Sanofi

For the period ended Dec 31, 2025. Filed Feb 17, 2026.

About this filing

The yearly report of a company based outside the US. It covers much of what a 10-K does, and may follow accounting rules other than US ones.

FY2025 · Filed Feb 17, 2026

SNY$47.04+0.3%Stored close · as of Nov 6, 2026

See the whole filing, with its images and exhibits

Contents

E. R&D Appendices

E. R&DAppendix

R&DPipeline

Registration
Name	Description	Indication
Dupixent(a)	IL4R mAb	Allergic fungal rhinosinusitis (US)Bullous pemphigoid (EU, JP)
teplizumab	CD3 mAb	Type 1 diabetes, stage 3 (US)
Wayrilz	BTK inhibitor	Immune thrombocytopenia (JP)
tolebrutinib	BTK inhibitor	Secondary progressive MS (US, EU)
Sarclisa	CD38 mAb subcutaneous	Relapsed/refractory MM

Vaccines
Name	Description	Indication	Name	Description	Indication
Immunology	Rare diseases
amlitelimab	OX40L mAb	Atopic dermatitis	Nexviazyme	Enzyme replacement therapy	Infantile-onset Pompe disease
Dupixent (a)	IL4R mAb	Chronic pruritus of unknown originLichen simplex chronicus	elenestinib	D816V-mutated KIT inhibitor	Indolent/smoldering systemic mastecytosis
duvakitug (b)	TL1A mAb	Crohn’s diseaseUlcerative colitis	fitusiran	RNAi targeting anti-thrombin	Hemophilia A and B (EU, JP)
itepekimab (a)	IL33 mAb	Chronic obstructive pulmonary disease (1) Chronic rhinosinusitis with nasal polyps	Wayrilz	BTK inhibitor	Sickle cell diseaseIgG4-related diseaseWarm autoimmune hemolytic anemia
lunsekimig	IL13×TSLP Nanobody® VHH	Chronic obstructive pulmonary disease	venglustat	Oral GCS inhibitor	Fabry diseaseGaucher disease type 3
Rezurock	ROCK2 inhibitor	Chronic lung allograft dysfunction
Neurology	Oncology
frexalimab (c)	CD40L mAb	Relapsing MSNon-relapsing secondary progressive MS	Sarclisa	CD38 mAb	NDMM, TE (HD7) (US)NDMM, TE (IsKia)Smoldering MM (ITHACA)
riliprubart	C1s mAb	SOC-refractory CIDPIVIg-treated CIDP
SP0087	Vero cell vaccine	Rabies
SP0218	Vero cell vaccine	Yellow fever
Fluzone HD	Multivalent inactivated vaccine	Flu (50 years+)
SP0202(d)	21-valent conjugate vaccine	Pneumococcal disease (children)

(1) itepekimab’s future development in COPD is dependent on further analysis of Phase 3 data and regulatory feedback.

Collaborations:(a) Regeneron; (b) Teva Pharmaceuticals; (c) ImmuNext; (d) SK biosience.

Abbreviations:

BTK: Bruton’s tyrosine kinase – CD: Cluster of differentiation – C1s: Complement component 1s – CIDP: Chronic inflammatory demyelinating polyneuropathy – CN: China –

EU: Europe – GCS: Glucosylceramide synthase – HD: High dose – IgG4: Immunoglobulin G4 – IL: Interleukin – IVIg: Intravenous immunoglobulin – JP: Japan – mAb:

Monoclonal antibody - MM: Multiple myeloma - MS: Multiple sclerosis - NDMM: Newly diagnosed multiple myeloma - RNAi: RNA interference - ROCK2: Rho Associated

coiled-coil containing protein kinase 2 – SOC: Standard of care – TE: Transplant eligible – TL1A: Tumor necrosis factor-like cytokine 1A – TSLP: Thymic stromal

lymphopoietin

SANOFI FORM 20-F 2025	57

PART I

ITEM 4. Information on the Company

Name	Description	Indication		Name	Description	Indication
Immunology		Rare diseases
amlitelimab	OX40L mAb	Asthma		Wayrilz	BTK inhibitor	Graves' disease
balinatunfib	oral TNFR1 signaling inhibitor	Crohn’s disease Ulcerative colitis		efdoralprin alfa	AAT fusion protein	Alpha-1 antitrypsin deficiency emphysema
brivekimig	TNFa×OX40L Nanobody® VHH	Crohn’s disease Hidradenitis suppurativaUlcerative colitisType 1 diabetes, stage 3		frexalimab rilzabrutinib brivekimig	CD40L mAbBTK inhibitorTNFa×OX40L Nanobody® VHH	Focal segmental glomerulosclerosis/minimal change disease
frexalimab(a)	CD40L mAb	Type 1 diabetes
itepekimab(b)	IL33 mAb	Chronic rhinosinusitis without nasal polyps		Oncology
lunsekimig	IL13×TSLP Nanobody® VHH	AsthmaAsthma, high-risk Atopic dermatitisChronic rhinosinusitis with nasal polyps		SAR445877	PD1×IL15 fusion protein	Solid tumors
riliprubart	C1s mAb	Antibody-mediated rejection		Sarclisa	CD38 mAb	Relapsed/refractory multiple myeloma in combination
rilzabrutinib	BTK inhibitor	AsthmaChronic spontaneous urticaria
SAR449028	Wild-type KIT inhibitor	Chronic induced/spontaneous urticariaAllergic rhinoconjunctivitis		Vaccines
SAR444336	Non-beta IL2 Synthorin	Microscopic colitis		SP0230	5-valent (ACWY+B) vaccine	Meningitis
SAR445399 (1)	IL1R3 mAb	Hidradenitis suppurativa		SP0256	mRNA vaccine	RSV+hMPV (older adults)
				SP0268	mRNA vaccine	Acne
Neurology		SP0289	mRNA vaccine	Flu H5 pandemic
SAR402663	sFLT01 AAV gene therapy	Wet age-related macular degeneration		SP0335	Inactivated adjuvanted vaccine	Flu H5 pandemic

Rare diseases
Name	Description	Indication	Name	Description	Indication
Immunology			Oncology
SAR446422	CD28×OX40 bispecific Ab	Inflammatory indication	SAR445953 (d)	CEACAM5-Topo1 ADC	Colorectal cancer
SAR446959	MMP13×ADAMTS5×CAP Nanobody® VHH	Knee osteoarthritis	SAR446523	GPRC5D mAb	Relapsed/refractory multiple myeloma
SAR448501	CD20 bispecific mAb	Inflammatory indication
SAR448755 (c)	STAT6 inhibitor	Inflammatory indication	Vaccines
			SP0287	Fluzone HD+Nuvaxovid	Flu+COVID-19
Neurology			SP0287	Flublok+Nuvaxovid	Flu+COVID-19
SAR446597	Bb×C1s AAV gene therapy	Geographic atrophy in dry age-related macular degeneration	SP0291	mRNA vaccine	RSV+hMPV+PIV3 (older adults)
SAR448851	TREM2 agonist	Alzheimer’s disease	SP0269	mRNA vaccine	Chlamydia
			SP0340	Subunit vaccine	RSV+hMPV (older adults)
			SP0341	Subunit vaccine	RSV+hMPV+PIV3 (older adults)
SAR446268	DMPK AAV gene therapy	Myotonic dystrophy type 1

(1) Also known as MAB212, in-licensed from MAB Discovery.

Collaborations:(a) ImmuNext; (b) Regeneron; (c) Recludix; (d) Pfizer

Abbreviations:

AAT: Alpha–1 antitrypsin – AAV: Adeno-associated virus – Ab: Antibody – ADAMTS5: A Disintegrin And Metalloproteinase with Thrombospondin Motifs 5 –

ADC: Antibody-drug conjugate – Bb: Factor Bb – BTK: Bruton’s tyrosine kinase – C1s: Complement component 1s – CAP: Cartilage anchoring protein – CD:

Cluster of differentiation – CEACAM5: Carcinoembryonic antigen cell adhesion molecule 5 – DMPK: dystrophia myotonica protein kinase 1 – GPRC5D: G-

protein-coupled receptor class 5 member D – H5: hemagglutinin 5 - hMPV: human Metapneumovirus – IL: Interleukin – IL1R3: Interleukin-1 receptor 3 –

mAb: Monoclonal antibody – MMP13: Matrix metallopeptidase 13 – mRNA: messenger RNA – PD1: Programmed death protein 1 – PIV3: Parainfluenza virus

type 3 – RSV: Respiratory syncytial virus – STAT6: Signal transducer and activator of transcription 6 – TNFa: Tumor necrosis factor alpha – TNFR1: Tumor

necrosis factor receptor 1 – Topo1: Topoisomerase - TREM2: triggering receptor expressed on myeloid cells 2 – TSLP: Thymic stromal lymphopoietin

58	SANOFI FORM 20-F 2025

PART I

ITEM 4A. Unresolved Staff Comments

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.