<SEC-DOCUMENT>0001193125-25-077305.txt : 20250410
<SEC-HEADER>0001193125-25-077305.hdr.sgml : 20250410
<ACCEPTANCE-DATETIME>20250410061138
ACCESSION NUMBER:		0001193125-25-077305
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20250410
FILED AS OF DATE:		20250410
DATE AS OF CHANGE:		20250410

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Sanofi
		CENTRAL INDEX KEY:			0001121404
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				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:		25826407

	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>d942506d6k.htm
<DESCRIPTION>6-K
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<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 April 2025 </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>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In April 2025, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated
herein by reference. </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="border-bottom:1.00pt solid #000000">Exhibit<br>No.</TD>
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<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; " ALIGN="center">Description</P></TD></TR>


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<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.1</TD>
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<TD VALIGN="top"><A HREF="d942506dex991.htm">Press Release dated April 8, 2025: Tolebrutinib phase 3 data published in NEJM demonstrate benefit on disability progression in multiple sclerosis </A></TD></TR>
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 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">2 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top: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: April&nbsp;10, 2025</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center">SANOFI&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;</TD></TR>
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<TD VALIGN="top">By</TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Alexandra Roger</P></TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
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<TD VALIGN="top">Name:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">Alexandra Roger</TD></TR>
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<TD VALIGN="top">Title:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">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
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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</TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7900e6"><I>Tolebrutinib phase 3 data published in NEJM demonstrate benefit on disability progression in
multiple sclerosis </I></FONT></P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="3%" 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:Verdana; font-size:10pt">Results from the HERCULES phase 3 study showed delay in disability progression in people living with <FONT
STYLE="white-space:nowrap">non-relapsing</FONT> secondary progressive multiple sclerosis </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:Verdana; font-size:10pt">Tolebrutinib has the potential to be the first therapy to modulate immunologic drivers of chronic inflammation behind the
blood&#150;brain barrier, a key driver of disability accumulation in MS </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:Verdana; font-size:10pt">Tolebrutinib is being evaluated under priority review in the US with a target action date of 28&nbsp;September 2025;
regulatory submission dossier&nbsp;is under review in the EU with a decision expected in Q1 2026 </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify"><B>Paris, April 8, 2025</B>.
<I>The New England Journal of Medicine</I> (NEJM) <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>published</U></FONT><FONT STYLE="font-family:Verdana"> positive results from the HERCULES phase 3 study demonstrating that
tolebrutinib delayed disability progression in people with <FONT STYLE="white-space:nowrap">non-relapsing</FONT> secondary progressive multiple sclerosis (nrSPMS), where there are currently no treatment options approved. These findings further
support the differentiated mechanism of oral, brain-penetrant tolebrutinib, targeting disability progression independent of relapse activity. These results were first presented at the </FONT><FONT
STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>ECTRIMS</U></FONT><FONT STYLE="font-family:Verdana"> conference on September&nbsp;20, 2024 in Copenhagen, Denmark and further analyses were also presented today during the Clinical
Trials Plenary Session at the 2025 Annual Meeting for the American Academy of Neurology (AAN) in San Diego, California. </FONT></P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Georgia" ALIGN="justify"><B><I><FONT STYLE="font-family:Georgia" COLOR="#7900e6">Robert Fox, MD</FONT> </I></B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Verdana" ALIGN="justify">Vice Chair of Research at Cleveland Clinic&#146;s Neurological Institute, Cleveland, Ohio, US, and chair of the HERCULES global
steering committee </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Georgia" ALIGN="justify"><I>&#147;Tolebrutinib represents a new class of therapy for the treatment of multiple sclerosis. In this large
phase 3 study, tolebrutinib was found to slow the progression of disability in a subset of multiple sclerosis for which we have no approved therapies &#150; <FONT STYLE="white-space:nowrap">non-relapsing</FONT> secondary progressive disease. The
results of this study signal a new chapter in multiple sclerosis because we finally found a potential way to treat <FONT STYLE="white-space:nowrap">non-relapsing</FONT> secondary progressive forms.&#148; </I></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Verdana">Dr Fox is a paid advisor to Sanofi for the HERCULES study. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Georgia" ALIGN="justify"><B><I><FONT STYLE="font-family:Georgia" COLOR="#7900e6">Erik Wallstr&ouml;m, MD, PhD</FONT> </I></B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Verdana" ALIGN="justify">Global Head of Neurology Development </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Georgia" ALIGN="justify"><I>&#147;By targeting disability progression mechanisms behind the blood-brain barrier, tolebrutinib has the potential to be a
practice-changing therapeutic option for people living with multiple sclerosis. The data published in NEJM support our larger commitment to the multiple sclerosis patient community, transforming the treatment paradigm to defy disability across the
disease spectrum.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The HERCULES data demonstrated that tolebrutinib delayed the time to onset of
<FONT STYLE="white-space:nowrap">6-month</FONT> confirmed disability progression (CDP) by 31% compared to placebo (hazard ratio [HR] 0.69; 95% confidence interval [CI] <FONT STYLE="white-space:nowrap">0.55-0.88;</FONT> p=0.003). Additionally,
results from the GEMINI 1 and 2 phase 3 studies, evaluating tolebrutinib in people with relapsing multiple sclerosis (RMS) were also <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>published</U></FONT><FONT
STYLE="font-family:Verdana"> in <I>NEJM </I>and presented today during the Clinical Trials Plenary Session at the AAN 2025 Annual Meeting. </FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The GEMINI 1 and 2 results did not show superiority on the primary endpoint of reducing annualized relapse rate (ARR) over teriflunomide. The ARR
during the study period was 0.13 in the tolebrutinib group and 0.12 in the teriflunomide group in GEMINI 1 (adjusted rate ratio, 1.06; 95% CI <FONT STYLE="white-space:nowrap">0.81-1.39;</FONT> p=0.67) and was 0.11 in both groups in GEMINI 2
(adjusted rate ratio, 1.00; 95% CI <FONT STYLE="white-space:nowrap">0.75-1.32;</FONT> p=0.98). A pooled analysis for a key secondary endpoint, not controlled for multiplicity, showed that tolebrutinib delayed the time to onset of <FONT
STYLE="white-space:nowrap">6-month</FONT> confirmed disability worsening by 29% versus teriflunomide (HR 0.71; 95% CI 0.53 to 0.95). </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Tolebrutinib was generally well-tolerated across all arms of the studies for all participants. In
HERCULES, liver enzyme elevations (&gt;3xULN) were observed in 4.0% of participants receiving tolebrutinib compared with 1.6% in the placebo group. A small (0.5%) proportion of participants in the tolebrutinib group experienced peak ALT increases of
&gt;20xULN, all occurring within the first 90 days of treatment. All but one case of liver enzyme elevations resolved without further medical intervention. Prior to the implementation of more frequent liver enzyme monitoring following treatment
initiation, one participant in the tolebrutinib arm received a liver transplant and died due to post-operative complications. The implementation of more frequent liver monitoring may help to mitigate serious liver sequelae. Other deaths in the study
were assessed as unrelated to treatment by investigators; deaths were even across the placebo and tolebrutinib arms at 0.3%. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">In an analysis of
the GEMINI 1 and 2 pooled safety data, adverse events observed between the tolebrutinib and teriflunomide arms were generally balanced. Liver enzyme elevations (&gt;3xULN) were observed in 5.6% of participants receiving tolebrutinib compared to 6.3%
in the teriflunomide arms. A small (0.5%) proportion of participants in the tolebrutinib group experienced peak ALT increases of &gt;20xULN, all occurring within the first 90 days of treatment. Deaths were balanced across the teriflunomide and
tolebrutinib arms, at 0.2% and 0.1% respectively, and were assessed as unrelated to treatment by the investigators. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The safety and efficacy of
tolebrutinib have not been determined by any regulatory authority. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The regulatory submission for tolebrutinib to treat nrSPMS and to slow
disability accumulation independent of relapse activity in adult patients is being evaluated under <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>priority review</U></FONT><FONT STYLE="font-family:Verdana"> by the US Food and
Drug Administration with a target action date of September&nbsp;28, 2025. A regulatory submission is also under review in the EU. </FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #b2b2b2">&nbsp;</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:11pt; font-family:Georgia" ALIGN="justify"><I><FONT
STYLE="font-family:Georgia" COLOR="#7900e6">About multiple sclerosis</FONT></I></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Multiple sclerosis is a chronic, immune-mediated disease of the
central nervous system that may result in accumulation of irreversible disabilities over time. The physical and cognitive disability impairments translate into gradual deterioration of health status, impacting patients&#146; quality of life.
Disability accumulation remains the significant unmet medical need in MS. To date, the primary target of currently approved medicines has been peripheral B and T cells, while innate immunity within the CNS, which is believed to drive disability
accumulation, remains largely unaddressed. Currently approved or late-stage medicines being tested for MS mainly target the adaptive immune system and/or do not act directly within the central nervous system to drive clinical benefit. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Living with nrSPMS refers to people with MS who have stopped experiencing relapses but continue to accumulate disability, experienced as symptoms such
as fatigue, cognitive impairment, balance and gait impairment, loss of bowel and/or bladder function, sexual disfunction, amongst others. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:11pt; font-family:Georgia" ALIGN="justify"><I><FONT
STYLE="font-family:Georgia" COLOR="#7900e6">About tolebrutinib</FONT></I></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Tolebrutinib is an investigational, oral, brain-penetrant and bioactive
Bruton&#146;s tyrosine kinase (BTK) inhibitor specifically designed to target smoldering neuroinflammation, a key driver of disability progression in multiple sclerosis. Unlike conventional MS therapies that primarily address peripheral
inflammation, tolebrutinib crosses the blood-brain barrier to achieve therapeutic cerebrospinal fluid concentrations, allowing it to modulate both <FONT STYLE="white-space:nowrap">B-lymphocytes</FONT> and disease-associated microglia within the
central nervous system. This mechanism is thought to directly address the underlying pathology of progressive MS by targeting the inflammatory processes that contribute to neurodegeneration and disability accumulation. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Tolebrutinib was previously granted breakthrough therapy designation by the FDA, based on positive results from the HERCULES phase 3 study in adults
with <FONT STYLE="white-space:nowrap">non-relapsing</FONT> secondary progressive MS. Tolebrutinib is being evaluated in a phase 3 clinical study for the treatment of primary progressive multiple sclerosis and its safety and efficacy have not been
determined by any regulatory authority worldwide. For more information on tolebrutinib clinical studies, please visit <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>www.clinicaltrials.gov</U></FONT><FONT
STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6">.</FONT><FONT STYLE="font-family:Verdana"> </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:Verdana" ALIGN="justify">Tolebrutinib represents Sanofi&#146;s commitment to developing innovative treatments that address
the underlying causes of neurological diseases and potentially transform the treatment landscape. Standing at the intersection of neurology and immunoscience, Sanofi is focused on improving the lives of those living with serious neuro-inflammatory
and neuro-degenerative conditions including MS, chronic inflammatory demyelinating polyneuropathy, Alzheimer&#146;s disease, Parkinson&#146;s disease, <FONT STYLE="white-space:nowrap">age-related</FONT> macular degeneration, and other neurological
diseases. The neurology pipeline currently has several projects in phase 3 studies across 7 indications. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:11pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7900e6"><I>About
HERCULES</I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">HERCULES (clinical study identifier: NCT04411641) was a double-blind randomized phase 3 study evaluating the efficacy and
safety of tolebrutinib in patients with nrSPMS. At baseline, nrSPMS was defined as having a SPMS diagnosis with an expanded disability status scale (EDSS) between 3.0 and 6.5, no clinical relapses for the previous 24 months and documented evidence
of disability accumulation in the previous 12 months. Participants were randomized (2:1) to receive either an oral daily dose of tolebrutinib or matching placebo for up to approximately 48 months. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The primary endpoint was <FONT STYLE="white-space:nowrap">6-month</FONT> CDP defined as the increase of
<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>1.0 point from the baseline EDSS score when the baseline score is <FONT STYLE="font-family:Times New Roman">&#8804;</FONT>5.0, or the increase of
<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>0.5 point when the baseline EDSS score was &gt;5.0. Secondary endpoints included time to onset of <FONT STYLE="white-space:nowrap">3-month</FONT> CDP as assessed by EDSS score, total number of
new or enlarging T2 hyperintense lesions as detected by MRI, time to onset of confirmed disability improvement, <FONT STYLE="white-space:nowrap">3-month</FONT> change in <FONT STYLE="white-space:nowrap">9-hole</FONT> peg test and <FONT
STYLE="white-space:nowrap">T25-FW</FONT> test as well as the safety and tolerability of tolebrutinib. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:11pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7900e6"><I>About GEMINI 1 and
2</I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">GEMINI 1 (clinical study identifier: NCT04410978) and GEMINI 2 (clinical study identifier: NCT04410991) were double-blind randomized
phase 3 studies evaluating the efficacy and safety of tolebrutinib compared to teriflunomide in patients with RMS. Participants were randomized in both studies (1:1) to receive either tolebrutinib and placebo daily or 14 mg teriflunomide and
placebo. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The primary endpoint for both studies was the annualized relapse rate for up to approximately 36 months defined as the number of
confirmed adjudicated protocol defined relapses. Secondary endpoints included time to onset of CDW, confirmed over at least 6 months, defined as an increase of <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>1.5 points from the baseline EDSS
score when the baseline score is 0, an increase of <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>1.0 point from the baseline EDSS score when the baseline score is 0.5 to <FONT STYLE="font-family:Times New Roman">&#8804;</FONT>5.5 or an
increase of <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>0.5 point from the baseline EDSS score when the baseline score was &gt;5.5 in addition to the total number of new and/or enlarging T2 hyperintense lesions as detected by MRI from
baseline through the end of study, the total number of Gd-enhancing T1 hyperintense lesions as detected by MRI from baseline through the end of study and the safety and tolerability of tolebrutinib. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7900e6"><I>About Sanofi </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" 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:Verdana" ALIGN="justify">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7900e6"><I>Media Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify"><B>Sandrine Guendoul</B> | +33 6 25 09 14 25 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify"><B>Evan Berland</B> | +1 215 432 0234 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>evan.berland@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify"><B>Nicolas Obrist</B> | +33 6 77 21 27 55 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>nicolas.obrist@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify"><B>L&eacute;o Le Bourhis</B> | +33 6 75 06 43 81 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>leo.lebourhis@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify"><B>Victor Rouault</B> | +33 6 70 93 71 40 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>victor.rouault@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify"><B>Timothy Gilbert</B> | +1 516 521 2929 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>timothy.gilbert@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>Investor Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Thomas Kudsk Larsen</B> | +44 7545 513 693 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>thomas.larsen@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Aliz&eacute; Kaisserian</B> | +33 6 47 04 12 11 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>alize.kaisserian@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Felix
Lauscher</B> | +1 908 612 7239 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify"><B>Keita Browne</B> | +1 781 249 1766 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>keita.browne@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify"><B>Nathalie Pham</B> | +33 7 85 93 30 17 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>nathalie.pham@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify"><B>Tarik Elgoutni</B> | +1 617 710 3587 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>tarik.elgoutni@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify"><B>Thibaud Ch&acirc;telet</B> | +33 6 80 80 89 90 | <FONT
STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>thibaud.chatelet@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana" ALIGN="justify"><B>Yun Li</B> | +33 6 84 00 90 72 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>yun.li3@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #b2b2b2">&nbsp;</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana" ALIGN="justify"><B>Sanofi forward-looking statements </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana" ALIGN="justify">This
press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and
estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding
future performance. Forward-looking statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;, &#147;believes&#148;, &#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although
Sanofi&#146;s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of
which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding
whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of
such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi&#146;s ability to benefit from external growth opportunities, to
complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest
rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial
condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi,
including those listed under &#147;Risk Factors&#148; and &#147;Cautionary Statement Regarding Forward-Looking Statements&#148; in Sanofi&#146;s annual report on Form <FONT STYLE="white-space:nowrap">20-F</FONT> for the year ended December&nbsp;31,
2024. 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:Verdana" ALIGN="justify">All trademarks mentioned in this press release are the property of the Sanofi group. </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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