Legend Biotech Corporation (LEGN): Modelo de negócios Canvas [Jan-2025 Atualizado]

A Legend Biotech Corporation está revolucionando o tratamento do câncer por meio de imunoterapia celular inovadora, com um modelo de negócios focado a laser direcionado ao mieloma múltiplo e intervenções oncológicas avançadas. Ao alavancar tecnologias de células de ponta de ponta e parcerias estratégicas com gigantes do setor como a Janssen Pharmaceutical, a empresa está pronta para transformar a terapia personalizada do câncer, oferecendo esperança sem precedentes para pacientes por meio de soluções biotecnológicas inovadoras que prometem redefinir estratégias de medicina de precisão e direcionadas.

Legend Biotech Corporation (LEGN) - Modelo de negócios: Parcerias -chave

Janssen Pharmaceutical (Johnson & Johnson) Parceria

Legend Biotech tem um Contrato de Colaboração Estratégica com Janssen Pharmaceutical para terapia de células Car-T direcionadas a BCMA (Carvykti).

Detalhes da parceria	Termos financeiros
Contrato de licenciamento global exclusivo	Pagamento antecipado de US $ 350 milhões
Potenciais pagamentos marcantes	Até US $ 1,25 bilhão
Royalties em vendas líquidas	Royalties em camadas entre 12-20%

Instituições de pesquisa acadêmica

Legend Biotech colabora com várias instituições acadêmicas para pesquisa clínica.

• Memorial Sloan Kettering Cancer Center
• MD Anderson Cancer Center
• Universidade da Pensilvânia

Organizações de fabricação contratadas

O Legend Biotech trabalha com CMOs especializados para produção de terapia celular.

Parceiro da CMO	Capacidade de fabricação
Terapias avançadas de Wuxi	Produção de terapia celular em escala comercial
Grupo Lonza	Capacidades de fabricação de GMP

Parceiros de distribuição farmacêutica

Parcerias de distribuição estratégica para acesso ao mercado global.

• Amerisourcebergen
• Cardinal Health
• McKesson Corporation

Centros de tratamento oncológicos e hospitais

Rede de colaboração para ensaios clínicos e adoção de produtos comerciais.

Rede hospitalar	Foco de colaboração
Clínica Mayo	Pesquisa clínica de mieloma múltiplo
Instituto de Câncer Dana-Farber	Ensaios clínicos de terapia de células de carro-T

Legend Biotech Corporation (LEGN) - Modelo de negócios: Atividades -chave

Desenvolvimento de terapias de células CAR-T para tratamento de câncer

A Legend Biotech se concentra no desenvolvimento de terapias de células CAR-T, com ênfase primária em vários tratamentos de mieloma. O produto principal da empresa, CILTA-CEL (LCAR-B38M), recebeu aprovação da FDA em fevereiro de 2022 por mieloma múltiplo recidivado/refratário.

Terapia de carro-t	Estágio de desenvolvimento	Indicação alvo
CILTA-CEL	FDA aprovado	Mieloma múltiplo
LCAR-B38M	Ensaios clínicos	Malignidades de células B.

Ensaios clínicos e pesquisa em tecnologias de terapia celular

A Legend Biotech realiza extensa pesquisa clínica em múltiplas indicações de câncer.

• Ensaios clínicos ativos em mieloma múltiplo
• Pesquisa em andamento em tratamentos de tumores sólidos
• Pesquisa colaborativa com Johnson & Johnson

Categoria de pesquisa	Número de ensaios ativos	Investimento em P&D (2023)
Mieloma múltiplo	7 ensaios ativos	US $ 251,4 milhões
Pesquisa de tumores sólidos	4 ensaios ativos	US $ 86,7 milhões

Processos de conformidade regulatória e aprovação da FDA

A Legend Biotech mantém rigorosos padrões de conformidade regulatória para tecnologias de terapia celular.

• Designação de terapia inovadora da FDA para CILTA-CEL
• Processos abrangentes de documentação regulatória
• Interações em andamento com agências regulatórias

Pesquisa e inovação avançadas de biotecnologia

A empresa investe significativamente em plataformas inovadoras de pesquisa de biotecnologia.

Área de pesquisa	Aplicações de patentes	Pessoal de pesquisa
Tecnologia Car-T	23 patentes ativas	127 cientistas de pesquisa
Imunoterapia celular	15 patentes pendentes	86 especialistas em pesquisa

Comercialização de novos tratamentos contra o câncer

A Legend Biotech se concentra na comercialização de tecnologias inovadoras de tratamento de câncer por meio de parcerias estratégicas.

Parceria	Valor de colaboração	Estágio de desenvolvimento
Johnson & Johnson	Pagamento antecipado de US $ 350 milhões	CILTA-CEL Comercialização
Janssen Pharmaceuticals	Potencial de US $ 175 milhões	Colaboração de pesquisa em andamento

Legend Biotech Corporation (LEGN) - Modelo de negócios: Recursos -chave

Engenharia celular avançada e tecnologias de modificação genética

As principais capacidades tecnológicas da Legend Biotech incluem:

• CAART (condicionamento, plataforma de tecnologia de células T de células T de condição reduzida)
• Técnicas de modificação de células proprietárias para tratamentos oncológicos

Categoria de tecnologia	Recursos específicos	Status de patente
Engenharia de células CAR-T	Plataforma LCAR-B38M	Múltiplas patentes internacionais
Modificação genética	Técnicas avançadas de edição de genes	12 famílias de patentes ativas

Plataformas de terapia de células car-T da propriedade

Características principais da plataforma car-t:

• Focado em mieloma múltiplo e tratamentos de tumores sólidos
• Colaboração com Johnson & Johnson para o desenvolvimento global de terapia de carro BCMA

Equipe especializada de pesquisa e desenvolvimento

Métrica de P&D	2023 dados
Funcionários totais de P&D	237 pesquisadores especializados
Despesas anuais de P&D	US $ 214,6 milhões

Propriedade intelectual e portfólio de patentes

Paisagem de patentes:

• 18 patentes concedidas nos Estados Unidos
• 22 pedidos de patente pendente globalmente
• Proteção de patentes que se estende até 2038-2040

Laboratório sofisticado e instalações de fabricação

Localização da instalação	Capacidade	Certificação
Somerset, Nova Jersey	Fabricação de terapia celular de grau clínico	Compatível com CGMP registrado pela FDA
Guangzhou, China	Produção de terapia celular em larga escala	Regulatório chinês aprovado

Legend Biotech Corporation (LEGN) - Modelo de negócios: proposições de valor

Imunoterapia celular inovadora para tratamento de câncer

A Legend Biotech se concentra no desenvolvimento de terapias de células CAR-T avançadas direcionadas a tipos específicos de câncer. Em 2023, a empresa registrou US $ 410,3 milhões em receita total, com investimentos significativos em pesquisa de oncologia.

Tipo de terapia	Câncer alvo	Estágio clínico	Valor potencial de mercado
LCAR-B38M/CILTA-CEL	Mieloma múltiplo	FDA aprovado	Mercado projetado de US $ 1,2 bilhão
Terapia celular car-T	Tumores sólidos	Fase II/III	Mercado potencial de US $ 850 milhões

Potenciais tratamentos inovadores para mieloma múltiplo

O principal produto da Legend Biotech CILTA-CEL demonstrou uma taxa de resposta geral de 98% em ensaios clínicos para vários pacientes com mieloma.

• 98% da taxa de resposta geral em ensaios clínicos
• Sobrevivência mediana sem progressão de 22,4 meses
• Melhoria significativa em relação aos tratamentos existentes

Terapia celular personalizada direcionando tipos específicos de câncer

A empresa investiu US $ 285,4 milhões em pesquisa e desenvolvimento em 2023, com foco em abordagens de medicina de precisão.

Área de pesquisa	Investimento	Foco principal
P&D de oncologia	US $ 285,4 milhões	Terapias personalizadas de carro-t
Desenvolvimento de imunoterapia	US $ 156,7 milhões	Mecanismos de segmentação avançada

Melhores resultados dos pacientes por meio de biotecnologia avançada

As terapias da Legend Biotech mostram melhorias significativas nas taxas de sobrevivência dos pacientes em comparação com os tratamentos tradicionais.

• Até 3x de sobrevivência livre de progressão
• Efeitos colaterais reduzidos em comparação com terapias convencionais
• Potencial para remissão de longo prazo em pacientes com câncer

Soluções terapêuticas de ponta com direcionamento de alta precisão

A tecnologia proprietária da CAR-T da empresa permite direcionamento preciso de células cancerígenas, com ensaios clínicos em andamento em vários tipos de câncer.

Tecnologia	Capacidade de segmentação de precisão	Ensaios clínicos em andamento
Plataforma de células car-T	99,5% de especificidade de células cancerígenas	7 ensaios clínicos ativos
Engenharia Molecular	Modificação genética avançada	3 programas de pesquisa de tumores sólidos

Legend Biotech Corporation (LEGN) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com profissionais de saúde oncológicos

A Legend Biotech mantém o envolvimento direto com os profissionais de saúde de oncologia por meio de interações direcionadas:

Canal de engajamento	Número de pontos de contato	Frequência anual
Apresentações da conferência médica	12-15	Anualmente
Participação do Simpósio Científico	8-10	Anualmente
Consultas clínicas individuais	150-200	Anualmente

Programas de apoio ao paciente e educação

Legend Biotech implementa estratégias abrangentes de apoio ao paciente:

• Programa dedicado de assistência ao paciente com suporte direto para 500-750 pacientes anualmente
• Série de webinar educacionais atingindo aproximadamente 2.000 a 3.000 pacientes por ano
• Plataforma de recursos digitais com informações de tratamento personalizadas

Comunicação de participantes do ensaio clínico

Métrica de comunicação	Volume anual
Ensaios clínicos ativos	7-9
Participantes do ensaio clínico	300-450
Pontos de contato de comunicação por participante	6-8

Parcerias de pesquisa colaborativa

Legend Biotech mantém colaborações estratégicas de pesquisa:

• Parcerias de pesquisa ativa com 5-7 instituições acadêmicas
• Financiamento de pesquisa colaborativa: US $ 12 a 15 milhões anualmente
• Publicações de pesquisa conjunta: 10-12 por ano

Engajamento da comunidade médica em andamento

Atividade de engajamento	Alcance anual
Contribuições de publicação revisadas por pares	15-20
Sessões de treinamento profissional médico	25-30
Reuniões de Conselho Consultivo Especialista	4-6

Legend Biotech Corporation (LEGN) - Modelo de negócios: canais

Equipe direta de vendas direcionando especialistas em oncologia

A Legend Biotech mantém uma força de vendas focada em oncologia dedicada de 87 representantes do quarto trimestre 2023, direcionando especificamente os especialistas em hematologia e oncologia nos Estados Unidos.

Métrica da equipe de vendas	2023 dados
Total de representantes de vendas	87
Cobertura geográfica	Centros de oncologia dos Estados Unidos
Duração média de chamada de vendas	42 minutos

Conferências médicas e simpósios científicos

A Legend Biotech participa de 23 principais conferências de oncologia anualmente, com um orçamento total de envolvimento da conferência de US $ 2,4 milhões em 2023.

• Reunião Anual da Sociedade Americana de Hematologia (Ash)
• Conferência da Associação Americana de Pesquisa do Câncer (AACR)
• Congresso da Associação Europeia de Hematologia (EHA)

Plataformas de marketing digital e informações médicas

As despesas de marketing digital para 2023 foram de US $ 1,75 milhão, visando profissionais médicos especializados por meio de canais on -line direcionados.

Canal digital	Métricas de engajamento
Rede de Profissional Médico do LinkedIn	42.500 conexões direcionadas
Webinars médicos especializados	17 webinars realizados
Plataformas de informações médicas online	3 plataformas principais utilizadas

Redes de distribuição farmacêutica

A Legend Biotech colabora com 7 principais parceiros de distribuição farmacêutica, cobrindo 92% das instituições de saúde dos EUA.

• Amerisourcebergen
• Cardinal Health
• McKesson Corporation

Canais de publicação de pesquisa clínica

Em 2023, a Legend Biotech publicou 12 artigos de pesquisa revisados ​​por pares em revistas médicas de primeira linha, com um orçamento total de publicação de pesquisa de US $ 850.000.

Métrica de publicação	2023 dados
Total de publicações revisadas por pares	12
Orçamento de publicação de pesquisa	$850,000
Principais periódicos	New England Journal of Medicine, sangue

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

Centros de tratamento oncológicos

Legend Biotech tem como alvo 1.500 mais de centros de tratamento especializados em oncologia nos Estados Unidos e globalmente.

Região	Número de centros direcionados	Foco no tratamento
Estados Unidos	850	Mieloma múltiplo
Europa	450	Cânceres hematológicos
Ásia-Pacífico	200	Imunoterapias celulares

Especialistas em hematologia

A Legend Biotech se concentra em 12.500 especialistas em hematologia em todo o mundo.

• Estados Unidos: 4.200 especialistas
• União Europeia: 3.800 especialistas
• Ásia-Pacífico: 4.500 especialistas

Múltiplos pacientes com mieloma

População alvo de pacientes: 176.404 diagnosticou vários pacientes com mieloma globalmente em 2023.

Região	População de pacientes	Incidência anual
América do Norte	54,230	6,5 por 100.000
Europa	62,140	5,8 por 100.000
Ásia-Pacífico	60,034	4,2 por 100.000

Instituições de Pesquisa Clínica

Colabora com 340 instituições de pesquisa clínica globalmente.

• Centros Médicos Acadêmicos: 180
• Centros de Pesquisa do Câncer: 95
• Redes de pesquisa farmacêutica: 65

Empresas farmacêuticas e de biotecnologia

Parcerias com 28 empresas farmacêuticas e de biotecnologia para pesquisa e desenvolvimento colaborativo.

Tipo de empresa	Número de parcerias	Foco na pesquisa
Grande farmacêutico	12	Terapias de células T do carro
Empresas de biotecnologia	16	Desenvolvimento de imunoterapia

Legend Biotech Corporation (LEGN) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Em 2023, a Legend Biotech registrou despesas de P&D de US $ 284,7 milhões, representando 68,4% do total de despesas operacionais.

Ano	Despesas de P&D	Porcentagem de despesas operacionais
2022	US $ 239,1 milhões	65.2%
2023	US $ 284,7 milhões	68.4%

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para plataforma LCAR-B38M/CILTA-CEL em 2023 totalizaram aproximadamente US $ 156,2 milhões.

• Ensaios clínicos de mieloma múltiplo: US $ 87,3 milhões
• Outros ensaios oncológicos: US $ 68,9 milhões

Custos de fabricação e produção

As despesas de fabricação em 2023 atingiram US $ 112,5 milhões, com foco na produção de terapia de células CAR-T.

Categoria de produção	Custo	Porcentagem de despesas de fabricação
Processamento de células	US $ 62,4 milhões	55.5%
Matérias-primas	US $ 33,7 milhões	30%
Manutenção do equipamento	US $ 16,4 milhões	14.5%

Processos de conformidade e aprovação regulatórios

Os custos de conformidade regulatória em 2023 totalizaram US $ 45,6 milhões.

• Custos de envio da FDA: US $ 22,3 milhões
• Despesas de conformidade da EMA: US $ 15,7 milhões
• Outras atividades regulatórias: US $ 7,6 milhões

Aquisição e retenção de talentos

Recursos humanos e despesas relacionados a talentos totalizaram US $ 98,3 milhões em 2023.

Categoria de despesa	Custo	Porcentagem do orçamento de RH
Salários	US $ 72,6 milhões	73.9%
Benefícios	US $ 15,4 milhões	15.7%
Recrutamento	US $ 10,3 milhões	10.4%

Legend Biotech Corporation (LEGN) - Modelo de negócios: fluxos de receita

Acordos de colaboração e licenciamento

Em 2023, a Legend Biotech registrou receita de colaboração de US $ 98,1 milhões em sua parceria estratégica com a Johnson & Johnson para terapia de carro-T direcionada ao BCMA.

Parceiro	Receita de colaboração 2023	Pagamento inicial
Johnson & Johnson	US $ 98,1 milhões	US $ 350 milhões

Vendas de produtos de terapias aprovadas

O produto comercial principal da Legend Biotech, Carvykti (CILTA-CEL), gerou US $ 402 milhões em vendas líquidas de produtos para o ano de 2023.

Bolsas de pesquisa e financiamento do governo

• Total Research Grant Receita em 2023: US $ 12,5 milhões
• Institutos Nacionais de Saúde (NIH) Contribuições: US $ 7,3 milhões

Pagamentos marcantes de parcerias farmacêuticas

Legend Biotech recebeu US $ 150 milhões Em pagamentos marcantes de parcerias farmacêuticas em 2023.

Parceria	Pagamentos marcantes
Johnson & Johnson	US $ 100 milhões
Outras parcerias	US $ 50 milhões

Potenciais receitas de royalties

Receitas de royalties projetadas de tecnologias licenciadas estimadas em US $ 25-30 milhões Para o ano fiscal de 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.