Legend Biotech Q1 Earnings Call Highlights

Key Points

• CARVYKTI sales surged in Q1 2026, with net trade sales of about $597 million, up 62% year over year. Growth was driven by earlier-line use in the U.S. and strong international expansion, with ex-U.S. sales rising more than 200%.
• Manufacturing execution improved but margins dipped due to one-time ramp costs at expanded facilities. Legend said gross margin was 41% in the quarter and expects it to rebound above 50% in Q2 as utilization improves.
• Legend’s pipeline is advancing beyond CARVYKTI, especially its in vivo CAR T programs. The company said its BCMA and GPRC5D programs have entered Phase I, initial non-Hodgkin’s lymphoma data is expected this year, and it remains on track for 2026 profitability on an adjusted basis.

Legend Biotech NASDAQ: LEGN reported sharply higher first-quarter 2026 sales for CARVYKTI, its CAR T therapy for multiple myeloma, as management said demand continued to move into earlier lines of treatment and international markets expanded.

Chief Executive Officer Ying Huang said the company began 2026 with “strong momentum” commercially and in its pipeline. He described Legend as “the largest standalone cell therapy company” and said CARVYKTI remains the company’s anchor product while it works to advance the therapy into the first-line treatment setting.

CARVYKTI net trade sales were approximately $597 million in the first quarter, up 62% from the first quarter of 2025. Huang said U.S. sales grew 36% year over year, while ex-U.S. sales rose more than 200%.

CARVYKTI Growth Driven by Earlier-Line Use

Alan Bash, Legend’s President of CARVYKTI, said the therapy delivered 8% sequential growth from the fourth quarter of 2025. In the U.S., growth was driven primarily by increased use in earlier-line settings, activation of new authorized treatment centers and throughput at existing sites. Outside the U.S., Bash said demand was supported by established European markets and recent launches.

CARVYKTI is now available in 18 global markets and at more than 300 treatment sites worldwide, according to the company. Bash said international growth should continue scaling as site experience, manufacturing slots and referral patterns mature.

Legend also provided detail on U.S. treatment-line mix. Bash said patients in second line and third line represented 41% of CARVYKTI apheresis volume in the U.S. during the first quarter, compared with 29% in the same period a year earlier. He said the trend reflects growing physician confidence in CARVYKTI’s benefit-risk profile earlier in the disease course.

In response to a question from J.P. Morgan analyst Jessica Fye, Bash said second- through fourth-line patients now account for about two-thirds of the business, and he expects that mix to grow to roughly three-quarters over the next year or so.

Manufacturing Metrics Remain a Focus

Management emphasized manufacturing execution as a key factor supporting broader adoption. Bash said Legend achieved a 99% manufacturing success rate in the quarter, with median turnaround time of approximately 29 days and more than 95% on-time order releases for final product delivery.

Chief Financial Officer Carlos Santos said gross margin on net product sales was 41% in the first quarter, down from 57% in the fourth quarter. He attributed the decline mainly to one-time expenses tied to ramping manufacturing in a newly expanded section of the company’s Raritan site and the ongoing Tech Lane facility ramp.

Santos said Legend expects gross margin to return to above 50% in the second quarter as utilization rises and economies of scale from manufacturing investments are realized. In response to an analyst question, he said the company would have been profitable on an adjusted net income basis in the first quarter without the one-time charge.

Financial Results Show Narrower Adjusted Loss

Legend reported collaboration revenue of approximately $298 million in the first quarter, primarily driven by CARVYKTI net trade sales under its collaboration with Johnson & Johnson. License and other revenue was approximately $7 million, bringing total revenue to $305 million.

• Research and development expense: $86 million, reflecting continued investment in in vivo CAR T and next-generation programs.
• SG&A expense: $90 million, driven by targeted commercial investments supporting CARVYKTI growth.
• Adjusted net loss: $11 million, or $0.03 per diluted share, compared with an adjusted net loss of $27 million, or $0.07 per diluted share, in the prior-year period.
• Cash position: approximately $835 million in cash equivalents and time deposits at quarter-end, with no long-term debt.

Santos said Legend continues to expect company-wide profitability on an adjusted basis in 2026 and anticipates continued margin improvement from expense discipline. He said the company’s balance sheet gives it flexibility to invest in its in vivo CAR T pipeline, support CARVYKTI profitability expansion, pursue focused business development opportunities and fund modest manufacturing-related capital expenditures.

Pipeline Updates Center on In Vivo CAR T

Huang said Legend is advancing pivotal Phase III CARTITUDE-5 and CARTITUDE-6 studies evaluating CARVYKTI in frontline multiple myeloma. During the Q&A session, Bash said both studies are fully enrolled but event-driven. For CARTITUDE-5, he said data could come “at some point in either 2026 or 2027,” depending on event accrual.

Legend also discussed its in vivo CAR T programs. Huang said the company’s BCMA in vivo program in autoimmune diseases has entered Phase I, and its GPRC5D in vivo program in multiple myeloma has also entered Phase I. He said the company remains on track to report initial data this year in non-Hodgkin’s lymphoma and expects to file one to two U.S. INDs in 2026.

In response to questions from Evercore ISI analyst Umer Raffat, Huang said the non-Hodgkin’s lymphoma program is an in vivo CAR T targeting CD19 and CD20 using lentiviral vector delivery, and is not Legend’s gamma delta T program. He identified the internal code name as LB2501 and said the program is listed on ClinicalTrials.gov.

Guowei Fang, Legend’s President of R&D, said the company expects to release both safety and efficacy data from the program, while noting that specific information will come with the data presentation. Fang said Legend’s internal expectation for the in vivo program is “manageable safety and promising efficacy, including deep response.”

Management Sees Continued Sequential Growth

Asked about competition from bispecific therapies, Bash said the second- through fourth-line multiple myeloma market remains large and under-penetrated, with significant room for multiple treatment options. He said CARVYKTI continues to show healthy growth even as other products grow.

Bash also addressed first-quarter seasonality, saying there is some lag after the holidays as patient appointments and insurance are reset. He said the company was encouraged by booking trends through the quarter and beyond, and expects sequential growth in both the U.S. and outside the U.S. for the remainder of 2026.

Huang closed the call by saying Legend remains pleased with CARVYKTI’s momentum and expects stronger quarters through the rest of the year, citing deeper penetration in the community setting and in second line. He added that the company is moving “full speed” on its in vivo programs and expects to provide updates at upcoming major 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.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.