Johnson & Johnson (JNJ) investor relations material

R&D and pipeline strategy

• Focused on oncology, immunology, and neuroscience as foundational therapeutic areas, with a balanced approach between internal discovery and external business development and M&A, currently about 60% of the development portfolio is internally derived.

• Recent acquisition of Halda brought a phase III-ready prostate cancer asset and a novel RIPTAC chemistry platform, expanding opportunities in oncology and other areas.

• Combination therapies and platform technologies are being advanced, including dual mechanism co-antibody therapeutics and robust bispecific platforms, with both internal and external sourcing.

Regulatory and policy environment

• Productive and collaborative interactions with the FDA, with ongoing efforts to streamline clinical development and regulatory requirements in the U.S.

• Recent FDA leadership changes and policy uncertainty are seen as opportunities for biopharma, with expectations for a reset and potential positive trends for the industry.

• Upcoming PDUFA negotiations and user fee cycles may face challenges due to leadership transitions and political dynamics, with transparency and accelerated pathways as key policy themes.

Immunology and ICOTYDE developments

• ICOTYDE, an oral IL-23 receptor-targeting therapy, recently approved for psoriasis, shows biologic-like efficacy and a clean safety profile, aiming to expand the market by offering a non-injectable option.

• Dose-ranging studies are ongoing for inflammatory bowel disease (IBD), with confidence in achieving efficacy comparable to biologics and a focus on minimally effective dosing.

• Clean label and ease of use are expected to drive adoption and market expansion, especially among patients reluctant to use injectables.