CARVYKTI's Triumph: Legend Biotech Hits Profitability Milestone, Eyes Next-Gen Therapies

SOMERSET, N.J. – March 10, 2026 – Legend Biotech has cemented its position as a formidable force in oncology, reporting that its blockbuster CAR-T cell therapy, CARVYKTI®, generated approximately $1.9 billion in net trade sales for the full year 2025. The company’s latest financial disclosures reveal a pivotal year, marked by the CARVYKTI® franchise achieving full-year profitability and the treatment reaching more than 10,000 patients globally.

The fourth-quarter results alone saw net trade sales of approximately $555 million, underscoring the powerful commercial momentum of the multiple myeloma treatment. This success is not just a financial victory; it represents a significant step forward in the company's journey from a clinical-stage biotech to a commercially viable leader in the cell therapy revolution.

“CARVYKTI® continued to build on its leadership in multiple myeloma CAR‑T in 2025, as we reached more than 10,000 patients treated and achieved franchise profitability,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “With expanding capacity and ongoing efforts to broaden adoption, including in the community setting, we are focused on executing against the opportunities ahead while extending our innovation leadership across in vivo and allogeneic programs.”

Dominating the Multiple Myeloma Market

CARVYKTI® (ciltacabtagene autoleucel) has rapidly become the “undisputed leader” in the competitive multiple myeloma CAR-T space. Its primary competitor, Abecma from Bristol Myers Squibb and 2seventy bio, also targets the B-cell maturation antigen (BCMA), but CARVYKTI's launch has been exceptionally strong. A key driver of this growth is the strategic push into earlier lines of therapy.

Initially approved for heavily pretreated patients, Legend Biotech and its partner Johnson & Johnson are working to make CARVYKTI® available to a broader patient population sooner in their treatment journey. Data from the pivotal Phase 3 CARTITUDE-4 study, which showed a 74% reduction in the risk of disease progression or death, supports this expansion. The company has already submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand its label for patients who have received at least one prior line of therapy. Industry analysis indicates that approximately 65% of CARVYKTI® patients are now being treated in the second to fourth-line setting, a significant shift that expands the therapy's market potential.

This move into earlier treatment lines is critical for maintaining market leadership and maximizing the therapy's impact, allowing patients to access this powerful one-time treatment before their disease becomes more advanced and refractory to other options.

Expanding Access and Manufacturing Might

Beyond clinical expansion, Legend Biotech is aggressively scaling its physical footprint to meet soaring demand. The company announced that CARVYKTI® is now available at 294 certified treatment centers across 14 markets worldwide. A crucial element of this strategy is the expansion into U.S. community hospital settings.

Historically, complex treatments like CAR-T therapy have been confined to large academic medical centers. By activating community-based sites—which now represent about a third of its 145 U.S. centers—Legend is making CARVYKTI® more accessible, reducing the significant travel and logistical burdens for patients and their families. While administering CAR-T in community settings presents challenges related to specialized infrastructure and staff training, the later onset of potential side effects with CARVYKTI® may facilitate its outpatient administration, a key goal for improving the patient experience.

Underpinning this commercial expansion is a massive investment in manufacturing. The recently completed expansion of the company's Raritan, New Jersey facility has made it the largest cell therapy manufacturing site in the United States. This state-of-the-art facility is designed to support the treatment of up to 10,000 patients annually, effectively doubling previous capacity and directly addressing the supply chain bottlenecks that have previously constrained the growth of cell therapies.

The Financial Inflection Point

Legend Biotech's 2025 financial results signal a company at an inflection point, transitioning from heavy R&D spending to sustainable profitability. The achievement of franchise profitability for CARVYKTI® is the first major step. The company's overall operating margin improved dramatically over the year, and it reported a positive adjusted net income of $2.5 million for the fourth quarter, a stark turnaround from the $59 million adjusted net loss in the same period of 2024.

Furthermore, the company's operating cash flow turned positive in the third quarter of 2025 and remained so in the fourth, indicating that the core business is now generating more cash than it consumes. With a robust cash position of $949 million as of year-end, Legend Biotech projects it has a financial runway extending beyond 2026, the year it believes it will achieve company-wide operating profit.

While the company still reported a net loss for the full year, primarily due to non-cash factors like unrealized foreign exchange losses, the underlying operational trends point toward a strengthening financial foundation. This financial health is crucial as it allows the company to not only scale its CARVYKTI® operations but also to fund the next wave of innovation.

Building the Future of Cell Therapy

While CARVYKTI® is the current star, Legend Biotech is actively investing in its next-generation pipeline to secure its long-term leadership. The company is advancing a diversified portfolio that includes both allogeneic (off-the-shelf) and in vivo CAR-T candidates, aiming to overcome the limitations of current autologous (patient-specific) therapies.

At the recent American Society of Hematology (ASH) Annual Meeting, the company presented encouraging first-in-human results for LUCAR-G39D, an allogeneic CAR-T candidate for B-cell non-Hodgkin lymphoma. Allogeneic therapies, derived from healthy donors, promise to reduce manufacturing time and cost, making cell therapy more readily available.

Perhaps even more revolutionary is the company's work in the in vivo space, where the first patient has been dosed. In vivo CAR-T involves engineering a patient's T-cells directly inside their body, potentially eliminating the complex and costly ex vivo manufacturing process altogether. To fuel these ambitious projects, Legend has opened a new 31,000-square-foot R&D facility in Philadelphia, Pennsylvania, dedicated to these advanced platforms. This dual strategy of maximizing its current blockbuster while pioneering the next frontier of cancer treatment positions Legend Biotech not just as a commercial success story, but as a key architect of the future of medicine.