2023 q1 Financial Results en
2023 q1 Financial Results en
Strong start into 2023 R&D update Business update Financial performance Outlook 2023 Appendices
Q1 2023 Results
Play to Win
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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Agenda
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
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Strong start
into 2023
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Key events
in Q1 2023 ALTUVIIIO™ Dupixent®
launch COPD readout
Fitusiran Tzield®
data publication acquisition 1
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R&D update
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Immunology franchise
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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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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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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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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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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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Business
update
Q1 2023
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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
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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
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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
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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%
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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.
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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).
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Enterogermina –
®1 “Bellies ready!”
7 quarters of market share gain
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
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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
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Simplifying Beyfortus
collaboration with AstraZeneca,
®
&
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 will pay royalties to Sobi as U.S. nirsevimab/Beyfortus® sales arise while the liability AstraZeneca had
towards Sobi has been terminated
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Outlook
2023
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2023 FY guidance
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Q&A session
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R&D
appendices
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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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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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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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H1 2023 H2 2023
COPD Positive pivotal trial readout (BOREAS)
Dupixent®
CIndU Efficacy criteria not met
As of March 31, 2023, barring unforeseen events. For abbreviations see slide 57.
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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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Financial
appendices
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377 +4.4%
87 98
84
69 63
53
Q1 2022 Q1 2023
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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
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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)
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
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Currency impact
€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
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-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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ESG
appendices
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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
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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-
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
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Collaborations
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
K Anti-CEACAM5/Topo1 Seagen
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Abbreviations
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