CARVYKTI Sales Climb 36% to $710 Million, But Legend Flags Slowdown

CARVYKTI generated $710 million in global net trade sales in the third quarter of 2026, up 36% year over year, yet Legend Biotech's executives warned that slower earlier-line gains in the United States and delayed international launches could temper expectations. The stock trades on NASDAQ under the ticker LEGN, and the call that followed the numbers told a story of growth shadowed by caution.

U.S. sales rose 19% from a year earlier. Sales outside the U.S. surged 86%. The company attributed the growth to adoption earlier in patients' treatment journeys and to launches in new countries.

Where does the money stand against expectations?

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

The takeaway: consensus may be running ahead of what the company believes the launch curve supports.

How fast is earlier-line use expanding?

Patients receiving CARVYKTI in their second or third line of treatment accounted for 50% of U.S. apheresis volume in the third quarter. That share stood at 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 in the treatment process.

Bash said Legend is gaining share in those settings despite competition from bispecific therapies, including TECVAYLI. Educating physicians and referring patients for consultations can make expansion in earlier lines a longer sales cycle, he noted.

Legend is also leaning on September updates to National Comprehensive Cancer Network guidelines. Bash said the guidelines recommend referring myeloma patients 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., growth came from new launches and established markets, including Germany, Spain and Italy. CARVYKTI is 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.

What did the profit picture show?

Total revenue increased 32% year over year. Legend 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.

Gross margin improved to 58%, above the company's expectation in the low-50% range, driven primarily by manufacturing efficiencies. Santos said Legend now expects fourth-quarter gross margin on net product sales in the high-50% range, though he cautioned margins could vary quarter to quarter.

The spending lines moved sharply:

• Research and development expenses fell 16% year over year as costs tied to later-stage frontline studies declined.
• Selling, general and administrative expenses decreased 20%, including a $24 million one-time share-based compensation credit; excluding that 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.

What is moving in the pipeline?

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 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%. 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.

In plain words: the quarter delivered revenue growth, a swing to adjusted profit and a stronger balance sheet, while the company worked to keep market expectations tethered to what its launch calendar can deliver.