Revenue Performance - Total revenue for the nine months ended September 30, 2024, was $440.72 million, a 114% increase from $205.68 million in the same period of 2023[14] - License revenue reached $120.12 million, up from $35.17 million year-over-year, representing a 241% increase[14] - Collaboration revenue increased to $314.56 million, compared to $170.37 million in the prior year, marking an 84% growth[14] - Total revenue for the nine months ended September 30, 2024, was $440.7 million, a significant increase of $235.0 million compared to $205.7 million for the same period in 2023[69] - License revenue increased to $120.1 million for the nine months ended September 30, 2024, up from $35.2 million in 2023, driven by $40.0 million from milestones under the Janssen Agreement and $45.0 million from the Novartis License Agreement[70][71] - Collaboration revenue rose to $314.6 million in 2024, compared to $170.4 million in 2023, primarily due to increased sales of CARVYKTI under the Janssen Agreement[72] Financial Loss and Improvement - The loss for the period was $203.31 million, a significant improvement from a loss of $373.44 million in the same period of 2023[14] - Basic and diluted loss per share improved to $0.56 from $1.07 year-over-year[14] - The loss for the nine months ended September 30, 2024, is $203.3 million, compared to a loss of $373.4 million for the same period in 2023, representing a 45.6% improvement[23] - Net loss for the period was $203.3 million, or ($0.56) per share, compared to a net loss of $373.4 million, or ($1.07) per share, for the same period in 2023, indicating improved financial performance[84] Assets and Liabilities - Total assets as of September 30, 2024, were $1.74 billion, down from $1.85 billion at the end of 2023[16] - Total liabilities increased to $619.72 million from $597.24 million at the end of 2023[16] - Total equity as of September 30, 2024, is $1,116.1 million, a decrease from $1,339.6 million as of September 30, 2023[19] - Cash and cash equivalents decreased to $459.28 million from $1.28 billion at the end of 2023[16] - Cash and cash equivalents as of September 30, 2024, totaled approximately $0.46 billion, with time deposits of approximately $0.76 billion, providing liquidity to fund operations into 2026[87][85] Cash Flow and Investment Activities - Cash used in operating activities for the nine months ended September 30, 2024, is $61.96 million, significantly reduced from $297.63 million in 2023[25] - Net cash used in investing activities for the nine months ended September 30, 2024, is $762.70 million, compared to $314.72 million in 2023, indicating increased investment activity[25] - Net cash provided by financing activities for the nine months ended September 30, 2024, was $6.0 million, a decrease from $790.6 million in 2023, reflecting reduced capital raising activities[95][96] Expenses - Research and development expenses rose to $309.11 million, compared to $276.54 million in the prior year, reflecting a 12% increase[14] - Administrative expenses increased to $102.58 million from $78.06 million year-over-year, a 31% rise[14] - The company recognized equity-settled share-based compensation expense of $55.55 million for the nine months ended September 30, 2024, compared to $35.09 million in 2023, reflecting increased compensation costs[25] - Research and development expenses for the nine months ended September 30, 2024, were $309.1 million, an increase of $32.6 million from $276.5 million in 2023, reflecting ongoing investment in cilta-cel and solid tumor programs[76] Inventory and Receivables - The company experienced a decrease in trade receivables of $99.34 million in the nine months ended September 30, 2024, compared to a minimal change in 2023[23] - The company reported a provision for inventory reserve of $6.83 million for the nine months ended September 30, 2024, compared to $1.34 million in 2023, indicating increased inventory risk management[23] - The reserve for inventory increased to $15.8 million as of September 30, 2024, compared to $8.9 million at the end of 2023, indicating higher expired materials[47] Shareholder and Financing Activities - The company issued ordinary shares resulting in a total increase in equity of $234.41 million from private placements and $349.28 million from registered direct offerings during the nine months ended September 30, 2023[19] - The weighted average number of ordinary shares in issue increased to 365,268,372 for the nine months ended September 30, 2024, from 348,293,363 in the prior year[40] - The company issued and fully paid 366,901,007 ordinary shares as of September 30, 2024, an increase from 363,822,069 shares as of December 31, 2023[55] Future Outlook and Plans - The company expects to incur significant capital expenditures in the coming years to ramp up manufacturing capabilities for CARVYKTI and advance clinical development programs[85] - The company expects expenses to increase due to ongoing research and development, clinical trials, and commercialization efforts for CARVYKTI, necessitating substantial additional funding[97] - Existing cash and cash equivalents are projected to fund operating expenses and capital expenditures for at least the next 12 months, despite potential fluctuations in cash requirements[98] - The company has a broad portfolio of earlier-stage product candidates, but may not generate necessary data for marketing approval, requiring continued reliance on additional financing[99] - Financing needs will be met through equity offerings, debt financings, collaborations, and licensing arrangements, which may dilute existing shareholders[100] Regulatory and Market Developments - The company received China's NMPA approval for CARVYKTI for the treatment of fourth-line plus multiple myeloma[66] - The company initiated commercial production at the Obelisc facility in Ghent, Belgium, and launched CARVYKTI in Switzerland during the third quarter[66] - The Novartis License Agreement, effective December 28, 2023, includes an upfront payment of $100 million and potential milestone payments of up to $1.01 billion[36] Economic and Risk Factors - The company has not experienced material impacts on its supply chain due to inflation and rising interest rates, maintaining robust sourcing strategies[67] - Inflation has not materially affected the company's financial condition or results of operations during the nine months ended September 30, 2024 and 2023[105] - The company does not believe it is exposed to any material foreign currency exchange rate risk[106]
Legend Biotech(LEGN) - 2024 Q3 - Quarterly Report