Legend Biotech (LEGN) Q2 2025: CARVICTI Sales Jump 136%, Expanding Early-Line Adoption and Global Reach
Legend Biotech’s record CARVICTI sales and broadening early-line use reinforce its leadership in cell therapy. The company’s operational efficiency and manufacturing scale are accelerating global access, while real-world data and regulatory tailwinds are deepening its clinical moat. With a robust pipeline and $1B in cash, Legend is positioned to drive durable growth and margin expansion into 2026.
Summary
- Early-Line Penetration Accelerates: Nearly 60% of CARVICTI orders now come from second to fourth line patients, solidifying clinical leadership.
- Manufacturing and Access Scale Up: 123 U.S. and 213 global treatment sites are active, with outpatient and community settings driving volume.
- Profitability Pathway in Focus: Operational efficiency and disciplined spending set up company-wide profitability by 2026.
Performance Analysis
Legend Biotech delivered a breakout quarter, with CARVICTI, its BCMA-targeted CAR-T therapy, driving a 136% year-over-year surge in net trade sales and setting a new industry record for single-quarter CAR-T revenue. U.S. net trade sales rose sharply, fueled by increased adoption in earlier lines of therapy, while ex-U.S. sales quadrupled, boosted by launches in new European and international markets. The company’s operational loss was nearly halved versus the prior year, reflecting both top-line momentum and improved cost discipline.
Gross margin on product sales reached 57%, and adjusted net income turned positive, underscoring the leverage from scale and mix shift. R&D spend moderated as a percentage of revenue, while SG&A grew to support global expansion and direct-to-patient outreach. With $1 billion in cash and equivalents, Legend maintains a strong balance sheet to fund pipeline innovation and manufacturing investments. The company reiterated its outlook for operational break-even in CARVICTI by year-end and company-wide profitability in 2026.
- Global Expansion Drives Top-Line Growth: CARVICTI launches in 11 ex-U.S. markets, with 59% quarter-over-quarter OUS sales growth.
- Community and Outpatient Penetration: Over half of patients now treated in outpatient settings, reducing inpatient bottlenecks and expanding access.
- Operational Efficiency Gains: Manufacturing success rates remain at 97%, and turnaround time stands at 30 days, supporting scalable growth.
Legend’s ability to execute on both commercial and operational fronts is translating into accelerating cash flow improvement and a clear path to sustainable profitability.
Executive Commentary
"We had quite an eventful second quarter as we made history with our long-term survival data at ASCO and achieved the most CAR-T sales ever during a single quarter. In the US, more than half of our utilization is now in the earlier line setting. We continue to anticipate achieving operational break-even for CARBICTI by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses."
Ying Huang, Chief Executive Officer
"Carvicti net trade sales of $439 million during the second quarter surpassed the previous CAR T industry record. Our manufacturing success rate remains at 97%, which we believe is the highest in the CAR T industry, and we are focused on continued reductions in our turnaround time, which stands at 30 days."
Alan Bash, President, CARVICTI
Strategic Positioning
1. Early-Line Expansion and Clinical Differentiation
Legend’s strategy to move CARVICTI into earlier lines of therapy is bearing fruit, with nearly 60% of orders now from second to fourth line patients. This shift is supported by CARTITUDE-4 data showing superior progression-free and overall survival versus standard of care, especially in high-risk subgroups. Earlier treatment correlates with improved safety and efficacy, reinforcing a virtuous cycle of physician and patient adoption.
2. Manufacturing Scale and Network Expansion
The company’s manufacturing infrastructure is scaling rapidly, with approvals for expanded capacity in Raritan and new production sites in Europe. A 97% success rate and 30-day turnaround underpin best-in-class reliability. Legend has activated 123 U.S. and 213 global treatment sites, including increasing penetration into community and outpatient settings, unlocking new patient pools and reducing access barriers.
3. Regulatory and Market Access Tailwinds
FDA removal of REMS (Risk Evaluation and Mitigation Strategies) requirements for CARVICTI has reduced patient monitoring burdens, improving the patient experience and broadening access. State-level changes such as Texas dropping FACT accreditation requirements further pave the way for community-based administration, which is critical for market expansion.
4. Pipeline and Next-Gen Platform Investment
Legend is leveraging its strong cash position to advance a robust pipeline, including solid-tumor CAR-Ts and the TAVEC (T-Cell Activation Vector) platform for off-the-shelf therapies. Early clinical signals from LB1908 and LB2102 highlight the potential to extend the company’s cell therapy leadership beyond multiple myeloma.
5. Patient and Physician Engagement Initiatives
Direct-to-patient campaigns and increased advocacy are driving awareness and referrals, especially as patients and caregivers become more informed about the survival benefits of CARVICTI. Physician education and real-world data dissemination further reinforce Legend’s differentiated position in the CAR-T landscape.
Key Considerations
Legend’s Q2 2025 results reflect a convergence of clinical, operational, and market access strengths that are reinforcing its leadership in cell therapy. The company’s focus on early-line adoption, manufacturing scale, and regulatory engagement is driving both top-line growth and cost leverage.
Key Considerations:
- Early-Line Therapy Drives Growth: Uptake in second to fourth line settings is expanding the addressable market and improving clinical outcomes.
- Community and Outpatient Penetration: Over 70% of patients originate from community settings, while more than half are treated outpatient, freeing up inpatient capacity.
- Manufacturing Scale as a Moat: High success rates and rapid turnaround times support both U.S. and international expansion, providing a durable competitive advantage.
- Profitability and Capital Allocation Discipline: Operating losses are narrowing even as pipeline and commercial investments continue, with a clear runway to company-wide profitability by 2026.
Risks
Legend faces competitive pressure from emerging cell therapies and potential biospecific entrants, though current data and physician sentiment favor CARVICTI’s durability and survival benefit. Regulatory changes or reimbursement shifts could impact access or pricing, particularly as more states evaluate FACT accreditation requirements. Manufacturing complexity and supply-demand balance remain execution risks as global volumes scale, and foreign exchange volatility could impact reported results.
Forward Outlook
For Q3 and the remainder of 2025, Legend guided to:
- Operational break-even for CARVICTI by year-end 2025
- Continued expansion of treatment sites and manufacturing capacity, especially in Europe
For full-year 2025, management reiterated:
- Company-wide profitability in 2026, excluding unrealized FX gains or losses
Management highlighted several factors that will drive results:
- Continued early-line adoption and global market launches
- Ongoing improvements in manufacturing efficiency and patient access
Takeaways
Legend’s Q2 performance cements its lead in commercial cell therapy, with early-line adoption and global expansion driving both growth and margin improvement.
- Clinical and Commercial Moat: Long-term survival data and early-line efficacy reinforce CARVICTI’s position as the BCMA CAR-T of choice, supported by robust real-world safety data.
- Operational Leverage: Manufacturing scale and disciplined spending are translating into improving cash flow and a credible path to profitability.
- Pipeline and Access Expansion: Next-gen platforms and regulatory tailwinds set the stage for further growth, while community and outpatient strategies broaden the patient base.
Conclusion
Legend Biotech’s record CARVICTI sales, expanding global reach, and operational discipline position it for sustainable growth and profitability. With a strong balance sheet and differentiated clinical profile, the company is set to extend its leadership in cell therapy as new indications and platforms mature.
Industry Read-Through
Legend’s results signal accelerating adoption of CAR-T therapies in earlier lines and community settings, raising the bar for durability and safety in cell therapy. The removal of REMS and evolving accreditation standards may catalyze broader access industry-wide, while manufacturing scale and turnaround time are emerging as key differentiators. Competitors face mounting pressure to match Legend’s clinical and operational benchmarks, and the focus on real-world data transparency is likely to shape physician and payer decision-making across the sector.