring of Ukraine No.234, July 2024Monthly Economic Monitoring of Ukraine No.234, July 2024
how can I sell hamster kombat tokens on kucoin exchange.
how can I sell hamster kombat tokens on kucoin exchange.how can I sell hamster kombat tokens on kucoin exchange.
how can I sell hamster kombat tokens on kucoin exchange.
CRYPTO SPACE 🪙
 
3. Elemental Economics - Supply and Costs.pdf
3. Elemental Economics - Supply and Costs.pdf3. Elemental Economics - Supply and Costs.pdf
3. Elemental Economics - Supply and Costs.pdf
Neal Brewster
 
how can I convert hamster kombat to other cryptocurrency - BITCOIN, USDT, BNB.
how can I convert hamster kombat to other cryptocurrency -  BITCOIN, USDT, BNB.how can I convert hamster kombat to other cryptocurrency -  BITCOIN, USDT, BNB.
how can I convert hamster kombat to other cryptocurrency - BITCOIN, USDT, BNB.
CRYPTO SPACE 🪙
 
How can i sell hamster kombat token on Binance exchange!
How can i sell hamster kombat token on Binance exchange!How can i sell hamster kombat token on Binance exchange!
How can i sell hamster kombat token on Binance exchange!
CRYPTO SPACE 🪙
 
Perfect trading ebook - is it a legitimate forex trading Ebook or SCAM!
Perfect trading ebook - is it a legitimate forex trading Ebook or SCAM!Perfect trading ebook - is it a legitimate forex trading Ebook or SCAM!
Perfect trading ebook - is it a legitimate forex trading Ebook or SCAM!
TRADERS / CRYPTO SPACE 💱
 
how much can I sell my Hamster Kombat coins.
how much can I sell my Hamster Kombat coins.how much can I sell my Hamster Kombat coins.
how much can I sell my Hamster Kombat coins.
CRYPTO SPACE 🪙
 
where to buy and sell hamster kombat tokens 🐹
where to buy and sell hamster kombat tokens 🐹where to buy and sell hamster kombat tokens 🐹
where to buy and sell hamster kombat tokens 🐹
CRYPTO SPACE 🪙
 
Has anyone made money from hamster kombat - the REAL truth.
Has anyone made money from hamster kombat - the REAL truth.Has anyone made money from hamster kombat - the REAL truth.
Has anyone made money from hamster kombat - the REAL truth.
CRYPTO SPACE 🪙
 
hamster kombat - The best way to gain Massively as beginner's.
hamster kombat - The best way to gain Massively as beginner's.hamster kombat - The best way to gain Massively as beginner's.
hamster kombat - The best way to gain Massively as beginner's.
CRYPTO SPACE 🪙
 
Tapswap launch date - what all miners need to know!
Tapswap launch date - what all miners need to know!Tapswap launch date - what all miners need to know!
Tapswap launch date - what all miners need to know!
CRYPTO SPACE 🪙
 
Economic Risk Factor Update: July 2024 [SlideShare]
Economic Risk Factor Update: July 2024 [SlideShare]Economic Risk Factor Update: July 2024 [SlideShare]
Economic Risk Factor Update: July 2024 [SlideShare]
Commonwealth
 
how can I successfully sell my tapswap currency?
how can I successfully sell my tapswap currency?how can I successfully sell my tapswap currency?
how can I successfully sell my tapswap currency?
CRYPTO SPACE 🪙
 
20240710 Calibre Mining 2024 Investor Presentation.pdf
20240710 Calibre Mining 2024 Investor Presentation.pdf20240710 Calibre Mining 2024 Investor Presentation.pdf
20240710 Calibre Mining 2024 Investor Presentation.pdf
Adnet Communications
 

Recently uploaded (20)

Domestic investment in pension schemes - a good thing?
Domestic investment in pension schemes - a good thing?Domestic investment in pension schemes - a good thing?
Domestic investment in pension schemes - a good thing?
 
Can I sell my hamster kombat tokens Now! (latest update - 2024)
Can I sell my hamster kombat tokens Now! (latest update - 2024)Can I sell my hamster kombat tokens Now! (latest update - 2024)
Can I sell my hamster kombat tokens Now! (latest update - 2024)
 
how to sell hamster kombat tokens before mainnet launch.
how to sell hamster kombat tokens before mainnet launch.how to sell hamster kombat tokens before mainnet launch.
how to sell hamster kombat tokens before mainnet launch.
 
When will I be able to sell my Tapswap token's?
When will I be able to sell my Tapswap token's?When will I be able to sell my Tapswap token's?
When will I be able to sell my Tapswap token's?
 
Is it possible to sell hamster kombat tokens?
Is it possible to sell hamster kombat tokens?Is it possible to sell hamster kombat tokens?
Is it possible to sell hamster kombat tokens?
 
Is hamster kombat currency tradable? If yes How!
Is hamster kombat currency tradable? If yes How!Is hamster kombat currency tradable? If yes How!
Is hamster kombat currency tradable? If yes How!
 
Monthly Economic Monitoring of Ukraine No.234, July 2024
Monthly Economic Monitoring of Ukraine No.234, July 2024Monthly Economic Monitoring of Ukraine No.234, July 2024
Monthly Economic Monitoring of Ukraine No.234, July 2024
 
how can I sell hamster kombat tokens on kucoin exchange.
how can I sell hamster kombat tokens on kucoin exchange.how can I sell hamster kombat tokens on kucoin exchange.
how can I sell hamster kombat tokens on kucoin exchange.
 
3. Elemental Economics - Supply and Costs.pdf
3. Elemental Economics - Supply and Costs.pdf3. Elemental Economics - Supply and Costs.pdf
3. Elemental Economics - Supply and Costs.pdf
 
how can I convert hamster kombat to other cryptocurrency - BITCOIN, USDT, BNB.
how can I convert hamster kombat to other cryptocurrency -  BITCOIN, USDT, BNB.how can I convert hamster kombat to other cryptocurrency -  BITCOIN, USDT, BNB.
how can I convert hamster kombat to other cryptocurrency - BITCOIN, USDT, BNB.
 
How can i sell hamster kombat token on Binance exchange!
How can i sell hamster kombat token on Binance exchange!How can i sell hamster kombat token on Binance exchange!
How can i sell hamster kombat token on Binance exchange!
 
Perfect trading ebook - is it a legitimate forex trading Ebook or SCAM!
Perfect trading ebook - is it a legitimate forex trading Ebook or SCAM!Perfect trading ebook - is it a legitimate forex trading Ebook or SCAM!
Perfect trading ebook - is it a legitimate forex trading Ebook or SCAM!
 
how much can I sell my Hamster Kombat coins.
how much can I sell my Hamster Kombat coins.how much can I sell my Hamster Kombat coins.
how much can I sell my Hamster Kombat coins.
 
where to buy and sell hamster kombat tokens 🐹
where to buy and sell hamster kombat tokens 🐹where to buy and sell hamster kombat tokens 🐹
where to buy and sell hamster kombat tokens 🐹
 
Has anyone made money from hamster kombat - the REAL truth.
Has anyone made money from hamster kombat - the REAL truth.Has anyone made money from hamster kombat - the REAL truth.
Has anyone made money from hamster kombat - the REAL truth.
 
hamster kombat - The best way to gain Massively as beginner's.
hamster kombat - The best way to gain Massively as beginner's.hamster kombat - The best way to gain Massively as beginner's.
hamster kombat - The best way to gain Massively as beginner's.
 
Tapswap launch date - what all miners need to know!
Tapswap launch date - what all miners need to know!Tapswap launch date - what all miners need to know!
Tapswap launch date - what all miners need to know!
 
Economic Risk Factor Update: July 2024 [SlideShare]
Economic Risk Factor Update: July 2024 [SlideShare]Economic Risk Factor Update: July 2024 [SlideShare]
Economic Risk Factor Update: July 2024 [SlideShare]
 
how can I successfully sell my tapswap currency?
how can I successfully sell my tapswap currency?how can I successfully sell my tapswap currency?
how can I successfully sell my tapswap currency?
 
20240710 Calibre Mining 2024 Investor Presentation.pdf
20240710 Calibre Mining 2024 Investor Presentation.pdf20240710 Calibre Mining 2024 Investor Presentation.pdf
20240710 Calibre Mining 2024 Investor Presentation.pdf
 

Presentation Part 2 – Leading with innovation

  • 1. 1 Vaccines Investor Event Part 2 Leading with innovation December 1st, 2021
  • 2. Vaccines Investor Event | Agenda Q&A session Thomas Triomphe Head of Vaccines GBU Paul Hudson Chief Executive Officer Thomas Triomphe Head of Vaccines GBU Bill Averbeck Head of Influenza Franchise Kimberly Tutwiler Head of RSV Franchise Q&A session Frank DeRosa Head of Research for mRNA CoE Jean-François Toussaint Thomas Grenier Head of Vaccines R&D Head of Franchises & Product Strategy Conclusion Growing current business Leading with innovation Introduction We Play to Win Winning in Influenza All infant protection against RSV Unlocking the potential of mRNA Broadening the pipeline to address unmet needs Building an innovative & diversified pipeline Jean-François Toussaint Head of Vaccines R&D CoE: Center of Excellence 2
  • 3. Jean-François Toussaint Building an innovative & diversified pipeline Head of Vaccines Research & Development
  • 4. Building an innovative and diversified pipeline to deliver sustainable growth 4 Opening a new chapter at Sanofi Vaccines, expanding to new disease areas Rejuvenated pipeline, with 10 new development candidates by 2025 (of which 6 mRNAs) Focused on first-in-class / best-in-class R&D objectives Leveraging state of the art immunology & antigen design Selecting the best technology platform for each target
  • 5. Broadening our pipeline & opening new areas for growth 5 Expanding research on additional vaccines candidates against chronic diseases < • Fluzone HD pediatric • Influenza QIV mRNA • Next-Gen Flu vaccines • PCV21 < • Chlamydia • Acne < • MenB • MenPenta • RSV toddler • RSV older adults & respiratory combo Influenza Pneumo New frontiers Meningitis RSV Deepen our leadership in existing franchises New Growth Areas = New RSV: Respiratory syncytial virus PCV: Pneumococcal conjugate vaccine HD: High-Dose QIV: Quadrivalent influenza vaccine
  • 6. Innovation addressing a large part of the population 6 Influenza Meningitis New frontiers RSV Adolescents Young adults(2) Adults(3) Older adults(4) Pneumo – RSV older adults & combos Influenza QIV & Next-Gen Flu vaccine MenB & MenPenta RSV toddler Pneumococcal Pneumococcal Chlamydia Acne – Pediatric Children(1) – 1.9bn Ex-U.S. 61m U.S. 1.2bn Ex-U.S. 44m U.S. 3.7bn Ex-U.S. 171m U.S. 0.7bn Ex-U.S. 55m U.S. Population (1) 0 – 14 years old (2) 15 – 24 years old (3) 25 – 65 years old (4) 65+ years old Source: Population estimates, The World Bank
  • 7. We added mRNA to our state of the art toolbox 7 We select the best platform for each target Established platforms mRNA & LNP platforms • Broad range of antigen targets • Viral & bacterial • Protein & polysaccharide • Proven efficacy across multiple diseases & populations • Proven tolerability from babies to older adults • Restricted to protein-based antigens • Particularly well suited for (respiratory) viral pathogens • Fast to clinic & low CMC costs • Potential to facilitate multi- component vaccines Subunit Vaccine Inactivated (killed) Vaccine Glyco- Conjugate Vaccine Viral Vector Vaccines Monoclonal Antibodies mRNA Vaccine Adjuvant  n Θ Live Attenuated Vaccine Lipid Nanoparticle CMC: Chemistry, manufacturing & controls
  • 8. Frank DeRosa Unlocking the potential of mRNA Head of Research mRNA CoE CoE: Center of Excellence
  • 9. 9 Sanofi mRNA Center of Excellence A biotech environment with Sanofi’s powerhouse • 400 dedicated employees in the U.S. (Cambridge) and France (Lyon) • Positive clinical results from COVID-19 and influenza monovalent mRNA candidates • Pivot to modified mRNA achieved; clinical trials planned to start in 2022 • Expansion of proprietary database ongoing internally & with partnerships mRNA Center of Excellence Moving fast beyond 1st generation mRNA • Deep vaccine & antigen design expertise • Well-established development platforms • Expertise in running clinical trials • Global manufacturing scale • Strong mRNA & LNP know-how • Proprietary algorithms & large LNP database • Large scale material production capabilities LNP: Lipid nanoparticles
  • 10. First clinical trial with our proprietary mRNA & LNP platform Optimized unmodified mRNA encoding prefusion full-length SARS-CoV-2 spike protein Proprietary LNP with customized composition and ratio mRNA 7.5µg 36 Days 21 0 Unmodified mRNA & proprietary LNP, using COVID-19 as a reference antigen Phase I design mRNA 15µg mRNA 45µg Control group (saline) Screening 10 LNP: Lipid nanoparticles
  • 11. Platform potential confirmed by positive interim results Pseudovirus nAb to D614G 14 days post-dose 2 (SARS-CoV-2 seronegative participants, n=41) GMT ratio Vaccinated / Convalescent 100% seroconversion for all doses ≥ 15µg Tolerability profile in line with other unmodified mRNA COVID-19 vaccines 1.0 0.6 0.8 7.5µg 15µg 45µg 1.1 Open label sentinels Human Conv. 7.5µg 45µg 15µg Dose 1 n=45 Dose 2 b=44 Open label sentinels Grade 3 adverse events 11 22% 18% 59% 18% 60% 50% Seroconversion (≥4-fold increase) 91% 100% 100% N/A GMT: Geometric mean titer Source: Data on file
  • 12. Progressing to clinic with influenza 12 n=30 mRNA 7.5µg ; LNP #1 29 Days 1 Unmodified mRNA & proprietary LNPs, for monovalent influenza vaccine Phase I design mRNA 15µg ; LNP #1 mRNA 45µg ; LNP #2 n=40 Control - monovalent Rec HA 45 µg (= Flublok concentration) mRNA 45µg ; LNP #1 mRNA 15µg ; LNP #2 mRNA 7.5µg ; LNP #2 n=30 n=30 n=30 n=30 n=30 Optimized unmodified mRNA encoding for the hemagglutinin protein of the A/H3N2 strain Two proprietary LNP options with customized composition and ratio 9 Screening LNP: Lipid nanoparticles
  • 13. First evidence that mRNA could work for influenza, pending improved reactogenicity 13 9.5 3.1 7.5μg 15μg 45μg 3.7 2.9 4.5 20.5 12.4 LNP #1 LNP #2 40% 7.5μg 22% 15μg 45μg 10% 20% 30% 89% 7% LNP #2 LNP #1 Sanofi’s mRNA monovalent Flu Immunogenicity Reactogenicity(2) GMT ratio Sanofi’s mRNA monovalent Flu LNP # 2 identified as a promising candidate for influenza vaccine Rec. HA Rec. HA Seroconversion(1) 30% 70% 44% 90% 40% 100% 73% Rec. HA: Recombinant HA HA: Hemagglutinin GMT: Geometric mean titer (1) Seroconversion: proportion of participants with D01 < 10 (1/dil) and post-titer >=40 (1/dil) or D01 >=10 (1/dil) and post-titer >= 4-fold increase (2) Grade 3 solicited reactions Source: Data on file
  • 14. Successfully pivoted to modified mRNA 14 Dose 3 Dose 2 Dose 1 0 28 42 56 0 28 42 56 0 28 42 Switch to modified mRNA achieved Unmodified mRNA 1-N-MEΨ modified mRNA mRNA-HA dose mRNA-HA dose 1/40 1/40 HAI Titer (Log10) Similar immunogenicity with modified mRNA in NHP Dose 2 Dose 1 0 28 42 56 0 28 42 56 0 28 42 56 Dose 3 56 • Pre-clinical data generated in multiple animal models • GMP material produced • On track to start clinical trials in influenza • H1 2022 for monovalent • H2 2022 for quadrivalent 1 0 2 3 4 5 2 0 1 3 4 5 First clinical data with modified mRNA expected in 2022 GMP: Good manufacturing practices NHP: Non-human primate Note: Study conducted in NHP with escalating two doses schedule (Day 0 and Day 28) - mRNA encoding for Flu Hemagglutinin Source: Data on file
  • 15. Biomarkers show clear path to reduce reactogenicity with modified mRNA and optimized LNPs 15 1 10 100 1,000 10,000 Mod. Un.Mod. Ø Ø Un.Mod. Un. Ø 10 1,000 1 100 Mod. Un. Mod. Ø Ø Un. Mod. Un. Ø IFN𝛼2 LNP #1 LNP #2 LNP #3 Proprietary ex-vivo MIMIC System® assay enabling evaluation of immune responses LNP #1 LNP #2 LNP #3 MCP-3 Modified mRNA & LNP optimization expected to reduce reactogenicity in the clinic LNP: Lipid nanoparticles Ø: no mRNA MIMIC: Modular Immune in vitro Construct Note: IFN𝛼2 and MCP-3 presumed biomarkers of reactogenicity Source: Data on file
  • 16. Overcoming mRNA thermostability challenges 16 Ready to go with lyophilized Stability of lyophilized mRNA drug product achieved Development of fully liquid formulation underway 0 0 6 3 50 75 9 12 25 100 Change in % mRNA Integrity Liquid LNP (2-8oC) Months 0 75 25 50 100 W1 In vivo potency in mice (%) W9 W3 W18 W25 Liquid stabilized prototype LNP (2-8oC) Classical LNP Proprietary lyophilized LNP (2-8oC) Storage at 4°C is needed for vaccines outside pandemic 1 12 48 Hexaxim Fluzone HD Shelf life at 2-8°C in the registered product labels (months) mRNA based COVID-19 vaccine Note: Fluzone HD: Egg-based influenza vaccine Hexaxim: 6-in-1 combination pediatric vaccine Source: Data on file
  • 17. Breaking barriers to unlock mRNA potential 17 Duration of expression Reactogenicity Thermostability Immunogenicity Targeting Applicable to pandemic market Required profile for general vaccine markets Optimal profile for therapeutics High High High Tolerability profile in line with established vaccines Tolerability profile in line with established vaccines Lyophilized or 9 – 12 months fully liquid Lyophilized or 9 – 12 months fully liquid Extended half-life Moderate to high ~1 month shelf life (2-8°C) 1 – 3 days 1 – 3 days - - Efficient cell & organ specificity 1st gen mRNA 2nd gen mRNA 3rd gen mRNA
  • 18. 18 Jean-François Toussaint Head of Vaccines Research & Development Thomas Grenier Head of Franchises & Product Strategy Broadening the pipeline to address unmet needs
  • 19. 82% 18% Influenza: further raising the bar 19 €6.7bn 2020 Market overview Standard dose vaccines • Accelerated mRNA QIV Influenza development • Raising the bar further with Next-Gen Flu • Machine Learning for better strain selection • Expanding on neuraminidase to induce greater protection Sanofi strategy to keep winning in flu Differentiated vaccines QIV: Quadrivalent influenza vaccine Source: Sanofi published sales and market estimates at 2020 exchange rate
  • 20. First milestone achieved for Sanofi mRNA QIV 20 • Optimized modified mRNA sequence • Encoding for 4 HA proteins • Optimized LNP to reduce reactogenicity 0 8 2 4 6 10 12 14 16 Log2 HA titers at Day 42(1) B Victoria B Yamagata H1N1 H3N2 Average QIV HA mRNA QIV Recombinant Protein Pre-clinical data generated with unmodified mRNA Pivoted to modified for final candidate LNP: Lipid nanoparticles HA: Hemagglutinin (1) Immunogenicity response in ferrets Source: Data on file
  • 21. Influenza mRNA QIV development with objective to demonstrate Protection Beyond Flu 21 • Two age cohorts (18-64yo & 65yo+) • Dose-selection trial • Comparison against standard of care • Quadrivalent vaccine based on WHO selected strains • Comparison to standard of care Selection of final composition for each population Registration trial designed to demonstrate vaccine efficacy & build safety database Phase I/II – Targeted initiation in 2022 Phase III – Targeted Initiation in 2023 WHO: World Health Organization
  • 22. Later strain selection not the solution for improved efficacy 22 Vaccine administration Influenza season 0.0 0.6 0.2 0.4 0.8 1.0 2013-06 2015-03 2013-08 Example of 2014-2015 season (H3N2 late mismatch)(3) 2013-07 2013-09 2013-10 2013-11 2013-12 2014-01 2014-02 2015-02 2014-03 2014-04 2014-05 2014-06 2014-09 2014-07 2014-08 2014-10 2014-11 2014-12 2015-01 2015-04 2015-05 Current WHO selection Shift in strain dynamic can occur late in season Only 2 out of past 10 years with strain mismatch Vaccine strain to predominant circulating strain similarity(1, 2) Predominant strain in adults ≥ 65yo(1) A/H3N2 (80.4%) A/H3N2 (87.0%) A/H3N2 (90.6%) A/H1N1 (71.0%) A/H3N2 (86.4%) A/H1N1 (57.2%) A/H1N1 (48.4%) A/H3N2 (79.0%) A/H3N2 (69.4%) A/H3N2 (53.3%) 2010-11 2011-12 2014-15 2019-20 2012-13 2013-14 2015-16 2016-17 2017-18 2018-19 Season 97% 82% 100% 100% 19% 100% 97% 93% 11% 54% (1) Adapted from Lee J, Lam J, Shin T, et al. Vaccine 2021 for season 2010-11 to 2018-19 data and from CDC FluView Summary ending July 25, 2020 for season 2019-20 data; Determined using national CDC viral surveillance data on adults 65 years of age and older (2) Antigenic Similarity of Reference Vaccine Strain to Predominant Circulating Strain based on CDC data on viral antigenic characterization comparing reference vaccine strains to circulating viruses; mismatched seasons includes seasons of antigenic mismatch (2009–10, 2014–15, 2018–19) as well as seasons where egg-adapted vaccine strains may have affected vaccine effectiveness (2012–13, 2016–17, 2017–18) (3) GISAID data analysis
  • 23. 81 66 79 62 54 35 36 43 Striving for better strain selection with Machine Learning 23 Higher seroconversion for ML-selected antigens(1) Antigens selected for cross-clade protection ML selected antigens showed greater breadth in Phase I translational study 66 28 ML - 4 WHO strain ML - 1 ML - 3 ML - 2 % subjects seroconverting to ≥ 5 out of 6 H3 strains % subjects seroconverting to 6 out of 6 H3 strains SoC *Line represents antibody response after vaccination > SoC(2) 3C.2 3C.3 ML-2 Read-out Other PC: Principal component SoC: Standard of care ML: Machine learning (1) Immunogenicity was assessed via a panel of 6 antigenically distinct influenza viruses from both 3C.2 and 3C.3 clades, isolated in 2016 and 2017; n=30 participants per arm (healthy adults aged 18-30) (2) Statistical significance ratio of 1.35x
  • 24. Exploring the potential of neuraminidase to further build Protection Beyond Flu 24 Fluzone SD/Fluzone HD already increase anti-NA titers(1) Exploring combined HA + NA multivalent vaccines Response in ferrets of multivalent protein and mRNA vaccines 6% 13% 24% 31% N2 N1 Fluzone SD Fluzone HD HA Response (2) Log2 HA titers 2 14 12 0 4 8 6 10 14 8 0 2 10 6 4 12 NA Response (3) Log2 NA titers B Victoria B Yamagata H1N1 H3N2 Multivalent Recombinant Protein Multivalent mRNA rHA Average NA: Neuraminidase HA: Hemagglutinin rHA: recombinant Hemagglutinin (1) Defined as ≥2-fold increase in enzyme-linked lectin assay; Graph shows proportion of subjects developing increase in anti-NA titers (2) Microneutralization assay (3) NA inhibition assay Source: Cate, Thomas R et al. Vaccine (2010); data on file
  • 25. 31% 13% 56% Respiratory Syncytial Virus: protection across all age groups 25 €8bn 2030 Market overview Nirsevimab: best-in-class mAb for All Infant Protection in first season Best-in-class protection for all ages <1 year old 1 - 5 years old 65+ years old RSV toddler: first-in-class Live Attenuated Virus vaccine for second season onwards RSV older adults: initiating standalone mRNA vaccine, and paving the way for respiratory combos in older adults mAb: monoclonal antibody Source: Sanofi forecast
  • 26. RSV burden does not stop after the first season • Excellent safety profile • Efficacy against medically- attended upper and lower respiratory tract infections RSV toddler vaccine target profile ~905k ~1,500k 1 to 4 years U.S. RSV-related hospital admissions(1) ~39k ~18k <1 year 1 to 4 years <1 year U.S. RSV-related outpatient visits(2) Note: Internal analysis based on following studies and World Bank 2020 demographic data (1) Rha B, Curns AT, Lively JY, et al. Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016. Pediatrics. 2020 (2) Emergency and Pediatric practices RSV-related outpatients estimate - Hall CB, Weinberg GA, Iwane MK, et al. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009 26
  • 27. FiC RSV toddler vaccine designed by reverse genetics 27 Ongoing Phase I/II in U.S. and Latin America (n=360 participants) – read-out expected in 2022 Deletion of NS2 • Improved immunogenicity • Improved safety Deletion of 1313 with I1314L as stabilizer Virus Epithelial cells NS1 NS2 N P M SH G F M2 L NS2 • Improved safety FiC: First-in-class Source: Data on file
  • 28. Clinical data shows evidence of efficacy by reducing medically attended acute respiratory illnesses 28 ∆NS2 vaccine candidate selected for further development Evidence of efficacy(1) for both upper and lower respiratory tract infections 0 1 2 3 4 5 6 7 8 Log 10 copies per mL 0 1 2 3 4 5 6 7 8 9 10 11 PRNT 60 (1/ log 2 ) 0 20 40 60 80 100 % VE, N=80 Upper and lower respiratory tract infections Lower respiratory tract infections Neutralization titer Vaccine shedding by PCR ∆ M2-2 Candidates ∆ NS2 ∆ M2-2 Candidates ∆ NS2 VE: vaccine efficacy PRNT: plaque reduction neutralizing titer PCR: polymerase chain reaction (1) Efficacy measured and displayed across all candidates and not just ∆NS2; p<0.05 significance for VE was observed for Upper and lower respiratory tract infections, however the Placebo group was small with 62 subjects of which 11 experienced RSV-related medically attended acute respiratory Illness (18%) Source: Ruth Karron et al; Am J Respir Crit Care Med 2021
  • 29. RSV in older adults: addressing a large burden 29 • Initiating standalone RSV mRNA vaccine to address high burden of disease in older adults • Low variability of RSV may allow for multiyear protection Estimated U.S. hospitalizations amid 65yo+ Estimated U.S. outpatient acute infection amid 65yo+ Virus evolution RSV 105k(2) 1,041k(1) Low Influenza 204k(3) 1,808k(1) High HMPV PIV 82k(2) 329k(1) 88k(2) 603k(1) Low Low Opportunity for RSV-based combos • Cumulated burden of RSV and HMPV comparable to Influenza • Potential for additional convenience and cost- effectiveness benefits HMPV: Human metapneumovirus PIV: Parainfluenza viruses (1) Estimate based on World Bank 2020 demographic data and on following study: Jackson ML, Starita L, Kiniry E, et al.. Clin Infect Dis. 2021 (2) Estimate based on World Bank 2020 demographic data and on following study: Sieling, William D et al. “Comparative incidence and burden of respiratory viruses associated with hospitalization in adults in New York City.” Influenza and other respiratory viruses vol. 15,5, 2021 (3) CDC data, 2018-2019 flu season
  • 30. Best-in-class RSV antigen through innovative design 30 RSV F antigen designed to focus on potent site 0 Improved immunogenicity over competing antigens Neutralization titer -1 Proven potency in mRNA format Competitive Elisa - Log 2 IT 50 Log2 RSV MN titer -1 0 2 8 4 6 Wild type RSV F FD3 RSV candidate Site 0 (Nirsevimab) Site 1 . Site 2 (Synagis) 8 12 4 16 D0 D28 D56 D0 D28 D56 mRNA Recombinant protein Site potency 104 101 102 103 Post-F Trimer FD3 RSV candidate DS-Cav1 Trimer Initiating Phase I with modified mRNA in 2022 P = 0.0003 P = 0.02 Source: Data on file
  • 31. State of the art HMPV antigen candidate identified 31 Cutting edge antigen design Proven potency in mRNA format Sanofi proprietary mAb focused on most potent site (Site 0) HMPV F Gen1(1) preF protein Gen3 preF protein Gen2 preF protein Log2 HMPV MN titer-1 16 8 4 12 4.5-fold 2.9-fold Gen1 preF protein Gen3 preF mRNA Log2 HMPV MN titer-1 8 4 12 16 D0 D28 D56 D0 D28 D56 Initiation of Phase I with RSV older adults combo planned for 2023 mAb: monoclonal antibody HMPV: Human metapneumovirus Note: Figure is from manuscript in preparation through SP/UT collaboration. SP innovation (1) Gen1 was unstable, necessitating next generation designs Source: Data on file
  • 32. Pneumococcal: more serotypes for better protection 32 Large established market 79% 6% 15% Prevnar (PCV13) Synflorix (PCV10) PPV Vx €6.2bn 2020 • Synergy with pediatric and older adult portfolio • State of the art formulation expertise with multi-valent vaccines • Partnership with SK Bioscience • Complementary capabilities • Investment and risk sharing Strong fit with existing franchises Source: Pfizer, GSK, Merck 2020 Annual Reports
  • 33. Raising the bar with PCV21 candidate 33 Addition of 9N serotype allowing for ~5-7% pts gain in IPD coverage 1 4 5 6B 7F 9V 14 18C 19F 23F 3 6A 19A 22F 33F 8 10A 11A 12F 15B 9N 17F 20 2 5.2% U.S. 2018(1) EU 2018(2) 26.1% 14.2% 14.0% 6.7% 38.9% 27.5% 29.0% 9.0% 29.3% IPD coverage in all ages by serotype (%) Serotype composition per vaccine NVT/NT PCV20 non-PCV15 PCV15 non-PCV13 PCV21 non-PCV20 PCV13 Pfizer Prevnar 20 Launch phase in the U.S. Merck PCV15 Launch phase in the U.S. Pfizer Prevnar 13 Sanofi PCV21 NVT: Non-vaccine type NT: Non-typable IPD: Invasive pneumococcal disease (1) All age groups - ABC data 2018. Metcalf et al. Clin Infect Dis. 2021 Jun 15;72(12):e948-e956 (2) All age groups - https://atlas.ecdc.europa.eu/public/index.aspx?Dataset=27&HealthTopic=40
  • 34. Extensive Phase II program across all age groups 34 Read-out in all 3 populations expected end of 2022; Phase III initiation planned in 2023 Adult ≥ 50 years old n=750 Toddler n=140 Infant Primary n=700 • Subjects naïve to prior PCV vaccination • 3 PCV21 formulations vs. PCV13 & Pneumovax23 • Booster dose for toddlers having received 3 doses of PCV13 • 3 PCV21 formulations vs. PCV13 • 2-4-6 months primary series & booster dose • 3 PCV21 formulations vs. PCV13 NCT04398706: Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants. (Sanofi, phase 2 trial, PSK00008, n = 840, recruiting, estimated study completion date July 2023) NCT04583618: Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years (Sanofi phase 2 trial PSK00009, n = 750; Estimated study completion data Jan 2022)
  • 35. 48% 34% 8% 10% Meningitis: Strengthening our leadership 35 €2.4bn 2020 • Established leader with Menactra in the U.S. • MenQuadfi as a new standard in MenACWY, with superior serotype C response to ease market conversion to quadrivalent • Aiming for competitive MenB with broader strain coverage & longer duration of protection • Paving the way for best-in-class MenPenta in fully liquid format MenC MenACWY MenB Other Market overview Source: Sanofi estimates
  • 36. MenQuadfi as a new standard in MenACWY 36 Broadest age indication U.S. ≥2 yo 2 months to 55 yo Not registered EU ≥12 months old ≥2 yo(2) ≥6 weeks Int'l ≥12 months old ≥2 yo ≥6 weeks MenQuadfi Sanofi (ACWY) Menveo GSK (ACWY) Nimenrix Pfizer (ACWY) (1) ≥6 weeks as of 2025 Enhanced immunogenicity, with superiority against MenC in toddlers Fully liquid quadrivalent (1) Submission for a liquid form announced in Q3 2021 (2) Indications as of 2 months old in some countries (using US file)
  • 37. MenQuadfi is the first & only ACWY vaccine to demonstrate superior immune response against serogroup C 37 Paving the way for MenPenta 515 32 227 Human complement SBA GMTs at D30 (hSBA GMTs) 2,143 315 1,624 Rabbit complement SBA GMTs at D30 (rSBA GMTs) Enabling switch from MenC to MenACWY without compromising on serotype C ACWY ACWY C only ACWY ACWY C only Nimenrix® (N=211) NeisVac-C® (N=216) MenQuadfi (N=214) Nimenrix® (N=210) NeisVac-C® (N=215) MenQuadfi (N=213) SBA: Serum bactericidal assay - Per-protocol analysis set GMT: Geometric mean titer Source: Knuf et al, (2021): Meningococcal serogroup C (MenC) immune response of a novel tetanus toxoid conjugate quadrivalent meningococcal vaccine (MenACYW-TT) compared to a quadrivalent (MCV4-TT) or monovalent (MenC-TT) meningococcal vaccine in healthy meningococcal vaccine-naïve toddlers
  • 38. Novel MenB vaccine aiming for increased protection 38 MenB Phase II read-out expected in 2022 – MenPenta Phase I initiation in 2023 Non-Lipidated fHBP A+B • Two fHBP covering all MenB strains • Non-lipidated formulation allowing for better safety NadA • Increasing strain coverage Outer Membrane Vesicle • Increasing strain coverage • Potential adjuvant effect MenB antigen formulation ST-32 ST-269 ST-213 ST-35 ST-11 ST-461 ST-103 MenB IMD isolates by prevalent clonal complex 4/4 ST-41/44 3/4 4/4 1/3 2/2 2/2 1/2 1/1 1/1 1/1 2/2 1/2 1/2 1/1 1/1 1/1 3/3 3/3 1/1 1/1 1/1 3/3 3/3 2/3 Broader coverage of MenB strains(1) Sanofi Pfizer GSK IMD: Invasive meningococcal disease fHBP: Factor H binding protein NadA: Neisserial adhesin A (1) Pre-clinical assessment of Serum Bactericidal Antibodies (SBA) against MenB IMD isolates; 18 strains identified as relevant with 1 secondary strain not tested in the preclinical study (not suitable with Research hSBA assay) Source: Pre-clinical study in animal model: Assessment of Serum Bactericidal Antibodies against an epidemiology relevant panel of MenB invasive clinical isolates build by key Reference Laboratories & Representative of current MenB molecular epidemiology
  • 39. Pioneering science to open new growth areas 39 >€2bn (peak) Market overview (estimate) Chlamydia Acne • Chlamydia: tackling the most common infectious cause of female infertility • Acne: first immunotherapy to treat acne Delivering first-in-class vaccines Source: Sanofi forecasts
  • 40. Chlamydia: a silent cause of infertility in women 40 Annual U.S. incidence in women ~800k non-diagnosed ~300k PID cases ~2m infections ~20k cases of infertility per year • 69% of estimated annual cases amid young women aged 24 years old or less • Undiagnosed cases can lead to severe complications, particularly in women • Pelvic Inflammatory Cases • Tubal infertility • Ectopic pregnancy • Chronic pelvic pain Overwhelming burden in young women PID: Pelvic inflammatory disease Source: Multiple sources for estimate reconstitution: CDC - Sexually Transmitted Disease Surveillance, 2019 & Chlamydia Fact Sheet, 2018; Land JA, Van Bergen JE, Morré SA, Postma MJ, Hum Reprod. Update, 2010; Price MJ, Ades AE, De Angelis D, et al. Am J Epidemiol., 2013 ; Heisterberg L. Obstet Gynecol., 1993; Ades AE, Price MJ, Kounali D, et al. Am J Epidemiol., 2017; World Bank demographic data 2020
  • 41. Chlamydia: mRNA best-suited platform to deliver desired immune response 41 mRNA-based multi-component vaccine Phase I launch expected in 2023 Selecting additional antigens to prevent Chlamydia entry in endocervical cells Optimized antigen for strong CD4 T-cells response(1) 3000 0 1000 2000 Antigen6 Antigen2 Antigen3 Antigen4 Antigen1 Antigen5 rAntigen+ adjuvant IFN-γ SFC/10(6) splenocytes mRNA without antigens with antigens Chlamydia infected cells (in red)(2) (1) Superior IFN-γ producing T cell with mRNA vs adjuvanted rAntigen (2) High throughput screening of neutralizing IgG and real time monitoring of infection kinetics in endocervical cell line with genetically engineered Chlamydia t. strains Source: Data on file
  • 42. Acne: a stigmatizing condition 42 • Significant psychological impact • Current SoC (oral isotretinoin) with severe side effects • Significant out-of-pocket expenses ($360-$720(2) / year in the U.S.) • P. acnes bacterium also associated with several conditions beyond acne: • Other dermatological conditions(3) • Medical device-related infections(4) • Prostatic inflammation thought to contribute to prostate cancer(5) Mild acne Severe acne Moderate acne ~140m worldwide cases(1) ~90m worldwide cases(1) (1) Source: IHME. GBD Results Tool; http://ghdx.healthdata.org/gbd-results-tool (2) Sanofi internal analysis (3) Bojar and Holland, 2004; Kurokawa et al., 2009; Barnard et al., 2016 (4) Piper KE et al, J Clin Microbiol. 2009;47(6):1878-1884; Niazi SA et al, Clin Oral Investig. 2016;20(8):2149-2160 (5) Cohen RJ et al, J Urol. 2005;173(6):1969-1974
  • 43. Immune system plays a significant role in moderate-to- severe acne 43 Vaccine solution as a first immunotherapy to safely treat moderate-to-severe acne <10k elements secreted by S. epidermidis TLRs (Toll-like receptors) Cutibacterium acnes Staphylococcus epidermidis Staphylococcus aureus C. acnes phylotype Origimm's antigens IA1 +++ IA2 +++ IB ++ IC +++ II ++ III (+) Origimm‘s antigen induce a functional immune response against C. acnes virulent strains Opsonophagocytic killing by antigen specific mouse sera Skin dysbiosis (acne patients) Skin homeostasis (healthy) Epidermis Dermis Hypodermis ◌ Keratinocytes ◌ Sebocytes ◌ Keratinocytes C. acnes Virulence factors Immune cells Inflammation Immune cells AMPs Bacterial proliferation 1 2 AMPs: Antimicrobial peptides PSMs: Phenol-soluble modulins Esp: Endopeptidase serine protease FFAs: Free Fatty Acids Source: Adapted from Fournière M et al., Microorganisms 2020
  • 44. Building an industry leading pipeline in Vaccines 44 Pre-clinical Phase I & II Phase III SP0273 Influenza monovalent vaccine mRNA Fluzone® HD - SP0178 Pediatric flu SP0218 Yellow fever vaccine SP0202 Pneumococcal SP0230 Meningitis B nirsevimab Respiratory Syncytial Virus SP0253 Recombinant COVID-19 VerorabVax® (VRVg) Rabies Influenza QIV mRNA RSV older adults combo mRNA MenPenta RSV older adults mRNA • Target to advance 10 clinical candidates by 2025, incl. 6 mRNA vaccines • Opportunity to be first-in-class and lead in several new therapeutic fields • Right mix between LCM, proven targets and breakthrough vaccines Future mRNA targets to be announced Next-Gen Flu vaccine Acne Chlamydia mRNA SP0125 Respiratory syncytial virus (toddlers) Pandemic Influenza Lifecycle management First-in-class Funded by BARDA LCM: Lifecycle management SP0148 HSV Type 2 vaccine not indicated above; as it will be discontinued after Phase I completion SP0273 monovalent mRNA Influenza vaccine will be discontinued after Phase I completion
  • 45. Opening a new chapter for Sanofi Vaccines R&D 45 Epidemic 2 Endemic diseases 1 Chronic diseases 3
  • 47. Our ambition in Vaccines 47 Continued strong growth driven by four core franchises: Influenza, Meningitis, PPH & Boosters, RSV More than doubling Vaccine sales by 2030(1) Unlocking the potential of mRNA in Vaccines with Next-Generation platform Building an industry leading pipeline to address unmet needs (1) Vs. 2018, risk adjusted, internal estimate
  • 48. Q&A session| Leading with innovation Jean-François Toussaint Head of Vaccines R&D Frank DeRosa Head of Research for mRNA CoE Thomas Grenier Head of Franchises & Product Strategy Thomas Triomphe Head of Vaccines GBU Jon Heinrichs Head of R&D RSV Franchise