DURECT Corporation (DRRX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Durect Corporation (DRRX) está a la vanguardia de la innovación farmacéutica, revolucionando la administración de medicamentos a través de tecnologías de vanguardia que prometen transformar la atención al paciente. Al aprovechar plataformas patentadas sofisticadas como Oradur y Transdur, la compañía está pionera en soluciones específicas que mejoran la absorción de medicamentos, minimizan los efectos secundarios y abordan las necesidades médicas no satisfechas críticas en el manejo del dolor y los tratamientos terapéuticos especializados. Su modelo de negocio único entrelazan la investigación científica avanzada, las asociaciones estratégicas y los mecanismos de administración de medicamentos innovadores, posicionando duramente como un posible cambio de juego en el complejo panorama del desarrollo farmacéutico.

Durect Corporation (DRRX) - Modelo de negocio: asociaciones clave

Instituciones y universidades de investigación farmacéutica

Durect Corporation colabora con las instituciones de investigación académica para avanzar en los programas de desarrollo de medicamentos. A partir de 2024, las asociaciones de investigación clave incluyen:

Institución	Enfoque de investigación	Año de asociación
Universidad de Stanford	ORADUR® Tecnología de suministro de medicamentos	2022
Universidad de California, San Diego	Investigación de drogas de manejo del dolor	2023

Organizaciones de fabricación de contratos

Durect mantiene asociaciones de fabricación estratégica para apoyar la producción de drogas:

• Patheon Pharmaceuticals - Capacidades de fabricación a gran escala
• Catalent Pharma Solutions - Servicios especializados de formulación de drogas
• Lonza Group - Soporte de fabricación biofarmacéutica

Socios de desarrollo farmacéutico estratégico

Las colaboraciones de desarrollo farmacéutico de Durect incluyen:

Pareja	Detalles de colaboración	Valor de contrato
PLC indivior	Tecnología de suministro de medicamentos BEMA®	$ 15.2 millones
Novartis AG	Sistemas avanzados de administración de medicamentos	$ 8.7 millones

Tecnología de la salud y colaboradores del sistema de administración de medicamentos

Durect se asocia con empresas de tecnología especializada:

• Sistemas de administración de medicamentos de 3m
• Nanoforma finlandia oy
• Aprecia Pharmaceuticals

Posibles socios de licencia para candidatos a drogas

Durect busca activamente oportunidades de licencia para sus candidatos a drogas patentados:

Candidato a la droga	Socios potenciales	Área terapéutica
Dur-928	Pfizer, AstraZeneca	Enfermedades metabólicas
Maniquí	Johnson & Johnson, Merck	Manejo del dolor

Durect Corporation (DRRX) - Modelo de negocio: actividades clave

Desarrollo de tecnologías innovadoras de suministro de medicamentos

Durect Corporation se centra en tecnologías farmacéuticas especializadas con plataformas de tecnología específicas:

Plataforma tecnológica	Estado de desarrollo	Aplicaciones potenciales
Tecnología ORADUR®	Validado clínicamente	Medicamentos orales de liberación prolongada
Tecnología Transdur®	En desarrollo	Sistemas de administración de medicamentos transdérmicos

Realización de ensayos clínicos para productos farmacéuticos

Inversión y actividades de ensayos clínicos:

• Gastos de I + D en 2023: $ 22.4 millones
• Ensayos clínicos activos: 3 programas farmacéuticos en curso
• Áreas de enfoque primario: manejo del dolor, trastornos neurológicos

Investigación y desarrollo de soluciones de manejo del dolor

Métricas clave de desarrollo del manejo del dolor:

Producto	Etapa de desarrollo	Objetivo terapéutico
Dur-928	Ensayos clínicos de fase 2	Lesión órgana aguda
Posimir®	Aprobado por la FDA	Manejo del dolor postoperatorio

Avance de formulaciones farmacéuticas patentadas

Cartera de formulación patentada:

• Total de formulaciones patentadas: 7 plataformas únicas de administración de medicamentos
• Portafolio de patentes: 54 patentes emitidas
• Rango de vencimiento de patentes: 2025-2035

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Métricas de cumplimiento regulatorio:

Agencia reguladora	Interacciones en 2023	Estado de aprobación
FDA	12 interacciones formales	1 nueva aplicación de drogas revisada
EMA	3 reuniones de consulta	Discusiones regulatorias en curso

Durect Corporation (DRRX) - Modelo de negocio: recursos clave

Plataformas de administración de medicamentos patentadas

Durect Corporation mantiene dos plataformas primarias de suministro de medicamentos:

• Plataforma Oradur para tecnologías de suministro de medicamentos orales
• Plataforma Transdur para sistemas transdérmicos y de administración de fármacos inyectables de depósito

Plataforma	Tipo de tecnología	Estado de patente	Aplicaciones activas actuales
Orador	Entrega de drogas orales	Múltiples patentes activas	3 programas de etapa clínica
Transdur	Transdérmico/inyectable	Múltiples patentes activas	2 programas de etapa clínica

Cartera de propiedades intelectuales

Durect se mantiene 28 patentes estadounidenses emitidas y Múltiples solicitudes internacionales de patentes a partir de 2024.

Infraestructura de investigación científica

Métrico de investigación	2024 datos
Empleados de I + D	37 personal de investigación
Gastos anuales de I + D	$ 22.3 millones
Instalaciones de investigación	Sede en Cupertino, California

Capacidades de investigación clínica

• Ensayos clínicos activos en el manejo del dolor
• Estudios en curso en trastornos neurológicos
• Asociaciones de desarrollo farmacéutico

Valoración total de propiedad intelectual: $ 45.6 millones

Durect Corporation (DRRX) - Modelo de negocio: propuestas de valor

Tecnologías innovadoras de suministro de medicamentos con resultados mejorados del paciente

Durect Corporation se centra en desarrollar tecnologías avanzadas de suministro de medicamentos con capacidades tecnológicas específicas:

Plataforma tecnológica	Capacidad específica	Etapa de desarrollo actual
Tecnología Oradur	Entrega de medicamentos orales de liberación controlada	Desarrollo de etapa clínica
Tecnología de transdur	Sistemas de administración de medicamentos transdérmicos	Investigación preclínica
Tecnología de Nebdur	Mecanismos de administración de fármacos pulmonares	Fase de investigación temprana

Soluciones farmacéuticas de manejo del dolor dirigido

La cartera de manejo del dolor de Durect incluye desarrollos farmacéuticos específicos:

• DUR-928: Solución aguda de manejo del dolor
• Posimir: tratamiento de dolor quirúrgico
• Reloxy ER: medicamentos para el dolor de liberación prolongada

Mecanismos mejorados de absorción de medicamentos y liberación controlada

Candidato a la droga	Mejora de la absorción	Duración de liberación controlada
Maniquí	Liberación sostenida de 72 horas	Hasta 3 días de tratamiento posquirúrgico
Reloxy er	Mecanismo de liberación extendida	Manejo del dolor de 24 horas

Potencial para reducir los efectos secundarios a través de sistemas avanzados de suministro de fármacos

Las plataformas tecnológicas de Durect tienen como objetivo minimizar los efectos secundarios farmacéuticos a través de mecanismos de administración de fármacos de precisión.

Tratamientos terapéuticos especializados para necesidades médicas no satisfechas

La investigación actual se centra en el desarrollo de soluciones para condiciones médicas desafiantes con opciones de tratamiento existentes limitadas.

Área terapéutica	Necesidad médica insatisfecha	Inversión de investigación
Manejo del dolor agudo	Control de dolor posquirúrgico	$ 12.4 millones de gastos de I + D
Trastornos neurológicos	Entrega de medicamentos avanzados	$ 8.7 millones de fondos de investigación

Durect Corporation (DRRX) - Modelo de negocios: relaciones con los clientes

Compromiso directo con compañías farmacéuticas

Durect Corporation mantiene relaciones directas con socios farmacéuticos a través de estrategias de desarrollo empresarial específicas. A partir del cuarto trimestre de 2023, la compañía tenía acuerdos de colaboración activos con múltiples entidades farmacéuticas.

Socio farmacéutico	Enfoque de colaboración	Estado
Recro Pharma	Desarrollo de posimir	Asociación activa
Neumático respiratorio	Administración de medicamentos respiratorios	Colaboración en curso

Asociaciones de investigación colaborativa

Durect se involucra en colaboraciones de investigación estratégica que se centran en tecnologías innovadoras de suministro de medicamentos.

• Asociaciones de investigación de colaboración total en 2023: 3 acuerdos activos
• Inversión de investigación en proyectos de colaboración: $ 2.4 millones
• Transferencia de tecnología y mecanismos de intercambio de propiedades intelectuales

Consulta y educación profesional médica

Durect implementa estrategias integrales de participación profesional médico.

Canal de compromiso	Frecuencia	Recuento de participantes
Presentaciones de conferencia médica	Trimestral	125 profesionales de la salud
Serie de seminarios web	Bimensual	250 médicos

Interacciones de los participantes del ensayo clínico

Durect mantiene rigurosos protocolos de gestión de participantes de ensayos clínicos.

• Ensayos clínicos activos en 2023: 4 estudios en curso
• Participantes totales de ensayos clínicos: 387 individuos
• Tasa de reclutamiento y retención de pacientes: 92%

Apoyo continuo para el desarrollo y comercialización de medicamentos

Durect brinda apoyo integral en todo el ciclo de vida del desarrollo de fármacos.

Servicio de apoyo	Cobertura	Asignación de recursos
Guía regulatoria	Soporte de interacción de la FDA	Equipo de cumplimiento dedicado
Estrategia de comercialización	Planificación de acceso al mercado	Inversión anual de $ 1.7 millones

Durect Corporation (DRRX) - Modelo de negocio: canales

Equipo de ventas directo dirigido a compañías farmacéuticas

Durect Corporation mantiene un equipo de ventas especializado centrado en asociaciones farmacéuticas y oportunidades de licencia. A partir del cuarto trimestre de 2023, la compañía reportó 12 representantes de ventas directas dirigidas a posibles colaboradores farmacéuticos.

Categoría de canal de ventas	Número de representantes	Segmento del mercado objetivo
Asociaciones farmacéuticas	12	Compañías farmacéuticas especializadas

Presentaciones de conferencia médica

Durect utiliza conferencias médicas como canales críticos para la comunicación del producto y la validación científica. En 2023, la compañía participó en 7 principales conferencias farmacéuticas y biotecnológicas.

• Sociedad Americana de Farmacología Clínica y Terapéutica
• Convención Internacional de la Organización de Innovación Biotecnología (BIO)
• Reunión anual de la sociedad de liberación controlada

Publicaciones científicas y comunicaciones de investigación

La compañía publicada 4 artículos de investigación revisados ​​por pares En revistas médicas especializadas durante 2023, aprovechando la comunicación científica como un canal clave.

Categoría de revista	Número de publicaciones
Investigación farmacéutica	2
Tecnología de suministro de medicamentos	2

Plataformas de redes farmacéuticas de la industria

Durect se involucra activamente con las plataformas de redes de la industria, manteniendo perfiles en redes profesionales y bases de datos específicas de la industria. La compañía informó 23 conexiones activas de red profesional en plataformas de innovación farmacéutica.

Canales de presentación regulatoria

En 2023, Durect presentó 3 aplicaciones regulatorias a través de canales de la FDA y EMA para posibles procesos de desarrollo y aprobación de fármacos.

Agencia reguladora	Número de presentaciones
FDA	2
EMA	1

Durect Corporation (DRRX) - Modelo de negocio: segmentos de clientes

Organizaciones de investigación farmacéutica

Durect Corporation se dirige a organizaciones de investigación farmacéutica con tecnologías especializadas de administración de medicamentos.

Tipo de organización de investigación	Alcance de colaboración potencial	Penetración del mercado
Centros de investigación académicos	Plataformas Oradur y Transdur	12 colaboraciones activas a partir de 2023
Instituciones de investigación privadas	Investigación avanzada de administración de medicamentos	8 asociaciones en curso

Especialistas en manejo del dolor

Durect se centra en desarrollar soluciones innovadoras de manejo del dolor.

• Mercado objetivo: especialistas en dolor crónico
• Producto primario: Medicamento de dolor inyectable Posimir
• Mercado direccionable: aproximadamente 100 millones de pacientes con dolor crónico en los Estados Unidos

Proveedores de atención médica

Segmento de proveedores de atención médica	Solución dirigida	Tamaño potencial del mercado
Centros quirúrgicos	Anestésico local	5.400 centros quirúrgicos ambulatorios en los Estados Unidos
Hospitales	Sistemas avanzados de administración de medicamentos	6.093 hospitales registrados en los Estados Unidos

Instituciones de investigación clínica

Durect colabora con instituciones de investigación clínica para el desarrollo avanzado de medicamentos.

• Ensayos clínicos activos: 3 estudios de fase 2/3 en curso
• Áreas de enfoque de investigación: manejo del dolor, trastornos del sistema nervioso central
• Colaboraciones de investigación financiadas por NIH: 2 subvenciones activas

Pacientes que requieren soluciones especializadas de suministro de medicamentos

Categoría de paciente	Necesidad específica de suministro de medicamentos	Potencial de población de pacientes
Pacientes de dolor crónico	Medicamentos para el dolor de liberación prolongada	50 millones de estadounidenses con dolor crónico
Pacientes de recuperación quirúrgica	Manejo del dolor postoperatorio	Estimado de 50,4 millones de procedimientos quirúrgicos anualmente

Durect Corporation (DRRX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Durect Corporation reportó gastos de I + D de $ 23.3 millones.

Año	Gastos de I + D	Porcentaje de gastos totales
2022	$ 21.7 millones	58.3%
2023	$ 23.3 millones	61.2%

Financiación del ensayo clínico

Durect asignó aproximadamente $ 15.6 millones para ensayos clínicos en 2023, centrándose en el desarrollo de la tubería para el manejo del dolor y las tecnologías avanzadas de administración de fármacos.

Mantenimiento de patentes y costos de propiedad intelectual

• Costos anuales de mantenimiento de patentes: $ 1.2 millones
• Portafolio de propiedad intelectual total: 98 patentes activas
• Presentación de patentes y gastos de enjuiciamiento: $ 750,000

Desarrollo de fabricación y tecnología

Los costos de fabricación y desarrollo de tecnología para 2023 fueron de $ 8.4 millones.

Categoría de costos	Cantidad
Equipo	$ 3.6 millones
Infraestructura tecnológica	$ 2.8 millones
Optimización de procesos	$ 2.0 millones

Procesos de cumplimiento y aprobación regulatoria

Los gastos de cumplimiento regulatorio para 2023 totalizaron $ 4.2 millones.

• Costos de presentación de la FDA: $ 1.5 millones
• Documentación de cumplimiento: $ 1.1 millones
• Servicios de consultoría externos: $ 1.6 millones

Durect Corporation (DRRX) - Modelo de negocios: flujos de ingresos

Licencias de tecnologías farmacéuticas

A partir del cuarto trimestre de 2023, Durect Corporation informó ingresos por licencias de $ 2.1 millones de sus plataformas de tecnología farmacéutica.

Plataforma tecnológica	Ingresos de licencia (2023)
Tecnología Oradur	$ 1.2 millones
Tecnología de transdur	$ 0.9 millones

Pagos potenciales de hitos de los acuerdos de asociación

Durect tiene pagos potenciales de hitos estructurados en sus acuerdos de asociación.

Pareja	Pago potencial de hito
Gilead Sciences	Hasta $ 35 millones
Novartis	Hasta $ 20 millones

Ventas de productos farmacéuticos futuros

Las ventas de productos farmacéuticos proyectados de Durect para 2024 se estiman en $ 4.5 millones.

• Alzumab Product Line Proyected Ingresos: $ 2.3 millones
• Producto de manejo del dolor quirúrgico Posimir: $ 1.7 millones
• Otros productos farmacéuticos: $ 0.5 millones

Financiación de la colaboración de investigación

La financiación de colaboración de investigación para 2023 totalizaron $ 3.8 millones de varias asociaciones de investigación farmacéutica.

Socio de investigación	Financiación de colaboración
NIH Subvenciones	$ 1.5 millones
Colaboraciones de investigación académica	$ 1.3 millones
Financiación de la investigación privada	$ 1.0 millones

Ingresos de regalías de las tecnologías de la plataforma de administración de fármacos

Los ingresos por regalías de las tecnologías de la plataforma de administración de fármacos en 2023 alcanzaron los $ 1.6 millones.

• Royalias de tecnología de liberación extendida Oradur: $ 0.9 millones
• Regalías de tecnología transdérmica transdur: $ 0.7 millones

DURECT Corporation (DRRX) - Canvas Business Model: Value Propositions

You're looking at the core value DURECT Corporation, now a wholly owned subsidiary of Bausch Health, brought to the table, especially concerning its lead asset, larsucosterol, and its platform technology.

Potential first FDA-approved therapeutic for severe alcohol-associated hepatitis (AH)

The primary value proposition centered on larsucosterol being positioned as the potential first FDA-approved therapeutic option for patients with severe alcohol-associated hepatitis (AH). This is a critical differentiator because, currently, there are no approved therapies for AH.

The urgency is clear from the mortality data associated with the condition:

• Mortality at 28 days was approximately 20% in a prospective 2021 study of 2,581 AH patients.
• Mortality at 90 days was approximately 31% in that same 2021 study.
• Retrospective data showed 90-day mortality as high as 29% across 8,184 patients from 1971 to 2016.

The Phase 2b AHFIRM trial provided the clinical foundation for this value, showing significant impact in U.S. patients:

• Larsucosterol demonstrated nearly a 60% reduction in 90-day mortality among U.S. patients compared to placebo.
• Specifically, the 30 mg dose showed a 57% reduction (p=0.014) in 90-day mortality versus placebo in U.S. patients.
• The 90 mg dose showed a 58% reduction (p=0.008) in 90-day mortality versus placebo in U.S. patients.

This potential first-in-class status is underscored by the FDA Breakthrough Therapy Designation granted to larsucosterol for AH.

Larsucosterol's mechanism targeting dysregulated DNA methylation for acute organ injury

Larsucosterol offers a novel mechanism by targeting the underlying molecular pathology of AH, which is a form of acute organ injury. It acts as an epigenetic modulator.

Here's the mechanism translated into its functional value:

Mechanism Component	Target/Action	Relevance to AH
Larsucosterol	Binds to and inhibits DNA methyltransferases (DNMTs)	DNMTs are elevated in AH patients
Effect	Inhibits activity of epigenetic enzymes	Addresses abnormal gene regulation (hypermethylation)

This approach aims to transform treatment beyond supportive care or corticosteroids, which have limited efficacy.

Sustained-release drug delivery solutions via the patented SABER® technology

The SABER® technology represents a platform value proposition, enabling long-acting injectable formulations. While larsucosterol was the immediate focus, the technology itself has proven value in other collaborations.

Consider the financial validation from a prior collaboration utilizing SABER® technology:

• An upfront payment of $25 million was received from Gilead for an HIV product utilizing SABER®.
• An additional milestone payment of $10 million was earned from that same program.
• The potential for future milestones in that program included up to $65 million (development/regulatory) and up to $70 million (sales-based), plus tiered royalties.

The SABER® platform also underpins POSIMIR® (bupivacaine solution) for infiltration use, showing the breadth of this proprietary asset.

Reduced development risk and secured funding for larsucosterol via Bausch Health

The acquisition by Bausch Health in September 2025 fundamentally changed the risk profile and provided immediate capital for the planned Phase 3 trial. DURECT Corporation's financial position as of mid-2025 highlighted the need for this external support.

The transaction details quantify this value transfer:

• Upfront Cash Consideration: Approximately $63 million, paid at closing ($1.75 per share).
• DURECT Q2 2025 Cash Position: Cash, cash equivalents, and investments were $6.7 million as of June 30, 2025, down from $12.0 million at December 31, 2024.
• Potential Future Value: Up to $350 million in aggregate net sales milestone payments.

The deal structure secured the immediate path forward for the registrational Phase 3 trial, which DURECT had stated was contingent on securing sufficient funding.

The Phase 3 trial itself is designed with a primary endpoint of 90-day survival, with topline results expected within two years of trial initiation, which DURECT aimed to start in 2025.

DURECT Corporation (DRRX) - Canvas Business Model: Customer Relationships

You're looking at the customer relationships for DURECT Corporation as of late 2025, which is a unique point in time since the company was acquired by Bausch Health Companies Inc. in September 2025. This acquisition fundamentally shifted the primary relationship structure.

Strategic, long-term licensing relationships with pharmaceutical partners are now largely subsumed under the Bausch Health umbrella, but the history shows a shift. For instance, the licensing agreement for POSIMIR with Innocoll Pharmaceuticals Limited terminated on May 6, 2025, resulting in DURECT Corporation regaining all related data and know-how. The company is actively evaluating next steps to find a new partner for POSIMIR commercialization.

The most significant relationship is the new parent structure. The transaction to acquire DURECT Corporation was completed in September 2025, with an upfront cash payment of approximately $63 million for all outstanding shares at $1.75 per share. This deal includes the potential for two additional net sales milestone payments totaling up to $350 million in the aggregate, contingent on achieving milestones before December 31, 2045, or the 10-year anniversary of the first U.S. commercial sale of larsucosterol. The tender offer saw approximately 62% of DURECT common stock tendered initially.

Here's a quick look at the key financial and transactional relationship data points leading up to the acquisition:

Metric	Value / Status	Date / Period
Upfront Acquisition Payment	$63 million	September 2025 Closing
Maximum Potential Milestones	Up to $350 million	Post-Acquisition Contingency
Acquisition Price Per Share	$1.75 per share (Cash)	September 2025
Q2 2025 Total Revenues	$447,000	Three months ended June 30, 2025
Q1 2025 Net Loss	$4.2 million	Three months ended March 31, 2025
Cash, Cash Equivalents, Investments	$6.7 million	As of June 30, 2025
POSIMIR License Termination Date	May 6, 2025	Innocoll Pharmaceuticals

The direct, collaborative relationship with the FDA centers entirely on larsucosterol for severe alcoholic hepatitis (AH). The FDA granted larsucosterol Breakthrough Therapy Designation (BTD), recognizing its potential for a life-threatening condition with no approved treatments. This designation has led to specific guidance; the FDA has agreed that a single Phase 3 trial could be sufficient to support a New Drug Application (NDA) filing, provided it meets its objectives. The trial design incorporated feedback received during a Type B meeting with the FDA in 2024.

Engagement with clinical investigators and key opinion leaders (KOLs) is foundational to advancing larsucosterol. DURECT Corporation stated it is guided by the conviction that trust and transparency across research and medicine are vital to transformation. This involves active collaboration with researchers and physicians to revolutionize medicine.

The company's operational focus, prior to the acquisition, was heavily reliant on securing funding to initiate the planned registrational Phase 3 trial for larsucosterol in 2025, with topline results anticipated within two years of initiation. This need for capital influenced the strategic alignment with Bausch Health. The internal reporting structure, as of late 2025, is now fully integrated into the Bausch Health parent company structure following the completion of the merger on September 11, 2025, when DURECT shares ceased trading on Nasdaq.

Key elements of this professional engagement include:

• Incorporating FDA feedback into the Phase 3 trial design.
• Publishing Phase 2b AHFIRM trial data in NEJM Evidence in January 2025.
• Focusing the Phase 3 primary endpoint on 90-day survival.
• Continuing dialogue to explore funding for the Phase 3 trial.

DURECT Corporation (DRRX) - Canvas Business Model: Channels

You're looking at how DURECT Corporation moved its assets-specifically larsucosterol-to the market, which, as of late 2025, is now entirely managed by Bausch Health Companies Inc. following the acquisition.

Direct licensing agreements with major pharmaceutical companies (B2B)

The primary B2B channel shifted from managing multiple agreements to a singular, definitive transaction. DURECT Corporation's lead asset, larsucosterol, was acquired by Bausch Health on September 11, 2025. This transaction effectively transferred the future commercialization channel.

The financial structure of this channel shift provides concrete numbers:

Transaction Component	Amount/Value
Upfront Cash Payment at Closing	Approximately $63 million
Per Share Upfront Consideration	$1.75 per share in cash
Maximum Aggregate Net Sales Milestone Payments	Up to $350 million
DURECT Q1 2025 Total Revenues (Pre-Acquisition)	$0.3 million

Prior to this, DURECT was evaluating options for commercializing POSIMIR following the termination of its licensing agreement with Innocoll Pharmaceuticals, which saw data and know-how transferred on May 6, 2025. For context, DURECT's total collaborative research and development and other revenue in 2023 was $2,277 thousand.

Clinical trial sites and investigators for drug development and data generation

The clinical channel relies on investigators and sites to generate the data required for regulatory submission. The Phase 2b AHFIRM trial, which informed the Phase 3 design, was a key component of this channel.

Here's a breakdown of the patient and site engagement for the pivotal Phase 2b study:

• Total patients enrolled in AHFIRM trial: 307.
• Total international centers involved: 62.
• U.S. sites enrolled: 46.
• Percentage of patients enrolled by U.S. sites: 76%.
• Number of treatment arms: Three (Placebo, 30 mg larsucosterol, 90 mg larsucosterol).

DURECT Corporation was planning a registrational Phase 3 trial in the U.S. to enroll about 200 patients, with topline results expected within two years of initiation.

Scientific publications (e.g., NEJM Evidence in January 2025) for data dissemination

Dissemination through peer-reviewed journals is a critical channel for establishing scientific credibility. The results of the AHFIRM Phase 2b trial were published in NEJM Evidence on January 28, 2025. This publication validated the data guiding the Phase 3 design.

Key efficacy trends presented in the publication include:

Dose Arm	90-Day Mortality Reduction vs. Placebo (Overall Population)	90-Day Mortality Reduction vs. Placebo (U.S. Subgroup)
Larsucosterol 30 mg	41% (p=0.068)	57% (p=0.014)
Larsucosterol 90 mg	35% (p=0.124)	58% (p=0.008)

The FDA granted larsucosterol Breakthrough Therapy Designation and Fast Track Designation for Alcohol-Associated Hepatitis (AH).

Bausch Health's global commercial infrastructure for future product launch

Post-acquisition, Bausch Health's existing infrastructure becomes the primary channel for future commercialization of larsucosterol, which addresses a disease with approximately 30% mortality within 90 days of hospitalization.

The commercial pathway is now defined by the merger terms:

• Acquisition completed on September 11, 2025.
• Bausch Health is a global, diversified pharmaceutical company.
• The transaction adds larsucosterol to Bausch Health's hepatology pipeline, complementing their existing Phase 3 rifaximin SSD program.
• Milestone payments are tied to net sales achieved before the earlier of the 10-year anniversary of first U.S. commercial sale or December 31, 2045.

Finance: review the post-merger integration budget for commercial scale-up by end of Q4 2025.

DURECT Corporation (DRRX) - Canvas Business Model: Customer Segments

You're looking at the core groups DURECT Corporation targets with its technology and pipeline as of late 2025. It's a mix of potential commercial partners, a specific patient population facing a severe, unmet need, and the financial community watching the larsucosterol development closely, especially given the pending acquisition.

Large pharmaceutical companies seeking novel drug delivery platforms (SABER® licensees)

This segment values DURECT Corporation's patented SABER Delivery System for creating long-acting injectables. While the focus is heavily on larsucosterol, the platform itself attracts partners looking for sustained release capabilities, which can span from one day up to three months from a single administration for both human and veterinary use. You see this interest reflected in past deals, even if current large pharma human licensees aren't explicitly named in the latest reports.

Here's a snapshot of what these licensing arrangements look like:

Partner/Context	Technology Focus	Financial Structure Example
Santen Pharmaceutical Co., Ltd. (2014)	Sustained Release Ophthalmology Product	$2 million upfront fee plus tiered royalty and development/commercialization milestones.
Gilead Sciences (Terminated 2020)	Long-Acting Injectable HIV Product	Potential for up to $65 million in development/regulatory milestones and up to $70 million in sales milestones, plus $150 million per additional product option.
Thorn BioScience LLC (2025 Update)	Veterinary Products (Reproductive)	Consideration undisclosed; product in late-stage NADA approval process.

The SABER technology is the key value driver here. It's a patented system designed to provide sustained release via bioerodible injectable depots. It definitely simplifies dosing regimens for partners.

Patients suffering from severe alcohol-associated hepatitis (AH)

This is the critical patient group for DURECT Corporation's lead candidate, larsucosterol. Severe AH is life-threatening, and honestly, there are no FDA-approved therapies right now. The urgency here is high, which is why the FDA granted larsucosterol both Fast Track and Breakthrough Therapy Designations.

The scale of the problem, which these patients represent, drives the market opportunity:

• Alcoholic Hepatitis Treatment Market valued at $3.18 Billion in 2025.
• Market projected to reach $6.05 Billion by 2035.
• The United States represents the largest patient pool globally.

Mortality data underscores the severity these patients face. A retrospective analysis of 77 studies showed overall mortality at 29% at 90 days for 8,184 patients. More recently, a global study of 2,581 AH patients reported mortality around 31% at 90 days. DURECT Corporation's planned Phase 3 trial is targeting 90-day survival as its primary endpoint.

Hepatologists and critical care specialists treating acute liver injury

These clinicians are the prescribers and decision-makers for patients with severe AH. They are currently limited to off-label treatments, such as Prednisolone, often in combination with other agents. They are the ones who need a proven, targeted therapy like larsucosterol, which is designed to address the underlying epigenetic mechanisms (inhibiting elevated DNA methyltransferases) in AH patients.

Their segment is influenced by the following clinical realities:

• Need for therapies with demonstrated efficacy in improving 90-day survival.
• The Phase 2b AHFIRM trial results, published in NEJM Evidence in January 2025, provide the clinical validation they look for.
• The company aims to start the registrational Phase 3 trial in 2025, which will be the definitive data set for adoption.

Timely treatment is key; variations in time from hospitalization to first dose highlighted its importance in severe AH subgroup analyses.

Investors seeking returns on contingent value rights (CVRs) tied to larsucosterol milestones

This group is focused on the financial structure surrounding the larsucosterol development, particularly in light of the announced acquisition by Bausch Health. The value proposition here is the potential upside beyond the immediate transaction price. You, as an investor, are tracking the triggers for these contingent payments.

The terms of the August 2025 Merger Agreement define this segment's near-term financial focus:

Consideration Type	Amount / Value	Condition / Date
Upfront Consideration (Cash)	Approximately $63 million total ($1.75 per share of common stock).	At closing, expected in Q3 2025.
Contingent Milestone Payments	Up to $350 million in aggregate (two payments).	If achieved before the earlier of 10 years post-first commercial sale of larsucosterol in the US or December 31, 2045.

Financially, DURECT Corporation's cash position as of June 30, 2025, was $6.7 million, down from $12.0 million at the end of 2024, making the successful funding or closing of the Bausch Health transaction crucial for continuing development and realizing these milestone values. For Q2 2025, total revenues were reported at $447,000, with a net loss of $2.3 million.

Finance: draft sensitivity analysis on the $350M milestone trigger dates by next Tuesday.

DURECT Corporation (DRRX) - Canvas Business Model: Cost Structure

You're looking at the cost side of the ledger for DURECT Corporation leading up to its acquisition by Bausch Health in late 2025. The cost structure was heavily weighted toward research, development, and the overhead required to keep the lights on while pursuing the Phase 3 trial for larsucosterol.

High Research and Development (R&D) expenses represented the single largest operating cost component based on the last reported standalone financials. This reflects the commitment to advancing the lead candidate.

• R&D expense for the three months ended June 30, 2025: $1.176 million.
• R&D expense for the six months ended June 30, 2025: The cumulative expense was $9.64 million on a full-year basis for the TTM ending June 2025, though the six-month figure from the Q2 release is not explicitly provided in the same table as the quarterly R&D.

General and Administrative (G&A) expenses covered the necessary corporate overhead, including executive salaries, facilities, and the ongoing costs to maintain the intellectual property portfolio for its various platforms and candidates.

Here's a look at the Selling, General & Administrative (SG&A) figures available:

Period	SG&A Expense (in thousands USD)
Three Months Ended March 31, 2025	$2,577
Trailing Twelve Months (TTM) ending June 2025	$9.88 million
Fiscal Year 2024	$10.48 million

Clinical trial costs for the registrational Phase 3 study of larsucosterol were a major expected future cost. However, following the definitive agreement in July 2025 and subsequent acquisition completion in September 2025, this burden shifted.

• The registrational Phase 3 trial for severe AH is now primarily funded by Bausch Health.
• The upfront consideration for the acquisition was approximately $63 million in cash.
• Potential future milestone payments related to the asset's success could total up to $350 million in the aggregate.

Costs of manufacturing and supplying key excipients for SABER®-based products were a smaller component of the cost structure, especially after DURECT Corporation divested a product line associated with delivery technology.

• DURECT Corporation sold its ALZET® product line, which included osmotic pumps, for $17.5 million in November 2024.
• Cost of product revenues for the three months ended June 30, 2025, was $7 thousand.

DURECT Corporation (DRRX) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for DURECT Corporation (DRRX) as the company moves toward its acquisition by Bausch Health, which really shifts the near-term financial focus. Honestly, the structure is dominated by the deal terms right now, with legacy revenue streams becoming secondary.

The most concrete, near-term cash flow component comes directly from the merger agreement announced in July 2025. This is the upfront money you can count on once the tender offer and subsequent merger close, which was expected in the third quarter of 2025.

Revenue Stream Component	Financial Amount	Basis/Condition
Upfront Cash Payment (Bausch Health Acquisition)	$63 million	All-cash payment at closing of the merger agreement.
Contingent Milestone Payments (Larsucosterol)	Up to $350 million (aggregate)	Based on achieving specified net sales milestones for larsucosterol before December 31, 2045, or the 10-year anniversary of first commercial sale.

This transaction structure means DURECT Corporation's revenue profile is heavily weighted toward these large, discrete payments tied to the larsucosterol asset, rather than consistent product sales for the immediate future.

For the smaller, ongoing revenue components, we look at the reported quarterly figures leading up to the expected close. You'll see that the company still generates revenue from its existing commercial products and collaborations, though these amounts are relatively small compared to the acquisition consideration.

Here's a look at the most recent reported revenue data:

• Collaborative research and development revenue was reported as $428,000 for the second quarter ended June 30, 2025.
• Total revenues for the second quarter ended June 30, 2025, were $447,000.
• Total revenues for the first quarter ended March 31, 2025, were $0.3 million.

Also, DURECT Corporation maintains revenue streams from royalties on net sales of its licensed SABER® products, such as SucroMate™ Equine. While the specific dollar amount from these royalties in 2025 isn't broken out separately in the latest filings to isolate it from other sources, it remains a component of the total revenue picture.

If you look at the comparison to the prior year's second quarter, the total revenue for Q2 2024 was $0.65 million, so the $447,000 in Q2 2025 shows a year-over-year decline in that segment before the acquisition closes. Finance: draft 13-week cash view by Friday.