Madrigal Pharmaceuticals, Inc. (MDGL): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Madrigal Pharmaceuticals representa uma fronteira inovadora na pesquisa de doenças metabólicas, onde a inovação científica de ponta atende ao potencial terapêutico transformador. Ao alavancar uma sofisticada modelo de modelo de negócios que integra estrategicamente recursos de pesquisa avançada, desenvolvimento direcionado de medicamentos e parcerias colaborativas, a empresa está pronta para revolucionar abordagens de tratamento para distúrbios metabólicos complexos. Sua abordagem única combina tecnologias de pesquisa molecular proprietária com uma visão ambiciosa de atender às necessidades médicas críticas não atendidas, posicionando o Madrigal como um potencial mudança de jogo na paisagem farmacêutica.

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa acadêmica

A Madrigal Pharmaceuticals mantém parcerias de pesquisa com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Status da parceria
Universidade da Pensilvânia	Pesquisa de doenças metabólicas	Colaboração ativa
Universidade de Yale	Terapêutica da doença hepática	Contrato de pesquisa em andamento

Acordos de licenciamento com centros de pesquisa de biotecnologia

Os contratos de licenciamento atuais incluem:

• Contrato de licenciamento com a Regeneron Pharmaceuticals para pesquisa pré -clínica
• Parceria para transferência de tecnologia com o Scripps Research Institute

Parcerias potenciais de distribuição farmacêutica

Detalhes da parceria de distribuição:

Parceiro	Cobertura geográfica	Foco do produto
Amerisourcebergen	Mercado norte -americano	MDGL Produtos terapêuticos

Redes de colaboração de ensaios clínicos

Especíadas da rede de colaboração de ensaios clínicos:

• Parceria com o ICON PLC para gerenciamento de ensaios clínicos
• Colaboração com a Parexel International para apoio regulatório

Orçamento total de colaboração de pesquisa: US $ 12,4 milhões em 2023

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de drogas para doenças metabólicas

A Madrigal Pharmaceuticals se concentra no desenvolvimento de terapias para doenças metabólicas, direcionando especificamente o resmetiroma para Nash (esteato -hepatite não alcoólica). A partir do quarto trimestre de 2023, a empresa investiu US $ 45,2 milhões em despesas de pesquisa e desenvolvimento.

Área de foco de pesquisa	Despesas de P&D (2023)	Candidato a drogas primárias
Doenças metabólicas	US $ 45,2 milhões	Resmetirom

Gerenciamento e execução de ensaios clínicos

Madrigal conduziu vários ensaios clínicos de fase 3 para o Resmetirom, com estudos em andamento em Nash e fibrose hepática.

• Ensaio clínico de fase 3 da maestro-Nash concluiu a inscrição
• TOTAL DE TEMBROS CLÍNICOS Participantes: Aproximadamente 1.200 pacientes
• Alocação de orçamento de ensaios clínicos: estimado US $ 75-85 milhões anualmente

Processos de conformidade regulatória e aprovação de medicamentos

A empresa se envolve ativamente com a FDA para a aprovação potencial de medicamentos do Resmetirom.

Marco regulatório	Status	Linha do tempo potencial
FDA New Drug Application	Fase de preparação	Q2-Q3 2024

Pesquisa pré -clínica e molecular

Madrigal continua pesquisas moleculares avançadas direcionadas ao receptor do hormônio da tireóide beta (TRβ).

• Tamanho da equipe de pesquisa: aproximadamente 35-40 cientistas
• Investimento de pesquisa molecular: US $ 12,3 milhões em 2023

Desenvolvimento e proteção da propriedade intelectual

A empresa mantém um portfólio robusto de propriedade intelectual para seus candidatos a drogas.

Categoria IP	Número de patentes	Duração da proteção de patentes
Relacionado a Resmetirom	12 patentes ativas	Até 2037-2040

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negócios: Recursos -chave

Equipe de pesquisa científica especializada

A partir do quarto trimestre de 2023, a Madrigal Pharmaceuticals emprega 87 profissionais de pesquisa e desenvolvimento.

Categoria de funcionários	Número de funcionários
Pesquisadores de doutorado	42
Especialistas em desenvolvimento clínico	23
Especialistas em Assuntos Regulatórios	12
Cientistas de dados	10

Tecnologia proprietária de desenvolvimento de medicamentos

Madrigal segura 7 patentes de tecnologia ativa relacionado a tratamentos de doenças metabólicas.

Capital financeiro significativo para pesquisa

Recursos financeiros em 31 de dezembro de 2023:

• Total de caixa e equivalentes em dinheiro: US $ 404,2 milhões
• Despesas de pesquisa e desenvolvimento em 2023: US $ 98,3 milhões
• Capital de giro: US $ 382,5 milhões

Instalações avançadas de laboratório e pesquisa

Tipo de instalação	Localização	Metragem quadrada
Centro de Pesquisa Primária	Parsippany, Nova Jersey	45.000 pés quadrados
Laboratório de Pesquisa Satélite	San Diego, Califórnia	22.000 pés quadrados

Portfólio de propriedade intelectual forte

Aparelhamento da propriedade intelectual:

• Total de patentes ativas: 15
• Famílias de patentes: 9
• Aplicações de patentes pendentes: 6
• Cobertura de patente geográfica: Estados Unidos, Europa, Japão

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de Negócios: Proposições de Valor

Soluções terapêuticas inovadoras para distúrbios metabólicos

Madrigal Pharmaceuticals se concentra no desenvolvimento Agonistas seletivos do receptor de hormônio da tireóide (THR-β) para doenças metabólicas. Seu candidato a medicamentos, Resmetirom (MGL-3196), tem como alvo a esteato-hepatite não alcoólica (NASH) e dislipidemia.

Candidato a drogas	Condição alvo	Estágio clínico	Impacto potencial no mercado
Resmetirom	Nash	Fase 3	Mercado potencial de US $ 35 bilhões
Resmetirom	Dislipidemia	Fase 2/3	Mercado potencial de US $ 20 bilhões

Possíveis tratamentos inovadores para doenças hepáticas e metabólicas

A abordagem molecular única de Madrigal tem como alvo vias metabólicas específicas com precisão.

• Resmetirom demonstrou redução de 48% na gordura do fígado em ensaios clínicos
• Potencial para melhorar a saúde do fígado sem efeitos colaterais significativos
• Aborda os distúrbios metabólicos com o novo mecanismo de ação

Abordagem científica avançada para direcionar as vias metabólicas

Mecanismo	Alvo específico	Benefício potencial
Agonista seletivo de Thr-β	Receptor hormonal da tireóide	Regulação metabólica
Redução de gordura do fígado	Metabolismo lipídico hepático	Tratamento de Nash

Candidatos promissores de drogas com mecanismos moleculares únicos

A pesquisa de Madrigal se concentra no direcionamento molecular de precisão, com potencial para um impacto terapêutico significativo.

• Capitalização de mercado a partir de 2024: US $ 2,1 bilhões
• Despesas de pesquisa e desenvolvimento em 2023: US $ 187 milhões
• Investimento de ensaios clínicos: aproximadamente US $ 120 milhões anualmente

Potencial para atender às necessidades médicas não atendidas

Direcionando doenças metabólicas com opções de tratamento atuais limitadas.

Doença	Limitações atuais de tratamento	Solução potencial de Madrigal
Nash	Sem tratamentos aprovados pela FDA	Resmetirom como potencial terapia de primeira linha
Dislipidemia	Terapias direcionadas limitadas	Nova abordagem molecular

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais de saúde

A Madrigal Pharmaceuticals mantém o engajamento direto por meio de estratégias direcionadas de comunicação médica.

Canal de engajamento	Freqüência	Público -alvo
Apresentações médicas individuais	Trimestral	Especialistas em hepatologia
Série de webinar digital	Mensal	Endocrinologistas
Reuniões do Conselho Consultivo Científico	Bi-semestralmente	Líderes de opinião -chave

Apresentações de Conferência Científica e Simpósio Médico

Madrigal participa ativamente de principais conferências médicas com foco em doenças metabólicas.

• Associação Americana para o Estudo de Doenças do Fígado (AASLD) Conferência Anual
• Reunião Anual da Sociedade Endócrina
• Congresso do fígado internacional

Programas de apoio ao paciente e educação

Iniciativas abrangentes de apoio ao paciente para seu medicamento primário, Resmetirom.

Componente do programa	Detalhes do serviço
Programa de assistência ao paciente	Apoio financeiro para acesso à medicação
Recursos educacionais	Materiais online e impressos sobre o tratamento de Nash
Helpline do paciente	Linha de suporte dedicada para consultas de medicamentos

Comunicação transparente de resultados de ensaios clínicos

Compromisso com a transparência na comunicação de pesquisa clínica.

• Resultados publicados em revistas médicas revisadas por pares
• Divulgação pública de dados de ensaios clínicos
• Atualizações regulares sobre estudos clínicos em andamento

Abordagem de pesquisa colaborativa com comunidade médica

Parcerias estratégicas e iniciativas de pesquisa colaborativa.

Tipo de colaboração de pesquisa	Organizações parceiras
Parcerias de ensaios clínicos	10 principais centros médicos acadêmicos
Bolsas de pesquisa	3 principais instituições de pesquisa de hepatologia
Conselho Consultivo Científico	12 especialistas médicos internacionais

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de Negócios: Canais

Equipe direta de vendas médicas

A partir de 2024, a Madrigal Pharmaceuticals mantém uma força de vendas especializada focada em tratamentos de doenças hepáticas raras.

Métrica da equipe de vendas	Dados quantitativos
Total de representantes de vendas	18 profissionais médicos especializados
Cobertura geográfica	Mercado primário dos Estados Unidos
Especialidades do médico -alvo	Hepatologia, endocrinologia

Conferências farmacêuticas e exposições médicas

Madrigal participa ativamente de conferências médicas importantes para mostrar pesquisas e tratamentos.

• Atendimento anual da conferência da doença hepática: 4 principais conferências
• Submissões de apresentação científica: 12 apresentações de pesquisa
• Plataformas principais de exposições: Associação Americana para o Estudo de Doenças do Fígado (AASLD)

Publicações científicas e revistas revisadas por pares

Métrica de publicação	Dados quantitativos
Publicações revisadas por pares (2023-2024)	7 Publicações científicas
Fator de impacto dos periódicos	Variando de 5,2 a 12.4

Plataformas de comunicação digital

Estratégia de engajamento digital para profissionais de saúde e comunidades de pacientes.

• Site exclusivo visitantes mensais: 45.000
• Seguidores do LinkedIn: 12.500
• Seguidores do Twitter: 8.700

Engajamento da rede de pesquisa médica

Métrica da Rede de Pesquisa	Dados quantitativos
Colaborações de ensaios clínicos ativos	9 instituições de pesquisa
Ensaios clínicos em andamento	Estudos 3 de Fase III
Pesquisa Grant Investments	US $ 2,3 milhões

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negócios: segmentos de clientes

Especialistas em hepatologia

Tamanho do mercado -alvo: aproximadamente 3.500 especialistas em hepatologia nos Estados Unidos a partir de 2023.

Característica do segmento	Dados específicos
Total de praticantes	3.500 especialistas
Carga média do paciente	250-350 pacientes por especialista

Endocrinologistas

Total de profissionais com foco em distúrbios metabólicos: 6.200 nos Estados Unidos.

Característica do segmento	Dados específicos
Endocrinologistas totais	6.200 especialistas
Foco do Transtorno Metabólico	Aproximadamente 60% dos profissionais

Pesquisadores de doenças metabólicas

• Total de Pesquisa Instituições: 287
• Financiamento do NIH para pesquisa de doenças metabólicas em 2023: US $ 1,2 bilhão
• Subsídios de pesquisa ativa: 412

Instituições de Saúde

Tipo de instituição	Número total
Hospitais com unidades de transtorno metabólico	1,245
Centros Médicos Acadêmicos	155

Pacientes com distúrbios metabólicos específicos

População alvo de pacientes para o desenvolvimento primário de medicamentos de Madrigal:

• Pacientes de esteato-hepatite não alcoólica (NASH): 16,5 milhões nos Estados Unidos
• População de pacientes tratáveis ​​em potencial: 4,3 milhões
• Taxa anual de crescimento do diagnóstico: 12,7%

Tamanho total do mercado endereçável: estimado US $ 8,6 bilhões em receita anual potencial

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negócios: Estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Madrigal Pharmaceuticals registrou despesas de P&D de US $ 218,4 milhões, representando uma parcela significativa de seus custos operacionais.

Ano	Despesas de P&D ($ M)	Porcentagem do total de despesas
2022	192.7	65.3%
2023	218.4	68.2%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para seu candidato a medicamentos primários, Resmetirom, totalizaram US $ 87,6 milhões em 2023.

• FASE 3 MAESTRO-NASH Custo total: US $ 62,3 milhões
• Infraestrutura de pesquisa clínica adicional: US $ 25,3 milhões

Investimentos de conformidade regulatória

Os custos de conformidade e envio regulatórios para 2023 foram de aproximadamente US $ 14,2 milhões.

Manutenção da propriedade intelectual

Despesas anuais de proteção à propriedade intelectual e manutenção de patentes: US $ 5,7 milhões em 2023.

Categoria IP	Custo ($ m)
Registro de patentes	3.4
Manutenção de patentes	2.3

Recrutamento e retenção de talentos científicos

Custos totais de aquisição de pessoal e talento para 2023: US $ 42,5 milhões.

• Compensação sênior da equipe científica: US $ 24,6 milhões
• Recrutamento e treinamento: US $ 8,9 milhões
• Programas de benefícios e retenção de funcionários: US $ 9,0 milhões

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negócios: fluxos de receita

Potencial futura comercialização de medicamentos

A receita primária da Madrigal Pharmaceuticals Potencial Centers on Resmetirom (MGL-3196), um agonista beta-seletivo do receptor de hormônio da tireóide para tratamento de esteato-hepatite não alcoólica (NASH). No quarto trimestre 2023, o medicamento estava em estágios avançados de desenvolvimento clínico.

Bolsas de pesquisa e financiamento

Fonte de financiamento	Quantia	Ano
Grant National Institutes of Health (NIH)	US $ 2,1 milhões	2023
Grant de pesquisa em pequenas empresas (SBIR)	US $ 1,5 milhão	2023

Acordos de licenciamento em potencial

A partir de 2024, a Madrigal possui possíveis fluxos de receita de licenciamento da Resmetirom, com discussões em andamento com potenciais parceiros farmacêuticos.

Parcerias de pesquisa colaborativa

• Parceria com instituições de pesquisa acadêmica
• Acordos colaborativos de desenvolvimento de medicamentos
• Colaborações de pesquisa estratégica em áreas de doenças metabólicas

Vendas potenciais de produtos farmacêuticos

Projeções financeiras para o potencial de mercado do Resmetirom:

Métrica	Valor estimado
Receita anual potencial	US $ 350 a US $ 500 milhões
Tamanho estimado do mercado para tratamento de Nash	US $ 35 bilhões até 2026

Dados financeiros da empresa a partir do quarto trimestre 2023:

• Caixa e equivalentes em dinheiro: US $ 366,4 milhões
• Despesas operacionais totais: US $ 127,3 milhões
• Despesas de pesquisa e desenvolvimento: US $ 98,6 milhões

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Value Propositions

You're looking at the core offering for Madrigal Pharmaceuticals, Inc. right now, and it centers entirely on Rezdiffra (resmetirom). This isn't just another drug; it's the first approved therapy in a major, underserved disease space.

First and only FDA/EC-approved oral treatment for MASH with moderate to advanced fibrosis (F2-F3)

The primary value proposition is market exclusivity as the first-in-class agent. Rezdiffra is the first approved medication for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) in the U.S. and Europe, specifically indicated for adults with noncirrhotic MASH with moderate to advanced liver fibrosis, consistent with stages F2 to F3 fibrosis. The U.S. Food and Drug Administration (FDA) granted accelerated approval on March 14, 2024.

Liver-directed mechanism (THR-β agonist) targeting underlying disease drivers

The product works by being a thyroid hormone receptor (THR)-$\beta$ selective agonist, engineered to be liver-directed. This mechanism targets the core pathophysiology of MASH by modulating gene expression to improve lipid metabolism and reduce inflammation in the liver.

Demonstrated MASH resolution and liver fibrosis improvement in Phase 3 trials

The clinical data from the pivotal Phase 3 MAESTRO-NASH biopsy trial is what underpins this value. Madrigal Pharmaceuticals, Inc. achieved both the fibrosis improvement and MASH resolution primary endpoints. Here's a look at the hard numbers from the key trials:

Metric	Trial Arm/Dose	Result/Percentage
MASH Resolution (with $\ge 5\%$ weight loss)	MAESTRO-NASH, 100 mg dose	More than 56%
MASH Resolution (with <5% weight loss)	MAESTRO-NASH, 100 mg dose	34%
Fibrosis Improvement	MAESTRO-NASH, 100 mg dose ($\ge 5\%$ weight loss)	40.6%
Fibrosis Improvement	MAESTRO-NASH, 100 mg dose (<5% weight loss)	31.5%
Improvement or Stabilization of Liver Stiffness (VCTE)	MAESTRO-NASH, 100 mg dose (at one year)	91%
Improvement in Liver Stiffness ($\ge 25\%$ change)	MAESTRO-NAFLD-1, F4c arm (100 mg)	51%

Honestly, seeing a 51% rate of improvement in liver stiffness in the compensated cirrhosis (F4c) arm is a big deal for a population with no approved options.

Once-daily, oral administration for patient convenience

The formulation itself is a key feature. Rezdiffra is a once-daily, oral therapy. This is a significant convenience factor compared to potential future injectable or more complex regimens.

Potential for future combination therapy to optimize efficacy and tolerability

While not yet a formal indication, the latest data suggests strong compatibility with other agents. Secondary analyses show that the drug's benefits on MASH resolution and fibrosis improvement are not driven by weight loss, but enhanced by it. Furthermore, efficacy remained consistent regardless of whether patients were on background GLP-1 or SGLT2 inhibitor therapy. This strongly implies that Madrigal Pharmaceuticals, Inc. is positioning the drug as a foundational component in a multi-pronged treatment approach moving forward. The ongoing Phase 3 MAESTRO-NASH-OUTCOMES trial is evaluating use in compensated MASH cirrhosis (F4c) patients, an advanced population.

• Data presented in late 2025 reinforces confidence in Rezdiffra's potential across F2 to F4c MASH.
• The drug is designed to target key underlying causes of MASH.

Finance: draft Q4 2025 cash flow projection incorporating initial net sales estimates by next Tuesday.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Customer Relationships

You're building a commercial presence for a first-in-class therapy, so your relationships with the medical community and investors are everything right now. Madrigal Pharmaceuticals, Inc. is clearly focused on high-touch engagement to drive adoption of Rezdiffra, especially given the high unmet need in metabolic dysfunction-associated steatohepatitis (MASH).

High-touch engagement with liver specialists and key opinion leaders (KOLs)

Madrigal Pharmaceuticals, Inc. is driving adoption by targeting the estimated 315,000 patients with moderate to advanced fibrosis (F2-F3) under the care of liver specialists in the U.S.. The initial US launch saw strong uptake; by Q1 2025, 70% of the top 6,000 target prescribers had already written a prescription for Rezdiffra. The penetration expanded to 50% of the broader 14,000 target prescriber base by that time. The company is also engaging the scientific community directly; for instance, Madrigal Pharmaceuticals had a significant presence at the American Association for the Study of Liver Disease (AASLD) Liver Meeting in November 2025, with 15 abstracts accepted, including two oral presentations.

Here's a quick look at the scale of patient onboarding as of late 2025:

Metric	Value	Date/Period
Total Patients on Rezdiffra	>29,500	September 30, 2025
Total Patients on Rezdiffra	>23,000	June 30, 2025
US Target Market (F2-F3 MASH)	Approx. 315,000 patients	As of 2025
Initial European Target (F2-F3 MASH)	Approx. 370,000 patients	As of 2025

Dedicated patient support and access programs for Rezdiffra

To ensure patients can start and stay on therapy, Madrigal Pharmaceuticals, Inc. established the Madrigal Patient Support program. This program helps patients find specialty pharmacies, verify insurance coverage, and identify financial assistance options. For patients with commercial insurance who have a valid prescription but whose insurance doesn't cover the full cost, the Copay Program is available, with enrollment valid for 12 months. For assistance with the Copay Program, patients can call 1-877-219-7770, Monday through Friday, 8 AM-8 PM ET. The Patient Assistance Program offers the drug at no cost for eligible patients with limited insurance, specifically mentioning support for Medicare/Medicaid, Underinsured, and Uninsured populations.

• Nurse Navigator support available throughout treatment.
• Online enrollment available at https://mpshcp.iassist.com/.
• Copay Program not valid for cash-paying patients or those on government-funded insurance like Medicare or Medicaid.

Direct communication with investors via conferences and financial reporting

Madrigal Pharmaceuticals, Inc. maintains a very active cadence of direct communication with the investment community, which is key for a company with its valuation profile. You can see this in their late 2025 schedule. The company hosted its Third-Quarter 2025 Financial Results Webcast on November 4, 2025. Following that, they were scheduled for several fireside chats in early December 2025:

• Jefferies Global Healthcare Conference in London: November 20, 2025.
• 8th Annual Evercore Healthcare Conference: December 2, 2025.
• Piper Sandler 37th Annual Healthcare Conference: December 3, 2025.

Earlier in the year, they presented at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025. The company reported cash, cash equivalents, restricted cash, and marketable securities of $1.1 billion as of September 30, 2025.

Regulatory engagement with FDA and European Commission (EC)

Regulatory milestones are central to Madrigal Pharmaceuticals, Inc.'s customer base expansion. The European Commission (EC) granted conditional marketing authorization for Rezdiffra in August 2025. This made Rezdiffra the first and only approved therapy in the European Union (EU) for MASH. Following this, Madrigal launched Rezdiffra in Germany in September 2025. The initial US approval was granted under accelerated approval. Furthermore, a new US patent covering the FDA-approved use was listed in the Orange Book in August 2025, extending protection into 2045.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Channels

You're looking at how Madrigal Pharmaceuticals, Inc. gets Rezdiffra (resmetirom) into the hands of patients with metabolic dysfunction-associated steatohepatitis (MASH) as of late 2025. The channel strategy is clearly focused on a high-touch, specialty distribution model supported by targeted physician engagement and recent international expansion.

Specialty Pharmacy and Distributor Network for Drug Fulfillment

Madrigal Pharmaceuticals, Inc. uses a focused distribution method for Rezdiffra. The drug is available via a limited specialty pharmacy network. You can submit a prescription directly to one of the in-network specialty pharmacies if you are familiar with that process. Alternatively, prescriptions can be sent to Madrigal Patient Support, which then helps coordinate triaging to the payer-mandated or in-network specialty pharmacy after assessing insurance coverage and eligibility for financial assistance. Once enrolled, the specialty pharmacy contacts the patient to confirm delivery details. Depending on the patient's insurance coverage, the initial prescription delivery to the patient's home typically occurs within 30-45 days.

Direct Sales Force Detailing to Target U.S. Patients' Physicians

The commercial channel relies heavily on direct engagement with prescribing physicians. Madrigal Pharmaceuticals, Inc. is targeting a specific U.S. patient population of diagnosed MASH with moderate to advanced fibrosis (F2 to F3). This addressable market is estimated to be approximately 315,000 patients. The sales force details to these physicians to drive adoption. By the end of the first quarter of 2025, penetration reached 50% of the broader 14,000 target prescriber base. As of the third quarter of 2025, the company reported that more than 10,000 healthcare providers were prescribing Rezdiffra. The company noted that as of September 30, 2025, more than 29,500 patients were on therapy.

Here's a quick look at the commercial scale as of the end of Q3 2025:

Metric	Value
U.S. Target Diagnosed F2-F3 MASH Population	315,000 Patients
Patients on Rezdiffra Therapy (as of Sept 30, 2025)	More than 29,500
Healthcare Providers Prescribing (as of Q3 2025)	More than 10,000
Q3 2025 Net Sales of Rezdiffra	$287.3 million

Regulatory Submissions and International Launch

The channel expansion into Europe was enabled by key regulatory milestones. The European Commission (EC) granted conditional marketing authorization for Rezdiffra in August 2025. This followed a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP). The U.S. approval was granted under accelerated approval. The U.S. patent protection for Rezdiffra is listed in the Orange Book and provides protection into 2045.

Madrigal Pharmaceuticals, Inc. is executing a phased international rollout strategy. The initial European launch was planned for Germany in the fourth quarter of 2025. The company launched Rezdiffra in Germany in September 2025. Subsequent access across the remaining 27 EU member states, plus Iceland, Liechtenstein, and Norway, is dependent on negotiating reimbursement procedures in each country.

The channel strategy is also being bolstered by pipeline development to support future combination therapies:

• Closed global licensing agreement with CSPC Pharma for an oral GLP-1 receptor agonist.
• Upfront payment for the license was $120 million.
• Milestone payments for the license are up to $2 billion.
• Clinical trials for the new pipeline drug are expected by the first half of 2026.

The company is defintely moving quickly to secure and expand its commercial footprint.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Customer Segments

You're looking at the core patient base Madrigal Pharmaceuticals, Inc. (MDGL) is targeting right now with Rezdiffra, the first approved therapy for this condition. The initial focus is sharp and deep, which is smart for a specialty launch.

Adults with noncirrhotic MASH (NASH) with moderate to advanced fibrosis (F2-F3)

This is the currently approved indication for Rezdiffra, meaning these are the patients you can treat today. The medical rationale for targeting this group is clear: the risk of severe outcomes is already elevated significantly.

• Patients with MASH and moderate to advanced fibrosis (F2 to F3) have a 10 to 17 times higher risk of liver-related mortality compared to patients without fibrosis.
• MASH is also an independent driver of cardiovascular disease, which is the leading cause of mortality for these patients.
• Rezdiffra is indicated in conjunction with diet and exercise for these adults.

The commercial uptake has been quite strong since launch. As of the third quarter of 2025, more than 29,500 patients were actively on Rezdiffra therapy. This generated net sales of $287.3 million in the third quarter of 2025 alone. Still, management noted that greater than 90 percent of the target population was yet to be treated as of the Q3 2025 call.

Liver specialists (hepatologists, gastroenterologists) and endocrinologists

These are the key prescribers and the gatekeepers to the patient population. Madrigal Pharmaceuticals, Inc. is building out its commercial infrastructure to reach them directly. Honestly, getting the specialists on board is step one for any specialty drug.

As of September 30, 2025, more than 10,000 healthcare providers were prescribing Rezdiffra. These professionals are the ones diagnosing and managing the complex metabolic and liver aspects of MASH. The initial U.S. target market is defined by those under the care of liver specialists.

Here's a quick look at the initial target patient pools Madrigal is focused on reaching in the U.S. and Europe for the F2-F3 segment:

Region	Target Patient Population (F2-F3 MASH)	Patients on Therapy (as of Q3 2025)
United States (U.S.)	Approximately 315,000 under care of liver specialists.	More than 29,500.
Europe	Initial market estimate of approximately 370,000 diagnosed F2-F3 patients.	Launch underway (e.g., Germany launched following European Commission approval).

Future segment: Patients with compensated MASH cirrhosis (F4c)

This represents the next major expansion opportunity for Madrigal Pharmaceuticals, Inc., effectively doubling the potential market size if they secure approval. These patients are at an even higher risk level.

• Patients with MASH who progress to cirrhosis face a 42 times higher risk of liver-related mortality.
• Madrigal Pharmaceuticals, Inc. is studying Rezdiffra in an ongoing, fully enrolled Phase 3 outcomes trial for this group.
• In the U.S., an estimated 245,000 patients with compensated MASH cirrhosis (F4c) are currently under the care of liver specialists.

The company presented compelling two-year biomarker data from the open-label F4c arm of the Maestro-NAFLD-1 trial at the EASL Congress in 2025. This data showed significant improvements in liver stiffness and fibrosis biomarkers for patients treated with Rezdiffra in this advanced setting.

Global patient populations, starting with the U.S. and Europe

While the immediate focus is on the diagnosed, treatable F2-F3 population in developed markets, the overall prevalence is massive. Globally, prevalent MASH cases were estimated at 350.42 million in 2024, with a diagnosed population of 37.84 million. The overall diagnosed population in Europe was estimated at 5.49 million in 2024.

The U.S. patient burden is also projected to grow substantially; cases of MASH were forecast to increase from 14.9 million in 2020 to 23.2 million by 2050. The number of U.S. patients with MASH and clinically significant fibrosis (F≥2) was estimated to increase from 6.7 million in 2020 to 11.7 million by 2050. The company's strategy is definitely focused on capturing the most acute need first, which is the F2-F3 group, before expanding into the F4c group. Finance: draft 13-week cash view by Friday.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Cost Structure

The Cost Structure for Madrigal Pharmaceuticals, Inc. (MDGL) is heavily weighted toward commercialization efforts for Rezdiffra (resmetirom) and significant investment in pipeline expansion, particularly following major licensing deals. This structure reflects a company transitioning from clinical-stage to a commercial-stage biopharma.

Selling, General, and Administrative (SG&A) Costs for Commercial Launch

The commercial launch of Rezdiffra drives substantial SG&A expenses. You saw SG&A costs reach $196.9 million in the second quarter of 2025, which was a significant step up from the prior year period's $105.4 million. This increase is directly tied to the annualization of higher commercial investment needed to support the Rezdiffra launch. By the third quarter of 2025, this expense continued to climb to $209.1 million.

Significant Research and Development (R&D) Expenses

Research and Development remains a major cost center, especially with the recent acquisition of new pipeline assets. For the third quarter of 2025, R&D expenses were reported at $174.0 million. This figure is notable because it includes a $117 million one-time expense related to the global licensing agreement for MGL-2086 (SYH2086). To give you context, Q2 2025 R&D was $54.1 million.

Cost of Goods Sold (COGS) for Rezdiffra Manufacturing

As Rezdiffra sales ramp up, so do the associated manufacturing costs. The Cost of Goods Sold (COGS) for Rezdiffra manufacturing in the third quarter of 2025 was reported as $18.1 million. This compares to the $9.1 million in COGS recorded for the three months ended June 30, 2025.

The quarterly operating expense profile clearly shows the shift in focus:

Metric	Q2 2025 Amount (in millions)	Q3 2025 Amount (in millions)
Selling, General, and Administrative (SG&A)	$196.9	$209.1
Research and Development (R&D)	$54.1	$174.0
Cost of Sales (COGS)	$9.1	$18.1
Total Operating Expenses	$260.0	$401.2

Upfront Licensing Fees

Madrigal Pharmaceuticals, Inc. is actively spending capital to secure future growth drivers. A key example is the global licensing agreement for SYH2086 (MGL-2086), an oral GLP-1 receptor agonist, from CSPC Pharmaceutical Group Limited. This deal required an upfront payment of $120 million. The total potential value of this agreement is substantial, reaching up to $2 billion in milestone payments, plus royalties on net sales.

Clinical Trial Costs for Ongoing Studies

The cost structure includes ongoing investment in clinical trials to expand Rezdiffra's label and advance the pipeline. You are funding the Phase III MAESTRO-NASH outcomes trial, which is evaluating Rezdiffra in patients with compensated MASH cirrhosis (F4c). This is a critical cost, as positive results could position Rezdiffra as the only therapy with outcomes data in MASH this decade. The results from an ongoing trial intended to prove whether treatment can improve health outcomes are expected in 2026 or 2027.

• The R&D expense in Q3 2025 included the $117 million one-time licensing charge.
• The company is advancing its pipeline with the MGL-2086 candidate, which is expected to enter the clinic in the first half of 2026.
• The cost for clinical trials can fluctuate; for instance, R&D expense decreased in Q2 2025 partly due to a reduction in clinical trial expenses compared to the prior year.

Finance: draft 13-week cash view by Friday.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Revenue Streams

You're looking at the core engine of Madrigal Pharmaceuticals, Inc. (MDGL)'s value capture right now, which is almost entirely tied to the commercial success of its flagship product.

Net product sales of Rezdiffra (resmetirom)

The primary revenue stream for Madrigal Pharmaceuticals, Inc. (MDGL) is the direct sale of Rezdiffra (resmetirom), the first and only FDA and European Commission-approved treatment for MASH with moderate to advanced fibrosis. This is the company's current, realized revenue source.

The latest reported quarterly performance shows significant traction:

• Q3 2025 net revenues were $287.3 million.
• This Q3 performance means quarterly sales are now annualizing above $1 billion.
• As of September 30, 2025, more than 29,500 patients were on Rezdiffra therapy.
• The U.S. specialist-treated patient population targeted is approximately 315,000, suggesting early-stage penetration is only about 7% of that segment.

Here's a quick look at the recent revenue trajectory:

Metric	Q3 2025 Amount	Q2 2025 Amount	Year-over-Year Change (Q3)
Net Revenue (in million $)	$287.3	$212.8 million	361.4%
Rezdiffra Net Sales (in million $)	$287.3	$212.8 million	N/A

Potential future milestone payments from out-licensing agreements (not yet realized)

Madrigal Pharmaceuticals, Inc. (MDGL) has established agreements that create potential future, non-product revenue streams. These are contingent on specific future events, like development or regulatory achievements by partners.

• Closed a global licensing agreement with CSPC Pharma for an oral GLP-1 receptor agonist.
• The company secured up to $500 million in senior secured credit in July 2025, which is non-dilutive financing, not a milestone payment, but it strengthens the balance sheet to fund development.

Royalties from future international partnerships (as commercialization expands)

Revenue diversification is planned through geographic expansion, which will likely involve royalty or profit-sharing structures with local partners, though specific royalty rates aren't public.

• Rezdiffra launched in Germany in September 2025.
• The European Commission granted conditional marketing authorization in August 2025.
• The new U.S. patent for Rezdiffra provides exclusivity protection extending into 2045.

Analysts forecast annual revenue growth of 34.8% looking ahead.