Legend Biotech announced that it is doubling its manufacturing capacity in 2025 for Carvykti, a CAR-T therapy used to treat relapsed or refractory multiple myeloma.
The company said it has initiated commercial production of Carvykti at a Novartis site “pursuant to the master manufacturing and supply agreement among Legend, Janssen, and Novartis.” Legend expects the approval of the new manufacturing facility in Raritan, New Jersey, in the second half of 2025. The company plans to initiate clinical and commercial production of Carvykti at the new Obelisc site in Ghent, Belgium.
“As we continue to work towards doubling Carvykti supply in 2025, we anticipate growth to be driven by capacity expansion in Belgium and in New Jersey,” Legend CEO Ying Huang told analysts in conference call on Tuesday.
The company forecasts modest growth in the first quarter of 2025 compared to the fourth quarter of 2024 — partly attributed to regulatory required facility maintenance in Q4 — followed by meaningful growth in Q2 and Q3 this year from step-ups in manufacturing at the Raritan site and the Novartis site ramping up commercial production.
William Blair analyst Sami Corwin in a Wednesday note to investors wrote that 2025 will be a milestone year for Legend as it seeks to double Carvykti manufacturing capacity, pushing the CAR-T therapy to achieve blockbuster revenue status.
By the end of 2025, Legend expects approximately two-thirds of Carvykti uptake will occur in the second- to fourth-line treatment setting. Carvykti, developed by Legend and Janssen, was approved as a second-line treatment in the U.S. and European Union after being a fifth-line treatment in the U.S. and a fourth line treatment in the EU.
“While the expansion of Carvykti in the second-line setting and approval of Carvykti in additional geographies will dramatically expand the number of patients who are eligible for Carvykti treatment, we think the number of available commercial manufacturing slots will be the primary driver of revenue and the stock over the next 12 months,” Corwin said, noting that Legend expects to exit the year with 10,000 manufacturing slots.
At Tuesday’s earnings call, Legend Interim CFO Jessie Yeung was asked by an analyst if there is any potential impact to the manufacturing costs of Carvykti or the company’s supply chain due the Trump administration’s tariffs on Canada, China, and Mexico.
“Under our current assessment, we have immaterial exposure to tariffs in Canada, Mexico and China,” Yeung said. “We will continue to monitor the situation closely. And just a reminder regarding your supply chain question, our potential product comes from the U.S. and Europe, and we plan to supply Europe from our Belgium facilities going forward.”