Sanofi (SAN) investor relations material

Pipeline and R&D progress

• Significant pipeline advancement, with notable excitement around Brevecumab and Amelior, despite mixed Itapecamab results creating strategic challenges.

• Tolibrutinib's PDUFA extension seen as positive, with FDA reviewing broader Gemini 1 and 2 data to better define the treatable MS population.

• R&D spend will increase slightly, with a focus on pruning and reallocating resources as data matures, especially in immunology.

• Amelior and Dupixent expected to drive growth, with Amelior potentially reaching $3–5B in atopic dermatitis if efficacy and safety hold.

• Oral TNF and other pipeline assets like rilzabrutinib and FREXA are progressing, with key data readouts expected in the near term.

Financial outlook and operational strategy

• Greater precision on year-end and 2026 outlook will be provided at Q3, with a focus on maintaining high growth and efficient P&L management.

• Margins expected to be clarified at Q3, with underlying P&L performance on track and positive sentiment in R&D investments.

• Specialty Care portfolio blend and blockbuster launches like Amvuttra and Dupixent are supporting strong financial performance.

• G&A management remains a priority, with high expectations for 2026 and continued investment to sustain high growth rates.

• Company aims to deliver $10B+ in new product sales by decade's end, with a disciplined approach to exclusivity management.

Regulatory and policy environment

• Ongoing dialogue with the US administration on MFN, IRA, and tariffs, with industry responses expected soon; preference for comprehensive solutions including PBM transparency and 340B reform.

• No clear path yet for MFN implementation; industry may seek to negotiate broader policy changes rather than piecemeal wins.

• Company remains committed to global patient access, resisting the idea of withdrawing innovation from Europe despite US market weighting.

• Pricing differentials between US and Europe are less extreme for government patients than commonly perceived, highlighting the need for PBM involvement.

• Regulatory focus for tolibrutinib is on defining the secondary progressive MS population and ensuring robust REMS for safety.