Legend Biotech (NASDAQ:LEGN) reported second-quarter 2026 results marked by continued global growth for CARVYKTI and the company’s first quarter of company-wide profitability on both an IFRS and adjusted basis, management said during its earnings call.
Interim Chief Executive Officer Alan Bash said the company generated approximately $657 million in worldwide net trade sales for CARVYKTI during the quarter, up 50% from a year earlier and 10% sequentially. He also said Legend generated adjusted net income of $63 million and expects to remain adjusted-net-income profitable during the second half of 2026.
CARVYKTI Growth Driven by Earlier-Line Use and International Expansion
CARVYKTI sales in the U.S. increased 32% year over year, while sales outside the U.S. rose 128%, according to Bash. U.S. sales grew 9% sequentially, supported primarily by accelerating adoption in earlier treatment lines. International sales increased 13% sequentially as launches continued across 19 markets and the company expanded its activated treatment-site network.
Legend said CARVYKTI is now available through 348 treatment sites globally. More than 150 authorized treatment centers are in the U.S., including community hospitals representing roughly 40% of those sites.
Management said use in the second through fourth lines of treatment now accounts for more than 70% of CARVYKTI’s U.S. volume. The company had previously said second- and third-line use represented 41% of total mix, but said it does not plan to provide that more detailed breakout every quarter.
Bash said the company and its partner, Johnson & Johnson, continue to position CARVYKTI as a “one-and-done” treatment option compared with continuous therapies. Management also cited clinical and real-world data suggesting patients may have better outcomes when they receive CAR-T therapy before other BCMA-directed treatment options.
Legend reiterated its view that CARVYKTI has peak annual sales potential above $5 billion.
In Vivo CAR-T Data and Pipeline Plans
The company highlighted early clinical data for LB2501, a CD19/CD20 dual-targeting in vivo CAR-T therapy being studied in relapsed or refractory non-Hodgkin’s lymphoma. Data presented at the European Hematology Association Congress included 12 patients in an ongoing China-based investigator-initiated Phase I dose-escalation trial.
At the second dose level, six patients with diffuse large B-cell lymphoma, mantle cell lymphoma or follicular lymphoma had a 100% objective response rate and an 83.3% complete response rate, Bash said. CAR-T cells were detected in peripheral blood for as long as 116 days. The treatment was reported to be well tolerated, with no dose-limiting toxicities, serious adverse events or deaths reported in the data set.
Legend expects to file a U.S. investigational new drug application for LB2501 by the end of 2026 and intends to conduct the initial U.S. Phase I study itself. The company said it plans to present additional data from the China study at future medical conferences and is ultimately targeting an update on six-month complete-response rates.
During the question-and-answer session, management also disclosed that Legend will conduct an investigator-initiated study in China of LB2505, an investigational BCMA-targeted in vivo CAR-T treatment for multiple myeloma. The program is subject to the company’s collaboration agreement with Johnson & Johnson, and management did not provide additional details.
Legend said it remains interested in pursuing in vivo CAR-T opportunities in autoimmune disease across multiple potential targets. Management distinguished its lentiviral vector-based platform from Sail’s preclinical circular mRNA and lipid nanoparticle platform.
Beyond in vivo programs, the company said it continues to advance autologous CAR-T candidates targeting Claudin 18.2, DLL3, GPRC5D and other targets, as well as allogeneic programs for autoimmune disease and B-cell malignancies. Interim Head of R&D Yuhong Qiu said Legend continues to see a role for allogeneic therapies and expects to provide future updates on its LUCAR-G39D program.
Financial Results, Margins and Cash Position
Chief Financial Officer Carlos Santos said total revenue increased 52% year over year, while operating margin improved to positive 15% from negative 9% in the prior-year period. He said revenue has grown at a 74% compound annual growth rate since the second quarter of 2023, while operating margin has improved from negative 142% over that span.
Gross margin on net product sales was 58% in the second quarter, compared with 41% in the first quarter. Santos said the first-quarter figure had been affected by one-time manufacturing-expansion costs that were reversed in the second quarter, along with other one-time favorability.
Management expects gross margin on net product sales to fall into the lower-50% range in the third quarter before rebounding to the mid-50% range in the fourth quarter. Santos said a growing outpatient mix, which is approaching 60% of total volume, introduces different margin dynamics. Over time, the company expects manufacturing scale and utilization to support gross margins of about 75%.
- Research and development expense declined 2% year over year as costs from later-stage BCMA frontline studies declined, partly offset by increased investment in in vivo assets.
- Selling, general and administrative expense increased 19%, primarily reflecting investments supporting CARVYKTI’s position in BCMA CAR-T markets.
- Income tax expense was $22.3 million, compared with about $600,000 a year earlier, reflecting higher taxable income in the U.S., Belgium and China.
Santos said Legend expects its tax rate to be in the high-20% range over the next several quarters, although the company is still negotiating a unilateral advanced pricing agreement with Chinese tax authorities.
As of June 30, Legend held approximately $965 million in cash equivalents and time deposits and had no long-term debt. The balance included about $212 million in net proceeds from a June public equity offering.
Management described the financing as opportunistic following the LB2501 data release and said the proceeds provide flexibility to accelerate development of the in vivo platform. The company also expects to fully settle a roughly $300 million loan obligation to Johnson & Johnson, including accrued interest, during 2026 through a combination of cash payments and collaboration-profit recoupments.
Legend maintained its objectives of sequential CAR-T growth through the rest of 2026, adjusted-net-income profitability in the second half, a fourth-quarter IND filing for LB2501 and additional in vivo data presentations at future medical meetings.
About Legend Biotech (NASDAQ:LEGN)
Legend Biotech (NASDAQ: LEGN) is a commercial-stage biopharmaceutical company specializing in the development and commercialization of chimeric antigen receptor T-cell (CAR-T) therapies for oncology. Headquartered in Somerset, New Jersey, with research and development operations in Shanghai, the company leverages a global infrastructure to advance innovative cellular therapies. Legend Biotech pursues a strategy of strategic collaboration to extend its reach, most notably through its partnership with Janssen Biotech, a subsidiary of Johnson & Johnson.
The company’s lead asset, ciltacabtagene autoleucel (commercially marketed as Carvykti), is a B-cell maturation antigen (BCMA)–directed CAR-T therapy for the treatment of relapsed or refractory multiple myeloma.
