<SEC-DOCUMENT>0001193125-23-259842.txt : 20231020
<SEC-HEADER>0001193125-23-259842.hdr.sgml : 20231020
<ACCEPTANCE-DATETIME>20231020143105
ACCESSION NUMBER:		0001193125-23-259842
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		8
CONFORMED PERIOD OF REPORT:	20231020
FILED AS OF DATE:		20231020
DATE AS OF CHANGE:		20231020

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Sanofi
		CENTRAL INDEX KEY:			0001121404
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				133529324
		STATE OF INCORPORATION:			I0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-31368
		FILM NUMBER:		231336904

	BUSINESS ADDRESS:	
		STREET 1:		46 AVENUE DE LA GRANDE ARMEE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75017
		BUSINESS PHONE:		33153774400

	MAIL ADDRESS:	
		STREET 1:		46 AVENUE DE LA GRANDE ARMEE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75017

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SANOFI-AVENTIS
		DATE OF NAME CHANGE:	20040826

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SANOFI SYNTHELABO SA
		DATE OF NAME CHANGE:	20010104
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>d568063d6k.htm
<DESCRIPTION>6-K
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<TITLE>6-K</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:2pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT STYLE="white-space:nowrap">6-K</FONT> </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF FOREIGN PRIVATE ISSUER </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE <FONT STYLE="white-space:nowrap">13a-16</FONT> OR <FONT STYLE="white-space:nowrap">15d-16</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:2pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">For the month of October 2023 </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Commission File Number: <FONT STYLE="white-space:nowrap">001-31368</FONT> </P>
<P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>SANOFI </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">(Translation of
registrant&#146;s name into English) </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">46, avenue de la Grande Arm&eacute;e, 75017 Paris, FRANCE </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">(Address of principal executive offices) </P> <P STYLE="font-size:24pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="justify">Indicate by check mark whether the registrant files or will file annual reports under cover Form <FONT STYLE="white-space:nowrap">20-F</FONT> or
Form <FONT STYLE="white-space:nowrap">40-F.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Form <FONT STYLE="white-space:nowrap">20-F</FONT> &#9746;&#8195;&#8195;&#8195;Form <FONT
STYLE="white-space:nowrap">40-F</FONT> &#9744; </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="justify">In October 2023, Sanofi published the press releases attached hereto as Exhibits 99.1, 99.2
and 99.3 which are incorporated herein by reference. </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P>
<P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom"><U>Exhibit&nbsp;No.</U></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center"><U>Description</U>&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;</TD></TR>


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<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d568063dex991.htm">Press Release dated October&nbsp;
13, 2023:<B> </B>Late-breaking amlitelimab Phase 2b data presented at EADV show potential <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> profile in atopic dermatitis </A></TD></TR>
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<TD VALIGN="top" NOWRAP>Exhibit 99.2</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d568063dex992.htm">Press Release dated October&nbsp;
18, 2023: TZIELD<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> Phase 3 data presented at ISPAD shows potential to slow the progression of Stage 3 type 1 diabetes in newly diagnosed children and adolescents; full data simultaneously published
 in The New England Journal of Medicine </A></TD></TR>
<TR STYLE="font-size:1pt">
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<TD VALIGN="top" NOWRAP>Exhibit 99.3</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d568063dex993.htm">Press Release dated October&nbsp;19, 2023: Sanofi delivers first medicines from Global Health Unit&#146;s Impact brand portfolio </A></TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:6%; font-size:9pt; font-family:Times New Roman" ALIGN="justify">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized. </P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:9pt">Dated: October&nbsp;20, 2023</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center">SANOFI</TD></TR>
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<TD VALIGN="bottom" NOWRAP> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:9pt">By&#8195;</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:9pt; font-family:Times New Roman" ALIGN="justify">/s/ Alexandra Roger</P></TD></TR>
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<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
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<TD VALIGN="bottom" NOWRAP> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="justify">Name: Alexandra Roger</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:Times New Roman" ALIGN="justify">Title: Head of Securities Law and Capital Markets</P></TD></TR>
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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>d568063dex991.htm
<DESCRIPTION>EX-99.1
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:14pt"><B>Press Release</B></P></TD>
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</TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Late-breaking amlitelimab Phase 2b data presented at EADV show potential <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> profile in atopic dermatitis </I></FONT></P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9744;</FONT></TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">Patients treated with amlitelimab experienced up to 61.5% improvement in average Eczema Area and Severity Index (EASI)
score from baseline at week 16, the primary endpoint, with continued improvement seen through 24 weeks </P></TD></TR></TABLE>
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<TD WIDTH="3%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9744;</FONT></TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">Clinically meaningful improvements were seen in all key secondary endpoints at week 16 with continued improvements
through week 24, including for IGA 0/1 where patients on the highest dose experienced 22.1% improvement at week 16 which increased to 45.5% by week 24 </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">Amlitelimab was well-tolerated and no fever/chills, oral ulcers or imbalances with conjunctivitis were observed across
doses </P></TD></TR></TABLE>
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<TD WIDTH="3%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9744;</FONT></TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">Amlitelimab has a unique <FONT STYLE="white-space:nowrap">non-depleting</FONT> mechanism of action targeting OX40-Ligand
with the potential to durably restore immune balance, sustained effect and infrequent dosing </P></TD></TR></TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris,
October</B><B></B><B>&nbsp;13, 2023</B>. Positive results from a Phase 2b study <FONT STYLE="white-space:nowrap">(STREAM-AD)</FONT> showed that amlitelimab significantly improved signs and symptoms of <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> atopic dermatitis in adults whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach. These detailed
results were presented today as part of a late-breaking session at the European Academy of Dermatology and Venereology (EADV) 2023 Congress in Berlin.&nbsp;The Phase 3 program for amlitelimab in atopic dermatitis is on track to start in the first
half of 2024. This program is part of Sanofi&#146;s immunology strategy built around exploring disruptive mechanisms of action designed to deliver first and
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> treatments for people living with chronic inflammatory diseases. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In this dose-ranging study, subcutaneous treatment with amlitelimab resulted in statistically significant improvements in the primary endpoint of
percent change in Eczema Area and Severity Index (EASI) score from baseline at 16 weeks compared to placebo for all four doses that were studied. Among these, patients treated with amlitelimab 250 mg Q4W with 500 mg loading dose (LD) had the
numerically highest response versus placebo, showing a 61.5% reduction in EASI from baseline at week 16 (P&lt;0.0001) and a 64.4% reduction at week 24 (P&lt;0.0001) vs. 29.4% at week 16 and 27.6% at week 24 for placebo. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Professor Stephan Weidinger, M.D, Ph.D </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL" ALIGN="justify">Director, Professor, Chair of Department of Dermatology and Allergy, University Hospital Schleswig-Holstein </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:2%; font-size:10pt; font-family:ARIAL" ALIGN="justify">&#147;<I>These results are exciting news for patients with <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> atopic dermatitis who continue to suffer from symptoms including persistent itch and skin lesions, despite available treatment options. Across all four doses studied, we saw consistent
improvements in important signs and symptoms of the disease with an unremarkable safety profile. These data also add to the growing body of evidence that targeting OX40-Ligand potentially stops the inflammatory cascade across multiple pathways
resulting in significant benefit for patients.&#148;</I> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Across amlitelimab doses, clinically meaningful and nominally significant improvements
were seen in all key secondary endpoints at weeks 16 and 24, including Investigator Global Assessment response of 0 (clear) or 1 (almost clear skin) (IGA 0/1), 75% reduction from baseline in EASI <FONT STYLE="white-space:nowrap">(EASI-75)</FONT> and
weekly average reduction of Peak Pruritus Numerical Rating Scale <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>4 points from baseline <FONT STYLE="white-space:nowrap">(PP-NRS</FONT>
<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>4), with the exception of the 250 mg (no LD) in IGA 0/1 at Week 16 (p=0.0562). </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">22.1% and 45.5% of patients treated with amlitelimab 250 mg with LD achieved IGA 0/1 at weeks 16 and
24, respectively, compared to 5.1% and 11.4% of placebo patients (P=0.0022 and P&lt;0.0001). Of patients treated with that same dose, 40.3% and 54.5% achieved <FONT STYLE="white-space:nowrap">EASI-75</FONT> at weeks 16 and 24, respectively, versus
11.4% and 17.7% on placebo (both P&lt;0.0001). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Across all doses at weeks 16 and 24, amlitelimab treatment substantially reduced levels of
biomarkers elevated in atopic dermatitis, including <FONT STYLE="white-space:nowrap">Th2-related</FONT> <FONT STYLE="white-space:nowrap">IL-13</FONT> and TARC, Th17/Th22-related <FONT STYLE="white-space:nowrap">IL-17A</FONT> and <FONT
STYLE="white-space:nowrap">IL-22,</FONT> and blood eosinophil counts, with significant reduction observed as early as week 4 in the 250 mg with LD arm. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Houman Ashrafian, M.D., Ph.D. </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL" ALIGN="justify">Global Head of Research&nbsp;&amp; Development, Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:2%; font-size:10pt; font-family:ARIAL" ALIGN="justify"><I>&#147;The data presented at EADV provide more detailed insight into amlitelimab&#146;s potential as a <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> therapy for people with atopic dermatitis. In addition, our ability to pursue a differentiated dosing regimen could be very meaningful to patients. We look
forward to initiating a larger Phase 3 development program for amlitelimab in atopic dermatitis in the first half of 2024, which further underscores our commitment to delivering a diverse range of solutions for this chronic condition.&#148;</I> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Amlitelimab was well-tolerated in the study across all dose arms and no new safety concerns were identified. The overall rates of treatment-emergent
adverse events (TEAEs) were 67.4% for amlitelimab and 60.3% for placebo. TEAEs more commonly observed with amlitelimab compared to placebo included nasopharyngitis (11.0% amlitelimab, 9.0% placebo), <FONT STYLE="white-space:nowrap">COVID-19</FONT>
(7.7% amlitelimab, 6.4% placebo) and headache (6.1% amlitelimab, 2.6% placebo). Worsening of atopic dermatitis was more commonly observed with placebo compared to amlitelimab (38.5% placebo, 17.1% amlitelimab). No adverse events such as fever or
chills, oral ulcers or imbalances with conjunctivitis were observed across doses. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Amlitelimab is a fully human
<FONT STYLE="white-space:nowrap">non-depleting</FONT> monoclonal antibody that binds to OX40-Ligand, a key immune regulator, and has the potential to be a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT>
treatment for a range of immune-mediated diseases and inflammatory disorders, including <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> atopic dermatitis and asthma. By targeting OX40-Ligand,
amlitelimab aims to restore balance between <FONT STYLE="white-space:nowrap">pro-inflammatory</FONT> and regulatory T cells. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Amlitelimab is
currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About <FONT
STYLE="white-space:nowrap">STREAM-AD</FONT> </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><FONT STYLE="white-space:nowrap">STREAM-AD,</FONT> a Phase 2b study, is a randomized
double-blind, placebo-controlled study, evaluating amlitelimab in adult patients with <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> atopic dermatitis whose disease was inadequately controlled with
topical therapies or where such therapies were not advisable. This study is designed with two parts and is double-blind through both. The first part is a <FONT STYLE="white-space:nowrap">24-week</FONT> treatment period and the second part, which is
still ongoing, is a <FONT STYLE="white-space:nowrap">36-week</FONT> maintenance/withdrawal period. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The primary endpoint is percentage change in
EASI from baseline at 16 weeks. Key secondary endpoints include change in EASI from baseline at 24 weeks, percentage of patients with a response of IGA 0 (clear) or 1 (almost clear skin) and a reduction from baseline <FONT
STYLE="font-family:Times New Roman">&#8805;</FONT> 2 points at 16 and 24 weeks, percentage of patients with at least a 75% reduction from baseline in EASI at 16 and 24 weeks, and proportion of patients with improvement (reduction) of weekly average
of pruritus NRS <FONT STYLE="font-family:Times New Roman">&#8805;</FONT> 4 with a baseline pruritus of <FONT STYLE="font-family:Times New Roman">&#8805;</FONT> 4 from baseline at 16 and 24 weeks. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In the first part, participants were randomized 1:1:1:1:1 to receive subcutaneous amlitelimab every four weeks or placebo. The doses were: 250 mg with
500 mg loading dose [LD] (n=77), 250 mg without LD (n=78), 125 mg without LD (n=77), 62.5 mg without LD, (n=79) or placebo (n=79). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The study
enrolled 390 people in Australia, Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, Spain, Taiwan, the United Kingdom and the United States. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.2 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom"> <P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:14pt; font-family:ARIAL" ALIGN="justify"><B>Press Release</B></P></TD>
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</TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>TZIELD<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> Phase 3 data
presented at ISPAD shows potential to slow the progression of Stage 3 type 1 diabetes in newly diagnosed children and adolescents; full data simultaneously published in The New England Journal of Medicine</I> </FONT></P>
<P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">TZIELD met the study&#146;s primary endpoint, significantly slowing the decline of
<FONT STYLE="white-space:nowrap">C-peptide</FONT> levels, compared to placebo </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">Numerical trends favoring TZIELD were seen in key secondary endpoints, whilst statistical significance was not achieved
</P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">PROTECT builds on the existing body of evidence on TZIELD&#146;s potential to slow the progression of type 1 diabetes
</P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">TZIELD fits at the intersection of Sanofi&#146;s growth in immune-mediated diseases and disease modifying therapies, and
the company&#146;s expertise in diabetes </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris, October</B><B></B><B>&nbsp;18, 2023. </B>New data from TZIELD&#146;s <FONT
STYLE="white-space:nowrap">(teplizumab-mzwv)</FONT> PROTECT Phase 3 trial were presented today at the 49<SUP STYLE="font-size:75%; vertical-align:top">th</SUP> Annual ISPAD Conference, in Rotterdam, The Netherlands. PROTECT studied the efficacy and
safety of TZIELD, compared to placebo, to slow the loss of beta cells and preserve beta cell function as measured by <FONT STYLE="white-space:nowrap">C-peptide,</FONT> in children and adolescents aged <FONT STYLE="white-space:nowrap">8-17</FONT>
years diagnosed in the preceding 6 weeks with Stage 3 autoimmune type 1 diabetes (T1D). The full data set has been simultaneously published in <FONT STYLE="font-family:ARIAL" COLOR="#0563c1"><I><U>The New England Journal of Medicine</U></I></FONT><FONT
STYLE="font-family:ARIAL">. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">TZIELD met the study&#146;s primary endpoint, demonstrating superior beta cell preservation assessed by
significantly slowing the decrease in mean <FONT STYLE="white-space:nowrap">C-peptide</FONT> levels (area under the curve [AUC] after a <FONT STYLE="white-space:nowrap">4-hour</FONT> mixed meal tolerance test) at trial completion, compared to
placebo. <FONT STYLE="white-space:nowrap">C-peptide</FONT> is a biomarker for beta cell function. This significant difference indicates the potential of TZIELD to slow the progression of Stage 3 type 1 diabetes in this population. While the
study&#146;s key secondary endpoints did not meet statistical significance, numerical trends favoring TZIELD were seen in relevant clinical parameters. On average, people on TZIELD required numerically fewer insulin units and had numerically higher
time in range, compared to those on placebo. HbA1c reductions and the overall rates of clinically important low blood sugar (hypoglycemic) events were similar among both study groups. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Kevan Herold, MD </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL" ALIGN="justify">C.N.H. Long Professor of Immunobiology and of Medicine (Endocrinology), Yale School of Medicine and Primary Investigator of PROTECT. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:2%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;Type 1 diabetes is a chronic autoimmune disease, driven by the destruction of the insulin-producing
beta cells, and as such, beta cell preservation remains a meaningful unmet need for all patients with diabete</I>s. <I>These new results build on the findings from multiple studies across different stages of the disease process, further supporting
TZIELD&#146;s potential to modulate the progression of T1D.&#148; </I> </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Jose Eduardo Neves, M.D. </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL" ALIGN="justify">Senior Vice President, Global Head of Medical Affairs, General Medicines, Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:2%; font-size:10pt; font-family:Times New Roman"><I>&#147;The PROTECT results are encouraging, as we believe they showcase the potential for TZIELD to slow down the
progression of Stage 3 T1D in this population, as well as pointing towards favorable trends in relevant aspects for clinicians and people living with type 1 diabetes. We look forward to discussing this new data with the scientific community and
regulatory authorities around the world.&#148;</I> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The availability of the PROTECT data represents a key early milestone for Sanofi on TZIELD,
following the acquisition of Provention Bio (a Sanofi Company) in April 2023. TZIELD is a strategic fit for Sanofi at the intersection of our growth in immune-mediated diseases and disease modifying therapies, and our company&#146;s expertise in
diabetes. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Key Results </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The PROTECT clinical trial was a randomized, double blind, placebo-controlled, multi-national trial. From baseline and through the trial&#146;s
completion at 78 weeks, the following was observed for TZIELD vs placebo: </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Primary endpoint </I></FONT></P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt"><B>Significantly less decrease in mean <FONT STYLE="white-space:nowrap">C-peptide</FONT> levels (area under the
concentration curve [AUC], following a <FONT STYLE="white-space:nowrap">4-hour</FONT> mixed-meal tolerance test [MMTT]):</B> difference in least-squares means (LSM) of 0.13 pmol/mL; (95% CI: 0.09, 0.17; P&lt;0.001). </P></TD></TR></TABLE>
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<TD WIDTH="12%">&nbsp;</TD>
<TD WIDTH="1%" VALIGN="top" ALIGN="left"><FONT STYLE="FONT-SIZE:95%">&#9675;</FONT></TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">94.9% of participants in the TZIELD group maintained peak <FONT STYLE="white-space:nowrap">C-peptide</FONT> levels <FONT
STYLE="font-family:Times New Roman">&#8805;</FONT>0.2 pmol/mL, compared with 79.2% of those who received the placebo (P&lt;0.001). </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><I>Secondary endpoints </I></FONT></P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt"><B>Numerically lower mean insulin dose in favor of TZIELD at Week 78</B>: the least-square mean (LSM) for insulin dose
at week 78 was 0.46 U/Kg/day (TZIELD) and 0.59 U/kg/day (placebo), difference <FONT STYLE="white-space:nowrap">-0.13</FONT> U/kg/day (95% CI: <FONT STYLE="white-space:nowrap">-0.28,</FONT> 0.02). </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt"><B>Comparable change in mean HbA1c:</B> LSM change of <FONT STYLE="white-space:nowrap">-1.98%</FONT> (TZIELD) vs <FONT
STYLE="white-space:nowrap">-1.89%</FONT> (placebo), difference <FONT STYLE="white-space:nowrap">-0.09</FONT> (95% CI: <FONT STYLE="white-space:nowrap">-0.42,</FONT> 0.24) </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt"><B>Numerically higher mean time in range at week 78 in favor of TZIELD (&gt;70 but </B><B></B><FONT
STYLE="font-family:Times New Roman">&#8804;</FONT><B></B><B></B><B>180 mg/dL)</B>: 68.7&plusmn;19.6% (TZIELD) vs 64.6&plusmn;22.4% (placebo). Difference of 4.71% (95% CI: <FONT STYLE="white-space:nowrap">-1.72,</FONT> 11.15). </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt"><B>Similar mean rates of overall clinically important hypoglycemic events:</B> estimated rates of 4.68 (TZIELD) (95% CI:
3.70, 5.91) vs 4.24 (placebo) (95% CI: 3.06, 5.89) events/patient-year, with an estimated rate ratio of 1.10 (95% CI: 0.74, 1.64). </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The safety results of the trial were consistent with previous data from TZIELD&#146;s currently approved FDA indication to delay the onset of Stage 3
type 1 diabetes in adults and children 8 years and older diagnosed with Stage 2 T1D, as well as other prior clinical studies with TZIELD. No new safety signals were identified. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Adverse events of special interest (AESI) were prespecified and occurred in 29% of those on TZIELD vs 21.6% on placebo, the most frequent one being
hypoglycemia (TZIELD: 13.4%; placebo: 16.2%). Other common adverse events (AEs) were headache, nausea, rash, lymphopenia and vomiting. Serious adverse events (SAEs) were reported by 5.5% of participant who received TZIELD vs 5.4% on placebo; the
most common SAEs were cytokine release syndrome (TZIELD: 1.4%; placebo 0%) and infections (TZIELD: 0%; placebo: 2.7%). </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">The use of TZIELD in the PROTECT population is investigational, and its safety and efficacy in this population has not
been evaluated by any regulatory authority. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About PROTECT </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">PROTECT (<FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#0563c1"><U>NCT03875729</U></FONT><FONT STYLE="font-family:ARIAL">) is a Phase 3, randomized, double
blind, placebo-controlled, multi-national clinical trial. It enrolled 328 children and adolescents (TZIELD n=217, placebo n=111) aged <FONT STYLE="white-space:nowrap">8-17</FONT> years diagnosed with clinical, Stage 3 T1D in the preceding 6 weeks;
randomization ratio of TZIELD:placebo was 2:1. Participants received a first course of 12 daily infusions (of either TZIELD or placebo) at randomization, followed by a second course of 12 daily infusions after 26 weeks (approx. 6 months). All
participants received <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> as required. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">The primary objective of
PROTECT was to determine whether TZIELD can slow down beta cell loss and preserve beta cell function measured by <FONT STYLE="white-space:nowrap">C-peptide,</FONT> compared to placebo. This was assessed via the trial&#146;s primary endpoint, which
measured the difference in mean change of <FONT STYLE="white-space:nowrap">C-peptide</FONT> level (area under the time-concentration curve [AUC] measured after a <FONT STYLE="white-space:nowrap">4-hour</FONT> mixed meal tolerance test) from baseline
to Week 78 between both groups. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Key secondary endpoints included HbA1c, time in range (TiR) as measured with a CGM, clinically important low blood sugar
(hypoglycemia) events and exogenous insulin use. Time in range was defined as: &gt;70 but <FONT STYLE="font-family:Times New Roman">&#8804;</FONT>180 mg/d. Clinically relevant hypoglycemic events were defined: level 2 hypoglycemia (&lt;54 mg/dL /
3.0 mmol/L) and level 3 hypoglycemia as episodes of severe cognitive impairment requiring external assistance for recovery, even in the absence of a blood glucose reading. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Other secondary endpoints were adverse events and overall safety aspects, as well as pharmacokinetics (PK) and immunogenicity of TZIELD. An observational extension
study following participants for a further 42 months is ongoing. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About TZIELD </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">TZIELD <FONT STYLE="white-space:nowrap">(teplizumab-mzwv)</FONT> is a <FONT STYLE="white-space:nowrap">CD3-directed</FONT> monoclonal antibody. TZIELD is the first and
only disease modifying therapy in autoimmune type 1 diabetes (T1D); it was approved by the U.S. FDA in November 2022 to delay the onset of Stage 3 type 1 diabetes in adults and children 8 years and older diagnosed with Stage 2 T1D. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About autoimmune, type 1 diabetes (T1D) </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">T1D is a chronic autoimmune condition where the body&#146;s ability to regulate blood sugar levels is impacted due to the gradual destruction of insulin producing beta
cells by one&#146;s own immune system. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">There are 3 stages to the progression of T1D: </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">In Stage 1, the autoimmune attack to the beta cells has started, and this can be detected by the presence of 2 or more <FONT
STYLE="white-space:nowrap">T1D-related</FONT> autoantibodies in the blood. During Stage 1, blood sugar levels are in a normal range. At this stage, T1D is asymptomatic. </P></TD></TR></TABLE>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">In Stage 2 (also asymptomatic), in addition to the presence of 2 or more
<FONT STYLE="white-space:nowrap">T1D-related</FONT> autoantibodies, blood sugar levels are now abnormal (dysglycemia) due to the progressive loss of beta cells / beta cell function. People diagnosed with Stage 2 T1D have a near 100% lifetime chance
of progression to Stage 3 T1D, with 75% of them progressing to it within five years. </P></TD></TR></TABLE>
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<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">Stage 3 (also known as clinical stage) comes once a significant portion of the beta cells have been destroyed. At this
point, rising blood sugar levels reach the point of clinical hyperglycemia (which defines diabetes), and many people will experience the classic symptoms that come with the onset of Stage 3 T1D: increased thirst, frequent urination, unexplained
weight loss, blurred vision and generalized fatigue. Management of Stage 3 T1D requires daily and burdensome insulin replacement therapy. </P></TD></TR></TABLE> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.50pt solid #cccccc">&nbsp;</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Sanofi
</I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people&#146;s lives.
Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of
people globally, while putting sustainability and social responsibility at the center of our ambitions. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sandrine
Guendoul</B><B></B>&nbsp;|&nbsp;+ 33 6 25 09 14 25 |&nbsp;<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Evan Berland </B>|&nbsp;+ 1 215 432 0234 |&nbsp;<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>evan.berland@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Victor Rouault</B><B></B>&nbsp;|&nbsp;+ 33 6 70 93 71 40 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>victor.rouault@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><I>Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Eva Schaefer-Jansen</B><B></B>&nbsp;|&nbsp;+ 33 7 86 80 56 39 |&nbsp;<FONT
STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>eva.schaefer-jansen@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Arnaud
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<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Corentine Driancourt</B><B></B>&nbsp;|&nbsp;+ 33 6 40 56 92 21 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>corentine.driancourt@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Felix
Lauscher</B><B></B>&nbsp;|&nbsp;+ 1&nbsp;908&nbsp;612 7239 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Tarik Elgoutni|</B> + 1 617 710 3587 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>tarik.elqoutni@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Nathalie Pham</B><B></B>&nbsp;|&nbsp;+ 33 7 85 93 30 17 |
<U><FONT STYLE="font-family:ARIAL" COLOR="#7a00e6">natalie.pham@sanofi.com</FONT></U><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #cccccc">&nbsp;</P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL"><B>Sanofi Forward-Looking Statement </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL" ALIGN="justify">This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
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statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;, &#147;believes&#148;, &#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although Sanofi&#146;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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties
inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks
associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, 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 &#147;Risk Factors&#148; and &#147;Cautionary Statement Regarding Forward-Looking Statements&#148; in Sanofi&#146;s annual report on Form <FONT
STYLE="white-space:nowrap">20-F</FONT> for the year ended December&nbsp;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. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.3 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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</TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Sanofi delivers first medicines from Global Health Unit&#146;s Impact brand
portfolio</I> </FONT></P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris, October</B><B></B><B>&nbsp;19, 2023.</B> Sanofi has delivered the first medicines from its Global Health Unit&#146;s
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">not-for-profit</FONT></FONT> Impact brand portfolio to the Republic of Djibouti. Enoxaparin Sodium Impact is an anticoagulant medicine indicated for the treatment of venous
thromboembolism including deep vein thrombosis, a potentially lethal disease often underdiagnosed on the African continent. With this first shipment to Djibouti, Sanofi delivers on its commitment to improve and accelerate affordable and sustainable
access to quality medicines, vaccines and healthcare for underserved populations. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Sanofi&#146;s social model to broaden access is channeled through
its Global Health Unit (GHU). The first global initiative of its kind, Sanofi&#146;s GHU aims to provide access to a broad portfolio of medicines in 40 countries with the highest unmet medical needs. To that point, the GHU created Impact, a unique <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">not-for-profit</FONT></FONT> brand with 30 <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> medicines produced by Sanofi, some of which are
considered &#147;essential&#148; by the World Health Organization (WHO). The Impact medicines cover a wide range of therapeutic areas, including diabetes, cardiovascular disease, tuberculosis, malaria and cancer. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Jon Fairest </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL" ALIGN="justify">Head, Global Health Unit, Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:2%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;I&#146;m delighted to see the very first Impact brand medicine, Enoxaparin Sodium Impact, arrive on
Djibouti soil. This is an important milestone in Sanofi&#146;s long-term objective to reach 2&nbsp;million people with noncommunicable diseases in underserved populations by 2030. But providing access to quality medicines and sustainable healthcare
to people in the 40 most underserved countries is not a simple task. It requires cross-sector partnerships on a global, regional, and importantly, on a local scale &#150; work Sanofi does on the ground with the GHU teams. After Djibouti, we are now
heading to Tanzania, scheduled to be the second country to receive an Impact brand medicine: Insulin Glargine Impact.&#148;</I> </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt;margin-bottom:0pt" ALIGN="center">


<IMG SRC="g568063g94j67.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The delivery of Enoxaparin Sodium Impact comes months after the signature of a partnership with the Republic of
Djibouti&#146;s Caisse Nationale de S&eacute;curit&eacute; Sociale (CNSS), the national social security fund. The partnership aims at improving diagnosis and management of cardiometabolic diseases and diabetes in Djibouti and to help local
communities gain sustainable access to quality medicines at accessible pricing, medical training and capacity building. </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Deka Ahmed Robleh </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL" ALIGN="justify">Managing Director, Caisse Nationale de S&eacute;curit&eacute; Sociale, Djibouti </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:2%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;In partnership with Sanofi&#146;s Global Health Unit, we are working to remove barriers that limit
access to quality treatment and care for noncommunicable disease patients in Djibouti. The availability of Enoxaparin Sodium Impact at accessible pricing addresses an unmet need in the management of venous thromboembolic disease, a condition often
underdiagnosed. Moreover, working with Sanofi within the local community to help train healthcare professionals, drive awareness around the management of cardiometabolic diseases and diabetes, and build capacity is critical to improving patient
outcomes throughout the country.&#148;</I> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Ahead of the delivery of the first
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">not-for-profit</FONT></FONT> Impact brand medicines, Sanofi&#146;s Global Health Unit has been working closely with local communities, authorities and
<FONT STYLE="white-space:nowrap">non-governmental</FONT> organizations to support the set up and development of sustainable healthcare systems for those who suffer from chronic diseases and require complex care, and to develop disease awareness
programs. To date, over 1,800 healthcare professionals have been trained in <FONT STYLE="white-space:nowrap">GHU-sponsored</FONT> programs globally. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt;margin-bottom:0pt" ALIGN="center">


<IMG SRC="g568063g20m29.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL" ALIGN="center">Tanzania is scheduled to be the second country to receive an Impact brand medicine: Insulin Glargine Impact </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The WHO estimates over 4.5&nbsp;billion people, or half the world&#146;s population, lacks coverage for essential health services<SUP
STYLE="font-size:75%; vertical-align:top">1</SUP>. According to the WHO, noncommunicable diseases (NCDs) are responsible for 41&nbsp;million people dying each year, with <FONT STYLE="white-space:nowrap">low-</FONT> and middle-income countries
accounting for 77% of all NCDs deaths<SUP STYLE="font-size:75%; vertical-align:top">2</SUP>. </P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #cccccc">&nbsp;</P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Sanofi
</I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people&#146;s lives.
Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of
people globally, while putting sustainability and social responsibility at the center of our ambitions. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Victor
Rouault</B><B></B>&nbsp;|&nbsp;+ 33 6 70 93 71 40 |&nbsp;<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>victor.rouault@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Evan Berland</B> | +1 215 432 0234 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>evan.berland@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sandrine
Guendoul</B><B></B>&nbsp;|&nbsp;+ 33 6 25 09 14 25 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:8.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:26%">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:7pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:75%; vertical-align:top">1</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:7pt; font-family:ARIAL; " ALIGN="justify"><FONT COLOR="#7a00e6"><U>https://www.who.int/news-room/fact-sheets/detail/universal-health-coverage-(uhc)</U></FONT>
</P></TD></TR></TABLE>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:75%; vertical-align:top">2</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">
<P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:7pt; font-family:ARIAL; " ALIGN="justify"><FONT COLOR="#7a00e6"><U>https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases#SnippetTab</U></FONT> </P></TD></TR></TABLE>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Investor Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Eva Schaefer-Jansen</B><B></B>&nbsp;|&nbsp;+ 33 7 86 80 56 39
|&nbsp;<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>eva.schaefer-jansen@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Arnaud
Del&eacute;pine</B><B></B>&nbsp;|&nbsp;+ 33 6 73 69 36 93 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>arnaud.delepine@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Corentine Driancourt</B><B></B>&nbsp;|&nbsp;+ 33 6 40 56 92 21 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>corentine.driancourt@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Felix
Lauscher</B><B></B>&nbsp;|&nbsp;+ 1&nbsp;908&nbsp;612 7239 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Tarik Elgoutni|</B> + 1 617 710 3587 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>tarik.elgoutni@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Nathalie Pham</B><B></B>&nbsp;|&nbsp;+ 33 7 85 93 30 17 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>nathalie.pham@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.50pt solid #cccccc">&nbsp;</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL"><B>Sanofi Forward-Looking Statements </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL" ALIGN="justify">This press release 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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking
statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;, &#147;believes&#148;, &#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although Sanofi&#146;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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties
inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks
associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, 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 &#147;Risk Factors&#148; and &#147;Cautionary Statement Regarding Forward-Looking Statements&#148; in Sanofi&#146;s annual report on Form <FONT
STYLE="white-space:nowrap">20-F</FONT> for the year ended December&nbsp;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. </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
