Legend Biotech Q1 FY26 earnings call LEGN

CARVYKTI demonstrated strong commercial performance in Q1 FY26, with net trade sales of $597 million, driven by significant year-over-year growth in both U.S. (36%) and ex-U.S. (over 200%) markets. The therapy is seeing increasing penetration in earlier lines of treatment, with 41% of U.S. apheresis volume coming from second and third-line settings, up from 29% a year ago. This trend is supported by growing physician confidence and the ability to reliably support the shift at scale. The company expects this earlier-line penetration to continue, potentially reaching 75% of its business over the next year or so. The overall multiple myeloma market in second to fourth line is estimated at 100,000 patients, with only about 5% having seen a BCMA therapy, indicating significant growth potential. Approximately 80% of patients in the U.S. are treated in the community setting, highlighting the importance of community adoption for CARVYKTI.

Legend Biotech is actively advancing its pipeline beyond CARVYKTI, with several In Vivo CAR-T programs showing progress. The BCMA In Vivo program for autoimmune diseases and the GPRC5D In Vivo program for multiple myeloma have both entered Phase I clinical trials. The company's In Vivo CAR-T program targeting CD19 and CD20 for Non-Hodgkin's Lymphoma (LB2501) is expected to report initial clinical data at a major medical meeting around mid-year 2026, focusing on both safety and efficacy. Management anticipates filing one to two U.S. INDs in 2026, underscoring its commitment to expanding its innovative cell therapy platforms. The In Vivo CAR-T platform is believed to have transformative potential by moving cell engineering and expansion into the patient's body, aiming for better cell thinness and improved clinical responses across different disease areas.

The company reported total revenue of $305 million for Q1 FY26, with collaboration revenue of $298 million primarily from CARVYKTI sales. Adjusted net loss significantly narrowed to $11 million, compared to $27 million in Q1 FY25, and the company remains confident in achieving company-wide adjusted profitability in 2026. Gross margin on net product sales was 41% in Q1, a decline from 57% in Q4 2025, attributed to one-time^📎 expenses for ramping up new manufacturing capacity at the Raritan and Tech Lane facilities. However, gross margin is expected to recover to over 50% in Q2 as utilization increases. The company ended the quarter with a strong balance sheet, holding $835 million in cash, cash equivalents, and time deposits, with no long-term debt, providing flexibility for strategic investments.

Legend Biotech continues to optimize its manufacturing capabilities, achieving a 99% manufacturing success rate and a median turnaround time of approximately 29 days for CARVYKTI in Q1 2026. Over 95% of final product deliveries were released on time. This operational efficiency is crucial for broadening adoption and supporting the shift towards earlier CAR-T treatment. Globally, CARVYKTI is now available in 18 markets and over 300 treatment sites, with international growth scaling as site experience, manufacturing slots, and referral patterns mature. In the U.S., the company has 148 authorized treatment centers, with about one-third being community and regional hospitals, bringing CARVYKTI closer to patients.

To strengthen its long-term R&D strategy and guide critical scientific and clinical decisions, Legend Biotech recently engaged six distinguished scientific advisers with deep expertise in oncology, immunology, cell therapy, and translational research. This initiative aims to leverage external expertise as the company broadens its pipeline and matures its next-generation cell therapy platforms. The R&D budget is increasingly being reinvested into promising In Vivo programs, utilizing the profitability generated by CARVYKTI to fund future growth and innovation.