Legend Biotech Q2 2024 Results and Recent Highlights

Legend Biotech Corporation, a prominent entity in cell therapy, has announced its unaudited financial results for the second quarter of 2024. The company has also highlighted several significant corporate developments, showcasing notable progress in its operations and regulatory achievements.

In the second quarter, the approval of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for relapsed and lenalidomide-refractory multiple myeloma patients in earlier treatment lines has driven increased demand and interest. The Chief Executive Officer, Ying Huang, Ph.D., expressed enthusiasm about the growing momentum for CARVYKTI® and its impact on both later and earlier line patients. He emphasized the company's focus on expanding manufacturing capabilities to meet rising demand, including the anticipated start of commercial production at the Obelisc facility in Belgium later in the year.

Regulatory milestones have been a significant highlight, with CARVYKTI® receiving approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada for treating adult patients with relapsed and refractory multiple myeloma. This approval applies to patients who have undergone specific prior therapies and are refractory to lenalidomide.

Key business developments include Novartis Pharmaceuticals Corporation initiating clinical production in July 2024 and the completion of CARTITUDE 5 enrollment within the same month. Additionally, positive results from the Phase 3 CARTITUDE-4 study were announced, indicating a significant improvement in overall survival for multiple myeloma patients treated with CARVYKTI® compared to standard-of-care treatments. These findings are to be presented at an upcoming medical conference and shared with regulatory authorities for potential label updates.

Furthermore, new data from the Phase 2 CARTITUDE-2 Cohort D study and updated data from the Phase 3 CARTITUDE-4 study were showcased at the 2024 ASCO Annual Meeting and the European Hematology Association's Hybrid Congress. On the financial front, Legend Biotech received a milestone payment of $30 million related to an agreement with Janssen Biotech, Inc.

Peter Salovey, Ph.D., was appointed to the company's Board of Directors, effective August 9, 2024. This addition is expected to bring valuable expertise to Legend Biotech's strategic direction.

The financial results for the second quarter of 2024 reveal a substantial increase in license revenue, attributed primarily to milestone achievements under the Janssen Agreement for cilta-cel. License revenue for the period reached $90.8 million, compared to $15.1 million in the same period of 2023. Collaboration revenue also saw a significant rise, amounting to $93.3 million, driven by the sales of CARVYKTI®.

Research and development expenses were reported at $112.6 million, reflecting ongoing investments in cilta-cel research and the initiation of clinical production in Belgium. Administrative expenses rose to $35.4 million, largely due to the expansion of administrative functions to support increased manufacturing capacity. Selling and distribution expenses increased to $30.1 million, driven by commercial activities for cilta-cel, including preparing for the second line indication launch.

The net loss for the quarter was $18.2 million, a marked improvement from the $199.1 million loss in the same period of 2023. As of June 30, 2024, Legend Biotech's cash and cash equivalents, deposits, and short-term investments totaled $1.3 billion, expected to provide financial runway into 2026, when the company anticipates achieving an operating profit.

Legend Biotech remains committed to advancing its cell therapy innovations and expanding its impact on treating life-threatening diseases. The company's strategic focus on enhancing manufacturing capacity and regulatory compliance positions it well for future growth in the biotechnology sector.