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

Madrigal Pharmaceuticals stellt einen bahnbrechenden Meilenstein in der Forschung zu Stoffwechselkrankheiten dar, wo modernste wissenschaftliche Innovation auf transformatives therapeutisches Potenzial trifft. Durch die Nutzung eines ausgefeilten Geschäftsmodells, das fortschrittliche Forschungskapazitäten, gezielte Arzneimittelentwicklung und Kooperationspartnerschaften strategisch integriert, ist das Unternehmen in der Lage, Behandlungsansätze für komplexe Stoffwechselstörungen zu revolutionieren. Ihr einzigartiger Ansatz kombiniert proprietäre molekulare Forschungstechnologien mit einer ehrgeizigen Vision, kritische ungedeckte medizinische Bedürfnisse zu erfüllen und positioniert Madrigal als potenziellen Game-Changer in der Pharmalandschaft.

Madrigal Pharmaceuticals, Inc. (MDGL) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit akademischen Forschungseinrichtungen

Madrigal Pharmaceuticals unterhält Forschungspartnerschaften mit folgenden akademischen Institutionen:

Institution	Forschungsschwerpunkt	Partnerschaftsstatus
Universität von Pennsylvania	Forschung zu Stoffwechselkrankheiten	Aktive Zusammenarbeit
Yale-Universität	Therapeutika für Lebererkrankungen	Laufende Forschungsvereinbarung

Lizenzvereinbarungen mit Biotechnologie-Forschungszentren

Zu den aktuellen Lizenzvereinbarungen gehören:

• Lizenzvereinbarung mit Regeneron Pharmaceuticals für präklinische Forschung
• Technologietransferpartnerschaft mit dem Scripps Research Institute

Potenzielle Partnerschaften im Arzneimittelvertrieb

Details zur Vertriebspartnerschaft:

Partner	Geografische Abdeckung	Produktfokus
AmerisourceBergen	Nordamerikanischer Markt	Therapeutische Produkte von MDGL

Netzwerke für die Zusammenarbeit bei klinischen Studien

Besonderheiten des Netzwerks für die Zusammenarbeit bei klinischen Studien:

• Partnerschaft mit ICON plc für das Management klinischer Studien
• Zusammenarbeit mit Parexel International zur regulatorischen Unterstützung

Gesamtbudget für Forschungszusammenarbeit: 12,4 Millionen US-Dollar im Jahr 2023

Madrigal Pharmaceuticals, Inc. (MDGL) – Geschäftsmodell: Hauptaktivitäten

Arzneimittelforschung und -entwicklung für Stoffwechselerkrankungen

Madrigal Pharmaceuticals konzentriert sich auf die Entwicklung von Therapien für Stoffwechselerkrankungen, insbesondere auf Resmetirom zur Behandlung von NASH (nichtalkoholische Steatohepatitis). Im vierten Quartal 2023 investierte das Unternehmen 45,2 Millionen US-Dollar in Forschungs- und Entwicklungskosten.

Forschungsschwerpunktbereich	F&E-Ausgaben (2023)	Primärer Arzneimittelkandidat
Stoffwechselkrankheiten	45,2 Millionen US-Dollar	Resmetirom

Management und Durchführung klinischer Studien

Madrigal hat mehrere klinische Phase-3-Studien für Resmetirom durchgeführt, darunter laufende Studien zu NASH und Leberfibrose.

• Die Rekrutierung für die klinische Phase-3-Studie MAESTRO-NASH ist abgeschlossen
• Gesamtteilnehmer an klinischen Studien: Ungefähr 1.200 Patienten
• Zuweisung des Budgets für klinische Studien: Geschätzte 75–85 Millionen US-Dollar pro Jahr

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Das Unternehmen arbeitet aktiv mit der FDA im Hinblick auf eine mögliche Arzneimittelzulassung von Resmetirom zusammen.

Regulatorischer Meilenstein	Status	Möglicher Zeitplan
Antrag der FDA für ein neues Arzneimittel	Vorbereitungsphase	Q2-Q3 2024

Präklinische und molekulare Forschung

Madrigal setzt seine fortgeschrittene molekulare Forschung im Hinblick auf den Schilddrüsenhormonrezeptor Beta (TRβ) fort.

• Größe des Forschungsteams: Ungefähr 35–40 Wissenschaftler
• Investitionen in die Molekularforschung: 12,3 Millionen US-Dollar im Jahr 2023

Entwicklung und Schutz von geistigem Eigentum

Das Unternehmen verfügt über ein solides Portfolio an geistigem Eigentum für seine Arzneimittelkandidaten.

IP-Kategorie	Anzahl der Patente	Patentschutzdauer
Resmetirom-bezogen	12 aktive Patente	Bis 2037-2040

Madrigal Pharmaceuticals, Inc. (MDGL) – Geschäftsmodell: Schlüsselressourcen

Spezialisiertes wissenschaftliches Forschungsteam

Im vierten Quartal 2023 beschäftigt Madrigal Pharmaceuticals 87 Forschungs- und Entwicklungsexperten.

Mitarbeiterkategorie	Anzahl der Mitarbeiter
Doktoranden	42
Spezialisten für klinische Entwicklung	23
Experten für regulatorische Angelegenheiten	12
Datenwissenschaftler	10

Proprietäre Technologie zur Arzneimittelentwicklung

Madrigal hält 7 aktive Technologiepatente im Zusammenhang mit der Behandlung von Stoffwechselerkrankungen.

Erhebliches Finanzkapital für die Forschung

Finanzielle Ressourcen zum 31. Dezember 2023:

• Gesamte Zahlungsmittel und Zahlungsmitteläquivalente: 404,2 Millionen US-Dollar
• Forschungs- und Entwicklungsausgaben im Jahr 2023: 98,3 Millionen US-Dollar
• Betriebskapital: 382,5 Millionen US-Dollar

Fortschrittliche Labor- und Forschungseinrichtungen

Einrichtungstyp	Standort	Quadratmeterzahl
Primäres Forschungszentrum	Parsippany, New Jersey	45.000 Quadratfuß
Satellitenforschungslabor	San Diego, Kalifornien	22.000 Quadratfuß

Starkes Portfolio an geistigem Eigentum

Aufschlüsselung des geistigen Eigentums:

• Gesamtzahl der aktiven Patente: 15
• Patentfamilien: 9
• Ausstehende Patentanmeldungen: 6
• Geografischer Patentschutz: USA, Europa, Japan

Madrigal Pharmaceuticals, Inc. (MDGL) – Geschäftsmodell: Wertversprechen

Innovative therapeutische Lösungen für Stoffwechselstörungen

Madrigal Pharmaceuticals konzentriert sich auf die Entwicklung selektive Agonisten des Schilddrüsenhormonrezeptors Beta (THR-β). bei Stoffwechselerkrankungen. Ihr führender Medikamentenkandidat, Resmetirom (MGL-3196), zielt auf nichtalkoholische Steatohepatitis (NASH) und Dyslipidämie ab.

Arzneimittelkandidat	Zielbedingung	Klinisches Stadium	Mögliche Auswirkungen auf den Markt
Resmetirom	NASH	Phase 3	Potenzieller Markt im Wert von 35 Milliarden US-Dollar
Resmetirom	Dyslipidämie	Phase 2/3	Potenzieller Markt im Wert von 20 Milliarden US-Dollar

Mögliche bahnbrechende Behandlungen für Leber- und Stoffwechselerkrankungen

Der einzigartige molekulare Ansatz von Madrigal zielt präzise auf bestimmte Stoffwechselwege ab.

• Resmetirom zeigte in klinischen Studien eine Reduzierung des Leberfetts um 48 %
• Potenzial zur Verbesserung der Lebergesundheit ohne nennenswerte Nebenwirkungen
• Behandelt Stoffwechselstörungen mit neuartigem Wirkmechanismus

Fortgeschrittener wissenschaftlicher Ansatz zur gezielten Steuerung von Stoffwechselwegen

Mechanismus	Spezifisches Ziel	Potenzieller Nutzen
Selektiver THR-β-Agonist	Schilddrüsenhormonrezeptor	Stoffwechselregulation
Leberfettreduktion	Leberfettstoffwechsel	NASH-Behandlung

Vielversprechende Arzneimittelkandidaten mit einzigartigen molekularen Mechanismen

Madrigals Forschung konzentriert sich auf präzises molekulares Targeting mit Potenzial für erhebliche therapeutische Auswirkungen.

• Marktkapitalisierung ab 2024: 2,1 Milliarden US-Dollar
• Forschungs- und Entwicklungsausgaben im Jahr 2023: 187 Millionen US-Dollar
• Investition in klinische Studien: Ungefähr 120 Millionen US-Dollar pro Jahr

Potenzial zur Deckung ungedeckter medizinischer Bedürfnisse

Bekämpfung von Stoffwechselerkrankungen mit begrenzten aktuellen Behandlungsmöglichkeiten.

Krankheit	Aktuelle Behandlungseinschränkungen	Madrigals mögliche Lösung
NASH	Keine von der FDA zugelassenen Behandlungen	Resmetirom als potenzielle Erstlinientherapie
Dyslipidämie	Begrenzte gezielte Therapien	Neuartiger molekularer Ansatz

Madrigal Pharmaceuticals, Inc. (MDGL) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Madrigal Pharmaceuticals pflegt direktes Engagement durch gezielte medizinische Kommunikationsstrategien.

Engagement-Kanal	Häufigkeit	Zielgruppe
Medizinische Einzelvorträge	Vierteljährlich	Spezialisten für Hepatologie
Digitale Webinar-Reihe	Monatlich	Endokrinologen
Sitzungen des wissenschaftlichen Beirats	Halbjährlich	Wichtige Meinungsführer

Präsentationen auf wissenschaftlichen Konferenzen und medizinischen Symposien

Madrigal nimmt aktiv an wichtigen medizinischen Konferenzen mit Schwerpunkt auf Stoffwechselerkrankungen teil.

• Jahreskonferenz der American Association for the Study of Liver Diseases (AASLD).
• Jahrestagung der Endocrine Society
• Internationaler Leberkongress

Patientenunterstützungs- und Aufklärungsprogramme

Umfassende Initiativen zur Patientenunterstützung für ihr Hauptmedikament Resmetirom.

Programmkomponente	Servicedetails
Patientenhilfsprogramm	Finanzielle Unterstützung für den Zugang zu Medikamenten
Bildungsressourcen	Online- und gedruckte Materialien zur NASH-Behandlung
Patienten-Hotline	Spezielle Support-Hotline für Medikamentenanfragen

Transparente Kommunikation der Ergebnisse klinischer Studien

Engagement für Transparenz in der klinischen Forschungskommunikation.

• Veröffentlichte Ergebnisse in von Experten begutachteten medizinischen Fachzeitschriften
• Offenlegung der Daten klinischer Studien
• Regelmäßige Updates zu laufenden klinischen Studien

Kollaborativer Forschungsansatz mit der medizinischen Gemeinschaft

Strategische Partnerschaften und gemeinsame Forschungsinitiativen.

Art der Forschungskooperation	Partnerorganisationen
Partnerschaften für klinische Studien	Top 10 der akademischen medizinischen Zentren
Forschungsstipendien	3 große hepatologische Forschungseinrichtungen
Wissenschaftlicher Beirat	12 internationale medizinische Experten

Madrigal Pharmaceuticals, Inc. (MDGL) – Geschäftsmodell: Kanäle

Direktes medizinisches Vertriebsteam

Ab 2024 unterhält Madrigal Pharmaceuticals ein spezialisiertes Vertriebsteam, das sich auf die Behandlung seltener Lebererkrankungen konzentriert.

Vertriebsteam-Metrik	Quantitative Daten
Gesamtzahl der Vertriebsmitarbeiter	18 spezialisierte medizinische Fachkräfte
Geografische Abdeckung	Primärmarkt der Vereinigten Staaten
Fachgebiete der Zielärzte	Hepatologie, Endokrinologie

Pharmazeutische Konferenzen und medizinische Ausstellungen

Madrigal nimmt aktiv an wichtigen medizinischen Konferenzen teil, um Forschung und Behandlungen vorzustellen.

• Teilnahme an der jährlichen Konferenz zu Lebererkrankungen: 4 große Konferenzen
• Einreichung wissenschaftlicher Präsentationen: 12 Forschungspräsentationen
• Wichtige Ausstellungsplattformen: American Association for the Study of Liver Diseases (AASLD)

Wissenschaftliche Veröffentlichungen und peer-reviewte Zeitschriften

Veröffentlichungsmetrik	Quantitative Daten
Von Experten begutachtete Veröffentlichungen (2023–2024)	7 wissenschaftliche Publikationen
Impact-Faktor von Zeitschriften	Im Bereich von 5,2 bis 12,4

Digitale Kommunikationsplattformen

Digitale Engagement-Strategie für medizinisches Fachpersonal und Patientengemeinschaften.

• Einzigartige monatliche Besucher der Website: 45.000
• LinkedIn-Follower: 12.500
• Twitter-Follower: 8.700

Engagement im medizinischen Forschungsnetzwerk

Metrik des Forschungsnetzwerks	Quantitative Daten
Aktive Zusammenarbeit bei klinischen Studien	9 Forschungseinrichtungen
Laufende klinische Studien	3 Phase-III-Studien
Investitionen in Forschungsstipendien	2,3 Millionen US-Dollar

Madrigal Pharmaceuticals, Inc. (MDGL) – Geschäftsmodell: Kundensegmente

Spezialisten für Hepatologie

Zielmarktgröße: Ungefähr 3.500 Hepatologiespezialisten in den Vereinigten Staaten ab 2023.

Segmentcharakteristik	Spezifische Daten
Gesamtpraktiker	3.500 Spezialisten
Durchschnittliche Patientenbelastung	250-350 Patienten pro Facharzt

Endokrinologen

Gesamtzahl der Ärzte, die sich auf Stoffwechselstörungen konzentrieren: 6.200 in den Vereinigten Staaten.

Segmentcharakteristik	Spezifische Daten
Total Endokrinologen	6.200 Spezialisten
Schwerpunkt Stoffwechselstörung	Ungefähr 60 % der Praktizierenden

Forscher für Stoffwechselkrankheiten

• Gesamtzahl der Forschungseinrichtungen: 287
• NIH-Finanzierung für die Erforschung von Stoffwechselerkrankungen im Jahr 2023: 1,2 Milliarden US-Dollar
• Aktive Forschungsstipendien: 412

Gesundheitseinrichtungen

Institutionstyp	Gesamtzahl
Krankenhäuser mit Abteilungen für Stoffwechselstörungen	1,245
Akademische medizinische Zentren	155

Patienten mit spezifischen Stoffwechselstörungen

Zielgruppe für die primäre Arzneimittelentwicklung von Madrigal:

• Patienten mit nichtalkoholischer Steatohepatitis (NASH): 16,5 Millionen in den Vereinigten Staaten
• Potenzielle behandelbare Patientenpopulation: 4,3 Millionen
• Jährliche Diagnosewachstumsrate: 12,7 %

Insgesamt adressierbare Marktgröße: Geschätzter potenzieller Jahresumsatz von 8,6 Milliarden US-Dollar

Madrigal Pharmaceuticals, Inc. (MDGL) – Geschäftsmodell: Kostenstruktur

Umfangreiche Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Madrigal Pharmaceuticals Forschungs- und Entwicklungskosten in Höhe von 218,4 Millionen US-Dollar, was einen erheblichen Teil seiner Betriebskosten darstellt.

Jahr	F&E-Ausgaben (Mio. USD)	Prozentsatz der Gesamtausgaben
2022	192.7	65.3%
2023	218.4	68.2%

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien für ihren Hauptmedikamentenkandidaten Resmetirom beliefen sich im Jahr 2023 auf insgesamt 87,6 Millionen US-Dollar.

• Gesamtkosten der Phase-3-MAESTRO-NASH-Studie: 62,3 Millionen US-Dollar
• Zusätzliche klinische Forschungsinfrastruktur: 25,3 Millionen US-Dollar

Investitionen in die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften und die Einreichung beliefen sich im Jahr 2023 auf etwa 14,2 Millionen US-Dollar.

Aufrechterhaltung des geistigen Eigentums

Jährliche Ausgaben für den Schutz geistigen Eigentums und die Aufrechterhaltung von Patenten: 5,7 Millionen US-Dollar im Jahr 2023.

IP-Kategorie	Kosten (Mio. USD)
Patentanmeldung	3.4
Patentpflege	2.3

Rekrutierung und Bindung wissenschaftlicher Talente

Gesamtkosten für Personal- und Talentakquise für 2023: 42,5 Millionen US-Dollar.

• Vergütung für leitende wissenschaftliche Mitarbeiter: 24,6 Millionen US-Dollar
• Rekrutierung und Schulung: 8,9 Millionen US-Dollar
• Mitarbeitervorteile und Mitarbeiterbindungsprogramme: 9,0 Millionen US-Dollar

Madrigal Pharmaceuticals, Inc. (MDGL) – Geschäftsmodell: Einnahmequellen

Potenzielle zukünftige Kommerzialisierung von Arzneimitteln

Das Hauptumsatzpotenzial von Madrigal Pharmaceuticals konzentriert sich auf Resmetirom (MGL-3196), einen beta-selektiven Schilddrüsenhormonrezeptor-Agonisten zur Behandlung der nichtalkoholischen Steatohepatitis (NASH). Im vierten Quartal 2023 befand sich das Medikament in einem fortgeschrittenen klinischen Entwicklungsstadium.

Forschungsstipendien und Finanzierung

Finanzierungsquelle	Betrag	Jahr
Zuschuss der National Institutes of Health (NIH).	2,1 Millionen US-Dollar	2023
Zuschuss für Small Business Innovation Research (SBIR).	1,5 Millionen Dollar	2023

Mögliche Lizenzvereinbarungen

Ab 2024 verfügt Madrigal über potenzielle Einnahmequellen aus der Lizenzierung von Resmetirom, wobei derzeit Gespräche mit potenziellen Pharmapartnern geführt werden.

Verbundforschungspartnerschaften

• Partnerschaft mit akademischen Forschungseinrichtungen
• Kooperationsvereinbarungen zur Arzneimittelentwicklung
• Strategische Forschungskooperationen im Bereich Stoffwechselerkrankungen

Potenzielle Verkäufe pharmazeutischer Produkte

Finanzprognosen für das Marktpotenzial von Resmetirom:

Metrisch	Geschätzter Wert
Möglicher Jahresumsatz	350–500 Millionen US-Dollar
Geschätzte Marktgröße für NASH-Behandlung	35 Milliarden US-Dollar bis 2026

Finanzdaten des Unternehmens, Stand Q4 2023:

• Zahlungsmittel und Zahlungsmitteläquivalente: 366,4 Millionen US-Dollar
• Gesamtbetriebskosten: 127,3 Millionen US-Dollar
• Forschungs- und Entwicklungskosten: 98,6 Millionen US-Dollar

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.