<SEC-DOCUMENT>0001193125-25-072904.txt : 20250404
<SEC-HEADER>0001193125-25-072904.hdr.sgml : 20250404
<ACCEPTANCE-DATETIME>20250404084346
ACCESSION NUMBER:		0001193125-25-072904
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20250404
FILED AS OF DATE:		20250404
DATE AS OF CHANGE:		20250404

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Sanofi
		CENTRAL INDEX KEY:			0001121404
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				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:		25812156

	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
<SEQUENCE>1
<FILENAME>d907131d6k.htm
<DESCRIPTION>6-K
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<TITLE>6-K</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT
STYLE="white-space:nowrap">6-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF
FOREIGN PRIVATE ISSUER </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE <FONT STYLE="white-space:nowrap">13a-16</FONT> OR
<FONT STYLE="white-space:nowrap">15d-16</FONT> </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of April 2025 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number: <FONT STYLE="white-space:nowrap">001-31368</FONT> </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>SANOFI </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Translation of
registrant&#146;s name into English) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>46, avenue de
la Grande Arm&eacute;e, 75017 Paris, FRANCE </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive offices) </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether the registrant files or will file annual reports under cover Form <FONT STYLE="white-space:nowrap">20-F</FONT> or Form <FONT
STYLE="white-space:nowrap">40-F.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Form <FONT STYLE="white-space:nowrap">20-F&#8194;&#9746;&#8195;&#8195;&#8195;Form</FONT> <FONT
STYLE="white-space:nowrap">40-F&#8194;&#9744;</FONT> </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In April 2025, 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:10pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="border-bottom:1.00pt solid #000000">Exhibit No.</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; " ALIGN="center">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="d907131dex991.htm">Press Release dated April&nbsp;3, 2025: Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines </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:10pt; font-family:Times New Roman" ALIGN="center">2 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top">Dated: April&nbsp;4, 2025</TD>
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<TD VALIGN="top" ALIGN="center">SANOFI</TD></TR>
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<TD VALIGN="top">By</TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Alexandra Roger</P></TD></TR>
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<TD VALIGN="top"></TD>
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<TD VALIGN="top">Name:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">Alexandra Roger</TD></TR>
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<TD VALIGN="top">Title:</TD>
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<TD VALIGN="top">Head of Legal Corporate&nbsp;&amp; Finance</TD></TR>
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 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">3 </P>

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<TYPE>EX-99.1
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<DESCRIPTION>EX-99.1
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" 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:18pt; margin-bottom:0pt; font-size:18pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines
</I></FONT></P> <P STYLE="font-size:10pt;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="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease </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="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia
</P></TD></TR></TABLE> <P STYLE="margin-top:20pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana"><B>Paris, April</B><B></B><B>&nbsp;3, 2025</B>. The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib,
an investigational, novel, advanced, oral, reversible Bruton&#146;s tyrosine kinase (BTK) inhibitor, for two rare diseases, warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease <FONT STYLE="white-space:nowrap">(IgG4-RD).</FONT> There is
still a significant unmet medical need for these two rare diseases, and neither have any currently approved medicine. FDA grants orphan drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer
than 200,000 people in the US. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><B><I>Karin Knobe, MD, PhD </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Verdana">Global Head of Development, Rare Diseases </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Georgia"><I>&#147;Orphan drug designation for these two rare, immune-mediated conditions validates our ongoing commitment to pursuing potential first- and <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> medicines for diseases that affect small populations but persist with unmet medical need. Our continued exploration of rilzabrutinib across multiple indications
speaks to our belief in its potential for multi-immune modulation, as well as our belief in supporting treatment options, no matter how rare a condition.&#148; </I></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana">Rilzabrutinib is currently under regulatory review in the US, the EU, and China for its potential use in immune thrombocytopenia (ITP). The target action date for the
FDA regulatory decision for ITP, which was granted fast track designation, is August&nbsp;29, 2025. Rilzabrutinib also received orphan drug designation for ITP in the US, EU, and Japan. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:12pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>wAIHA and <FONT STYLE="white-space:nowrap">IgG4-RD</FONT> supporting data </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana">Results from a phase 2b study on wAIHA <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>presented at ASH 2024</U></FONT><FONT
STYLE="font-family:Verdana"> (clinical study identifier: NCT05002777) demonstrated that treatment with rilzabrutinib showed clinically meaningful outcomes on response rate and disease markers. </FONT></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana">In <FONT STYLE="white-space:nowrap">IgG4-RD</FONT> patients, results from a phase 2a study (clinical study identifier: NCT04520451) showed treatment with
rilzabrutinib for 52 weeks led to reduction in disease flare, other disease markers, and glucocorticoid sparing. More detailed results will be shared at a forthcoming medical meeting. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana">The safety profile of rilzabrutinib in both studies was consistent with previous studies. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>About rilzabrutinib </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana">Rilzabrutinib is an
investigational, oral, reversible, BTK inhibitor that has the potential to be a first- and <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> treatment of several immune-mediated diseases. BTK, expressed in
B cells, macrophages, and other innate immune cells, plays a critical role in inflammatory pathways and multiple immune-mediated disease processes. With the application of Sanofi&#146;s TAILORED
COVALENCY<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> technology, rilzabrutinib can selectively inhibit the BTK target while potentially reducing the risk of <FONT STYLE="white-space:nowrap">off-target</FONT> side effects. Based on its
ability to drive multi-immune modulation, rilzabrutinib holds great promise in the treatment of multiple clinical indications. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>About wAIHA </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana">Affecting one to three people out of 100,000 in the US each year, wAIHA is a rare, potentially life-threatening, autoimmune disorder where autoantibodies lead to the
premature destruction of the body&#146;s own red blood cells (hemolysis). People living with wAIHA may experience debilitating fatigue, thromboembolism, dizziness, palpitations, and shortness of breath as the rate of production of new red blood
cells in their bone marrow cannot compensate quickly enough for premature destruction of red blood cells. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>About <FONT
STYLE="white-space:nowrap">IgG4-RD</FONT> </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana"><FONT STYLE="white-space:nowrap">IgG4-RD</FONT> affects approximatively eight out of 100,000 adult patients
in the US each year and is a rare, progressive, relapsing, chronic fibro-inflammatory condition which can manifest in almost every organ and can lead to organ damage and irreversible dysfunction with a sometimes-fatal outcome. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>About ITP </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana">ITP is a rare, complex autoimmune
disorder characterized by low platelet counts (less than 100,000/&micro;L) resulting from both increased platelet destruction and decreased platelet production. Beyond bruising and bleeding, which can include potentially life-threatening episodes
like intracranial hemorrhage, people living with ITP may experience arterial or venous thrombosis, which can result from the ITP itself, from other medical comorbidities, or may also be associated with the use of certain other ITP treatments.
Additionally, people living with ITP often experience easily overlooked symptoms that can significantly impair their quality of life, such as unexplained fatigue, anxiety or depression, and cognitive impairment. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>About Sanofi </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana">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:10pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Sandrine Guendoul</B> |
+33 6 25 09 14 25 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Evan Berland</B> | +1 215 432 0234 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>evan.berland@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Nicolas Obrist</B> | +33 6 77 21 27 55 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>nicolas.obrist@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>L&eacute;o Le
Bourhis</B> | +33 6 75 06 43 81 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>leo.lebourhis@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Victor Rouault</B> | +33 6 70 93 71 40 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>victor.rouault@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Timothy Gilbert</B> | +1 516 521 2929 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>timothy.gilbert@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT
 COLOR="#7900e6"><I>Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Thomas Kudsk Larsen</B> |+44 7545 513 693 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>thomas.larsen@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Aliz&eacute;
Kaisserian </B>| +33 6 47 04 12 11 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>alize.kaisserian@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Felix Lauscher </B>| +1 908 612 7239 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Keita Browne </B>| +1 781 249 1766 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>keita.browne@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Nathalie Pham
</B>| +33 7 85 93 30 17 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>nathalie.pham@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Tarik Elgoutni </B>| +1 617 710 3587 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>tarik.elgoutni@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Thibaud Ch&acirc;telet</B> | +33 6 80 80 89 90 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>thibaud.chatelet@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Yun Li</B> |
+33 6 84 00 90 72 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>yun.li3@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:16pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana"><B>Sanofi forward-looking statements </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana">This press release contains
forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their
underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance.
Forward-looking statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;, &#147;believes&#148;, &#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although Sanofi&#146;s
management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are
difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks
and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and
when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product
candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi&#146;s ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates,
volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the
</P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="right">2/3</TD></TR></TABLE>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana">
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, 2024. 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:7pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana">All trademarks mentioned in this press release are the property of the Sanofi group. </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
