Press Release: Continued strong growth in Q3 with key regulatory milestones achieved

Continued strong growth in Q3 with key regulatory milestones achieved

Paris, October 28, 2022

Q3 2022 sales growth of 9.0% at CER driven by Specialty Care and Vaccines

• Specialty Care grew 19.9% driven by Dupixent^® performance (€2,314 million, +44.5%) and launch momentum in Rare Disease
• Vaccines up 23.5% from strong Flu sales in the quarter, rebound of Travel vaccines and growth of Meningitis and PPH franchises
• General Medicines achieved 2.4% core assets growth despite lower Lovenox^® sales due to decreasing demand from COVID-19
• CHC up 1.9% with strong growth in Digestive Wellness and Cough & Cold in a normalizing market environment post-COVID-19

Q3 2022 business EPS⁽¹⁾ up 17.9% at CER driven by higher sales and margin expansion

• BOI margin up 1.9 ppt to 36.0% due to gross margin improvement from efficiency gains, product mix and EUROAPI deconsolidation
• Business EPS⁽¹⁾ of €2.88, up 32.1% on a reported basis and 17.9% at CER
• IFRS EPS of €1.66, down 9.8 %, reflecting a €1,586 billion impairment charge related to SAR444245

Progress on Corporate Social Responsibility strategy

• Access to Medicine Foundation recognized Sanofi Global Health Unit’s work to improve insulin access in low-middle income countries

Key R&D milestones and regulatory achievements

• Dupixent^® approved in the U.S. as the first and only treatment for adults with prurigo nodularis
• FDA granted priority review for Altuviiio™ (efanesoctocog alfa) for the treatment of hemophilia A
• FDA approved Xenpozyme^TM for the treatment of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients
• CHMP recommended approval of Beyfortus^® (nirsevimab) for prevention of RSV disease in infants
• CHMP recommended approval of Enjaymo™ in adult patients with cold agglutinin disease (CAD)

Full-year 2022 business EPS guidance revise upward

• Sanofi now expects 2022 business EPS⁽¹⁾ to grow approximately 16%⁽²⁾ at CER, barring unforeseen major adverse events. Applying average October 2022 exchange rates, the positive currency impact on 2022 business EPS is estimated between +9.5% to +10.5%

Sanofi Chief Executive Officer, Paul Hudson, commented:

“Our strong results for the third quarter demonstrate that Sanofi is on the right path, with a remarkable performance of 20% growth in both Specialty Care and Vaccines, leading us to again raise our business EPS guidance for the full-year. Our commitment to breakthrough science is bearing fruit. Three of our priority first or best-in-class medicines reached important regulatory milestones. Beyfortus^® was recommended by EMA’s CHMP for prevention of RSV disease in all infants while Altuviiio™ was granted priority review by the US FDA for people with hemophilia A. Dupixent^® keeps breaking new ground with a recent US FDA approval making it the first and only treatment indicated for prurigo nodularis, the second indication in dermatology, and fifth overall for Dupixent in the US. Social impact continues to be at the center of our company’s agenda, as illustrated by the introduction of our first two carbon offsetting programs. Looking ahead, we are well positioned to achieve our BOI margin target of 30% in 2022 and to stay focused on our ambition to transform the practice of medicines for patients around the world.”

Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7). (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 7). The consolidated income statement for Q3 2022 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2021 business EPS was €6.56; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 7).

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