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Here are 1-2 brief analogies for Rockwell Medical (RMTI):

• Baxter International for kidney dialysis.
• A specialized Amgen for iron management in dialysis patients.

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• Triferic AVNU: An iron replacement product administered intravenously during hemodialysis to maintain hemoglobin in adult patients with chronic kidney disease.
• Hemodialysis Concentrates and Powders: Essential solutions and powders manufactured and distributed for use in the hemodialysis process to treat end-stage renal disease.

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Rockwell Medical (RMTI) Major Customers

Rockwell Medical (RMTI) primarily sells its products, which include Triferic and dialysate concentrates, to other companies within the healthcare sector, specifically those involved in renal care and dialysis. Their major customers include:

• DaVita Inc. (Symbol: DVA): DaVita is explicitly mentioned in Rockwell Medical's public filings as a significant customer. DaVita is one of the largest kidney care and dialysis providers globally, operating numerous dialysis centers primarily in the United States.
• Other Large and Medium-Sized Dialysis Organizations: These are healthcare companies that own and operate multiple dialysis clinics. While not always named individually in Rockwell Medical's public disclosures (beyond specific mentions like DaVita), these organizations collectively represent a substantial portion of Rockwell Medical's customer base for products like Triferic and dialysate concentrates. They are direct purchasers of Rockwell Medical's products for use in their clinics.
• Healthcare Distributors: Rockwell Medical also sells its products to wholesale distributors who then supply these products to various dialysis clinics, hospitals with dialysis units, and other healthcare facilities. These distributors act as intermediaries in the supply chain to reach a wider network of healthcare providers.

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Mark Strobeck, Ph.D. President and Chief Executive Officer

Dr. Strobeck brings over 20 years of operating, business development, capital raising, and investing experience in life sciences for both private and public biotechnology companies. Prior to joining Rockwell Medical in July 2022, he served as a Managing Partner at Aquilo Partners, a life science investment banking firm. He was previously Chief Operating Officer at Zyla Lifesciences, which was acquired by Assertio Therapeutics. He also served as President and CEO of Corridor Pharmaceuticals, which was acquired by AstraZeneca, and Chief Business Officer of Topaz Pharmaceuticals, acquired by Sanofi Pasteur. Dr. Strobeck also held management roles at GlaxoSmithKline plc and venture capital firms SR One Limited and EuclidSR Partners.

Jesse Neri Senior Vice President, Chief Financial Officer

Mr. Neri has nearly 25 years of experience leading finance functions at both public and private companies. He joined Rockwell Medical in October 2023 as SVP, Finance and was promoted to Chief Financial Officer in December 2024. Before Rockwell Medical, he was the Executive Director of Finance at Hemavant Sciences and Aruvant Sciences, clinical-stage biopharmaceutical companies that are part of the Roivant portfolio. Mr. Neri also served as Senior Vice President of Finance at Zyla Life Sciences, where he played a key role in its acquisition by Assertio Therapeutics in May 2020. Earlier, he was Vice President of Financial Planning and Analysis at Symphony Health Solutions, a private equity-backed market research company.

Heather R. Hunter Senior Vice President, Chief Operating Officer

Ms. Hunter joined Rockwell Medical in August 2022 as SVP, Chief Corporate Affairs Officer, and was promoted to Chief Operating Officer in September 2025. With over two decades of experience, she focuses on modernizing infrastructure, implementing operational efficiencies, and aligning execution with strategic priorities. Her prior experience includes roles as Vice President, Communications and Corporate Affairs at Venatorx Pharmaceuticals, a private, venture-backed company; Vice President, Marketing and Communications at Safeguard Scientifics, a venture capital firm; and Vice President, Corporate Communications at W.P. Carey.

Megan Timmins Executive Vice President, Chief Legal Officer and Secretary

Ms. Timmins has over twenty years of legal experience, including six years in the life sciences industry, and has served as Rockwell Medical's Executive Vice President, Chief Legal Officer and Secretary since August 2021. Before joining Rockwell, she held positions as Senior Vice President, General Counsel, and Corporate Secretary at Assertio Holdings, Inc. and Zyla Life Sciences (formerly Egalet Corporation), both publicly traded pharmaceutical companies.

Rashad Brown Vice President, Manufacturing and Supply Chain

Mr. Brown joined Rockwell Medical in November 2025, bringing over 20 years of leadership experience in manufacturing operations and supply chain optimization within regulated healthcare environments. He has previously held positions at Abbott Laboratories, Fresenius Medical Care, and Hearing Lab Technology. In his role, Mr. Brown oversees the company's manufacturing processes and supply chain operations.

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1. Loss of Major Customer and Revenue Decline: Rockwell Medical is facing a significant risk due to the reduction in contracts with its largest customer, DaVita. This has led to a substantial decline in net sales, with Q3 2025 net sales decreasing by 44% compared to Q3 2024, primarily due to this reduction. DaVita's contribution to Rockwell Medical's total revenues dropped from 52% in Q3 2024 to 12% in Q3 2025. The company anticipates a decline of $31 million to $38 million in net sales from this customer in 2025.
2. Unprofitability and Cash Burn: The company has a history of operating at a loss and burning through cash. In the last year, Rockwell Medical reported an earnings before interest and tax (EBIT) loss and burnt through US$2.9 million of cash, incurring a loss of US$5.9 million. While the company currently has net cash, its historical reliance on issuing new shares to finance operating losses poses a risk of future shareholder dilution.
3. Intense Competition and Regulatory Challenges: Rockwell Medical operates in a highly competitive market, particularly facing a formidable competitor in Fresenius Medical Care (FMS), which holds a significant market share and possesses greater resources. Additionally, as a healthcare company, Rockwell Medical is subject to substantial regulatory risks, including the resource-intensive and unpredictable approval processes of bodies like the FDA. The emergence of alternative and at-home dialysis technologies also presents a threat to Rockwell Medical's market share and potential revenue growth.

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The primary clear emerging threat for Rockwell Medical (RMTI) is the increasing market penetration and adoption of Hypoxia-Inducible Factor Prolyl Hydroxylase (HIF-PH) inhibitors for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis.

Specifically, Akebia Therapeutics' Vafseo (vadadustat), an oral HIF-PH inhibitor, received FDA approval in March 2023 for this patient population. As a new class of oral medication, Vafseo offers an alternative treatment pathway for anemia management in dialysis patients, a core market for Rockwell Medical's Triferic (ferric pyrophosphate citrate) and other anemia-related products.

While Triferic focuses on iron replacement to maintain hemoglobin and iron levels and reduce the need for intravenous iron and erythropoiesis-stimulating agents (ESAs), HIF-PH inhibitors like Vafseo directly stimulate red blood cell production, potentially reducing or replacing the need for ESAs. The availability of a new, orally administered agent directly targeting anemia in dialysis patients could shift treatment paradigms, capture market share, and reduce the overall demand for products like Triferic that address aspects of anemia management in this competitive landscape.

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Rockwell Medical (symbol: RMTI) has the following addressable markets for its main products:

• Hemodialysis Concentrates: The total addressable market in the U.S. is estimated at approximately $450 million in 2024, with an estimated Compound Annual Growth Rate (CAGR) of 4-6% through 2028. Another estimate for the U.S. in-center hemodialysis concentrates market values it at $380 million, anticipated to grow to approximately $500 million by 2026.
• Calcitriol: The global calcitriol market was valued at USD 456.19 million in 2024 and is projected to grow to USD 471.25 million in 2025 and USD 611.02 million by 2033, demonstrating a CAGR of 3.3% during the forecast period (2025–2033). North America accounted for a substantial share of the global calcitriol market in 2023.
• Triferic (and Triferic AVNU): Rockwell Medical discontinued the commercialization of Triferic and Triferic AVNU in the United States in the fourth quarter of 2022. The company is pursuing international partnerships for the development and commercialization of Triferic outside the United States.

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1. Expansion of Customer Base and New Partnerships: Rockwell Medical is actively pursuing new customer contracts and diversifying its customer base to offset the anticipated decline in volumes from its largest customer. The company aims to target additional customers, representing an estimated 14.5 million gallons of potential business within its distribution footprint. Recent agreements, such as the three-year product purchase agreement with Sanderling Renal Services, have expanded Rockwell Medical's distribution capabilities into new regions like Utah and other states, focusing on rural and underserved communities. Additionally, Rockwell Medical has renewed its supply agreement with Aqua Dialysis, expanding distribution to all Texas-based clinics, and entered into a multi-year partnership agreement with Innovative Renal Care (IRC) to supply hemodialysis concentrates to IRC's dialysis centers across the United States.

2. International Market Expansion for Existing Products: While commercialization of Triferic was discontinued in the United States, Rockwell Medical is pursuing international opportunities for its Ferric Pyrophosphate Citrate (FPC) program. Triferic and Triferic AVNU have been approved in South Korea, with a partner having launched Triferic in the third quarter of 2022. Furthermore, Rockwell anticipates approval for Triferic AVNU in Turkey in 2024, following a Marketing Authorization application and a grant of accelerated review status.

3. Development and Commercialization of FPC for New Indications: Rockwell Medical is exploring new applications for its proprietary parenteral iron product, Ferric Pyrophosphate Citrate (FPC). The company is initiating a clinical trial program for FPC for the treatment of iron deficiency anemia in the home-infusion setting, a large and growing segment of healthcare where FPC may offer advantages over existing therapies. Rockwell is also researching the application of FPC in the treatment of hospitalized acute heart failure patients, a condition affecting over a million people annually in the U.S.

4. Strategic Acquisitions: Rockwell Medical has demonstrated a strategy of growth through acquisitions, such as its acquisition of the hemodialysis concentrates business from Evoqua, which expanded its market share and customer base. The company is actively exploring partnerships and acquisitions as part of its strategy to compensate for potential revenue declines and diversify its operations.

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Share Issuance

• In 2022, Rockwell Medical received approximately $30.016 million from the issuance of common and preferred shares.
• As of January 2025, Rockwell Medical has a controlled equity offering sales agreement that permits the company to raise up to $25 million through stock issuance at market prices if necessary.
• A potential equity raise capped at $25 million in 2025 is projected to result in a 34% share dilution under a bull case scenario.

Capital Expenditures

• For the first six months of 2022, Rockwell Medical utilized $39 thousand for the purchase of property and equipment.
• The primary focus for capital allocation in 2025 is on continuing to invest in capital, specifically targeting the expansion of manufacturing automation.