On July 31, 2025 Sanofi reported double-digit sales and solid business EPS growth (Press release, Sanofi, JUL 31, 2025, View Source [SID1234654688]). 2025 sales guidance is now high single-digit growth, at upper end of range.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Q2 sales growth of 10.1% at CER1 and business EPS2 of €1.59
•Pharma launches increased sales by 39.8%, reaching €0.9 billion, driven by ALTUVIIIO
•Dupixent sales increased by 21.1% to €3.8 billion, supported by the COPD launch
•Vaccines sales increased by 10.3% to €1.2 billion
•Research and Development expenses were €1.9 billion, up 17.7%
•Selling, general and administrative expenses were €2.3 billion, up 7.8%
•Business EPS was €1.59, up 8.3% at CER and up 1.9% reported; IFRS EPS was €3.24
Pipeline progress
•Three regulatory approvals: Dupixent BP (US), Sarclisa NDMM, TE (EU), and MenQuadfi meningitis (US)
•Three phase 3 readouts, incl. itepekimab COPD (one met primary endpoint/one did not); positive SP0087 in rabies prevention
•Seven regulatory designations, including orphan and fast track, in rare diseases, neurology, and oncology
Capital allocation
•Sanofi and CD&R closed the Opella transaction, creating an independent global consumer healthcare leader
•Acquisitions completed: Blueprint, in rare diseases/immunology, and Dren Bio’s DR-0201, early-stage pipeline in immunology
•Acquisitions announced: Vigil, in Alzheimer’s disease, and Vicebio, in respiratory vaccines, adding to the early-stage pipeline3
Sustainability
•Sanofi ranked the world’s tenth most sustainable company and number one in Pharmaceuticals & Biotechnology by TIME
Guidance
•In 2025, sales are anticipated to grow by a high single-digit percentage at CER (previously mid-to-high single-digit). Sanofi confirms the expectation of a strong business EPS rebound with growth at a low double-digit percentage at CER (before share buyback), now including all expenses from newly acquired businesses4
•Sanofi intends to complete its €5 billion share buyback program in 2025. 80.3% has been repurchased to date
Paul Hudson, Chief Executive Officer: "We delivered strong performance in Q2 with 10.1% sales growth. Our nine newly launched medicines and vaccines grew by 47.3%. Eight years after market introduction, Dupixent grew by more than 20%, supported by the COPD launch. Based on strong sales performance in H1, we are refining our 2025 sales guidance to the upper end of our previous range. At the same time, we confirm our guidance of a strong business EPS rebound, which now includes all expenses from newly acquired businesses.
Our pipeline continues to make progress despite the mixed results with itepekimab in COPD. We are progressing the data analysis and once finished, we will discuss with regulatory authorities. We remain steadfast in our dedication to bringing new medicines and vaccines to patients. We eagerly anticipate several important phase 3 data readouts in the second half of the year, including amlitelimab in atopic dermatitis and tolebrutinib in primary progressive multiple sclerosis.
Earlier in July, we successfully closed the acquisition of Blueprint in rare diseases, and we are anticipating the closing of the Vigil acquisition in neurology during Q3. Sanofi will remain focused on strategically redeploying capital towards growth and differentiated science with attractive financial returns. We continue to advance our strategy as an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth."
Q2 2025 Change Change
at CER H1 2025 Change Change
at CER
IFRS net sales reported €9,994 m +6.0 % +10.1 % €19,889 m +8.3 % +9.9 %
IFRS net income reported €3,939 m +253.9 % — €5,812 m +158.8 % —
IFRS EPS reported €3.24 +264.0 % — €4.74 +163.3 % —
Free cash flow5 €1,429 m +65.8 % — €2,458 m +474.3 % —
Business operating income €2,461 m -2.4 % +3.3 % €5,363 m +8.6 % +10.8 %
Business net income €1,940 m -0.6 % +5.1 % €4,152 m +7.6 % +9.8 %
Business EPS €1.59 +1.9 % +8.3 % €3.39 +9.7 % +12.0 %

Q2 and H1 2025 summary
A conference call and webcast for investors and analysts will begin at 14:30 CEST with details on sanofi.com, including slides.

The performance shown in this press release covers the three-month period to June 30, 2025 (the quarter or Q2 2025) and the six-month period to June 30, 2025 (the half or H1 2025) compared to the three-month period to June 30, 2024 (Q2 2024) and the six-month period to June 30, 2024 (H1 2024) respectively. All percentage changes in sales in this press release are at CER.

In Q2 2025, sales were €9,994 million and increased by 10.1%. Exchange rate movements had a negative effect of 4.1 percentage points (pp); therefore, as reported, sales increased by 6.0%. The divestments of medicines/portfolio streamlining had a negative impact of 0.4pp on sales growth. In H1 2025, sales were €19,889 million and increased by 9.9%. Exchange rate movements had a negative effect of 1.6pp; therefore, as reported, sales increased by 8.3%. The divestments of medicines/portfolio streamlining had a negative impact of 0.4pp on sales growth.
Sales by geography
Net sales
(€ million)
Q2 2025 Change
at CER H1 2025 Change
at CER
United States 4,878 +17.3 % 9,535 +16.4 %
Europe 2,101 +3.0 % 4,144 +1.8 %
Rest of World 3,015 +4.4 % 6,210 +6.4 %
of which China 687 +1.8 % 1,388 +0.1 %

US sales were €4,878 million and increased by 17.3%. The performance was primarily driven by Immunology, pharma launches, Lantus insulin, while Vaccine sales increased at a slower pace.
Europe sales were €2,101 million and increased by 3.0%. Growth was driven by Immunology, pharma launches, and Vaccines. Other main medicine sales were lower.
Rest of World sales were €3,015 million and increased by 4.4%. The performance was led by Vaccines, including Beyfortus, Immunology, pharma launches, Toujeo insulin, while other main medicines declined. China sales were €687 million and increased by 1.8% in a declining market, impacted by the renewed national reimbursement drug list and volume-based procurement.
Business operating income
In Q2 2025, business operating income (BOI) was €2,461 million and increased by 3.3% (-2.4% reported) from €2,521 million in Q2 2024. The ratio of BOI to net sales was 25.1% and decreased by 1.6pp (24.6% reported, down by 2.1pp). The decrease was mainly driven by higher R&D expenses (up by 17.7%) and higher Regeneron profit sharing. In H1 2025, BOI was €5,363 million and increased by 10.8% (8.6% reported) from 4,938 million in H1 2024. The ratio of BOI to net sales was 27.1% and increased by 0.2pp (27.0% reported, up by 0.1pp).
Business development
Business development, including strategic investments in external innovation is an integral part of Sanofi’s efforts to access optionality for promising scientific developments to contribute to pipeline replenishment.
In early June, Sanofi announced the intention to acquire Blueprint Medicines Corporation (Blueprint), a US publicly traded biopharma company focused on systemic mastocytosis (SM), a rare disease. Blueprint developed Ayvakit/Ayvakyt (avapritinib), approved in the US and the EU, with net revenues of $479 million in 2024 and $175 million in Q2 2025, representing year-on-year growth of 52.5% versus Q2 2024. The acquisition will also bring elenestinib, a potential next-generation medicine for SM, as well as BLU-808, a highly selective and potent oral wild-type KIT inhibitor that has the potential to treat a broad range of diseases in immunology. Furthermore, Blueprint’s established presence among allergists, dermatologists, and immunologists is expected to enhance Sanofi’s growing presence in immunology and its own pipeline. The total equity value of the transaction, including potential contingent value right payments, represents c.$9.5 billion on a fully diluted basis. The acquisition closed on July 17, 2025, from which date Blueprint became fully consolidated in Sanofi.
In May, Sanofi announced the intention to acquire Vigil Neuroscience, Inc. (Vigil), a publicly traded biotech company focused on developing novel therapies for neurodegenerative diseases. This acquisition in neurology, one of Sanofi’s four strategic disease areas, enhances Sanofi’s early-stage pipeline and includes VG-3927, which will be evaluated in a phase 2 clinical study in Alzheimer’s disease. VG-3927 is an oral small molecule TREM2 agonist. The total equity value of the transaction represents c.$470 million on a fully diluted basis. The companies expect the transaction to close in Q3 2025.1
On July 22, Sanofi announced the intention to acquire Vicebio Limited (Vicebio), a privately held biotechnology company headquartered in London, UK. The acquisition brings an early-stage combination vaccine candidate for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), both respiratory viruses, and expands the capabilities in vaccine design and development with Vicebio’s ‘Molecular Clamp’ technology. The vaccine candidate complements Sanofi’s position in the respiratory vaccines area where the company is present in flu and RSV prevention. It also allows Sanofi to offer increased physician and patient choice in RSV and hMPV by adding a non-mRNA vaccine to its pipeline.

Biopharma segment
Pharma
Launches
Net sales
(€ million)
Q2 2025 Change
at CER H1 2025 Change
at CER
ALTUVIIIO 291 +91.8 % 542 +95.4 %
Nexviazyme/Nexviadyme
192 +17.3 % 387 +21.6 %
Sarclisa 140 +19.0 % 276 +22.5 %
Rezurock 132 +21.1 % 263 +28.0 %
Cablivi 69 +29.6 % 136 +20.4 %
Xenpozyme 54 +48.6 % 110 +54.2 %
Tzield 18 +63.6 % 29 +38.1 %
Qfitlia 1 — % 1 — %
Total 897 +39.8 % 1,744 +41.7 %

ALTUVIIIO (hemophilia A) sales were €291 million of which 82% were in the US. Growth was driven by continued patient switches from older plasma-derived and recombinant factor medicines and to a lesser extent from non-factor treatments. Rest of World sales of €53 million benefited from the launch in Japan and supply sales to the collaborator Sobi. The hemophilia A franchise (ALTUVIIIO and Eloctate combined) sales were €356 million and increased by 41.1%, primarily driven by ALTUVIIIO’s strong performance of €291 million, while Eloctate contributed €65 million.
Nexviazyme/Nexviadyme (Pompe disease) sales were €192 million and increased by 17.3%, driven by Europe (+30.8%). In the US (+13.5%), all eligible/non-pediatric patients have converted from Myozyme/Lumizyme. The Pompe disease franchise (Nexviazyme/Nexviadyme and Myozyme/Lumizyme combined) sales were €332 million and decreased by 1.7%.
Sarclisa (multiple myeloma) sales were €140 million and increased by 19.0%, driven by increased use in the front-line setting and market share gains globally.
Rezurock (chronic graft-versus-host disease, third line) sales were €132 million and increased by 21.1%, driven by launches gaining further momentum in Europe (sales of €14 million) and in Rest of World (sales of €11 million), including in China.
Cablivi (acquired thrombotic thrombocytopenic purpura) sales were €69 million and increased by 29.6%, driven by more patients being identified for treatment in the US and Europe.
Xenpozyme (acid sphingomyelinase deficiency) sales were €54 million and increased by 48.6%, mainly driven by Europe.
Tzield (delay onset of type 1 diabetes) sales were €18 million and increased by 63.6% with sales benefiting from the continued investment in education and progress in screening.
Qfitlia (hemophilia A and B) sales were €1 million with several patients treated following approval in the US in March 2025.
Immunology
Net sales
(€ million)
Q2 2025 Change
at CER H1 2025 Change
at CER
Dupixent 3,832 +21.1 % 7,312 +20.7 %

Dupixent sales were €3,832 million and increased by 21.1%. Global sales were driven by continued strong demand in all approved indications, including atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease (COPD), and bullous pemphigoid. In the US sales were €2,807 million and increased by 22.7% driven by volume across all indications, established as well as newly approved. In Europe, sales were €485 million and increased by 21.3% reflecting strong momentum in all approved indications. In Rest of World, sales were €540 million and increased by 12.9%, driven by volume growth in Japan and other geographies, partially offset by the impact of the national reimbursement drug list renewal in China. In H1 2025, sales were €7,312 million and increased by 20.7%, driven by strong demand across all approved indications and geographies.
SANOFI PRESS RELEASE Q2 2025
3

Other main medicines
Net sales
(€ million)
Q2 2025 Change
at CER H1 2025 Change
at CER
Lantus 426 +11.5 % 876 +17.7 %
Toujeo 338 +10.5 % 692 +10.3 %
Fabrazyme 263 -0.4 % 525 +1.0 %
Plavix 229 +1.3 % 473 +1.9 %
Lovenox 209 -15.6 % 447 -11.0 %
Cerezyme 173 -7.8 % 363 -8.6 %
Alprolix 145 +7.8 % 305 +13.7 %
Myozyme/Lumizyme 140 -19.4 % 275 -24.8 %
Praluent 137 +10.3 % 267 +8.5 %
Thymoglobulin 126 +2.3 % 248 +2.4 %
Cerdelga 80 — % 166 +1.2 %
Eloctate 65 -35.2 % 135 -28.8 %
Aubagio 73 -29.0 % 138 -33.0 %

Lantus sales were €426 million and increased by 11.5%. US sales were €199 million and increased by 32.9% benefiting from windfall sales due to the unavailability of competing medicines. In 2025, customer demand is expected to normalize as the current windfall sales diminish. In Europe and Rest of World, combined sales decreased by 2.5%.
Toujeo sales were €338 million and increased by 10.5%, driven by Rest of World (+20.8%) where Toujeo continued to increase its basal insulin market share. Sales in Europe (+3.3%) and US (+3.3%) increased slightly.
Fabrazyme sales were €263 million and broadly stable with slight growth in the number of patients.
Plavix sales were €229 million and increased by 1.3%, reflecting volume growth in Rest of World offset by volume-based procurement in China.
Lovenox sales were €209 million and decreased by 15.6%, mainly as the result of impact from biosimilar competition in Europe.
Cerezyme sales were €173 million and decreased by 7.8%, driven by an element of phasing. The Gaucher disease franchise (Cerezyme and Cerdelga) sales were €253 million and decreased by 5.5%.
Alprolix sales were €145 million and increased by 7.8%, benefiting from supply sales to the collaborator Sobi.
Myozyme/Lumizyme sales were €140 million and decreased by 19.4% due to the ongoing shift to Nexviazyme/Nexviadyme.
Praluent sales were €137 million and increased by 10.3% because of higher sales in Europe, partly offset by lower sales in Rest of World.
Thymoglobulin sales were €126 million and increased by 2.3%, reflecting higher sales in the US and Europe.
Cerdelga sales were €80 million and stable with modest patient growth in the US and Rest of World.
Eloctate sales were €65 million and decreased by 35.2% because of patients converting to ALTUVIIIO.
Aubagio sales were €73 million and decreased by 29.0%, reflecting losses of exclusivity in the US and the EU in 2023. Quarterly performance benefited from clinical-study supplies to a pharma company. Aubagio sales are expected to continue to decrease.
Vaccines
Net sales
(€ million)
Q2 2025 Change
at CER H1 2025 Change
at CER
Polio/Pertussis/Hib primary and booster vaccines 693 +1.3 % 1,361 +2.4 %
Meningitis, Travel and endemic vaccines 307 +7.4 % 609 +5.5 %
Influenza vaccines 141 +26.1 % 214 +15.4 %
RSV (Beyfortus) 72 +322.2 % 356 +79.0 %
Total 1,214 +10.3 % 2,540 +10.9 %

Vaccines sales were €1,214 million and increased by 10.3%, mainly due to the geographic rollout of Beyfortus infant protection.
Polio/Pertussis/Hib (PPH) primary and booster vaccines sales were €693 million and increased by 1.3%, driven by demand for pediatric combinations in Rest of World.
Meningitis, Travel and endemic vaccines sales were €307 million, and increased by 7.4%, driven by increased meningitis vaccinations in Rest of World and phasing of travel and endemic vaccines.
Influenza vaccines sales were €141 million and increased by 26.1% due to one-offs from late-season immunizations in the US and Europe, while Southern Hemisphere sales decreased slightly.
Beyfortus sales were €72 million through expansion of infant protection in Rest of World, including countries in the Southern Hemisphere and Japan. Beyfortus now protects infants in more than 25 countries.
SANOFI PRESS RELEASE Q2 2025
4

Business operating income
In Q2 2025, Biopharma BOI was €2,454 million and increased by 3.1% (-2.5% reported) from €2,517 million in Q2 2024. The ratio of BOI to net sales was 25.0% and decreased by 1.7pp (24.6% reported, down by 2.1pp). The decrease was mainly driven by higher R&D expenses (up by 17.7%) and higher Regeneron profit sharing. In H1 2025, Biopharma BOI was €5,347 million and increased by 11.0% (8.8% reported) from €4,916 million in H1 2024. The ratio of BOI to net sales was 27.0% and increased by 0.2pp (26.9% reported, up by 0.1pp).
Pipeline update
Sanofi has 82 projects in a pipeline across four main disease areas (Immunology, Rare diseases, Neurology, and selectively in Oncology) and Vaccines, including 40 potential new medicines and vaccines. The following section highlights significant developments in the late- and mid-stage pipeline since the prior results press release.
Highlights
Regulatory approvals
Dupixent – BP (US)
Sarclisa – NDMM, TE (EU)
MenQuadfi – meningitis (six weeks+) (US)
Regulatory submission acceptances Dupixent – BP (JP)
Cerezyme – GD3 (US)
Phase 3 data readouts itepekimab – COPD primary endpoint met (AERIFY-1); not met (AERIFY-2)
SP0087 – rabies primary endpoint met
Phase 3 study starts SP0218 – yellow fever
Regulatory designations riliprubart – AMR orphan drug (US)
rilzabrutinib – SCD orphan drug (US)
rilzabrutinib – IgG4-RD fast track (US)
rilzabrutinib – IgG4-RD orphan (EU)
riliprubart – CIDP orphan drug (JP)
SAR446597 – dAMD/GA fast track (US)
SAR446523 – R/R MM orphan drug (US)

Immunology
Dupixent (dupilumab)
The US Food and Drug Administration (FDA) approved Dupixent for the treatment of adult patients with bullous pemphigoid (BP). BP primarily affects elderly patients, and is characterized by intense itch, painful blisters, and lesions, as well as reddening of the skin. It can be chronic and relapsing with underlying type-2 inflammation. The blisters and rash can form over much of the body and cause the skin to bleed and break down, resulting in patients being more prone to infection and affecting their daily functioning. Available treatment options are limited and can add to overall disease burden by suppressing a patient’s immune system. The FDA evaluated Dupixent under priority review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. Dupixent was previously granted orphan drug designation by the FDA for BP, which applies to investigational medicines intended for the treatment of rare diseases that affect fewer than 200,000 people in the US. Additional regulatory applications are under review around the world, including in the EU, Japan (recently submitted), and China.
Rezurock (belumosudil)
The ROCKnrol-1 phase 3 study (clinical study identifier: NCT06143891) evaluating Rezurock in first-line chronic graft-versus-host disease will be discontinued based on a pre-specified futility interim analysis. No major safety concerns were identified.
itepekimab (IL33 monoclonal antibody, mAb)
The AERIFY-1 phase 3 study (clinical study identifier: NCT04701983) evaluating itepekimab in former smokers with inadequately controlled COPD met the primary endpoint of a statistically significant reduction in moderate or severe acute exacerbations compared to placebo of 27% at week 52 for the once every two weeks dose schedule, a clinically meaningful benefit. With a reduction of only 2% at week 52, the AERIFY-2 phase 3 study (clinical study identifier: NCT04751487) did not meet the same primary endpoint. In the studies, patients were randomized to receive itepekimab every two weeks, every four weeks, or placebo, which was added to inhaled triple or double standard-of-care therapy. The safety of itepekimab was consistent across the studies, and adverse events were generally comparable between treatment and placebo groups. Sanofi and Regeneron are reviewing the data, including the apparent loss of benefit in AERIFY-2, and will discuss with regulatory authorities to evaluate next steps. Detailed results will be presented at a forthcoming medical meeting.
riliprubart (C1s mAb)
The US FDA granted orphan drug designation to riliprubart for the treatment of antibody-mediated rejection (AMR) in solid organ transplantation. This designation reflects Sanofi’s commitment to addressing a critical unmet need in transplant medicine, where AMR remains a significant challenge with no FDA-approved treatments available.
SAR444656 (IRAK4 degrader)
In late June, Sanofi’s collaborator Kymera Therapeutics, Inc. announced that development would not continue of KT-474 (SAR444656). The molecule was in phase 2 development for AD (clinical study identifier: NCT06058156) and hidradenitis suppurativa (clinical study identifier: NCT06028230). Instead, a second molecule, KT-485 (to be named SAR447971), against the same target is being prioritized for development under the existing IRAK4 collaboration.

Rare diseases
Cerezyme (imiglucerase)
The US FDA accepted for review the submission of the supplemental biologics license application (sBLA) for Cerezyme to treat patients with Gaucher disease type 3 (GD3), with no age limitation for patients with GD1 and GD3. The target action date for the FDA decision is January 13, 2026.
rilzabrutinib (BTK inhibitor)
•The US FDA granted orphan drug designation to rilzabrutinib, a novel, advanced, oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor that works via multi-immune modulation, to target a reduction in vaso-occlusive crises in sickle cell disease (SCD).
•In addition, the US FDA granted fast-track designation (FTD) to rilzabrutinib for the treatment of IgG4-related disease (IgG4-RD). FTD is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses.
•The European Medicines Agency (EMA) granted orphan designation for rilzabrutinib in IgG4-RD. Previously, in April 2025, the US FDA granted orphan drug designation to rilzabrutinib in the same indication.
Neurology
riliprubart (C1s mAb)
The Ministry of Health, Labour and Welfare (MHLW) in Japan granted orphan drug designation to riliprubart for people with chronic inflammatory demyelinating polyneuropathy (CIDP). Despite available therapies, many CIDP patients are left with residual symptoms, including weakness, numbness, and fatigue that can lead to long-term morbidity and diminished quality of life. C.30% of people with CIDP do not respond to standard therapies. The MHLW grants orphan drug designation to medicines that address rare medical diseases or conditions with unmet medical needs. There is currently c.4,000 people diagnosed with CIDP in Japan.
SAR446597 (C1s/Bb gene therapy)
The US FDA granted FTD to SAR446597, a one-time intravitreal gene therapy for the treatment of geographic atrophy due to dry age-related macular degeneration. SAR446597 delivers genetic material encoding two therapeutic antibody fragments that target and inhibit two critical components of the complement pathway: C1s in the classical pathway and factor Bb in the alternative pathway. Sanofi plans to start a phase 1/2 study to evaluate the safety, tolerability, and efficacy of SAR446597. Sanofi is also currently evaluating SAR402663, a one-time intravitreal gene therapy, in a phase 1/2 clinical study (clinical study identifier: NCT06660667), for the treatment of patients with neovascular wet age-related macular degeneration.
Oncology
Sarclisa (isatuximab)
Following the earlier positive opinion by the EMA’s Committee for Medicinal Products for Human Use, the European Commission approved Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. The approval is based on results from part one of the two-part, double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7 phase 3 study (clinical study identifier: NCT03617731). Sarclisa-VRd demonstrated a deep and rapid response in transplant-eligible (TE) NDMM patients compared to VRd alone, reflected by a statistically significant minimal residual disease (MRD) negativity benefit at the end of the 18-week induction period, which was the primary endpoint of part one. These MRD results were supported by the final progression-free survival (PFS) analysis of part one (induction and transplant), which demonstrated a statistically significant and clinically meaningful improvement in PFS in patients treated with Sarclisa-VRd during induction, regardless of the maintenance therapy received.
SAR446523 (GPRC5D mAb)
The US FDA granted orphan drug designation to SAR446523 for the treatment of relapsed/refractory MM (R/R MM). SAR446523 is a mAb that targets G protein-coupled receptor, class C, group 5, member D (GPRC5D), a potential target for immunotherapy in MM. The GPRC5D mAb recently entered phase 1 testing (clinical study identifier: NCT06630806).
Vaccines
MenQuadfi (meningitis (six weeks+))
The US FDA updated MenQuadfi’s approval to now include active immunization in children aged six weeks to 23 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.
SP0087 (rabies)
The phase 3 study (clinical study identifier: NCT04127786) of the new vero cell vaccine for the prevention of rabies read out positively on safety and immunogenicity. The next-generation rabies vaccine is intended for both pre-exposure and post-exposure prevention of rabies. This study and previous studies will support a US regulatory submission in H2 2025.
SANOFI PRESS RELEASE Q2 2025
6

SP0218 (yellow fever)
The vaccine candidate is in development to prevent yellow fever infection from nine months of age. A phase 3 study in adults (clinical study identifier: NCT07002060) using the new vero cell vaccine commenced dosing the first patient.
Nuvaxovid (COVID-19)
Sanofi’s collaborator, Novavax, Inc. announced that the US FDA approved the BLA for Nuvaxovid for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and in individuals aged 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g., asthma, cancer, diabetes, obesity, smoking). Nuvaxovid has been available for use in the US under Emergency Use Authorization since July 2022 and has full market approvals in the EU and other jurisdictions. Under a May 2024 agreement, Sanofi has a co-exclusive license to co-commercialize Nuvaxovid in most countries worldwide and a sole license for use in combination with Sanofi’s flu vaccines, currently in phase 1 testing.
Anticipated major upcoming pipeline milestones
Medicine/vaccine Indication Description
H2 2025 Dupixent CSU regulatory decision (EU)
amlitelimab AD phase 3 data (first readout)
itepekimab COPD (subject to further analysis and regulatory discussions) regulatory submission (US, EU)
balinatunfib rheumatoid arthritis phase 2 data
Rezurock
chronic graft-versus-host disease, third line
regulatory decision (EU)
teplizumab delay onset of type 1 diabetes regulatory decision (EU, CN)
early intervention in type 1 diabetes regulatory decision (EU)
rilzabrutinib immune thrombocytopenia (ITP) regulatory decision (US, EU)
regulatory submission (JP)
Qfitlia hemophilia A/B regulatory decision (CN)
efdoralprin alfa alpha-1 antitrypsin deficiency (AATD) emphysema phase 2 data
tolebrutinib
non-relapsing, secondary progressive multiple sclerosis (nrSPMS)
regulatory decision (US)
primary progressive MS (PPMS) phase 3 data
Sarclisa subcutaneous formulation regulatory submission
SAR447873 gastroenteropancreatic neuroendocrine tumors phase 2 data (final)
Fluzone HD influenza (50 years+) phase 3 data
SP0087 rabies regulatory submission (US, EU)
SP0230 meningitis phase 2 data
SP0256 RSV (older adults) phase 2 data
H1 2026 Dupixent BP regulatory decision (EU, JP, CN)
itepekimab COPD (subject to further analysis and regulatory discussions) regulatory submission (JP, CN)
amlitelimab
AD
phase 3 data (full readout)
lunsekimig asthma phase 2 data
eclitasertib
ulcerative colitis
phase 2 data
Cerezyme GD3 regulatory decision (US)
Nexviazyme infantile-onset Pompe disease phase 3 data
venglustat Fabry disease phase 3 data
regulatory submission (US)
GD3 phase 3 data
regulatory submission
tolebrutinib nrSPMS regulatory decision (EU)
PPMS regulatory submission (US, EU)
Fluzone HD influenza (50 years+) regulatory submission (US)
SP0125 RSV (toddlers) phase 3 data
H2 2026 frexalimab
systemic lupus erythematosus
phase 2 data
rilzabrutinib ITP regulatory decision (CN)
Nexviazyme infantile-onset Pompe disease regulatory submission (US, EU)
efdoralprin alfa AATD emphysema regulatory submission (US)
riliprubart CIDP phase 3 data
Fluzone HD influenza (50 years+) regulatory submission (EU)
SP0218 yellow fever phase 3 data

Sustainability update
Reducing healthcare’s environmental footprint: from ambition to results
With 3.6 billion people living in areas sensitive to climate change globally1, Sanofi aims to reduce the environmental footprint of its medicines and vaccines via the eco-design approach, spanning the entire lifecycle – from raw materials, manufacturing, device, and packaging, all the way to distribution, patient use, and end of life.
Starting in 2025, all new medicines and vaccines adopt an eco-design approach, and, by 2030, so will Sanofi’s 20 top sellers. Leveraging a science-based life-cycle assessment methodology2 and its own ISO-compliant eco-design digital intelligence tool, Sanofi has already achieved results of eco-design applications in some of its top-selling medicines and vaccines:
•For Dupixent3, the carbon footprint was reduced by 53%, water use cut by 62%, and resource depletion reduced by 30% by optimizing the active ingredient manufacturing process with the partner Regeneron.
•For Toujeo3, 27% carbon footprint reduction, 11% water savings, and 18% resource reduction was achieved, through improved manufacturing, packaging, and device production.
•For Hexaxim3, production and packaging were also optimized, resulting in 17% lower carbon footprint, 19% less water use, and 6% fewer resources used.
All measures were compared to the previous generation of those medicines and vaccines. These improvements demonstrate Sanofi’s commitment to reducing environmental impact across its product range.
Decarbonizing patient care pathways
The healthcare sector generates c.5% of global greenhouse gas emissions, with about half of that attributable to the patient care pathway4. As a key player, Sanofi has the capacity to lead efforts to reduce emissions related to the patient journey.
Sanofi is increasing its efforts to generate and analyze data that examines how its treatments can help to decarbonize patient care pathways. Sanofi has already identified several ways to reduce environmental impact across patient care, such as prioritizing prevention, optimizing treatments, and improving care settings.
In a recent study conducted in Spain using real-world evidence, Sanofi demonstrated the positive environmental impact of the all-infant 2023-2024 immunization program against RSV with Beyfortus5. With immunization coverage exceeding 90% for in-season births and approaching 90% for out-of-season births6, RSV prevention contributed to lower greenhouse gas emissions through reduced healthcare system utilization and decreased patient transportation, as evidenced by fewer visits to primary care physicians, emergency rooms, and specialists, as well as reduced hospitalizations. The program reduced RSV-related CO2 emissions by 47% compared to the previous year’s standard of care, equivalent to 4.9 kilotons of CO2.