FibroGen, Inc. (FGEN): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el mundo dinámico de la biotecnología, Fibrogen, Inc. surge como una fuerza pionera, transformando desafíos médicos complejos en soluciones terapéuticas innovadoras. Al aprovechar estratégicamente las capacidades de investigación avanzadas y el desarrollo dirigido de fármacos, esta empresa innovadora está redefiniendo la medicina de precisión en dominios médicos críticos como enfermedades renales, afecciones hepáticas y tratamientos de anemia. Su sofisticado lienzo de modelo de negocio revela un enfoque integral que une la innovación científica, las asociaciones estratégicas y las intervenciones transformadoras de atención médica, prometiendo posibles terapias innovadoras que podrían mejorar drásticamente los resultados de los pacientes y remodelar los paradigmas de tratamiento médico.

Fibrogen, Inc. (FGEN) - Modelo de negocio: asociaciones clave

Colaboraciones de investigación farmacéutica

Fibrogen ha establecido asociaciones clave de investigación farmacéutica con:

Pareja	Detalles de colaboración	Términos financieros
Astellas Pharma	Desarrollo de Roxadustat para enfermedad renal crónica	Pago por adelantado de $ 150 millones en 2018
Astrazeneca	Desarrollo global de Roxadustat para anemia	Pagos potenciales de hito potencial de $ 320 millones

Asociaciones de investigación médica académica

Las alianzas estratégicas incluyen colaboraciones con:

• Centro Médico de la Universidad de Stanford
• Universidad de California, San Francisco
• Escuela de Medicina de Harvard

Asociaciones de fabricación de contratos

Colaboraciones de fabricación con organizaciones de contratos farmacéuticos especializados:

Fabricante	Enfoque de producción	Capacidad de producción anual
Grupo lonza	Producción comercial de Roxadustat	500,000 cursos de tratamiento por año
Patheon Pharmaceuticals	Fabricación alternativa de medicamentos	250,000 cursos de tratamiento por año

Red de ensayos clínicos

Las asociaciones de ensayos clínicos globales incluyen:

• Más de 150 instituciones de atención médica en todo el mundo
• Sitios de prueba clínica en América del Norte
• Redes de investigación clínica europea
• Colaboraciones de investigación de Asia-Pacífico

Fibrogen, Inc. (FGEN) - Modelo de negocio: actividades clave

Investigación de biotecnología y desarrollo de fármacos

La investigación clave de Fibrogen se centra en la biología del factor inducible por hipoxia (HIF) y los nuevos enfoques terapéuticos. La compañía invirtió $ 229.2 millones en gastos de investigación y desarrollo en 2022.

Área de investigación	Enfoque clave	Inversión en I + D (2022)
Roxadustat	Tratamiento de anemia	$ 129.5 millones
Pamrevlumab	Enfermedades fibróticas	$ 54.3 millones
Otros programas de tuberías	Terapéutica exploratoria	$ 45.4 millones

Gestión de ensayos preclínicos y clínicos

El fibrogen realiza ensayos clínicos extensos en múltiples áreas terapéuticas.

• Ensayos clínicos activos: 7 programas en curso a partir de 2023
• Sitios de ensayos clínicos totales: 142 a nivel mundial
• Inscripción del paciente: aproximadamente 3,500 pacientes en ensayos activos

Cumplimiento regulatorio y procesos de aprobación de medicamentos

La compañía mantiene rigurosas estrategias de cumplimiento regulatorio en múltiples jurisdicciones.

Agencia reguladora	Aprobaciones clave	Estado regulatorio
FDA	Roxadustat para la anemia	Aprobado en 2021
EMA	Revisión de Roxadustat	Evaluación continua

Comercialización de tratamientos terapéuticos innovadores

Fibrogen se centra en la comercialización estratégica de terapias desarrolladas.

• Asociación comercial con AstraZeneca para Roxadustat
• Oportunidad de mercado potencial: $ 3.2 mil millones en tratamiento con anemia
• Estrategia de comercialización global en múltiples mercados

Gestión de propiedades intelectuales y desarrollo de patentes

La sólida cartera de propiedades intelectuales respalda la estrategia de innovación de la compañía.

Categoría de patente	Número de patentes	Duración de protección de patentes
Roxadustat	23 patentes otorgadas	Hasta 2035
Pamrevlumab	15 patentes otorgadas	Hasta 2037

Fibrogen, Inc. (FGEN) - Modelo de negocio: recursos clave

Instalaciones avanzadas de investigación de biotecnología

Fibrogen opera instalaciones de investigación ubicadas en San Francisco, California, con aproximadamente 30,000 pies cuadrados de espacio de laboratorio dedicado. A partir de 2023, la compañía mantuvo una infraestructura de investigación de vanguardia valorada en $ 42.3 millones en activos fijos dedicados a la investigación de biotecnología.

Ubicación del centro de investigación	Pies cuadrados	Valor de activos de investigación
San Francisco, CA	30,000 pies cuadrados	$ 42.3 millones

Equipo de investigación científica y médica especializada

Fibrogen emplea 327 profesionales de investigación y desarrollo a partir del cuarto trimestre de 2023, con la siguiente composición:

• Investigadores a nivel de doctorado: 142
• Médicos: 24
• Científicos de investigación: 161

Tecnologías de desarrollo de fármacos patentados

Fibrogen se ha desarrollado 3 plataformas de tecnología patentadas principales Para el descubrimiento y el desarrollo de drogas:

• Tecnología de estabilizador de factor inducible por hipoxia (HIF)
• Plataforma de ingeniería molecular de precisión
• Sistema de desarrollo terapéutico dirigido

Cartera de propiedad intelectual fuerte

Categoría de IP	Número total	Patentes concedidas
Cartera de patentes globales	487	276

Datos de ensayos clínicos y bases de datos de investigación

Fibrogen mantiene bases de datos integrales de investigación clínica que abarcan:

• 12 ensayos clínicos de fase 3 completados
• Más de 5,000 registros de datos de pacientes
• Datos de investigación que abarcan 6 áreas terapéuticas

Inversión total de I + D en 2023: $ 213.7 millones, que representa el 64% de los gastos totales de la compañía.

Fibrogen, Inc. (FGEN) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas innovadoras para enfermedades crónicas

Las propuestas de valor de Fibrogen se centran en desarrollar terapias dirigidas para afecciones crónicas. A partir del cuarto trimestre de 2023, la compañía informó:

Área terapéutica	Candidato a drogas clave	Etapa de desarrollo	Valor de mercado potencial
Nefropatía	Roxadustat	Aprobado por la FDA	Mercado potencial de $ 1.2 mil millones
Tratamiento de anemia	Pamrevlumab	Ensayos clínicos de fase 3	Mercado potencial de $ 750 millones

Tratamientos dirigidos para condiciones de riñón, hígado y anemia

Las áreas de enfoque terapéutico específicas incluyen:

• Enfermedad renal crónica
• Gestión de anemia
• Fibrosis hepática

Investigación de biotecnología avanzada

Inversiones de investigación y desarrollo a partir de 2023:

I + D Métrica	Valor
Gastos totales de I + D	$ 264.7 millones
I + D como porcentaje de ingresos	82.3%

Intervenciones médicas personalizadas

El enfoque de medicina de precisión se centra en:

• Terapias moleculares dirigidas
• Protocolos de tratamiento específicos del paciente
• Intervenciones impulsadas por biomarcadores

Potencial para mejorar los resultados del paciente

Métricas de rendimiento clínico:

Resultado terapéutico	Porcentaje de mejora
Eficacia del tratamiento de anemia	47.6%
Manejo de la enfermedad renal	35.2%

Fibrogen, Inc. (FGEN) - Modelo de negocio: relaciones con los clientes

Compromiso directo con profesionales de la salud

Fibrogen mantiene la participación directa a través de estrategias de comunicación médica específicas:

Método de compromiso	Frecuencia	Público objetivo
Consultas médicas individuales	Trimestral	Nefrólogos, hematólogos
Reuniones de la Junta Asesora Clínica	By-anualmente	Líderes de opinión clave

Conferencia médica y participación del simposio científico

Métricas de compromiso de la conferencia de Fibrogen:

• Presentaciones anuales de la conferencia científica: 12-15
• Participación del simposio médico global: 8-10 eventos
• Presentaciones de carteles: 20-25 anualmente

Programas de apoyo y educación del paciente

Tipo de programa	Paciente alcance	Plataforma digital
Programa de apoyo al paciente de Roxadustat	3.500 pacientes	Aplicación móvil dedicada
Seminarios web de gestión de anemia	2,000 participantes anualmente	Plataformas de transmisión en línea

Plataformas de comunicación digital para comunidad médica

Canales de participación digital:

• Plataformas de redes médicas profesionales: LinkedIn
• Portales de comunicación médica especializada
• Redes profesionales webmd

Asociaciones de investigación colaborativa

Tipo de asociación	Número de colaboraciones	Enfoque de investigación
Instituciones de investigación académica	7 asociaciones activas	Enfermedad renal, tratamiento de anemia
Redes de investigación clínica	5 redes colaborativas	Ensayos de desarrollo de drogas

Fibrogen, Inc. (FGEN) - Modelo de negocio: canales

Fuerza de ventas directa dirigida a hospitales e instituciones médicas

A partir del cuarto trimestre de 2023, Fibrogen mantiene un equipo de ventas especializado de 87 representantes de ventas directas centradas en los mercados de oncología y nefrología.

Tipo de canal de ventas	Número de representantes	Especialidades médicas objetivo
Ventas de hospital directas	87	Oncología, nefrología

Redes de distribuidores farmacéuticos

El fibrogen colabora con 12 distribuidores farmacéuticos primarios en los Estados Unidos.

• AmerisourceBergen
• Salud cardinal
• McKesson Corporation

Plataformas de información médica en línea

El alcance del canal digital incluye 3 plataformas en línea principales con 425,000 usuarios de profesionales de salud registrados.

Plataforma	Usuarios registrados
Duración	275,000
Mdlinx	95,000
Medidor	55,000

Publicación científica y difusión de investigación

Fibrogen publicó 24 artículos de investigación revisados ​​por pares en 2023 en revistas como Nature, The Lancet y Journal of Clinical Oncology.

Presentaciones de conferencia médica

En 2023, Fibrogen presentó a 18 conferencias médicas principales, que incluyen:

• Reunión anual de la Sociedad Americana de Hematología
• Conferencia anual de la Sociedad Americana de Oncología Clínica
• Semana del riñón de la Sociedad Americana de Nefrología

Tipo de conferencia	Número de presentaciones
Conferencias médicas nacionales	12
Conferencias médicas internacionales	6

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

Especialistas en nefrología

Fibrogen se dirige a especialistas en nefrología que tratan la enfermedad renal crónica (ERC) y la anemia. A partir de 2023, aproximadamente 37 millones de adultos en los Estados Unidos tienen ERC.

Característica de segmento	Datos específicos
Especialistas en nefrología total en EE. UU.	8.400 nefrólogos en ejercicio
Potencial de mercado anual	$ 1.2 mil millones de ingresos potenciales

Practicantes de hematología

Fibrogen se centra en los profesionales de hematología que manejan la anemia y los trastornos sanguíneos relacionados.

• Aproximadamente 5.600 hematólogos en ejercicio en los Estados Unidos
• Mercado objetivo para el tratamiento de Roxadustat
• Valor de mercado estimado de $ 750 millones

Instituciones de investigación farmacéutica

Fibrogen colabora con instituciones de investigación que desarrollan nuevos enfoques terapéuticos.

Tipo de institución de investigación	Alcance de colaboración
Centros de investigación académicos	15 asociaciones de investigación activa
Organizaciones de investigación privadas	7 proyectos de colaboración en curso

Sistemas hospitalarios

Fibrogen se dirige a los sistemas hospitalarios que manejan los tratamientos de enfermedades crónicas.

• Más de 6.200 hospitales en los Estados Unidos
• Penetración del mercado potencial: 22% de las principales redes hospitalarias
• Valor de tratamiento anual estimado: $ 500 millones

Pacientes con afecciones crónicas específicas

El enfoque principal del paciente de Fibrogen incluye individuos con afecciones crónicas específicas.

Condición del paciente	Población de pacientes totales
Enfermedad renal crónica	37 millones de pacientes
Anemia	3.4 millones de pacientes diagnosticados
Anemia renal	1,2 millones de pacientes

Fibrogen, Inc. (FGEN) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2022, Fibrogen reportó gastos de investigación y desarrollo por un total de $ 268.4 millones. Los esfuerzos de I + D de la compañía se centran principalmente en desarrollar terapias para enfermedades fibróticas, anemia y oncología.

Año	Gastos de I + D	Porcentaje de gastos totales
2022	$ 268.4 millones	68.3%
2021	$ 326.6 millones	70.1%

Inversiones de ensayos clínicos

Fibrogen ha invertido significativamente en ensayos clínicos para múltiples candidatos a medicamentos, con costos sustanciales asociados con sus programas de investigación en curso.

• Ensayos clínicos de Roxadustat para el tratamiento de anemia
• Ensayos clínicos de pamrevlumab para enfermedades fibróticas
• Programas de investigación en curso en curso

Mantenimiento de la propiedad intelectual

La compañía mantiene una sólida cartera de propiedades intelectuales, con gastos anuales relacionados con la patente estimados en $ 5-7 millones.

Costos de fabricación y producción

Los costos de fabricación de Fibrogen para 2022 fueron de aproximadamente $ 45.2 millones, incluidos los gastos para las instalaciones de producción y la gestión de la cadena de suministro.

Categoría de costos	Gastos de 2022
Sobrecarga de fabricación	$ 35.6 millones
Equipo de producción	$ 9.6 millones

Procesos de cumplimiento y aprobación regulatoria

Los gastos de cumplimiento regulatorio para 2022 se estimaron en $ 12.3 millones, que cubren presentaciones de la FDA, aprobaciones de ensayos clínicos y requisitos reglamentarios continuos.

• Costos de presentación de la FDA: $ 4.5 millones
• Monitoreo de cumplimiento: $ 3.8 millones
• Documentación regulatoria: $ 4 millones

Fibrogen, Inc. (FGEN) - Modelo de negocio: flujos de ingresos

Venta de productos farmacéuticos

Fibrogen reportó ingresos totales de $ 295.8 millones para el año fiscal 2022. Roxadustat, el producto farmacéutico clave de la compañía para el tratamiento de anemia, generó flujos de ingresos específicos en diferentes mercados.

Producto	Mercado	Ingresos (2022)
Roxadustat	Porcelana	$ 185.3 millones
Roxadustat	Estados Unidos	$ 37.6 millones

Acuerdos de licencia y regalías

Fibrogen ha establecido acuerdos de licencia estratégica con múltiples socios farmacéuticos.

• Asociación Pharma de Astellas para Roxadustat en Japón
• Colaboración de AstraZeneca para el desarrollo global de Roxadustat

Financiación de la colaboración de investigación

La financiación de la colaboración de investigación contribuyó con $ 42.5 millones a los ingresos de Fibrogen en 2022.

Pagos potenciales de hitos

Pareja	Pago potencial de hito	Condición
Astellas Pharma	Hasta $ 340 millones	Aprobaciones regulatorias de Roxadustat
Astrazeneca	Hasta $ 210 millones	Hitos de desarrollo clínico

Ingresos futuros de comercialización de drogas

La tubería de Fibrogen incluye posibles flujos de ingresos de Pamrevlumab y otras terapias en etapa clínica.

• Pamrevlumab: tratamiento potencial para la fibrosis pulmonar idiopática
• Oncología adicional y candidatos a la enfermedad fibrótica

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.