Sanofi (SAN) investor relations material

Leadership and strategic direction

• Recent leadership changes include a new CEO since April and a new head of R&D, with a renewed focus on I&I, rare diseases, and vaccines, while exploring additional therapeutic areas and white spaces.

• Late-stage pipeline has undergone critical review, resulting in terminations of several programs, with ongoing rigorous assessment and a shift toward quicker, more transparent decision-making.

• R&D is central to business development, with a sharpened focus on scientific merit, strategic fit, unmet need, and financial return in asset evaluation.

• Organizational structure now places BD and M&A under the CFO, enhancing collaboration with R&D and bringing in new expertise at the executive level.

• Communication on strategy will be ongoing, with updates expected at Q3 earnings rather than a single major event.

Portfolio management and business development

• Portfolio review includes a balanced approach to internal and external innovation, aiming for a 50/50 split and leveraging external partnerships and venture investments.

• BD focus has broadened from early-stage bolt-ons to phase-agnostic opportunities, with attention to strategic and scientific fit and financials.

• Active efforts are underway in oncology, neurology, and ophthalmology, with initial focus on areas adjacent to existing expertise, especially in rare and I&I diseases.

• R&D is deeply involved in due diligence for both early and late-stage assets, ensuring scientific rigor and value chain integration.

• Partnerships and platform deals are being prioritized to enhance research productivity and external innovation sourcing.

Pipeline updates and clinical development

• Recent terminations in the late-stage pipeline have led to a more rigorous and risk-balanced approach to capital allocation and program advancement.

• Phase III starts are proceeding with added scrutiny from new leadership, emphasizing risk assessment and portfolio balance.

• Key assets discussed include lunsekimig (TSLP/IL-13 bispecific), revekimab (OX40 ligand), frexalimab (non-depleting CD40 ligand), riliprubart, and duvakitug alfa, with detailed rationale for ongoing or future studies.

• Frexalimab's trial design has shifted to a non-inferiority primary endpoint, with disability progression as a key secondary measure.

• Duvakitug alfa is progressing toward an accelerated approval filing, with ongoing regulatory discussions and additional safety data from open-label extension studies.