Gilead Sciences (GILD) Jefferies Global Healthcare Conference 2025 summary

R&D pipeline focus and progress

• Emphasis on virology, oncology, and immunology as core therapeutic areas, with significant pipeline advancement in each.

• Lenacapavir is a major upcoming event in HIV prevention, with a PDUFA date around June 18–19 and expectations for a successful launch.

• Oncology progress highlighted by positive TRODELVY data in first-line triple-negative breast cancer, expanding patient reach and duration of therapy.

• Immunology portfolio includes oral alpha-4 beta-7, IRAK4, and STAT6 degrader, with early-stage programs advancing.

• Up to nine additional virology launches are possible before 2033, broadening prevention and treatment options.

HIV prevention and treatment innovation

• Lenacapavir launch preparations are comprehensive, focusing on prescriber engagement, reimbursement, and site readiness, with access to 75% of sites expected within six months post-launch.

• Once-yearly intramuscular lenacapavir for PrEP showed strong pharmacokinetic data and will enter phase III later this year.

• Potential for accelerated approval of once-yearly PrEP via PK bridging study design is under discussion.

• HIV treatment pipeline includes daily, weekly, monthly, and six-monthly regimens, with a focus on patient optionality and quality of response.

• Combination therapies, such as lenacapavir plus broadly neutralizing antibodies and oral bictegravir/lenacapavir, are advancing for resistant and complex cases.

Oncology and cell therapy developments

• Anito-cel (Arcellx BCMA CAR-T) data to be presented at EHA shows 97% overall response and 68% complete response, with a favorable safety profile and potential for outpatient use.

• Manufacturing for anito-cel is underway in Maryland, with turnaround times of 14–17 days and high reliability rates, supporting a 2026 launch goal.

• Regulatory strategy includes co-primary endpoints (MRD and PFS) for pivotal studies, aligning with FDA expectations.

• Yescarta and Tecartus face competitive headwinds, with flat growth expected this year, but next-generation constructs like Kite 363 show promise for future growth.

• TRODELVY's first-line triple-negative breast cancer data positions it as a potential new standard of care, with additional studies in HR-positive and adjuvant settings underway.