<SEC-DOCUMENT>0001193125-24-224663.txt : 20240924
<SEC-HEADER>0001193125-24-224663.hdr.sgml : 20240924
<ACCEPTANCE-DATETIME>20240924145156
ACCESSION NUMBER:		0001193125-24-224663
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		8
CONFORMED PERIOD OF REPORT:	20240924
FILED AS OF DATE:		20240924
DATE AS OF CHANGE:		20240924

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:		241319485

	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>d873867d6k.htm
<DESCRIPTION>6-K
<TEXT>
<HTML><HEAD>
<TITLE>6-K</TITLE>
</HEAD>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:14pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:2pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT STYLE="white-space:nowrap">6-K</FONT> </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF FOREIGN PRIVATE ISSUER </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE <FONT STYLE="white-space:nowrap">13a-16</FONT> OR <FONT STYLE="white-space:nowrap">15d-16</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P> <P STYLE="font-size:14pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:2pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">For the month of September 2024 </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Commission File Number: <FONT STYLE="white-space:nowrap">001-31368</FONT> </P>
<P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>SANOFI </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">(Translation of
registrant&#146;s name into English) </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">46, avenue de la Grande Arm&eacute;e, 75017 Paris, FRANCE </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">(Address of principal executive offices) </P> <P STYLE="font-size:24pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="justify">Indicate by check mark whether the registrant files or will file annual reports under cover Form <FONT STYLE="white-space:nowrap">20-F</FONT> or
Form <FONT STYLE="white-space:nowrap">40-F.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Form <FONT STYLE="white-space:nowrap">20-F</FONT> &#9746;&#8195;&#8195;&#8195;Form <FONT
STYLE="white-space:nowrap">40-F</FONT> &#9744; </P>
</DIV></Center>


<p style="margin-top:1em; margin-bottom:0em; page-break-before:always"> </p>
<HR SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="justify">In September 2024, Sanofi published the press releases attached hereto as Exhibits 99.1, 99.2
and 99.3 which are incorporated herein by reference. </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P>
<P STYLE="font-size:24pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:9pt" ALIGN="center">


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<TD></TD>

<TD VALIGN="bottom" WIDTH="3%"></TD>
<TD WIDTH="89%"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:9pt">
<TD VALIGN="bottom"><U>Exhibit&nbsp;No.</U></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center"><U>Description</U>&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;</TD></TR>


<TR STYLE="font-size:1pt">
<TD HEIGHT="24"></TD>
<TD HEIGHT="24" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:9pt">
<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d873867dex991.htm">Press Release dated September&nbsp;
20, 2024: Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in <FONT STYLE="white-space:nowrap">non-relapsing</FONT> secondary progressive multiple sclerosis phase 3 study </A></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="24"></TD>
<TD HEIGHT="24" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:9pt">
<TD VALIGN="top" NOWRAP>Exhibit 99.2</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d873867dex992.htm">Press Release dated September&nbsp;20, 2024: Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old </A></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="24"></TD>
<TD HEIGHT="24" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:9pt">
<TD VALIGN="top" NOWRAP>Exhibit 99.3</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d873867dex993.htm">Press Release dated September&nbsp;
21, 2024: Sarclisa approved in the US as the first anti-CD38 therapy in combination with <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> treatment for adult patients with newly diagnosed multiple myeloma
 not eligible for transplant </A></TD></TR>
</TABLE>
</DIV></Center>


<p style="margin-top:1em; margin-bottom:0em; page-break-before:always"> </p>
<HR SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:6%; font-size:9pt; font-family:Times New Roman" ALIGN="justify">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized. </P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:9pt" ALIGN="center">


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<TD WIDTH="4%"></TD>

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<TD WIDTH="35%"></TD>

<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="3%"></TD></TR>


<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:9pt">
<TD VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:9pt">Dated: September&nbsp;24, 2024</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center">SANOFI</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="13"></TD>
<TD HEIGHT="13" COLSPAN="2"></TD>
<TD HEIGHT="13" COLSPAN="2"></TD>
<TD HEIGHT="13" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:9pt">
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:9pt">By&#8195;</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:9pt; font-family:Times New Roman" ALIGN="justify">/s/ Alexandra Roger</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:9pt">&#8195;&#8195;</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:9pt">
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:9pt">Name: Alexandra Roger</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:9pt">
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Title: Head of Legal Corporate&nbsp;&amp; Finance</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD></TR>
</TABLE>
</DIV></Center>

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</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>d873867dex991.htm
<DESCRIPTION>EX-99.1
<TEXT>
<HTML><HEAD>
<TITLE>EX-99.1</TITLE>
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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>
<P STYLE="margin-top:0pt;margin-bottom:0pt" ALIGN="right">


<IMG SRC="g873867g0924154045812.jpg" ALT="LOGO" STYLE="width:1.56458in;height:0.434722in;">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:14pt; font-family:ARIAL"><B>Press Release </B></P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><I>Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in <FONT STYLE="white-space:nowrap">non-relapsing</FONT> secondary progressive multiple sclerosis phase 3 study</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%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&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="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">Data presented at ECTRIMS show that tolebrutinib, a brain-penetrant BTK inhibitor, addresses disability accumulation that
occurs independently from relapse activity </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&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="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">Global regulatory submissions will begin in H2 2024 </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>Paris, September</B><B></B><B>&nbsp;20, 2024.</B> Positive results from the HERCULES phase 3 study in people with
<FONT STYLE="white-space:nowrap">non-relapsing</FONT> secondary progressive multiple sclerosis (nrSPMS) demonstrated that tolebrutinib delayed the time to onset of <FONT STYLE="white-space:nowrap">6-month</FONT> confirmed disability progression
(CDP) by 31% compared to placebo (HR 0.69; 95% CI <FONT STYLE="white-space:nowrap">0.55-0.88;</FONT> p=0.0026). Further analysis of secondary endpoints demonstrated that the number of participants who experienced confirmed disability improvement
increased by nearly <FONT STYLE="white-space:nowrap">two-fold,</FONT> 10% with tolebrutinib compared to 5% with placebo (HR 1.88; 95% CI 1.10 to 3.21; nominal p=0.021). These results were presented today as a late-breaking presentation at the
European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 conference in Copenhagen, Denmark. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><B><I>Robert Fox, MD </I></B></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:2%; font-size:10pt; font-family:ARIAL">Vice Chair of Research at Cleveland Clinic&#146;s Neurological Institute,
Cleveland, Ohio and Chair of the HERCULES Global Steering Committee </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:2%; font-size:10pt; font-family:Times New Roman"><I>&#147;Secondary progressive multiple sclerosis is
characterized by insidious worsening of disability over time, independent of relapses,&nbsp;and represents a critical unmet need because&nbsp;we don&#146;t have effective treatments.&nbsp;The results of HERCULES&nbsp;show clearly&nbsp;that
tolebrutinib&nbsp;delayed disability progression in people with nrSPMS&nbsp;&#150;&nbsp;and some&nbsp;people&nbsp;even improved disability&nbsp;&#150;&nbsp;by uniquely targeting the biological processes driving&nbsp;disease progression in the
brain.&#148; Dr.&nbsp;Fox is a paid advisor to Sanofi for the HERCULES trial.</I> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Based on preliminary analysis of the HERCULES study, there was a slight increase
in tolebrutinib-treated patients of some adverse events. Liver enzyme elevations (&gt;3xULN) were observed in 4.1% of participants receiving tolebrutinib compared with 1.6% in the placebo group, a side effect also reported with other BTK inhibitors
in MS. A small (0.5%) proportion of participants in the tolebrutinib group experienced peak ALT increases of &gt;20xULN, all occurring within the first 90 days of treatment. All but one case of liver enzyme elevations resolved without further
medical intervention. Prior to the implementation of the revised study protocol with more stringent monitoring, one participant in the tolebrutinib arm received a liver transplant and died due to post-operative complications. To date, the
implementation of more frequent monitoring has mitigated such serious liver sequelae. Other deaths in the trial were assessed as unrelated to treatment by investigator; deaths were even across the placebo and tolebrutinib arms at 0.3%. </P>
<P STYLE="font-size:8pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:9.5pt" ALIGN="center">


<TR>

<TD WIDTH="35%"></TD>

<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="32%"></TD>

<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="31%"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:ARIAL; font-size:9.5pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1.00pt solid #999999; BORDER-TOP:1.00pt solid #999999; BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666; padding-left:8pt">
<P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9.5pt; font-family:ARIAL">Adverse events (<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>10%*)</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1.00pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" STYLE="BORDER-TOP:1.00pt solid #999999; BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">tolebrutinib</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">N=752 (%)</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1.00pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" STYLE="BORDER-TOP:1.00pt solid #999999; BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666; padding-right:2pt"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">placebo</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">N=375&nbsp;(%)</P></TD></TR>


<TR STYLE="page-break-inside:avoid ; font-family:ARIAL; font-size:9.5pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1.00pt solid #999999; BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-left:8pt">
<P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:9.5pt; font-family:ARIAL"><FONT STYLE="white-space:nowrap">COVID-19</FONT> infections</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999">192&nbsp;(25.5%)</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-right:2pt">85 (22.7%)</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:ARIAL; font-size:9.5pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1.00pt solid #999999; BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-left:8pt">
<P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:9.5pt; font-family:ARIAL">Urinary tract infections</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999">85 (11.3%)</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-right:2pt">49 (13.1%)</TD></TR>
</TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL">*For participants receiving tolebrutinib </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Houman Ashrafian, MD, PhD </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL">Head of Research&nbsp;&amp; Development, Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:2%; font-size:10pt; font-family:Times New Roman"><I>&#147;With no treatment options currently available for the broad population of patients with secondary progressive
multiple sclerosis,&nbsp;tolebrutinib has demonstrated its ability to delay disability by targeting underlying drivers of the disease. We look forward to discussing these results with healthcare</I> <I>authorities and&nbsp;are eager to see the
results of tolebrutinib in primary progressive MS when they become available next year.&nbsp;We extend our deepest appreciation to the study participants, their families, and the healthcare professionals involved in these trials</I>.&#148; </P>
<P STYLE="font-size:18pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</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">The GEMINI 1 and 2 phase 3 study results of tolebrutinib compared to Aubagio (teriflunomide), a <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> treatment, in participants with relapsing multiple sclerosis (RMS) were also presented today as a late-breaking presentation at ECTRIMS. Both studies did not
meet their primary endpoints of statistically significant improvement in annualized relapse rates (ARR) compared to Aubagio. However, in the key secondary endpoint, a pooled analysis of data from GEMINI 1 and 2, tolebrutinib delayed the time to
onset of <FONT STYLE="white-space:nowrap">6-month</FONT> confirmed disability worsening (CDW) by 29% (HR 0.71; 95% CI: <FONT STYLE="white-space:nowrap">0.53-0.95;</FONT> nominal p=0.023). The results of the 29% delay in CDW endpoint in participants
with RMS are in line with the 31% delay in CDP observed in participants with nrSPMS. The significant impact of tolebrutinib on disability accumulation versus Aubagio, in the absence of a statistically superior impact on relapses, suggests that
tolebrutinib may address smoldering neuroinflammation, which manifests as progression independent of relapses. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Furthermore, results showed historically low ARR in
the Aubagio arm in both GEMINI 1 and 2, and no difference was observed between Aubagio and tolebrutinib in a pooled analysis. These relapse rates amount to approximately 1 relapse every 8 years. </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" STYLE=" BORDER-TOP:1.00pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center" STYLE="BORDER-TOP:1.00pt solid #999999; BORDER-RIGHT:1.50pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666">tolebrutinib&nbsp;ARR</TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1.00pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center" STYLE="BORDER-TOP:1.00pt solid #999999; BORDER-RIGHT:1.50pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666; padding-right:2pt">Aubagio&nbsp;ARR</TD></TR>


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<TD VALIGN="top" STYLE="BORDER-LEFT:1.50pt solid #999999; BORDER-RIGHT:1.50pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-left:8pt"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:9.5pt; font-family:ARIAL">GEMINI 1</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; margin-left:1.00em; text-indent:-1.00em; font-size:7.5pt; font-family:ARIAL">(adjusted rate ratio 1.06; 95% CI: 0.80 to 1.39; p=0.67)</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP STYLE="BORDER-RIGHT:1.50pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">0.13</P></TD>
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<TD VALIGN="top" NOWRAP STYLE="BORDER-RIGHT:1.50pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-right:2pt"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">0.12</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:ARIAL; font-size:7.5pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1.50pt solid #999999; BORDER-RIGHT:1.50pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-left:8pt"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:9.5pt; font-family:ARIAL">GEMINI 2</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; margin-left:1.00em; text-indent:-1.00em; font-size:7.5pt; font-family:ARIAL">(adjusted rate ratio 1.00; 95% CI: 0.75 to 1.32; p=0.98)</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP STYLE="BORDER-RIGHT:1.50pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">0.11</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP STYLE="BORDER-RIGHT:1.50pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-right:2pt"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">0.11</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:ARIAL; font-size:7.5pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1.50pt solid #999999; BORDER-RIGHT:1.50pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-left:8pt"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:9.5pt; font-family:ARIAL">Pooled analysis</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; margin-left:1.00em; text-indent:-1.00em; font-size:7.5pt; font-family:ARIAL">(adjusted rate ratio 1.03; 95% CI: 0.84 to 1.25; p=0.80)</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP STYLE="BORDER-RIGHT:1.50pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">0.12</P></TD>
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<TD VALIGN="top" NOWRAP STYLE="BORDER-RIGHT:1.50pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-right:2pt"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">0.12</P></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">In preliminary analysis of the GEMINI 1 and 2 pooled safety data, adverse events observed between the tolebrutinib and Aubagio arms were
generally balanced. Liver enzyme elevations (&gt;3x ULN) were observed in 5.6% of participants receiving tolebrutinib compared with 6.3% of participants receiving Aubagio, a side effect reported with other BTK inhibitors in MS and resolved without
further medical intervention. A small (0.5%) proportion of participants in the tolebrutinib group experienced peak ALT increases of &gt;20xULN, all occurring within the first 90 days of treatment. Deaths were balanced across the Aubagio and
tolebrutinib arms, at 0.2% and 0.1% respectively, and were assessed as unrelated to treatment by investigator. </P> <P STYLE="font-size:8pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" STYLE="BORDER-LEFT:1.00pt solid #999999; BORDER-TOP:1.00pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666; padding-left:8pt"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9.5pt; font-family:ARIAL">Adverse events (<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>10%*)</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1.00pt solid #999999; BORDER-TOP:1.00pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" STYLE="BORDER-TOP:1.00pt solid #999999; BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">Tolebrutinib</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">N=933 (%)</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1.00pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" STYLE="BORDER-TOP:1.00pt solid #999999; BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:2.00pt solid #666666; padding-right:2pt"> <P STYLE="font-size:2pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">Aubagio</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9.5pt; font-family:ARIAL" ALIGN="center">N=939&nbsp;(%)</P></TD></TR>


<TR STYLE="page-break-inside:avoid ; font-family:ARIAL; font-size:9.5pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-left:8pt"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:9.5pt; font-family:ARIAL"><FONT
STYLE="white-space:nowrap">COVID-19</FONT> infections</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999">225&nbsp;(24.1%)</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-right:2pt">252&nbsp;(26.8%)</TD></TR>
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<TD VALIGN="top" STYLE="BORDER-LEFT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-left:8pt">
<P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:9.5pt; font-family:ARIAL">Nasopharyngitis</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999">119 (12.8%)</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-right:2pt">105 (11.2%)</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:ARIAL; font-size:9.5pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-left:8pt">
<P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:9.5pt; font-family:ARIAL">Headache</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999">117 (12.5%)</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.50pt solid #999999">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1.00pt solid #999999; BORDER-BOTTOM:1.50pt solid #999999; padding-right:2pt">98 (10.4%)</TD></TR>
</TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL">* For participants receiving tolebrutinib </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Study
results will form the basis for future discussions with global regulatory authorities with submissions starting in H2 2024. Tolebrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory
authority.</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">The PERSEUS phase 3 study in primary progressive MS is currently ongoing with study results anticipated in H2 2025. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Multiple Sclerosis </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Multiple
sclerosis is a chronic, immune-mediated, neurodegenerative disease that results in accumulation of irreversible disabilities over time. The physical and cognitive disability impairments translate into gradual deterioration of health status and lower
quality of life, impacting patients&#146; care and life expectancy. Disability accumulation remains the significant unmet medical need in MS. To date, the primary target of current therapies has been peripheral B and T cells, while innate immunity,
which is believed to drive disability accumulation, remains largely unaddressed by current therapies. Currently approved, or medicines being tested for MS mainly target the adaptive immune system and/or do not act directly within the central nervous
system (CNS) to drive clinical benefit. </P> <P STYLE="font-size:18pt; margin-top:0pt; margin-bottom:0pt">&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">RMS refers to people with MS who experience episodes of new or worsening symptoms (known as relapses) followed by
periods of partial or complete recovery. nrSPMS refers to people with MS who have stopped experiencing confirmed relapses but continue to experience accumulation of disability, experienced as symptoms such as fatigue, cognition impairment, balance
and gait impairment, loss of bowel and/or bladder function, sexual disfunction, amongst others. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About HERCULES </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">HERCULES (NCT04411641) was a double-blind randomized phase 3 clinical study evaluating the efficacy and safety of tolebrutinib in participants with nrSPMS. nrSPMS was
defined at baseline as having a SPMS diagnosis with an expanded disability status scale (EDSS) between 3.0 and 6.5, no clinical relapses for the previous 24 months and documented evidence of disability accumulation in the previous 12 months.
Participants were randomized (2:1) to receive either an oral daily dose of tolebrutinib or matching placebo for up to approximately 48 months. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">The primary endpoint
was <FONT STYLE="white-space:nowrap">6-month</FONT> CDP defined as the increase of <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>1.0 point from the baseline EDSS score when the baseline score is
<FONT STYLE="font-family:Times New Roman">&#8804;</FONT>5.0, or the increase of <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>0.5 point when the baseline EDSS score was &gt;5.0. Secondary endpoints included
<FONT STYLE="white-space:nowrap">3-month</FONT> change in 9 hole peg test and <FONT STYLE="white-space:nowrap">T25-FW</FONT> test, time to onset of <FONT STYLE="white-space:nowrap">3-month</FONT> CDP as assessed by EDSS score, total number of new or
enlarging T2 hyperintense lesions as detected by MRI, change in cognitive function at the EOS compared to baseline as assessed by the Symbol Digit Modalities Test and by the California Verbal Learning Test as well as the safety and tolerability of
tolebrutinib. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About GEMINI <SUB STYLE="font-size:75%; vertical-align:bottom">1</SUB> and <SUB
STYLE="font-size:75%; vertical-align:bottom">2</SUB> </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">GEMINI 1 (clinical study identifier: NCT04410978) and GEMINI 2 (clinical study identifier:
NCT04410991) were double-blind randomized phase 3 clinical studies evaluating the efficacy and safety of tolebrutinib compared to Aubagio in participants with relapsing forms of MS. Participants were randomized in both studies (1:1) to receive
either tolebrutinib and placebo daily or 14mg Aubagio and placebo. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">The primary endpoint for both studies was the annualized relapse rate for up to approximately 36
months defined as the number of confirmed adjudicated protocol defined relapses. Secondary endpoints included time to onset of CDW, confirmed over at least 6 months, defined as an increase of
<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>1.5 points from the baseline EDSS score when the baseline score is 0, an increase of <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>1.0 point from the baseline EDSS score when the
baseline score is 0.5 to <FONT STYLE="font-family:Times New Roman">&#8804;</FONT>5.5 or an increase of <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>0.5 point from the baseline EDSS score when the baseline score was &gt;5.5 in addition to
the total number of new and/or enlarging T2 hyperintense lesions as detected by MRI from baseline through the end of study, the total number of Gd-enhancing T1 hyperintense lesions as detected by MRI from baseline through the end of study and the
safety and tolerability of tolebrutinib. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About tolebrutinib </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Tolebrutinib is an investigational, oral, brain-penetrant, and bioactive Bruton&#146;s tyrosine kinase (BTK) inhibitor that achieves CSF concentrations predicted to
modulate B lymphocytes and disease-associated microglia. Tolebrutinib is being evaluated in phase 3 clinical studies for the treatment of various forms of multiple sclerosis and its safety and efficacy have not been evaluated by any regulatory
authority worldwide. For more information on tolebrutinib clinical studies, please visit <FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U>www.clinicaltrials.gov</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 #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">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 the world, 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">&nbsp;</P>
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 <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 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Evan Berland</B> | +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>Nicolas
Obrist</B><B></B>&nbsp;|&nbsp;+ 33 6 77 21 27 55 | <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: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: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>Thomas Kudsk Larsen</B> |+ 44 7545 513 693 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>thomas.larsen@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>Aliz&eacute;
Kaisserian</B><B></B>&nbsp;|&nbsp;+ 33 6 47 04 12 11 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>alize.kaisserian@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>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>Keita Browne</B><B></B>&nbsp;|&nbsp;+ 1 781 249 1766 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>keita.browne@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; 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>Thibaud Ch&acirc;telet</B> | + 33 6 80 80 89 90 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>thibaud.chatelet@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="font-size:20pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:8.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.50pt solid #cccccc">&nbsp;</P>
<P STYLE="margin-top:2pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL"><B>Sanofi forward-looking statements </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL">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,&nbsp;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, 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:12pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL">All trademarks mentioned
in this press release are the property of the Sanofi group, </P> <P STYLE="font-size:18pt; 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 recommended for EU approval by the CHMP to treat eosinophilic esophagitis in
children as young as 1 year old</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">Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved
histological remission, compared to placebo, consistent with improvements seen in adults and adolescents </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">If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group
</P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris and Tarrytown, NY, September</B><B></B><B>&nbsp;20, 2024. </B>The European Medicines Agency&#146;s Committee for
Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the expanded approval of Dupixent (dupilumab) in the European Union (EU) for eosinophilic esophagitis (EoE) in children down to 1 year of age. The recommendation is for
children aged 1 to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy. The European Commission is expected to announce a final decision in the coming
months. Dupixent is already <FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#0563c1"><U>approved</U></FONT><FONT STYLE="font-family:ARIAL"> in the EU for certain adults and adolescents aged 12 years and older with EoE. </FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The positive CHMP opinion is supported by a <FONT STYLE="white-space:nowrap">two-part</FONT> (Part A and B) EoE KIDS phase 3 study in children aged one
to 11 years. In Part A, a significantly greater proportion of children receiving weight-based doses of Dupixent achieved histological disease remission at week 16, compared to placebo, with results sustained for up to one year in Part B. At week 16,
caregivers of children treated with Dupixent also observed improvements in the frequency and severity of EoE signs, and fewer days with at least one sign of EoE, compared to placebo. These data established a bridge showing the response to Dupixent
in children with EoE is similar to that of the approved adult and adolescent EoE populations. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The safety results in the EoE KIDS study were
generally consistent with the known safety profile of Dupixent in adolescents and adults with EoE. AEs more commonly observed with Dupixent (<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>10%) in either weight-based dosing regimen compared
to placebo during Part A were <FONT STYLE="white-space:nowrap">COVID-19,</FONT> nausea, injection site pain and headache. The long-term safety profile of Dupixent evaluated in Part B was similar to that observed during Part A. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Results from the study were recently <FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#0563c1"><U>published</U></FONT><FONT
STYLE="font-family:ARIAL"> in <I>The New England Journal of Medicine</I>. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The use of Dupixent in children aged one to 11 years with EoE is
investigational in the EU and is not yet approved. </P> <P STYLE="font-size:18pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>About EoE </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">EoE is a chronic, progressive disease associated with <FONT STYLE="white-space:nowrap">type-2</FONT> inflammation that is thought to be responsible for
damaging the esophagus and impairing its function. Diagnosis is difficult, as symptoms can be mistaken for other conditions and there are delays in diagnosis. EoE can severely impact a child&#146;s ability to eat and may also cause vomiting,
abdominal pain, difficulty swallowing, decreased appetite and challenges thriving. Continuous management of EoE may be needed to reduce the risk of complications and disease progression. </P>
<P STYLE="margin-top:18pt; 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" ALIGN="justify">Dupixent (dupilumab) is a fully human
monoclonal antibody that inhibits the signaling of the <FONT STYLE="white-space:nowrap">interleukin-4</FONT> (IL4) and <FONT STYLE="white-space:nowrap">interleukin-13</FONT> (IL13) pathways and is not an immunosuppressant. The Dupixent development
program has shown significant clinical benefit and a decrease in <FONT STYLE="white-space:nowrap">type-2</FONT> inflammation in phase 3 studies, establishing that IL4 and IL13 are key and central drivers of the
<FONT STYLE="white-space:nowrap">type-2</FONT> inflammation that plays a major role in multiple related and often <FONT STYLE="white-space:nowrap">co-morbid</FONT> diseases. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis,
asthma, chronic rhinosinusitis with nasal polyps, EoE, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different age populations. More than 1,000,000 patients are being treated with Dupixent globally.
</P> <P STYLE="margin-top:18pt; 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" 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 studies involving more than 10,000 patients with various chronic diseases driven in part by <FONT
STYLE="white-space:nowrap">type-2</FONT> 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 <FONT STYLE="white-space:nowrap">type-2</FONT> inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin 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:10pt; font-family:ARIAL"><B>About Regeneron </B></P> <P STYLE="margin-top:0pt; 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 by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine
has led to numerous approved treatments and&nbsp;product candidates in development, most 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, neurological 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&nbsp;pushes the boundaries of scientific discovery and&nbsp;accelerates drug development&nbsp;using&nbsp;our proprietary technologies, such
as<I>&nbsp;VelociSuite</I><I><SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP></I><I>,</I> which produces optimized fully human antibodies and new classes of bispecific antibodies.&nbsp;We are shaping the next frontier of medicine with
data-powered insights from the&nbsp;Regeneron Genetics Center<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>&nbsp;and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to
potentially treat or cure diseases. </P> <P STYLE="font-size:18pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</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="justify">For more information, please visit
<FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#0563c1"><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="#0563c1"><U>LinkedIn</U></FONT><FONT
STYLE="font-family:ARIAL">, </FONT><FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#0563c1"><U>Instagram</U></FONT><FONT STYLE="font-family:ARIAL">, </FONT><FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#0563c1"><U>Facebook</U></FONT><FONT
STYLE="font-family:ARIAL"><U></U>&nbsp;or </FONT><FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#0563c1"><U>X</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>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 the world, 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:8pt; font-family:ARIAL">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Sanofi Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sandrine
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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;,
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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, 2023. Other than as required by applicable law, Sanofi
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.3 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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</TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Sarclisa approved in the US as the first anti-CD38 therapy in combination with <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant </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">Approval based on positive results from the IMROZ phase 3 study demonstrating Sarclisa in combination with bortezomib,
lenalidomide, and dexamethasone (VRd) significantly improved progression-free survival (PFS), compared to <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> in newly diagnosed adult patients not eligible
for autologous stem cell transplant (ASCT) </P></TD></TR></TABLE>
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<TD WIDTH="1%" 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">Third indication for Sarclisa, evaluated under FDA Priority Review, underscores Sanofi&#146;s commitment to helping
close a critical care gap in multiple myeloma (MM) </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>PARIS, September</B><B></B><B>&nbsp;21, 2024</B>. The US Food and Drug
Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for
autologous stem cell transplant (ASCT). Sarclisa is the first anti-CD38 therapy in combination with <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> VRd to significantly reduce disease progression or
death (by 40%) compared to VRd alone for patients with NDMM not eligible for transplant. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Thomas Martin M.D.
</I></B></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL" ALIGN="justify">Helen Diller Family Comprehensive Cancer Center Clinical Professor of Medicine at the University of California San
Francisco </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:9%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;Multiple myeloma is most frequently diagnosed in patients 65 years and older, yet the
options for treatment in this population are limited due to a combination of age, frailty, and <FONT STYLE="white-space:nowrap">co-morbidities.</FONT> This has resulted in a longstanding need for new treatment options that can potentially improve
the <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care.</FONT></FONT> The significant clinical benefit and improvements in progression-free survival demonstrated by the IMROZ regimen of isatuximab plus VRd versus VRd
alone make today&#146;s approval an important moment for this vulnerable patient population and the larger multiple myeloma community.&#148;</I> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">This decision marks the third approved indication for Sarclisa in the US and the first approved indication in newly diagnosed patients. The FDA
evaluated Sarclisa for this indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. Sarclisa is also currently approved in more than
50 countries across two indications for the treatment of people with relapsed or refractory disease. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Brian
Foard </I></B></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL" ALIGN="justify">Executive Vice President, Head of Specialty Care, Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:9%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;Since first launching in 2020, we have made significant progress towards our ambition of establishing
Sarclisa as a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> therapy. The FDA&#146;s decision marks another momentous milestone toward our goal and expands the reach of this potentially transformative
therapy to a larger population. With today&#146;s approval, doctors now have an important new option at their disposal that&#146;s been shown to slow disease progression for longer compared to the current <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">standard-of-care</FONT></FONT> for adults living with newly diagnosed multiple myeloma who are not eligible for transplant in the US.&#148;</I> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Results from the IMROZ phase 3 study supporting Sarclisa in NDMM not eligible for ASCT </I></FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The FDA approval is based on data from the IMROZ phase 3 study recently presented at the American Society of Clinical Oncology (ASCO) 2024 annual
meeting and published in <I><FONT STYLE="font-family:ARIAL" COLOR="#7a00e6"><U>The New England Journal of Medicine</U></FONT></I>. IMROZ is the first global phase 3 study of an anti-CD38 monoclonal antibody in combination with <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> VRd to significantly improve PFS versus VRd alone. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In the IMROZ study, <FONT STYLE="white-space:nowrap">Sarclisa-VRd</FONT> followed by <FONT
STYLE="white-space:nowrap">Sarclisa-Rd</FONT> met the primary endpoint of PFS, significantly reducing the risk of recurrence or death by 40%, compared to VRd followed by Rd, in patients with NDMM not eligible for ASCT (HR 0.60; 95% CI: 0.44 to 0.81,
p=0.0009). At a median <FONT STYLE="white-space:nowrap">follow-up</FONT> of 59.7 months, the median PFS with the <FONT STYLE="white-space:nowrap">Sarclisa-VRd</FONT> combination was not reached versus 54.3 months with VRd. The&nbsp;estimated <FONT
STYLE="white-space:nowrap">PFS-rate</FONT> at 60 months was 63.2% for patients treated with <FONT STYLE="white-space:nowrap">Sarclisa-VRd&nbsp;versus</FONT> 45.2% for VRd. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><FONT STYLE="white-space:nowrap">Sarclisa-VRd</FONT> also met several secondary endpoints which demonstrated deep responses in this patient population:
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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">Approximately three-quarters (74.7%) of patients treated with <FONT STYLE="white-space:nowrap">Sarclisa-VRd</FONT>
achieved a complete response (CR) or better compared to 64.1% of patients taking VRd (OR 1.7; 95% CI: <FONT STYLE="white-space:nowrap">1.097-2.5;</FONT> p=0.0160). </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">More than half (55.5%) of patients treated with <FONT STYLE="white-space:nowrap">Sarclisa-VRd</FONT> achieved MRD
negative CR compared to 40.9% of patients taking VRd (OR 1.8; 95% CI: <FONT STYLE="white-space:nowrap">1.229-2.646;</FONT> p=0.0026). </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The safety and tolerability of Sarclisa observed in this study was consistent with the established safety profile of Sarclisa and VRd with no new safety
signals observed. The most common adverse reactions (<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>20%) were upper respiratory tract infections, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, musculoskeletal pain, cataract,
constipation, peripheral edema, rash, infusion-related reaction, insomnia, and <FONT STYLE="white-space:nowrap">COVID-19.</FONT> The most common hematologic laboratory abnormalities (<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>80%) were
decreased hemoglobin, decreased leukocytes, decreased lymphocytes, decreased platelets, and decreased neutrophils. Serious adverse reactions occurred in 71% of patients receiving Sarclisa combination therapy. The most frequent serious adverse
reaction occurring in more than 5% of patients was pneumonia (30%). Permanent discontinuation of treatment due to an adverse reaction occurred in 22.8% of patients treated with Sarclisa combination therapy, compared to 26% in the comparator arm.
</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Advancing Sarclisa in multiple myeloma </I></FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Sanofi continues to advance Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies
across the MM treatment continuum spanning six potential indications. In addition, the company is evaluating a subcutaneous administration method for Sarclisa in clinical studies. The safety and efficacy of Sarclisa has not been evaluated by any
regulatory authority outside of its approved indications and methods of delivery. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In September, isatuximab-irfc (Sarclisa) was also added to the
National Comprehensive Cancer Network (NCCN<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>) Clinical Practice Guidelines in Oncology (NCCN Guidelines<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>) for MM <FONT
STYLE="white-space:nowrap">non-transplant</FONT> candidates as an NCCN Category 1 Preferred option in combination with VRd for patients &lt;80 years old who are not frail. Category 1 is based upon high-level evidence, there is uniform NCCN consensus
that the intervention is appropriate. Preferred intervention are interventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><I>*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application
or use in any way.</I> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Sarclisa </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Sarclisa (isatuximab) is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity.
It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for antibody-based
therapeutics such as Sarclisa. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Based on the <FONT STYLE="white-space:nowrap">ICARIA-MM</FONT> phase 3 study, Sarclisa is approved in
more than 50 countries, including the US and the EU, in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed refractory MM (RRMM) who have received <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>2
prior therapies, including lenalidomide and a proteasome inhibitor and who progressed on last therapy. Based on the IKEMA phase 3 study, Sarclisa is also approved in 50 countries in combination with carfilzomib and dexamethasone, including in the US
for the treatment of patients with RRMM who have received 1&#150;3 prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, the <FONT STYLE="white-space:nowrap">non-proprietary</FONT> name
for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of biological products guidance for industry issued by the US Food and Drug Administration. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Sarclisa continues to be evaluated in multiple ongoing phase 3 clinical studies in combination with current standard treatments across the MM treatment
continuum. It is also under investigation for the treatment of other hematologic malignancies, and its safety and efficacy have not been evaluated by any regulatory authority outside of its approved indication. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Sanofi is committed to pursuing the advancement of Sarclisa through several investigational studies across the MM treatment continuum. Various
patient-centric clinical development programs aim to bring Sarclisa to more patients, intercept the disease earlier in the treatment journey, explore potential new combinations and assess subcutaneous administration via a proprietary on body device
system. The safety and efficacy of Sarclisa has not been evaluated by any regulatory authority outside of its approved indications and methods of delivery. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In striving to become the number one immunoscience company globally, Sanofi remains committed to advancing oncology innovation. Through focused
strategic decisions the company has reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive progress. Efforts are centered on
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">difficult-to-treat</FONT></FONT> cancers such as select hematologic malignancies, and solid tumors with critical unmet needs, including multiple myeloma, acute myeloid leukemia,
certain types of lymphomas, as well as gastrointestinal and lung cancers. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">For more information on Sarclisa clinical studies, please visit <FONT
STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U>www.clinicaltrials.gov</U></FONT><FONT STYLE="font-family:ARIAL">. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><I>About multiple myeloma </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">MM is the second most common hematologic malignancy<SUP
STYLE="font-size:75%; vertical-align:top">1</SUP>, affecting more than 130,000 patients in the US; approximately 32,000 Americans are diagnosed with MM each year.<SUP STYLE="font-size:75%; vertical-align:top">2</SUP> Despite available treatments, MM
remains an incurable malignancy with an estimated 52% five-year survival rate for newly diagnosed patients.<SUP STYLE="font-size:75%; vertical-align:top">3</SUP> According to physician-based surveys, the majority of NDMM patients are not considered
eligible for transplant, creating a need for new frontline therapeutic options, particularly due to high attrition rates in subsequent lines of therapy. </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:1.00pt 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 the world, 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: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>&nbsp;sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Evan Berland</B> | +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>Nicolas
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<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>&nbsp;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>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: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>Thomas Kudsk Larsen</B> |+ 44 7545 513 693 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>thomas.larsen@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>Aliz&eacute;
Kaisserian</B><B></B>&nbsp;|&nbsp;+ 33 6 47 04 12 11 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>alize.kaisserian@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>
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 <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>Keita
Browne</B><B></B>&nbsp;|&nbsp;+ 1 781 249 1766 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>keita.browne@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; font-family:ARIAL"><B>Tarik Elgoutni </B>| + 1 617 710 3587 |
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<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:1.00pt solid #cccccc">&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 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, 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:12pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL" ALIGN="justify">All trademarks mentioned in this press release
are the property of the Sanofi group. </P> <P STYLE="line-height:8.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:26%">&nbsp;</P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL" ALIGN="justify"><SUP STYLE="font-size:75%; vertical-align:top">1</SUP> Kazandjian. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. <FONT
STYLE="white-space:nowrap">2016;43(6):676-681.</FONT> doi:10.1053/j/seminoncol.2016.11.004. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL" ALIGN="justify"><SUP STYLE="font-size:75%; vertical-align:top">2</SUP>
National Cancer Institute. Myeloma Cancer Stat Facts. Available at: www.seer.cancer.gov/statfacts/html/mulmy.html. Accessed on December&nbsp;12, 2019. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL" ALIGN="justify"><SUP STYLE="font-size:75%; vertical-align:top">3</SUP> Fonseca, R., Usmani, S.Z., Mehra, M. et al. Frontline treatment patterns and attrition rates by
subsequent lines of therapy in patients with newly diagnosed multiple myeloma. <I>BMC Cancer</I>. 2020: 20(1087).
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">https://doi.org/10.1186/s12885-020-07503-y.</FONT></FONT></FONT> </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
