<SEC-DOCUMENT>0001193125-24-047460.txt : 20240227
<SEC-HEADER>0001193125-24-047460.hdr.sgml : 20240227
<ACCEPTANCE-DATETIME>20240227113537
ACCESSION NUMBER:		0001193125-24-047460
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		10
CONFORMED PERIOD OF REPORT:	20240227
FILED AS OF DATE:		20240227
DATE AS OF CHANGE:		20240227

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Sanofi
		CENTRAL INDEX KEY:			0001121404
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		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:		24683713

	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>d702412d6k.htm
<DESCRIPTION>6-K
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<HTML><HEAD>
<TITLE>6-K</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;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="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT
STYLE="white-space:nowrap">6-K</FONT> </B></P> <P STYLE="font-size:12pt;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="margin-top:12pt; margin-bottom:0pt; font-size:12pt; 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:12pt; 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:12pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of February 2024 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number: <FONT STYLE="white-space:nowrap">001-31368</FONT> </B></P>
<P STYLE="font-size:12pt;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="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>SANOFI </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Translation of
registrant&#146;s name into English) </B></P> <P STYLE="font-size:12pt;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="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>46, avenue de
la Grande Arm&eacute;e, 75017 Paris, FRANCE </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive offices) </B></P>
<P STYLE="font-size:12pt;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="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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:10pt; font-family:Times New Roman" ALIGN="center">Form <FONT STYLE="white-space:nowrap">20-F&#8194;&#9746;&#8195;&#8195;Form</FONT> <FONT
STYLE="white-space:nowrap">40-F&#8194;&#9744;</FONT> </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In February 2024, Sanofi published the press releases attached hereto as Exhibits 99.1, 99.2, 99.3, 99.4 and
99.5 which are incorporated herein by reference. </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="88%"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; "><U>Exhibit&nbsp;No.</U></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; " ALIGN="center"><U>Description</U></P></TD></TR>


<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d702412dex991.htm">Press Release dated February&nbsp;15, 2024: Phase 2 data published in NEJM show potential of frexalimab as high-efficacy therapy in relapsing MS </A></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP>Exhibit 99.2</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d702412dex992.htm">Press Release dated February&nbsp;16, 2024: Japan first in the world to approve Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> for chronic spontaneous urticaria (CSU) </A></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP> <P STYLE="margin-bottom:1pt; margin-top:0pt; font-size:10pt; font-family:Times New Roman">Exhibit 99.3</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman"><A HREF="d702412dex993.htm">Press Release dated February&nbsp;
22, 2024: Sanofi&#146;s Board of Directors proposes the appointment of Clotilde Delbos, Anne-Fran&ccedil;oise Nesmes and John Sundy as independent Directors </A></P></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP>Exhibit 99.4</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d702412dex994.htm">Press Release dated February&nbsp;23, 2024: Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation
</A></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP>Exhibit 99.5<BR></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d702412dex995.htm">Press Release dated February&nbsp;
24, 2024: Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved disease activity in adults with chronic spontaneous urticaria </A></TD></TR>
</TABLE>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">2 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">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:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Dated: February&nbsp;27, 2024</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center">SANOFI</TD></TR>
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<TD VALIGN="top">By</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Alexandra Roger</P></TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="top">Name: Alexandra Roger</TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">Title: Head of Legal Corporate&nbsp;&amp; Finance</TD></TR>
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 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">3 </P>

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<TYPE>EX-99.1
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<DESCRIPTION>EX-99.1
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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: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"><FONT STYLE="font-family:ARIAL; font-size:14pt"><B>Press Release</B></FONT></TD>
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</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Phase 2 data published in NEJM show potential of frexalimab as high-efficacy therapy
in relapsing MS</I> </FONT></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 WIDTH="4%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</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">High-dose frexalimab significantly reduced disease activity, demonstrating 89% reduction in new brain lesions
</P></TD></TR></TABLE>
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<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</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">Phase 3 trials in relapsing MS and <FONT STYLE="white-space:nowrap">non-relapsing</FONT> secondary progressive MS
currently underway </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris, February</B><B></B><B>&nbsp;15, 2024.</B> <I>The New England Journal of Medicine</I> <FONT
STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U>published</U></FONT><FONT STYLE="font-family:ARIAL"> results from a positive Phase 2 clinical trial demonstrating frexalimab significantly slowed disease activity in people with relapsing
multiple sclerosis (MS), corresponding to 89% and 79% reduction in new gadolinium-enhancing (GdE) T1 brain lesions at Week 12 in the high- and <FONT STYLE="white-space:nowrap">low-dose</FONT> treatment arms compared to placebo, meeting the
study&#146;s primary endpoint. Findings also showed both doses of frexalimab provided significant reduction in new or enlarging T2 lesions, a secondary endpoint of the study. Frexalimab is Sanofi&#146;s novel second-generation investigational
anti-CD40L antibody that has a unique method of action with the potential to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion. These data were previously presented at Consortium of Multiple Sclerosis
Centers annual meeting 2023. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><B>Patrick Vermersch, MD, PhD</B> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL" ALIGN="justify">University of Lille, CHU Lille, France </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;These published Phase 2 results for frexalimab represent important data in not only the potential
treatment of MS but to the broader MS community. Of note, at Week 12, both doses of frexalimab provided reduction of new lesions &#150; a standard measure of active inflammation in MS &#150; and was well-sustained over time and well tolerated,
especially at the high dose of frexalimab where 96% of patients were free of new active lesions after 24 weeks of treatment.&#148;</I> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Results
published in <I>NEJM</I> stem from the Phase 2 clinical trial that randomized 129 adults with relapsing MS to receive one of two doses of the anti-CD40L antibody frexalimab (n=52 and n=51, in the high- and
<FONT STYLE="white-space:nowrap">low-dose</FONT> treatment arms, respectively) or matching placebo (n=12 and n=14, respectively; pooled for efficacy analyses). In the high-dose treatment arm, participants received 1200 mg of frexalimab intravenously
every 4 weeks with an 1800 mg loading dose. In the <FONT STYLE="white-space:nowrap">low-dose</FONT> treatment arm, participants received 300 mg of frexalimab subcutaneously every 2 weeks with a 600 mg loading dose. After 12 weeks of treatment, both
doses of frexalimab led to significant reductions in: </P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</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">The number of new GdE <FONT STYLE="white-space:nowrap">T1-lesions</FONT> at Week 12, providing rate ratios of 0.11 (95%
CI, 0.03 to 0.38) and 0.21 (95% CI, 0.08 to 0.56), corresponding to 89% and 79% reduction in the high- and <FONT STYLE="white-space:nowrap">low-dose</FONT> treatment arms versus placebo, the primary endpoint. </P></TD></TR></TABLE>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</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">The number of new/enlarging <FONT STYLE="white-space:nowrap">T2-lesions</FONT> at Week 12, providing rate ratios of 0.08
(95% CI, 0.03 to 0.26) and 0.14 (95% CI, 0.05 to 0.41), corresponding to 92% and 86% reduction in the high- and <FONT STYLE="white-space:nowrap">low-dose</FONT> treatment arms versus placebo, respectively, a secondary endpoint.
</P></TD></TR></TABLE>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</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">The total number of GdE <FONT STYLE="white-space:nowrap">T1-lesions</FONT> at Week 12 providing rate ratios of 0.12 (95%
CI, 0.04 to 0.36) and 0.20 (95% CI, 0.07 to 0.53) corresponding to 88% and 80% reduction, respectively, another secondary endpoint. </P></TD></TR></TABLE>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The effects on the primary endpoint were sustained over time across both treatment arms, with even greater reduction seen in the high-dose frexalimab
treatment arm, as 96% of these study participants were free of new GdE <FONT STYLE="white-space:nowrap">T1-lesions</FONT> at Week 24. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Exploratory
endpoints looked at changes in the Multiple Sclerosis Impact Scale 29 <FONT STYLE="white-space:nowrap">(MSIS-29),</FONT> a patient-reported outcome, plasma neurofilament light chain (NfL), which has been identified as a biomarker of neuroaxonal
damage and MS disease activity, as well as plasma levels of CXCL13, a biomarker of inflammatory activity. Over 12 weeks of treatment, patient-reported outcome </P>
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<FONT STYLE="white-space:nowrap">MSIS-29</FONT> physical impact scores improved significantly in participants receiving the higher dose of frexalimab. The least-square [LS] mean difference (95%
confidence interval) was <FONT STYLE="white-space:nowrap">-7.9</FONT> <FONT STYLE="white-space:nowrap">(-14.7,-1.2),</FONT> compared to pooled placebo. Both doses of frexalimab achieved a reduction in NfL levels relative to baseline (24% and 18% in
the high-and <FONT STYLE="white-space:nowrap">low-dose</FONT> treatment arms, respectively) and in CXCL13 levels relative to baseline (21% and 30% in the high-and <FONT STYLE="white-space:nowrap">low-dose</FONT> treatment arms, respectively)
compared to pooled placebo at Week&nbsp;12. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Frexalimab was well-tolerated, and 125 (97%) participants completed Part A and continued to the
open-label Part B. The most common adverse events (<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>5%) in any frexalimab-treated group were <FONT STYLE="white-space:nowrap">COVID-19</FONT> (n=5 [9.8%] in the lower-dose group; all
uncomplicated cases of mild or moderate intensity) and headache (n=1 [2.0%] and n=3 [5.8%] in the <FONT STYLE="white-space:nowrap">low-</FONT> and high-dose group, respectively). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Sanofi has initiated Phase 3 clinical trials of frexalimab in relapsing MS and <FONT STYLE="white-space:nowrap">non-relapsing</FONT> secondary
progressive MS. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About the Phase 2 trial </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The Phase 2 trial was a randomized, double-blind, placebo-controlled trial evaluating frexalimab in participants with relapsing MS. Participants were
randomized (4:4:1:1) to receive either high or low doses of frexalimab or matching placebo for 12 weeks (Part A). The primary endpoint was the reduction in the number of new GdE T1 MRI brain lesions at Week 12. Secondary endpoints included
additional <FONT STYLE="white-space:nowrap">MRI-based</FONT> efficacy measures as well as the safety, tolerability and pharmacokinetics of frexalimab. After Week 12, participants receiving placebo switched to respective frexalimab arms and entered
the open-label Part B, which is currently ongoing. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About frexalimab </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Frexalimab (SAR441344) is a potentially <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-disease</FONT></FONT> second generation
investigational anti-CD40L antibody that blocks the costimulatory CD40/CD40L pathway which is important for activation and function of adaptive (T and B cells) and innate (macrophages/microglia and dendritic cells) immunity. Through this unique
upstream mechanism of action, frexalimab has the potential to address both acute and chronic neuroinflammation in MS, without causing lymphocyte depletion. Sanofi is developing frexalimab under an exclusive license from ImmuNext Inc. Frexalimab is
being evaluated in Phase 3 clinical trials for Multiple Sclerosis and Phase 2 clinical trials for Sjogren&#146;s Syndrome, Systemic Lupus Erythematosus, and Type 1 Diabetes, and its safety and efficacy have not been reviewed by any regulatory
authority. For more information on frexalimab clinical trials, please visit www.clinicaltrials.gov. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:12pt; 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:10pt; font-family:ARIAL">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:12pt; 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 | <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>Sally Bain</B><B></B>&nbsp;|&nbsp;+ 1 617 834 6026 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>sally.bain@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> | + 33 6 70 93 71 40 |
<U><FONT STYLE="font-family:ARIAL" COLOR="#7a00e6">victor.rouault@sanofi.com</FONT></U><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Timothy Gilbert</B> | + 1 516 521
2929 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>timothy.gilbert@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:12pt; 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&nbsp;|</B><B></B>&nbsp;+ 1 617 710 3587 |&nbsp;<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="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:8pt; font-family:ARIAL"><B>Sanofi Forward-Looking Statements </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; 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 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 &#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, 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&#146;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.&nbsp;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:18pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Japan first in the world to approve Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> for chronic
spontaneous urticaria (CSU) </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 STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="justify"><I>Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to
placebo</I> </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="justify"><I>CSU is the fifth approved indication for Dupixent in Japan and the sixth indication for Dupixent globally </I>
</P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris and Tarrytown, N.Y. February</B><B></B><B>&nbsp;16, 2024. </B>The Ministry of Health, Labor and Welfare (MHLW) in Japan
has granted marketing and manufacturing authorization for Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not
adequately controlled with existing therapy. Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch. CSU is
typically treated with histamine (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria. However, the disease remains uncontrolled despite antihistamine treatment in many patients, some of whom are left
with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life. Approximately 110,000 people aged 12 years and older suffer from uncontrolled <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> CSU in Japan, for which there are currently limited treatments. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The Japanese approval is based primarily on data from <FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#4a569e"><U>Study A</U></FONT><FONT
STYLE="font-family:ARIAL"> of the LIBERTY-CUPID clinical trial program evaluating Dupixent as an <FONT STYLE="white-space:nowrap">add-on</FONT> therapy to
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> H1 antihistamines compared to antihistamines alone (placebo) in 138 patients with CSU who remained symptomatic despite antihistamine use and were not
previously treated with omalizumab. This study met the primary and all key secondary endpoints. Patients taking Dupixent added to <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> antihistamines
experienced a significant reduction in itch severity compared to standard of care alone at 24 weeks. The safety profile of Dupixent in CSU was generally consistent with the known safety of Dupixent in its approved dermatological indications.
</FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In addition to CSU, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal
polyposis (CRSwNP), and prurigo nodularis. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>About Dupixent </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Dupixent is a fully human monoclonal antibody that inhibits the signaling of the <FONT STYLE="white-space:nowrap">interleukin-4</FONT> <FONT
STYLE="white-space:nowrap">(IL-4)</FONT> and <FONT STYLE="white-space:nowrap">interleukin-13</FONT> <FONT STYLE="white-space:nowrap">(IL-13)</FONT> pathways and is not an immunosuppressant. The Dupixent development program has shown significant
clinical benefit and a decrease in type 2 </P>
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<TD VALIGN="top" ALIGN="right"><FONT STYLE="background-color:#cccccc; " COLOR="#4a569e">&#8201;1&#8201;</FONT>&#8201;/&#8201;&#8201;<FONT STYLE="background-color:#cccccc; " COLOR="#4a569e">&#8201;4&#8201;</FONT></TD></TR></TABLE>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">
inflammation in Phase 3 trials, establishing that <FONT STYLE="white-space:nowrap">IL-4</FONT> and <FONT STYLE="white-space:nowrap">IL-13</FONT> are key and central drivers of the type 2
inflammation that plays a major role in multiple related and often <FONT STYLE="white-space:nowrap">co-morbid</FONT> diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, CRSwNP, prurigo nodularis and
eosinophilic esophagitis (EoE). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients
with atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis, and CSU in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Japan, Europe and the U.S. More than
800,000 patients are being treated with Dupixent globally. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The potential use of Dupixent in CSU is under clinical development in additional
countries around the world, and its safety and efficacy have not been fully evaluated by any regulatory authority outside of Japan. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>Dupilumab development
program </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been
studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2
inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin, chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation, and bullous pemphigoid. These potential uses of dupilumab
are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.</P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><I>About Sanofi </I></FONT></P> <P STYLE="margin-top:2pt; 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:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Sanofi is
listed on EURONEXT: SAN and NASDAQ: SNY.</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Regeneron </I></FONT></P>
<P STYLE="margin-top:2pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious
diseases. Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous <FONT STYLE="white-space:nowrap">FDA-approved</FONT> treatments and product
candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases,
hematologic conditions, infectious diseases and rare diseases. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Regeneron is accelerating and improving the traditional drug development process
through our proprietary <I>VelociSuite</I><I><SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP></I><I> </I>technologies, such as <I>VelocImmune</I><I>&reg;</I>,<I> </I>which uses unique genetically humanized mice to produce optimized fully
human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. </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">For more information about Regeneron, please visit <FONT
STYLE="font-family:ARIAL; font-size:10pt" COLOR="#954f72"><U>www.Regeneron.com</U></FONT><FONT STYLE="font-family:ARIAL"> or follow Regeneron on </FONT><FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#954f72"><U>LinkedIn</U></FONT><FONT
STYLE="font-family:ARIAL">. </FONT></P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Sanofi Media Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sally Bain</B><B></B>&nbsp;|&nbsp;+ 1 617 834 6026 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>sally.bain@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"> <B></B> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Victor
Rouault</B> | + 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:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Sanofi Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Eva
Schaefer-Jansen </B>| + 33 7 86 80 56 39 | <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>| + 33 06 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> | + 33 06 40 56 92 |
<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> | + 1 908 612 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"><U> </U> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Nathalie Pham</B> | + 33 07 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="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><I>Regeneron Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Ilana Yellen </B>| +1
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">914-330-9618|</FONT></FONT> <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>ilana.yellen@regeneron.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Regeneron Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Vesna
Tosic </B>| + 914 847 5443 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>vesna.tosic@regeneron.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:1px 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"><I>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.</I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL"><B>Regeneron Forward-Looking Statements and Use of Digital Media </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL" ALIGN="justify"><I>This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of
Regeneron Pharmaceuticals, Inc. (&#147;Regeneron&#148; or the &#147;Company&#148;), and actual events or results may differ materially from these forward-looking statements. Words such as &#147;anticipate,&#148; &#147;expect,&#148;
&#147;intend,&#148; &#147;plan,&#148; &#147;believe,&#148; &#147;seek,&#148; &#147;estimate,&#148; variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking
statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by
Regeneron and/or its collaborators or licensees (collectively, &#147;Regeneron&#146;s Products&#148;) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, &#147;Regeneron&#146;s Product
Candidates&#148;) and research and clinical programs now underway or planned, including without limitation Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab) for the treatment of chronic spontaneous urticaria
(&#147;CSU&#148;); uncertainty of the utilization, market acceptance, and commercial success of Regeneron&#146;s Products and Regeneron&#146;s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether
mandated or voluntary), such as the studies discussed or referenced in this press release, on any of the foregoing (including whether the results of any such studies will be deemed sufficient for regulatory approval of Dupixent for the treatment of
CSU by regulatory agencies of other countries); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron&#146;s Product Candidates and new indications for Regeneron&#146;s Products, such as Dupixent for
the treatment of chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, bullous pemphigoid, and other potential indications, as well as potential regulatory approval of Dupixent for the
treatment in CSU by regulatory agencies of other countries; the ability of Regeneron&#146;s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution,
and other steps related to Regeneron&#146;s Products and Regeneron&#146;s Product Candidates; the ability of Regeneron </I></P>
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to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron&#146;s Products (such as Dupixent) and Regeneron&#146;s Product
Candidates in patients, including serious complications or side effects in connection with the use of Regeneron&#146;s Products and Regeneron&#146;s Product Candidates in clinical trials; determinations by regulatory and administrative governmental
authorities which may delay or restrict Regeneron&#146;s ability to continue to develop or commercialize Regeneron&#146;s Products and Regeneron&#146;s Product Candidates (such as potential regulatory approval of Dupixent for the treatment in CSU in
other countries); ongoing regulatory obligations and oversight impacting Regeneron&#146;s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of
Regeneron&#146;s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage
and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron&#146;s Products and Regeneron&#146;s
Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to
clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the
assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron&#146;s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be
cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the <FONT STYLE="white-space:nowrap">COVID-19</FONT> pandemic) on Regeneron&#146;s business; and risks associated with intellectual property of other
parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (aflibercept) Injection), other
litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron&#146;s business,
prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron&#146;s filings with the U.S. Securities and Exchange Commission, including its Form <FONT
STYLE="white-space:nowrap">10-K</FONT> for the year ended December&nbsp;31, 2023. Any forward-looking statements are made based on management&#146;s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking
statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information,
future events, or otherwise. </I></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL" ALIGN="justify"><I>Regeneron uses its media and investor relations website and social media outlets to publish important information
about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron&#146;s media and investor relations website
(https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). </I></P>
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</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Sanofi&#146;s Board of Directors proposes the appointment of Clotilde Delbos,
Anne-Fran&ccedil;oise Nesmes and John Sundy as independent Directors </I></FONT></P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris, February</B><B></B><B>&nbsp;22, 2024</B>. At its meeting
on February&nbsp;22, 2024, Sanofi&#146;s Board of Directors has decided to propose, on the occasion of its next General Shareholder Meeting to be held on April&nbsp;30, 2024, the renewal of the terms of office of Rachel Duan and Lise Kingo and the
appointment of Clotilde Delbos, Anne-Fran&ccedil;oise Nesmes and John Sundy as independent Directors. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Diane Souza, Member of the Audit and
Compensation Committees, and Thomas S&uuml;dhof, Chairman of the Scientific Committee, will leave the Board of Directors at the end of their second terms. The Chairman warmly thanked them for their valued contribution to the Board of Directors and
the specialized committees to which they belonged during their terms in office. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The Chairman specified that, in order to prepare as effectively as
possible for the end, in 2025, of the term of office as director of Fabienne Lecorvaisier, Chairman of the Audit Committee, the Board of Directors will temporarily comprise 17 members as from the General Shareholder Meeting of April&nbsp;30, 2024.
</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Clotilde Delbos</B> is currently director of Axa and Alstom. She held various positions in internal audit, merger and acquisitions and treasury,
in California, Brussels and France, notably at Price Waterhouse and the Pechiney group, before becoming Division Chief Financial Officer. In 2012, she joined the Renault Group. In 2016, Clotilde Delbos was appointed Group Chief Financial Officer and
Chairman of Board of Directors of RCI Banque. She was then appointed Interim Chief Executive Officer of Renault SA, Deputy Chief Executive Officer of the group and Chief Executive Officer of Mobilize. Clotilde Delbos was awarded the <I>L&eacute;gion
d&#146;Honneur</I> in 2021. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Clotilde Delbos graduated from EM Lyon with a specialization in accounting. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Anne-Fran&ccedil;oise Nesmes</B> is currently Chief Financial Officer of Smith + Nephew PLC, a role from which she will step down at the end of the
first quarter of 2024. She joined the Board of Compass Group PLC as a <FONT STYLE="white-space:nowrap">non-executive</FONT> director in 2018 and currently serves as Senior Independent Director, Chair of the Audit Committee and a member of the
Corporate Responsibility, Nomination and Remuneration Committees. She held a number of finance positions in international companies before joining GlaxoSmithKline PLC in 1997, where she worked for 16 years, including as Senior Vice President of
Finance for global vaccines. She then became Chief Financial Officer of Dechra Pharmaceuticals PLC and Merlin Entertainments PLC (2013-2020). </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Anne-Fran&ccedil;oise Nesmes holds a Master&#146;s degree from Grenoble Business School and a Master&#146;s degree in Business Administration from Henley
Management College. She is also a Chartered Management Accountant. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>John Sundy</B> is currently Chief Medical Officer and Head of Research and
Development at Seicmic Therapeutic, a machine learning immunology company and is Adjunct Professor of Medicine in the Division of Rheumatology and Immunology at Duke University School of Medicine. He was a tenured faculy member at Duke University
before moving to the biotech industry in 2014. Between 2014 and 2021, he held several management positions including Senior Vice President at Gilead Sciences, and Chief Medical Officer at Pandion Therapeutics. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">He is also a director of Neutrolis, Inc, and the Childhood Arthritis and Rheumatology Research Alliance, and serves on the Steering Committee of the NIH
Immune Tolerance Network. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">John Sundy obtained a B.S. in biology from Bucknell University and an M.D./Ph.D from Hahnemann University with a
specialization in immunology, and completed clinical training in rheumatology and allergy/immunology at Duke. </P>
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<P STYLE="margin-top:24pt; margin-bottom:0pt; margin-left:7%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Fr&eacute;d&eacute;ric Oud&eacute;a </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:7%; font-size:10pt; font-family:ARIAL" ALIGN="justify">Chairman of the Board of Directors </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:7%; margin-right:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;The arrivals of Clotilde Delbos, Anne-Fran&ccedil;oise Nesmes and John Sundy will strengthen the
Board of Directors&#146; expertise in finance and science, notably in the field of immunology. I would like to pay tribute to the remarkable contribution of Diane Souza and Thomas S&uuml;dhof to the work of the Board, and I am delighted that the
Board continues to diversify its profiles and competencies, in line with the Group&#146;s strategic developments.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The composition of the
Board&#146;s specialized committees will be reviewed following the Annual General Meeting of Shareholders scheduled for April&nbsp;30, 2024. </P> <P STYLE="font-size:24pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px 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:10pt; font-family:ARIAL" ALIGN="justify">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:12pt; 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 | <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>Nicolas Obrist</B><B></B>&nbsp;|&nbsp;+ 33 6 77 21 27 55
|<U></U>&nbsp;<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>nicolas.obrist@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 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:1px solid #cccccc">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.4 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> sBLA accepted for
FDA Priority Review for treatment of COPD with type 2 inflammation </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 STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="justify"><I>Priority Review granted based on positive results from two Phase 3 trials</I> </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="justify"><I>If approved, Dupixent would be the only biologic therapy for COPD and the first new treatment approach for the
disease in more than a decade</I> </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="justify"><I>Regulatory submissions are also under review in China and Europe</I> </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>Paris and Tarrytown, N.Y. February</B><B></B><B>&nbsp;23, 2024. </B>The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental
Biologics License Application (sBLA) for Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab) in a sixth potential indication as an <FONT STYLE="white-space:nowrap">add-on</FONT> maintenance treatment in certain adult
patients with uncontrolled chronic obstructive pulmonary disease (COPD). The target action date for the FDA decision is June&nbsp;27, 2024. Regulatory submissions are also under review in China and the European Union. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The sBLA, as well as other submissions around the world, is supported by data from the Phase 3 COPD clinical research program evaluating the efficacy
and safety of Dupixent in adults who were current or former smokers with uncontrolled COPD with evidence of type 2 inflammation (screening blood eosinophils <U>&gt;</U>300 cells/microliter). All patients were on background maximal <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> inhaled therapy (nearly all on triple therapy). The primary endpoint was met in both trials
(<FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#0563c1"><U>BOREAS</U></FONT><FONT STYLE="font-family:ARIAL">, </FONT><FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#0563c1"><U>NOTUS</U></FONT><FONT STYLE="font-family:ARIAL">),
showing Dupixent significantly reduced annualized moderate or severe acute COPD exacerbations by 30% and 34% respectively, compared to placebo. In both trials, Dupixent also rapidly and significantly improved lung function compared to placebo, with
improvements sustained at 52 weeks. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Safety results in both trials were generally consistent with the known safety profile of Dupixent in its
approved indications. Adverse events more commonly observed with Dupixent (<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>5%) compared to placebo in either trial were back pain, <FONT STYLE="white-space:nowrap">COVID-19,</FONT> diarrhea,
headache and nasopharyngitis. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to
provide significant improvements in the treatment, diagnosis or prevention of serious conditions. The potential use of Dupixent in COPD is currently under clinical development, and its safety and efficacy for this indication have not been fully
evaluated by any regulatory authority.</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>About COPD </B> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">COPD
is a respiratory disease that damages the lungs and causes progressive lung function decline. Symptoms include persistent cough, breathlessness and excessive mucus production that may not only impair the ability to perform routine daily activities,
but can also lead to anxiety, depression and sleep disturbances. COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to
hospitalization. Smoking and exposure to noxious particles are key risk factors for COPD, but even individuals who quit smoking can still develop or continue having the disease. There have been no new treatment approaches approved for more than a
decade. In the U.S., approximately 300,000 people live with uncontrolled COPD with evidence of type 2 inflammation. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>About Sanofi and Regeneron&#146;s COPD Clinical Research Program </B> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Sanofi&nbsp;and Regeneron are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease progression
through the investigation of two potentially <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> biologics, Dupixent and itepekimab. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Dupixent inhibits the signaling of the <FONT STYLE="white-space:nowrap">interleukin-4</FONT> <FONT STYLE="white-space:nowrap">(IL-4)</FONT> and <FONT
STYLE="white-space:nowrap">interleukin-13</FONT> <FONT STYLE="white-space:nowrap">(IL-13)</FONT> pathways and the program focuses on a specific population of people with evidence of type 2 inflammation. Itepekimab is a fully human monoclonal
antibody that binds to and inhibits <FONT STYLE="white-space:nowrap">interleukin-33</FONT> <FONT STYLE="white-space:nowrap">(IL-33),</FONT> an initiator and amplifier of broad inflammation in COPD. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Itepekimab is currently under clinical investigation, with two Phase 3 trials currently enrolling, and its safety and efficacy have not been evaluated by any regulatory
authority. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>About Dupixent</B> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B></B>Dupixent is a fully human monoclonal
antibody that inhibits the signaling of the <FONT STYLE="white-space:nowrap">interleukin-4</FONT> <FONT STYLE="white-space:nowrap">(IL-4)</FONT> and <FONT STYLE="white-space:nowrap">interleukin-13</FONT>
<FONT STYLE="white-space:nowrap">(IL-13)</FONT> pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that <FONT
STYLE="white-space:nowrap">IL-4</FONT> and <FONT STYLE="white-space:nowrap">IL-13</FONT> are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often <FONT STYLE="white-space:nowrap">co-morbid</FONT>
diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis and chronic spontaneous urticaria (CSU).
</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE,
prurigo nodularis and CSU in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 800,000 patients are being treated with
Dupixent globally. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>Dupilumab Development Program </B> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Dupilumab is being
jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2
inflammation. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2
inflammation or other allergic processes in Phase 3 trials, including chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation and bullous pemphigoid. These
potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>About Regeneron </B> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Regeneron (NASDAQ: REGN) is a leading biotechnology company
that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has
led to numerous <FONT STYLE="white-space:nowrap">FDA-approved</FONT> treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye
diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases. </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:ARIAL">Regeneron is accelerating and improving the traditional drug development process through our proprietary
<I>VelociSuite</I><I><SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP></I> technologies, such as <I>VelocImmune</I><I><SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP></I>, which uses unique genetically humanized mice to produce
optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">For more information about Regeneron, please visit&nbsp;<FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#0563c1"><U>www.Regeneron.com</U></FONT><FONT
STYLE="font-family:ARIAL">&nbsp;or follow Regeneron on&nbsp;</FONT><FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#0563c1"><U>LinkedIn</U></FONT><FONT STYLE="font-family:ARIAL">.</FONT></P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Sanofi </I></FONT></P> <P STYLE="margin-top:2pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">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:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">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>Sanofi Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Timothy Gilbert</B><B></B>&nbsp;|&nbsp;+ 1 516 521 2929 | <FONT
STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>timothy.gilbert@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> | + 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:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Evan
Berland</B><B></B>&nbsp;|&nbsp;+ 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>Sally Bain</B><B></B>&nbsp;|&nbsp;+ 1 617 834 6026 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>sally.bain@sanofi.com</U></FONT><FONT
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.5 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom"><FONT STYLE="font-family:ARIAL; font-size:14pt"><B>Press Release</B></FONT></TD>
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</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and
significantly improved disease activity in adults with chronic spontaneous urticaria</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">Late-breaking data at 2024 AAAAI showed rilzabrutinib, an oral BTK inhibitor, significantly reduced weekly itch severity
score (ISS7) as early as the first week of treatment in adults with moderate to severe CSU </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">Data form the basis for the Phase 3 CSU and prurigo nodularis programs to start in 2024 </P></TD></TR></TABLE>
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<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</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">Pivotal Phase 3 readout in immune thrombocytopenia and Phase 2 readouts in asthma, IgG4-related disease and warm
autoimmune hemolytic anemia expected in 2024 </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">Rilzabrutinib is one of 12 potential blockbusters in Sanofi&#146;s leading immunology pipeline </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris, February</B><B></B><B>&nbsp;24, 2024</B>. Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved
itch, hives and urticaria in adults with <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines. These
results were presented today in a late-breaking poster at the 2024 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in Washington, DC and form the basis for the Phase 3 program which is on track to start in 2024. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Professor Marcus Maurer, M.D. </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL" ALIGN="justify">Professor of Dermatology and Allergy, Executive Director of the Institute of Allergology at the Charit&eacute; Berlin </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><I>&#147;People with CSU are living with debilitating symptoms such as intensely itchy recurrent hives, swelling, or both which can have a high impact on
their <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">day-to-day</FONT></FONT> lives. These data are promising news for patients that cannot be controlled with
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> antihistamines &#150; the possibility of controlling itch rapidly with an oral medicine would offer an important advancement in the treatment of this
disease.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Naimish Patel, M.D. </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL">Head of Global Development, Immunology and Inflammation, Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><I>&#147;These data reinforce the potential of rilzabrutinib as a treatment option for patients with <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> CSU and we believe that the rapid improvement of itch could make a meaningful difference in alleviating the physical and psychosocial burden these patients suffer from. Based on these data,
later this year we will advance rilzabrutinib into Phase 3 development in both CSU and prurigo nodularis, another skin disorder characterized by relentless itching. We also look forward to data readouts for rilzabrutinib in 2024 with the opportunity
to further demonstrate its potential impact across multiple immune-mediated diseases.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Key
Results</I></B></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In this dose-ranging study, different doses of rilzabrutinib were evaluated: 400 mg once every evening (QPM), 400 mg twice a
day (BID), 400 mg three times a day (TID). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In the <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">intent-to-treat</FONT></FONT>
(ITT) population which included either patients who were previously na&iuml;ve or incomplete responders to omalizumab, Rilzabrutinib 400 mg TID demonstrated: </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">Significant reduction from baseline in weekly itch severity score (ISS7) at Week 12, a key symptom of the disease,
[least squares mean (LSM) <FONT STYLE="white-space:nowrap">-9.58</FONT> vs <FONT STYLE="white-space:nowrap">-6.31,</FONT> respectively; p=0.0181]. Significant changes in ISS7 were seen as early as Week 1. </P></TD></TR></TABLE>
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<TD WIDTH="4%">&nbsp;</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">Significant reduction from baseline to week 12 in weekly urticaria activity score (UAS7) [LSM <FONT
STYLE="white-space:nowrap">-17.95</FONT> vs <FONT STYLE="white-space:nowrap">-11.20,</FONT> respectively; p=0.0116]. </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">Significant reduction from baseline to week 12 in weekly hives severity score (HSS7) [LSM
<FONT STYLE="white-space:nowrap">-8.31</FONT> vs <FONT STYLE="white-space:nowrap">-4.89;</FONT> p&lt;0.0100]. </P></TD></TR></TABLE>
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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:ARIAL" ALIGN="center"><FONT COLOR="#4a569e">Internal </FONT></P>
<P STYLE="margin-top:36pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Rilzabrutinib was generally well-tolerated with no events of cytopenia, bleeding or atrial fibrillation seen with other BTK inhibitor.
Treatment-emergent AEs occurring at a higher frequency with rilzabrutinib vs placebo were diarrhea (29.3% TID and BID, 7.9% QPM, 15% placebo), nausea (19.5% TID, 17.1% BID, 13.2% QPM, 5.0% placebo), headache (9.8% TID, 14.6% BID, 5.3% QPM, 0.0%
placebo) and abdominal pain (0.0% TID, 12.2% BID, 2.6% QPM, 5.0% placebo). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Rilzabrutinib is currently under clinical investigation, and its safety
and efficacy have not been evaluated by any regulatory authority. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About CSU </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">CSU is an inflammatory skin condition driven mainly by the activation of cutaneous mast cells, which causes itchy recurrent hives, swelling, or both. CSU
is typically treated with H1 antihistamines and biologics; however, the disease remains uncontrolled in up to 50% of patients, who are left with limited alternative treatment options. These individuals continue to experience debilitating symptoms
that can significantly impact quality of life. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About the RILECSU study </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">RILECSU is a <FONT STYLE="white-space:nowrap">52-week</FONT> Phase 2 study, comprising a <FONT STYLE="white-space:nowrap">12-week</FONT> randomized,
double-blind, placebo-controlled, dose-ranging, efficacy and safety period, followed by a <FONT STYLE="white-space:nowrap">40-week</FONT> open-label extension period. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">RILECSU is evaluating rilzabrutinib in adult patients with
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> CSU who remain symptomatic despite use of H1 antihistamine treatment and are either na&iuml;ve to or incomplete responders to omalizumab. The primary
endpoint was change from baseline in weekly itch severity score ISS7 at 12 weeks. Secondary endpoints include change from baseline in weekly UAS7 at 12 weeks and change from baseline weekly HSS7 at 12 weeks. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Participants in the trial (n=160) were randomized 1:1:1:1 to rilzabrutinib 400mg once every evening (QPM), 400mg twice a day (BID), 400mg three times a
day (TID), or matching placebo. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Rilzabrutinib </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Rilzabrutinib is an oral, reversible, covalent BTK inhibitor that has the potential to be a first- or <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">best-in-class</FONT></FONT> treatment of a number of immune-mediated diseases. BTK, expressed in B cells and mast cells, plays a critical role in multiple immune-mediated disease processes. With the application of
Sanofi&#146;s TAILORED COVALENCY<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> technology, rilzabrutinib can selectively inhibit the BTK target while potentially reducing the risk of <FONT STYLE="white-space:nowrap">off-target</FONT>
side effects. </P> <P STYLE="font-size:24pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #d8d8d8">&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:12pt; 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>Sally Bain</B><B></B>&nbsp;|&nbsp;+ 1 617 834 6026 |&nbsp;<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>sally.bain@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
|&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:12pt; 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">&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:ARIAL" ALIGN="center"><FONT COLOR="#4a569e">Internal </FONT></P>
<P STYLE="margin-top:36pt; 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:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #d8d8d8">&nbsp;</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sanofi Forward-Looking Statements </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; 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 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 &#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, 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&#146;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 &#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, 2023. 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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