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ROCKWELL MEDICAL, INC.

For the period ended Dec 31, 2024. Filed Mar 20, 2025.

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About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Mar 20, 2025

RMTI$7.52-2.7%Stored close · as of Nov 9, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

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Contents

Table of Contents

Page
PART I
Item 1. Business.4
Item 1A. Risk Factors.17
Item 1B. Unresolved Staff Comments.30
Item 1C. Cybersecurity.30
Item 2. Properties.32
Item 3. Legal Proceedings.32
Item 4. Mine Safety Disclosures.32
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.33
Item 6. Reserved.33
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.33
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.39
Item 8. Financial Statements and Supplementary Data.39
Item 9. Changes In and Disagreements With Accountants on Accounting and Financial Disclosure.39
Item 9A. Controls and Procedures.40
Item 9B. Other Information.41
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.41
PART III
Item 10. Directors, Executive Officers and Corporate Governance.42
Item 11. Executive Compensation.42
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.42
Item 13. Certain Relationships and Related Transactions, and Director Independence.42
Item 14. Principal Accounting Fees and Services.42
PART IV
Item 15. Exhibits, Financial Statement Schedules.43
SIGNATURES46

Forward Looking Statements

We make, or incorporate by reference, “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, in this Annual Report on Form 10-K. All statements other than statements of historical fact are forward-looking statements. Our forward-looking statements are subject to risks and uncertainties and include information about our current expectations and possible or assumed future results of our operations. When we use words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,” “plan,” “potential,” “predict,” “forecast,” “project,” “intend,” or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward-looking statements. Our forward looking statements also include, without limitation, statements about our liquidity and capital resources; our ability to continue as a going concern; our ability to successfully negotiate a contract extension and/or future volume commitments by DaVita; our ability to successfully integrate acquisitions; our ability to raise additional capital; our ability to successfully implement certain cost containment and cost-cutting measures; our ability to achieve profitability; our ability to successfully execute on our business strategy; and statements regarding our anticipated future financial condition, operating results, cash flows and business plans. Because these forward-looking statements are based on estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different from the anticipated future results, performance or achievements expressed or implied by any forward-looking statements. Such business, economic and competitive uncertainties include:

our ability to fill the revenue gap resulting from the lost DaVita business;

any change in our customers’ interest in buying bundled products that include concentrates;

any further increases in raw material, labor, fuel or other input costs, particularly if we are unable to pass these cost increases along to our customers;

our ability to negotiate favorable agreements with customers and obtain and/or retain major customers and distributors;

the duration over which our cash balances will fund our operations;

our ability to grow our business;

our expectations for generating revenue or becoming profitable on a sustained basis;

our ability to obtain additional financing and raise capital as necessary to fund operations or pursue business opportunities;

our expectations regarding our ability to enter into marketing and other partnership agreements, including amendments to our existing agreements;

our ability to comply with affirmative and negative covenants under our Loan and Security Agreement (the "Loan Agreement") with Innovatus Life Sciences Lending Fund I, LP, (“Innovatus”);

the effects of macroeconomic conditions, geopolitical events and pandemics on patients, our customers and distributors, and our business, including manufacturing operations and suppliers;

the availability of adequate reimbursement for our products from insurance companies and the government;

our ability to use existing inventory before shelf life expiration;

the safety and efficacy of our products;

our expectations regarding the timing of submissions to, and decisions made by, the U.S. Food and Drug Administration ("FDA"), and other regulatory agencies, including foreign regulatory agencies;

our estimates regarding the capacity of manufacturing and other facilities to support our products;

our ability to compete against other companies;

our ability to attract and retain key personnel;

our expectations for increases or decreases in expenses;

our expectations for incurring capital expenditures to expand our manufacturing capabilities;

our expectations regarding the effect of changes in accounting guidance or standards on our operating results;

the impact of any cybersecurity breaches or cyber crime that we, our vendors or our customers may experience;

the impact of healthcare reform laws and other government laws and regulations;

the impact of potential shareholder activism; and

those factors identified in this Annual Report on Form 10-K under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in other filings we periodically make with the Securities and Exchange Commission.

You should evaluate all forward-looking statements made in this Annual Report on Form 10-K, including the documents we incorporate by reference, in the context of these risks, uncertainties and other factors. Other factors not currently anticipated may also materially and adversely affect our results of operations, cash flows, business, prospects and financial position.

Readers should not place undue reliance on any such forward-looking statements, which are based on information available to us on the date of this report or, if made elsewhere, as of the date made. We do not undertake, and expressly disclaim, any intention to update or alter any statements whether as a result of new information, future events or otherwise except as required by law.

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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.