What Legend Biotech (LEGN) Said on Its Q3 Earnings Call

Key Points

• CARVYKTI sales grew 36% year over year to $710 million in Q3, supported by earlier-line use and international launches. However, Legend said U.S. earlier-line adoption is slower than expected and overseas launches have been delayed; it expects double-digit global sales growth in 2027, while current consensus is at the high end of its expectations.
• Legend reported adjusted net income of $55.6 million, versus an adjusted loss a year earlier, and reiterated its expectation of full-year 2026 adjusted profitability. Gross margin reached 58%, and the company ended the quarter with about $853 million in cash and no long-term debt.
• The company received FDA clearance to begin a study of its investigational in vivo CAR-T therapy LB2501; early results from a small patient group showed responses, but Legend said more patients and longer follow-up are needed. It also cited durable five-year CARVYKTI results and expects frontline trial readouts no earlier than 2027.

Legend Biotech NASDAQ: LEGN reported 36% growth in third-quarter global net trade sales of its multiple myeloma treatment CARVYKTI, while executives said slower-than-anticipated gains in earlier-line U.S. patients and international launch delays could temper sales expectations.

CARVYKTI sales reached $710 million in the third quarter of 2026, with U.S. sales rising 19% and sales outside the U.S. increasing 86% from a year earlier. The company said growth reflected adoption earlier in patients’ treatment journeys and launches in new countries.

Chief Financial Officer Carlos Santos said the company expects double-digit global CARVYKTI sales growth in 2027, but current net trade sales consensus is at the higher end of the scenarios Legend anticipates. Fourth-quarter sales consensus is also at the high end of the company’s expected range, he said.

“We are seeing a slower earlier-line share growth in the U.S. than we had initially anticipated,” Santos said, also citing launch delays outside the U.S. Legend does not provide formal sales guidance.

Earlier-line use and international expansion

Patients receiving CARVYKTI in their second or third line of treatment accounted for 50% of U.S. apheresis volume in the third quarter, up from 41% in the first quarter of 2026 and 29% in the first quarter of 2025, said Alan Bash, president of CARVYKTI. Apheresis is the cell-collection step used in the treatment process.

Bash said the company is gaining share in those treatment settings despite competition from bispecific therapies, including TECVAYLI. He said educating physicians and referring patients for consultations can make expansion in earlier lines a longer sales cycle.

Legend is also emphasizing September updates to National Comprehensive Cancer Network guidelines. Bash said the guidelines recommend referring patients with myeloma to a T-cell therapy-capable center at first relapse and suggest CAR-T is preferred when both BCMA CAR-T and T-cell engagers are viable options.

Outside the U.S., Bash said growth came from new launches and established markets, including Germany, Spain and Italy. CARVYKTI was available in 20 markets worldwide, and Legend reported 373 active treatment sites globally.

Chief Executive Officer Ingrid Zhang said she remained confident in CARVYKTI’s potential to generate more than $5 billion in peak sales, citing earlier-line use, possible frontline opportunities and geographic expansion. That figure is a company expectation, not a reported sales result.

Adjusted profit improves

Legend’s total revenue increased 32% year over year. The company reported adjusted net income of $55.6 million, or $0.14 per diluted share, compared with an adjusted net loss of $18.7 million, or $0.05 per diluted share, a year earlier. Adjusted net income is a non-IFRS measure.

Santos said gross margin improved to 58%, above the company’s expectation in the low-50% range, primarily because of manufacturing efficiencies. Legend now expects fourth-quarter gross margin on net product sales in the high-50% range, though Santos cautioned that margins could vary from quarter to quarter.

Research and development expenses fell 16% year over year as costs associated with later-stage frontline studies declined. Selling, general and administrative expenses decreased 20%, including a $24 million one-time share-based compensation credit; excluding the credit, those expenses would have risen 8%.

Legend ended the quarter with approximately $853 million in cash equivalents and time deposits and no long-term debt, Santos said. The company reiterated its expectation of full-year 2026 profitability on an adjusted net income basis.

Pipeline and clinical updates

Legend received U.S. Food and Drug Administration clearance to begin a clinical study of LB2501, an investigational in vivo CAR-T therapy targeting CD19 and CD20 in relapsed or refractory B-cell malignancies.

Interim Head of Research and Development Yuhong Qiu said an abstract for the upcoming American Society of Hematology meeting included 19 patients across three dose levels. All eight patients at dose level two had an overall response and a complete response, while three of five patients at dose level three had both responses. Median follow-up across all patients was 4.8 months.

Qiu said no dose-limiting toxicities, ICANS or non-ICANS neurotoxicities were reported in that dataset. Additional updated data, including for dose level three, are expected at the meeting. She cautioned that more patients and longer follow-up are needed to better understand the relationship between dose and response.

For CARVYKTI, Zhang highlighted five-year follow-up from the 20-patient CARTITUDE-2 cohort A study: Half of patients remained alive and progression-free without further anti-myeloma treatment, and overall survival was 69%. She said no new CAR-T-cell-related neurotoxicity was reported during extended follow-up.

Legend is also studying CARVYKTI in frontline settings. Bash said the earliest previously stated timing for a CARTITUDE-5 readout was 2027, with CARTITUDE-6 expected later. Both studies are event-driven, meaning results depend on the required events occurring.

About Legend Biotech (NASDAQ:LEGN)

Legend Biotech is a biotechnology company focused on developing cell therapies for cancer, with an emphasis on chimeric antigen receptor (CAR) T-cell treatments. Founded in 2014, the company is headquartered in Somerset, New Jersey, and conducts research and development activities in the United States and China.

Its lead product is CARVYKTI (ciltacabtagene autoleucel), a BCMA-directed CAR-T therapy for certain adults with relapsed or refractory multiple myeloma. Legend developed the therapy with Janssen, now part of Johnson & Johnson's Innovative Medicine business, which collaborates on its commercialization.

Legend's pipeline includes additional investigational cell therapies for cancer.

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