<SEC-DOCUMENT>0001193125-23-061027.txt : 20230306
<SEC-HEADER>0001193125-23-061027.hdr.sgml : 20230306
<ACCEPTANCE-DATETIME>20230306115726
ACCESSION NUMBER:		0001193125-23-061027
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20230306
FILED AS OF DATE:		20230306
DATE AS OF CHANGE:		20230306

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:		23708164

	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>d451787d6k.htm
<DESCRIPTION>6-K
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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 March 2023 </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&nbsp;&nbsp;&#9746;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form</FONT> <FONT STYLE="white-space:nowrap">40-F&nbsp;&nbsp;&#9744;</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; 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:12pt; margin-bottom:0pt; font-size:10pt; 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="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 2023, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated
herein by reference. </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP> <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; ">Exhibit&nbsp;No.</P></TD>
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<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; " ALIGN="center">Description</P></TD></TR>


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<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.1</TD>
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<TD VALIGN="top"><A HREF="d451787dex991.htm">Press Release dated March&nbsp;
2, 2023: Completed XTEND-Kids Phase 3 study strengthens potential of ALTUVIIIO<SUP STYLE="font-size:75%; vertical-align:top">TM</SUP> to redefine expectations for treatment of children &lt;12 years of age with hemophilia A </A></TD></TR>
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 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">2 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top">Dated: March&nbsp;6, 2023</TD>
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<TD VALIGN="top" COLSPAN="3" ALIGN="center">SANOFI</TD></TR>
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<TD VALIGN="top">By</TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Alexandra Roger</P></TD></TR>
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<TD VALIGN="top">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:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">3 </P>

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<TYPE>EX-99.1
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 <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:18pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Completed XTEND-Kids Phase 3 study strengthens potential of ALTUVIIIO<SUP
STYLE="font-size:75%; vertical-align:top">TM</SUP> to redefine expectations for treatment of children &lt;12 years of age with hemophilia A </I></FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>Paris,
March</B><B></B><B>&nbsp;2, 2023. </B>The XTEND-Kids phase 3 pivotal study evaluating the safety, efficacy and pharmacokinetics of ALTUVIIIO as once-weekly prophylaxis in previously treated patients &lt;12 years of age with severe hemophilia A met
its primary endpoint of safety, with no FVIII inhibitors detected in 74 children, with more than 50 children experiencing at least 50 exposure days, nearly a full year of treatment. The completion of XTEND-Kids represents the final milestone needed
for regulatory submission in the EU. </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>Karin Knobe, MD, PhD </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL">Therapeutic Area Head, Rare Diseases and Rare Blood Disorders, Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:4%; font-size:10pt; font-family:ARIAL"><I>&#147;At Sanofi, we never settle. We work alongside patients, caregivers, and advocacy organizations to understand the needs of the
hemophilia community and pursue <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> technologies to meet those needs. We strive for a future where every child with hemophilia can play without fear, travel
free from a rigid treatment schedule, and pursue their dreams unencumbered by worry.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Hemophilia A is a rare, lifelong condition in which the ability of a
person&#146;s blood to clot properly is impaired, leading to excessive bleeds and spontaneous bleeds into joints that can result in joint damage and chronic pain, and potentially impact quality of life. The severity of hemophilia is determined by
the level of clotting factor activity in a person&#146;s blood, and there is a negative correlation between risk of bleeding and factor activity levels. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">ALUTVIIIO
is a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class,</FONT></FONT> high-sustained FVIII therapy <FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U>approved</U></FONT><FONT STYLE="font-family:ARIAL">
by the US Food and Drug Administration (FDA) for routine prophylaxis, <FONT STYLE="white-space:nowrap">on-demand</FONT> treatment and control of bleeding episodes, and perioperative management of bleeding in adults and children in February 2023.
Granted </FONT><FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U>Breakthrough Therapy designation</U></FONT><FONT STYLE="font-family:ARIAL"> by the FDA in May 2022&#151;the first FVIII therapy to receive this
designation&#151;ALTUVIIIO also received </FONT><FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U>Fast Track designation</U></FONT><FONT STYLE="font-family:ARIAL"> in February 2021 and Orphan Drug designation in 2017. The European
Commission granted Orphan Drug designation in June 2019. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About XTEND-Kids</I><B> </B><I> </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">The XTEND-Kids study (NCT04759131) was an open-label, <FONT STYLE="white-space:nowrap">non-randomized</FONT> interventional study of the safety, efficacy, and
pharmacokinetics of once-weekly ALTUVIIIO in previously treated patients younger than 12 years of age with severe hemophilia A. Patients received once-weekly ALTUVIIIO prophylaxis (50 IU/kg) for 52 weeks which provided high-sustained FVIII levels
throughout the weekly dosing interval with a median (IQR) annualized bleeding rate (ABR) of 0.00 (0.00, 1.02) and an estimated mean (95% CI) ABR of 0.89 (0.56 ; 1.42). The primary endpoint was the occurrence of inhibitor development (baseline to 52
weeks). No inhibitors were detected in this study. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About ALTUVIIIO<SUP STYLE="font-size:75%; vertical-align:top">&#153;</SUP>
</I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">ALTUVIIIO [Antihemophilic Factor (Recombinant), <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">Fc-VWF-XTEN</FONT></FONT> Fusion
Protein-ehtl] is a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> high-sustained factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for adults
and children with hemophilia A. ALTUVIIIO has a 3 to 4 fold longer half-life relative to standard and extended half-life factor VIII products, providing high-sustained factor activity levels throughout
(<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>40%) for most of the week and at 15% at the end of the dosing interval. ALTUVIIIO is the first factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which
imposes a half-life limitation on earlier generation factor VIII therapies. ALTUVIIIO builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and
XTEN<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>&nbsp;polypeptides to extend its time in circulation. XTEN<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> is a registered trademark of Amunix Pharmaceuticals, Inc. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About the XTEND Clinical Programs </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">The XTEND clinical program is comprised of two Phase 3 trials in hemophilia A: <FONT STYLE="white-space:nowrap">XTEND-1</FONT> in people 12 years or older and XTEND-Kids
in children younger than 12 years old. There is also an ongoing extension study (XTEND-ed). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">The Phase 3 <FONT STYLE="white-space:nowrap">XTEND-1</FONT> study
(NCT04161495)&nbsp;was&nbsp;an open-label, <FONT STYLE="white-space:nowrap">non-randomized</FONT> interventional study assessing the safety, efficacy, and pharmacokinetics of&nbsp;once-weekly&nbsp;ALTUVIIIO in people 12 years of age or older (n=159)
with severe hemophilia A who were previously treated with factor VIII replacement therapy.&nbsp;The study consisted of two parallel treatment arms &#151; the prophylaxis Arm A (n=133), in which patients who had received prior factor VIII prophylaxis
were treated with once-weekly intravenous&nbsp;ALTUVIIIO prophylaxis&nbsp;(50 IU/kg) for 52 weeks, and the <FONT STYLE="white-space:nowrap">on-demand</FONT> Arm B (n=26), in which patients who had received prior
<FONT STYLE="white-space:nowrap">on-demand</FONT> factor&nbsp;VIII&nbsp;therapy began with 26 weeks of <FONT STYLE="white-space:nowrap">on-demand&nbsp;ALTUVIIIO&nbsp;(50</FONT> IU/kg), then switched to once-weekly prophylaxis with ALTUVIIIO (50
IU/kg) for an additional 26 weeks. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">The primary efficacy endpoint of <FONT STYLE="white-space:nowrap">XTEND-1</FONT> was the mean&nbsp;annualized bleeding rate
(ABR)&nbsp;in Arm A, and the key secondary endpoint was an intra-patient comparison of ABR during the ALTUVIIIO weekly prophylaxis treatment period versus the prior&nbsp;factor VIII&nbsp;prophylaxis ABR for a subset of participants in Arm A
who&nbsp;had&nbsp;participated&nbsp;in a previous observational study (Study 242HA201/OBS16221). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">The XTEND-Kids study (NCT04759131) was an open-label, <FONT
STYLE="white-space:nowrap">non-randomized</FONT> interventional study of the safety, efficacy, and pharmacokinetics of once-weekly ALTUVIIIO in previously treated patients younger than 12 years of age with severe hemophilia A. Patients received
once-weekly ALTUVIIIO prophylaxis (50 IU/kg) for 52 weeks. The primary endpoint was the occurrence of inhibitor development. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About the Sanofi and Sobi collaboration </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Sobi and Sanofi collaborate on the development and commercialization of Alprolix<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> and Elocta<SUP
STYLE="font-size:75%; vertical-align:top">&reg;</SUP>/Eloctate<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>. The companies also collaborate on the development and commercialization of efanesoctocog alfa, or ALTUVIIIO in the US. Sobi has
final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Sanofi has final development and commercialization rights in North America and all other regions in the
world excluding the Sobi territory. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Sobi<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to
innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East, Asia and Australia. In 2022, revenue amounted to SEK 18.8&nbsp;billion.
Sobi&#146;s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at&nbsp;sobi.com,&nbsp;<U>LinkedIn</U> and&nbsp;<U>YouTube</U>. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><I>About Sanofi </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">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:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL">Sanofi is listed on EURONEXT: SAN
and NASDAQ: SNY </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>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="#7a00e6"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sally
Bain</B><B></B>&nbsp;|&nbsp;+ 1 617 834 6026 |&nbsp;<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><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>Evan Berland</B> | +1 215 432 0234 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>evan.berland@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Kate
Conway</B><B></B>&nbsp;|&nbsp;+ 1&nbsp;508 364 4931 |&nbsp;<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>kate.conway@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Victor Rouault</B><B></B>&nbsp;|&nbsp;+ 33 6 70 93 71 40 |&nbsp;<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>victor.rouault@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&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:Times New Roman"><FONT COLOR="#7a00e6"><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="#7a00e6"><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="#7a00e6"><U>arnaud.delepine@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Corentine Driancourt</B><B></B>&nbsp;|&nbsp;+ 33 6 40 56 92 21 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><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="#7a00e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Tarik Elgoutni|</B> + 1 617 710 3587 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>tarik.elgoutni@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Nathalie Pham</B><B></B>&nbsp;|&nbsp;+ 33 7 85 93 30 17 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>nathalie.pham@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><I>Sobi Contacts: </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Media Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL">For Sobi Media contacts, click <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>here</U></FONT><FONT STYLE="font-family:ARIAL">. </FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL">For details on how
to contact the Sobi Investor Relations Team, click <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>here</U></FONT><FONT STYLE="font-family:ARIAL">. </FONT></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">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 <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, 2022. 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:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
