Legend Biotech (LEGN) Q3 2025: CARVICTI Sales Up 84% as Capacity Expansion Targets 10,000 Doses
Legend Biotech’s Q3 saw CARVICTI, its flagship CAR-T therapy, deliver record-setting growth and operational leverage, positioning the company to scale annualized capacity to 10,000 doses globally by 2026. With demand outpacing prior supply constraints and an expanding treatment network, Legend’s execution in both community and academic settings is reshaping the multiple myeloma landscape. Management’s confidence in profitability and durable global leadership is underpinned by clinical data, manufacturing momentum, and a robust balance sheet.
Summary
- CARVICTI’s Clinical and Commercial Momentum: Record patient uptake and label expansion reinforce its best-in-class profile in multiple myeloma cell therapy.
- Manufacturing and Network Expansion: All four production nodes now operational, supporting a path to 10,000 annual doses by next year.
- Profitability in Sight: Operational efficiency and disciplined cost management position Legend for company-wide profitability in 2026.
Performance Analysis
Legend Biotech’s third quarter marked a step-change in both sales trajectory and operational discipline, driven by surging demand for CARVICTI, its CAR-T therapy for multiple myeloma. CARVICTI’s net trade sales surged 84% year-over-year, with over 9,000 patients treated to date, making this the fastest and largest CAR-T launch on record. U.S. sales led the charge, but international momentum was even more pronounced, with rest-of-world sales nearly quintupling versus last year, reflecting strong launches in Germany, Spain, and Belgium.
Gross margin held steady at 57%, while operating loss narrowed by 38% year-over-year, a sign of improved cost discipline despite ongoing investment in pipeline and manufacturing capacity. Operational cash flow turned positive, with $29 million generated this quarter, underlining the company’s move toward self-sustaining growth. The expansion of authorized treatment centers—now over 250 globally—has been pivotal, especially as 60% of U.S. utilization now comes from earlier line settings, a critical demand driver given superior efficacy in less heavily pre-treated patients.
- International Acceleration: Ex-U.S. sales up 58% quarter-over-quarter, with new markets and local production (Tech Lane) ramping quickly.
- Community Penetration: One-third of U.S. sites are community or regional hospitals, now contributing about half of network growth.
- Cost Structure Improvement: Operating expenses as a percentage of revenue declined, reflecting automation and expense control even as R&D investment continues.
Legend’s ability to match supply with demand, eliminate patient waitlists, and maintain high manufacturing utilization sets a strong precedent for continued volume-driven margin leverage.
Executive Commentary
"As we approach 10,000 annualized dose manufacturing capacity, we continue to extend our leadership in cell therapy through further advancing the field of CAR-T in multiple myeloma."
Ying Huan, Chief Executive Officer
"Our operating loss of $70 million in the same period one year ago was reduced by 38% to a $43 million operating loss during the third quarter. This meaningful improvement in operating results was driven by our operational efficiency and disciplined expense management."
Carlos Santos, Chief Financial Officer
Strategic Positioning
1. CARVICTI Franchise Expansion
Legend’s core business model is anchored in CARVICTI, a one-time CAR-T infusion for multiple myeloma, now the only therapy in its class with a demonstrated overall survival benefit in its U.S. label. This clinical edge, validated by five-year data showing one-third of patients progression-free, is driving both physician and patient preference, especially in earlier lines of therapy where efficacy and safety are maximized.
2. Manufacturing Scale and Network Reach
The company’s four-node manufacturing network (Raritan, Novartis, Tech Lane, Obelisk) is now fully operational, supporting global supply and eliminating bottlenecks. Capacity is set to double, with the ability to deliver 10,000 doses annually by 2026 and a longer-term goal of 20,000 as efficiencies improve. This scale is key to meeting demand and supporting further international launches.
3. Community Setting Penetration
Legend’s unique outpatient administration profile and removal of REMS (Risk Evaluation and Mitigation Strategy) restrictions are enabling broader adoption in community practices, where roughly half of patients are now dosed outside of hospital settings. The company’s network strategy targets both referring physicians and direct administration in community oncology groups—a critical differentiator as competitors lag in this channel.
4. Pipeline and Next-Generation Cell Therapy
Beyond multiple myeloma, Legend is advancing new indications, including solid tumors and non-Hodgkin lymphoma. Early data from its allogeneic gamma-delta T cell platform (LUCAR-G35D) show promising safety and durability, with upcoming ASH presentations expected to reinforce the pipeline’s potential. The new Philadelphia research facility, focused on in vivo delivery, signals a commitment to next-generation innovation.
5. Financial Discipline and Capital Allocation
With nearly $1 billion in cash and equivalents, Legend is prioritizing investments in its franchise, pipeline acceleration, and manufacturing infrastructure, while maintaining discipline to achieve company-wide profitability in 2026. Operating leverage is improving as automation and process optimization offset R&D and SG&A growth.
Key Considerations
This quarter’s performance underscores Legend’s transition from a high-growth launch story to an operationally efficient, globally scaled cell therapy leader. The company’s execution in expanding both supply and demand, while maintaining clinical leadership, is central to its long-term thesis.
Key Considerations:
- Demand Shift to Earlier Lines: Superior efficacy and safety in less heavily pre-treated patients are driving both guidelines and real-world adoption toward second and third-line settings.
- Network Expansion Pace: With 132 U.S. sites and over 250 globally, Legend is closing the gap with competitors and targeting full coverage of all major CAR-T centers by 2026.
- Operational Efficiency: Improved out-of-spec rates (now 6%–9%) and automation are supporting both margin gains and higher throughput.
- International Launch Execution: Tech Lane and Obelisk facilities enable rapid European ramp, with strong demand in Germany, Spain, and Belgium.
- Pipeline Read-Through: Data from LUCAR-G35D and other assets at ASH will be key for investor confidence in Legend’s next wave of innovation.
Risks
Legend faces intensifying competitive threats, with new CAR-T entrants and regimens (such as the upcoming “Anita Sell” competitor) potentially challenging its market share and efficacy narrative. Manufacturing scale-up carries operational risk, especially as out-of-spec rates and site onboarding dynamics evolve. Regulatory or reimbursement shifts, particularly in international markets, could impact pricing and access. Finally, continued investment in pipeline and capacity must be balanced against the need for sustainable profitability.
Forward Outlook
For Q4 2025, Legend expects:
- Continued strong CARVICTI demand and site expansion, with no supply constraints.
- Further international growth as Tech Lane ramps and additional European markets launch.
For full-year 2026, management reiterated:
- Profitability for the company, excluding unrealized foreign exchange gains or losses.
- Annualized manufacturing capacity of 10,000 doses globally, with all four nodes at high utilization.
Management highlighted the tailwinds from label expansion, earlier line adoption, and operational leverage as key drivers for next year’s performance.
- ASH data releases and physician education efforts will remain central to demand generation.
- Community channel penetration and outpatient dosing are expected to accelerate.
Takeaways
Legend Biotech’s Q3 confirms its emergence as the global leader in multiple myeloma cell therapy, with best-in-class efficacy, robust commercial execution, and a clear path to profitability.
- Clinical and Commercial Leadership: CARVICTI’s unmatched survival data and label advantage drive both physician preference and patient uptake, supporting durable franchise value.
- Operational Scale and Efficiency: Full utilization of a four-node manufacturing network and disciplined expense management are translating into narrowing losses and positive cash flow.
- Future Growth Catalysts: Expansion into new geographies, earlier lines of therapy, and next-generation pipeline assets position Legend for sustained outperformance, with ASH data and community adoption as near-term watchpoints.
Conclusion
Legend Biotech’s Q3 execution demonstrates a rare combination of clinical, commercial, and operational momentum in the cell therapy space. As the company approaches full-scale capacity, expands global access, and advances its pipeline, investors should watch for continued margin leverage and data-driven demand growth into 2026.
Industry Read-Through
Legend’s results signal a maturing CAR-T market where clinical differentiation, manufacturing scale, and community channel penetration are decisive competitive levers. The company’s ability to eliminate supply constraints and enable outpatient dosing sets a new operational bar for cell therapy peers. Competitors must now demonstrate both superior efficacy and real-world scalability, especially as earlier line adoption becomes the standard of care. For the broader oncology sector, Legend’s experience highlights the importance of network effects, label expansion, and disciplined capital allocation in translating scientific leadership into durable commercial franchises.