Legend Biotech Corporation (NASDAQ: LEGN), a global leader in cell therapy, has announced its unaudited financial results and notable corporate developments for the second quarter of 2024.
CEO Statement
Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech, commented, “The approval of CARVYKTI® for second-line use has significantly increased demand and interest from both patients and the healthcare community. We are seeing growing momentum for CARVYKTI®, not only among later-line patients but also among those in earlier lines of treatment. Our progress in both inpatient and outpatient settings is encouraging, and we are excited to expand our reach with our transformative one-time treatment. We anticipate commencing commercial production at our Obelisc facility in Belgium later this year to meet the rising demand, while we continue to focus on scaling up our manufacturing capabilities.”
Regulatory Updates
- The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved CARVYKTI® for adult patients with relapsed and refractory multiple myeloma who have undergone at least one prior therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), and are refractory to lenalidomide.
- Health Canada has also approved CARVYKTI® for adult patients with multiple myeloma who have had one to three prior lines of therapy, including a PI and an IMiD, and are refractory to lenalidomide.
Key Business Developments
- Novartis Pharmaceuticals Corporation commenced clinical production in July 2024.
- Enrollment in the CARTITUDE 5 study was completed in July 2024.
- Positive results from the second interim analysis of the Phase 3 CARTITUDE-4 study were announced, showing a statistically significant and clinically meaningful improvement in overall survival for multiple myeloma patients treated with CARVYKTI® compared to standard treatments. These findings will be presented at upcoming medical meetings and shared with regulatory agencies for global label updates.
- New data from the Phase 2 CARTITUDE-2 Cohort D study and updated data from the Phase 3 CARTITUDE-4 study of cilta-cel were featured at the 2024 ASCO Annual Meeting and EHA 2024 Hybrid Congress.
- On June 28, 2024, Legend Biotech received a $30 million milestone payment related to the Janssen Agreement.
- On August 8, 2024, Peter Salovey, Ph.D., joined the Company’s Board of Directors, effective August 9, 2024.
Second Quarter 2024 Financial Results
- License Revenue: $90.8 million for the quarter ended June 30, 2024, up from $15.1 million in the same period of 2023. The increase is due to $60.0 million in revenue from milestones achieved under the Janssen Agreement for cilta-cel and $15.7 million from activities related to the Novartis License Agreement.
- Collaboration Revenue: $93.3 million for Q2 2024, compared to $58.2 million in Q2 2023, reflecting increased revenue from CARVYKTI® sales under the Janssen Agreement.
- Collaboration Cost of Revenue: $45.4 million for Q2 2024, up from $32.7 million in Q2 2023, due to higher costs associated with CARVYKTI® sales.
- Cost of License and Other Revenue: $5.1 million for Q2 2024, related to the Novartis License Agreement. No such costs were incurred in Q2 2023.
- Research and Development Expenses: $112.6 million for Q2 2024, compared to $95.8 million in Q2 2023, driven by ongoing cilta-cel research, clinical production startup costs in Belgium, and investment in solid tumor programs.
- Administrative Expenses: $35.4 million for Q2 2024, up from $27.8 million in Q2 2023, due to expanded administrative functions and infrastructure investments.
- Selling and Distribution Expenses: $30.1 million for Q2 2024, compared to $21.4 million in Q2 2023, primarily due to commercial activities for cilta-cel, including sales force expansion and second-line indication launch preparation.
- Net Loss: $18.2 million for Q2 2024, significantly reduced from a net loss of $199.1 million in Q2 2023.
- Cash Position: $1.3 billion in cash and equivalents as of June 30, 2024.
Legend Biotech remains committed to advancing its innovative therapies and expanding its production capabilities to meet growing patient needs.
