<SEC-DOCUMENT>0001193125-25-194750.txt : 20250903
<SEC-HEADER>0001193125-25-194750.hdr.sgml : 20250903
<ACCEPTANCE-DATETIME>20250903124417
ACCESSION NUMBER:		0001193125-25-194750
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20250903
FILED AS OF DATE:		20250903
DATE AS OF CHANGE:		20250903

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:		251288402

	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>d52080d6k.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:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:24pt; 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:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">For the month of September 2025 </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:20pt; 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&#8217;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:30pt; 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;&#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 August 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:9pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom"><U>Exhibit&nbsp;No.</U></TD>
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<TD VALIGN="bottom" ALIGN="center"><U>Description</U>&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8194;</TD></TR>
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<TD VALIGN="top">Exhibit&nbsp;99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d52080dex991.htm">Press Release dated August&nbsp;29, 2025: Sanofi&#8217;s Wayrilz approved in US as first BTK inhibitor for immune thrombocytopenia </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:6%; 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:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom">Dated: September&nbsp;3, 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&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;</TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">By&#8195;&#8195;</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">/s/&nbsp;<U>Alexandra&nbsp;Roger&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;</U></TD></TR>
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<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Name: Alexandra Roger</TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Title:&nbsp;Head&nbsp;of&nbsp;Legal&nbsp;Corporate&nbsp;&amp;&nbsp;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:9pt; font-family:Times New Roman" ALIGN="center">3 </P>

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<TYPE>EX-99.1
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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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<TD VALIGN="bottom"><FONT STYLE="font-family:Verdana; font-size:14pt"><B>Press Release</B></FONT></TD>
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</TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7900e6"><I>Sanofi&#8217;s Wayrilz approved in US as first BTK inhibitor for immune thrombocytopenia
</I></FONT></P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Novel treatment targets BTK through multi-immune modulation to help address root causes of ITP </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Approval based on LUNA 3 phase 3 study that demonstrated rapid and durable platelet response and improvements in other
ITP symptoms </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of
life; more than 25,000 US adults could benefit from advanced treatment </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify"><B>Paris, August</B><B></B><B>&nbsp;29, 2025</B> &#8211;
The US Food and Drug Administration (FDA) has approved Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The approval was based on the pivotal
LUNA 3 phase 3 study, in which Wayrilz met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:6%; font-size:10pt; font-family:Verdana" ALIGN="justify"><I>&#8220;The burden of immune thrombocytopenia can be both physical and emotional with significant overlooked symptoms that can
impact various aspects of daily living,&#8221; said</I><B><I> Caroline Kruse</I></B><I>,</I><B><I> </I></B><I>President and CEO at the Platelet Disorder Support Association.</I><B><I> </I></B><I>&#8220;We are pleased to have a new treatment option
that can help ease the ongoing strain of managing the disease for patients and their families.&#8221;</I> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">As a novel oral, reversible,
Bruton&#8217;s tyrosine kinase (BTK) inhibitor, Wayrilz can help address the root causes of ITP through multi-immune modulation, targeting different pathways across the immune system. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:6%; font-size:10pt; font-family:Verdana" ALIGN="justify">&#8220;<I>With its differentiated mechanism of action, </I><I>Wayrilz</I><I> has the potential to become a treatment of choice for
immune thrombocytopenia patients who have not responded to a prior therapy,</I><I>&#8221;</I><I> said</I><B><I> </I></B><B><I>Brian Foard</I></B><I>,</I><I> </I>Executive Vice President, Head of Specialty Care at Sanofi.<I> </I><I>&#8220;</I><I>Its
multi-immune modulation approach shows promise in addressing the key drivers of immune thrombocytopenia, which aligns with Sanofi&#8217;s commitment to adapting and evolving therapeutic solutions to help tackle ongoing unmet patient needs. This
approval underscores Sanofi&#8217;s expertise and ambitions at the junction of rare and immunological disease.&#8221; </I> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The LUNA 3 phase 3
study, <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>presented</U></FONT><FONT STYLE="font-family:Verdana"> at the 66th American Society of Hematology&nbsp;Annual Meeting and Exposition, evaluated the efficacy and safety of
Wayrilz compared to placebo in adults (n=202) with persistent or chronic ITP. Patients who achieved platelet count response at 12 weeks were eligible to continue the full <FONT STYLE="white-space:nowrap">24-week</FONT> double-blind period (64% of
patients in the Wayrilz arm and 32% of patients in the placebo arm). Patients receiving Wayrilz experienced the following compared to patients receiving placebo: </FONT></P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Statistically significant durable platelet response at week 25 (23% of patients in Wayrilz arm vs. 0% in placebo arm;
p&lt;0.0001)</P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Faster time to first platelet response (36 days in Wayrilz arm vs. not reached in placebo arm; p&lt;0.0001)
</P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Longer duration of platelet response (least square mean of 7 weeks in Wayrilz arm vs. 0.7 weeks in placebo arm)
</P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Patients receiving Wayrilz reported an overall <FONT STYLE="white-space:nowrap">10.6-point</FONT> improvement across nine
health-related quality of life measures compared to a <FONT STYLE="white-space:nowrap">2.3-point</FONT> increase in the placebo arm, based on The Immune Thrombocytopenia Patient Assessment Questionnaire, a clinical tool designed to measure ITP
symptoms. The results of this analysis are descriptive and were not powered for statistical significance. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The most common adverse reactions (incidence
<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>10%) are diarrhea, nausea, headache, abdominal pain, and <FONT STYLE="white-space:nowrap">COVID-19.</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:6%; font-size:10pt; font-family:Verdana" ALIGN="justify"><I>&#8220;Traditionally, immune thrombocytopenia management has focused on restoring platelet counts and reducing bleeding risk, which
for some patients may result in suboptimal responses, persistent symptoms, or unacceptable treatment complications,&#8221; said </I><B><I>David Kuter, MD</I></B><I>, Director of Clinical Hematology at Massachusetts General Hospital and Professor of
Medicine at Harvard Medical School, study author. &#8220;Through multi-immune modulation, Wayrilz can offer a new option for patients, including those who fail steroids or do not respond to existing treatment.&#8221;</I> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Wayrilz was approved in the United Arab Emirates for adult patients with persistent or chronic ITP who have had an insufficient response or
intolerance to a previous treatment in June 2025. Wayrilz is currently under regulatory review for ITP in the EU and China. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">It received Fast
Track and Orphan Drug Designations (ODD) from the FDA for ITP, with similar orphan designations in Japan and the EU. Most recently, the FDA granted Wayrilz ODD for three additional rare diseases, including warm autoimmune hemolytic anemia (wAIHA),
IgG4-related disease <FONT STYLE="white-space:nowrap">(IgG4-RD),</FONT> and sickle cell disease (SCD). Wayrilz also received FDA Fast Track Designation and European Medicines Agency orphan designation in
<FONT STYLE="white-space:nowrap">IgG4-RD.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Wayrilz patients will have access to Sanofi&#8217;s HemAssist patient support program that
offers assistance for all treatments within Sanofi&#8217;s rare blood disorder portfolio. HemAssist aims to help patients and their caregivers with the support they need throughout their treatment journey, including navigation of access and
insurance coverage, determining eligibility for financial assistance programs, and providing educational resources. Patient costs for treatment will vary based on insurance and patients without insurance coverage can work with HemAssist to identify
potential options by visiting <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>https://www.sanofihemassist.com</U></FONT><FONT STYLE="font-family:Verdana"> or by calling <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">1-833-723-5463.</FONT></FONT></FONT> </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7900e6"><I>About the LUNA 3
study </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">LUNA 3 (clinical study identifier: <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>NCT04562766</U></FONT><FONT
STYLE="font-family:Verdana">) was a randomized, multicenter, phase 3 study evaluating the efficacy and safety of Wayrilz vs. placebo in adult and adolescent patients with persistent or chronic ITP. Patients received either oral Wayrilz 400 mg twice
a day or placebo through a <FONT STYLE="white-space:nowrap">12-</FONT> to <FONT STYLE="white-space:nowrap">24-week</FONT> double-blind treatment period, followed by a <FONT STYLE="white-space:nowrap">28-week</FONT> open-label treatment period, and
then a <FONT STYLE="white-space:nowrap">4-week</FONT> safety <FONT STYLE="white-space:nowrap">follow-up</FONT> or long-term extension period. The adolescent part of the study is ongoing. The primary endpoint is durable platelet response, defined as
the proportion of participants able to achieve platelet counts at or above 50,000/&micro;L for more than <FONT STYLE="white-space:nowrap">two-thirds</FONT> of at least 8 <FONT STYLE="white-space:nowrap">non-missing</FONT> weekly scheduled platelet
measurements during the last 12 weeks of the <FONT STYLE="white-space:nowrap">24-week</FONT> blinded treatment period in the absence of rescue therapy. Secondary endpoints included time to platelet response (platelet&nbsp;count&nbsp;<FONT
STYLE="font-family:Times New Roman">&#8805;</FONT>50 x 10<SUP STYLE="font-size:75%; vertical-align:top">9</SUP>/L&nbsp;or&nbsp;between&nbsp;30x10<SUP STYLE="font-size:75%; vertical-align:top">9</SUP>/L and&nbsp;&lt;50x10<SUP
STYLE="font-size:75%; vertical-align:top">9</SUP>/L&nbsp;and&nbsp;at&nbsp;least&nbsp;doubled&nbsp;from&nbsp;baseline in absence of rescue therapy), number of weeks maintaining a specific platelet response (i.e., doubled or within range), rescue
therapy use, physical fatigue score, and bleeding score. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7900e6"><I>About Wayrilz </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Wayrilz (rilzabrutinib) is the first BTK inhibitor for ITP that helps address the root cause of disease through multi-immune modulation. This
innovative therapy is approved in the US for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Additionally, Wayrilz is approved in the United Arab Emirates for adult
patients with persistent or chronic ITP who have had an insufficient response or intolerance to a previous treatment. BTK, expressed in B cells, macrophages, and other innate immune cells, plays a critical role in multiple immune-mediated disease
processes and inflammatory pathways. With the application of Sanofi&#8217;s TAILORED COVALENCY<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> technology, Wayrilz can selectively inhibit the BTK target. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Wayrilz is being studied across a variety of rare diseases, including wAIHA, <FONT STYLE="white-space:nowrap">IgG4-RD,</FONT> and SCD. These
additional indications are currently under investigation and have not been approved by regulatory authorities.<B> </B> </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>About ITP </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">ITP is a disease of complex immune dysregulation that causes low platelet counts (&lt;100,000/&micro;L), resulting in a variety of bleeding symptoms
and thromboembolism risk. Beyond bruising and bleeding, which can include potentially life-threatening episodes like intracranial hemorrhage, people living with ITP may experience reduced quality of life, including physical fatigue and cognitive
impairment. </P> <P STYLE="margin-top:12pt; 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" ALIGN="justify">Sanofi is an R&amp;D driven, <FONT STYLE="white-space:nowrap">AI-powered</FONT> biopharma company committed to improving people&#8217;s lives and
delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is
guided by one purpose: we chase the miracles of science to improve people&#8217;s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare,
environmental, and societal challenges of our time. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family: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><B></B>&nbsp;|&nbsp;+33 6 25 09 14 25 |<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>&nbsp;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>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><B></B>&nbsp;|&nbsp;+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><B></B>&nbsp;|&nbsp;+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:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>L&eacute;a Ubaldi</B><B></B>&nbsp;| +33 6 30 19 66 46
|&nbsp;<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>lea.ubaldi@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:12pt; 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><B></B>&nbsp;|&nbsp;+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><B></B>&nbsp;|&nbsp;+1&nbsp;908&nbsp;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><B></B>&nbsp;|&nbsp;+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><B></B>&nbsp;|&nbsp;+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"> <B></B> </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.li@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana">
</FONT></P> <P STYLE="margin-top:12pt; 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 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 &#8220;expects&#8221;, &#8220;anticipates&#8221;, &#8220;believes&#8221;,
&#8220;intends&#8221;, &#8220;estimates&#8221;, &#8220;plans&#8221;, and similar expressions. Although Sanofi&#8217;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 &#8220;Risk Factors&#8221; and &#8220;Cautionary
Statement Regarding Forward-Looking Statements&#8221; in Sanofi&#8217;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:12pt; 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>
