Gilead Sciences (GILD) investor relations material

Strategic evolution and portfolio expansion

• Significant investment in global manufacturing and diversification, enabling expansion into oncology and future autoimmune indications.

• Focus on moving cell therapies beyond academic centers to community and outpatient settings, improving patient access.

• Acquisition of Interius Biotherapeutics brings in vivo CAR T platform, aiming for off-the-shelf, lower-cost therapies.

• Early in vivo data shows promising efficacy and persistence, with potential for use in hematology and autoimmune diseases.

• Removal of REMS requirement by FDA reduces patient and caregiver burden, supporting broader adoption.

Pipeline and product development

• Next product, Anida Cell, targets multiple myeloma with potential launch in 2026; data shows strong efficacy and differentiated safety.

• Manufacturing for Anida Cell established, with capacity for up to 24,000 therapies annually by 2026.

• Ongoing studies in second and frontline settings for multiple myeloma, aiming to address broader patient populations.

• Next-generation CAR Ts, including bispecific and dual co-stimulatory domain constructs, advancing in lymphoma, autoimmune, and neurology indications.

• Phase I data in GBM shows high response rates without lymphodepletion, informing future solid tumor strategies.

Commercial and regulatory outlook

• Data supports similar outcomes for inpatient and outpatient administration, encouraging expansion to community and regional centers.

• FDA engagement remains constructive for upcoming filings, with 2026 targeted for Anida Cell launch.

• Market opportunity in multiple myeloma is significant, with all patients progressing through multiple lines of therapy.

• Early-stage programs in autoimmune and neurology, including lupus and MS, leverage dual-antigen CAR T constructs.

• Upcoming data releases expected for three next-gen lymphoma products, with focus on efficacy and outpatient safety profile.