<SEC-DOCUMENT>0001193125-23-263528.txt : 20231026
<SEC-HEADER>0001193125-23-263528.hdr.sgml : 20231026
<ACCEPTANCE-DATETIME>20231026071627
ACCESSION NUMBER:		0001193125-23-263528
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		5
CONFORMED PERIOD OF REPORT:	20231026
FILED AS OF DATE:		20231026
DATE AS OF CHANGE:		20231026

FILER:

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

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-31368
		FILM NUMBER:		231347489

	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>
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<TYPE>6-K
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<FILENAME>d567156d6k.htm
<DESCRIPTION>6-K
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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: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: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: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:9pt; font-family:Times New Roman" ALIGN="center">For the month of
October 2023 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Commission File Number: <FONT STYLE="white-space:nowrap">001-31368</FONT> </P>
<P STYLE="margin-top:12pt; 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="margin-top:18pt; 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&#8194;&#9746;&#8195;&#8195;&#8195;Form</FONT> <FONT STYLE="white-space:nowrap">40-F&#8194;&#9744;</FONT> </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="justify">In October 2023, Sanofi published the media update and the press release attached hereto as
Exhibits 99.1 and 99.2 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:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:9pt; font-family:Times New Roman; ">Exhibit No.</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:9pt; font-family:Times New Roman; " ALIGN="center">Description</P></TD></TR>


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<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d567156dex991.htm">Media Update dated October 20, 2023: Sanofi and Regeneron provide update on Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab) sBLA for Chronic Spontaneous Urticaria
</A></TD></TR>
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<TD VALIGN="top" NOWRAP>Exhibit 99.2<BR></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d567156dex992.htm">Press Release dated October&nbsp;
22, 2023: Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab) Phase 3 Results show sustained efficacy for up to one year in children 1 to 11 years of age with eosinophilic esophagitis (EoE) </A></TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; 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: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:9pt">
<TD VALIGN="bottom">Dated: October&nbsp;26, 2023</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" COLSPAN="3" ALIGN="center">SANOFI</TD></TR>
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<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">By</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000">&nbsp;</TD>
<TD VALIGN="bottom" STYLE="BORDER-BOTTOM:1px solid #000000">/s/ Alexandra Roger <BR></TD></TR>
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<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Name: Alexandra Roger <BR>Title: Head of Securities Law and Capital Markets</TD></TR>
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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="top"><FONT STYLE="font-size:14pt"><B>Media Update</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="#6600ff"><I>Sanofi and Regeneron provide update on Dupixent<SUP
STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab) sBLA for Chronic Spontaneous Urticaria</I> </FONT></P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><B>Paris and Tarrytown, N.Y.
October</B><B></B><B>&nbsp;20, 2023. </B>The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA) for
Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP><SUP STYLE="font-size:75%; vertical-align:top"> </SUP>(dupilumab) in chronic spontaneous urticaria (CSU). CSU is an inflammatory skin condition, which causes sudden and debilitating
hives and swelling on the skin. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The CRL states that additional efficacy data are required to support an approval; it did not identify any issues
with safety or manufacturing. An ongoing clinical trial (Study C) continues to enroll patients, with results expected in late 2024 that are anticipated to provide the additional efficacy data. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Sanofi and Regeneron remain committed to working with the FDA to advance the study of Dupixent for patients living with CSU who are inadequately
controlled by antihistamines. </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 currently under clinical development, and the safety and efficacy 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 the CSU Clinical Trial Program </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The clinical trial program, known as LIBERTY-CUPID, includes Studies A, B and C, three Phase 3 randomized, double-blind, placebo-controlled trials
evaluating the efficacy and safety of Dupixent in two different patient populations with uncontrolled CSU. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Study A evaluated 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 in 138 patients with CSU aged 6 years and older
who remained symptomatic despite antihistamine use and were not previously treated with omalizumab. Efficacy and safety data from Study A were the basis of the sBLA. Study B evaluated Dupixent in 108 patients with CSU aged 12 to 80 years who
remained symptomatic despite <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> treatment and were intolerant or incomplete responders to omalizumab, with results providing additional supporting data for
the sBLA. Study C is an ongoing trial investigating Dupixent in the same population as Study A. </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" ALIGN="justify">Dupixent is a fully human monoclonal antibody that inhibits the signaling of the <FONT STYLE="white-space:nowrap">IL-4</FONT> and <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), prurigo nodularis and 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 or prurigo nodularis 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 750,000 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" 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>
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 <P STYLE="margin-top:0pt; 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 pediatric EoE, 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" 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 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. Regeneron&#146;s 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 its proprietary <I>VelociSuite</I><SUP
STYLE="font-size:75%; vertical-align:top">&reg;</SUP> technologies, such as <I>VelocImmune</I><SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>, 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<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>, 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" ALIGN="justify">For additional information about Regeneron, please visit <U><FONT STYLE="font-family:arial" COLOR="#7a00e6">www.regeneron.com</FONT></U><FONT
STYLE="font-family:arial"> or follow Regeneron on LinkedIn. </FONT></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:12pt; 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><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:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#6600ff"><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 | <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;+ 1 908 612 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
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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
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="right"><B>Exhibit 99.2 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman"><FONT COLOR="#6600ff"><I>Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab) Phase 3 Results show
sustained efficacy for up to one year in children 1 to 11 years of age with eosinophilic esophagitis (EoE) </I></FONT></P> <P STYLE="font-size:12pt;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">Late-breaking presentation at ACG 2023 showed histologic and endoscopic improvements were maintained with no new
safety signals to week 52 with higher dose Dupixent in these children </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">Data reinforce the role of type 2 inflammation in EoE and the importance of targeting both <FONT
STYLE="white-space:nowrap">IL-4</FONT> and <FONT STYLE="white-space:nowrap">IL-13</FONT> pathways </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">sBLA for Dupixent to treat children aged 1 to 11 years with EoE is under Priority Review in the U.S.; if approved,
Dupixent would be the first and only <FONT STYLE="white-space:nowrap">FDA-approved</FONT> treatment for these children with EoE </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. October</B><B></B><B>&nbsp;22, 2023. </B>Positive results from a Phase 3 trial demonstrated the efficacy and safety profile
of Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab) for up to one year (52 weeks) in children aged 1 to 11 years with eosinophilic esophagitis (EoE) was consistent. These results represent the first analysis of
longer-term data in this age group and will be featured in a late-breaking session on October&nbsp;25 at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting. </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>Mirna Chehade, M.D., MPH</I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial" ALIGN="justify">Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine, Mount Sinai</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;Eosinophilic esophagitis, or EoE, is a chronic and debilitating condition that can impact children in their most
vulnerable years of life, causing persistent difficulties with eating, abdominal pain, and/or failure to thrive. Dupilumab is the first and only therapeutic approved for adults and adolescents 12 years and older who weigh at least 40 kg with EoE.
Some children with EoE may have <FONT STYLE="white-space:nowrap">sub-optimal</FONT> response to currently unapproved standard of care therapies, underscoring the need for treatments targeting key pathways driving inflammation in EoE. Data from this
Phase 3 trial support the potential of dupilumab to treat EoE in children, with sustained efficacy and safety, which is particularly critical for these children.&#148; </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The late-breaking data to be presented at ACG feature results from children enrolled in the extended active treatment period (Part B) of a Phase 3
trial, following 16 weeks of Dupixent treatment or placebo in <FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>Part A</U></FONT><FONT STYLE="font-family:arial"> of the trial. All children in Part B were treated with higher or lower
dose Dupixent for an additional 36 weeks, providing up to 52 weeks of data. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">In Part B, there were 37 patients who continued on higher dose
Dupixent and 18 who switched from placebo to higher dose Dupixent. At one year, outcomes of secondary endpoints (as evaluated with descriptive statistics based on all observed data) among children who continued on higher dose Dupixent and for those
switching from placebo to higher dose Dupixent was, respectively, as follows: </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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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">63% and 53% achieved histological disease remission </P></TD></TR></TABLE>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<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">0.97 and 0.89 reduction from baseline in disease severity and 0.89 and 0.86 reduction from baseline in extent,
respectively, as measured at the microscopic level in biopsy specimens </P></TD></TR></TABLE>
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<TD WIDTH="5%">&nbsp;</TD>
<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">4.8 and <FONT STYLE="white-space:nowrap">3.6-point</FONT> reduction in abnormal endoscopic findings from baseline
</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">0.30 and <FONT STYLE="white-space:nowrap">0.47-point</FONT> numerical improvement in caregiver reported pediatric signs
and symptoms, as measured by <FONT STYLE="white-space:nowrap">PESQ-C</FONT> </P></TD></TR></TABLE>
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<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="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">5.96 and 5.48 percentile increase in body weight for age percentile from baseline </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Safety results in Part B of the trial were generally consistent with Part A and the known safety profile of Dupixent in its <FONT
STYLE="white-space:nowrap">FDA-approved</FONT> EoE indication for adult and adolescent patients aged 12 years and older who weigh at least 40 kg. AEs reported in <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>20% of patients who remained on
higher dose Dupixent in Part B and those who switched from placebo to higher dose Dupixent in Part B, respectively, included: <FONT STYLE="white-space:nowrap">COVID-19</FONT> (n=11/37, n=5/18; all cases were mild or moderate and did not lead to
study treatment discontinuation), injection site reaction (n=5/37, n=5/18), cough (n=3/37, n=4/18) and headache (n=3/37, n=4/18). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">In September, the
U.S. Food and Drug Administration <FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>accepted</U></FONT><FONT STYLE="font-family:arial"> for Priority Review the supplemental Biologics License Application for higher dose Dupixent to
treat children aged 1 to 11 years with EoE, with a target action date of January 31, 2024. This potential use of Dupixent in children with EoE aged 1 to 11 years is currently under clinical development, and its safety and efficacy have not been
fully evaluated by any regulatory authority in this setting. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About Eosinophilic Esophagitis </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">EoE is a chronic, progressive disease driven in part by type 2 inflammation that damages the esophagus and prevents it from working properly. In
children, common symptoms of EoE include heartburn, vomiting, abdominal discomfort, trouble swallowing, food refusal and failure to thrive. These symptoms can impact growth and development and can cause food-related fear and anxiety, which can
persist through adulthood. Dietary adjustments, which oftentimes include the elimination of food groups, are the standard treatment for EoE, as well as the use of treatments not approved for the disease, such as proton pump inhibitors and swallowed
topical corticosteroids. Continuous treatment of EoE may be needed to reduce the risk of complications and disease recurrence. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About the Dupixent Pediatric
Eosinophilic Esophagitis Trial </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The Phase 3, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in
children aged 1 to 11 years with EoE, as determined by histological, endoscopic and patient- or caregiver-reported measures. At baseline, 98% of these patients had at least one <FONT STYLE="white-space:nowrap">co-existing</FONT> type 2 inflammatory
disease such as food allergy, allergic rhinitis, asthma and atopic dermatitis. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Part A, a <FONT STYLE="white-space:nowrap">16-week,</FONT>
double-blind treatment period, enrolled 102 patients and evaluated Dupixent subcutaneously at either a higher dose or lower dose regimen based on weight (ranging from <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>5 kg to &lt;60 kg). The
dosing frequency ranged between every two weeks and every four weeks, based on weight. The primary endpoint was histological disease remission, which was defined as peak esophageal intraepithelial eosinophil count of <FONT
STYLE="font-family:Times New Roman">&#8804;</FONT>6 eosinophils (eos)/high power field (hpf). </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Part B was a <FONT STYLE="white-space:nowrap">36-week</FONT> extended active treatment period in which
eligible children from Part A in the Dupixent group maintained their dose level; those in the placebo group were randomized to either a higher or lower dose. In Part B, secondary endpoints included: </P>
<P STYLE="font-size:6pt;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">Histological disease remission (peak esophageal intraepithelial eosinophil count of <FONT
STYLE="font-family:Times New Roman">&#8804;</FONT>6 eosinophils [eos]/high power field [hpf]) </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">Histopathologic measures of the severity and extent of tissue scarring in the esophagus (EoE-HSS grade and stage scores,
which measure changes in eight cellular and tissue features on <FONT STYLE="white-space:nowrap">0-3</FONT> scales, respectively) </P></TD></TR></TABLE>
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<TD WIDTH="5%">&nbsp;</TD>
<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">Abnormal endoscopic findings (EoE Endoscopic Reference Score [EoE-EREFS] on a
<FONT STYLE="white-space:nowrap">0-18</FONT> scale) </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">Changes in caregiver-reported symptoms (proportion of days with 1 or more EoE signs [e.g., stomach pain, vomiting, food
refusal] by the Pediatric EoE Sign/Symptom Questionnaire-caregiver version <FONT STYLE="white-space:nowrap">[PESQ-C])</FONT> </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">Change from baseline in body weight for age percentile </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The trial is ongoing with a <FONT STYLE="white-space:nowrap">108-week</FONT> open-label extension period (Part C) to evaluate longer-term outcomes. </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" ALIGN="justify">Dupixent is a fully human monoclonal antibody
that inhibits the signaling of the <FONT STYLE="white-space:nowrap">IL-4</FONT> and <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), prurigo
nodularis and 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 or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in&nbsp;Europe, the&nbsp;U.S.&nbsp;and&nbsp;Japan. More than
750,000 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" 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, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, 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" ALIGN="justify">Regeneron is a leading biotechnology company that invents, develops, and commercializes life- transforming medicines for people with serious diseases.
Founded and led for 35 years by physician-scientists, Regeneron&#146;s 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 Regeneron&#146;s laboratories. Regeneron&#146;s 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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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Regeneron is accelerating and improving the traditional drug development process through its
proprietary <I>VelociSuite</I><I><SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP></I> technologies, such as <I>VelocImmune</I><SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>, 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<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>, 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" ALIGN="justify">For additional information about Regeneron, 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 LinkedIn. </FONT></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:12pt; 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>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 | <U><FONT STYLE="font-family:arial" COLOR="#7a00e6">sally.bain@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>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>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>Sharon Chen </B>| +1
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">914-847-1546|</FONT></FONT> <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>sharon.chen@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:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&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: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:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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 <P STYLE="margin-top:0pt; 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&nbsp;Regeneron Pharmaceuticals, Inc.&nbsp;(&#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 children aged 1 to 11 years with
eosinophilic esophagitis (&#147;pediatric EoE&#148;); 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
pediatric EoE, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, bullous pemphigoid, and other potential indications; 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), including the studies discussed or referenced in this press release,
on any of the foregoing or any potential regulatory approval of Regeneron&#146;s Products (such as Dupixent) and Regeneron&#146;s Product Candidates; 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 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; 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>&nbsp;(aflibercept) Injection and <FONT STYLE="white-space:nowrap">REGEN-COV</FONT><SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>&nbsp;(casirivimab and imdevimab)), 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&nbsp;U.S. Securities and Exchange Commission, including its Form <FONT
STYLE="white-space:nowrap">10-K</FONT> for the year ended&nbsp;December 31, 2022&nbsp;and its Form <FONT STYLE="white-space:nowrap">10-Q</FONT> for the quarterly period ended&nbsp;June 30, 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:12pt; 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
(<FONT STYLE="font-family:arial" COLOR="#0563c1"><U>https://investor.regeneron.com</U></FONT>) and its LinkedIn page (<FONT STYLE="font-family:arial" COLOR="#0563c1"><U>https://www.linkedin.com/company/regeneron-pharmaceuticals</U></FONT>). </I></P>

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