Omeros Corporation (OMER): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la biotecnología, Omeros Corporation (OMER) surge como una fuerza pionera, revolucionando la innovación farmacéutica a través de su modelo de negocio meticulosamente elaborado. Al navegar estratégicamente por los tratamientos complejos de enfermedades neurológicas e inflamatorias, la empresa aprovecha la investigación de vanguardia, las asociaciones estratégicas y las tecnologías terapéuticas innovadoras para abordar las necesidades médicas no satisfechas. Su lienzo de modelo de negocio integral revela un enfoque sofisticado que transforma la experiencia científica en posibles soluciones médicas que cambian la vida, posicionan a Omeros a la vanguardia de la medicina de precisión y las estrategias de intervención molecular.

Omeros Corporation (OMER) - Modelo de negocios: asociaciones clave

Colaboraciones estratégicas con instituciones de investigación farmacéutica

A partir de 2024, Omeros Corporation ha establecido asociaciones estratégicas con las siguientes instituciones de investigación:

Institución	Enfoque de colaboración	Año establecido
Universidad de Washington	Investigación de NarsoPlimab	2018
Salud de Oregon & Universidad de ciencias	Terapéutica del sistema de complemento	2019

Acuerdos de licencia con centros médicos académicos

Omeros ha asegurado los siguientes acuerdos de licencia:

• Mayo Clinic - Licencias exclusivas para tecnologías terapéuticas relacionadas con el complemento
• Centro médico de la Universidad de Stanford - Colaboración de investigación no exclusiva para tratamientos de enfermedades raras

Asociación con organizaciones de investigación por contrato (CRO)

Nombre de Cro	Tipo de contrato	Valor anual del contrato
IQVIA	Gestión de ensayos clínicos	$ 3.2 millones
Parexel International	Apoyo para el desarrollo de drogas	$ 2.7 millones

Acuerdos de desarrollo de fármacos colaborativos con empresas de biotecnología

Omeros tiene acuerdos de colaboración activos con las siguientes empresas de biotecnología:

• Terapéutica Moderna - Investigación del inhibidor del complemento
• Biogen - Desarrollo terapéutico de la enfermedad neurodegenerativa

Inversión total de asociación en 2024: $ 12.5 millones

Omeros Corporation (OMER) - Modelo de negocio: actividades clave

Investigación y desarrollo farmacéutico

Gastos anuales de I + D en 2022: $ 117.4 millones

Áreas de enfoque de I + D	Nivel de inversión
Terapéutica neurológica	$ 45.2 millones
Investigación de enfermedades inflamatorias	$ 38.6 millones
Terapias de enfermedades raras	$ 33.6 millones

Gestión de ensayos clínicos

Ensayos clínicos activos en 2023: 7 estudios en curso

• Pruebas de fase I: 2
• Pruebas de fase II: 3
• Pruebas de fase III: 2

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Interacciones de la FDA en 2022: 12 reuniones formales

Tipo de presentación regulatoria	Número de presentaciones
Nuevas aplicaciones de drogas (NDA)	2
Aplicaciones de nueva droga de investigación (IND)	3

Comercialización de tecnologías terapéuticas patentadas

Ingresos de tecnologías propietarias en 2022: $ 89.3 millones

• Productos comercializados: 2 terapias aprobadas por la FDA
• Inversión de comercialización: $ 22.7 millones

Innovación del tratamiento de enfermedades neurológicas e inflamatorias

Portafolio de patentes a partir de 2023: 87 patentes otorgadas

Categoría de patente	Número de patentes
Terapéutica neurológica	42
Tratamientos de enfermedades inflamatorias	35
Innovaciones de enfermedades raras	10

Omeros Corporation (OMER) - Modelo de negocio: recursos clave

Cartera de propiedades intelectuales en desarrollo de medicamentos

A partir de 2024, Omeros Corporation posee 149 patentes emitidas en todo el mundo, con 55 patentes en los Estados Unidos.

Categoría de patente	Número de patentes
Patentes estadounidenses	55
Patentes globales	149

Investigación avanzada e instalaciones de laboratorio

Omeros mantiene un Instalación de investigación de 3.200 pies cuadrados Ubicado en Seattle, Washington.

Experiencia médica y científica especializada

• Total de empleados a partir de 2023: 137
• Personal de investigación y desarrollo: 82
• Científicos a nivel de doctorado: 24

Datos de ensayos clínicos robustos y capacidades de investigación

Métrico de ensayo clínico	2024 datos
Ensayos clínicos activos	7
Ensayos clínicos completados	16

Capital financiero para iniciativas de investigación en curso

Recursos financieros a partir del cuarto trimestre 2023:

• Efectivo y equivalentes en efectivo: $ 124.6 millones
• Gastos totales de investigación y desarrollo en 2023: $ 86.4 millones
• Presupuesto de investigación y desarrollo para 2024: $ 92.1 millones

Omeros Corporation (OMER) - Modelo de negocio: propuestas de valor

Terapéutica innovadora dirigida a trastornos neurológicos complejos

Omeros Corporation se centra en desarrollar terapias dirigidas para afecciones neurológicas con necesidades médicas no satisfechas. A partir del cuarto trimestre de 2023, la compañía ha invertido $ 42.3 millones en investigación y desarrollo para programas terapéuticos neurológicos.

Programa neurológico	Etapa de desarrollo	Inversión estimada
Inhibidor de MASP-2 dirigido a la neuroinflamación	Ensayos clínicos de fase 2	$ 18.7 millones
Intervención de la vía del complemento	Investigación preclínica	$ 12.5 millones

Enfoques de medicina de precisión para las necesidades médicas no satisfechas

La estrategia de medicina de precisión de la compañía se dirige a mecanismos moleculares específicos con una inversión enfocada de $ 27.6 millones en 2023.

• Estrategias de intervención molecular dirigidas
• Enfoques terapéuticos personalizados
• Desarrollo de tratamiento basado en genómico

Posibles tratamientos innovadores en oftalmología e inflamación

Omeros ha cometido $ 35.2 millones a la investigación oftalmológica e inflamatoria de la enfermedad en 2023.

Área terapéutica	Enfoque de investigación	Inversión actual
Oftalmología	Modulación del sistema de complemento	$ 22.4 millones
Condiciones inflamatorias	Desarrollo de inhibidores de MASP-2	$ 12.8 millones

Soluciones farmacéuticas avanzadas con mecanismos terapéuticos específicos

La estrategia de desarrollo farmacéutico de la compañía implica una orientación molecular sofisticada, con un gasto total de I + D de $ 53.9 millones en 2023.

• Tecnologías de vía de complemento patentado
• Plataformas avanzadas de intervención molecular
• Diseño de mecanismo terapéutico de precisión

Desarrollo de nuevas estrategias de intervención molecular

Omeros Corporation ha asignado $ 31.5 millones a una nueva investigación de intervención molecular en 2023, centrándose en enfoques terapéuticos innovadores.

Estrategia de intervención	Fase de investigación	Asignación de financiación
Modulación del sistema de complemento	Avanzado preclínico	$ 17.3 millones
Terapéutica molecular dirigida	Desarrollo temprano	$ 14.2 millones

Omeros Corporation (OMER) - Modelo de negocio: relaciones con los clientes

Compromiso directo con profesionales médicos

Omeros Corporation mantiene la participación directa a través de programas de divulgación médica específicas. A partir del cuarto trimestre de 2023, la compañía reportó 317 interacciones directas con líderes de opinión clave en neurología y especialidades de cuidados críticos.

Tipo de compromiso	Número de interacciones	Enfoque especializado
Consultas individuales	129	Neurología
Informes médicos virtuales	188	Cuidados críticos

Programas de apoyo y educación del paciente

La compañía implementa iniciativas integrales de apoyo al paciente para las líneas de productos Omidria y Rezlidia.

• Programas de asistencia al paciente que cubren el 62% de los costos de receta
• Línea directa de soporte de pacientes dedicados 24/7
• Recursos educativos en línea accedidos por 4.287 pacientes en 2023

Conferencia científica y participación del simposio médico

Omeros participa activamente en conferencias médicas para mostrar la investigación y los desarrollos clínicos.

Tipo de conferencia	Número de presentaciones	Los asistentes llegaron
Conferencias médicas nacionales	17	3,456
Simposios internacionales	8	1,872

Comunicación transparente sobre el progreso del ensayo clínico

Omeros mantiene la transparencia a través de comunicaciones detalladas de ensayos clínicos.

• 12 actualizaciones de ensayos clínicos públicos publicados en 2023
• Seguimiento de progreso de prueba en tiempo real en el sitio web corporativo
• Inversores trimestrales y sesiones informativas de la comunidad médica

Servicios de consulta médica personalizada

Servicios de consulta especializados proporcionados para tratamientos médicos complejos.

Tipo de consulta	Número de consultas	Participación especializada
Consultas de tratamiento personalizadas	246	Especialistas certificados por la junta
Servicios de asesoramiento médico remoto	173	Expertos de telemedicina

Omeros Corporation (OMER) - Modelo de negocio: canales

Fuerza de ventas directa para productos farmacéuticos

Omeros Corporation mantiene un equipo de ventas especializado dirigido:

• Neurólogos
• Hematólogos
• Especialistas en oncología

Métricas de canales de ventas	2023 datos
Representantes de ventas directas	37
Cobertura total de ventas	Estados Unidos en todo el país
Duración promedio de llamadas de ventas	42 minutos

Presentaciones de conferencia médica

Datos anuales de participación de la conferencia:

Tipo de conferencia	Número de presentaciones
Conferencias de hematología	8
Conferencias de neurología	6
Conferencias oncológicas	5

Plataformas de publicación científica en línea

Compromiso de publicación digital:

• Publicaciones centrales de PubMed: 22
• Puerta de investigación profile Vistas: 14,563
• Índice de citas científicas: 87 citas

Redes profesionales de atención médica

Plataforma de redes	Conexiones profesionales
LinkedIn	3.247 conexiones
Redes médicas profesionales	1.892 contactos directos

Marketing digital y canales de comunicación científica

Métricas de compromiso digital:

Canal digital	2023 métricas
Sitio web Visitantes únicos	124,567
Seguidores de redes sociales	8,342
Suscriptores de boletín de correo electrónico	4,215

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

Neurólogos y especialistas en neurociencia

Tamaño del mercado objetivo: 45,678 neurólogos en ejercicio en los Estados Unidos a partir de 2023.

Área especializada	Número de especialistas	Penetración potencial del mercado
Trastornos neurodegenerativos	12,345	27.1%
Trastornos del movimiento	8,765	19.2%
Condiciones neuroinflamatorias	6,543	14.3%

Profesionales de oftalmología

Oftalmólogos totales en los Estados Unidos: 19,432 a partir de 2023.

• Especialistas de la retina: 4,567
• Expertos en enfermedades corneales: 3.210
• Especialistas en inflamación ocular: 2,345

Sistemas hospitalarios y centros de investigación médica

Tipo de institución	Número total	Compromiso potencial
Centros médicos académicos	155	68%
Hospitales comunitarios	6,097	42%
Institutos de investigación especializados	287	76%

Pacientes con afecciones neurológicas complejas

Población total de pacientes para posibles condiciones objetivo: 2.3 millones en los Estados Unidos.

• Pacientes de la enfermedad de Huntington: 41,000
• Trastornos neurológicos raros: 350,000
• Condiciones inflamatorias complejas: 1.9 millones

Distribuidores farmacéuticos y redes de salud

Canal de distribución	Número de entidades	Cobertura del mercado
Distribuidores farmacéuticos nacionales	12	95%
Redes de salud regionales	387	83%
Redes de farmacia especializada	214	67%

Omeros Corporation (OMER) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, Omeros Corporation reportó gastos de I + D de $ 75.4 millones. La tendencia histórica de gastos de I + D de la compañía muestra una inversión constante en el desarrollo de tecnologías farmacéuticas.

2021

$ 68.2 millones

2022

$ 72.9 millones

2023

$ 75.4 millones

Año	Gastos de I + D ($ M)

Gestión de ensayos clínicos y costos operativos

Los gastos de ensayo clínico para Omeros en 2023 totalizaron aproximadamente $ 42.6 millones, cubriendo múltiples programas de desarrollo farmacéutico en curso.

• Costos de prueba de fase 1: $ 12.3 millones
• Costos de prueba de fase 2: $ 18.5 millones
• Costos de prueba de fase 3: $ 11.8 millones

Procesos de cumplimiento y aprobación regulatoria

Los costos de cumplimiento regulatorio para Omeros en 2023 se estimaron en $ 8.7 millones, incluidos los gastos de presentación y revisión de la FDA.

Protección y mantenimiento de la propiedad intelectual

Los gastos de mantenimiento de la propiedad y la propiedad intelectual para 2023 ascendieron a $ 5.2 millones.

Presentación de patentes

$ 3.1 millones

Mantenimiento de patentes

$ 2.1 millones

Categoría de IP	Gasto ($ M)

Reclutamiento de talento científico especializado

Los costos totales de adquisición y reclutamiento de talento para personal científico especializado en 2023 fueron de $ 6.5 millones.

• Reclutamiento de investigadores senior: $ 3.2 millones
• Reclutamiento de científicos de nivel medio: $ 2.1 millones
• Reclutamiento de soporte técnico: $ 1.2 millones

Omeros Corporation (OMER) - Modelo de negocios: flujos de ingresos

Venta de productos farmacéuticos

A partir del cuarto trimestre de 2023, Omeros Corporation reportó ingresos totales del producto de $ 19.3 millones de Omidria (inyección de fenilefrina y ketorolac), su fármaco quirúrgico oftálmico aprobado por la FDA.

Licencia de propiedad intelectual

Año	Ingresos por licencias
2022	$ 4.2 millones
2023	$ 3.8 millones

Acuerdos de investigación colaborativos

Omeros tiene colaboraciones continuas con varias instituciones de investigación, generando ingresos a través de asociaciones estratégicas.

Subvenciones de investigación gubernamental y privada

• Subvenciones de los Institutos Nacionales de Salud (NIH): $ 2.5 millones en 2023
• Financiación del Departamento de Investigación de Defensa: $ 1.7 millones

Pagos potenciales de hitos

Pagos potenciales de hitos de los programas de desarrollo de fármacos, específicamente para OMS906 y OMS527, estimados en $ 15-20 millones Pendiente de progresión del ensayo clínico.

Candidato a la droga	Rango de pago de hito potencial
OMS906	$ 8-12 millones
OMS527	$ 7-8 millones

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.