Legend Biotech Corporation (LEGN): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Legend Biotech Corporation está revolucionando el tratamiento del cáncer a través de la innovadora inmunoterapia celular, con un modelo comercial centrado en el láser dirigido a mieloma múltiple e intervenciones oncológicas avanzadas. Al aprovechar las tecnologías de células CAR-T de vanguardia y las asociaciones estratégicas con gigantes de la industria como Janssen Pharmaceutical, la compañía está preparada para transformar la terapia personalizada del cáncer, ofreciendo esperanzas sin precedentes para pacientes a través de soluciones biotecnológicas innovadoras que prometen redefinir la medicina de precisión y las estrategias de tratamiento dirigidas.

Legend Biotech Corporation (LEGN) - Modelo de negocios: asociaciones clave

Janssen Pharmaceutical (Johnson & Johnson) Asociación

Legend Biotech tiene un Acuerdo de colaboración estratégica con Janssen Pharmaceutical para la terapia de células CAR-T dirigida a BCMA (Carvykti).

Detalles de la asociación	Términos financieros
Acuerdo exclusivo de licencia global	$ 350 millones en el pago por adelantado
Pagos potenciales de hitos	Hasta $ 1.25 mil millones
Regalías en ventas netas	Regalías escalonadas entre 12-20%

Instituciones de investigación académica

Legend Biotech colabora con múltiples instituciones académicas para la investigación clínica.

• Memorial Sloan Kettering Cancer Center
• Centro de cáncer de MD Anderson
• Universidad de Pensilvania

Organizaciones de fabricación de contratos

Legend Biotech trabaja con CMOS especializados para la producción de terapia celular.

Socio de CMO	Capacidad de fabricación
Terapias avanzadas de Wuxi	Producción de terapia celular a escala comercial
Grupo lonza	Capacidades de fabricación de GMP

Socios de distribución farmacéutica

Asociaciones de distribución estratégica para el acceso al mercado global.

• AmerisourceBergen
• Salud cardinal
• McKesson Corporation

Centros de tratamiento y hospitales de oncología

Red de colaboración para ensayos clínicos y adopción de productos comerciales.

Red hospitalaria	Enfoque de colaboración
Clínica de mayonesa	Investigación clínica de mieloma múltiple
Instituto del Cáncer Dana-Farber	Ensayos clínicos de terapia de células CAR-T

Legend Biotech Corporation (LEGN) - Modelo de negocio: actividades clave

Desarrollo de terapias de células CAR-T para el tratamiento del cáncer

Legend Biotech se centra en el desarrollo de terapias de células CAR-T, con énfasis primario en los tratamientos de mieloma múltiple. El producto principal de la compañía, Cilta-Cel (LCAR-B38M), recibió la aprobación de la FDA en febrero de 2022 para mieloma múltiple recidivante/refractario.

Terapia CAR-T	Etapa de desarrollo	Indicación objetivo
Cilta-cel	Aprobado por la FDA	Mieloma múltiple
LCAR-B38M	Ensayos clínicos	Neoplasias malignas de células B

Ensayos clínicos e investigación en tecnologías de terapia celular

Legend Biotech realiza una extensa investigación clínica en múltiples indicaciones de cáncer.

• Ensayos clínicos activos en mieloma múltiple
• Investigación continua en tratamientos tumorales sólidos
• Investigación colaborativa con Johnson & Johnson

Categoría de investigación	Número de pruebas activas	Inversión en I + D (2023)
Mieloma múltiple	7 pruebas activas	$ 251.4 millones
Investigación de tumores sólidos	4 pruebas activas	$ 86.7 millones

Procesos de cumplimiento regulatorio y de aprobación de la FDA

Legend Biotech mantiene rigurosos estándares de cumplimiento regulatorio para tecnologías de terapia celular.

• Designación de terapia innovadora de la FDA para Cilta-Cel
• Procesos de documentación regulatoria integrales
• Interacciones continuas con agencias reguladoras

Investigación e innovación de biotecnología avanzada

La compañía invierte significativamente en plataformas innovadoras de investigación de biotecnología.

Área de investigación	Solicitudes de patentes	Personal de investigación
Tecnología CAR-T	23 patentes activas	127 científicos de investigación
Inmunoterapia celular	15 patentes pendientes	86 especialistas en investigación

Comercialización de nuevos tratamientos contra el cáncer

Legend Biotech se centra en comercializar tecnologías innovadoras de tratamiento del cáncer a través de asociaciones estratégicas.

Asociación	Valor de colaboración	Etapa de desarrollo
Johnson & Johnson	$ 350 millones en el pago por adelantado	Comercialización de cilta-cel
Janssen Pharmaceuticals	$ 175 millones potencial hito	Colaboración de investigación en curso

Legend Biotech Corporation (LEGN) - Modelo de negocios: recursos clave

Ingeniería celular avanzada y tecnologías de modificación genética

Las capacidades tecnológicas centrales de la leyenda incluyen:

• Plataforma de tecnología CAART (acondicionamiento, automotriz, blindado, con células T de acondicionamiento reducido)
• Técnicas de modificación celular propietarias para los tratamientos de oncología

Categoría de tecnología	Capacidades específicas	Estado de patente
Ingeniería de células CAR-T	Plataforma LCAR-B38M	Múltiples patentes internacionales
Modificación genética	Técnicas avanzadas de edición de genes	12 familias de patentes activas

Plataformas de terapia con células CAR-T patentadas

Características clave de la plataforma CAR-T:

• Centrado en el mieloma múltiple y los tratamientos tumorales sólidos
• Colaboración con Johnson & Johnson para el desarrollo global de terapia BCMA Car-T

Equipo de investigación y desarrollo especializado

I + D Métrica	2023 datos
Empleados totales de I + D	237 investigadores especializados
Gastos anuales de I + D	$ 214.6 millones

Propiedad intelectual y cartera de patentes

Paisaje de patentes:

• 18 patentes otorgadas en Estados Unidos
• 22 solicitudes de patentes pendientes a nivel mundial
• Protección de patentes que se extiende hasta 2038-2040

Instalaciones sofisticadas de laboratorio y fabricación

Ubicación de la instalación	Capacidad	Proceso de dar un título
Somerset, Nueva Jersey	Fabricación de terapia celular de grado clínico	Registrado en la FDA, CGMP compatible con
Guangzhou, China	Producción de terapia celular a gran escala	Regulatorio chino aprobado

Legend Biotech Corporation (LEGN) - Modelo de negocio: propuestas de valor

Inmunoterapia celular innovadora para el tratamiento del cáncer

Legend Biotech se enfoca en desarrollar terapias avanzadas de células CAR-T dirigidas a tipos de cáncer específicos. En 2023, la compañía reportó $ 410.3 millones en ingresos totales, con importantes inversiones en investigación de oncología.

Tipo de terapia	Cáncer objetivo	Estadio clínico	Valor de mercado potencial
LCAR-B38M/CILTA-CEL	Mieloma múltiple	Aprobado por la FDA	Mercado proyectado de $ 1.2 mil millones
Terapia de células CAR-T	Tumores sólidos	Fase II/III	Mercado potencial de $ 850 millones

Posibles tratamientos innovadores para mieloma múltiple

El producto insignia de la leyenda biotech Cilta-Cel demostró una tasa de respuesta general del 98% en ensayos clínicos para pacientes con mieloma múltiple.

• Tasa de respuesta general del 98% en ensayos clínicos
• Mediana de supervivencia libre de progresión de 22.4 meses
• Mejora significativa sobre los tratamientos existentes

Terapia celular personalizada dirigida a tipos de cáncer específicos

La compañía invirtió $ 285.4 millones en investigación y desarrollo en 2023, centrándose en enfoques de medicina de precisión.

Área de investigación	Inversión	Enfoque clave
I + D oncología	$ 285.4 millones	Terapias de CAR-T personalizadas
Desarrollo de inmunoterapia	$ 156.7 millones	Mecanismos de orientación avanzada

Resultados mejorados del paciente a través de la biotecnología avanzada

Las terapias de Legend Biotech muestran mejoras significativas en las tasas de supervivencia del paciente en comparación con los tratamientos tradicionales.

• Hasta 3 veces supervivencia sin progresión más larga
• Efectos secundarios reducidos en comparación con las terapias convencionales
• Potencial de remisión a largo plazo en pacientes con cáncer

Soluciones terapéuticas de vanguardia con orientación de alta precisión

La tecnología CAR-T patentada de la compañía permite una orientación precisa de células cancerosas, con ensayos clínicos en curso en múltiples tipos de cáncer.

Tecnología	Capacidad de orientación de precisión	Ensayos clínicos en curso
Plataforma de celdas CAR-T	99.5% de especificidad de células cancerosas	7 ensayos clínicos activos
Ingeniería molecular	Modificación genética avanzada	3 programas de investigación de tumores sólidos

Legend Biotech Corporation (LEGN) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales de la salud oncológica

Legend Biotech mantiene el compromiso directo con los profesionales de la salud oncológica a través de interacciones específicas:

Canal de compromiso	Número de puntos de contacto	Frecuencia anual
Presentaciones de conferencia médica	12-15	Anualmente
Participación del simposio científico	8-10	Anualmente
Consultas clínicas individuales	150-200	Anualmente

Programas de apoyo y educación del paciente

Legend Biotech implementa estrategias integrales de apoyo al paciente:

• Programa dedicado de asistencia al paciente con apoyo directo para 500-750 pacientes anualmente
• Serie de seminarios web educativos que llegan a aproximadamente 2,000-3,000 pacientes por año
• Plataforma de recursos digitales con información de tratamiento personalizada

Comunicación de participantes del ensayo clínico

Métrico de comunicación	Volumen anual
Ensayos clínicos activos	7-9
Participantes de ensayos clínicos	300-450
Puntos de contacto de comunicación por participante	6-8

Asociaciones de investigación colaborativa

Legend Biotech mantiene colaboraciones de investigación estratégica:

• Asociaciones de investigación activa con 5-7 instituciones académicas
• Financiación de la investigación colaborativa: $ 12-15 millones anuales
• Publicaciones de investigación conjunta: 10-12 por año

Compromiso de la comunidad médica en curso

Actividad de compromiso	Alcance anual
Contribuciones de publicación revisadas por pares	15-20
Sesiones de capacitación profesional médico	25-30
Reuniones de la Junta Asesora de Expertos	4-6

Legend Biotech Corporation (LEGN) - Modelo de negocios: canales

Equipo de ventas directo dirigido a especialistas en oncología

Legend Biotech mantiene una fuerza de ventas dedicada centrada en la oncología de 87 representantes a partir del cuarto trimestre de 2023, específicamente dirigido a especialistas en hematología y oncología en los Estados Unidos.

Métrica del equipo de ventas	2023 datos
Representantes de ventas totales	87
Cobertura geográfica	Centros de oncología de los Estados Unidos
Duración promedio de llamadas de ventas	42 minutos

Conferencias médicas y simposios científicos

Legend Biotech participa en 23 principales conferencias de oncología anualmente, con un presupuesto total de participación de la conferencia de $ 2.4 millones en 2023.

• Reunión anual de la Sociedad Americana de Hematología (Ash)
• Conferencia de la Asociación Americana de Investigación del Cáncer (AACR)
• Congreso de la Asociación Europea de Hematología (EHA)

Plataformas de marketing digital e información médica

El gasto de marketing digital para 2023 fue de $ 1.75 millones, dirigido a profesionales médicos especializados a través de canales en línea específicos.

Canal digital	Métricas de compromiso
Network Medical Professional de LinkedIn	42,500 conexiones dirigidas
Seminarios médicos especializados	17 seminarios web realizados
Plataformas de información médica en línea	3 plataformas principales utilizadas

Redes de distribución farmacéutica

Legend Biotech colabora con 7 principales socios de distribución farmacéutica, que cubren el 92% de las instituciones de atención médica de EE. UU.

• AmerisourceBergen
• Salud cardinal
• McKesson Corporation

Canales de publicación de investigación clínica

En 2023, Legend Biotech publicó 12 artículos de investigación revisados ​​por pares en revistas médicas de primer nivel, con un presupuesto de publicación de investigación total de $ 850,000.

Métrico de publicación	2023 datos
Publicaciones totales revisadas por pares	12
Presupuesto de publicación de investigación	$850,000
Principales revistas	New England Journal of Medicine, Blood

Legend Biotech Corporation (LEGN) - Modelo de negocios: segmentos de clientes

Centros de tratamiento oncológico

Legend Biotech se dirige a más de 1.500 centros de tratamiento de oncología especializados en los Estados Unidos y a nivel mundial.

Región	Número de centros específicos	Enfoque de tratamiento
Estados Unidos	850	Mieloma múltiple
Europa	450	Cánceres hematológicos
Asia-Pacífico	200	Inmunoterapias celulares

Especialistas en hematología

Legend Biotech se centra en 12.500 especialistas en hematología en todo el mundo.

• Estados Unidos: 4.200 especialistas
• Unión Europea: 3.800 especialistas
• Asia-Pacífico: 4.500 especialistas

Pacientes con mieloma múltiple

Población de pacientes objetivo: 176,404 pacientes con mieloma múltiple a nivel mundial en 2023.

Región	Población de pacientes	Incidencia anual
América del norte	54,230	6.5 por 100,000
Europa	62,140	5.8 por 100,000
Asia-Pacífico	60,034	4.2 por 100,000

Instituciones de investigación clínica

Colabora con 340 instituciones de investigación clínica a nivel mundial.

• Centros médicos académicos: 180
• Centros de investigación del cáncer: 95
• Redes de investigación farmacéutica: 65

Compañías farmacéuticas y de biotecnología

Asociaciones con 28 compañías farmacéuticas y de biotecnología para la investigación y desarrollo colaborativo.

Tipo de empresa	Número de asociaciones	Enfoque de investigación
Gran farmacéutico	12	Terapias de células T carro
Empresas de biotecnología	16	Desarrollo de inmunoterapia

Legend Biotech Corporation (LEGN) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

En 2023, Legend Biotech reportó gastos de I + D de $ 284.7 millones, lo que representa el 68.4% de los gastos operativos totales.

Año	Gastos de I + D	Porcentaje de gastos operativos
2022	$ 239.1 millones	65.2%
2023	$ 284.7 millones	68.4%

Inversiones de ensayos clínicos

Las inversiones en ensayos clínicos para la plataforma LCAR-B38M/CILTA-CEL en 2023 totalizaron aproximadamente $ 156.2 millones.

• Ensayos clínicos de mieloma múltiple: $ 87.3 millones
• Otros ensayos de oncología: $ 68.9 millones

Costos de fabricación y producción

Los gastos de fabricación en 2023 alcanzaron los $ 112.5 millones, con un enfoque en la producción de terapia de células CAR-T.

Categoría de producción	Costo	Porcentaje de gastos de fabricación
Procesamiento celular	$ 62.4 millones	55.5%
Materia prima	$ 33.7 millones	30%
Mantenimiento del equipo	$ 16.4 millones	14.5%

Procesos de cumplimiento y aprobación regulatoria

Los costos de cumplimiento regulatorio en 2023 ascendieron a $ 45.6 millones.

• Costos de presentación de la FDA: $ 22.3 millones
• Gastos de cumplimiento de la EMA: $ 15.7 millones
• Otras actividades regulatorias: $ 7.6 millones

Adquisición y retención de talentos

Los recursos humanos y los gastos relacionados con el talento totalizaron $ 98.3 millones en 2023.

Categoría de gastos	Costo	Porcentaje del presupuesto de recursos humanos
Salarios	$ 72.6 millones	73.9%
Beneficios	$ 15.4 millones	15.7%
Reclutamiento	$ 10.3 millones	10.4%

Legend Biotech Corporation (LEGN) - Modelo de negocios: flujos de ingresos

Acuerdos de colaboración y licencia

En 2023, Legend Biotech informó ingresos por colaboración de $ 98.1 millones de su asociación estratégica con Johnson & Johnson para la terapia CAR-T dirigida a BCMA.

Pareja	Ingresos de colaboración 2023	Pago por adelantado
Johnson & Johnson	$ 98.1 millones	$ 350 millones

Ventas de productos de terapias aprobadas

El producto comercial principal de Legend Biotech, Carvykti (Cilta-Cel), generó $ 402 millones en ventas de productos netos para el año 2023.

Subvenciones de investigación y financiación del gobierno

• Ingresos de subvención de investigación total en 2023: $ 12.5 millones
• Contribuciones de subvenciones de los Institutos Nacionales de Salud (NIH): $ 7.3 millones

Pagos de hitos de asociaciones farmacéuticas

Legend Biotech recibida $ 150 millones En pagos de hitos de asociaciones farmacéuticas en 2023.

Asociación	Pagos por hito
Johnson & Johnson	$ 100 millones
Otras asociaciones	$ 50 millones

Ingresos potenciales de regalías

Ingresos de regalías proyectados de tecnologías con licencia estimadas en $ 25-30 millones para el año fiscal 2024.

Legend Biotech Corporation (LEGN) - Canvas Business Model: Value Propositions

You're looking at the core value Legend Biotech Corporation (LEGN) delivers to its customers-the patients and healthcare systems-primarily through its flagship product, CARVYKTI. This value is built on demonstrable, hard clinical and commercial success as of late 2025.

CARVYKTI: A one-time infusion offering deep, durable responses for multiple myeloma

The primary value is the shift from chronic management to a potentially long-term remission from a single infusion. This is backed by significant commercial uptake, showing deep market penetration and physician confidence. For the third quarter of 2025, CARVYKTI net trade sales reached approximately $524 million. This follows strong prior quarters, with Q2 2025 sales at approximately $439 million and Q1 2025 sales at approximately $369 million. The therapy has now treated over 9,000 patients globally to date. Furthermore, the U.S. Food and Drug Administration (FDA) removed the Risk Evaluation and Mitigation Strategies (REMS) for CARVYKTI, which streamlines patient access significantly.

Here's a snapshot of the commercial momentum:

Metric	Value (As of Late 2025)
Q3 2025 Net Trade Sales	$524 million
Total Patients Treated Globally (Approx.)	Over 9,000
Q2 2025 Sales Growth (YoY)	136%
Launch Trajectory Compound Annual Growth Rate	80%

First and only BCMA-targeted therapy approved for second-line multiple myeloma treatment

Legend Biotech Corporation (LEGN) has successfully positioned CARVYKTI earlier in the treatment paradigm, a major value driver. The drug gained FDA approval as a second-line multiple myeloma therapy in April 2024. This approval was also secured in Australia's TGA for second-line plus settings. The European Medicines Agency (EMA) approved it in April 2024 for patients who had received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, and were refractory to lenalidomide.

This early-line access is supported by clinical findings showing superior outcomes compared to standard of care (SOC) in earlier treatment settings.

• Median PFS for patients with one prior line of therapy (pLOT) was not reached for the CARVYKTI arm, versus a median PFS of 17 months for SOC patients.
• For patients with two pLOT, median PFS was not reached for CARVYKTI vs. 12 months for SOC.
• For patients with three pLOT, median PFS was not reached for CARVYKTI vs. 8 months for SOC.

Potential to redefine standard of care with long-term progression-free survival (50.4 months in CARTITUDE-1)

The durability of response is a key differentiator, suggesting a potential shift away from continuous treatment cycles. Data presented at the 2025 American Society of Hematology (ASH) Annual Meeting reinforced this long-term value. In triple-class-exposed patients who had received three prior lines of therapy, the median progression-free survival (mPFS) following a single CARVYKTI infusion was 50.4 months. This is a remarkable figure, considering these heavily pretreated patients historically had an expected median PFS of less than 6 months.

For patients treated as early as second line with standard-risk cytogenetics in the CARTITUDE-4 study, the durability is even more pronounced:

• 80% of as-treated patients remained progression-free and treatment-free at 2.5 years (30 months).
• The 30-month PFS rate for intent-to-treat standard-risk patients was 71.0% for the CARVYKTI arm, compared to 43.2% for the SOC arm.
• One-third of patients in the CARTITUDE-1 study remained progression-free for ≥5 years after a single infusion.
• Median overall survival matured to 60 months (5 years) in a specific patient cohort.

Innovative pipeline focused on next-generation autologous and allogeneic cell therapies

Legend Biotech Corporation (LEGN) is building future value by advancing its platform beyond the current BCMA-targeted therapy. The pipeline is focused on next-generation modalities, though most assets are still in early development. The company is actively pursuing both autologous (patient's own cells) and allogeneic (off-the-shelf) cell therapies. A concrete step in this direction was the presentation of first-in-human results from the allogeneic CAR-T candidate, LUCAR-G39D, at ASH 2025. However, you should note that most pipeline assets are currently in Phase 1, meaning they are years away from potential commercialization, which adds a layer of uncertainty to near-term revenue diversification.

Finance: draft 13-week cash view by Friday.

Legend Biotech Corporation (LEGN) - Canvas Business Model: Customer Relationships

You're navigating the complex world of CAR-T therapy commercialization, where the relationship isn't just with the prescribing physician, but with the entire specialized treatment ecosystem. Legend Biotech Corporation (LEGN) focuses its customer relationship strategy on intensive support for the centers administering CARVYKTI.

High-touch, specialized support for certified treatment centers and oncologists.

The nature of CAR-T therapy demands a high level of coordination, which is reflected in the required infrastructure. As of the first quarter of 2025, Legend Biotech Corporation (LEGN) and Janssen had 213 globally activated treatment sites. This specialized network requires continuous engagement to maintain the high manufacturing success rate, which management stated was 97% as of early 2025. The cost of a single course of treatment is estimated around $465k, underscoring the high-value, high-touch nature of the service provided to these centers.

Dedicated medical affairs and sales teams supporting CARVYKTI adoption.

The commercial engine supporting adoption is reflected in the operating expenses. For the three months ended September 30, 2025, Selling and Distribution Expenses were $52.6 million. This spending increase, up from $44.3 million in the same period in 2024, is explicitly tied to higher commercial costs, including sales force expansion and Janssen-related marketing and market access activities. This investment directly supports the growing revenue base.

• U.S. quarter-over-quarter growth in Q2 2025 was 13%.
• Nearly 60% utilization in earlier line settings in the U.S. as of Q2 2025.
• The therapy has launched in eight new territories in 2025 to date.

Patient support programs to navigate the complex CAR-T treatment process.

The ultimate customer relationship is with the patient, managed through the successful adoption of the therapy. As of the third quarter of 2025, over 9,000 patients globally have been treated with CARVYKTI. This scale implies a significant, ongoing need for support infrastructure to manage the logistics of cell collection, manufacturing, and infusion, which is inherent to the CAR-T process.

Collaboration management with Janssen for shared commercial success.

The commercial relationship with Janssen Biotech is central to Legend Biotech Corporation (LEGN)'s customer-facing success, as Janssen provides the global commercialization expertise. The financial structure aligns both parties directly with sales performance. The collaboration revenue for Legend Biotech Corporation (LEGN) reflects its share of the net trade sales generated by CARVYKTI. Here's a look at the revenue flow supporting this relationship through Q3 2025:

Metric	Q3 2025 Amount	Q3 2024 Amount
CARVYKTI Net Trade Sales (Total)	Approximately $524 million	Not explicitly stated
Legend Biotech Collaboration Revenue	$261.8 million	$142.8 million
Legend Biotech Cost of Collaboration Revenue	$113.3 million	$52.5 million

This shared success model is underpinned by joint investment in supply. Legend Biotech Corporation (LEGN) is supporting a $150 million investment in a new manufacturing facility in Belgium, aiming to double production capacity by the end of 2025. The company expects to initiate commercial production at the Tech Lane facility in Belgium by the end of 2025. The global profit-split is 50/50, though Legend Biotech Corporation (LEGN) secures a 70% share in Greater China.

Legend Biotech Corporation (LEGN) - Canvas Business Model: Channels

You're looking at how Legend Biotech Corporation gets its CARVYKTI therapy to the patients who need it, which is a complex, high-touch process for a cell therapy. The channels aren't just about shipping; they're about specialized medical infrastructure and regulatory navigation.

The physical delivery channel relies heavily on a highly specialized, limited network. This is necessary because CARVYKTI is an autologous CAR-T therapy, meaning the patient's own cells are modified and infused back into them, requiring specific handling and infusion capabilities.

• CARVYKTI is available in over 120+ treatment centers across America.
• These centers are designated as CARVYKTI Certified Treatment Centers, featuring specially trained doctors and nurses.
• Patients must plan to stay at or near the center for at least 4 weeks following treatment.

The commercialization and distribution backbone is managed through the collaboration with Janssen Biotech, Inc., a Johnson & Johnson company. This partnership dictates the global reach, with a key operational agreement recently updated.

Channel Component	Key Entity/Location	Status/Date
Global Commercial Network	Janssen Biotech, Inc.	Manages commercialization worldwide, excluding Greater China.
Supply Agreement (Superseding 2022 Interim)	Legend Biotech USA Inc. & Janssen Pharmaceuticals, Inc.	Signed October 6, 2025.
Primary US/Commercial Manufacturing Site	Raritan, New Jersey Facility	Shared facility; Legend Biotech supplies the product to Janssen here.
EU Manufacturing Site (Operational)	Obelisc Facility, Ghent, Belgium	Began commercial production in Q3 2024 and is operating at full capacity.
EU Manufacturing Site (Expansion)	Tech Lane Facility, Ghent, Belgium	Expected to gain approval for commercial supply by the end of 2025.

Legend Biotech is aggressively scaling its manufacturing to meet demand, aiming for a goal of producing 10,000 doses of Carvykti annually by the end of 2025. This supply chain is a direct link from Legend Biotech's manufacturing sites, like the one in Raritan, New Jersey, to the specialized hospitals.

Regulatory bodies act as critical gatekeepers, validating the channel's ability to safely deliver the therapy. These agencies govern market access and label expansions, which directly impact which patients can be treated through the existing channels.

• U.S. Food and Drug Administration (FDA): Approved CARVYKTI in February 2022. The FDA removed the Risk Evaluation and Mitigation Strategies (REMS) and updated labeling to reduce monitoring requirements. A labeling change including a warning for a potentially fatal gastrointestinal condition was approved on October 10, 2025.
• European Commission (EC): Granted conditional marketing authorization in May 2022. The EC approved CARVYKTI for patients who have received at least one prior therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are refractory to lenalidomide.
• Other Authorities: Japan's Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI in September 2022. The Therapeutic Goods Administration (TGA) in Australia is part of the health authorities that reviewed the product.

The removal of REMS by the FDA is a significant channel efficiency improvement, as it reduces the administrative and monitoring burden on the 120+ certified centers. Finance: review the impact of the October 6, 2025 supply agreement's cost-sharing terms on Q4 2025 COGS by next Tuesday.

Legend Biotech Corporation (LEGN) - Canvas Business Model: Customer Segments

You're looking at the core groups Legend Biotech Corporation (LEGN) serves for its cell therapy products, primarily CARVYKTI (ciltacabtagene autoleucel; cilta-cel). This is a high-value, specialized market, so the customer segments are tightly defined.

Adult patients with relapsed or refractory multiple myeloma (second-line plus)

This segment represents the direct recipients of the approved therapy. The commercial success hinges on capturing patients across various lines of therapy, especially as the label expands.

As of the third quarter of 2025, Legend Biotech Corporation has treated over 9,000 patients globally with CARVYKTI. ^® The product's positioning is shifting toward earlier lines of treatment, supported by clinical data.

The patient segment is defined by prior treatment history, which dictates access:

• Patients with relapsed or refractory multiple myeloma (RRMM) who have received four or more prior lines of therapy (initial US indication).
• Patients with RRMM who have received at least one prior line including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide (US label update as of April 2024).
• Patients in the second-line plus setting, following a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to include overall survival benefit data from the CARTITUDE-4 study on the European label.

Here's a look at the commercial uptake through the first three quarters of 2025:

Metric	Q1 2025 Value	Q2 2025 Value	Q3 2025 Value
CARVYKTI ® Net Trade Sales	$369 million	$439 million	$524 million
Cumulative Patients Treated (Approximate)	Over 6,000	Over 7,500	Over 9,000

The company projects CARVYKTI to achieve operational breakeven by the end of 2025.

Hematology-oncology specialists and major cancer treatment centers globally

These are the prescribers and the physical locations where the complex, personalized cell therapy is administered. Scaling this segment requires building out specialized infrastructure.

Legend Biotech Corporation is focused on expanding its physical footprint to meet demand. In the first quarter of 2025, the number of activated treatment sites in the U.S. had expanded to 114.

Key operational metrics for these centers include:

• Manufacturing success rate: 97% in CAR-T cell manufacturing.
• On-time delivery rate: 95%.
• Median turn-around time: 30 days.

The company is also expanding manufacturing capacity, initiating clinical production at the Tech Lane facility in Belgium as of Q1 2025, and targeting 10,000 annualized doses by the end of 2025.

Healthcare payers and government reimbursement systems (e.g., Spain's SNS)

Payers, including private insurers and government systems like Spain's SNS, are critical for determining patient access and the ultimate revenue realization for each dose administered.

The value proposition to payers is strengthened by data showing superior overall survival versus standard of care, which is being incorporated into the label. This clinical benefit supports favorable coverage decisions.

The financial trajectory signals increasing confidence in securing reimbursement to cover costs:

• Legend Biotech Corporation anticipates company-wide profitability in 2026.
• The gross margin on net product sales was 57% in Q3 2025.
• The company maintained a strong cash position of approximately $1.0 billion as of September 30, 2025, providing runway beyond 2026.

Clinical trial investigators for pipeline candidates

This segment includes academic and clinical researchers who participate in the development of Legend Biotech Corporation's next-generation therapies, which extends beyond multiple myeloma.

Investigators are engaged in studies for pipeline candidates targeting other hematological malignancies and solid tumors. For example, preliminary results from Phase 1 dose-escalation studies for LB2102 (lung cancers) and LB1908 (gastroesophageal cancers) were featured at major medical meetings in 2025.

The development of LB2102, a DLL-3 targeting CAR-T therapy, is associated with license revenue recognized over time as the Phase 1 clinical trial progresses.

Key engagement points for investigators include:

• Presenting data at major congresses like ASCO and EHA in 2025.
• Participation in Phase 1 dose-escalation studies for solid tumor programs.

Finance: draft 13-week cash view by Friday.

Legend Biotech Corporation (LEGN) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving Legend Biotech Corporation's operations as of late 2025. The cost structure is heavily weighted toward supporting its commercial success and pipeline development.

A primary cost component is the High Cost of Collaboration Revenue. For the three months ended September 30, 2025, this cost totaled $113.3 million. This increase from the prior year was primarily due to Legend Biotech's share of the cost of sales connected with CARVYKTI® sales under the Janssen Agreement and expenditures made to support expansion in manufacturing capacity.

The commitment to pipeline advancement is reflected in Significant Research and Development (R&D) expenses. These expenses reached $113.1 million for the three months ended September 30, 2025. This rise from the prior year was attributed to higher pipeline-related research and development activities, plus expenditures in BCMA front line clinical studies.

The company is actively engaged in Capital expenditures for expanding global manufacturing capacity. A concrete example of this investment is the €165 million joint investment with Johnson & Johnson to expand the state-of-the-art facility at Tech Lane Ghent Science Park in Belgium. This second phase of investment reinforces the Ghent operations as a major European hub for cell therapies.

Commercial scaling drives the Selling and Distribution expenses. These amounted to $52.6 million for the third quarter of 2025. This figure reflects higher commercial costs, including sales force expansion and Janssen-related marketing and market access activities, which naturally rose alongside collaboration revenue.

The final area outlined in the cost structure involves the Costs associated with maintaining and defending intellectual property. While specific figures for IP defense are not itemized separately in the readily available Q3 2025 data, these costs are embedded within the overall operating expenses, including R&D and administrative overhead.

Here's a quick look at the key expense categories for the third quarter of 2025:

Cost Category	Amount (Q3 2025)
Cost of Collaboration Revenue	$113.3 million
Research and Development Expenses	$113.1 million
Selling and Distribution Expenses	$52.6 million

You can see the scale of investment in the following operational areas:

• Expansion of CAR-T manufacturing in Ghent, Belgium, involving a €165 million joint investment.
• Higher commercial costs tied to sales force expansion.
• Expenditures supporting pipeline research and clinical studies.

Legend Biotech Corporation (LEGN) - Canvas Business Model: Revenue Streams

You're looking at the core money-making engine for Legend Biotech Corporation as of late 2025, and it's heavily concentrated around one blockbuster asset. Honestly, the revenue structure is straightforward: it's all about the success of CARVYKTI (ciltacabtagene autoleucel) through the Janssen collaboration, supplemented by specific licensing income. Here's the quick math on what hit the books for the third quarter ending September 30, 2025.

The primary financial inflows are clearly delineated into product-related collaboration revenue and distinct license revenue. It's important to note that the massive CARVYKTI net trade sales figure is the gross number driving the collaboration revenue split, not a separate, additive revenue line for Legend Biotech's total top line, which is a common structure in these co-commercialization deals.

Revenue Component	Q3 2025 Amount (USD)	Primary Driver/Source
CARVYKTI Net Trade Sales (Gross Driver)	$524 million	Global commercialization of CARVYKTI
Collaboration Revenue	$261.8 million	Legend Biotech's share from CARVYKTI sales under the Janssen Agreement
License Revenue	$10.5 million	Novartis License Agreement (recognized over time based on Phase 1 trial activities for LB2102)

That collaboration revenue of $261.8 million, combined with the $10.5 million in license revenue, aligns almost perfectly with the reported total revenue of approximately $272 million for the quarter. That's a massive jump, showing the commercial momentum is translating directly into the recognized income stream.

Beyond the recurring and recognized revenue, you have to factor in the contingent, but significant, potential income streams that underpin the long-term valuation of these partnerships. These are the non-guaranteed, performance-based payments that can provide substantial, albeit lumpy, boosts to the financials.

• Potential milestone payments from the Janssen collaboration agreement.
• Potential milestone payments from the Novartis License Agreement for LB2102, which has up to $1.01 billion in potential milestones mentioned in prior agreements, though the Q3 recognition was tied to ongoing trial activities.
• Revenue recognition tied to the progression of pipeline assets in clinical trials under various agreements.

If onboarding takes 14+ days, churn risk rises, but for revenue recognition, the key action is tracking the progress of the LB2102 trial to estimate the timing of the next license revenue tranche. Finance: draft 13-week cash view by Friday.