What changed in this filing

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Item 1. Financial Statements

2025-11-12 compared with 2025-08-14 · 168 added, 125 removed, 579 unchanged (34% of the section changed)

4 unchanged sentences

(In thousands, except share and par value amounts)

September 30,

2025 December 31,

8 unchanged sentences

Right of Use Assets - Operating, net 2,991 3,215

Right of Use Assets - Financing, net 1,066 1,344

Right of Use Assets - Finance, net 753 1,344

Intangible Assets, net 9,794 10,207

7 unchanged sentences

Lease Liabilities - Operating - Current 1,318 1,566

Lease Liabilities - Financing - Current 622 599

Lease Liabilities - Finance - Current 461 599

Deferred License Revenue - Current — 46

9 unchanged sentences

Commitments and Contingencies (see Note 13)

September 30,

2025 December 31,

1 unchanged sentence

Preferred Stock, $ 0.0001 par value, 2,000,000 shares authorized;

15,000 shares issued and outstanding at June 30, 2025 and December 31, 2024

15,000 shares issued and outstanding at September 30, 2025 and December 31, 2024

Common Stock, $ 0.0001 par value;

170,000,000 shares authorized;

34,430,352 and 34,056,920 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively

39,405,301 and 34,056,920 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively

Additional Paid-in Capital 439,381 430,207

8 unchanged sentences

(In thousands, except share and per share amounts)

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

19 unchanged sentences

AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME

(In thousands)

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

16 unchanged sentences

Balance as of January 1, 2025

15,000 $ — 34,056,920 $ 3 $ 430,207 $ ( 397,678 ) $ 54 $ 32,586

Net Loss — — — — — ( 1,515 ) — ( 1,515 )

4 unchanged sentences

Balance as of March 31, 2025

15,000 — 34,257,903 3 430,652 ( 399,193 ) 60 31,522

Net Loss — — — — — ( 1,492 ) — ( 1,492 )

4 unchanged sentences

Balance as of June 30, 2025

15,000 — 34,430,352 3 431,034 ( 400,685 ) 57 30,409

Net Loss — — — — — ( 1,753 ) — ( 1,753 )

Reclassification of Realized Gain on Available-for-Sale Investments — — — — — — ( 61 ) ( 61 )

Unrealized Gain on Available-for-Sale Investments — — — — — — 77 77

Issuance of Common Stock, net of offering costs/At-the-Market Offering — — 4,964,636 1 7,799 — — 7,800

Issuance of Common Stock upon Exercise of Options — — 10,313 — 16 — — 16

Stock-based Compensation — — — — 532 — — 532

Balance as of September 30, 2025

15,000 $ — 39,405,301 $ 4 $ 439,381 $ ( 402,438 ) $ 73 $ 37,020

The accompanying notes are an integral part of the condensed consolidated financial statements.

6 unchanged sentences

COMPREHENSIVE

INCOME (LOSS) TOTAL

(LOSS) INCOME TOTAL

STOCKHOLDERS'

1 unchanged sentence

Balance as of January 1, 2024

15,000 $ — 29,130,607 $ 3 $ 418,487 $ ( 397,198 ) $ ( 1 ) $ 21,291

Net Loss — — — — — ( 1,731 ) — ( 1,731 )

6 unchanged sentences

Balance as of March 31, 2024

15,000 — 29,556,474 3 419,545 ( 398,929 ) 24 20,643

Net Income — — — — — 343 — 343

5 unchanged sentences

Balance as of June 30, 2024

15,000 — 31,030,218 3 422,086 ( 398,586 ) ( 5 ) 23,498

Net Income — — — — — 1,664 — 1,664

Unrealized Gain on Available-for-Sale Investments — — — — — — 13 13

Issuance of Common Stock, net of offering costs/At-the-Market Offering — — 1,282,546 — 3,630 — — 3,630

Issuance of Common Stock upon Exercise of Options — — 6,042 — 9 — — 9

Stock-based Compensation — — — — 321 — — 321

Balance as of September 30, 2024

15,000 $ — 32,318,806 $ 3 $ 426,046 $ ( 396,922 ) $ 8 $ 29,135

The accompanying notes are an integral part of the condensed consolidated financial statements.

3 unchanged sentences

(In thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Cash Flows From Operating Activities:

Net Loss $ ( 3,007 ) $ ( 1,388 )

Net (Loss) Income $ ( 4,760 ) $ 276

Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:

2 unchanged sentences

Write-off of Inventory 178 —

Change in Inventory Reserves ( 61 ) 314

Non-cash Lease Expense from Right of Use Assets 1,616 1,446

2 unchanged sentences

Realized Gain on Sale of Investments ( 181 ) ( 51 )

Gain on ROU early terminations ( 24 ) —

Changes in Operating Assets and Liabilities:

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Deferred License Revenue ( 475 ) ( 34 )

Net Cash Used In Operating Activities ( 1,643 ) ( 938 )

Net Cash (Used In) Provided By Operating Activities ( 2,950 ) 3,337

Cash Flows From Investing Activities:

Purchases of Investments Available-for-Sale ( 12,957 ) ( 5,921 )

Sale of Investments Available-for-Sale 6,000 2,003

Purchase of Equipment ( 227 ) ( 425 )

Net Cash (Used In) Provided By Investing Activities ( 104 ) 1,578

Proceeds from sales of Investments Available-for-Sale 9,000 2,003

Purchases of Equipment ( 456 ) ( 616 )

Net Cash Used In Investing Activities ( 4,413 ) ( 4,534 )

Cash Flows From Financing Activities:

3 unchanged sentences

Deferred Consideration Paid in Connection with Evoqua Asset Acquisition

Net Cash (Used In) Provided By Financing Activities ( 1,433 ) 2,243

( 1,621 ) ( 976 )

Net Cash Provided By Financing Activities 5,311 4,556

Effect of Exchange Rate Changes on Cash and Cash Equivalents — ( 4 )

7 unchanged sentences

Right of Use Assets - Operating Obtained in Exchange for Lease Liabilities - Operating $ 1,006 $ 1,984

De-recognition of Lease Liability - Finance and ROU Asset - Finance upon early termination $ 228 $ —

Change in Unrealized Gain on Investments Available-for-Sale $ 19 $ 13

Increase in Prepaid Assets from Insurance Financing Note Payable $ 660 $ 670

Proceeds from Issuance of Common Stock Upon Exercise of Options in Accounts Receivable, net $ — $ 9

The accompanying notes are an integral part of the condensed consolidated financial statements.

5 unchanged sentences

(the "Company," "Rockwell," or "Rockwell Medical") is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide.

Rockwell is a leading supplier of liquid and dry, acid and bicarbonate concentrates for dialysis patients in the United States.

Rockwell is a supplier of liquid and dry, acid and bicarbonate concentrates for dialysis patients in the United States.

Hemodialysis is the most common form of end-stage kidney disease treatment and is usually performed in freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or a patient’s home.

Rockwell manufactures hemodialysis concentrates under current Good Manufacturing Practices ("cGMP") regulations at its three facilities in Michigan, South Carolina, and Texas, and manufactures dry acid concentrate mixers at its facility in Iowa.

Rockwell manufactures hemodialysis concentrates under current Good Manufacturing Practices ("cGMP") regulations at its facilities in Michigan and Texas, and manufactures dry acid concentrate mixers at its facility in Iowa.

The Company previously operated a manufacturing facility in South Carolina, but the Company concluded manufacturing at that manufacturing facility in the third quarter of 2025 as part of its ongoing efforts to streamline operations and improve efficiency.

Rockwell delivers the majority of its hemodialysis concentrates products and mixers to dialysis clinics throughout the United States and internationally utilizing its own delivery trucks and third-party carriers.

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Liquidity and Capital Resources

As of June 30, 2025, Rockwell had approximately $ 18.4 million of cash, cash equivalents and investments available-for-sale, and net working capital of $ 20.7 million.

Net cash used in operating activities for the six months ended June 30, 2025 was approximately $ 1.6 million.

As of September 30, 2025, Rockwell had approximately $ 23.7 million of cash, cash equivalents and investments available-for-sale, and net working capital of $ 27.9 million.

Net cash used in operating activities for the nine months ended September 30, 2025 was approximately $ 3.0 million.

Based on the currently available net working capital along with the expectation of management of its ability to execute on its operational plans as discussed below, management believes the Company currently has sufficient funds to meet its operating requirements for at least the next twelve months from the date of the filing of this report.

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The Company is subject to certain covenants and cure provisions under its Loan Agreement (as defined below in Note 15) with Innovatus Life Sciences Lending Fund I, LP ("Innovatus"), which was amended on January 2, 2024 to include, among other things, an interest-only period for 30 months, or up to 36 months if certain conditions are met, and to extend the maturity date to January 1, 2029 (See Note 15 for further detail).

The Company has satisfied those conditions and will now make interest-only payments for the full 36 months.

As of June 30, 2025, the Company was in compliance with all covenants, except for the revenue covenant, which was remediated pursuant to the terms of the Loan Agreement by agreeing to an updated financial projection with Innovatus.

The Company has satisfied those conditions and will make interest-only payments for the full 36 months.

As of September 30, 2025, the Company was in compliance with all covenants.

In addition, the global macroeconomic environment is uncertain, and could be negatively affected by, among other things, changes in U.S.

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federal statute passed by the 119th United States Congress that included tax and spending policies (the “Act”), which contains a broad range of tax reform provisions affecting businesses, including extending or reinstating certain provisions of the 2017 Tax Cuts and Jobs Act, tax relief measures, modifications of certain energy tax credits granted under the Inflation Reduction Act and limits on various tax deductions, among other key provisions.

The Company is currently evaluating the full effects of the Act on its condensed consolidated financial statements.

As the Act was signed into law after the close of the second quarter, the impacts are not included in the Company’s operating results for the six months ended June 30, 2025.

The Company evaluated the Act and concluded it will not have a material impact on its condensed consolidated financial statements.

Rockwell has utilized a range of financing methods to fund its operations in the past;

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Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements.

The condensed consolidated balance sheet at June 30, 2025, and the condensed consolidated statements of operations, comprehensive loss, changes in stockholders' equity, and cash flows for the three and six months ended June 30, 2025 and 2024 are unaudited, but include all adjustments, consisting of normal recurring adjustments the Company considers necessary for a fair presentation of the financial position, operating results, and cash flows for the periods presented.

The results for the three and six months ended June 30, 2025 are not necessarily indicative of results to be expected for the year ending December 31, 2025 or for any future interim period.

The condensed consolidated balance sheet at September 30, 2025, and the condensed consolidated statements of operations, comprehensive loss, changes in stockholders' equity, and cash flows for the three and nine months ended September 30, 2025 and 2024 are unaudited, but include all adjustments, consisting of normal recurring adjustments the Company considers necessary for a fair presentation of the financial position, operating results, and cash flows for the periods presented.

The results for the three and nine months ended September 30, 2025 are not necessarily indicative of results to be expected for the year ending December 31, 2025 or for any future interim period.

The condensed consolidated balance sheet at December 31, 2024 has been derived from audited financial statements;

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The most significant accounting estimates inherent in the preparation of the financial statements include estimates associated with revenue recognition and impairments of long-lived assets.

Restructuring and Other Charges

During the third quarter of 2025, the Company concluded manufacturing at its facility in Greer, South Carolina as part of its ongoing efforts to streamline operations and improve efficiency.

This was neither material to the Company’s overall financial position nor performance.

As a result, the Company incurred severance expense and other closure-related costs during the three and nine months ended September 30, 2025 of $ 0.5 million and $ 0.8 million, respectively, which were included in cost of sales on the accompanying condensed consolidated statements of operations.

No impairment losses were recorded, as the plant's assets were either fully depreciated prior to closure or transferred to other operating locations.

The closure is not expected to have a significant impact on the Company's future operations, and the restructuring activities associated with this closure are expected to be substantially completed by December 31, 2025.

Income (Loss) Per Share

Basic and diluted net income (loss) per share for the three and six months ended June 30, 2025 and 2024 was calculated as follows:

Three Months Ended June 30, Six Months Ended June 30,

Basic and diluted net income (loss) per share for the three and nine months ended September 30, 2025 and 2024 was calculated as follows:

Three Months Ended September 30, Nine Months Ended September 30,

(In thousands, except share and per share amounts) 2025 2024 2025 2024

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Incremental Shares Attributable to the Assumed Vesting of Unvested Restricted Stock Units — 318,046 — 282,340

Incremental Shares Attributable to the Assumed Conversion of Preferred Stock — 1,363,636 — —

Incremental Shares Attributable to the Assumed Exercise of Warrants — 61,124 — 12,154

Diluted Weighted Average Number of Shares of Common Stock Outstanding 36,024,940 32,420,168 34,817,973 31,013,464

9 unchanged sentences

computation of diluted EPS attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

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The Company is currently assessing the impact this ASU will have on the consolidated financial statements and footnote disclosures.

In November 2024, the FASB issued ASC 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):

Disaggregation of Income Statement Expense s, which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation and amortization) included in certain expense captions presented on the consolidated statement of operations.

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The Company is currently assessing the impact this ASU will have on the consolidated financial statements and footnote disclosures.

In July 2025, the FASB issued ASU 2025-05, Financial Instruments - Credit Losses (Topic 326):

Measurement of Credit Losses for Accounts Receivable and Contract Assets , which simplifies the estimation of credit losses on current accounts receivable and contract assets by allowing the election of a practical expedient to assume that the current conditions as of the consolidated balance sheet date will remain unchanged for the remaining life of the asset when developing a reasonable and supportable forecast as part of estimating expected credit losses on these assets.

The guidance in this ASU is effective for fiscal years beginning after December 15, 2025 and for interim periods within those fiscal years.

Early adoption is permitted.

If adopted in an interim period, entities are required to apply the new guidance as of the beginning of the annual reporting period that includes such interim period.

The Company is currently assessing the impact this ASU will have on the consolidated financial statements and footnote disclosures .

Revenue Recognition

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Rockwell's customer mix is diverse, with most customer sales concentrations under 10%.

For the three months ended June 30, 2025, revenues from sales to three customers, DaVita, Inc.

("DaVita"), Fresenius Medical Care North America ("Fresenius") and Nipro Medical Corporation ("Nipro") were approximately 11 %, 10 % and 11 % of total revenues for the period, respectively, and 20 %, 10 % and 9 % of total revenues for the six months ended June 30, 2025, respectively.

For the three months ended June 30, 2024, revenues from DaVita, Fresenius and Nipro were approximately 45 %, 8 % and 7 % of total revenues for the period, respectively, and 44 %, 7 % and 6 % of total revenues for the six months ended June 30, 2024, respectively.

At June 30, 2025, DaVita, Nipro and Fresenius represented 5 %, 15 %, and 11 % of the total net consolidated accounts receivable balance, respectively.

For the three months ended September 30, 2025, revenues from sales to two customers, DaVita, Inc.

("DaVita") and another customer were approximately 12 % and 11 % of total revenues for the period, respectively, and 17 % and 10 % of total revenues for the nine months ended September 30, 2025, respectively.

For the three months ended September 30, 2024, revenues from DaVita was 52 % of total revenues for the period, and 47 % of total revenues for the nine months ended September 30, 2024.

At September 30, 2025, DaVita represented 12 % of the total net consolidated accounts receivable balance.

At December 31, 2024, DaVita represented 20 % of the total net consolidated accounts receivable balance.

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The Company received upfront fees under three distribution and license agreements, which were recognized as revenue over the estimated term of the applicable distribution and license agreement as regulatory approval was not received and the Company did not have sufficient experience in China, India, South Korea and Turkey to determine that regulatory approval was probable as of the execution of the agreement.

During the six months ended June 30, 2025, all remaining deferred revenue relating to the distribution and license agreements was recognized, resulting in $ 0.3 million of revenue recorded.

During the nine months ended September 30, 2025, all remaining deferred

revenue relating to the distribution and license agreements was recognized, resulting in $ 0.3 million of revenue recorded.

All license agreements have been terminated.

Product Purchase Agreement

On September 18, 2023, Rockwell and its long-time customer, DaVita, a leading provider of kidney care, entered into an Amended and Restated Products Purchase Agreement (the "Amended Agreement"), which amends and restates the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates.

On September 18, 2023, Rockwell and its long-time customer, DaVita, a provider of kidney care, entered into an Amended and Restated Products Purchase Agreement (the "Amended Agreement"), which amends and restates the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates.

Under the Amended Agreement, the Company and DaVita agreed to an increase in product pricing, effective September 1, 2023.

The term of the Amended Agreement was scheduled to expire on December 31, 2024.

expiration, the Company received written notice from DaVita, notifying the Company that DaVita intended to extend the term of the Amended Agreement through December 31, 2025 (the "Extension Term").

However, DaVita subsequently indicated that it will completely transition to another supplier by mid-2025, subject to further discussion between Rockwell and DaVita.

DaVita has agreed to quarterly, non-refundable payments totaling $ 1.3 million during the six months ended June 30, 2025 to ensure supply continuity during the transition period for products purchased.

These quarterly, non-refundable payments of $ 0.3 million and $ 1.3 million were recorded as revenue during the three and six months ended June 30, 2025, respectively.

Prior to the expiration, the Company received written notice from DaVita, notifying the Company that DaVita intended to extend the term of the Amended Agreement through December 31, 2025 (the "Extension Term").

However , DaVita subsequently indicated that it will completely transition to another supplier, subject to further discussion between Rockwell and DaVita.

DaVita has agreed to quarterly, non-refundable payments totaling $ 1.7 million during the nine months ended September 30, 2025 to ensure supply continuity during the transition period for products purchased.

These quarterly, non-refundable payments of $ 0.4 million and $ 1.7 million were recorded as revenue during the three and nine months ended September 30, 2025, respectively.

Discussions between Rockwell and DaVita are ongoing and the Company continues to supply DaVita as of the filing date of this report.

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Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition.

In thousands Three Months Ended June 30, 2025 Six Months Ended June 30, 2025

In thousands Three Months Ended September 30, 2025 Nine Months Ended September 30, 2025

Products By Geographic Area Total U.S.

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Net Revenue $ 15,927 $ 13,824 $ 2,103 $ 50,912 $ 44,449 $ 6,463

In thousands Three Months Ended June 30, 2024 Six Months Ended June 30, 2024

In thousands Three Months Ended September 30, 2024 Nine Months Ended September 30, 2024

Products By Geographic Area Total U.S.

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The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers.

In thousands June 30, 2025 December 31, 2024 January 1, 2024

In thousands September 30, 2025 December 31, 2024 January 1, 2024

Accounts Receivable, net $ 8,328 $ 8,291 $ 10,901

Contract Liabilities, which are included in deferred license revenue $ — $ 475 $ 521

There were no other material contract assets recorded on the condensed consolidated balance sheets as of June 30, 2025 and December 31, 2024.

The Company does not generally accept returns of its concentrate products and no material reserve for returns of concentrates products was established as of June 30, 2025 or December 31, 2024.

There were no other material contract assets recorded on the condensed consolidated balance sheets as of September 30, 2025 and December 31, 2024.

The Company does not generally accept returns of its concentrate products and no material provision for returns of concentrates products was established as of September 30, 2025 or December 31, 2024.

Transaction price allocated to remaining performance obligations

Revenue expected to be recognized in any future year related to remaining performance obligations, excluding revenue pertaining to contracts that have an original expected duration of one year or less, contracts where revenue is recognized as invoiced and contracts with variable consideration related to undelivered performance obligations, was nil as of June 30, 2025.

The Company applies the practical expedient in ASC 606, paragraph 606-10-50-14 and does not disclose information about remaining performance obligations that have original expected durations of one year or less.

ROCKWELL MEDICAL, INC.

AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

Intangible Assets and Deferred Consideration

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The details of our intangible assets subject to amortization are set forth below (in thousands):

June 30, 2025

September 30, 2025

Useful Life Gross Carrying Amount Accumulated Amortization Net Carrying Amount

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Customer Relationships 20 years $ 11,035 $ ( 828 ) $ 10,207

During each of the three months ended June 30, 2025 and 2024, the Company recorded amortization of its customer relationship intangible asset of $ 0.1 million.

During each of the six months ended June 30, 2025 and 2024, the Company recorded amortization of its customer relationship intangible asset of $ 0.3 million.

Estimated future amortization expense on the Company's customer relationships intangible asset as of June 30, 2025 is as follows (table in thousands):

During each of the three months ended September 30, 2025 and 2024, the Company recorded amortization of its customer relationship intangible asset of $ 0.1 million.

During each of the nine months ended September 30, 2025 and 2024, the Company recorded amortization of its customer relationship intangible asset of $ 0.4 million.

Estimated future amortization expense on the Company's customer relationships intangible asset as of September 30, 2025 is as follows (table in thousands):

Year ending December 31:

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Total $ 9,794

Deferred Consideration

A portion of the purchase price of the Evoqua Asset Acquisition was deferred on the acquisition date, with payment terms extending through April 2026.

During the three and six months ended June 30, 2025, we made payments of $ 0.4 million and $ 0.9 million, respectively.

As of June 30, 2025, a deferred consideration liability of $ 2.5 million is presented in Deferred Consideration - Current on the accompanying condensed consolidated balance sheet.

ROCKWELL MEDICAL, INC.

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Notes to Condensed Consolidated Financial Statements

Deferred Consideration

A portion of the purchase price of the Evoqua Asset Acquisition was deferred on the acquisition date, with payment terms extending through April 2026.

During the three and nine months ended September 30, 2025, the Company made payments of $ 0.8 million and $ 1.6 million, respectively.

As of September 30, 2025, a deferred consideration liability of $ 1.8 million is presented in Deferred Consideration - Current on the accompanying condensed consolidated balance sheet.

Investments - Available-for-Sale

Investments available-for-sale consisted of the following as of June 30, 2025 and December 31, 2024 (table in thousands):

June 30, 2025

Investments available-for-sale consisted of the following as of September 30, 2025 and December 31, 2024 (table in thousands):

September 30, 2025

Amortized Cost Unrealized Gain Fair Value

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The fair value of investments available-for-sale are determined using quoted market prices from daily exchange-traded markets based on the closing price as of the balance sheet date and are classified as a Level 1 measurement under ASC 820, Fair Value Measurements.

During the three and six months ended June 30, 2025, the Company sold the investments outstanding as of March 31, 2025 and December 31, 2024 for $ 0.1 million and $ 0.1 million, respectively, which is included in realized gain on available-for-sale investments on the condensed consolidated statements of operations.

As of June 30, 2025, the Company's remaining available-for-sale securities are U.S.

During the three and nine months ended September 30, 2025, the Company sold investments outstanding for a gain of $ 0.1 million and $ 0.2 million, respectively, which is included in realized gain on available-for-sale investments on the condensed consolidated statements of operations.

As of September 30, 2025, the Company's remaining available-for-sale securities are U.S.

Department of the Treasury bonds and are all due within one year.

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The accounting policies of the segment are the same as those described in the summary of significant accounting policies.

The CODM assesses performance for the segment and decides how to allocate resources based on net loss that also is reported on the statements of operations and comprehensive loss as net loss.

The CODM assesses performance for the segment and decides how to allocate resources based on net (loss) income that also is reported on the statements of operations and comprehensive loss as net loss.

The CODM uses net loss to monitor budget and forecast versus actual results in assessing segment performance, as well as cash forecast models, in order to evaluate operating results and performance in deciding how to allocate resources.

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Notes to Condensed Consolidated Financial Statements

The Company’s significant segment expenses for its one segment for the three and six months ended June 30, 2025 and 2024 consisted of the following (table in thousands):

Three Months Ended June 30, Six Months Ended June 30,

The Company’s significant segment expenses for its one segment for the three and nine months ended September 30, 2025 and 2024 consisted of the following (table in thousands):

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

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Net (Loss) Income $ ( 1,753 ) $ 1,664 $ ( 4,760 ) $ 276

Components of inventory, net of reserves, as of June 30, 2025 and December 31, 2024 were as follows (table in thousands):

Components of inventory, net of reserves, as of September 30, 2025 and December 31, 2024 were as follows (table in thousands):

September 30,

2025 December 31,

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(See Note 4, Deferred License Revenue section).

During the six months ended June 30, 2025, the Company wrote off this remaining inventory balance, resulting in an expense of $ 0.2 million recorded within cost of sales in the condensed consolidated statement of operations.

As of June 30, 2025 and December 31, 2024, Rockwell had total current concentrate inventory aggregating $ 4.7 million and $ 6.2 million, respectively, against which Rockwell had reserved $ 0.5 million at both June 30, 2025 and December 31, 2024.

During the nine months ended September 30, 2025, the Company wrote off this remaining inventory balance, resulting in an expense of $ 0.2 million recorded within cost of sales in the condensed consolidated statement of operations.

As of September 30, 2025 and December 31, 2024, Rockwell had total current concentrate inventory aggregating $ 4.4 million and $ 6.2 million, respectively, against which Rockwell had reserved $ 0.4 million and $ 0.5 million at September 30, 2025 and December 31, 2024, respectively.

ROCKWELL MEDICAL, INC.

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Property and Equipment

As of June 30, 2025 and December 31, 2024, the Company’s property and equipment consisted of the following (table in thousands):

As of September 30, 2025 and December 31, 2024, the Company’s property and equipment consisted of the following (table in thousands):

September 30,

2025 December 31,

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Property and Equipment, net $ 4,952 $ 5,785

Depreciation and amortization expense for each of the three months ended June 30, 2025 and 2024 was $ 0.4 million.

Depreciation and amortization expense for each of the six months ended June 30, 2025 and 2024 was $ 0.8 million.

Depreciation and amortization expense for each of the three months ended September 30, 2025 and 2024 was $ 0.4 million.

Depreciation and amortization expense for each of the nine months ended September 30, 2025 and 2024 was $ 1.2 million.

Accrued Liabilities

Accrued liabilities as of June 30, 2025 and December 31, 2024 consisted of the following (table in thousands):

Accrued liabilities as of September 30, 2025 and December 31, 2024 consisted of the following (table in thousands):

September 30,

2025 December 31,

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If the Company’s common stock trades above $ 22.00 for a period of 30 calendar days, the accretion will thereafter cease.

As of June 30, 2025, the Series X Preferred Stock accreted a total of $ 0.5 million.

As of September 30, 2025, a total of $ 0.5 million of the Series X Preferred Stock had been accreted, of which $ 0.2 million accreted during the nine months ended September 30, 2025.

The Series X Convertible Preferred Stock is convertible to common stock at a rate equal to the Face Amount, divided by a conversion price of $ 11.00 per share (subject to adjustment for future stock splits, reverse stock splits and similar recapitalization events).

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The Company will assess at each reporting period whether conditions have changed to now meet the mandatory redemption definition which could trigger liability classification.

As of each of June 30, 2025 and December 31, 2024, there were 2,000,000 shares of preferred stock, $ 0.0001 par value per share, authorized and 15,000 shares of preferred stock issued and outstanding.

As of June 30, 2025 and 2024, the Company reserved for issuance the following shares of common stock related to the potential exercise of employee stock options, unvested restricted stock and awards, convertible preferred stock, and warrants (collectively, "common stock equivalents"):

As of June 30,

As of each of September 30, 2025 and December 31, 2024, there were 2,000,000 shares of preferred stock, $ 0.0001 par value per share, authorized and 15,000 shares of preferred stock issued and outstanding.

As of September 30, 2025 and 2024, the Company reserved for issuance the following shares of common stock related to the potential exercise of employee stock options, unvested restricted stock and awards, convertible preferred stock, and warrants (collectively, "common stock equivalents"):

As of September 30,

Common Stock and Common Stock Equivalents:

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The offering and sale of such shares has been registered under the Securities Act of 1933, as amended.

During the three and six months ended June 30, 2025, no shares were sold pursuant to the Sales Agreement.

During the three and nine months ended September 30, 2025, 4,964,636 shares were sold pursuant to the Sales Agreement for gross proceeds of $ 8.0 million, net of offering costs of $ 0.2 million, for net proceeds of $ 7.8 million.

Approximately $ 13.1 million remains available for sale under the ATM facility.

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The number of shares of common stock for which the warrant is exercisable and the exercise price are subject to certain proportional adjustments as set forth in the Third Amendment.

The warrant is equity-classified with a fair value of approximately $ 0.2 million at issuance, which was treated as a debt issuance cost and is being amortized through interest expense over the remaining contractual term of the Term Loans, as defined and described in Note 15.

ROCKWELL MEDICAL, INC.

AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

The warrant is equity-classified with a fair value of approximately $ 0.2 million

at issuance, which was treated as a debt issuance cost and is being amortized through interest expense over the remaining contractual term of the Term Loans, as defined and described in Note 15.

Stock-based Compensation

The Company recognized total stock-based compensation expense during the three and six months ended June 30, 2025 and 2024 as follows (table in thousands):

Three Months Ended June 30, Six Months Ended June 30,

The Company recognized total stock-based compensation expense during the three and nine months ended September 30, 2025 and 2024 as follows (table in thousands):

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

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Performance-based Restricted Stock Awards

A summary of the Company’s performance-based restricted stock awards during the six months ended June 30, 2025 is as follows:

A summary of the Company’s performance-based restricted stock awards during the nine months ended September 30, 2025 is as follows:

Performance-based Restricted Stock Awards Number of Shares Weighted Average

Unvested at January 1, 2025 891 $ 62.70

Unvested at June 30, 2025 891 $ 62.70

Unvested at September 30, 2025 891 $ 62.70

Performance-based restricted stock awards are measured based on their fair value on the date of grant and amortized over the vesting period of 20 months.

As of June 30, 2025, there is no unrecognized stock-based compensation expense related to performance-based restricted stock awards.

As of September 30, 2025, there is no unrecognized stock-based compensation expense related to performance-based restricted stock awards.

Restricted Stock Units - Market Condition

During the three months ended June 30, 2025, the Company granted 717,000 restricted stock units with a market condition ("RSU-MC") under its Amended and Restated 2018 Long Term Incentive Plan.

During the nine months ended September 30, 2025, the Company granted 717,000 restricted stock units with a market condition ("RSU-MC") under its Amended and Restated 2018 Long Term Incentive Plan with a grant date fair value of $ 0.6 million.

The RSU-MCs are subject to both service and market based vesting conditions.

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The RSU-MCs qualify as equity instruments and are accounted for under ASC 718, Compensation, Stock Compensation ("ASU 718").

The fair value of RSU-MCs was measured on the date of grant using the Monte Carlo Simulation valuation model.

The stock-based compensation expense recorded in connection with these restricted stock units during the six months ended June 30, 2025 was insignificant.

The vesting periods range from one to three years.

The stock-based compensation expense recorded in connection with the RSU-MCs was $ 0.1 million for the three and nine months ended September 30, 2025.

The fair value of RSU-MCs was measured on the date of grant using the Monte Carlo Simulation valuation model based on the following assumptions:

Exercise price $ 1.07

Expected stock price volatility 93.0 %

Risk-free interest rate 4.0 %

Term (years) 2.50

ROCKWELL MEDICAL, INC.

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Service-based Restricted Stock Units

A summary of the Company’s service-based restricted stock units during the six months ended June 30, 2025 is as follows:

A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2025 and 2024 is as follows:

Service-based Restricted Stock Units Number of Shares Weighted Average

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Vested ( 417,649 ) 1.85

Unvested at June 30, 2025 1,166,660 $ 1.12

Unvested at September 30, 2025 1,166,660 $ 1.12

The fair value of service-based restricted stock units is measured on the date of grant and amortized over the vesting period.

The vesting periods range from one to three years.

As of June 30, 2025, the unrecognized stock-based compensation expense was $ 1.1 million, which is expected to be recognized over the next 1.6 years.

As of September 30, 2025, the unrecognized stock-based compensation expense was $ 0.9 million, which is expected to be recognized over the next 1.4 years.

Service-based Stock Option Awards

The fair value of the service-based stock option awards granted during the six months ended June 30, 2025 were based on the following assumptions:

Six Months Ended

June 30, 2025

Six Months Ended

June 30, 2024

The fair value of the service-based stock option awards granted during the nine months ended September 30, 2025 and 2024 were based on the following assumptions:

Nine Months Ended September 30, 2025 Nine Months Ended September 30, 2024

Exercise price $ 1.07 - $ 1.26

$ 1.39 - $ 1.80

Expected stock price volatility 90.4 % - 91.2 %

Risk-free interest rate 3.74 % - 4.14 %

4.31 % - 4.45 %

Term (years) 5.62 - 5.86

A summary of the Company’s service-based stock option activity for the six months ended June 30, 2025 is as follows:

A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2025 is as follows:

Service-based Stock Option Awards Shares

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Granted 1,502,500 1.07

Exercised ( 10,313 ) 1.48

Forfeited ( 50,805 ) 1.42

Expired ( 45,767 ) 3.08

Outstanding at June 30, 2025

Outstanding at September 30, 2025

3,281,862 $ 2.71 8.3 $ 192

Exercisable at June 30, 2025

Exercisable at September 30, 2025

1,108,150 $ 5.47 6.8 $ —

The aggregate intrinsic value is calculated as the difference between the closing price of the Company's common stock at the date indicated and the exercise price of the stock options that had strike prices below the closing price.

As of June 30, 2025, total stock-based compensation expense related to unvested options not yet recognized totaled approximately $ 1.5 million, which is expected to be recognized over the next 2.8 years.

As of September 30, 2025, total stock-based compensation expense related to unvested options not yet recognized totaled approximately $ 1.2 million, which is expected to be recognized over the next 2.5 years.

Commitments and Contingencies

From time to time, the Company has been or may become a party to various disputes, legal actions, proceedings and investigations involving claims incidental to the conduct of its business, including actions by customers, employees, government entities and third parties.

Due to the contract-intensive nature of the Company's business, the Company has been or may in the

ROCKWELL MEDICAL, INC.

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Notes to Condensed Consolidated Financial Statements

future become involved in disputes or legal actions with its contract counterparties, which could have a negative impact on the Company's business, results of operations or financial condition.

entities and third parties.

Due to the contract-intensive nature of the Company's business, the Company has been or may in the future become involved in disputes or legal actions with its contract counterparties, which could have a negative impact on the Company's business, results of operations or financial condition.

Product License Agreements

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The Company shall also pay to Charak a percentage of any sublicense income received during the term of the TPN Agreement, which amount shall not be less than a minimum royalty on net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis.

The potential milestone payments are not considered probable, and no milestone payments have been accrued as of June 30, 2025 and December 31, 2024.

The potential milestone payments are not considered probable, and no milestone payments have been accrued as of September 30, 2025 and December 31, 2024.

Rockwell leases its production facilities and administrative offices as well as certain equipment used in its operations including leases on transportation equipment used in the delivery of its products.

The lease terms range from monthly to six years .

Rockwell occupies a 51,000 square foot facility and a 17,500 -square foot facility in Wixom, Michigan under a lease

expiring in August 2027.

The lease terms range from monthly to six

Rockwell occupies a 51,000 square foot facility and a 17,500 -square foot facility in Wixom, Michigan under a lease expiring in August 2027.

During March 2024, the lease for the Wixom facilities was extended by three years to August 2027, which was accounted for as a modification.

Rockwell also occupies two other manufacturing facilities, a 51,000 -square foot facility in Grapevine, Texas under a lease expiring in December 2025, and a 57,000 -square foot facility in Greer, South Carolina under a lease expiring February 2026.

During the three months ended June 30, 2025, Rockwell entered into a lease for a 16,800 -square foot storage facility in Allentown, Pennsylvania, that expires in April 2030, resulting in the recognition of a right-of-use asset and corresponding liability of approximately $ 1.0 million on the condensed consolidated balance sheets.

During the nine months ended September 30, 2025, Rockwell entered into a lease for a 16,800 -square foot storage facility in Allentown, Pennsylvania, that expires in April 2030, resulting in the recognition of a right-of-use asset and corresponding lease liability of approximately $ 1.0 million on the condensed consolidated balance sheets.

The following summarizes quantitative information about the Company’s operating and finance leases (table in thousands):

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

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Financing Cash Flows from Finance Leases $ 124 $ 140 $ 418 $ 416

2025 June 30,

September 30,

2025 September 30,

Weighted-average Remaining Lease Term – Operating Leases 2.7 2.6

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Year ending December 31, 2029 282 —

Remaining future payments 96 —

Total 3,420 940

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Operating and Finance Lease Liabilities $ 3,042 $ 884

ROCKWELL MEDICAL, INC.

AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

Loan and Security Agreement

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If the Company is unable to comply with the covenants under the Third Amendment, it would pursue all available cure options in order to regain compliance.

However, the Company may not be able to mutually agree with Innovatus on appropriate remedies to cure a future breach of a covenant, which could give rise to an event of default.

The Loan Agreement includes a financial covenant that requires actual consolidated revenue from the sale and supply of hemodialysis products for the trailing six-month period (ended

on the date when tested), to be not less than 80.0 % of the projections for the same period beginning with the quarter ending September 30, 2024.

Because those projections were submitted prior to the loss of a substantial amount of business from DaVita, we did not satisfy this covenant in the second quarter of 2025.

We subsequently resolved the noncompliance by submitting an updated financial projection to Innovatus, which Innovatus accepted.

As of June 30, 2025, the Company was in compliance with all covenants under the Third Amendment, other than as described above.

However, the Company may not be able to mutually agree with Innovatus on appropriate remedies to cure a future

breach of a covenant, which could give rise to an event of default.

As of September 30, 2025, the Company was in compliance with all covenants under the Third Amendment.

In connection with the execution of the Third Amendment, on January 2, 2024, the Company issued a warrant to purchase shares of the Company’s common stock.

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For additional information, see Note 11.

The effective interest rate used to amortize the debt issuance cost relating to these warrants is 11.0 % as of June 30, 2025.

For each of the three months ended June 30, 2025 and 2024, interest expense amounted to $ 0.2 million.

For each of the six months ended June 30, 2025 and 2024, interest expense amounted to $ 0.5 million.

As of June 30, 2025, the outstanding balance of the Term Loans was $ 8.6 million, net of unamortized issuance costs and discount of $ 0.6 million, and including $ 0.8 million of premium accretion, and paid-in-kind interest of $ 0.2 million.

The effective interest rate used to amortize the debt issuance cost relating to these warrants is 11.0 % as of September 30, 2025.

For each of the three months ended September 30, 2025 and 2024, interest expense amounted to $ 0.2 million.

For the nine months ended September 30, 2025 and 2024, interest expense amounted to $ 0.7 million and $0.7 million respectively.

As of September 30, 2025, the outstanding balance of the Term Loans was $ 8.7 million, net of unamortized issuance costs and discount of $ 0.5 million, and including $ 0.8 million of premium accretion, and paid-in-kind interest of $ 0.3 million.

The Loan Agreement is secured by all assets of the Company and Rockwell Transportation, Inc.

and contains customary representations and warranties and covenants, subject to customary carve outs, and initially included financial covenants related to liquidity and sales of Triferic.

The following table reflects the schedule of principal payments on the Term Loans as of June 30, 2025 (table in thousands):

June 30, 2025

The following table reflects the schedule of principal payments on the Term Loans as of September 30, 2025 (table in thousands):

September 30, 2025

2025 (remaining) $ —

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Principal and interest payments related to this note began on July 3, 2025 and are being paid in 10 equal monthly payments of $ 0.1 million, with the final payment due on April 3, 2026.

As of June 30, 2025, the Company's insurance financing note payable balance was $ 0.7 million.

As of September 30, 2025, the Company's insurance financing note payable balance was $ 0.5 million.

On June 4, 2024, the Company entered into a short-term note payable with a principal amount of $ 0.7 million, bearing interest at a rate of 7.89 % per annum to finance various insurance policies, which required an upfront payment of $ 0.2 million.

Principal and interest payments related to this note began on July 3, 2024 and were paid in 10 equal monthly payments of $ 0.1 million, with the final payment due on April 3, 2025.

During the six months ended June 30, 2025, the Company's insurance financing note payable balance was paid in full.

During the nine months ended September 30, 2025, the Company's insurance financing note payable balance was paid in full.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements