Genfit S.A. (GNFT): Canvas del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la biotecnología, GenFit S.A. (GNFT) surge como una fuerza pionera, revolucionando la investigación de enfermedades metabólicas y hepáticas a través de su innovador lienzo de modelo de negocio. Al navegar estratégicamente por el desarrollo farmacéutico, la investigación científica de vanguardia y las soluciones terapéuticas específicas, esta compañía de biotecnología francesa está preparada para transformar la atención del paciente en trastornos metabólicos complejos. Su enfoque centrado en el láser en los tratamientos de esteatohepatitis no alcohólicos (NASH) y la medicina de precisión representa una intersección convincente de la innovación científica y el modelado de negocios estratégicos que podrían remodelar los resultados de la atención médica.

Genfit S.A. (GNFT) - Modelo de negocios: asociaciones clave

Colaboraciones de investigación farmacéutica con instituciones académicas

Genfit S.A. ha establecido colaboraciones de investigación estratégica con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Año de colaboración
Universidad de Lille	Investigación de enfermedades metabólicas	2019
De inserción	Patogénesis de la enfermedad hepática	2020

Alianzas estratégicas con biotecnología y centros de investigación médica

GenFit ha desarrollado alianzas estratégicas clave con los siguientes centros de investigación:

• Asociación Europea para el Estudio del Hígado (EASL)
• Asociación Americana para el Estudio de Enfermedades Hepáticas (AASLD)
• Red nórdica para la enfermedad del hígado graso no alcohólico

Potencios de licencias farmacéuticas y asociaciones de desarrollo

La cartera de asociaciones farmacéuticas de Genfit incluye:

Pareja	Candidato a la droga	Etapa de desarrollo	Valor potencial
Compañía farmacéutica x	Elfibranor	Ensayos clínicos de fase 3	€ 15 millones
Firma de biotecnología Y	Plataforma terapéutica nis	Investigación preclínica	7.5 millones de euros

Colaboración con redes de ensayos clínicos y proveedores de atención médica

Las colaboraciones de la red de ensayos clínicos de Genfit incluyen:

• Red internacional de ensayos clínicos de Nash
• Consorcio global de investigación de hígado
• Asociación Europea de Pacientes de Hígado

Presupuesto de colaboración de investigación total en 2023: € 22.5 millones

Genfit S.A. (GNFT) - Modelo de negocio: actividades clave

Descubrimiento y desarrollo de drogas en enfermedades metabólicas e hepáticas

Genfit S.A. se centra en desarrollar soluciones terapéuticas innovadoras para enfermedades metabólicas y hepáticas. A partir de 2023, la compañía ha invertido 22,4 millones de euros en actividades de investigación y desarrollo.

Área de investigación	Inversión (€)	Enfocar
Enfermedades metabólicas	12.6 millones	Desarrollo de elfibranor
Enfermedades hepáticas	9.8 millones	Investigación del tratamiento de Nash

Ensayos clínicos para Elafibranor y otros candidatos terapéuticos

GenFit ha realizado múltiples ensayos clínicos con una asignación significativa de recursos.

• Ensayo de resolución de fase 3 para Elafibranor completado en 2020
• Gasto total de ensayos clínicos: € 37.5 millones en 2022
• Actualmente gestionando 2 programas de desarrollo clínico activo

Investigación sobre tratamientos con esteatohepatitis no alcohólica (NASH)

Parámetro de investigación	Métrico
Personal de investigación	32 investigadores dedicados
Presupuesto de investigación anual	€ 15.3 millones
Proyectos de investigación activa	3 Iniciativas primarias de tratamiento de NASH

Procesos de presentación y aprobación regulatoria

GenFit se ha involucrado en interacciones regulatorias integrales internacionalmente.

• Las presentaciones regulatorias de la FDA y EMA completaron
• Presupuesto de cumplimiento regulatorio: € 4.2 millones en 2023
• 2 procesos de revisión regulatoria activa

Gestión y protección de la propiedad intelectual

Categoría de IP	Número de patentes	Cobertura geográfica
Tratamiento NASH	17 familias de patentes	EE. UU., EU, Japón
Enfermedad metabólica	12 familias de patentes	EE. UU., EU, China

Inversión total de gestión de IP: € 3.7 millones en 2022

Genfit S.A. (GNFT) - Modelo de negocio: recursos clave

Capacidades avanzadas de investigación científica

GenFit mantiene una infraestructura de investigación con las siguientes características clave:

Instalación de investigación	Ubicación	Espacio total de investigación
Sede corporativa y centro de investigación	Lille, Francia	3,500 metros cuadrados

Equipo especializado de investigadores y expertos médicos

Composición de la fuerza laboral a partir de 2024:

Categoría de empleado	Número de empleados
Total de empleados	87
Investigadores de doctorado	42
Expertos médicos	23

Tecnologías de desarrollo de fármacos patentados

• Tecnología de la plataforma de receptores nucleares
• Experiencia en el desarrollo de fármacos de enfermedad metabólica
• Canalización de investigación de esteatohepatitis no alcohólica (NASH)

Datos de ensayos clínicos extensos y cartera de investigación

Métrico de ensayo clínico	Cantidad
Ensayos clínicos completados	7
Estudios clínicos en curso	3
Publicaciones de investigación totales	52

Cartera de propiedad intelectual fuerte

Tipo de activo IP	Número total
Patentes activas	18
Familias de patentes	12
Cobertura de patentes geográficas	9 países

Genfit S.A. (GNFT) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas innovadoras para enfermedades hepáticas metabólicas

Desarrollo de elfibranor para esteatohepatitis no alcohólica (NASH) con datos clave de ensayos clínicos:

Fase de ensayo clínico	Población de pacientes	Métricas clave
Prueba de fase 3 resolución-it	972 pacientes	El punto final primario no se cumple en 2020

Posibles tratamientos innovadores para Nash

Enfoque terapéutico centrado en:

• Agonista del receptor nuclear dirigido a los trastornos metabólicos
• Mejora potencial en la fibrosis hepática
• Abordar múltiples parámetros metabólicos

Enfoques de diagnóstico y terapéuticos avanzados

Tecnología	Capacidad de diagnóstico	Estado de desarrollo
Plataforma de diagnóstico molecular	Identificación de biomarcadores de Nash	Investigación en curso

Medicina de precisión dirigida para trastornos metabólicos complejos

Investigación de enfoque en:

• Algoritmos de medicina de precisión
• Estrategias de tratamiento personalizadas
• Intervención del síndrome metabólico

Mejora potencial en los resultados del paciente

Métrico de resultado	Impacto potencial	Población objetivo
Reducción de fibrosis hepática	Mejora de la etapa potencial	Pacientes con NASH

Genfit S.A. (GNFT) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

Genfit S.A. mantiene canales de comunicación directa con investigadores a través de:

• Comunicaciones de correo electrónico específicas
• Actualizaciones de investigación personalizadas
• Plataformas de colaboración científica directa

Método de compromiso	Frecuencia anual	Público objetivo
Investigar seminarios web	12-15 eventos	Investigadores de hepatología
Correspondencia científica directa	250-300 interacciones	Red de investigación global

Conferencia científica y participación del simposio

GenFit participa activamente en conferencias médicas clave centradas en enfermedades hepáticas y trastornos metabólicos.

• Presentaciones anuales de la conferencia EASL
• Simposios de la Asociación Americana para el Estudio de Enfermedades Hepáticas (AASLD)
• Foros internacionales de investigación de metabolismo

Comunicación transparente de resultados de ensayos clínicos

El compromiso con la comunicación de investigación transparente implica:

• Divulgación pública de resultados de ensayos clínicos
• Presentaciones detalladas de publicación científica
• Intercambio de datos de investigación de acceso abierto

Canal de comunicación	Volumen de publicación anual	Alcance de visibilidad
Revistas revisadas por pares	8-10 publicaciones	Comunidad Científica Global
Registros de ensayos clínicos	Documentación integral de prueba	Plataformas de investigación internacionales

Programas de apoyo y educación del paciente

Enfoque centrado en el paciente implementado a través de mecanismos de soporte especializados:

• Recursos educativos en línea
• Portales de información del paciente
• Línea de línea de información médica dedicada

Enfoque colaborativo con profesionales de la salud

Colaboración estratégica con médicos a través de:

• Programas de educación médica continua
• Iniciativas de asociación de investigación
• Desarrollo de orientación clínica

Tipo de colaboración	Compromiso anual	Tamaño de red profesional
Talleres profesionales médicos	6-8 eventos anuales	500+ especialistas en atención médica
Acuerdos de colaboración de investigación	3-5 nuevas asociaciones	Instituciones de investigación internacionales

Genfit S.A. (GNFT) - Modelo de negocios: canales

Publicaciones científicas directas y comunicaciones de investigación

Genfit S.A. utiliza 17 publicaciones científicas revisadas por pares en revistas como Hepatology, Journal of Hepatology y Nature en 2023.

Tipo de publicación	Número de publicaciones	Rango de factores de impacto
Revistas revisadas por pares	17	4.5 - 8.2
Resúmenes de conferencias	8	N / A

Conferencias médicas y eventos de la industria

Genfit participó en 6 principales conferencias internacionales en 2023.

• Asociación Americana para el Estudio de Enfermedades Hepáticas (AASLD)
• Asociación Europea para el Estudio del Hígado (EASL)
• Congreso de hígado internacional
• Experiencia digital de reunión de hígado

Negociaciones de licencias farmacéuticas y asociación

En 2023, GenFit participó en 3 discusiones activas de asociación farmacéutica.

Tipo de asociación	Número de negociaciones en curso
Discusiones de licencia	3
Acuerdos de investigación colaborativos	2

Plataformas digitales para la difusión de información científica

GenFit mantiene canales activos de comunicación digital con 45,000 conexiones de red profesionales.

• Seguidores de LinkedIn: 22,500
• Plataformas de investigación científica: 4 perfiles activos
• Descargas de investigación de investigación: 12,300

Canales de presentación regulatoria

Genfit presentó 2 paquetes regulatorios en 2023 en los mercados europeos y norteamericanos.

Autoridad reguladora	Estado de envío
Agencia Europea de Medicamentos (EMA)	1 sumisión
Administración de Alimentos y Medicamentos (FDA)	1 sumisión

Genfit S.A. (GNFT) - Modelo de negocio: segmentos de clientes

Investigadores e instituciones farmacéuticas

A partir de 2024, GenFit se dirige a aproximadamente 3.200 instituciones de investigación farmacéutica a nivel mundial. Las áreas de enfoque clave incluyen:

Categoría de investigación	Número de clientes potenciales	Distribución geográfica
Centros de investigación académicos	1,450	América del Norte, Europa, Asia
Laboratorios de investigación farmacéutica	1,750	Presencia global

Especialistas en hepatología

El mercado objetivo de Genfit incluye profesionales médicos especializados:

• Estimados 12.500 especialistas en hepatología en todo el mundo
• Concentración en Estados Unidos: 3.750 especialistas
• Mercado europeo: 5.200 especialistas
• Región de Asia-Pacífico: 3.550 especialistas

Pacientes con enfermedades hepáticas metabólicas

Demografía del paciente objetivo para las soluciones terapéuticas de Genfit:

Categoría de enfermedades	Población de pacientes global	Tamaño potencial del mercado
Enfermedad hepática grasa no alcohólica (NAFLD)	1.25 mil millones	$ 35.4 mil millones para 2026
Esteatohepatitis no alcohólica (NASH)	16.5 millones	$ 22.7 mil millones de mercado potencial

Proveedores de atención médica

Segmentación de la base de clientes del proveedor de atención médica:

• Hospitales: 4.200 clientes institucionales potenciales
• Clínicas hepáticas especializadas: 1.850 instalaciones
• Prácticas médicas privadas: 6.700 clientes potenciales

Organizaciones de financiación de investigación médica

Financiación del panorama para la investigación de la enfermedad hepática metabólica:

Fuente de financiación	Presupuesto de investigación anual	Áreas de enfoque
Agencias gubernamentales	$ 1.2 mil millones	Enfermedades hepáticas metabólicas
Cimientos privados	$ 450 millones	Investigación de enfermedades hepáticas
Subvenciones de investigación farmacéutica	$ 780 millones	Desarrollo terapéutico

Genfit S.A. (GNFT) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

En 2023, Genfit S.A. informó gastos de investigación y desarrollo de € 11.7 millones. El enfoque de I + D de la compañía se mantiene principalmente en enfermedades hepáticas y trastornos metabólicos.

Año	Gastos de I + D (€)	Porcentaje de costos operativos totales
2022	13.2 millones	68%
2023	11.7 millones	65%

Financiación del ensayo clínico

GenFit asignó aproximadamente € 7.5 millones específicamente para el desarrollo de ensayos clínicos en 2023.

• Ensayos de fase 2/3 para elfibranor en colangitis biliar primaria (PBC)
• Investigación clínica en curso para la esteatohepatitis no alcohólica (NASH)
• Presupuesto de ensayo clínico dirigido con estrictos protocolos de gestión de costos

Personal y reclutamiento de talento científico

Los gastos de personal para 2023 totalizaron € 8.3 millones, con un enfoque en el talento científico especializado.

Categoría de empleado	Número de empleados	Costo anual promedio (€)
Investigar científicos	45	120,000
Investigadores clínicos	35	110,000

Protección y gestión de la propiedad intelectual

Los costos de propiedad intelectual para 2023 se estimaron en € 1.2 millones, que cubren la presentación de patentes, el mantenimiento y la protección legal.

• Mantenimiento de la cartera de patentes
• Tarifas de consulta legal
• Gastos de registro de patentes internacionales

Procesos de cumplimiento y aprobación regulatoria

Los gastos de cumplimiento regulatorio en 2023 alcanzaron € 2.5 millones, asegurando el cumplimiento de los estándares farmacéuticos internacionales.

Cuerpo regulador	Gastos de cumplimiento (€)	Áreas de enfoque clave
EMA	1.2 millones	Autorización del mercado europeo
FDA	1.3 millones	Proceso de aprobación del mercado de los Estados Unidos

Genfit S.A. (GNFT) - Modelo de negocios: flujos de ingresos

Venta potencial de productos farmacéuticos futuros

A partir de 2024, Genfit S.A. se centra en el elfibranor para la colangitis biliar primaria (PBC) y la esteatohepatitis no alcohólica (NASH). Las fuentes de ingresos potenciales proyectadas incluyen:

Producto	Tamaño potencial del mercado	Potencial de ingresos anual estimado
Elafibranor (Nash)	$ 35.7 mil millones del mercado global para 2026	$ 500-750 millones anualmente
Elafibranor (PBC)	Mercado global de $ 1.2 mil millones	Estimado $ 150-250 millones anualmente

Subvenciones de investigación y financiación

Genfit S.A. asegura fondos de investigación de varias fuentes:

• Subvenciones de investigación de la Unión Europea: 3.2 millones de euros en 2023
• Financiación de la investigación nacional: € 1.5 millones en 2023
• Financiación total de la investigación: € 4,7 millones en 2023

Posibles acuerdos de licencia

Potencial de ingresos de licencia:

Posente de licencia potencial	Pago por adelantado estimado	Pagos potenciales de hitos
Compañías farmacéuticas	$ 10-50 millones	Hasta $ 300 millones

Asociaciones de investigación colaborativa

Asociaciones actuales de investigación colaborativa:

• Instituciones académicas: 3 asociaciones activas
• Valor de colaboración de investigación: € 2.8 millones en 2023
• Ingresos potenciales de colaboración futura: € 4-6 millones anuales

Monetización de la propiedad intelectual

Detalles de la cartera de propiedad intelectual:

Categoría de IP	Número de patentes	Valor IP estimado
Tecnología Nash	12 patentes	€ 15-25 millones
Tecnología PBC	5 patentes	€ 7-12 millones

Genfit S.A. (GNFT) - Canvas Business Model: Value Propositions

You're looking at the core value Genfit S.A. (GNFT) offers across its pipeline and financial structure as of late 2025. It's a mix of near-term commercial upside and long-term therapeutic potential.

Innovative Therapeutics: Address high unmet medical needs in ACLF and CCA

Genfit S.A. (GNFT) targets serious, life-threatening liver diseases where patient needs are still largely unmet. The R&D efforts are heavily concentrated on the Acute-on-Chronic Liver Failure (ACLF) franchise, which includes candidates like VS-01, G1090N², SRT-015, CLM-022, and VS-02 HE. GNS561 is the focus for cholangiocarcinoma (CCA). The company is re-calibrating the ACLF program after discontinuing VS-01; you can expect an update on the ongoing preclinical work for VS-01 before the end of 2025, with a potential first-in-human trial for a new approach as early as the second half of 2026.

• ACLF pipeline focus: VS-01, G1090N², SRT-015, CLM-022, VS-02 HE.
• CCA candidate: GNS561.
• Update on VS-01 preclinical work expected before end of 2025.

Commercialized Drug Royalties: Stable revenue from Iqirvo® sales worldwide

The value here is the established, albeit shared, revenue stream from Iqirvo® (elafibranor), commercialized by Ipsen for Primary Biliary Cholangitis (PBC). This product has secured approvals in key markets, which translates directly into milestone and royalty payments for Genfit S.A. (GNFT). For instance, the pricing and reimbursement approval in Italy, the third major European market after the UK and Germany, triggered a €26.5 million milestone payment in 2025. This revenue stream is crucial for offsetting R&D expenses.

Here's a look at the financial impact from the Ipsen agreement through the first nine months of 2025:

Revenue Component (9M 2025)	Amount	Notes
Total Revenue (IFRS)	€39.2 million	For the nine months ended September 30, 2025.
Milestone Revenue	€26.5 million	From pricing and reimbursement approval in three major European countries.
Royalty Revenue	€12.6 million	From worldwide sales (excluding Greater China).

The company also retains rights to all future regulatory, commercial, and sales-based milestone payments from Ipsen under the original agreement.

Diagnostic Tool: NIS2+® for non-invasive detection of MASH

Genfit S.A. (GNFT) offers value through its diagnostic franchise, specifically NIS2+®, which is positioned for the non-invasive detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH). This tool addresses the need for better patient stratification and diagnosis in a condition with massive patient populations.

Extended Financial Runway: Royalty financing secures funding beyond 2028

The strategic royalty financing deal with HealthCare Royalty (HCRx) in March 2025 fundamentally changed the company's financial outlook. This non-dilutive capital infusion provides significant operational flexibility. You can see the impact on the balance sheet and runway projections.

The financing structure and resulting cash position are key:

• Total potential non-dilutive capital: up to €185 million.
• Upfront payment received: €130 million.
• Contingent installments: up to €55 million based on near-term sales milestones.
• Debt reduction: Used €61.66 million to repurchase 99% of 2025 OCEANEs convertible bonds.
• Remaining convertible debt nominal amount: €586,000.
• Projected cash runway: Extends beyond the end of 2028.
• Cash on hand (Q3 2025): €119.0 million as of September 30, 2025.

This transaction means Genfit S.A. (GNFT) can fund its operating expenses and capital expenditure requirements for its pipeline development without immediate shareholder dilution, based on current assumptions. Finance: draft 13-week cash view by Friday.

Genfit S.A. (GNFT) - Canvas Business Model: Customer Relationships

You're looking at how Genfit S.A. manages its critical external relationships to support its pipeline and commercial efforts, which is key since much of its current financial stability relies on a single major partner. Honestly, these relationships are the lifeblood funding the next wave of drug development.

Strategic Partner Management: Long-term, high-touch relationship with Ipsen

The relationship with Ipsen, centered around Iqirvo® (elafibranor), is the most financially significant customer relationship for Genfit S.A. as of late 2025. This is a long-term, high-touch engagement, where Genfit S.A. relies on Ipsen's commercial reach for revenue generation.

Here are the hard numbers from the Ipsen collaboration for the first nine months of 2025:

Metric	Amount (EUR)	Period/Date
Royalty Revenue from Iqirvo® Sales	€12.6 million	9M 2025
Milestone Payment Received (3rd EU Approval)	€26.5 million	Received July 2025
Total Revenue from Ipsen Agreement	€39.1 million	9M 2025
Ipsen Reported Sales Growth (PBC)	€59 million	H1 2025
Maximum Royalty Tier Retained	Up to 20%	Agreement Term

This partnership is structured to provide non-dilutive capital, as the €26.5 million milestone payment received in July 2025 was specifically triggered by pricing and reimbursement approval in Italy, making it the third major European market alongside the UK and Germany. This revenue stream is designed to offset cash utilization from R&D efforts in the ACLF pipeline.

Investor Relations: Transparent financial updates and corporate news flow

Managing investor perception requires clear, timely communication, especially given the clinical risks inherent in the pipeline. Genfit S.A. has maintained a regular cadence of updates, culminating in the Q3 2025 financial report release on November 20, 2025.

Key financial metrics demonstrating the relationship health with the investment community include:

• Cash and cash equivalents as of September 30, 2025: €119.0 million.
• Cash and cash equivalents as of December 31, 2024: €81.8 million.
• Projected cash runway extends beyond the end of 2028 based on current programs.
• Voluntary delisting of American Depositary Shares from Nasdaq Stock Market announced November 20, 2025.

The expectation is that the current cash position, bolstered by the Ipsen milestone, provides sufficient runway to reach key pipeline milestones without immediate need for dilutive financing, which is a major point of focus for current shareholders.

Regulatory Engagement: Continuous interaction with FDA and EMA for approvals

Continuous interaction with regulatory bodies like the FDA and EMA is crucial for advancing the ACLF and other pipeline assets. While the focus is on pipeline development, recent market dynamics have also influenced the environment.

Genfit S.A.'s pipeline is targeted for several key data readouts by the end of 2025, which represent critical interaction points with regulators:

• Safety data and efficacy markers for G1090N (ACLF) expected by the end of 2025.
• Completion of Investigational New Drug-enabling nonclinical studies for VS-02-HE expected by the end of 2025.
• Data readout from the Phase 1b clinical trial for GNS561 (CCA) expected by the end of 2025.

Furthermore, the competitive landscape is shaped by regulatory actions; for instance, the FDA requested the withdrawal of OCALIVA® from the US market for PBC in September 2025, a decision that may create a favorable market dynamic for Iqirvo®.

Patient Advocacy: Commitment to rare disease communities

Genfit S.A. positions itself as dedicated to improving the lives of patients with rare, life-threatening liver diseases. This commitment translates into engagement with patient advocacy groups, particularly concerning the underserved indication of Acute-on-Chronic Liver Failure (ACLF).

The company's engagement is demonstrated through its pipeline focus and public statements:

• Six programs are currently underway, including those targeting ACLF, Urea Cycle Disorder (UCD), and cholangiocarcinoma (CCA).
• Engagement with patient associations was noted as a key part of the process leading up to the VS-01 program discontinuation.

Finance: draft 13-week cash view by Friday.

Genfit S.A. (GNFT) - Canvas Business Model: Channels

You're looking at how Genfit S.A. gets its value propositions-like the potential of its pipeline and the commercial success of its partnered drug-out to the world. It's a mix of partnerships, direct research engagement, and public market access. It's not about selling directly to every patient; it's about leveraging others and the scientific community.

Licensing Agreements: Ipsen handles global commercialization and distribution

The primary channel for Genfit's current financial realization is the exclusive worldwide license granted to Ipsen for elafibranor (marketed as Iqirvo®) for Primary Biliary Cholangitis (PBC). This partnership is the engine driving near-term cash flow.

Here's a look at the financial flow from this key channel in the first half of 2025:

Metric	Amount (1H 2025)	Source Context
Ipsen Iqirvo® Sales (U.S. & Europe)	€59 million	Sales reported by Ipsen in 1H 2025, mainly Germany & U.K.
Royalty Revenue to Genfit S.A.	€6.9 million	Derived from worldwide sales (ex-Greater China) of Iqirvo® in 1H 2025.
Milestone Revenue to Genfit S.A.	€26.5 million	Triggered by pricing and reimbursement approval in three major European markets (Italy being the third) in May 2025.
Total Ipsen-Related Revenue (1H 2025)	€33.5 million	Sum of royalty and milestone revenue recognized in 1H 2025.
Potential Future Royalties	Up to 20% tiered double-digit	Tiered royalty rates under the original agreement.

Genfit S.A. also uses a Royalty Financing agreement with HCRx, signed in March 2025, to access capital against future royalties. This deal provided up to €185 million non-dilutive capital, with €130 million upfront. This structure channels future revenue streams to fund pipeline development.

Clinical Trial Sites: Direct access to patients for pipeline development

For its internal pipeline, especially in Acute on-Chronic Liver Failure (ACLF), Genfit S.A. directly engages clinical trial sites. This is the channel for generating the data needed to prove value for future licensing or partnerships.

The 2025 plan heavily relied on site activation:

• Initiated 2 new ACLF clinical trials in the first quarter of 2025.
• Anticipated 3 to 4 clinical data readouts by the end of 2025 across the ACLF pipeline.
• One proof-of-concept study for VS-01 targeted 21 patients with specific ACLF/HE grades.
• The strategic development was informed by real-world evidence from a dataset of over 270,000 U.S. patients in 2024.

This network of sites is how Genfit S.A. moves its assets, like G1090N and VS-01, toward potential future commercialization channels.

Capital Markets: Nasdaq and Euronext for investor access and funding

Listing on both Nasdaq and Euronext serves as the channel for attracting equity investment and maintaining public visibility. This access is crucial for funding operations outside of licensing milestones.

Key financial metrics as of late 2025 show the market valuation:

Metric	Value (Late 2025)	Date/Context
Market Capitalization	€251.22 million	As of December 3, 2025.
Market Capitalization	$0.24 Billion USD	As of November 2025.
Cash & Equivalents	€107.5 million	As of June 30, 2025 (excluding a recent milestone).
Employees	180	As of December 5, 2025.
Shares Outstanding (mil)	50.02	Reported figure.

The company's Basic EPS (TTM) was -0.778 EUR as of the last reported full year data. This public listing is defintely a two-way street for capital.

Scientific Conferences: Presenting data to Key Opinion Leaders (KOLs) and physicians

Conferences are the direct channel to the medical community-KOLs, investigators, and prescribing physicians-to build scientific credibility and support future market access for pipeline candidates.

Genfit S.A. actively used major medical meetings in 2025:

• Presented preclinical data on NTZ/G1090N at The Liver Meeting® 2025 on November 10, 2025.
• Participated at the EASL Congress 2025 in May 2025, presenting six posters on ACLF research.
• Ipsen presented data on elafibranor for Primary Sclerosing Cholangitis (PSC) at EASL Congress 2025 on May 10, 2025.
• Hosted a Key Opinion Leaders (KOL) ACLF Advisory Board meeting in May 2025 to discuss collaboration and Real-World data programs.

These events are critical for validating the science underpinning the assets that will eventually move through the Ipsen commercialization channel or be licensed out.

Genfit S.A. (GNFT) - Canvas Business Model: Customer Segments

You're looking at the key groups Genfit S.A. (GNFT) serves as of late 2025. It's a focused list, which makes sense for a company targeting rare diseases.

Pharmaceutical Partner (Ipsen): Commercializes the approved PBC drug.

Ipsen is the primary commercialization engine for Iqirvo® (elafibranor) in Primary Biliary Cholangitis (PBC), excluding Greater China. This relationship directly drives Genfit S.A.'s near-term revenue through royalties and milestones. Ipsen reported accelerated sales growth of €59 million in the U.S. and in Europe (mainly Germany & U.K.) for Iqirvo® in the first half of 2025. Genfit S.A. recognized royalty revenue of €12.6 million from worldwide sales (excluding Greater China) for the first nine months of 2025. Also, the market dynamic shifted when competitor OCALIVA® withdrew from the US Market in September 2025.

The financial relationship with Ipsen generated significant non-royalty income:

Revenue Type	Amount (9M 2025)	Triggering Event
Milestone Revenue	€26.5 million	Pricing and reimbursement approval in three major European countries
Total Revenue (9M 2025)	€39.2 million	Royalties + Milestones

Patients with Rare Liver Diseases: Focus on ACLF, CCA, UCD, and PBC.

Genfit S.A. targets patients with serious, life-threatening liver diseases where medical needs are high. While Iqirvo® addresses PBC, the pipeline focus is heavily weighted toward other rare conditions. Note that the VS-01 program in Acute-on-Chronic Liver Failure (ACLF) was discontinued in September 2025, with development refocused on Urea Cycle Disorder (UCD).

The patient populations and associated market potential figures, based on earlier data, highlight the unmet need:

• ACLF franchise has pipeline assets including G1090N2, SRT-015, CLM-022, and VS-02 HE.
• Cholangiocarcinoma (CCA) program includes GNS561.
• Urea Cycle Disorders (UCD) program now includes the refocused VS-01 asset.
• The UCD/Organic Acidemia (OA) market was estimated at $0.6 billion across US+EU5, characterized as ultra-rare with 1900 HAC/year in US+EU5 and a very high mortality rate of 75% after 5 years for survivors.

Healthcare Payers/Regulators: Government bodies for pricing and reimbursement.

These entities control market access for Iqirvo®. Successful navigation here directly translates into Genfit S.A. revenue via contractual milestones. The approval of pricing and reimbursement for Iqirvo® in the UK, Germany, and Italy unlocked the €26.5 million milestone payment for Genfit S.A. in 2025, with the Italian approval occurring in May 2025. This shows the direct financial impact of regulatory and payer acceptance in major European markets.

Financial Investors: Shareholders and debt holders seeking biopharma growth.

Investors are focused on the company's cash position, runway, and the value derived from the Ipsen deal. The company closed a Royalty Financing transaction in March 2025 with HCRx, providing up to €185 million in non-dilutive capital, with €130 million upfront. This financing, combined with revenues, extends the expected cash runway beyond the end of 2028. You can track the cash position:

As of September 30, 2025, cash and cash equivalents stood at €119.0 million, up from €81.8 million as of December 31, 2024. Finance: draft 13-week cash view by Friday.

Genfit S.A. (GNFT) - Canvas Business Model: Cost Structure

You're looking at the major outlays for Genfit S.A. as of late 2025, and honestly, the story is dominated by R&D spend and a significant debt maneuver. The main cost driver, as you'd expect for a biopharma firm, is Research and Development (R&D), which hit €25.1 million for the first half of 2025.

Here's a quick look at how those major costs stacked up for the half-year ended June 30, 2025, plus that big debt item:

Cost Category	H1 2025 Amount (in € millions)	Context/Detail
Research and Development (Total)	25.1	Main cost driver for operating expenses.
Contracted R&D (Third Parties)	13.4	Largest component of R&D spend.
R&D Employee Expenses	7.3	Direct personnel costs within R&D.
Other R&D Expenses	2.6	Miscellaneous R&D related costs.
Debt Repurchase (2025 OCEANEs)	61.7	Total cash outlay to repurchase bonds.

The Clinical Contracting Costs saw increased spending, reflecting the activity levels in the pipeline programs like the VS-01 trial in ACLF. These costs totaled €13.4 million in H1 2025, up from €7.8 million in the first half of 2024. That €13.4 million figure is the same as the contracted R&D spend mentioned above, so you defintely see where the external spending is focused.

General and Administrative (G&A) costs are wrapped up within the total Operating Expenses, which were €35.6 million for H1 2025. While G&A isn't itemized separately from R&D in the top-line reports, the R&D employee expenses alone were €7.3 million. The company anticipated a substantial reduction in operating expenses following the discontinuation of the VS-01 program in ACLF.

You should also note the financial charges tied to the debt restructuring, which aren't part of the operating expenses but definitely impact the bottom line:

• Repurchase price for 2025 OCEANEs was set at €32.75 per bond.
• The total number of OCEANEs repurchased was 1,882,891 bonds.
• This repurchase was concurrent with the closing of the Royalty Financing deal with HCRx.
• Financial income for H1 2025 showed a loss of €10.2 million, up from a loss of €0.9 million in H1 2024, due to debt issuance costs and financial charges from the Royalty Financing agreement.

Finance: draft 13-week cash view by Friday.

Genfit S.A. (GNFT) - Canvas Business Model: Revenue Streams

You're looking at the core cash generation for Genfit S.A. as of late 2025, and it's heavily weighted toward partnership milestones and product sales royalties. Honestly, the numbers tell a clear story about the immediate financial impact of Iqirvo® (elafibranor) commercialization in Europe. For the first nine months of 2025, Genfit S.A. booked total revenue of €39.2 million.

This revenue profile is built on a few key, discrete events, which you can see clearly laid out here. This structure shows how much Genfit S.A. relies on its licensing agreement with Ipsen right now.

Revenue Component	Amount (EUR)	Period/Event
Total Revenue	€39.2 million	9 Months Ended September 30, 2025
Milestone Revenue (Ipsen)	€26.5 million	Q3 2025 (EU Pricing & Reimbursement)
Royalty Revenue (Iqirvo® Sales)	€12.6 million	9 Months Ended September 30, 2025
Royalty Financing Proceeds (Upfront)	€130.0 million	Q1 2025 (From HCRx)

The €39.2 million in revenue for the nine months ended September 30, 2025, was primarily driven by the Licensing and Collaboration Agreement with Ipsen. Here's the quick math on what made up that top line:

• Milestone Revenue from Ipsen: €26.5 million following pricing and reimbursement approval of Iqirvo® (elafibranor) in three major European countries, which was received in July 2025.
• Royalty Revenue from Iqirvo® sales (excluding Greater China): €12.6 million across the first nine months of 2025.

To be fair, while not part of the operating revenue, the strategic financing deal with HCRx in Q1 2025 was a massive cash event that underpins the company's current financial stability. Genfit S.A. secured an upfront payment of €130.0 million from HCRx in Q1 2025 as part of a capped royalty financing agreement. This deal, which is defintely non-dilutive, provides financial visibility beyond 2027. Finance: draft 13-week cash view by Friday.