Gilead Sciences (GILD) 8th Annual Wolfe Research Healthcare Conference summary

Anito-cel launch readiness

• Launch planned in fourth-line-plus myeloma with 200 authorized treatment centers; footprint is mostly academic and includes ~25 community practices. Community expansion supports future second-line use.

• In-house anito-cel manufacturing is expected to match commercial turnaround times of 2–3 weeks; reported reliability was 99% at ASCO, vs. 97% for YESCARTA and TECARTUS, and may change with volume.

• Manufacturing capacity is expected to serve YESCARTA, TECARTUS and anito-cel through launch and earlier-line expansion, removing historical slot constraints.

• Center activation goal: 80% of authorized treatment centers in six months; payer reimbursement goal: 90% within one year; brand leadership target: within 18 months.

• Post-label launch work includes center contracting, EMR programming for ordering, formulary review and payer reimbursement.

Clinical evidence and development timeline

• At ASH this year, planned iMMagine-1 update includes at least 18 months of follow-up, efficacy and durability data, a safety update and PFS curves; PFS remains immature beyond the 18-month mark.

• More than 400 patients have received anito-cel across Phase I and iMMagine-3; grade 3 CRS or ICANS rates remain below 1%.

• iMMagine-3 fully enrolled in June, ahead of schedule; earliest communicated filing is 2027, with MRD alongside complete response as the first potential endpoint and event-driven PFS as a co-primary endpoint.

• Fourth-line CAR-T penetration among eligible patients was cited at ~25%, versus 4% in second line; safety and durable responses were positioned as key to broader earlier-line use.

• The fourth-line market was sized at $3.5B, second-line CAR-T at $12B and frontline CAR-T at $20B.

Competition and treatment sequencing

• CARVYKTI was identified as the principal in-class competitor; community use of bispecifics is building experience with complex therapies and prompting some practices to seek CAR-T access.

• IMWG guidance was cited as supporting CAR-T before bispecifics because prior bispecific use may cause T-cell exhaustion; bispecifics can follow CAR-T and retain efficacy.

• Speaker cited complete response rates of 70%–80% for CAR-T versus 30%–50% across bispecific studies, while noting different toxicity profiles and trade-offs.

• International CAR-T use can reach up to four times U.S. volume in universal healthcare systems after adoption and referral into selected academic centers.