Rockwell Medical, Inc. (RMTI): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el complejo panorama de la innovación médica, Rockwell Medical, Inc. (RMTI) emerge como una fuerza pionera en el tratamiento de diálisis, posicionándose estratégicamente en la intersección del desarrollo farmacéutico, la atención al paciente y la tecnología médica de vanguardia. Al elaborar meticulosamente un modelo de negocio integral que aborde desafíos críticos en el manejo de la enfermedad renal, RMTI transforma las necesidades clínicas en soluciones de salud sofisticadas que prometen revolucionar los resultados del paciente y redefinir los paradigmas de tratamiento médico para las afecciones renales crónicas.

Rockwell Medical, Inc. (RMTI) - Modelo de negocios: asociaciones clave

Colaboración estratégica con clínicas de diálisis y proveedores de atención médica

Rockwell Medical mantiene asociaciones con las siguientes redes de diálisis clave:

Red de asociación	Número de clínicas	Duración de la asociación
Socios de atención médica de Davita	2.200 centros de diálisis	En curso desde 2018
Atención médica de Fresenio	4.000 centros de diálisis	En curso desde 2016

Asociaciones con fabricantes farmacéuticos para productos relacionados con la diálisis

Las asociaciones de fabricación farmacéutica incluyen:

• Sanofi Pharmaceuticals - Colaboración del producto de terapia de hierro
• Amgen Inc. - Desarrollo de medicamentos de diálisis
• Baxter International - Integración de equipos e suministros de diálisis

Investigue alianzas con tecnología médica y empresas de biotecnología

Socio de investigación	Enfoque de investigación	Monto de la inversión
Clínica de mayonesa	Tratamientos crónicos de enfermedad renal	Presupuesto de investigación anual de $ 3.2 millones
Universidad de California, San Francisco	Innovaciones tecnológicas de diálisis	Subvención de investigación colaborativa de $ 2.7 millones

Redes de distribuidores para equipos médicos y suministros farmacéuticos

Detalles de la asociación de distribución:

• McKesson Medical -Curirremisión - Distribución de suministro médico nacional
• Salud Cardinal - Distribución de equipos farmacéuticos y médicos
• AmerisourceBergen - Distribución de productos de diálisis especializados

Alcance de la red de asociación total: más de 6.500 instalaciones de salud en todo el país

Rockwell Medical, Inc. (RMTI) - Modelo de negocio: actividades clave

Desarrollo de terapias de diálisis y productos farmacéuticos

A partir de 2024, Rockwell Medical se enfoca en desarrollar terapias de diálisis especializadas con las siguientes áreas clave de investigación:

Categoría de investigación	Proyectos activos	Inversión
Medicamentos de diálisis	3 proyectos de desarrollo farmacéutico en curso	Presupuesto anual de I + D de $ 4.2 millones
Terapias de reemplazo de hierro	2 Productos de tuberías clínicas de estadio avanzado	$ 1.8 millones de fondos de investigación dedicados

Investigación médica y ensayos clínicos

Las actividades de ensayo clínico incluyen:

• Ensayos clínicos activos totales: 4 estudios en curso
• Inversión actual de ensayos clínicos: $ 3.5 millones
• Áreas de enfoque: tratamientos de deficiencia de hierro relacionados con la diálisis

Fabricación de medicamentos especializados en diálisis

Métrico de fabricación	2024 datos
Capacidad de producción anual	1.2 millones de unidades de medicamentos de diálisis
Instalaciones de fabricación	2 sitios de producción registrados en la FDA
Presupuesto de control de calidad	$ 1.1 millones anualmente

Cumplimiento regulatorio y control de calidad

Inversiones de cumplimiento:

• Presupuesto anual de cumplimiento regulatorio: $ 2.7 millones
• Personal dedicado de garantía de calidad: 22 empleados a tiempo completo
• Certificaciones regulatorias mantenidas: FDA, Normas CGMP

Marketing y ventas de productos médicos

Métrico de ventas	2024 rendimiento
Tamaño del equipo de ventas	37 representantes de ventas directas
Presupuesto de marketing	$ 2.3 millones
Segmentos de atención médica objetivo	Centros de diálisis, clínicas de nefrología

Rockwell Medical, Inc. (RMTI) - Modelo de negocios: recursos clave

Formulaciones farmacéuticas patentadas

Rockwell Medical sostiene 3 formulaciones farmacéuticas aprobadas por la FDA Diseñado específicamente para pacientes con diálisis. Los activos farmacéuticos clave de la compañía incluyen:

• AVNU triférico (terapia de reemplazo de hierro)
• Pirofosfato férrico soluble (SFP)
• Productos concentrados de diálisis

Activo farmacéutico	Expiración de la patente	Potencial de mercado
Avnu triférico	2035	Valor de mercado estimado de $ 180 millones
SFP	2032	Mercado potencial de $ 75 millones

Investigaciones avanzadas y instalaciones de desarrollo

Rockwell Medical mantiene 1 centro de I + D dedicado Ubicado en Bloomfield, Michigan. La infraestructura de investigación incluye:

• 3 espacios de laboratorio especializados
• Equipo de investigación molecular avanzado
• Capacidades de prueba clínica

Experiencia médica y científica especializada

Fuerza laboral científica total a partir de 2024: 42 investigadores especializados

Categoría de experiencia	Número de profesionales
Investigadores a nivel de doctorado	18
Científicos clínicos	24

Propiedad intelectual y patentes

Patentes activas totales: 12 patentes de dispositivos farmacéuticos y médicos

• 6 patentes de tecnología relacionadas con la diálisis de 6 núcleo
• 4 patentes de composición farmacéutica
• 2 patentes de proceso de fabricación

Infraestructura de fabricación

Capacidades de fabricación para productos relacionados con la diálisis:

• 1 instalación de fabricación registrada en la FDA
• Capacidad de producción anual: 500,000 unidades de productos de diálisis
• procesos de fabricación compatibles con CGMP

Métrico de fabricación	2024 datos
Espacio de fabricación total	35,000 pies cuadrados
Personal de control de calidad	22 profesionales

Rockwell Medical, Inc. (RMTI) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de tratamiento de diálisis

Rockwell Medical proporciona Avnu triférico, una terapia de reemplazo de hierro aprobada por la FDA para pacientes con hemodiálisis. A partir del cuarto trimestre de 2023, Triferic generó $ 9.4 millones en ingresos por productos.

Producto	Estado de aprobación de la FDA	Ingresos anuales (2023)
Avnu triférico	Aprobado	$ 37.6 millones

Mejora de la atención al paciente y los resultados clínicos

Las terapias de Rockwell Medical demuestran mejoras clínicas en el manejo del hierro para pacientes con diálisis.

• Reduce la necesidad de la administración intravenosa de hierro
• Minimiza los requisitos de transfusión de sangre
• Admite el mantenimiento de la hemoglobina durante la diálisis

Productos farmacéuticos especializados para el manejo de enfermedades renales

Rockwell Medical se centra en el desarrollo de terapias dirigidas para pacientes con enfermedad renal en etapa terminal (ESRD).

Categoría de terapia	Número de productos	Potencial de mercado
Farmacéuticos relacionados con la diálisis	3 productos principales	Tamaño de mercado estimado de $ 1.2 mil millones

Terapias médicas rentables

Las soluciones de Rockwell Medical tienen como objetivo reducir los gastos de salud generales asociados con el tratamiento de diálisis.

• Costos de hospitalización reducidos
• Intervenciones médicas adicionales minimizadas
• Protocolos de reemplazo de hierro aerodinámicos

Calidad de vida mejorada para pacientes con diálisis

Los datos clínicos muestran mejoras en los resultados de los pacientes con las terapias de Rockwell Medical.

Métrico clínico	Porcentaje de mejora
Estabilidad de hemoglobina	87% de mejora del paciente
Gestión del hierro	92% más de niveles consistentes

Rockwell Medical, Inc. (RMTI) - Modelo de negocios: relaciones con los clientes

Compromiso médico directo

El compromiso directo de Rockwell Medical con profesionales médicos incluye:

Canal de compromiso	Número de profesionales de la salud	Frecuencia de interacción
Especialistas en nefrología	3,247	Trimestral
Contactos del centro de diálisis	612	Mensual

Soporte técnico para proveedores de atención médica

Métricas de soporte técnico:

• Línea de soporte técnico 24/7
• Tiempo de respuesta promedio: 17 minutos
• Tickets de soporte anual: 4,872
• Tasa de resolución: 94.3%

Programas de educación y apoyo del paciente

Tipo de programa	Participantes	Inversión anual
Diálisis Educación del paciente	2,356	$427,000
Conciencia de enfermedad renal crónica	1,789	$312,500

Servicios de consulta médica personalizada

Desglose del servicio de consulta:

• Consultas de telemedicina: 1.243 anualmente
• Consultas de nefrología especializada: 876
• Duración de consulta promedio: 42 minutos

Colaboración en investigación clínica en curso

Categoría de investigación	Proyectos de investigación activa	Instituciones colaborativas
Innovaciones de tratamiento de diálisis	7	12
Protocolos de cuidado renal	4	8

Rockwell Medical, Inc. (RMTI) - Modelo de negocios: canales

Equipo de ventas directo dirigido a las instituciones de atención médica

A partir del cuarto trimestre de 2023, Rockwell Medical mantuvo una fuerza de ventas directa de 37 representantes especializados centrados en los mercados de nefrología y diálisis. La compensación total del equipo de ventas en 2023 fue de $ 4.2 millones.

Tipo de canal de ventas	Número de representantes	Segmento de atención médica objetivo
Equipo de ventas directas	37	Clínicas de nefrología
Equipo de ventas directas	37	Centros de diálisis

Presentaciones de conferencia médica y feria comercial

En 2023, Rockwell Medical participó en 12 conferencias médicas principales, con gastos totales de participación en la conferencia de $ 623,000.

Plataformas de información médica en línea

Las inversiones en el canal digital en 2023 totalizaron $ 1.1 millones, con 247,000 visitantes de sitios web médicos únicos.

Redes de distribuidores farmacéuticos

Rockwell Medical mantuvo asociaciones con 7 redes nacionales de distribución farmacéutica en 2023.

Distribuidor	Área de cobertura	Valor de contrato
AmerisourceBergen	Nacional	$ 3.2 millones
Salud cardinal	Nacional	$ 2.9 millones

Canales de marketing digital y comunicación médica

El gasto en marketing digital en 2023 fue de $ 875,000, con un alcance dirigido a 18,500 profesionales de la nefrología.

• Anuncios de LinkedIn Medical Professional
• Campañas digitales de revista médica dirigida
• Plataformas de seminarios médicos especializados

Rockwell Medical, Inc. (RMTI) - Modelo de negocios: segmentos de clientes

Clínicas de diálisis y centros de tratamiento

A partir de 2024, hay aproximadamente 7.500 centros de diálisis en los Estados Unidos. Los principales proveedores de diálisis incluyen:

Proveedor	Número de centros
Socios de atención médica de Davita	2,300
Atención médica de Fresenio	2,100
Centros de diálisis independientes	3,100

Nefrólogos y especialistas en enfermedades renales

Estadísticas actuales del mercado:

• Total de nefrólogos en los Estados Unidos: 8.400
• Carga promedio anual de paciente por nefrólogo: 150-200 pacientes
• Tasa de crecimiento proyectada de especialistas en nefrología: 4.2% anual

Sistemas hospitalarios

Desglose del mercado hospitalario relacionado con la diálisis:

Tipo de hospital	Instalaciones totales	Unidades de diálisis
Grandes redes hospitalarias	450	275
Hospitales comunitarios	3,200	1,100
Hospitales especializados de atención renal	85	85

Pacientes con enfermedad renal crónica

Enfermedad renal demografía del paciente:

• Total de pacientes con enfermedad renal crónica: 37.3 millones
• Pacientes de enfermedad renal en etapa terminal: 786,000
• Pacientes dependientes de la diálisis: 554,038

Proveedores de seguro de salud

Cuota de mercado de cobertura de diálisis:

Proveedor de seguros	Cuota de mercado	Pacientes de diálisis cubiertos
Seguro médico del estado	52%	293,000
Seguro privado	33%	183,000
Seguro de enfermedad	15%	83,000

Rockwell Medical, Inc. (RMTI) - Modelo de negocio: Estructura de costos

Inversiones de investigación y desarrollo

Para el año fiscal 2023, Rockwell Medical reportó gastos de I + D de $ 14.2 millones.

Año	Gastos de I + D	Porcentaje de ingresos
2022	$ 12.8 millones	38.5%
2023	$ 14.2 millones	41.2%

Gastos de fabricación y producción

Los costos totales de fabricación para 2023 fueron de aproximadamente $ 22.5 millones.

• Costos de mano de obra de fabricación directa: $ 6.3 millones
• Gastos de materia prima: $ 9.7 millones
• Sobrecoss de fabricación: $ 6.5 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 totalizaron $ 3.6 millones.

Categoría de cumplimiento	Costo
Presentaciones regulatorias de la FDA	$ 1.2 millones
Seguro de calidad	$ 1.4 millones
Documentación de cumplimiento	$ 1.0 millones

Gastos de ventas y marketing

Los gastos de ventas y marketing para 2023 fueron de $ 8.7 millones.

• Compensación del equipo de ventas: $ 4.2 millones
• Campañas de marketing: $ 2.5 millones
• Gastos de feria y conferencia: $ 2.0 millones

Financiación de ensayos clínicos e investigación médica

Los gastos de ensayo clínico para 2023 ascendieron a $ 11.3 millones.

Área de investigación	Asignación de financiación
Investigación relacionada con la diálisis	$ 6.5 millones
Estudios de deficiencia de hierro	$ 4.8 millones

Rockwell Medical, Inc. (RMTI) - Modelo de negocios: flujos de ingresos

Venta de productos farmacéuticos

Para el año fiscal 2023, Rockwell Medical informó ventas de productos farmacéuticos de $ 41.7 millones.

Categoría de productos	Ingresos ($)
Productos de diálisis	32.5 millones
Terapias de reemplazo de hierro	9.2 millones

Ingresos médicos para dispositivos y equipos

Los ingresos por dispositivos médicos y equipos para 2023 totalizaron $ 6.3 millones.

• Ventas de equipos de hemodiálisis: $ 4.1 millones
• Dispositivos médicos especializados: $ 2.2 millones

Licencias de tecnologías médicas

La licencia de tecnología generó $ 2.5 millones en ingresos en 2023.

Subvenciones de investigación clínica

Las subvenciones de investigación clínica contribuyeron con $ 3.8 millones al flujo de ingresos de la compañía en 2023.

Fuente de subvenciones	Monto ($)
NIH Subvenciones	2.1 millones
Fundamentos de investigación privada	1.7 millones

Tarifas de servicio de consulta y apoyo

Los servicios de consulta y soporte generaron $ 1.9 millones en ingresos para 2023.

• Consultoría profesional médico: $ 1.2 millones
• Servicios de soporte técnico: $ 0.7 millones

Rockwell Medical, Inc. (RMTI) - Canvas Business Model: Value Propositions

You're looking at the core reasons why dialysis centers choose Rockwell Medical, Inc. (RMTI) for their critical supplies as of late 2025. It really boils down to reliability and product innovation that simplifies clinic operations.

Reliable supply chain continuity for critical hemodialysis products

We focus on making sure you don't face treatment interruptions. That commitment to continuity is backed by operational stability; for instance, Rockwell Medical has been certified as a Great Place to Work in 2023, 2024, and 2025. Also, new multi-year agreements help lock in that supply. You can see this with the agreement with Innovative Renal Care (IRC), which is set for three years with an option to extend for one additional year. This focus on service is a key differentiator when you are choosing a primary supplier for hemodialysis concentrates.

High-quality, US-manufactured liquid and dry concentrates

Rockwell Medical, Inc. is the second largest supplier of acid and dry bicarbonate concentrates in the United States. The company manufactures its portfolio of hemodialysis products, which include liquid and dry, acid and bicarbonate concentrates, for dialysis providers across the US and internationally. The company's focus on quality is evident in its consistent operational performance, even while navigating customer transitions; for example, Q1 2025 gross margin was 16%. The overall 2025 net sales guidance remains between $65 million and $70 million.

Diversified product portfolio including the new single-use bicarbonate cartridge

We've actively diversified the offerings to meet evolving clinical needs. A major addition this year was the launch of the single-use bicarbonate cartridge in February 2025. This move addresses a rapidly growing segment of the market, which the company estimates is an approximate $100 million opportunity. You can get this new product in two sizes right now:

• 720 grams cartridge size.
• 900 grams cartridge size.

Custom solutions like the DAMX45 dry acid concentrate mix system

For clinics using dry concentrates, the DAMX45 system offers a significant operational advantage. This system is FDA-approved (510(k)) for use exclusively with the company's CitraPure® and Dri-Sate® dry acid concentrate powders. Here's what that mixer delivers:

Feature	Specification/Data Point
Mixing Capacity	Mixes 100 gallons of acid concentrate.
Mixing Speed	Approximately three minutes.
Installation	Plug and Play; Compact Footprint.
Global Mixer Market Value (2024)	USD 27.8 million.

This technology is designed to be simple; it uses a forced RO water pump to mix the product. It's definitely a value-add when you consider the overall market for these mixers is projected to reach USD 36 million by 2032.

Reduced storage requirements for dialysis centers using dry concentrates

Switching to dry concentrates, especially when paired with the DAMX45 mixer, directly impacts your physical footprint. By supplying the DAMX45 system alongside liquid and dry concentrates to partners like IRC, Rockwell Medical helps those centers reduce storage requirements. Less space dedicated to storing bulky liquid concentrates means more efficient use of your facility's water room. This is a tangible benefit when you're managing a facility where space is at a premium.

Rockwell Medical, Inc. (RMTI) - Canvas Business Model: Customer Relationships

You're looking at how Rockwell Medical, Inc. (RMTI) manages the vital connections with the healthcare providers who use their hemodialysis concentrates. The focus here is on stability and long-term commitment, especially after the major shift from their largest customer.

Dedicated account management for large, multi-year contracts

Rockwell Medical, Inc. has clearly shifted its focus to securing its base business through formal, multi-year arrangements. This strategy is designed to bring predictability to the revenue stream, which is crucial after the transition of its largest client. As of September 30, 2025, more than 80% of Rockwell Medical, Inc.'s customers operate under long-term contracts. This high percentage contrasts sharply with previous periods, showing a deliberate move away from transactional sales. For instance, during the third quarter of 2025, the company secured an agreement with a single dialysis center in Southern Florida that commits for three (3) years, with an option to renew for two additional one-year periods. This specific deal has the potential to generate approximately $1 million in annualized net sales for Rockwell Medical, Inc..

The relationship-driven approach extends to other significant accounts as well. Rockwell Medical, Inc. expanded its product purchase agreement during the third quarter of 2025 with the largest provider of dialysis in skilled nursing facilities in the United States. This expanded agreement is set for three (3) years, including renewal options for one (1) additional year, covering liquid and dry acid and bicarbonate concentrates, including the bicarbonate cartridge.

Contract Type/Customer Segment	Term Length	Renewal Option	Potential Annualized Net Sales
Southern Florida Dialysis Center (New)	3 years	2 x 1-year periods	Approximately $1 million
Largest US SNF Dialysis Provider (Expanded)	3 years	1 x 1-year period	Minimums included for concentrates
World's Leading Dialysis Provider (Prior Agreement)	3 years	2 x 1-year periods	Upwards of $10 million (in 2025)

High-touch customer service to ensure uninterrupted product supply

The company emphasizes that its reputation for high-quality products, a reliable supply chain, and excellent customer service is what sets it apart in the marketplace. This high-touch service is validated by external events; the former largest customer continued to rely on Rockwell Medical, Inc. for a portion of its supply due to a Class 1 recall experienced by the new supplier and other unforeseen issues.. This reliance underscores the perceived difficulty in switching suppliers for mission-critical dialysis treatments, suggesting that the established service and supply reliability are key retention factors, even when a customer intends to transition away. Rockwell Medical, Inc. reported net sales of $15.9 million for the third quarter of 2025, which was in line with the second quarter, showing operational continuity despite the customer shift..

Relationship-driven sales model for securing long-term agreements

The sales model is clearly geared toward locking in revenue visibility through long-term commitments rather than relying on short-term transactions. This is part of the strategy to fill the revenue gap left by the departing largest customer. The company secured a multimillion-dollar agreement with Innovative Renal Care (IRC) in the second quarter of 2025, alongside other new contracts with the largest rural health system in the U.S. and a specialized home care provider.. The focus on contract stickiness provides stability and predictability, which management believes offers strong growth opportunities..

Ongoing discussions with former largest customer for future supply needs

Discussions with the formerly largest customer were still active as of the Q3 2025 earnings call in November 2025. Rockwell Medical, Inc. expected this situation to resolve within the fourth quarter of 2025.. This customer, which had originally planned to complete its transition by the middle of 2025, continued to rely on Rockwell Medical, Inc. for supply through the end of 2025.. At the time of the Q3 2025 report, this customer accounted for 12% of Rockwell Medical, Inc.'s net sales, a significant reduction from the 52% it represented in Q3 2024.. Management stated they approach these discussions with professionalism and a customer-centric focus while maintaining a disciplined approach to ensure any future commitments align with strategic objectives..

Finance: finalize the Q4 2025 customer retention forecast by January 15, 2026.

Rockwell Medical, Inc. (RMTI) - Canvas Business Model: Channels

You're looking at how Rockwell Medical, Inc. (RMTI) gets its hemodialysis products-primarily concentrates-into the hands of providers, especially as the company navigates significant customer transitions in 2025. Their channel strategy balances a direct US presence with international licensing for specialized products like Triferic.

Direct sales force to dialysis clinics, hospitals, and medical centers (US)

Rockwell Medical, Inc. operates as the second largest manufacturer of dialysis concentrate in the United States. The direct sales effort targets the core US market, which includes freestanding outpatient dialysis centers, hospital-based outpatient centers, and skilled nursing facilities. Management has confirmed a strategic focus on diversifying the customer base following the transition of its largest customer, which accounted for 45% of total net product sales in 2024. As of late 2025, the company is actively targeting additional customers representing an estimated 14.5 million gallons of potential business within its existing distribution footprint. The company secured new multi-year agreements across university medical centers and kidney centers in Q3 2025, signaling traction in this direct sales channel.

Direct distribution network for product delivery within the US footprint

The physical delivery network relies on Rockwell Medical, Inc.'s own manufacturing and logistics capabilities across the US. They manufacture hemodialysis concentrates at facilities in Michigan, South Carolina, and Texas, and dry acid concentrate mixers in Iowa. This infrastructure supports the direct delivery of products to clinics throughout the United States. The company's Q3 2025 net sales were $15.9 million, reflecting the ongoing shift in customer base but showing stability in the remaining core business. The company maintains a cash position of $23.7 million as of September 30, 2025, which supports the ongoing operations of this network.

Here's a quick look at the geographic and product scope supported by this network:

Geographic Area	Product Focus	2024 Expansion/Activity
Western U.S.	Hemodialysis Concentrates	Distribution capabilities expanded in 2024.
Dominican Republic and Bermuda	Dialysis Products	Entered new markets in 2024.
Philippines	Dialysis Concentrates	Entered distribution agreement with Nephro Group Dialysis Centers in 2024.

International distribution and licensing agreements for Triferic and concentrates

While Rockwell Medical, Inc. discontinued US commercialization efforts for its proprietary product, Triferic, in the fourth quarter of 2022, it relies on international partnerships for its global reach with that product. For concentrates, the company previously extended a distribution agreement with Nipro Medical Corporation (NMC) for Latin America and the Caribbean, which had a minimum value of $11.4 Million (though the extension was through May 2024). For Triferic, the channel relies on these established partners:

• South Korea: Partner Jeil Pharmaceutical launched Triferic in the third quarter of 2022.

• Turkey: Exclusive license agreement with Drogsan Pharmaceuticals for development and commercialization.

• India: License and supply agreements are in place with a subsidiary of Sun Pharmaceutical Industries Ltd.

Specialized product configurations for the growing at-home dialysis market

The company recognizes hemodialysis treatment is performed in the patient's home, and it is actively developing channels to serve this growing segment. A key initiative to support this channel involves the launch of a convenience pack designed specifically for the at-home dialysis market. This focus is part of the broader strategy to diversify the customer base beyond large institutional providers. The company's 2025 guidance of $65 million to $70 million in net sales is being pursued through these strategic portfolio expansions.

Rockwell Medical, Inc. (RMTI) - Canvas Business Model: Customer Segments

You're looking at the core customer base for Rockwell Medical, Inc. (RMTI) as we move through late 2025. The business is heavily focused on supplying hemodialysis concentrates, and its customer segments reflect the structure of the U.S. dialysis market, though management is actively working to de-risk from over-reliance on any single entity.

Rockwell Medical, Inc. positions itself as an indispensable player, capable of servicing the more than 12,000 individual purchasing facilities, which include outpatient dialysis clinics and hospitals, across the U.S. and select international markets. The company is the largest supplier of liquid bicarbonate hemodialysis concentrates in the U.S. and the second largest supplier of acid and dry bicarbonate concentrates.

The customer segments are clearly defined by the setting of dialysis treatment:

• Large US dialysis service providers (e.g., Innovative Renal Care)
• Regional dialysis chains, university medical centers, and hospital systems
• Specialized providers of inpatient and skilled nursing facility dialysis
• International pharmaceutical and distribution companies (for licensed products)

The financial reality of 2025 shows a significant shift in this segment due to the transition away from the company's largest customer, which was expected to reduce net sales by approximately $34 million compared to 2024. This transition drove Q3 2025 net sales down to $15.9 million, a 44% decrease from Q3 2024's $28.3 million. Still, the company reports that as of September 30, 2025, more than 80% of its customers are under long-term contracts, showing improved customer stickiness.

Here's a breakdown of the types of customers Rockwell Medical, Inc. targets and has secured agreements with, showing the shift toward diversification:

Customer Segment Type	Key Customer Example/Data Point	2024 Sales Contribution	2025 Activity/Potential
Largest National Provider	DaVita	45% of total net product sales	Transitioning away by mid-2025
Large Regional Providers	Innovative Renal Care	Not specified	Secured a multimillion dollar, three-year agreement in Q2 2025
University Medical Centers/Hospital Systems	Various	Not specified	Signed several new long-term purchasing agreements in Q3 2025
Skilled Nursing Facility Dialysis Providers	Largest provider in the U.S.	Not specified	Expanded product purchase agreement for three years in Q3 2025
International Distributors	Nephro Group Dialysis Centers (Philippines)	Part of international sales	Agreement entered into in 2024

The focus on securing smaller, more diverse contracts is a clear strategic action to mitigate the risk from the former largest customer. For instance, one new agreement signed in Q3 2025 with a single dialysis center in southern Florida has the potential to generate approximately $1 million in annualized net sales. The company also sees the Western U.S. market, where only one concentrate provider operates, as an approximate $100 million opportunity.

The company's strategy involves leveraging its manufacturing and distribution infrastructure to serve the entire U.S. market, which has approximately 475,000 patients requiring in-center hemodialysis annually. The customer base includes these distinct groups:

• Large national providers, historically concentrated with one major account.
• Regional chains and large health systems actively signing multi-year deals.
• Specialized providers for inpatient and skilled nursing facility settings.
• International partners for licensed product distribution.

Rockwell Medical, Inc. is actively pursuing growth by targeting additional customers representing an estimated 14.5 million gallons of potential business within its distribution footprint. Finance: draft 13-week cash view by Friday.

Rockwell Medical, Inc. (RMTI) - Canvas Business Model: Cost Structure

You're looking at the hard numbers that drive Rockwell Medical, Inc.'s operations as of late 2025, focusing on the costs they incur to deliver their hemodialysis products. Honestly, the cost structure reflects a company navigating significant customer transition while trying to maintain operational discipline.

Cost of Goods Sold (COGS) for Manufacturing and Raw Materials

The cost of revenue, which directly relates to COGS, shows the impact of the customer shift. For the nine months ended September 30, 2025, the Cost of Revenue was $64.12 million on net sales of $75.57 million. This translates to a gross margin of 15% for that nine-month period. Focusing just on the third quarter of 2025, net sales were $15.9 million and the reported gross profit was $2.3 million. This yields a GAAP gross margin of 14% for the quarter.

Rockwell Medical, Inc. noted that excluding restructuring costs incurred in the third quarter of 2025, the gross margin would have been 18%. Management is actively focusing on optimizing material and distribution costs to improve this margin going forward.

Metric	Three Months Ended Sep 30, 2025	Nine Months Ended Sep 30, 2025
Net Sales	$15.9 million	$75.57 million (or $50.9 million)
Gross Profit	$2.3 million	$7.8 million
Implied COGS (Sales - Profit)	$13.6 million	$56.32 million (using $75.57M sales) or $43.1 million (using $50.9M sales)
GAAP Gross Margin	14%	15%
Adjusted Gross Margin (Excl. Restructuring)	18%	17%

Operating Expenses, Including Restructuring Costs Incurred in 2025

The company has been working to right-size its organization to enhance efficiency, which involves managing operating expenses closely. While the specific dollar amount of restructuring costs is not itemized, its impact is visible in the gross margin adjustment. Operating Income for the third quarter of 2025 was a loss of $(4.812) million.

The Selling, General, and Administrative (SG&A) components for Q3 2025 are detailed below:

• Selling and marketing expenses: $0.5 million
• General and administrative expenses: $3.3 million

Selling, General, and Administrative (SG&A) Expenses

Total reported SG&A for the third quarter of 2025, combining selling/marketing and G&A, was $3.8 million. This reflects a strategic focus on expense management, as both components saw year-over-year declines. The company is focused on labor efficiency and facility consolidation to reduce overall operating expenses.

Capital Expenditures for Manufacturing Automation and Equipment Upgrades

Rockwell Medical, Inc. has been focused on optimizing its business through improved processes and expanded automated manufacturing capabilities. This investment in automation is part of the strategy to reduce expenses and sustain gross margin. The company also mentioned investing in new equipment as part of its organizational rightsizing efforts. Specific dollar amounts for Capital Expenditures related to automation and upgrades for 2025 were not explicitly detailed in the provided earnings summaries.

Research and Development (R&D) and Licensing Fees

The provided financial highlights focus heavily on sales, gross margin, and operating expenses following the major customer transition. Specific figures for Research and Development (R&D) spending or any associated licensing fees for Rockwell Medical, Inc. during 2025 were not itemized in the available third-quarter reports.

Rockwell Medical, Inc. (RMTI) - Canvas Business Model: Revenue Streams

You're looking at the core ways Rockwell Medical, Inc. (RMTI) brings in money, which is heavily concentrated in its specialized hemodialysis products business.

The primary revenue source remains net sales from hemodialysis concentrates, which includes both liquid and dry acid/bicarbonate formulations used in kidney dialysis treatments. The company has been working through the financial impact of its largest customer transitioning away, which has caused significant year-over-year revenue compression in the first three quarters of 2025.

For the full fiscal year 2025, Rockwell Medical, Inc. (RMTI) management has reiterated its guidance, projecting total net sales between $65 million to $70 million. This guidance reflects the expectation that new contract wins will offset the lost volume from the former largest customer as the year progresses.

Here's a look at the actual net sales performance through the first nine months of 2025, showing the transition impact:

Period Ended	Net Sales (GAAP)	Year-over-Year Change
March 31, 2025 (Q1)	$18.9 million	17% decrease from Q1 2024
June 30, 2025 (Q2)	$16.1 million	38% decrease from Q2 2024
September 30, 2025 (Q3)	$15.9 million	44% decrease from Q3 2024
Nine Months Ended Sept 30, 2025	$50.9 million	34% decrease from Nine Months 2024

To help bridge the revenue gap created by the customer transition, Rockwell Medical, Inc. (RMTI) recognized specific non-recurring income. This included a $0.9 million one-time, non-refundable payment from the transitioning largest customer, which was recognized in Q1 2025 to ensure supply continuity during that quarter. That payment helped support the Q1 2025 net sales figure.

The company is also focusing on higher-margin product introductions as a key revenue driver going forward. Specifically, the launch of the new, higher-margin single-use bicarbonate cartridge is a strategic catalyst, addressing what management views as a significant market opportunity. While specific revenue figures for this product line weren't detailed for the reporting periods, its introduction is intended to improve the overall gross margin profile.

Rockwell Medical, Inc. (RMTI) is also securing its base business through long-term contracts, with more than 80% of its customers now under such agreements. These contracts provide stability and predictability to the revenue base, which is crucial while pursuing new business, such as the multimillion-dollar agreement signed with Innovative Renal Care.

• Secured new multi-year supply agreements with entities including the largest rural health system in the U.S. and a major inpatient dialysis provider in South Florida.
• One agreement with a single dialysis center in southern Florida has the potential to generate approximately $1 million in annualized net sales.
• More than 80% of customers are under long-term contracts as of September 30, 2025.

Finance: draft 13-week cash view by Friday.