Legend Biotech (LEGN) Q1 2025: CARVICTI Sales Up 135% as Early-Line Uptake Accelerates
Legend Biotech’s first quarter saw a decisive expansion in CARVICTI’s global footprint and deepening penetration into earlier lines of multiple myeloma, with operational discipline driving margin gains and a clear path toward profitability. Manufacturing scale and clinical data momentum underpin management’s confidence in sustained growth, while pipeline investments and next-gen in vivo CAR-T initiatives signal a broader ambition to lead in cell therapy innovation. Investor focus now shifts to community adoption, label expansion, and the pace of pipeline readouts as LEGN navigates competitive and regulatory landscapes.
Summary
- Community Oncology Penetration Ramps: CARVICTI’s early-line adoption is rising, supported by physician education and label expansion.
- Manufacturing Execution Drives Efficiency: Capacity gains and a 97% success rate reduce turnaround times and support global launches.
- Profitability Path Clarifies: Operational break-even for CARVICTI by year-end and company-wide profitability targeted for 2026.
Performance Analysis
Legend Biotech delivered a standout quarter, with CARVICTI, its BCMA-targeted CAR-T therapy for multiple myeloma, generating $369 million in net trade sales, reflecting a 135% year-over-year surge. US sales contributed $318 million, up 127% YoY, while ex-US (OUS) revenue more than doubled, driven by launches in Germany, Switzerland, Austria, and Brazil, and new market entries in Spain, the UK, Denmark, Belgium, and Israel.
Operational leverage materialized visibly, as gross margin on net product sales improved to 63% from 59% last quarter, and operating loss was cut by more than half to $51 million. Disciplined expense management was evident, with R&D expenses nearly flat YoY and SG&A rising modestly. The company ended the quarter with $1 billion in cash, supporting continued investment in manufacturing and R&D. Adjusted net loss per share narrowed to $0.07 from $0.23 YoY, underscoring progress toward cash flow break-even.
- Global Demand Strength: Over 6,000 patients have now been treated with CARVICTI, with early-line use accounting for more than half of US volume.
- Manufacturing Scale-Up: New facilities in Belgium (Tech Lane) and New Jersey (Raritan) are on track, targeting 10,000 annualized doses by year-end.
- Margin Expansion: Improved manufacturing efficiency and cost discipline supported sequential gross margin gains.
Legend’s performance signals a durable growth trajectory, with execution in both commercial and operational domains setting a foundation for future profitability and pipeline advancement.
Executive Commentary
"We continue to anticipate achieving operational break-even for CARVICTI by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses."
Ying Huang, Chief Executive Officer
"Our operating loss of $118 million in the same period one year ago was reduced by over half to an operating loss of $51 million. The meaningful improvement in operating results was driven by our operational efficiency, and discipline expense management."
Jesse Young, Interim Chief Financial Officer
Strategic Positioning
1. Early-Line Penetration and Community Oncology Adoption
Legend’s commercial focus is shifting toward earlier treatment lines, with more than half of US CARVICTI utilization now in the second-through-fourth-line setting. Physician preference for CARVICTI in early lines jumped from 34% to 55% after new data presentations, and management is intensifying education and referral efforts among community oncologists, who represent nearly 80% of the patient base. Label expansions in Europe and Australia further support broader adoption.
2. Manufacturing and Supply Chain Resilience
Operational execution remains a core differentiator, as Legend maintains a 97% manufacturing success rate and 95% on-time delivery, with median turnaround times now at 30 days (and 27 days at the Raritan site). Capacity is being expanded through new facilities in Belgium (Tech Lane) and New Jersey (Raritan), with Tech Lane already producing clinically and commercial production imminent. Novartis partnership is also ramping contributions, supporting the 10,000 annualized dose target for 2025.
3. Pipeline and Next-Generation Platform Development
Legend is building on its CAR-T leadership with a robust pipeline, including in vivo CAR-T delivery, which aims to reprogram immune cells directly in the body, eliminating the need for ex vivo cell engineering. First patient dosing for in vivo CAR-T is expected in mid-2025, with preliminary results by year-end. Additional clinical readouts are expected for autoimmune and oncology indications, including DLL3 and Claudin 18.2 programs.
4. Regulatory and Label Expansion Strategy
Management is focused on securing overall survival (OS) as a US label claim for CARVICTI, following its inclusion in the EU label. Ongoing dialogue with FDA leverages recent survival data (hazard ratio 0.55), and management is open to exploring minimal residual disease (MRD) as a surrogate endpoint for future frontline trials, aligning with evolving regulatory standards.
5. Capital Allocation and Cash Runway
Legend’s $1 billion cash position provides ample runway through profitability, including $150 million in joint CapEx with J&J for Tech Lane expansion. No near-term capital raise is anticipated, and disciplined spending is expected to continue as pipeline and commercial investments ramp.
Key Considerations
Legend’s Q1 results reflect a business in transition from rapid launch to operational scalability, with several levers influencing future performance and investor focus:
Key Considerations:
- Community Uptake Remains Critical: Penetration beyond academic centers is essential for sustained growth, with referral and direct administration pilots underway.
- Manufacturing Scale as Competitive Moat: High success rates and reduced turnaround times differentiate Legend in a crowded CAR-T landscape.
- Label Expansion and Data Readouts: Survival data and upcoming ASCO presentations could catalyze further adoption in both US and EU markets.
- Pipeline Diversification: In vivo CAR-T and autoimmune programs offer optionality but require execution and validation.
- Reimbursement and Pricing Dynamics: US and ex-US pricing bands and mandatory rebates limit downside, but payer pushback and competitive launches warrant monitoring.
Risks
Legend faces execution risk in driving community oncology adoption, as infrastructure hurdles, accreditation, and referral patterns will determine the pace of early-line penetration. Regulatory timelines for label expansions and pipeline approvals remain uncertain, and competitive CAR-T and bispecific entrants could pressure share and pricing. Manufacturing scale-up must stay ahead of demand, and macroeconomic or reimbursement shifts could impact margins or uptake.
Forward Outlook
For Q2 2025, Legend expects:
- Modest sequential growth in CARVICTI sales, with acceleration in the back half of the year as new capacity comes online.
- Further improvement in manufacturing efficiency and continued margin expansion.
For full-year 2025, management reiterated:
- Operational break-even for CARVICTI by year-end.
- Company-wide profitability targeted for 2026 (excluding FX impacts).
Management highlighted several factors that will shape the year:
- Expanded manufacturing capacity in Europe and the US to support demand.
- Key clinical data and regulatory milestones, including US label expansion for overall survival.
Takeaways
Legend’s Q1 2025 results reinforce its leadership in cell therapy, with commercial execution, operational discipline, and a robust pipeline supporting a clear growth and profitability trajectory.
- Early-Line Penetration: Physician preference and label expansion are driving CARVICTI adoption in earlier lines, with community oncology engagement a key lever for future growth.
- Operational Execution: Manufacturing scale and efficiency improvements are supporting both margin gains and global expansion, creating a competitive moat.
- Pipeline Optionality: In vivo CAR-T and autoimmune programs add long-term upside, but require successful execution and differentiation in a rapidly evolving field.
Conclusion
Legend Biotech’s Q1 showcased commercial momentum, operational leverage, and pipeline ambition, setting the stage for continued growth as the company targets early-line multiple myeloma dominance and next-generation cell therapy leadership. Execution on community adoption, label expansion, and pipeline validation will determine the pace and durability of value creation from here.
Industry Read-Through
Legend’s performance and strategic focus offer several read-throughs for the cell therapy and oncology sectors. The shift toward earlier-line adoption of CAR-T therapies underscores the importance of real-world data, community engagement, and label expansion in driving commercial success. Manufacturing efficiency and supply chain resilience are emerging as key differentiators, while the race to develop in vivo and off-the-shelf cell therapies highlights the need for innovation and scalability. Competitors in the CAR-T and bispecific antibody space must adapt to rapidly evolving clinical and regulatory expectations, as survival data and payer dynamics increasingly shape market access and pricing power.