Group 1 - Sanofi has filed its 2024 U.S. Form 20-F with the SEC and the French "Document d'Enregistrement Universel" with the AMF, which includes the Annual Financial Report [1] - These documents contain complete audited financial statements and are available on the company's website as well as the SEC and AMF websites [1] - Hard copies of the financial documents can be requested free of charge [1] Group 2 - Sanofi is an innovative global healthcare company focused on improving people's lives through scientific advancements [2] - The company operates in approximately 100 countries and aims to transform medical practices by providing life-changing treatments and vaccines [2] - Sustainability and social responsibility are central to Sanofi's ambitions [2]

Acquisitions and Divestments - Sanofi entered into a definitive agreement with Recordati for the sale of its global rights to Enjaymo, receiving an upfront payment of $825 million and potential milestone payments of up to $250 million based on sales[654]. - In 2023, there were no material divestments reported by Sanofi[655]. - Sanofi completed the acquisition of Inhibrx for $2,035 million, with $1,885 million allocated to in-process development for SAR447537[658][659]. - The acquisition of QRIB Intermediate Holdings, LLC was completed for $1,419 million, impacting cash flows with a net outflow of $1,410 million[662]. - Sanofi acquired Provention Bio, Inc. for approximately $2.8 billion, resulting in a net cash outflow of $2,722 million[663]. - The acquisition of Amunix Pharmaceuticals, Inc. involved a fixed payment of €970 million and contingent consideration of up to $225 million, with a net cash outflow of €852 million[665]. Financial Performance - Consolidated net sales for the year ended December 31, 2024, amounted to €41,081 million, an increase of 8.6% compared to 2023[692]. - At constant exchange rates, net sales rose by 11.3%, driven mainly by strong performances for Dupixent, Beyfortus, and ALTUVIIIO[692]. - Gross profit for 2024 was €31,081 million, representing 75.7% of net sales, compared to 76.7% in 2023[691]. - Research and development expenses increased to €7,394 million, accounting for 18.0% of net sales, up from 17.2% in 2023[691]. - Operating income for 2024 was €7,252 million, or 17.7% of net sales, compared to 18.4% in 2023[691]. - Net income attributable to equity holders of Sanofi was €5,560 million, representing 13.5% of net sales, compared to 14.3% in 2023[691]. - Basic earnings per share for 2024 was €4.44, an increase from €4.31 in 2023[691]. - Financial expenses decreased to €1,073 million in 2024, down from €1,293 million in 2023[691]. Sales Performance - Dupixent sales reached €13,072 million, with a reported increase of 22.0% and a constant exchange rate increase of 23.1%[697]. - Biopharma segment net sales reached €41,081 million in 2024, up 8.6% on a reported basis and 11.3% at constant exchange rates (CER)[698]. - ALTUVIIIO sales amounted to €682 million, with 90% generated in the United States, driven by patient switches from older treatments[700]. - Nexviazyme/Nexviadyme sales were €667 million, up 61.2% year-on-year, now accounting for 50% of total Pompe franchise sales[701]. - Sarclisa reported sales of €471 million, up 29.7% at CER, with strong growth across all regions[702]. - Rezurock sales reached €470 million, an increase of 51.6% at CER, driven by strong uptake in the US and launch countries[703]. - Cablivi sales were €249 million, up 9.7% at CER, with significant growth in the United States[704]. - Lantus sales increased to €1,628 million, up 20.8% at CER, primarily due to the withdrawal of a competing medicine[707]. - Toujeo sales rose to €1,227 million, reflecting a 13.4% increase at CER, driven by growth in China[708]. - Total hemophilia A franchise sales (ALTUVIIIO + Eloctate) amounted to €1,050 million, representing a 67.8% increase at CER[700]. Tax and Revenue Recognition - Sanofi's revenue recognition policies ensure that revenue from sales is recognized when control over the product is transferred to the customer, in accordance with IFRS 15[668]. - The company recognizes deferred income taxes on tax loss carry-forwards and temporary differences, with deferred tax assets not recognized if it is more likely than not that they will not be realized[684]. Cash Flow and Impact - Sanofi's cash impact from the deconsolidation of EUROAPI was a net cash inflow of €101 million[656]. - The acquisition-related costs for Inhibrx were included in the total acquisition price, reflecting the company's strategy to enhance its rare disease pipeline[659].

Core Insights - The E.mbrace phase 3 clinical study for the extraintestinal pathogenic E. coli vaccine candidate by Sanofi and Johnson & Johnson has been discontinued due to insufficient efficacy in preventing invasive E. coli disease compared to placebo [1][7] - No safety concerns were identified during the study, and participants who developed invasive E. coli disease received appropriate treatment [1][7] Study Details - The E.mbrace study was a randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and immunogenicity of a single dose of the vaccine candidate in preventing invasive E. coli disease, including sepsis and bacteremia [3] - The study began in June 2021, enrolling adults aged 60 years or older with a history of urinary tract infections in the past two years, conducted at over 250 sites across five continents [4] Financial Impact - Following the study's discontinuation, Sanofi recorded an impairment charge of $250 million before tax in Q4 2024, affecting the full-year IFRS EPS, which decreased from €4.59 to €4.44 [5] - The business net income and business EPS remain unchanged at €8,912 million and €7.12 respectively, with no change to the financial guidance for 2025 [5] Company Commitment - Sanofi expressed disappointment over the trial results but remains committed to driving innovation in research and development, particularly in areas of high unmet medical need [2]

Execution of a share buyback agreement for up to €2 billion Paris, February 7, 2025. On January 30, 2025, Sanofi announced its intention to execute a share buyback program in 2025 of €5 billion, preferably through block trades and in the open market with the purpose of cancellation. A first tranche of this program was announced on February 3, 2025, and executed on February 5, 2025, for an amount of €3 billion, through an off-market block trade with the long-standing shareholder L’Oréal. On February 6, 2025, ...

Sanofi announces buy back of shares from L’Oréal Paris, February 3, 2025. Sanofi today announces the acquisition of 2.3% of its shares from long-standing shareholder L’Oréal. This transaction is part of Sanofi’s share buyback program announced on January 30, 2025. It is fully aligned with Sanofi’s capital allocation policy and focus on sustainable value creation for shareholders. François Roger Chief Financial Officer, Sanofi“L’Oréal has been a trusted shareholder and partner for decades, playing a key role ...

Sarclisa is the first anti-CD38 treatment approved in China for patients with newly diagnosed multiple myeloma ineligible for transplant  Approval based on positive results from the IMROZ phase 3 study that demonstrated Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved progression-free survival, compared to VRd alone in transplant-ineligible newly diagnosed multiple myeloma Second approval in China in three weeks following the R/R MM indication announced o ...

Press Release Sanofi: Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025 Paris, January 30, 2025 Q4: sales growth of 10.3% at CER and business EPS of €1.31 1 2 FY: double-digit sales growth and business EPS guidance exceeded 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 vacc ...

Sanofi (SNY) reported fourth-quarter 2024 adjusted earnings of 70 cents per American depositary share, which missed the Zacks Consensus Estimate of 71 cents per share. Earnings of €1.31 per share declined 14.9% on a reported basis and 11% on a constant currency rate (“CER”) basis.Find the latest EPS estimates and surprises on Zacks Earnings Calendar.Net sales rose 9.1% on a reported basis to $11.27 billion (€10.56 billion). Exchange rate movements hurt sales by 1.2% in the quarter. Sales rose 10.3% on a CER ...

Sanofi (SNY) announced that the European Commission (“EC”) has granted marketing authorization to expand the use of its multiple myeloma (MM) drug, Sarclisa (isatuximab).With this nod, Sarclisa is now approved, in combination with Velcade (bortezomib) and Bristol Myers’ (BMY) Revlimid (lenalidomide) and dexamethasone (“VRd”), for the treatment of patients with newly diagnosed MM (NDMM) who are not eligible forautologous stem cell transplant.This approval was expected as the EMA’s Committee for Medicinal Pro ...

Sarclisa approved in the EU as the first anti-CD38 therapy in combination with standard-of-care VRd to treat transplant-ineligible newly diagnosed multiple myeloma Approval is based on positive results from the IMROZ phase 3 study, demonstrating Sarclisa in combination with standard-of-care treatment significantly improved PFS, compared to the standard of care alone in TI NDMMRepresents third indication in the EU, including two for the treatment of adult patients with R/R MM, and one in NDMM Paris, January ...