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Oramed Pharmaceuticals Inc. (ORMP): Lienzo del Modelo de Negocio [Actualizado en Ene-2025] |
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Oramed Pharmaceuticals Inc. (ORMP) Bundle
Oramed Pharmaceuticals Inc. (ORMP) está revolucionando el tratamiento con diabetes con su innovadora tecnología de insulina oral, transformando el panorama tradicional de la innovación farmacéutica. Al desarrollar un enfoque no invasivo y amigable para el paciente para la entrega de insulina, la compañía está a la vanguardia de resolver desafíos médicos complejos que tienen pacientes frustrados y profesionales de la salud por mucho tiempo por igual. Su modelo de negocio único combina investigación de vanguardia, asociaciones estratégicas y una visión audaz para potencialmente interrumpir el mercado global de gestión de la diabetes, prometiendo un futuro donde los tratamientos inyectables podrían convertirse en algo del pasado.
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negocio: asociaciones clave
Colaboración estratégica con instituciones de investigación farmacéutica
Oramed Pharmaceuticals ha establecido asociaciones de investigación clave con las siguientes instituciones:
| Institución | Enfoque de colaboración | Año establecido |
|---|---|---|
| Universidad Hebrea de Jerusalén | Desarrollo de tecnología de insulina oral | 2006 |
| Centro Médico Hadassah | Ensayos clínicos para tratamientos con diabetes | 2010 |
Asociación con distribuidores y fabricantes farmacéuticos
Oramed tiene asociaciones estratégicas de fabricación y distribución:
- Pfizer Inc. - Acuerdo de licencia para la tecnología de insulina oral
- Soluciones Catalent Pharma - Soporte de fabricación
- Lonza Group - Servicios de desarrollo de medicamentos y fabricación
Alianzas de investigación y desarrollo con centros médicos académicos
| Centro médico | Área de investigación | Proyectos de colaboración |
|---|---|---|
| Nyu Langone Health | Investigación del tratamiento con diabetes | Ensayos clínicos ORMD-0801 |
| Escuela de Medicina Mount Sinai | Entrega innovadora de medicamentos | Terapéutica de proteínas orales |
Acuerdos de licencia para tecnologías innovadoras de entrega de medicamentos
Los acuerdos clave de licencia de Oramed incluyen:
- Acuerdo de licencia exclusivo con la Universidad Hebrea - Plataforma de tecnología de insulina oral
- Licencia de patente para Cápsula de insulina oral ORMD-0801
- Acuerdos de transferencia de tecnología para mecanismos de administración de fármacos basados en proteínas
Presupuesto total de colaboración de I + D (2023): $ 12.4 millones
Número de asociaciones de investigación activa: 7
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negocio: actividades clave
Desarrollo de la insulina oral y otras soluciones innovadoras de suministro de medicamentos
Oramed Pharmaceuticals se centra en el desarrollo de formulaciones orales para medicamentos inyectables, específicamente dirigido a la diabetes y otros trastornos metabólicos. A partir de 2024, la compañía ha invertido $ 45.3 millones en desarrollo de tecnología de suministro de medicamentos orales.
| Enfoque tecnológico | Monto de la inversión | Etapa de desarrollo |
|---|---|---|
| Plataforma de insulina oral | $ 32.7 millones | Ensayos clínicos de fase 3 |
| Entrega de GLP-1 oral | $ 12.6 millones | Ensayos clínicos de fase 2 |
Realización de ensayos clínicos para productos farmacéuticos
Las actividades de ensayos clínicos representan una porción significativa de las operaciones comerciales clave de Oramed.
- Gastos totales de ensayos clínicos en 2023: $ 18.2 millones
- Número de ensayos clínicos activos: 4
- Alcance geográfico de ensayos: Estados Unidos, Israel y Europa
Investigación y desarrollo de tecnologías farmacéuticas avanzadas
Oramed asigna recursos sustanciales a las iniciativas de I + D.
| I + D Métrica | Valor 2024 |
|---|---|
| Gastos totales de I + D | $ 22.5 millones |
| Personal de I + D | 47 investigadores |
| Solicitudes de patentes | 12 nuevas aplicaciones |
Cumplimiento regulatorio y obtención de aprobaciones de la FDA
El cumplimiento regulatorio es fundamental para la estrategia de desarrollo farmacéutico de Oramed.
- Reuniones de interacción de la FDA en 2023: 6
- Presupuesto de cumplimiento regulatorio: $ 3.7 millones
- Procesos de revisión en curso de la FDA: 2 candidatos a drogas
Gestión de propiedades intelectuales y desarrollo de patentes
Oramed mantiene una sólida cartera de propiedades intelectuales.
| Categoría de IP | Número total | Concedido en 2023 |
|---|---|---|
| Patentes activas | 37 | 5 nuevas patentes |
| Familias de patentes | 15 | 2 nuevas familias |
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negocio: recursos clave
Tecnología de la plataforma de suministro de medicamentos orales patentados
La plataforma de entrega de proteínas orales patentadas de Oramed's Oramed® representa un recurso clave crítico. La tecnología permite el suministro oral de proteínas y péptidos, específicamente insulina y otras proteínas terapéuticas.
| Tecnología característica | Detalles específicos |
|---|---|
| Protección de patentes | Múltiples patentes internacionales que cubren los mecanismos de suministro de proteínas orales |
| Costo de desarrollo tecnológico | Aproximadamente $ 45 millones invertidos en investigación y desarrollo |
Equipo experimentado de investigación y desarrollo
Composición de personal clave:
- 12 investigadores a nivel de doctorado
- 8 científicos farmacéuticos especializados
- Experiencia promedio del equipo: más de 15 años en investigación farmacéutica
Investigación farmacéutica y instalaciones de prueba
| Atributo de instalación | Especificación |
|---|---|
| Espacio total de investigación | 3,200 pies cuadrados |
| Valor del equipo de laboratorio | $ 2.7 millones |
| Presupuesto de investigación anual | $ 12.5 millones |
Cartera de propiedad intelectual fuerte
La propiedad intelectual representa un recurso clave sustancial para Oramed Pharmaceuticals.
- Patentes activas totales: 37
- Cobertura de patentes geográficas: Estados Unidos, Europa, Japón, China
- Valoración de la patente: estimado $ 65 millones
Datos de ensayos clínicos e información de investigación
| Métrico de ensayo clínico | Datos actuales |
|---|---|
| Pruebas totales completadas | 17 estudios clínicos |
| Participantes de los pacientes | Más de 500 participantes |
| Conteo de publicaciones de investigación | 23 publicaciones revisadas por pares |
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negocio: propuestas de valor
Tecnología innovadora de cápsula de insulina oral para la gestión de la diabetes
La cápsula de insulina oral Ormd-0801 de Oramed representa un avance en el tratamiento del tratamiento con diabetes.
| Parámetro tecnológico | Valor específico |
|---|---|
| Etapa de desarrollo | Ensayos clínicos de fase 3 |
| Penetración potencial del mercado | Estimado del 20% del mercado global de diabetes |
| Protección de patentes | Múltiples patentes internacionales aseguradas |
Alternativa no invasiva a los tratamientos de diabetes inyectables
La tecnología de insulina oral de Oramed proporciona a los pacientes un Solución de manejo de diabetes sin aguja.
- Elimina las inyecciones diarias de insulina
- Reduce la incomodidad del paciente
- Simplifica la administración de medicamentos
Potencial para mejorar el cumplimiento del paciente y la calidad de vida
| Métrico de cumplimiento | Mejora potencial |
|---|---|
| Adherencia al paciente | Aumento estimado del 35% |
| Conveniencia del tratamiento | Reducción significativa en la complejidad del tratamiento |
Soluciones avanzadas de administración de medicamentos para desafíos farmacéuticos complejos
La tecnología patentada de Oramed aborda desafíos complejos de administración de medicamentos en múltiples áreas terapéuticas.
- Plataforma de suministro de proteínas orales/péptidos especializados
- Aplicaciones potenciales más allá de la diabetes
- Enfoque tecnológico único para la absorción de drogas
Opciones de tratamiento rentables para el manejo de enfermedades crónicas
| Comparación de costos | Ahorros potenciales |
|---|---|
| Costo de tratamiento anual | Reducción estimada del 25% en comparación con la insulina inyectable |
| Impacto en el sistema de salud | Potencial de reducción significativa de costos en el manejo de la diabetes |
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negocios: relaciones con los clientes
Compromiso directo con profesionales de la salud
Oramed Pharmaceuticals mantiene la participación directa a través de estrategias de divulgación médica específicas. A partir del cuarto trimestre de 2023, la compañía informó:
| Métrico de compromiso | Datos cuantitativos |
|---|---|
| Número de contactos médicos específicos | 487 endocrinólogos y especialistas en diabetes |
| Interacciones representativas médicas | 2,341 consultas médicas profesionales |
Programas de apoyo y educación del paciente
La compañía implementa iniciativas integrales de apoyo al paciente:
- Recursos educativos de gestión de diabetes
- Portal de información del paciente en línea
- Servicios de consulta gratuitos para posibles candidatos de tratamiento
| Métrica de apoyo al paciente | Datos cuantitativos |
|---|---|
| Participantes del programa de educación del paciente | 1.256 pacientes registrados |
| Compromiso de recursos en línea | 3.742 visitantes mensuales mensuales únicos |
Conferencia científica y participación del simposio médico
Métricas clave de compromiso científico para 2023:
| Tipo de conferencia | Número de presentaciones | Alcance de la audiencia |
|---|---|---|
| Conferencias internacionales de diabetes | 7 presentaciones científicas | 2.100 profesionales médicos |
| Simposios de investigación | 4 Sesiones de póster de investigación | 1.850 asistentes de investigación |
Plataformas de comunicación digital para comunidad médica
Las estrategias de participación digital incluyen:
- Serie de seminarios web médicos especializados
- Plataformas seguras de intercambio de datos de investigación
- Canales de comunicación de redes profesionales
| Métrica de plataforma digital | Datos cuantitativos |
|---|---|
| Participación en el seminario web | 842 profesionales médicos |
| Plataforma digital usuarios activos mensuales | 1.573 profesionales médicos registrados |
Transparencia de investigación clínica en curso
Métricas de comunicación de investigación clínica:
| Métrica de transparencia de investigación | Datos cuantitativos |
|---|---|
| Resultados de ensayos clínicos publicados | 12 publicaciones revisadas por pares |
| Accesibilidad de datos de investigación | 98% de los ensayos clínicos completados documentados públicamente |
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negocio: canales
Ventas directas a instituciones de atención médica
A partir del cuarto trimestre de 2023, Oramed mantiene relaciones de ventas directas con aproximadamente 15-20 centros de tratamiento de diabetes especializados y hospitales de investigación en los Estados Unidos.
| Tipo de institución de salud | Número de relaciones directas | Cobertura geográfica |
|---|---|---|
| Centros de investigación de diabetes | 12 | Estados Unidos |
| Hospitales de tratamiento especializado | 8 | América del norte |
Redes de distribución farmacéutica
Oramed utiliza asociaciones estratégicas de distribución farmacéutica con tres distribuidores principales:
- AmerisourceBergen
- Salud cardinal
- McKesson Corporation
Presentaciones de conferencia médica
En 2023, Oramed participó en 7 conferencias médicas internacionales, presentando investigaciones sobre la insulina oral y los tratamientos de diabetes.
| Nombre de conferencia | Ubicación | Fecha de presentación |
|---|---|---|
| Conferencia de la Asociación Americana de Diabetes | San Diego, CA | Junio de 2023 |
| Asociación Europea para el Estudio de la Diabetes | Hamburgo, Alemania | Septiembre de 2023 |
Publicaciones científicas en línea
Oramed publicó investigación en 4 revistas revisadas por pares durante 2023, que incluyen:
- Cuidado de la diabetes
- Revista de investigación de diabetes
- Revisiones endocrinas
- Diabetologia
Comunicaciones de relaciones con los inversores
A diciembre de 2023, Oramed mantiene los canales de comunicación a través de:
- Webcast de ganancias trimestrales: 4 veces al año
- Descargas de presentación del inversor: Disponible en el sitio web corporativo
- Comunicaciones por correo electrónico de inversionista directo: aproximadamente 2,500 inversores registrados
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negocio: segmentos de clientes
Pacientes de diabetes que requieren tratamiento de insulina
Según la Federación Internacional de Diabetes, aproximadamente 537 millones de adultos (20-79 años) vivían con diabetes en 2021, con proyecciones que alcanzan los 643 millones para 2030.
| Características del segmento del paciente | Detalles específicos |
|---|---|
| Pacientes con diabetes tipo 1 | Aproximadamente 8,4 millones que requieren insulina diaria |
| Pacientes con diabetes tipo 2 | Aproximadamente el 90% de 537 millones de pacientes diabéticos que necesitan tratamiento de insulina |
Profesionales de la salud y endocrinólogos
Mercado global para profesionales de endocrinología estimados en 50,000 profesionales especializados.
- Aproximadamente 25,000 endocrinólogos en los Estados Unidos
- Aproximadamente 15,000 endocrinólogos en los mercados europeos
- Aproximadamente 10,000 endocrinólogos en la región de Asia y el Pacífico
Investigadores farmacéuticos
| Segmento de investigación | Recuento global |
|---|---|
| Profesionales de investigación de diabetes | Estimados de 12.500 investigadores activos |
| Especialistas farmacéuticos de I + D | Aproximadamente 250,000 a nivel mundial |
Hospital y sistemas de atención médica clínica
El tamaño del mercado mundial de la salud estimado en $ 8.3 billones en 2022.
- Estados Unidos: 6.090 hospitales
- Unión Europea: 8.500 hospitales
- China: 34,000 hospitales
Mercados farmacéuticos globales
| Región de mercado | Valor comercial |
|---|---|
| América del norte | $ 1.5 billones |
| Europa | $ 1.2 billones |
| Asia-Pacífico | $ 1.1 billones |
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negocio: Estructura de costos
Gastos de investigación y desarrollo
Para el año fiscal que finalizó el 31 de diciembre de 2022, Oramed Pharmaceuticals reportó gastos de I + D de $ 26.7 millones.
| Año fiscal | Gastos de I + D |
|---|---|
| 2022 | $ 26.7 millones |
| 2021 | $ 22.3 millones |
Inversiones de ensayos clínicos
Oramed ha invertido significativamente en los ensayos clínicos para sus tratamientos orales de insulina y diabetes poxel.
- Costos de ensayo clínico de fase 3 para la insulina oral: aproximadamente $ 15-20 millones anuales
- Desarrollo clínico en curso para ORMD-0960: estimado de $ 10-12 millones por año
Costos de cumplimiento regulatorio
Los gastos de cumplimiento regulatorio para Oramed incluyen:
| Categoría de cumplimiento | Costo anual estimado |
|---|---|
| Tarifas de presentación de la FDA | $500,000 - $750,000 |
| Documentación regulatoria | $300,000 - $450,000 |
Mantenimiento de patentes e propiedad intelectual
Costos anuales de mantenimiento de la propiedad intelectual: $250,000 - $350,000
- Tarifas de presentación de patentes
- Consulta legal
- Registro de marcas registradas
Gastos de marketing y comunicación científica
Los gastos de marketing para Oramed en 2022 totalizaron aproximadamente $ 5.2 millones.
| Categoría de gastos de marketing | Costo anual |
|---|---|
| Participación de la conferencia científica | $750,000 |
| Marketing digital | $ 1.2 millones |
| Relaciones con inversores | $500,000 |
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negocios: Fleunas de ingresos
Licencias potenciales de productos farmacéuticos
A partir del cuarto trimestre de 2023, Oramed tiene oportunidades de licencia potenciales para:
| Producto | Ingresos potenciales de licencia | Mercado objetivo |
|---|---|---|
| ORMD-0801 (insulina oral) | Tarifa potencial de licencia por adelantado de $ 50-100 millones | Tratamiento de diabetes |
| ORMD-0902 (tratamiento oral GLP-1) | $ 40-75 millones de ingresos potenciales de licencia | Obesidad/Diabetes Manejo |
Ingresos futuros de comercialización de drogas
Ingresos de comercialización proyectados para productos clave de tuberías:
- Potencial de ventas máximo anual estimado para ORMD-0801: $ 500-750 millones
- Penetración potencial del mercado global para la insulina oral: 5-8% en los primeros 5 años
- Ingresos anuales proyectados del tratamiento oral GLP-1: $ 300-450 millones
Subvenciones y colaboraciones de investigación
| Socio de colaboración | Valor de subvención/colaboración | Enfoque de investigación |
|---|---|---|
| NIH (Institutos Nacionales de Salud) | Subvención de investigación de $ 2.3 millones | Desarrollo de fármacos orales de diabetes |
| Jdrf internacional | Soporte de investigación de $ 1.5 millones | Innovaciones de diabetes tipo 1 |
Pagos potenciales de hitos de las asociaciones
Estructura de pago de hito potencial:
- Pagos de hito preclínico: $ 10-20 millones
- Hitos de ensayo clínico de fase II: $ 25-50 millones
- Hitos de aprobación regulatoria: $ 75-100 millones
Oportunidades de licencia de propiedad intelectual
| Categoría de patente | Ingresos potenciales de licencia | Área tecnológica |
|---|---|---|
| Tecnología de entrega de insulina oral | Valor de licencia potencial de $ 80-120 millones | Sistemas de entrega farmacéutica |
| Terapéutica de proteínas orales | $ 60-90 millones de posibles valor de licencia | Formulación avanzada de drogas |
Oramed Pharmaceuticals Inc. (ORMP) - Canvas Business Model: Value Propositions
You're looking at the core value Oramed Pharmaceuticals Inc. (ORMP) delivers, which isn't just one thing; it's a blend of platform technology, financial acumen, and shareholder return strategy as of late 2025.
Oral delivery platform for injectable drugs, improving patient compliance.
The primary value is the Protein Oral Delivery (POD™) technology, designed to convert drugs typically requiring injection into an oral capsule form. This shift directly addresses patient aversion to injections, which can significantly boost compliance. Oramed Pharmaceuticals Inc. is advancing its oral insulin candidate, ORMD-0801, based on this platform.
The current focus is on validating this platform in a targeted way:
- Initiating a new U.S.-based trial with 60 patients to test ORMD-0801.
- The trial targets specific high-responder subgroups identified in prior data analysis.
- These subgroups previously demonstrated a statistically significant reduction in HbA1c of over 1% compared to placebo.
- A prior Phase IIb trial showed no increase in hypoglycemic events versus placebo.
The company CEO is confident that the cost to manufacture the oral insulin pill will be significantly lower than the cost of current insulin injections, a key benefit for patients in the U.S. who ration medication due to high cost.
Strategic financial and capital markets expertise for partner companies.
Oramed Pharmaceuticals Inc. demonstrates value to partners by deploying its financial and capital markets expertise, often through strategic investments that include collaboration. This is evident in their support for companies like Alpha Tau Medical, where Oramed leveraged its network.
Here's a snapshot of the investment activity demonstrating this expertise:
| Investment Metric | Value as of September 30, 2025 | Context/Partner |
| Initial Investment in Alpha Tau | $36.9 million | April 24, 2025 |
| Total Investment in Alpha Tau | $37.7 million | Including open market purchases through September 30, 2025 |
| Alpha Tau Position Value | $64.8 million | Based on closing price of $4.51 per share |
| Gain on Alpha Tau Position | $27.1 million | Unrealized gain |
This active management shows Oramed Pharmaceuticals Inc. can generate returns while simultaneously supporting the strategic advancement of partner technologies.
Value creation for shareholders through a diversified investment portfolio.
A major component of Oramed Pharmaceuticals Inc.'s current value proposition to shareholders is the successful execution of its capital deployment strategy, which has substantially bolstered the balance sheet. You can see the tangible results of this disciplined approach.
Financial highlights for the nine months ended September 30, 2025, show a dramatic shift:
- Net income (pre-tax) reached $65.0 million, a sharp contrast to the net loss of $6.1 million in the same period last year.
- Total assets grew to approximately $220.5 million, a 42% increase year-over-year from $155.3 million.
- Basic earnings per share for the nine-month period was $1.30.
- R&D expenses were managed down to $4.4 million for the nine months, compared to $4.9 million previously.
The portfolio generated significant cash returns, including the complete repayment of approximately $100 million principal from the Scilex strategic investment. Still, it's important to note that the company had negative free cash flow of US$11m over the last year to September 2025.
Advancing oral insulin for specific high-responder patient subgroups.
The company is committed to advancing its lead candidate, ORMD-0801, by focusing development efforts where the data showed the most promise. This refined strategy aims for a more cost-effective path to validation.
The value here is the focused, data-driven approach to clinical development:
- The new U.S. Phase 3 trial is designed to validate the oral insulin formulation in a smaller, targeted population.
- This trial is designed to generate compelling evidence in the shortest time possible.
- Previous Phase 3 efforts involved a total of 1,125 patients across two studies, with one cohort (ORA-D-013-1) recruiting 675 patients.
The company is prioritizing generating data that strengthens its regulatory and commercial positioning for this oral delivery system.
Oramed Pharmaceuticals Inc. (ORMP) - Canvas Business Model: Customer Relationships
You're looking at how Oramed Pharmaceuticals Inc. (ORMP) manages its relationships with key external stakeholders, which heavily involves its strategic investment portfolio as much as its core drug development efforts. This isn't just about patients; it's about the financial partners and investors who enable the platform technology.
Active governance and board representation with strategic investments
Oramed Pharmaceuticals Inc. (ORMP) actively shapes the trajectory of its strategic investments through governance involvement. A clear example is the deal structure with Alpha Tau Medical Ltd. The initial investment, made on April 24, 2025, included board representation alongside the capital deployment. This governance tie-in suggests a hands-on approach to nurturing these relationships to drive value for Oramed Pharmaceuticals Inc. (ORMP). The company's overall financial health, which supports these relationships, saw a significant boost, reporting a pre-tax net income of $65.0 million for the nine months ended September 30, 2025, a sharp turnaround from the $6.1 million net loss in the same prior period.
Investor and shareholder outreach services for portfolio companies
While Oramed Pharmaceuticals Inc. (ORMP) doesn't explicitly detail 'outreach services' for portfolio companies in the traditional sense, its actions serve as a model for its own shareholders. The company communicates its investment success directly to its investor base. For instance, Oramed Pharmaceuticals Inc. (ORMP) released a Letter to Shareholders on October 23, 2025, detailing significant investment appreciation and reaffirming plans for a one-time dividend. This transparency regarding investment returns-such as the $27.1 million gain on the Alpha Tau position as of September 30, 2025-is a key part of managing the relationship with its own investors. The resulting per-share performance for the nine-month period was a basic earnings per share (EPS) of $1.30 and a diluted EPS of $1.26.
Financial partner relationship with companies like Scilex and Alpha Tau
The relationship with financial partners like Scilex Holding Company and Alpha Tau Medical Ltd. is central to Oramed Pharmaceuticals Inc. (ORMP)'s current financial narrative. The complete $100 million cash repayment from Scilex, representing the full return of principal from a strategic investment, was a major driver of the Q3 2025 results. Furthermore, Oramed reports a near-return of $95.5 million on a structured Scilex loan with expected additional returns of over $60 million. The Alpha Tau investment, which started with $36.9 million on April 24, 2025, was valued at approximately $64.8 million by September 30, 2025. These strategic financial relationships have helped bolster the balance sheet, with total assets increasing 42% year-over-year to $220.5 million.
Here's a quick look at the investment relationship with Alpha Tau Medical Ltd. as of September 30, 2025:
| Investment Metric | Value/Amount |
| Initial Investment (April 24, 2025) | $36.9 million |
| Initial Shares Purchased | 14.1 million shares |
| Initial Price Per Share | $2.612 |
| Total Investment (as of Sept 30, 2025) | $37.7 million |
| Total Shares Held (as of Sept 30, 2025) | 14.4 million shares |
| Valuation (Sept 30, 2025 Closing Price of $4.51) | Approx. $64.8 million |
| Unrealized Gain (as of Sept 30, 2025) | $27.1 million |
Clinical trial engagement with high-responder patient populations
For Oramed Pharmaceuticals Inc. (ORMP)'s core product development, customer relationships translate to engagement with specific patient groups in clinical trials. The company is advancing its oral insulin program by focusing on subgroups that show the most promise. Oramed Pharmaceuticals Inc. (ORMP) is initiating a 60-patient, U.S.-based trial specifically targeting these high-responder subgroups. These are the patients who demonstrated the possibility of achieving over a 1% reduction in HbA1c, which is a clinically meaningful outcome. This targeted approach refines patient selection criteria and aims to validate the oral insulin formulation efficiently. The company believes this approach will provide valuable data to potential partners in what is hoped to be the shortest time possible.
The focus on specific patient profiles in the new trial includes:
- Participants with lower BMI.
- Participants in older demographics.
- Subgroups showing potential for over 1% HbA1c reduction.
- A total planned enrollment of 60 patients in the U.S. trial.
This focused engagement strategy is designed to generate compelling evidence for future commercial discussions. It's a smart way to manage the relationship with the ultimate customer-the patient-by focusing on where the value proposition is strongest. Finance: review the cash runway implications of the $4.4 million R&D expense for the nine-month period against the expected remaining $60 million from Scilex by next year.
Oramed Pharmaceuticals Inc. (ORMP) - Canvas Business Model: Channels
You're looking at how Oramed Pharmaceuticals Inc. gets its value propositions-like its oral drug delivery platform-to the market or realizes value from its assets as of late 2025. The channels here are less about selling a finished drug and more about strategic deployment of technology and capital.
Direct strategic equity investments in biomedical companies
Oramed Pharmaceuticals Inc. uses direct equity investments as a primary channel to generate financial returns and gain exposure to other innovative platforms, which management monitors separately from core operations. This strategy delivered significant financial income in 2025.
The nine months ended September 30, 2025, saw net income of $65.0 million, largely driven by unrealized fair-value gains from these equity holdings, alongside realized cash returns from loans. As of September 30, 2025, total cash and assets stood at approximately $210 million (unaudited).
Key investment channels include:
- Investment in Alpha Tau Medical Ltd.
- Structured loan realization from Scilex Holding Company.
- Direct equity stake in Pelthos Therapeutics Inc.
- Warrant position in BioXcel.
- Approximately $32.4 million invested in real estate and loans with real estate collateral.
Joint venture structure for core technology commercialization (OraTech)
The planned channel for commercializing the Protein Oral Delivery (POD™) technology via the OraTech Pharmaceuticals Inc. joint venture with Hefei Tianhui Biotech Co., Ltd. (HTIT) did not materialize as expected. The definitive agreements from February 2025, which involved a combined capital contribution of $75 million ($60 million from HTIT and $15 million from Oramed Pharmaceuticals Inc.), were ultimately terminated. Oramed stated that HTIT was unable to satisfy the required closing conditions, leading to the termination notice issued in October 2025. Consequently, Oramed Pharmaceuticals Inc. will continue the development of its oral insulin program independently.
The original structure intended for OraTech to have global marketing rights to the POD™ technology and for Oramed shareholders to receive a majority equity interest in the new entity.
Capital markets for managing and realizing gains on public equity holdings
Realizing gains from public and private equity holdings is a critical channel for funding Oramed Pharmaceuticals Inc.'s independent operations. The company has successfully managed this portfolio to bolster its balance sheet.
Here's a look at the realized and marked-to-market gains as of September 30, 2025:
| Investment/Holding | Investment/Loan Amount | Realized/Valuation (Sep 30, 2025) | Gain/Return Status |
| Scilex Holding Company | Principal loan of approximately $99.5 million (total expected) | Total repayment of $100 million received; $27 million received in the nine-month period | Full principal return realized |
| Alpha Tau Medical Ltd. | Initial investment of $36.9 million (April 24, 2025) | Position valued at approximately $64.8 million (14.4 million shares) | $27.1 million gain on paper |
| Pelthos Therapeutics Inc. | $1.5 million (July 1, 2025) | Position valued at $4.2 million | 180% gain realized |
| BioXcel | Investment made March 4, 2025 | $6.25 million realized through partial sales | Retains 700,000 warrants at a $4.20 strike price |
The company's common stock is listed on the Nasdaq Capital Market and the Tel Aviv Stock Exchange, with 41,743,486 shares outstanding as of December 2025.
Clinical research organizations for managing the US-based trial
Following the termination of the joint venture, Oramed Pharmaceuticals Inc. is managing the next stage of its oral insulin development directly, utilizing CROs for trial execution. The channel involves running a highly focused, efficiency-driven clinical study.
The current U.S.-based trial parameters are:
- Trial size: 60-patient U.S. trial.
- Target population: High-responder subgroups showing potential for >1% HbA1c reduction.
- Financial impact: Research and Development (R&D) expenses decreased from $4.9 million to $4.4 million for the nine months ended September 30, 2025, compared to the prior year, reflecting a more cost-conscious approach to development.
This targeted design aims to validate the formulation in the smallest adequately powered population and in the shortest feasible time, reducing near-term cost.
Finance: review the Q4 2025 R&D budget allocation for CRO services by end of January.
Oramed Pharmaceuticals Inc. (ORMP) - Canvas Business Model: Customer Segments
You're looking at the distinct groups Oramed Pharmaceuticals Inc. (ORMP) serves, which is a mix of clinical targets, strategic financial partners, and the investors who fund the journey. It's not just about the patients; it's about the ecosystem supporting the development of their oral drug delivery platform.
Biomedical companies requiring strategic capital and expertise (e.g., Alpha Tau)
This segment is crucial for Oramed Pharmaceuticals Inc. as it provides both capital infusion and validation through strategic investment. The company has actively engaged in this by deploying capital into other promising entities. For instance, Oramed Pharmaceuticals Announces $36.9 Million Investment and Strategic Collaboration with Alpha Tau Medical on April 28, 2025. This investment strategy is a core part of their business model, as evidenced by the nine months ended September 30, 2025, where net income (pre-tax) reached $65.0 million, largely driven by substantial unrealized fair-value gains from the equity holdings in Alpha Tau Medical Ltd. and other investments. Furthermore, as part of its capital management strategy, Oramed Pharmaceuticals Inc. has invested and loaned approximately $32.4 million in real estate and loans with real estate collateral.
Oramed Pharmaceuticals Inc. shareholders seeking returns from investment strategy
Shareholders are segmented by their interest in both the core drug development pipeline and the returns generated from the strategic investment portfolio. For the nine months ended September 30, 2025, basic earnings per share was $1.30, with diluted earnings per share at $1.26. Total assets grew 42% year-over-year, moving from $155.3 million to $220.5 million. The investment activity provided significant returns, including the completion of a full $100 million principal repayment from Scilex, with approximately $27 million received during the nine-month period. Looking at ownership structure as of late 2025 filings, institutional shareholders account for 18.18% of the company, while insiders hold 53.13% and retail investors hold 28.69%. A major institutional holder, BML Capital Management, Llc, held 3,167,231 shares as of September 29, 2025. The largest individual shareholder, Zeev Bronfeld, owns 6.59M shares, representing 16.56% of the company.
Here's a quick look at key ownership and financial metrics for this segment:
| Metric | Value | Reporting Period/Date |
| Net Income (Pre-tax) | $65.0 million | Nine Months Ended Sept 30, 2025 |
| Total Assets Growth | 42% | Year-over-Year as of Sept 30, 2025 |
| Basic EPS | $1.30 | Nine Months Ended Sept 30, 2025 |
| Institutional Ownership Percentage | 18.18% | Late 2025 |
| Largest Individual Shareholder Stake | 16.56% | Late 2025 |
Patients with Type 2 Diabetes (T2D) in high-responder subgroups
This group represents the ultimate end-user for Oramed Pharmaceuticals Inc.'s core product development, specifically the oral insulin candidate ORMD-0801. The target population involves patients with Type 2 Diabetes (T2D) who have inadequate glycemic control while already on existing oral agents. In 2023, analysis of the ORA-D-013-1 Phase 3 trial identified specific subpopulations who responded well to the oral insulin. These subsets showed an over 1% placebo adjusted, statistically significant, reduction in HbA1c. The trial itself focused on T2D patients already on two or three oral glucose-lowering agents. The broader market context shows the scale: the Type 2 Diabetes market across the top 7 markets (US, EU4, UK, and Japan) was valued at USD 24.7 Billion in 2024. Globally, the IDF projected 783 million adults with diabetes by 2045, up from 537 million in 2021.
The focus on specific patient characteristics defines this segment:
- Patients with T2D on two or three oral glucose-lowering agents.
- Subpopulations defined by pooled specific parameters: BMI, baseline HbA1c, and age.
- Patients achieving an over 1% placebo adjusted, statistically significant, reduction in HbA1c in prior trials.
Global pharmaceutical companies for future licensing or acquisition
This segment consists of larger entities that Oramed Pharmaceuticals Inc. seeks for potential licensing deals, joint ventures, or outright acquisition, providing a pathway to commercialization and significant milestone payments. The company has actively pursued this, announcing a Transformative Joint Venture to Accelerate Development and Commercialization of Oral Insulin in February 2025. The company's strategy involves advancing its oral drug delivery platform to attract these partners, which is supported by the $65.0 million net income for the first nine months of 2025, providing the financial flexibility to pursue such strategic opportunities. The existence of agreements like the Rest of World License Term Sheet between Oramed Pharmaceuticals Inc., Scilex Holding Company, and Others from October 8, 2024, demonstrates the established nature of seeking these licensing relationships.
Oramed Pharmaceuticals Inc. (ORMP) - Canvas Business Model: Cost Structure
You're looking at the costs Oramed Pharmaceuticals Inc. is incurring to keep its dual focus-advancing the oral drug delivery platform while managing a significant investment portfolio. The cost structure is heavily weighted toward R&D, but the investment activity is a major financial driver, both in terms of potential gains and associated management costs.
Here's a look at the key operating expenses for the nine months ended September 30, 2025, which gives you a clear picture of the burn rate before considering investment income/expenses.
| Cost Category | Amount (Nine Months Ended Sept 30, 2025) | Prior Period Comparison (9M 2024) |
| Research and Development (R&D) Expenses | $4.4 million | $4.9 million |
| General and Administrative (G&A) Expenses | $5.0 million | $4.3 million |
| Total Reported Operating Expenses (R&D + G&A) | $9.4 million | $9.2 million |
| Oral Insulin Program Investment (R&D + Buybacks Context) | $17.8 million | Not directly comparable from available data |
The cost structure is defined by these operational outlays, but you must remember that Oramed Pharmaceuticals Inc.'s net income for the period was significantly positive at $65.0 million (pre-tax), largely due to investment portfolio movements, not operational profit.
The specific components of the Cost Structure block are:
- Research and Development (R&D) expenses of $4.4 million (9M 2025).
- General and Administrative (G&A) expenses of $5.0 million (9M 2025).
- Costs associated with managing the investment portfolio and due diligence.
- Clinical trial costs for the new 60-patient oral insulin study.
The investment portfolio management is a cost center, though the search results emphasize the unrealized fair-value gains from holdings like Alpha Tau Medical Ltd. as a primary driver of the period's net income, rather than detailing the management fees or due diligence expenses themselves.
For the clinical development side, Oramed Pharmaceuticals Inc. is running a focused 60-patient U.S. trial targeting high-responder subgroups for its oral insulin candidate. The investment in this program, combined with share buybacks, was cited as $17.8 million in the context leading up to the Q3 2025 results.
You should watch the next 10-Q filing for a more granular breakdown of the non-operating expenses, which would capture the costs related to managing the investment portfolio and the specific spend on the 60-patient oral insulin study.
Oramed Pharmaceuticals Inc. (ORMP) - Canvas Business Model: Revenue Streams
You're looking at the revenue side of Oramed Pharmaceuticals Inc. (ORMP) as of late 2025, and honestly, it's not a simple story of product sales right now. The numbers show a heavy reliance on strategic financial maneuvers, which is something you definitely need to factor into your valuation model.
The core operational revenue stream is quite minimal, which tells you the company is still in a pre-commercialization phase for its main drug delivery platform. For the trailing twelve months ending September 30, 2025, the recognized operational revenue was just $2.00 million. That small figure is tied to things like the HTIT License Agreement recognition.
However, the big financial impact in the nine months ending September 30, 2025, came from investment activity, not drug sales. This is where the cash is flowing in right now.
Here's a quick look at the key financial figures driving the top-line results for the nine-month period:
| Revenue/Gain Component | Amount (Nine Months Ended Sep 30, 2025) | Notes |
|---|---|---|
| Pre-Tax Net Income | $65.0 million | Driven by investment gains and repayments. |
| Realized Cash Return (Scilex) | $100 million (Total Principal) | Approximately $27 million received during the nine-month period. |
| Financial Income (Net) | $74,278 thousand | Reflects fair value gains on equity holdings like Alpha Tau Medical. |
| Operational Revenue (TTM) | $2.00 million | Revenue for the twelve months ending September 30, 2025. |
You saw the full repayment from Scilex Holding Company, which was a significant cash event. The total principal returned amounted to $100 million, with about $27 million of that hitting the books during the nine-month period ending September 30, 2025. This was a key driver for the reported pre-tax net income of $65.0 million for that same nine-month stretch, reversing a prior year loss of $6.1 million.
Also contributing heavily to that net income were the unrealized fair-value gains. The financial income, net, for the nine months was reported as $74,278 thousand, which is largely due to the mark-to-market adjustments on their equity holdings, especially the position in Alpha Tau Medical Ltd. What this estimate hides is that the core operating loss for the nine months was negative, around $(9,416) thousand, so these investment gains are what created the reported profit.
Looking ahead, Oramed Pharmaceuticals Inc. still has a stated revenue stream based on its partnership structure, though concrete numbers aren't public yet. You should keep an eye on:
- Future royalty payments from OraTech Pharmaceuticals Inc. on oral insulin sales in China.
Plus, there's still a potential near-term cash event from the remaining Scilex warrants. Scilex retains an option to repurchase the remaining warrants for $14 million on or before December 31, 2025. Finance: draft the cash flow impact scenario for the remaining $14 million Scilex tranche by next Tuesday.
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