Legend Biotech Corp Q3 FY2026 earnings call

• CEO Ingrid Zung emphasized maximizing Carvykti adoption, advancing the next-generation pipeline, and achieving sustained profitability.
• Carvykti achieved global growth with 373 active treatment sites worldwide.
• Long-term data from CARTITUDE 2 Cohort A showed 5-year progression-free survival of 50% and overall survival of 69%.
• FDA cleared the IND application for LB2501, an investigational in vivo CD19/CD20 dual-targeting CAR-T therapy.
• LB2501 demonstrated 100% objective response rate (ORR) and 100% complete response (CR) rates at dose level 2 in relapsed/refractory B-cell non-Hodgkin lymphoma.
• NCCN guidelines updated to prefer CAR T-cell therapy over bispecifics in certain settings, supporting earlier line use.
• The company maintains a cash position of approximately $853 million with no long-term debt.

Total revenue increased 32% year-over-year, driven by strong demand for Carvykti. Net-trade sales for Carvykti reached approximately $710 million, representing a 36% year-over-year increase. In the United States, net-trade sales grew 19% year-over-year, while international markets saw an 86% year-over-year increase. Gross margins improved significantly to 58%, exceeding expectations due to manufacturing efficiencies. Adjusted net income was $55.6 million ($0.14 per diluted share), compared to an adjusted net loss of $18.7 million in the same period last year.

• Management remains confident in achieving company-wide profitability for the full year 2026 on an adjusted net income basis.
• Q4 gross margin outlook revised upward to the high 50% range.
• Expectations for 2027 include double-digit year-over-year growth for Carvykti globally.
• Current consensus for 2027 net trade sales is viewed as being at the higher end of internal scenarios, though launch delays outside the U.S. and slower early-line share growth in the U.S. are noted factors.

• Increasing competition in earlier-line multiple myeloma settings from bispecifics (e.g., Tebentafud/Tecdrera) and competitor CAR-T therapies.
• Potential impact of prior BCMA-directed therapies on patient eligibility for late-line BCMA CAR-T treatments.
• Operational challenges in expanding global patient access and treatment center networks.
• Uncertainty regarding the timing of clinical readouts for pivotal trials like CARTITUDE 5 and 6, which are event-driven.

Q: Analyst asked about LB2501 data updates at ASH and competitive dynamics against AnaptysBio’s BCMA CAR-T. / A: Yu Hongqiu confirmed expanded data for LB2501 at ASH, showing 100% ORR/CR at dose level 2 and 60% at dose level 3 with no neurotoxicity. Alan Bash highlighted Carvykti’s unique five-year data and real-world experience, noting that competitor data is limited and derived from different patient populations, emphasizing Carvykti’s superior safety profile through bridging therapy education.

Q: Analyst questioned why US sales growth has been flat despite shifting to earlier lines and favorable NCCN guidelines. / A: Alan Bash explained that while early-line adoption is growing (now 50% of US volume from lines 2-3), competition from bispecifics is intensifying. He stressed that NCCN guidelines support “CAR-T first” to preserve future options, and confidence remains that this educational push will eventually drive resumption of US growth.

Q: Analyst asked for visibility on 2027 trajectory amidst competitive headwinds. / A: Carlos Santos stated they expect double-digit YoY growth in 2027 but acknowledged current consensus is at the high end of their view due to OUS launch delays and slower US early-line share gains. Alan Bash added that only 15-20% of early-line patients are BCMA-exposed, leaving significant room for growth toward a $5 billion peak potential.

Q: Analyst inquired about the timing of CARTITUDE 5 and 6 top-line results and competitiveness in early lines. / A: Alan Bash noted these are event-driven studies; earliest readout for CART 5 is 2027. Regarding competition, he reiterated that using CAR-T before bispecifics yields better outcomes and preserves both treatment options, validating the strategy supported by NCCN guidelines.

Q: Analyst asked about the threshold effect observed in LB2501 dose levels and plans for autoimmune applications. / A: Yu Hongqiu explained a clear threshold exists between dose level 1 (no response) and level 2 (100% response), requiring more patients for confirmation. He also confirmed interest in exploring the in vivo platform for autoimmune diseases via Investigator-Initiated Trials in China to establish proof-of-concept.