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2023 q1 Financial Results en

Sanofi reported a strong start to 2023 with total sales up 5.5%, driven by growth in Specialty Care and Vaccines. The company highlighted advancements in its R&D pipeline, particularly in immunology and neurology, and plans to leverage innovation for future growth. Financial performance and outlook for 2023 indicate ambitions for significant sales growth and new product launches.

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0% found this document useful (0 votes)
32 views58 pages

2023 q1 Financial Results en

Sanofi reported a strong start to 2023 with total sales up 5.5%, driven by growth in Specialty Care and Vaccines. The company highlighted advancements in its R&D pipeline, particularly in immunology and neurology, and plans to leverage innovation for future growth. Financial performance and outlook for 2023 indicate ambitions for significant sales growth and new product launches.

Uploaded by

Andy Hua
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices

Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices

Q1 2023 Results
Play to Win

April 27, 2023


Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices

Forward-looking statements
This document 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 labelling and other matters that could affect the availability or commercial potential of such
product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial
success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain
regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and
subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and
other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole.
The risks and uncertainties also include the uncertainties 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, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.

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Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices

Agenda

01 Strong start into 2023


Paul Hudson

02 R&D update
Dietmar Berger

03 Business update
Bill Sibold, Thomas Triomphe,
Olivier Charmeil & Julie Van Ongevalle

04 Financial performance
and outlook 2023
Jean-Baptiste de Chatillon

4 Investor Relations
Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices

Strong start
into 2023
Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices

Q1 2023: Strong growth driven by Specialty Care,


Vaccines & CHC
Specialty Care Vaccines GenMed
Total sales up 5.5%
€4.3bn €1.2bn €3.3bn
+18.3% +15.2% -11.4% 3 GBUs with double-digit growth

GenMed with solid demand for


Core assets
core assets; Lantus® net price
Consumer
€1.6bn decline in China and U.S.
Healthcare +1.6%
€1.5bn
+11.2%

All growth at CER unless footnoted. Growth rate is vs Q1 2022.

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Advancing the pipeline: Steppingstones for future growth

Key events
in Q1 2023 ALTUVIIIO™ Dupixent®
launch COPD readout

Fitusiran Tzield®
data publication acquisition 1

1. Subject to customary closing conditions.

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Play to Win: Leverage innovation to drive next growth chapter


Toda
y

2020-2022 2023-2025 2026-2030

Refocus with Transformative Industry leader in immunology


decisive actions launches with >€22bn sales by 2030
Guidance of
BOI margin of
Growth through Agile and efficient Doubling vaccines sales by 20301
winning assets resource deployment >32%
by 2025 No meaningful LOE
Margin expansion Leading R&D
productivity Ambition to launch 3-5 new products
with €2-5bn peak sales potential each

Barring unforeseen events. 1. Sales from 2018.

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Upcoming investor events

ATS Investor call Vaccines event R&D Day


May 22, Washington DC June 29, London H2 2023

9 Investor Relations
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R&D update
Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices

Immunology franchise

Core TAs Science driven

Lead Expand Disrupt


Key Type 2 Breakthrough Transformative
inflammatory medicines beyond technologies
diseases Type 2

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Dupixent® (dupilumab) – positive results in uncontrolled


COPD patients from BOREAS trial
Phase 3 BOREAS trial design:
Key findings
Assess safety and efficacy in 939 patients,
Significant, clinically meaningful, Significant improvements in lung
ages 40-80, with moderate to severe function relative to the placebo
30% reduction in moderate or
COPD and evidence of type 2 inflammation;
severe exacerbations compared
current/former smokers, uncontrolled with placebo
disease with maximal standard of care
inhaled therapies1
Dupixent® (dupilumab) or a placebo Q2W in Improvements in quality of life and Safety findings consistent
addition to triple combo standard therapy reductions in the severity of with known safety profile
COPD respiratory symptoms of Dupixent®
Primary endpoint: Changes in the relative to placebo
frequency of COPD exacerbations — rapid
and acute episodes of respiratory symptom
worsening — over a year of treatment Data presentation
May 19-24, Washington DC

Dupixent® is under investigation in COPD and not yet approved by any regulatory agency to treat this indication. 1. Including corticosteroids, long-acting beta agonists, and long-acting muscarinic antagonists.

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Potential to lead in COPD with two biologics to address


uncontrolled COPD in patients who failed standard of care

Patient population Dupixent® and itepekimab - two distinct mechanisms of action


G71 – 2035e addressing different COPD populations with limited overlap
Non-Type 2 Type 2 2023 2024 2025

Former U.S. expected


submission
smokers
(70%) Boreas EU expected
Dupixent ®3
submission
itepekimab2 and
itepekimab2 Notus
~1,139K patients First-in-
~640K patients disease

itepekimab Aerify 1
Current
smokers First-in-class
Dupixent ®3
anti-IL-33
(30%) only Aerify 2
~270K patients

1. G7 countries: U.S., France, Germany, Italy, Japan, UK, Canada. 2. Itepekimab is under investigation and not yet approved by any regulatory agency. Itepekimab is being developed in collaboration with Regeneron.
3. Dupixent is not yet approved for COPD and is being studied in patients with uncontrolled COPD treated with current SoC triple therapy. Patient populations exclude never smokers.
®

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Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices

Strong immunology pipeline with 12 novel molecules


to build and expand in leading franchise
Orals Injectables
rilzabrutinib (BTKi) Dupixent®
AD
IRAK4 degrader amlitelimab (anti-OX40L)
Dermatology
CSU rilzabrutinib (BTKi) Dupixent®
Psoriasis Oral TNF inhibitor
Dupixent®
Asthma rilzabrutinib (BTKI) amlitelimab (anti-OX40L)
Respiratory Anti-IL-13/TSLP Nanobody® VHH
Dupixent®
COPD
itepekimab (anti-IL-33)
EoE Dupixent®
EG Dupixent®
Gastroenterology
Dupixent®
UC eclitasertib (RIPK1i)
non-beta IL-2 (Synthorin™)
frexalimab (anti-CD40L)
Autoimmune Lupus eclitasertib (RIPK1i)
Anti-CD38 mAb Next Generation

Dupixent® is under investigation in CSU, COPD, EG and UC and not yet approved by any regulatory agency to treat these indications.

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Neurology: A strong pipeline in multiple sclerosis

Multiple sclerosis is a serious, life-long neuro-


degenerative disease affecting more than 2.3m tolebrutinib First pivotal readout
people worldwide (BTK inhibitor)
late ’23/early ’24
Great unmet need remains, especially in the ability Phase 3 trials in (event-driven)
RMS, PPMS, SPMS
to treat the progressive aspects of the disease

frexalimab Data presentation


(anti-CD40L) at medical congress
later this year
Phase 2 in RMS

SAR443820
(RIPK1 inhibitor) Data in 2024
Above from left to right: Dov, multiple sclerosis, Israel; Cassie, Entered Phase 2 in MS
multiple sclerosis, Australia; Dave, multiple sclerosis, UK

SAR443820 (RIPK1i) also in Phase 2 in ALS and Phase 1 opt-in in Alzheimer’s Disease.

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Oncology: Scientific presence at AACR 2023

Anti-CEACAM5/Topo1K Additional abstracts


Planning to move to Phase 1 in CRC later this year presented at
Overall Response Rate Selective inhibition, Well tolerated after SAR445514I
of 55% with high and with no or very low 4 weeks at >50mg/kg Anti-BCMA/NK-Cell engager in RRMM
moderate CEACAM5 cytotoxicity in CEACAM5
expression negative cells Tang, A. The novel trifunctional anti-BCMA NK cell
engager SAR’514 has potent in-vitro, in-vivo and ex-vivo
anti-myeloma effect through dual NK cell engagement
Tumor CEACAM5 expression by IHC CEACAM5-Topo1 activity in mice models

CRC 100
PD SAR445877
SD

High H+M 50
PR
CR
Anti-PD1/IL-15 fusion protein in
Solid Tumors
RTV (%)

87% 96%
0
Bernardo, M. Preclinical characterization of SAR445877,
CEACAM5 High (H) an anti-PD-1 antibody-IL-15 mutein fusion protein with
= Intensity 2+/3+, Prevalence ≥50% -50
robust anti-tumor efficacy as monotherapy and in
CEACAM5 H + Moderate (M) combination with PD-L1 blockade
= Intensity 2+/3+, Prevalence ≥1% -100
SD at 10 mg/kg

Source: Y. Baudat, A novel topoisomerase I inhibitor antibody-drug conjugate targeting CEACAM5 has potent anti-tumor activity in colorectal cancer models.
PDX models are sorted by increasing sensitivity to ADC. The response was determined by comparing tumor volume change at time T to its baseline with ∆RTV = (Vt-V0) / V0 × 100.

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Specialty Care Vaccines GenMed Consumer Healthcare

Business
update
Q1 2023
Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices

Specialty Care Vaccines GenMed Consumer Healthcare

Specialty Care performance €4.3bn sales +18.3%


Q1 2023
Dupixent®
Dupixent® Strong demand in Q1 across geographies,
demographics and new indications continued
€2,316m
>600K patients on treatment globally
+39.7%

Rare Diseases
Double-digit growth driven by launch
performance of Nexviazyme® and
Xenpozyme® as well as favorable shipping
Neurology, pattern in RoW region
Oncology &
Rheumatology Rare Diseases1 Oncology sales lower due to Jevtana®
€718m €1,254m U.S. competition and Libtayo® deconsolidation,
-17.7% +14.8% more than offsetting Sarclisa® launch uptake;
U.S. Aubagio® generic entrants

All growth at CER unless footnoted. Growth rate is vs Q1 2022.


1. Rare Diseases includes Rare Blood Disorders.

19 Investor Relations
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Specialty Care Vaccines GenMed Consumer Healthcare

Dupixent® - off to a strong start towards €10bn in 2023

Global Dupixent® sales (€m) Q1 performance


2,316 Worldwide growth of Ex-U.S. contributing
Ex-U.S. U.S.
+40% vs Q1 2022 24% of total sales
Ex-U.S.
557
(+30%)1

1,614
Milestone achievements
438 U.S. • COPD BOREAS Phase 3 positive results
(+43%)1
1,047 • CSU file accepted by FDA, PDUFA on October 22, 2023

776
254 1,759 • AD 6m-5 years old approved in Europe
163 • EoE 1-11 yrs, 52 weeks positive data
1,176
329 793
63 613
107
12 266
95
Q1 ’18 Q1 ’19 Q1 ’20 Q1 ’21 Q1 ’22 Q1 ’23

All growth at CER. 1. Represents growth Q1 2023 vs Q1 2022.

20 Investor Relations
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Specialty Care Vaccines GenMed Consumer Healthcare

Defining a new standard for Hemophilia A

Strong launch indicators, including direct


contracts with customers who account for
>90% of total Hem A purchases
“We’ve been waiting
Positive topline results from for this outcome, and
XTEND-Kids study I imagine this will lead
to practice changes.”
EU regulatory submission anticipated in 2023 Nathan T. Connell, MD, MPH
Brigham and Women's Hospital

Japan and Taiwan approvals


anticipated in H2 2023

21 Investor Relations
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Specialty Care Vaccines GenMed Consumer Healthcare

Vaccines performance €1.2bn sales +15.2%


Q1 2023

Growth driven by delivery of


Influenza Polio COVID-19 contracts and recovery
€63m Pertussis / Hib of Travel & Booster vaccines
+6.1% €537m
-11.3% PPH
Product discontinuation and high base
Booster
of comparison for IPV
vaccines
€124m
+11.9% Influenza
Flu Southern Hemisphere sales benefitted
from fast time to market
Others Meningitis
€194m Travel & Endemic
+781.8%
€249m
+16.7%
All growth at CER unless footnoted. Growth rate is vs Q1 2022.

22 Investor Relations
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Specialty Care Vaccines GenMed Consumer Healthcare

Sanofi Vaccines leading with innovation

Beyfortus®
Consistent and high efficacy of c.80% against RSV LRTI
Ability to protect all infants against all clinical endpoints1, for
the entire RSV season, regardless of the month of birth
Consistent,
Data to be shared on key programs:
Protect all
strong efficacy
across multiple
Maintained
protection
Flexible
administration,
Able to reach
high • RSV Toddler
infants during endpoints and throughout aligned with immunization
1st RSV season severities entire season season rates • mRNA RSV Older Adult
nirsevimab • mRNA quadrivalent influenza
Maternal
• Pneumococcal conjugate
immunization • Meningococcal

Ready to be launched in 2023/24 season2

No head-to-head nirsevimab-maternal immunization study conducted.


1. Simões, E, et al. Pooled efficacy of nirsevimab against RSV lower respiratory tract infection in preterm and term infants. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress and Data presented to ACIP Oct 20 2022.
2. Approved in EU, UK and Canada; pending approval in U.S.

23 Investor Relations
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Specialty Care Vaccines GenMed Consumer Healthcare

GenMed performance €3.3bn sales -11.4%


Q1 2023

Core assets on track


Core assets Non-core assets
Robust growth of Praluent® and Rezurock®
€1,617m €1,520m Lovenox® reflects post-COVID-19 market
+1.6% -20.5% dynamics and biosimilars competition

Non-core assets
Lower Lantus® sales due to VBP China
and U.S. net price pressure

Portfolio streamlining
Industrial Impact on sales -1.2ppts
sales
€135m
-27.5%

All growth at CER unless footnoted. Growth rate is vs Q1 2022.

24 Investor Relations
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Specialty Care Vaccines GenMed Consumer Healthcare

Transforming the practice of medicine in Type 1 diabetes

TzieldTM delays the onset of


First and only disease
Type 1 diabetes – typically
modifying therapy
diagnosed ~12-14 yrs1

Today patients face huge Sales


TzieldTM has the potential to offer
burden with life expectancy children ∼1,0003 more days potential
reduced by ~16 yrs2 without glycemic treatment up to
€2bn4

Leverage existing TzieldTM receives positive response from


prescriber network and diabetes communities (families, HCPs,
screening capabilities PAGs and payers) encouraging use of
existing screening initiatives

Acquisition subject to customary closing conditions. 1. IDF Diabetes Atlas 10th Edition. 2. Rawshani 2018 Lancet. 3. Mean delay based on pivot clinical trial is of 2 years and 8 months. 4. Based on existing indication.

25 Investor Relations
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Specialty Care Vaccines GenMed Consumer Healthcare

Improving access to diabetes care in Ghana


Sanofi is strengthening its commitment to improving access to prevention, treatment and care
for people living with diabetes in LMICs and underserved communities

Sanofi has signed its first partnership with


Ghana Ministry Of Health. The program of
this partnership includes: We are aiming to
impact the lives of
High-quality Patient HCP capacity 190,000 people
analog disease building, living in LMICs with
insulins at awareness diabetes either Type 1 or Type 2
an affordable management
price and digital
diabetes within 5 years
solutions

26 Investor Relations
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Specialty Care Vaccines GenMed Consumer Healthcare

CHC: Sustaining robust growth


Market with high growth rate
Growth (MAT, in %)
Positive price effect in the recent past

+10.4% Pandemic-driven volume gains maintained


+9.9%
+9.2%
Cough & Cold continues to be the strong driver
+8.2%
+7.8%
+7.2%

Sanofi contributes to the


strong momentum
+3.1%
Digestive Wellness outperformed the market
for 7 quarters in a row
Geo-expansion of leading brands, e.g. Allegra
-1.8% New product launch: Cialis® Together
Dec-20 Dec-21 Dec-22 Feb-23 OTC approved in the UK
Delta vs. -4.9pt +0.6pt -0.5pt -1.0pt
market
CHC business operating as a standalone
Market Sanofi
since Jan 1, 2023

Market: Total retail sales of the OTC market, excl. China, incl. ~50% of the eCom channel (data provided by various vendors,
e.g. IQVIA, Nielsen, IRI, Intage, and compiled by Sanofi).

27 Investor Relations
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Specialty Care Vaccines GenMed Consumer Healthcare

CHC performance €1.5bn sales +11.2%


Q1 2023

Digestive Wellness Allergy Q1 organic growth +12.7%


€425m €276m
+21.5% +17.0% 8th consecutive growth quarter
Growth from all geographies also benefitting
from favorable inventory phasing
Pain Care
Digestive Wellness brands expanding
Others €306m leadership in all geographies
€189m +4.7%
Cough & Cold category growing in Europe
-1.6%
thanks to 360 campaign activation

Physical & Cough & Cold


Mental Wellness €145m
€154m +22.3%
-2.6%
All growth at CER. Growth rate is vs Q1 2022. Organic growth: Excluding impacts of divestments & acquisitions.

28 Investor Relations
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Specialty Care Vaccines GenMed Consumer Healthcare

Enterogermina –
®1 “Bellies ready!”
7 quarters of market share gain

#1 Probiotic brand worldwide2 A brand linked to a purpose


Engaging consumers
Born in Italy Expanded from in our ambition to
in 1958 kid’s tummy prevent childhood
recovery post
mortality from diarrhea
antibiotic use
1 million beneficiaries
through our
now programs from
to adult
marketed in 2019 to 2025
and wellbeing
55 countries

1. Contains Bacillus clausii or other probiotics. 2. Based on total retail sales of the OTC market, excl. China, incl. ~50% of the eCom channel (data provided by various vendors, e.g. IQVIA, Nielsen, IRI, Intage, and compiled by Sanofi).

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Financial
performance
Q1 2023
Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices

Double-digit EPS growth driven by sales and margin expansion


€m Q1 2023 Q1 2022 % Change
Net Sales 10,222 9,674 +5.5%
Sales growth
+5.5%
Other revenues 641 379 +61.7%
Gross profit 7,784 7,175 +8.1%
Gross margin % 76.1%1 74.2%1 Gross margin
1.9bps improvement
R&D (1,563) (1,489) +3.9%
SG&A (2,607) (2,379) +8.7%
Operating Expenses (4,170) (3,868) +6.9% Other current
Other current operating income & expenses (304) (265) +12.1% operating income
Business Operating Income 3,333 3,065 +9.3% & expenses
+12.1%
Business operating margin 32.6% 1
31.7% 1

Effective tax rate 19% 19%


Total Business Net Income 2,699 2,424 +11.9%
EPS
+11.9%
Average number of shares 1,249.3 1,249.2
Business EPS 2.16 1.94 +11.9%

All growth at CER. 1. Margin at published rate.

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CHC P&L
€m Q1 2023 Q1 2022 % Change
Net Sales 1,495 1,354 +11.2%
Sales growth
+11.2%
Other revenues 15 14 +0%
Gross profit 1,002 902 +12.0%
Gross margin % 67.0%1 66.6%1
SG&A
+8.5%
R&D (53) (41) +29.3%
SG&A (484) (447) +8.5%
Operating Expenses (537) (488) +10.2% Other current
Other current operating income & expenses 71 123 -39.8% operating income
Business Operating Income 534 531 +2.4% & expenses
-39.8%
Business operating margin 35.7% 1
39.2% 1

All growth at CER. 1. Margin at published rate.

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Simplifying Beyfortus
collaboration with AstraZeneca,
®

simultaneously signing agreement with Sobi


AstraZeneca Sobi
Collaboration agreement Royalty interest agreement

Sanofi acquires additional Sanofi transfers royalty


U.S. rights from AstraZeneca interest to Sobi

&
Intangible asset Financial liability
Price of U.S. rights to obtain Initial recognition at Fair Value of U.S. royalties to Sobi
full commercial control (Fair Value) Liability reduced over time by royalty payments
Amortized below BNI Remeasured below BNI

Sanofi consolidates 100% of nirsevimab/Beyfortus® U.S. economics in Business Operating Income

Sanofi will pay royalties to Sobi as U.S. nirsevimab/Beyfortus® sales arise while the liability AstraZeneca had
towards Sobi has been terminated

33 Investor Relations
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Outlook
2023
Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices

2023 FY Sales P&L


business • Dupixent® expected to
reach €10bn
• Slight improvement of gross
margin due to Specialty Care
outlook • Aubagio® LoE full impact
growth despite Aubagio® LoE

starting in Q2 • OPEX growth due to


investments in launches
• GenMed low single-digit decline and R&D; CHC stand-alone
• Positive effect of higher stock • Capital gains from product
in trade in Q1 CHC sales divestments expected to
reach approximately €600m,
the remainder mainly in
H2 20231
• Tax rate of 19%

Barring unforeseen events. 1. Capital gains were €307m in Q1 2023.

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2023 FY guidance

EPS growth Currency impact 1

Low single-digit approximately


growth at CER -5.5% to -6.5%

Barring unforeseen events. 1. Based on April 2023 average rates.

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Q&A session
Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices

R&D appendices Financial appendices ESG appendices Collaborations Abbreviations

R&D
appendices
Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices

R&D appendices Financial appendices ESG appendices Collaborations Abbreviations

R&D Pipeline Phase III & Registration


Phase III Registration
Name Description Indication Name Description Indication
Dupixent®A Anti-IL-4/IL-13 mAb Bullous Pemphigoid Dupixent®A Anti-IL-4/IL-13 mAb Chronic Spontaneous Urticaria
Dupixent®A Anti-IL-4/IL-13 mAb Chronic Obstructive Pulmonary Disease Beyfortus®1,B Anti-RSV mAb Respiratory Syncytial Virus (RSV)
Dupixent®A Anti-IL-4/IL-13 mAb Chronic Pruritus of Unknown Origin
itepekimabA Anti-IL-33 mAb Chronic Obstructive Pulmonary Disease
Sarclisa® Anti-CD38 mAb + combinations 1L Newly Diag. MM Ti (IMROZ)
Sarclisa® Anti-CD38 mAb + combinations 1L Newly Diag. MM Te (GMMG)
Sarclisa® Anti-CD38 mAb + combinations Smoldering MM (ITHACA)
Sarclisa® Anti-CD38 mAb SubQ. + combinations 2/3L Relapsed, Refractory MM (IRAKLIA)
tusamitamab ravtansine Anti-CEACAM5 ADC 2/3L NSCLC
tolebrutinib BTK inhibitor Relapsing Multiple Sclerosis
tolebrutinib BTK inhibitor Primary Progressive MS
tolebrutinib BTK inhibitor Secondary Progressive MS
Nexviazyme® Enzyme Replacement Therapy (GAA) Pompe Disease - Infantile Onset
venglustat Oral GCS inhibitor GM2 Gangliosidosis
venglustat Oral GCS inhibitor Gaucher Disease Type 3
venglustat Oral GCS inhibitor Fabry Disease
fitusiran RNAi targeting anti-thrombin Hemophilia A and B
fitusiran RNAi targeting anti-thrombin Hemophilia A and B pediatric
rilzabrutinib BTK inhibitor Immune Thrombocytopenia
MenQuadfi® Meningococcal (A,C,Y,W) conjugate vaccine Meningitis 6w+ (U.S. / EU)
VRVg Purified vero rabies Vaccine Rabies
Beyfortus®1,B Anti-RSV mAb RSV infant (HARMONIE)

Immuno-inflammation
Oncology
Neurology
Rare Diseases
Rare Blood Disorders
Vaccines

As of March 31, 2023. For collaborations see slide 56. For abbreviations see slide 57.
1. Also known as nirsevimab. Approved in EU and the UK.

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R&D Pipeline – Phase II


Phase II
Name Description Indication Name Description Indication
Polyarticular Juvenile Idiopathic SAR4450884 Complement C1s inhibitor CIDP
R Kevzara®A Anti-IL-6 mAb
Arthritis frexalimabD,3 Anti-CD40L mAb Multiple Sclerosis
R Kevzara®A Anti-IL-6 mAb Systemic Juvenile Arthritis SAR443820C,6 RIPK1 inhibitor Amyotrophic Lateral Sclerosis
amlitelimab1 Anti-OX40L mAb Atopic Dermatitis SAR443820C,6 RIPK1 inhibitor Multiple Sclerosis
amlitelimab1 Anti-OX40L mAb Asthma BTK inhibitor Warm Autoimmune Hemolytic
rilzabrutinib
rilzabrutinib BTK inhibitor IgG4-related disease Anemia
rilzabrutinib BTK inhibitor Atopic Dermatitis SAR4450885 Complement C1s inhibitor Cold Agglutinin Disease
rilzabrutinib BTK inhibitor Asthma Fluzone® HD7 Inactivated Influenza Vaccine (IIV) Pediatric Influenza
rilzabrutinib BTK inhibitor Chronic Spontaneous Urticaria SP0218 Vero cell Vaccine Yellow fever
eclitasertibC,2 RIPK1 inhibitor Cutaneous Lupus Erythematosus SP0202E Next Generation Conjugate Vaccine Pneumococcal
eclitasertibC,2 RIPK1 inhibitor Ulcerative Colitis SP0125 Live Attenuated Virus Vaccine RSV toddler
frexalimabD,3 Anti-CD40L mAb Sjogren’s Syndrome SP0230 Multicomponent Vaccine Meningitis B
frexalimabD,3 Anti-CD40L mAb Systemic Lupus Erythematosus
SAR4450884 Complement C1s inhibitor Antibody-Mediated Rejection
Sarclisa® Anti-CD38 mAb 1/2L AML / ALL pediatrics
Sarclisa® Anti-CD38 mAb + combinations Relapsed, Refractory MM
alomfilimab5 Anti-ICOS mAb Solid tumors
tusamitamab ravtansine Anti-CEACAM5 ADC + ramucirumab 2/3L NSCLC
tusamitamab ravtansine Anti-CEACAM5 ADC Exploratory Solid tumors
tusamitamab ravtansine Anti-CEACAM5 ADC + pembrolizumab 1L NSCLC
tusamitamab ravtansine Anti-CEACAM5 ADC + ramucirumab Gastric cancer

Immuno-inflammation
Oncology
Neurology
Rare Diseases
Rare Blood Disorders
Vaccines
R Registrational Study (other than Phase 3)

As of March 31, 2023. For collaborations see slide 56. For abbreviations see slide 57.
1. Formerly known as SAR445229/KY1005. 2. Also known as SAR443122/DNL758. 3. Also known as SAR441344. 4. Formerly known as BIVV020. 5. Formerly known as KY1044/SAR445256. 6. Also known as DNL788. 7. Also known as SP0178.

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R&D Pipeline – Phase I


Phase I
Name Description Indication
SAR441566 Oral TNF inhibitor Inflammatory indication
SAR444656F,1 IRAK4 degrader Atopic Dermatitis
SAR444336 Non-beta IL-2 SynthorinTM Inflammatory indication
SAR444559 Anti-CD38 mAb Next Generation Inflammatory indication
SAR442970 Anti-TNFa/OX40L Nanobody® VHH Inflammatory indication
SAR443765 Anti-IL-13/TSLP Nanobody® VHH Inflammatory indication
SAR441000G Cytokine mRNA Solid tumors
SAR442257 CD38/CD28/CD3 T-Cell engager MM / N-H Lymphoma
SAR444881H Anti-ILT2 mAb Solid tumors
SAR4454192 NK-Cell-based immunotherapy Acute Myeloid Leukemia
SAR443216 CD3/CD28/HER2 T-Cell engager Gastric cancer
SAR4457103 Anti-PDL1/IL-15 fusion protein Solid tumors
SAR4458774 Anti-PD1/IL-15 fusion protein Solid tumors
SAR443579I Trifunctional anti-CD123 NK-Cell engager Acute Myeloid Leukemia
SAR4463095 HER2 T-Cell engager Solid tumors
SAR444200 Anti-GPC3/TCR Nanobody® VHH Solid tumors
SAR4442456 Non-alpha IL-2 SynthorinTM (dose optimization) Solid tumors
SAR446159J,7 Anti-Synuclein/IGF1R mAb Parkinson’s disease
SAR442501 Anti-FGFR3 Ab Achondroplasia
SAR443809 Anti-Factor Bb mAb Rare renal diseases
SAR439459 Anti-TGFb mAb Osteogenesis Imperfecta
SP0273 mRNA QIV Influenza
SP0274 mRNA RSV RSV older adults

Immuno-inflammation
Oncology
Neurology
Rare Diseases
Rare Blood Disorders
Vaccines

As of March 31, 2023. For collaborations see slide 56. For abbreviations see slide 57.
1. Also known as KT474. 2. Formerly known as KDS1001. 3. Formerly known as KD033. 4. Formerly known as KD050. 5. Formerly known as AMX-818. 6. Formerly known as THOR707. 7. Also known as ABL301.

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Expected major R&D milestones in 2023

H1 2023 H2 2023
COPD Positive pivotal trial readout (BOREAS)
Dupixent®
CIndU Efficacy criteria not met

Sarclisa® (1L MM) Pivotal trial readout (IMROZ)


Oncology
tusamitamab ravtansine (2/3L NSCLC) Interim Analysis (LC03, event-driven)

Neurology tolebrutinib GEMINI 1/2 readouts (event-driven)

fitusiran (Hem A/B) Pivotal trial readout


Rare Blood Disorders
ALTUVIIIO™ (Hem A) U.S. Approved

Vaccines Beyfortus® U.S. Approval

As of March 31, 2023, barring unforeseen events. For abbreviations see slide 57.

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Expected submission timelines

2023 2024 2025 and beyond


®A Nexviazyme® Dupixent®A tolebrutinib
Kevzara®A Dupixent
Pompe Disease - Infantile CPUO PPMS
Polyarticular juvenile idiopathic arthritis COPD Onset

Sarclisa® venglustat Dupixent®A tolebrutinib


1L Newly Diag. MM Ti (IMROZ) GM2 gangliosidosis Bullous pemphigoid SPMS

Sarclisa® rilzabrutinib Kevzara®A venglustat


1L Newly Diag. MM Te (GMMG) ITP Systemic Juvenile Arthritis Gaucher Type 3

tusamitamab ravtansine fitusiran amlitelimab venglustat


2/3L NSCLC Hemophilia A/B Atopic Dermatitis Fabry Disease

tolebrutinib MenQuadfi® itepekimabA fitusiran


RMS 6w+ COPD Hemophilia A/B ped

Sarclisa® VRVg
Smoldering MM Purified vero rabies vaccine

Sarclisa® SubQ
3L RR MM (IRAKLIA)

Immuno-inflammation
Oncology
Neurology
Rare Diseases
Rare Blood Disorders
Vaccines

As of March 31, 2023. For collaborations see slide 56. For abbreviations see slide 57.
Excluding Phase 1 and 2 (without Proof of Commercial Concept); Projects within a specified year are not arranged by submission timing.

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R&D appendices Financial appendices ESG appendices Collaborations Abbreviations

Financial
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GenMed Q1 2023 core assets performance

Core asset sales (in € million)


-11.9%

377 +4.4%

323 -6.5% +21.4%


289
274
261
236 243
196 +42.0%
-6.9%
+15.1%

87 98
84
69 63
53

Q1 2022 Q1 2023

All growth at CER unless footnoted.

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R&D appendices Financial appendices ESG appendices Collaborations Abbreviations

Main product sales

Q1 2023 sales (€m) Growth


Dupixent 2,316 39.7%
Polio/Pertussis/Hib Vaccines 537 -11.3%
Lantus 447 -32.6%
Aubagio 419 -16.9%
Lovenox 323 -11.9%
Toujeo 289 4.4%
Meningitis, Travel and Endemic Vaccines 249 16.7%
Fabrazyme 246 11.8%
Plavix 236 -6.5%
Myozyme 228 -3.0%
Cerezyme 196 26.7%
Alprolix 125 12.0%
Eloctate 118 -15.9%
Aprovel 110 -12.0%
Thymoglobulin 109 11.3%
Praluent 98 42.0%
Sarclisa 87 33.8%
Multaq 84 -6.9%
Nexviazyme 81 163.3%
Jevtana 79 -21.4%

All growth at CER unless footnoted.

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nirsevimab/Beyfortus®
Initial agreement Sanofi-AstraZeneca (March 2017)

Major markets (U.S., FR, DE, ES, IT, UK, JP) Rest of World markets
Net sales Sanofi consolidates worldwide net sales

Cost of sales Sanofi consolidates worldwide cost of sales (finished goods purchased from AstraZeneca)

R&D AstraZeneca & Sanofi share the alliance development costs 50/50

Sanofi expenses 100% of its SG&A (and further shares 50/50 Sanofi expenses 100% of its SG&A
SG&A in OOIE) (not shared)

Other operating Alliance profit Sanofi shares with AstraZeneca the alliance commercial Sanofi pays to AstraZeneca
income and expenses & loss profit & loss 50/50 25% of net revenues

Upfront EUR 120M paid by Sanofi to AstraZeneca upon closing (March 2017)
Intangible asset
Beyfortus Regulatory
AstraZeneca received from Sanofi EUR 55M and will receive EUR 65M for BLA Approval in the U.S.
(amortized below BNI milestones
over useful life)
Sales
AstraZeneca to receive up to EUR 375M sales milestones from Sanofi, upon achievement of certain sales related milestones
milestones

Above BNI Below BNI

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Sanofi accounting of nirsevimab/Beyfortus®


Updated and new agreements Sanofi-AstraZeneca and Sanofi-Sobi (April 2023)
Updated agreement Sanofi-AstraZeneca

U.S. Major markets (CN, FR, DE, ES, IT, UK, JP) Rest of World markets
Net sales Sanofi consolidates worldwide net sales
Cost of sales Sanofi consolidates worldwide cost of sales (finished goods purchased from AstraZeneca)

R&D Sanofi bears 100 % of the costs from April 2023 onward AstraZeneca & Sanofi share the alliance development costs
SG&A Sanofi bears 100 % of the costs from April 2023 onward Sanofi expenses 100% of its SG&A Sanofi expenses 100% of
(and further shares 50/50 in OOIE) its SG&A (not shared)

Other Alliance profit Sanofi consolidates 100% of the economics in the U.S. Sanofi shares with AstraZeneca the alliance Sanofi pays to AstraZeneca
operating & loss from April 2023 onward commercial profit & loss 50/50 25% of net revenues
income and
expenses

Intangible Upfront EUR 120M paid by Sanofi to AstraZeneca upon closing (March 2017)
asset
Beyfortus Regulatory milestones AstraZeneca received from Sanofi EUR 55M and will receive EUR 65M for BLA Approval in the U.S.
(amortized
below BNI Sales milestones AstraZeneca to receive up to EUR 375M sales milestones from Sanofi, upon achievement of certain sales related milestones
over useful
life) Additional rights Sanofi records price of U.S rights to obtain full commercial control (Fair Value)
from AstraZeneca
(Amendment April 2023)

Royalty Agreement Sanofi–Sobi (April 2023)

Financial liability (Sobi) Initial recognition at Fair Value of U.S. royalties due to Sobi - Liability reduced by royalty payments over time -
Subsequent re-measurement in P&L below BNI

Above BNI Below BNI

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Q1 sales and EPS

Currency impact

Company sales Business EPS


€1,108m +0.31

€661m

€475m +0.12
€341m +0.09
+0.07
€225m
+0.04
€16m -0.01

Q4 Q1 Q2 Q3 Q4 Q1 Q4 Q1 Q2 Q3 Q4 Q1

2021 2022 2023 2021 2022 2023

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Net debt evolution in 2022


€ millions
6,437

-1,754
5,305

405

333
-408 292

Net Debt FCF before Proceeds Asset Restructuring Other4 Net Debt
December 31, restructuring, from acquisition & similar March 31,
20222,3 acquisitions disposals items 20232,3
& disposals

1. Credit ratings reaffirmed: Moody’s A1/stable, S&P AA/stable, Scope AA/stable as of March 31, 2023. 2. Including derivatives used to manage net debt: €142m at December 31, 2022 and €138m at March 31, 2023.
3. Effective January 1, 2019, net debt does not include lease liabilities following the first-time application of IFRS16. 4. Including €363m use of funds from acquisition of treasury shares.

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2023 currency sensitivity and Q1 2023 currency exposure

2023 Business EPS currency sensitivity Currency exposure on Q1 2023 sales


Currency Variation Business EPS sensitivity
U.S. Dollar + 0.05 USD/EUR - EUR 0.17 Others 17.1%
Japanese Yen + 5 JPY/EUR - EUR 0.02
Chinese Yuan + 0.2 CNY/EUR - EUR 0.03
Russian ruble 1.5%
Brazilian Real + 0.4 BRL/EUR - EUR 0.02
Russian Ruble + 10 RUB/EUR - EUR 0.02 Canadian $ 1.1%
British Pound 1.1%
Australian $ 1.3%

Currency average rates Mexican Pesos 1.4% US $ 41.1%

Brazilian Real 2.8%


Q1 2022 Q1 2023 % change
EUR/USD 1.123 1.073 -4.4% Japanese Yen 3.9%
EUR/JPY 130.473 142.049 +8.9% Chinese Yuan 6.7%
EUR/CNY 7.135 7.349 +3%
EUR/BRL 5.883 5.575 -5.2% Euro € 22.0%
EUR/RUB 97.949 78.351 -20.0%

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ESG
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Sanofi ESG Q1 achievements

Affordable access R&D for unmet needs

Sanofi Global Health Unit Rare disease vials donation Polio eradication Pediatric cancer
#Patients treated treatment development
Q1 2022 Q1 2023
Q1 2022 Q1 2023
Q1 2022 Q1 2023
998 1,065 Q4 2022 Q1 2023
patients patients 16 million IPV 7 million IPV
NCD NCD doses supplied doses supplied 1 asset 2 assets
treated treated
46,300 54,396 to UNICEF to UNICEF pre-clinical in protocol
12 countries 19 countries 22,682 21,542 assessment preparation for
vials donated vials donated complete clinical study
Sleeping sickness elimination 1 asset in
Tuberculosis Tuberculosis
35,094 3,022 Global access plan protocol
FY 20211 FY 2022 preparation for
Q4 2022 Q1 2023 clinical study
2 million Data updated
Global access 6 global access patients tested annually at 1 additional
Malaria Malaria plan initiated plans initiated for HAT Q2 23 asset identified
1,024,170 2,725,117 for 2 assets or developed for clinical
covering more development
than 10 805
indications patients treated

Data in YTD unless stated otherwise. 1. Data provided by WHO.

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Sanofi ESG Q1 achievements

Planet care In and beyond the workplace

Blister-free syringe vaccines Scope 1 & 2 Diverse Senior Engagement


GHG emissions reduction Leadership with communities
FY 2022 FY 2023
Q4 2022 Q1 2023 Q4 2022 Q1 2023 Q4 2022 Q1 2023
33% of blister Data updated
free syringe annually at -29.4% -30.5% 37.2% of our 37.5% of our 4,975
vaccines Q4 23 vs 2019 vs 2019 executives executives volunteers Next update in
produced and and Q2 2023
41.7% of 42.1% of 26,906 hours
Renewable electricity our senior our senior
Eco-design leaders were leaders were
& eco-car fleet From Leaders to Citizens
women women
Q4 2022 Q1 2023
Q4 2022 Q1 2023
Q4 2022 Q1 2023
7 LCAs 7 LCAs
completed & completed & More than half 65% of the leaders
62% 62.6% have completed the
1 in progress1 4 in progress of the leaders
renewable renewable have completed eLearning phase
(new products electricity electricity
Eco-design and marketed the initial
digital solution product)1 eLearning 9% of the leaders
launched 34.1% 34.9% phase have completed
eco-fleet eco-fleet the full program

Data in YTD unless stated otherwise. 1. Since 2019.

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Sanofi ESG ratings


Rating agencies

2
SCORE

Climate
21.5
86/100 71/100 A Change: A B 4.3/5 3.47/5 64/100
Medium risk
Water: A-

New rating done 21.2 70/100 A A/A B 4.2/5 3.47/5 62/100


in 2022

One of the highest 11 th among 433 Percentile of 97 Within the top 6 Leading position 1 st decile of the 476 With very high Top 10 1 st pharmaceutical
scores across all pharmaceutical within 156 scored highest rated companies in the rating across the company company out of 57
sectors globally companies companies in the pharmaceutical industry 3 pillars ESG Score in progress
80 points for its industry companies since 2018
solid fundamentals
& strong
preparedness
opinion of
6 points

Vs previous rating

Scores assigned by the rating agencies are not equivalent.

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R&D appendices Financial appendices ESG appendices Collaborations Abbreviations

Collaborations

Ref Name Developed in collaboration with…

A Dupixent® Regeneron
itepekimab
Kevzara®

B Beyfortus® AstraZeneca

C eclitasertib Denali
SAR443820

D frexalimab ImmuNext

E SP0202 SK

F SAR444656 Kymera

G SAR441000 BioNTech

H SAR444881 Biond

I SAR443579 Innate Pharma


SAR445514

J SAR446159 ABL Bio

K Anti-CEACAM5/Topo1 Seagen

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Abbreviations

Ab Antibody HCP Healthcare Professionals NKp46 Natural Killer 46-kDa protein


AD Atopic Dermatitis HD High Dose NSCLC Non-Small Cell Lung Cancer
ADC Antibody Drug Conjugate HS Hidradenitis Suppurativa PAG Patient Advocacy Groups
ALL Acute Lymphoblastic Leukemia HER2 Human Epidermal growth factor Receptor 2 PD Progressive Disease
AML Acute Myeloid Leukemia IA Interim analysis PD-1 Programmed Death protein 1
BCMA B-Cell Maturation Antigen ICOS Inducible COStimulatory molecule PD-L1 Programmed Death ligand 1
BTD Breakthrough Therapy Designation IGF1R Insulin Like Growth Factor 1 Receptor PPMS Primary Progressive Multiple Sclerosis
BTK Bruton’s Tyrosine Kinase IL Interleukin PR Partial Repsonse
CD Cluster of Differentiation ILT2 Ig-like transcript 2 QIV Quadrivalent Influenza vaccine
CEACAM5 Carcinoembryonic Antigen Cell Adhesion IPV Inactivated Poliomyelitis Vaccine Q2W Every 2 weeks
Molecule 5 IRAK4 Interleukin 1 Receptor Associated Kinase 4 RIPK1 Receptor-Interacting serine/threonine-
CIDP Chronic Inflammatory Demyelinating ITP Immune Thrombocytopenia Protein Kinase 1
Polyneuropathy RMS Relapsing Multiple Sclerosis
LOE Loss Of Exclusivity
CInDU Chronic Inducible Cold Urticaria RNAi RNA interference
LRTD Lower Respiratory Tract Diseases
COPD Chronic Obstructive Pulmonary Disease RRMM Relapsed-Refractory Multiple Myeloma
mAb monoclonal Antibody
CPUO Chronic Pruritus of Unknown Origin RSV Respiratory Syncytial Virus
Medically-Attended Lower Repiratory Tract
CR Complete Response MA-LRTI
Infections SPMS Secondary-Progressive Multiple Sclerosis
CSU Chronic Spontaneous Urticaria MAT Moving Annual Total TCR T cell receptor
EG Eosinophilic Gastritis MM Multiple Myeloma Te Transplant eligible
EoE Eosinophilic Esophagitis mRNA messenger RNA TGFb Transforming Growth Factor beta
FGFR3 Fibroblast Growth Factor Receptor 3 MS Multiple Sclerosis Ti Transplant ineligible
GAA Acid Alpha-Glucosidase NCD Non Communicable Diseases TNF Tumor Necrosis Factor
GCS Glucosylceramide Synthase N-H Non-Hodgkin TSLP Thymic Stromal Lymphopoietin
GPC3 Glypican-3 NK Natural Killer UC Ulcerative Colitis
HAT Human African Trypanosomiasis VBP Volume-based Procurement

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