Financial Performance and Funding - For the year ended December 31, 2023, Legend Biotech transferred $1.27 billion through capital contributions or intercompany loans to its subsidiaries [51]. - Legend Biotech has not declared or paid any cash dividends and has no plans to do so in the near future, intending to apply future earnings to fund clinical development and expansion [50]. - The company has incurred net losses and negative cash flow from operations historically, relying on various funding sources including milestone payments and equity securities [51]. - The company reported net losses of $518.3 million for the year ended December 31, 2023, and an accumulated deficit of $1,661.7 million as of the same date [94]. - The company expects to continue incurring significant losses in the foreseeable future due to ongoing research and development, manufacturing investments, and commercialization efforts [95]. - The company anticipates needing substantial additional funding to complete the development of its product candidates and to sustain operations [97]. - The company relies on additional financing to achieve business objectives, which may not be available on acceptable terms [99]. Regulatory and Compliance Risks - The company faces significant legal and operational risks due to the evolving PRC laws and regulations, which could adversely affect its operations and the value of its ADSs [37]. - The PRC government has indicated an intent to exert more oversight over offerings conducted outside of the PRC, which could limit the company's ability to offer securities to investors [40]. - The company is subject to potential penalties and operational restrictions if deemed non-compliant with PRC regulations, which could materially affect its business [51]. - The Holding Foreign Companies Accountable Act may lead to trading prohibitions if the PCAOB cannot inspect the company's auditor for three consecutive years [42]. - The company has not received or been denied permissions from PRC authorities for its operations, but regulatory developments are being closely monitored [49]. - The company is subject to significant regulatory challenges and risks due to the genetic modification of patient cells in its therapies [113]. - Future regulatory changes could impose additional restrictions, creating uncertainties that may materially affect the company's business and results of operations [191]. Product Development and Clinical Trials - The company is substantially dependent on the commercial success of CARVYKTI for sustaining its business [62]. - The company has established manufacturing facilities in the United States and Belgium to support CARVYKTI production for the U.S. and European markets [67]. - The company is expanding manufacturing capacity at current sites and engaging third-party contract manufacturing organizations to meet anticipated demand for CARVYKTI globally [68]. - The company plans to establish additional manufacturing capacity in the United States and Europe, which involves significant risks and complexities [70]. - The company faces challenges in scaling and validating production processes for cell therapy products, which could impact product availability [72]. - The company initiated the Phase 3 CARTITUDE-5 clinical trial in August 2021, targeting enrollment of approximately 650 patients [105]. - A Phase 3 CARTITUDE-6 clinical trial was initiated in October 2023, targeting enrollment of approximately 750 patients [105]. - The company has a broad portfolio of earlier-stage autologous CAR-T product candidates targeting various cancers, currently in clinical trials [106]. - The company may encounter difficulties in patient enrollment for clinical trials, which could delay development and adversely affect regulatory approval timelines [128]. Market and Competitive Landscape - The commercial success of CARVYKTI will depend on market acceptance by physicians and payors, which is uncertain and may require significant resources for education and marketing [78]. - The potential market for CARVYKTI may be smaller than anticipated, affecting revenue generation and business sustainability [80]. - The company faces significant competition from established pharmaceutical and biotechnology companies, which may impact its market position and profitability [86]. - The company has limited marketing and market access capabilities and plans to invest significantly to enhance these capabilities [84]. - The addressable market for certain product candidates may be limited, as projections regarding the size of the patient population could be incorrect [139]. Manufacturing and Operational Challenges - The manufacturing process for CAR-T cell therapies is complex and costly, with higher production costs compared to traditional small molecule drugs [158]. - The "vein-to-vein" cycle for autologous T cell therapy typically takes approximately four to six weeks, involving multiple steps and human participants [162]. - The company is increasing its facilities and development capabilities, which requires significant capital expenditures and may affect financial condition if costs exceed expectations [171]. - The company is susceptible to product loss or failure due to logistical issues in the manufacturing process, which could impact clinical trial timelines [158]. - Manufacturing facilities are subject to government inspections, and failure to meet regulatory standards could delay product approvals and commercialization efforts [160]. Data Privacy and Security Risks - The company faces a variety of evolving threats, including social-engineering attacks, malware, and denial-of-service attacks, which have increased in number and sophistication [177]. - Increased operating expenses and cash requirements may arise from security incidents, along with potential additional indebtedness or contingent liabilities [178]. - Disruptions or security breaches could result in significant delays in regulatory approval efforts and increase costs to recover or reproduce lost data [179]. - The company may incur material costs related to significant security breaches, and there is uncertainty regarding the adequacy of insurance coverage for such events [180]. - Compliance with stringent data privacy and security laws could lead to government enforcement actions, including fines or penalties, which may adversely affect the company's operations [183]. Internal Controls and Financial Reporting - The company identified material weaknesses in internal control over financial reporting for the fiscal years ended December 31, 2021, and December 31, 2022 [209]. - Affected audited financial statements for the years ended December 31, 2021, 2020, and 2019 were restated, leading to a conclusion of material weakness in internal controls [210]. - The company remediated previously identified material weaknesses by implementing additional review and monitoring controls, hiring new personnel, and engaging external resources [214]. - As of December 31, 2023, the company concluded that the material weaknesses were fully remediated [214]. - The company is subject to reporting obligations under U.S. securities laws, including the Sarbanes-Oxley Act, which requires annual assessment of internal controls [215].

Financial Data and Key Metrics Changes - In Q4 2024, Legend Biotech reported total net sales of CARVYKTI at approximately $334 million, representing a 110% increase year-over-year and a 17% increase from Q3 2024 [13][23] - Total revenues for Q4 were $187 million, consisting of $168 million from collaboration revenue and $18 million from license revenue [24] - The net profit for Q4 was $26 million, or $0.07 per share, compared to a net loss of $145 million, or $0.40 per share, for the same period last year [24][25] - Adjusted net loss for Q4 was $59 million, or $0.16 per share, compared to an adjusted net loss of $89 million, or $0.24 per share, for the same period last year [32] Business Line Data and Key Metrics Changes - CARVYKTI's sales trajectory has been attributed to its unique profile and strong manufacturing and commercial execution, with a significant increase in outpatient administration [15][19] - The company has treated over 5,000 patients with CARVYKTI, creating a comprehensive patient dataset in multiple myeloma [17] Market Data and Key Metrics Changes - In the U.S., the number of certified hospitals to treat with CARVYKTI has increased to 104, with outpatient administration expected to account for a majority of the volume by the end of the year [15][19] - Internationally, sales outside the U.S. reached $31 million, a 138% increase year-over-year, driven by capacity increases and launches in several countries [14] Company Strategy and Development Direction - The company aims to achieve operational breakeven for CARVYKTI by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses [8] - Legend Biotech is expanding its pipeline programs to include blood cancers, next-generation multiple myeloma therapies, solid tumor programs, and autoimmune diseases [20][21] - A new research facility is being built in Philadelphia to support pipeline investments, expected to open later this year [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for CARVYKTI, particularly in the outpatient setting, and highlighted the importance of educating community physicians [108][111] - The company anticipates that supply constraints will be alleviated by the end of 2025, allowing supply to meet demand [124] Other Important Information - The FDA approved the Novartis facility for commercial production of CARVYKTI, with clinical production expected to begin soon [11] - The company has received reimbursement approval for CARVYKTI in Spain, enhancing its market presence [13][101] Q&A Session Summary Question: Safety profile and trial management for CARVYKTI - Management discussed ongoing efforts to manage ICANS and neurotoxicity through predictive biomarkers and upcoming investigator-initiated trials [36][40] Question: Commercial revenue breakdown and demand for CAR-T therapy - The company reported strong receptivity to CARTITUDE-4 data, with nearly 60% of usage converted to earlier lines of therapy [53][55] Question: Share count and pipeline data expectations - The increase in share count was clarified as a result of net profit calculations, and management provided insights into upcoming data from early pipeline programs [58][62] Question: Revenue growth cadence and capacity expectations - Management indicated that Q1 growth may be modest due to seasonal factors, with more significant growth expected in Q2 and Q3 [70] Question: Positioning of CAR-T therapies in solid tumor treatment - Management highlighted ongoing efforts to innovate in solid tumors and the importance of safety and efficacy in driving commercial success [80][81] Question: Demand fulfillment in Europe - The company is working to meet demand in Europe through its facilities, with recent approvals expected to enhance supply capabilities [145]

Financial Data and Key Metrics Changes - In Q4 2024, Legend Biotech reported total net sales of CARVYKTI at approximately $334 million, representing a 110% increase year-over-year and a 17% increase from Q3 2024 [13][23] - Total revenues for Q4 were $187 million, consisting of $168 million from collaboration revenue and $18 million from license revenue, with a net profit of $26 million or $0.07 per share compared to a net loss of $145 million or $0.40 per share in the same period last year [24][25] - The adjusted net loss for Q4 was $59 million or $0.16 per share, an improvement from an adjusted net loss of $89 million or $0.24 per share for the same period last year [32] Business Line Data and Key Metrics Changes - CARVYKTI's sales trajectory has been strong, with a significant increase in demand and capacity expansion contributing to the sales growth [11][14] - The collaboration cost of revenue for Q4 was $69 million, up from $32 million year-over-year, reflecting increased manufacturing capacity expansion [26] - Selling and distribution expenses rose to $49 million in Q4 from $34 million in the same period last year, driven by commercial activities for CARVYKTI [29] Market Data and Key Metrics Changes - In the U.S., the number of certified hospitals to treat with CARVYKTI has increased to 104, with outpatient administration expected to account for a majority of the volume by the end of the year [15][112] - Internationally, sales outside the U.S. reached $31 million, a 138% increase year-over-year, attributed to capacity increases and launches in several countries [14] Company Strategy and Development Direction - The company aims to achieve operational breakeven for CARVYKTI by the end of 2025 and anticipates company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses [8][33] - Legend Biotech is expanding its pipeline programs to include blood cancers, next-generation multiple myeloma therapies, solid tumor programs, and autoimmune diseases [20][21] - The company is also building a new research facility in Philadelphia to support its pipeline investments [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of CARVYKTI, highlighting its unique profile and the strong demand in the market [11][12] - The management team noted that the FDA's recent recommendations regarding MRD negativity as a potential surrogate endpoint could open up further opportunities for CARVYKTI [9] - The company is optimistic about its ability to meet increasing demand through capacity expansions in both the U.S. and Europe [19][100] Other Important Information - The company has treated over 5,000 patients with CARVYKTI, creating a comprehensive patient dataset that continues to generate new data on its benefit-risk profile [17] - The company has received reimbursement approval for CARVYKTI in Spain, enhancing its market presence in Europe [13] Q&A Session Summary Question: Inquiry about safety profile and trial plans for managing ICANS and neurotoxicity - Management discussed ongoing efforts to harmonize ALC cut-offs for risk mitigation strategies and plans for future investigator-initiated trials [36][40] Question: Plans for ASCO updates - Management indicated excitement about data to be presented at ASCO but could not disclose specifics until abstracts are accepted [46] Question: Commercial revenue breakdown and demand for CAR-T therapy - Management reported strong receptivity to CARTITUDE-4 data and noted nearly 60% of usage has shifted to earlier lines of therapy [53][54] Question: Share count and pipeline data expectations - Management clarified the increase in share count and provided insights into upcoming data from early pipeline programs [58][62] Question: Revenue growth cadence and capacity expectations - Management expects modest growth in Q1 due to seasonal factors but anticipates significant growth in Q2 and Q3 as manufacturing capacity increases [68][70] Question: Positioning of CAR-T therapies in solid tumor treatment - Management discussed ongoing dose escalation studies for DLL-3 and Claudin18.2% CAR-T therapies, with plans for data presentation later this year [75][78] Question: Demand fulfillment in Europe - Management acknowledged challenges in meeting demand in Europe but emphasized ongoing efforts to ramp up supply from their facilities [145]

Financial Performance - Total revenue for 2024 reached approximately $1.297 billion, with CARVYKTI net trade sales of $963 million, marking a significant increase from the previous year[6]. - License revenue for the year ended December 31, 2024, was $138.4 million, up from $35.2 million in 2023, reflecting a growth of 293%[8]. - Collaboration revenue for the year was $482.6 million, compared to $249.8 million in 2023, representing an increase of 93%[9]. - Net income for the fourth quarter of 2024 was $26.3 million, a turnaround from a net loss of $144.8 million in the same quarter of 2023[18]. - Adjusted net loss for the year was $188.8 million, a reduction from $335.7 million in 2023, indicating improved financial performance[19]. - Total revenue for Q4 2024 reached $186.5 million, a significant increase of 134% compared to $79.5 million in Q4 2023[25]. - Basic net income per share for Q4 2024 was $0.07, compared to a loss of $0.40 per share in Q4 2023[26]. - Adjusted net loss for Q4 2024 was $59.1 million, compared to an adjusted net loss of $88.5 million in Q4 2023[34]. Cash and Assets - As of December 31, 2024, the company had approximately $1.1 billion in cash and cash equivalents, providing a financial runway into the second quarter of fiscal year 2026[5]. - Cash and cash equivalents at the end of 2024 were $286.7 million, down from $1.28 billion at the end of 2023, representing a decrease of 78%[29]. - Total assets decreased to $1.67 billion in December 2024 from $1.85 billion in December 2023, a decline of 9%[27]. - The company reported cash flows used in operating activities of $82.1 million for Q4 2024, an improvement from $95.6 million in Q4 2023[29]. Expenses - Research and development expenses for the year were $413.5 million, an increase of $31.3 million from 2023, primarily due to cilta-cel activities[13]. - Selling and distribution expenses for the year were $147.5 million, up from $94.2 million in 2023, reflecting increased commercial activities[15]. - Research and development expenses for the year 2024 totaled $413.5 million, an increase from $382.2 million in 2023[25]. Product Performance - Over 5,000 patients have been treated with CARVYKTI to date, demonstrating the product's market penetration[6]. - The Phase 3 CARTITUDE-4 study showed that 89% of evaluable patients achieved minimal residual disease negativity at the 10 threshold within two months[7].

Core Insights - Legend Biotech Corporation reported strong financial results for 2024, with total revenue nearing blockbuster status, driven by the success of CARVYKTI in treating multiple myeloma patients [2][6][22] Financial Performance - As of December 31, 2024, Legend Biotech had approximately $1.1 billion in cash and cash equivalents and time deposits, providing a financial runway into the second quarter of fiscal year 2026 [4][6] - Total revenue for the fourth quarter of 2024 was $186.5 million, compared to $79.5 million for the same period in 2023, marking a significant increase [5][9] - License revenue for the year ended December 31, 2024, was $138.4 million, a substantial increase from $35.2 million in 2023, primarily due to the Novartis License Agreement [5][8] - Collaboration revenue for the year was $482.6 million, up from $249.8 million in 2023, reflecting increased sales of CARVYKTI [9] Operational Highlights - CARVYKTI net trade sales reached approximately $334 million in the fourth quarter and $963 million for the full year 2024, with over 5,000 patients treated to date [6][7] - Spain's national health system approved reimbursement for CARVYKTI in second-line plus settings for multiple myeloma patients, expanding its market access [6][7] Expenses and Losses - Research and development expenses for the year were $413.5 million, compared to $382.2 million in 2023, driven by activities related to cilta-cel and solid tumor programs [13] - Administrative expenses increased to $136.8 million for the year, reflecting the expansion of administrative functions and headcount [14] - Selling and distribution expenses rose to $147.5 million, primarily due to costs associated with commercial activities for cilta-cel [15] Net Income and Adjusted Loss - For the fourth quarter of 2024, net income was $26.3 million, or $0.07 per share, a significant improvement from a net loss of $144.8 million, or $0.40 per share, in the same quarter of 2023 [19] - The adjusted net loss for the fourth quarter was $59.1 million, or an adjusted net loss of $0.16 per share, compared to an adjusted net loss of $88.5 million, or $0.24 per share, in the prior year [20][35]

Core Insights - Legend Biotech Corporation will host a conference call on March 11, 2025, to discuss its fourth-quarter and full-year 2024 results [1] - The company is a leader in cell therapy, particularly known for its CAR-T cell therapy product, CARVYKTI, for treating multiple myeloma [3] Company Overview - Legend Biotech employs over 2,500 individuals and is recognized as the largest standalone cell therapy company [3] - The company collaborates with Johnson & Johnson to develop and market CARVYKTI, which is a one-time treatment for relapsed or refractory multiple myeloma [3] - Legend Biotech aims to enhance patient access and therapeutic potential of CARVYKTI while driving future innovations in its cell therapy pipeline [3]

现在回头看，人口老龄化在长尺度上确实带来了持续的超额动力，和科技突破以及支付能力提升一起，推动卫 生支出占中国GDP的比重从以前的3%提高到现在的超过7%，预计10年内会进一步提升到10%以上。但医药的 需求优势是个相对优势，随着中国名义GDP的持续减速，过去几年医药行业的整体营收增速也在不可避免地趋 势性放缓。 反而是 国内医药的供给端，凭借成功的转型升级释放工程师红利优势，开始出现越来越明显的加速突破迹象 。当前阶段，中国医药行业相比海外的供给优势明显强化，而需求优势明显弱化，这对我们的投资方向选择可 能有着较为重要的影响。 青侨阳光医药投资 - 月度思考 几年前，当大家谈起投资医药的逻辑时，最常听到的理由是人口老龄化，因为老龄人口占比提升会给医药带来 源源不断的需求增强。 以下图统计的公司为例，用2023年的研发开支去除以在研管线数量得出的每10亿美元支撑的研发管线数，欧美 头部药企普遍是15-16款左右，日本药企典型是30+款，而中国药企平均有100+款，超过欧美MNC(跨国公司)的 6倍！考虑国际多中心临床的规模和占比等，日本药企或许更具可比性，但就算跟日本企业比，中国药企的成 本效率优势依然十分巨 ...

Investment Rating - The report maintains a "Buy" rating for Legend Biotech (LEGN US) with a target price of $76, indicating a potential upside of 119.2% from the current price of $34.67 [2][3]. Core Insights - Legend Biotech's CARVYKTI® sales in Q4 2024 exceeded expectations, with a year-over-year increase of 110% to $334 million, slightly above the forecast of $322 million. The sales also showed a 17% quarter-over-quarter growth, driven by capacity expansion and market penetration in the 2L+ treatment segment [1]. - The company has treated a total of 5,000 patients with CARVYKTI® across commercial sales and clinical studies, showcasing effective commercialization efforts [1]. - For the full year of 2024, CARVYKTI® sales reached $960 million, and the report anticipates sales to double to $1.9 billion in 2025 due to new capacity coming online and the product's approval in mainland China and more European countries [1]. Summary by Sections Sales Performance - Q4 2024 CARVYKTI® sales were $334 million, a 110% increase year-over-year and a 17% increase quarter-over-quarter [1]. - The sales growth in Q4 2024 improved from 88% in Q3 2024, indicating strong market demand and effective sales strategies [1]. Future Projections - The report projects that CARVYKTI® sales will double to $1.9 billion in 2025, supported by new production capacities and market expansions [1]. - The anticipated approval of CARVYKTI® in China and further commercialization in Europe are key drivers for this growth [1]. Market Position - The report highlights that Legend Biotech's current stock price is undervalued, with market concerns over competitive products being deemed excessive [1]. - The company is positioned as a key recommendation in the pharmaceutical sector, reflecting confidence in its growth trajectory and market strategy [1].

Company Overview - The Fortune Teller is a team of two analysts with over 30 years of combined market experience [1] - One of the principals is a formerly licensed investment advisor with a background in asset management [1] - The team holds BAs in Accounting & Economics and Computer Sciences, as well as MBAs, which they use to inform their stock selections [1] Service Offerings - The Fortune Teller leads the investing group Wheel of Fortune, which provides actionable trading ideas across all asset classes, sectors, and industries [1] - The service aims to be a one-stop-shop for investment and portfolio ideas while educating subscribers [1] - Features include the Funds Macro Portfolio (ETFs and CEFs) for less active investors and the Single Macro Portfolio (single equity focused) for more active investors [1] - The service also offers educational content and a live chat room for discussions with like-minded investors and The Fortune Teller team [1]

Company Updates - Legend Biotech Corporation will present the latest company updates at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025, at 3:45 p.m. PT [1] - The presentation will be led by Ying Huang, Ph.D., the Chief Executive Officer of the company [1] Access Information - Investors and interested parties can access the live audio webcast through the Investor Relations section of Legend's website, with a replay available approximately 48 hours after the event [2] Company Overview - Legend Biotech is a global biotechnology company focused on treating and potentially curing life-threatening diseases, headquartered in Somerset, New Jersey [3] - The company is developing advanced cell therapies utilizing various technology platforms, including autologous and allogeneic chimeric antigen receptor T-cell, gammadelta T cell, and natural killer (NK) cell-based immunotherapy [3] - Legend Biotech operates three R&D sites globally to discover innovative therapeutics for patients [3]