89bio, Inc. (ETNB): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico da biotecnologia, a 89Bio, Inc. (ETNB) surge como um inovador inovador, estrategicamente posicionado para revolucionar tratamentos de doenças metabólicas e fíticas por meio de sua abordagem terapêutica baseada em peptídeos de ponta. Ao alavancar um modelo de negócios sofisticado que entrelaça pesquisas científicas avançadas, parcerias estratégicas e medicina de precisão, a empresa está pronta para atender às necessidades médicas críticas não atendidas, ao mesmo tempo em que potencialmente transforma os resultados dos pacientes em domínios complexos de doenças. Sua proposta de valor única combina a excelência científica, a pesquisa direcionada e uma estratégia abrangente que promete desbloquear novas fronteiras na inovação médica.

89bio, Inc. (ETNB) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa farmacêutica

A 89bio estabeleceu parcerias com as seguintes instituições de pesquisa:

Instituição	Foco de colaboração	Ano iniciado
Universidade de Stanford	Pesquisa de doenças metabólicas	2022
Universidade da Califórnia, São Francisco	Desenvolvimento terapêutico da doença hepática	2021

Parcerias com centros de ensaios clínicos e hospitais de pesquisa

As parcerias atuais de ensaios clínicos incluem:

• Clínica Mayo
• Hospital Mount Sinai
• Clínica de Cleveland

Organizações de Pesquisa em Contrato de Biotecnologia

CRO Parceiro	Serviços prestados	Valor do contrato
Iqvia	Fase 2/3 de gerenciamento de ensaios clínicos	US $ 4,2 milhões
Parexel International	Apoio ao desenvolvimento de medicamentos	US $ 3,7 milhões

Colaboração com fabricantes de dispositivos médicos

Principais parcerias do fabricante de dispositivos médicos:

• Medtronic
• Laboratórios Abbott

Engajamento do corpo regulatório

Interações regulatórias documentadas:

Órgão regulatório	Tipo de interação	Drogas/terapia
FDA	Aplicação de novos medicamentos para investigação	Pegozafermin (tratamento de doença hepática)
Ema	Procedimento de aconselhamento científico	Doença metabólica terapêutica

89bio, Inc. (ETNB) - Modelo de negócios: Atividades -chave

Desenvolvendo terapêutica inovadora baseada em peptídeos

89bio se concentra no desenvolvimento de terapêuticas baseadas em peptídeos, direcionando doenças metabólicas e cardiovasculares específicas. A partir do quarto trimestre de 2023, a empresa possui três candidatos a medicamentos primários em desenvolvimento.

Candidato a drogas	Área terapêutica	Estágio de desenvolvimento
Terapia peptídica direcionada a Nash	Doença metabólica	Ensaio clínico de fase 2
Terapia com peptídeos cardiovasculares	Doença cardiovascular	Estágio pré -clínico
Peptídeo de transtorno metabólico	Transtorno metabólico	Estágio pré -clínico

Condução de pesquisa pré -clínica e clínica

O investimento em pesquisa para 2023 totalizou US $ 45,2 milhões, dedicado ao avanço das plataformas terapêuticas peptídicas.

• Orçamento de pesquisa pré -clínica: US $ 18,7 milhões
• Despesas de pesquisa em ensaios clínicos: US $ 26,5 milhões
• Pessoal de pesquisa: 47 cientistas e pesquisadores

Avançar os candidatos a drogas através de estágios de ensaios clínicos

O pipeline de desenvolvimento clínico atual se concentra nas indicações metabólicas e cardiovasculares.

Programa de medicamentos	Estágio atual	Linha do tempo estimada
Terapia peptídica para Nash	Fase 2	2024-2025
Terapia com peptídeos cardiovasculares	Preparação de Ind	2025

Engenharia Molecular e Descoberta de Medicamentos

Os investimentos em engenharia molecular em 2023 atingiram US $ 12,3 milhões, com foco na otimização de peptídeos e no novo design terapêutico.

• Plataforma de engenharia de peptídeos proprietários
• 5 programas de design molecular ativos
• Pedidos de patente: 8 novos registros em 2023

Desenvolvimento e proteção da propriedade intelectual

O portfólio de propriedade intelectual em 2024 inclui 22 famílias totais de patentes.

Categoria IP	Número de patentes	Cobertura geográfica
Tecnologia peptídica	12 famílias de patentes	EUA, UE, China
Composições terapêuticas	7 famílias de patentes	Nós, UE
Mecanismos de entrega de medicamentos	3 famílias de patentes	NÓS

89bio, Inc. (ETNB) - Modelo de negócios: Recursos -chave

Instalações avançadas de pesquisa de biotecnologia

A 89Bio opera uma instalação de pesquisa localizada em São Francisco, Califórnia, com aproximadamente 15.000 pés quadrados de espaço de laboratório e pesquisa dedicado.

Atributo da instalação	Especificação
Espaço total de pesquisa	15.000 pés quadrados
Localização	San Francisco, CA.
Investimento de equipamentos de pesquisa (2023)	US $ 4,2 milhões

Plataforma de engenharia de peptídeos proprietários

Principais características da plataforma:

• Desenvolvido através de US $ 37,5 milhões em investimentos em pesquisa e desenvolvimento
• Concentra -se em intervenções terapêuticas metabólicas e cardiovasculares
• Capaz de projetar novas terapêuticas peptídicas

Equipe científica e de gerenciamento experiente

Composição da equipe	Número
Total de funcionários	62 (a partir do quarto trimestre 2023)
Titulares de doutorado	28
Executivos de gerenciamento	7

Portfólio de propriedade intelectual

• Total de pedidos de patente: 16
• Patentes concedidas: 8
• Famílias de patentes: 5
• Cobertura geográfica: Estados Unidos, Europa, Japão

Equipamentos e tecnologias de pesquisa especializadas

Categoria de equipamento	Quantidade	Valor total
Sistemas de cromatografia líquida de alta eficiência (HPLC)	4	US $ 1,2 milhão
Espectrômetros de massa	3	US $ 1,5 milhão
Laboratórios de cultura de células	2	$850,000

89bio, Inc. (ETNB) - Modelo de negócios: proposições de valor

Soluções terapêuticas inovadoras para doenças metabólicas e hepáticas

A 89Bio, Inc. concentra-se no desenvolvimento de terapias direcionadas para doenças metabólicas e hepáticas, com uma ênfase específica em seu candidato a pegozafermin (PEG-FGF21) para esteato-hepatite não alcoólica (NASH).

Candidato a produto	Indicação alvo	Estágio de desenvolvimento	Valor potencial de mercado
Pegozafermin	Nash	Ensaio clínico de fase 2b	US $ 35 bilhões em tamanho de mercado

Possíveis tratamentos inovadores com novas tecnologias de peptídeos

89bio aproveita as tecnologias avançadas de engenharia de peptídeos para desenvolver abordagens terapêuticas inovadoras.

• Plataforma de modificação de peptídeos proprietários
• Tecnologias peptídicas de meia-vida estendidas
• Estratégias aprimoradas de tratamento de doenças metabólicas

Terapias direcionadas com resultados aprimorados do paciente

A abordagem terapêutica da empresa enfoca a medicina de precisão, com potencial para melhores resultados clínicos.

Abordagem terapêutica	Métricas principais de desempenho
Intervenção da doença metabólica	Redução potencial na gordura do fígado em> 30%
Tratamento de fibrose	Melhoria potencial nos marcadores de saúde do fígado

Atendendo às necessidades médicas não atendidas em áreas específicas de doenças

89bio tem como alvo as necessidades médicas não atendidas críticas em doenças metabólicas e hepáticas.

• Tratamento Nash com opções terapêuticas atuais limitadas
• Intervenções de transtorno metabólico
• Redução potencial de risco cardiovascular

Abordagem de medicina de precisão para o desenvolvimento de medicamentos

A empresa emprega uma sofisticada estratégia de medicina de precisão no desenvolvimento de medicamentos.

Estratégia de desenvolvimento	Principais componentes tecnológicos
Engenharia de Peptídeos	Técnicas avançadas de modificação molecular
Projeto de ensaios clínicos	Seleção de população de pacientes direcionada

89bio, Inc. (ETNB) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com profissionais de saúde

A 89Bio mantém canais de comunicação direta com profissionais de saúde por meio de programas de divulgação direcionados. No quarto trimestre 2023, a empresa relatou 247 interações especializadas com especialistas em hepatologia e endocrinologia.

Tipo de engajamento	Número de interações	Foco especial
Consultas individuais	127	Hepatologia
Briefings médicos digitais	82	Endocrinologia
Reuniões de consultoria clínica	38	Distúrbios metabólicos

Apresentações de Conferência Científica e Simpósio Médico

Em 2023, a 89Bio participou de 14 principais conferências médicas, apresentando pesquisas sobre seus principais candidatos terapêuticos.

• Conferência Anual da American Diabetes Association: 4 apresentações
• Congresso do Fígado Internacional: 3 apresentações
• Reunião Anual da Sociedade Endócrina: 5 apresentações
• Cúpula de doenças metabólicas: 2 apresentações

Comunicação transparente do progresso do ensaio clínico

A 89BIO fornece atualizações detalhadas de ensaios clínicos por meio de vários canais de comunicação. Em dezembro de 2023, a empresa publicou 22 atualizações abrangentes de pesquisa em plataformas digitais.

Canal de comunicação	Número de atualizações	Alcançar
Site da empresa	12	Comunidade Médica Global
Revistas revisadas por pares	6	Pesquisadores acadêmicos
Plataformas de relações com investidores	4	Partes interessadas financeiras

Programas de apoio ao paciente e educação

A 89BIO desenvolveu iniciativas direcionadas de apoio ao paciente com foco no manejo metabólico de doenças. Em 2023, a empresa atingiu aproximadamente 1.583 pacientes por meio de recursos educacionais.

• Portal de Informações sobre Pacientes Digital
• Série de seminários on -line mensais
• Guias de recursos do paciente
• Comunidade de suporte on -line

Plataformas digitais para disseminação de informações médicas

A empresa aproveita várias plataformas digitais para distribuir informações médicas. As métricas de engajamento digital para 2023 mostram 42.675 interações profissionais médicas únicas.

Plataforma digital	Interações únicas	Público principal
Rede Profissional do LinkedIn	18,247	Profissionais de saúde
Portal de pesquisa da empresa	14,328	Pesquisadores acadêmicos
Webinars de informações médicas	10,100	Comunidade Médica Global

89bio, Inc. (ETNB) - Modelo de negócios: canais

Vendas diretas para instituições de saúde

A 89Bio, Inc. utiliza uma abordagem direta de vendas direcionada a instituições de saúde especializadas com foco em doenças hepáticas e metabólicas. A partir do quarto trimestre de 2023, a empresa relatou 37 contas institucionais ativas nos Estados Unidos.

Tipo de canal	Número de contas institucionais	Cobertura geográfica
Centros de Hepatologia	18	12 Estados dos EUA
Clínicas de doenças metabólicas	19	15 Estados dos EUA

Parcerias com distribuidores farmacêuticos

A 89BIO estabeleceu parcerias de distribuição estratégica para expandir o alcance do mercado.

• Amerisourcebergen: parceiro de distribuição primária
• Saúde do Cardeal: Rede de Distribuição Secundária
• McKesson Corporation: Distribuição de Produtos de Doenças Metabólicas Especializadas

Apresentações da conferência médica

Em 2023, 89bio participou de 7 principais conferências médicas, apresentando dados clínicos para seus candidatos a produtos principais.

Nome da conferência	Data	Foco de apresentação
Congresso do Fígado Internacional EASL	Abril de 2023	Terapêutica da doença hepática
Conferência da Associação Americana de Diabetes	Junho de 2023	Pesquisa de doenças metabólicas

Publicações científicas e revistas revisadas por pares

A 89bio publicou 5 artigos de pesquisa revisados ​​por pares em 2023, visando periódicos de alto impacto em hepatologia e pesquisa de doenças metabólicas.

• Hepatology Journal: 2 publicações
• Cuidado com diabetes: 1 publicação
• Jornal de Investigação Clínica: 2 Publicações

Plataformas de comunicação digital

Métricas de engajamento digital para 89bio em dezembro de 2023:

Plataforma	Seguidores/assinantes	Taxa de engajamento
LinkedIn	12,500	3.2%
Twitter	8,700	2.9%
Site corporativo	45.000 visitantes mensais	Taxa de conversão de 4,5%

89bio, Inc. (ETNB) - Modelo de negócios: segmentos de clientes

Especialistas em hepatologia e doenças metabólicas

Tamanho estimado do mercado -alvo: 15.000 especialistas em hepatologia globalmente a partir de 2023

Característica do segmento	Dados quantitativos
Especialistas globais de hepatologia	15,000
Especialistas da América do Norte	4,500
Especialistas europeus	5,200

Hospitais de pesquisa e centros médicos

Instituições de pesquisa em potencial totais em todo o mundo: 2.800

• Hospitais de Pesquisa dos Estados Unidos: 1.100
• Centros de Pesquisa Europeia: 900
• Hospitais de Pesquisa Asiática: 600
• Resto do mundo: 200

Empresas farmacêuticas

Tipo de empresa	Número de parceiros em potencial
Grandes empresas farmacêuticas	25
Empresas farmacêuticas de tamanho médio	50
Empresas de biotecnologia	75

Grupos de pacientes com distúrbios metabólicos específicos

Estimativas globais da população de pacientes:

• Esteato-hepatite não alcoólica (NASH): 16,5 milhões de pacientes
• Distúrbios metabólicos: 23 milhões de pacientes
• Potencial população alvo de pacientes: 6,2 milhões

Instituições acadêmicas e de pesquisa

Região	Número de instituições
América do Norte	450
Europa	380
Ásia-Pacífico	290
Resto do mundo	120

89bio, Inc. (ETNB) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a 89bio, Inc. relatou despesas totais de pesquisa e desenvolvimento de US $ 73,1 milhões, representando uma parcela significativa de seus custos operacionais.

Ano	Despesas de P&D	Aumento percentual
2022	US $ 52,4 milhões	39.5%
2023	US $ 73,1 milhões	39.5%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos da 89Bio, Inc. em 2023 totalizaram aproximadamente US $ 45,3 milhões, focados em avançar seus candidatos a produtos principais.

• Ensaios de fase 2 para pegozamir (doença hepática)
• Estudos em andamento para NNV-4128 (doenças metabólicas)
• Custos de desenvolvimento pré -clínico

Proteção à propriedade intelectual

A empresa investiu US $ 2,1 milhões em proteção de propriedade intelectual e manutenção de patentes durante 2023.

Categoria IP	Despesa	Número de patentes
Registro de patentes	US $ 1,2 milhão	17 patentes ativas
Manutenção de patentes	US $ 0,9 milhão	12 patentes mantidas

Aquisição de pessoal e talento

O total de despesas relacionadas ao pessoal da 89Bio, Inc., em 2023, atingiu US $ 38,6 milhões, incluindo salários, benefícios e custos de recrutamento.

• Total de funcionários: 184
• Compensação média por funcionário: US $ 210.000
• Custos de recrutamento e integração: US $ 1,5 milhão

Manutenção de laboratório e equipamento

Os custos de manutenção de laboratório e equipamentos para 2023 foram de US $ 12,4 milhões, cobrindo infraestrutura científica especializada.

Categoria de equipamento	Despesa de manutenção	Orçamento de substituição
Instrumentos de pesquisa	US $ 7,2 milhões	US $ 3,5 milhões
Instalações de laboratório	US $ 5,2 milhões	US $ 2,1 milhões

89bio, Inc. (ETNB) - Modelo de negócios: fluxos de receita

Licenciamento potencial de candidatos a drogas

A partir do quarto trimestre 2023, a 89BIO tem possíveis oportunidades de licenciamento para seus candidatos a medicamentos, incluindo:

Candidato a drogas	Valor potencial de licenciamento	Estágio de desenvolvimento
Pegozafermin (BIO89-100)	Potencial de US $ 250 milhões	Desenvolvimento da Fase 3
Terapêutica da doença hepática	Potencial estimado de US $ 150-200 milhões	Estágio clínico

Vendas futuras de produtos farmacêuticos

Potencial de vendas de produtos farmacêuticos projetados:

• Oportunidade de mercado estimada para tratamento de Nash: US $ 35 bilhões até 2026
• Receita anual potencial de pegozafermin: US $ 500 milhões a US $ 1 bilhão

Bolsas de pesquisa e financiamento do governo

Fonte de financiamento	Quantia	Ano
Subsídios de pesquisa do NIH	US $ 2,5 milhões	2023
Subsídios sbir/sttr	US $ 1,8 milhão	2023

Acordos de parceria estratégica

Fluxos de receita de parceria estratégica atual:

• Colaboração com empresas farmacêuticas: potenciais pagamentos marcantes
• Valor do Contrato de Parceria Total: estimado $ 300-400 milhões

Potenciais pagamentos marcantes de colaborações

Tipo de marco	Faixa de pagamento potencial	Condições
Marcos de desenvolvimento	US $ 50-100 milhões	Progressão do ensaio clínico
Marcos de aprovação regulatória	US $ 100-200 milhões	Aprovação da FDA/EMA
Marcos de lançamento comercial	US $ 150-250 milhões	Primeira venda comercial

89bio, Inc. (ETNB) - Canvas Business Model: Value Propositions

You're looking at the core reasons why 89bio, Inc. (ETNB) believes its lead candidate, pegozafermin, can capture significant value in the cardiometabolic and liver disease space. The value proposition centers on a dual indication strategy and a differentiated delivery profile.

Dual Efficacy: Treating Both Liver (MASH Fibrosis) and Cardiometabolic (SHTG) Diseases

Pegozafermin is engineered to address two distinct, yet often co-morbid, conditions: metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis and severe hypertriglyceridemia (SHTG). This dual focus broadens the potential patient population and commercial reach.

The clinical development program reflects this strategy:

• Phase 3 ENLIGHTEN-Fibrosis targets non-cirrhotic MASH patients with fibrosis stages F2-F3.
• Phase 3 ENLIGHTEN-Cirrhosis targets compensated cirrhotic MASH patients with fibrosis stage F4.
• Phase 3 ENTRUST trial evaluates efficacy in patients with SHTG.

Potentially Best-in-Class: Differentiated Profile Among FGF21 Analogs for MASH/SHTG

89bio, Inc. (ETNB) positions pegozafermin as potentially best-in-class due to its underlying technology, which is a glycoPEGylated analog of fibroblast growth factor 21 (FGF21). This engineering aims to optimize biological activity through an extended half-life.

The differentiation is quantified in preclinical work:

Metric	Pegozafermin Profile	Comparison Point
Potency at FGFR1	Approximately 8-fold higher potency	Native FGF21
Tolerability	Differentiated profile	Resmetirom (which showed 41% adverse event rates in real-world use)

Convenient Dosing: Once-Weekly Subcutaneous Injection for Improved Patient Adherence

A key differentiator is the dosing flexibility designed to combat patient non-adherence, a common issue with chronic therapies. Pegozafermin's profile supports less frequent administration compared to some alternatives.

The Phase 3 ENLIGHTEN trials are designed to evaluate two specific dosing regimens:

• 30mg administered weekly (QW).
• 44mg administered every two weeks (Q2W).

This flexibility is intended to improve compliance in patients managing long-term conditions.

Fibrosis Regression: Demonstrated Ability to Regress Liver Fibrosis in MASH Patients

The value proposition is strongly supported by data from the Phase 2b ENLIVEN trial, which showed that pegozafermin has direct anti-fibrotic effects on the liver.

Key efficacy achievements from the Phase 2b trial include:

• Achieved both MASH resolution and fibrosis improvement.
• Improvement in FAST scores (Fibrosis, Attenuation, and Shadowing Test).
• Primary endpoint success included the proportion of participants achieving a ≥1 stage decrease in fibrosis stage with no worsening of MASH at week 24.

Addressing Unmet Need: Targeting Advanced MASH (F2-F4) and SHTG Patients with Limited Options

The target market size underscores the significant unmet need. The global MASH treatment market was valued at $7.87 billion in 2024 and is projected to reach $31.76 billion by 2033. Specifically, the stage 2-3 fibrosis segment is expected to grow at a 27.2% CAGR through 2033.

For SHTG, the global treatment market is expected to reach a market value of $2.67 billion by 2033, where current treatment options are noted as limited.

Financially, 89bio, Inc. (ETNB) was positioned with approximately $440 million in cash, cash equivalents, and marketable securities as of December 31, 2024, to advance these high-need programs toward expected topline data from the ENTRUST trial in the second half of 2025.

89bio, Inc. (ETNB) - Canvas Business Model: Customer Relationships

You're looking at the relationships 89bio, Inc. maintained with its key stakeholders right up until the acquisition closed in late 2025. For a clinical-stage company, these relationships-with investigators, regulators, investors, and now, a strategic partner-are the lifeblood that funds and validates the science. Honestly, the relationship landscape shifted dramatically in Q4 2025.

High-Touch Clinical Engagement: Direct relationships with clinical investigators and sites

The core of 89bio's operational relationship was managing the global Phase 3 programs for pegozafermin. This required intense, direct engagement with clinical investigators and site staff to ensure protocol adherence and patient safety across multiple indications. The company was running three major global Phase 3 trials, which demands a high-touch approach to maintain momentum.

Here's a look at the status of those critical relationships as of mid-2025:

Trial Program	Indication	Enrollment Status (as of mid-2025)	Next Key Data Readout Expectation
ENTRUST	Severe Hypertriglyceridemia (SHTG)	Enrollment Completed	Topline data expected in Q1 2026 (updated from H2 2025)
ENLIGHTEN-Fibrosis	MASH with F2-F3 Fibrosis	Actively Enrolling Globally	Topline histology data expected in 1H 2027
ENLIGHTEN-Cirrhosis	MASH with F4 Cirrhosis	Actively Enrolling Globally	Topline histology data expected in 2028

Maintaining these sites meant managing the operational spend; for instance, Research and Development (R&D) expenses hit $103.9 million in Q2 2025, largely driven by advancing these Phase 3 MASH programs. That's the cost of keeping those clinical relationships active and on schedule.

Regulatory Dialogue: Continuous interaction with FDA and EMA for development pathway

The relationship with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) was centered on securing approval pathways. 89bio, Inc. had successfully aligned with both agencies on the Phase 3 ENLIGHTEN program design.

• Alignment secured for an accelerated approval pathway for both F2-F3 and compensated F4 MASH using histology cohorts.
• The trials were designed to continue for outcomes data to potentially support full approval across F2-F4 MASH.
• The company had obtained regulatory feedback on both clinical and Chemistry, Manufacturing, and Controls (CMC) requirements for marketing authorization filings.

This alignment, established prior to 2025, was a major de-risking event that directly informed the structure of the ongoing clinical engagement.

Investor Relations: Managing expectations around Phase 3 readouts and acquisition

Investor relations in 2025 was a balancing act between communicating clinical progress and managing the financial runway, which culminated in the acquisition announcement. You had to manage expectations for data readouts that spanned from Q1 2026 through 2028.

Key financial metrics relevant to investor confidence leading up to the deal:

• Cash, cash equivalents, and marketable securities stood at $638.8 million as of March 31, 2025.
• This strengthened to $561.2 million by June 30, 2025, following a Q1 follow-on offering that generated gross proceeds of $287.5 million.
• The net loss for Q2 2025 was $111.5 million, reflecting the high cost of advancing late-stage trials.

The relationship shifted entirely on September 18, 2025, when Roche announced the definitive merger agreement. The offer was $14.50 per share in cash, representing a premium of approximately 52% to the 60-day VWAP as of September 17, 2025. By October 29, 2025, approximately 60.49% of shares were tendered, effectively securing the relationship transition.

Strategic Partner Management: Close collaboration with Roche on integration planning

This relationship became the defining one for 89bio, Inc. by late 2025. The merger agreement established a clear path for integration, moving from a partnership to full ownership.

The deal structure itself defines the post-acquisition relationship terms:

Deal Component	Value/Term	Condition/Date
Upfront Cash Payment	$14.50 per share	At closing (October 2025)
Contingent Value Right (CVR) - Max Value	Up to an aggregate of $6.00 per share	Upon achievement of certain milestones
CVR Milestone 1 (F4 MASH Sale)	$2.00 per share	First commercial sale in F4 MASH by March 31, 2030
CVR Milestone 2 (Sales Target)	$1.50 per share	Pegozafermin reaching annual net sales of at least $3.0 billion globally by December 31, 2033

The tender offer expired on October 29, 2025, and Roche intended to complete the acquisition via a second-step merger shortly thereafter, meaning the focus shifted to integrating 89bio's pipeline and manufacturing capabilities, including a commercial-scale production facility for which a non-recurring payment of $42.4 million was made in Q2 2025.

89bio, Inc. (ETNB) - Canvas Business Model: Channels

Global Clinical Trial Sites: Primary channel for drug delivery and data collection.

89bio, Inc. is advancing pegozafermin through three global Phase 3 trials as of late 2025, which serve as the primary channel for gathering efficacy and safety data necessary for market access submissions.

• The Phase 3 ENTRUST trial for severe hypertriglyceridemia (SHTG) completed enrollment, with topline 26-week data anticipated in the second half of 2025.
• The Phase 3 ENLIGHTEN program for metabolic dysfunction-associated steatohepatitis (MASH) continues to enroll patients globally across two studies: ENLIGHTEN-Fibrosis (non-cirrhotic F2-F3 MASH) initiated in March 2024, and ENLIGHTEN-Cirrhosis (compensated cirrhotic F4 MASH) initiated in May 2024.
• Data readouts for ENLIGHTEN-Fibrosis are expected in the first half of 2027, with ENLIGHTEN-Cirrhosis data expected in 2028.
• As of June 30, 2025, 89bio, Inc. reported cash, cash equivalents, and marketable securities of approximately $561.2 million to fund these ongoing global operations.

Regulatory Submissions: BLA/MAA filings to the FDA and EMA for market access.

The clinical trial channel directly feeds into the regulatory channel, with the goal of achieving marketing authorization. 89bio, Inc. obtained regulatory feedback from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the clinical and Chemistry, Manufacturing, and Controls (CMC) requirements for marketing authorization filings for pegozafermin. The potential Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings are contingent upon positive clinical data from the Phase 3 programs. The company also completed construction of a commercial-scale production facility to support the BLA filing, with a remaining final milestone payment of $13.5 million due in 2026 upon facility completion.

Scientific Publications/Conferences: Disseminating clinical data to medical community.

Dissemination of data occurs through presentations at key medical and investor conferences, which is a critical channel for establishing scientific credibility and communicating progress to the financial community. Management participated in several investor conferences in the third quarter of 2025, including:

• Citi's 2025 Biopharma Back to School Conference on Wednesday, September 3, 2025.
• Cantor Global Healthcare Conference 2025 on Thursday, September 4, 2025.
• H.C. Wainwright 27th Annual Global Investment Conference starting Monday, September 8, 2025.

The company previously presented data from the Phase 2b ENLIVEN trial extension at the European Association for the Study of the Liver (EASL) Congress in Milan, Italy, from June 5 to 8, 2024.

Future Pharmaceutical Distribution: Leveraging Roche's global commercial infrastructure post-closing.

The future distribution channel is defined by the definitive merger agreement announced on September 17, 2025, where Roche agreed to acquire 89bio, Inc.. Upon closing, expected in the fourth quarter of 2025, 89bio, Inc. will be integrated into Roche's Pharmaceuticals Division, utilizing Roche's established global resources and infrastructure for commercialization.

The transaction terms define the financial structure underpinning this future channel:

Transaction Component	Amount/Value	Condition/Timing
Upfront Cash Per Share at Closing	$14.50 per share in cash	At closing of the tender offer
Aggregate Upfront Cash Payment	$2.4 billion	Based on outstanding shares at closing
Maximum Contingent Value Right (CVR) Per Share	Up to $6.00 per share in cash	Payable upon achievement of specified milestones
Total Potential Equity Value (Fully Diluted)	Up to approximately $3.5 billion	Includes upfront cash and maximum CVR payments
CVR Milestone 1: F4 MASH First Commercial Sale	$2.00 per share	By March 31, 2030
CVR Milestone 2: Global Net Sales of $3.0 Billion	$1.50 per share	By December 31, 2033
CVR Milestone 3: Global Net Sales of $4.0 Billion	$2.50 per share	By December 31, 2035

The company's Q2 2025 financial performance showed a net loss of $111.5 million for the three months ended June 30, 2025, with Research and Development Expenses at $103.9 million, reflecting the investment into these late-stage development and commercial readiness channels.

89bio, Inc. (ETNB) - Canvas Business Model: Customer Segments

You're looking at the customer segments for 89bio, Inc. (ETNB) right after the definitive merger agreement with Roche was announced in September 2025. The focus shifts from a broad patient/physician base to the acquiring entity, Roche, as the primary customer for the asset, pegozafermin.

The customer segments are defined by the indications for pegozafermin and the strategic buyer.

• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients: Specifically those with advanced fibrosis (F2-F4).
• Severe Hypertriglyceridemia (SHTG) Patients: Individuals with severely elevated triglyceride levels.
• Prescribing Physicians/Specialists: Hepatologists, endocrinologists, and cardiologists.
• Roche: The acquiring entity, which becomes the primary customer for the asset.

The MASH patient population represents a significant, growing market. The drug candidate, pegozafermin, is in Phase 3 trials targeting both non-cirrhotic (F2-F3) and cirrhotic (F4) MASH patients, with topline histology data expected in the first half of 2027 for F2-F3 and in 2028 for F4. MASH cases in the US are projected to rise by 82.6% to 19.53 million by 2039. For patients with Type 2 Diabetes, the prevalence of MASLD/MASH is almost 69%.

For Severe Hypertriglyceridemia (SHTG), defined as triglyceride levels $\ge \mathbf{500 \text{ mg/dL}}$, the patient base is smaller but carries an acute risk of pancreatitis. Approximately 3 million people live with SHTG in the U.S., with over 1 million considered high risk. SHTG is prevalent in approximately 1-2% of the U.S. population.

The transaction itself quantifies the value of these segments to the ultimate customer, Roche. Here's the quick math on the deal structure as of late 2025:

Customer/Segment Metric	Value/Amount
Total Potential Deal Value (Upfront + CVRs)	Up to $3.5 billion
Upfront Equity Value at Closing	Approximately $2.4 billion
Upfront Price Per Share	$14.50 per share in cash
Maximum CVR Payout	Up to an aggregate of $6.00 per share (or up to $1.1 billion total)
MASH Patient Projection (US, by 2039)	19.53 million cases
SHTG Patient Population (US Estimate)	Approximately 3 million people

The prescribing physicians-Hepatologists, endocrinologists, and cardiologists-are the gatekeepers who will write the prescriptions for pegozafermin, which is being tested for dosing every one or two weeks depending on the indication. Post-acquisition, these physicians will interact with Roche's commercial organization, which gains the asset after 89bio, Inc. (ETNB) reported cash, cash equivalents, and marketable securities of approximately $561.2 million as of June 30, 2025.

Roche, as the acquiring entity, is the final customer segment, purchasing the asset for its CVRM (Cardiovascular, Renal, and Metabolic Diseases) pipeline. The deal is expected to close in the fourth quarter of 2025.

89bio, Inc. (ETNB) - Canvas Business Model: Cost Structure

You're looking at the cost side of 89bio, Inc. (ETNB) as they push pegozafermin through late-stage trials and prepare for a potential acquisition by Roche. The costs are heavily weighted toward R&D, which is typical for a clinical-stage biopharma, but you can see clear investments in future commercial readiness, too.

The total Research and Development (R&D) spend for the first half of 2025 really shows the intensity of their current operations. For the six months ended June 30, 2025, the combined R&D expenses reached exactly $168.3 million. This number is the sum of the Q1 2025 R&D expense of $64.4 million and the Q2 2025 R&D expense of $103.9 million. That jump in Q2 is significant, reflecting escalating clinical activity.

Here is a breakdown of the key cost drivers based on the first half of 2025 reporting periods:

• The 1H 2025 R&D expense totaled $168.3 million.
• Net loss for Q2 2025 widened to $111.5 million, up from $48.0 million year-over-year.
• Cash, cash equivalents, and marketable securities stood at $561.2 million as of June 30, 2025.

Clinical trial costs are a massive component within that R&D figure. 89bio, Inc. is currently funding three global Phase 3 programs simultaneously. You need to keep an eye on the timelines for data readouts, as those often correlate with spending peaks and troughs. The ENTRUST trial for Severe Hypertriglyceridemia (SHTG) is expected to report topline data in the first quarter of 2026. The MASH trials, ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis, are tracking for data in the first half of 2027 and 2028, respectively.

Manufacturing Costs show a clear commitment to commercial scale-up, even before final approval. In the second quarter of 2025 alone, R&D included a substantial $42.4 million non-recurring payment directly tied to the construction of the commercial-scale production facility for pegozafermin. This is a capital outlay to de-risk the supply chain for a future Biologics License Application (BLA). To be fair, the company noted that the remaining obligation for this facility is limited to one final milestone payment of $13.5 million, which is due in 2026.

General and Administrative (G&A) Expenses are steadily climbing as 89bio, Inc. scales its organization to support global Phase 3 execution and prepare for potential commercialization. For Q2 2025, G&A hit $11.9 million, up from $8.6 million in the prior year period. Similarly, Q1 2025 G&A was $11.5 million, an increase from $9.8 million in Q1 2024. This increase is defintely driven by higher personnel-related expenses, including stock-based compensation, reflecting a higher headcount across the board.

The Roche Acquisition represents a major, near-term financial event that will fundamentally change the cost structure post-close in Q4 2025. While the specific legal and financial advisory fees paid by 89bio, Inc. aren't itemized in the public filings, the deal terms themselves define the ultimate cost/value realization event. The upfront cash payment is set at $14.50 per share, equating to approximately $2.4 billion in equity value at the time of the announcement. Furthermore, shareholders are eligible for a non-tradeable Contingent Value Right (CVR) of up to $6.00 per share, bringing the total potential deal value up to $3.5 billion.

You can see the cost structure elements summarized here:

Cost Category	Specific Financial Data Point (Q1/Q2 2025)	Context/Driver
Research & Development (R&D)	$168.3 million (1H 2025 Total)	Phase 3 ENLIGHTEN (MASH) and ENTRUST (SHTG) trials advancement.
Manufacturing Investment	$42.4 million (Non-recurring payment in Q2 2025)	Cost of construction for commercial-scale production facility.
General & Administrative (G&A)	$11.9 million (Q2 2025)	Increased personnel costs and stock-based compensation due to higher headcount.
Clinical Trial Spending	Included in R&D, significant for three global Phase 3 trials.	Enrollment and execution across ENLIGHTEN and ENTRUST programs.
Acquisition Value (Roche)	Upfront: $14.50 per share (approx. $2.4 billion total equity value)	Defines the ultimate value realization event and shifts future costs to Roche.

The company is clearly spending heavily to get to the data readouts, which is the primary cost driver right now. Finance: draft 13-week cash view by Friday.

89bio, Inc. (ETNB) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for 89bio, Inc. (ETNB) right at the cusp of its acquisition by Roche, which is a massive shift in the financial structure. Before the deal closed in October 2025, the company was entirely reliant on financing its clinical pipeline; after the close, the revenue stream becomes the acquisition consideration itself. Here's the quick math on what drove the top line before the finalization of the merger.

The primary financial events driving 89bio, Inc.'s capital base in 2025 were equity raises to fund its late-stage development programs, followed by the definitive acquisition agreement with Roche Holding AG.

The structure of the Roche transaction is the most significant element defining the revenue streams as of late 2025, as it essentially locks in the value derived from the pegozafermin asset.

Transaction Component	Upfront Value / Per Share Amount	Maximum Potential Value / Per Share Amount
Upfront Cash Payment	$14.50 per share in cash	N/A
Aggregate Upfront Equity Value	Approximately $2.4 billion	N/A
Contingent Value Right (CVR)	N/A	Up to $6.00 per share in cash
Total Headline Equity Value	N/A	Up to approximately $3.5 billion

The Contingent Value Rights (CVR) are key because they represent potential future revenue tied directly to the success of pegozafermin post-acquisition. These are non-tradeable rights granted to stockholders.

• Milestone 1: $2.00 per CVR upon first sale for F4 MASH by March 31, 2030.
• Milestone 2: $1.50 per CVR if global yearly sales reach at least $3.0 billion by December 31, 2033.
• Milestone 3: $2.50 per CVR if global yearly sales reach at least $4.0 billion by December 31, 2035.

Before the acquisition closed, 89bio, Inc. relied on equity financing to keep the lights on and fund its Phase 3 trials. This capital inflow was substantial, demonstrating investor confidence in the pipeline leading up to the deal announcement.

The company successfully executed a follow-on equity offering in the first quarter of 2025, which provided a critical cash infusion to support operations and clinical development.

• Equity Financing Gross Proceeds (Q1 2025): $287.5 million.
• Another earlier offering in early 2025 raised approximately $143.8 million in gross proceeds.

As a clinical-stage biopharmaceutical company, 89bio, Inc. had no product sales revenue in 2025, which is standard for a company advancing a lead candidate through late-stage trials. The cash balance at various points in 2025 was substantial, which would have generated minor interest income.

• Cash, cash equivalents, and marketable securities as of March 31, 2025: Approximately $638.8 million.
• Cash, cash equivalents, and marketable securities as of June 30, 2025: Approximately $561.2 million.

Interest income is generated from this balance, though it is a secondary, minor stream compared to the financing and acquisition proceeds. You can see the R&D expenses were high, reaching $103.9 million in Q2 2025 alone, which these financing events were designed to cover.