Madrigal Pharmaceuticals, Inc. (MDGL): Business Model Canvas [Jan-2025 Mis à jour]

Madrigal Pharmaceuticals représente une frontière révolutionnaire dans la recherche sur les maladies métaboliques, où l'innovation scientifique de pointe rencontre un potentiel thérapeutique transformateur. En tirant parti d'une toile de modèle commercial sophistiqué qui intègre stratégiquement les capacités de recherche avancées, le développement de médicaments ciblés et les partenariats collaboratifs, la société est prête à révolutionner les approches de traitement pour les troubles métaboliques complexes. Leur approche unique combine des technologies de recherche moléculaire propriétaires avec une vision ambitieuse de répondre aux besoins médicaux critiques non satisfaits, positionnant Madrigal comme un changeur de jeu potentiel dans le paysage pharmaceutique.

Madrigal Pharmaceuticals, Inc. (MDGL) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les établissements de recherche universitaires

Madrigal Pharmaceuticals maintient des partenariats de recherche avec les établissements universitaires suivants:

Institution	Focus de recherche	Statut de partenariat
Université de Pennsylvanie	Recherche de maladies métaboliques	Collaboration active
Université de Yale	Thérapeutique des maladies du foie	Accord de recherche en cours

Accords de licence avec centres de recherche en biotechnologie

Les accords de licence actuels comprennent:

• Contrat de licence avec Regeneron Pharmaceuticals pour la recherche préclinique
• Partenariat de transfert de technologie avec Scripps Research Institute

Partenariats potentiels de distribution pharmaceutique

Détails du partenariat de distribution:

Partenaire	Couverture géographique	Focus du produit
Amerisourcebergen	Marché nord-américain	Produits thérapeutiques MDGL

Réseaux de collaboration d'essais cliniques

Spécificiaires du réseau de collaboration des essais cliniques:

• Partenariat avec Icon PLC pour la gestion des essais cliniques
• Collaboration avec Parexel International pour le soutien réglementaire

Budget total de collaboration de recherche: 12,4 millions de dollars en 2023

Madrigal Pharmaceuticals, Inc. (MDGL) - Modèle d'entreprise: activités clés

Recherche et développement de médicaments pour les maladies métaboliques

Madrigal Pharmaceuticals se concentre sur le développement de thérapies pour les maladies métaboliques, ciblant spécifiquement le resmétirom pour NASH (stéatohépatite non alcoolique). Au quatrième trimestre 2023, la société a investi 45,2 millions de dollars dans les frais de recherche et de développement.

Domaine de mise au point de recherche	Dépenses de R&D (2023)	Candidat au médicament principal
Maladies métaboliques	45,2 millions de dollars	Resmetirom

Gestion et exécution des essais cliniques

Madrigal a mené plusieurs essais cliniques de phase 3 pour Resmetirom, avec des études en cours dans la fibrose de Nash et du foie.

• MAESTRO-NASH Phase 3 Essai clinique achevé l'inscription
• Participants totaux d'essai cliniques: environ 1 200 patients
• Attribution du budget des essais cliniques: estimation de 75 à 85 millions de dollars par an

Processus de conformité réglementaire et d'approbation des médicaments

La société s'engage activement avec la FDA pour l'approbation potentielle des médicaments de Resmetirom.

Jalon réglementaire	Statut	Chronologie potentielle
FDA Nouvelle application de médicament	Phase de préparation	Q2-Q3 2024

Recherche préclinique et moléculaire

Madrigal poursuit une recherche moléculaire avancée ciblant le récepteur de l'hormone thyroïdienne bêta (TRβ).

• Taille de l'équipe de recherche: environ 35-40 scientifiques
• Investissement de recherche moléculaire: 12,3 millions de dollars en 2023

Développement et protection de la propriété intellectuelle

La société maintient un portefeuille de propriété intellectuelle robuste pour ses candidats au médicament.

Catégorie IP	Nombre de brevets	Durée de protection des brevets
Resmetirom lié	12 brevets actifs	Jusqu'en 2037-2040

Madrigal Pharmaceuticals, Inc. (MDGL) - Modèle d'entreprise: Ressources clés

Équipe de recherche scientifique spécialisée

Depuis le quatrième trimestre 2023, Madrigal Pharmaceuticals emploie 87 professionnels de la recherche et du développement.

Catégorie des employés	Nombre d'employés
Chercheurs de doctorat	42
Spécialistes du développement clinique	23
Experts en affaires réglementaires	12
Data scientifiques	10

Technologie de développement de médicaments propriétaires

Madrigal tient 7 brevets technologiques actifs liés aux traitements de maladies métaboliques.

Capital financier important pour la recherche

Ressources financières au 31 décembre 2023:

• Total des équivalents en espèces et en espèces: 404,2 millions de dollars
• Dépenses de recherche et développement en 2023: 98,3 millions de dollars
• Fonds de roulement: 382,5 millions de dollars

Installations avancées de laboratoire et de recherche

Type d'installation	Emplacement	En pieds carrés
Centre de recherche primaire	Parsippany, New Jersey	45 000 pieds carrés
Laboratoire de recherche par satellite	San Diego, Californie	22 000 pieds carrés

Portfolio de propriété intellectuelle solide

Répartition des propriétés intellectuelles:

• Brevets actifs totaux: 15
• Familles de brevets: 9
• Demandes de brevet en instance: 6
• Couverture des brevets géographiques: États-Unis, Europe, Japon

Madrigal Pharmaceuticals, Inc. (MDGL) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques innovantes pour les troubles métaboliques

Madrigal Pharmaceuticals se concentre sur le développement Agonistes sélectifs du récepteur d'hormones thyroïdiens (THR-β) pour les maladies métaboliques. Leur candidat en médicament principal, Resmétirom (MGL-3196), cible la stéatohépatite non alcoolique (NASH) et la dyslipidémie.

Drogue	Condition cible	Étape clinique	Impact potentiel du marché
Resmetirom	Nash	Phase 3	Marché potentiel de 35 milliards de dollars
Resmetirom	Dyslipidémie	Phase 2/3	Marché potentiel de 20 milliards de dollars

Traitements de percée potentielles pour les maladies hépatiques et métaboliques

L'approche moléculaire unique de Madrigal cible des voies métaboliques spécifiques avec précision.

• Resmetirom a démontré une réduction de 48% des graisses hépatiques dans les essais cliniques
• Potentiel pour améliorer la santé du foie sans effets secondaires significatifs
• Aborde les troubles métaboliques avec un nouveau mécanisme d'action

Approche scientifique avancée pour cibler les voies métaboliques

Mécanisme	Cible spécifique	Avantage potentiel
Agoniste sélectif de THR-β	Récepteur de l'hormone thyroïdienne	Réglementation métabolique
Réduction des graisses du foie	Métabolisme lipidique hépatique	Traitement de Nash

Des candidats à un médicament prometteur avec des mécanismes moléculaires uniques

Les recherches de Madrigal se concentrent sur le ciblage moléculaire de précision avec un potentiel d'impact thérapeutique significatif.

• Capitalisation boursière à partir de 2024: 2,1 milliards de dollars
• Dépenses de recherche et développement en 2023: 187 millions de dollars
• Investissement en essai clinique: environ 120 millions de dollars par an

Potentiel pour répondre aux besoins médicaux non satisfaits

Ciblant les maladies métaboliques avec des options de traitement actuelles limitées.

Maladie	Limites de traitement actuelles	Solution potentielle de Madrigal
Nash	Aucun traitement approuvé par la FDA	Resmetirom comme thérapie potentielle de première ligne
Dyslipidémie	Thérapies ciblées limitées	Nouvelle approche moléculaire

Madrigal Pharmaceuticals, Inc. (MDGL) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

Madrigal Pharmaceuticals maintient un engagement direct grâce à des stratégies de communication médicale ciblées.

Canal de fiançailles	Fréquence	Public cible
Présentations médicales individuelles	Trimestriel	Spécialistes de l'hépatologie
Série de webinaires numériques	Mensuel	Endocrinologues
Réunions du conseil consultatif scientifique	Bi-annuellement	Leaders d'opinion clés

Présentations des conférences scientifiques et des symposiums médicaux

Madrigal participe activement à des conférences médicales clés axées sur les maladies métaboliques.

• American Association for the Study of Liver Diseases (AASLD) Conférence annuelle
• Réunion annuelle de la Société endocrine
• Congrès international du foie

Programmes de soutien aux patients et d'éducation

Initiatives complètes de soutien aux patients pour leur médicament principal, Resmetirom.

Composant de programme	Détails du service
Programme d'aide aux patients	Support financier pour l'accès aux médicaments
Ressources éducatives	Matériel en ligne et imprimé sur le traitement de Nash
Service d'assistance aux patients	Ligne de support dédiée aux demandes de médicaments

Communication transparente des résultats des essais cliniques

Engagement à la transparence dans la communication de recherche clinique.

• Résultats publiés dans des revues médicales évaluées par des pairs
• Divulgation publique des données d'essai cliniques
• Mises à jour régulières sur les études cliniques en cours

Approche de recherche collaborative avec la communauté médicale

Partenariats stratégiques et initiatives de recherche collaborative.

Type de collaboration de recherche	Organisations partenaires
Partenariats d'essais cliniques	Top 10 des centres médicaux académiques
Subventions de recherche	3 Institutions de recherche d'hépatologie majeure
Conseil consultatif scientifique	12 experts médicaux internationaux

Madrigal Pharmaceuticals, Inc. (MDGL) - Modèle d'entreprise: canaux

Équipe de vente médicale directe

En 2024, Madrigal Pharmaceuticals maintient une force de vente spécialisée axée sur les traitements de maladie hépatique rares.

Métrique de l'équipe de vente	Données quantitatives
Représentants des ventes totales	18 professionnels de la santé spécialisés
Couverture géographique	Marché primaire des États-Unis
Spécialités des médecins cibles	Hépatologie, endocrinologie

Conférences pharmaceutiques et expositions médicales

Madrigal participe activement à des conférences médicales clés pour présenter la recherche et les traitements.

• Conférence annuelle des maladies du foie Associé: 4 conférences majeures
• Soumissions de présentation scientifique: 12 présentations de recherche
• Plateformes d'expositions clés: American Association for the Study of Liver Diseases (AASLD)

Publications scientifiques et revues à comité de lecture

Métrique de publication	Données quantitatives
Publications évaluées par des pairs (2023-2024)	7 publications scientifiques
Facteur d'impact des revues	Allant de 5,2 à 12.4

Plateformes de communication numérique

Stratégie d'engagement numérique pour les professionnels de la santé et les communautés de patients.

• Site Web Visiteurs mensuels uniques: 45 000
• LinkedIn adepte: 12 500
• Twitter abonnés: 8,700

Engagement du réseau de recherche médicale

Métrique du réseau de recherche	Données quantitatives
Collaborations d'essais cliniques actifs	9 institutions de recherche
Essais cliniques en cours	3 essais de phase III
Investissements de subvention de recherche	2,3 millions de dollars

Madrigal Pharmaceuticals, Inc. (MDGL) - Modèle d'entreprise: segments de clientèle

Spécialistes de l'hépatologie

Taille du marché cible: environ 3 500 spécialistes de l'hépatologie aux États-Unis en 2023.

Caractéristique du segment	Données spécifiques
Total des praticiens	3 500 spécialistes
Charge moyenne des patients	250 à 350 patients par spécialiste

Endocrinologues

Total des praticiens se concentrant sur les troubles métaboliques: 6 200 aux États-Unis.

Caractéristique du segment	Données spécifiques
Endocrinologistes totaux	6 200 spécialistes
Focus des troubles métaboliques	Environ 60% des praticiens

Chercheurs en maladie métabolique

• Institutions de recherche totale: 287
• Financement du NIH pour la recherche sur les maladies métaboliques en 2023: 1,2 milliard de dollars
• Subventions de recherche active: 412

Institutions de soins de santé

Type d'institution	Nombre total
Hôpitaux atteints de troubles métaboliques	1,245
Centres médicaux académiques	155

Patients souffrant de troubles métaboliques spécifiques

Cible la population de patients pour le principal développement de médicaments de Madrigal:

• Patients non alcooliques de stéatohépatite (NASH): 16,5 millions aux États-Unis
• Population potentielle de patients traitables: 4,3 millions
• Taux de croissance du diagnostic annuel: 12,7%

Taille totale du marché adressable: 8,6 milliards de dollars de revenus annuels potentiels

Madrigal Pharmaceuticals, Inc. (MDGL) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2023, Madrigal Pharmaceuticals a déclaré des dépenses de R&D de 218,4 millions de dollars, ce qui représente une partie importante de leurs coûts opérationnels.

Année	Dépenses de R&D ($ m)	Pourcentage des dépenses totales
2022	192.7	65.3%
2023	218.4	68.2%

Coûts de gestion des essais cliniques

Les frais d'essai cliniques pour leur principal candidat médicamenteux, Resmetirom, ont totalisé 87,6 millions de dollars en 2023.

• Phase 3 Trial de maestro-nash Coût total: 62,3 millions de dollars
• Infrastructure de recherche clinique supplémentaire: 25,3 millions de dollars

Investissements de conformité réglementaire

Les frais de conformité et de soumission réglementaires pour 2023 étaient d'environ 14,2 millions de dollars.

Maintenance de la propriété intellectuelle

Dépenses annuelles sur la protection de la propriété intellectuelle et l'entretien des brevets: 5,7 millions de dollars en 2023.

Catégorie IP	Coût ($ m)
Dépôt de brevet	3.4
Entretien de brevets	2.3

Recrutement et rétention des talents scientifiques

Total des frais d'acquisition du personnel et des talents pour 2023: 42,5 millions de dollars.

• Rémunération de personnel scientifique senior: 24,6 millions de dollars
• Recrutement et formation: 8,9 millions de dollars
• Programmes d'avantages sociaux et de rétention des employés: 9,0 millions de dollars

Madrigal Pharmaceuticals, Inc. (MDGL) - Modèle d'entreprise: Strots de revenus

Commercialisation potentielle des médicaments futurs

Le principal potentiel des revenus de Madrigal Pharmaceutical est centré sur Resmetirom (MGL-3196), un agoniste sélectif bêta du récepteur hormone thyroïdienne pour le traitement à la stéatohépatite non alcoolique (NASH). Au quatrième trimestre 2023, le médicament était en phase de développement clinique avancé.

Subventions et financement de recherche

Source de financement	Montant	Année
Subvention des National Institutes of Health (NIH)	2,1 millions de dollars	2023
Grant de recherche sur l'innovation des petites entreprises (SBIR)	1,5 million de dollars	2023

Accords de licence potentiels

Depuis 2024, Madrigal a une licence potentielle des sources de revenus de Resmetirom, avec des discussions en cours avec des partenaires pharmaceutiques potentiels.

Partenariats de recherche collaborative

• Partenariat avec les établissements de recherche universitaires
• Accords de développement de médicaments collaboratifs
• Collaborations de recherche stratégique dans les zones de maladies métaboliques

Ventes potentielles de produits pharmaceutiques

Projections financières pour le potentiel du marché des resagetirom:

Métrique	Valeur estimée
Revenus annuels potentiels	350 à 500 millions de dollars
Taille estimée du marché pour le traitement NASH	35 milliards de dollars d'ici 2026

Données financières de l'entreprise auprès du quatrième trimestre 2023:

• Equivalents en espèces et en espèces: 366,4 millions de dollars
• Dépenses d'exploitation totales: 127,3 millions de dollars
• Dépenses de recherche et de développement: 98,6 millions de dollars

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.