Legend Biotech Corporation Q1 FY2026 earnings call

Commercial Performance of Carvicti

• Carvicti is the market-leading profitable CAR-T therapy for multiple myeloma, and is now available across 18 global markets with over 300 authorized treatment centers, including 148 in the U.S. where 1/3 of centers are community/regional hospitals.
• 41% of U.S. apheresis volume for Carvicti in Q1 2026 came from second- and third-line patients, up from 29% in Q1 2025, reflecting growing physician adoption of earlier CAR-T use. Two-thirds of current Carvicti volume is in lines 2 through 4.
• Manufacturing metrics remained best-in-class: 99% manufacturing success rate, 29-day median turnaround time, and 95%+ on-time final product delivery.

Pipeline Progress

• Two pivotal Phase 3 trials (CARTITUDE-5 and CARTITUDE-6) evaluating Carvicti in frontline multiple myeloma are fully enrolled, and are event-driven.
• Two in vivo CAR-T programs have entered Phase 1: the BCMA program for autoimmune diseases, and the GPRC5D program for multiple myeloma.
• Lead in vivo CAR-T program LB2501 (CD19/CD20 targeting for non-Hodgkin lymphoma) is on track to report initial data in 2026, and the company expects to file 1-2 new INDs in the U.S. in 2026.
• The company added 6 new distinguished scientific advisors to support R&D strategy as the pipeline broadens.

Financial Position

• The company ended Q1 2026 with $835 million in cash, cash equivalents, and time deposits, with no long-term debt, providing sufficient flexibility for pipeline investment, manufacturing expansion, and focused business development.
• The 41% Q1 gross margin decline was driven by one-time costs from ramping up new manufacturing capacity at the Raritan and Tech Lane facilities.

Carvicti (CARVIC-T): Net trade sales of $597 million in Q1 2026, representing 62% year-over-year growth (36% YoY growth in the U.S., over 200% YoY growth ex-U.S.) and 8% sequential growth from Q4 2025. Carvicti revenue accounts for approximately 97.4% of total company revenue. Collaboration revenue (driven by Carvicti sales under the J&J collaboration) was $298 million, and license and other revenue was $7 million, bringing total company revenue to $305 million. Gross margin on net product sales was 41% in Q1 2026, down from 57% in Q4 2025 due to one-time manufacturing ramp-up costs. R&D expense was $86 million, SG&A expense was $90 million, and adjusted net loss was $11 million (0.03 cents per diluted share), narrowing from an adjusted net loss of $27 million (0.07 cents per diluted share) in Q1 2025.

• Management reaffirmed its prior guidance to achieve full-year 2026 company-wide profitability on an adjusted (non-IFRS) basis.
• Gross margin is expected to return to over 50% in Q2 2026 as new manufacturing capacity ramps up utilization and economies of scale are realized.
• The share of Carvicti revenue from earlier lines (second and third line) is expected to grow to approximately three-quarters of total U.S. volume over the next 1-2 years, from 41% in Q1 2026.
• Management expects sequential quarter-over-quarter revenue growth for Carvicti in both the U.S. and ex-U.S. markets for the remainder of 2026.
• Initial clinical data for the LB2501 in vivo non-Hodgkin lymphoma program is expected to be presented at a major medical conference around mid-year 2026.

• Forward-looking statements (including pipeline data timelines, profitability projections, and growth outlooks) are subject to inherent risks and uncertainties that could cause actual results to differ materially from expectations, as detailed in the company's SEC filings.
• The Phase 3 CARTITUDE-5 and CARTITUDE-6 trials are event-driven, so there is uncertainty around the timing of data readouts, which could differ from prior investor expectations of end-of-2026 data.
• Clinical trial success is not guaranteed: initial data from early-stage in vivo programs may not meet safety or efficacy expectations, and longer follow-up is required to assess durability of response.
• Increasing competition from bispecific therapies and other BCMA CAR-T products in earlier lines of multiple myeloma could impact Carvicti's market share growth.

Q: When will non-Hodgkin lymphoma in vivo CAR-T data be presented, and how much durability data will be included? / A: Management confirmed the data will be presented for the first time at a major mid-year 2026 medical conference, but cannot confirm the specific meeting until abstracts are officially accepted. Because this is the first disclosure, follow-up will not be very long, but a reasonable number of patients will be included in the presentation.

Q: Can you clarify the LB2501 in vivo CAR-T program, what will its first data disclosure include? / A: LB2501 is not an allogeneic gamma delta T program, it is an autologous in vivo CAR-T targeting CD19/CD20 via a lentiviral vector. The full protocol is already available on clinicaltrials.gov. Management expects to disclose both safety and preliminary efficacy data with the first release, and the program's internal goal is to achieve manageable safety and promising deep responses.

Q: How will the Carvicti line-of-therapy mix change over 1-2 years, and how much of the Q1 gross margin decline is one-time? / A: Management expects early-line (second/third line) volume to grow to around three-quarters of total U.S. Carvicti business over the next 1-2 years, as adoption grows and the treatment paradigm shifts. The entire Q1 gross margin decline was a one-time impact from ramping new manufacturing capacity, and gross margin will return to over 50% in Q2 2026; the company does not disclose specific breakdowns of the one-time cost amount.

Q: What is the competitive benchmark for LB2501, and do you expect platform success in NHL to translate to multiple myeloma? / A: The lead in vivo program LB2501 targets NHL, and management's benchmark is deep and durable response, aligned with the platform's transformative goal of moving cell engineering into the patient to improve fitness. Management believes the platform's core advantage will translate across disease areas, including multiple myeloma.

Q: What is your outlook for Carvicti growth given new competition in second-line multiple myeloma? / A: Management notes the early-line multiple myeloma market is very large (around 100,000 patients) with less than 5% penetration of BCMA-targeted therapies to date, so it is not a zero-sum market. Carvicti continues to see healthy growth alongside competing products, with significant remaining room for expansion.