Legend Biotech Reports Strong CARVYKTI® Growth with $963 Million in 2024 Sales, Treating Over 5,000 Patients
核心洞察
Legend Biotech reported CARVYKTI® net trade sales of $963 million for full year 2024, with over 5,000 patients treated to date, positioning the CAR-T (搜索) therapy as a market leader in multiple myeloma (搜索) treatment.
The company initiated commercial production at a Novartis facility and secured reimbursement approval from Spain's national health system for CARVYKTI® in second-line plus settings, expanding patient access.
With $1.1 billion in cash reserves, Legend Biotech expects financial runway into Q2 2026, when it anticipates achieving operating profit excluding unrealized foreign exchange impacts.
Legend Biotech Corporation (NASDAQ: LEGN) has reported robust financial results for the fourth quarter and full year 2024, highlighting the continued commercial success of its flagship CAR-T (搜索) cell therapy CARVYKTI® for multiple myeloma (搜索).
The company announced CARVYKTI® net trade sales of approximately $334 million for the fourth quarter and $963 million for the full year 2024, approaching blockbuster status. To date, over 5,000 patients have been treated with the therapy, cementing CARVYKTI®'s position as the market leader for CAR-T (搜索) therapy in multiple myeloma (搜索).
"We are coming off a tremendously successful year. Our 2024 total revenue nearly achieved blockbuster status, and we are just now building out our many opportunities with CARVYKTI," said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. "CARVYKTI has already helped thousands of multiple myeloma (搜索) patients. Even though CARVYKTI is the market leader for CAR-T (搜索) in multiple myeloma, we are still working relentlessly to elevate our commercial, manufacturing, regulatory and clinical efforts."
Manufacturing and Market Expansion
In a significant development for its manufacturing capabilities, Legend Biotech initiated commercial production of CARVYKTI® at a Novartis production facility in the first quarter of 2025, pursuant to a master manufacturing and supply agreement among Legend, Janssen, and Novartis. This expansion is expected to increase production capacity to meet growing demand.
The company also announced that Spain's national health system, Sistema Nacional de Salud (SNS), approved reimbursement for CARVYKTI® for multiple myeloma (搜索) patients who have received at least one prior line of treatment. This approval expands access to the therapy in a key European market.
Clinical Progress
Legend Biotech reported positive three-year follow-up data from the Phase 3 CARTITUDE-4 study, demonstrating that CARVYKTI® increased minimal residual disease (MRD) negativity rates compared to standard of care for patients with relapsed or refractory multiple myeloma (搜索). In the study, 89 percent of evaluable patients achieved MRD negativity at the 10-5 threshold, with most patients achieving this status in less than two months.
Alan Bash, President of CARVYKTI, noted during the earnings call that there has been strong receptivity to CARVYKTI®'s clinical profile and its approval for earlier lines of therapy. The company has converted nearly 60% of usage to second through fourth-line populations, indicating robust market uptake.
Financial Performance
For the fourth quarter of 2024, Legend Biotech reported:
- Total revenue of $186.5 million, compared to $79.5 million in Q4 2023
- Net income of $26.3 million, or $0.07 per share, compared to a net loss of $144.8 million, or $0.40 per share, in Q4 2023
For the full year 2024:
- Total revenue of $627.2 million, compared to $285.1 million in 2023
- Net loss of $177.0 million, or $0.48 per share, compared to a net loss of $518.3 million, or $1.47 per share, in 2023
Collaboration revenue for the year ended December 31, 2024, was $482.6 million, compared to $249.8 million for 2023, representing an increase of $232.8 million due to increased sales of CARVYKTI® in connection with the Janssen Agreement.
The company reported cash and cash equivalents, and time deposits of $1.1 billion as of December 31, 2024, which it believes will provide financial runway into the second quarter of fiscal year 2026, when Legend Biotech anticipates potentially achieving an operating profit excluding unrealized foreign exchange gains or losses.
Future Outlook
Looking ahead, Legend Biotech executives indicated that growth will not be perfectly linear throughout 2025. They expect modest growth in Q1 due to seasonality and facility maintenance, with more significant growth anticipated in Q2 and Q3 as manufacturing capacity increases.
When asked about potential competition in 2026, CEO Ying Huang expressed confidence in maintaining market leadership due to CARVYKTI®'s unmatched depth and durability of response, convenience of one-time treatment, and strong efficacy data. The company expects the majority of revenue to come from second to fourth-line indications by 2026.
Regarding safety management, particularly neurotoxicity concerns, company representatives highlighted promising studies using absolute lymphocyte count (ALC) as a predictive biomarker. They plan to harmonize ALC cutoffs in ongoing CARTITUDE studies and expect data presentations this year and next, with mitigation strategies being incorporated into their trials.
"While we are focused on executing with excellence for CARVYKTI this year, we continue to prioritize the right investments to enhance our opportunities as a stand-alone cell therapy company for the long term," Huang added.
As the largest standalone cell therapy company with over 2,500 employees, Legend Biotech continues to build an end-to-end cell therapy company centered in the US, with plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.