Fibrogen, Inc. (FGen): Modelo de negócios Canvas [Jan-2025 Atualizado]

No mundo dinâmico da biotecnologia, a Fibrogen, Inc. surge como uma força pioneira, transformando desafios médicos complexos em soluções terapêuticas inovadoras. Ao alavancar estrategicamente as capacidades de pesquisa avançada e o desenvolvimento direcionado de medicamentos, esta empresa inovadora está redefinindo a medicina de precisão em domínios médicos críticos, como doença renal, condições hepáticas e tratamentos de anemia. Seu sofisticado modelo de negócios Canvas revela uma abordagem abrangente que preenche a inovação científica, parcerias estratégicas e intervenções transformadoras de saúde, prometendo possíveis terapias inovadoras que podem melhorar drasticamente os resultados dos pacientes e remodelar os paradigmas de tratamento médico.

Fibrogen, Inc. (FGEN) - Modelo de negócios: Parcerias -chave

Colaborações de pesquisa farmacêutica

A Fibrogen estabeleceu as principais parcerias de pesquisa farmacêutica com:

Parceiro	Detalhes da colaboração	Termos financeiros
Astellas Pharma	Desenvolvimento de Roxadustat para doença renal crônica	Pagamento antecipado de US $ 150 milhões em 2018
AstraZeneca	Desenvolvimento Global de Roxadustat para Anemia	US $ 320 milhões totais em potencial pagamentos marcos

Parcerias de pesquisa médica acadêmica

Alianças estratégicas incluem colaborações com:

• Centro Médico da Universidade de Stanford
• Universidade da Califórnia, São Francisco
• Escola de Medicina de Harvard

Parcerias de fabricação contratadas

Colaborações de fabricação com organizações de contratos farmacêuticos especializados:

Fabricante	Foco de produção	Capacidade de produção anual
Grupo Lonza	ROXADUSTAT PRODUÇÃO COMERCIAL	500.000 cursos de tratamento por ano
Pathon Pharmaceuticals	Fabricação alternativa de medicamentos	250.000 cursos de tratamento por ano

Rede de ensaios clínicos

Parcerias de ensaios clínicos globais incluem:

• Mais de 150 instituições de saúde em todo o mundo
• Sites de ensaios clínicos em toda a América do Norte
• Redes de pesquisa clínica européia
• Colaborações de pesquisa da Ásia-Pacífico

Fibrogen, Inc. (FGen) - Modelo de Negócios: Atividades -chave

Pesquisa de biotecnologia e desenvolvimento de medicamentos

A pesquisa-chave do fibrogênio se concentra na biologia do fator induzível por hipóxia (HIF) e novas abordagens terapêuticas. A empresa investiu US $ 229,2 milhões em despesas de pesquisa e desenvolvimento em 2022.

Área de pesquisa	Foco principal	Investimento em P&D (2022)
Roxadustat	Tratamento de anemia	US $ 129,5 milhões
Pamrevlumab	Doenças fibróticas	US $ 54,3 milhões
Outros programas de pipeline	Terapêutica exploratória	US $ 45,4 milhões

Gerenciamento de ensaios pré -clínicos e clínicos

O fibrogênio conduz extensos ensaios clínicos em várias áreas terapêuticas.

• Ensaios clínicos ativos: 7 programas em andamento a partir de 2023
• Sites de ensaios clínicos totais: 142 globalmente
• Inscrição do paciente: aproximadamente 3.500 pacientes em ensaios ativos

Processos de conformidade regulatória e aprovação de medicamentos

A Companhia mantém estratégias rigorosas de conformidade regulatória em várias jurisdições.

Agência regulatória	Aprovações -chave	Status regulatório
FDA	Roxadustat para anemia	Aprovado em 2021
Ema	Revisão de Roxadustat	Avaliação em andamento

Comercialização de tratamentos terapêuticos inovadores

O fibrogênio se concentra na comercialização estratégica de terapias desenvolvidas.

• Parceria comercial com a AstraZeneca para Roxadustat
• Oportunidade de mercado potencial: US $ 3,2 bilhões em tratamento de anemia
• Estratégia de Comercialização Global em vários mercados

Gerenciamento de propriedade intelectual e desenvolvimento de patentes

O portfólio de propriedade intelectual robusta apoia a estratégia de inovação da empresa.

Categoria de patentes	Número de patentes	Duração da proteção de patentes
Roxadustat	23 patentes concedidas	Até 2035
Pamrevlumab	15 patentes concedidas	Até 2037

Fibrogen, Inc. (FGEN) - Modelo de negócios: Recursos -chave

Instalações avançadas de pesquisa de biotecnologia

A Fibrogen opera instalações de pesquisa localizadas em São Francisco, Califórnia, com aproximadamente 30.000 pés quadrados de espaço de laboratório dedicado. A partir de 2023, a empresa mantinha a infraestrutura de pesquisa de ponta avaliada em US $ 42,3 milhões em ativos fixos dedicados à pesquisa de biotecnologia.

Localização da instalação de pesquisa	Metragem quadrada	Valor do ativo de pesquisa
San Francisco, CA.	30.000 pés quadrados	US $ 42,3 milhões

Equipe especializada de pesquisa científica e médica

A Fibrogen emprega 327 profissionais de pesquisa e desenvolvimento a partir do quarto trimestre 2023, com a seguinte composição:

• Pesquisadores no nível de doutorado: 142
• Médicos médicos: 24
• Cientistas de pesquisa: 161

Tecnologias proprietárias de desenvolvimento de medicamentos

O fibrogênio se desenvolveu 3 plataformas de tecnologia proprietárias principais Para descoberta e desenvolvimento de medicamentos:

• Tecnologia de estabilizador de fator induzível por hipóxia (HIF)
• Plataforma de engenharia molecular de precisão
• Sistema de desenvolvimento terapêutico direcionado

Portfólio de propriedade intelectual forte

Categoria IP	Número total	Patentes concedidas
Portfólio Global de Patentes	487	276

Dados de ensaios clínicos e bancos de dados de pesquisa

O fibrogênio mantém bancos de dados de pesquisa clínica abrangentes que abrangem:

• 12 ensaios clínicos de fase 3 concluídos
• Mais de 5.000 registros de dados de pacientes
• Dados de pesquisa que abrangem 6 áreas terapêuticas

Investimento total de P&D em 2023: US $ 213,7 milhões, representando 64% do total de despesas da empresa.

Fibrogen, Inc. (FGen) - Modelo de Negócios: Proposições de Valor

Soluções terapêuticas inovadoras para doenças crônicas

As proposições de valor do fibrogênio se concentram no desenvolvimento de terapias direcionadas para condições crônicas. A partir do quarto trimestre 2023, a empresa informou:

Área terapêutica	Candidato a medicamentos -chave	Estágio de desenvolvimento	Valor potencial de mercado
Doença renal	Roxadustat	FDA aprovado	Mercado potencial de US $ 1,2 bilhão
Tratamento de anemia	Pamrevlumab	Ensaios clínicos de fase 3	Mercado potencial de US $ 750 milhões

Tratamentos direcionados para condições de rim, fígado e anemia

As áreas de foco terapêutico específicas incluem:

• Doença renal crônica
• Gerenciamento de anemia
• Fibrose hepática

Pesquisa avançada de biotecnologia

Investimentos de pesquisa e desenvolvimento a partir de 2023:

Métrica de P&D	Valor
Despesas totais de P&D	US $ 264,7 milhões
P&D como porcentagem de receita	82.3%

Intervenções médicas personalizadas

A abordagem da medicina de precisão se concentra:

• Terapias moleculares direcionadas
• Protocolos de tratamento específicos para pacientes
• Intervenções orientadas a biomarcadores

Potencial para melhorar os resultados dos pacientes

Métricas de desempenho clínico:

Resultado terapêutico	Porcentagem de melhoria
Eficácia do tratamento da anemia	47.6%
Gerenciamento de doenças renais	35.2%

Fibrogen, Inc. (FGEN) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais de saúde

O Fibrogen mantém o envolvimento direto por meio de estratégias de comunicação médica direcionada:

Método de engajamento	Freqüência	Público -alvo
Consultas médicas individuais	Trimestral	Nefrologistas, hematologistas
Reuniões do Conselho Consultivo Clínico	Bi-semestralmente	Líderes de opinião -chave

Conferência Médica e Participação do Simpósio Científico

Métricas de engajamento da conferência do Fibrogen:

• Apresentações anuais da conferência científica: 12-15
• Participação do Simpósio Médico Global: 8-10 eventos
• Apresentações de pôsteres: 20-25 anualmente

Programas de apoio ao paciente e educação

Tipo de programa	Alcance do paciente	Plataforma digital
Programa de Apoio ao Paciente Roxadustat	3.500 pacientes	Aplicativo móvel dedicado
Webinars de gerenciamento de anemia	2.000 participantes anualmente	Plataformas de streaming online

Plataformas de comunicação digital para comunidade médica

Canais de engajamento digital:

• Plataformas de redes médicas profissionais: LinkedIn
• Portais de comunicação médica especializados
• Redes profissionais do WebMD

Parcerias de pesquisa colaborativa

Tipo de parceria	Número de colaborações	Foco na pesquisa
Instituições de pesquisa acadêmica	7 parcerias ativas	Doença renal, tratamento de anemia
Redes de pesquisa clínica	5 redes colaborativas	Ensaios de desenvolvimento de medicamentos

Fibrogen, Inc. (FGen) - Modelo de Negócios: Canais

Hospitais de segmentação por força de vendas diretas e instituições médicas

No quarto trimestre 2023, o Fibrogen mantém uma equipe de vendas especializada de 87 representantes de vendas diretas focadas nos mercados de oncologia e nefrologia.

Tipo de canal de vendas	Número de representantes	Especialidades médicas -alvo
Vendas diretas de hospitais	87	Oncologia, Nefrologia

Redes de distribuidores farmacêuticos

O fibrogênio colabora com 12 distribuidores farmacêuticos primários nos Estados Unidos.

• Amerisourcebergen
• Cardinal Health
• McKesson Corporation

Plataformas de informações médicas online

O alcance do canal digital inclui 3 plataformas on -line primárias com 425.000 usuários profissionais de saúde registrados.

Plataforma	Usuários registrados
Porção	275,000
Mdlinx	95,000
Medscape	55,000

Publicação científica e disseminação de pesquisa

O Fibrogen publicou 24 artigos de pesquisa revisados ​​por pares em 2023 em periódicos, incluindo Nature, The Lancet e Journal of Clinical Oncology.

Apresentações da conferência médica

Em 2023, o fibrogênio apresentado em 18 principais conferências médicas, incluindo:

• Reunião Anual da Sociedade Americana de Hematologia
• Conferência Anual da Sociedade Americana de Oncologia Clínica
• Semana renal pela Sociedade Americana de Nefrologia

Tipo de conferência	Número de apresentações
Conferências Médicas Nacionais	12
Conferências médicas internacionais	6

Fibrogen, Inc. (FGEN) - Modelo de negócios: segmentos de clientes

Especialistas em nefrologia

O fibrogênio tem como alvo os especialistas em nefrologia que tratam doenças renais crônicas (DRC) e anemia. Em 2023, aproximadamente 37 milhões de adultos nos Estados Unidos têm DRC.

Característica do segmento	Dados específicos
Especialistas totais de nefrologia em nós	8.400 nefrologistas praticantes
Potencial anual de mercado	Receita potencial de US $ 1,2 bilhão

Praticantes de hematologia

O fibrogênio se concentra nos profissionais de hematologia que gerenciam anemia e distúrbios do sangue relacionados.

• Aproximadamente 5.600 hematologistas praticantes nos Estados Unidos
• Mercado -alvo para tratamento de Roxadustat
• Valor de mercado estimado de US $ 750 milhões

Instituições de pesquisa farmacêutica

O fibrogênio colabora com instituições de pesquisa que desenvolvem novas abordagens terapêuticas.

Tipo de instituição de pesquisa	Escopo de colaboração
Centros de pesquisa acadêmica	15 parcerias de pesquisa ativas
Organizações de pesquisa privada	7 projetos colaborativos em andamento

Sistemas hospitalares

O fibrogênio tem como alvo os sistemas hospitalares que gerenciam tratamentos de doenças crônicas.

• Mais de 6.200 hospitais nos Estados Unidos
• Penetração potencial de mercado: 22% das principais redes hospitalares
• Valor anual estimado do tratamento: US $ 500 milhões

Pacientes com condições crônicas específicas

O foco primário do paciente do fibrogênio inclui indivíduos com condições crônicas específicas.

Condição do paciente	População total de pacientes
Doença renal crônica	37 milhões de pacientes
Anemia	3,4 milhões de pacientes diagnosticados
Anemia renal	1,2 milhão de pacientes

Fibrogen, Inc. (FGen) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2022, o Fibrogen relatou despesas de pesquisa e desenvolvimento, totalizando US $ 268,4 milhões. Os esforços de P&D da empresa se concentram principalmente no desenvolvimento de terapias para doenças fibróticas, anemia e oncologia.

Ano	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 268,4 milhões	68.3%
2021	US $ 326,6 milhões	70.1%

Investimentos de ensaios clínicos

O Fibrogen investiu significativamente em ensaios clínicos para vários candidatos a medicamentos, com custos substanciais associados aos seus programas de pesquisa em andamento.

• Ensaios clínicos de Roxadustat para tratamento de anemia
• Ensaios clínicos de pamrevlumab para doenças fibróticas
• Programas de pesquisa em andamento em andamento

Manutenção da propriedade intelectual

A empresa mantém um portfólio robusto de propriedade intelectual, com despesas anuais relacionadas a patentes estimadas em US $ 5-7 milhões.

Custos de fabricação e produção

Os custos de fabricação da Fibrogen para 2022 foram de aproximadamente US $ 45,2 milhões, incluindo despesas com instalações de produção e gerenciamento da cadeia de suprimentos.

Categoria de custo	2022 Despesas
Manufatura de sobrecarga	US $ 35,6 milhões
Equipamento de produção	US $ 9,6 milhões

Processos de conformidade e aprovação regulatórios

As despesas de conformidade regulatória para 2022 foram estimadas em US $ 12,3 milhões, cobrindo envios da FDA, aprovações de ensaios clínicos e requisitos regulatórios em andamento.

• Custos de envio da FDA: US $ 4,5 milhões
• Monitoramento de conformidade: US $ 3,8 milhões
• Documentação regulatória: US $ 4 milhões

Fibrogen, Inc. (FGen) - Modelo de negócios: fluxos de receita

Vendas farmacêuticas de produtos

A Fibrogen relatou receita total de US $ 295,8 milhões para o ano fiscal de 2022. Roxadustat, o principal produto farmacêutico da empresa para tratamento de anemia, gerou fluxos de receita específicos em diferentes mercados.

Produto	Mercado	Receita (2022)
Roxadustat	China	US $ 185,3 milhões
Roxadustat	Estados Unidos	US $ 37,6 milhões

Acordos de licenciamento e royalties

A Fibrogen estabeleceu acordos estratégicos de licenciamento com vários parceiros farmacêuticos.

• Astellas Pharma Partnership for Roxadustat no Japão
• AstraZeneca Collaboration for Global Roxadustat Development

Financiamento de colaboração de pesquisa

O financiamento de colaboração de pesquisa contribuiu com US $ 42,5 milhões para a receita da Fibrogen em 2022.

Potenciais pagamentos marcantes

Parceiro	Pagamento em potencial	Doença
Astellas Pharma	Até US $ 340 milhões	Aprovações regulatórias de Roxadustat
AstraZeneca	Até US $ 210 milhões	Marcos de desenvolvimento clínico

Futuras receitas de comercialização de medicamentos

O oleoduto do Fibrogen inclui possíveis fluxos de receita do Pamervlumab e outros terapêuticos em estágio clínico.

• Pamrevlumab: tratamento potencial para fibrose pulmonar idiopática
• Oncologia adicional e candidatos a doenças fibróticas

FibroGen, Inc. (FGEN) - Canvas Business Model: Value Propositions

You're looking at the core value FibroGen, Inc. (FGEN) is offering to patients and the market as of late 2025, which is heavily centered on its focused, U.S.-centric pipeline following a major corporate transaction.

Potential first-in-class Antibody-Drug Conjugate (ADC), FG-3246, for mCRPC

FG-3246, which targets CD46, is positioned as a potential first-in-class Antibody-Drug Conjugate (ADC) for metastatic castration-resistant prostate cancer (mCRPC), offering an androgen receptor agnostic and non-PSMA approach. The company initiated the Phase 2 monotherapy, dose-optimization study for FG-3246 in the third quarter of 2025.

Earlier Phase 1 data from study NCT03575819 provided a strong foundation for this value proposition. Here's a quick look at the numbers from that initial work:

Metric	Value	Context
Phase 1 Enrollment	56 patients	Total enrolled across dose escalation and expansion phases.
Median Prior Therapies	5 lines	Indicates activity in a heavily pretreated population.
Maximum Tolerated Dose (MTD)	2.7 mg/kg	Dose determined using adjusted body weight, administered every 3 weeks.
Confirmed Objective Response Rate (ORR)	20%	Demonstrated anti-cancer activity.
Median Duration of Response	7.5 months	Duration of patient response to treatment.
Disease Control Rate (DCR)	80%	Combined rate of objective response or stable disease.
Median radiographic Progression-Free Survival (rPFS)	8.7 months	Observed in the efficacy analysis set of 40 subjects.

The development path includes an investigator-sponsored study of FG-3246 in combination with enzalutamide, with topline results expected at a medical conference in the first quarter of 2026. Furthermore, interim results from the ongoing Phase 2 monotherapy trial are anticipated in the second half of 2026.

Oral treatment option (Roxadustat) for anemia in lower-risk MDS patients

FibroGen, Inc. is advancing Roxadustat as a potential oral treatment for anemia in lower-risk myelodysplastic syndromes (LR-MDS) patients with a high red blood cell (RBC) transfusion burden. This offers a differentiated mechanism of action and oral route compared to existing injectable agents.

• The company reached agreement with the U.S. Food and Drug Administration (FDA) on important design elements for the pivotal Phase 3 trial.
• Final Phase 3 protocol submission to the FDA is planned for the fourth quarter of 2025.
• In a post-hoc subgroup analysis from the MATTERHORN Phase 3 trial, 36% of LR-MDS patients with high transfusion burden achieved transfusion independence for at least 56 days, compared to only 7% on placebo.
• Lower-risk MDS patients represent approximately 77% of the total diagnosed MDS population in the U.S.
• Annual incidence rates of MDS in the U.S. are estimated at 4.9/100,000 adults.
• Approximately 80% of MDS patients have anemia at diagnosis.

Simplified, focused pipeline post-China sale to drive US development

The value proposition is underpinned by a significant financial restructuring completed in August 2025, which streamlined the company to focus on its wholly owned, late-stage U.S. assets. FibroGen, Inc. completed the sale of its China operations to AstraZeneca for a total consideration of approximately $220 million. This total consideration comprised $85 million in enterprise value and approximately $135 million in net cash held in China.

This transaction provided substantial financial breathing room. As of September 30, 2025, FibroGen, Inc. reported cash, cash equivalents, investments, and accounts receivable of $121.1 million, which is expected to fund operating plans into 2028. This focus is reflected in the cost structure:

• Total operating costs and expenses for the third quarter of 2025 were $6.5 million, an 86% decrease from $47.8 million in the third quarter of 2024.
• R&D expenses for Q3 2025 were $1.2 million, a 94% decrease year-over-year from $20 million in Q3 2024.
• Full year 2025 guidance for total operating costs and expenses is between $50 million and $60 million, representing a 70% reduction from full year 2024 at the midpoint.

Companion diagnostic (FG-3180) to select patients for FG-3246

To enhance the precision and potential efficacy of FG-3246, the development program includes FG-3180, an associated CD46-targeted PET biomarker. This diagnostic agent is being evaluated to select patients and predict response to the ADC. The Phase 2 monotherapy trial for FG-3246 will assess the diagnostic performance of FG-3180, with an interim analysis for this combined program anticipated in the second half of 2026. This integrated approach aims to de-risk the oncology development pathway.

FibroGen, Inc. (FGEN) - Canvas Business Model: Customer Relationships

You're looking at how FibroGen, Inc. manages its critical external relationships, which are heavily weighted toward regulatory bodies and strategic pharma partners. It's a classic biotech model where external validation and collaboration drive the value chain.

Direct, high-touch engagement with the U.S. Food and Drug Administration (FDA) is paramount, especially given past regulatory hurdles with roxadustat. FibroGen, Inc. successfully reached agreement with the U.S. Food and Drug Administration (FDA) on important design elements for the pivotal Phase 3 trial for roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell (RBC) transfusion burden. This followed a Type-C meeting with the FDA in July 2025. The company plans to submit the final Phase 3 protocol to the FDA in the fourth quarter of 2025. That's the next big regulatory gate to clear.

Strategic management of existing licensing partnerships is currently dominated by the finalization of the China divestiture. The sale of FibroGen China to AstraZeneca was completed in the third quarter of 2025 for a total consideration of approximately $220 million. This total consideration consisted of an enterprise value of $85 million plus approximately $135 million in net cash held in China at closing. This was an increase from the initial estimate of approximately $160 million total consideration. FibroGen, Inc. maintains its rights to roxadustat in the U.S. and in all markets outside of China, South Korea, and those licensed to Astellas. The Astellas collaboration continues for roxadustat commercialization in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

Investor relations communication centers on pipeline progression and financial stability following the China transaction. The company reported cash, cash equivalents, accounts receivable, and investments of $121.1 million as of September 30, 2025. The completion of the China sale is key, as it extended the company's cash runway into 2028. You can see the financial shift in the second quarter of 2025, where operating costs and expenses decreased by 72% year-over-year, with Research & Development (R&D) expenses down 82% and Selling, General & Administrative (SG&A) expenses down 53%.

Relationships with key opinion leaders (KOLs) and clinical investigators are tied directly to the FG-3246 program. The investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) is a major focus. Topline results from this investigator-sponsored study are expected to be presented at a medical conference in the first quarter of 2026.

Here's a quick view of the key financial and partnership metrics as of late 2025:

Relationship/Metric	Key Data Point (Late 2025)	Context/Date
FDA Engagement (Roxadustat)	Pivotal Phase 3 protocol submission planned for Q4 2025	LR-MDS indication agreement reached in July 2025
AstraZeneca China Sale (Total Consideration)	Approximately $220 million	Completed in Q3 2025
AstraZeneca China Sale (Enterprise Value)	$85 million	Part of total consideration
AstraZeneca China Sale (Net Cash Component)	Approximately $135 million	Part of total consideration
Cash Position (Consolidated)	$121.1 million	As of September 30, 2025
Cash Runway Extension	Into 2028	Post-China sale
Q2 2025 YoY OpEx Reduction	72% decrease	Resulting from operational streamlining
FG-3246 Investigator Study Readout	Expected in 1Q 2026	Combination study with enzalutamide

The Q2 2025 net loss from continuing operations was $13.7 million, on total revenue from continuing operations of $1.3 million. That's the cost of keeping the U.S. pipeline moving forward.

• Astellas collaboration territories include Japan, Europe, Turkey, Russia, and the Middle East.
• FibroGen, Inc. retains roxadustat rights in the U.S., Canada, and Mexico.
• The FG-3246 Phase 2 monotherapy trial initiation was expected in Q3 2025.

FibroGen, Inc. (FGEN) - Canvas Business Model: Channels

Licensing and collaboration agreements for ex-US commercialization.

Asset	Territory/Partner	Status/Financial Detail
Roxadustat	China (Sale to AstraZeneca)	Total consideration expected to be approximately $210 million; Enterprise value of $85 million plus estimated net cash held in China of approximately $125 million. Closing expected in 3Q 2025.
Roxadustat	Japan, Europe, Turkey, Russia, CIS, Middle East, South Africa	Collaboration with Astellas for commercialization.
Roxadustat	U.S., Canada, Mexico, South Korea	FibroGen maintains sole rights outside of Astellas' licensed territories and China/South Korea.

Clinical trial sites and hospitals for drug development and testing.

• Investigator-sponsored Phase 1b/2 study of FG-3246 in combination with enzalutamide is being conducted at UCSF.
• Investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 PET tracer for CD46 is also underway at UCSF.
• Initiation of the Phase 2 monotherapy dose optimization study of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) anticipated in the third quarter of 2025.
• Topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide expected in the fourth quarter of 2025.

Future commercial sales force or new partners for US market access.

For roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) in the U.S., FibroGen is exploring options for either internal development or partnership opportunities following agreement with the FDA on pivotal Phase 3 trial design elements.

The company's financial position, supported by the China sale proceeds, extends the cash runway into 2028, which funds U.S. development initiatives. Operating costs were slashed by 72% and R&D expenses by 82% year-over-year as of Q2 2025. The market cap contextually stood at $34 million as of Q2 2025.

FibroGen, Inc. (FGEN) - Canvas Business Model: Customer Segments

You're looking at the specific groups of people or organizations that FibroGen, Inc. (FGEN) is trying to reach and serve with its late-stage pipeline assets as of late 2025. This is where the value of their assets is realized, so the numbers here are critical for understanding their focus.

The primary customer segments for FibroGen, Inc. (FGEN) are defined by the indications for their two main clinical programs: FG-3246 in oncology and roxadustat in hematology, alongside the strategic segment of global pharma entities.

For the LR-MDS indication, the target patient population in the U.S. is substantial, though FibroGen is focusing on a specific, high-need subset. Roughly 75K patients live with Myelodysplastic Syndrome (MDS) in the U.S., and about 77% of those, or approximately 58K patients, are diagnosed with lower-risk MDS (LR-MDS). Of these, around 85% have anemia, meaning approximately 49K patients in the U.S. have anemia in LR-MDS. The specific group targeted for the pivotal Phase 3 trial of roxadustat requires a high transfusion burden, defined as patients needing $\ge$ 4 pRBC units in two consecutive 8-week periods and being refractory to, intolerant to, or ineligible for prior Erythropoiesis-Stimulating Agents (ESAs). The planned Phase 3 trial aims to enroll approximately 200 patients.

In oncology, the segment is Patients with metastatic castration-resistant prostate cancer (mCRPC). FibroGen is advancing FG-3246, an Antibody-Drug Conjugate (ADC) targeting CD46, which has potential in multiple lines of mCRPC and other solid tumors. The company initiated the Phase 2 monotherapy trial for FG-3246 in Q3 2025, and topline results from the investigator-sponsored study combining FG-3246 with enzalutamide are expected in Q4 2025.

The third segment involves Global pharmaceutical partners, which is a key customer base for potential out-licensing or strategic alliances, especially for the U.S. development of roxadustat in LR-MDS. FibroGen recently completed a major transaction with one such partner. The sale of FibroGen China to AstraZeneca was expected to have a total consideration of approximately $210 million, which included an enterprise value of $85 million plus estimated net cash held in China at closing of approximately $125 million (based on Q2 2025 updates). This transaction is expected to extend the company's cash runway into 2028.

Here's a quick look at the patient population scale and key financial events shaping these segments:

Customer Segment Focus	Target Indication/Role	Estimated U.S. Population Size	Key Program/Financial Event (Late 2025)
LR-MDS Patients	Anemia with High Transfusion Burden (Roxadustat)	Approximately 58K LR-MDS patients in the U.S.	Phase 3 protocol submission planned for Q4 2025.
mCRPC Patients	Metastatic Castration-Resistant Prostate Cancer (FG-3246)	Not explicitly quantified in search results for the U.S. market.	Phase 2 monotherapy trial initiation in Q3 2025.
Global Pharmaceutical Partners	Potential Licensees/Acquirers for U.S. Assets	N/A (Corporate Entities)	Sale of FibroGen China for $\sim$$210 million total consideration.

FibroGen, Inc. (FGEN) is clearly prioritizing these specific patient groups where their novel mechanism of action drugs, FG-3246 and roxadustat, aim to address significant unmet needs.

The company's focus areas for these customer segments include:

• Patients with metastatic castration-resistant prostate cancer (mCRPC).
• Patients with lower-risk Myelodysplastic Syndromes (LR-MDS) anemia and high transfusion burden.
• Global pharmaceutical partners seeking oncology and anemia assets.

For the LR-MDS segment, the oral convenience of roxadustat is a key differentiator against existing injectable Standard of Care (SOC) agents. For the mCRPC segment, FG-3246 offers a novel mechanism by binding a unique epitope on CD46 present on cancer cells. The company's cash position, extended into 2028 post-China sale, provides flexibility to pursue these segments internally or via partnership.

Finance: draft 13-week cash view by Friday.

FibroGen, Inc. (FGEN) - Canvas Business Model: Cost Structure

You're looking at the cost structure for FibroGen, Inc. (FGEN) as of late 2025, post-China transaction, which has clearly reshaped their expense profile. Here's the quick math on the key cost components based on the Q3 2025 reporting period.

The company has aggressively streamlined its operating expenses. Total operating costs and expenses for the third quarter of 2025 were reported at only $6.5 million, a significant drop from $47.8 million in the third quarter of 2024, representing an 86% year-over-year decrease.

The primary drivers of this cost reduction are evident in the breakdown of R&D and SG&A spending.

Cost Category	Q3 2025 Amount (in thousands)	Q3 2024 Amount (in thousands)	Year-over-Year Change
Research and Development (R&D)	$1,209	$19,974	-94%
Selling, General and Administrative (SG&A)	$5,295	$9,362	-43%

The R&D expense reduction was substantial, falling from $20 million in Q3 2024 to just $1.2 million in Q3 2025, a 94% decrease year-over-year. This reduction was achieved through steps to lower fixed cost infrastructure across both project and FTE (Full-Time Equivalent) spend.

General and Administrative (G&A) expenses, reported as SG&A, also saw a major cut, decreasing by 43%, from $9.4 million in Q3 2024 to $5.3 million in Q3 2025. For the full year 2025, FibroGen, Inc. is guiding total operating costs and expenses, including stock-based compensation, to be between $50 million and $60 million, which is a 70% reduction from full year 2024 at the midpoint.

Regarding clinical trial costs, the focus is on pipeline advancement:

• FG-3246 Phase 2 monotherapy trial initiation occurred in the third quarter of 2025.
• Interim analysis for the FG-3246 Phase 2 trial is anticipated in the second half of 2026.
• Roxadustat Phase 3 protocol submission for LR-MDS is anticipated in the fourth quarter of 2025.

Specific dollar amounts for the clinical trial costs themselves aren't itemized in the Q3 2025 data provided, but the activities are clearly underway. What this estimate hides is the future spend required to complete these trials.

A major, non-recurring cost event was the debt settlement. Upon closing the sale of FibroGen China in August 2025, FibroGen, Inc. successfully repaid its senior secured term loan with Morgan Stanley Tactical Value (MSTV). This resulted in a cash outflow of approximately $80.9 million. That outflow covered the $75 million principal balance accrued and unpaid interest, plus an applicable prepayment penalty.

Finance: draft 13-week cash view by Friday.

FibroGen, Inc. (FGEN) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of FibroGen, Inc. (FGEN) as of late 2025, and it's heavily shaped by a major, recent, one-time event alongside ongoing partnership contributions. The core business model relies on past licensing deals for its key asset, roxadustat, which is approved outside the U.S.

Collaboration revenue from partners like Astellas and AstraZeneca.

FibroGen, Inc. maintains rights to roxadustat in the U.S., Canada, and Mexico, while Astellas and FibroGen, Inc. collaborate on commercialization in territories including Japan, Europe, Turkey, Russia, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca is the partner for the China operations sale. Revenue from continuing operations, which largely reflects these collaborations outside of the China sale impact, was reported as follows:

• Q3 2025 total revenue from continuing operations: $1.1 million.
• Q2 2025 total revenue from continuing operations: $1.3 million.
• For the three months ended June 30, 2025, amounts recognized as license revenue and development revenue under the Astellas Japan Agreement were not material.

Full-year 2025 revenue guidance is between $6 million and $8 million.

Despite the low quarterly revenue from continuing operations, the company reiterated its forecast for the entire fiscal year 2025.

Metric	Value	Period/Context
Full-Year 2025 Revenue Guidance	$6 million to $8 million	Full Year 2025
Q3 2025 Revenue (Continuing Operations)	$1.1 million	Three Months Ended September 30, 2025
Q2 2025 Revenue (Continuing Operations)	$1.3 million	Three Months Ended June 30, 2025

Potential future milestone payments from existing licensing deals.

While specific future milestone amounts for late 2025 aren't detailed as firm guidance, the progression of clinical assets suggests potential triggers. For instance, topline results from the investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) are expected in the fourth quarter of 2025. Also, the final protocol submission for the pivotal Phase III trial for roxadustat is anticipated in the fourth quarter of 2025.

One-time cash inflow of approximately $220 million from the China sale in Q3 2025.

The most significant financial event impacting the balance sheet was the completion of the sale of FibroGen China to AstraZeneca in August 2025. This transaction provided a substantial, non-recurring cash infusion, which was used to pay down debt and extend the cash runway into 2028.

• Total consideration received: approximately $220 million.
• Enterprise value component: $85 million.
• Net cash held in China at closing: approximately $135 million.
• This total consideration was an increase of $60 million from the initial net cash guidance provided in February 2025.

This deal fundamentally reset the company's financial footing, though it is not part of the recurring revenue stream.