Omeros Corporation (OMER): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico da biotecnologia, a Omeros Corporation (OMER) surge como uma força pioneira, revolucionando a inovação farmacêutica por meio de seu modelo de negócios meticulosamente criado. Ao navegar estrategicamente aos tratamentos complexos de doenças neurológicas e inflamatórias, a empresa aproveita a pesquisa de ponta, parcerias estratégicas e as tecnologias terapêuticas inovadoras para atender às necessidades médicas não atendidas. Sua abrangente modelo de negócios Canvas revela uma abordagem sofisticada que transforma a experiência científica em possíveis soluções médicas que mudam a vida, posicionando omeros na vanguarda da medicina de precisão e estratégias de intervenção molecular.

Omeros Corporation (OMER) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa farmacêutica

A partir de 2024, a Omeros Corporation estabeleceu parcerias estratégicas com as seguintes instituições de pesquisa:

Instituição	Foco de colaboração	Ano estabelecido
Universidade de Washington	Narsoplimab Research	2018
Saúde do Oregon & Universidade de Ciências	Complemento terapêutica do sistema	2019

Acordos de licenciamento com centros médicos acadêmicos

Omeros garantiu os seguintes acordos de licenciamento:

• Mayo Clinic - Licenciamento exclusivo para tecnologias terapêuticas relacionadas a complementares
• Centro Médico da Universidade de Stanford - Colaboração de pesquisa não exclusiva para tratamentos de doenças raras

Parceria com organizações de pesquisa contratada (CROs)

Nome do CRO	Tipo de contrato	Valor anual do contrato
Iqvia	Gerenciamento de ensaios clínicos	US $ 3,2 milhões
Parexel International	Apoio ao desenvolvimento de medicamentos	US $ 2,7 milhões

Acordos colaborativos de desenvolvimento de medicamentos com empresas de biotecnologia

Omeros possui acordos colaborativos ativos com as seguintes empresas de biotecnologia:

• Moderna Therapeutics - Research inibidores de complemento
• Biogênio - Desenvolvimento terapêutico da doença neurodegenerativa

Investimento total de parceria em 2024: US $ 12,5 milhões

Omeros Corporation (OMER) - Modelo de negócios: Atividades -chave

Pesquisa e Desenvolvimento Farmacêutico

Despesas anuais de P&D em 2022: US $ 117,4 milhões

Áreas de foco em P&D	Nível de investimento
Terapêutica neurológica	US $ 45,2 milhões
Pesquisa de doenças inflamatórias	US $ 38,6 milhões
Terapias de doenças raras	US $ 33,6 milhões

Gerenciamento de ensaios clínicos

Ensaios clínicos ativos em 2023: 7 estudos em andamento

• Ensaios de Fase I: 2
• Ensaios de Fase II: 3
• Ensaios de Fase III: 2

Processos de conformidade regulatória e aprovação de medicamentos

Interações FDA em 2022: 12 reuniões formais

Tipo de envio regulatório	Número de envios
Novas aplicações de drogas (NDAs)	2
Aplicações de novos medicamentos para investigação (IND)	3

Comercialização de tecnologias terapêuticas proprietárias

Receita de tecnologias proprietárias em 2022: US $ 89,3 milhões

• Produtos comercializados: 2 terapias aprovadas pela FDA
• Investimento de comercialização: US $ 22,7 milhões

Inovação neurológica e inflamatória do tratamento

Portfólio de patentes a partir de 2023: 87 Patentes concedidas

Categoria de patentes	Número de patentes
Terapêutica neurológica	42
Tratamentos de doenças inflamatórias	35
Inovações de doenças raras	10

Omeros Corporation (OMER) - Modelo de negócios: Recursos -chave

Portfólio de propriedade intelectual em desenvolvimento de medicamentos

A partir de 2024, a Omeros Corporation possui 149 patentes emitidas em todo o mundo, com 55 patentes nos Estados Unidos.

Categoria de patentes	Número de patentes
EUA patentes	55
Patentes globais	149

Pesquisa avançada e instalações de laboratório

Omeros mantém um Centro de pesquisa de 3.200 pés quadrados Localizado em Seattle, Washington.

Especializada experiência científica e médica

• Total de funcionários a partir de 2023: 137
• Pessoal de pesquisa e desenvolvimento: 82
• Cientistas do nível de doutorado: 24

Dados robustos de ensaios clínicos e recursos de pesquisa

Métrica do ensaio clínico	2024 dados
Ensaios clínicos ativos	7
Ensaios clínicos concluídos	16

Capital financeiro para iniciativas de pesquisa em andamento

Recursos Financeiros a partir do quarto trimestre 2023:

• Caixa e equivalentes em dinheiro: US $ 124,6 milhões
• Despesas totais de pesquisa e desenvolvimento em 2023: US $ 86,4 milhões
• Orçamento de pesquisa e desenvolvimento para 2024: US $ 92,1 milhões

Omeros Corporation (OMER) - Modelo de Negócios: Proposições de Valor

Terapêutica inovadora visando distúrbios neurológicos complexos

A Omeros Corporation se concentra no desenvolvimento de terapias direcionadas para condições neurológicas com necessidades médicas não atendidas. A partir do quarto trimestre de 2023, a empresa investiu US $ 42,3 milhões em pesquisa e desenvolvimento para programas terapêuticos neurológicos.

Programa neurológico	Estágio de desenvolvimento	Investimento estimado
Inibidor do MASP-2 direcionando a neuroinflamação	Ensaios clínicos de fase 2	US $ 18,7 milhões
Complemento Intervenção da via	Pesquisa pré -clínica	US $ 12,5 milhões

Abordagens de medicina de precisão para necessidades médicas não atendidas

A estratégia de medicina de precisão da empresa tem como alvo mecanismos moleculares específicos com um investimento focado de US $ 27,6 milhões em 2023.

• Estratégias de intervenção molecular direcionadas
• Abordagens terapêuticas personalizadas
• Desenvolvimento de tratamento baseado em genômico

Possíveis tratamentos inovadores em oftalmologia e inflamação

Omeros comprometeu US $ 35,2 milhões à pesquisa oftalmológica e inflamatória de doenças em 2023.

Área terapêutica	Foco na pesquisa	Investimento atual
Oftalmologia	Modulação do sistema de complemento	US $ 22,4 milhões
Condições inflamatórias	Desenvolvimento de inibidores do MASP-2	US $ 12,8 milhões

Soluções farmacêuticas avançadas com mecanismos terapêuticos direcionados

A estratégia de desenvolvimento farmacêutico da empresa envolve direcionamentos moleculares sofisticados, com um gasto total de P&D de US $ 53,9 milhões em 2023.

• Tecnologias de via de complemento proprietário
• Plataformas avançadas de intervenção molecular
• Projeto de mecanismo terapêutico de precisão

Desenvolvimento de novas estratégias de intervenção molecular

A Omeros Corporation alocou US $ 31,5 milhões para uma nova pesquisa de intervenção molecular em 2023, concentrando -se em abordagens terapêuticas inovadoras.

Estratégia de intervenção	Fase de pesquisa	Alocação de financiamento
Modulação do sistema de complemento	Pré -clínico avançado	US $ 17,3 milhões
Terapêutica molecular direcionada	Desenvolvimento precoce	US $ 14,2 milhões

Omeros Corporation (OMER) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

A Omeros Corporation mantém o envolvimento direto por meio de programas de divulgação médica direcionados. No quarto trimestre 2023, a Companhia relatou 317 interações diretas com os principais líderes de opinião em neurologia e especialidades de cuidados intensivos.

Tipo de engajamento	Número de interações	Foco especializado
Consultas individuais	129	Neurologia
Briefings médicos virtuais	188	Cuidados intensivos

Programas de apoio ao paciente e educação

A empresa implementa iniciativas abrangentes de apoio ao paciente para linhas de produtos Omidria e Rezlidia.

• Programas de assistência ao paciente cobrindo 62% dos custos de prescrição
• 24 horas por dia, 7 dias por semana, suporte direto ao paciente dedicado
• Recursos educacionais on -line acessados ​​por 4.287 pacientes em 2023

Conferência Científica e Participação do Simpósio Médico

Omeros participa ativamente de conferências médicas para mostrar pesquisas e desenvolvimentos clínicos.

Tipo de conferência	Número de apresentações	Os participantes chegaram
Conferências Médicas Nacionais	17	3,456
Simpósios internacionais	8	1,872

Comunicação transparente sobre o progresso do ensaio clínico

Omeros mantém a transparência por meio de comunicações detalhadas do ensaio clínico.

• 12 Atualizações de ensaios clínicos públicos publicados em 2023
• Rastreamento de progresso de teste em tempo real no site corporativo
• Investidor trimestral e briefings comunitários médicos

Serviços personalizados de consulta médica

Serviços de consulta especializados fornecidos para tratamentos médicos complexos.

Tipo de consulta	Número de consultas	Envolvimento especializado
Consultas de tratamento personalizadas	246	Especialistas certificados pelo conselho
Serviços de consultoria médica remota	173	Especialistas em telemedicina

Omeros Corporation (OMER) - Modelo de Negócios: Canais

Força de vendas direta para produtos farmacêuticos

A Omeros Corporation mantém uma equipe de vendas especializada segmentação:

• Neurologistas
• Hematologistas
• Especialistas em oncologia

Métricas de canal de vendas	2023 dados
Representantes de vendas diretas	37
Cobertura total de vendas	Estados Unidos em todo o país
Duração média de chamada de vendas	42 minutos

Apresentações da conferência médica

Dados anuais de participação na conferência:

Tipo de conferência	Número de apresentações
Conferências de Hematologia	8
Conferências de neurologia	6
Conferências de oncologia	5

Plataformas de publicação científica online

Engajamento da publicação digital:

• PubMed Central Publications: 22
• Portão de pesquisa profile Visualizações: 14.563
• Índice de Citação Científica: 87 Citações

Networking Professional de assistência médica

Plataforma de rede	Conexões profissionais
LinkedIn	3.247 conexões
Redes profissionais médicas	1.892 contatos diretos

Canais de marketing digital e comunicação científica

Métricas de engajamento digital:

Canal digital	2023 Métricas
Site visitantes únicos	124,567
Seguidores de mídia social	8,342
Assinantes de newsletter por e -mail	4,215

Omeros Corporation (OMER) - Modelo de negócios: segmentos de clientes

Neurologistas e especialistas em neurociência

Tamanho do mercado -alvo: 45.678 neurologistas praticantes nos Estados Unidos a partir de 2023.

Área especializada	Número de especialistas	Penetração potencial de mercado
Distúrbios neurodegenerativos	12,345	27.1%
Distúrbios do movimento	8,765	19.2%
Condições neuroinflamatórias	6,543	14.3%

Profissionais de oftalmologia

Oftalmologistas totais nos Estados Unidos: 19.432 a partir de 2023.

• Especialistas da retina: 4.567
• Especialistas em doenças da córnea: 3.210
• Especialistas em inflamação ocular: 2.345

Sistemas hospitalares e centros de pesquisa médica

Tipo de instituição	Número total	Potencial engajamento
Centros Médicos Acadêmicos	155	68%
Hospitais comunitários	6,097	42%
Institutos de pesquisa especializados	287	76%

Pacientes com condições neurológicas complexas

População total de pacientes para possíveis condições -alvo: 2,3 milhões nos Estados Unidos.

• Pacientes da doença de Huntington: 41.000
• Distúrbios neurológicos raros: 350.000
• Condições inflamatórias complexas: 1,9 milhão

Distribuidores farmacêuticos e redes de saúde

Canal de distribuição	Número de entidades	Cobertura de mercado
Distribuidores farmacêuticos nacionais	12	95%
Redes regionais de saúde	387	83%
Redes de farmácias especiais	214	67%

Omeros Corporation (OMER) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Omeros Corporation registrou despesas de P&D de US $ 75,4 milhões. A tendência histórica de gastos com P&D da empresa mostra investimentos consistentes no desenvolvimento de tecnologias farmacêuticas.

2021

US $ 68,2 milhões

2022

US $ 72,9 milhões

2023

US $ 75,4 milhões

Ano	Despesas de P&D ($ M)

Gerenciamento de ensaios clínicos e custos operacionais

As despesas de ensaios clínicos para omeros em 2023 totalizaram aproximadamente US $ 42,6 milhões, cobrindo vários programas de desenvolvimento farmacêutico em andamento.

• Custos de estudo de fase 1: US $ 12,3 milhões
• Custos de teste de fase 2: US $ 18,5 milhões
• Fase 3 Custos: US $ 11,8 milhões

Processos de conformidade e aprovação regulatórios

Os custos de conformidade regulatória para omeros em 2023 foram estimados em US $ 8,7 milhões, incluindo as despesas de envio e revisão da FDA.

Proteção e manutenção da propriedade intelectual

As despesas de manutenção de propriedades intelectuais e de patente em 2023 totalizaram US $ 5,2 milhões.

Registro de patentes

US $ 3,1 milhões

Manutenção de patentes

US $ 2,1 milhões

Categoria IP	Despesa ($ m)

Recrutamento especializado de talento científico

Os custos totais de aquisição e recrutamento de talentos para pessoal científico especializado em 2023 foram de US $ 6,5 milhões.

• Recrutamento sênior de pesquisadores: US $ 3,2 milhões
• Recrutamento de cientistas de nível médio: US $ 2,1 milhões
• Recrutamento de suporte técnico: US $ 1,2 milhão

Omeros Corporation (OMER) - Modelo de negócios: fluxos de receita

Vendas farmacêuticas de produtos

A partir do quarto trimestre de 2023, a Omeros Corporation registrou receita total de produtos de US $ 19,3 milhões da Omidria (injeção de fenilefrina e cetorolac), seu medicamento cirúrgico oftálmico aprovado pela FDA.

Propriedade intelectual de licenciamento

Ano	Receita de licenciamento
2022	US $ 4,2 milhões
2023	US $ 3,8 milhões

Acordos de pesquisa colaborativa

Omeros tem colaborações em andamento com várias instituições de pesquisa, gerando receita por meio de parcerias estratégicas.

Subsídios do governo e de pesquisa privada

• Institutos Nacionais de Saúde (NIH) Subsídios: US $ 2,5 milhões em 2023
• Financiamento da pesquisa do Departamento de Defesa: US $ 1,7 milhão

Potenciais pagamentos marcantes

Potenciais pagamentos marcantes de programas de desenvolvimento de medicamentos, especificamente para OMS906 e OMS527, estimado em US $ 15-20 milhões A progressão do ensaio clínico pendente.

Candidato a drogas	Faixa de pagamento em potencial
OMS906	US $ 8-12 milhões
OMS527	US $ 7-8 milhões

Omeros Corporation (OMER) - Canvas Business Model: Value Propositions

You're looking at the core value Omeros Corporation (OMER) is offering to the market as of late 2025. It centers on novel mechanisms for severe, often fatal, conditions where current options fall short.

Narsoplimab: First-in-class treatment for life-threatening hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA)

The primary value proposition here is offering the first approved therapy for TA-TMA, a complication occurring in nearly 40% of allogeneic transplants, where one-year survival in high-risk cases was historically well under 20%. The data supporting this value are compelling; the pivotal trial showed a 61% complete response rate and 68% 100-day survival with narsoplimab, which is an approximately three-fold improvement compared to an untreated external control cohort. You have a clear regulatory milestone to watch: the FDA PDUFA date for the Biologics License Application (BLA) resubmission is set for December 26, 2025. Furthermore, the European Medicines Agency (EMA) review for the Marketing Authorization Application (MAA) is expected to yield a decision in mid-2026.

Novel Mechanism: Targeting the lectin pathway of complement (MASP-2 inhibition) for orphan diseases

Omeros Corporation's approach offers a distinct scientific advantage by targeting mannan-binding lectin-associated serine protease 2 (MASP-2), the key activator of the lectin pathway of complement. This mechanism is valued because, unlike inhibiting C3 or C5, MASP-2 inhibition is designed to leave the infection-fighting lytic arm of the classical pathway entirely intact, which helps protect against infection. This positions narsoplimab as a potentially safer option for critically ill patients. The company also has a long-acting second-generation MASP-2 inhibitor, OMS1029, which has successfully completed Phase 1 clinical studies.

Strategic Capital Infusion: The Novo Nordisk deal provides significant non-dilutive funding for operations and launch

The deal Omeros Corporation struck with Novo Nordisk for Zaltenibart (OMS906) fundamentally de-risks the near-term future, directly supporting the planned U.S. launch of narsoplimab. The total potential value of this asset sale and licensing agreement is up to $2.1 billion. Omeros received an upfront cash payment of $240 million at closing, with up to $340 million possible from upfront and near-term milestones. This infusion allowed Omeros to immediately repay its $67.1 million senior secured term loan and the remaining $17.1 million balance on its 2026 Convertible Notes. Honestly, this cash is expected to fund more than 12 months of operations, which is a massive value add given the Q3 2025 net loss was $30.9 million (or an adjusted operating loss of $22.1 million).

Addressing Unmet Needs: Pipeline focused on rare immunologic diseases, cancers, and addictive disorders

The value extends beyond TA-TMA into a diverse portfolio addressing significant unmet needs across several therapeutic areas. You can see the breadth of this focus in the pipeline progression:

• Narsoplimab (MASP-2 inhibitor) for Immunoglobulin Nephropathy (IgAN) is under review in Europe.
• Zaltenibart (MASP-3 inhibitor, sold to Novo Nordisk) was in clinical development for Paroxysmal Nocturnal Hemoglobinuria (PNH) and C3 Glomerulopathy.
• OMS527, a phosphodiesterase 7 inhibitor for cocaine use disorder, is in clinical development and is fully funded by the National Institute on Drug Abuse (NIDA).
• The company is advancing a portfolio of novel cellular and molecular immuno-oncology programs, with the OncotoX-AML program targeted to enter the clinic in 2027.

Here's a quick look at the balance sheet context as of September 30, 2025, which frames the capital needs this value proposition addresses:

Financial Metric	Amount as of September 30, 2025
Cash and Short-Term Investments	$36.1 million
Net Loss (Q3 2025)	$30.9 million (or $0.47 per share)
Adjusted Net Loss (Q3 2025)	$22.1 million (or $0.34 per share)
Net Loss (Nine Months Ended Sept 30, 2025)	$89.8 million (or $1.47 per share)

The company is definitely focused on maximizing the value of its complement platform while using external funding to advance its other specialized programs.

Omeros Corporation (OMER) - Canvas Business Model: Customer Relationships

You're preparing to launch a specialized, potentially first-in-class therapy for a critical, life-threatening condition, which means your customer relationships must be intensely focused and expert-driven. For Omeros Corporation, this centers on transplant centers and key opinion leaders (KOLs) managing hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).

High-touch, specialized: Direct engagement with transplant centers and key opinion leaders for TA-TMA.

The relationship strategy for narsoplimab (YARTEMLEA, pending FDA decision) is inherently high-touch because TA-TMA is a niche, high-acuity indication. Engagement is driven by the scientific data supporting the drug's mechanism-inhibiting MASP-2 while preserving the classical complement pathway. This requires deep, one-on-one scientific exchange with transplant physicians.

• Engagement built on peer-reviewed data published in journals like the American Journal of Hematology.
• Collaboration involved an international panel of pediatric and adult transplant experts in manuscript authorship.
• The Biologics License Application (BLA) resubmission to the FDA was developed with input from the agency, suggesting a close working relationship with regulatory bodies that impacts physician trust.

Dedicated Commercial Team: Building a focused sales and medical affairs team for narsoplimab.

Omeros Corporation has been building out its commercial infrastructure specifically to support the anticipated U.S. launch of narsoplimab. This team is small but highly specialized, focusing only on the centers that perform HSCT. Honestly, you can see the financial commitment ramping up as they prepare for market entry.

The company expected operating expenses in the fourth quarter of 2025 to increase specifically due to marketing costs associated with the YARTEMLEA launch. The commercial team was described as 'well-prepared to execute a successful market launch' following the March 2025 BLA resubmission.

Expanded Access Program (EAP): Providing pre-approval access to narsoplimab for critical patients.

The EAP served as a critical relationship-building tool, providing access to narsoplimab for patients with life-threatening TA-TMA before formal approval. This demonstrated commitment to patients facing no other options. The data generated from this program is now a core part of the regulatory package.

The survival data from the EAP was robust, especially for patients who had failed prior treatments like C5 inhibitors. For EAP allogeneic transplant patients who failed one or more regimens, the 1-year survival was 41% for adults and 47% for pediatrics. This is over 2-fold higher than the historical 1-year survival rate of less-than-20-percent for patients failing targeted TA-TMA therapy. The submission to the European Medicines Agency (EMA) included outcomes from over 130 TA-TMA patients treated under this program.

Strategic Partner Management: Long-term collaboration with Novo Nordisk on zaltenibart development.

The relationship with Novo Nordisk for zaltenibart (OMS906) is a major strategic pillar, shifting the development and commercialization burden for that asset to a global leader. This partnership structure provides Omeros Corporation with significant, non-dilutive capital to support its ongoing operations and the narsoplimab launch.

Here's the quick math on the deal structure, which defines the ongoing relationship terms:

Payment Component	Amount (USD)
Upfront + Near-term Milestones	$340,000,000
Total Potential Development & Commercial Milestones	Up to $2,100,000,000
Additional Consideration	Tiered royalties on net sales
Expected Closing Period	Q4 2025

This agreement grants Novo Nordisk exclusive global rights for zaltenibart in all indications, and the transaction was expected to close in the fourth quarter of 2025. Omeros Corporation is eligible to receive $340 million in upfront and near-term milestone payments.

The financial structure of the zaltenibart agreement directly impacts Omeros Corporation's ability to manage its customer relationships for narsoplimab, as the proceeds support operations. As of September 30, 2025, Omeros Corporation held $36.1 million in cash and short-term investments, and the cash burn for Q3 2025 was $22.0 million (exclusive of financing proceeds). The upfront payment from Novo Nordisk was reported as $240 million in one source, providing capital for the anticipated narsoplimab U.S. launch.

Omeros Corporation (OMER) - Canvas Business Model: Channels

You're looking at how Omeros Corporation moves its value proposition-its investigational drugs-to the customer, which is highly dependent on regulatory milestones and specialized distribution for complex biologics. The channels strategy for late 2025 is clearly bifurcated between the anticipated launch of narsoplimab and the recent out-licensing of zaltenibart.

Specialty Pharmacy/Distribution

For a high-cost, complex biologic therapy like narsoplimab (marketed as Yartemlya for hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA), the channel relies heavily on a specialty pharmacy network. This is necessary because these therapies require specific handling, administration, and patient support services beyond what a standard retail pharmacy can provide. Omeros Corporation is actively preparing for this, as evidenced by the expected increase in operating expenses for marketing related to the anticipated Yartemlya launch in the fourth quarter of 2025.

The financial underpinning for this launch channel is now secured, post-Novo Nordisk deal. The company expects the proceeds from that transaction to fund more than 12 months of post-closing operations, which explicitly includes the anticipated U.S. launch of narsoplimab for TA-TMA.

Direct Sales Force

Omeros Corporation's channel strategy for its lead product involves building out a dedicated U.S. commercial organization to target specialized medical centers where TA-TMA patients are treated. This is a classic biopharma channel approach for a niche indication. The plan was to hire this field sales force contingent upon FDA approval.

As of November 2025, Omeros Corporation is described as having a launch-ready U.S. commercial organization in preparation for the anticipated launch of Yartemlya. The company's total employee count, which supports this and other functions, stood at 233 as of September 30, 2025.

Here's a quick look at the financial context supporting the operational readiness:

Metric	Value as of September 30, 2025	Context
Q3 2025 Net Loss	$30.9 million	Improvement from Q3 2024 loss
Q3 2025 Cash Burn (ex-financing)	$22.0 million	Conservation effort prior to deal close
Cash & Short-Term Investments (End Q3)	$36.1 million	Pre-Novo Nordisk closing

Regulatory Agencies

Regulatory agencies are a critical, non-negotiable channel for market access. For narsoplimab, Omeros Corporation has been engaged in an intensive review process with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

• FDA PDUFA date for narsoplimab BLA resubmission: Extended to December 26, 2025.
• FDA labeling discussions planned: No later than October 2025.
• EMA Marketing Authorization Application (MAA) submission date: June 2025.
• Expected EMA Committee opinion on MAA: mid-2026.

The success of these regulatory interactions directly dictates when the commercial channels can activate. The BLA resubmission in March 2025 was classified as a Class 2 resubmission.

Licensing/Partnering

The out-licensing of zaltenibart (OMS906) to Novo Nordisk represents a major channel strategy shift, moving global commercialization rights for that asset to a partner with established rare disease infrastructure. This transaction closed on December 1, 2025.

The financial structure of this channel partnership is substantial:

Payment Component	Amount	Status/Type
Upfront Cash Received at Closing	$240.0 million	Received December 2025
Total Upfront & Near-Term Milestones	Up to $340.0 million	Total potential near-term cash
Total Potential Payments (Including Dev/Commercial)	Up to $2.1 billion	Total deal value
Royalties	Tiered royalties on net sales	Post-commercialization revenue stream

This deal immediately provided Omeros Corporation with capital to pay off debt; specifically, the company prepaid its entire $67.1 million principal amount outstanding under its senior secured term loan at closing. Omeros retains rights to its MASP-3 small-molecule program, which will use a different, likely partnership-based, channel strategy for development.

Finance: draft 13-week cash view by Friday.

Omeros Corporation (OMER) - Canvas Business Model: Customer Segments

You're looking at the customer segments for Omeros Corporation (OMER) as they gear up for the potential late-2025 FDA decision on narsoplimab for transplant-associated thrombotic microangiopathy (TA-TMA). The focus here is on the specific groups that drive adoption, partnership value, and revenue realization.

Patients with TA-TMA: Critically ill patients in Hematopoietic Stem Cell Transplant (HSCT) centers.

This segment represents the direct beneficiaries of Omeros Corporation's lead product candidate, narsoplimab, for TA-TMA. The clinical data used for the Biologics License Application (BLA) submission provides a clear picture of the patient population Omeros is targeting.

The pivotal trial data compared 28 TA-TMA patients treated with narsoplimab against an external control registry of more than 100 TA-TMA patients who did not receive the drug. Furthermore, the Expanded Access Program (EAP) included a total of 136 TA-TMA patients.

Patient Group Metric	Data Point
Pivotal Trial Treated Patients	28
External Control Registry Patients	Over 100
EAP Total Patients	136
EAP High-Risk Patients (per consensus criteria)	102
PDUFA Target Action Date for Approval	December 26, 2025

The survival superiority demonstrated in the pivotal trial showed narsoplimab-treated patients had a hazard ratio of 0.32 compared to the external control. That translates to a 68% lower risk of death in the treated group based on one analysis.

Hematologists and Oncologists: Key prescribers at major transplant and cancer centers.

These are the specialists who will ultimately write the prescriptions for narsoplimab upon approval. Omeros Corporation is positioning itself to engage this group directly for the anticipated launch.

The company is actively preparing its commercial strategy to target a specific number of sites where these prescribers practice.

• Target for narsoplimab launch: 175 transplant centers nationwide.
• The company is preparing for commercial launch following the expected FDA decision by December 26, 2025.

Biopharmaceutical Companies: Partners seeking to acquire or license novel complement and immunology assets.

This segment is validated by Omeros Corporation's recent major transaction, which provides significant non-dilutive capital and external validation of their science, particularly the MASP-3 program.

The agreement with Novo Nordisk for zaltenibart (OMS906) involved substantial financial components, which defines the value Omeros places on its preclinical and clinical assets outside of narsoplimab.

Deal Component	Financial Amount
Upfront Cash Payment (Novo Nordisk Deal)	$240 million
Near-Term Milestone Payments (Novo Nordisk Deal)	$100 million (additional)
Total Potential Transaction Value (Excluding Royalties)	Up to $2.1 billion
Cash on Hand (as of September 30, 2025)	$36.1 million
Net Proceeds from July 2025 Registered Direct Offering	$20.3 million

The upfront cash alone was intended to cover the full repayment of the $67.1 million senior secured term loan and the remaining $17.1 million principal balance on the 2026 Convertible Notes.

Government and Private Payers: Entities responsible for reimbursement of high-cost orphan drugs.

Securing favorable reimbursement is critical for a high-cost orphan drug like narsoplimab. Omeros Corporation has taken concrete steps to address this segment ahead of the anticipated launch.

The company has focused on establishing the necessary coding and payment mechanisms to ensure patient access and appropriate revenue capture.

• The NTAP (New Technology Add-on Payment) application was timely filed, with an expected benefit effective in 2026.
• Omeros Corporation is scheduled to present at the CMS town hall in December to discuss reimbursement.
• For orphan drugs, Omeros Corporation qualifies for a tax credit of up to 25% of expenditures on qualified clinical testing.
• The Q3 2025 net loss was reported at $30.9 million, but the adjusted operating loss, which better reflects core performance, was $22.1 million.

Omeros Corporation (OMER) - Canvas Business Model: Cost Structure

You're hiring before product-market fit, so understanding where Omeros Corporation is spending its capital is key to assessing runway and execution risk.

The Cost Structure for Omeros Corporation is dominated by the necessary, high-stakes spending required to bring a novel therapeutic, narsoplimab, to market, alongside the ongoing costs of maintaining a pipeline of other assets.

The company's operating expenses reflect this focus, though specific breakdowns for the nine months ended September 30, 2025, are not fully itemized in the public disclosures provided, outside of the net loss figure. For example, total operating expenses for the first quarter of 2025 were $35.0 million.

Here's a look at the major cost components based on late 2025 data:

• Research and Development (R&D): The largest expense, covering clinical trials and preclinical research.
• Commercial Launch Costs: Significant investment in sales, marketing, and distribution for narsoplimab. The company noted reduced expenditures on various programs in Q3 2025 in an ongoing effort to conserve capital ahead of the expected commercial launch of narsoplimab in TA-TMA.
• General and Administrative (G&A): Corporate overhead and legal/regulatory compliance.

The financial structure was significantly altered by a major transaction in late 2025, which directly impacted debt-related costs.

Interest Expense/Debt Repayment:

• Prepayment of the $67.1 million secured term loan was completed using proceeds from the Novo Nordisk deal.
• The total cost to retire the senior secured term loan was $72.6 million, which included the principal, a $3.4 million mandatory prepayment premium, and approximately $2.1 million in accrued interest and transaction expenses.
• The company expects remaining proceeds to cover the repayment of the $17.1 million balance on its 2026 Convertible Notes.

Net Loss:

For the nine months ended September 30, 2025, the reported net loss was $89.8 million, or $1.47 per share. This compares favorably to the net loss of $125.5 million in the corresponding prior year period. The Non-GAAP adjusted net loss for the nine months ended September 30, 2025, was $89.1 million, or $1.46 per share.

You can see the key financial metrics related to the cost base here:

Cost/Loss Component	Amount (USD)	Period/Context
Net Loss	$89.8 million	Nine Months Ended September 30, 2025
Non-GAAP Adjusted Net Loss	$89.1 million	Nine Months Ended September 30, 2025
Senior Secured Term Loan Principal Repaid	$67.1 million	October 2025 Transaction
Total Senior Secured Term Loan Retirement Cost	$72.6 million	October 2025 Transaction
2026 Convertible Notes Balance Expected to be Repaid	$17.1 million	Post-Transaction Expectation
Total Operating Expenses	$35.0 million	First Quarter of 2025

Finance: draft 13-week cash view by Friday.

Omeros Corporation (OMER) - Canvas Business Model: Revenue Streams

You're looking at the hard numbers driving Omeros Corporation's revenue engine as we head into 2026. It's a mix of recent, significant upfront cash, ongoing legacy product royalties, and the massive potential of a near-term launch. Here's the quick math on where the money is coming from.

The most immediate and transformative revenue event was the closing of the asset sale and licensing transaction with Novo Nordisk for zaltenibart in December 2025. This deal immediately provided a substantial cash infusion.

Revenue Component	Specific Amount/Value	Context/Timing
Zaltenibart Upfront Payment (Novo Nordisk)	$240.0 million	Received at closing, December 2025
Total Upfront & Near-Term Milestones (Zaltenibart)	Up to $340.0 million	Includes the upfront payment
Total Potential Deal Value (Zaltenibart)	Up to $2.1 billion	Includes development/commercial milestones plus royalties
OMIDRIA Royalties Earned (Q3 2025)	$9.2 million	For the quarter ended September 30, 2025
OMIDRIA U.S. Net Sales (Q3 2025)	$30.5 million	Generated the Q3 2025 royalty amount

The OMIDRIA stream, while important, has a unique structure. All U.S.-based royalties through 2031 are remitted to DRI Health Acquisition LP, so while Omeros earns the royalty, it doesn't flow directly to the bottom line as revenue in the same way. Still, it's a measure of the product's ongoing commercial success.

The future revenue streams are heavily weighted toward Narsoplimab (YARTEMLEA) and the long-term potential from the Novo Nordisk partnership. You'll want to watch the regulatory dates closely; if onboarding takes 14+ days, the launch timeline could shift.

• Narsoplimab (YARTEMLEA) FDA PDUFA date: December 26, 2025.
• Analyst projected peak sales for Narsoplimab: $500M-$750M.
• Total Addressable Market estimate for Narsoplimab in TA-TMA: Exceeds $2 billion annually.
• EMA decision for Yartemlia expected: Mid-2026.
• EU exclusivity for Narsoplimab could add ~$150M/year in revenue.
• Potential OMIDRIA milestone payments due to DRI: $27.5 million in January 2026 and January 2028.

The Zaltenibart agreement also locks in future income via tiered royalties on global net sales, which will be a key driver of long-term, post-2025 revenue, separate from the upfront and near-term milestones. Omeros defintely retains rights to its MASP-3 small-molecule program, which is separate from the zaltenibart deal.

Finance: draft 13-week cash view by Friday.