Company Primer | Sanofi SA | 17 Oct 2025

Dupixent-led growth, mixed Vaccines, margin levers; model 2026–27 headwind

OVERVIEW

Sanofi is a global biopharma now oriented firmly around specialty care and vaccines after separating Consumer Health in 2025. The growth engine is Immunology via the Dupixent alliance, which continues to compound across dermatology, respiratory and newer Type‑2 indications, with COPD, CSU and bullous pemphigoid broadening its reach. Vaccines remain scale and seasonal, with RSV infant protection (Beyfortus) expanding, but US flu pricing a near-term drag. Specialty Rare Diseases and Hematology provide high‑margin durability (Nexviazyme, ALTUVIIIO), while selective Oncology (Sarclisa, Ayvakit from Blueprint) is building from a smaller base. Execution focus is on scaling new launches, managing legacy runoff in General Medicines, and stepping up R&D to fund late‑stage programs (amlitelimab in AD/asthma; tolebrutinib in MS).

2025 guidance points to high single‑digit sales and low double‑digit EPS growth at constant currency, despite FX headwinds. Consensus has reset Vaccines lower and costs higher versus early‑year assumptions, while leaving potential upside if Dupixent COPD adoption accelerates and gross‑margin mix continues to improve. Model the Dupixent/Regeneron balance unwind into 2026–27.

Segments

Immunology (c.45% EBIT mix, est.): Dupixent alliance drives mix - Broad Type‑2 anti‑inflammatory biologic with strong payer access and real‑world outcomes; COPD/CSU/BP expand TAM.
- Products: Dupixent across AD, asthma, CRSwNP, EoE, PN, CSU, COPD, BP.
- Customers: Payers, dermatologists, pulmonologists, allergists/ENT, specialty pharmacies; US, Europe, Japan, China, RoW.
- Key channels: Cencora, McKesson, Cardinal, CVS Caremark, Express Scripts; NHS England.
Vaccines (c.25% EBIT mix, est.): RSV expansion vs flu pricing - Pediatric combos, meningitis/travel and influenza; Beyfortus scaling geographically with public program coverage.
- Sub‑segments: RSV Infant (Beyfortus), Influenza (incl. high‑dose/cell-based), PPH/combos & MenQuadfi.
- Customers: Public health programs, pharmacies, hospitals; US, Europe, China, Japan, EM; CDC/VFC, UNICEF/PAHO, VaxServe.
Rare Diseases & Hematology (c.15% EBIT mix, est.): high‑value orphan - ERT/orals (Fabry, Gaucher, Pompe, ASMD) and bleeding disorders/aTTP.
- Sub‑segments: Lysosomal Storage Disorders; Hemophilia & aTTP.
- Customers: Specialty centers/hospitals, public payers; US/EU/Japan/China; Cencora Specialty, NHS England.
General Medicines (c.8% EBIT mix, est.): declining but cash generative - Basal insulins and established CV/specialty brands; exposure to biosimilars and China VBP.
- Products: Toujeo, Lantus, Plavix, Lovenox, Praluent, Thymoglobulin.
- Channels: Wholesalers, retail/hospitals; US/EU/China/LatAm.
Oncology & Transplant (c.5% EBIT mix, est.): selective focus - Sarclisa in MM, Rezurock in cGVHD; Ayvakit adds SM; Jevtana declining.
- Customers: Hospitals/oncology centers, payers; US/EU/Japan.
Neurology & Other (c.2% EBIT mix, est.): MS/T1D options - Aubagio runoff; tolebrutinib in development; Tzield building.
- Customers: Neurology/endocrine centers; US/EU/Japan.

Key Debates

Dupixent COPD ramp and durability set 2025–27 slope - COPD opens a large new pool, but pulmonologist behavior, coverage breadth and education pace will govern the trajectory. Low biologic penetration and broad Type‑2 efficacy argue for runway; inhaled SOC dynamics, competitor messaging and DTC cadence are swing factors.
- Track US coverage milestones, pulmonology NBRx conversion, and adherence vs asthma/AD cohorts.
- Watch label scope and real‑world exacerbation reduction in high‑risk subgroups.
Time horizon: MT; Materiality: high
Alliance economics: Regeneron development balance unwind - As the historical dev. balance is fully reimbursed by 2026, Sanofi loses that P&L tailwind, creating modeled BOI headwinds (~€300m in 2026; ~€800m in 2027). Ongoing profit‑share and emerging royalties (e.g., Amvuttra) should partly cushion, but EPS growth optics may soften even with Dupixent volume growth.
- Build explicit bridges from 2025 to 2027 BOI/EPS including margin mix and royalty ramps.
- Sensitize to FX and R&D phasing to isolate the structural reset.
Time horizon: MT; Materiality: high
Vaccines: Beyfortus scaling versus flu pricing pressure - RSV infant protection is expanding across geographies, but US flu prebooking has signaled intensifying price competition. Management guides flu down mid‑teens and Beyfortus "modest" growth in 2025; net vaccine profit growth hinges on RSV coverage gains and influenza mix (high‑dose/cell-based) resilience.
- Monitor ACIP/state coverage rates, CDC RSV/Flu severity timing, and Q3/Q4 shipment phasing (75/25 split for flu).
Time horizon: ST; Materiality: high
Amlitelimab Phase 3: second immunology pillar or overlap? - If Phase 3 in AD and respiratory is positive with convenient dosing, amlitelimab could complement Dupixent, diversifying the franchise and supporting pricing power; trial risk and competitive benchmarks (biologics/JAKs) are meaningful. Time horizon: MT; Materiality: high
Blueprint/Ayvakit integration and SM ramp - Rapid growth in systemic mastocytosis strengthens the rare immunology footprint; realization depends on seamless integration, life‑cycle (elenestinib), and global access. Upside may de‑risk outer‑year mix as legacy brands fade. Time horizon: MT; Materiality: medium
Hemophilia portfolio durability amid modality shifts - ALTUVIIIO momentum is strong, but non‑factor (Hemlibra), gene therapies (Roctavian/Hemgenix), and siRNA (Qfitlia) will reshape prophylaxis choices. Safety, regimen convenience and center protocols should drive switch rates. Time horizon: LT; Materiality: medium
Policy, FX and China pricing - US Part D redesign and potential tariff/IRA changes, alongside China NRDL/VBP, introduce net price/volume uncertainty; FX remains a 2025 headwind. Aggregate drag could offset operational outperformance. Time horizon: ST; Materiality: medium

Recent Reporting

Strong 1H momentum and mix improvement

H1 2025 sales +9.9% CER; Q2 +10.1% (reported +6.0% on FX headwind). Gross margin expanded ~+1.8pp H1 on specialty mix and efficiencies; business EPS +12% CER in H1.
Growth breadth: Dupixent +21% in Q2 (COPD/CSU/BP adds); launches +40% (ALTUVIIIO standout); Vaccines +10% with Beyfortus roll‑out. US +17% offsets softer China.

Key KPIs (CER unless stated)

KPI	Q1 2025	Q2 2025	H1 2025	Comment
Net sales (€bn)	9.9 (+9.7%)	10.0 (+10.1%)	19.9 (+9.9%)	FX −4.1pp in Q2
Business EPS (€)	1.79 (+15.7%)	1.59 (+8.3%)	3.39 (+12.0%)	Mix, leverage
Gross margin %	78.0	77.5	77.7	+150–230bps YoY
Dupixent sales (€bn)	3.50 (+20%)	3.83 (+21.1%)	7.31 (+20.7%)	COPD/CSU/BP expansion
Launches (€bn)	1.10	0.90 (+39.8%)	1.74 (+41.7%)	ALTUVIIIO €291m Q2 (+92%)
Vaccines (€bn)	n/a	1.21 (+10.3%)	2.54 (+10.9%)	Beyfortus H1 €356m (+79%)

Profitability/opex and guidance

BOI margin Q2: 25.1% at CER (−1.6pp) on higher R&D and Dupixent profit‑share; SG&A ratio −40–70bps YoY evidences leverage.
2025 guidance: sales high single‑digit CER (upper end) and low double‑digit EPS growth CER; FX headwinds ~−4% sales/~−6% EPS.
Vaccines: flu down mid‑teens YoY; ~75% Q3, ~25% Q4; Beyfortus FY "modest" growth with Q3≈Q4. R&D to increase moderately in H2.

Consensus setup and revisions (Apr vs Oct 2025)

Metric	FY25E Apr	FY25E Oct	Δ	FY26E Apr	FY26E Oct	Δ
Revenue (€bn)	44.65	43.60	−1.05	47.76	46.39	−1.37
Gross profit (€bn)	33.78	33.21	−0.57	36.74	35.18	−1.56
Business EPS (€)	8.24	7.78	−0.46	9.11	8.41	−0.70

What moved and why

Vaccines cut (flu pricing; lower Novavax) offsets steady Immunology/launches and Ayvakit addition. R&D raised, SG&A trimmed; GM lowered on vaccine mix and cautious FX.
FY25 mix: Dupixent ~€15.3bn; ALTUVIIIO ~€1.1bn; Vaccines ~€8.2bn (Beyfortus ~€1.84bn).
H2 bridge: FY25E €43.6bn implies H2 €23.7bn; seasonality sensible given flu phasing and "modest" RSV growth.

Where consensus may be off

Potential conservatism: gross‑margin progression (mix/efficiencies) and Dupixent COPD/CSU/BP uplift.
Potential aggression: outer‑year Ayvakit ramp and residual Novavax revenue.
Outer years reflect BOI headwinds as Regeneron balance reimbursement ends (~€300m 2026; ~€800m 2027).

Upcoming event: Q3 2025 results — 24 Oct 2025 (confirmed).

Lead Indicators

Indicator	Target	Justification
IQVIA/Symphony weekly NBRx/TRx for Dupixent	Immunology (Dupixent)	High‑frequency uptake by indication and specialty; best volume read.
Regeneron quarterly alliance disclosures	Immunology (Dupixent)	Profit‑share, coverage and pipeline color directly relevant.
US PBM formulary updates (Express Scripts/CVS)	Dupixent COPD/CSU/BP	Access/tier shifts drive initiations and net price.
CDC FluView and RSV surveillance	Vaccines (Flu, Beyfortus)	Season severity/timing correlates with ordering and in‑season push.
ACIP meeting materials	Vaccines (Beyfortus, Flu, MenQuadfi)	Policy/coverage decisions affecting uptake and funding.
China NRDL/VBP announcements	Company	Price/volume inflections for Dupixent and established brands.
ClinicalTrials.gov (amlitelimab, tolebrutinib)	Pipeline	Milestone timing, status changes and posted results.

Model Drivers

Model product-by-product volumes, price/mix and geography, then roll to segments and group. For Dupixent, anchor on patient starts by indication, adherence, penetration gains and US net pricing; overlay Regeneron profit‑share and the 2026–27 development balance step‑down. In Vaccines, model doses shipped, prebooking and ASPs; for Beyfortus, apply monthly infant coverage and country rollouts. In Specialty, track active patients and switches to next‑gen assets; General Medicines follows share and price erosion. Cascade gross margin from mix/efficiencies; align R&D/SG&A with launch and pipeline cadence; include FX.

Immunology: new starts by indication/geography; penetration; net price/rebate trends; COPD access curve.
Vaccines: flu doses and ASP by channel; RSV coverage by season/country; tender volumes.
Rare/Heme: treated patients; switch rates (Nexviazyme, ALTUVIIIO); aTTP incidence for Cablivi.
Oncology/SM: Sarclisa regimen share; Ayvakit SM patient adds.
China pricing: NRDL/VBP cuts vs elasticity.
Alliances/royalties: Regeneron profit‑share schedule; Amvuttra royalty ramp.
P&L: gross‑margin mix; R&D/SG&A phasing; FX sensitivities; share count/buybacks.

Read-across Peers

Peer	Score	Justification
— Type‑2/Respiratory Immunology —
Regeneron – Dupixent alliance disclosures	●●●●●	Direct partner; identical KPIs and economics.
Tezspire (AstraZeneca/Amgen)	●●●●●	Severe asthma biologic; pulmonology and payer read‑across.
Xolair (Roche/Novartis)	●●●●●	CSU/CRSwNP overlap; class access and share.
Nucala/Fasenra (GSK/AstraZeneca)	●●●●●	Eosinophilic asthma trends inform biologic mix.
Lebrikizumab/Ebglyss (Lilly/Almirall)	●●●●●	AD competitor; label/access benchmarks vs Dupixent.
Rinvoq (AbbVie) – AD	●●●●●	Oral JAK affects step‑edits and initiation mix.
Trelegy/Breztri (GSK/AZ)	●●●●●	Inhaled COPD base that biologics add onto.
— Vaccines (Flu/RSV/PPH/Meningitis) —
GSK – Vaccines (incl. Arexvy)	●●●●●	RSV/flu pricing and share posture.
Pfizer – Abrysvo & broader vaccines	●●●●●	Maternal RSV strategy competes for infant protection budgets.
CSL Seqirus – Influenza	●●●●●	US/EU flu prebooking and pricing trends.
Moderna – mRNA seasonal vaccines	●●●●●	Potential competitive pressure in adult respiratory.
Novavax – Nuvaxovid (co‑commercial)	●●●●●	Partnered COVID revenue; execution variability.
Bavarian Nordic – Travel/Rabies	●●●●●	Travel/endemic vaccine category proxy.
— Rare Diseases & Hematology —
Takeda – Rare disease (ex‑Shire)	●●●●●	Fabry/Pompe/Gaucher competition and pricing.
Amicus – Galafold/AT‑GAA	●●●●●	Direct Fabry/Pompe read‑across for switches.
Chiesi – Elfabrio (Fabry)	●●●●●	Fabry competition; payer/KOL sentiment.
Roche/Chugai – Hemlibra	●●●●●	Non‑factor prophylaxis benchmark vs ALTUVIIIO.
BioMarin – Roctavian (Hem A)	●●●●●	Gene therapy adoption impacting factor market.
CSL Behring – Hemgenix/Idelvion	●●●●●	Gene therapy/extended half‑life dynamics in heme.
Sobi – Hematology partner	●●●●●	Shared products/geos; tender and switch read‑through.
— Oncology & Systemic Mastocytosis —
J&J – Darzalex (MM)	●●●●●	CD38 incumbent; regimen share vs Sarclisa.
BMS – Revlimid/Pomalyst; Abecma	●●●●●	Backbone/CAR‑T dynamics shape MM sequencing.
GSK – Blenrep (MM)	●●●●●	Later‑line competitor; MM algorithm shifts.
Novartis – Rydapt (SM)	●●●●●	SM comparator; informs Ayvakit positioning.
— Neurology/MS —
Roche – Ocrevus	●●●●●	PPMS/nrSPMS benchmark vs tolebrutinib.
Novartis – Kesimpta	●●●●●	Self‑administered anti‑CD20; MS treatment mix.
TG Therapeutics – Briumvi	●●●●●	Anti‑CD20 competitor; access/adoption signals.
— General Medicines (Insulins/CV) —
Novo Nordisk – Basal insulins	●●●●●	Basal share/pricing and GLP‑1 substitution.
Eli Lilly – Basal insulin	●●●●●	US payer dynamics and discounting read‑across.
Amgen – Repatha (PCSK9)	●●●●●	Direct Praluent comparator; payer tactics/price.
Viatris/Biocon – Insulin biosimilars	●●●●●	Competitive pricing pressure on glargine.
— Alliances/Royalties —
Alnylam – Amvuttra	●●●●●	Royalty ramp supportive to margins late decade.

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