<SEC-DOCUMENT>0001193125-23-192069.txt : 20230724
<SEC-HEADER>0001193125-23-192069.hdr.sgml : 20230724
<ACCEPTANCE-DATETIME>20230724124350
ACCESSION NUMBER:		0001193125-23-192069
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20230724
FILED AS OF DATE:		20230724
DATE AS OF CHANGE:		20230724

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:		231104303

	BUSINESS ADDRESS:	
		STREET 1:		46 AVENUE DE LA GRANDE ARMEE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75017
		BUSINESS PHONE:		33153774400

	MAIL ADDRESS:	
		STREET 1:		46 AVENUE DE LA GRANDE ARMEE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75017

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SANOFI-AVENTIS
		DATE OF NAME CHANGE:	20040826

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SANOFI SYNTHELABO SA
		DATE OF NAME CHANGE:	20010104
</SEC-HEADER>
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<TYPE>6-K
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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:14pt;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: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:8pt;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:9pt; font-family:Times New Roman" ALIGN="center">For the month of
July 2023 </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:12pt; 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: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:12pt; 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&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: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 July 2023, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated herein
by reference. </P> <P STYLE="margin-top:30pt; 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="top" NOWRAP>Exhibit&nbsp;99.1</TD>
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<TD VALIGN="top"><A HREF="d545759dex991.htm">Press Release dated July&nbsp;17, 2023:<B> </B>FDA approves Beyfortus<SUP STYLE="font-size:75%; vertical-align:top">&#153;</SUP> (nirsevimab-alip) to protect infants against RSV 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: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:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top">Dated: July&nbsp;24, 2023</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" COLSPAN="3" NOWRAP ALIGN="center">SANOFI&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;
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<TD VALIGN="bottom" NOWRAP>By</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP><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;&nbsp;&nbsp;</U></TD></TR>
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<TD VALIGN="bottom" NOWRAP>Name: Alexandra Roger</TD></TR>
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<TD VALIGN="bottom" NOWRAP>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:9pt; font-family:Times New Roman" ALIGN="center">3 </P>

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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:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>FDA approves Beyfortus<SUP STYLE="font-size:75%; vertical-align:top">&#153;</SUP>
(nirsevimab-alip) to protect infants against RSV 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"><FONT STYLE="font-family:Times New Roman">&#9679;</FONT></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"><I>Beyfortus</I><I><SUP STYLE="font-size:75%; vertical-align:top">&#153;</SUP></I><I> </I>is the first monoclonal
antibody approved to protect all infants through their first RSV season </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:ARIAL; font-size:10pt">Across all clinical endpoints, a single dose of <I>Beyfortus </I>delivered high, consistent and sustained efficacy and
favorable safety against RSV disease </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:ARIAL; font-size:10pt">Approval also includes use for children up to 24 months of age who remain vulnerable to severe RSV disease through their
second RSV season </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris, July</B><B></B><B>&nbsp;17, 2023</B>. The U.S. Food and Drug Administration (FDA) has approved Sanofi
and AstraZeneca&#146;s <I>Beyfortus</I><SUP STYLE="font-size:75%; vertical-align:top">&#153;</SUP> (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during
or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. The companies plan to make <I>Beyfortus </I>available in the U.S. ahead of the upcoming
2023-2024 RSV season. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">RSV is the leading cause of hospitalization for infants under the age of one in the U.S., averaging 16 times higher than the
annual rate for influenza.<SUP STYLE="font-size:75%; vertical-align:top">1,2</SUP> Each year, an estimated 590,000 RSV disease cases in infants under one require medical care, including physician office, urgent care, emergency room visits and
hospitalizations.<SUP STYLE="font-size:75%; vertical-align:top">3</SUP> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><B><I>Thomas Triomphe
</I></B></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL">Executive Vice President, Vaccines, 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;Today&#146;s approval marks an unprecedented moment for protecting infant health in the U.S.,
following an RSV season that took a record toll on infants, their families, and the U.S. healthcare system. Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during
their first RSV season. I am proud that, by prioritizing this potential game-changer, we are now about to bring Beyfortus to American families.&#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="#7a00e6"><B><I>Iskra Reic </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL">Executive Vice President, Vaccines and Immune Therapies, AstraZeneca </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;Beyfortus represents an opportunity for a paradigm-shift in preventing serious respiratory disease
due to RSV across a broad infant population in the U.S. The science that Beyfortus is built on demonstrates AstraZeneca&#146;s continued leadership in addressing the needs of the most vulnerable populations and reducing the burden on healthcare
systems.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The FDA decision follows the <FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#0562c1"><U>positive
recommendation</U></FONT><FONT STYLE="font-family:ARIAL"> of the FDA Antimicrobial Drugs Advisory Committee and was based on the extensive <I>Beyfortus </I>clinical development program spanning three pivotal late-stage clinical trials. Across all
clinical endpoints, a single dose of <I>Beyfortus </I>demonstrated high and consistent efficacy against RSV LRTD extending through five months, a typical RSV season. </FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><I>Beyfortus </I>was well tolerated with a favorable safety profile that was consistent across all clinical trials. The overall rates of adverse events
were comparable between <I>Beyfortus </I>and placebo and the majority of adverse events were mild or moderate in severity. The most common adverse events were rash and injection site reactions. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The single administration of <I>Beyfortus </I>was developed to correspond with the beginning of the RSV season for babies born prior to the season or at
birth for those born during the RSV season. In clinical trials, <I>Beyfortus </I>helped prevent RSV LRTD requiring medical care in all infant populations studied, including those born healthy at term, late preterm or preterm, or with specific health
conditions that make them vulnerable to severe RSV disease. RSV disease </P>
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requiring medical care included physician office, urgent care, emergency room visits and hospitalizations. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><I>Beyfortus, </I>jointly developed by Sanofi and AstraZeneca, was approved in the European Union in October 2022, in Great Britain in November 2022,
and recently received approval in Canada in April 2023. Regulatory applications are also currently under review in China, Japan and several other countries. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>About RSV </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">RSV is a very contagious virus that can lead to serious respiratory illness for infants, according to the Centers for Disease Control and Prevention
(CDC). RSV symptoms can include runny nose, coughing, sneezing, fever, decrease in appetite, and wheezing.<SUP STYLE="font-size:75%; vertical-align:top">4</SUP> Two out of three infants are infected with RSV during their first year of life and
almost all children are infected by their second birthday.<SUP STYLE="font-size:75%; vertical-align:top">4,5</SUP> In the U.S., RSV is the leading cause of hospitalization in infants under 12 months, averaging 16 times higher than the annual rate
for influenza.<SUP STYLE="font-size:75%; vertical-align:top">1,2</SUP> Approximately 75% of infants hospitalized for RSV are born healthy and at term with no underlying conditions.<SUP STYLE="font-size:75%; vertical-align:top">6</SUP> Each year in
the U.S., an estimated 590,000 RSV disease cases in infants under one require medical care, including physician office, urgent care, emergency room visits and hospitalizations.<SUP STYLE="font-size:75%; vertical-align:top">3</SUP> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>About Beyfortus </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In the U.S., <I>Beyfortus </I>is a single-dose long-acting antibody designed to help prevent RSV lower respiratory tract disease in all infants through
their first RSV season. <I>Beyfortus</I> is also indicated for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><I>Beyfortus, </I>provided directly to newborns and infants as a single dose, offers rapid protection via an antibody to help prevent LRTD caused by
RSV, without requiring activation of the immune system.<SUP STYLE="font-size:75%; vertical-align:top">7</SUP> <I>Beyfortus </I>administration can be timed to the start of the RSV season. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In <FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#0562c1"><U>March 2017</U></FONT><FONT STYLE="font-family:ARIAL">, Sanofi and AstraZeneca
announced an agreement to develop and commercialize <I>Beyfortus</I>. Under the terms of the agreement, AstraZeneca leads development and manufacturing activities and Sanofi leads commercialization activities and records revenues. Under the terms of
the global agreement, Sanofi made an upfront payment of <FONT STYLE="font-family:Times New Roman">&#128;</FONT>120m, has paid development and regulatory milestones of <FONT STYLE="font-family:Times New Roman">&#128;</FONT>55m and will pay up to a
further <FONT STYLE="font-family:Times New Roman">&#128;</FONT>440m upon achievement of certain regulatory and sales-related milestones. The two companies share costs and profits in all territories except in the U.S. where Sanofi consolidates 100%
of the economic benefits in its Business Operating Income. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><I>Beyfortus </I>has been granted special designations to facilitate expedited
development by several regulatory agencies around the world. These include Breakthrough Therapy Designation and Priority Review designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough
Therapy Designation from the U.S. Food and Drug Administration; access granted to the European Medicines Agency (EMA) PRIority MEdicines (PRIME) scheme and EMA accelerated assessment; Promising Innovative Medicine designation by the UK Medicines and
Healthcare products Regulatory Agency; and has been named &#147;a medicine for prioritized development&#148; under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development.
</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><I>Beyfortus </I>has been granted marketing authorization in the European Union, Great Britain and Canada for the prevention of RSV lower
respiratory tract disease in newborns and infants from birth through their first RSV season and is currently undergoing regulatory review in China, Japan and several other countries. In Canada, nirsevimab is also approved for children up to 24
months of age who remain vulnerable to severe RSV disease through their second RSV season and such indication is under review at the EMA level. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>About the clinical trials </I></FONT></P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The Phase 2b trial (Trial 03) was a randomized, placebo-controlled trial designed to measure the
efficacy of <I>Beyfortus </I>against medically attended lower respiratory tract disease (LRTD) caused by RSV through 150 days post-dose in healthy preterm infants of 29 to less than 35 weeks&#146; gestation (n=1,453). Infants were randomized (2:1)
to receive a single 50 mg intramuscular injection of <I>Beyfortus </I>(n=969) or placebo (n=484) regardless of weight at the RSV season start. The primary endpoint was met, significantly reducing the incidence of medically attended RSV LRTD by 70.1%
(95% CI: 52.3, 81.2; P&lt;0.001) compared to placebo. In a prespecified secondary endpoint, <I>Beyfortus </I>reduced medically attended RSV LRTD with hospitalization by 78.4% (95% CI 51.9, 90.3) versus placebo. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The <I>Beyfortus </I>dosing regimen was determined based on further exploration of the Phase 2b data and was used in subsequent trials as a single 50 mg
dose for those who weigh less than 5 kg, or a single 100 mg dose for those who weigh 5 kg or greater. A <FONT STYLE="white-space:nowrap">post-hoc</FONT> analysis of the Phase 2b study that applied the recommended 50 mg dose in a subgroup of infants
weighing less than 5 kg showed the efficacy of <I>Beyfortus </I>against medically attended RSV LRTD and medically attended RSV LRTD with hospitalization was 86.2% (95% CI 68.0, 94.0) and 86.5% (95% CI 53.5, 96.1), respectively. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The Phase 3 MELODY trial (Trial 04) was a randomized, double-blind, placebo-controlled trial conducted across 21 countries designed to determine the
safety and efficacy of <I>Beyfortus </I>against medically attended LRTD caused by RSV in healthy term and late preterm infants (35 weeks gestational age or greater) entering their first RSV season, including efficacy against severe disease such as
hospitalization, through 150 days after dosing. The primary endpoint was met, reducing the incidence of medically attended RSV LRTD by 74.9% (95% CI 50.6, 87.3; P&lt;0.001) compared to placebo. The efficacy of <I>Beyfortus </I>against the secondary
endpoint of hospitalization was 60.2% (95% CI: <FONT STYLE="white-space:nowrap">-14.6,</FONT> 86.2). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">MEDLEY (Trial 05) was a Phase 2/3, randomized,
double-blind, palivizumab-controlled trial with the primary objective of assessing safety and tolerability for <I>Beyfortus </I>in preterm infants of less than 35 weeks&#146; gestational age and infants with congenital heart disease (CHD) and/or
chronic lung disease (CLD) of prematurity eligible to receive palivizumab. Between July 2019 and May 2021, a total of 925 infants at higher risk for severe RSV disease entering their first RSV season were randomized to receive <I>Beyfortus </I>or
palivizumab. Safety was assessed by monitoring the occurrence of treatment emergent adverse events (TEAEs) and treatment emergent severe adverse events (TESAEs) through 360 days post-dose. Serum levels of <I>Beyfortus </I>following dosing (on day
151) in this trial were comparable with those observed in the Phase 3 MELODY trial (Trial 04), indicating similar protection in this population to that in healthy term and late preterm infants is likely. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The safety profile of <I>Beyfortus </I>was similar to palivizumab in the MEDLEY Phase 2/3 trial and consistent with the safety profile in healthy term,
late preterm and preterm infants compared to placebo across the MELODY and Phase 2b trials. While uncommon, the most reported adverse reactions were rash 14 days post-dose, (the majority of which were mild to moderate) and <FONT
STYLE="white-space:nowrap">non-serious</FONT> injection site reactions within 7 days post-dose. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The results of MELODY, Phase 2/3 MEDLEY and the
Phase 2b trials illustrate that <I>Beyfortus </I>helps protect infants during their first RSV season against RSV disease with a single dose. This <FONT STYLE="white-space:nowrap">all-infant</FONT> population includes healthy term, late preterm, and
preterm infants, as well as infants with specific health conditions that make them vulnerable to severe RSV disease. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">These trials form the basis of
regulatory submissions that began in 2022. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #cccccc">&nbsp;</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><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
</P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">
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: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" ALIGN="justify"><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>| + 33 6 25 09 14 25 |
<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>|
+ 1 617 834 6026 | <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>Nicolas Obrist </B>| + 33 6 77 21 27 55 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>nicolas.obrist@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" ALIGN="justify"><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>| + 33 7 86 80 56 39 | <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>| + 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>| + 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>| + 1 908 612 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>|
+ 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="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #cccccc">&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:8pt; 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 and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial
results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;,
&#147;believes&#148;, &#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although Sanofi&#146;s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data
and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as
their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and
commercial success of therapeutic alternatives, Sanofi&#146;s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related
pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact
that pandemics or other 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, 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:12pt; margin-bottom:0pt; font-size:11pt; font-family:ARIAL"><B>References </B></P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:9.5pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="4%" VALIGN="top" ALIGN="left">1.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL; " ALIGN="left">Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J
Pediatr. 2003;143(5 Suppl):S127-S132. doi:10.1067/s0022-3476(03)00510-9. </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:9.5pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="4%" VALIGN="top" ALIGN="left">2.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL; " ALIGN="left">Zhou H, et al. Hospitalizations associated with influenza and respiratory syncytial virus in the United States,
1993-2008. Clin Infect Dis. 2012;54:1427&#150;1436. </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:9.5pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="4%" VALIGN="top" ALIGN="left">3.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL; " ALIGN="left">Rainisch G, et al. Estimating the impact of multiple immunization products on medically- attended respiratory syncytial
virus (RSV) infections in infants. Vaccine. 2020;38(2):251-257. https://doi.org/10.1016/j.vaccine.2019.10.023 </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:9.5pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="4%" VALIGN="top" ALIGN="left">4.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL; " ALIGN="left">Centers for Disease Control and Prevention. RSV in Infants and Young Children.
https://www.cdc.gov/rsv/high-risk/infants-young-children.html. Accessed July 2023. </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:9.5pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="4%" VALIGN="top" ALIGN="left">5.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL; " ALIGN="left">Walsh, EE. Respiratory Syncytial Virus Infection: An Illness for All Ages. Clinics in Chest Medicine. <FONT
STYLE="white-space:nowrap">2017;38(1):29-36.</FONT> <FONT COLOR="#0562c1"><U>https://doi.org/10.1016/j.ccm.2016.11.010</U></FONT>. </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:9.5pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="4%" VALIGN="top" ALIGN="left">6.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL; " ALIGN="left">Esposito S, et al. RSV Prevention in All Infants: Which Is the Most Preferable Strategy? Front Immunol. 2022; 13:
880368. doi: 10.3389/fimmu.2022.880368. </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:9.5pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="4%" VALIGN="top" ALIGN="left">7.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:9.5pt; font-family:ARIAL; " ALIGN="left">Centers for Disease Control and Prevention. Vaccines&nbsp;&amp; Immunizations. August 18, 2017. <FONT
STYLE="white-space:nowrap">https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm.</FONT> Accessed July 2023. </P></TD></TR></TABLE>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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