Genfit S.A. (GNFT): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico da biotecnologia, Genfit S.A. (GNFT) surge como uma força pioneira, revolucionando a pesquisa metabólica e de doenças hepáticas por meio de sua inovadora modelo de negócios. Ao navegar estrategicamente no desenvolvimento farmacêutico, na pesquisa científica de ponta e nas soluções terapêuticas direcionadas, esta empresa francesa de biotecnologia está pronta para transformar o atendimento ao paciente em distúrbios metabólicos complexos. Sua abordagem focada em laser em tratamentos de esteato-hepatite não alcoólica (NASH) e medicina de precisão representa uma interseção atraente de inovação científica e modelagem estratégica de negócios que podem potencialmente reformular os resultados da saúde.

Genfit S.A. (GNFT) - Modelo de negócios: Parcerias -chave

Colaborações de pesquisa farmacêutica com instituições acadêmicas

A GenFit S.A. estabeleceu colaborações de pesquisa estratégica com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Ano de colaboração
Universidade de Lille	Pesquisa de doenças metabólicas	2019
Inserv	Patogênese da doença hepática	2020

Alianças estratégicas com centros de biotecnologia e pesquisa médica

A Genfit desenvolveu alianças estratégicas importantes com os seguintes centros de pesquisa:

• Associação Europeia para o Estudo do Fígado (EASL)
• Associação Americana para o Estudo de Doenças do Fígado (AASLD)
• Rede nórdica para doença hepática gordurosa não alcoólica

Potenciais parcerias de licenciamento e desenvolvimento farmacêuticas

O portfólio de parceria farmacêutica da Genfit inclui:

Parceiro	Candidato a drogas	Estágio de desenvolvimento	Valor potencial
Empresa farmacêutica x	Elafibranor	Ensaios clínicos de fase 3	€ 15 milhões
Empresa de biotecnologia y	NIS Plataforma terapêutica	Pesquisa pré-clínica	€ 7,5 milhões

Colaboração com redes de ensaios clínicos e profissionais de saúde

As colaborações de rede de ensaios clínicos da Genfit incluem:

• Rede Internacional de Ensaios Clínicos de Nash
• Consórcio Global de Pesquisa Fígado
• Associação Européia de Pacientes Fígures

Orçamento total de colaboração de pesquisa em 2023: € 22,5 milhões

Genfit S.A. (GNFT) - Modelo de negócios: Atividades -chave

Descoberta e desenvolvimento de medicamentos em doenças metabólicas e hepáticas

A Genfit S.A. se concentra no desenvolvimento de soluções terapêuticas inovadoras para doenças metabólicas e hepáticas. Em 2023, a empresa investiu 22,4 milhões de euros em atividades de pesquisa e desenvolvimento.

Área de pesquisa	Investimento (€)	Foco
Doenças metabólicas	12,6 milhões	Desenvolvimento da Elafibranor
Doenças hepáticas	9,8 milhões	NASH PESQUISA DE TRATAMENTO

Ensaios clínicos para Elafibranor e outros candidatos terapêuticos

A GenFit realizou vários ensaios clínicos com alocação significativa de recursos.

• Fase 3 Resolve-It Trial para Elafibranor concluído em 2020
• Despesas totais de ensaios clínicos: € 37,5 milhões em 2022
• Atualmente gerenciando 2 programas de desenvolvimento clínico ativos

Pesquisa sobre tratamentos de esteato-hepatite não alcoólica (NASH)

Parâmetro de pesquisa	Métrica
Pessoal de pesquisa	32 pesquisadores dedicados
Orçamento de pesquisa anual	€ 15,3 milhões
Projetos de pesquisa ativa	3 iniciativas primárias de tratamento de Nash

Processos de envio e aprovação regulatórios

O Genfit se envolveu em interações regulatórias abrangentes internacionalmente.

• Submissões regulatórias da FDA e EMA concluídas
• Orçamento de conformidade regulatória: 4,2 milhões de euros em 2023
• 2 processos de revisão regulatória ativos

Gerenciamento de propriedade intelectual e proteção

Categoria IP	Número de patentes	Cobertura geográfica
Tratamento de Nash	17 famílias de patentes	EUA, UE, Japão
Doença metabólica	12 famílias de patentes	EUA, UE, China

Investimento total de gerenciamento de IP: € 3,7 milhões em 2022

Genfit S.A. (GNFT) - Modelo de negócios: Recursos -chave

Capacidades avançadas de pesquisa científica

O Genfit mantém uma infraestrutura de pesquisa com as seguintes características -chave:

Instalação de pesquisa	Localização	Espaço total de pesquisa
Sede corporativa e centro de pesquisa	Lille, França	3.500 metros quadrados

Equipe especializada de pesquisadores e especialistas médicos

Composição da força de trabalho a partir de 2024:

Categoria de funcionários	Número de funcionários
Total de funcionários	87
Pesquisadores de doutorado	42
Especialistas médicos	23

Tecnologias proprietárias de desenvolvimento de medicamentos

• Tecnologia de plataforma de receptores nucleares
• Experiência metabólica de desenvolvimento de medicamentos para doenças
• Pipeline de pesquisa de esteato-hepatite não alcoólica (NASH)

Extenso portfólio de dados de ensaios clínicos e pesquisa

Métrica do ensaio clínico	Quantidade
Ensaios clínicos concluídos	7
Estudos clínicos em andamento	3
Publicações totais de pesquisa	52

Portfólio de propriedade intelectual forte

Tipo de ativo IP	Número total
Patentes ativas	18
Famílias de patentes	12
Cobertura de patente geográfica	9 países

Genfit S.A. (GNFT) - Modelo de Negócios: Proposições de Valor

Soluções terapêuticas inovadoras para doenças hepáticas metabólicas

Desenvolvimento de Elafibranor para esteato-hepatite não alcoólica (NASH) com os principais dados de ensaios clínicos:

Fase de ensaios clínicos	População de pacientes	Métricas -chave
Fase 3 Resolve-It Trial	972 pacientes	Endpoint primário não atingido em 2020

Possíveis tratamentos inovadores para Nash

Abordagem terapêutica com foco em:

• Agonista do receptor nuclear direcionando distúrbios metabólicos
• Melhoria potencial na fibrose hepática
• Abordando vários parâmetros metabólicos

Abordagens avançadas de diagnóstico e terapêutico

Tecnologia	Capacidade de diagnóstico	Status de desenvolvimento
Plataforma de diagnóstico molecular	Nash Biomarker Identification	Pesquisa em andamento

Medicina de precisão direcionada para distúrbios metabólicos complexos

Pesquisa foco em:

• Algoritmos de medicina de precisão
• Estratégias de tratamento personalizadas
• Intervenção da síndrome metabólica

Melhoria potencial nos resultados dos pacientes

Métrica de resultado	Impacto potencial	População -alvo
Redução da fibrose hepática	Melhoria potencial em estágio	Pacientes Nash

Genfit S.A. (GNFT) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

Genfit S.A. mantém canais de comunicação direta com os pesquisadores por meio de:

• Comunicações de email direcionadas
• Atualizações de pesquisa personalizadas
• Plataformas de colaboração científica direta

Método de engajamento	Frequência anual	Público -alvo
Pesquisa on -line	12-15 eventos	Pesquisadores de hepatologia
Correspondência científica direta	250-300 interações	Rede de Pesquisa Global

Conferência Científica e Participação do Simpósio

O Genfit participa ativamente de conferências médicas importantes com foco em doenças hepáticas e distúrbios metabólicos.

• Apresentações anuais da conferência EASL
• Associação Americana para o Estudo de Simpósios de Doenças do Fígado (AASLD)
• Fóruns Internacionais de Pesquisa do Metabolismo

Comunicação transparente de resultados de ensaios clínicos

Compromisso com a comunicação transparente de pesquisa envolve:

• Divulgação pública de resultados de ensaios clínicos
• Envios detalhados de publicação científica
• Compartilhamento de dados de pesquisa de acesso aberto

Canal de comunicação	Volume anual de publicação	Alcance de visibilidade
Revistas revisadas por pares	8-10 publicações	Comunidade científica global
Registros de ensaios clínicos	Documentação abrangente de avaliação	Plataformas de pesquisa internacionais

Programas de apoio ao paciente e educação

Abordagem centrada no paciente implementado por meio de mecanismos de suporte especializados:

• Recursos educacionais online
• Portais de informação do paciente
• Helplines de informações médicas dedicadas

Abordagem colaborativa com profissionais de saúde

Colaboração estratégica com médicos através de:

• Programas contínuos de educação médica
• Iniciativas de parceria de pesquisa
• Desenvolvimento de orientação clínica

Tipo de colaboração	Engajamento anual	Tamanho da rede profissional
Workshops profissionais médicos	6-8 eventos anuais	500 mais de especialistas em saúde
Acordos de colaboração de pesquisa	3-5 novas parcerias	Instituições de Pesquisa Internacional

Genfit S.A. (GNFT) - Modelo de Negócios: Canais

Publicações científicas diretas e comunicações de pesquisa

A GenFit S.A. utiliza 17 publicações científicas revisadas por pares em periódicos como Hepatologia, Journal of Hepatology e Nature em 2023.

Tipo de publicação	Número de publicações	Faixa de fatores de impacto
Revistas revisadas por pares	17	4.5 - 8.2
Resumos da conferência	8	N / D

Conferências médicas e eventos do setor

A Genfit participou de 6 principais conferências internacionais em 2023.

• Associação Americana para o Estudo de Doenças do Fígado (AASLD)
• Associação Europeia para o Estudo do Fígado (EASL)
• Congresso do fígado internacional
• Experiência digital de reunião de fígado

Negociações de licenciamento e parceria farmacêuticos

Em 2023, o Genfit se envolveu em 3 discussões ativas em parcerias farmacêuticas.

Tipo de parceria	Número de negociações em andamento
Discussões de licenciamento	3
Acordos de pesquisa colaborativa	2

Plataformas digitais para disseminação de informações científicas

A Genfit mantém canais de comunicação digital ativos com 45.000 conexões de rede profissional.

• Seguidores do LinkedIn: 22.500
• Plataformas de pesquisa científica: 4 perfis ativos
• ResearchGate Downloads: 12.300

Canais de submissão regulatórios

A GenFit enviou 2 pacotes regulatórios em 2023 nos mercados europeu e norte -americano.

Autoridade regulatória	Status de envio
Agência Europeia de Medicamentos (EMA)	1 envio
Food and Drug Administration (FDA)	1 envio

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

Pesquisadores e instituições farmacêuticas

A partir de 2024, a Genfit tem como alvo aproximadamente 3.200 instituições de pesquisa farmacêutica em todo o mundo. As principais áreas de foco incluem:

Categoria de pesquisa	Número de clientes em potencial	Distribuição geográfica
Centros de pesquisa acadêmica	1,450	América do Norte, Europa, Ásia
Laboratórios de pesquisa farmacêutica	1,750	Presença global

Especialistas em hepatologia

O mercado -alvo da Genfit inclui profissionais médicos especializados:

• Estimado 12.500 especialistas em hepatologia em todo o mundo
• Concentração nos Estados Unidos: 3.750 especialistas
• Mercado europeu: 5.200 especialistas
• Região da Ásia-Pacífico: 3.550 especialistas

Pacientes com doenças hepáticas metabólicas

Demografia de pacientes com alvo para soluções terapêuticas da Genfit:

Categoria de doença	População global de pacientes	Tamanho potencial de mercado
Doença hepática gordurosa não alcoólica (DHGNA)	1,25 bilhão	US $ 35,4 bilhões até 2026
Esteato-hepatite não alcoólica (Nash)	16,5 milhões	US $ 22,7 bilhões de mercado potencial

Provedores de saúde

Segmentação da base de clientes do provedor de saúde:

• Hospitais: 4.200 clientes institucionais em potencial
• Clínicas de fígado especializadas: 1.850 instalações
• Práticas médicas privadas: 6.700 clientes em potencial

Organizações de financiamento de pesquisa médica

Financiamento do cenário para pesquisa metabólica de doenças hepáticas:

Fonte de financiamento	Orçamento de pesquisa anual	Áreas de foco
Agências governamentais	US $ 1,2 bilhão	Doenças hepáticas metabólicas
Fundações privadas	US $ 450 milhões	Pesquisa de doenças hepáticas
Subsídios de pesquisa farmacêutica	US $ 780 milhões	Desenvolvimento terapêutico

Genfit S.A. (GNFT) - Modelo de Negócios: Estrutura de Custo

Extensas despesas de pesquisa e desenvolvimento

Em 2023, a Genfit S.A. relatou despesas de pesquisa e desenvolvimento de 11,7 milhões de euros. O foco de P&D da empresa permanece principalmente em doenças hepáticas e distúrbios metabólicos.

Ano	Despesas de P&D (€)	Porcentagem de custos operacionais totais
2022	13,2 milhões	68%
2023	11,7 milhões	65%

Financiamento de ensaios clínicos

A Genfit alocou aproximadamente 7,5 milhões de euros especificamente para o desenvolvimento de ensaios clínicos em 2023.

• Fase 2/3 Ensaios para Elafibranor na colangite biliar primária (PBC)
• Pesquisa clínica em andamento para esteato-hepatite não alcoólica (NASH)
• Orçamento de ensaio clínico direcionado com protocolos rígidos de gerenciamento de custos

Pessoal e recrutamento de talentos científicos

As despesas de pessoal para 2023 totalizaram € 8,3 milhões, com foco em talentos científicos especializados.

Categoria de funcionários	Número de funcionários	Custo médio anual (€)
Cientistas de pesquisa	45	120,000
Pesquisadores clínicos	35	110,000

Proteção e Gerenciamento de Propriedade Intelectual

Os custos de propriedade intelectual para 2023 foram estimados em 1,2 milhão de euros, cobrindo o registro, manutenção e proteção legal de patentes.

• Manutenção do portfólio de patentes
• Taxas de consulta legal
• Despesas internacionais de registro de patentes

Processos de conformidade e aprovação regulatórios

As despesas de conformidade regulatória em 2023 atingiram 2,5 milhões de euros, garantindo a adesão aos padrões farmacêuticos internacionais.

Órgão regulatório	Despesas de conformidade (€)	Principais áreas de foco
Ema	1,2 milhão	Autorização do mercado europeu
FDA	1,3 milhão	Processo de aprovação do mercado dos EUA

Genfit S.A. (GNFT) - Modelo de negócios: fluxos de receita

Vendas futuras de produtos farmacêuticos futuros

A partir de 2024, Genfit S.A. se concentra no Elafibranor para colangite biliar primária (PBC) e esteato-hepatite não alcoólica (NASH). Os fluxos de receita potenciais projetados incluem:

Produto	Tamanho potencial de mercado	Potencial estimado de receita anual
Elafibranor (Nash)	US $ 35,7 bilhões no mercado global até 2026	Estimado US $ 500-750 milhões anualmente
Elafibranor (PBC)	Mercado global de US $ 1,2 bilhão	Estimado US $ 150-250 milhões anualmente

Bolsas de pesquisa e financiamento

Genfit S.A. protege o financiamento da pesquisa de várias fontes:

• Subsídios de pesquisa da União Europeia: € 3,2 milhões em 2023
• Financiamento Nacional de Pesquisa: 1,5 milhão de euros em 2023
• Financiamento total da pesquisa: 4,7 milhões de euros em 2023

Acordos de licenciamento em potencial

Potencial de receita de licenciamento:

Potencial parceiro de licenciamento	Pagamento inicial estimado	Potenciais pagamentos marcantes
Empresas farmacêuticas	US $ 10-50 milhões	Até US $ 300 milhões

Parcerias de pesquisa colaborativa

Parcerias de pesquisa colaborativa atuais:

• Instituições acadêmicas: 3 parcerias ativas
• Valor de colaboração de pesquisa: 2,8 milhões de euros em 2023
• Receita futura de colaboração potencial: 4-6 milhões de euros anualmente

Monetização da propriedade intelectual

Detalhes da carteira de propriedade intelectual:

Categoria IP	Número de patentes	Valor de IP estimado
Nash Technology	12 patentes	€ 15-25 milhões
Tecnologia PBC	5 patentes	€ 7 a 12 milhões

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.