Rockwell Medical, Inc. (RMTI): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário complexo da inovação médica, a Rockwell Medical, Inc. (RMTI) surge como uma força pioneira no tratamento com diálise, se posicionando estrategicamente na interseção do desenvolvimento farmacêutico, atendimento ao paciente e tecnologia médica de ponta. Ao elaborar meticulosamente um modelo de negócios abrangente que aborda desafios críticos no gerenciamento de doenças renais, a RMTI transforma as necessidades clínicas em soluções sofisticadas de assistência médica que prometem revolucionar os resultados dos pacientes e redefinir os paradigmas de tratamento médico para condições renais crônicas.

Rockwell Medical, Inc. (RMTI) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com clínicas de diálise e profissionais de saúde

A Rockwell Medical mantém parcerias com as seguintes redes de diálise -chave:

Rede de parceiros	Número de clínicas	Duração da parceria
Davita Healthcare Partners	2.200 centros de diálise	Em andamento desde 2018
Cuidados médicos de Fresenius	4.000 centros de diálise	Em andamento desde 2016

Parcerias com fabricantes farmacêuticos para produtos relacionados à diálise

Parcerias de fabricação farmacêutica incluem:

• Sanofi Pharmaceuticals - Colaboração de produtos de terapia de ferro
• Amgen Inc. - Desenvolvimento de medicamentos para diálise
• Baxter International - Equipamento de diálise e integração de suprimentos

Alianças de pesquisa com empresas de tecnologia médica e biotecnologia

Parceiro de pesquisa	Foco na pesquisa	Valor do investimento
Clínica Mayo	Tratamentos crônicos de doença renal	Orçamento de pesquisa anual de US $ 3,2 milhões
Universidade da Califórnia, São Francisco	Inovações tecnológicas de diálise	Granda de pesquisa colaborativa de US $ 2,7 milhões

Redes de distribuidores para equipamentos médicos e suprimentos farmacêuticos

Detalhes da parceria de distribuição:

• McKesson Medical -Surgical - distribuição nacional de suprimentos médicos
• Cardinal Health - Distribuição de equipamentos farmacêuticos e médicos
• Amerisourcebergen - Distribuição de produtos especializada em diálise

Alcance da Rede de Parceria Total: Mais de 6.500 instalações de saúde em todo o país

Rockwell Medical, Inc. (RMTI) - Modelo de negócios: Atividades -chave

Desenvolvimento de terapias de diálise e produtos farmacêuticos

A partir de 2024, a Rockwell Medical se concentra no desenvolvimento de terapias especializadas em diálise com as seguintes áreas -chave de pesquisa:

Categoria de pesquisa	Projetos ativos	Investimento
Medicamentos de diálise	3 projetos de desenvolvimento farmacêutico em andamento	US $ 4,2 milhões anuais de P&D Orçamento
Terapias de reposição de ferro	2 Produtos de oleoduto clínico em estágio avançado	US $ 1,8 milhão de financiamento de pesquisa dedicado

Pesquisa médica e ensaios clínicos

As atividades de ensaios clínicos incluem:

• Ensaios clínicos ativos totais: 4 estudos em andamento
• Investimento atual de ensaios clínicos: US $ 3,5 milhões
• Áreas de foco: tratamentos de deficiência de ferro relacionados à diálise

Fabricação de medicamentos especializados em diálise

Métrica de fabricação	2024 dados
Capacidade de produção anual	1,2 milhão de unidades de medicamentos para diálise
Instalações de fabricação	2 locais de produção registrados pela FDA
Orçamento de controle de qualidade	US $ 1,1 milhão anualmente

Conformidade regulatória e controle de qualidade

Investimentos de conformidade:

• Orçamento anual de conformidade regulatória: US $ 2,7 milhões
• Pessoal de garantia de qualidade dedicada: 22 funcionários em tempo integral
• Certificações regulatórias mantidas: FDA, padrões CGMP

Marketing e vendas de produtos médicos

Métrica de vendas	2024 Performance
Tamanho da equipe de vendas	37 representantes de vendas diretas
Orçamento de marketing	US $ 2,3 milhões
Segmentos de assistência médica -alvo	Centros de diálise, Clínicas de Nefrologia

Rockwell Medical, Inc. (RMTI) - Modelo de negócios: Recursos -chave

Formulações farmacêuticas proprietárias

Rockwell Medical Holds 3 Formulações farmacêuticas aprovadas pela FDA Projetado especificamente para pacientes com diálise. Os principais ativos farmacêuticos da empresa incluem:

• Triferic Avnu (terapia de reposição de ferro)
• Pirofosfato férrico solúvel (SFP)
• Diálise concentra produtos

Ativo farmacêutico	Expiração de patentes	Potencial de mercado
Triferic Avnu	2035	US $ 180 milhões no valor estimado de mercado
SFP	2032	Mercado potencial de US $ 75 milhões

Instalações avançadas de pesquisa e desenvolvimento

Rockwell Medical mantém 1 centro de P&D dedicado Localizado em Bloomfield, Michigan. A infraestrutura de pesquisa inclui:

• 3 espaços de laboratório especializados
• Equipamento avançado de pesquisa molecular
• Capacidades de teste clínico

Especializada Especialização Médica e Científica

Força de trabalho científica total a partir de 2024: 42 pesquisadores especializados

Categoria de especialização	Número de profissionais
Pesquisadores de nível de doutorado	18
Cientistas clínicos	24

Propriedade intelectual e patentes

Total de patentes ativas: 12 patentes de dispositivos farmacêuticos e médicos

• 6 Patentes tecnológicas relacionadas à diálise central
• 4 patentes de composição farmacêutica
• 2 patentes do processo de fabricação

Infraestrutura de fabricação

Capacidades de fabricação para produtos relacionados à diálise:

• 1 Instalação de fabricação registrada pela FDA
• Capacidade anual de produção: 500.000 unidades de produtos de diálise
• Processos de fabricação compatíveis com CGMP

Métrica de fabricação	2024 dados
Espaço de fabricação total	35.000 pés quadrados
Equipe de controle de qualidade	22 profissionais

Rockwell Medical, Inc. (RMTI) - Modelo de negócios: proposições de valor

Soluções de tratamento inovadoras de diálise

Rockwell Medical fornece Triferic Avnu, uma terapia de reposição de ferro aprovada pela FDA para pacientes com hemodiálise. A partir do quarto trimestre 2023, o TriFeric gerou US $ 9,4 milhões em receita de produtos.

Produto	Status de aprovação da FDA	Receita anual (2023)
Triferic Avnu	Aprovado	US $ 37,6 milhões

Melhor atendimento ao paciente e resultados clínicos

As terapias da Rockwell Medical demonstram melhorias clínicas no manejo de ferro para pacientes com diálise.

• Reduz a necessidade de administração intravenosa de ferro
• Minimiza os requisitos de transfusão de sangue
• Suporta a manutenção de hemoglobina durante a diálise

Produtos farmacêuticos especializados para gerenciamento de doenças renais

A Rockwell Medical se concentra no desenvolvimento de terapias direcionadas para pacientes com doença renal em estágio final (DRT).

Categoria de terapia	Número de produtos	Potencial de mercado
Farmacêuticos relacionados à diálise	3 produtos principais	US $ 1,2 bilhão, tamanho estimado do mercado

Terapias médicas econômicas

As soluções da Rockwell Medical visam reduzir as despesas gerais de saúde associadas ao tratamento com diálise.

• Custos de hospitalização reduzidos
• Intervenções médicas adicionais minimizadas
• Protocolos de substituição de ferro simplificados

Qualidade de vida aprimorada para pacientes com diálise

Os dados clínicos mostram melhorias nos resultados dos pacientes com as terapias da Rockwell Medical.

Métrica clínica	Porcentagem de melhoria
Estabilidade da hemoglobina	87% de melhora do paciente
Gerenciamento de ferro	92% mais níveis consistentes

Rockwell Medical, Inc. (RMTI) - Modelo de negócios: relacionamentos com o cliente

Engajamento profissional médico direto

O envolvimento direto da Rockwell Medical com profissionais médicos inclui:

Canal de engajamento	Número de profissionais de saúde alcançados	Frequência de interação
Especialistas em nefrologia	3,247	Trimestral
Contatos do centro de diálise	612	Mensal

Suporte técnico para profissionais de saúde

Métricas de suporte técnico:

• Linha de suporte técnico 24/7
• Tempo médio de resposta: 17 minutos
• Tickets de suporte anual: 4.872
• Taxa de resolução: 94,3%

Programas de educação e apoio do paciente

Tipo de programa	Participantes	Investimento anual
Diálise Educação do paciente	2,356	$427,000
Consciência da doença renal crônica	1,789	$312,500

Serviços personalizados de consulta médica

Redução do serviço de consulta:

• Consultas de telemedicina: 1.243 anualmente
• Consultas de nefrologia especializadas: 876
• Duração média da consulta: 42 minutos

Colaboração em andamento em andamento de pesquisa clínica

Categoria de pesquisa	Projetos de pesquisa ativa	Instituições colaborativas
Inovações de tratamento de diálise	7	12
Protocolos de atendimento renal	4	8

Rockwell Medical, Inc. (RMTI) - Modelo de Negócios: Canais

Equipe direta da equipe de vendas direcionando instituições de saúde

No quarto trimestre 2023, a Rockwell Medical manteve uma força de vendas direta de 37 representantes especializados focados nos mercados de nefrologia e diálise. A compensação total da equipe de vendas em 2023 foi de US $ 4,2 milhões.

Tipo de canal de vendas	Número de representantes	Segmento de assistência médica -alvo
Equipe de vendas diretas	37	Clínicas de Nefrologia
Equipe de vendas diretas	37	Centros de diálise

Apresentações da Conferência Médica e da Feira

Em 2023, a Rockwell Medical participou de 12 principais conferências médicas, com despesas totais de participação na conferência de US $ 623.000.

Plataformas de informações médicas online

Os investimentos em canais digitais em 2023 totalizaram US $ 1,1 milhão, com 247.000 visitantes exclusivos do site profissional médico.

Redes de distribuidores farmacêuticos

A Rockwell Medical manteve parcerias com 7 redes nacionais de distribuição farmacêutica em 2023.

Distribuidor	Área de cobertura	Valor do contrato
Amerisourcebergen	Nacional	US $ 3,2 milhões
Cardinal Health	Nacional	US $ 2,9 milhões

Canais de marketing digital e comunicação médica

As despesas de marketing digital em 2023 foram de US $ 875.000, com divulgação direcionada para 18.500 profissionais de nefrologia.

• Anúncios profissionais médicos do LinkedIn
• Campanhas digitais de diário médico direcionado
• Plataformas de on -line médicas especializadas

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

Clínicas de diálise e centros de tratamento

Em 2024, existem aproximadamente 7.500 centros de diálise nos Estados Unidos. Os principais provedores de diálise incluem:

Provedor	Número de centros
Davita Healthcare Partners	2,300
Cuidados médicos de Fresenius	2,100
Centros independentes de diálise	3,100

Nefrologistas e especialistas em doenças renais

Estatísticas atuais do mercado:

• Nefrologistas totais nos Estados Unidos: 8.400
• Carga média anual do paciente por nefrologista: 150-200 pacientes
• Taxa de crescimento projetada de especialistas em nefrologia: 4,2% anualmente

Sistemas hospitalares

Repartição do mercado hospitalar relacionado à diálise:

Tipo de hospital	Total de instalações	Unidades de diálise
Grandes redes hospitalares	450	275
Hospitais comunitários	3,200	1,100
Hospitais de atendimento renal especializados	85	85

Pacientes com doença renal crônica

Demografia de pacientes com doença renal:

• Pacientes totais com doença renal crônica: 37,3 milhões
• Pacientes de doença renal em estágio final: 786.000
• Pacientes dependentes de diálise: 554.038

Provedores de seguros de saúde

Participação de mercado de cobertura de diálise:

Provedor de seguros	Quota de mercado	Pacientes com diálise cobertos
Medicare	52%	293,000
Seguro privado	33%	183,000
Medicaid	15%	83,000

Rockwell Medical, Inc. (RMTI) - Modelo de negócios: estrutura de custos

Investimentos de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Rockwell Medical registrou despesas de P&D de US $ 14,2 milhões.

Ano	Despesas de P&D	Porcentagem de receita
2022	US $ 12,8 milhões	38.5%
2023	US $ 14,2 milhões	41.2%

Despesas de fabricação e produção

Os custos totais de fabricação para 2023 foram de aproximadamente US $ 22,5 milhões.

• Custos de mão -de -obra de fabricação direta: US $ 6,3 milhões
• Despesas de matéria -prima: US $ 9,7 milhões
• Manufatura de sobrecarga: US $ 6,5 milhões

Custos de conformidade regulatória

As despesas de conformidade regulatória para 2023 totalizaram US $ 3,6 milhões.

Categoria de conformidade	Custo
Submissões regulatórias da FDA	US $ 1,2 milhão
Garantia de qualidade	US $ 1,4 milhão
Documentação de conformidade	US $ 1,0 milhão

Despesas de vendas e marketing

As despesas de vendas e marketing de 2023 foram de US $ 8,7 milhões.

• Compensação da equipe de vendas: US $ 4,2 milhões
• Campanhas de marketing: US $ 2,5 milhões
• Feira de feira e despesas da conferência: US $ 2,0 milhões

Ensaio clínico e financiamento de pesquisa médica

As despesas de ensaios clínicos em 2023 totalizaram US $ 11,3 milhões.

Área de pesquisa	Alocação de financiamento
Pesquisa relacionada à diálise	US $ 6,5 milhões
Estudos de deficiência de ferro	US $ 4,8 milhões

Rockwell Medical, Inc. (RMTI) - Modelo de negócios: fluxos de receita

Vendas farmacêuticas de produtos

Para o ano fiscal de 2023, as vendas de produtos farmacêuticos relatados pela Rockwell Medical de US $ 41,7 milhões.

Categoria de produto	Receita ($)
Produtos de diálise	32,5 milhões
Terapias de reposição de ferro	9,2 milhões

Receita de dispositivos médicos e equipamentos

A receita médica de dispositivos e equipamentos para 2023 totalizou US $ 6,3 milhões.

• Vendas de equipamentos de hemodiálise: US $ 4,1 milhões
• Dispositivos médicos especializados: US $ 2,2 milhões

Licenciamento de tecnologias médicas

O licenciamento de tecnologia gerou US $ 2,5 milhões em receita em 2023.

Subsídios de pesquisa clínica

As doações de pesquisa clínica contribuíram com US $ 3,8 milhões para o fluxo de receita da empresa em 2023.

Fonte de concessão	Valor ($)
NIH Grants	2,1 milhões
Fundações de pesquisa privada	1,7 milhão

Taxas de serviço de consulta e suporte

Os serviços de consulta e suporte geraram US $ 1,9 milhão em receita para 2023.

• Consultoria profissional médica: US $ 1,2 milhão
• Serviços de suporte técnico: US $ 0,7 milhão

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.