<SEC-DOCUMENT>0001193125-22-289614.txt : 20221121
<SEC-HEADER>0001193125-22-289614.hdr.sgml : 20221121
<ACCEPTANCE-DATETIME>20221121100500
ACCESSION NUMBER:		0001193125-22-289614
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20221121
FILED AS OF DATE:		20221121
DATE AS OF CHANGE:		20221121

FILER:

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

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-31368
		FILM NUMBER:		221403889

	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
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 <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:10pt;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:10pt; 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:10pt; 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:10pt;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:10pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">For the month of
November 2022 </P> <P STYLE="margin-top:10pt; 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:10pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>SANOFI </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">(Translation of
registrant&#146;s name into English) </P> <P STYLE="margin-top:10pt; 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:10pt; 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:10pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Form <FONT STYLE="white-space:nowrap">20-F&nbsp;&nbsp;&#9746;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</FONT>
Form <FONT STYLE="white-space:nowrap">40-F&nbsp;&nbsp;&#9744;</FONT> </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">Indicate by check mark if the registrant is submitting the Form <FONT
STYLE="white-space:nowrap">6-K</FONT> in paper as permitted by Regulation <FONT STYLE="white-space:nowrap">S-T</FONT> Rule 101(b)(1): ________ </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">Indicate by
check mark if the registrant is submitting the Form <FONT STYLE="white-space:nowrap">6-K</FONT> in paper as permitted by Regulation <FONT STYLE="white-space:nowrap">S-T</FONT> Rule 101(b)(7): ________ </P>
 <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">1 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">In November 2022, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated
herein by reference. </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P> <P STYLE="font-size:24pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" ALIGN="center"><U>Description</U></TD></TR>


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<TD VALIGN="top" NOWRAP><FONT STYLE="font-size:10pt">Exhibit&nbsp;99.1</FONT></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d613490dex991.htm">Press Release dated November&nbsp;
17, 2022: European Commission approves Enjaymo<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (sutimlimab) for treatment of hemolytic anemia in adult patients with cold agglutinin disease </A></TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; 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:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top">Dated: November&nbsp;21, 2022</TD>
<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="top" ALIGN="center">SANOFI</TD></TR>
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<TD VALIGN="top">By&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"><U>/s/ Alexandra
Roger&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</U></TD></TR>
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<TD VALIGN="top">Name: Alexandra Roger</TD></TR>
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<TD VALIGN="top">Title: Head of Securities Law and Capital Markets</TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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</TABLE> <P STYLE="margin-top:20pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>European Commission approves
Enjaymo<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (sutimlimab) for treatment of hemolytic anemia in adult patients with cold agglutinin disease </I></FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">Enjaymo is the <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-and-only</FONT></FONT> approved
therapeutic option approved for hemolytic anemia in adult patients with cold agglutinin disease </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris, November 17, 2022.</B>
The European Commission (EC) has granted marketing authorization for Enjaymo<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP><SUP STYLE="font-size:75%; vertical-align:top"> </SUP>(sutimlimab) for the treatment of<I> </I>hemolytic anemia in
adult patients with cold agglutinin disease (CAD), a rare, serious, and chronic autoimmune hemolytic anemia, where the body&#146;s immune system mistakenly attacks healthy red blood cells and causes their rupture, known as hemolysis. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Dietmar Berger, MD, PhD </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL">Chief Medical Officer, Global Head of Development at Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;This approval highlights our ambition to develop first- and <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">best-in-class</FONT></FONT> medicines that transform people&#146;s lives. Up until now, patients in Europe had to rely on a combination of cold avoidance, blood transfusions and
<FONT STYLE="white-space:nowrap">off-label</FONT> treatments to manage their disease. The approval of Enjaymo by the European Commission provides patients, for the first time, with access to a therapy that can make a meaningful difference in the
treatment and daily experience of living with CAD.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Enjaymo is currently the only approved treatment for CAD and is a <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> humanized monoclonal antibody that is designed to selectively target and inhibit the classical complement pathway specific serine protease, C1s. It will be
available as a 50mg/mL solution for infusion. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Alexander R&ouml;th, MD </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL">Department of Hematology and Stem Cell Transplantation, University Hospital, University of Duisburg-Essen, Germany </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;Coupled with diagnostic journeys that can last years, the impact of fatigue on quality of life in CAD
is often debilitating and is comparable to conditions such as cancer-related anemia and other autoimmune disorders. Clinicians now have a much-needed therapeutic option to offer to their patients.&#148; </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>About the CADENZA and CARDINAL Clinical Trials </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The EC
approval is based on data from two Phase 3 clinical trials: CADENZA, a double-blind, placebo-controlled clinical trial of adults with CAD without a recent history of blood transfusion (within the past 6 months), and CARDINAL, a <FONT
STYLE="white-space:nowrap">26-week</FONT> open label, <FONT STYLE="white-space:nowrap">single-arm</FONT> pivotal study in patients with CAD who have had a recent blood transfusion. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In the CADENZA Part A trial, eligible patients were randomized 1:1 to receive a fixed weight-based dose (6.5g or 7.5g) of Enjaymo or placebo via
intravenous infusion on Day 0, Day 7, and then once every other week up to Week 26. The open-label Part B of the study assessed long-term safety as well as durability of response to Enjaymo in patients with CAD. In the CADENZA Part A study, Enjaymo
met its primary composite endpoint and all secondary endpoints and demonstrated inhibition of hemolysis, increase in hemoglobin levels, and clinically meaningful improvement in The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
scores. Enjaymo demonstrated an acceptable safety profile and was generally well-tolerated. 96% of patients in the Enjaymo group and 100% of patients in the placebo group experienced at least one treatment emergent adverse event (TEAE). Headache
(22.7% vs 10.0%), hypertension (22.7% vs 0%), rhinitis (18.2% vs 0%), Raynaud phenomenon (18.2% vs 0%), and acrocyanosis (13.6% vs 0%) were reported more frequently in Enajymo-treated patients compared with placebo. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In the CARDINAL Part A trial, patients received a fixed weight-based dose (6.5g or 7.5g) of Enjaymo
via intravenous infusion on Day 0, Day 7, and then once every other week up to Week 26. Part B of the study evaluated the long-term safety as well as durability of response to Enjaymo in patients with CAD over a
<FONT STYLE="white-space:nowrap">2-year</FONT> follow up. In the CARDINAL Part A study, the efficacy of Enjaymo was assessed based on the achievement of a primary composite endpoint (Hb<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>12 g/dL
or an increase of at least 2 g/dL; no blood transfusion or prohibited medications from Weeks 5 through 26) and different secondary endpoints, including improvements in hemoglobin, normalization of bilirubin, and FACIT-fatigue score. The most common
adverse reactions occurring in 10% or more of patients were respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and peripheral edema. Serious adverse reactions were reported in 13% (3/24) of patients who
received Enjaymo. These serious adverse reactions were streptococcal sepsis and staphylococcal wound infection (n=1), arthralgia (n=1), and respiratory tract infection (n=1). </P> <P STYLE="font-size:24pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #7f7f7f">&nbsp;</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Enjaymo<SUP
STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (sutimlimab) </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Enjaymo is a humanized monoclonal antibody that is designed to
selectively target and inhibit C1s in the classical complement pathway, which is part of the innate immune system. By blocking C1s, Enjaymo inhibits the activation of the complement cascade in the immune system and inhibits <FONT
STYLE="white-space:nowrap">C1-activated</FONT> hemolysis in CAD to prevent the abnormal destruction of healthy red blood cells. Enjaymo does not inhibit the lectin and alternative pathways. Enjaymo was approved by the US Food and Drug Administration
(FDA) in February 2022 as the first and only treatment indicated to decrease the need for red blood cell transfusion due to hemolysis in adults with CAD. The Japanese Ministry of Health, Labor and Welfare approved Enjaymo in June 2022. The European
Medicines Agency (EMA) also made the decision to maintain orphan designation. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#9f11e6"><I>About cold agglutinin disease </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Cold agglutinin disease (CAD) is a rare type of autoimmune hemolytic anemia, where part of the body&#146;s immune system mistakenly destroys healthy red
blood cells (hemolysis). CAD impacts the lives of an estimated 12,000 people in the US, Europe, and Japan and is associated with profound fatigue and increased risk of thromboembolic events and mortality. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#9f11e6"><I>About Sanofi </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">We are
an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people&#146;s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the
impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:ARIAL">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#9f11e6"><I>Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sandrine
Guendoul</B><B></B>&nbsp;|&nbsp;+ 33 6 25 09 14 25 |&nbsp;<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#6e00b8"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sally Bain</B><B></B>&nbsp;|&nbsp;+ 1 617 834 6026 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#9f11e6"><U>sally.bain@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Kate Conway</B><B></B>&nbsp;|&nbsp;+ 1&nbsp;508 364 4931
|&nbsp;<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#9f11e6"><U>kate.conway@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#6e00b8"><I>Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Eva Schaefer-Jansen</B><B></B>&nbsp;|&nbsp;+ 33 7 86 80 56 39 |&nbsp;<FONT
STYLE="font-family:ARIAL; font-size:8pt" COLOR="#9f11e6"><U>eva.schaefer-jansen@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Arnaud
Del&eacute;pine</B><B></B>&nbsp;|&nbsp;+ 33 6 73 69 36 93 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#9f11e6"><U>arnaud.delepine@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Corentine Driancourt</B><B></B>&nbsp;|&nbsp;+ 33 6 40 56 92 21 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#9f11e6"><U>corentine.driancourt@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Felix
Lauscher</B><B></B>&nbsp;|&nbsp;+ 1&nbsp;908&nbsp;612 7239 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#9f11e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Priya Nanduri</B><B></B>&nbsp;|&nbsp;+ 1 617 764 6418| <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#9f11e6"><U>priya.nanduri@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Nathalie Pham</B><B></B>&nbsp;|&nbsp;+ 33 7 85 93 30 17 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#9f11e6"><U>nathalie.pham@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #7f7f7f">&nbsp;</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL"><B>Sanofi Forward-Looking Statements </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL" ALIGN="justify">This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking
statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;, &#147;believes&#148;, &#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although Sanofi&#146;s management believes
that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and
</P>
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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 <FONT
STYLE="white-space:nowrap">COVID-19</FONT> will 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, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise
any forward-looking information or statements. </P>
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