Press Release: Solid Q2 performance and strong pipeline momentum, Full-year 2023 business EPS guidance raised

Solid Q2 performance and strong pipeline momentum, Full-year 2023 business EPS guidance raised

Paris, July 28, 2023

Q2 2023 sales growth of 3.3% at CER and business EPS⁽¹⁾ growth of 8.1% at CER

• Specialty Care grew 11.8% driven by Dupixent^® (€2,562 million, +34.2%) and Nexviazyme^® (€103 million, +146.5%) more than offsetting anticipated impact of Aubagio^® generic competition in the U.S.
• Vaccines up 9.1% due to strong PPH vaccines sales in Rest of World region and COVID vaccine supply in Europe
• General Medicines core assets grew 2.4%, non-core assets lower mainly due to Lantus^® (€353 million, -36.5%)
• CHC sales growth continued (+0.7%) despite unfavorable effect from inventory build in the prior quarter
• Business EPS⁽¹⁾ of €1.74 up 0.6% on a reported basis and 8.1% at CER
• IFRS EPS of €1.15 (up 22.3%)

Key R&D milestones and regulatory achievements in Q2

• Nirsevimab unanimous FDA AdCom vote for prevention of RSV lower respiratory tract disease in infants
• Dupixent^® BOREAS Phase 3 COPD results presented at ATS and published in the New England Journal of Medicine
• Itepekimab in COPD passed a recent interim futility analysis of the Phase 3 AERIFY studies
• Amlitelimab positive Phase 2b data support potential for transformational target profile in Atopic Dermatitis
• Frexalimab Phase 2b primary endpoint met demonstrating significantly reduced disease activity in MS
• Vaccines pipeline moving at pace with 12 innovative assets with new data highlighted at a recent investor event

Progress on Corporate Social Responsibility strategy in Q2

• Inclusivity targets implemented across clinical trial; 45% of U.S. trials achieved at least 1 target
• B Corp Certification granted to CHC North America in recognition of environmental and social achievements

Full-year 2023 business EPS guidance revised upward

• Sanofi now expects 2023 business EPS⁽¹⁾ to grow mid single-digit⁽²⁾ at CER, barring unforeseen major adverse events. Applying average July 2023 exchange rates, the currency impact on 2023 business EPS is estimated between -6.5% to -7.5%. This upgrade includes approximately €400 million of expected one-off COVID vaccine revenues in the second half of the year.

Paul Hudson, Sanofi Chief Executive Officer, commented:

“We have delivered yet another quarter of growth, with Specialty Care and Vaccines as the main drivers. As we move into the second half our Play to Win strategy, we are particularly enthusiastic about the strong flow of positive R&D data readouts and regulatory achievements of this second quarter, highlighting the significant growth potential of our innovative pipeline assets. With the FDA approval of Beyfortus^® for the prevention of RSV in all infants in July, the landmark Phase 3 data in COPD with Dupixent^®, and the important clinical milestones with amlitelimab and frexalimab which support our decision to initiate pivotal trials, we expect to add multiple innovative medicines to our existing growth drivers over the coming years. As we enter the second half of 2023, we are executing on our new launches and we are encouraged by the early launch indicators of ALTUVIIIO^TM and TZIELD^TM, while navigating the anticipated impact from generic competition on Aubagio^®. Our strong results in the first six months make us confident in our outlook for the remainder of the year and as a consequence we are raising our full-year 2023 EPS guidance to mid single-digit growth.”

Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 9). (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 9). The consolidated income statement for Q2 2023 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2022 business EPS was €8.26; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 9).

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