Madrigal Pharmaceuticals, Inc. (MDGL): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Madrigal Pharmaceuticals representa una frontera innovadora en la investigación de enfermedades metabólicas, donde la innovación científica de vanguardia cumple con el potencial terapéutico transformador. Al aprovechar un lienzo de modelo de negocio sofisticado que integra estratégicamente las capacidades de investigación avanzadas, el desarrollo de fármacos dirigidos y las asociaciones colaborativas, la compañía está preparada para revolucionar los enfoques de tratamiento para trastornos metabólicos complejos. Su enfoque único combina tecnologías de investigación moleculares patentadas con una visión ambiciosa de abordar las necesidades médicas no satisfechas críticas, posicionando a Madrigal como un posible cambio de juego en el paisaje farmacéutico.

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negocios: asociaciones clave

Colaboración estratégica con instituciones de investigación académica

Madrigal Pharmaceuticals mantiene asociaciones de investigación con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Estado de asociación
Universidad de Pensilvania	Investigación de enfermedades metabólicas	Colaboración activa
Universidad de Yale	Terapéutica de la enfermedad hepática	Acuerdo de investigación en curso

Acuerdos de licencia con Centros de Investigación de Biotecnología

Los acuerdos de licencia actuales incluyen:

• Acuerdo de licencia con Regeneron Pharmaceuticals para la investigación preclínica
• Asociación de transferencia de tecnología con Scripps Research Institute

Potencios de distribución farmacéutica de la distribución

Detalles de la asociación de distribución:

Pareja	Cobertura geográfica	Enfoque del producto
AmerisourceBergen	Mercado norteamericano	Productos terapéuticos MDGL

Redes de colaboración de ensayos clínicos

Detalios de red de colaboración de ensayos clínicos:

• Asociación con ICON PLC para gestión de ensayos clínicos
• Colaboración con Parexel International para apoyo regulatorio

Presupuesto de colaboración de investigación total: $ 12.4 millones en 2023

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negocio: actividades clave

Investigación y desarrollo de drogas para enfermedades metabólicas

Madrigal Pharmaceuticals se centra en el desarrollo de terapias para enfermedades metabólicas, específicamente dirigirse a resmetirom para NASH (esteatohepatitis no alcohólica). A partir del cuarto trimestre de 2023, la compañía invirtió $ 45.2 millones en gastos de investigación y desarrollo.

Área de enfoque de investigación	Gasto de I + D (2023)	Candidato de drogas primarias
Enfermedades metabólicas	$ 45.2 millones	Resmetirom

Gestión y ejecución del ensayo clínico

Madrigal ha realizado múltiples ensayos clínicos de fase 3 para resmetirom, con estudios en curso en Nash y fibrosis hepática.

• El ensayo clínico de Fase 3 de maestro de masa se completó la inscripción
• Participantes totales de ensayos clínicos: aproximadamente 1,200 pacientes
• Asignación del presupuesto del ensayo clínico: estimado de $ 75-85 millones anuales

Cumplimiento regulatorio y procesos de aprobación de medicamentos

La Compañía se involucra activamente con la FDA para la posible aprobación de drogas de Resmetirom.

Hito regulatorio	Estado	Línea de tiempo potencial
Aplicación de drogas nuevas de la FDA	Fase de preparación	Q2-Q3 2024

Investigación preclínica y molecular

Madrigal continúa una investigación molecular avanzada dirigida a la beta de receptor de hormona tiroidea (TRβ).

• Tamaño del equipo de investigación: aproximadamente 35-40 científicos
• Inversión de investigación molecular: $ 12.3 millones en 2023

Desarrollo y protección de la propiedad intelectual

La compañía mantiene una sólida cartera de propiedades intelectuales para sus candidatos a drogas.

Categoría de IP	Número de patentes	Duración de protección de patentes
Relacionado con Resmetirom	12 patentes activas	Hasta 2037-2040

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negocios: recursos clave

Equipo de investigación científica especializada

A partir del cuarto trimestre de 2023, Madrigal Pharmaceuticals emplea a 87 profesionales de investigación y desarrollo.

Categoría de empleado	Número de empleados
Investigadores de doctorado	42
Especialistas en desarrollo clínico	23
Expertos en asuntos regulatorios	12
Científicos de datos	10

Tecnología de desarrollo de fármacos patentados

Madrigal sostiene 7 patentes de tecnología activa relacionado con tratamientos de enfermedades metabólicas.

Capital financiero significativo para la investigación

Recursos financieros al 31 de diciembre de 2023:

• Cash total y equivalentes de efectivo: $ 404.2 millones
• Gastos de investigación y desarrollo en 2023: $ 98.3 millones
• Capital de trabajo: $ 382.5 millones

Instalaciones avanzadas de laboratorio e investigación

Tipo de instalación	Ubicación	Pies cuadrados
Centro de investigación primario	Parsippany, Nueva Jersey	45,000 pies cuadrados
Laboratorio de investigación satelital	San Diego, California	22,000 pies cuadrados

Cartera de propiedad intelectual fuerte

Desglose de la propiedad intelectual:

• Patentes activas totales: 15
• Familias de patentes: 9
• Aplicaciones de patentes pendientes: 6
• Cobertura de patentes geográficas: Estados Unidos, Europa, Japón

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas innovadoras para trastornos metabólicos

Madrigal Pharmaceuticals se centra en el desarrollo agonistas selectivos del receptor de hormona tiroidea (THR-β) para enfermedades metabólicas. Su candidato principal de drogas, Resmetirom (MGL-3196), se dirige a la esteatohepatitis no alcohólica (NASH) y la dislipidemia.

Candidato a la droga	Condición objetivo	Estadio clínico	Impacto potencial en el mercado
Resmetirom	Nash	Fase 3	Mercado potencial de $ 35 mil millones
Resmetirom	Dislipidemia	Fase 2/3	Mercado potencial de $ 20 mil millones

Posibles tratamientos innovadores para enfermedades hepáticas y metabólicas

El enfoque molecular único de Madrigal se dirige a vías metabólicas específicas con precisión.

• Resmetirom demostró una reducción del 48% en la grasa hepática en ensayos clínicos
• Potencial para mejorar la salud del hígado sin efectos secundarios significativos
• Aborda los trastornos metabólicos con un mecanismo de acción novedoso

Enfoque científico avanzado para atacar las vías metabólicas

Mecanismo	Objetivo específico	Beneficio potencial
Agonista selectivo de THR-β	Receptor de hormona tiroidea	Regulación metabólica
Reducción de grasa hepática	Metabolismo lipídico hepático	Tratamiento NASH

Candidatos de drogas prometedores con mecanismos moleculares únicos

La investigación de Madrigal se centra en la orientación molecular de precisión con potencial para un impacto terapéutico significativo.

• Capitalización de mercado a partir de 2024: $ 2.1 mil millones
• Gastos de investigación y desarrollo en 2023: $ 187 millones
• Inversión de ensayos clínicos: aproximadamente $ 120 millones anuales

Potencial para abordar las necesidades médicas no satisfechas

Dirigido a enfermedades metabólicas con opciones de tratamiento actuales limitadas.

Enfermedad	Limitaciones de tratamiento actuales	Solución potencial de Madrigal
Nash	Sin tratamientos aprobados por la FDA	Resmetirom como potencial terapia de primera línea
Dislipidemia	Terapias dirigidas limitadas	Enfoque molecular novedoso

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales de la salud

Madrigal Pharmaceuticals mantiene la participación directa a través de estrategias de comunicación médica específicas.

Canal de compromiso	Frecuencia	Público objetivo
Presentaciones médicas individuales	Trimestral	Especialistas en hepatología
Serie de seminarios web digitales	Mensual	Endocrinólogos
Reuniones de la junta asesora científica	By-anualmente	Líderes de opinión clave

Conferencia científica y presentaciones de simposio médico

Madrigal participa activamente en conferencias médicas clave centradas en enfermedades metabólicas.

• Conferencia anual de la Asociación Americana para el Estudio de Enfermedades Hepáticas (AASLD)
• Reunión anual de la sociedad endocrina
• Congreso de hígado internacional

Programas de apoyo y educación del paciente

Iniciativas integrales de apoyo al paciente para su fármaco primario, Resmetirom.

Componente del programa	Detalles del servicio
Programa de asistencia al paciente	Apoyo financiero para el acceso a la medicación
Recursos educativos	Materiales en línea e impresos sobre el tratamiento de Nash
Línea de ayuda de paciente	Línea de soporte dedicada para consultas de medicamentos

Comunicación transparente de resultados de ensayos clínicos

Compromiso con la transparencia en la comunicación de investigación clínica.

• Resultados publicados en revistas médicas revisadas por pares
• Divulgación pública de datos de ensayos clínicos
• Actualizaciones periódicas sobre estudios clínicos en curso

Enfoque de investigación colaborativa con comunidad médica

Asociaciones estratégicas e iniciativas de investigación colaborativa.

Tipo de colaboración de investigación	Organizaciones asociadas
Asociaciones de ensayos clínicos	Top 10 centros médicos académicos
Subvenciones de investigación	3 principales instituciones de investigación de hepatología
Junta Asesora Científica	12 expertos médicos internacionales

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negocios: canales

Equipo directo de ventas médicas

A partir de 2024, Madrigal Pharmaceuticals mantiene una fuerza de ventas especializada centrada en tratamientos raros de enfermedades hepáticas.

Métrica del equipo de ventas	Datos cuantitativos
Representantes de ventas totales	18 profesionales médicos especializados
Cobertura geográfica	Mercado primario de los Estados Unidos
Especialidades médicas objetivo	Hepatología, endocrinología

Conferencias farmacéuticas y exhibiciones médicas

Madrigal participa activamente en conferencias médicas clave para mostrar investigaciones y tratamientos.

• Asistencia anual de la conferencia de enfermedades hepáticas: 4 conferencias principales
• Presentación científica Presentación: 12 presentaciones de investigación
• Plataformas de exhibición clave: Asociación Americana para el Estudio de Enfermedades del Hígado (AASLD)

Publicaciones científicas y revistas revisadas por pares

Métrico de publicación	Datos cuantitativos
Publicaciones revisadas por pares (2023-2024)	7 publicaciones científicas
Factor de impacto de las revistas	Que va de 5.2 a 12.4

Plataformas de comunicación digital

Estrategia de participación digital para profesionales de la salud y comunidades de pacientes.

• Sitio web Visitantes mensuales únicos: 45,000
• Seguidores de LinkedIn: 12,500
• Seguidores de Twitter: 8,700

Compromiso de la red de investigación médica

Métrica de la red de investigación	Datos cuantitativos
Colaboraciones de ensayos clínicos activos	9 Instituciones de investigación
Ensayos clínicos en curso	TRABAJOS DE FASE III
Inversiones de subvenciones de investigación	$ 2.3 millones

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

Especialistas en hepatología

Tamaño del mercado objetivo: aproximadamente 3.500 especialistas en hepatología en los Estados Unidos a partir de 2023.

Característica de segmento	Datos específicos
Total practicantes	3.500 especialistas
Carga promedio de pacientes	250-350 pacientes por especialista

Endocrinólogos

Total practicantes que se centran en los trastornos metabólicos: 6.200 en los Estados Unidos.

Característica de segmento	Datos específicos
Endocrinólogos totales	6.200 especialistas
Enfoque de trastorno metabólico	Aproximadamente el 60% de los practicantes

Investigadores de enfermedades metabólicas

• Instituciones de investigación totales: 287
• Financiación de NIH para la investigación de enfermedades metabólicas en 2023: $ 1.2 mil millones
• Subvenciones de investigación activa: 412

Instituciones de atención médica

Tipo de institución	Número total
Hospitales con unidades de trastorno metabólico	1,245
Centros médicos académicos	155

Pacientes con trastornos metabólicos específicos

La población de pacientes objetivo para el desarrollo principal de fármacos de Madrigal:

• Pacientes de esteatohepatitis no alcohólica (NASH): 16,5 millones en los Estados Unidos
• Potencial de la población de pacientes tratables: 4.3 millones
• Tasa de crecimiento del diagnóstico anual: 12.7%

Tamaño total del mercado direccionable: estimado de $ 8.6 mil millones en posibles ingresos anuales

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, Madrigal Pharmaceuticals reportó gastos de I + D de $ 218.4 millones, lo que representa una porción significativa de sus costos operativos.

Año	Gastos de I + D ($ M)	Porcentaje de gastos totales
2022	192.7	65.3%
2023	218.4	68.2%

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para su candidato principal de fármacos, Resmetirom, totalizaron $ 87.6 millones en 2023.

• Costo total de prueba de masa de fase 3: $ 62.3 millones
• Infraestructura de investigación clínica adicional: $ 25.3 millones

Inversiones de cumplimiento regulatorio

Los costos de cumplimiento y presentación regulatoria para 2023 fueron de aproximadamente $ 14.2 millones.

Mantenimiento de la propiedad intelectual

Gastos anuales de protección de propiedad intelectual y mantenimiento de patentes: $ 5.7 millones en 2023.

Categoría de IP	Costo ($ M)
Presentación de patentes	3.4
Mantenimiento de patentes	2.3

Reclutamiento y retención de talento científico

Costos totales de adquisición de personal y talento para 2023: $ 42.5 millones.

• Compensación de personal científico senior: $ 24.6 millones
• Reclutamiento y capacitación: $ 8.9 millones
• Programas de beneficios y retención de empleados: $ 9.0 millones

Madrigal Pharmaceuticals, Inc. (MDGL) - Modelo de negocios: flujos de ingresos

Comercialización potencial de drogas futuras

El potencial principal de ingresos de Madrigal Pharmaceuticals se centra en resmetirom (MGL-3196), un agonista beta-selectivo receptor de hormona tiroidea para el tratamiento de esteatohepatitis no alcohólica (NASH). A partir del cuarto trimestre de 2023, el fármaco estaba en etapas de desarrollo clínico avanzados.

Subvenciones de investigación y financiación

Fuente de financiación	Cantidad	Año
Subvención de los Institutos Nacionales de Salud (NIH)	$ 2.1 millones	2023
Subvención de Investigación de Innovación de Pequeñas Empresas (SBIR)	$ 1.5 millones	2023

Posibles acuerdos de licencia

A partir de 2024, Madrigal tiene posibles flujos de ingresos de licencias de Resmetirom, con discusiones en curso con posibles socios farmacéuticos.

Asociaciones de investigación colaborativa

• Asociación con instituciones de investigación académica
• Acuerdos de desarrollo de fármacos colaborativos
• Colaboraciones de investigación estratégica en áreas de enfermedades metabólicas

Venta potencial de productos farmacéuticos

Proyecciones financieras para el potencial de mercado de Resmetirom:

Métrico	Valor estimado
Ingresos anuales potenciales	$ 350- $ 500 millones
Tamaño estimado del mercado para el tratamiento de NASH	$ 35 mil millones para 2026

Datos financieros de la empresa a partir del cuarto trimestre 2023:

• Equivalentes de efectivo y efectivo: $ 366.4 millones
• Gastos operativos totales: $ 127.3 millones
• Gastos de investigación y desarrollo: $ 98.6 millones

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.