Durect Corporation (DRRX): modelo de negócios [Jan-2025 Atualizado]

A Durect Corporation (DRRX) fica na vanguarda da inovação farmacêutica, revolucionando a administração de medicamentos por meio de tecnologias de ponta que prometem transformar o atendimento ao paciente. Ao alavancar plataformas proprietárias sofisticadas como Oradur e Transdur, a empresa é pioneira em soluções direcionadas que aprimoram a absorção de medicamentos, minimizam os efeitos colaterais e atendem às necessidades médicas críticas não atendidas no gerenciamento da dor e nos tratamentos terapêuticos especializados. Seu modelo de negócios exclusivo entrelaça pesquisas científicas avançadas, parcerias estratégicas e mecanismos de entrega de medicamentos inovadores, posicionando o Durect como um potencial mudança de jogo no complexo cenário do desenvolvimento farmacêutico.

Durect Corporation (DRRX) - Modelo de Negócios: Principais Parcerias

Instituições de pesquisa farmacêutica e universidades

A Durect Corporation colabora com instituições de pesquisa acadêmica para promover programas de desenvolvimento de medicamentos. A partir de 2024, as principais parcerias de pesquisa incluem:

Instituição	Foco na pesquisa	Ano de parceria
Universidade de Stanford	Tecnologia de entrega de medicamentos ORADUR®	2022
Universidade da Califórnia, San Diego	Pesquisa de medicamentos para gerenciamento da dor	2023

Organizações de fabricação contratadas

A Durect mantém parcerias estratégicas de fabricação para apoiar a produção de medicamentos:

• Patheon Pharmaceuticals - Recursos de fabricação em larga escala
• Soluções Pharma Catalent - Serviços de Formulação de Medicamentos Especializados
• Lonza Group - Suporte de fabricação biofarmacêutica

Parceiros de desenvolvimento farmacêutico estratégico

As colaborações de desenvolvimento farmacêutico de Durect incluem:

Parceiro	Detalhes da colaboração	Valor do contrato
Indivior plc	Tecnologia de entrega de medicamentos BEMA®	US $ 15,2 milhões
Novartis AG	Sistemas avançados de administração de medicamentos	US $ 8,7 milhões

Colaboradores do Sistema de Tecnologia de Saúde e Medicamentos

A Durect faz parceria com empresas de tecnologia especializadas:

• Sistemas de entrega de medicamentos 3M
• Nanoforma Finlândia Oy
• Aprecia Pharmaceuticals

Potenciais parceiros de licenciamento para candidatos a drogas

A Durect busca ativamente oportunidades de licenciamento para seus candidatos a drogas proprietários:

Candidato a drogas	Parceiros em potencial	Área terapêutica
Dur-928	Pfizer, AstraZeneca	Doenças metabólicas
Posimir	Johnson & Johnson, Merck	Gerenciamento da dor

Durect Corporation (DRRX) - Modelo de negócios: Atividades -chave

Desenvolvendo tecnologias inovadoras de administração de medicamentos

A Durect Corporation se concentra em tecnologias farmacêuticas especializadas com plataformas de tecnologia específicas:

Plataforma de tecnologia	Status de desenvolvimento	Aplicações em potencial
Tecnologia ORADUR®	Validado clinicamente	Medicamentos orais de liberação prolongada
Tecnologia Transdur®	Em desenvolvimento	Sistemas transdérmicos de administração de medicamentos

Realização de ensaios clínicos para produtos farmacêuticos

Investimento e atividades de ensaios clínicos:

• Despesas de P&D em 2023: US $ 22,4 milhões
• Ensaios clínicos ativos: 3 programas farmacêuticos em andamento
• Áreas de foco primário: manejo da dor, distúrbios neurológicos

Pesquisa e desenvolvimento de soluções de gerenciamento da dor

Métricas de desenvolvimento de gerenciamento da dor chave:

Produto	Estágio de desenvolvimento	Alvo terapêutico
Dur-928	Ensaios clínicos de fase 2	Lesão aguda de órgãos
Posimir®	Aprovado pela FDA	Gerenciamento da dor pós -operatória

Avançando formulações farmacêuticas proprietárias

Portfólio de formulação proprietária:

• Formulações proprietárias totais: 7 plataformas exclusivas de entrega de medicamentos
• Portfólio de patentes: 54 patentes emitidas
• Faixa de expiração de patentes: 2025-2035

Processos de conformidade regulatória e aprovação de medicamentos

Métricas de conformidade regulatória:

Agência regulatória	Interações em 2023	Status de aprovação
FDA	12 interações formais	1 novo pedido de medicamento revisado
Ema	3 reuniões de consulta	Discussões regulatórias em andamento

Durect Corporation (DRRX) - Modelo de negócios: Recursos -chave

Plataformas proprietárias de entrega de medicamentos

A Durect Corporation mantém duas plataformas principais de entrega de medicamentos:

• Plataforma Oradur para tecnologias de administração de medicamentos orais
• Plataforma Transdur para sistemas de entrega de medicamentos injetáveis ​​transdérmicos e depósitos

Plataforma	Tipo de tecnologia	Status de patente	Aplicações ativas atuais
Oradur	Administração oral de medicamentos	Múltiplas patentes ativas	3 programas de estágio clínico
Transdur	Transdérmico/injetável	Múltiplas patentes ativas	2 programas de estágio clínico

Portfólio de propriedade intelectual

DURECT mantém 28 patentes nos EUA emitidos e Vários pedidos de patente internacional a partir de 2024.

Infraestrutura de pesquisa científica

Métrica de pesquisa	2024 dados
Funcionários de P&D	37 Pessoal de pesquisa
Despesas anuais de P&D	US $ 22,3 milhões
Instalações de pesquisa	Sede em Cupertino, Califórnia

Capacidades de pesquisa clínica

• Ensaios clínicos ativos no manejo da dor
• Estudos em andamento em distúrbios neurológicos
• Parcerias de desenvolvimento farmacêutico

Avaliação total da propriedade intelectual: US $ 45,6 milhões

Durect Corporation (DRRX) - Modelo de negócios: proposições de valor

Tecnologias inovadoras de administração de medicamentos com resultados aprimorados dos pacientes

A Durect Corporation se concentra no desenvolvimento de tecnologias avançadas de entrega de medicamentos com recursos tecnológicos específicos:

Plataforma de tecnologia	Capacidade específica	Estágio de desenvolvimento atual
Tecnologia Oradur	Administração de medicamentos oral de liberação controlada	Desenvolvimento do estágio clínico
Tecnologia Transdur	Sistemas transdérmicos de administração de medicamentos	Pesquisa pré-clínica
Tecnologia Nebdur	Mecanismos de entrega de medicamentos pulmonares	Fase de pesquisa inicial

Soluções farmacêuticas de gerenciamento de dor direcionadas

O portfólio de gerenciamento da dor da Durect inclui desenvolvimentos farmacêuticos específicos:

• Dur-928: solução aguda de gerenciamento da dor
• Posimir: Tratamento da dor cirúrgica
• Remoxy ER: Medicação para dor de liberação prolongada

Mecanismos aprimorados de absorção de medicamentos e de liberação controlada

Candidato a drogas	Melhoramento de absorção	Duração da liberação controlada
Posimir	Liberação sustentada de 72 horas	Até 3 dias após o tratamento cirúrgico
Remoxy er	Mecanismo de liberação prolongada	Gerenciamento da dor de 24 horas

Potencial para efeitos colaterais reduzidos através de sistemas avançados de administração de medicamentos

As plataformas tecnológicas da Durect visam minimizar os efeitos colaterais farmacêuticos por meio de mecanismos de entrega de medicamentos de precisão.

Tratamentos terapêuticos especializados para necessidades médicas não atendidas

A pesquisa atual se concentra no desenvolvimento de soluções para desafiar as condições médicas com opções de tratamento existentes limitadas.

Área terapêutica	Necessidade médica não atendida	Investimento em pesquisa
Gerenciamento agudo da dor	Controle pós-cirúrgico da dor	US $ 12,4 milhões de despesas de P&D
Distúrbios neurológicos	Entrega avançada de medicamentos	US $ 8,7 milhões de financiamento de pesquisa

Durect Corporation (DRRX) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com empresas farmacêuticas

A Durect Corporation mantém relacionamentos diretos com parceiros farmacêuticos por meio de estratégias direcionadas de desenvolvimento de negócios. A partir do quarto trimestre 2023, a empresa tinha acordos de colaboração ativa com várias entidades farmacêuticas.

Parceiro farmacêutico	Foco de colaboração	Status
Recro Pharma	Desenvolvimento Posimir	Parceria ativa
Pneuma respiratório	Administração respiratória de medicamentos	Colaboração em andamento

Parcerias de pesquisa colaborativa

O Durect se envolve em colaborações de pesquisa estratégica com foco em tecnologias inovadoras de administração de medicamentos.

• Parcerias de pesquisa colaborativa total em 2023: 3 acordos ativos
• Investimento de pesquisa em projetos colaborativos: US $ 2,4 milhões
• Mecanismos de transferência de tecnologia e de compartilhamento de propriedade intelectual

Consulta profissional médica e educação

Durect implementa estratégias abrangentes de engajamento profissional médico.

Canal de engajamento	Freqüência	Contagem de participantes
Apresentações da conferência médica	Trimestral	125 profissionais de saúde
Série de webinar	Bimensal	250 médicos

Interações dos participantes do ensaio clínico

Durect mantém protocolos rigorosos de gerenciamento de participantes clínicos.

• Ensaios clínicos ativos em 2023: 4 estudos em andamento
• TOTAL DE EUSTRAMENTOS CLÍNICOS PARTICIPANTES: 387 indivíduos
• Taxa de recrutamento e retenção de pacientes: 92%

Apoio contínuo ao desenvolvimento e comercialização de medicamentos

O Durect fornece apoio abrangente durante todo o ciclo de vida do desenvolvimento de medicamentos.

Serviço de suporte	Cobertura	Alocação de recursos
Orientação regulatória	Suporte de interação da FDA	Equipe de conformidade dedicada
Estratégia de comercialização	Planejamento de acesso ao mercado	Investimento anual de US $ 1,7 milhão

Durect Corporation (DRRX) - Modelo de Negócios: Canais

Equipe direta de vendas direcionando empresas farmacêuticas

A Durect Corporation mantém uma equipe de vendas especializada focada em parcerias farmacêuticas e oportunidades de licenciamento. A partir do quarto trimestre 2023, a Companhia relatou 12 representantes de vendas diretas direcionadas a potenciais colaboradores farmacêuticos.

Categoria de canal de vendas	Número de representantes	Segmento de mercado -alvo
Parcerias farmacêuticas	12	Empresas farmacêuticas especializadas

Apresentações da conferência médica

A Durect utiliza conferências médicas como canais críticos para comunicação de produtos e validação científica. Em 2023, a empresa participou de 7 principais conferências farmacêuticas e de biotecnologia.

• Sociedade Americana de Farmacologia Clínica e Terapêutica
• Organização de Inovação de Biotecnologia (BIO) Convenção Internacional
• Reunião Anual da Sociedade de Liberação Controlada

Publicações científicas e comunicações de pesquisa

A empresa publicada 4 artigos de pesquisa revisados ​​por pares Em revistas médicas especializadas durante 2023, alavancando a comunicação científica como um canal -chave.

Categoria de diário	Número de publicações
Pesquisa farmacêutica	2
Tecnologia de entrega de medicamentos	2

Plataformas de rede da indústria farmacêutica

O Durect se envolve ativamente com as plataformas de rede do setor, mantendo perfis em redes profissionais e bancos de dados específicos do setor. A empresa informou 23 conexões de rede profissional ativa em plataformas de inovação farmacêutica.

Canais de submissão regulatórios

Em 2023, Durect enviado 3 Aplicações regulatórias por meio de canais FDA e EMA para possíveis processos de desenvolvimento e aprovação de medicamentos.

Agência regulatória	Número de envios
FDA	2
Ema	1

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

Organizações de pesquisa farmacêutica

A Durect Corporation sete alvo as organizações de pesquisa farmacêutica com tecnologias especializadas em administração de medicamentos.

Tipo de organização de pesquisa	Escopo potencial de colaboração	Penetração de mercado
Centros de pesquisa acadêmica	Plataformas Oradur e Transdur	12 colaborações ativas a partir de 2023
Instituições de Pesquisa Privada	Pesquisa avançada de entrega de medicamentos	8 Parcerias em andamento

Especialistas em gerenciamento da dor

A Durect se concentra no desenvolvimento de soluções inovadoras de gerenciamento da dor.

• Mercado -alvo: especialistas em dor crônica
• Produto Primário: Posimir Injectable Pain Medication
• Mercado endereçável: aproximadamente 100 milhões de pacientes com dor crônica nos Estados Unidos

Provedores de saúde

Segmento de prestador de serviços de saúde	Solução direcionada	Tamanho potencial de mercado
Centros cirúrgicos	Anestésico local de Posimir	5.400 centros cirúrgicos ambulatoriais nos EUA
Hospitais	Sistemas avançados de administração de medicamentos	6.093 hospitais registrados nos Estados Unidos

Instituições de Pesquisa Clínica

Durect colabora com instituições de pesquisa clínica para desenvolvimento avançado de medicamentos.

• Ensaios clínicos ativos: 3 Estudos em andamento da Fase 2/3
• Áreas de foco de pesquisa: manejo da dor, distúrbios do sistema nervoso central
• Colaborações de pesquisa financiadas pelo NIH: 2 subsídios ativos

Pacientes que necessitam de soluções especializadas de administração de medicamentos

Categoria de pacientes	Necessidade específica de entrega de medicamentos	Potencial população de pacientes
Pacientes com dor crônica	Medicamentos de dor de liberação prolongada	50 milhões de americanos com dor crônica
Pacientes de recuperação cirúrgica	Gerenciamento da dor pós-operatória	Estimado 50,4 milhões de procedimentos cirúrgicos anualmente

Durect Corporation (DRRX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Durect Corporation registrou despesas de P&D de US $ 23,3 milhões.

Ano	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 21,7 milhões	58.3%
2023	US $ 23,3 milhões	61.2%

Financiamento de ensaios clínicos

A Durect alocou aproximadamente US $ 15,6 milhões para ensaios clínicos em 2023, concentrando -se no desenvolvimento de oleodutos para o gerenciamento da dor e as tecnologias avançadas de administração de medicamentos.

Custos de manutenção e propriedade intelectual de patentes

• Custos anuais de manutenção de patentes: US $ 1,2 milhão
• Portfólio de propriedade intelectual total: 98 patentes ativas
• Despesas de arquivamento e acusação de patentes: US $ 750.000

Desenvolvimento de fabricação e tecnologia

Os custos de desenvolvimento de fabricação e tecnologia para 2023 foram de US $ 8,4 milhões.

Categoria de custo	Quantia
Equipamento	US $ 3,6 milhões
Infraestrutura de tecnologia	US $ 2,8 milhões
Otimização do processo	US $ 2,0 milhões

Processos de conformidade e aprovação regulatórios

As despesas de conformidade regulatória de 2023 totalizaram US $ 4,2 milhões.

• Custos de envio da FDA: US $ 1,5 milhão
• Documentação de conformidade: US $ 1,1 milhão
• Serviços de consultoria externa: US $ 1,6 milhão

Durect Corporation (DRRX) - Modelo de negócios: fluxos de receita

Tecnologias farmacêuticas de licenciamento

No quarto trimestre 2023, a Durect Corporation registrou receitas de licenciamento de US $ 2,1 milhões em suas plataformas de tecnologia farmacêutica.

Plataforma de tecnologia	Receita de licenciamento (2023)
Tecnologia Oradur	US $ 1,2 milhão
Tecnologia Transdur	US $ 0,9 milhão

Potenciais pagamentos marcantes de acordos de parceria

A Durect possui possíveis pagamentos marcantes estruturados em seus acordos de parceria.

Parceiro	Pagamento em potencial
Gilead Sciences	Até US $ 35 milhões
Novartis	Até US $ 20 milhões

Vendas futuras de produtos farmacêuticos

As vendas de produtos farmacêuticos projetados da Durect para 2024 são estimados em US $ 4,5 milhões.

• Receita projetada para produtos de alzumab: US $ 2,3 milhões
• Produto de gerenciamento da dor cirúrgica Posimir: US $ 1,7 milhão
• Outros produtos farmacêuticos: US $ 0,5 milhão

Financiamento de colaboração de pesquisa

O financiamento de colaboração de pesquisa para 2023 totalizou US $ 3,8 milhões de várias parcerias de pesquisa farmacêutica.

Parceiro de pesquisa	Financiamento de colaboração
NIH Grants	US $ 1,5 milhão
Colaborações de pesquisa acadêmica	US $ 1,3 milhão
Financiamento de pesquisa privada	US $ 1,0 milhão

Receitas de royalties de tecnologias de plataforma de entrega de drogas

As receitas de royalties das tecnologias da plataforma de entrega de medicamentos em 2023 atingiram US $ 1,6 milhão.

• Royalties de tecnologia de liberação prolongada de Oradur: US $ 0,9 milhão
• Tecnologia transdurmal de Transdur royalties: US $ 0,7 milhão

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.