Gilead Sciences, Inc. (GILD) RBC Capital Markets Global Healthcare Conference (Transcript)

At the RBC Capital Markets Global Healthcare Conference, Gilead Sciences' Cindy Perettie discussed the company's CAR-T franchise, highlighting promising efficacy and safety data for anito-cel in multiple myeloma, with high overall and complete response rates and a favorable safety profile potentially enabling outpatient therapy. Gilead is engaging with regulatory agencies for iMMagine-1 filing, aiming for fourth-line approval, and leveraging its manufacturing expertise to achieve turnaround times comparable to Yescarta and Tecartus. Perettie also addressed challenges in the lymphoma space, including competition from bispecifics, and outlined strategies to expand CAR-T access, improve manufacturing automation, and explore next-generation constructs, including bicistronic CAR-Ts for both hematologic malignancies and autoimmune diseases, as well as solid tumor applications.

Analysis

Gilead Sciences, through its Kite division, presented a compelling case for its CAR-T candidate anito-cel in multiple myeloma, highlighting mature data from approximately 12.6 months of average follow-up showing a 97% overall response rate, a 68% complete response rate, and a favorable safety profile with Grade 3 or above Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) at 1% or less, potentially enabling outpatient administration. The company is advancing anito-cel towards a fourth-line approval, leveraging its robust manufacturing network which demonstrated a seamless tech transfer from partner Arcellx and aims for turnaround times and 96% reliability comparable to its established Yescarta and Tecartus products by its planned 2026 launch. While acknowledging Q1 headwinds for its existing lymphoma franchise, which saw Tecartus sales decline 22% due to in-class and out-of-class competition despite Yescarta's modest 2% growth, Gilead outlined strategies to improve market penetration beyond the current 20% of eligible lymphoma patients, including expanding into community settings and advancing manufacturing automation. Future growth is further supported by a pipeline of next-generation CAR-Ts, such as a 3-day manufacturing process for lymphoma yielding more potent cells at lower doses, and bicistronic CD19/CD20 constructs designed for enhanced efficacy and safety, which are also being explored for autoimmune indications like lupus and MS, alongside early-stage programs in solid tumors, exemplified by glioblastoma CAR-T data for 15-18 patients anticipated at ASCO.

Key Decisions for Investors

• Investors should closely monitor upcoming EHA data and regulatory milestones for anito-cel, as its differentiated efficacy, safety profile, and potential for outpatient use could significantly impact its market adoption in multiple myeloma upon its targeted 2026 launch.
• Careful evaluation of Gilead's ability to navigate competitive pressures in the lymphoma market, particularly for Tecartus, and successfully execute on strategies to expand Yescarta/Tecartus access and transition to next-generation products is warranted.
• The long-term investment thesis may be influenced by progress in the bicistronic CAR-T platform across hematology and autoimmune diseases, and early signals from solid tumor programs like the glioblastoma candidate, though significant data readouts for new indications such as autoimmune diseases are not expected before 2026.