NEW YORK – Legend Biotech is investing $150 million to expand a manufacturing plant for its BCMA-directed CAR T-cell therapy Carvykti (ciltacabtagene autoleucel) this year, Legend's interim CFO Jessie Yeung said in a call to discuss the firm's fourth quarter 2024 financials earlier this week.
The Somerset, New Jersey-based company markets Carvykti with Janssen in the US as a treatment for relapsed or refractory multiple myeloma. Originally approved in 2022 for multiple myeloma patients who had received at least four lines of therapy, it garnered approval in April 2024 for patients who have received one to three prior lines of therapy including a proteosome inhibitor and an immunomodulatory drug and are refractory to Bristol Myers Squibb's Revlimid (lenalidomide).
In Q4 2024, Janssen and Legend reported that Carvykti sales more than doubled to $334 million from $159 million in Q4 2023. However, Legend sees the potential to double the annual sales volume of the product from an estimated 10,000 doses in 2025 to 20,000 doses in 2027, by using a new section at its existing manufacturing facility in Raritan, New Jersey, and expanding its Tech Lane plant in Ghent, Belgium. The company hopes to begin implementing these manufacturing expansion plans in the second half of 2025.
CAR T-cell therapy developers have struggled to keep up with demand for their cell therapy products. For example, during Gilead's Q4 2024 earnings call, company executives noted they were working with industry groups and manufacturers to "address barriers" to its cell therapies, especially for patients getting care at community oncology practices.
Under a license agreement signed in November 2023, Novartis is manufacturing Legend's CAR T-cell therapies targeting DLL3 at the Raritan plant. Legend CEO Ying Huang said during the earnings call that Tech Lane "is another critical component of our plans for serving patients in Europe and beyond to meet increasing demand."
Legend and Janssen are jointly investing in the Tech Lane expansion. "Phase 1 [of the expansion] will be completed this year … we will have clinical production in the first half [of 2025], commercial production in the second half," Yeung said during the investor call. "And for Phase 2, we will invest incrementally $150 million, and that will start in the second half of 2025. We expect to complete [the facility] in 2028."
Legend reported revenue of $186.5 million in Q4 2024, more than double its Q4 2023 revenue of $79.4 million. The company had net income of $26.3 million, or $.07 per share, in Q4 2024, compared to a loss of $144.8 million, or $.40 per share, in the year-ago quarter. Legend's full-year revenues for 2024 were $627 million, compared to $285 million in 2023. Its net loss was $177.0 million, or $.48 per share, for 2024 versus a loss of $518.3 million, or $1.47 per share, in 2023. It had $286.7 million in cash and cash equivalents at the end of last year.