<SEC-DOCUMENT>0001193125-24-218683.txt : 20240913
<SEC-HEADER>0001193125-24-218683.hdr.sgml : 20240913
<ACCEPTANCE-DATETIME>20240913124650
ACCESSION NUMBER:		0001193125-24-218683
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		8
CONFORMED PERIOD OF REPORT:	20240913
FILED AS OF DATE:		20240913
DATE AS OF CHANGE:		20240913

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:		241297109

	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>d822844d6k.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 September 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> </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&#8194;&#9746;&#8195;&#8195;&#8195;Form</FONT> <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 September 2024, Sanofi published the press releases attached hereto as Exhibits 99.1, 99.2 and 99.3 which
are 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 HEIGHT="8" COLSPAN="2"></TD></TR>
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<TD VALIGN="top" NOWRAP>Exhibit 99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d822844dex991.htm">Press Release dated September&nbsp;11, 2024: Dupixent is the first and only biologic to achieve significant improvements in disease remission and symptoms in bullous pemphigoid positive pivotal study</A></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
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<TD VALIGN="top" NOWRAP>Exhibit 99.2</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d822844dex992.htm">Press Release dated September&nbsp;11, 2024: Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU </A></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.3</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d822844dex993.htm">Press Release dated September&nbsp;12, 2024: Sanofi, RadioMedix, and Orano Med announce licensing agreement on next-generation radioligand medicine for rare cancers </A></TD></TR>
</TABLE>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size: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:12pt; 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: September&nbsp;13, 2024</TD>
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<TD VALIGN="top" ALIGN="center">SANOFI</TD></TR>
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<TD VALIGN="top">By</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<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 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>d822844dex991.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:14pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Dupixent is the first and only biologic to achieve significant improvements in disease remission and
symptoms in bullous pemphigoid positive pivotal study </I></FONT></P> <P STYLE="font-size:18pt;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="2%" VALIGN="top" ALIGN="left">&#149;</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">Study met the primary and all key secondary endpoints in adults with <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> disease; five times more patients achieved sustained disease remission with Dupixent than placebo </P></TD></TR></TABLE>
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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">Dupixent is the first medicine to show significant steroid-sparing effect in this debilitating and life-threatening disease
</P></TD></TR></TABLE>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</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">If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S. and European Union
</P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>Paris and Tarrytown, NY, September</B><B></B><B>&nbsp;11, 2024. </B>A<B> </B>Dupixent (dupilumab) pivotal study (ADEPT) in bullous pemphigoid
(BP) met the primary and all key secondary endpoints evaluating its investigational use in adults with <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> disease. In the study, five times more Dupixent
patients achieved sustained disease remission compared to those on placebo. Sustained disease remission was defined as complete clinical remission with completion of oral corticosteroids (OCS) taper by week 16 without relapse and no rescue therapy
use during the <FONT STYLE="white-space:nowrap">36-week</FONT> treatment period. Dupixent was previously granted Orphan Drug Designation by the U.S. Food and Drug Administration for BP, which applies to investigational medicines intended for the
treatment of rare diseases that affect fewer than 200,000 people in the U.S. This study will support regulatory submissions around the world, starting with the U.S. later this year. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">BP, a chronic and relapsing disease, is characterized by intense itch and blisters, reddening of the skin, and painful chronic lesions. The blisters and rash can form
over much of the body and cause the skin to bleed and crust, resulting in patients being more prone to infection and affecting their daily functioning. </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, M.D., Ph.D. </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial">Chief Medical Officer, Global Head of Development at Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;The itchy blisters caused by bullous pemphigoid can be so intense they are debilitating, especially for elderly
patients. There is a significant unmet medical need for new medicines for people suffering with this <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">hard-to-treat</FONT></FONT> disease in which the standard of care is oral and
topical corticosteroids and immunosuppressants &#150; treatments that have poor clinical outcomes and safety concerns, respectively, and should be used sparingly in an elderly population. These positive pivotal results for bullous pemphigoid add to
an immense body of scientific evidence that underscores the important role IL4 and IL13 play in driving diseases characterized by itch. Combined with the consistent safety profile of the other dermatology indications, these results show the
potential of Dupixent to transform the treatment paradigm for bullous pemphigoid.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">In the ADEPT study, 106 adults with <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> BP were randomized to receive Dupixent 300 mg (n=53) every two weeks after an initial loading dose or placebo (n=53), </P>
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 </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="right"><FONT STYLE="font-family:arial;background-color:#e6e6e6; font-size:10pt" COLOR="#2b579a">1</FONT><FONT
STYLE="font-family:arial">/</FONT><FONT STYLE="font-family:arial;background-color:#e6e6e6; font-size:10pt" COLOR="#2b579a">6</FONT><FONT STYLE="font-family:arial"> </FONT></P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">
along with <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> OCS. During treatment, all patients underwent a protocol-defined OCS tapering regimen
if control of disease activity was maintained. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">For the primary endpoint, 20% of Dupixent patients experienced sustained disease remission at 36 weeks compared to
4% for placebo (p=0.0114). For the components comprising the primary endpoint &#150; with patients having to achieve all components &#150; efficacy among patients receiving Dupixent compared to placebo was as follows*: </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 ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">Absence of disease relapse after patient completed OCS taper: 59% vs. 16% (nominal p=0.0023) </P></TD></TR></TABLE>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</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">Absence of need for rescue therapy<B> </B>during treatment period: 42% vs. 12% (nominal p=0.0004) </P></TD></TR></TABLE>
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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">Achievement of complete remission and off<B> </B>OCS by week 16: 38% vs. 27% (not significant) </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><I>*Components were not separately included in <FONT STYLE="white-space:nowrap">pre-specified</FONT> statistical analyses and are therefore nominal </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">For selected secondary endpoints, results for Dupixent compared to placebo were statistically significant as follows: </P>
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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">Patients achieving <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>90% reduction in disease severity: 41% vs. 10%
(p=0.0003) </P></TD></TR></TABLE>
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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">Patients achieving clinically meaningful itch reduction: 40% vs. 11% (p=0.0006) </P></TD></TR></TABLE>
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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">Secondary endpoints assessing decreased OCS use, and time to use of rescue medications, also favored Dupixent and were
significant (p=0.0220 and p=0.0016, respectively) </P></TD></TR></TABLE>
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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">Reduction in disease severity from baseline: 77% vs. 51% (p=0.0021) </P></TD></TR></TABLE>
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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">Reduction in itch from baseline: 52% vs. 27% (p=0.0021) </P></TD></TR></TABLE>
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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">Days of complete remission off OCS: 40 vs. 13 (p=0.0072) </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">In this older population, overall rates of adverse events (AEs) were 96% (n=51) for Dupixent and 96% (n=51) for placebo. AEs more commonly observed with Dupixent
compared to placebo in more than 3 patients included peripheral edema (n=8 vs. n=5), arthralgia (n=5 vs. n=3), back pain (n=4 vs. n=2), blurred vision (n=4 vs. n=0), hypertension (n=4 vs. n=3), asthma (n=4 vs. n=1), conjunctivitis (n=4 vs. n=0),
constipation (n=4 vs. n=1), upper respiratory tract infection (n=3 vs. n=1), limb injury (n=3 vs. n=2), and insomnia (n=3 vs. n=2). There were no AEs leading to death in the Dupixent group and 2 AEs leading to death in the placebo group. </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>George D. Yancopoulos, M.D., Ph.D. </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial">Board <FONT STYLE="white-space:nowrap">co-Chair,</FONT> President, and Chief Scientific Officer at Regeneron </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;Bullous pemphigoid is a debilitating skin disease with a high mortality rate due to infection. Dupixent is the first
medication to show significant and robust impacts in this patient population. These latest pivotal results reaffirm the underlying role <FONT STYLE="white-space:nowrap">type-2</FONT> inflammation plays in driving multiple skin diseases. We look
forward to further advancing this research and sharing the positive results from the bullous pemphigoid pivotal trial with regulatory authorities.&#148; </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Additionally, a small separate phase 3 study (Study A) evaluating the investigational use of Dupixent in adults with uncontrolled and severe chronic pruritus of unknown
origin (CPUO) did not achieve statistical significance in its primary itch responder endpoint (despite favorable numerical improvements), but showed nominally significant improvements in all </P>
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other itch endpoints including: change from baseline; percent of patients achieving no/mild itch; and change in itch-related quality of life from baseline. Safety results were generally
consistent with the known safety profile of Dupixent in its approved dermatological indications. The Dupixent phase 3 study program in CPUO consists of Study A and Study B. Study B is planned to initiate as a subsequent pivotal study. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Detailed efficacy and safety results for both BP and CPUO studies are planned for presentation at a forthcoming medical meeting. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">The safety and efficacy of Dupixent in BP and CPUO are currently under clinical investigation and have not been evaluated by any regulatory authority. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About the Dupixent BP pivotal study </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">ADEPT is a randomized, phase 2/3,
double-blind, placebo-controlled study evaluating the efficacy and safety of Dupixent in 106 adults with <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> BP for a
<FONT STYLE="white-space:nowrap">52-week</FONT> treatment period. After randomization, patients received Dupixent or placebo every two weeks, with OCS treatment. During treatment, OCS taper was initiated after patients experienced two weeks of
sustained control of disease activity. OCS tapering could start between four to six weeks after randomization and was continued as long as disease control was maintained, with the intent of completion by 16 weeks. After OCS tapering, patients were
only treated with Dupixent or placebo for at least 20 weeks, unless rescue treatment was required. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">The primary endpoint evaluated the proportion of patients
achieving sustained disease remission at 36 weeks. Sustained disease remission was defined as complete clinical remission with completion of OCS taper by 16 weeks without relapse and no rescue therapy use during the
<FONT STYLE="white-space:nowrap">36-week</FONT> treatment period. Relapse was defined as appearance of <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>3 new lesions a month or <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>1 large
lesion (&gt;10cm in diameter) that did not heal within a week. Rescue therapy could include treatment with high-potency topical corticosteroids, OCS (including increase of OCS dose during the taper or
<FONT STYLE="white-space:nowrap">re-initiation</FONT> of OCS after completion of the OCS taper), systemic <FONT STYLE="white-space:nowrap">non-steroidal</FONT> immunosuppressive medications, or immunomodulating biologics. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Select secondary endpoints evaluated at 36 weeks included: </P>
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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">Proportion of patients achieving <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>90% reduction in Bullous
Pemphigoid Disease Area Index (BPDAI; <FONT STYLE="white-space:nowrap">scale:0-360)</FONT> </P></TD></TR></TABLE>
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<TD WIDTH="2%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">Proportion of patients with
<FONT STYLE="font-family:Times New Roman">&#8805;</FONT><FONT STYLE="white-space:nowrap">4-point</FONT> reduction in Peak Pruritus Numerical Rating Scale <FONT STYLE="white-space:nowrap">(PP-NRS;</FONT> scale
<FONT STYLE="white-space:nowrap">0-10)</FONT> </P></TD></TR></TABLE>
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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">Total cumulative OCS dose </P></TD></TR></TABLE>
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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">Time to first use of rescue medication </P></TD></TR></TABLE>
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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">Percent change from baseline in BPDAI </P></TD></TR></TABLE>
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<TD WIDTH="2%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">Percent change in weekly average of daily <FONT STYLE="white-space:nowrap">PP-NRS</FONT> </P></TD></TR></TABLE>
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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">Duration of complete remission while not requiring OCS </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About the Dupixent CPUO phase 3 program </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">The Dupixent phase 3 program in CPUO
consists of Study A and Study B. Study A was a randomized, phase 3, double-blind, placebo-controlled study evaluating the efficacy and safety of Dupixent in adults with uncontrolled, severe CPUO. During the
<FONT STYLE="white-space:nowrap">4-week</FONT> <FONT STYLE="white-space:nowrap">run-in</FONT> period, patients received a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> regimen comprised of a <FONT
STYLE="white-space:nowrap">non-sedative</FONT> antihistamine and moisturizer to confirm they were refractory to available options. During </P>
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the following <FONT STYLE="white-space:nowrap">24-week</FONT> treatment period, patients received Dupixent or placebo every two weeks added to the <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">standard-of-care</FONT></FONT> regimen. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">The primary endpoint evaluated the proportion of patients with a clinically meaningful
improvement in itch from baseline at 24 weeks, measured by a <FONT STYLE="font-family:Times New Roman">&#8805;</FONT><FONT STYLE="white-space:nowrap">4-point</FONT> reduction in the worst-itch numerical rating scale
<FONT STYLE="white-space:nowrap">(WI-NRS;</FONT> scale: <FONT STYLE="white-space:nowrap">0-10).</FONT> The key secondary endpoint evaluated the proportion of patients with a <FONT STYLE="font-family:Times New Roman">&#8805;</FONT><FONT
STYLE="white-space:nowrap">4-point</FONT> reduction in <FONT STYLE="white-space:nowrap">WI-NRS</FONT> at 12 weeks. Additional secondary endpoints included: </P>
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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">Proportion of patients achieving no/mild pruritus on Patient Global Impression of Severity (PGIS) of pruritus
</P></TD></TR></TABLE>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="2%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">Absolute change and percent change from baseline in the weekly average of daily itch-related sleep disturbances at 24 weeks
measured by the sleep disturbance NRS (scale: <FONT STYLE="white-space:nowrap">0-10)</FONT> </P></TD></TR></TABLE>
<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="4%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="2%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">Absolute change from baseline in itch-related quality of life measured by the ItchyQoL (scale: <FONT
STYLE="white-space:nowrap">22-110)</FONT> </P></TD></TR></TABLE>
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<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="2%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">Absolute change from baseline in health-related quality of life at 24 weeks measured by the Dermatology Life Quality Index
(scale: <FONT STYLE="white-space:nowrap">0-30)</FONT> </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Study B is planned to initiate as a subsequent pivotal study. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About Dupixent </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Dupixent (dupilumab) is a fully human monoclonal antibody
that inhibits the signaling of the <FONT STYLE="white-space:nowrap">interleukin-4</FONT> (IL4) and <FONT STYLE="white-space:nowrap">interleukin-13</FONT> (IL13) pathways and is not an immunosuppressant. The Dupixent development program has shown
significant clinical benefit and a decrease in <FONT STYLE="white-space:nowrap">type-2</FONT> inflammation in phase 3 studies, establishing that IL4 and IL13 are key and central drivers of the <FONT STYLE="white-space:nowrap">type-2</FONT>
inflammation that plays a major role in multiple related and often <FONT STYLE="white-space:nowrap">co-morbid</FONT> diseases. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Dupixent has received regulatory
approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and
chronic obstructive pulmonary disease in different age populations. More than 1,000,000 patients are being treated with Dupixent globally. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>Dupilumab development
program </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more
than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by <FONT STYLE="white-space:nowrap">type-2</FONT> inflammation. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by
<FONT STYLE="white-space:nowrap">type-2</FONT> inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and bullous pemphigoid. These potential uses of dupilumab are currently under clinical
investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About Regeneron </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases.
Founded and </P>
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led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most
of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic
conditions, infectious diseases, and rare diseases. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary
technologies, such as <I>VelociSuite</I><I><SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP></I><I>,</I> which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine
with data-powered insights from the Regeneron Genetics Center<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP><I> </I>and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to
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<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Regeneron Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Ilana
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</FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Regeneron Investor Relations </I></FONT></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>Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU
</I></FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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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">Confirming the results of <FONT STYLE="white-space:nowrap">CUPID-A,</FONT> this second pivotal study in <FONT
STYLE="white-space:nowrap">biologic-na&iuml;ve</FONT> patients met primary and key secondary endpoints, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores compared to placebo
</P></TD></TR></TABLE>
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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">More than 300,000 people in the US suffer from chronic spontaneous urticaria (CSU) that is inadequately controlled by
antihistamines </P></TD></TR></TABLE>
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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">Data will support regulatory resubmission in the US by <FONT STYLE="white-space:nowrap">year-end;</FONT> if approved,
Dupixent would be the first targeted therapy for CSU in a decade </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>Paris and Tarrytown, NY, September</B><B></B><B>&nbsp;11, 2024. </B>A<B>
</B>Dupixent (dupilumab) confirmatory phase 3 study (LIBERTY-CUPID Study C) met the primary and key secondary endpoints for the investigational treatment of patients with uncontrolled, <FONT STYLE="white-space:nowrap">biologic-na&iuml;ve</FONT> CSU
receiving background therapy with antihistamines. CSU is a chronic skin condition that causes sudden and debilitating hives and persistent itch, which can impact quality of life. This positive study confirms <FONT
STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>results</U></FONT><FONT STYLE="font-family:arial"> from Study A, the first phase 3 study of Dupixent in this setting. Earlier this year, Japan was the first country in the world to </FONT><FONT
STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>approve</U></FONT><FONT STYLE="font-family:arial"> and launch Dupixent for adult and adolescent CSU patients based on the results from Study A. </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, M.D., Ph.D. </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial">Chief Medical Officer, Global Head of Development at Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;The positive pivotal data from this study reinforce the potential of Dupixent to offer a new treatment option for the
many people suffering from chronic spontaneous urticaria who do not respond to <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> antihistamines. With clinically meaningful reductions in itch and hives
for patients receiving Dupixent, we look forward to sharing these data with the FDA to bring Dupixent to patients with CSU in the US as soon as possible. With Dupixent now treating 1&nbsp;million patients across seven approved indications, these new
results underscore there are still many more patients that Dupixent can potentially benefit.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Study C enrolled 151 children and adults randomized to
receive Dupixent (n=74) or placebo (n=77) added to <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> <FONT STYLE="white-space:nowrap">histamine-1</FONT> (H1) antihistamines. At 24 weeks, efficacy among
patients receiving Dupixent compared to placebo was as follows: </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9679;</FONT></TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<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">8.64-point</FONT> reduction in itch severity from baseline with Dupixent versus a <FONT
STYLE="white-space:nowrap">6.10-point</FONT> reduction with placebo (p=0.02) </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:arial; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
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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">15.86-point</FONT> reduction in urticaria activity (itch and hive) severity from baseline
with Dupixent versus an <FONT STYLE="white-space:nowrap">11.21-point</FONT> reduction with placebo (p=0.02) </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Notably, 30% of Dupixent-treated
patients reported no urticaria (complete response), compared to 18% of those on placebo (p=0.02). </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">The safety results were generally consistent with the known safety profile of Dupixent in its approved dermatological
indications. Overall rates of treatment emergent adverse events (AE) were 53% for Dupixent and 53% for placebo. AEs more commonly observed with Dupixent (<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>5%) compared to placebo included
injection site reactions (12% vs. 4%), accidental overdose (7% vs. 3%), and <FONT STYLE="white-space:nowrap">COVID-19</FONT> infection (8% vs. 5%). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Detailed
results from this study will be provided to the US Food and Drug Administration in response to the <FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>additional data requested</U></FONT><FONT STYLE="font-family:arial"> for inclusion
in the supplemental biologics application for Dupixent in CSU. These data are also planned for presentation at a forthcoming medical meeting. </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>George D. Yancopoulos, M.D., Ph.D. </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial">Board <FONT STYLE="white-space:nowrap">Co-Chair,</FONT> President, and Chief Scientific Officer at Regeneron </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;Patients with uncontrolled chronic spontaneous urticaria experience debilitating itch and hives that appear without
warning and disrupt their lives. With a nearly 50% reduction in itch and urticaria activity scores compared to placebo, these positive phase 3 results reaffirm the potential of Dupixent to bring relief and its well-established safety profile to
those living with this chronic inflammatory skin disease.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Outside of Japan, the safety and efficacy of Dupixent for CSU has not been fully evaluated by
any regulatory authority. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About CSU </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">CSU is a chronic inflammatory skin
disease driven in part by <FONT STYLE="white-space:nowrap">type-2</FONT> inflammation, which causes sudden and debilitating hives and persistent itch. CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to
control symptoms of urticaria. However, the disease remains uncontrolled despite antihistamine treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can
be debilitating and significantly impact their quality of life. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About the Dupixent phase 3 CSU program (LIBERTY-CUPID) </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">The LIBERTY-CUPID Phase 3 study program evaluating Dupixent in CSU consists of Study A, <FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>Study
B</U></FONT><FONT STYLE="font-family:arial">, and Study C. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Study C was a randomized, double-blind, placebo-controlled clinical study that evaluated the
efficacy and safety of Dupixent as an <FONT STYLE="white-space:nowrap">add-on</FONT> to <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> antihistamines compared to antihistamines alone in 151 patients
aged six years and older with CSU who remained symptomatic despite antihistamine use and were not previously treated with omalizumab (i.e., <FONT STYLE="white-space:nowrap">biologic-na&iuml;ve).</FONT> The primary endpoint assessed the change from
baseline in itch at 24 weeks (measured by the weekly itch severity score [ISS7], <FONT STYLE="white-space:nowrap">0-21</FONT> scale). A key secondary endpoint was the change from baseline in itch and hives at 24 weeks (measured by the weekly
urticaria activity score [UAS7], <FONT STYLE="white-space:nowrap">0-42</FONT> scale). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Study A supported the <FONT
STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>approval</U></FONT><FONT STYLE="font-family:arial"> of Dupixent in Japan for the treatment of CSU in people aged 12 years and older whose disease is not adequately controlled with existing
therapy. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Results from Study A and Study B, which assessed Dupixent in patients aged 12 years and older who were uncontrolled on <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> H1 antihistamines and refractory to omalizumab, were <FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>published</U></FONT><FONT
STYLE="font-family:arial"> in <I>The Journal of Allergy and Clinical Immunology</I>. </FONT></P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About Dupixent </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Dupixent
(dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the <FONT STYLE="white-space:nowrap">interleukin-4</FONT> (IL4) and <FONT STYLE="white-space:nowrap">interleukin-13</FONT> (IL13) pathways and is not an
immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in <FONT STYLE="white-space:nowrap">type-2</FONT> inflammation in phase 3 studies, establishing that IL4 and IL13 are key and central drivers
of the <FONT STYLE="white-space:nowrap">type-2</FONT> inflammation that plays a major role in multiple related and often <FONT STYLE="white-space:nowrap">co-morbid</FONT> diseases. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic
rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, CSU, and chronic obstructive pulmonary disease in different age populations. More than 1,000,000 patients are being treated with Dupixent globally. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>Dupilumab development program </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Dupilumab is being jointly developed by Sanofi
and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by
<FONT STYLE="white-space:nowrap">type-2</FONT> inflammation. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a
broad range of diseases driven by <FONT STYLE="white-space:nowrap">type-2</FONT> inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and bullous pemphigoid. These potential uses of dupilumab are
currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About
Regeneron </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with
serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown
in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases,
and rare diseases. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as
<I>VelociSuite</I><I><SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP></I><I>,</I> which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered
insights from the Regeneron Genetics Center<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP><I> </I>and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or
cure diseases. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">For more information, please visit <FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>www.Regeneron.com</U></FONT><FONT
STYLE="font-family:arial"> or follow Regeneron on </FONT><FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>LinkedIn</U></FONT><FONT STYLE="font-family:arial"><U>, <FONT STYLE="font-family:arial" COLOR="#0563c1">Instagram</FONT></U><FONT
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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 the world, is dedicated to </P>
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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
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<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Sanofi Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Sandrine
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<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:arial" ALIGN="justify">This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
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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. </P>
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<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:arial"><B>Regeneron Forward-Looking Statements and Use of Digital Media </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:arial">This press
release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (&#147;Regeneron&#148; or the &#147;Company&#148;), and actual events or results
may differ materially from these forward-looking statements. Words such as &#147;anticipate,&#148; &#147;expect,&#148; &#147;intend,&#148; &#147;plan,&#148; &#147;believe,&#148; &#147;seek,&#148; &#147;estimate,&#148; variations of such words, and
similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature,
timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, &#147;Regeneron&#146;s Products&#148;) and product candidates being
developed by Regeneron and/or its collaborators or licensees (collectively, &#147;Regeneron&#146;s Product Candidates&#148;) and research and clinical programs now underway or planned, including without limitation Dupixent<SUP
STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron&#146;s Product Candidates and new indications for Regeneron&#146;s Products, such
as Dupixent for the treatment of chronic spontaneous urticaria (&#147;CSU&#148;) as discussed in this press </P>
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release as well as other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regeneron&#146;s Products and Regeneron&#146;s Product Candidates and
the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron&#146;s
Products (such as Dupixent for the treatment of CSU) and Regeneron&#146;s Product Candidates; whether the results from the confirmatory Phase 3 trial discussed in this press release will be sufficient for purposes of the request from the U.S. Food
and Drug Administration for additional data to include in the supplemental biologics application for Dupixent in CSU; the ability of Regeneron&#146;s collaborators, licensees, suppliers, or other third parties (as applicable) to perform
manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron&#146;s Products and Regeneron&#146;s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product
candidates; safety issues resulting from the administration of Regeneron&#146;s Products (such as Dupixent) and Regeneron&#146;s Product Candidates in patients, including serious complications or side effects in connection with the use of
Regeneron&#146;s Products and Regeneron&#146;s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron&#146;s ability to continue to develop or
commercialize Regeneron&#146;s Products and Regeneron&#146;s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron&#146;s Products, research and clinical programs, and business, including those relating to patient
privacy; the availability and extent of reimbursement of Regeneron&#146;s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost
effective than, Regeneron&#146;s Products and Regeneron&#146;s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other
studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of
its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron&#146;s agreements with Sanofi and Bayer (or their
respective affiliated companies, as applicable) to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the <FONT STYLE="white-space:nowrap">COVID-19</FONT> pandemic) on Regeneron&#146;s business; and
risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA<SUP
STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or
joined by the U.S. Department of Justice and the U.S. Attorney&#146;s Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron&#146;s
business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron&#146;s filings with the U.S. Securities and Exchange Commission, including its Form <FONT
STYLE="white-space:nowrap">10-K</FONT> for the year ended December&nbsp;31, 2023 and its Form <FONT STYLE="white-space:nowrap">10-Q</FONT> for the quarterly period ended June&nbsp;30, 2024. Any forward-looking statements are made based on
management&#146;s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement,
including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information
about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron&#146;s media and investor relations website (<FONT
STYLE="font-family:arial; font-size:7pt" COLOR="#0563c1"><U>https://investor.regeneron.com</U></FONT><FONT STYLE="font-family:arial">) and its LinkedIn page
(</FONT><FONT STYLE="font-family:arial; font-size:7pt" COLOR="#0563c1"><U>https://www.linkedin.com/company/regeneron-pharmaceuticals</U></FONT><FONT STYLE="font-family:arial">). </FONT></P>
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 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Sanofi, RadioMedix, and Orano Med announce licensing agreement on next-generation radioligand
medicine for rare&nbsp;cancers </I></FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><B>Paris, France, and Houston, Texas, September</B><B></B><B>&nbsp;12, 2024. </B>As part of its effort to
develop innovative treatments for people living with rare cancers, Sanofi has entered into an exclusive licensing agreement with RadioMedix, Inc., a US clinical-stage biotechnology company developing radiopharmaceuticals for PET imaging and targeted
alpha therapy (TAT) against unmet medical needs in cancer, and Orano Med, a French clinical-stage biotechnology company, subsidiary of the Orano Group, developing <FONT STYLE="white-space:nowrap">lead-212</FONT> (<SUP
STYLE="font-size:75%; vertical-align:top">212</SUP>Pb) radioligand therapies (RLTs) against cancer. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">This collaboration between Sanofi, RadioMedix
and Orano Med focuses specifically on the late-stage project, AlphaMedix<SUP STYLE="font-size:75%; vertical-align:top">TM</SUP> (<SUP STYLE="font-size:75%; vertical-align:top">212</SUP><FONT STYLE="white-space:nowrap">Pb-DOTAMTATE),</FONT> which
currently is being evaluated for the treatment of adult patients with unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumors (NETs), a rare cancer. AlphaMedix<SUP STYLE="font-size:75%; vertical-align:top">TM
</SUP>is a TAT which consists of a somatostatin receptor-targeting peptide complex radiolabeled with <FONT STYLE="white-space:nowrap">lead-212</FONT> (<SUP STYLE="font-size:75%; vertical-align:top">212</SUP>Pb) that serves as an in vivo generator of
alpha particles. </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 </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial">Chief Medical Officer, Global Head of Development, Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;We are excited to develop a leading-edge project in the&nbsp;rapidly evolving&nbsp;field of radioligand
therapies&nbsp;in rare cancers. Early results for 212Pb have demonstrated its differentiated&nbsp;biophysical and&nbsp;clinical profile, reinforcing its potential to be a transformative radioligand&nbsp;therapeutic&nbsp;for patients across multiple <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">difficult-to-treat</FONT></FONT> rare cancers.&nbsp;This agreement underscores our efforts to explore innovative collaborations that leverage&nbsp;novel&nbsp;technologies&nbsp;to address
the needs of people living with cancer.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><FONT STYLE="font-family:arial; font-size:10pt" COLOR="#7a00e6"><U>AlphaMedix<SUP
STYLE="font-size:75%; vertical-align:top">TM</SUP> has recently been granted Breakthrough Therapy Designation</U></FONT><FONT STYLE="font-family:arial"> in gastroenteropancreatic neuroendocrine tumors
<FONT STYLE="white-space:nowrap">(GEP-NETs)</FONT> from the US Food and Drug Administration (FDA) for patients who are na&iuml;ve to peptide-receptor radionuclide therapy. The FDA&#146;s decision was based on findings from phase 1<SUP
STYLE="font-size:75%; vertical-align:top">i</SUP> and 2 clinical studies, which found that AlphaMedix<SUP STYLE="font-size:75%; vertical-align:top">TM</SUP> was well tolerated and provided substantial reduction in tumor burden, with a durable
response rate (ORR according to RECIST 1.1) of 62.5%.<SUP STYLE="font-size:75%; vertical-align:top">i</SUP> AlphaMedix<SUP STYLE="font-size:75%; vertical-align:top">TM</SUP> is currently completing phase 2 clinical development, and the data is being
discussed with the FDA for potential regulatory filing and approval. </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>Ebrahim S. Delpassand
</I></B></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial">Chairman and CEO, RadioMedix </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;The Breakthrough Therapy Designation of AlphaMedix is a testament of its success in validating targeted alpha
therapies. We see this as a potential for the future of nuclear&nbsp;oncology&nbsp;in&nbsp;general,&nbsp;and today it is pioneering&nbsp;next-generation&nbsp;treatment&nbsp;for&nbsp;patients&nbsp;with neuroendocrine tumors. In our research, we have
seen that&nbsp;significantly higher energy delivery over much shorter path lengths in the tissue of alpha emitters can overcome the limitations of currently available beta emitter radioligand therapies. We believe 212Pb is an ideal alpha emitter
with highly desirable physical and supply </I></P>
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characteristics&nbsp;in comparison&nbsp;to other alpha emitters. RadioMedix has been one of the pioneers in the field of radioligand therapy in the U.S and, through this licensing agreement with
Sanofi, our goal is to bring this potentially life-saving therapy&nbsp;to as many patients as possible.&#148; </I></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>Julien Dodet </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial">President and CEO, Orano Med </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;At Orano Med, we are at the forefront of innovation in radioligand therapy and are developing a global industrial
platform for the manufacture and distribution of our 212Pb-conjugated drugs. This marks a pivotal moment to expedite the development of this new therapy and in our fight against cancer. Through this agreement, we aim to lead the charge in advancing
radioligand therapies with the ambition to revolutionize cancer therapeutics.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Under the licensing agreement, Sanofi will be responsible
for the global commercialization of AlphaMedix<SUP STYLE="font-size:75%; vertical-align:top">TM</SUP>, while Orano Med will be responsible for the manufacturing of AlphaMedix<SUP STYLE="font-size:75%; vertical-align:top">TM</SUP> through its global
industrial platform currently under development. Under the terms of the agreement, RadioMedix and Orano Med will receive an upfront payment of <FONT STYLE="font-family:Times New Roman">&#128;</FONT>100&nbsp;million and up to <FONT
STYLE="font-family:Times New Roman">&#128;</FONT>220&nbsp;million in sales milestones and be eligible for tiered royalties. This agreement is subject to standard regulatory approvals required for transactions of this nature. </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, Sanofi remains committed to advancing oncology innovation. Through focused
strategic decisions the company has reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive progress. Efforts are centered on
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">difficult-to-treat</FONT></FONT> cancers such as 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:12pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About neuroendocrine tumors </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Neuroendocrine tumors (NETs) are a heterogeneous group of rare cancers that originate from neuroendocrine cells. These cancers occur mostly in the
gastrointestinal tract and pancreas but can also occur in other tissues including the thymus, lung, and other uncommon sites such as ovaries, heart, and prostate. Most NETs strongly express somatostatin receptors. In the United States, around 12,000
patients annually are expected to be diagnosed with neuroendocrine tumors, with an average <FONT STYLE="white-space:nowrap">5-year</FONT> survival rate of 60% at a metastatic stage. Despite the global prevalence of NETs increasing each year, it is
considered a rare cancer that is estimated to affect approximately 35/100,000 individuals worldwide. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About RadioMedix
</I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">RadioMedix, Inc. is a clinical-stage biotechnology company, based in Houston and Humble, Texas. The company is focused on innovative
targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. RadioMedix is developing radiopharmaceuticals for PET imaging and therapy (alpha- and beta-labeled agents). The company established contract service facilities for
academic and industrial partners. including a cGMP and analytical suite for Phase <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">I-II-III</FONT></FONT> clinical trials and commercial launch. To learn more, visit <FONT
STYLE="font-family:arial; font-size:10pt" COLOR="#7a00e6"><U>www.radiomedix.com and LinkedIn</U></FONT><FONT STYLE="font-family:arial">. For more information about this press release, please contact: </FONT><FONT
STYLE="font-family:arial; font-size:10pt" COLOR="#7a00e6"><U>radiomedix@knbcomm.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>About Orano Med </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Orano Med, a subsidiary of the Orano Group, is a clinical-stage biotechnology company that develops a
new generation of targeted therapies against cancer using the unique properties of <FONT STYLE="white-space:nowrap">lead-212</FONT> (<SUP STYLE="font-size:75%; vertical-align:top">212</SUP>Pb), an alpha-emitting radioisotope and one of the more
potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT). The company is developing several treatments using<SUP STYLE="font-size:75%; vertical-align:top">&nbsp;212</SUP>Pb combined with various targeting
agents. Orano Med has<SUP STYLE="font-size:75%; vertical-align:top">&nbsp;212</SUP>Pb manufacturing facilities, laboratories, and R&amp;D centers in France and in the US and is currently investing to further expand its
<FONT STYLE="white-space:nowrap">GMP-manufacturing</FONT> capacities for<SUP STYLE="font-size:75%; vertical-align:top">&nbsp;212</SUP>Pb radiolabeled pharmaceuticals in North America and Europe. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">As a recognized international operator in the field of nuclear materials, Orano Group delivers
solutions to address present and future global energy and health challenges. Its expertise and mastery of cutting-edge technologies enable Orano to offer its customers high value-added products and services throughout the entire fuel cycle. Every
day, the Orano group&#146;s 17,500 employees draw on their skills, unwavering dedication to safety and constant quest for innovation, with the commitment to develop <FONT STYLE="white-space:nowrap">know-how</FONT> in the transformation and control
of nuclear materials, for the climate and for a healthy and resource-efficient world, now and tomorrow. </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" 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">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:11pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Contacts </I></FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><I>Sanofi 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>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><B></B>&nbsp;|&nbsp;+ 33 6 77 21 27 55 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>nicolas.obrist@sanofi.com<B> </B></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; font-family:arial"><B>Timothy Gilbert</B><B></B>&nbsp;|&nbsp;+ 1 516 521 2929 |
<FONT STYLE="font-family:arial; font-size:8pt" 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"><FONT
 COLOR="#7a00e6"><I>Sanofi Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Thomas Kudsk Larsen</B> |+ 44 7545 513 693 |
<FONT STYLE="font-family:arial; font-size:8pt" 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:8pt; font-family:arial"><B>Aliz&eacute;
Kaisserian</B><B></B>&nbsp;|&nbsp;+ 33 6 47 04 12 11 | <FONT STYLE="font-family:arial; font-size:8pt" 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:8pt; font-family:arial">More contact information available <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:9.5pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>RadioMedix </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><FONT COLOR="#7a00e6"><U>radiomedix@knbcomm.com</U> </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9.5pt; font-family:Times New Roman"><FONT
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2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:arial" ALIGN="justify">All trademarks mentioned in this press release are the property of the Sanofi group with the exception of AlphaMedix. </P>
<P STYLE="line-height:8.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:26%">&nbsp;</P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:8pt; font-family:arial" ALIGN="justify"><SUP
STYLE="font-size:75%; vertical-align:top">i</SUP> Delpassand ES, Tworowska I, Esfandiari R, et al. Targeted <FONT STYLE="font-family:Times New Roman"><FONT STYLE="FONT-FAMILY:SYMBOL">&#097;</FONT></FONT>-Emitter Therapy with 212Pb-DOTAMTATE for the
Treatment of Metastatic SSTR-Expressing Neuroendocrine Tumors: <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">First-in-Humans</FONT></FONT> Dose-Escalation Clinical Trial. <I>J Nucl Med</I>. 2022;63(9):1326-1333.
doi:10.2967/jnumed.121.263230. </P>
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