Rockwell Medical, Inc. (RMTI): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage complexe de l'innovation médicale, Rockwell Medical, Inc. (RMTI) émerge comme une force pionnière dans le traitement de la dialyse, se positionnant stratégiquement à l'intersection du développement pharmaceutique, des soins aux patients et de la technologie médicale de pointe. En fabriquant méticuleusement un modèle commercial complet qui relève des défis critiques dans la gestion des maladies rénales, RMTI transforme les besoins cliniques en solutions de soins de santé sophistiquées qui promettent de révolutionner les résultats des patients et de redéfinir les paradigmes de traitement médical pour les affections rénales chroniques.

Rockwell Medical, Inc. (RMTI) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les cliniques de dialyse et les prestataires de soins de santé

Rockwell Medical maintient des partenariats avec les principaux réseaux de dialyse suivants:

Réseau de partenaires	Nombre de cliniques	Durée du partenariat
DAVITA SEALTCARE PARTENERS	2 200 centres de dialyse	En cours depuis 2018
Fresenius Medical Care	4 000 centres de dialyse	En cours depuis 2016

Partenariats avec des fabricants pharmaceutiques pour les produits liés à la dialyse

Les partenariats de fabrication pharmaceutique comprennent:

• Sanofi Pharmaceuticals - Collaboration de produits de thérapie de fer
• Amgen Inc. - Développement de médicaments en dialyse
• Baxter International - Équipement de dialyse et intégration de l'alimentation

Alliances de recherche avec des technologies de technologie médicale et de biotechnologie

Partenaire de recherche	Focus de recherche	Montant d'investissement
Clinique de mayo	Traitements chroniques des maladies rénales	Budget de recherche annuel de 3,2 millions de dollars
Université de Californie, San Francisco	Innovations technologiques de dialyse	Subvention de recherche collaborative de 2,7 millions de dollars

Réseaux de distributeurs pour l'équipement médical et les fournitures pharmaceutiques

Détails du partenariat de distribution:

• McKesson Medical-Surgical - National Medical Supply Distribution
• Cardinal Health - Distribution des équipements pharmaceutiques et médicaux
• Amerisourcebergen - Distribution spécialisée des produits de dialyse

Total Partnership Network Reach: Plus de 6 500 établissements de santé à l'échelle nationale

Rockwell Medical, Inc. (RMTI) - Modèle d'entreprise: Activités clés

Développement de thérapies en dialyse et de produits pharmaceutiques

En 2024, Rockwell Medical se concentre sur le développement de thérapies de dialyse spécialisées avec les principaux domaines de recherche suivants:

Catégorie de recherche	Projets actifs	Investissement
Médicaments contre la dialyse	3 projets de développement pharmaceutique en cours	Budget annuel de 4,2 millions de dollars
Thérapies de remplacement du fer	2 produits avancés de pipeline clinique de scène	Financement de recherche dédié à 1,8 million de dollars

Recherche médicale et essais cliniques

Les activités des essais cliniques comprennent:

• Essais cliniques actifs totaux: 4 études en cours
• Investissement actuel des essais cliniques: 3,5 millions de dollars
• Zones de mise au point: Traitements de carence en fer liée à la dialyse

Fabrication de médicaments de dialyse spécialisés

Métrique manufacturière	2024 données
Capacité de production annuelle	1,2 million d'unités de médicaments contre la dialyse
Installations de fabrication	2 sites de production enregistrés par la FDA
Budget de contrôle de la qualité	1,1 million de dollars par an

Conformité réglementaire et contrôle de la qualité

Investissements de conformité:

• Budget annuel de conformité réglementaire: 2,7 millions de dollars
• Personnel d'assurance qualité dédiée: 22 employés à temps plein
• Certifications réglementaires maintenues: FDA, normes CGMP

Marketing et ventes de produits médicaux

Métrique des ventes	2024 performance
Taille de l'équipe de vente	37 représentants des ventes directes
Budget marketing	2,3 millions de dollars
Segments de soins de santé cibles	Centres de dialyse, cliniques de néphrologie

Rockwell Medical, Inc. (RMTI) - Modèle d'entreprise: Ressources clés

Formulations pharmaceutiques propriétaires

Rockwell Medical tient 3 formulations pharmaceutiques approuvées par la FDA spécialement conçu pour les patients dialysés. Les principaux actifs pharmaceutiques de l'entreprise comprennent:

• Avnu triFéric (thérapie de remplacement du fer)
• Pyrophosphate ferrique soluble (SFP)
• Produits de concentré de dialyse

Actif pharmaceutique	Expiration des brevets	Potentiel de marché
Avnu triférique	2035	Valeur marchande estimée de 180 millions de dollars
SFP	2032	Marché potentiel de 75 millions de dollars

Installations de recherche et développement avancées

Rockwell Medical maintient 1 centre de R&D dédié Situé à Bloomfield, Michigan. L'infrastructure de recherche comprend:

• 3 espaces de laboratoire spécialisés
• Équipement de recherche moléculaire avancée
• Capacités de test clinique

Expertise médicale et scientifique spécialisée

Total des effectifs scientifiques à partir de 2024: 42 chercheurs spécialisés

Catégorie d'expertise	Nombre de professionnels
Chercheurs de doctorat	18
Scientifiques des cliniciens	24

Propriété intellectuelle et brevets

Brevets actifs totaux: 12 brevets pharmaceutiques et médicaux

• 6 brevets technologiques liés à la dialyse de base
• 4 brevets de composition pharmaceutique
• 2 brevets de processus de fabrication

Infrastructure de fabrication

Capacités de fabrication pour les produits liés à la dialyse:

• 1 usine de fabrication enregistrée par la FDA
• Capacité de production annuelle: 500 000 unités de produits de dialyse
• Processus de fabrication conformes au CGMP

Métrique manufacturière	2024 données
Espace de fabrication total	35 000 pieds carrés
Personnel de contrôle de la qualité	22 professionnels

Rockwell Medical, Inc. (RMTI) - Modèle d'entreprise: propositions de valeur

Solutions de traitement de dialyse innovantes

Rockwell Medical fournit Avnu triférique, une thérapie de remplacement du fer approuvée par la FDA pour les patients atteints d'hémodialyse. Au quatrième trimestre 2023, Triferic a généré 9,4 millions de dollars de revenus de produits.

Produit	Statut d'approbation de la FDA	Revenus annuels (2023)
Avnu triférique	Approuvé	37,6 millions de dollars

Amélioration des soins aux patients et des résultats cliniques

Les thérapies de Rockwell Medical démontrent des améliorations cliniques de la gestion du fer pour les patients dialysés.

• Réduit le besoin d'administration intraveineuse de fer
• Minimise les exigences de transfusion sanguine
• Prend en charge l'entretien de l'hémoglobine pendant la dialyse

Produits pharmaceutiques spécialisés pour la gestion des maladies rénales

Rockwell Medical se concentre sur le développement de thérapies ciblées pour les patients atteints d'une maladie rénale (ESRD).

Catégorie de thérapie	Nombre de produits	Potentiel de marché
Pharmaceutiques liées à la dialyse	3 produits primaires	1,2 milliard de dollars de taille du marché estimé

Thérapies médicales rentables

Les solutions de Rockwell Medical visent à réduire les dépenses globales des soins de santé associées au traitement de dialyse.

• Réduction des coûts d'hospitalisation
• Interventions médicales supplémentaires minimisées
• Protocoles de remplacement de fer rationalisés

Qualité de vie améliorée pour les patients dialysés

Les données cliniques montrent des améliorations des résultats des patients avec les thérapies de Rockwell Medical.

Métrique clinique	Pourcentage d'amélioration
Stabilité de l'hémoglobine	87% d'amélioration des patients
Gestion du fer	92% de niveaux plus cohérents

Rockwell Medical, Inc. (RMTI) - Modèle d'entreprise: relations avec les clients

Engagement professionnel médical direct

L'engagement direct de Rockwell Medical avec les professionnels de la santé comprend:

Canal de fiançailles	Le nombre de professionnels de la santé atteint	Fréquence d'interaction
Spécialistes en néphrologie	3,247	Trimestriel
Contacts centraux de dialyse	612	Mensuel

Support technique aux prestataires de soins de santé

Métriques de support technique:

• Ligne de support technique 24/7
• Temps de réponse moyen: 17 minutes
• Billets de soutien annuels: 4 872
• Taux de résolution: 94,3%

Programmes d'éducation et de soutien aux patients

Type de programme	Participants	Investissement annuel
Dialyse Éducation des patients	2,356	$427,000
Sensibilisation aux maladies rénales chroniques	1,789	$312,500

Services de consultation médicale personnalisés

Répartition des services de consultation:

• Consultations de télémédecine: 1 243 par an
• Consultations spécialisées en néphrologie: 876
• Durée moyenne de la consultation: 42 minutes

Collaboration de recherche clinique en cours

Catégorie de recherche	Projets de recherche actifs	Institutions collaboratives
Innovations de traitement de dialyse	7	12
Protocoles de soins rénaux	4	8

Rockwell Medical, Inc. (RMTI) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les institutions de soins de santé

Depuis le quatrième trimestre 2023, Rockwell Medical a maintenu une force de vente directe de 37 représentants spécialisés axés sur les marchés de néphrologie et de dialyse. La rémunération totale de l'équipe de vente en 2023 était de 4,2 millions de dollars.

Type de canal de vente	Nombre de représentants	Segment cible des soins de santé
Équipe de vente directe	37	Cliniques de néphrologie
Équipe de vente directe	37	Centres de dialyse

Présentations de conférences et de salons médicaux

En 2023, Rockwell Medical a participé à 12 conférences médicales majeures, avec des frais de participation totale de 623 000 $.

Plateformes d'information médicale en ligne

Les investissements des canaux numériques en 2023 ont totalisé 1,1 million de dollars, avec 247 000 visiteurs de sites Web professionnels médicaux uniques.

Réseaux de distributeurs pharmaceutiques

Rockwell Medical a maintenu des partenariats avec 7 réseaux nationaux de distribution pharmaceutique en 2023.

Distributeur	Zone de couverture	Valeur du contrat
Amerisourcebergen	National	3,2 millions de dollars
Santé cardinale	National	2,9 millions de dollars

Canaux de marketing numérique et de communication médicale

Les dépenses de marketing numérique en 2023 étaient de 875 000 $, avec une sensibilisation ciblée à 18 500 professionnels en néphrologie.

• Publicités professionnelles médicales LinkedIn
• Campagnes numériques de journal médical ciblées
• Plateformes de webinaires médicaux spécialisés

Rockwell Medical, Inc. (RMTI) - Modèle d'entreprise: segments de clientèle

Cliniques de dialyse et centres de traitement

En 2024, il y a environ 7 500 centres de dialyse aux États-Unis. Les principaux fournisseurs de dialyse comprennent:

Fournisseur	Nombre de centres
DAVITA SEALTCARE PARTENERS	2,300
Fresenius Medical Care	2,100
Centres de dialyse indépendants	3,100

Néphrologues et spécialistes des maladies rénales

Statistiques actuelles du marché:

• Néphrologues totaux aux États-Unis: 8 400
• Charge annuelle moyenne des patients par néphrologue: 150-200 patients
• Taux de croissance projeté des spécialistes de la néphrologie: 4,2% par an

Systèmes hospitaliers

Répartition du marché hospitalier lié à la dialyse:

Type d'hôpital	Total des installations	Unités de dialyse
Grands réseaux d'hôpital	450	275
Hôpitaux communautaires	3,200	1,100
Hôpitaux spécialisés de soins rénaux	85	85

Patients atteints d'une maladie rénale chronique

Demographie des patients atteints de maladie rénale:

• Patients totaux atteints d'une maladie rénale chronique: 37,3 millions
• Patiens des maladies rénales terminales: 786 000
• Patients dépendants de la dialyse: 554 038

Fournisseurs d'assurance de santé

Part de marché de la couverture de dialyse:

Assureur	Part de marché	Patiens de dialyse couverts
Médicament	52%	293,000
Assurance privée	33%	183,000
Medicaid	15%	83,000

Rockwell Medical, Inc. (RMTI) - Modèle d'entreprise: Structure des coûts

Investissements de recherche et développement

Pour l'exercice 2023, Rockwell Medical a déclaré des frais de R&D de 14,2 millions de dollars.

Année	Dépenses de R&D	Pourcentage de revenus
2022	12,8 millions de dollars	38.5%
2023	14,2 millions de dollars	41.2%

Frais de fabrication et de production

Les coûts de fabrication totaux pour 2023 étaient d'environ 22,5 millions de dollars.

• Coût de main-d'œuvre de fabrication directe: 6,3 millions de dollars
• Dépenses de matières premières: 9,7 millions de dollars
• Fabrication des frais généraux: 6,5 millions de dollars

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour 2023 ont totalisé 3,6 millions de dollars.

Catégorie de conformité	Coût
Soumissions réglementaires de la FDA	1,2 million de dollars
Assurance qualité	1,4 million de dollars
Documentation de conformité	1,0 million de dollars

Dépenses de vente et de marketing

Les frais de vente et de marketing pour 2023 étaient de 8,7 millions de dollars.

• Compensation de l'équipe de vente: 4,2 millions de dollars
• Campagnes marketing: 2,5 millions de dollars
• Dépenses de salon et de conférence: 2,0 millions de dollars

Essai clinique et financement de recherche médicale

Les dépenses d'essai cliniques pour 2023 s'élevaient à 11,3 millions de dollars.

Domaine de recherche	Allocation de financement
Recherche liée à la dialyse	6,5 millions de dollars
Études de carence en fer	4,8 millions de dollars

Rockwell Medical, Inc. (RMTI) - Modèle d'entreprise: Strots de revenus

Ventes de produits pharmaceutiques

Pour l'exercice 2023, Rockwell Medical a rapporté des ventes de produits pharmaceutiques de 41,7 millions de dollars.

Catégorie de produits	Revenus ($)
Produits de dialyse	32,5 millions
Thérapies de remplacement du fer	9,2 millions

Revenus de dispositifs médicaux et d'équipement

Les revenus des dispositifs médicaux et de l'équipement pour 2023 ont totalisé 6,3 millions de dollars.

• Ventes d'équipement d'hémodialyse: 4,1 millions de dollars
• Dispositifs médicaux spécialisés: 2,2 millions de dollars

Licence des technologies médicales

Les licences technologiques ont généré 2,5 millions de dollars de revenus en 2023.

Subventions de recherche clinique

Les subventions de recherche clinique ont contribué 3,8 millions de dollars à la source de revenus de l'entreprise en 2023.

Source d'octroi	Montant ($)
Subventions NIH	2,1 millions
Fondations de recherche privée	1,7 million

Frais de service de consultation et de support

Les services de consultation et de soutien ont généré 1,9 million de dollars de revenus pour 2023.

• Conseil professionnel médical: 1,2 million de dollars
• Services de support technique: 0,7 million de dollars

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.