SANOFI overview

Interim late-breaking clinical data validate not-alpha profile of THOR-707 (SAR444245), Sanofi’s novel investigational IL-2 Early clinical results are consistent with preclinical studies and suggest THOR-707 (SAR444245) may promote an anti-tumor immune response without alpha-mediated side effects, both alone and in combination with anti-PD-1 THOR-707, a precisely PEGylated, engineered version of IL-2 built on Sanofi’s Synthorin™ technology platform, is being studied in a trial of adults...

FDA approves Sarclisa ® (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma Sarclisa regimen reduced risk of disease progression or death by 45% compared to standard of care in patients who had relapsed after one to three prior therapies While the median progression free survival (PFS) for Sarclisa combination therapy is not yet reached, consistent improvement in PFS is seen across patient subgroups This is the second FDA...

Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Règlement général de l’Autorité des Marchés Financiers (Regulation of the French stock market authority) Sanofi a French société anonyme with a registered share capital of 2,517,943,476 € Registered office : 54, rue La Boétie - 75008 Paris - France Registered at the Paris Commercial and Companies...

Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels Expected to enroll 415 participants; interim results expected in Q3 2021 In parallel, preclinical studies are underway to evaluate additional mRNA candidates against emerging SARS-CoV-2 variants PARIS and LEXINGTON, MASS. – March 12, 2021 - Sanofi Pasteur, the vaccines...

FDA accepts Dupixent ® (dupilumab) for review in children with moderate-to-severe asthma Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to improve lung function in children aged 6 to 11 years with asthma in a randomized Phase 3 trial, while also further adding to the well-established safety profile of Dupixent Dupixent has the potential to be a best-in-class treatment option in this younger population of children aged 6...

FDA approves Libtayo® (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50% Libtayo was superior in extending overall survival compared to chemotherapy in a pivotal trial that allowed for certain disease characteristics frequently underrepresented in advanced NSCLC trials This is the third approval for Libtayo in the U.S. PARIS and TARRYTOWN, N.Y. – February 22, 2021 - The U.S. Food and Drug Administration (FDA) has...

Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Règlement général de l’Autorité des Marchés Financiers (Regulation of the French stock market authority) Sanofi a French société anonyme with a registered share capital of 2,517,943,476 € Registered office : 54, rue La Boétie - 75008 Paris - France Registered at the Paris Commercial and Companies...

FDA approves Libtayo ® (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma Following Priority Review Libtayo receives full approval in locally advanced basal cell carcinoma (BCC) and accelerated approval in metastic BCC Libtayo now approved for patients with advanced stages of the two most common skin cancers in the U.S. PARIS and TARRYTOWN, N.Y. – February 9, 2021 - The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor...

Q4 2020 sales growth (2) of 4.2% and business EPS growth of 9.8% at CER Specialty Care sales grew 18.3%, driven by strong Dupixent ® performance (+54.2% to €982 million). Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. General Medicines declined 7.5%, reflecting lower U.S. Diabetes sales, COVID environment and portfolio streamlining. CHC down 3.0% due to decreased sales of Cough & Cold related portfolio in Europe partially offset...

Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Règlement général de l’Autorité des Marchés Financiers (Regulation of the French stock market authority) Sanofi a French société anonyme with a registered share capital of 2,517,873,886 € Registered office : 54, rue La Boétie – 75008 Paris – France Registered at the Paris Commercial and...

Availability of the Q4 2020 Memorandum for modelling purposes Paris, France – December 17, 2020 - Sanofi announced today that its Q4 2020 Memorandum for modelling purposes is available on the "Investors" page of the company's website: https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/Q4-results-2020 As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on...

Sanofi renews partnership with the WHO to fight Neglected Tropical Diseases and eliminate sleeping sickness before 2030 A new five-year US$ 25 million (US$ 5 million/year) financial support to prevent and treat Neglected Tropical Diseases Strong Company commitment to meet the goals of the new WHO NTDs Roadmap and sustainably eliminate sleeping sickness before 2030 20-year partnership outstanding legacy with a decrease of 97% in sleeping sickness cases worldwide PARIS - December 15, 2020 - Sanofi...

Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly Phase 1/2 interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years Insufficient response in older adults demonstrates the need to refine the concentration of antigen in order to provide high-level immune response across all age groups Companies plan a Phase 2b study with an improved...

Sanofi pioneers sustainable finance in the pharmaceutical industry with the signing of its two first sustainability-linked revolving credit facilities Sanofi has successfully refinanced and extended two syndicated credit facilities for a total amount of €8 billion. Sanofi is the first large biopharmaceutical company to integrate environmental and social features in sustainability-linked credit facilities. PARIS – December 9, 2020 - Sanofi pioneers sustainable finance in the pharmaceutical...

Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Règlement général de l’Autorité des Marchés Financiers (Regulation of the French stock market authority) Sanofi a French société anonyme with a registered share capital of 2,517,873,886 € Registered office : 54, rue La Boétie – 75008 Paris – France Registered at the Paris Commercial and...