交银国际研究 财务模型更新 | 医药 | 收盘价 | | 目标价 | 潜在涨幅 | 2026 年 3 月 18 日 | | --- | --- | --- | --- | --- | --- | | 美元 | | 19.10 | 美元 60.40↓ | +216.2% | | | 传奇生物 (LEGN US) | | | | | | 2026 年盈亏平衡可期，未来研发重心转向 in vivo CAR-T，维持买入 我们认为，2026 年有望成为公司业务重要转折点：1）财务方面，Carvykti 持 续放量将推动公司层面实现盈亏平衡；2）后 Carvykti 时代的研发布局思路逐 步清晰， in vivo（体内） CAR-T 年内早期数据读出和 BD 潜力可期。当前股价 已充分反映市场对 BCMA 领域竞争格局的预期，安全边际较高，维持买入。 个股评级 买入 1 年股价表现 资料来源： FactSet 3/25 7/25 11/25 3/26 -60% -50% -40% -30% -20% -10% 0% 10% 20% LEGN US 恒生指数 股份资料 | 52周高位 (美元) | 44.32 | | - ...

2026 年盈亏平衡可期，未来研发重心转向 in vivo CAR-T，维持买入 我们认为，2026 年有望成为公司业务重要转折点：1）财务方面，Carvykti 持 续放量将推动公司层面实现盈亏平衡；2）后 Carvykti 时代的研发布局思路逐 步清晰， in vivo（体内） CAR-T 年内早期数据读出和 BD 潜力可期。当前股价 已充分反映市场对 BCMA 领域竞争格局的预期，安全边际较高，维持买入。 个股评级 买入 1 年股价表现 交银国际研究 财务模型更新 | 医药 | 收盘价 | | 目标价 | 潜在涨幅 | 2026 年 3 月 18 日 | | --- | --- | --- | --- | --- | --- | | 美元 | | 19.10 | 美元 60.40↓ | +216.2% | | | 传奇生物 (LEGN US) | | | | | | 资料来源： FactSet 3/25 7/25 11/25 3/26 -60% -50% -40% -30% -20% -10% 0% 10% 20% LEGN US 恒生指数 股份资料 | 52周高位 (美元) | 44.32 | | - ...

Core Insights - The report highlights that Legend Biotech is expected to reach breakeven in 2026, with a focus on in vivo CAR-T research moving forward [1][2] - The stock is rated as a "Buy" with a target price of $60.40, indicating a potential upside of 216.2% from the current closing price of $19.10 [1] Financial Performance - In Q4 2025, Legend Biotech reported revenues of $283 million, representing a year-over-year growth of 52% and a quarter-over-quarter growth of 4% [1] - The strong sales of Carvykti contributed significantly, marking the first year of profitability for this product line [1] - The adjusted net profit for Q4 2025 was $2.5 million, indicating a return to profitability for the quarter [1] Market Position and Strategy - Management emphasized the advantages of Carvykti over Tec-Dara in terms of administration convenience and patient survival benefits [2] - Currently, BCMA therapies hold only a 5% market share in the community treatment of 2-4 line multiple myeloma patients in the U.S., indicating significant growth potential [2] - The company, along with its partner Johnson & Johnson, plans to increase annual production capacity to 20,000 doses [2] Future Outlook - The company maintains guidance for a revenue growth of approximately 50% in 2026, with expectations for Carvykti to achieve consecutive quarter-over-quarter growth [1] - Key catalysts for the next 12 months include the CARTITUDE-5 study results expected by the end of 2026 or in the first half of 2027, and a continued shift in R&D focus towards in vivo CAR-T [2]

Corporate Structure and Financial Overview - Legend Biotech operates as a Cayman Islands holding company with subsidiaries primarily in the United States, PRC, and EU, and investors hold equity securities of the holding company, not the operating subsidiaries[32]. - The company has not declared or paid any cash dividends and intends to use future earnings to fund clinical development, manufacturing expansion, and pipeline programs[46]. - The company has incurred net losses and negative cash flow from operations historically, relying on payments from collaborations and equity securities for funding[47]. - The company has incurred significant net losses of $296.8 million and $177.0 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of $2.0 billion as of December 31, 2025[93]. - The company believes its existing cash and cash equivalents will fund operating expenses for at least the next 12 months, but additional capital may be required for cilta-cel and other candidates[99]. Regulatory Environment and Compliance - As of the report date, the PRC subsidiaries have obtained necessary licenses and permits for operations, but uncertainties remain regarding compliance with evolving PRC laws and regulations[43]. - The PRC government has indicated increased oversight on foreign investments and offerings, which could materially affect the company's operations and securities value[36]. - The Holding Foreign Companies Accountable Act may lead to trading prohibitions if the PCAOB cannot inspect the company's auditor for two consecutive years[39]. - Regulatory developments in China are being closely monitored, as changes could necessitate additional approvals or impact business operations[45]. - The company may face significant adverse consequences if it cannot lawfully transfer personal data from the EEA or the UK to the United States, including operational disruptions and regulatory actions[197]. Product Development and Clinical Trials - The company has initiated the Phase 3 CARTITUDE-5 clinical trial with an enrollment target of approximately 650 patients[109]. - The company has also initiated the Phase 3 CARTITUDE-6 clinical trial targeting approximately 750 patients[109]. - The company reported ongoing and planned research and development for cilta-cel targeting relapsed and lenalidomide-refractory multiple myeloma (RRMM)[95]. - The company is highly dependent on regulatory approval for cilta-cel and other pipeline programs, which require significant preclinical studies and clinical trials before commercialization[117]. - The time required to obtain marketing approval from regulatory authorities is unpredictable and typically takes many years, influenced by various factors including regulatory discretion[118]. Manufacturing and Supply Chain Challenges - Manufacturing capabilities for CARVYKTI are being established in the United States and Belgium to meet anticipated demand[59]. - The company faces challenges in scaling production and ensuring compliance with regulatory requirements for cell therapy products[65]. - Logistical operations are complex due to the limited stability of T cells used in manufacturing, which could lead to delays[66]. - The manufacturing process is susceptible to various risks, including logistical issues and human errors, which could result in reduced production yields and product defects[161]. - The company may encounter difficulties in scaling up manufacturing processes, which could lead to delays or interruptions in the supply of commercial products[159]. Market and Competitive Landscape - The company is substantially dependent on the commercial success of CARVYKTI for sustaining its business[57]. - The commercial success of CARVYKTI will depend on market acceptance by physicians, third-party payors, and the medical community, which may not be guaranteed[72]. - The company faces significant competition in the biopharmaceutical industry, with major pharmaceutical and biotechnology companies developing similar products, which could impact market share[81]. - The company may face challenges in achieving significant market share for CARVYKTI if the estimated patient population is lower than anticipated[74]. - The U.S. government is pursuing "Most Favored Nation" drug pricing strategies that could adversely affect the company's revenue and profitability[90]. Collaborations and Partnerships - The company has a significant collaboration with Janssen for the development and commercialization of cilta-cel[216]. - The revenue generated from the Janssen Agreement has significantly contributed to the company's revenue, with an upfront payment of $350.0 million received in 2018 and an additional $415.0 million in milestone payments to date[222]. - The company is eligible to receive up to an aggregate of $1.01 billion in milestone payments from Novartis upon achieving specified clinical, regulatory, and commercial milestones[224]. - The company relies on third-party contract research organizations (CROs) for marketing approvals and may enter into distribution agreements with pharmaceutical leaders to optimize product launches[218]. - The company may seek additional collaborations for product development, but finding suitable partners on commercially reasonable terms may be challenging[229]. Risks and Liabilities - The company holds $10 million in product liability insurance, which may not be adequate to cover potential liabilities[88]. - There is a risk of significant liability and reputational harm if the company's information technology systems or those of third parties are compromised, potentially disrupting product development[184]. - The company may face significant negative consequences if undesirable side effects are identified post-approval, including potential withdrawal of regulatory approvals[153]. - The company may experience disagreements with collaborators regarding milestone payments, which could lead to disputes and impair collaborations[225]. - The company may need to expend significant resources on specific product candidates, potentially foregoing more profitable opportunities[168]. Human Resources and Management - The company has approximately 2,900 full-time employees as of December 31, 2025, and anticipates needing additional personnel to support product development and commercialization efforts[172]. - Retaining key members of senior management and attracting qualified personnel is critical for the company's future success in the competitive biopharmaceutical industry[177]. - The company emphasizes the critical importance of recruiting and retaining qualified personnel across various functions, including managerial, financial, and scientific roles, to achieve its research and commercialization objectives[178]. Economic and Geopolitical Factors - Unfavorable global economic conditions, including inflation and geopolitical tensions, could adversely affect the company's business and financial condition[210]. - Changes in U.S. and international trade policies, including tariffs, may impact the company's operations and financial results[211][212]. - Future acquisitions or strategic collaborations may increase capital requirements, dilute shareholder value, and incur additional debt or liabilities, posing various risks[179].

Core Insights - The management of Legend Biotech emphasized the increasing utilization of CARVYKTI earlier in treatment courses, with approximately 65% of patients now treated in the second- to fourth-line settings [1][5] - CARVYKTI net trade sales reached approximately $555 million in Q4 2025, marking a 66% year-over-year increase, supported by share gains and site expansion [3][6] - The company achieved profitability for CARVYKTI in 2025 and anticipates enterprise-wide profitability in 2026 [4][21] Sales Performance - In the U.S., net trade sales were reported at $420 million, a 38% increase year-over-year and a 6% sequential rise, attributed to shipment seasonality [2] - Outside the U.S., sales reached $135 million, more than tripling compared to the prior year and increasing by 5% sequentially, with notable strength in Germany, Spain, and Belgium [2] Clinical Data and Treatment Efficacy - Clinical data indicated a median progression-free survival of 50.4 months for triple-class-exposed patients, with 65% of patients treated in the second- to fourth-line settings [5][7] - Long-term data presented at key meetings showed that 80% of standard-risk patients remained progression-free after 2.5 years, with 93% of those progression-free at one year remaining alive and progression-free at 2.5 years [8] Manufacturing and Capacity - Legend Biotech has established manufacturing capacity for 10,000 doses, with plans to expand to 20,000 doses in collaboration with Johnson & Johnson, achieving a manufacturing success rate of 97-99% [5][12][13] - The company reported improved gross margins, with a gross margin of 61% and a gross margin on CARVYKTI net product sales of 57% [15][14] Financial Results - The fourth-quarter revenue was reported at $306 million, a 64% increase year-over-year, with operating margin improving from -142% to -6% over ten consecutive quarters [15][17] - Legend Biotech ended the year with $949 million in cash and equivalents, with operating cash flow outlays significantly reduced from $82 million to $12 million year-over-year [18] Future Outlook - The company is committed to sequential growth throughout 2026, with management expressing confidence in achieving approximately 50% top-line growth year-over-year based on market consensus [19] - Investment priorities include advancing in vivo programs, supporting CARVYKTI profit expansion, and modest capital expenditures related to manufacturing [21]

Financial Data and Key Metrics Changes - In Q4 2025, revenue reached $306 million, reflecting a 64% year-over-year growth, with a gross margin of 61% [24][26] - The operating margin improved from -142% in Q2 2023 to -6% in Q4 2025, indicating significant operational leverage [24][26] - Adjusted net income was reported at $2.5 million, a transformation from a $59 million adjusted net loss a year ago [26] Business Line Data and Key Metrics Changes - CARVYKTI net trade sales were approximately $555 million in Q4 2025, a 66% increase year-over-year and a 6% increase from Q3 2025 [7][16] - U.S. net trade sales of CARVYKTI were $420 million, growing 38% year-over-year [16] - Outside the U.S., sales reached $135 million, representing over a threefold increase compared to the same period a year ago [16] Market Data and Key Metrics Changes - CARVYKTI is now offered in 14 global markets, with 294 treatment sites worldwide [16][18] - The majority of CARVYKTI utilization is in earlier line settings, with approximately 65% of patients treated in the second to fourth line settings [16][22] - The market for BCMA-directed therapies remains under-penetrated, with less than 5% of patients in the second through fourth line treated with a BCMA targeting agent in 2025 [17] Company Strategy and Development Direction - The company aims to achieve company-wide profitability in 2026, following CARVYKTI's profitability in 2025 [7][15] - There is a strategic focus on expanding CARVYKTI's use in earlier treatment lines, supported by clinical evidence showing better outcomes [17][23] - The partnership with Johnson & Johnson is aimed at scaling CARVYKTI to an anticipated peak annual sales potential of over $5 billion [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sequential growth throughout 2026, targeting approximately 50% top-line growth from the previous year [31] - The company is optimistic about the long-term growth potential of CARVYKTI, given the significant unmet needs in the multiple myeloma market [17][24] - Management highlighted the importance of effective bridging therapy in improving patient outcomes and safety [19][22] Other Important Information - The company ended the year with $949 million in cash equivalents, providing flexibility for future investments [27] - The Tech Lane facility in Belgium began commercial production in September 2025, supporting growth in ex-U.S. markets [16][17] - The company plans to file one to two U.S. INDs by the end of the year, focusing on advancing its R&D pipeline [14] Q&A Session Summary Question: Expectations for CARVYKTI growth in 2026 - Management expects sequential growth throughout 2026, confident in achieving approximately 50% top-line growth from last year [31] Question: Focused synergistic business development - The company is interested in complementary technologies and potential partnerships to accelerate the development of in vivo CAR T assets [32] Question: Positioning of bispecifics relative to CARVYKTI - Management believes there is a significant unmet need in second and third line settings, with a unique value proposition for CARVYKTI [35] Question: Community setting expansion hurdles - Continued education and training for community physicians are essential for expanding CARVYKTI's adoption in community hospitals [39] Question: Current CAR-T penetration targets - The company sees significant growth potential in both late-line and early-line multiple myeloma treatments, with a focus on improving patient outcomes [44][46] Question: Impact of recent M&A in the space - The acquisition of a competitor validates the market's value, with the company prepared for increased competition [58][59] Question: MRD results and potential filing acceleration - The company is exploring the correlation between MRD activity and clinical outcomes, which could accelerate FDA filing times for future trials [70]

Financial Data and Key Metrics Changes - In Q4 2025, revenue reached $306 million, representing a 64% year-over-year growth [23] - Gross margin remained strong at 61%, with CARVYKTI net product sales gross margin at 57% [23] - Operating margin improved from -142% in Q2 2023 to -6% in Q4 2025, reflecting operational leverage [23][24] - Adjusted net income was reported at $2.5 million, a significant improvement from a $59 million adjusted net loss a year ago [25] Business Line Data and Key Metrics Changes - CARVYKTI net trade sales were approximately $555 million in Q4 2025, a 66% increase year-over-year [7] - U.S. net trade sales of CARVYKTI were $420 million, growing 38% year-over-year [16] - Outside the U.S., sales reached $135 million, representing over a 3x increase compared to the same period a year ago [16] Market Data and Key Metrics Changes - CARVYKTI is now offered in 14 global markets, with 294 treatment sites worldwide [16] - The majority of CARVYKTI utilization is in earlier line settings, with approximately 65% of patients from the second to fourth line [16] - BCMA-directed therapies remain under-penetrated in earlier lines, with less than 5% of patients in the second through fourth line treated with a BCMA targeting agent in 2025 [17] Company Strategy and Development Direction - The company aims to become a fully scaled CAR-T leader and achieve company-wide profitability in 2026 [7] - There is a strategic focus on expanding CARVYKTI's use in earlier lines, supported by evidence showing better outcomes with earlier intervention [17][22] - The partnership with Johnson & Johnson is aimed at scaling CARVYKTI to an anticipated potential of over $5 billion in peak annual sales [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sequential growth throughout 2026, targeting approximately 50% top-line growth from the previous year [31] - The company is optimistic about the long-term growth potential of CARVYKTI, given the significant unmet needs in the multiple myeloma market [17][22] - Management highlighted the importance of effective bridging therapy in improving patient outcomes and safety [19][88] Other Important Information - The company ended the year with $949 million in cash equivalents, providing flexibility for future investments [26] - The company plans to file one to two U.S. INDs by the end of the year, focusing on advancing its R&D pipeline [14] Q&A Session Summary Question: Expectations for CARVYKTI growth in 2026 and business development focus - Management expects sequential growth throughout 2026, confident in delivering approximately 50% top-line growth [31] - Business development efforts will focus on complementary technologies and potential partnerships to accelerate global development [32] Question: Positioning of bispecifics in early lines relative to CARVYKTI - Management believes there is a significant unmet need in second and third lines, with a unique value proposition for CARVYKTI as a one-time infusion [35] Question: Hurdles for community setting expansion - Continued education and training for community physicians are crucial for expanding CARVYKTI's adoption in community hospitals [40] Question: Current CAR-T penetration and growth opportunities - Management sees significant growth opportunities across all segments, including academic centers and community hospitals, with a focus on early line use [48] Question: Impact of recent M&A in the space - The acquisition of a competitor validates the market's value, with management confident in CARVYKTI's unmatched efficacy and durability [60] Question: Pipeline strategy and long-term data confidence - Management is particularly excited about in vivo CAR-T approaches, leveraging their experience with lentiviral vectors while remaining open to exploring other technologies [82]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 reached $306 million, representing a 64% year-over-year growth [22] - Gross margin remained strong at 61%, with CARVYKTI net product sales gross margin at 57% [22] - Operating margin improved from -142% in Q2 2023 to -6% in Q4 2025, reflecting operational leverage [22][24] - Adjusted net income was reported at $2.5 million, a significant improvement from a $59 million adjusted net loss a year ago [24] Business Line Data and Key Metrics Changes - CARVYKTI net trade sales were approximately $555 million in Q4 2025, a 66% increase year-over-year [5][14] - U.S. net trade sales of CARVYKTI were $420 million, growing 38% year-over-year [14] - Outside the U.S., sales reached $135 million, representing over a threefold increase compared to the same period last year [14] Market Data and Key Metrics Changes - CARVYKTI is now offered in 14 global markets, with 294 treatment sites worldwide [14] - The majority of CARVYKTI patients (approximately 65%) are from the second to fourth line settings [14][76] - BCMA-directed therapies remain under-penetrated in earlier lines, with less than 5% of patients in the second through fourth line treated with a BCMA targeting agent in 2025 [15] Company Strategy and Development Direction - The company aims to achieve company-wide profitability in 2026, following CARVYKTI's profitability in 2025 [5][13] - Focus on expanding CARVYKTI's use in earlier treatment lines, supported by clinical evidence showing better outcomes [15][20] - Plans to file one to two U.S. INDs by the end of the year and to explore synergistic business development opportunities [12][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sequential growth throughout 2026, targeting approximately 50% top-line growth for CARVYKTI [30] - The company is optimistic about capturing a significant market share in the under-penetrated multiple myeloma market [15][45] - Management highlighted the importance of effective bridging therapy in improving patient outcomes and safety [19][90] Other Important Information - The company ended the year with $949 million in cash equivalents, providing flexibility for future investments [25] - Manufacturing capacity has been expanded to support annual production of 10,000 doses, with plans to increase to 20,000 doses [11][52] Q&A Session Summary Question: Expectations for CARVYKTI growth in 2026 and business development focus - Management expects sequential growth throughout 2026, confident in achieving approximately 50% top-line growth [30] - Business development efforts will focus on complementary technologies and potential partnerships to accelerate global development [31] Question: Positioning of bispecifics in early lines relative to CARVYKTI - Management noted a significant unmet need in second and third lines, with CARVYKTI's unique value proposition supporting its growth in these settings [34] Question: Community setting expansion hurdles - Continued education and training for community physicians are essential for expanding CARVYKTI's adoption in community hospitals [39][40] Question: Current CAR-T penetration targets - Management believes there is significant growth potential in both late and early lines, with plans to increase annual supply to meet demand [45][47] Question: Competitive dynamics following recent M&A in the space - The acquisition of a competitor validates the market's value, with management confident in CARVYKTI's unmatched efficacy and durability [59][61] Question: Pipeline strategy and in vivo programs - The company is particularly excited about in vivo CAR T approaches due to their convenience and potential for broader applications [82]

March 10, 2026 Fourth Quarter and Full Year 2025 Financial Results & Corporate Update This presentation is for investor relations purposes only - Not for product promotional purposes 1 Agenda | 1 | Opening Remarks | | --- | --- | | 2 | Q4 2025 Highlights & Recent Accomplishments | | 3 | ASH & Tandem Summary | | 4 | Pipeline | | 5 | CARVYKTI® Performance Overview | | 6 | Financial Performance | | 7 | Q&A | 2 This presentation is for investor relations purposes only - Not for product promotional purposes Ying ...

Core Insights - Legend Biotech Corporation reported strong financial results for Q4 and the full year 2025, highlighting significant growth in collaboration revenue and advancements in its CAR-T therapy, CARVYKTI [1][5][7]. Financial Performance - As of December 31, 2025, Legend Biotech had approximately $949 million in cash and cash equivalents and time deposits [4][7]. - Collaboration revenue for Q4 2025 was $277.6 million, a 65.2% increase from $168.0 million in Q4 2024, driven by CARVYKTI sales under the Janssen collaboration [5]. - License and other revenue rose to $28.7 million in Q4 2025 from $18.5 million in Q4 2024, primarily due to a milestone achievement under the Janssen Agreement [6]. - Total revenue for the year ended December 31, 2025, was $1.0289 billion, compared to $627.3 million in 2024 [20]. - The operating loss for Q4 2025 was $19.7 million, significantly improved from a loss of $79.3 million in Q4 2024 [13]. - Net loss for Q4 2025 was $30.9 million, or $0.08 per share, compared to a net income of $26.4 million, or $0.07 per share, in Q4 2024 [14]. Business Developments - CARVYKTI has treated over 10,000 patients and achieved franchise profitability for the full year 2025 [2][7]. - The company expanded its manufacturing capabilities, completing an expansion at its Raritan facility, which is now the largest cell therapy manufacturing site in the U.S. [7]. - CARVYKTI is now available in 14 markets across 294 sites worldwide, with ongoing efforts to increase adoption in community settings [7]. - The company advanced its early-stage cell therapy portfolio, including the first patient dosing of in vivo candidates and presented first-in-human results for LUCAR-G39D, an allogeneic CAR-T therapy [6][7]. Research and Development - Research and development expenses for Q4 2025 were $101.3 million, a slight decrease from $104.4 million in Q4 2024, reflecting lower expenditures in BCMA clinical programs [10]. - The company opened a new 31,000-square-foot R&D facility in Philadelphia, Pennsylvania, to support its development efforts [7]. Market Position - Legend Biotech is positioned as a leader in cell therapy, particularly with its CARVYKTI product, which is pivotal in the treatment of relapsed or refractory multiple myeloma [17].