Legend Biotech (NASDAQ:LEGN) executives highlighted accelerating global demand for CARVYKTI, improving profitability metrics, and expanding manufacturing capacity during the company’s fourth quarter 2025 earnings call. Management said CARVYKTI reached profitability in 2025 and the company expects to be profitable on an enterprise-wide basis in 2026.
CARVYKTI sales growth and market expansion
Chief Executive Officer Ying Huang said CARVYKTI net trade sales were approximately $555 million in the fourth quarter, up 66% year-over-year. President of CARVYKTI Alan Bash said growth was supported by continued share gains, site expansion, and a broader geographic footprint, with CARVYKTI now available in 14 global markets and supported by 294 global treatment sites.
Management repeatedly emphasized that CARVYKTI utilization is increasingly shifting earlier in the treatment course. Bash said approximately 65% of patients are now treated in the second- to fourth-line setting. Huang added that in Spain—where CARVYKTI launched in 2025—about 70% to 75% of use is already in the second- and third-line setting.
Clinical updates: durability data and patient management focus
Huang pointed to new long-term data presented at the American Society of Hematology annual meeting and the 2026 Tandem meeting, arguing the results reinforce better outcomes when CARVYKTI is used earlier. Among highlights, she said triple-class-exposed multiple myeloma patients with three prior lines of therapy in CARTITUDE-1 and CARTITUDE-4 achieved a median progression-free survival of 50.4 months after a single infusion.
Huang also cited CARTITUDE-4 analyses in standard-risk cytogenetics, saying 80% of patients remained progression-free and off treatment after 2.5 years, and that among standard-risk patients who were progression-free at one year, 93% remained alive and progression-free at 2.5 years. She added that translational analyses suggested stronger immune fitness and a more immunocompetent tumor microenvironment in patients treated earlier.
Bash said a key area of recent emphasis is patient management, particularly the role of effective bridging therapy to reduce tumor burden and mitigate neurotoxicity risks such as Parkinsonism. He referenced a study across more than 20 academic centers published by Dr. Anita D’Souza, noting no cases of colitis or Parkinsonism following at least one cycle of talquetamab bridging therapy and CARVYKTI infusion in a study that included more than 130 patients (with 98 treated with CARVYKTI). He also referenced a Stanford-led study by Dr. Surbhi Sidana of 761 CARVYKTI-treated patients, stating that 21 of 22 Parkinsonism cases occurred in patients who did not respond to bridging therapy.
On ongoing mitigation work, Bash said the multicenter CITADEL study evaluating ALC monitoring and management approaches is expected to have data presented at some point this year. He also noted updated NCCN guidance in January that included talquetamab as a bridging therapy option and expanded discussion of bridging therapy before CAR T infusion.
Beyond CARVYKTI, Huang said the company presented at ASH on Lucar-G39D, an allogeneic gamma delta CAR T-cell therapy targeting CD19 and CD20 in relapsed or refractory B-cell non-Hodgkin’s lymphoma, which she said showed manageable safety and encouraging antitumor activity.
Manufacturing scale, capacity, and gross margin discussion
Huang said Legend’s expanded manufacturing network, including physical expansion at the Raritan facility, provides installed capacity to support annual production of 10,000 doses across manufacturing nodes, and said CARVYKTI’s overall manufacturing success rate is 97%. She also cited a commercial manufacturing analysis (July 2024 through October 2025) showing 99% manufacturing success for products from patients with 1–3 prior lines of therapy (with 6.5% out-of-spec product) versus 97% success for fourth line and beyond (with 9.2% out-of-spec product).
During Q&A, management clarified that the 10,000-dose figure reflects overall capacity to produce doses, with adjustments for shutdown days, non-clinical runs, and out-of-spec product. Huang also said Legend and Johnson & Johnson are planning, through ongoing capital expenditures, to supply up to 20,000 doses into U.S. and European markets.
Asked about gross margins, Bash said network utilization has improved year-over-year, while noting that Tech Lane was ramped in 2025 and that higher volumes there could reduce manufacturing costs and support network improvement over time.
Financial results and path to profitability
Chief Financial Officer Carlos Santos reported fourth-quarter revenue of $306 million, up 64% year-over-year, with gross margin of 61% and gross margin on CARVYKTI net product sales of 57%. Santos said operating margin improved from -142% in the second quarter of 2023 to -6% in the fourth quarter of 2025, marking improvement over 10 consecutive quarters.
Total operating expenses grew 6% year-over-year, which Santos said lagged revenue growth and reflected operating leverage. He reported R&D declined 3% year-over-year as BCMA frontline programs matured and investment shifted toward next-generation in vivo efforts, while SG&A rose 22% due to commercial investments including sales force expansion and direct-to-consumer campaigns.
The operating loss improved to approximately -$20 million. On an adjusted basis excluding items including stock-based compensation and unrealized foreign exchange gains or losses, Legend reported adjusted net income of $2.5 million compared with an adjusted net loss of $59 million a year earlier. Adjusted diluted EPS was $0.01 versus -$0.15 in the prior-year quarter.
Legend ended the year with $949 million in cash, cash equivalents, and time deposits. Santos said operating cash flow outlays were $12 million in the quarter, compared with $82 million in outlays in the year-ago period.
- Profitability outlook: Management said CARVYKTI became profitable in 2025 and the company expects enterprise-wide profitability in 2026.
- Investment priorities: Santos outlined advancing in vivo programs, focused business development, supporting CARVYKTI profit expansion, and modest manufacturing-related capital expenditures.
On 2026 commercial expectations, Huang told analysts the company is committed to sequential growth through all four quarters and said management feels “reasonably confident” in delivering CARVYKTI in line with what she characterized as roughly 50% top-line growth year-over-year based on street consensus.
Separately, Huang discussed business development interest in complementary in vivo CAR T technologies beyond the company’s lentiviral vector-based delivery approach, including potential partnerships to accelerate global development of its own in vivo assets. She also said Legend is open to non-viral delivery platforms and to evaluating opportunities outside oncology and hematology, including potential applications in autoimmune disease.
About Legend Biotech (NASDAQ:LEGN)
Legend Biotech (NASDAQ: LEGN) is a commercial-stage biopharmaceutical company specializing in the development and commercialization of chimeric antigen receptor T-cell (CAR-T) therapies for oncology. Headquartered in Somerset, New Jersey, with research and development operations in Shanghai, the company leverages a global infrastructure to advance innovative cellular therapies. Legend Biotech pursues a strategy of strategic collaboration to extend its reach, most notably through its partnership with Janssen Biotech, a subsidiary of Johnson & Johnson.
The company’s lead asset, ciltacabtagene autoleucel (commercially marketed as Carvykti), is a B-cell maturation antigen (BCMA)–directed CAR-T therapy for the treatment of relapsed or refractory multiple myeloma.
