Legend Biotech Corporation Q4 FY2025 earnings call

• Legend closed 2025 as the largest standalone cell therapy company with commercial scale and next-gen pipeline optionality. Carvicti had net trade sales of $555 million in Q4 2025, a 66% Y/Y increase, with over 10,000 multiple myeloma patients treated. Ryotan facility expansion gives capacity for 10,000 doses annually. Carvicti's launch is strongest CAR-T launch, with 97% manufacturing success rate and offered in 14 markets. Presented data at ASH on CARVICTI's efficacy and manufacturing. Partnership with J&J for capacity expansion. R&D pipeline includes in vivo programs, leveraging IIT in China, plan to file 1-2 US INDs by end of 2025. - Alan discussed Carvicti's global growth: net trade sales grew 66% Y/Y and 6% Q/Q. US net trade sales $420 million, up 38% Y/Y and 6% Q/Q. Outside US, sales $135 million, over threefold Y/Y increase. BCMA directed therapies under-penetrated in earlier lines, CARVICTI well-positioned. Community adoption: Carvicti in 294 treatment sites, 65% of patients in second to fourth line setting. - Carlos talked about financial performance: revenue growth, improving operating margin, Carvicti franchise profitable in 2025, on track for enterprise-wide profitability in 2026. Cash position $949 million, investment priorities include advancing in vivo programs, business development, supporting CARVICTI profit expansion, and manufacturing capacity expansion.

In the fourth quarter, Carvicti net trade sales were approximately $555 million, a 66% year-over-year increase. Revenue reached $306 million, up 64% year-over-year. Gross margin remained strong at 61%, with Carvicti net product sales gross margin at 57%. R&D declined 3% year over year, SCNA grew 22%, and operating loss improved by 75% versus the prior year to approximately negative $20 million. Adjusted net income was positive $2.5 million, with adjusted diluted income per share at one cent.

• Anticipate company-wide profitability in 2026. - Expect sequential growth throughout 2026 for Carvicti. - Plan to file 1-2 US INDs by end of 2025. - Expect to present clinical data in 2026 for in vivo programs.

Q: Comment on Carvicti growth pace in 2026 and business development.

A: Ying said planning sequential growth, confident in 50% top-line growth from last year. BD includes interested in complementary technologies, potential co-development or partnering with existing assets.

Q: Docs' positioning of bispecifics in early lines relative to Carvicti.

A: Alan said significant opportunity in second and third line, fastest-growing segment is second and third line, Carvicti has unique value proposition in earlier lines aligning with IMWG guidelines.

Q: Hurdles for community expansion.

A: Luke said continued education, community physicians understanding referral base without REMS, examples of activated treatment centers.

Q: CAR-T penetrations and community hospitals growth.

A: Ying said CAR-T underpenetrated, strategy includes efficacy, one-time convenience, health economic benefit. Alan said all segments represent growth opportunity.

Q: Raritan facility and gross margins.

A: Alan said Raritan has capacity for 10,000 doses, high utilization. Carlos said gross margin improved, Tech Lane facility ramp up will help cost of goods manufacturing come down.

Q: M&A in space and CARVIC's competition.

A: Ying said acquisition validates market value, CARVIC has unmatched efficacy. Alan said prepared for any timing for CAR-T sales, data maturity raises bar.

Q: CAR-T market saturation and in vivo tech.

A: Ying said not zero-sum game, capacity to increase. James said Legend uses lentiviral infrastructure, open to other technologies.

Q: Ibertamide MDA and Partitude 6 filing.

A: Ying said FDA draft guidance, CAR-T35 top line data soon, may be first to discuss MRD correlation.

Q: Techdara launch ex-US and Carvicti patient split.

A: Alan said Carvicti uptake in XUS markets, 65% of patients in second to fourth line.

Q: Pipeline strategy and in vivo programs.

A: Leo said interested in in vivo CAR-T, track metrics like MRD negativity. Jane said Citadel study data in 2026, in vivo program data planned for 2026 medical meeting.

Q: Manufacturing scale-up.

A: Ying said 10,000 doses represent overall capacity, with adjustments for drop-offs, out of spec, etc.