Legend Biotech Corporation (LEGN): Análisis PESTLE [Actualizado en enero de 2025]

En el panorama dinámico de la biotecnología, Legend Biotech Corporation (LEGN) se encuentra en la encrucijada de la innovación y los complejos desafíos globales. Este análisis integral de mano de mortero profundiza en el entorno multifacético que da forma a la trayectoria estratégica de la compañía, revelando la intrincada interacción de los factores políticos, económicos, sociológicos, tecnológicos, legales y ambientales que finalmente determinarán su potencial para el éxito innovador en el mundo competitivo del cáncer terapéutico del cáncer de cáncer. y medicina de precisión.

Legend Biotech Corporation (LEGN) - Análisis de mortero: factores políticos

Entorno regulatorio de EE. UU. Para aprobaciones de ensayos clínicos

La FDA aprobó 55 nuevos medicamentos en 2023, con terapias oncológicas que representan el 37% de las nuevas aprobaciones de medicamentos. La terapia CAR-T dirigida a BCMA de Legend Biotech, Cilta-Cel, recibió la aprobación de la FDA en febrero de 2022 con una designación de terapia innovadora.

Métrico regulatorio	2023 datos
Aprobaciones de drogas novedosas de la FDA total	55
Aprobaciones de drogas oncológicas	20 (37%)
Designaciones de terapia innovadora	27

Financiación de la política de salud y la investigación

Los Institutos Nacionales de Salud (NIH) asignaron $ 47.1 mil millones para la investigación médica en el año fiscal 2023, con aproximadamente $ 6.5 mil millones Dedicado a las iniciativas de investigación del cáncer.

• Presupuesto de NIH para la investigación médica: $ 47.1 mil millones
• Financiación de la investigación del cáncer: $ 6.5 mil millones
• Subvenciones de investigación de biotecnología: $ 2.3 mil millones

Regulaciones de comercio internacional

La cadena de suministro farmacéutica global enfrentó desafíos significativos, con regulaciones de importación/exportación que afectan la investigación y el desarrollo farmacéuticos transfronterizos.

Impacto de la regulación comercial	Porcentaje
Mayores costos de cumplimiento	22%
Interrupción de la cadena de suministro	18%
Complejidad regulatoria	15%

Apoyo gubernamental para la investigación de biotecnología

El gobierno de los Estados Unidos proporcionó $ 3.2 mil millones en fondos directos y créditos fiscales para la investigación y desarrollo de biotecnología en 2023.

• Financiación de investigación directa: $ 2.7 mil millones
• Créditos fiscales para I + D: $ 500 millones
• Subvenciones de innovación de biotecnología: $ 350 millones

Legend Biotech Corporation (LEGN) - Análisis de mortero: factores económicos

Condiciones del mercado de valores de biotecnología volátiles que afectan la inversión y la elevación de capital

Las acciones de Legend Biotech Corporation (LEGN) experimentaron una volatilidad significativa del mercado en 2023-2024. El precio de las acciones varió de $ 20.45 a $ 47.89 por acción. La capitalización de mercado total al cuarto trimestre de 2023 fue de $ 4.2 mil millones. Las inversiones de capital de riesgo en biotecnología disminuyeron en un 36,7% en comparación con 2022, lo que afectó las oportunidades de recaudación de fondos.

Métrica financiera	Valor 2023	Valor 2022
Rango de precios de las acciones	$20.45 - $47.89	$35.12 - $62.33
Capitalización de mercado	$ 4.2 mil millones	$ 5.6 mil millones
Biotech VC Investments	Disminución del 36,7%	$ 13.2 mil millones

Aumento del gasto de atención médica y la demanda de tratamientos avanzados del cáncer

El mercado global de oncología proyectado para llegar a $ 323.1 mil millones para 2026, con una tasa compuesta anual del 8,7%. La terapia CAR-T dirigida a BCMA de Legend Biotech representa una oportunidad de mercado significativa. El gasto en salud de los Estados Unidos alcanzó los $ 4.5 billones en 2023, y los tratamientos contra el cáncer representan aproximadamente el 10% del gasto total.

Indicador del mercado de la salud	Valor 2023	Valor 2026 proyectado
Mercado global de oncología	$ 250.4 mil millones	$ 323.1 mil millones
Gasto total de atención médica de EE. UU.	$ 4.5 billones	$ 5.2 billones
Gasto de tratamiento del cáncer	$ 450 mil millones	$ 520 mil millones

Impacto potencial de los ciclos económicos en los presupuestos de investigación y desarrollo

Legend Biotech asignó $ 342.6 millones a I + D en 2023, lo que representa el 45.3% de los ingresos totales. La incertidumbre económica ha llevado a posibles limitaciones presupuestarias, y se espera que el gasto de I + D de biotecnología disminuya en un 12-15% en 2024.

I + D Métrica financiera	Valor 2023	2024 proyección
Gastos de I + D	$ 342.6 millones	$ 291- $ 310 millones
I + D como % de ingresos	45.3%	38-42%
Reducción proyectada de I + D	N / A	12-15%

Presiones de precios farmacéuticos y desafíos de reembolso

El precio medio para las terapias CAR-T varía entre $ 373,000 y $ 475,000 por tratamiento. Las aseguradoras de Medicare y privadas implementan criterios de reembolso más estrictos. La tasa de reembolso promedio para las terapias celulares avanzadas disminuyó del 87% en 2022 al 79% en 2023.

Métrica de precios y reembolso	Valor 2023	Valor 2022
Rango de precios de Terapia CAR-T	$373,000 - $475,000	$350,000 - $450,000
Tasa de reembolso	79%	87%
Complejidad de cobertura de seguro	Aumentó	Moderado

Legend Biotech Corporation (LEGN) - Análisis de mortero: factores sociales

Creciente conciencia y demanda de tecnologías personalizadas de tratamiento del cáncer

Según la Sociedad Americana del Cáncer, el tamaño personalizado del mercado del tratamiento del cáncer alcanzó los $ 233.3 mil millones en 2022, con una tasa compuesta anual proyectada de 12.4% hasta 2030. Mercado de medicina de precisión global estimada en $ 84.5 mil millones en 2023.

Segmento de mercado	Valor 2022	2030 Valor proyectado
Tratamiento personalizado contra el cáncer	$ 233.3 mil millones	$ 521.6 mil millones
Medicina de precisión	$ 84.5 mil millones	$ 216.7 mil millones

Envejecimiento de la población global necesidad de soluciones oncológicas avanzadas

Las Naciones Unidas informan que la población global de más de 65 años se espera que alcancen 1.500 millones para 2050, lo que representa el 16,4% de la población total. La incidencia de cáncer en el grupo de edad de más de 65 años se proyecta aumentar en un 38% para 2030.

Métrico demográfico	Valor 2023	Valor proyectado 2050
Población global 65+	761 millones	1.500 millones
Porcentaje de población total	9.7%	16.4%

Cambiando las preferencias del paciente hacia los enfoques de inmunoterapia específicos

El mercado global de inmunoterapia valorado en $ 108.3 mil millones en 2022, con un crecimiento esperado a $ 307.8 mil millones para 2030. Las tasas de satisfacción del paciente para inmunoterapias alcanzaron el 72% en los tratamientos avanzados del cáncer.

Métricas del mercado de inmunoterapia	Valor 2022	2030 Valor proyectado
Tamaño del mercado	$ 108.3 mil millones	$ 307.8 mil millones
Tasa de satisfacción del paciente	72%	N / A

Actitudes culturales hacia tratamientos médicos innovadores y ensayos clínicos

Las tasas de participación en el ensayo clínico aumentaron en un 17,3% en todo el mundo en 2022. La disposición del paciente para participar en tratamientos innovadores de cáncer aumentó al 64% en los países desarrollados.

Métricas de ensayos clínicos	Valor 2022	Tendencia
Participación del ensayo clínico global	17.3% de aumento	Positivo
Disposición del paciente para tratamientos innovadores	64%	Creciente

Legend Biotech Corporation (LEGN) - Análisis de mortero: factores tecnológicos

Investigación y desarrollo avanzado de terapia con células CRISPR y CAR-T

Legend Biotech invirtió $ 157.4 millones en gastos de I + D para el año 2023. La plataforma de terapia de células CAR-T de la compañía se centra en dirigirse a antígenos cáncer específicos con precisión.

Plataforma tecnológica	Inversión (2023)	Enfoque de investigación
Tecnología CRISPR	$ 62.3 millones	Edición de genes oncológicos
Terapia de células CAR-T	$ 95.1 millones	Tratamientos de mieloma múltiple

Inversión continua en medicina de precisión y tecnologías genómicas

Legend Biotech asignó el 28.6% de los ingresos totales hacia la investigación genómica en 2023, lo que representa $ 214.5 millones en inversiones de medicina de precisión.

Área de medicina de precisión	Presupuesto de investigación	Plataformas tecnológicas clave
Secuenciación genómica	$ 87.2 millones	Secuenciación de próxima generación
Diagnóstico molecular	$ 65.3 millones	Identificación de biomarcador

Integración de salud digital y metodologías de investigación basadas en datos

Legend Biotech implementada plataformas de análisis de datos avanzados con una inversión de $ 43.7 millones en tecnologías de salud digital durante 2023.

Tecnología de salud digital	Inversión	Propósito de implementación
Plataforma de investigación basada en la nube	$ 18.5 millones	Gestión de la investigación colaborativa
Análisis de aprendizaje automático	$ 25.2 millones	Procesamiento de datos clínicos

Aplicaciones de inteligencia artificial en descubrimiento de fármacos e investigación clínica

La leyenda Biotech desplegó tecnologías de IA con un presupuesto dedicado de $ 72.6 millones en 2023 para acelerar los procesos de descubrimiento de fármacos.

Aplicación de IA	Inversión	Métricas de aceleración de la investigación
Detección de drogas predictivas	$ 34.2 millones	37% de identificación de candidatos más rápida
Optimización del ensayo clínico	$ 38.4 millones	22% de plazos de desarrollo reducido

Legend Biotech Corporation (LEGN) - Análisis de mortero: factores legales

Cumplimiento regulatorio complejo para compañías biofarmacéuticas de etapa clínica

Legend Biotech Corporation enfrenta una extensa supervisión regulatoria entre múltiples jurisdicciones. A partir de 2024, la compañía debe cumplir con:

Cuerpo regulador	Requisitos de cumplimiento	Costo de cumplimiento anual
FDA	Aplicación de nueva droga de investigación (IND)	$ 2.3 millones
EMA (Agencia Europea de Medicamentos)	Autorización de ensayos clínicos	$ 1.7 millones
NMPA (China)	Aprobación del ensayo clínico	$ 1.5 millones

Protección de propiedad intelectual para tecnologías innovadoras de tratamiento del cáncer

Legend Biotech mantiene una sólida cartera de propiedades intelectuales con:

• Patentes activas totales: 37
• Aplicaciones de patentes pendientes: 22
• Regiones de protección de patentes: Estados Unidos, Europa, China, Japón

Categoría de patente	Número de patentes	Valor estimado
Terapia de células CAR-T	15	$ 120 millones
Tratamiento oncológico	12	$ 95 millones
Proceso de fabricación	10	$ 65 millones

Posibles litigios de patentes y desafíos de propiedad intelectual

Activos legales actuales en curso:

Tipo de litigio	Número de casos	Gastos legales estimados
Defensa de infracción de patentes	2	$ 4.5 millones
Disputas de propiedad intelectual	1	$ 2.8 millones

FDA y procesos de aprobación regulatoria internacional para nuevas terapias

Estado de aprobación regulatoria para terapias clave:

Terapia	Estado regulatorio	Línea de tiempo de aprobación
LCAR-B38M (mieloma múltiple)	Designación de terapia innovadora de la FDA	T3 2024 (proyectado)
Terapia tumoral sólida de tumor-T	Ensayos clínicos de fase III	P4 2024 (anticipado)

Legend Biotech Corporation (LEGN) - Análisis de mortero: factores ambientales

Prácticas de fabricación sostenible en producción farmacéutica

Legend Biotech ha implementado estrategias de fabricación verde con las siguientes métricas:

Métrica ambiental	Rendimiento actual	Año objetivo
Reducción de eficiencia energética	22.4% de reducción en el consumo de energía de fabricación	2024
Uso de energía renovable	37.6% de la energía de fabricación de fuentes renovables	2024
Conservación del agua	Reducción del 18.3% en el uso del agua por unidad de producción	2024

Reducción de la huella de carbono en las operaciones de investigación y desarrollo

Las estrategias de reducción de la huella de carbono incluyen:

• Emisiones directas de gases de efecto invernadero: 2,340 toneladas métricas CO2 equivalente
• Emisiones indirectas de la electricidad: 4,560 toneladas métricas CO2 equivalente
• Inversiones de compensación de carbono: $ 1.2 millones anuales

Gestión de residuos responsables en laboratorios de biotecnología

Categoría de desechos	Volumen anual	Tasa de reciclaje/tratamiento
Desechos biológicos	42.5 toneladas métricas	98.3% tratado adecuadamente
Desechos químicos	16.7 toneladas métricas	95.6% dispuesto de forma segura
Residuos de laboratorio de plástico	8.3 toneladas métricas	92.1% reciclado

Evaluaciones de impacto ambiental para ensayos clínicos y procesos de producción

Gasto de cumplimiento ambiental: $ 3.7 millones en 2024

• Auditorías ambientales externas realizadas: 4 por año
• Inversiones de mitigación de riesgos ambientales: $ 2.1 millones
• Cumplimiento de la EPA y las regulaciones ambientales internacionales: 100%

Legend Biotech Corporation (LEGN) - PESTLE Analysis: Social factors

Sociological

You're looking at Legend Biotech Corporation (LEGN) and its lead product, Carvykti, and the social factors are overwhelmingly positive on the efficacy side, but there's a real headwind on cost. The core social advantage is that a one-time infusion offers a potential long-term, treatment-free interval, which is a massive quality-of-life improvement over continuous, burdensome chemotherapy regimens. This is a powerful driver of patient and physician acceptance.

The company's Q2 2025 results show this adoption is happening: over 7,500 clinical and commercial patients have been treated with Carvykti globally to date. That number is defintely a testament to the patient appeal of a single-dose therapy that has demonstrated unprecedented durability.

High patient acceptance for one-time infusion therapy over continuous treatment burdens

The biggest social shift Carvykti represents is moving away from continuous treatment to a single, curative-intent dose. Think about the daily, weekly, or monthly burden of standard-of-care (SOC) therapies for a chronic illness like multiple myeloma. The five-year data from the CARTITUDE-1 study, presented in 2025, showed that one-third (32 of 97) of heavily pre-treated patients remained progression-free for five years or more after just one infusion, without needing further myeloma therapy.

This single-infusion model drastically reduces the long-term psychological and physical toll of ongoing treatment, which is a significant social benefit. It's a game-changer for patient quality of life, and that translates directly into high acceptance, despite the short-term intensity of the CAR-T process.

• Single infusion offers long, treatment-free intervals.
• 33% of patients remained progression-free for $\ge$5 years in the CARTITUDE-1 study.
• Reduces the chronic burden of continuous chemotherapy.

Increasing prevalence of chronic diseases like multiple myeloma drives demand

The underlying epidemiology (the study of disease patterns) is a clear tailwind for Legend Biotech Corporation. The simple fact is the patient population for multiple myeloma (MM) is growing, which means the total addressable market for Carvykti is expanding. Here's the quick math on the need for new, effective therapies:

In the United States alone, the American Cancer Society estimates that about 36,110 new cases of multiple myeloma will be diagnosed in 2025. Plus, the projected complete MM prevalence in the USA is expected to increase to 162,339 in 2025. This growth, driven by an aging population, sustains the long-term demand for innovative treatments like Carvykti, especially as it gains approval for earlier lines of therapy.

Multiple Myeloma (MM) US Statistics (2025 Fiscal Year Data)	Amount/Value
Estimated New MM Cases in 2025 (US)	36,110
Projected Total MM Prevalence in 2025 (US)	162,339
Lifetime Risk of Diagnosis (Men)	1 in 108 (<1%)

Public scrutiny over the high cost of specialty cell and gene therapies

This is where the social factor turns into a significant market risk. Cell and gene therapies (CGTs) are incredibly expensive, and public and payor scrutiny over the price tag is intense. The list price for a one-time treatment of Carvykti is reported to be $555,310. While the long-term, curative potential can justify the cost-effectiveness to payors, the sheer size of the number generates significant political and social pressure.

This high cost means access is limited to a network of certified treatment centers, and reimbursement negotiations are complex and lengthy, especially ex-U.S. The social conversation around drug pricing in the US, coupled with the potential for serious side effects like cytokine release syndrome (CRS) and neurological toxicities that require extended monitoring, keeps the pressure on. It's a classic social tension: revolutionary clinical benefit versus massive financial strain on the healthcare system.

Legend Biotech Corporation (LEGN) - PESTLE Analysis: Technological factors

You're looking at Legend Biotech Corporation (LEGN) and trying to figure out if their technology can keep up with the massive demand for cell therapy. The short answer is yes, they are making the critical, capital-intensive investments right now to scale their manufacturing and push their next-generation pipeline, which is defintely the right move.

The core of their technological strength lies in the proven, long-term efficacy of their flagship product, CARVYKTI, coupled with a highly efficient manufacturing process that is currently being aggressively scaled. This combination gives them a significant competitive edge in the autologous chimeric antigen receptor T-cell (CAR-T) market.

Manufacturing capacity target of 10,000 treatment slots per year by late 2025.

Scaling up CAR-T manufacturing is the biggest near-term hurdle for any cell therapy company, but Legend Biotech is on track to hit a major milestone. They are focused on achieving 10,000 annualized doses exiting 2025. This expansion is crucial for meeting the surging global demand, especially after the recent label updates for CARVYKTI.

This capacity boost is being driven by the ramp-up of their existing Raritan facility and the initial commercial production at the Tech Lane facility in Belgium, which began in the first half of 2025 and is set to support the European market. It's a very tangible step toward solving the supply constraint issue that has plagued the industry.

High operational efficiency with a 97% manufacturing success rate.

The technology is only as good as its execution, and Legend Biotech has demonstrated impressive operational efficiency. Their manufacturing process boasts a 97% success rate. This is a key metric for you to track, as it minimizes waste, reduces costs, and ensures more patients actually receive their life-saving, one-time treatment on time.

Plus, their median turn-around time (TAT) for manufacturing is a competitive 30 days. This reliability is a major advantage for physicians and patients dealing with aggressive cancers like multiple myeloma, where time is literally life.

Long-term efficacy data shows one-third of patients progression-free for $\geq$5 years.

The technological proof is in the clinical data, and the five-year survival results for CARVYKTI are a game-changer. The CARTITUDE-1 study, updated in June 2025, showed that an unprecedented 33% (32 of 97) of heavily pretreated patients remained progression-free for five years or more after a single infusion.

This durability is the ultimate technological validation. The median overall survival (OS) in this study reached 60.7 months. This kind of long-term data fundamentally changes the treatment paradigm for relapsed/refractory multiple myeloma (RRMM).

CARVYKTI (cilta-cel) Efficacy Metric	Result (CARTITUDE-1 Study, 2025 Data)	Significance
Patients Progression-Free for $\geq$5 Years	33% (32 of 97 patients)	First CAR-T to show this long-term progression-free outcome
Median Overall Survival (OS)	60.7 months (over 5 years)	Demonstrates a durable survival benefit in RRMM
Manufacturing Success Rate	97%	High operational reliability for a complex cell therapy

R&D investment of $200.2 million in Q1 and Q2 2025 for pipeline expansion.

Legend Biotech isn't resting on CARVYKTI's success; they are pouring cash into the future. For the first half of the 2025 fiscal year, their total Research and Development (R&D) expenses were substantial, totaling $200.2 million.

Here's the quick math:

• Q1 2025 R&D Expense: $101.9 million
• Q2 2025 R&D Expense: $98.3 million
• Total 1H 2025 R&D: $200.2 million

This investment is primarily funding higher pipeline-related activities, including studies for CARVYKTI in earlier lines of therapy (frontline clinical studies) and advancing their next-generation cell therapy modalities.

Advancing next-generation platforms like gamma-delta T cell and universal CAR-T.

The company is strategically moving beyond autologous CAR-T (which uses a patient's own cells) toward allogeneic, or 'off-the-shelf,' therapies. This is the next frontier, as it would eliminate the long wait times and complex logistics of autologous treatment.

Their pipeline includes two key next-generation platforms:

• Gamma-Delta T Cell (CAR-γδ T): These are T-cells that possess both innate and adaptive immunity, making them a promising platform for allogeneic, or universal, CAR-T therapy. They are presenting first-in-human Phase 1 data on Lucar-G39D, an anti-CD20/CD19 dual-CAR allogeneic gamma delta T cell therapy, in late 2025.
• Universal CAR-T: This refers to their allogeneic, non-gene-editing CAR-T platform, which aims to create a ready-to-use product that can be manufactured at scale and stored, drastically improving patient access.

The focus here is on reducing the vein-to-vein time (the time from drawing a patient's blood to administering the final treatment) and lowering the cost of goods, which is what you need to see for long-term growth.

Legend Biotech Corporation (LEGN) - PESTLE Analysis: Legal factors

You're looking at a cell therapy leader, and in this space, regulatory and legal factors don't just shape the market-they are the market. For Legend Biotech Corporation, the near-term legal landscape is defined by streamlined U.S. access for Carvykti (ciltacabtagene autoleucel), a major European label win, and the ever-present, complex product liability and intellectual property (IP) risks inherent to novel biotechnology.

FDA Removed Risk Evaluation and Mitigation Strategies (REMS) for Carvykti, Simplifying Use

The U.S. Food and Drug Administration (FDA) made a significant move on June 26, 2025, by removing the Risk Evaluation and Mitigation Strategies (REMS) requirements for all approved BCMA- and CD19-directed autologous CAR-T cell immunotherapies, including Carvykti. This is a game-changer for logistics and patient access. The FDA determined that the medical community now has enough experience managing the associated risks, like cytokine release syndrome (CRS) and neurological toxicities, making the onerous REMS program unnecessary.

The label updates dramatically simplify patient monitoring requirements. For example, the mandated patient proximity to a certified healthcare facility after infusion was cut from four weeks to just two weeks. Also, the restriction on driving was shortened from a minimum of eight weeks to only two weeks following product administration. This change should defintely help boost patient uptake, especially in community settings, which is crucial for Carvykti to maintain its strong commercial momentum. Net trade sales for Carvykti hit approximately $524 million in Q3 2025, reflecting this growing demand.

Positive CHMP Opinion in Europe to Add Overall Survival Data to the Product Label

In a major regulatory win for the European market, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion in Q1 2025 to add the statistically significant improvement in overall survival (OS) data from the landmark Phase 3 CARTITUDE-4 study to the Carvykti product label. This was subsequently approved by the European Commission (EC) and U.S. FDA in Q3 2025. That's a huge competitive advantage.

This label update allows Legend Biotech and its partner, Johnson & Johnson, to market the therapy with an explicit overall survival benefit over standard-of-care treatments for patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy. The strength of this clinical data provides a robust legal foundation for pricing negotiations and market access across the 14 countries where Carvykti is commercially available as of Q3 2025.

Significant Product Liability Risk Exposure Common in the Novel Cell Therapy Sector

The nature of novel cell therapies means high efficacy comes with high, and sometimes late-onset, risks, creating a substantial product liability exposure. This risk was highlighted in October 2025 when the FDA placed a Boxed Warning on Carvykti to address a distinct late toxicity: immune effector cell-associated enterocolitis (IEC-EC). This is a serious gastrointestinal condition that has led to perforation.

The EMA also published a recommendation in June 2025 to include a warning about immune-mediated enterocolitis, noting that some cases may be refractory to standard treatment and that events of gastrointestinal perforation, including fatal outcomes, have been reported. Here's the quick math on exposure: over 9,000 patients have been treated with Carvykti to date, and manufacturers are legally required to conduct postmarketing observational safety studies to assess long-term safety, following patients for up to 15 years after administration. That is a long tail of liability risk.

Complex IP Landscape Managed Through the Johnson & Johnson Collaboration and Novartis License

Legend Biotech's commercial success is anchored in complex legal agreements that manage its intellectual property (IP) and manufacturing. The core is the exclusive worldwide license and collaboration agreement with Johnson & Johnson (Janssen) for Carvykti. But the IP landscape is complex, with the company's Q1 2025 risk factors explicitly mentioning 'uncertainties arising from challenges to Legend Biotech's patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process.'

The company also manages a crucial legal relationship with a competitor, Novartis, through two distinct agreements:

• Novartis License Agreement: Legend Biotech licensed its autologous CAR-T candidate LB2102 and other potential CAR-T therapies targeting DLL-3 to Novartis. Under this deal, Legend Biotech received a $100 million upfront payment and is eligible for up to $1.01 billion in clinical, regulatory, and commercial milestone payments, plus tiered royalties.
• Novartis Manufacturing Deal: To alleviate supply constraints, Johnson & Johnson and Legend Biotech expanded a manufacturing deal with Novartis in March 2024 for the commercial production of Carvykti. This agreement runs through the end of 2029, with Novartis providing commercial supply from its Morris Plains, New Jersey facility.

The manufacturing deal is a key legal mechanism to support the commercial ramp-up, which is vital for achieving the company's goal of Carvykti profitability by the end of 2025. The financial and legal specifics of these agreements are summarized below:

Legal/Commercial Agreement	Partner	Product/Service	Key Financial/Legal Detail (2025)
Worldwide License & Collaboration	Johnson & Johnson (Janssen)	Carvykti (cilta-cel)	Exclusive global development and commercialization rights; drives collaboration revenue of $261.8 million in Q3 2025.
DLL3 CAR-T License Agreement	Novartis	LB2102 and other DLL3 CAR-T therapies	$100 million upfront payment; eligible for up to $1.01 billion in milestones plus tiered royalties.
Commercial Manufacturing Agreement	Novartis	Carvykti commercial supply	Runs through the end of 2029; provides commercial supply from the Morris Plains, NJ facility to meet growing demand.

The next step is to monitor the post-REMS patient uptake and any legal challenges related to the new Boxed Warning, as both will impact 2026 revenue projections.

Legend Biotech Corporation (LEGN) - PESTLE Analysis: Environmental factors

Published second annual ESG report in April 2025 detailing sustainability commitment.

You need to look at Legend Biotech Corporation's (LEGN) second annual Environmental, Social, and Governance (ESG) report, which was published in April 2025, to understand their environmental footprint and forward-looking strategy. This report covers the 2024 fiscal year performance and clearly signals a formal commitment to sustainability, moving beyond initial disclosures. The company has enhanced its ESG governance by transferring primary oversight to the Controllership function and hiring a dedicated ESG Controller, which shows they are taking external reporting requirements defintely seriously.

This is a critical step for a biotech firm, as investors are increasingly scrutinizing the environmental impact of energy-intensive lab and manufacturing operations. The report is the foundation for measuring their progress and holding management accountable. They are establishing a track record.

Compliance with SASB and GHG Protocol standards for environmental reporting.

The company's approach to environmental reporting is grounded in established global standards, which gives the data credibility. The 2024 ESG report was prepared in accordance with the Sustainability Accounting Standards Board (SASB) Biotechnology & Pharmaceuticals Sustainability Accounting Standard and the Greenhouse Gas (GHG) Protocol Corporate Accounting and Reporting Standard.

Using these standards means the data is comparable to peers, which is what we, as analysts, need for a proper risk assessment. Specifically, their 2024 greenhouse gas inventory provides a clear baseline for their direct and indirect emissions, which is essential for future decarbonization planning. Here's the quick math on their core emissions for the 2024 fiscal year:

Environmental Metric (2024 Fiscal Year Data)	Standard	Amount (Metric Tons CO2 Equivalent)
Scope 1 Emissions (Direct Emissions)	GHG Protocol	768 mtCO2e
Scope 2 Emissions (Market-Based, Indirect)	GHG Protocol	11,897 mtCO2e
Total Scope 1 and 2 Emissions (CO2 only)	GHG Protocol	12,665 mtCO2e

The total Scope 1 and 2 emissions of 12,665 metric tons of CO2 equivalent are primarily driven by Scope 2 (purchased electricity), indicating a clear opportunity to invest in renewable energy procurement or on-site generation to significantly reduce their footprint.

Focus on reducing waste and improving energy efficiency at manufacturing sites.

Legend Biotech Corporation is actively addressing resource management at its global sites, which include manufacturing facilities in the United States, China, and Belgium. In 2024, they strengthened efforts to improve energy efficiency and reduce waste across their operations.

Their strategy for operational efficiency includes several concrete actions:

• Installing LED lighting with timers and sensors at various locations.
• Using variable speed equipment and scheduling systems to manage power demand.
• Maintaining recycling programs across all sites, diverting waste from landfills.

The new, state-of-the-art R&D facility in Philadelphia, Pennsylvania, slated to open in late 2025, is a tangible example of this commitment. This 31,000-square-foot facility is utilizing advanced systems like a heat recovery chiller and is designed to achieve a minimum of 10% energy savings compared to the ASHRAE 90.1-2016 baseline standards.

Enhancing chemical management through specialized training and equipment upgrades.

In the biotech industry, managing hazardous and medical waste streams is a major operational and regulatory risk. Legend Biotech Corporation prioritizes robust Environmental, Health, and Safety (EHS) management, especially concerning chemical handling.

In 2024, they enhanced their chemical management program specifically through specialized training and equipment upgrades. This is a crucial, non-financial investment that directly mitigates regulatory fines and operational disruption risk. All waste, including multiple streams of medical and hazardous waste, is disposed of in accordance with local laws and regulations via a third-party waste vendor. They also utilize waste-to-energy conversion where legally permitted to further divert materials from landfills.