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

In der komplexen Landschaft der medizinischen Innovation erweist sich Rockwell Medical, Inc. (RMTI) als Pionier in der Dialysebehandlung und positioniert sich strategisch an der Schnittstelle zwischen pharmazeutischer Entwicklung, Patientenversorgung und modernster Medizintechnik. Durch die sorgfältige Ausarbeitung eines umfassenden Geschäftsmodells, das kritische Herausforderungen bei der Behandlung von Nierenerkrankungen angeht, wandelt RMTI klinische Anforderungen in anspruchsvolle Gesundheitslösungen um, die versprechen, die Patientenergebnisse zu revolutionieren und medizinische Behandlungsparadigmen für chronische Nierenerkrankungen neu zu definieren.

Rockwell Medical, Inc. (RMTI) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit Dialysekliniken und Gesundheitsdienstleistern

Rockwell Medical unterhält Partnerschaften mit den folgenden wichtigen Dialysenetzwerken:

Partnernetzwerk	Anzahl der Kliniken	Dauer der Partnerschaft
DaVita Healthcare-Partner	2.200 Dialysezentren	Laufend seit 2018
Fresenius Medical Care	4.000 Dialysezentren	Laufend seit 2016

Partnerschaften mit Pharmaherstellern für dialysebezogene Produkte

Zu den Partnerschaften in der Pharmaindustrie gehören:

• Sanofi Pharmaceuticals – Zusammenarbeit bei Produkten zur Eisentherapie
• Amgen Inc. – Entwicklung von Dialysemedikamenten
• Baxter International – Dialyseausrüstung und Versorgungsintegration

Forschungsallianzen mit Medizintechnik- und Biotechnologieunternehmen

Forschungspartner	Forschungsschwerpunkt	Investitionsbetrag
Mayo-Klinik	Behandlungen chronischer Nierenerkrankungen	Jährliches Forschungsbudget von 3,2 Millionen US-Dollar
Universität von Kalifornien, San Francisco	Innovationen in der Dialysetechnologie	Verbundforschungsstipendium in Höhe von 2,7 Millionen US-Dollar

Vertriebsnetzwerke für medizinische Geräte und pharmazeutische Produkte

Details zur Vertriebspartnerschaft:

• McKesson Medical-Surgical – Nationaler Vertrieb medizinischer Versorgung
• Cardinal Health – Vertrieb von pharmazeutischen und medizinischen Geräten
• AmerisourceBergen – Spezialisierter Vertrieb von Dialyseprodukten

Gesamtreichweite des Partnerschaftsnetzwerks: Über 6.500 Gesundheitseinrichtungen im ganzen Land

Rockwell Medical, Inc. (RMTI) – Geschäftsmodell: Hauptaktivitäten

Entwicklung von Dialysetherapien und pharmazeutischen Produkten

Ab 2024 konzentriert sich Rockwell Medical auf die Entwicklung spezialisierter Dialysetherapien mit den folgenden Forschungsschwerpunkten:

Forschungskategorie	Aktive Projekte	Investition
Dialysemedikamente	3 laufende pharmazeutische Entwicklungsprojekte	Jährliches F&E-Budget von 4,2 Millionen US-Dollar
Eisenersatztherapien	2 fortgeschrittene klinische Pipeline-Produkte	1,8 Millionen US-Dollar zweckgebundene Forschungsfinanzierung

Medizinische Forschung und klinische Studien

Zu den Aktivitäten klinischer Studien gehören:

• Insgesamt aktive klinische Studien: 4 laufende Studien
• Aktuelle Investition in klinische Studien: 3,5 Millionen US-Dollar
• Schwerpunkte: Dialysebedingte Eisenmangelbehandlungen

Herstellung spezieller Dialysemedikamente

Fertigungsmetrik	Daten für 2024
Jährliche Produktionskapazität	1,2 Millionen Einheiten Dialysemedikamente
Produktionsanlagen	2 FDA-registrierte Produktionsstandorte
Qualitätskontrollbudget	1,1 Millionen US-Dollar pro Jahr

Einhaltung gesetzlicher Vorschriften und Qualitätskontrolle

Compliance-Investitionen:

• Jährliches Budget für die Einhaltung gesetzlicher Vorschriften: 2,7 Millionen US-Dollar
• Engagiertes Qualitätssicherungspersonal: 22 Vollzeitmitarbeiter
• Behördliche Zertifizierungen werden beibehalten: FDA, cGMP-Standards

Marketing und Vertrieb von Medizinprodukten

Verkaufsmetrik	Leistung 2024
Größe des Vertriebsteams	37 Direktvertriebsmitarbeiter
Marketingbudget	2,3 Millionen US-Dollar
Zielsegmente im Gesundheitswesen	Dialysezentren, Nephrologiekliniken

Rockwell Medical, Inc. (RMTI) – Geschäftsmodell: Schlüsselressourcen

Proprietäre pharmazeutische Formulierungen

Rockwell Medical hält 3 von der FDA zugelassene pharmazeutische Formulierungen speziell für Dialysepatienten entwickelt. Zu den wichtigsten pharmazeutischen Vermögenswerten des Unternehmens gehören:

• Triferic AVNU (Eisenersatztherapie)
• Lösliches Eisenpyrophosphat (SFP)
• Dialysekonzentratprodukte

Pharmazeutischer Vermögenswert	Patentablauf	Marktpotenzial
Triferic AVNU	2035	Geschätzter Marktwert: 180 Millionen US-Dollar
SFP	2032	75 Millionen US-Dollar potenzieller Markt

Fortschrittliche Forschungs- und Entwicklungseinrichtungen

Rockwell Medical behauptet 1 eigenes Forschungs- und Entwicklungszentrum befindet sich in Bloomfield, Michigan. Die Forschungsinfrastruktur umfasst:

• 3 spezialisierte Laborräume
• Fortschrittliche Ausrüstung für die molekulare Forschung
• Klinische Testmöglichkeiten

Spezialisierte medizinische und wissenschaftliche Expertise

Gesamter wissenschaftlicher Personalbestand im Jahr 2024: 42 spezialisierte Forscher

Kategorie „Expertise“.	Anzahl der Fachkräfte
Forscher auf Doktorandenniveau	18
Klinische Wissenschaftler	24

Geistiges Eigentum und Patente

Gesamtzahl der aktiven Patente: 12 Patente für Arzneimittel und Medizinprodukte

• 6 Kernpatente für dialysebezogene Technologie
• 4 Patente für pharmazeutische Zusammensetzungen
• 2 Herstellungsprozesspatente

Fertigungsinfrastruktur

Fertigungskapazitäten für dialysebezogene Produkte:

• 1 von der FDA registrierte Produktionsstätte
• Jährliche Produktionskapazität: 500.000 Einheiten Dialyseprodukte
• cGMP-konforme Herstellungsprozesse

Fertigungsmetrik	Daten für 2024
Gesamte Produktionsfläche	35.000 Quadratmeter
Mitarbeiter der Qualitätskontrolle	22 Profis

Rockwell Medical, Inc. (RMTI) – Geschäftsmodell: Wertversprechen

Innovative Dialysebehandlungslösungen

Rockwell Medical bietet Triferic AVNU, eine von der FDA zugelassene Eisenersatztherapie für Hämodialysepatienten. Im vierten Quartal 2023 erzielte Triferic einen Produktumsatz von 9,4 Millionen US-Dollar.

Produkt	FDA-Zulassungsstatus	Jahresumsatz (2023)
Triferic AVNU	Genehmigt	37,6 Millionen US-Dollar

Verbesserte Patientenversorgung und klinische Ergebnisse

Die Therapien von Rockwell Medical zeigen klinische Verbesserungen im Eisenmanagement für Dialysepatienten.

• Reduziert den Bedarf an intravenöser Eisenverabreichung
• Minimiert den Bedarf an Bluttransfusionen
• Unterstützt die Aufrechterhaltung des Hämoglobins während der Dialyse

Spezialisierte pharmazeutische Produkte für die Behandlung von Nierenerkrankungen

Rockwell Medical konzentriert sich auf die Entwicklung gezielter Therapien für Patienten mit terminaler Niereninsuffizienz (ESRD).

Therapiekategorie	Anzahl der Produkte	Marktpotenzial
Dialysebezogene Arzneimittel	3 Hauptprodukte	Geschätzte Marktgröße: 1,2 Milliarden US-Dollar

Kostengünstige medizinische Therapien

Die Lösungen von Rockwell Medical zielen darauf ab, die mit der Dialysebehandlung verbundenen Gesamtgesundheitskosten zu senken.

• Reduzierte Krankenhauskosten
• Minimierung zusätzlicher medizinischer Eingriffe
• Optimierte Eisenersatzprotokolle

Verbesserte Lebensqualität für Dialysepatienten

Klinische Daten zeigen Verbesserungen der Patientenergebnisse durch die Therapien von Rockwell Medical.

Klinische Metrik	Verbesserungsprozentsatz
Hämoglobinstabilität	87 % Patientenverbesserung
Eisenmanagement	92 % gleichmäßigere Werte

Rockwell Medical, Inc. (RMTI) – Geschäftsmodell: Kundenbeziehungen

Direktes medizinisches Fachpersonal-Engagement

Die direkte Zusammenarbeit von Rockwell Medical mit medizinischen Fachkräften umfasst:

Engagement-Kanal	Anzahl der erreichten medizinischen Fachkräfte	Interaktionshäufigkeit
Spezialisten für Nephrologie	3,247	Vierteljährlich
Kontakte des Dialysezentrums	612	Monatlich

Technischer Support für Gesundheitsdienstleister

Kennzahlen zum technischen Support:

• Technischer Support rund um die Uhr
• Durchschnittliche Reaktionszeit: 17 Minuten
• Jährliche Support-Tickets: 4.872
• Auflösungsrate: 94,3 %

Patientenaufklärungs- und Unterstützungsprogramme

Programmtyp	Teilnehmer	Jährliche Investition
Aufklärung von Dialysepatienten	2,356	$427,000
Aufklärung über chronische Nierenerkrankungen	1,789	$312,500

Personalisierte medizinische Beratungsdienste

Aufschlüsselung der Beratungsleistungen:

• Telemedizinische Konsultationen: 1.243 jährlich
• Spezialisierte Nephrologie-Konsultationen: 876
• Durchschnittliche Beratungsdauer: 42 Minuten

Laufende klinische Forschungskooperation

Forschungskategorie	Aktive Forschungsprojekte	Kollaborative Institutionen
Innovationen in der Dialysebehandlung	7	12
Protokolle zur Nierenpflege	4	8

Rockwell Medical, Inc. (RMTI) – Geschäftsmodell: Kanäle

Direktvertriebsteam für Gesundheitseinrichtungen

Im vierten Quartal 2023 verfügte Rockwell Medical über ein Direktvertriebsteam von 37 spezialisierten Vertretern, die sich auf die Märkte Nephrologie und Dialyse konzentrieren. Die Gesamtvergütung des Vertriebsteams belief sich im Jahr 2023 auf 4,2 Millionen US-Dollar.

Vertriebskanaltyp	Anzahl der Vertreter	Zielsegment Gesundheitswesen
Direktvertriebsteam	37	Kliniken für Nephrologie
Direktvertriebsteam	37	Dialysezentren

Präsentationen auf medizinischen Konferenzen und Messen

Im Jahr 2023 nahm Rockwell Medical an 12 großen medizinischen Konferenzen teil, wobei sich die Gesamtkosten für die Konferenzteilnahme auf 623.000 US-Dollar beliefen.

Online-Plattformen für medizinische Informationen

Die Investitionen in digitale Kanäle beliefen sich im Jahr 2023 auf insgesamt 1,1 Millionen US-Dollar, mit 247.000 einzelnen Besuchern der Website von Medizinern.

Pharmazeutische Vertriebsnetzwerke

Rockwell Medical unterhielt im Jahr 2023 Partnerschaften mit sieben nationalen Pharmavertriebsnetzwerken.

Händler	Abdeckungsbereich	Vertragswert
AmerisourceBergen	National	3,2 Millionen US-Dollar
Kardinalgesundheit	National	2,9 Millionen US-Dollar

Digitales Marketing und medizinische Kommunikationskanäle

Die Ausgaben für digitales Marketing beliefen sich im Jahr 2023 auf 875.000 US-Dollar, mit gezielter Ansprache von 18.500 Nephrologie-Experten.

• LinkedIn-Anzeigen für medizinische Fachkräfte
• Gezielte digitale Kampagnen für medizinische Fachzeitschriften
• Spezialisierte medizinische Webinar-Plattformen

Rockwell Medical, Inc. (RMTI) – Geschäftsmodell: Kundensegmente

Dialysekliniken und Behandlungszentren

Im Jahr 2024 gibt es in den Vereinigten Staaten etwa 7.500 Dialysezentren. Zu den Top-Dialyseanbietern gehören:

Anbieter	Anzahl der Zentren
DaVita Healthcare-Partner	2,300
Fresenius Medical Care	2,100
Unabhängige Dialysezentren	3,100

Nephrologen und Spezialisten für Nierenerkrankungen

Aktuelle Marktstatistiken:

• Gesamtzahl der Nephrologen in den Vereinigten Staaten: 8.400
• Durchschnittliche jährliche Patientenbelastung pro Nephrologe: 150–200 Patienten
• Voraussichtliche Wachstumsrate der Nephrologie-Spezialisten: 4,2 % jährlich

Krankenhaussysteme

Aufschlüsselung des Marktes für Dialysekrankenhäuser:

Krankenhaustyp	Gesamtausstattung	Dialyseeinheiten
Große Krankenhausnetzwerke	450	275
Gemeinschaftskrankenhäuser	3,200	1,100
Spezialkrankenhäuser für Nierenversorgung	85	85

Patienten mit chronischer Nierenerkrankung

Demografische Daten von Patienten mit Nierenerkrankungen:

• Gesamtzahl der Patienten mit chronischer Nierenerkrankung: 37,3 Millionen
• Patienten mit Nierenerkrankungen im Endstadium: 786.000
• Dialysepflichtige Patienten: 554.038

Krankenversicherungsanbieter

Marktanteil der Dialyseabdeckung:

Versicherungsanbieter	Marktanteil	Abgedeckte Dialysepatienten
Medicare	52%	293,000
Private Versicherung	33%	183,000
Medicaid	15%	83,000

Rockwell Medical, Inc. (RMTI) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungsinvestitionen

Für das Geschäftsjahr 2023 meldete Rockwell Medical Forschungs- und Entwicklungskosten in Höhe von 14,2 Millionen US-Dollar.

Jahr	F&E-Ausgaben	Prozentsatz des Umsatzes
2022	12,8 Millionen US-Dollar	38.5%
2023	14,2 Millionen US-Dollar	41.2%

Herstellungs- und Produktionskosten

Die gesamten Herstellungskosten für 2023 beliefen sich auf etwa 22,5 Millionen US-Dollar.

• Direkte Arbeitskosten in der Fertigung: 6,3 Millionen US-Dollar
• Rohstoffkosten: 9,7 Millionen US-Dollar
• Fertigungsaufwand: 6,5 Millionen US-Dollar

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Ausgaben für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf insgesamt 3,6 Millionen US-Dollar.

Compliance-Kategorie	Kosten
Zulassungsanträge der FDA	1,2 Millionen US-Dollar
Qualitätssicherung	1,4 Millionen US-Dollar
Compliance-Dokumentation	1,0 Millionen US-Dollar

Vertriebs- und Marketingausgaben

Die Vertriebs- und Marketingkosten beliefen sich im Jahr 2023 auf 8,7 Millionen US-Dollar.

• Vergütung des Vertriebsteams: 4,2 Millionen US-Dollar
• Marketingkampagnen: 2,5 Millionen US-Dollar
• Ausgaben für Messe und Konferenz: 2,0 Millionen US-Dollar

Finanzierung klinischer Studien und medizinischer Forschung

Die Ausgaben für klinische Studien beliefen sich im Jahr 2023 auf 11,3 Millionen US-Dollar.

Forschungsbereich	Mittelzuweisung
Dialysebezogene Forschung	6,5 Millionen Dollar
Studien zu Eisenmangel	4,8 Millionen US-Dollar

Rockwell Medical, Inc. (RMTI) – Geschäftsmodell: Einnahmequellen

Vertrieb pharmazeutischer Produkte

Für das Geschäftsjahr 2023 meldete Rockwell Medical einen Umsatz mit pharmazeutischen Produkten in Höhe von 41,7 Millionen US-Dollar.

Produktkategorie	Umsatz ($)
Dialyseprodukte	32,5 Millionen
Eisenersatztherapien	9,2 Millionen

Umsatz mit medizinischen Geräten und Ausrüstung

Der Umsatz mit medizinischen Geräten und Ausrüstung belief sich im Jahr 2023 auf insgesamt 6,3 Millionen US-Dollar.

• Umsatz mit Hämodialysegeräten: 4,1 Millionen US-Dollar
• Spezialisierte medizinische Geräte: 2,2 Millionen US-Dollar

Lizenzierung medizinischer Technologien

Die Technologielizenzierung generierte im Jahr 2023 einen Umsatz von 2,5 Millionen US-Dollar.

Klinische Forschungsstipendien

Zuschüsse für klinische Forschung trugen im Jahr 2023 3,8 Millionen US-Dollar zur Einnahmequelle des Unternehmens bei.

Grant-Quelle	Betrag ($)
NIH-Stipendien	2,1 Millionen
Private Forschungsstiftungen	1,7 Millionen

Gebühren für Beratungs- und Supportleistungen

Beratungs- und Supportdienste generierten im Jahr 2023 einen Umsatz von 1,9 Millionen US-Dollar.

• Medizinische Fachberatung: 1,2 Millionen US-Dollar
• Technische Supportleistungen: 0,7 Millionen US-Dollar

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.