<SEC-DOCUMENT>0001193125-25-070866.txt : 20250402
<SEC-HEADER>0001193125-25-070866.hdr.sgml : 20250402
<ACCEPTANCE-DATETIME>20250402061555
ACCESSION NUMBER:		0001193125-25-070866
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		7
CONFORMED PERIOD OF REPORT:	20250402
FILED AS OF DATE:		20250402
DATE AS OF CHANGE:		20250402

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:		25801943

	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>d913001d6k.htm
<DESCRIPTION>6-K
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<HTML><HEAD>
<TITLE>6-K</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT
STYLE="white-space:nowrap">6-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF
FOREIGN PRIVATE ISSUER </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE <FONT STYLE="white-space:nowrap">13a-16</FONT> OR
<FONT STYLE="white-space:nowrap">15d-16</FONT> </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of 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>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In March 2025, Sanofi published the press releases 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: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>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" ALIGN="center">


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<TD WIDTH="88%"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"><B>Exhibit</B><br><B>No.</B></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"><B>Description</B></P></TD></TR>


<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d913001dex991.htm">Press Release dated March 28, 2025 Dupixent approved as the first-ever biologic medicine in Japan for patients with COPD </A></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP>Exhibit 99.2</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d913001dex992.htm">Press Release dated March 28, 2025 : Press Release: Qfitlia approved as the first therapy in the US to treat hemophilia A or B with or without inhibitors </A></TD></TR>
</TABLE>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">2 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top: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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<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom">Dated: April 2nd, 2025</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" ALIGN="center">SANOFI</TD></TR>
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<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD>
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<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">By</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Alexandra Roger</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Name:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Alexandra Roger</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Title:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Head of Legal Corporate &amp; Finance</TD></TR>
</TABLE>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">3 </P>

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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>d913001dex991.htm
<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:14pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt;margin-bottom:0pt" ALIGN="right">


<IMG SRC="g913001g0402064844124.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:14pt; margin-bottom:0pt; font-size:14pt; font-family:arial" ALIGN="justify"><B>Press Release </B></P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#6600ff"><I>Dupixent approved as the first-ever biologic medicine in Japan for patients with COPD </I></FONT></P>
<P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="1%" VALIGN="top" ALIGN="justify"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">&#149;</P></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">Following recent approvals in the EU, China, and the US, this approval was based on pivotal phase 3 results in adults
with elevated eosinophils </P></TD></TR></TABLE>
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<TD WIDTH="1%" VALIGN="top" ALIGN="justify"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">&#149;</P></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">Approval marks the first new treatment approach for COPD in more than a decade in Japan and the sixth approved
indication for chronic diseases with underlying type 2 inflammation </P></TD></TR></TABLE> <P STYLE="margin-top:14pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><B>Paris and Tarrytown, NY, March</B><B></B><B>&nbsp;28,
2025. </B>The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately
controlled with existing therapy. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The approval in Japan was based on data from the landmark <FONT
STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>BOREAS</U></FONT><FONT STYLE="font-family:arial"> phase 3 study. The study evaluated Dupixent added to background maximal
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> inhaled therapy (with nearly all patients on triple therapy or double therapy if inhaled corticosteroids were contraindicated) in adults with
uncontrolled COPD and elevated blood eosinophils. In the study, Dupixent significantly reduced exacerbations and improved lung function compared to placebo. Safety results in the study were generally consistent with the known safety profile of
Dupixent in its approved indications. The most commonly reported adverse event with Dupixent was injection site reaction. Results from BOREAS and the replicate
</FONT><FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>NOTUS</U></FONT><FONT STYLE="font-family:arial"> phase 3 study were published in <I>The New England Journal of Medicine</I>. </FONT></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">In addition to COPD, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis
(CRSwNP), prurigo nodularis, and chronic spontaneous urticaria (CSU). Dupixent for the treatment of COPD has been approved in more than 45 countries worldwide, including the 27 member countries of the EU. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><B>About COPD </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">COPD is a chronic respiratory
disease that damages the lungs and causes progressive lung function decline and is the fourth leading cause of death worldwide. Symptoms include persistent cough, excessive mucus production, and shortness of breath that may impair the ability to
perform routine daily activities, which may lead to sleep disturbances, anxiety, and depression. COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid medicine
and/or antibiotics. Smoking and exposure to noxious inhaled particles are key risk factors for COPD, and even individuals who stop smoking can still have progressive lung disease. About half of COPD patients continue to experience exacerbations
despite being on triple inhaled therapy. Patients with COPD and elevated eosinophils have an increased risk of exacerbations and COPD-related hospitalizations within a year. </P>
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<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="right"><FONT STYLE="background-color:#d8d8d8; " COLOR="#2b579a">1</FONT>/<FONT STYLE="background-color:#d8d8d8; " COLOR="#2b579a">4</FONT></P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><B>About Sanofi and Regeneron&#146;s COPD clinical research program </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Sanofi and Regeneron are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease
progression through the clinical assessment of two biologics, Dupixent and itepekimab. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Dupixent is a <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">first-in-class</FONT></FONT> biologic that inhibits the signaling of the <FONT STYLE="white-space:nowrap">interleukin-4</FONT> (IL4) and <FONT STYLE="white-space:nowrap">interleukin-13</FONT> (IL13) pathways and the
program focuses on a specific population of people with evidence of <FONT STYLE="white-space:nowrap">type-2</FONT> inflammation. Itepekimab is a fully human monoclonal antibody that binds to and inhibits
<FONT STYLE="white-space:nowrap">interleukin-33</FONT> (IL33), an initiator and amplifier of broad inflammation in COPD. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Itepekimab is currently
under clinical investigation for COPD in two phase 3 studies and its safety and efficacy have not been evaluated by any regulatory authority. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><B>About Dupixent </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Dupixent (dupilumab) is
available in Japan in a 300 mg dose as a <FONT STYLE="white-space:nowrap">pre-filled</FONT> syringe or <FONT STYLE="white-space:nowrap">pre-filled</FONT> pen and is now available for COPD. Dupixent is intended for injection under the skin
(subcutaneous injection) and is given every other week. It can be given in a clinic or at home by self-administration after training by a healthcare professional. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Dupixent 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 the <FONT
STYLE="white-space:nowrap">type-2</FONT> inflammation that plays a major role in multiple related and often <FONT STYLE="white-space:nowrap">co-morbid</FONT> diseases. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis,
asthma, CRSwNP, eosinophilic esophagitis, prurigo nodularis, CSU, and COPD in different age populations. More than one million patients are being treated with Dupixent globally. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><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 assessed across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by <FONT
STYLE="white-space:nowrap">type-2</FONT> inflammation. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">In addition to the currently approved indications, Sanofi and Regeneron are studying
dupilumab in a broad range of diseases driven by <FONT STYLE="white-space:nowrap">type-2</FONT> inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin, bullous pemphigoid, and lichen simplex
chronicus. 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:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><B>About Regeneron </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Regeneron (NASDAQ: REGN) is
a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into
medicine has led to numerous approved treatments and&nbsp;product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory
diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. </P> <P STYLE="font-size:14pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Regeneron&nbsp;pushes the boundaries of scientific discovery and&nbsp;accelerates drug
development&nbsp;using&nbsp;our proprietary technologies, such as<I>&nbsp;VelociSuite</I><I><SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP></I><I>,</I> which produces optimized fully human antibodies and new classes of bispecific
antibodies.&nbsp;We are shaping the next frontier of medicine with data-powered insights from the&nbsp;Regeneron Genetics Center<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>&nbsp;and pioneering genetic medicine platforms, enabling us to
identify innovative targets and complementary approaches to potentially treat or cure diseases. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">For more information, please visit <FONT
STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>www.Regeneron.com</U></FONT><FONT STYLE="font-family:arial"> or follow Regeneron on </FONT><FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>LinkedIn</U></FONT><FONT
STYLE="font-family:arial">, </FONT><FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>Instagram</U></FONT><FONT STYLE="font-family:arial">, </FONT><FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>Facebook</U></FONT><FONT
STYLE="font-family:arial"> or </FONT><FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>X</U></FONT><FONT STYLE="font-family:arial">. </FONT></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#6600ff"><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:10pt; margin-bottom:0pt; font-size:8pt; font-family:arial" ALIGN="justify">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#6600ff"><I>Sanofi Media Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial" ALIGN="justify"><B>Sandrine Guendoul</B> | +33 6 25 09 14 25 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><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" ALIGN="justify"><B>Evan Berland</B> | +1 215 432 0234 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><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" ALIGN="justify"><B>Nicolas Obrist</B> | +33 6 77 21 27 55 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><U>nicolas.obrist@sanofi.com</U></FONT><FONT
STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial" ALIGN="justify"><B>L&eacute;o Le Bourhis</B> | +33 6 75 06 43 81 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><U>leo.lebourhis@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" ALIGN="justify"><B>Victor Rouault</B> | +33 6 70 93 71 40 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><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" ALIGN="justify"><B>Timothy Gilbert</B> | +1 516 521 2929 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><U>timothy.gilbert@sanofi.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#6600ff"><I>Sanofi Investor Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial" ALIGN="justify"><B>Thomas Kudsk Larsen</B> |+44 7545 513 693 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><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" ALIGN="justify"><B>Aliz&eacute; Kaisserian</B> | +33 6 47 04 12 11 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><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" ALIGN="justify"><B>Felix Lauscher</B> | +1 908 612 7239 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><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" ALIGN="justify"><B>Keita Browne</B> | +1 781 249 1766 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><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" ALIGN="justify"><B>Nathalie Pham</B> | +33 7 85 93 30 17 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><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" ALIGN="justify"><B>Tarik Elgoutni</B> | +1 617 710 3587 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><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" ALIGN="justify"><B>Thibaud Ch&acirc;telet</B> | +33 6 80 80 89 90 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><U>thibaud.chatelet@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" ALIGN="justify"><B>Yun Li</B> | +33 6 84 00 90 72 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><U>yun.li3@sanofi.com</U></FONT><FONT
STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#6600ff"><I>Regeneron Media Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial" ALIGN="justify"><B>Hannah Kwagh </B>| +1 <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">914-847-6314|</FONT></FONT> <FONT
STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><U>hannah.kwagh@regeneron.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT
 COLOR="#6600ff"><I>Regeneron Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial" ALIGN="justify"><B>Mark Hudson </B>| +1
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">914-847-3482</FONT></FONT> | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#6600ff"><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:1px solid #000000">&nbsp;</P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:7pt; font-family:arial" ALIGN="justify"><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 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, 2024. 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="font-size:14pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:arial" ALIGN="justify"><I>All trademarks mentioned in this press release are the property of the Sanofi group except for
</I>VelociSuite<I> and </I>Regeneron Genetics Center<I>.</I> </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:7pt; font-family:arial" ALIGN="justify"><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">This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of
Regeneron Pharmaceuticals, Inc. (&#147;Regeneron&#148; or the &#147;Company&#148;), and actual events or results may differ materially from these forward-looking statements. Words such as &#147;anticipate,&#148; &#147;expect,&#148;
&#147;intend,&#148; &#147;plan,&#148; &#147;believe,&#148; &#147;seek,&#148; &#147;estimate,&#148; variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking
statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by
Regeneron and/or its collaborators or licensees (collectively, &#147;Regeneron&#146;s Products&#148;) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, &#147;Regeneron&#146;s Product
Candidates&#148;) and research and clinical programs now underway or planned, including without limitation Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab) for the treatment of chronic obstructive pulmonary disease;
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; 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 adults with chronic pruritus of unknown origin, bullous pemphigoid, lichen simplex chronicus, and other potential indications; 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; changes in laws, regulations, and policies
affecting the healthcare industry; 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 (including biosimilar versions of Regeneron&#146;s
Products); 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 on Regeneron&#146;s business; and risks associated with 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), risks associated with intellectual property of other parties and pending or future
litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (aflibercept) Injection), the ultimate outcome of any such
proceedings and investigations, and the impact any of the foregoing may have on Regeneron&#146;s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in
Regeneron&#146;s filings with the U.S. Securities and Exchange Commission, including its Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the year ended December&nbsp;31, 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:10pt; margin-bottom:0pt; font-size:7pt; font-family:arial" ALIGN="justify">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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 <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:14pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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</TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#6600ff"><I>Qfitlia approved as the first therapy in the US to treat hemophilia A or B with or
without inhibitors </I></FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="2%" VALIGN="top" ALIGN="justify"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">&#149;</P></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">Qfitlia (fitusiran), the first antithrombin-lowering therapy in hemophilia, offers consistent protection with as few as
six injections a year via a prefilled pen or vial and syringe </P></TD></TR></TABLE>
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<TD WIDTH="2%" VALIGN="top" ALIGN="justify"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">&#149;</P></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">Unique mechanism helps reduce the frequency of bleeding episodes for people with hemophilia </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><B>Paris, March</B><B></B><B>&nbsp;28, 2025</B>. The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first
antithrombin-lowering (AT) therapy for<B> </B>routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors. The
approval is based on data from the ATLAS phase 3 studies that demonstrated clinically meaningful bleed protection as measured by annualized bleeding rates (ABR) across hemophilia patients with or without inhibitors. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#6600ff"><B><I>Phil Gattone </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial" ALIGN="justify">President and CEO, National Bleeding Disorders Foundation </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;Current treatment options can make people with hemophilia feel they need to choose between effective bleed control and
convenient dosing schedules, leading to trade-offs when it comes to disease management. Qfitlia takes a novel approach to providing protection for people living with hemophilia while reducing the frequency of dosing for patients and their
families.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">By lowering AT, a protein that inhibits blood clotting, Qfitlia helps increase thrombin generation to restore hemostasis in
people with hemophilia. Qfitlia uses small-interfering RNA technology, which enables low treatment frequency, subcutaneous dosing, and low volume injections. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#6600ff"><B><I>Brian Foard </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial" ALIGN="justify">Executive Vice President, Head of Specialty Care, Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;This approval highlights our commitment to advancing innovation and improving care for the rare blood disorders
community. Qfitlia has the potential to meaningfully change the hemophilia landscape through effective bleed protection, infrequent dosing, and simplified administration. Our robust portfolio of hemophilia treatment options continues to grow as we
focus on offering protection with reduced treatment burden that best fits an individual&#146;s needs.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT
 COLOR="#6600ff"><B><I>Guy Young, MD </I></B></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial" ALIGN="justify">Director, Hemostasis and Thrombosis Center at Children&#146;s Hospital, Los
Angeles </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;Qfitlia delivers the fewest doses of any prophylactic therapy in hemophilia, and its unique mechanism
allows it to be used to treat all types of hemophilia, including with inhibitors and hemophilia B, where unmet medical needs remain. By targeting antithrombin, which can be reliably measured with an
<FONT STYLE="white-space:nowrap">FDA-cleared</FONT> blood assay, Qfitlia is proven to help rebalance hemostasis and improve bleed rates and protection.&#148; </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">In the ATLAS clinical development program, Qfitlia demonstrated low bleed rates across subgroups with as few as six injections a year. Key results
include: </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="2%" VALIGN="top" ALIGN="justify"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">&#149;</P></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">Significant bleed reduction by 71% in ABR for patients without inhibitors treated with Qfitlia prophylaxis compared to
clotting factor concentrate <FONT STYLE="white-space:nowrap">on-demand</FONT> (estimated mean: ABR 9.0 vs. 31.4, respectively; p&lt;0.0001) and by 73% in ABR compared to bypassing agent <FONT STYLE="white-space:nowrap">on-demand</FONT> for patients
with inhibitors (estimated mean: ABR 5.1 vs. 19.1, respectively; p=0.0006) </P></TD></TR></TABLE>
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<TD WIDTH="2%" VALIGN="top" ALIGN="justify"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">&#149;</P></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">Median observed ABR during the open-label extension study was 3.8 (IQR: 0.0&#150;11.2) in patients without inhibitors
and 1.9 (IQR: 0.0&#150;5.6) in patients with inhibitors </P></TD></TR></TABLE>
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<TD WIDTH="2%" VALIGN="top" ALIGN="justify"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">&#149;</P></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">Median observed annualized spontaneous bleeding rate during the open-label extension study was 1.9 (interquartile range
(IQR): <FONT STYLE="white-space:nowrap">0.0-7.5)</FONT> in patients without inhibitors and 1.9 (IQR: <FONT STYLE="white-space:nowrap">0.0-3.7)</FONT> in patients with inhibitors </P></TD></TR></TABLE>
<P STYLE="font-size:14pt; 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">Nearly half of patients in the open-label extension study experienced one or fewer bleeds (31% 0 bleeds and 47% <FONT
STYLE="white-space:nowrap">0-1</FONT> bleeds) </P></TD></TR></TABLE> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">There is also the potential for significant adverse reactions, including thrombotic
events, acute and recurrent gallbladder disease, and hepatotoxicity. The most common adverse reactions (incidence &gt;10%) are viral infection, nasopharyngitis, and bacterial infection.<B> </B> </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">In conjunction with the Qfitlia approval, the FDA also cleared the Siemens Healthineers&#146;
INNOVANCE<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP><SUP STYLE="font-size:75%; vertical-align:top"> </SUP>Antithrombin assay as a companion diagnostic for Qfitlia to measure AT levels. Through the Qfitlia Testing Program with Labcorp,
the <FONT STYLE="white-space:nowrap">FDA-cleared</FONT> companion diagnostic will be available to patients prescribed Qfitlia to measure AT levels at no cost. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Qfitlia can offer the fewest doses of all prophylactic therapies, and it will have a comparable price to other prophylactic hemophilia treatments.
HemAssist is launching alongside Qfitlia to provide comprehensive patient support services, including insurance and financial assistance as well as educational resources. This program is for patients prescribed Qfitlia or other hemophilia treatments
from Sanofi&#146;s portfolio. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The FDA granted Qfitlia Orphan Drug Designation for hemophilia A and B, Fast Track Designation for hemophilia A and B
with and without factor VIII or IX inhibitors, and Breakthrough Therapy Designation for hemophilia B with factor IX inhibitors. A regulatory submission for Qfitlia for the treatment of hemophilia A or B in adults and adolescents with or without
inhibitors is under review in Brazil. A regulatory decision is expected in China in the second half of 2025. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#6600ff"><I>About hemophilia </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Hemophilia A and B are rare, congenital, lifelong, bleeding disorders in which the ability of a person&#146;s blood to clot is impaired, leading to
excessive bleeds and spontaneous bleeds into joints that can result in joint damage and chronic pain, and significantly impact quality of life. Hemophilia A and B are caused by a deficiency of factor VIII and IX, respectively, resulting in
insufficient thrombin generation and ineffective clot formation, which is further complicated in people who develop inhibitors to their factor treatment.</P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#6600ff"><I>About the ATLAS clinical development program </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The efficacy and safety of Qfitlia is being investigated in the ATLAS clinical development program. The program includes completed phase 3 studies <FONT
STYLE="white-space:nowrap">ATLAS-INH</FONT> (NCT03417102), <FONT STYLE="white-space:nowrap">ATLAS-A/B</FONT> (NCT03417245), and <FONT STYLE="white-space:nowrap">ATLAS-PPX</FONT> (NCT03549871). There are three ongoing phase 3 studies <FONT
STYLE="white-space:nowrap">ATLAS-NEO</FONT> (NCT05662319), ATLAS-PEDS (NCT03974113), and ATLAS OLE (NCT03754790). </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The ongoing <FONT
STYLE="white-space:nowrap">ATLAS-OLE</FONT> study is a <FONT STYLE="white-space:nowrap">single-arm,</FONT> phase 3, open-label study evaluating the safety and efficacy of Qfitlia with a revised <FONT STYLE="white-space:nowrap">AT-based</FONT> dosing
regimen <FONT STYLE="white-space:nowrap">(AT-DR),</FONT> which was designed to maintain an AT target range of <FONT STYLE="white-space:nowrap">15%-35%</FONT> in patients who have completed a prior phase 3 ATLAS clinical trial. This study includes
lower doses and less-frequent dosing than earlier studies of Qfitlia. The efficacy of Qfitlia <FONT STYLE="white-space:nowrap">AT-DR</FONT> treatment was assessed by comparing the <FONT STYLE="white-space:nowrap">AT-DR</FONT> treatment data from <FONT
STYLE="white-space:nowrap">ATLAS-OLE</FONT> to the control data from studies <FONT STYLE="white-space:nowrap">ATLAS-INH</FONT> and <FONT STYLE="white-space:nowrap">ATLAS-A/B.</FONT> The analyses follow the intent to treat principle. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#6600ff"><I>About Qfitlia </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Qfitlia (fitusiran) is a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> AT lowering therapy approved by
the US FDA for prophylactic treatment of adults and pediatric patients (aged 12 and older) living with hemophilia A and B with or without factor VIII or IX inhibitors, and is administered via subcutaneous injection with a convenient, prefilled pen
for the 50 mg dose. Qfitlia prevents bleeds and helps rebalance hemostasis by lowering AT, a protein that inhibits blood clotting, to promote thrombin generation. Qfitlia is a small interference RNA therapeutic that utilizes Alnylam Pharmaceutical
Inc.&#146;s <FONT STYLE="white-space:nowrap">ESC-GalNAc</FONT> conjugate technology. </P> <P STYLE="font-size:14pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#6600ff"><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
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
