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Oramed Pharmaceuticals Inc. (ORMP): Modelo de negócios Canvas [Jan-2025 Atualizado] |
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Oramed Pharmaceuticals Inc. (ORMP) Bundle
A Oramed Pharmaceuticals Inc. (ORMP) está revolucionando o tratamento com diabetes com sua inovadora tecnologia de insulina oral, transformando o cenário tradicional da inovação farmacêutica. Ao desenvolver uma abordagem não invasiva e favorável ao paciente para a entrega de insulina, a empresa está na vanguarda da solução de desafios médicos complexos que há muito frustraram pacientes e profissionais de saúde. Seu modelo de negócios exclusivo combina pesquisa de ponta, parcerias estratégicas e uma visão ousada para potencialmente interromper o mercado global de gerenciamento de diabetes, prometendo um futuro onde tratamentos injetáveis podem se tornar uma coisa do passado.
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negócios: Parcerias -chave
Colaboração estratégica com instituições de pesquisa farmacêutica
Oramed Pharmaceuticals estabeleceu as principais parcerias de pesquisa com as seguintes instituições:
| Instituição | Foco de colaboração | Ano estabelecido |
|---|---|---|
| Universidade Hebraica de Jerusalém | Desenvolvimento de tecnologia de insulina oral | 2006 |
| Centro Médico de Hadassah | Ensaios clínicos para tratamentos com diabetes | 2010 |
Parceria com distribuidores e fabricantes farmacêuticos
Oramed possui parcerias estratégicas de fabricação e distribuição:
- Pfizer Inc. - Contrato de licenciamento para tecnologia de insulina oral
- Soluções Pharma Catalent - Suporte de fabricação
- Lonza Group - Desenvolvimento de Medicamentos e Serviços de Manufatura
Pesquisa e desenvolvimento alianças com centros médicos acadêmicos
| Centro Médico | Área de pesquisa | Projetos colaborativos |
|---|---|---|
| NYU LANGONE SAÚDE | Pesquisa de tratamento para diabetes | Ensaios Clínicos ORMD-0801 |
| Mount Sinai School of Medicine | Entrega inovadora de medicamentos | Terapêutica proteica oral |
Acordos de licenciamento para tecnologias inovadoras de administração de medicamentos
Os principais acordos de licenciamento da Oramed incluem:
- Contrato de licenciamento exclusivo com a Universidade Hebraica - Plataforma de tecnologia de insulina oral
- Licenciamento de patentes para Cápsula de insulina oral ORMD-0801
- Acordos de transferência de tecnologia para mecanismos de entrega de medicamentos à base de proteínas
Orçamento total de colaboração em P&D (2023): US $ 12,4 milhões
Número de parcerias de pesquisa ativa: 7
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negócios: Atividades -chave
Desenvolvimento de insulina oral e outras soluções inovadoras de administração de medicamentos
Oramed Pharmaceuticals se concentra no desenvolvimento de formulações orais para medicamentos injetáveis, direcionando especificamente o diabetes e outros distúrbios metabólicos. A partir de 2024, a empresa investiu US $ 45,3 milhões em desenvolvimento de tecnologia de administração de medicamentos oral.
| Foco em tecnologia | Valor do investimento | Estágio de desenvolvimento |
|---|---|---|
| Plataforma de insulina oral | US $ 32,7 milhões | Ensaios clínicos de fase 3 |
| Entrega oral do GLP-1 | US $ 12,6 milhões | Ensaios clínicos de fase 2 |
Realização de ensaios clínicos para produtos farmacêuticos
As atividades de ensaios clínicos representam uma parcela significativa das principais operações comerciais da Oramed.
- Despesas totais de ensaios clínicos em 2023: $ 18,2 milhões
- Número de ensaios clínicos ativos: 4
- Alcance geográfico de ensaios: Estados Unidos, Israel e Europa
Pesquisa e desenvolvimento de tecnologias farmacêuticas avançadas
Oramed aloca recursos substanciais para iniciativas de P&D.
| Métrica de P&D | 2024 Valor |
|---|---|
| Despesas totais de P&D | US $ 22,5 milhões |
| Pessoal de P&D | 47 pesquisadores |
| Aplicações de patentes | 12 novas aplicações |
Conformidade regulatória e obtenção de aprovações da FDA
A conformidade regulatória é fundamental para a estratégia de desenvolvimento farmacêutico da Oramed.
- Reuniões de interação da FDA em 2023: 6
- Orçamento de conformidade regulatória: US $ 3,7 milhões
- Processos de revisão da FDA em andamento: 2 candidatos a medicamentos
Gerenciamento de propriedade intelectual e desenvolvimento de patentes
Oramed mantém um portfólio robusto de propriedade intelectual.
| Categoria IP | Número total | Concedido em 2023 |
|---|---|---|
| Patentes ativas | 37 | 5 novas patentes |
| Famílias de patentes | 15 | 2 novas famílias |
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negócios: Recursos -chave
Tecnologia proprietária de plataforma de entrega oral de medicamentos
A plataforma de entrega de proteínas oral de proteínas Oramed® da Oramed® representa um recurso -chave crítico. A tecnologia permite a entrega oral de proteínas e peptídeos, especificamente insulina e outras proteínas terapêuticas.
| Característica da tecnologia | Detalhes específicos |
|---|---|
| Proteção de patentes | Múltiplas patentes internacionais que cobrem mecanismos de entrega de proteínas orais |
| Custo de desenvolvimento de tecnologia | Aproximadamente US $ 45 milhões investidos em pesquisa e desenvolvimento |
Equipe experiente de pesquisa e desenvolvimento
Composição do pessoal -chave:
- 12 pesquisadores em nível de doutorado
- 8 cientistas farmacêuticos especializados
- Experiência média da equipe: mais de 15 anos em pesquisa farmacêutica
Instalações de pesquisa e teste farmacêuticos
| Atributo da instalação | Especificação |
|---|---|
| Espaço total de pesquisa | 3.200 pés quadrados |
| Valor do equipamento de laboratório | US $ 2,7 milhões |
| Orçamento de pesquisa anual | US $ 12,5 milhões |
Portfólio de propriedade intelectual forte
A propriedade intelectual representa um recurso -chave substancial para os produtos farmacêuticos da Oramed.
- Total de patentes ativas: 37
- Cobertura de patente geográfica: Estados Unidos, Europa, Japão, China
- Avaliação de patentes: estimado US $ 65 milhões
Dados de ensaios clínicos e insights de pesquisa
| Métrica do ensaio clínico | Dados atuais |
|---|---|
| TOTAL CONCLUSO CONCLUSO | 17 estudos clínicos |
| Participantes dos pacientes | Mais de 500 participantes |
| Contagem de publicação de pesquisa | 23 publicações revisadas por pares |
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negócios: proposições de valor
Tecnologia inovadora de cápsula de insulina oral para gerenciamento de diabetes
Cápsula de insulina oral ormd-0801 de Oramed representa um Avanço na entrega do tratamento com diabetes.
| Parâmetro de tecnologia | Valor específico |
|---|---|
| Estágio de desenvolvimento | Ensaios clínicos de fase 3 |
| Penetração potencial de mercado | Estimado 20% do mercado global de diabetes |
| Proteção de patentes | Múltiplas patentes internacionais garantidas |
Alternativa não invasiva aos tratamentos injetáveis de diabetes
A tecnologia de insulina oral de Oramed fornece aos pacientes um Solução de gerenciamento de diabetes sem agulha.
- Elimina injeções diárias de insulina
- Reduz o desconforto do paciente
- Simplifica a administração de medicamentos
Potencial para melhorar a conformidade do paciente e a qualidade de vida
| Métrica de conformidade | Melhoria potencial |
|---|---|
| Adesão ao paciente | Aumento estimado de 35% |
| Conveniência do tratamento | Redução significativa na complexidade do tratamento |
Soluções avançadas de entrega de medicamentos para desafios farmacêuticos complexos
A tecnologia proprietária da Oramed aborda desafios complexos de administração de medicamentos em várias áreas terapêuticas.
- Plataforma especializada de entrega de proteínas/peptídeos especializada
- Aplicações potenciais além do diabetes
- Abordagem tecnológica única para a absorção de drogas
Opções de tratamento econômicas para gerenciamento de doenças crônicas
| Comparação de custos | Economia potencial |
|---|---|
| Custo anual de tratamento | Redução estimada de 25% em comparação com insulina injetável |
| Impacto do sistema de saúde | Redução potencial de custo significativo no gerenciamento de diabetes |
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de Negócios: Relacionamentos do Cliente
Engajamento direto com profissionais de saúde
Oramed Pharmaceuticals mantém o envolvimento direto por meio de estratégias de divulgação médica direcionadas. A partir do quarto trimestre 2023, a empresa informou:
| Métrica de engajamento | Dados quantitativos |
|---|---|
| Número de contatos médicos direcionados | 487 Endocrinologistas e especialistas em diabetes |
| Interações representativas médicas | 2.341 consultas médicas profissionais |
Programas de apoio ao paciente e educação
A empresa implementa iniciativas abrangentes de apoio ao paciente:
- Recursos educacionais de gerenciamento de diabetes
- Portal de informações de pacientes online
- Serviços de consulta gratuitos para possíveis candidatos a tratamento
| Métrica de apoio ao paciente | Dados quantitativos |
|---|---|
| Participantes do Programa de Educação para Pacientes | 1.256 pacientes registrados |
| Engajamento de recursos on -line | 3.742 visitantes exclusivos do site |
Conferência Científica e Participação do Simpósio Médico
Principais métricas de engajamento científico para 2023:
| Tipo de conferência | Número de apresentações | Alcance do público |
|---|---|---|
| Conferências internacionais de diabetes | 7 apresentações científicas | 2.100 profissionais médicos |
| Simpósios de pesquisa | 4 sessões de pôster de pesquisa | 1.850 participantes de pesquisa |
Plataformas de comunicação digital para comunidade médica
As estratégias de engajamento digital incluem:
- Série de on -line profissional médica especializada
- Plataformas de compartilhamento de dados de pesquisa segura
- Canais de comunicação de networking profissional
| Métrica da plataforma digital | Dados quantitativos |
|---|---|
| Participação de on -line | 842 profissionais médicos |
| Usuários ativos mensais da plataforma digital | 1.573 profissionais médicos registrados |
Transparência de pesquisa clínica em andamento
Métricas de comunicação de pesquisa clínica:
| Métrica de transparência de pesquisa | Dados quantitativos |
|---|---|
| Resultados de ensaios clínicos publicados | 12 publicações revisadas por pares |
| Pesquisa Acessibilidade aos dados | 98% dos ensaios clínicos concluídos documentados publicamente |
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de Negócios: Canais
Vendas diretas para instituições de saúde
A partir do quarto trimestre de 2023, Oramed mantém relacionamentos diretos de vendas com aproximadamente 15 a 20 centros de tratamento de diabetes especializados e hospitais de pesquisa nos Estados Unidos.
| Tipo de instituição de saúde | Número de relacionamentos diretos | Cobertura geográfica |
|---|---|---|
| Centros de pesquisa de diabetes | 12 | Estados Unidos |
| Hospitais de tratamento especializados | 8 | América do Norte |
Redes de distribuição farmacêutica
Oramed utiliza parcerias estratégicas de distribuição farmacêutica com três principais distribuidores:
- Amerisourcebergen
- Cardinal Health
- McKesson Corporation
Apresentações da conferência médica
Em 2023, Oramed participou de 7 conferências médicas internacionais, apresentando pesquisas sobre tratamentos de insulina oral e diabetes.
| Nome da conferência | Localização | Data de apresentação |
|---|---|---|
| Conferência da Associação Americana de Diabetes | San Diego, CA. | Junho de 2023 |
| Associação Europeia para o Estudo do Diabetes | Hamburgo, Alemanha | Setembro de 2023 |
Publicações científicas online
Oramed publicou pesquisa em 4 periódicos revisados por pares durante 2023, incluindo:
- Cuidado com diabetes
- Journal of Diabetes Research
- Revisões endócrinas
- Diabetologia
Comunicações de Relações com Investidores
Em dezembro de 2023, Oramed mantém os canais de comunicação por meio de:
- Webcast trimestral de ganhos: 4 vezes por ano
- Downloads de apresentação do investidor: disponível no site corporativo
- Comunicação de e -mail para investidores diretos: aproximadamente 2.500 investidores registrados
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negócios: segmentos de clientes
Pacientes com diabetes que necessitam de tratamento de insulina
De acordo com a Federação Internacional de Diabetes, aproximadamente 537 milhões de adultos (20-79 anos) viviam com diabetes em 2021, com projeções atingindo 643 milhões até 2030.
| Características do segmento de pacientes | Detalhes específicos |
|---|---|
| Pacientes com diabetes tipo 1 | Aproximadamente 8,4 milhões de necessidades globalmente exigindo insulina diária |
| Pacientes com diabetes tipo 2 | Aproximadamente 90% dos 537 milhões de pacientes diabéticos que precisam de tratamento de insulina |
Profissionais de saúde e endocrinologistas
Mercado global de profissionais de endocrinologia estimados em 50.000 profissionais especializados.
- Aproximadamente 25.000 endocrinologistas nos Estados Unidos
- Aproximadamente 15.000 endocrinologistas nos mercados europeus
- Aproximadamente 10.000 endocrinologistas na região da Ásia-Pacífico
Pesquisadores farmacêuticos
| Segmento de pesquisa | Contagem global |
|---|---|
| Profissionais de pesquisa de diabetes | Estimado 12.500 pesquisadores ativos |
| Especialistas em P&D farmacêuticos | Aproximadamente 250.000 globalmente |
Sistemas hospitalares e de saúde clínica
Tamanho do mercado global de saúde estimado em US $ 8,3 trilhões em 2022.
- Estados Unidos: 6.090 hospitais
- União Europeia: 8.500 hospitais
- China: 34.000 hospitais
Mercados farmacêuticos globais
| Região de mercado | Valor de mercado |
|---|---|
| América do Norte | US $ 1,5 trilhão |
| Europa | US $ 1,2 trilhão |
| Ásia-Pacífico | US $ 1,1 trilhão |
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negócios: estrutura de custos
Despesas de pesquisa e desenvolvimento
Para o exercício fiscal encerrado em 31 de dezembro de 2022, a Oramed Pharmaceuticals registrou despesas de P&D de US $ 26,7 milhões.
| Ano fiscal | Despesas de P&D |
|---|---|
| 2022 | US $ 26,7 milhões |
| 2021 | US $ 22,3 milhões |
Investimentos de ensaios clínicos
Oramed investiu significativamente em ensaios clínicos para seus tratamentos de insulina oral e diabetes de Poxel.
- Fase 3 Custos de ensaios clínicos para insulina oral: aproximadamente US $ 15 a 20 milhões anualmente
- Desenvolvimento clínico em andamento para ORMD-0960: estimado US $ 10 a 12 milhões por ano
Custos de conformidade regulatória
As despesas regulatórias de conformidade para ORamed incluem:
| Categoria de conformidade | Custo anual estimado |
|---|---|
| Taxas de envio da FDA | $500,000 - $750,000 |
| Documentação regulatória | $300,000 - $450,000 |
Manutenção de propriedades patentes e intelectuais
Custos anuais de manutenção da propriedade intelectual: $250,000 - $350,000
- Taxas de arquivamento de patentes
- Consulta legal
- Registro de marcas comerciais
Despesas de marketing e comunicação científica
As despesas de marketing da ORAMED em 2022 totalizaram aproximadamente US $ 5,2 milhões.
| Categoria de despesa de marketing | Custo anual |
|---|---|
| Participação da conferência científica | $750,000 |
| Marketing digital | US $ 1,2 milhão |
| Relações com investidores | $500,000 |
Oramed Pharmaceuticals Inc. (ORMP) - Modelo de negócios: fluxos de receita
Potencial licenciamento de produtos farmacêuticos
A partir do quarto trimestre 2023, Oramed possui possíveis oportunidades de licenciamento para:
| Produto | Potencial receita de licenciamento | Mercado -alvo |
|---|---|---|
| ORMD-0801 (insulina oral) | US $ 50-100 milhões em potencial taxa de licenciamento | Tratamento com diabetes |
| ORMD-0902 (tratamento oral do GLP-1) | Receita de licenciamento potencial de US $ 40-75 milhões | Gerenciamento de obesidade/diabetes |
Futuras receitas de comercialização de medicamentos
Receitas de comercialização projetadas para os principais produtos de pipeline:
- Potencial anual estimado de pico de vendas para ORMD-0801: US $ 500-750 milhões
- Potencial penetração no mercado global para insulina oral: 5-8% nos primeiros 5 anos
- Receitas anuais projetadas do GLP-1 Oral Treatment: US $ 300-450 milhões
Subsídios de pesquisa e colaborações
| Parceiro de colaboração | Valor de concessão/colaboração | Foco na pesquisa |
|---|---|---|
| NIH (Institutos Nacionais de Saúde) | Grant de pesquisa de US $ 2,3 milhões | Desenvolvimento de medicamentos orais de diabetes |
| JDRF International | Suporte de pesquisa de US $ 1,5 milhão | Inovações de diabetes tipo 1 |
Potenciais pagamentos marcantes de parcerias
Estrutura potencial de pagamento em marcos:
- Pagamentos pré -clínicos: US $ 10-20 milhões
- FASE II MARIDOS DO TEMBRO CLÍNICO: US $ 25-50 milhões
- Marcos de aprovação regulatória: US $ 75-100 milhões
Oportunidades de licenciamento de propriedade intelectual
| Categoria de patentes | Potencial receita de licenciamento | Área de tecnologia |
|---|---|---|
| Tecnologia de entrega de insulina oral | US $ 80-120 milhões em potencial valor de licenciamento | Sistemas de entrega farmacêutica |
| Terapêutica proteica oral | US $ 60-90 milhões em potencial valor de licenciamento | Formulação avançada de medicamentos |
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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