On January 30, 2025 Sanofi reported Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025 (Press release, Sanofi, JAN 30, 2025, View Source [SID1234649963]).
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Q4: sales growth of 10.3% at CER1 and business EPS2 of €1.31
•Pharma launches up 56.5%, reaching sales of €0.8 billion, 8% of total sales, led by ALTUVIIIO
•Dupixent sales up 16.0% to €3.5 billion
•Vaccines sales up 10.8% to €2.2 billion, driven by Beyfortus sales in Europe
•Business EPS of €1.31, -11.0% at CER and -14.9% reported; IFRS EPS of €0.54
FY: double-digit sales growth and business EPS guidance exceeded
•Sales totaled €41.1 billion, an increase of 11.3% at CER
•Sales targets exceeded: Dupixent >€13 billion and Beyfortus blockbuster status (€1.7 billion) in its first full year
•Research and Development expenses reached €7.4 billion, up 14.6%, in line with commitments
•Business EPS of €7.12, +4.1% at CER, above guidance, and -1.8% reported; IFRS EPS of €4.59
•The Board of Directors met on January 29, 2025; proposes a dividend of €3.92 for 2024, 30th year of consecutive increases
Pipeline: increased investment and progress
•Q4: four regulatory approvals: Dupixent EoE (children) (EU), Kevzara PMR (EU), Cerdelga GD1 (children) (EU), Efluelda flu (JP)3
•FY: 14 regulatory approvals of medicines and vaccines, 21 regulatory submission acceptances, and eight positive phase 3 readouts emphasize a positive and improving pipeline momentum
Further progress towards a focused biopharma business
•Intention to sell a controlling stake in Opella consumer health at an attractive valuation; closing in Q2 2025 at the earliest4
Guidance
•In 2025, sales are anticipated to grow by a mid-to-high single-digit percentage at CER5. Sanofi confirms the expectation of a strong rebound in business EPS with growth at a low double-digit percentage at CER (before share buyback).6
•Sanofi intends to execute a share buyback program in 2025 of €5 billion. Shares will be purchased preferably through block trades and in the open market with the purpose of cancellation.
Paul Hudson, Chief Executive Officer: "We achieved double-digit sales growth in 2024 while pursuing the transformation of the company. Innovation was a key driver of our growth as launches already contributed 11 percent of sales, with Beyfortus becoming a blockbuster in its first full year of sales. We exceeded our business EPS guidance. In 2024, we announced an intention to sell a controlling stake in Opella consumer health, which will make Sanofi a focused, science-driven biopharma company. We increased R&D investments and achieved significant progress with our pipeline in 2024, including positive phase 3 study results for new medicines such as rilzabrutinib in rare diseases and tolebrutinib in multiple sclerosis. As we enter 2025, we expect continued, solid growth in sales and a strong rebound in earnings. We are also confident in the mid to long-term growth prospects of Sanofi, supported by ongoing launches, Dupixent (currently expected to reach sales of around €22 billion in 20307, in line with the current ambition), and expected future launches from our pipeline."
Q4 2024 Change Change
at CER FY 2024 Change Change
at CER
IFRS net sales reported €10,564 m +9.1 % +10.3 % €41,081 m +8.6 % +11.3 %
IFRS net income reported €683 m — — €5,744 m +6.4 % —
IFRS EPS reported €0.54 — — €4.59 +6.5 % —
Free cash flow8 €2,340 m -25.5 % — €5,955 m -19.6 % —
Business operating income €2,078 m -11.8 % -7.7 % €11,343 m +1.5 % +7.6 %
Business net income €1,642 m -15.1 % -11.2 % €8,912 m -1.8 % +4.1 %
Business EPS €1.31 -14.9 % -11.0 % €7.12 -1.8 % +4.1 %
Q4 and FY 2024 summary
A conference call and webcast for investors and analysts will begin at 15:00 CET. Details can be accessed via sanofi.com, including presentation slides.
The performance shown in this press release covers the three-month period to December 31, 2024 (the quarter or Q4 2024) and the 12-month period to December 31, 2024 (the year or FY 2024) compared to the three-month period to December 31, 2023 (Q4 2023) and the 12-month period to December 31, 2023 (FY 2023) respectively. All percentage changes in sales in this press release are at CER and the commentary below emphasizes the recent quarterly performance, unless stated otherwise.
In Q4 2024, sales were €10,564 million and increased by 10.3%. Exchange rate movements had a negative effect of 1.2 percentage points (pp); therefore, as reported, sales increased by 9.1%. The divestments of medicines/portfolio streamlining had a negative impact of 0.6pp.
In FY 2024, sales were €41,081 million and increased by 11.3%. Exchange rate movements had a negative effect of 2.7pp; therefore, as reported, sales increased by 8.6%. The divestments of medicines/portfolio streamlining had a negative impact of 0.7pp.
Sales by geography
Net sales
(€ million)
Q4 2024 Change
at CER FY 2024 Change
at CER
United States 5,151 +13.3 % 19,986 +16.2 %
Europe 2,433 +6.0 % 9,027 +2.3 %
Rest of World 2,980 +8.8 % 12,068 +10.7 %
of which China 549 -10.4 % 2,666 -0.5 %
US sales were €5,151 million and increased by 13.3%. The strong performance was driven by launches, including Beyfortus, and by Dupixent and Lantus. Other main medicines, and vaccines excluding Beyfortus had slightly lower sales during the quarter.
Europe sales were €2,433 million and increased by 6.0%. Growth was driven by Beyfortus, Dupixent and pharma launches. Other medicines, including Aubagio which faced generic competition, and flu vaccines all had lower sales during Q4.
Rest of World sales were €2,980 million and increased by 8.8%. The performance was led by Dupixent, Beyfortus, PPH and booster vaccines, and pharma launches offset by flu vaccines and legacy medicines, including Plavix. China sales were €549 million and decreased by 10.4%, generally impacted by one-off inventory effects ahead of upcoming changes to the national reimbursement drug list and volume-based procurement. In the year, China sales were broadly stable. Hyperinflation in Argentina contributed 1.8pp to the total Sanofi growth rate in the quarter and 1.4pp in the year.
Business operating income
In Q4 2024, business operating income (BOI) was €2,078 million and decreased by 7.7% (-11.8% reported). The ratio of BOI to net sales was 20.4% and decreased by 3.9pp (19.7% reported, down by 4.6pp). This decrease was mainly driven by a lower gross margin and higher R&D expenses. In FY 2024, BOI was €11,343 million and increased by 7.6% (+1.5% reported). The ratio of BOI to net sales was 28.6% and decreased by 1.0pp (27.6% reported, down by 2.0pp).
Business development
Business development, including strategic investments in external innovation is an integrated part of Sanofi’s efforts to continuously access optionality from new and promising scientific developments and platforms and replenish the pipeline.
In October, Sanofi made a strategic equity investment in Resalis Therapeutics, an Italian company dedicated to developing RNA-based therapies that tackle the root causes of complex metabolic disorders. Sanofi also participated in a €82 million series D financing of Agomab, a Belgian company focused on achieving disease modification by modulating fibrosis and regeneration in chronic indications such as fibrostenosing Crohn’s disease and idiopathic pulmonary fibrosis.
In November, Sanofi made a strategic investment in Zucara, a Canadian company, as part of a $20 million series B financing. As part of the agreement, Sanofi will receive an exclusive right of first negotiation.
In November, Recordati announced the closing of the acquisition of global rights to Enjaymo. Enjaymo is a targeted, biologic medicine approved in the US, the EU and Japan for the treatment of cold agglutinin disease, a rare lymphoproliferative disease.
Biopharma segment
Pharma
Pharma launches
Net sales
(€ million)
Q4 2024 Change
at CER FY 2024 Change
at CER
ALTUVIIIO 230 +143.6 % 682 +330.2 %
Nexviazyme/Nexviadyme
184 +42.0 % 667 +61.2 %
Rezurock 132 +53.5 % 470 +51.6 %
Sarclisa 130 +30.1 % 471 +29.7 %
Cablivi 73 +24.1 % 249 +9.7 %
Xenpozyme 38 +50.0 % 151 +68.1 %
Enjaymo
22 -8.7 % 105 +48.6 %
Tzield 18 +80.0 % 54 +116.0 %
Total 827 +56.5 % 2,849 +71.4 %
ALTUVIIIO (hemophilia A) sales were €230 million of which more than 85% were in the US. Growth continued to be driven by patient switches from older factor medicines and an increasing percentage from non-factor treatments. Rest of World sales of €32 million benefited from supply sales for the ongoing launch of Altuvoct in countries served by Sobi. The hemophilia A franchise (ALTUVIIIO and Eloctate) sales were €311 million and increased by 57.4% as fewer patients switch away from Eloctate.
Nexviazyme/Nexviadyme (Pompe disease) sales were €184 million and increased by 42.0%, driven by Europe (+68.6%) and Rest of World (+55.0%). In the US (+26.3%), most patients have already converted from Myozyme/Lumizyme. The Pompe disease franchise (Nexviazyme/Nexviadyme and Myozyme/Lumizyme) sales were €316 million and increased by 9.7%.
Rezurock (chronic graft-versus-host disease) sales were €132 million and increased by 53.5%, driven by the US (+43.4%) and by launches in Europe (sales of €8 million) and in Rest of World (sales of €5 million).
Sarclisa (multiple myeloma) sales were €130 million and increased by 30.1%, driven by increased use in earlier lines of treatment, mainly in second-line combination treatment, and market share gains in general, in Europe and in Rest of World, including Japan.
Cablivi (acquired thrombotic thrombocytopenic purpura) sales were €73 million and increased by 24.1%, driven by an increased number of patients being identified for appropriate treatment, in the US and from launches in Europe and in Rest of World.
Xenpozyme (acid sphingomyelinase deficiency) sales were €38 million and increased by 50.0%, driven by an increased number of patients being identified for appropriate treatment across all geographies.
Enjaymo (cold agglutinin disease) sales were €22 million and decreased by 8.7%. On November 29, 2024, Recordati announced the closing of the acquisition of global rights to Enjaymo at which point Sanofi stopped booking in-market sales of the medicine.
Tzield (delay onset of type 1 diabetes) sales were €18 million, a sequential increase from Q3 2024 of €3 million, reflecting continued growth in patients and infusions supported by ongoing efforts to increase awareness and screening.
Immunology
Net sales
(€ million)
Q4 2024 Change
at CER FY 2024 Change
at CER
Dupixent 3,458 +16.0 % 13,072 +23.1 %
Dupixent sales were €3,458 million and increased by 16.0%. In the US, sales were €2,551 million and increased by 10.4%. Growth was driven by continued strong prescription trends in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis. The launch in COPD has initiated and is expected to gain momentum in 2025. Sales growth was impacted by fewer business days in Q4 2024 compared to prior periods and a year-end gross-to-net adjustment. In Europe, Dupixent sales were €431 million and increased by 30.4% reflecting continued growth in all approved indications. Following the July 2024 EU approval in COPD, Europe benefited from initial sales in Germany while reimbursement decisions are anticipated throughout Europe in 2025. In Rest of World, sales were €476 million and increased by 38.1%, driven mainly by sales in Japan. In FY 2024, Dupixent sales were €13,072 million and increased by 23.1%, exceeding the target of around €13 billion in sales in 2024 at constant exchange rates.
SANOFI PRESS RELEASE Q4 2024
3
Other main medicines
Net sales
(€ million)
Q4 2024 Change
at CER FY 2024 Change
at CER
Lantus 439 +63.4 % 1,628 +20.8 %
Toujeo 290 +6.5 % 1,227 +13.4 %
Fabrazyme 269 +12.4 % 1,047 +9.1 %
Lovenox 231 -7.6 % 982 -7.0 %
Plavix 211 -16.9 % 914 -0.4 %
Cerezyme 171 +33.8 % 742 +20.3 %
Alprolix 169 +19.0 % 588 +9.6 %
Myozyme/Lumizyme 132 -17.0 % 671 -12.3 %
Thymoglobulin 125 +15.2 % 492 +7.3 %
Praluent 110 -6.8 % 483 +15.2 %
Cerdelga 87 +16.0 % 333 +12.8 %
Eloctate 81 -21.4 % 368 -20.8 %
Aubagio 78 -35.5 % 379 -59.4 %
Lantus sales were €439 million and increased by 63.4%. US sales were €193 million and benefited from a lower base of comparison from a net-price adjustment in the prior period and another quarter of windfall sales due to the continued unavailability of a competing medicine. In 2025, customer demand is expected to normalize and windfall sales to reduce as well.
Toujeo sales were €290 million and increased by 6.5%, mainly driven by Europe (+10.1%) and Rest of World (+7.4%) where Toujeo continued to increase its basal insulin market share. US sales declined slightly (-4.3%) as windfall sales started to subside.
Fabrazyme sales were €269 million and increased by 12.4%, mainly driven by growth in the number of patients and improved treatment compliance.
Lovenox sales were €231 million and decreased by 7.6%, reflecting the continued impact from volume-based procurement in China and biosimilar competition in Europe.
Plavix sales were €211 million and decreased by 16.9%, reflecting renewal of volume-based procurement in China and market volatility in Japan.
Cerezyme sales were €171 million and increased by 33.8%, driven by growth in the number of patients in Rest of World as well as an element of high-inflation boost from Argentina. The Gaucher disease franchise (Cerezyme and Cerdelga) sales were €258 million and increased by 27.4%.
Alprolix sales were €169 million and increased by 19.0%, benefiting from an increase in US market share and supply sales to Sobi.
Myozyme/Lumizyme sales were €132 million and decreased by 17.0% due to the aforesaid shift to Nexviazyme/Nexviadyme.
Thymoglobulin sales were €125 million and increased by 15.2%, reflecting increased sales in the US and in Rest of World.
Praluent sales were €110 million and decreased by 6.8%, reflecting lower sales in Rest of World, specifically in China.
Cerdelga sales were €87 million and increased by 16.0%, primarily driven by a higher number of patients and volume in the US.
Eloctate sales were €81 million and decreased by 21.4%, mainly due to patients converting to ALTUVIIIO in the US and in Japan.
Aubagio sales were €78 million and decreased by 35.5%, reflecting the loss of exclusivity starting in the US in March 2023 followed by the EU in September 2023. Aubagio sales are expected to continue to decrease albeit at a slower rate.
Vaccines
Net sales
(€ million)
Q4 2024 Change
at CER FY 2024 Change
at CER
RSV (Beyfortus) 841 +106.6 % 1,686 +214.4 %
Polio/Pertussis/Hib vaccines and boosters 632 +10.8 % 2,741 +1.2 %
Influenza vaccines 454 -36.8 % 2,555 -1.3 %
Meningitis, Travel and endemic vaccines 249 -4.2 % 1,316 +5.4 %
Total 2,177 +10.8 % 8,299 +13.5 %
Vaccines sales were €2,177 million and increased by 10.8%, driven by continued Beyfortus roll-out, mostly in Europe. In FY 2024, sales were €8,299 million and increased by 13.5%. This performance was driven by a successful roll-out of Beyfortus, reaching €1.7 billion in sales, partly offset by the absence of COVID-19 sales compared to €226 million in FY 2023.
Beyfortus sales were €841 million, driven by additional sales in Europe, in particular Germany, and in the US. Beyfortus is now protecting babies in more than 20 countries. The continued successful roll-out was enabled by additional manufacturing capacity approved during the second half-year of 2024.
Polio/Pertussis/Hib (PPH) and booster vaccines sales were €632 million and increased by 10.8%, driven by increased booster demand in several countries to re-vaccinate adolescents and adults.
Influenza vaccines sales were €454 million and decreased by 36.8%, due to earlier deliveries in Q3 2024 compared to last year.
Meningitis, Travel and endemic vaccines sales were €249 million and decreased by 4.2%, reflecting unfavorable US Centers for Disease Control and Prevention buying patterns partly offset by continued MenQuadfi roll-out in Europe and Rest of World.
Biopharma business operating income
In Q4 2024, Biopharma BOI was €2,038 million and decreased by 8.9% (-13.0% reported). The ratio of BOI to net sales was 20.0% and decreased by 4.2pp (19.3% reported, down by 4.9pp). This decrease was mainly driven by a lower gross margin and higher R&D expenses. In FY 2024, BOI was €11,285 million and increased by 7.3% (+1.2% reported). The ratio of BOI to net sales was 28.4% and decreased by 1.1pp (27.5% reported, down by 2.0pp).
Pipeline update
Sanofi has 83 projects in a pipeline across four main disease areas (Immunology, Rare diseases, Neurology, and Oncology) and Vaccines, including 38 potential new medicines (NMEs) and vaccines (NVEs). The following section highlights significant developments in the late- and mid-stage pipeline in the quarter:
Highlights
Regulatory approvals Dupixent – EoE (children) (EU)
Kevzara – Polymyalgia rheumatica (PMR) (EU)
Cerdelga – GD1 (children) (EU)
Efluelda – Influenza (JP)
Regulatory submissions/acceptances1
Dupixent – CSU (US)
Dupixent – BP (US1)
rilzabrutinib – ITP (US, EU, CN)
Tzield – DO (EU)
Tzield – EI (EU)
tolebrutinib – SPMS (US1)
Sarclisa – NDMM, TE (HD7 study) (EU)
Phase 3 study starts Fluzone HD – Flu (50 years+)
SP0202 – Pneumococcal disease
Dupixent – Lichen simplex chronicus
Immunology
Dupixent (dupilumab)
•Following the adoption of a positive opinion by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use, the EU approved Dupixent to treat eosinophilic esophagitis (EoE) in children as young as one year of age. The approval covers children aged one to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy. The approval is based on the two-part (Part A and B) EoE KIDS phase 3 study (clinical study identifier: NCT04394351). This expands the initial approval in the EU for EoE in adults and adolescents and makes Dupixent the first and only medicine indicated to treat these young patients.
•The US Food and Drug Administration (FDA) accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025.
•Regeneron announced that the sBLA for Dupixent to treat adults with moderate-to-severe bullous pemphigoid (BP) had been submitted to the FDA. BP is a chronic and relapsing disease characterized by intense itch and blisters, reddening of the skin, and painful chronic lesions. The blisters and rash can form over much of the body and cause the skin to bleed and crust, resulting in patients being more prone to infection and affecting their daily functioning. Regeneron and Sanofi are awaiting regulatory submission acceptance in the US.
•The STYLE 1 (clinical study identifier: NCT06687967) and STYLE 2 (clinical study identifier: NCT06687980) phase 3 studies of Dupixent compared with placebo in patients with lichen simplex chronicus commenced dosing the first patient.
duvakitug (TL1A mAb)
The RELIEVE UCCD phase 2b study (clinical study identifier: NCT05499130) met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease (CD). RELIEVE UCCD assessed duvakitug, a human IgG1-λ2 monoclonal antibody targeting TL1A, for the treatment of moderate-to-severe inflammatory bowel disease. In the study, 36.2% (low dose) and 47.8% (high dose) of patients with UC treated with duvakitug achieved clinical remission compared to 20.4% on placebo, placebo-adjusted rates were 15.7% (low dose) and 27.4% (high dose), at week 14 (p=0.050 and 0.003, respectively). In patients with CD, 26.1% (low dose) and 47.8% (high dose) treated with duvakitug achieved endoscopic response compared to 13.0% on placebo, placebo-adjusted rates were 13.0% (low dose) and 34.8% (high dose), at week 14 (p=0.058 and <0.001, respectively). Overall, the treatment effect was consistent across subgroups. This is the first and only randomized, placebo-controlled study to evaluate the impact of an anti-TL1A monoclonal antibody in CD. Detailed results are expected to be presented at the 20th Congress of the European Crohn’s and Colitis Organisation in February 2025.
Tzield (teplizumab)
The EMA accepted for review the regulatory submission for Tzield in children and adolescents to delay the onset (DO) of stage 3 type 1 diabetes (T1D) as well as for the early intervention (EI) of stage 3 T1D. Tzield is approved in the US to delay the onset of stage 3 T1D.
balinatunfib (oral TNFR1si)
The SPECIFY-CD phase 2 study (clinical study identifier: NCT06637631) of balinatunfib compared with placebo in adults with moderate-to-severe CD commenced dosing the first patient.
lunsekimig (IL13xTSLP Nanobody VHH)
The AIRLYMPUS phase 2 study (clinical study identifier: NCT06676319) of subcutaneous lunsekimig compared with placebo as an add-on therapy in high-risk asthma adults not currently eligible for biologic treatments commenced dosing the first patient.
Rare diseases
rilzabrutinib (BTK inhibitor)
•Positive results from the LUNA 3 phase 3 study (clinical study identifier: NCT04562766) of rilzabrutinib in adults with persistent or chronic immune thrombocytopenia (ITP), a rare immune-mediated disease, were presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego, US. The primary endpoint was met, with rilzabrutinib demonstrating durable platelet response in 23% of ITP adult patients compared to 0% on the placebo arm (p<0.0001). Platelet response was achieved in 65% (n=86) of patients receiving rilzabrutinib compared to 33% (n=23) of patients on placebo. Other key secondary endpoints were met including reduced bleeding, number of weeks with platelet response, the need for rescue therapy use, and improved physical fatigue and quality of life measures. Rilzabrutinib is under regulatory review in the EU, China, and the US with a target date for the FDA decision of August 29, 2025.
•During the quarter, the 52-week open-label two-cohort phase 2 study (clinical study identifier: NCT04520451) of rilzabrutinib in IgG4-related disease showed considerable outcomes on disease flare and glucocorticoid sparing. Data are planned to be shared at a medical meeting later this year.
Cerdelga (eliglustat)
Cerdelga was approved in the EU for the treatment of children with Gaucher disease type 1 (GD1), expanding the current use in adults.
Neurology
tolebrutinib (BTK inhibitor)
The FDA granted breakthrough-therapy designation to tolebrutinib for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). This is based on positive results from the HERCULES phase 3 study (clinical study identifier: NCT04411641), demonstrating that tolebrutinib delayed the time to onset of 6-month confirmed disability progression by 31% compared to placebo (HR 0.69; 95% CI 0.55-0.88; p=0.0026), with further analysis of secondary endpoints demonstrating that the number of participants who experienced confirmed disability improvement was nearly double with tolebrutinib (10%) compared to those on placebo (5%) (HR 1.88; 95% CI 1.10-3.21; nominal p=0.021). Sanofi is awaiting regulatory submission acceptance in the US with an EU submission anticipated during H1 2025.
The PERSEUS phase 3 study in primary progressive MS (PPMS) is ongoing with study results anticipated in H2 2025 (clinical study identifier: NCT04458051).
Oncology
Sarclisa (isatuximab)
The EMA accepted for review the regulatory submission for Sarclisa in combination with lenalidomide, bortezomib, and dexamethasone (RVd) induction therapy in transplant-eligible, newly diagnosed multiple myeloma (NDMM, TE) based on the GMMG-HD7 phase 3 study (clinical study identifier: NCT03617731). In the study, Sarclisa significantly prolonged progression-free survival from first randomization, resulting in a statistically significant and clinically meaningful 30% reduction in disease progression or death, compared to RVd induction regardless of the maintenance regimen (HR 0.70; 95% CI 0.52-0.95; stratified log-rank p=0.0184).
Vaccines
SP0202 (PCV21)
A phase 3 program (clinical study identifier: NCT06736041) was initiated for SP0202, a 21-valent pneumococcal conjugate vaccine (PCV21). SP0202 is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter phase 3 in infants and toddlers. The phase 3 program will include more than 7,700 infants, toddlers, young children, and adolescents across multiple geographies, including in the US, Europe, Australia, Asia, and Latin America. In addition, Sanofi and SK bioscience expanded the agreement to develop, license and commercialize next-generation PCVs for both pediatric and adult populations. Despite decades of public health vaccination programs, invasive pneumococcal disease continues to inflict a substantial burden of disease, primarily due to Streptococcus pneumoniae serotypes that are not included in currently available conjugate vaccines. Next-generation PCVs have the potential to extend vaccine coverage of disease-causing serotypes.
SANOFI PRESS RELEASE Q4 2024
6
SP0178 (Fluzone HD)
The vaccine candidate is in development to prevent influenza infections in people aged 50 to 64 years. A phase 3 study (clinical study identifier: NCT06641180) commenced dosing the first patient.
SP0287 (Fluzone HD/Flublok and Nuvaxovid)
The FDA granted fast-track designation to two combination vaccine candidates to prevent influenza and COVID-19 infections in people 50 years of age and older. Both candidates combine two already licensed and authorized vaccines with proven efficacy through randomized controlled studies, and with favorable tolerability.
The first combination vaccine candidate (clinical study identifier: NCT06695117) consists of the inactivated flu vaccine Fluzone High-Dose combined with the adjuvanted recombinant Nuvaxovid COVID-19 vaccine. The second candidate (clinical study identifier: NCT06695130) combines the recombinant protein-based flu vaccine Flublok with Nuvaxovid. Two separate phase 1/2 studies have initiated.
SP0289 (flu H5 mRNA)
The FDA granted fast-track designation to the vaccine candidate to prevent pandemic influenza and a phase 1/2 study (clinical study identifier: NCT06727058) commenced dosing the first patient.
SP0256 (RSV+hMPV mRNA)
The FDA granted fast-track designation to the vaccine candidate to prevent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) infections in people aged 60 to 75 years. A phase 1/2 study (clinical study identifier: NCT06583031) is ongoing.
Anticipated major upcoming pipeline milestones
Medicine/vaccine Indication Description
H1 2025 Dupixent COPD Regulatory decision (JP)
CSU Regulatory decision (US, EU)
amlitelimab Asthma Phase 2 data
Hidradenitis suppurativa (HS) Phase 2 data
balinatunfib (oral TNFR1si) Psoriasis Phase 2 data
brivekimig (TNFaxOX40L) HS Phase 2 data
Cerezyme Gaucher disease type 3 (GD3) Regulatory submission (US)
rilzabrutinib ITP Regulatory submission (JP)
fitusiran Hemophilia A/B Regulatory decision (US)
tolebrutinib SPMS Regulatory submission (EU)
Sarclisa
NDMM, transplant ineligible (IMROZ study)
Regulatory decision (JP, CN)
Subcutaneous formulation Regulatory submission (US, EU)
SAR447873 Gastroenteropancreatic neuroendocrine tumors Phase 2 data (final)
MenQuadfi Meningitis (six weeks+) Regulatory decision (US)
SP0087 Rabies Phase 3 data
SANOFI PRESS RELEASE Q4 2024
7
H2 2025 Dupixent BP Regulatory decision (US)
itepekimab COPD Phase 3 data
Regulatory submission (US, EU)
balinatunfib Rheumatoid arthritis Phase 2 data
Rezurock
Chronic graft-versus-host disease, third line
Regulatory decision (EU)
Tzield Delay onset of type 1 diabetes Regulatory decision (EU, CN)
Early intervention in type 1 diabetes Regulatory decision (EU)
rilzabrutinib ITP Regulatory decision (US, EU, CN)
fitusiran Hemophilia A/B Regulatory decision (CN)
venglustat Fabry disease (FD) Phase 3 data
GD3 Phase 3 data
SAR447537 Alpha-1 antitrypsin deficiency Phase 2 data
tolebrutinib SPMS Regulatory decision (US)
PPMS Phase 3 data
Sarclisa NDMM, TE (HD7) Regulatory decision (EU)
Subcutaneous formulation Regulatory submission (JP, CN)
SP0087 Rabies Regulatory submission (US, EU)
SP0230 Meningitis Phase 2 data
SP0256 RSV (older adults) Phase 2 data
Fluzone HD Influenza (50 years+) Phase 3 data
2026 itepekimab COPD Regulatory submission (JP, CN)
Bronchiectasis Phase 2 data
amlitelimab
Atopic dermatitis (AD)
Phase 3 data
lunsekimig Asthma Phase 2 data
Chronic rhinosinusitis with nasal polyps Phase 2 data
frexalimab
Systemic lupus erythematosus
Phase 2 data
eclitasertib
UC
Phase 2 data
SAR444656
HS
Phase 2 data
AD Phase 2 data
Nexviazyme Infantile-onset Pompe disease Phase 3 data
Regulatory submission
venglustat FD Regulatory submission
GD3 Regulatory submission
SAR447537 Alpha-1 antitrypsin deficiency Regulatory submission
tolebrutinib PPMS Regulatory submission (US, EU)
riliprubart Chronic inflammatory demyelinating polyradiculoneuropathy Phase 3 data
Regulatory submission
Fluzone HD Influenza (50 years+) Regulatory submission
SP0218
Yellow fever
Phase 3 data
Regulatory submission
SP0282 E. coli sepsis Phase 3 data
SP0125 RSV (toddlers) Phase 3 data
Corporate Social Responsibility update at the end of Q4 2024
Access
Sanofi is ranked 3rd in the 2024 Access to Medicine (ATM) Index
The ATM Index evaluates the efforts of 20 leading pharmaceutical companies in expanding access to essential medicines across low- and middle-income countries (LMICs). It measures progress across three critical areas: governance of access, research and development, and equitable product delivery.
In the 2024 ATM Index, Sanofi ranked third, significantly improving its performance from the previous edition of the index, where Sanofi was ranked eighth.
Sanofi’s performance reflects leadership in "governance of access", where Sanofi ranked first, with the integrated access-to-medicine strategy that is linked to leadership incentives and a clear methodology for tracking patient reach. Furthermore, Sanofi has consistently implemented structured access planning for projects in the pipeline. In addition, the vaccines portfolio, as well as the Global Health Unit (GHU) support equitable product delivery and capacity building initiatives that strengthen local healthcare systems. The GHU was also recognized as a best practice example for inclusive business models by the ATM Index report.
As an example, Sanofi concluded a manufacturing partnership with Biovac in South Africa in 2024, designed to enable regional manufacturing of polio vaccines to serve the potential needs of over 40 African countries. Sanofi will continue to produce the bulk of the Inactivated Polio Vaccine (IPV) and Biovac, who will hold the marketing authorization, will be responsible for final formulation, filling, packaging, and delivery of millions of IPV doses to UNICEF for countries supported by the Global Alliance for Vaccines and Immunization (GAVI) in Africa.
As showcased in its first Impact Report, the GHU significantly scaled its operations in 2024, delivering medicines from its Impact portfolio, a dedicated line of high-quality, affordable treatments for noncommunicable diseases (NCDs) to 30 LMICs. This includes life-saving treatments for diabetes, cardiovascular diseases, and cancer, with a clear goal to reach two million patients by 2030.
The GHU invests heavily in strengthening of health systems, from training healthcare workers to supporting infrastructure improvements. In Zanzibar, Sanofi worked with local organizations to deliver integrated care for cardio-metabolic diseases, using digital self-management tools and community health ambassadors to reach patients in remote areas. In Djibouti, Sanofi collaborated with the Ministry of Health to improve care for diabetes and hypertension through health worker training programs and supply chain optimization.
Since its launch, the GHU has:
•Reached over 790,000 patients with NCD treatments;
•Trained over 13,000 healthcare providers and community health workers in NCD management; and
•Supported 128 health facilities in optimizing access and availability of NCD treatments.
Q4 and FY 2024 financial results
Business net income1
Net sales were €10,564 million in Q4 2024 and increased by 9.1% (10.3% at CER). In FY 2024, net sales were €41,081 million and increased by 8.6% (11.3% at CER).
Other revenues were €856 million in Q4 2024 and decreased by 38.0% (37.9% at CER) due to COVID-19 revenue of €411 in Q4 2023. VaxServe sales of non-Sanofi products were €560 million and decreased by 21.2% (21.5% at CER). In FY 2024, other revenues were €3,205 million and decreased by 15.7% (13.3% at CER) due to COVID-19 revenue of €509 million in 2023. VaxServe sales of non-Sanofi products were €1,959 million and decreased by 9.6% (9.5% at CER). In addition, other revenues included sales of Opella products in certain markets (€339 million), supply sales to Opella (€163 million), royalties (€121 million) and others/manufacturing services (€623 million).
Gross profit was €7,844 million in Q4 2024 and increased by 5.4% (6.9% at CER). The gross margin was 74.3% and decreased by 2.5pp (74.5% at CER, down by 2.3pp). The lower gross margin was caused by the lack of COVID-19 other revenue in 2024. In FY 2024, the gross profit was €31,091 million and increased by 7.2% (10.3% at CER). The gross margin was 75.7% and decreased by 1.0pp (76.1% at CER, down by 0.6 pp). The lower gross margin was primarily due to the lack of COVID-19 other revenue in 2024.
Research and Development expenses were €2,257 million in Q4 2024 and increased by 24.4% (24.4% at CER). This reflected increased activity in mid- and late-stage development as several new medicines advanced to phase 3 studies or additional phase 2 studies were initiated in new indications. C.€60 million of the increase was from one-off costs associated with portfolio prioritization, including in oncology. The ratio of R&D to net sales was 21.4% and increased by 2.7pp. In FY 2024, R&D expenses were €7,394 million and increased by 13.6% (14.6% at CER). This increase reflected similar factors as mentioned above. The ratio of R&D to net sales was 18.0% and increased by 0.8pp.
Selling, general and administrative expenses were €2,648 million in Q4 2024 and increased by 7.4% (7.9% at CER), a moderate increase that still generated growth leverage. The ratio of SG&A to net sales was 25.1% and decreased by 0.4pp. In FY 2024, SG&A expenses were €9,183 million and increased by 2.8% (4.5% at CER). The ratio of SG&A to net sales was 22.4% and decreased by 1.2pp.
Total operating expenses were €4,905 million in Q4 2024 and increased by 14.6% (14.9% at CER). In FY 2024, total operating expenses were €16,577 million and increased by 7.4% (8.8% at CER).
Other operating income net of expenses was -€886 million in Q4 2024 compared to -€844 million in Q4 2023. Income included €179 million from divestments of medicines/portfolio streamlining, compared to €62 million in Q4 2023. The income was more than offset by an expense of €1,044 million from the share of profit in the Regeneron monoclonal antibody alliance compared to €889 million in Q4 2023. More details are in appendix 7. In FY 2024, other operating income net of expenses was -€3,293 million compared to -€2,464 million in 2023. Income from divestments was €394 million compared to €452 million in 2023. Expenses from the Regeneron monoclonal antibody alliance were €3,947 million compared to €3,196 million in FY 2023.
Share of profit from associates was €32 million in Q4 2024 compared to €41 million in Q4 2023 and included the share of US profit related to Vaxelis. In FY 2024, share of profit from associates was €136 million compared to €101 million in FY 2023.
Business operating income was €2,078 million in Q4 2024 and decreased by 11.8% (-7.7% at CER). The ratio of BOI to net sales was 19.7% and decreased by 4.6pp (20.4% at CER, down by 3.9pp). In FY 2024, BOI was €11,343 million and increased by 1.5% (+7.6% at CER). The ratio of BOI to net sales was 27.6% and decreased by 2.0pp (28.6% at CER, down by 1.0pp).
Net financial expenses were €62 million in Q4 2024 compared to €45 million in Q4 2023. In FY 2024, net financial expenses were €263 million compared to €168 million in FY 2023, reflecting increased net debt and higher average interest rates.
The effective tax rate increased to 18.8% in Q4 2024 from 16.5% in Q4 2023 and increased to 19.8% in FY 2024 from 17.7% in FY 2023. The effective tax rate has increased mainly due to the implementation of the Organisation for Economic Co-operation and Development Pillar Two rules.
Business net income was €1,642 million in Q4 2024 and decreased by 15.1% (-11.2% at CER). The ratio of business net income to net sales was 15.5% and decreased by 4.5pp (16.1% at CER, down by 3.9pp). In FY 2024, business net income was €8,912 million and decreased by 1.8% (+4.1% at CER). The ratio of business net income to net sales was 21.7% and decreased by 2.3pp (22.5% at CER, down by 1.5pp).
Business earnings per share (EPS) was €1.31 in Q4 2024 and decreased by 14.9% (-11.0% at CER). The average number of shares outstanding was 1,253.6 million compared to 1,253.6 million in Q4 2023. In FY 2024, business earnings per share was 7.12 and decreased by 1.8% (+4.1% at CER). The average number of shares outstanding was 1,251.4 million compared to 1,251.7 million in FY 2023.
Opella
Sanofi intends to sell a controlling stake in Opella consumer health to CD&R with a closing in Q2 2025 at the earliest. Sanofi will retain c.48% ownership.
In Q4 2024, and under the new scope of reporting, sales were €1,202 million and increased by 8% from €1,108 million in Q4 2023, primarily driven by the Wellness category (Qunol and Digestive). The Seasonal category remained stable in a lower Cough & Cold market. In FY 2024, also under the new scope of reporting, sales were €4,948 million and increased by 4% from €4,765 million in 2023. On January 21, 2025, Opella announced that the FDA had lifted a clinical hold on its planned actual use trial (AUT) to support the switch of Cialis (tadalafil) from a prescription to an over-the-counter medicine. This decision allows for the initiation of the AUT.
Appendix 1: Q4 2024 net sales by medicine/vaccine and geography
Q4 2024
(€ million)
Total sales
% CER % reported United States % CER Europe % CER Rest of World % CER
Immunology
Dupixent 3,458 +16.0 % +15.7 % 2,551 +10.4 % 431 +30.4 % 476 +38.1 %
Kevzara 126 +21.0 % +20.0 % 76 +24.6 % 32 +3.2 % 18 +46.2 %
Rare diseases
Fabrazyme 269 +12.4 % +11.2 % 139 +7.0 % 63 +5.0 % 67 +34.0 %
ALTUVIIIO (*) 230 +143.6 % +144.7 % 198 +114.1 % — — % 32 +1500.0 %
Nexviazyme/Nexviadyme (*) 184 +42.0 % +40.5 % 97 +26.3 % 59 +68.6 % 28 +55.0 %
Cerezyme 171 +33.8 % +28.6 % 48 — % 63 +16.7 % 60 +116.1 %
Alprolix 169 +19.0 % +19.0 % 129 +15.3 % — — % 40 +32.3 %
Myozyme 132 -17.0 % -17.0 % 49 -15.5 % 55 -28.6 % 28 +16.7 %
Cerdelga 87 +16.0 % +16.0 % 50 +19.0 % 32 +6.7 % 5 +66.7 %
Eloctate 81 -21.4 % -21.4 % 53 -23.2 % — — % 28 -17.6 %
Cablivi (*) 73 +24.1 % +25.9 % 42 +46.4 % 26 — % 5 +20.0 %
Aldurazyme 69 +16.1 % +11.3 % 18 +5.9 % 21 +4.8 % 30 +33.3 %
Xenpozyme (*) 38 +50.0 % +46.2 % 24 +41.2 % 8 +33.3 % 6 +133.3 %
Enjaymo (*) 22 -8.7 % -4.3 % 11 -7.7 % 3 +200.0 % 8 -33.3 %
Neurology
Aubagio 78 -35.5 % -35.5 % 42 -2.3 % 27 -61.4 % 9 +12.5 %
Oncology
Sarclisa (*) 130 +30.1 % +26.2 % 54 +20.0 % 36 +32.1 % 40 +43.3 %
Jevtana 77 +1.3 % +1.3 % 58 +3.6 % 2 — % 17 -5.3 %
Fasturtec 51 +27.5 % +27.5 % 34 +30.8 % 12 +20.0 % 5 +25.0 %
Other main medicines
Lantus 439 +63.4 % +59.1 % 193 +464.7 % 80 -3.6 % 166 +12.6 %
Toujeo 290 +6.5 % +4.3 % 46 -4.3 % 120 +10.1 % 124 +7.4 %
Lovenox 231 -7.6 % -12.2 % 2 +100.0 % 131 -12.7 % 98 -1.8 %
Plavix 211 -16.9 % -16.9 % 1 -50.0 % 22 -8.3 % 188 -17.5 %
Rezurock (*) 132 +53.5 % +53.5 % 119 +43.4 % 8 +300.0 % 5 +400.0 %
Thymoglobulin 125 +15.2 % +11.6 % 82 +14.3 % 10 — % 33 +21.2 %
Praluent 110 -6.8 % -6.8 % — — % 85 +6.3 % 25 -34.2 %
Aprovel 105 -0.9 % -0.9 % 1 — % 18 -10.0 % 86 +1.2 %
Multaq 77 -12.6 % -11.5 % 68 -12.8 % 3 — % 6 -16.7 %
Soliqua/iGlarLixi 58 -1.6 % -4.9 % 20 -28.6 % 13 +44.4 % 25 +12.5 %
Tzield (*) 18 +80.0 % +80.0 % 17 +70.0 % — — % 1 — %
Mozobil 12 -60.6 % -63.6 % 3 -62.5 % 4 -76.5 % 5 -25.0 %
Others 1,010 -11.1 % -13.5 % 85 -24.1 % 309 -9.6 % 616 -9.9 %
Industrial Sales 124 -25.3 % -25.3 % — -100.0 % 123 -23.1 % 1 -80.0 %
Vaccines
RSV (Beyfortus) (**) 841 +106.6 % +105.1 % 420 +34.6 % 335 +252.6 % 86 — %
Polio/Pertussis/Hib vaccines and boosters 632 +10.8 % +10.1 % 143 -12.9 % 116 +5.5 % 373 +25.6 %
Influenza vaccines 454 -36.8 % -38.7 % 178 -18.8 % 130 -49.2 % 146 -40.2 %
Meningitis, Travel and endemic vaccines 249 -4.2 % -5.3 % 101 -22.9 % 56 +22.2 % 92 +10.3 %
Biopharma 10,564 +10.3 % +9.1 % 5,151 +13.3 % 2,433 +6.0 % 2,980 +8.8 %
Pharma launches (*) 827 +56.5 % +55.7 % 562 +53.8 % 140 +44.3 % 125 +87.1 %
Launches (*), (**) 1,668 +78.3% +77.3% 982 +44.9% 475 +147.4% 211 +212.9%
SANOFI PRESS RELEASE Q4 2024
14
Appendix 1: FY 2024 net sales by medicine/vaccine and geography
FY 2024
(€ million)
Total sales
% CER % reported United States % CER Europe % CER Rest of World % CER
Immunology
Dupixent 13,072 +23.1 % +22.0 % 9,544 +17.2 % 1,618 +31.9 % 1,910 +50.8 %
Kevzara 424 +21.0 % +18.8 % 246 +26.2 % 121 +5.2 % 57 +38.3 %
Rare diseases
Fabrazyme 1,047 +9.1 % +5.8 % 531 +5.6 % 254 +5.4 % 262 +19.9 %
ALTUVIIIO (*) 682 +330.2 % +328.9 % 617 +298.1 % — — % 65 +1575.0 %
Nexviazyme/Nexviadyme (*) 667 +61.2 % +56.9 % 361 +32.7 % 201 +101.0 % 105 +132.1 %
Cerezyme 742 +20.3 % +8.2 % 191 +1.1 % 244 +6.6 % 307 +45.5 %
Alprolix 588 +9.6 % +8.9 % 464 +5.5 % — — % 124 +28.0 %
Myozyme 671 -12.3 % -14.2 % 234 -7.5 % 260 -23.8 % 177 +2.1 %
Cerdelga 333 +12.8 % +11.7 % 186 +13.4 % 128 +8.5 % 19 +37.5 %
Eloctate 368 -20.8 % -21.9 % 236 -30.8 % — — % 132 +5.4 %
Cablivi (*) 249 +9.7 % +9.7 % 136 +21.4 % 93 -6.1 % 20 +23.5 %
Aldurazyme 297 +12.2 % +6.5 % 72 +7.5 % 84 +2.4 % 141 +20.8 %
Xenpozyme (*) 151 +68.1 % +65.9 % 81 +55.8 % 46 +48.4 % 24 +225.0 %
Enjaymo (*) 105 +48.6 % +45.8 % 58 +40.5 % 17 +183.3 % 30 +29.2 %
Neurology
Aubagio 379 -59.4 % -60.3 % 187 -59.1 % 152 -65.2 % 40 -17.2 %
Oncology
Sarclisa (*) 471 +29.7 % +23.6 % 200 +21.2 % 134 +20.7 % 137 +52.4 %
Jevtana 290 -7.8 % -9.4 % 214 -7.0 % 7 -41.7 % 69 -5.1 %
Fasturtec 183 +8.2 % +7.6 % 119 +8.2 % 48 +9.3 % 16 +5.9 %
Other main medicines
Lantus 1,628 +20.8 % +14.6 % 638 +127.0 % 340 -4.8 % 650 -5.8 %
Toujeo 1,227 +13.4 % +9.3 % 217 +1.9 % 479 +8.6 % 531 +23.0 %
Lovenox 982 -7.0 % -12.5 % 9 +28.6 % 567 -9.0 % 406 -4.9 %
Plavix 914 -0.4 % -3.6 % 6 -25.0 % 91 -5.2 % 817 +0.4 %
Rezurock (*) 470 +51.6 % +51.6 % 425 +40.6 % 28 +460.0 % 17 +700.0 %
Thymoglobulin 492 +7.3 % +2.9 % 312 +6.5 % 39 +2.7 % 141 +10.1 %
Praluent 483 +15.2 % +14.5 % — -100.0 % 340 +14.9 % 143 +15.0 %
Aprovel 416 +1.0 % -0.2 % 4 -55.6 % 73 -6.4 % 339 +4.2 %
Multaq 311 -9.6 % -9.6 % 278 -10.3 % 11 -8.3 % 22 — %
Soliqua/iGlarLixi 227 +7.8 % +4.6 % 75 -20.0 % 48 +40.0 % 104 +25.3 %
Tzield (*) 54 +116.0 % +116.0 % 52 +108.0 % 1 — % 1 — %
Mozobil 74 -65.9 % -66.4 % 12 -89.9 % 39 -44.3 % 23 -22.6 %
Others 4,262 -7.7 % -11.7 % 364 -16.9 % 1,263 -6.8 % 2,635 -6.8 %
Industrial Sales 523 -5.1 % -5.1 % 1 -75.0 % 520 -1.5 % 2 -89.5 %
Vaccines
RSV (Beyfortus) (**) 1,686 +214.4 % +208.2 % 1,068 +167.3 % 440 +214.3 % 178 — %
Polio/Pertussis/Hib vaccines and boosters 2,741 +1.2 % -0.9 % 679 -5.5 % 497 +4.0 % 1,565 +3.5 %
Influenza vaccines 2,555 -1.3 % -4.3 % 1,433 +4.3 % 640 -7.8 % 482 -7.4 %
Meningitis, Travel and endemic vaccines 1,316 +5.4 % +3.9 % 736 +1.5 % 204 +28.7 % 376 +3.2 %
Biopharma 41,081 +11.3 % +8.6 % 19,986 +16.2 % 9,027 +2.3 % 12,068 +10.7 %
Pharma launches (*) 2,849 71.4 % 68.6 % 1,930 71.6 % 520 47.9 % 399 +108.9 %
Launches (*), (**) 4,535 +106.3 % +102.7 % 2,998 +97.0 % 960 +95.3 % 577 +199.1 %
SANOFI PRESS RELEASE Q4 2024
15
Appendix 2: Business net income statement
Q4 2024 Biopharma Other Total group
(€ million) Q4 2024
Q4 2023 (1)
Change Q4 2024
Q4 2023 (1)
Change Q4 2024
Q4 2023 (1)
Change
Net sales 10,564 9,687 9.1 % — — — % 10,564 9,687 9.1 %
Other revenues 774 1,309 -40.9 % 82 72 13.9 % 856 1,381 -38.0 %
Cost of sales
(3,524) (3,571) -1.3 % (52) (54) -3.7 % (3,576) (3,625) -1.4 %
As % of net sales (33.4 %) (36.9 %) (33.9 %) (37.4 %)
Gross profit 7,814 7,425 5.2 % 30 18 66.7 % 7,844 7,443 5.4 %
As % of net sales 74.0 % 76.6 % 74.3 % 76.8 %
Research and development expenses (2,257) (1,814) 24.4 % — (1) -100.0 % (2,257) (1,815) 24.4 %
As % of net sales (21.4 %) (18.7 %) (21.4 %) (18.7 %)
Selling and general expenses (2,647) (2,465) 7.4 % (1) (1) — % (2,648) (2,466) 7.4 %
As % of net sales (25.1 %) (25.4 %) (25.1 %) (25.5 %)
Other operating income/expenses (897) (842) 11 (2) (886) (844)
Share of profit/loss of associates* and joint ventures 32 41 — — 32 41
Net income attributable to non-controlling interests (7) (3) — — (7) (3)
Business operating income 2,038 2,342 -13.0 % 40 14 185.7 % 2,078 2,356 -11.8 %
As % of net sales 19.3 % 24.2 % 19.7 % 24.3 %
Financial income and expenses (62) (45)
Income tax expenses (374) (376)
Tax rate** (18.8 %) (16.5 %)
Business net income 1,642 1,935 -15.1 %
As % of net sales 15.5 % 20.0 %
Business earnings/share (in euros)*** 1.31 1.54 -14.9 %
* Net of tax.
** Determined based on business income before tax, associates, and non-controlling interests.
*** Based on an average number of shares outstanding of 1,253.6 million in Q4 2024 and 1,253.6 million in Q4 2023.
(1) Figures for comparative periods (2023) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued operation.
SANOFI PRESS RELEASE Q4 2024
16
FY 2024 Biopharma Other Total group
(€ million) FY 2024
FY 2023 (1)
Change FY 2024
FY 2023 (1)
Change FY 2024
FY 2023 (1)
Change
Net sales 41,081 37,817 8.6 % — — — % 41,081 37,817 8.6 %
Other revenues 2,866 3,505 -18.2 % 339 296 14.5 % 3,205 3,801 -15.7 %
Cost of sales
(12,973) (12,415) 4.5 % (222) (204) 8.8 % (13,195) (12,619) 4.6 %
As % of net sales (31.6 %) (32.8 %) (32.1 %) (33.4 %)
Gross profit 30,974 28,907 7.2 % 117 92 27.2 % 31,091 28,999 7.2 %
As % of net sales 75.4 % 76.4 % 75.7 % 76.7 %
Research and development expenses (7,393) (6,505) 13.7 % (1) (2) -50.0 % (7,394) (6,507) 13.6 %
As % of net sales (18.0 %) (17.2 %) (18.0 %) (17.2 %)
Selling and general expenses (9,113) (8,854) 2.9 % (70) (79) -11.4 % (9,183) (8,933) 2.8 %
As % of net sales (22.2 %) (23.4 %) (22.4 %) (23.6 %)
Other operating income/expenses (3,305) (2,476) 12 12 (3,293) (2,464)
Share of profit/loss of associates* and joint ventures 136 101 — — 136 101
Net income attributable to non-controlling interests (14) (18) — — (14) (18)
Business operating income 11,285 11,155 1.2 % 58 23 152.2 % 11,343 11,178 1.5 %
As % of net sales 27.5 % 29.5 % 27.6 % 29.6 %
Financial income and expenses (263) (168)
Income tax expenses (2,168) (1,934)
Tax rate** (19.8 %) (17.7 %)
Business net income 8,912 9,076 -1.8 %
As % of net sales 21.7 % 24.0 %
Business earnings/share (in euros)*** 7.12 7.25 -1.8 %
* Net of tax.
** Determined based on Business income before tax, associates, and non-controlling interests.
*** Based on an average number of shares outstanding of 1,251.4 million in FY 2024 and 1,251.7 million in FY 2023.
(1) Figures for comparative periods (2023) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued operation.
SANOFI PRESS RELEASE Q4 2024
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Appendix 3: Consolidated income statement
(€ million) Q4 2024
Q4 2023 (1)
FY 2024
FY 2023 (1)
Net sales 10,564 9,687 41,081 37,817
Other revenues 856 1,381 3,205 3,801
Cost of sales (3,576) (3,629) (13,205) (12,628)
Gross profit 7,844 7,439 31,081 28,990
Research and development expenses (2,257) (1,815) (7,394) (6,507)
Selling and general expenses (2,648) (2,466) (9,183) (8,933)
Other operating income 363 204 1,089 979
Other operating expenses (1,249) (1,048) (4,382) (3,443)
Amortization of intangible assets (450) (496) (1,749) (1,911)
Impairment of intangible assets (200) (877) (9) (896)
Fair value remeasurement of contingent consideration (22) (64) (96) (93)
Restructuring costs and similar items (191) (506) (1,396) (1,030)
Other gains and losses, and litigation (5) 13 (470) (196)
Operating income 1,185 384 7,491 6,960
Financial expenses (235) (616) (1,073) (1,293)
Financial income 111 157 519 584
Income before tax and associates and joint ventures 1,061 (75) 6,937 6,251
Income tax expense (190) 90 (1,259) (1,017)
Share of profit/(loss) of associates and joint ventures 9 (134) 60 (136)
Net income from continuing operations 880 (119) 5,738 5,098
Net income from discontinued operations
(185) (439) 64 338
Net income 695 (558) 5,802 5,436
Net income attributable to non-controlling interests 12 (3) 58 36
Net income attributable to equity holders of Sanofi 683 (555) 5,744 5,400
Average number of shares outstanding (million) 1,253.6 1,253.6 1,251.4 1,251.7
Basic earnings per share from continuing operations (in euros)
0.69 (0.09) 4.54 4.04
Basic earnings per share from discontinued operations (in euros)
(0.15) (0.35) 0.05 0.27
Basic earnings per share (in euros)
0.54 (0.44) 4.59 4.31
(1) Figures for comparative periods (2023) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued operation.
SANOFI PRESS RELEASE Q4 2024
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Appendix 4: Reconciliation of net income attributable to equity holders of Sanofi to business net income
(€ million) Q4 2024
Q4 2023 (1)
FY 2024
FY 2023 (1)
Net income attributable to equity holders of Sanofi 683 (555) 5,744 5,400
Net income from discontinued operations 185 439 (64) (338)
Amortization of intangible assets(2)
450 496 1,749 1,911
Impairment of intangible assets 200 877 9 896
Fair value remeasurement of contingent consideration 24 54 127 93
Expenses arising from the impact of acquisitions on inventories — 3 10 9
Restructuring costs and similar items 191 506 1,396 1,030
Other gains and losses, and litigation 5 (13) 470 196
Financial (income) / expense related to liabilities carried at amortized cost other than net indebtedness 62 414 291 541
Tax effect of the items listed above: (82) (470) (828) (940)
Amortization and impairment of intangible assets (149) (225) (304) (473)
Fair value remeasurement of contingent consideration (6) (5) (25) (13)
Restructuring costs and similar items 56 (148) (320) (299)
Other items 17 (92) (179) (155)
Other tax effects (102) 6 (81) 23
Other items 26 178 89 255
Business net income 1,642 1,935 8,912 9,076
IFRS earnings per share(3) (€)
0.54 (0.44) 4.59 4.31
(1) Figures for comparative periods (2023) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued operation.
(2) Of which related to amortization expense generated by the intangible assets measured at their acquisition-date fair values: -€407 million in Q4 2024 and -€480 million in Q4 2023.
(3) Q4: based on an average number of shares outstanding of 1,253.6 million in Q4 2024 and 1,253.6 million in Q4 2023.
FY: based on an average number of shares outstanding of 1,251.4 million in FY 2024 and 1,251.7 million in FY 2023.
SANOFI PRESS RELEASE Q4 2024
19
Appendix 5: Change in net debt
(€ million) FY 2024
FY 2023 (3)
Business net income 8,912 9,076
Depreciation, amortization and impairment of property, plant and equipment and software 1,546 1,509
Other items (626) (555)
Operating cash flow 9,832 10,030
Changes in working capital (507) 207
Acquisitions of property, plant and equipment and software (1,808) (1,677)
Free cash flow before restructuring, acquisitions, and disposals 7,517 8,560
Acquisitions of intangibles assets, investments, and other long-term financial assets(1)
(1,434) (1,091)
Restructuring costs and similar items paid (933) (849)
Proceeds from disposals of property, plant, and equipment, intangible assets, and other non-current assets net of taxes(1)
805 789
Free cash flow 5,955 7,409
Acquisitions(2)
(2,509) (3,149)
Proceeds net of taxes (2)
609 —
Issuance of Sanofi shares 187 195
Acquisition of treasury shares (302) (593)
Dividends paid to shareholders of Sanofi (4,704) (4,454)
Other items (439) (464)
Net cash provided by/(used in) the discontinued Opella business 322 (300)
Change in net debt before Opella reclassification to "Assets held-for-sale" (881) (1,356)
Impact on net debt of the reclassification of Opella to "Assets held-for-sale" (98) —
Change in net debt (979) (1,356)
Beginning of period 7,793 6,437
Closing of net debt 8,772 7,793