<SEC-DOCUMENT>0001193125-24-248128.txt : 20241031
<SEC-HEADER>0001193125-24-248128.hdr.sgml : 20241031
<ACCEPTANCE-DATETIME>20241031065626
ACCESSION NUMBER:		0001193125-24-248128
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20241031
FILED AS OF DATE:		20241031
DATE AS OF CHANGE:		20241031

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:		241412365

	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>d901443d6k.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:16pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:22%">&nbsp;</P></center> <P STYLE="margin-top:16pt; 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:16pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:22%">&nbsp;</P></center> <P STYLE="margin-top:16pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">For the month of
October 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:16pt; 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:24pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">Indicate
by check mark whether the registrant files or will file annual reports under cover Form <FONT STYLE="white-space:nowrap">20-F</FONT> or Form <FONT STYLE="white-space:nowrap">40-F.</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Form <FONT STYLE="white-space:nowrap">20-F</FONT> &#9746;&#8195;&#8195;Form <FONT STYLE="white-space:nowrap">40-F</FONT> &#9744; </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">1 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">In October 2024, Sanofi published the press release attached hereto as Exhibit 99.1 which is 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>
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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" NOWRAP 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="d901443dex991.htm">Press Release dated October&nbsp;24, 2024: Dupixent late-breaking positive phase 3 data in chronic spontaneous urticaria to be presented at ACAAI. </A></TD></TR>
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 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">2 </P>

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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:7%; font-size:9pt; font-family:Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized. </P> <P STYLE="font-size:16pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top">Dated: October&nbsp;31, 2024</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
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<TD VALIGN="bottom" NOWRAP> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:Times New Roman">By&#8195;&#8195;</P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" NOWRAP> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">SANOFI</P> <P STYLE="font-size:12pt; margin-top:0pt; margin-bottom:0pt" align="left">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:9pt; font-family:Times New Roman">/s/ Alexandra Roger</P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" NOWRAP> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt" align="left">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:Times New Roman">&#8195;&#8195;&#8195;</P></TD></TR>
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<TD VALIGN="top" NOWRAP> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">Name: Alexandra Roger</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:Times New Roman">Title: Head of Legal
Corporate&nbsp;&amp; Finance</P></TD>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Dupixent late-breaking positive phase 3 data in chronic spontaneous urticaria to be presented at
ACAAI </I></FONT></P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9679;</FONT></TD>
<TD WIDTH="2%" 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">Dupixent significantly reduced itch and hive activity from baseline; 41% of patients achieved well-controlled disease
status </P></TD>
<TD WIDTH="4%">&nbsp;</TD></TR></TABLE>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9679;</FONT></TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">Confirmatory data to support US regulatory resubmission by <FONT STYLE="white-space:nowrap">year-end;</FONT> if approved,
Dupixent would be the first new targeted treatment for people living with chronic spontaneous urticaria in more than 10 years </P></TD>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9679;</FONT></TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">More than 300,000 people in the US suffer from chronic spontaneous urticaria that is inadequately controlled by
antihistamines </P></TD>
<TD WIDTH="4%">&nbsp;</TD></TR></TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>Paris and Tarrytown, NY, October</B><B></B><B>&nbsp;24, 2024. </B>Positive data from the phase 3 LIBERTY-CUPID Study C
evaluating the investigational use of Dupixent (dupilumab) in biologic-naive patients with uncontrolled chronic spontaneous urticaria (CSU) who receive background therapy with antihistamines will be presented in a late-breaking oral presentation at
the American College of Allergy, Asthma and Immunology (ACAAI) 2024 Annual Scientific Meeting in Boston, Massachusetts. Results showed treatment with Dupixent significantly reduced itch and urticaria activity (itch and hive) scores from baseline,
and a higher proportion of patients achieved well-controlled disease status, compared to placebo. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Thomas B.
Casale, M.D. </I></B></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:4%; font-size:10pt; font-family:arial" ALIGN="justify">Professor, Internal Medicine, Morsani College of Medicine at the University of South
Florida, USA </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;Chronic spontaneous urticaria is an inflammatory skin condition that affects
patients with unpredictable episodes of intense itching and hives, often severely impacting their daily lives. These data confirm results seen in the previous Study A and reinforce the potential of Dupixent to significantly alleviate symptoms for
patients, helping them to better control this challenging disease.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Study C enrolled 151 children and adults who were randomized to receive Dupixent
(n=74) or placebo (n=77) added to <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> <FONT STYLE="white-space:nowrap">histamine-1</FONT> (H1) antihistamines. At 24 weeks, Dupixent demonstrated
significant improvements compared to placebo on: </P>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9679;</FONT></TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">Itch severity score <FONT STYLE="white-space:nowrap">(8.64-</FONT> vs. <FONT STYLE="white-space:nowrap">6.10-point</FONT>
reduction from baseline; p=0.02) </P></TD></TR></TABLE>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9679;</FONT></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">Urticaria (itch and hive) activity score <FONT STYLE="white-space:nowrap">(15.86-</FONT> vs.
<FONT STYLE="white-space:nowrap">11.21-point</FONT> reduction from baseline; p=0.02) </P></TD></TR></TABLE>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9679;</FONT></TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">Well-controlled disease status (urticaria activity score <FONT STYLE="font-family:Times New Roman">&#8804;</FONT>6; 41% vs.
23%; p=0.005) </P></TD></TR></TABLE>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9679;</FONT></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">Complete response (urticaria activity score=0; 30% vs. 18%; p=0.02) </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">The safety results in Study C were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. Overall rates of treatment
emergent adverse events (AEs) were 53% for both Dupixent and placebo. AEs more commonly observed with Dupixent (<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>5%) compared to placebo included injection site reactions (12% vs. 4%),
accidental overdose (7% vs. 3%) and <FONT STYLE="white-space:nowrap">COVID-19</FONT> infection (8% vs. 5%). </P>
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 </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="right"><FONT STYLE="font-family:arial;background-color:#e6e6e6; font-size:10pt" COLOR="#2b579a">1</FONT><FONT
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Dupixent has been approved for CSU in Japan, the United Arab Emirates (UAE) and is also under regulatory review in the
European Union based on earlier trial readouts. Outside of Japan and the UAE, the safety and efficacy of Dupixent for CSU has 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 CSU </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">CSU is a chronic inflammatory skin disease driven in part by <FONT
STYLE="white-space:nowrap">type-2</FONT> inflammation, which causes sudden and debilitating hives and persistent itch. CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria.
However, the disease remains uncontrolled despite antihistamine treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and
significantly impact their quality of life. More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About the
Dupixent phase 3 CSU program (LIBERTY-CUPID) </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">The LIBERTY-CUPID Phase 3 study program evaluating Dupixent for CSU consists of <FONT
STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>Study A</U></FONT><FONT STYLE="font-family:arial">, </FONT><FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>Study B</U></FONT><FONT STYLE="font-family:arial">, and
</FONT><FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>Study C</U></FONT><FONT STYLE="font-family:arial">. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Study C was a randomized,
double-blind, placebo-controlled clinical study that evaluated the efficacy and safety of Dupixent as an <FONT STYLE="white-space:nowrap">add-on</FONT> to
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> antihistamines compared to antihistamines alone in 151 patients aged six years and older with CSU who remained symptomatic despite antihistamine use and
were not previously treated with omalizumab (i.e., <FONT STYLE="white-space:nowrap">biologic-na&iuml;ve).</FONT> The primary endpoint assessed the change from baseline in itch at 24 weeks (measured by the weekly itch severity score [ISS7], <FONT
STYLE="white-space:nowrap">0-21</FONT> scale). Secondary endpoints at 24 weeks, measured by the weekly urticaria activity score (UAS7) included the change from baseline in itch and hives (UAS7, <FONT STYLE="white-space:nowrap">0-42</FONT> scale),
proportion of patients achieving well-controlled disease status (UAS7 <FONT STYLE="font-family:Times New Roman">&#8804;</FONT>6), and complete response (UAS7=0). </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">Dupixent (dupilumab) is a fully human monoclonal antibody
that inhibits the signaling of the IL4 and 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 two of the key and central drivers of <FONT STYLE="white-space:nowrap">type-2</FONT> inflammation that play 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">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, eosinophilic esophagitis, 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:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>Dupilumab development program </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Dupilumab is being
jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical 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>
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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">In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of
diseases driven in part 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:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About
Regeneron </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with
serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and 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">Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as
<I>VelociSuite</I>&reg;, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center&reg; and pioneering genetic
medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">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&nbsp;</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: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: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>Sanofi Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Sandrine
Guendoul </B>| + 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><B></B>&nbsp;|&nbsp;+ 1 215 432 0234 |<U></U>&nbsp;<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>evan.berland@sanofi.com</U></FONT><FONT
STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Victor Rouault</B> | + 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>Sanofi 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="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Regeneron Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Ilana
Yellen </B>| +1 <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">914-330-9618|</FONT></FONT> <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>ilana.yellen@regeneron.com</U></FONT><FONT STYLE="font-family:arial">
</FONT></P>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Regeneron Investor Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Mark Hudson </B>| + <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">914-847-3482</FONT></FONT> | <FONT
STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>mark.hudson@regeneron.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #b7b7b7">&nbsp;</P> <P STYLE="margin-top:14pt; margin-bottom:0pt; font-size:7pt; font-family:arial"><B>Sanofi forward-looking statements </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:arial" ALIGN="justify">This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking
statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;, &#147;believes&#148;, &#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although Sanofi&#146;s management believes
that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include
among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties
inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks
associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers,
suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in
the public filings with the SEC and the AMF made by Sanofi, including those listed under &#147;Risk Factors&#148; and &#147;Cautionary Statement Regarding Forward-Looking Statements&#148; in Sanofi&#146;s annual report on Form <FONT
STYLE="white-space:nowrap">20-F</FONT> for the year ended December&nbsp;31, 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:8pt; margin-bottom:0pt; font-size:7pt; font-family:arial" ALIGN="justify">All trademarks mentioned in this press release are the property of the Sanofi group with the exception of VelociSuite and Regeneron Genetics Center. </P>
<P STYLE="margin-top:8pt; 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">This press
release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (&#147;Regeneron&#148; or the &#147;Company&#148;), and actual events or results
may differ materially from these forward-looking statements. Words such as &#147;anticipate,&#148; &#147;expect,&#148; &#147;intend,&#148; &#147;plan,&#148; &#147;believe,&#148; &#147;seek,&#148; &#147;estimate,&#148; variations of such words, and
similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature,
timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, &#147;Regeneron&#146;s Products&#148;) and product candidates being
developed by Regeneron and/or its collaborators or licensees (collectively, &#147;Regeneron&#146;s Product Candidates&#148;) and research and clinical programs now underway or planned, including without limitation Dupixent<SUP
STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron&#146;s Product Candidates and new indications for Regeneron&#146;s Products, such
as Dupixent for the treatment of chronic spontaneous urticaria (&#147;CSU&#148;) as discussed in this press release as well as the treatment of chronic pruritus of unknown origin, 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 for the treatment of CSU in countries other than Japan and the United Arab Emirates)
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><SUP STYLE="font-size:75%; vertical-align:top">
</SUP>(aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the
U.S. Attorney&#146;s Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:arial">
on Regeneron&#146;s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron&#146;s filings with
the U.S. Securities and Exchange Commission, including its Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the year ended December&nbsp;31, 2023 and its Form <FONT STYLE="white-space:nowrap">10-Q</FONT> for the quarterly period ended
June&nbsp;30, 2024. 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. </P>
<P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:7pt; font-family:arial">Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be
deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron&#146;s media and investor relations website (https://investor.regeneron.com ) and its LinkedIn page
(https://www.linkedin.com/company/regeneron-pharmaceuticals). </P>
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