Durect Corporation (DRRX): Canvas du modèle d'entreprise [Jan-2025 MISE À JOUR]

Durect Corporation (DRRX) est à l'avant-garde de l'innovation pharmaceutique, révolutionnant la prestation de médicaments grâce à des technologies de pointe qui promettent de transformer les soins aux patients. En tirant parti des plates-formes propriétaires sophistiquées comme Oradur et Transdur, la société est des solutions ciblées pionnières qui améliorent l'absorption des médicaments, minimisent les effets secondaires et répondent aux besoins médicaux critiques non satisfaits dans la gestion de la douleur et les traitements thérapeutiques spécialisés. Leur modèle commercial unique entrelace la recherche scientifique avancée, les partenariats stratégiques et les mécanismes de révolution de la livraison de médicaments, positionnant DURECT comme un changement de jeu potentiel dans le paysage complexe du développement pharmaceutique.

Durect Corporation (DRRX) - Modèle d'entreprise: partenariats clés

Institutions et universités de recherche pharmaceutique

Durect Corporation collabore avec les établissements de recherche universitaires pour faire progresser les programmes de développement de médicaments. En 2024, les principaux partenariats de recherche comprennent:

Institution	Focus de recherche	Année de partenariat
Université de Stanford	Technologie d'administration de médicaments Oradur®	2022
Université de Californie, San Diego	Recherche de médicaments sur la gestion de la douleur	2023

Organisations de fabrication de contrats

DURECT maintient des partenariats de fabrication stratégiques pour soutenir la production de médicaments:

• Patheon Pharmaceuticals - Capacités de fabrication à grande échelle
• Solutions pharmatriques de catale - services de formulation de médicaments spécialisés
• Group Lonza - Support de fabrication biopharmaceutique

Partenaires stratégiques de développement pharmaceutique

Les collaborations de développement pharmaceutique de Durect comprennent:

Partenaire	Détails de collaboration	Valeur du contrat
Indivior PLC	Technologie de livraison de médicaments BEMA®	15,2 millions de dollars
Novartis AG	Systèmes avancés d'administration de médicaments	8,7 millions de dollars

Collaborateurs de technologies de la technologie des soins de santé et de médicaments

DURECT s'associe à des entreprises technologiques spécialisées:

• Systèmes de livraison de médicaments 3M
• Finlande nanoforme oy
• Apria Pharmaceuticals

Partenaires de licence potentiels pour les candidats à la drogue

Durect recherche activement des possibilités de licence pour ses candidats propriétaires de drogue:

Drogue	Partenaires potentiels	Zone thérapeutique
DUR-928	Pfizer, AstraZeneca	Maladies métaboliques
Posimir	Johnson & Johnson, Merck	Gestion de la douleur

Durect Corporation (DRRX) - Modèle d'entreprise: activités clés

Développer des technologies innovantes d'administration de médicaments

Durect Corporation se concentre sur des technologies pharmaceutiques spécialisées avec des plateformes technologiques spécifiques:

Plate-forme technologique	Statut de développement	Applications potentielles
Technologie Oradur®	Cliniquement validé	Médicaments oraux à libération prolongée
Technologie Transdur®	En développement	Systèmes d'administration de médicaments transdermiques

Effectuer des essais cliniques pour les produits pharmaceutiques

Investissement et activités des essais cliniques:

• Dépenses de R&D en 2023: 22,4 millions de dollars
• Essais cliniques actifs: 3 programmes pharmaceutiques en cours
• Principaux domaines d'intervention: gestion de la douleur, troubles neurologiques

Recherche et développement de solutions de gestion de la douleur

Mesures de développement de la gestion de la douleur clé:

Produit	Étape de développement	Cible thérapeutique
DUR-928	Essais cliniques de phase 2	Blessure aux organes aigus
Posimir®	Approuvé par la FDA	Gestion de la douleur postopératoire

Formulations pharmaceutiques propriétaires avancées

Portfolio de formulation propriétaire:

• Formulations propriétaires totales: 7 plates-formes d'administration de médicaments uniques
• Portefeuille de brevets: 54 brevets délivrés
• Plage d'expiration des brevets: 2025-2035

Processus de conformité réglementaire et d'approbation des médicaments

Métriques de la conformité réglementaire:

Agence de réglementation	Interactions en 2023	Statut d'approbation
FDA	12 interactions formelles	1 nouvelle demande de médicament examinée
Ema	3 réunions de consultation	Discussions réglementaires en cours

Durect Corporation (DRRX) - Modèle d'entreprise: Ressources clés

Plateformes de livraison de drogues propriétaires

Durect Corporation conserve deux principales plateformes de livraison de médicaments:

• Plateforme Oradur pour les technologies d'administration de médicaments orales
• Plateforme Transdur pour les systèmes d'administration de médicaments injectables transdermiques et dépôt

Plate-forme	Type de technologie	Statut de brevet	Applications actives actuelles
Oradur	Livraison de médicaments oraux	Multiples brevets actifs	3 programmes de scène clinique
Transdur	Transdermique / injectable	Multiples brevets actifs	2 programmes de scène clinique

Portefeuille de propriété intellectuelle

Durect tient 28 Brevets américains délivrés et Demandes de brevets internationaux multiples En 2024.

Infrastructure de recherche scientifique

Métrique de recherche	2024 données
Employés de R&D	37 Personnel de recherche
Dépenses annuelles de R&D	22,3 millions de dollars
Installations de recherche	Siège social à Cupertino, en Californie,

Capacités de recherche clinique

• Essais cliniques actifs en gestion de la douleur
• Études en cours sur les troubles neurologiques
• Partenariats de développement pharmaceutique

Évaluation totale de la propriété intellectuelle: 45,6 millions de dollars

Durect Corporation (DRRX) - Modèle d'entreprise: propositions de valeur

Technologies innovantes d'administration de médicaments avec des résultats améliorés pour les patients

Durect Corporation se concentre sur le développement de technologies avancées d'administration de médicaments avec des capacités technologiques spécifiques:

Plate-forme technologique	Capacité spécifique	Étape de développement actuelle
Technologie Oradur	Livraison de médicaments oraux à libération contrôlée	Développement de stade clinique
Technologie Transdur	Systèmes d'administration de médicaments transdermiques	Recherche préclinique
Technologie de Nebdur	Mécanismes d'administration de médicament pulmonaire	Phase de recherche précoce

Solutions pharmaceutiques de gestion de la douleur ciblée

Le portefeuille de gestion de la douleur de Durect comprend des développements pharmaceutiques spécifiques:

• DUR-928: solution de gestion de la douleur aiguë
• Posimir: traitement de la douleur chirurgicale
• Remoxy ER: analgésiques à libération prolongée

Amélioration des mécanismes d'absorption des médicaments et de libération contrôlée

Drogue	Amélioration de l'absorption	Durée de libération contrôlée
Posimir	Libération prolongée de 72 heures	Jusqu'à 3 jours après le traitement chirurgical
Remoxy er	Mécanisme à libération prolongée	Gestion de la douleur 24h / 24

Potentiel de réduction des effets secondaires grâce à des systèmes avancés d'administration de médicaments

Les plates-formes technologiques de Durect visent à minimiser les effets secondaires pharmaceutiques par le biais de mécanismes de précision d'administration de médicaments.

Traitements thérapeutiques spécialisés pour les besoins médicaux non satisfaits

Les recherches actuelles se concentrent sur le développement de solutions pour des conditions médicales difficiles avec des options de traitement existantes limitées.

Zone thérapeutique	Besoin médical non satisfait	Investissement en recherche
Gestion de la douleur aiguë	Contrôle post-chirurgical de la douleur	Dépenses de R&D de 12,4 millions de dollars
Troubles neurologiques	Administration avancée de médicaments	Financement de la recherche de 8,7 millions de dollars

Durect Corporation (DRRX) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les sociétés pharmaceutiques

Durect Corporation entretient des relations directes avec des partenaires pharmaceutiques grâce à des stratégies de développement commercial ciblées. Au quatrième trimestre 2023, la société avait des accords de collaboration actifs avec plusieurs entités pharmaceutiques.

Partenaire pharmaceutique	Focus de la collaboration	Statut
Recro Pharma	Développement de posi	Partenariat actif
Pneuma respiratoire	Livraison de médicaments respiratoires	Collaboration continue

Partenariats de recherche collaborative

DURECT s'engage dans des collaborations de recherche stratégique en se concentrant sur les technologies innovantes d'administration de médicaments.

• Partenariats totaux de recherche collaborative en 2023: 3 accords actifs
• Investissement de recherche dans des projets collaboratifs: 2,4 millions de dollars
• Transfert de technologie et mécanismes de partage de la propriété intellectuelle

Consultation et éducation professionnelles médicales

DURECT met en œuvre des stratégies complètes d'engagement professionnel médical.

Canal de fiançailles	Fréquence	Comptage des participants
Présentations de la conférence médicale	Trimestriel	125 professionnels de la santé
Webinaire Series	Bimensuel	250 médecins

Interactions des participants aux essais cliniques

DURECT maintient des protocoles de gestion des participants cliniques rigoureux.

• Essais cliniques actifs en 2023: 4 études en cours
• Participants totaux d'essai cliniques: 387 individus
• Taux de recrutement et de rétention des patients: 92%

Soutien continu au développement et à la commercialisation des médicaments

DURECT fournit un soutien complet tout au long du cycle de vie du développement des médicaments.

Service d'assistance	Couverture	Allocation des ressources
Orientation réglementaire	Support d'interaction FDA	Équipe de conformité dédiée
Stratégie de commercialisation	Planification d'accès au marché	1,7 million de dollars d'investissement annuel

Durect Corporation (DRRX) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les sociétés pharmaceutiques

Durect Corporation maintient une équipe de vente spécialisée axée sur les partenariats pharmaceutiques et les opportunités de licence. Au quatrième trimestre 2023, la société a déclaré 12 représentants des ventes directes ciblant les collaborateurs pharmaceutiques potentiels.

Catégorie de canal de vente	Nombre de représentants	Segment du marché cible
Partenariats pharmaceutiques	12	Sociétés pharmaceutiques spécialisées

Présentations de la conférence médicale

DURECT utilise des conférences médicales comme canaux critiques pour la communication des produits et la validation scientifique. En 2023, l'entreprise a participé à 7 principales conférences pharmaceutiques et biotechnologiques.

• Société américaine de pharmacologie clinique et de thérapie
• Biotechnology Innovation Organisation (BIO) Convention internationale
• Réunion annuelle de la société de libération contrôlée

Publications scientifiques et communications de la recherche

La société a publié 4 articles de recherche évalués par des pairs Dans des revues médicales spécialisées en 2023, tirant parti de la communication scientifique comme canal clé.

Catégorie de journal	Nombre de publications
Recherche pharmaceutique	2
Technologie de livraison de médicaments	2

Plateformes de réseautage de l'industrie pharmaceutique

Durect s'engage activement avec les plateformes de réseautage de l'industrie, en maintenant les profils sur les réseaux professionnels et les bases de données spécifiques à l'industrie. La société a signalé 23 Connexions de réseau professionnel actif Dans les plateformes d'innovation pharmaceutique.

Canaux de soumission réglementaires

En 2023, Durect a soumis 3 Applications réglementaires Grâce aux canaux FDA et EMA pour les processus potentiels de développement et d'approbation des médicaments.

Agence de réglementation	Nombre de soumissions
FDA	2
Ema	1

Durect Corporation (DRRX) - Modèle d'entreprise: segments de clientèle

Organisations de recherche pharmaceutique

Durect Corporation cible les organisations de recherche pharmaceutique avec des technologies spécialisées de livraison de médicaments.

Type d'organisation de recherche	Portée de collaboration potentielle	Pénétration du marché
Centres de recherche universitaires	Plates-formes Oradur et Transdur	12 collaborations actives à partir de 2023
Institutions de recherche privées	Recherche avancée de la livraison de médicaments	8 partenariats en cours

Spécialistes de la gestion de la douleur

DURECT se concentre sur le développement de solutions innovantes de gestion de la douleur.

• Marché cible: spécialistes de la douleur chronique
• Produit primaire: analgésique injectable de posimir
• Marché adressable: environ 100 millions de patients souffrant de douleur chronique aux États-Unis

Fournisseurs de soins de santé

Segment des prestataires de soins de santé	Solution ciblée	Taille du marché potentiel
Centres chirurgicaux	Anesthésie locale de posirir	5 400 centres chirurgicaux ambulatoires aux États-Unis
Hôpitaux	Systèmes avancés d'administration de médicaments	6 093 hôpitaux enregistrés aux États-Unis

Institutions de recherche clinique

Durect collabore avec les établissements de recherche clinique pour le développement avancé des médicaments.

• Essais cliniques actifs: 3 études en cours de phase 2/3
• Régers de recherche sur la recherche: gestion de la douleur, troubles du système nerveux central
• Collaborations de recherche financées par les NIH: 2 subventions actives

Patients nécessitant des solutions spécialisées d'administration de médicaments

Catégorie de patients	Besoin d'administration de médicaments spécifique	Population potentielle de patients
Patiens de douleur chronique	Médicaments contre la douleur à libération prolongée	50 millions d'Américains souffrant de douleur chronique
Patients de récupération chirurgicale	Gestion postopératoire de la douleur	Estimé 50,4 millions de procédures chirurgicales par an

Durect Corporation (DRRX) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Durect Corporation a déclaré des frais de R&D de 23,3 millions de dollars.

Année	Dépenses de R&D	Pourcentage des dépenses totales
2022	21,7 millions de dollars	58.3%
2023	23,3 millions de dollars	61.2%

Financement des essais cliniques

DURECT a alloué environ 15,6 millions de dollars pour les essais cliniques en 2023, en se concentrant sur le développement de pipelines pour la gestion de la douleur et les technologies avancées d'administration de médicaments.

Entretien des brevets et frais de propriété intellectuelle

• Coûts de maintenance annuelle des brevets: 1,2 million de dollars
• Portfolio total de propriété intellectuelle: 98 brevets actifs
• Dépôt de brevets et frais de poursuite: 750 000 $

Fabrication et développement technologique

Les coûts de fabrication et de développement technologique pour 2023 étaient de 8,4 millions de dollars.

Catégorie de coûts	Montant
Équipement	3,6 millions de dollars
Infrastructure technologique	2,8 millions de dollars
Optimisation du processus	2,0 millions de dollars

Processus de conformité et d'approbation réglementaires

Les dépenses de conformité réglementaire pour 2023 ont totalisé 4,2 millions de dollars.

• Coûts de soumission de la FDA: 1,5 million de dollars
• Documentation de la conformité: 1,1 million de dollars
• Services de conseil externe: 1,6 million de dollars

DURECT Corporation (DRRX) - Modèle d'entreprise: Strots de revenus

Licence des technologies pharmaceutiques

Au quatrième trimestre 2023, Durect Corporation a rapporté des revenus de licence de 2,1 millions de dollars de ses plateformes de technologie pharmaceutique.

Plate-forme technologique	Revenus de licence (2023)
Technologie Oradur	1,2 million de dollars
Technologie Transdur	0,9 million de dollars

Paiements de jalons potentiels à partir des accords de partenariat

Durect a des paiements de jalons potentiels structurés dans ses accords de partenariat.

Partenaire	Paiement de jalon potentiel
Sciences de Gilead	Jusqu'à 35 millions de dollars
Novartis	Jusqu'à 20 millions de dollars

Ventes de produits pharmaceutiques futures

Les ventes de produits pharmaceutiques projetées de Durect pour 2024 sont estimées à 4,5 millions de dollars.

• Revenus projetés en alzumab: 2,3 millions de dollars
• Produit de gestion de la douleur chirurgicale de Posimir: 1,7 million de dollars
• Autres produits pharmaceutiques: 0,5 million de dollars

Financement de collaboration de recherche

Le financement de la collaboration de recherche pour 2023 a totalisé 3,8 millions de dollars provenant de divers partenariats de recherche pharmaceutique.

Partenaire de recherche	Financement de collaboration
Subventions NIH	1,5 million de dollars
Collaborations de recherche universitaire	1,3 million de dollars
Financement de recherche privée	1,0 million de dollars

Revenus de redevances des technologies de plate-forme d'administration de médicaments

Les revenus de redevances de la plate-forme de livraison de médicaments en 2023 ont atteint 1,6 million de dollars.

• Royalités technologiques à libération prolongée d'Oradur: 0,9 million de dollars
• Royalités de la technologie Transdur Transdermal: 0,7 million de dollars

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.