<SEC-DOCUMENT>0001193125-22-256358.txt : 20221003
<SEC-HEADER>0001193125-22-256358.hdr.sgml : 20221003
<ACCEPTANCE-DATETIME>20221003112458
ACCESSION NUMBER:		0001193125-22-256358
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20221003
FILED AS OF DATE:		20221003
DATE AS OF CHANGE:		20221003

FILER:

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

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-31368
		FILM NUMBER:		221286492

	BUSINESS ADDRESS:	
		STREET 1:		54 RUE LA BOETIE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75008
		BUSINESS PHONE:		33153774400

	MAIL ADDRESS:	
		STREET 1:		54 RUE LA BOETIE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75008

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

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SANOFI SYNTHELABO SA
		DATE OF NAME CHANGE:	20010104
</SEC-HEADER>
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<TYPE>6-K
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size: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:9pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT
STYLE="white-space:nowrap">6-K</FONT> </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF FOREIGN PRIVATE ISSUER </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE <FONT STYLE="white-space:nowrap">13a-16</FONT> OR <FONT STYLE="white-space:nowrap">15d-16</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P> <P STYLE="font-size:4pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">For the month of
October 2022 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Commission File Number: <FONT STYLE="white-space:nowrap">001-31368</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>SANOFI </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">(Translation of
registrant&#146;s name into English) </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">54, rue La Bo&eacute;tie, 75008 Paris, FRANCE </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">(Address of principal executive offices) </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">Indicate
by check mark whether the registrant files or will file annual reports under cover Form <FONT STYLE="white-space:nowrap">20-F</FONT> or Form <FONT STYLE="white-space:nowrap">40-F.</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Form <FONT STYLE="white-space:nowrap">20-F</FONT> &#9746;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form <FONT
STYLE="white-space:nowrap">40-F</FONT> &#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">Indicate by check mark if the registrant is submitting the Form <FONT STYLE="white-space:nowrap">6-K</FONT>
in paper as permitted by Regulation <FONT STYLE="white-space:nowrap">S-T</FONT> Rule 101(b)(1): ________ </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">Indicate by check mark if the registrant is
submitting the Form <FONT STYLE="white-space:nowrap">6-K</FONT> in paper as permitted by Regulation <FONT STYLE="white-space:nowrap">S-T</FONT> Rule 101(b)(7): ________ </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">In September 2022, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated
herein by reference. </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P> <P STYLE="font-size:20pt;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:9pt; font-family:Times New Roman; ">Exhibit&nbsp;No.</P></TD>
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<TD VALIGN="bottom" ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:9pt; font-family:Times New Roman; " ALIGN="center">Description</P></TD></TR>


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<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.1</TD>
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<TD VALIGN="top"><A HREF="d258365dex991.htm">Press Release dated September&nbsp;28, 2022: Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab) approved by FDA as the first and only treatment indicated for prurigo nodularis
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 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">2 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; text-indent:6%; font-size:9pt; font-family:Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top"><FONT STYLE="font-size:9pt">Dated: October 03, 2022</FONT></TD>
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<TD VALIGN="top" ALIGN="center">SANOFI</TD></TR>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:9pt; font-family:Times New Roman">/s/ Alexandra Roger</P></TD></TR>
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<TD VALIGN="top">Name: Alexandra Roger</TD></TR>
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<TD VALIGN="top">Title: Head of Securities Law and Capital Markets</TD></TR>
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 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">3 </P>

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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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</TABLE> <P STYLE="margin-top:20pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab)
approved by FDA as the first and only treatment indicated for prurigo nodularis </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 ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">Dupixent significantly reduced itch and skin lesions compared to placebo in <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">direct-to-Phase</FONT></FONT> 3 program consisting of two pivotal trials </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">About 75,000 adults in the U.S. living with prurigo nodularis are most in need of new treatment options
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">Approval represents the second dermatology indication for Dupixent and fifth disease indication overall in the U.S.
</P></TD></TR></TABLE> <P STYLE="margin-top:20pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris and Tarrytown, N.Y. September</B><B></B><B>&nbsp;28, 2022</B>. The U.S. Food and Drug Administration (FDA) has approved
Dupixent<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dupilumab) for the treatment of adult patients with prurigo nodularis. With this approval, Dupixent becomes the first and only medicine specifically indicated to treat prurigo
nodularis in the U.S. Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and its impact on quality of life is one of the highest among inflammatory skin diseases. The FDA evaluated the Dupixent application
for prurigo nodularis under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Naimish Patel, M.D </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL">Head of Global Development, Immunology and Inflammation, Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;Until today, there were limited treatment options to manage the relentless itch and associated
sensations of burning and stinging skin that can negatively impact the lives of patients struggling with prurigo nodularis. Dupixent has the potential to transform the
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> for prurigo nodularis patients by alleviating the key hallmarks of the disease, such as reducing itch and achieving clearer skin. With Dupixent now
approved in two diseases in dermatology where type 2 inflammation is a central driver, we look forward to further evaluating the potential of inhibiting <FONT STYLE="white-space:nowrap">IL-4</FONT> and <FONT STYLE="white-space:nowrap">IL-13</FONT>
in other chronic skin diseases.&#148; </I></P> <P STYLE="margin-top:18pt; 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">President and Chief Scientific Officer, Regeneron </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;Patients living with prurigo nodularis must often contend with dozens, if not hundreds, of itchy and
painful nodules covering their body and have not had an approved treatment option for their disease. Dupixent has already transformed the treatment landscape of several diseases driven by type 2 inflammation &#150; including atopic dermatitis,
asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis &#150; and been prescribed to more than half a million patients around the world for its approved indications. With this approval, those suffering with prurigo
nodularis finally have a medicine to address the debilitating signs and symptoms of the disease.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The FDA approval is based on data from
two Phase 3 trials, <FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U>PRIME</U></FONT><FONT STYLE="font-family:ARIAL"> and </FONT><FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U>PRIME2, </U></FONT><FONT
STYLE="font-family:ARIAL">evaluating the efficacy and safety of Dupixent in adults with prurigo nodularis. Efficacy in these trials assessed the proportion of subjects with clinically meaningful reduction in itch, clearing of skin, or both:
</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="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">About three times as many Dupixent patients (60% and 58%) experienced a clinically meaningful reduction in itch from
baseline at 24 weeks, compared to 18% and 20% for placebo, the primary endpoint in PRIME. </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">44% and 37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline at 12 weeks,
compared to 16% and 22% for placebo, the primary endpoint in PRIME2. </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">More than twice as many Dupixent patients (48% and 45%) achieved clear or almost clear skin at 24 weeks, compared to 18%
and 16% for placebo. </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:ARIAL; font-size:10pt">More than three times as many Dupixent patients (39% and 32%) experienced both a clinically meaningful reduction in itch
and clear or almost clear skin, compared to 9% and 9% of placebo patients at 24 weeks. </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The safety results of the trial were
generally consistent with the known safety profile of Dupixent in its approved dermatology indication. The most common adverse events (<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>2%) from pooled PRIME and PRIME2 data more frequently
observed with Dupixent than placebo were nasopharyngitis (5% Dupixent, 2% placebo), conjunctivitis (4% Dupixent, 1% placebo), herpes infection (3% Dupixent, 0% placebo), dizziness (3% Dupixent, 1% placebo), muscle pain (3% Dupixent, 1% placebo), and
diarrhea (3% Dupixent, 1% placebo). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">A regulatory filing for prurigo nodularis is under review by the European Medicines Agency, and submissions to
regulatory authorities in additional countries are also planned in 2022. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>About Prurigo Nodularis </B></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">People with prurigo nodularis experience intense, persistent itch with thick skin lesions (called nodules) that can cover most of the body. The disease
is often painful, with burning, stinging and tingling of the skin. The impact of prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch and is comparable to other debilitating chronic
diseases that can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. There are about 75,000 adults in the
U.S. living with prurigo nodularis and are most in need of new treatment options. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>About the Dupixent Prurigo Nodularis Trials </B></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The PRIME and PRIME2 Phase 3 double-blind, placebo-controlled trials evaluated the efficacy and safety of Dupixent in 311 adults with uncontrolled
prurigo nodularis. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In PRIME and PRIME2, the primary endpoint evaluated the proportion of patients with clinically meaningful improvement in itch
from baseline (measured by a <FONT STYLE="font-family:Times New Roman">&#8805;</FONT><FONT STYLE="white-space:nowrap">4-point</FONT> reduction in Worst-Itch Numeric Rating Scale <FONT STYLE="white-space:nowrap">[WI-NRS]</FONT> on a <FONT
STYLE="white-space:nowrap">0-10</FONT> scale) at 24 and 12 weeks, respectively. Additional endpoints included the proportion of patients with clear or almost clear skin of nodules at 24 weeks (measured by a score of 0 or 1 on the Investigator&#146;s
Global Assessment <FONT STYLE="white-space:nowrap">PN-Stage</FONT> [IGA <FONT STYLE="white-space:nowrap">PN-S]</FONT> on a <FONT STYLE="white-space:nowrap">0-4</FONT> scale), and the proportion of patients who achieved a clinically meaningful
response in both <FONT STYLE="white-space:nowrap">WI-NRS</FONT> and IGA <FONT STYLE="white-space:nowrap">PN-S.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>About Dupixent </B></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Dupixent is administered as an injection under the skin (subcutaneous injection) at different injection sites. In patients aged 18 years and older with
prurigo nodularis, Dupixent 300 mg is administered with a <FONT STYLE="white-space:nowrap">pre-filled</FONT> syringe or <FONT STYLE="white-space:nowrap">pre-filled</FONT> pen every two weeks following an initial loading dose. Dupixent is intended
for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Regeneron and Sanofi are committed to helping patients in the U.S. who are prescribed Dupixent gain access to the medicine and receive the support they
may need with the DUPIXENT <I>MyWay</I><I><SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP></I> program. For more information, please call <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">1-844-DUPIXENT</FONT></FONT> <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">(1-844-387-4936)</FONT></FONT></FONT> or visit <FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U>www.DUPIXENT.com</U></FONT><FONT
STYLE="font-family:ARIAL">. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients
with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE) or prurigo nodularis in different age populations. Dupixent is currently approved across these indications in the U.S. and for one
or more of these indications in more than 60 countries, including in the European Union and Japan. More than 500,000 patients have been treated with Dupixent globally. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Dupixent is a fully human monoclonal antibody that inhibits the signaling of the <FONT STYLE="white-space:nowrap">interleukin-4</FONT> <FONT
STYLE="white-space:nowrap">(IL-4)</FONT> and <FONT STYLE="white-space:nowrap">interleukin-13</FONT> <FONT STYLE="white-space:nowrap">(IL-13)</FONT> pathways and is not an immunosuppressant. The Dupixent development program has shown significant
clinical benefit and a decrease in type 2 </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">
inflammation in Phase 3 trials, establishing that <FONT STYLE="white-space:nowrap">IL-4</FONT> and <FONT STYLE="white-space:nowrap">IL-13</FONT> are key and central drivers of the type 2
inflammation that plays a major role in multiple related and often <FONT STYLE="white-space:nowrap">co-morbid</FONT> diseases. These diseases include approved indications for Dupixent such as prurigo nodularis, atopic dermatitis, asthma, CRSwNP and
EoE. </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:10pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">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 trials involving more than 10,000 patients with various chronic diseases driven in part by type 2
inflammation. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by
type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin,
chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis 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:10pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Regeneron is a leading biotechnology
company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into
medicine has led to nine <FONT STYLE="white-space:nowrap">FDA-approved</FONT> treatments and numerous product candidates in development, almost all 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, pain, hematologic conditions, infectious diseases and rare diseases. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Regeneron is accelerating and improving the traditional drug development process through our proprietary <I>VelociSuite</I><SUP
STYLE="font-size:75%; vertical-align:top">&reg;</SUP> technologies, such as <I>VelocImmune</I><SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>, which uses unique genetically humanized mice to produce optimized fully human antibodies and
bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>, which is conducting one of the largest genetics sequencing efforts in the world. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">For more information, please visit <FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U>www.Regeneron.com</U></FONT><FONT
STYLE="font-family:ARIAL"> or follow @Regeneron on Twitter. </FONT></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
some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally,
while putting sustainability and social responsibility at the center of our ambitions. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:ARIAL">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Sanofi Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sally
Bain</B><B></B>&nbsp;|&nbsp;+ 1 617 834 6026 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>sally.bain@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; 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>Eva
Schaefer-Jansen </B>| + 33 7 86 80 56 39 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>eva.schaefer-jansen@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Arnaud Del&eacute;pine </B>| + 33 06 73 69 36 93 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>arnaud.delepine@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Corentine Driancourt</B> | + 33 06 40 56 92 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>corentine.driancourt@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Felix
Lauscher</B> | + 1 908 612 7239 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Priya Nanduri</B> |+ 1 617 764 6418 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>priya.nanduri@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Nathalie Pham</B> | + 33 07 85 93 30 17 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>nathalie.pham@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
 <p STYLE="margin-top: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: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>Hannah Kwagh </B>| + 1 914 847 6314 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>hannah.kwagh@regeneron.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>Regeneron Investor Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Vesna Tosic </B>| + 914 847 5443 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>vesna.tosic@regeneron.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sanofi Disclaimers
or Forward-Looking Statements </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL" ALIGN="justify">This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act
of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from
the product. Forward-looking statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;, &#147;believes&#148;, &#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although
Sanofi&#146;s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of
which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be
commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing
issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that <FONT
STYLE="white-space:nowrap">COVID-19</FONT> will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any
material effect of <FONT STYLE="white-space:nowrap">COVID-19</FONT> on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate
other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under &#147;Risk Factors&#148; and
&#147;Cautionary Statement Regarding Forward-Looking Statements&#148; in Sanofi&#146;s annual report on Form <FONT STYLE="white-space:nowrap">20-F</FONT> for the year ended December&nbsp;31, 2021. Other than as required by applicable law, Sanofi
does not undertake any obligation to update or revise any forward-looking information or statements. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:8pt; 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" ALIGN="justify">This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future
performance of&nbsp;Regeneron Pharmaceuticals, Inc.&nbsp;(&#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 impact of <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">SARS-CoV-2</FONT></FONT>
(the virus that has caused the <FONT STYLE="white-space:nowrap">COVID-19</FONT> pandemic) on Regeneron&#146;s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron&#146;s and its
collaborators&#146; ability to continue to conduct research and clinical programs, Regeneron&#146;s ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or
licensees (collectively, &#147;Regeneron&#146;s Products&#148;), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron&#146;s Products 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>&nbsp;(dupilumab) for the treatment of prurigo nodularis; uncertainty of the utilization, market acceptance, and commercial success of Regeneron&#146;s Products (such as Dupixent) 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; 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&nbsp;Dupixent for the treatment of&nbsp;pediatric eosinophilic esophagitis,
hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal
polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoid, and other potential indications; 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, including without limitation Dupixent; 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&nbsp;Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable) to be cancelled or terminated; 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>&nbsp;(aflibercept) Injection, Dupixent, Praluent<SUP
STYLE="font-size:75%; vertical-align:top">&reg;</SUP>&nbsp;(alirocumab), and REGEN-COV<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>&nbsp;(casirivimab and imdevimab)), other litigation and other proceedings and government investigations
relating to the Company and/or its operations, 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&nbsp;U.S. Securities and Exchange Commission, including its Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the year ended&nbsp;December
31, 2021 and its Form <FONT STYLE="white-space:nowrap">10-Q</FONT> for the quarterly period ended&nbsp;June 30, 2022. 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. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL" ALIGN="justify">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<I> </I>(<U>http://newsroom.regeneron.com</U>) and its Twitter feed (<U>http://twitter.com/regeneron</U>). </P>
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