<SEC-DOCUMENT>0001193125-24-199330.txt : 20240813
<SEC-HEADER>0001193125-24-199330.hdr.sgml : 20240813
<ACCEPTANCE-DATETIME>20240813060525
ACCESSION NUMBER:		0001193125-24-199330
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20240813
FILED AS OF DATE:		20240813
DATE AS OF CHANGE:		20240813

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Sanofi
		CENTRAL INDEX KEY:			0001121404
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		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:		241198630

	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>d835901d6k.htm
<DESCRIPTION>6-K
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<HTML><HEAD>
<TITLE>6-K</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT
STYLE="white-space:nowrap">6-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF
FOREIGN PRIVATE ISSUER </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE <FONT STYLE="white-space:nowrap">13a-16</FONT> OR
<FONT STYLE="white-space:nowrap">15d-16</FONT> </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of August 2024 </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> Form <FONT STYLE="white-space:nowrap">20-F&#8194;</FONT> &#9746;&#8195;Form <FONT STYLE="white-space:nowrap">40-F&#8194;&#9744;</FONT> </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In August 2024, 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>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; " ALIGN="center">Description</P></TD></TR>


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<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d835901dex991.htm">Press Release dated August&nbsp;
8, 2024: Sarclisa induction treatment demonstrated significantly improved progression-free survival in patients with newly diagnosed multiple myeloma eligible for transplant </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: August&nbsp;13, 2024</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3" ALIGN="center">SANOFI</TD></TR>
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<TD HEIGHT="16" COLSPAN="2"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">By</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000">&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000">/s/ Alexandra Roger</TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">Name: Alexandra Roger</TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Title: Head of Legal Corporate&nbsp;&amp; Finance</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
<SEQUENCE>2
<FILENAME>d835901dex991.htm
<DESCRIPTION>EX-99.1
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size: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"><FONT COLOR="#7a00e6"><I>Sarclisa induction treatment demonstrated significantly improved progression-free survival in
patients with newly diagnosed multiple myeloma eligible for transplant </I></FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
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<TD WIDTH="3%">&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="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">Sarclisa (isatuximab) in combination with
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> lenalidomide, bortezomib, and dexamethasone (RVd) during <FONT STYLE="white-space:nowrap">18-week</FONT> induction treatment followed by transplant
resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared to RVd induction therapy, regardless of maintenance therapy assignment, in the investigational use for transplant-eligible newly
diagnosed multiple myeloma (NDMM) </P></TD></TR></TABLE>
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<TD WIDTH="3%">&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="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt"><FONT STYLE="white-space:nowrap">GMMG-HD7</FONT> is one of six phase 3 studies to report positive results for Sarclisa in
multiple myeloma (MM), which includes four positive readouts of a Sarclisa-based quadruplet in the frontline setting </P></TD></TR></TABLE>
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<TD WIDTH="3%">&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="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">Results reinforce the potential of Sarclisa as a backbone therapy when added to the current
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> in various MM patient populations </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris, August</B><B></B><B>&nbsp;8, 2024.</B> New results from the <FONT STYLE="white-space:nowrap">two-part,</FONT> double-randomized,
German-speaking Myeloma Multicenter Group <FONT STYLE="white-space:nowrap">(GMMG)-HD7</FONT> phase 3 study show that Sarclisa (isatuximab) in combination with lenalidomide, bortezomib, and dexamethasone (RVd) during induction therapy in
transplant-eligible, newly diagnosed multiple myeloma (NDMM) significantly prolonged progression-free survival (PFS) from first randomization, resulting in a statistically significant and clinically meaningful reduction in disease progression or
death, compared to RVd induction regardless of the maintenance regimen. Full results will be submitted for presentation at a forthcoming medical meeting. </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>Hartmut Goldschmidt, MD </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL" ALIGN="justify">President of GMMG, Professor of Medicine at the Heidelberg University Hospital (UKHD), Germany and principal investigator of the study
</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:4%; font-size:10pt; font-family:ARIAL" ALIGN="justify"><I>&#147;Successful induction therapy is one of the most critical components to reduce the relapse or recurrence
risk in patients with newly diagnosed multiple myeloma. While we observed this investigational combination showed improved minimal residual disease negativity rates in the bone marrow, indicating potentially deeper responses after induction, further
<FONT STYLE="white-space:nowrap">follow-up</FONT> was needed to better understand how this translated to long-term outcomes. These data provide evidence that the Isa-RVd regimen potentially improves progression-free survival in the frontline,
transplant-eligible population and supports the potential of this quadruplet to become a new <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> induction regimen in this treatment setting.&#148; </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">GMMG-HD7 is one of six phase 3 studies to report positive results for Sarclisa in patients with multiple myeloma, which includes four positive readouts
of a Sarclisa-based quadruplet in the frontline setting. The most recent included <FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U>results</U></FONT><FONT STYLE="font-family:ARIAL"> from the IMROZ phase 3 study evaluating the
investigational use of Sarclisa with VRd versus VRd for patients with transplant-ineligible NDMM, demonstrating a statistically significant and clinically meaningful improvement in PFS and a higher proportion of patients with minimal residual
disease (MRD) negativity. </FONT></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" ALIGN="justify">Chief Medical Officer and 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:ARIAL" ALIGN="justify"><I>&#147;The <FONT STYLE="white-space:nowrap">GMMG-HD7</FONT> study was designed to better understand the distinct
effect of targeting CD38 with Sarclisa in induction versus maintenance treatment of transplant-eligible patients. These data build upon our belief that Sarclisa has the potential to be a <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">best-in-class</FONT></FONT> CD38 therapy that could improve long-term outcomes versus the <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> for certain patients. We look
forward to the full data presentation and continuing our mission of helping make a meaningful difference for people living with multiple myeloma.&#148; </I></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">In December 2021, Sanofi and GMMG
<FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U>shared the results</U></FONT><FONT STYLE="font-family:ARIAL"> from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM
patients. The GMMG-initiated study is being conducted in close collaboration with Sanofi based on jointly defined research. Sanofi provided financial support to GMMG for this study. The use of Sarclisa in combination with RVd is investigational and
has not been evaluated by any regulatory authority. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">While considered a rare disease, MM is the second most common hematologic malignancy,<SUP
STYLE="font-size:75%; vertical-align:top">1</SUP> with more than 180,000 new diagnoses of MM worldwide yearly.<SUP STYLE="font-size:75%; vertical-align:top">2</SUP> Despite available treatments, MM remains an incurable malignancy in most patients
with an estimated 61% five-year survival rate for newly diagnosed patients.<SUP STYLE="font-size:75%; vertical-align:top">3</SUP> Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after
treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="justify"><FONT
 COLOR="#7a00e6"><I>About the <FONT STYLE="white-space:nowrap">GMMG-HD7</FONT> study </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><FONT STYLE="white-space:nowrap">GMMG-HD7</FONT> is
a pivotal randomized, open-label, multicenter, <FONT STYLE="white-space:nowrap">2-part</FONT> phase 3 study evaluating Sarclisa in combination with RVd versus RVd induction followed by post-transplant
<FONT STYLE="white-space:nowrap">re-randomization</FONT> to Sarclisa plus lenalidomide versus lenalidomide maintenance in transplant-eligible NDMM patients. The study enrolled 662 patients with transplant-eligible NDMM across 67 sites in Germany. In
the first part of the study, all participants were equally randomized to receive three <FONT STYLE="white-space:nowrap">42-day</FONT> cycles of RVd in both arms of the study, while Sarclisa was added to only one study arm. In the second part of the
study, patients were <FONT STYLE="white-space:nowrap">re-randomized</FONT> post-transplant to receive Sarclisa plus lenalidomide or lenalidomide alone as maintenance therapy. During the study, Sarclisa was administered through an intravenous
infusion at a dose of 10 mg/kg once weekly for the first four weeks of cycle one, then every other week for the rest of the induction period. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">MRD
negativity was assessed by next-generation flow cytometry (sensitivity of 1x10<SUP STYLE="font-size:75%; vertical-align:top">-5</SUP>) after induction. In the latest readout of the study, PFS for both Sarclisa plus RVd as an induction therapy,
regardless of maintenance treatment, and Sarclisa plus lenalidomide as a maintenance regimen were measured from first randomization. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><FONT
STYLE="white-space:nowrap">GMMG-HD7</FONT> protocol defined the primary endpoints of MRD negativity after induction treatment for the first part of the study, and PFS following the second randomization after transplant for part two of the study, in
which Sarclisa was added to lenalidomide maintenance, with the latter primary endpoint anticipated to be available at a later date. The key secondary endpoint for the first part of the study was PFS from first randomization. Additional secondary
endpoints included rates of complete response after induction, and intensification, overall survival, and safety. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>About Sarclisa </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Sarclisa (isatuximab) is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity.
It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for antibody-based
therapeutics such as Sarclisa. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Based on the <FONT STYLE="white-space:nowrap">ICARIA-MM</FONT> phase 3 study, Sarclisa is approved in more than 50
countries, including the US and the EU, in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed refractory MM (RRMM) who have received <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>2 prior therapies,
including lenalidomide and a proteasome inhibitor and who progressed on last therapy. Based on the IKEMA phase 3 study, Sarclisa is also approved in 50 countries in combination with carfilzomib and dexamethasone, including in the US for the
treatment of patients with RRMM who have received 1&#150;3 prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, the <FONT STYLE="white-space:nowrap">non-proprietary</FONT> name for
Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of biological products guidance for industry issued by the US Food and Drug Administration. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Sarclisa continues to be evaluated in multiple ongoing phase 3 clinical studies in combination with current standard treatments across the MM treatment
continuum. It is also under </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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investigation for the treatment of other hematologic malignancies, and its safety and efficacy have not been evaluated by any regulatory authority outside of its approved indication. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Sanofi is committed to pursuing the advancement of Sarclisa through several investigational studies across the MM treatment continuum. Various
patient-centric clinical development programs aim to bring Sarclisa to more patients, intercept the disease earlier in the treatment journey, and explore potential new combinations including assessing subcutaneous administration via a proprietary on
body device system. The safety and efficacy of Sarclisa has not been evaluated by any regulatory authority outside of its approved indications and methods of delivery. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In striving to become the number one immunoscience company globally, there is a commitment to advancing oncology innovation. The pipeline is being
reshaped and prioritized, leveraging expertise in immunoscience to drive progress. Efforts are centered on select hematologic malignancies and solid tumors with critical unmet needs, including multiple myeloma, acute myeloid leukemia, certain types
of lymphomas, as well as gastrointestinal and lung cancers.</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">For more information on Sarclisa clinical studies, please visit <FONT
STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U>www.clinicaltrials.gov</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 #b2b2b2">&nbsp;</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>About the
German-speaking Myeloma Multicenter Group (GMMG) </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:ARIAL" ALIGN="justify">GMMG is the largest study group focusing on MM in Germany, with headquarters based in
Heidelberg. Within the last 20+ years, the GMMG study group has performed numerous studies including five randomized, multicenter phase 3 studies with 4,000 patients enrolled from about 90 participating and
<FONT STYLE="white-space:nowrap">co-treating</FONT> centers throughout Germany. The overall goal of GMMG is to generate improved therapies for myeloma patients through the development and testing of novel and personalized, genome- and
signaling-driven treatment strategies. The GMMG has set itself the goal of achieving further approvals for effective antibody-based drug combinations for the first-line treatment of myeloma patients, in which antibody-based treatment regimens have
been integrated into seven GMMG study concepts (CONCEPT, DANTE, DADA, HD6, HD7, HD8, HD9 and HD10). </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 the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of
people globally, while putting sustainability and social responsibility at the center of our ambitions.</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL" ALIGN="justify">Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; 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:9pt; font-family:ARIAL" ALIGN="justify"><B>Sandrine Guendoul</B><B></B>&nbsp;|&nbsp;+ 33 6 25 09 14 25
|&nbsp;<FONT STYLE="font-family:ARIAL; font-size:9pt" 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:9pt; font-family:ARIAL" ALIGN="justify"><B>Evan Berland</B> | +1 215 432 0234 | <FONT STYLE="font-family:ARIAL; font-size:9pt" 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:9pt; font-family:ARIAL" ALIGN="justify"><B>Nicolas Obrist</B><B></B>&nbsp;|&nbsp;+ 33 6 77 21 27 55 | <FONT
STYLE="font-family:ARIAL; font-size:9pt" COLOR="#7a00e6"><U>nicolas.obrist@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:ARIAL" ALIGN="justify"><B>Victor
Rouault</B><B></B>&nbsp;|&nbsp;+ 33 6 70 93 71 40 |<FONT STYLE="font-family:ARIAL; font-size:9pt" COLOR="#7a00e6"><U>&nbsp;victor.rouault@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:ARIAL" ALIGN="justify"><B>Timothy Gilbert</B><B></B>&nbsp;|&nbsp;+ 1 516 521 2929 |
<FONT STYLE="font-family:ARIAL; font-size:9pt" COLOR="#7a00e6"><U>timothy.gilbert@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; 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:9pt; font-family:ARIAL" ALIGN="justify"><B>Thomas Kudsk Larsen</B> |+ 44 7545 513 693 | <FONT STYLE="font-family:ARIAL; font-size:9pt" COLOR="#7a00e6"><U>thomas.larsen@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:ARIAL" ALIGN="justify"><B>Aliz&eacute; Kaisserian</B><B></B>&nbsp;|&nbsp;+ 33 6 47 04 12 11 | <FONT
STYLE="font-family:ARIAL; font-size:9pt" COLOR="#7a00e6"><U>alize.kaisserian@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:ARIAL" ALIGN="justify"><B>Arnaud
Del&eacute;pine</B><B></B>&nbsp;|&nbsp;+ 33 6 73 69 36 93 |<FONT STYLE="font-family:ARIAL; font-size:9pt" 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:9pt; font-family:ARIAL" ALIGN="justify"><B>Felix Lauscher</B><B></B>&nbsp;|&nbsp;+ 1&nbsp;908&nbsp;612 7239 |
<FONT STYLE="font-family:ARIAL; font-size:9pt" 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:9pt; font-family:ARIAL" ALIGN="justify"><B>Keita Browne</B><B></B>&nbsp;|&nbsp;+ 1 781 249 1766 |
<FONT STYLE="font-family:ARIAL; font-size:9pt" COLOR="#7a00e6"><U>keita.browne@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:ARIAL" ALIGN="justify"><B>Nathalie Pham</B><B></B>&nbsp;|&nbsp;+ 33 7 85 93 30 17 |
<FONT STYLE="font-family:ARIAL; font-size:9pt" COLOR="#7a00e6"><U>nathalie.pham@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:ARIAL" ALIGN="justify"><B>Tarik
Elgoutni </B>| + 1 617 710 3587 | <FONT STYLE="font-family:ARIAL; font-size:9pt" 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:9pt; font-family:ARIAL" ALIGN="justify"><B>Thibaud Ch&acirc;telet</B> | + 33 6 80 80 89 90 |
<FONT STYLE="font-family:ARIAL; font-size:9pt" COLOR="#7a00e6"><U>thibaud.chatelet@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL" ALIGN="justify"><B>Sanofi Forward-Looking Statements </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL" ALIGN="justify"><I>This
press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and
estimates 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 </I></P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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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.&nbsp;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, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.</I></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL" ALIGN="justify"><I>All trademarks mentioned in this press release are the property of the Sanofi group. </I></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL" ALIGN="justify"><I><U>&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;</U> </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><SUP STYLE="font-size:75%; vertical-align:top">1</SUP> Kazandjian. Multiple myeloma epidemiology and survival: A unique malignancy. <I>Semin Oncol</I>. <FONT
STYLE="white-space:nowrap">2016;43(6):676-681.</FONT> doi:10.1053/j/seminoncol.2016.11.004. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><SUP STYLE="font-size:75%; vertical-align:top">2</SUP> World Health
Organization. Multiple Myeloma. <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U><FONT STYLE="white-space:nowrap">35-multiple-myeloma-fact-sheet.pdf</FONT> (who.int).</U></FONT><FONT STYLE="font-family:ARIAL"> Accessed March 2024.
</FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><SUP STYLE="font-size:75%; vertical-align:top">3</SUP> National Cancer Institute. Surveillance, Epidemiology, and End Results Program (SEER). Cancer Stat
Facts: Myeloma. Available at: <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>https://seer.cancer.gov/statfacts/html/mulmy.html</U></FONT><FONT STYLE="font-family:ARIAL">. Accessed August 2024. </FONT></P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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