Legend Biotech is profitable on one drug and betting on in vivo CAR-T

Legend Biotech has one big product, a new chief executive and a small bet on a new way of making CAR-T. The product is paying: the company posted a profit in the second quarter. The question is how long it can last and what comes next.

The technology

Legend makes CAR-T therapies, in which a patient's immune cells are engineered to attack cancer. Its product is Carvykti, which targets BCMA on myeloma cells and is developed and sold with Johnson & Johnson. Carvykti net trade sales were $657 million in the second quarter and about $710 million in the third, per preliminary figures from J&J's Janssen unit. The five-year follow-up of 20 patients in CARTITUDE-2 Cohort A showed 50% alive and progression-free without further treatment.

The newer approach is in vivo CAR-T, where a vector delivers the CAR gene to T cells inside the body. The lead candidate, LB2501, got FDA IND clearance on Oct. 15. In a 12-patient China study, all six patients at the higher dose responded.

The odds

Carvykti is approved, so the odds that matter are for label expansion and the early pipeline. The front-line CARTITUDE-5 and -6 studies sit in patient follow-up. In the BIO/Informa/QLS study of 2011-2020 programs, 57.8% of phase 3 programs reached a filing and 90.6% of filings were approved. For hematology, the study put the chance of approval from phase I at 23.9%.

LB2501 and the rest of the early pipeline face the long odds of any early program: 52.0% of drugs move from phase I to II, and 7.9% reach approval from phase I across all programs. The 6-for-6 response at the higher dose is real but tiny.

The money

Cash and time deposits were about $965 million at June 30, 2026, and the company says this gives it runway beyond 2026. The balance includes about $212 million net from a June offering of 7.7 million ADSs at $29.35 each. Second-quarter collaboration revenue was $326.1 million, operating income was $57.7 million and net income was $33.2 million. Adjusted net income was $63.1 million.

Not all of that repeats. License and other revenue included $56.0 million in Janssen milestones, and net income benefited from lower foreign exchange losses. The tax line rose to $22.3 million, and an advance pricing agreement with Chinese tax authorities is still open.

The risks

The first is concentration. Carvykti is the revenue base, and growth is slowing: year-over-year sales growth was 62% in the first quarter and 50% in the second, and the third-quarter sequential rise was about 8%, by our calculation from the filings. Fierce Pharma cited pressure from Gilead's anito-cel and J&J's bispecific combinations, and reported that shares fell 10% on July 15, the day second-quarter sales came out roughly in line with expectations.

The second is leadership. Ying Huang resigned in July, and Ingrid Zhang became CEO on Sept. 15, so strategy could shift. Third, the pipeline is early. Fierce reported investor concern about the lack of mid- to late-stage assets besides Carvykti.

Our read

Legend has crossed from loss to profit on the strength of one drug, and it has the cash to fund its pipeline for now. The Carvykti sales line is still rising, but at a slower pace, and competitors are arriving in the same patient group. The in vivo program is the most interesting new asset, though its efficacy rests on six patients. The next steps are the third-quarter report, the start of the U.S. LB2501 study and any change in strategy under the new CEO. None has a date in the filings reviewed.