CCIR

Fourth-quarter 2019 sales performance driven by Dupixent and Vaccines. Net sales were €9,608 million, up 6.8% on a reported basis and 4.7%(3) at CER. Dupixent (global sales €679 million, up 135%) the largest growth contributor, drove Sanofi Genzyme GBU

sales up 19.7%. Vaccines sales increased 22.0%, reflecting majority of U.S. influenza vaccine shipments in Q4.

CHC sales down 5.2%, mainly due to Zantac voluntary recall, non-core divestments and changing regulatory requirements. Primary Care GBU sales declined 8.7% due to lower sales in Diabetes and Established Products. Lower China sales (down 21.0%) due to anticipated price and inventory adjustments on Plavix and Avapro in the channel.

Full-year 2019 sales growth of 3.6% at CER/CS and business EPS growth of 6.8% at CER. Net sales were €36,126 million, up 4.8% on a reported basis and 2.8% at CER (up 3.6% at CER/CS. Dupixent sales reached €2,074 million, on track with ambition to achieve more than €10 billion peak sales.

Vaccines sales increased 9.3% to €5,731 million, supporting expected mid-to-high single digit CAGR from 2018 to 2025. Business operating income margin improved 1.2 percentage points to 27.0%, trending towards objective of 30% by 2022.

Q4 2019 business EPS up 17.3% at CER to €1.34. Full-year 2019 business EPS of €5.99 up 6.8% at CER. Full-year 2019 IFRS EPS of €2.24 (down 35.1%(2)), reflecting a €3.6 billion impairment charge mainly related to Eloctate.

Board proposes annual dividend of €3.15, the 26th consecutive increase in dividend. Significant R&D advances and regulatory milestones. SAR442168, a BTK inhibitor, achieved proof of concept in relapsing multiple sclerosis; phase 3 program to be initiated mid-2020.

Dupixent submitted to FDA (priority review) and EMA as first biologic for children aged 6-11 years with atopic dermatitis. Dupixent phase 3 pivotal studies initiated in bullous pemphigoid, chronic spontaneous urticaria and prurigo nodularis. Dupixent efficacy and safety further supported by 3-year data from OLE (Open Label Extension) study. Fluzone High-Dose Quadrivalent approved in the U.S. Sutimlimab demonstrated positive phase 3 results in cold agglutinin disease. SAR408701, an anti-CEACAM5 antibody-drug conjugate, entered into phase 3 in non-small cell lung cancer. Olipudase demonstrated positive pivotal topline data in adult and pediatric patients with acid sphingomyelinase deficiency.

Successful completion of Synthorx acquisition enhances Sanofi’s position as an emerging leader in oncology and immunology.

2020 financial outlook. Sanofi expects 2020 business EPS to grow around 5%(5) at CER, barring unforeseen major adverse events. Applying average January 2020 exchange rates, the positive currency impact on 2020 business EPS is estimated to be around 1%.