LEGN

Leadership Transition

• A leadership transition is underway following the departure of former CEO Dr. Ying Huang, with Alan Bash appointed as interim CEO
• Management emphasizes this is a leadership change, not a strategy change; core priorities remain unchanged: maximizing Carvicti value, advancing the next-generation pipeline, and strengthening cross-company execution

Commercial Operations for Carvicti

• Carvicti maintains global market leadership in BCMA CAR-T therapy for multiple myeloma, with strong growth driven by increasing adoption in earlier lines of therapy
• Earlier line usage (2nd to 4th line of therapy) now represents over 70% of total US volume, up from 41% reported in the prior quarter
• Outpatient setting usage now accounts for approximately 60% of total Carvicti volume
• The global network of authorized treatment centers has expanded to 348 sites, with 40% of US sites being community hospitals to expand patient access; a new recent launch in Ireland brings Carvicti to 19 ex-US markets
• Management confirms Carvicti retains a peak annual sales potential estimate exceeding $5 billion

Pipeline and Clinical Progress

• Presented encouraging Phase 1 data for LB2501, a CD19-CD20 dual-targeted in vivo CAR-T therapy for relapsed/refractory non-Hodgkin lymphoma, at the European Hematology Association (EHA) Congress
  • At the second dose level, LB2501 achieved 100% objective response rate and 83.3% complete response rate across 6 patients, with no dose-limiting toxicities, no serious adverse events, and CAR-T persistence detectable up to 116 days
• LB2102, a DLL3-targeted CAR-T therapy for small cell lung cancer licensed to Novartis, demonstrated a manageable safety profile and encouraging clinical activity in heavily pretreated patients: higher dose levels achieved 28.6% objective response rate and 78.6% disease control rate with durable responses
• New CARTITUDE program data for Carvicti confirms durable efficacy and consistent safety across multiple myeloma cytogenetic risk groups, with low incidence of immune effector cell-associated enterocolitis and 30-month overall survival exceeding 85% in responding patients from the CARTITUDE IV subgroup analysis
• Multiple frontline multiple myeloma studies for Carvicti (including CARTITUDE 5 and CARTITUDE 6) remain ongoing, to support expansion into the first-line indication
• The pipeline remains diversified across autologous, allogeneic, and in vivo CAR-T modalities, with additional candidates targeting solid tumor and hematology indications in development

Financial Position

• Completed a public equity offering in Q2 2026, generating $212 million in net proceeds
• Ended Q2 2026 with $965 million in cash, cash equivalents, and time deposits, with no long-term debt

• Management reaffirms full-year 2026 adjusted net income profitability for the full company, and confirms profitability will be maintained in both Q3 and Q4 2026
• Q3 2026 gross margin on net product sales is expected to be in the lower 50% range, with a rebound to the mid-50% range expected in Q4 2026, driven by an extra selling week in the 2026 calendar and expanded international volume
• Over the long term, management expects gross margins will improve to ~75%, aligned with large molecule industry standards, as manufacturing volume scales and capacity reaches steady state utilization
• Management anticipates an effective tax rate in the high 20% range over the next several quarters, as the company is now profitable on a quarterly basis
• A US IND submission for LB2501 is expected by the end of Q4 2026, to initiate a US-based clinical trial for non-Hodgkin lymphoma
• Management expects continued sequential quarter-over-quarter global sales growth for Carvicti across both half of 2026

Legend Biotech's revenue is almost entirely generated by its lead product Carvicti (CAR-T therapy for multiple myeloma). In Q2 2026, Carvicti delivered global net trade sales of $657 million, representing 50% year-over-year growth and 10% sequential quarter-over-quarter growth. Carvicti sales accounted for approximately 98% of Legend Biotech's total Q2 2026 revenue. US Carvicti sales grew 32% year-over-year with 9% sequential quarter-over-quarter growth, while ex-US sales grew 128% year-over-year with 13% sequential quarter-over-quarter growth. Total company revenue increased 52% year-over-year in Q2 2026, with positive operating margin of 15% (improved from negative 9% YoY and negative 142% three years prior). Gross margin on net product sales was 58% in Q2 2026, an improvement of 17 percentage points from Q1 2026, which was suppressed by one-time manufacturing expansion costs. Adjusted net income was $63 million (note: the transcript contains a typo stating $630 million, confirmed by per-share data) or $0.16 per diluted share, up from adjusted net income of $10 million or $0.03 per diluted share in Q2 2025. Total operating expenses increased only 7% year-over-year, with R&D expenses down 2% YoY and SG&A up 19% YoY.

• Foreign exchange rate fluctuations between the Euro and US dollar could create increasing divergence between Legend's reported Carvicti revenue and its collaboration partner J&J's reported revenue, as ex-US sales grow to represent a larger share of total revenue
• Quarter-to-quarter variability in gross margin is expected, driven by shifts in revenue mix (increasing outpatient share) and manufacturing volume scaling
• Tax rate guidance remains preliminary, as the company has not yet finalized a unilateral advanced pricing agreement with Chinese tax authorities
• Solid tumor indications for in vivo CAR-T remain challenging, with unique biological and clinical hurdles that have not yet been solved

Q: What is the update on the BCMA-targeted in vivo CAR-T program LB2505 under the J&J collaboration? / A: Legend will conduct an investigator-initiated clinical study of LB2505 for multiple myeloma in China. The program remains subject to the terms of the existing collaboration agreement with J&J, so no additional details can be shared at this time, with updates to come later when appropriate.

Q: When can we expect updated Phase 1 data for LB2501, and what duration of response is needed to confirm durable complete responses? / A: Management is targeting six-month complete response rate as the key endpoint to confirm durability, with updates planned for future major medical conferences. Early data already shows response durability up to 120 days as of the EHA presentation.

Q: What is the board focusing on in the permanent CEO search, and will Legend develop LB2501 independently or partner? / A: The board is conducting a thorough holistic search without an artificial deadline, evaluating candidates holistically for the company's current growth stage with no pre-determined narrow profile. Legend intends to conduct the LB2501 Phase 1 trial independently, with existing capabilities and financial flexibility to do so, and remains open to long-term partnership options for the broader in vivo platform to maximize value.

Q: What is the motivation for the recent equity offering, given the company is targeting profitability? / A: The offering was opportunistic, timed after positive LB2501 clinical data, to add additional capital flexibility. The proceeds will accelerate development of LB2501 and the broader in vivo platform, enable full repayment of the outstanding $300 million collaboration loan from J&J (expected to be fully settled in 2026), and create greater business development optionality for the future.

Q: What is the current treatment line mix for Carvicti, and how does management view competition and sequencing relative to bispecific therapies? / A: 2nd to 4th line therapy now makes up over 70% of US Carvicti volume, with 2nd and 3rd line alone representing 41% of total volume in the prior quarter, showing significant progress in earlier adoption. Carvicti's key differentiation from bispecifics is its one-and-done treatment model versus continuous therapy, offering patients the potential for long-term treatment-free remissions and possible cure. Real-world and biological data supports sequencing CAR-T earlier than bispecifics for better patient outcomes, which is the consensus among key opinion leaders.