Sanofi SA Earnings - Q1 2026 Analysis & Highlights
Sanofi reported strong Q1 2026 results driven by double-digit sales and earnings growth, with significant momentum from Dupixent and recent pharmaceutical launches, while management outlined comprehensive lifecycle management strategies for key products and provided guidance for profitable growth throughout 2026.
Key Financial Results
Net sales grew 13.6% to €10.5 billion in Q1 2026, supported by Dupixent, recent launches, and recent acquisitions.
Business EPS grew strongly at 14%, driven by operational leverage.
On a like-for-like basis, group sales increased by 12% at constant exchange rates.
Gross profit and margins were up at constant exchange rates, supported by favorable product mix and continued operational efficiencies.
Operating expenses increased by 7%, driven by increased SG&A spend due to 2025 business development and M&A activity, including Blueprint and Dynavax, as well as some one-off items.
Operating expenses as a percentage of sales came down by 1.9 percentage points, showing the ongoing impact of efficiency programs.
BOI was up by 10.9% and BOI margin was slightly down due to higher profit sharing and the phasing of capital gains, which were approximately €230 million last year versus only €40 million this year.
Tax rate was in line with the rate of the first quarter of 2025, with a similar additional French corporate income tax contribution in both years.
Business Segment Results
Dupixent delivered exceptional sales growth with first quarter sales approaching €4.2 billion, with strong year-over-year growth driven by continued market penetration across existing and new indications, as well as a lower basis of comparison in the U.S. last year.
Dupixent is now approved in nine indications and reached more than 1.4 million patients, with U.S. approval in February in allergic fungal rhinosinusitis.
Launch portfolio grew by 44% versus last year or approximately 22%, excluding acquisition, with launches representing 14% of total sales.
ALTUVIIIO led performance with €325 million in sales, up 42%, followed by Beyfortus with €284 million, reflecting continued global expansion.
Sarclisa grew by 30% to €167 million by higher demand in all geographies, reflecting increased use in the frontline setting.
Ayvakit delivered €170 million and Heplisav-B contributed €46 million since the completion of the Dynavax acquisition.
Rare diseases business reached nearly €1.8 billion and grew by 20%, led by Ayvakit and ALTUVIIIO, with new launches contributing to almost half of sales.
Vaccine sales reached €1.3 billion in the first quarter, reflecting solid underlying fundamentals.
PPH and booster now include Heplisav-B, which grew by 18% on a market pro forma basis following the consolidation of Dynavax in February.
Other medicines were impacted by the ongoing divestment of legacy medicines and modest contraction in older medicines in the rest of the world.
Capital Allocation
Sanofi will complete its €1 billion share buyback program in the coming days.
Sanofi signed an agreement to divest Medley, its Brazilian Generics business under very favorable market conditions, with the incoming disposal to be booked below BOI and subject to antitrust approvals.
The Medley transaction is expected to close at the earliest around the end of 2026.
Approximately €400 million of capital gains from divestments are now expected in 2026.
Industry Trends and Dynamics
Atopic dermatitis remains substantially biologic under-penetrated with significant heterogeneity and disease, with opportunities for novel mechanisms of action.
More competition in immunology is helping to create more awareness and more adoption of advanced treatments, with new entrants and new mechanisms of action driving market expansion.
Atopic dermatitis advanced therapy penetration is barely above 18%, indicating significant room for market growth.
Rare diseases collectively impact hundreds of millions of individuals worldwide, with many people facing years of misdiagnosis and limited treatment options.
Competitive Landscape
Dupixent remains the number one prescribed biologic medicine across top specialists in the U.S., reflecting the confidence of physicians in Dupixent's efficacy and safety profile.
Lunsekimig showed statistically significant and clinically meaningful reduction in exacerbations in moderate-to-severe asthma, with differentiation on FEV1 and patient-reported outcomes compared to existing therapies.
Amlitelimab demonstrated low rates of conjunctivitis, pyrexia, chills, and headache that were observed with other molecules, with rates of fever, chills and pyrexia extremely low and lower than any other molecule on the OX40 pathway.
Nuvaxovid, Sanofi's non-mRNA COVID-19 vaccine, continues to differentiate on tolerability as supported by data presented at ESCMID, a key advantage that could help drive higher COVID immunization rates.
Macroeconomic Environment
Q1 2025 performance partly reflected higher growth to net price adjustments, with GTN fluctuating from quarter-to-quarter due to many different factors.
Q1 in the US usually is highest because of the annual insurance benefit resetting.
Growth Opportunities and Strategies
Sanofi has three pillars for sustaining value creation of Dupixent franchise: Defend, Extend, and Innovate.
Defend: Sanofi has a robust patent portfolio of issued patents and pending applications with expiration dates running from 2031 to 2045, with a vigorous defense plan with the expectation to protect Dupixent innovations beyond the U.S. compound patent expiration in March 2031.
Extend: Sanofi has the potential to extend Dupixent's dosing interval to every four weeks to improve patient convenience through a higher dose approach in asthma and a co-formulation approach for which clinical studies are expected to start in the second half of 2026.
The co-formulation technology is with a partner, is precedented, and will be used across the majority of Dupixent indications.
Innovate: Sanofi can potentially pursue new molecules to leverage existing alliance infrastructure to bring new medicines to patients.
Lunsekimig, an anti-IL-13 TSLP bispecific, demonstrated statistically significant and clinically meaningful changes in nasal polyp score, patient-reported nasal congestion and obstruction in inadequately controlled chronic rhinosinusitis with nasal polyps.
Duvakitug achieved ulcerative colitis clinical remission, placebo adjusted of 27% and Crohn's disease endoscopic response placebo adjusted rate of 35% in the RELIEVE UCCD Phase II study.
During monthly maintenance and induction responder patients, duvakitug demonstrated UC clinical remission rates of 58% and CD endoscopic response rates of 55%, suggesting robust sustained efficacy with a convenient monthly subcutaneous dosing.
Venglustat met its primary endpoint in the LEAP2MONO Phase III study in type 3 Gaucher disease, representing a significant milestone for patients with this debilitating neurological form of the disease.
Sanofi licensed in rovadicitinib, a JAK/ROCK inhibitor from Sino Biopharm already approved in China for first-line myelofibrosis, with an ongoing Phase III study in third-line graft-versus-host disease.
Sanofi licensed in a CD19 BCMA CD3 T cell engager from Kali Therapeutics currently in Phase I in immune-mediated disease.
Sanofi has built a deep differentiated expertise across rare disease, spanning from lysosomal storage disease, rare blood disorders and more recently, systemic mastocytosis disorders.
Sanofi's 25-year partnership with the WHO to eliminate sleeping sickness has achieved three major milestones, with new cases reduced by 98% between 2001 and 2024.
Acoziborole, co-developed with DNDi, received a positive CHMP opinion and is the first single-dose treatment requiring no hospitalization or lumbar puncture.
Financial Guidance and Outlook
Sanofi confirms guidance of high-single-digit sales growth at constant exchange rates, with business EPS expected to grow slightly faster than sales.
Tougher comparison base in H2 with Dupixent's new indication launches and the consolidation of Ayvakit, which started in July 2025.
Volume-driven growth is anticipated to continue with some normalization in the second half of the year as new launches annualize and comparisons get tougher.
Profit sharing will continue to grow faster than Dupixent sales and financial expenses are expected to increase this year, with higher debt level from BD and M&A activities last year and potentially further deals this year.
Sanofi expects approximately €400 million of capital gains from divestments in 2026.
R&D reimbursement from Regeneron will have a negative impact on BOI of approximately €400 million in 2026 and approximately €700 million in 2027.
BOI will increase both in margin and in absolute value in both 2026 and 2027, allowing Sanofi to absorb the R&D reimbursement impact through its growth profile and profitable growth.
Sanofi could invest up to €15 billion this year on retain of AA rating in BD and M&A, with the amount potentially increasing to €10 billion more if buying commercialized assets.
Sanofi is targeting the same three therapeutic areas as priority for BD and M&A: immunology, rare disease and vaccines, while not eliminating the possibility to invest in white spaces.
Pipeline and Regulatory Progress
Dupixent received multiple label expansions in the EU for chronic spontaneous urticaria in children, in Japan for bullous pemphigoid and in the US for allergic fungal rhinosinusitis.
EU approval was obtained for Rezurock in third line chronic graft-versus-host disease, marking an important milestone for patients with limited treatment options.
US label expansion was received for Teplizumab to delay the onset of Stage 3 Type 1 diabetes in children, as early as one year of age.
Amlitelimab showed continuous improvement for both every four and 12 week dosing schedules versus placebo through week 24 across all three pivotal studies COAST 1, COAST 2 and SHORE, with no evidence of plateau.
Amlitelimab was well tolerated with low rates of conjunctivitis, pyrexia, chills, and headache, with no cases of Kaposi sarcoma observed in Phase 3 studies.
Two cases of Kaposi sarcoma were observed in ATLANTIS Phase 2 study and ESTUARY Phase 3 extension study, both cutaneous in nature with both patients recovering after discontinuation of treatment.
Overall rates of malignancy were similar to placebo for amlitelimab.
Regulatory submission for amlitelimab is anticipated at some point in H2 2026.
Lunsekimig Phase 2 study in moderate-to-severe asthma demonstrated statistically significant and clinically meaningful reduction in exacerbations regardless of biomarker status over 48 weeks.
Lunsekimig Phase 2 study in inadequately controlled chronic rhinosinusitis with nasal polyps demonstrated statistically significant and clinically meaningful changes in nasal polyp score, patient-reported nasal congestion and obstruction and the Lund-Mackay CT score at week 24.
Both lunsekimig studies showed acceptable safety profiles.
Phase 3 studies for lunsekimig are expected to be discussed soon, with ongoing PERSEPHONE and THESEUS replicated Phase II/III studies in inadequately controlled COPD patients with an eosinophilic phenotype.
Amlitelimab was deprioritized in asthma to focus resources on the most promising opportunities.
CEREN 1 and 2 Phase III studies for itepekimab in chronic rhinosinusitis with nasal polyps are ongoing with readouts anticipated next year.
Sanofi is in discussions with regulatory authorities and with partner Regeneron regarding a potential Phase III study for itepekimab in COPD.
Sanofi does not anticipate waiting for the AIRLYMPUS results before moving forward with lunsekimig Phase 3 progression.
Progression to Phase 3 for lunsekimig will be subject to internal portfolio decision-making and regulatory conversation.
Fabry disease: the PERIDOT Phase III study did not meet its primary endpoint, with the CARAT Phase III study ongoing as Sanofi evaluates the path forward.
Tolebrutinib is still under review with the EU for SPMS, with frexalimab in phase 3 for RMS and SPMS, and riliprubart in phase 3 for CIDP.
Riliprubart recruitment is picking up after initial screening challenges, with Sanofi optimistic about the impact riliprubart can have on patient outcomes.
Wayrilz is advancing with lifecycle management plans beyond ITP.
Sarclisa is expanding with a subcutaneous formulation with recent positive EU recommendations.
Expected 2026 and 2027 key news flows include the last Phase 3 for amlitelimab in AD required for regulatory submission, multiple regulatory submissions based on data already received, and regulatory decisions for medicines and vaccines under review.
2027 expected news flows include 2b data for brivekimig in HS, followed by phase 3 studies of frexalimab in RMS and riliprubart in CIDP.
