Form 10-Q - Quarterly report [Sections 13 or 15(d)]

United States

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q

__________________________________________________

(Mark One)


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 000-23661

ROCKWELL MEDICAL, INC.

(Exact name of registrant as specified in its charter)


Delaware									38-3317208
(State or other jurisdiction of incorporation or organization)									(I.R.S. Employer Identification No.)
30142 S. Wixom Road, Wixom, Michigan									48393
(Address of principal executive offices)									(Zip Code)

(248) 960-9009

(Registrant’s telephone number, including area code)

(Former name, former address and former fiscal year,

if changed since last report)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No

Securities registered pursuant to Section 12(b) of the Act:

Title of each class:

Trading Symbol

Name of each exchange on which registered:

Common Stock, par value $0.0001

RMTI

Nasdaq Capital Market

The number of shares of common stock outstanding as of November 8, 2024 was 32,318,806.

Rockwell Medical, Inc. and Subsidiaries

Index to Form 10-Q


			Page
Part I — Financial Information (unaudited)

Item 1 - Unaudited Financial Statements

Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023			3

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2024 and 2023			5

Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2024 and 2023			6

Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Nine Months Ended September 30, 2024 and 2023			7

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023			8

Notes to Condensed Consolidated Financial Statements			9

Item 2 - Management’s Discussion and Analysis of Financial Condition and Results of Operations			16

Item 3 - Quantitative and Qualitative Disclosures about Market Risk			18

Item 4 - Controls and Procedures			18

Part II — Other Information

Item 1 - Legal Proceedings			18

Item 1A - Risk Factors			19

Item 2 - Unregistered Sales of Equity Securities and Use of Proceeds			19

Item 3 - Defaults Upon Senior Securities			19

Item 4 - Mine Safety Disclosures			19

Item 5 - Other Information			19

Item 6 - Exhibits			19

Signatures			20

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and par value amounts)


	September 30, 2024		December 31, 2023
ASSETS
Cash and Cash Equivalents	$	12,338	$	8,983
Investments Available-for-Sale	5,934		1,952
Accounts Receivable, net	8,886		10,901

Inventory, net	5,888		5,871
Prepaid and Other Current Assets	1,171		1,063
Total Current Assets	34,217		28,770
Property and Equipment, net	5,795		6,402
Inventory, Non-Current	178		178
Right of Use Assets - Operating, net	3,598		2,713
Right of Use Assets - Financing, net	1,482		1,903
Intangible Assets, net	10,345		10,759
Goodwill	921		921
Other Non-Current Assets	548		527
Total Assets	$	57,084	$	52,173
LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts Payable	$	2,607	$	4,516
Accrued Liabilities	6,290		7,149
Deferred Consideration - Current	2,274		2,500
Lease Liabilities - Operating - Current	1,554		1,381
Lease Liabilities - Financing - Current	587		558
Deferred License Revenue - Current	46		46

Insurance Financing Note Payable	469		244
Customer Deposits	351		243

Total Current Liabilities	14,178		16,637

Lease Liabilities - Operating - Long-Term	2,098		1,433
Lease Liabilities - Financing - Long-Term	1,085		1,530
Term Loan - Long-Term, net of issuance costs	8,383		8,293
Deferred License Revenue - Long-Term	441		475
Deferred Consideration - Long-Term	1,750		2,500
Long Term Liability - Other	14		14
Total Liabilities	27,949		30,882


	September 30, 2024		December 31, 2023
Stockholders’ Equity:
Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; 15,000 shares issued and outstanding at September 30, 2024 and December 31, 2023	—		—
Common Stock, $0.0001 par value; 170,000,000 shares authorized; 32,318,806 and 29,130,607 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	3		3
Additional Paid-in Capital	426,046		418,487
Accumulated Deficit	(396,922)		(397,198)
Accumulated Other Comprehensive Income (Loss)	8		(1)
Total Stockholders’ Equity	29,135		21,291
Total Liabilities and Stockholders’ Equity	$	57,084	$	52,173

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

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share amounts)


	Three Months Ended September 30, 2024		Three Months Ended September 30, 2023		Nine Months Ended September 30, 2024		Nine Months Ended September 30, 2023
Net Sales	$	28,316	$	23,771	$	76,824	$	61,519
Cost of Sales	22,077		21,569		62,971		55,685
Gross Profit	6,239		2,202		13,853		5,834
Research and Product Development	—		494		18		939
Selling and Marketing	726		556		1,906		1,584
General and Administrative	3,577		2,889		10,802		9,434

Operating Income (Loss)	1,936		(1,737)		1,127		(6,123)

Other Expense:
Realized Gain on Available-for-Sale Investments	—		220		51		220

Interest Expense	(302)		(411)		(965)		(1,193)
Interest Income	30		56		63		169
Total Other Expense, net	(272)		(135)		(851)		(804)

Net Income (Loss)	$	1,664	$	(1,872)	$	276	$	(6,927)

Basic Net Income (Loss) per Share	$	0.05	$	(0.07)	$	0.01	$	(0.32)
Diluted Net Income (Loss) per Share	$	0.04	$	(0.07)	$	0.01	$	(0.32)
Basic Weighted Average Shares Outstanding	31,551,805		27,521,088		30,447,588		21,526,978
Diluted Weighted Average Shares Outstanding	32,420,168		27,521,088		31,013,464		21,526,978

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

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(In thousands)


	Three Months Ended September 30, 2024		Three Months Ended September 30, 2023		Nine Months Ended September 30, 2024		Nine Months Ended September 30, 2023
Net Income (Loss)	$	1,664	$	(1,872)	$	276	$	(6,927)
Reclassification of Realized Gain on Available-for-Sale Investments Included in Net Income	—		—		(25)		—
Unrealized Gain (Loss) on Available-for-Sale Investments	13		(69)		38		(90)
Foreign Currency Translation Adjustments	—		—		(4)		(4)
Comprehensive Income (Loss)	$	1,677	$	(1,941)	$	285	$	(7,021)

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

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

(In thousands, except share amounts)


	PREFERRED STOCK			COMMON STOCK			ADDITIONAL PAID-IN CAPITAL		ACCUMULATED DEFICIT		ACCUMULATED OTHER COMPREHENSIVE (LOSS) INCOME		TOTAL STOCKHOLDERS' EQUITY
	SHARES	AMOUNT		SHARES	AMOUNT
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)
Unrealized Gain on Available-for-Sale Investments	—	—		—	—		—		—		25		25

Issuance of Common Stock, net of offering costs/At-The-Market	—	—		358,210	—		560		—		—		560
Vesting of Restricted Stock Units Issued, net of taxes withheld	—	—		67,657	—		—		—		—		—
Issuance of Warrant in connection with the Third Amendment (Note 11)	—	—		—	—		247		—		—		247
Stock-based Compensation	—	—		—	—		251		—		—		251
Balance as of March 31, 2024	15,000	—		29,556,474	3		419,545		(398,929)		24		20,643
Net Income	—	—		—	—		—		343		—		343
Reclassification of Realized Gains on Available-for-Sale Debt Instrument Investments Included in Net Income	—	—		—	—		—		—		(25)		(25)
Foreign Currency Translation Adjustments	—	—		—	—		—		—		(4)		(4)

Issuance of Common Stock, net of offering costs/At-the-Market Offering	—	—		1,350,169	—		2,203		—		—		2,203


Vesting of Restricted Stock Units Issued, net of taxes withheld	—	—		123,575	—		—		—		—		—

Stock-based Compensation	—	—		—	—		338		—		—		338
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.

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

(In thousands, except share amounts)


	PREFERRED STOCK			COMMON STOCK			ADDITIONAL PAID-IN CAPITAL		ACCUMULATED DEFICIT		ACCUMULATED OTHER COMPREHENSIVE INCOME		TOTAL STOCKHOLDERS' EQUITY
	SHARES	AMOUNT		SHARES	AMOUNT
Balance as of January 1, 2023	15,000	$	—	12,163,673	$	1	$	402,701	$	(388,759)	$	163	$	14,106
Net Loss	—	—		—	—		—		(1,750)		—		(1,750)
Unrealized Loss on Available-for-Sale Investments	—	—		—	—		—		—		(3)		(3)
Foreign Currency Translation Adjustments	—	—		—	—		—		—		(4)		(4)
Issuance of Common Stock upon Exercise of Pre-Funded Warrants	—	—		389,000	—		—		—		—		—
Issuance of Warrants related to Debt Financing	—	—		—	—		—		—		—		—
Stock-based Compensation	—	—		—	—		193		—		—		193
Balance as of March 31, 2023	15,000	—		12,552,673	1		402,894		(390,509)		156		12,542
Net Loss	—	—		—	—		—		(3,305)		—		(3,305)
Unrealized Loss on Available-for-Sale Investments	—	—		—	—		—		—		(18)		(18)
Foreign Currency Translation Adjustments	—	—		—	—		—		—		(1)		(1)
Issuance of Common Stock, net of offering costs/Public Offering	—	—		4,118,000	1		—		—		—		1


Vesting of Restricted Stock Units Issued, net of taxes withheld	—	—		125,000	—		—		—		—		—

Stock-based Compensation	—	—		—	—		309		—		—		309
Balance as of June 30, 2023	15,000	—		16,795,673	2		403,203		(393,814)		137		9,528
Net Loss	—	—		—	—		—		(1,872)		—		(1,872)
Unrealized Loss on Available-for-Sale Investments	—	—		—	—		—		—		(69)		(69)


Issuance of Common Stock in Connection with Exercise of the Prior Warrant and Pre-Funded Warrants, net of offering costs	—	—		11,693,990	1		13,718		—		—		13,719
Stock-based Compensation	—	—		—	—		212		—		—		212
Balance as of September 30, 2023	15,000	$	—	28,489,663	$	3	$	417,133	$	(395,686)	$	68	$	21,518

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

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)


	Nine Months Ended September 30, 2024		Nine Months Ended September 30, 2023
Cash Flows From Operating Activities:
Net Income (Loss)	$	276	$	(6,927)
Adjustments To Reconcile Net Income (Loss) To Net Cash Provided By (Used In) Operating Activities:
Depreciation and Amortization	1,637		894
Stock-based Compensation	910		714

Increase in Inventory Reserves	314		1,098
Non-cash Lease Expense from Right of Use Assets	1,446		1,529
Amortization of Debt Financing Costs and Accretion of Debt Discount and Premium	337		276
Loss on Disposal of Assets	—		1
Realized Gain on Sale of Investments	(51)		(220)
Changes in Operating Assets and Liabilities:
Accounts Receivable	2,024		(3,102)

Inventory	(331)		1,561
Prepaid and Other Assets	541		875
Accounts Payable	(1,909)		(124)
Lease Liabilities	(1,072)		(1,113)
Accrued and Other Liabilities	(751)		(1,033)
Deferred License Revenue	(34)		(3,798)
Net Cash Provided By (Used In) Operating Activities	3,337		(9,369)
Cash Flows From Investing Activities:
Purchase of Investments Available-for-Sale	(5,921)		(3,752)
Sale of Investments Available-for-Sale	2,003		11,301
Purchase of Equipment	(616)		(241)
Cash Paid in Connection with Evoqua Asset Acquisition	—		(12,361)
Net Cash Used In Investing Activities	(4,534)		(5,053)
Cash Flows From Financing Activities:


Payments on Debt	—		(500)
Payments on Insurance Financing Note Payable	(445)		(748)
Payments on Financing Lease Liabilities	(416)		(388)


Proceeds from Issuance of Common Stock	6,393		13,763
Offering Costs from Issuance of Common Stock	—		(43)
Deferred Consideration Paid in Connection with Evoqua Asset Acquisition	(976)		—




Net Cash Provided By Financing Activities	4,556		12,084

Effect of Exchange Rate Changes on Cash and Cash Equivalents	(4)		(5)

Net Increase (Decrease) in Cash and Cash Equivalents	3,355		(2,343)
Cash and Cash Equivalents at Beginning of Period	8,983		10,102
Cash and Cash Equivalents at End of Period	$	12,338	$	7,759

Supplemental Disclosure of Cash Flow Information:
Cash Paid for Interest	$	645	$	929



Supplemental Disclosure of Non-cash Investing and Financing Activities:
Issuance of Warrant in connection with the Third Amendment as Debt Issuance Costs	$	247	$	—
Right of Use Assets - Operating Obtained in Exchange for Lease Liabilities - Operating	$	1,984	$	—
Change in Unrealized Gain (Loss) on Investments Available-for-Sale	$	13	$	(90)
Increase in Prepaid Assets from Insurance Financing Note Payable	$	670	$	733
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.

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. Description of Business

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

Rockwell is the largest supplier of liquid bicarbonate concentrates and the second largest supplier of acid and dry 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 at freestanding outpatient dialysis centers, at hospital-based outpatient centers, at skilled nursing facilities, or in a patient’s home.

Rockwell manufactures hemodialysis concentrates at its facilities in Michigan, South Carolina, and Texas totaling approximately 175,000 square feet, and manufactures its dry acid concentrate mixers at its facility in Iowa. Additionally, in July 2023, the Company purchased customer relationships, equipment and inventory from Evoqua Water Technologies LLC ("Evoqua") related to the manufacturing and sale of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization in Minnesota.

The Company operates in a single segment.

Rockwell was incorporated in the state of Michigan in 1996 and re-domiciled to the state of Delaware in 2019. Rockwell's headquarters is located at 30142 Wixom Road, Wixom, Michigan 48393.

2. Liquidity and Capital Resources

As of September 30, 2024, Rockwell had approximately $18.3 million of cash, cash equivalents and investments available-for-sale, and working capital of $20.0 million. Net cash provided by operating activities for the nine months ended September 30, 2024 was approximately $3.3 million. Based on the currently available 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.

The Company continues to review its operational plans and execute on the acquisition of new customers, and has implemented cost containment activities. The Company may require additional capital to sustain its operations and make the investments it needs to execute its strategic plan. Additionally, the Company's operational plans include raising capital, if needed, by using the remaining $4.5 million available under its at-the-market ("ATM") facility or other methods or forms of financings, subject to existing limitations. If the Company attempts to obtain additional debt or equity financing, the Company cannot assume such financing will be available on favorable terms, if at all.

The Company is subject to certain covenants and cure provisions under its Loan Agreement with Innovatus Life Sciences Lending Fund I, LP ("Innovatus"), which, on January 2, 2024, was amended 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). As of September 30, 2024, the Company is in compliance with all covenants.

In addition, the global macroeconomic environment is uncertain, and could be negatively affected by, among other things, increased U.S. trade tariffs and trade disputes with other countries, instability in the global capital and credit markets, recent bank failures in the United States, supply chain weaknesses, and instability in the geopolitical environment, including as a result of the Russian invasion of Ukraine, the Middle East conflict and other political tensions, and the occurrence of natural disasters and public health crises. Such challenges have caused, and may continue to cause, recession fears, rising interest rates, foreign exchange volatility and inflationary pressures. At this time, the Company is unable to quantify the potential effects, if any, of this economic and political instability on its future operations.

Rockwell has utilized a range of financing methods to fund its operations in the past; however, current conditions in the financial and credit markets may limit the availability of funding or refinancing or increase the cost of funding. Due to the

rapidly evolving nature of the global situation, it is not possible to predict the extent to which these conditions could adversely affect the Company's liquidity and capital resources in the future.

3. Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements

The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U. S. 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 September 30, 2024, and the condensed consolidated statements of operations, comprehensive income (loss), changes in stockholders' equity, and cash flows for the three and nine months ended September 30, 2024 and 2023 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, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024 or for any future interim period. The condensed consolidated balance sheet at December 31, 2023 has been derived from audited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2023 and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 as filed with the SEC on March 21, 2024. The Company’s consolidated subsidiaries consist of its wholly-owned subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited.

The accompanying condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated in consolidation.

Use of Estimates

The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Income (Loss) Per Share

Basic and diluted net income (loss) per share for the three and nine months ended September 30, 2024 and 2023 was calculated as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(In thousands, except share and per share amounts)	2024		2023		2024		2023
Numerator:
Net Income (Loss)	$	1,664	$	(1,872)	$	276	$	(6,927)

Less: Undistributed Earnings to Participating Securities	(233)		—		(40)		—
Net Income (Loss) Attributable to Common Stockholders	$	1,431	$	(1,872)	$	236	$	(6,927)

Denominator:
Basic Weighted Average Number of Shares of Common Stock Outstanding	31,551,805		27,521,088		30,447,588		21,526,978
Incremental Shares Attributable to the Assumed Exercise of Outstanding Options to Purchase Common Stock	489,193		—		271,382		—
Incremental Shares Attributable to the Assumed Vesting of Unvested Restricted Stock Units	318,046		—		282,340		—
Incremental Shares Attributable to the Assumed Exercise of Warrants	61,124		—		12,154		—

Diluted Weighted Average Number of Shares of Common Stock Outstanding	32,420,168		27,521,088		31,013,464		21,526,978
Basic Net Income (Loss) per Share Attributable to Common Stockholders	$	0.05	$	(0.07)	$	0.01	$	(0.32)
Diluted Net Income (Loss) per Share Attributable to Common Stockholders	$	0.04	$	(0.07)	$	0.01	$	(0.32)

Basic income (loss) per share (“EPS”) is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period, excluding the effects of any potentially dilutive securities. Diluted EPS gives effect to the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock, using the more dilutive of the two- class method and the if-converted method in the period of earnings. The two class method is an earnings allocation method that determines income (loss) per share (when there are earnings) for common stock and participating securities. The if-converted method assumes all convertible securities are converted into common stock. Diluted EPS excludes all dilutive potential shares of common stock if their effect is anti-dilutive.

The Company’s potentially dilutive securities include stock options, restricted stock awards and units, convertible preferred stock and warrants. The following table includes the potential shares of common stock that were excluded from the computation of diluted EPS per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2024	2023	2024	2023
Warrants to Purchase Common Stock	3,793,388	4,045,278	3,793,388	4,045,278
Options to Purchase Common Stock	268,978	1,367,493	284,296	1,367,493
Convertible Preferred Stock	—	1,363,636	—	1,363,636
Unvested Restricted Stock Units	—	287,400	—	287,400
Unvested Restricted Stock Awards	891	891	891	891
Total	4,063,257	7,064,698	4,078,575	7,064,698

Adoption of Recent Accounting Pronouncements

The Company continually assesses new accounting pronouncements to determine their applicability. When it is determined a new accounting pronouncement affects the Company’s financial reporting, the Company undertakes a review to determine the consequences of the change to its consolidated financial statements and assures there are sufficient controls in place to ascertain the Company’s consolidated financial statements properly reflect the change.

In November 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2023-07, Segment Reporting - Improvements to Reportable Segment Disclosures, which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. The amendments in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is in the process of determining the effect this ASU will have on the disclosures contained in the notes to the consolidated financial statements.

In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which updates income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This ASU also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in this ASU are effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is in the process of determining the effect this ASU will have on the disclosures contained in the notes to the consolidated financial statements.

In November 2024, the FASB issued ASC 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, 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. This new standard is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the consolidated financial statements. The Company is currently assessing the impact this ASU will have on the consolidated financial statements and footnote disclosures.

4. Asset Acquisition

On July 10, 2023, the Company executed and consummated the transactions contemplated by an Asset Purchase Agreement (the “Purchase Agreement”) with Evoqua (the "Evoqua Acquisition"). Subject to the terms and conditions of the Purchase Agreement, at the closing of the transaction (the “Closing”), the Company purchased customer relationships, equipment and inventory from Evoqua, which were related to its manufacturing and selling of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization.

Pursuant to the Purchase Agreement, total consideration was $17.4 million, comprising a cash payment at Closing of $12.4 million (inclusive of transaction costs) and two $2.5 million deferred payments. On July 12, 2024, the Company and Evoqua executed an amendment to the Purchase Agreement (the "First Amendment"), which stipulated that the first deferred payment would be partially offset by $0.3 million to reimburse the Company for certain expenses incurred following the close of the Evoqua Acquisition and split the first deferred payment into four quarterly installments to be paid through April 2025. The First Amendment also split the second deferred payment into four quarterly installments to be paid from July 2025 through April 2026. During the three and nine months ended September 30, 2024, the Company paid the first installment of the first deferred payment of $0.6 million. The remaining installments due within the next twelve months are included as Deferred Consideration - Current on the Company's condensed consolidated balance sheets.

The transaction was accounted for as an asset acquisition, as the acquired assets did not meet the definition of a business as defined by Accounting Standards Codification ("ASC") 805, Business Combinations.

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

The purchase price was allocated, on a relative fair value basis, to the assets acquired at the July 10, 2023 acquisition date as follows (table in thousands):



Consideration
Cash Payment	$	12,233
Deferred Consideration	5,000
Transaction Costs	128
Total Consideration	$	17,361

Assets Acquired
Customer Relationships Intangible Asset	$	11,035
Equipment	5,093
Inventory	1,233
Total Assets Acquired	$	17,361

The fair value of the customer relationships intangible asset was determined using a multi-period excess earnings method, a form of the income approach, which incorporates the estimated future cash flows to be generated from the customer base. Key assumptions included discounted cash flow, estimated life cycle and customer attrition rates. Customer relationships are being amortized over a period of 20 years. Given that the acquired equipment had been recently purchased and recorded at fair value, the Company determined the fair value of the equipment using a cost approach, which considered assumptions over the equipment's current replacement cost and useful life. Inventory was purchased directly from the contract manufacturer holding the inventory, which approximated fair value.

During the three and nine months ended September 30, 2024, the Company recorded amortization of its customer relationship intangible asset of $0.1 million and $0.4 million, respectively, resulting in a net intangible asset of $10.3 million as of September 30, 2024. During the three and nine months ended September 30, 2023, the Company recorded amortization of its customer relationship intangible asset of $0.1 million.

Estimated future amortization expense on the Company's customer relationships intangible asset as of September 30, 2024 is as follows (table in thousands):


Year ending December 31:
2024 (remainder of year)	$	138
2025	552
2026	552
2027	552
2028	552
Thereafter	7,999
Total	$	10,345

5. Revenue Recognition

The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers, issued by the FASB. The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle:

•Step 1: Identify the contract with the customer

•Step 2: Identify the performance obligations in the contract

•Step 3: Determine the transaction price

•Step 4: Allocate the transaction price to the performance obligations in the contract

•Step 5: Recognize revenue when the company satisfies a performance obligation

Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by Rockwell from a customer, are excluded from revenue.

Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer.

Nature of goods and services

Rockwell operates in one market segment, the hemodialysis market, which involves the manufacture, sale and distribution of hemodialysis products to hemodialysis clinics, including pharmaceutical, dialysis concentrates, dialysis kits and other ancillary products used in the dialysis process.

Rockwell's customer mix is diverse, with most customer sales concentrations under 10% and one customer, DaVita, Inc. ("DaVita"), at approximately 52% and 50% of total net product sales for the three months ended September 30, 2024 and 2023, respectively, and 47% and 50% of total net product sales for the nine months ended September 30, 2024 and 2023, respectively. Rockwell's accounts receivable from this customer were approximately 40% of the total net consolidated accounts receivable balance at each of September 30, 2024 and December 31, 2023. See below and Note 10 for additional information regarding the Company's contracts with DaVita.

Product Sales

The Company accounts for individual products and services separately if they are distinct (i.e., if a product or service is separately identifiable from other items and if a customer can benefit from it on its own or with other resources that are readily available to the customer). The consideration, including any discounts, is allocated between separate products and services based on their stand-alone selling prices. The stand-alone selling prices are determined based on the cost plus margin approach.

Drug and dialysis concentrate products are sold directly to dialysis clinics and to wholesale distributors in both domestic and international markets. Distribution and license agreements for which upfront fees are received are evaluated upon execution or modification of the agreement to determine if the agreement creates a separate performance obligation from the underlying product sales. For all existing distribution and license agreements, the distribution and license agreement is not a distinct performance obligation from the product sales. In instances where regulatory approval of the product has not been established and the Company does not have sufficient experience with the foreign regulatory body to conclude that regulatory approval is probable, the revenue for the performance obligation is recognized over the term of the license agreement (over time recognition). Conversely, when regulatory approval already exists or is probable, revenue is recognized at the point in time that control of the product transfers to the customer.

For the majority of the Company's international customers, the Company recognizes revenue at the shipping point, which is generally the Company's plant or warehouse. For other business, the Company recognizes revenue based on when the customer takes control of the product. The amount of revenue recognized is based on the purchase order less returns and adjusted for any rebates, discounts, chargebacks or other amounts paid to customers estimated at the time of sale. Customers typically pay for the product based on customary business practices with payment terms averaging 30 days, while a small subset of customers have payment terms averaging 60 days.

Deferred License Revenue

The Company received upfront fees under five distribution and license agreements that have been deferred as a contract liability and presented on the accompanying condensed consolidated balance sheets as deferred license revenue. The amounts received from Wanbang Biopharmaceuticals Co., Ltd. (“Wanbang”), Sun Pharmaceutical Industries Ltd. ("Sun Pharma"), Jeil Pharmaceutical Co., Ltd. ("Jeil Pharma") and Drogsan Pharmaceuticals ("Drogsan Pharma") are 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, respectively, to determine that regulatory approval was probable as of the execution of the agreement. The amounts received from Baxter Healthcare Corporation (“Baxter”) were deferred and recognized as revenue at the point in time the estimated product sales under the agreement occurred. During the

nine months ended September 30, 2023, all remaining deferred revenue relating to the Wanbang and Baxter agreements was recognized as revenue. For additional information related to the Company's deferred license revenue, see Note 10.

Product Purchase Agreements

On September 18, 2023, the Company and its long-time partner, 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. Under the Amended Agreement, the Company and DaVita agreed to an increase in product pricing, effective September 1, 2023 and a one-time payment of $0.4 million to Rockwell on or after December 1, 2023, which was recorded as revenue recognized during the fourth quarter of 2023. The term of the Amended Agreement will expire on December 31, 2024. While the Company received written notice from DaVita in September 2024 that notified the Company that DaVita extends the term of the Amended Agreement through December 31, 2025 ("Extension Term"), there can be no assurance of any further extensions. Product pricing will be increased for the Extension Term. DaVita has indicated to Rockwell that DaVita expects volumes to decline during the Extension Term. DaVita is required to provide a twelve-month binding forecast on or before December 15, 2024. In the event that DaVita does not meet its forecasts, it is required to pay the Company for the amount forecasted or purchase additional product; otherwise, the Company may terminate the Amended Agreement. Upon expiration or termination of the Amended Agreement, and upon request by DaVita, the Company has agreed it would provide transition services to DaVita during a transition period. As of the date of this filing, the Company has received no such notification.

Disaggregation of revenue

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


In thousands	Three Months Ended September 30, 2024						Nine Months Ended September 30, 2024
Products By Geographic Area	Total		U.S.		Rest of World		Total		U.S.		Rest of World
Drug Revenues

License Fee – Over time	$	11	$	—	$	11	$	34	$	—	$	34
Total Drug Products	11		—		11		34		—		34
Concentrate Products
Product Sales – Point-in-time	28,305		26,247		2,058		76,790		70,390		6,400

Total Concentrate Products	28,305		26,247		2,058		76,790		70,390		6,400
Net Revenue	$	28,316	$	26,247	$	2,069	$	76,824	$	70,390	$	6,434


In thousands	Three Months Ended September 30, 2023						Nine Months Ended September 30, 2023
Products By Geographic Area	Total		U.S.		Rest of World		Total		U.S.		Rest of World
Drug Revenues

License Fee – Over time	$	2,197	$	—	$	2,197	$	2,327	$	—	$	2,327
Total Drug Products	2,197		—		2,197		2,327		—		2,327
Concentrate Products
Product Sales – Point-in-time	21,574		19,741		1,833		57,720		52,326		5,394
License Fee – Over time	—		—		—		1,472		1,472		—
Total Concentrate Products	21,574		19,741		1,833		59,192		53,798		5,394
Net Revenue	$	23,771	$	19,741	$	4,030	$	61,519	$	53,798	$	7,721

Contract balances

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


In thousands	September 30, 2024		December 31, 2023		January 1, 2023
Accounts Receivable, net	$	8,886	$	10,901	$	6,259
Contract Liabilities, which are included in deferred license revenue	$	487	$	521	$	4,331

There were no other material contract assets recorded on the condensed consolidated balance sheets as of September 30, 2024 and December 31, 2023. The Company does not generally accept returns of its concentrate products and no material reserve for returns of concentrates products was established as of September 30, 2024 or December 31, 2023.

The contract liabilities primarily relate to upfront fees under distribution and license agreements with Wanbang, Sun Pharma, Jeil Pharma, and Drogsan Pharma.

Transaction price allocated to remaining performance obligations

For the nine months ended September 30, 2024 and 2023, the Company recognized an immaterial amount and $3.8 million as revenue from amounts classified as contract liabilities (i.e., deferred license revenue) as of December 31, 2023 and 2022, respectively.

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, totaled $0.5 million as of September 30, 2024. The amount relates primarily to upfront payments and consideration received from customers that are received in advance of the customer assuming control of the related products. 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.

6. Investments - Available-for-Sale

Investments available-for-sale consisted of the following as of September 30, 2024 and December 31, 2023 (table in thousands):


	September 30, 2024
	Amortized Cost		Unrealized Gain		Unrealized Loss		Accrued Interest		Fair Value
Available-for-Sale Securities
Debt securities	$	5,921	$	13	$	—	$	—	$	5,934


	December 31, 2023
	Amortized Cost		Unrealized Gain		Unrealized Loss		Accrued Interest		Fair Value
Available-for-Sale Securities
Debt securities	$	1,948	$	4	$	—	$	—	$	1,952

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 nine months ended September 30, 2024, the Company sold the investments outstanding as of December 31, 2023 for a realized gain of $0.1 million, which is included in realized gain on available-for-sale investments on the condensed consolidated statements of operations.

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

As of September 30, 2024, the Company's remaining available-for-sale securities are all due within one year.

7. Inventory

Components of inventory, net of reserves, as of September 30, 2024 and December 31, 2023 were as follows (table in thousands):


	September 30, 2024		December 31, 2023
Inventory - Current Portion
Raw Materials	$	2,152	$	2,250
Work in Process	319		351
Finished Goods	3,417		3,270
Total Current Inventory	5,888		5,871
Inventory - Long Term (1)	178		178
Total Inventory	$	6,066	$	6,049

__________

1.Represents inventory related to Triferic raw materials, which is expected to be utilized for the Company's international partnerships, net of a reserve of $1.1 million related to the termination of the development of Triferic in Wanbang in August 2023 as a result of the failure to demonstrate efficacy when compared with a placebo in its phase III clinical studies.

As of September 30, 2024 and December 31, 2023, Rockwell had total current concentrate inventory aggregating $6.2 million and $5.9 million, respectively, against which Rockwell had reserved $0.3 million and $25,000 at September 30, 2024 and December 31, 2023, respectively.

8. Property and Equipment

As of September 30, 2024 and December 31, 2023, the Company’s property and equipment consisted of the following (table in thousands):


	September 30, 2024		December 31, 2023
Machinery and Equipment	$	11,598	$	11,131
Information Technology & Office Equipment	1,845		1,845
Leasehold Improvements	1,542		1,423
Laboratory Equipment	807		807
Total Property and Equipment	15,792		15,206
Accumulated Depreciation and Amortization	(9,997)		(8,804)
Property and Equipment, net	$	5,795	$	6,402

Depreciation and amortization expense for each of the three months ended September 30, 2024 and 2023 was $0.4 million. Depreciation and amortization expense for the nine months ended September 30, 2024 and 2023 was $1.2 million and $0.8 million, respectively.

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

9. Accrued Liabilities

Accrued liabilities as of September 30, 2024 and December 31, 2023 consisted of the following (table in thousands):


	September 30, 2024		December 31, 2023
Accrued Compensation and Benefits	$	2,654	$	2,413
Accrued Unvouchered Receipts	2,214		1,663
Accrued Workers Compensation	340		254
Accrued Manufacturing Expense	—		1,064
Other Accrued Liabilities	1,082		1,755
Total Accrued Liabilities	$	6,290	$	7,149

10. Deferred License Revenue

In October 2014, the Company entered into an exclusive distribution agreement with Baxter, which had a term of 10 years, and received an upfront fee of $20 million. Under the exclusive distribution agreement, Baxter distributed and commercialized Rockwell’s hemodialysis concentrates products and provided customer service and order delivery to nearly all U.S. customers. The upfront fee was recorded as deferred license revenue and was being recognized based on the proportion of product shipments to Baxter in each period, compared with total expected sales volume over the term of the distribution agreement. On November 9, 2022, Rockwell incurred a fee to Baxter, which was reflected as a reduction to revenue on the consolidated statements of operations, and was payable in two equal installments on January 1, 2023 and April 1, 2023, to reacquire its distribution rights to its hemodialysis concentrates products from Baxter and terminated the distribution agreement. Exclusivity and other provisions associated with the distribution agreement terminated November 9, 2022 and the remaining operational elements of the agreement terminated December 31, 2022. To ensure that customer needs continued to be met after January 1, 2023, Rockwell agreed to provide certain services to a group of Baxter's customers until March 31, 2023, and Baxter and Rockwell worked together to transition customers’ purchases of Rockwell’s hemodialysis concentrates through that date. Following the reacquisition of these rights, Rockwell is now unrestricted in its ability to sell its hemodialysis concentrates products to dialysis clinics throughout the United States and around the world. The Company recognized the remaining revenue of $1.5 million during the nine months ended September 30, 2023.

The remaining agreements with Sun Pharma, Jeil Pharmaceutical, and Drogsan Pharmaceuticals comprise the current and long-term portions of deferred license revenue on the condensed consolidated balance sheets as of September 30, 2024 and December 31, 2023.

11. Stockholders’ Equity

Preferred Stock

On April 6, 2022, the Company and DaVita entered into the Securities Purchase Agreement (the "SPA"), which provided for the issuance by the Company of up to $15 million of preferred stock to DaVita. On April 6, 2022, the Company issued 7,500 shares of Series X Preferred Stock for gross proceeds of $7.5 million. On June 16, 2022, the Company issued an additional 7,500 shares of the Series X Preferred Stock to DaVita for gross proceeds of $7.5 million.

The Series X Preferred Stock was issued for a price of $1,000 per share (the "Face Amount"), subject to accretion at a rate of 1% per annum, compounded annually. If the Company’s common stock trades above $22.00 for a period of 30 calendar days, the accretion will thereafter cease. As of September 30, 2024, the Series X Preferred Stock accreted a total of $0.3 million.

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). As a result, each share of Series X Preferred Stock will initially convert into approximately 91 shares of common stock. DaVita’s right to convert to common stock is subject to a beneficial ownership limitation, which is initially set at 9.9% of the outstanding common stock, which limitation may be reset (not to exceed 19.9%) at DaVita’s option and upon providing prior written notice to the Company. In addition, any debt financing is limited by the terms of our SPA with DaVita. Specifically, until DaVita owns less than 50% of its investment, the Company may only incur additional debt in the form of a purchase money loan, a working capital line of up to $5 million, or refinance existing debt, unless DaVita consents.

Additionally, the Series X Preferred Stock has a deemed liquidation event and redemption clause which could be triggered if the sale of all or substantially all of the Company's assets relating to the Company's dialysis concentrates business line. Since the Series X Preferred Stock may be redeemed if certain assets are sold at the option of the holder, but is not mandatorily redeemable and the sale of the assets that would allow for redemption is within the control of the Company, the preferred stock has been classified as permanent equity and initially recognized at fair value of $15 million (the proceeds on the date of issuance) less issuance costs of $0.1 million, resulting in an initial value of $14.9 million. 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 September 30, 2024 and December 31, 2023, 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.

Common Stock

As of September 30, 2024 and 2023, the Company reserved for issuance the following shares of common stock related to the potential exercise of employee stock options, unvested restricted stock, convertible preferred stock, pre-funded warrants and all other warrants (collectively, "common stock equivalents"):


	As of September 30,
Common Stock and Common Stock Equivalents:	2024	2023
Common Stock	32,318,806	28,489,663
Common Stock Issuable upon Exercise of Pre-funded Warrants	—	—
Common Stock and Pre-funded Stock Warrants	32,318,806	28,489,663
Options to Purchase Common Stock	1,874,729	1,367,493
Unvested Restricted Stock Awards	891	891
Unvested Restricted Stock Units	534,309	287,400
Convertible Preferred Stock	1,391,045	1,363,636

Warrants to Purchase Common Stock	3,984,484	4,045,278
Total	40,104,264	35,554,361

During the three months ended September 30, 2024 and 2023, nil and 1,793,000 Pre-Funded Warrants were exercised, respectively. During the nine months ended September 30, 2024 and 2023, nil and 6,300,000 Pre-Funded Warrants were exercised, respectively.

Controlled Equity Offering

On April 8, 2022, the Company entered into the Sales Agreement (the "ATM facility") with Cantor Fitzgerald & Co. as Agent, pursuant to which the Company may offer and sell from time to time up to $12.2 million of shares of Company’s common stock through the Agent. The offering and sale of such shares has been registered under the Securities Act of 1933, as amended.

During the nine months ended September 30, 2024, 2,990,925 shares were sold pursuant to the Sales Agreement for net proceeds of $6.4 million. Approximately $4.5 million remains available for sale under the ATM facility.

Private Placement

On July 10, 2023, the Company entered into a letter agreement (the “Letter Agreement”) with Armistice Capital Master Fund Ltd. (“Armistice”), which held a warrant (the “Prior Warrant”) to purchase 9,900,990 shares of common stock of the Company (the “Common Stock”) with an exercise price of $1.39 per share, offering Armistice the opportunity to exercise the Prior Warrant for cash, provided the Prior Warrant was exercised for cash on or prior to 5:00 P.M. Eastern Time on July 10, 2028 (the “End Date”). In addition, Armistice would receive a “reload” warrant (the “Reload Warrant”) to purchase 3,750,000 shares of Common Stock with an exercise price of $5.13 per share, the closing price as reported by the Nasdaq Capital Market

on July 7, 2023. The Reload Warrant may be exercised at all times prior to the 54 months' anniversary of its issuance date. The Prior Warrant and the Reload Warrant both provide that a holder (together with its affiliates) may not exercise any portion of the Prior Warrant or the Reload Warrant to the extent that the holder would own more than 9.99% of the Company’s outstanding Common Stock immediately after exercise, as such percentage ownership is determined in accordance with the terms of such warrant. To the extent the exercise of the Prior Warrant would result in Armistice holding more than 9.99% of the Company’s outstanding Common Stock, such shares of Common Stock in excess of 9.99% will be held in abeyance.

Armistice exercised the Prior Warrant on July 10, 2023, and the Company received gross proceeds of approximately $13.8 million.

Third Amendment

In connection with the execution of the Third Amendment, as defined and described in Note 15, on January 2, 2024, the Company issued to Innovatus a warrant to purchase 191,096 shares of the Company’s common stock with an exercise price of $1.83 per share. The warrant may be exercised on a cashless basis, and is immediately exercisable through January 2, 2029. 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 will be amortized through interest expense over the remaining contractual term of the Term Loan.

The fair value of the warrant at the issuance date was calculated using the Black-Scholes pricing model and include the following assumptions:



Expected Stock Price Volatility			85.00%
Risk-free Interest Rate			3.93%
Term (years)			5.0
Dividend Yield			0%

12. Stock-Based Compensation

The Company recognized total stock-based compensation expense during the three and nine months ended September 30, 2024 and 2023 as follows (table in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Service-based awards:

Restricted Stock Units	$	163	$	112	$	440	$	276
Stock Option Awards	158		100		470		438






Total	$	321	$	212	$	910	$	714

Performance Based Restricted Stock Awards

A summary of the Company’s performance based restricted stock awards during the nine months ended September 30, 2024 is as follows:


Performance Based Restricted Stock Awards	Number of Shares	Weighted Average Grant-Date Fair Value
Unvested at January 1, 2024	891	$	62.70

Unvested at September 30, 2024	891	$	62.70

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

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 September 30, 2024, there is no unrecognized stock-based compensation expense related to performance based restricted stock awards.

Service Based Restricted Stock Units

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


Service Based Restricted Stock Units	Number of Shares	Weighted Average Grant-Date Fair Value
Unvested at January 1, 2024	258,885	$	1.97
Granted	466,656	1.58
Vested	(191,232)	2.18

Unvested at September 30, 2024	534,309	$	1.48

The fair value of service based restricted stock units are measured based on their fair value on the date of grant and amortized over the vesting period. The vesting periods range from 1 to 3 years. As of September 30, 2024, the unrecognized stock-based compensation expense was $0.5 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 for the nine months ended September 30, 2024 and 2023 were based on the following assumptions:


	Nine Months Ended September 30, 2024	Nine Months Ended September 30, 2023
Exercise Price	$1.39 - $1.80	$1.37 - $2.83
Expected Stock Price Volatility	81.8%	81.6% - 81.8%
Risk-free Interest Rate	4.31% - 4.45%	3.41% - 3.46%
Term (years)	5.61 - 5.62	5.6 - 6

A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2024 is as follows:


Service Based Stock Option Awards	Shares Underlying Options	Weighted Average Exercise Price		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value (in $1,000's)
Outstanding at January 1, 2024	1,328,621	$	5.22
Granted	569,160	1.40
Exercised	(6,042)	1.49
Forfeited	(15,073)	1.83
Expired	(1,937)	4.79
Outstanding at September 30, 2024	1,874,729	$	4.10	8.2	$	4,068

Exercisable at September 30, 2024	632,600	$	8.73	7.2	$	1,105

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

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.

The weighted average grant date fair value for service based stock option awards granted during the nine months ended September 30, 2024 and 2023 was $0.99 and $1.03, respectively.

As of September 30, 2024, total stock-based compensation expense related to unvested options not yet recognized totaled approximately $0.7 million, which is expected to be recognized over the next 2.9 years.

13. License Agreements

Product License Agreements

The Company is a party to a Licensing Agreement between the Company and Charak, LLC ("Charak") dated January 7, 2002 (the "2002 Agreement") that grants the Company exclusive worldwide rights to certain patents and information related to its Triferic product. On October 7, 2018, the Company entered into a Master Services and IP Agreement (the “Charak MSA”) with Charak and Dr. Ajay Gupta, a former Officer of the Company. Pursuant to the MSA, the parties entered into three additional agreements described below related to the license of certain soluble ferric pyrophosphate (“SFP”) intellectual property owned by Charak. As of September 30, 2024 and December 31, 2023, the Company has accrued $0.1 million relating to certain IP reimbursement expenses and certain sublicense royalty fees, which is included within accrued liabilities on the condensed consolidated balance sheets.

Pursuant to the Charak MSA, the aforementioned parties entered into an Amendment, dated as of October 7, 2018 (the “Charak Amendment”), to the 2002 Agreement, under which Charak granted the Company an exclusive, worldwide, non-transferable license to commercialize SFP for the treatment of patients with renal failure. The Charak Amendment amends the royalty payments due to Charak under the 2002 Agreement such that the Company is liable to pay Charak royalties on net sales by the Company of products developed under the license, which includes the Company’s Triferic product, at a specified rate until December 31, 2021 and thereafter at a reduced rate from January 1, 2022 until February 1, 2034. Additionally, the Company is required to pay Charak a percentage of any sublicense income during the term of the agreement, which cannot be less than a minimum specified percentage of net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and can be no 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.

Also pursuant to the Charak MSA, the Company and Charak entered into a Commercialization and Technology License Agreement IV Triferic dated as of October 7, 2018 (the “IV Agreement”), under which Charak granted the Company an exclusive, sub-licensable, royalty-bearing license to SFP for the purpose of commercializing certain intravenous-delivered products incorporating SFP for the treatment of iron disorders worldwide for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. The Company was liable to pay Charak royalties on net sales by the Company of products developed under the license at a specified rate until December 31, 2021. From January 1, 2022 until February 1, 2034, the Company is liable to pay Charak a base royalty at a reduced rate on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the IV Agreement, which amount shall not be less than a minimum specified percentage of 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.

Also pursuant to the Charak MSA, the Company and Charak entered into a Technology License Agreement TPN Triferic dated as of October 7, 2018 (the “TPN Agreement”), pursuant to which Charak granted the Company an exclusive, sub-licensable, royalty-bearing license to SFP for the purpose of commercializing worldwide certain TPN products incorporating SFP. The license grant under the TPN Agreement continues for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. During the term of the TPN Agreement, the Company is liable to pay Charak a base royalty on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. 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

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

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 yet considered probable, and no milestone payments have been accrued as of September 30, 2024 and December 31, 2023.

14. Leases

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. During the nine months ended September 30, 2024, the lease for the Wixom facilities was extended by three years to August 2027, which was accounted for as a modification. As a result of the modification, the operating lease right of use asset and lease liabilities increased by $1.5 million. 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. In addition, Rockwell occupied 4,100 square feet of office space in Hackensack, New Jersey. This lease was subleased on December 15, 2021 and expired on October 31, 2024.

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


	Three Months Ended September 30, 2024			Three Months Ended September 30, 2023			Nine Months Ended September 30, 2024			Nine Months Ended September 30, 2023
Operating Leases
Operating Lease Cost	$	418		$	422		$	1,179		$	1,281
Variable Lease Cost	126			112			376			336
Operating Lease Expense	544			534			1,555			1,617
Finance Leases
Amortization of Right-of-use Assets	139			142			421			424
Interest on Lease Obligations	28			36			89			113
Finance Lease Expense	167			178			510			537
Short-term Lease Rent Expense	5			4			16			12
Total Rent Expense	$	716		$	716		$	2,081		$	2,166

Other Information
Operating Cash Flows from Operating Leases	$	449		$	461		$	1,312		$	1,363
Operating Cash Flows from Finance Leases	$	28		$	37		$	89		$	114
Financing Cash Flows from Finance Leases	$	140		$	130		$	416		$	388


Weighted-average Remaining Lease Term – Operating Leases	2.6			2.5			2.6			2.5
Weighted-average Remaining Lease Term – Finance Leases	2.7			3.7			2.7			3.7
Weighted-average Discount Rate – Operating Leases	6.3		%	6.5		%	6.3		%	6.5		%
Weighted-average Discount Rate – Finance Leases	6.4		%	6.4		%	6.4		%	6.4		%

Future minimum rental payments under operating and finance lease agreements are as follows (in thousands):


	Operating		Finance
Year ending December 31, 2024 (remaining)	$	441	$	167
Year ending December 31, 2025	1,716		676
Year ending December 31, 2026	1,075		666
Year ending December 31, 2027	655		311
Year ending December 31, 2028	57		—

Total	3,944		1,820
Less Present Value Discount	(292)		(148)
Operating and Finance Lease Liabilities	$	3,652	$	1,672

15. Loan and Security Agreement

On March 16, 2020, the Company and Rockwell Transportation, Inc., as Borrowers, entered into a Loan and Security Agreement (the "Loan Agreement") with Innovatus, as collateral agent and the lenders party thereto, pursuant to which Innovatus, as a lender, agreed to make certain term loans to the Company in the aggregate principal amount of up to $35.0 million (the "Term Loans"). Funding of the first $22.5 million tranche was completed on March 16, 2020. The Company is no longer eligible to draw on additional tranches, which were tied to the achievement of certain milestones. Net draw down proceeds were $21.2 million with closing costs of $1.3 million. The Company also owes an additional fee equal to 4.375% of the funded amount of the Term Loans, or $1.0 million (such additional fee, the "Final Fee") at maturity. The Company is accreting up to this Final Fee premium with a charge against interest expense on the accompanying condensed consolidated statements of operations.

In connection with each funding of the Term Loans, the Company was required to issue to Innovatus a warrant (the “Warrants”) to purchase a number of shares of the Company’s common stock equal to 3.5% of the principal amount of the relevant Term Loan funded divided by the exercise price. In connection with the first tranche of the Term Loans, the Company issued a Warrant to Innovatus, exercisable for an aggregate of 43,388 shares of the Company’s common stock at an exercise price of $18.15 per share. The Warrant may be exercised on a cashless basis and is immediately exercisable through the seventh anniversary of the applicable funding date. The number of shares of common stock for which the Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Warrant. The Company evaluated the warrant under ASC 470, Debt, and recognized an additional debt discount of approximately $0.5 million based on the relative fair value of the base instruments and warrants. The Company calculated the fair value of the warrant using the Black-Scholes model.

The Term Loan was scheduled to mature on March 16, 2025, and bore interest at the greater of (i) Prime Rate (as defined in the Loan Agreement) and (ii) 4.75%, plus 4.00%, with an initial interest rate of 8.75% per annum. The Company had the option, under certain circumstances, to add 1.00% of such interest rate amount to the then outstanding principal balance in lieu of paying such amount in cash.

In September 2021, the Company entered into an amendment to the Loan Agreement in which the Company, in exchange for Innovatus lowering the sales covenants, agreed to: (i) prepay an aggregate principal amount of $7.5 million in ten installments commencing on December 1, 2021; (ii) pay an additional prepayment premium of 5% on prepaid amounts if the Company elected to prepay all outstanding Term Loans on or before September 24, 2023; and (iii) maintain minimum liquidity of no less than $5.0 million if the aggregate principal amount of Term Loans was greater than $15 million pursuant to the liquidity covenant in the Loan Agreement.

On November 10, 2022, the Company entered into a Second Amendment to the Loan and Security Agreement (the “Second Amendment”) dated as of November 14, 2022 with Innovatus. Pursuant to the Second Amendment, the Company (i) prepaid an additional aggregate principal amount of $5.0 million in Term Loans in one installment on November 14, 2022; and (ii) paid interest only payments until September 2023, at which time it resumed scheduled debt payments. The financial covenant related to the sales of Triferic was replaced with the trailing 6 months revenue of the Company's concentrates products.

On January 2, 2024, the Company entered into the Third Amendment to and Restatement of the Loan and Security Agreement (the "Third Amendment") with Innovatus, dated January 1, 2024. The Third Amendment provides for the continuation of term loans initially borrowed under the Loan Agreement amounting to $8.0 million as of January 1, 2024. The Company will make interest-only payments on the Term Loans for 30 months, or up to 36 months if certain conditions are met. The Company will make equal monthly payments of principal, together with applicable interest, in arrears, starting either August 1, 2026 or February 1, 2027, depending on whether the interest only period is extended to 36 months after the Effective Date. The Term Loans will mature on January 1, 2029, unless earlier repaid. Effective on January 1, 2024, the Term Loans bear interest equal to the sum of (i) the greater of (a) Prime Rate (as defined in the Third Amendment) and (b) 7.50% plus (ii) 3.50%. At the Company's option, 2.00% of the interest due on any applicable interest payment date during the interest-only period may be paid in-kind by adding such amount to the then outstanding principal balance of the Term Loans. The Term Loans may be voluntarily prepaid in full (but not partially) at any time, upon at least seven business days’ prior notice. In connection with any voluntary prepayment or satisfaction of the Term Loans prior to the maturity date (including any acceleration), the Company will pay all accrued and unpaid interest and all other amounts due in connection with the Term Loans, together with (x) a prepayment fee (the “Prepayment Fee”) equal to: (i) 6.0% of the principal amount of the Term Loans prepaid if the payment is made before January 1, 2025; (ii) 2.0% of the principal amount of the Term Loans prepaid if the payment is made after January 1, 2025 but on or before January 1, 2026; (iii) 1.0% of the principal amount of the Term Loans prepaid if the payment is made after January 1, 2026 but on or before January 1, 2027; or (iv) 0% of the principal amount of the Term Loans prepaid if the payment is made after January 1, 2027 through maturity, and (y) the Final Fee. The Term Loans will be mandatorily prepaid upon a change in control of the Company, or upon any early termination/acceleration of the Term Loans. In the event of a mandatory prepayment of the Term Loans, the Company shall be required to pay the Prepayment Fee (if applicable), as well as the Final Fee. The Third Amendment Final Fee shall be due and payable at maturity if it has not previously been paid in full in connection with a prepayment of the Term Loans. The Third Amendment was treated as a modification for accounting purposes.

The Third Amendment contains various financial covenants and customary representations and warranties and affirmative and negative covenants, subject to exceptions as described in the Third Amendment. The Company's ability to comply with the covenants under the Third Amendment may be adversely affected by events beyond its control. 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. However, as of September 30, 2024, 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. The warrant is equity-classified with a fair value of $0.2 million at issuance, which was treated as a debt issuance cost and will be amortized through interest expense over the remaining contractual term of the Term Loan. For additional information, see Note 11.

The effective interest rate is 11.5% as of September 30, 2024. For the three months ended September 30, 2024 and 2023, interest expense amounted to $0.2 million and $0.3 million, respectively. For the nine months ended September 30, 2024 and 2023, interest expense amounted to $0.7 million and $0.9 million, respectively. As of September 30, 2024, the outstanding balance of the Term Loan was $8.4 million, net of unamortized issuance costs and discount of $0.6 million, and including $0.8 million of premium accretion, $0.1 million related to a fee resulting from the Third Amendment, and paid-in-kind interest of $0.1 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 Loan as of September 30, 2024 (in thousands):


	September 30, 2024
2024 (remaining)	$	—
2025	—
2026	1,366
2027	3,279
2028	3,279
2029 (inclusive of Final Fee)	1,256
Total Debt Maturities	9,180
Unamortized Issuance Costs, Discount and Premium, net	(797)
Term Loan - Long-Term, net of issuance costs	$	8,383

16. Insurance Financing Note Payable

On June 3, 2023, the Company entered into a short-term note payable for $0.7 million, bearing interest at a rate of 9.59% per annum to finance various insurance policies. Principal and interest payments related to this note began on July 3, 2023 and were paid on a straight-line amortization over nine months with the final payment due on March 3, 2024. During the nine months ended September 30, 2024, the Company's insurance financing note payable balance was paid in full.

On June 24, 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 will be paid in 10 equal monthly payments of $0.1 million, with the final payment due on April 3, 2025. As of September 30, 2024, the balance of the insurance financing note payable was $0.5 million.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis should be read in conjunction with our condensed consolidated financial statements and related notes in “Item 1. Condensed Consolidated Financial Statements”. References in this report to “Rockwell,” the “Company,” “we,” “our” and “us” are references to Rockwell Medical, Inc. and its subsidiaries.

Forward-Looking Statements

We make forward-looking statements in this report and may make such statements in future filings with the U.S. Securities and Exchange Commission ("SEC"). We may also make forward-looking statements in our press releases or other public or shareholder communications. 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,” “is focused on” 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 successfully integrate acquisitions; the size of the hemodialysis concentrates market opportunity; our ability to successfully execute on our business strategy; our ability to raise additional capital; our ability to successfully implement certain cost containment and cost-cutting measures; our ability to maintain profitability and statements regarding our anticipated future financial condition, operating results, cash flows and business plans.

While we believe our forward-looking statements are reasonable, you 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. 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. Factors that might cause such a difference include, without limitation, the risks and uncertainties discussed in this report, “Item 1A — Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 and from time to time in our other reports filed with the SEC.

Other factors not currently anticipated may also materially and adversely affect our results of operations, cash flow and financial position. There can be no assurance future results will meet expectations. Forward-looking statements speak only as of the date of this report and we expressly disclaim any intent to update or alter any statements whether as a result of new information, future events or otherwise, except as may be required by applicable law.

Overview

Rockwell Medical is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide.

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. Rockwell has developed a core expertise in manufacturing and delivering hemodialysis concentrates, and has built a longstanding reputation for reliability, quality, and excellent customer service.

Rockwell provides the hemodialysis community with products controlled by a Quality Management System regulated by the U.S. Food and Drug Administration ("FDA"). Rockwell is ISO 13485 Certified and adheres to current Good Manufacturing Practices ("cGMP") and Association for Advancement of Medical Instrumentation ("AAMI") standards. Rockwell manufactures hemodialysis concentrates at its facilities in Michigan, South Carolina, and Texas totaling approximately 175,000 square feet, and manufactures its dry acid concentrate mixers at its facility in Iowa. In addition, the Company manufactures hemodialysis concentrates in Minnesota under a contract manufacturing agreement with a contract

manufacturing organization. (See Note 4 of the accompanying condensed consolidated interim financial statements for further detail). On February 12, 2024, the Company entered into an amendment to its contract manufacturing agreement to extend the term to December 31, 2024. The Company plans to transfer the manufacturing of the former Evoqua product line to one of its own manufacturing facilities by the end of 2024, which the Company believes will reduce production costs for these products.

During the three months ended September 30, 2024, Rockwell Medical received the Notice of Extension of Term (the "Extension") of the Amended and Restated Products Purchase Agreement (the "Amended Agreement"), dated September 21, 2023, which amended and restated the Products Purchase Agreement, dated July 1, 2019, with DaVita. The Extension extends the term of the Amended Agreement through December 31, 2025 (the "Extension Term"), during which Extension Term product pricing will be increased. DaVita has indicated to Rockwell that DaVita expects volumes to decline during the Extension Term as DaVita works to diversify its supplier base. Rockwell believes that net sales to DaVita in 2025 will decline between approximately $31 million and $37 million. DaVita is required to provide Rockwell with a twelve-month binding forecast on or before December 15, 2024, at which time the Company will be able to determine the actual impact on net sales in 2025. Under the terms of the Amended Agreement, DaVita is committed to purchasing at least the amount provided in the binding forecast. DaVita's product purchases have historically ranged between a gross loss to single digit gross margin, excluding the special large order of premium-priced product described below.

Results of Operations for the Three Months Ended September 30, 2024 and 2023

The following table summarizes our operating results for the periods presented below (dollars in thousands):


	Three Months Ended September 30,
	2024		% of Revenue		2023		% of Revenue		% Change

Net Sales	$	28,316			$	23,771			19	%
Cost of Sales	22,077		78	%	21,569		91	%	2	%
Gross Profit	6,239		22	%	2,202		9	%

Research and Product Development	—		—	%	494		2	%	(100)	%
Selling and Marketing	726		3	%	556		2	%	31	%
General and Administrative	3,577		13	%	2,889		12	%	24	%

Operating Income (Loss)	$	1,936	6	%	$	(1,737)	(7)	%

Net Sales

During the three months ended September 30, 2024, net sales were $28.3 million compared to net sales of $23.8 million during the three months ended September 30, 2023. The increase of $4.5 million was due to $6.7 million from product revenue, partially offset by a decrease of $2.2 million from non-product revenue. Overall, product revenue for the three months ended September 30, 2024 was $28.3 million compared to product revenue of $21.6 million for the three months ended September 30, 2023. The increase of $6.7 million was driven by $4.5 million from a special large order of premium-priced product, as well as $2.5 million of increased sales and price increases to existing customers. Net sales of non-product revenue were not material during the three months ended September 30, 2024 compared to non-product revenue of $2.2 million during the three months ended September 30, 2023, which was the result of deferred license revenue recognition related to the termination of the Wanbang Agreement.

Gross Profit

Cost of sales for the three months ended September 30, 2024 was $22.1 million, resulting in gross profit of $6.2 million for the three months ended September 30, 2024, compared to cost of sales of $21.6 million and a gross profit of $2.2 million for the three months ended September 30, 2023. Gross profit increased by $4.0 million driven by $1.5 million from a special large order of premium-priced product, as well as $2.5 million from increased sales and price increases to existing customers and $1.1 million of lower costs, partially offset by a decrease of $1.1 million associated with the termination of the Wanbang agreement for the three months ended September 30, 2023.

Research and Product Development Expense

Research and product development expenses were nil and $0.5 million for the three months ended September 30, 2024 and 2023, respectively. The decrease of approximately $0.5 million was driven by severance cost in the three months ended September 30, 2023.

Selling and Marketing Expense

Selling and marketing expenses were $0.7 million and $0.6 million for the three months ended September 30, 2024 and 2023, respectively.

General and Administrative Expense

General and administrative expenses were $3.6 million for the three months ended September 30, 2024, compared with $2.9 million for the three months ended September 30, 2023. The increase of $0.6 million was primarily due to increased compensation expense related to bonuses.

Other Expense

Total other expense of $0.3 million and $0.1 million for the three months ended September 30, 2024 and 2023, respectively, was primarily driven by interest expense related to our debt facility (See Note 15 to the condensed consolidated financial statements included elsewhere in this Form 10-Q). For the three months ended September 30, 2023, the interest expense is partially offset by $0.2 million of realized gains on available-for-sale investments.

Results of Operations for the Nine Months Ended September 30, 2024 and 2023

The following table summarizes our operating results for the periods presented below (dollars in thousands):


	Nine Months Ended September 30,
	2024		% of Revenue		2023		% of Revenue		% Change

Net Sales	$	76,824			$	61,519			25	%
Cost of Sales	62,971		82	%	55,685		91	%	13	%
Gross Profit	13,853		18	%	5,834		9	%

Research and Product Development	18		—	%	939		2	%	(98)	%
Selling and Marketing	1,906		2	%	1,584		3	%	20	%
General and Administrative	10,802		14	%	9,434		15	%	15	%

Operating Loss	$	1,127	2	%	$	(6,123)	(11)	%

Net Sales

During the nine months ended September 30, 2024, our net sales were $76.8 million compared to net sales of $61.5 million during the nine months ended September 30, 2023. Product revenue for the nine months ended September 30, 2024 was $76.8 million compared to product revenue of $57.7 million for the nine months ended September 30, 2023. The increase of $19.1 million was primarily due to $6.4 million from customers added through the Evoqua asset acquisition, $5.4 million from a special large order of premium-priced product, as well as $7.2 million of increased sales and price increases to existing customers. Net sales of non-product revenue were not material during the nine months ended September 30, 2024 compared to $3.8 million during the nine months ended September 30, 2023, which was the result of $2.3 million and $1.5 million of deferred license revenue recognition related to the terminations of the Wanbang Agreement and Baxter Distribution Agreement, respectively.

Gross Profit

Cost of sales for the nine months ended September 30, 2024 was $63.0 million, resulting in gross profit of $13.9 million for the nine months ended September 30, 2024, compared to cost of sales of $55.7 million and a gross profit of $5.8 million for the nine months ended September 30, 2023. Gross profit increased by $8.0 million driven by $7.1 million of price increases to existing customers, $1.6 million from a special large order of premium-priced product and $1.4 million of lower costs, partially offset by $1.5 million and $1.1 million of gross profit for the nine months ended September 30, 2023 associated with deferred license revenue recognition related to the terminations of the Baxter Distribution Agreement and the Wanbang agreement, respectively.

Research and Product Development Expense

Research and product development expenses were immaterial and $0.9 million for the nine months ended September 30, 2024 and 2023, respectively. The decrease of approximately $0.9 million is due to the decision to pause all research and development related to Triferic in 2023.

Selling and Marketing Expense

Selling and marketing expenses were $1.9 million and $1.6 million for the nine months ended September 30, 2024 and 2023, respectively. The increase of $0.3 million is primarily due to higher employee compensation expenses.

General and Administrative Expense

General and administrative expenses were $10.8 million for the nine months ended September 30, 2024, compared with $9.4 million for the nine months ended September 30, 2023. The increase of $1.4 million was primarily due to increased compensation expense related to bonuses, additional administrative costs and amortization of intangible assets.

Other Expense

Total other expense of $0.9 million and $0.8 million for the nine months ended September 30, 2024 and 2023, respectively, was driven by interest expense of $1.0 million and $1.2 million, respectively, related to our debt facility (See Note 15 to the condensed consolidated financial statements included elsewhere in this Form 10-Q), partially offset by $0.1 million and $0.2 million of interest income, respectively, as well as realized gains on available-for-sale of investments of $0.1 million and $0.2 million, respectively.

Liquidity and Capital Resources

As of September 30, 2024, we had approximately $18.3 million of cash, cash equivalents and investments available-for-sale, and working capital of $20.0 million. Based on the currently available 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.

Additionally, the Company's operational plans include raising capital, if needed, by using the $4.5 million remaining availability under its at-the-market ("ATM") facility or other methods or forms of financings, subject to existing limitations. Under the ATM, we have the ability to control the timing and price at which capital is raised.

The actual amount of cash that we will need to execute our business strategy is subject to many factors, including, but not limited to, the costs associated with our manufacturing and transportation operations related to our concentrate business.

We may elect to raise capital in the future through one or more of the following: (i) equity and debt raises through the equity and capital markets, though there can be no assurance we will be able to secure additional capital or funding on acceptable terms, or if at all; and (ii) strategic transactions, including potential alliances and collaborations focused on markets outside the United States, as well as potential combinations (including by merger or acquisition) or other corporate transactions.

We believe our ability to fund our activities in the long term will be highly dependent upon (i) our ability to execute on the growth strategy of our hemodialysis concentrates business and maintain sales with existing customers, (ii) our ability to achieve sustained profitability, and (iii) our ability to identify, develop, in-license, or acquire new products in developing our renal care product portfolio. All of these strategies are subject to significant risks and uncertainties such that there can be no assurance we will be successful in achieving them. If we are unsuccessful in executing our business plan and we are unable to raise the required capital, we may be forced to curtail all of our activities and, ultimately, cease operations. Even if we are able to raise sufficient capital, such financings may only be available on unattractive terms, or result in significant dilution of stockholders’ interests and, in such event, the market price of our common stock may decline.

If the Company attempts to obtain additional debt or equity financing, the Company cannot assume such financing will be available on favorable terms, if at all. In addition, any debt financing is limited by the terms of our Securities Purchase Agreement with DaVita. Specifically, until DaVita owns less than 50% of its investment, the Company may only incur additional debt in the form of a purchase money loan, a working capital line of up to $5 million or to refinance existing debt, unless DaVita consents.

The Company is subject to certain covenants and cure provisions under its Loan Agreement with Innovatus. As of September 30, 2024, the Company is in compliance with all covenants. On January 2, 2024, the Company's Loan Agreement was amended to include, among other things, an interest-only period for 30 months, or up to 36 months if certain conditions are met, and extend the maturity date to January 1, 2029 (See Note 15 to the accompanying condensed consolidated financial statements).

The global macroeconomic environment is uncertain, and could be negatively affected by, among other things, increased U.S. trade tariffs and trade disputes with other countries, instability in the global capital and credit markets, recent bank failures in the United States, supply chain weaknesses, and instability in the geopolitical environment, including as a result of the Russian invasion of Ukraine, the Middle East conflict and other political tensions, and the occurrence of natural disasters and public health crises. Such challenges have caused, and may continue to cause, recession fears, rising interest rates, foreign exchange volatility and inflationary pressures. At this time, the Company is unable to quantify the potential effects of this economic instability on our future operations. Due to the rapidly evolving nature of the global situation, it is not possible to predict the extent to which these conditions could adversely affect the Company's liquidity and capital resources in the future.

Cash Provided By (Used In) Operating Activities

Net cash provided by operating activities was $3.3 million for the nine months ended September 30, 2024 compared to net cash used in operating activities of $9.4 million for the nine months ended September 30, 2023. The change in cash provided by operating activities during the current period as compared to cash used in operating activities in the prior period was primarily due to (i) an increase in net income of approximately $7.2 million, (ii) an increase in cash provided by changes in current balance sheet accounts in the ordinary course of business of approximately $5.9 million, primarily due to increases of $5.1 million of accounts receivable, net and $3.8 million of deferred license revenue, partially offset by decreases of $1.8 million of accounts payable and $1.2 million of inventory, partially offset by (iii) a decrease in cash provided from non-cash adjustments primarily related to a decrease of $0.8 million in inventory reserves.

Cash Used In Investing Activities

Net cash used in investing activities was $4.5 million during the nine months ended September 30, 2024 compared to net cash used in investing activities of $5.1 million for the nine months ended September 30, 2023. Net cash used in investing activities during the nine months ended September 30, 2024 was driven primarily by (i) net cash payments from purchases and sales of our available-for-sale investments of $3.9 million during the period. Net cash used in investing activities during the nine months ended September 30, 2023 was primarily due to the cash paid in connection with the Evoqua Asset Acquisition of $12.4 million, partially offset by the net cash proceeds from sales and purchase of available-for-sale investments during the period of $7.5 million.

Cash Provided By Financing Activities

Net cash provided by financing activities was $4.6 million during the nine months ended September 30, 2024 compared to net cash provided by financing activities of $12.1 million for the nine months ended September 30, 2023. Net cash provided by financing activities during the nine months ended September 30, 2024 was primarily due to the gross proceeds from the issuance of common stock in connection with the ATM facility of $6.4 million, partially offset by the cash paid in

connection with the Evoqua Asset Acquisition of $1.0 million. Net cash provided by financing activities for the nine months ended September 30, 2023 was primarily due to the gross proceeds from the issuance of common stock in connection with the exercise of the Prior Warrant and Pre-Funded Warrants of $13.8 million.

Contractual Obligations and Other Commitments

See Note 13 to the condensed consolidated financial statements included elsewhere in this Form 10-Q for additional disclosures. There have been no other material changes from the contractual obligations and other commitments disclosed in Note 14 and 15 to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023.

Critical Accounting Policies and Significant Judgments and Estimates

Our critical accounting policies and significant estimates are detailed in our Annual Report on Form 10-K for the year ended December 31, 2023.

Recently issued and adopted accounting pronouncements:

We have evaluated all recently issued accounting pronouncements and believe such pronouncements do not have a material effect our financial statements. See Note 3 to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

Per §229.305 of Regulation S-K, the Company, designated a Smaller Reporting Company as defined in §229.10(f)(1) of Regulation S-K, is not required to provide the disclosure required by this Item.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures designed to ensure material information required to be disclosed in our reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and such information is accumulated and communicated to our management, including our Chief Executive Officer as appropriate, to allow timely decisions regarding required financial disclosure. In designing and evaluating the disclosure controls and procedures, we recognized a control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. Management was required to apply its judgment in evaluating the cost‑benefit relationship of possible controls and procedures.

Under the supervision of and with the participation of our management, including the Company’s Chief Executive Officer, we evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2024. Based upon that evaluation, our Chief Executive Officer concluded our disclosure controls and procedures were effective as of September 30, 2024.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting in connection with the evaluation required by Rule 13a-15(d) of the Exchange Act that occurred during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

Item 1. Legal Proceedings

We may be involved in certain routine legal proceedings from time to time before various courts and governmental agencies. We cannot predict the final disposition of such proceedings. We regularly review legal matters and record provisions for claims considered probable of loss. The resolution of these pending proceedings is not expected to have a material effect on our operations or consolidated financial statements in the period in which they are resolved.

Item 1A. Risk Factors

Our business is subject to various risks, including those described in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023. There have been no material changes to the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2023 under "Item 1A - Risk Factors."

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

None.

Item 6. Exhibits

The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.


EXHIBIT INDEX
Exhibit No.						Description














31.1*						Certification pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934



32.1**						Certification pursuant to 18 U.S.C. Section 1350 and Rule 13a-14(b) of the Securities Exchange Act of 1934

101.INS*						XBRL Instance Document

101.SCH*						XBRL Taxonomy Extension Schema

101.CAL*						XBRL Taxonomy Extension Calculation Linkbase

101.DEF*						XBRL Taxonomy Extension Definition Database

101.LAB*						XBRL Taxonomy Extension Label Linkbase

101.PRE*						XBRL Taxonomy Extension Presentation Linkbase

104*						The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, formatted in Inline XBRL (included as Exhibit 101)

*						Filed herewith
**						Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	ROCKWELL MEDICAL, INC.
	(Registrant)

Date: November 12, 2024		/s/ Mark Strobeck
		Mark Strobeck, Ph.D. Chief Executive Officer (Principal Executive Officer and Interim Financial Officer)

Exhibit 31.1

CERTIFICATION PURSUANT TO RULE 13a‑14(a)

I, Mark Strobeck, certify that:

1.have reviewed this quarterly report on Form 10‑Q of Rockwell Medical, Inc.;

2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a‑15(e) and 15d‑15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a‑15(f) and 15d‑15(f)) for the registrant and have:

a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.


Date:			November 12, 2024

			/s/ Mark Strobeck Mark Strobeck (Principal Executive Officer and Principal Financial Officer)

EXHIBIT 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Rockwell Medical, Inc. (the “Company”) on Form 10‑Q for the quarter ending June 30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Periodic Report”), each of the undersigned, in the capacities and on the dates indicated below, hereby certifies pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that based on my knowledge:

1.the Periodic Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

2.the information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


Date: November 12, 2024			/s/ Mark Strobeck
			Mark Strobeck (Principal Executive Officer and Principal Financial Officer)

Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2024	Nov. 08, 2024
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Entity File Number	000-23661
Entity Registrant Name	ROCKWELL MEDICAL, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	38-3317208
Entity Address, Address Line One	30142 S. Wixom Road
Entity Address, City or Town	Wixom
Entity Address, State or Province	MI
Entity Address, Postal Zip Code	48393
City Area Code	248
Local Phone Number	960-9009
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Title of 12(b) Security	Common Stock, par value $0.0001
Trading Symbol	RMTI
Security Exchange Name	NASDAQ
Entity Common Stock, Shares Outstanding (in shares)		32,318,806
Entity Central Index Key	0001041024
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
ASSETS
Cash and Cash Equivalents	$ 12,338	$ 8,983
Investments Available-for-Sale	5,934	1,952
Accounts Receivable, net	8,886	10,901
Inventory, net	5,888	5,871
Prepaid and Other Current Assets	1,171	1,063
Total Current Assets	34,217	28,770
Property and Equipment, net	5,795	6,402
Inventory, Non-Current	178	178
Right of Use Assets - Operating, net	3,598	2,713
Right of Use Assets - Financing, net	1,482	1,903
Intangible Assets, net	10,345	10,759
Goodwill	921	921
Other Non-Current Assets	548	527
Total Assets	57,084	52,173
LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts Payable	2,607	4,516
Accrued Liabilities	6,290	7,149
Deferred Consideration - Current	2,274	2,500
Lease Liabilities - Operating - Current	1,554	1,381
Lease Liabilities - Financing - Current	587	558
Deferred License Revenue - Current	46	46
Insurance Financing Note Payable	469	244
Customer Deposits	351	243
Total Current Liabilities	14,178	16,637
Lease Liabilities - Operating - Long-Term	2,098	1,433
Lease Liabilities - Financing - Long-Term	1,085	1,530
Term Loan - Long-Term, net of issuance costs	8,383	8,293
Deferred License Revenue - Long-Term	441	475
Deferred Consideration - Long-Term	1,750	2,500
Long Term Liability - Other	14	14
Total Liabilities	27,949	30,882
Stockholders’ Equity:
Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; 15,000 shares issued and outstanding at September 30, 2024 and December 31, 2023	0	0
Common Stock, $0.0001 par value; 170,000,000 shares authorized; 32,318,806 and 29,130,607 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	3	3
Additional Paid-in Capital	426,046	418,487
Accumulated Deficit	(396,922)	(397,198)
Accumulated Other Comprehensive Income (Loss)	8	(1)
Total Stockholders’ Equity	29,135	21,291
Total Liabilities and Stockholders’ Equity	$ 57,084	$ 52,173

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Statement of Financial Position [Abstract]
Preferred shares, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred shares, shares authorized (in shares)	2,000,000	2,000,000
Preferred shares, shares issued (in shares)	15,000	15,000
Preferred shares, shares outstanding (in shares)	15,000	15,000
Common shares, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common shares, shares authorized (in shares)	170,000,000	170,000,000
Common shares, shares issued (in shares)	32,318,806	29,130,607
Common shares, shares outstanding (in shares)	32,318,806	29,130,607

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Income Statement [Abstract]
Net Sales	$ 28,316	$ 23,771	$ 76,824	$ 61,519
Cost of Sales	22,077	21,569	62,971	55,685
Gross Profit	6,239	2,202	13,853	5,834
Research and Product Development	0	494	18	939
Selling and Marketing	726	556	1,906	1,584
General and Administrative	3,577	2,889	10,802	9,434
Operating Income (Loss)	1,936	(1,737)	1,127	(6,123)
Other Expense:
Realized Gain on Available-for-Sale Investments	0	220	51	220
Interest Expense	(302)	(411)	(965)	(1,193)
Interest Income	30	56	63	169
Total Other Expense, net	(272)	(135)	(851)	(804)
Net Income (Loss)	$ 1,664	$ (1,872)	$ 276	$ (6,927)
Basic Net Income (Loss) per Share (in dollars per share)	$ 0.05	$ (0.07)	$ 0.01	$ (0.32)
Diluted Net Income (Loss) per Share (in dollars per share)	$ 0.04	$ (0.07)	$ 0.01	$ (0.32)
Basic Weighted Average Shares Outstanding (in shares)	31,551,805	27,521,088	30,447,588	21,526,978
Diluted Weighted Average Shares Outstanding (in shares)	32,420,168	27,521,088	31,013,464	21,526,978

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Statement of Comprehensive Income [Abstract]
Net Income (Loss)	$ 1,664	$ (1,872)	$ 276	$ (6,927)
Reclassification of Realized Gain on Available-for-Sale Investments Included in Net Income	0	0	(25)	0
Unrealized Gain (Loss) on Available-for-Sale Investments	13	(69)	38	(90)
Foreign Currency Translation Adjustments	0	0	(4)	(4)
Comprehensive Income (Loss)	$ 1,677	$ (1,941)	$ 285	$ (7,021)

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Total	Prior Warrants and Pre-funded Warrants	At-the-Market Offering	Public Offering	PREFERRED STOCK	COMMON STOCK	COMMON STOCK Prior Warrants and Pre-funded Warrants	COMMON STOCK Pre-funded Warrants	COMMON STOCK At-the-Market Offering	COMMON STOCK Public Offering	ADDITIONAL PAID-IN CAPITAL	ADDITIONAL PAID-IN CAPITAL Prior Warrants and Pre-funded Warrants	ADDITIONAL PAID-IN CAPITAL At-the-Market Offering	ACCUMULATED DEFICIT	ACCUMULATED OTHER COMPREHENSIVE (LOSS) INCOME
Beginning balance (in shares) at Dec. 31, 2022					15,000
Beginning balance at Dec. 31, 2022					$ 0
Beginning balance (in shares) at Dec. 31, 2022						12,163,673
Beginning balance at Dec. 31, 2022	$ 14,106					$ 1					$ 402,701			$ (388,759)	$ 163
Increase (Decrease) in Shareholders' Equity
Net Income (Loss)	(1,750)													(1,750)
Unrealized Gain (Loss) on Available-for-Sale Investments	(3)														(3)
Foreign Currency Translation Adjustments	(4)														(4)
Issuance of Common Stock upon Exercise of Options, in Connection with Exercise of the Prior Warrant and Pre-Funded Warrants, net of offering costs (in shares)								389,000
Stock-based Compensation	193										193
Ending balance (in shares) at Mar. 31, 2023					15,000
Ending balance at Mar. 31, 2023					$ 0
Ending balance (in shares) at Mar. 31, 2023						12,552,673
Ending balance at Mar. 31, 2023	12,542					$ 1					402,894			(390,509)	156
Beginning balance (in shares) at Dec. 31, 2022					15,000
Beginning balance at Dec. 31, 2022					$ 0
Beginning balance (in shares) at Dec. 31, 2022						12,163,673
Beginning balance at Dec. 31, 2022	14,106					$ 1					402,701			(388,759)	163
Increase (Decrease) in Shareholders' Equity
Net Income (Loss)	(6,927)
Reclassification of Realized Gains on Available-for-Sale Debt Instrument Investments Included in Net Income	0
Foreign Currency Translation Adjustments	$ (4)
Ending balance (in shares) at Sep. 30, 2023					15,000
Ending balance at Sep. 30, 2023					$ 0
Ending balance (in shares) at Sep. 30, 2023	28,489,663					28,489,663
Ending balance at Sep. 30, 2023	$ 21,518					$ 3					417,133			(395,686)	68
Beginning balance (in shares) at Mar. 31, 2023					15,000
Beginning balance at Mar. 31, 2023					$ 0
Beginning balance (in shares) at Mar. 31, 2023						12,552,673
Beginning balance at Mar. 31, 2023	12,542					$ 1					402,894			(390,509)	156
Increase (Decrease) in Shareholders' Equity
Net Income (Loss)	(3,305)													(3,305)
Unrealized Gain (Loss) on Available-for-Sale Investments	(18)														(18)
Foreign Currency Translation Adjustments	(1)														(1)
Issuance of Common Stock, net of offering costs/At-The-Market (in shares)										4,118,000
Issuance of Common Stock, net of offering costs/At-The-Market				$ 1						$ 1
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares)						125,000
Stock-based Compensation	309										309
Ending balance (in shares) at Jun. 30, 2023					15,000
Ending balance at Jun. 30, 2023					$ 0
Ending balance (in shares) at Jun. 30, 2023						16,795,673
Ending balance at Jun. 30, 2023	9,528					$ 2					403,203			(393,814)	137
Increase (Decrease) in Shareholders' Equity
Net Income (Loss)	(1,872)													(1,872)
Unrealized Gain (Loss) on Available-for-Sale Investments	(69)														(69)
Reclassification of Realized Gains on Available-for-Sale Debt Instrument Investments Included in Net Income	0
Foreign Currency Translation Adjustments	0
Issuance of Common Stock upon Exercise of Options, in Connection with Exercise of the Prior Warrant and Pre-Funded Warrants, net of offering costs (in shares)							11,693,990
Issuance of Common Stock in Connection with Exercise of the Prior Warrant and Pre-Funded Warrants, net of offering costs		$ 13,719					$ 1					$ 13,718
Stock-based Compensation	$ 212										212
Ending balance (in shares) at Sep. 30, 2023					15,000
Ending balance at Sep. 30, 2023					$ 0
Ending balance (in shares) at Sep. 30, 2023	28,489,663					28,489,663
Ending balance at Sep. 30, 2023	$ 21,518					$ 3					417,133			(395,686)	68
Beginning balance (in shares) at Dec. 31, 2023	15,000				15,000
Beginning balance at Dec. 31, 2023	$ 0				$ 0
Beginning balance (in shares) at Dec. 31, 2023	29,130,607					29,130,607
Beginning balance at Dec. 31, 2023	$ 21,291					$ 3					418,487			(397,198)	(1)
Increase (Decrease) in Shareholders' Equity
Net Income (Loss)	(1,731)													(1,731)
Unrealized Gain (Loss) on Available-for-Sale Investments	25														25
Issuance of Common Stock, net of offering costs/At-The-Market (in shares)									358,210
Issuance of Common Stock, net of offering costs/At-The-Market			$ 560										$ 560
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares)						67,657
Issuance of Warrant in connection with the Third Amendment (Note 11)	247										247
Stock-based Compensation	251										251
Ending balance (in shares) at Mar. 31, 2024					15,000
Ending balance at Mar. 31, 2024					$ 0
Ending balance (in shares) at Mar. 31, 2024						29,556,474
Ending balance at Mar. 31, 2024	$ 20,643					$ 3					419,545			(398,929)	24
Beginning balance (in shares) at Dec. 31, 2023	15,000				15,000
Beginning balance at Dec. 31, 2023	$ 0				$ 0
Beginning balance (in shares) at Dec. 31, 2023	29,130,607					29,130,607
Beginning balance at Dec. 31, 2023	$ 21,291					$ 3					418,487			(397,198)	(1)
Increase (Decrease) in Shareholders' Equity
Net Income (Loss)	276
Reclassification of Realized Gains on Available-for-Sale Debt Instrument Investments Included in Net Income	(25)
Foreign Currency Translation Adjustments	$ (4)
Issuance of Common Stock, net of offering costs/At-The-Market (in shares)									2,990,925
Ending balance (in shares) at Sep. 30, 2024	15,000				15,000
Ending balance at Sep. 30, 2024	$ 0				$ 0
Ending balance (in shares) at Sep. 30, 2024	32,318,806					32,318,806
Ending balance at Sep. 30, 2024	$ 29,135					$ 3					426,046			(396,922)	8
Beginning balance (in shares) at Mar. 31, 2024					15,000
Beginning balance at Mar. 31, 2024					$ 0
Beginning balance (in shares) at Mar. 31, 2024						29,556,474
Beginning balance at Mar. 31, 2024	20,643					$ 3					419,545			(398,929)	24
Increase (Decrease) in Shareholders' Equity
Net Income (Loss)	343													343
Reclassification of Realized Gains on Available-for-Sale Debt Instrument Investments Included in Net Income	(25)														(25)
Foreign Currency Translation Adjustments	(4)														(4)
Issuance of Common Stock, net of offering costs/At-The-Market (in shares)									1,350,169
Issuance of Common Stock, net of offering costs/At-The-Market			2,203										2,203
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares)						123,575
Stock-based Compensation	338										338
Ending balance (in shares) at Jun. 30, 2024					15,000
Ending balance at Jun. 30, 2024					$ 0
Ending balance (in shares) at Jun. 30, 2024						31,030,218
Ending balance at Jun. 30, 2024	23,498					$ 3					422,086			(398,586)	(5)
Increase (Decrease) in Shareholders' Equity
Net Income (Loss)	1,664													1,664
Unrealized Gain (Loss) on Available-for-Sale Investments	13														13
Reclassification of Realized Gains on Available-for-Sale Debt Instrument Investments Included in Net Income	0
Foreign Currency Translation Adjustments	0
Issuance of Common Stock, net of offering costs/At-The-Market (in shares)									1,282,546
Issuance of Common Stock, net of offering costs/At-The-Market			$ 3,630										$ 3,630
Issuance of Common Stock upon Exercise of Options (in shares)						6,042
Issuance of Common Stock upon Exercise of Options		$ 9									9
Stock-based Compensation	$ 321										321
Ending balance (in shares) at Sep. 30, 2024	15,000				15,000
Ending balance at Sep. 30, 2024	$ 0				$ 0
Ending balance (in shares) at Sep. 30, 2024	32,318,806					32,318,806
Ending balance at Sep. 30, 2024	$ 29,135					$ 3					$ 426,046			$ (396,922)	$ 8

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash Flows From Operating Activities:
Net Income (Loss)	$ 276	$ (6,927)
Adjustments To Reconcile Net Income (Loss) To Net Cash Provided By (Used In) Operating Activities:
Depreciation and Amortization	1,637	894
Stock-based Compensation	910	714
Increase in Inventory Reserves	314	1,098
Non-cash Lease Expense from Right of Use Assets	1,446	1,529
Amortization of Debt Financing Costs and Accretion of Debt Discount and Premium	337	276
Loss on Disposal of Assets	0	1
Realized Gain on Sale of Investments	(51)	(220)
Changes in Operating Assets and Liabilities:
Accounts Receivable	2,024	(3,102)
Inventory	(331)	1,561
Prepaid and Other Assets	541	875
Accounts Payable	(1,909)	(124)
Lease Liabilities	(1,072)	(1,113)
Accrued and Other Liabilities	(751)	(1,033)
Deferred License Revenue	(34)	(3,798)
Net Cash Provided By (Used In) Operating Activities	3,337	(9,369)
Cash Flows From Investing Activities:
Purchase of Investments Available-for-Sale	(5,921)	(3,752)
Sale of Investments Available-for-Sale	2,003	11,301
Purchase of Equipment	(616)	(241)
Cash Paid in Connection with Evoqua Asset Acquisition	0	(12,361)
Net Cash Used In Investing Activities	(4,534)	(5,053)
Cash Flows From Financing Activities:
Payments on Debt	0	(500)
Payments on Insurance Financing Note Payable	(445)	(748)
Payments on Financing Lease Liabilities	(416)	(388)
Proceeds from Issuance of Common Stock	6,393	13,763
Offering Costs from Issuance of Common Stock	0	(43)
Deferred Consideration Paid in Connection with Evoqua Asset Acquisition	(976)	0
Net Cash Provided By Financing Activities	4,556	12,084
Effect of Exchange Rate Changes on Cash and Cash Equivalents	(4)	(5)
Net Increase (Decrease) in Cash and Cash Equivalents	3,355	(2,343)
Cash and Cash Equivalents at Beginning of Period	8,983	10,102
Cash and Cash Equivalents at End of Period	12,338	7,759
Supplemental Disclosure of Cash Flow Information:
Cash Paid for Interest	645	929
Supplemental Disclosure of Non-cash Investing and Financing Activities:
Issuance of Warrant in connection with the Third Amendment as Debt Issuance Costs	247	0
Right of Use Assets - Operating Obtained in Exchange for Lease Liabilities - Operating	1,984	0
Change in Unrealized Gain (Loss) on Investments Available-for-Sale	13	(90)
Increase in Prepaid Assets from Insurance Financing Note Payable	670	733
Proceeds from Issuance of Common Stock Upon Exercise of Options in Accounts Receivable, net	$ 9	$ 0

Description of Business	9 Months Ended
Description of Business	Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Description of Business	Description of Business Rockwell Medical, Inc. (the "Company", "Rockwell", "we", or "us") is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide. Rockwell is the largest supplier of liquid bicarbonate concentrates and the second largest supplier of acid and dry 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 at freestanding outpatient dialysis centers, at hospital-based outpatient centers, at skilled nursing facilities, or in a patient’s home. Rockwell manufactures hemodialysis concentrates at its facilities in Michigan, South Carolina, and Texas totaling approximately 175,000 square feet, and manufactures its dry acid concentrate mixers at its facility in Iowa. Additionally, in July 2023, the Company purchased customer relationships, equipment and inventory from Evoqua Water Technologies LLC ("Evoqua") related to the manufacturing and sale of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization in Minnesota. 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. The Company operates in a single segment. Rockwell was incorporated in the state of Michigan in 1996 and re-domiciled to the state of Delaware in 2019. Rockwell's headquarters is located at 30142 Wixom Road, Wixom, Michigan 48393.

Liquidity and Capital Resources	9 Months Ended
Liquidity and Capital Resources	Sep. 30, 2024
Liquidity and Capital Resources [Abstract]
Liquidity and Capital Resources	Liquidity and Capital Resources As of September 30, 2024, Rockwell had approximately $18.3 million of cash, cash equivalents and investments available-for-sale, and working capital of $20.0 million. Net cash provided by operating activities for the nine months ended September 30, 2024 was approximately $3.3 million. Based on the currently available 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. The Company continues to review its operational plans and execute on the acquisition of new customers, and has implemented cost containment activities. The Company may require additional capital to sustain its operations and make the investments it needs to execute its strategic plan. Additionally, the Company's operational plans include raising capital, if needed, by using the remaining $4.5 million available under its at-the-market ("ATM") facility or other methods or forms of financings, subject to existing limitations. If the Company attempts to obtain additional debt or equity financing, the Company cannot assume such financing will be available on favorable terms, if at all. The Company is subject to certain covenants and cure provisions under its Loan Agreement with Innovatus Life Sciences Lending Fund I, LP ("Innovatus"), which, on January 2, 2024, was amended 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). As of September 30, 2024, the Company is in compliance with all covenants. In addition, the global macroeconomic environment is uncertain, and could be negatively affected by, among other things, increased U.S. trade tariffs and trade disputes with other countries, instability in the global capital and credit markets, recent bank failures in the United States, supply chain weaknesses, and instability in the geopolitical environment, including as a result of the Russian invasion of Ukraine, the Middle East conflict and other political tensions, and the occurrence of natural disasters and public health crises. Such challenges have caused, and may continue to cause, recession fears, rising interest rates, foreign exchange volatility and inflationary pressures. At this time, the Company is unable to quantify the potential effects, if any, of this economic and political instability on its future operations. Rockwell has utilized a range of financing methods to fund its operations in the past; however, current conditions in the financial and credit markets may limit the availability of funding or refinancing or increase the cost of funding. Due to the rapidly evolving nature of the global situation, it is not possible to predict the extent to which these conditions could adversely affect the Company's liquidity and capital resources in the future.

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements

Use of Estimates

Income (Loss) Per Share

Basic and diluted net income (loss) per share for the three and nine months ended September 30, 2024 and 2023 was calculated as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(In thousands, except share and per share amounts)	2024		2023		2024		2023
Numerator:
Net Income (Loss)	$	1,664	$	(1,872)	$	276	$	(6,927)

Less: Undistributed Earnings to Participating Securities	(233)		—		(40)		—
Net Income (Loss) Attributable to Common Stockholders	$	1,431	$	(1,872)	$	236	$	(6,927)

Denominator:
Basic Weighted Average Number of Shares of Common Stock Outstanding	31,551,805		27,521,088		30,447,588		21,526,978
Incremental Shares Attributable to the Assumed Exercise of Outstanding Options to Purchase Common Stock	489,193		—		271,382		—
Incremental Shares Attributable to the Assumed Vesting of Unvested Restricted Stock Units	318,046		—		282,340		—
Incremental Shares Attributable to the Assumed Exercise of Warrants	61,124		—		12,154		—

Diluted Weighted Average Number of Shares of Common Stock Outstanding	32,420,168		27,521,088		31,013,464		21,526,978
Basic Net Income (Loss) per Share Attributable to Common Stockholders	$	0.05	$	(0.07)	$	0.01	$	(0.32)
Diluted Net Income (Loss) per Share Attributable to Common Stockholders	$	0.04	$	(0.07)	$	0.01	$	(0.32)


	Three Months Ended September 30,		Nine Months Ended September 30,
	2024	2023	2024	2023
Warrants to Purchase Common Stock	3,793,388	4,045,278	3,793,388	4,045,278
Options to Purchase Common Stock	268,978	1,367,493	284,296	1,367,493
Convertible Preferred Stock	—	1,363,636	—	1,363,636
Unvested Restricted Stock Units	—	287,400	—	287,400
Unvested Restricted Stock Awards	891	891	891	891
Total	4,063,257	7,064,698	4,078,575	7,064,698

Adoption of Recent Accounting Pronouncements

Asset Acquisition

9 Months Ended

Sep. 30, 2024

Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract]

Asset Acquisition

The purchase price was allocated, on a relative fair value basis, to the assets acquired at the July 10, 2023 acquisition date as follows (table in thousands):



Consideration
Cash Payment	$	12,233
Deferred Consideration	5,000
Transaction Costs	128
Total Consideration	$	17,361

Assets Acquired
Customer Relationships Intangible Asset	$	11,035
Equipment	5,093
Inventory	1,233
Total Assets Acquired	$	17,361

Estimated future amortization expense on the Company's customer relationships intangible asset as of September 30, 2024 is as follows (table in thousands):


Year ending December 31:
2024 (remainder of year)	$	138
2025	552
2026	552
2027	552
2028	552
Thereafter	7,999
Total	$	10,345

Revenue Recognition

9 Months Ended

Sep. 30, 2024

Revenue from Contract with Customer [Abstract]

Revenue Recognition

•Step 1: Identify the contract with the customer

•Step 2: Identify the performance obligations in the contract

•Step 3: Determine the transaction price

•Step 4: Allocate the transaction price to the performance obligations in the contract

•Step 5: Recognize revenue when the company satisfies a performance obligation

Nature of goods and services

Product Sales

Deferred License Revenue

Product Purchase Agreements

Disaggregation of revenue

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


In thousands	Three Months Ended September 30, 2024						Nine Months Ended September 30, 2024
Products By Geographic Area	Total		U.S.		Rest of World		Total		U.S.		Rest of World
Drug Revenues

License Fee – Over time	$	11	$	—	$	11	$	34	$	—	$	34
Total Drug Products	11		—		11		34		—		34
Concentrate Products
Product Sales – Point-in-time	28,305		26,247		2,058		76,790		70,390		6,400

Total Concentrate Products	28,305		26,247		2,058		76,790		70,390		6,400
Net Revenue	$	28,316	$	26,247	$	2,069	$	76,824	$	70,390	$	6,434


In thousands	Three Months Ended September 30, 2023						Nine Months Ended September 30, 2023
Products By Geographic Area	Total		U.S.		Rest of World		Total		U.S.		Rest of World
Drug Revenues

License Fee – Over time	$	2,197	$	—	$	2,197	$	2,327	$	—	$	2,327
Total Drug Products	2,197		—		2,197		2,327		—		2,327
Concentrate Products
Product Sales – Point-in-time	21,574		19,741		1,833		57,720		52,326		5,394
License Fee – Over time	—		—		—		1,472		1,472		—
Total Concentrate Products	21,574		19,741		1,833		59,192		53,798		5,394
Net Revenue	$	23,771	$	19,741	$	4,030	$	61,519	$	53,798	$	7,721

Contract balances

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


In thousands	September 30, 2024		December 31, 2023		January 1, 2023
Accounts Receivable, net	$	8,886	$	10,901	$	6,259
Contract Liabilities, which are included in deferred license revenue	$	487	$	521	$	4,331

The contract liabilities primarily relate to upfront fees under distribution and license agreements with Wanbang, Sun Pharma, Jeil Pharma, and Drogsan Pharma.

Transaction price allocated to remaining performance obligations

Investments - Available-for-Sale

9 Months Ended

Sep. 30, 2024

Investments, Debt and Equity Securities [Abstract]

Investments - Available-for-Sale

Investments available-for-sale consisted of the following as of September 30, 2024 and December 31, 2023 (table in thousands):


	September 30, 2024
	Amortized Cost		Unrealized Gain		Unrealized Loss		Accrued Interest		Fair Value
Available-for-Sale Securities
Debt securities	$	5,921	$	13	$	—	$	—	$	5,934


	December 31, 2023
	Amortized Cost		Unrealized Gain		Unrealized Loss		Accrued Interest		Fair Value
Available-for-Sale Securities
Debt securities	$	1,948	$	4	$	—	$	—	$	1,952

As of September 30, 2024, the Company's remaining available-for-sale securities are all due within one year.

Inventory

9 Months Ended

Sep. 30, 2024

Inventory Disclosure [Abstract]

Inventory

Components of inventory, net of reserves, as of September 30, 2024 and December 31, 2023 were as follows (table in thousands):


	September 30, 2024		December 31, 2023
Inventory - Current Portion
Raw Materials	$	2,152	$	2,250
Work in Process	319		351
Finished Goods	3,417		3,270
Total Current Inventory	5,888		5,871
Inventory - Long Term (1)	178		178
Total Inventory	$	6,066	$	6,049

__________

Property and Equipment

9 Months Ended

Sep. 30, 2024

Property, Plant and Equipment [Abstract]

Property and Equipment

As of September 30, 2024 and December 31, 2023, the Company’s property and equipment consisted of the following (table in thousands):


	September 30, 2024		December 31, 2023
Machinery and Equipment	$	11,598	$	11,131
Information Technology & Office Equipment	1,845		1,845
Leasehold Improvements	1,542		1,423
Laboratory Equipment	807		807
Total Property and Equipment	15,792		15,206
Accumulated Depreciation and Amortization	(9,997)		(8,804)
Property and Equipment, net	$	5,795	$	6,402

Accrued Liabilities

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

Accrued Liabilities

Accrued liabilities as of September 30, 2024 and December 31, 2023 consisted of the following (table in thousands):


	September 30, 2024		December 31, 2023
Accrued Compensation and Benefits	$	2,654	$	2,413
Accrued Unvouchered Receipts	2,214		1,663
Accrued Workers Compensation	340		254
Accrued Manufacturing Expense	—		1,064
Other Accrued Liabilities	1,082		1,755
Total Accrued Liabilities	$	6,290	$	7,149

Deferred License Revenue	9 Months Ended
Deferred License Revenue	Sep. 30, 2024
Revenue from Contract with Customer [Abstract]
Deferred License Revenue	Deferred License Revenue In October 2014, the Company entered into an exclusive distribution agreement with Baxter, which had a term of 10 years, and received an upfront fee of $20 million. Under the exclusive distribution agreement, Baxter distributed and commercialized Rockwell’s hemodialysis concentrates products and provided customer service and order delivery to nearly all U.S. customers. The upfront fee was recorded as deferred license revenue and was being recognized based on the proportion of product shipments to Baxter in each period, compared with total expected sales volume over the term of the distribution agreement. On November 9, 2022, Rockwell incurred a fee to Baxter, which was reflected as a reduction to revenue on the consolidated statements of operations, and was payable in two equal installments on January 1, 2023 and April 1, 2023, to reacquire its distribution rights to its hemodialysis concentrates products from Baxter and terminated the distribution agreement. Exclusivity and other provisions associated with the distribution agreement terminated November 9, 2022 and the remaining operational elements of the agreement terminated December 31, 2022. To ensure that customer needs continued to be met after January 1, 2023, Rockwell agreed to provide certain services to a group of Baxter's customers until March 31, 2023, and Baxter and Rockwell worked together to transition customers’ purchases of Rockwell’s hemodialysis concentrates through that date. Following the reacquisition of these rights, Rockwell is now unrestricted in its ability to sell its hemodialysis concentrates products to dialysis clinics throughout the United States and around the world. The Company recognized the remaining revenue of $1.5 million during the nine months ended September 30, 2023. The remaining agreements with Sun Pharma, Jeil Pharmaceutical, and Drogsan Pharmaceuticals comprise the current and long-term portions of deferred license revenue on the condensed consolidated balance sheets as of September 30, 2024 and December 31, 2023.

Stockholders’ Equity

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

Stockholders' Equity

Stockholders’ Equity

Preferred Stock

Common Stock


	As of September 30,
Common Stock and Common Stock Equivalents:	2024	2023
Common Stock	32,318,806	28,489,663
Common Stock Issuable upon Exercise of Pre-funded Warrants	—	—
Common Stock and Pre-funded Stock Warrants	32,318,806	28,489,663
Options to Purchase Common Stock	1,874,729	1,367,493
Unvested Restricted Stock Awards	891	891
Unvested Restricted Stock Units	534,309	287,400
Convertible Preferred Stock	1,391,045	1,363,636

Warrants to Purchase Common Stock	3,984,484	4,045,278
Total	40,104,264	35,554,361

Controlled Equity Offering

Private Placement

Armistice exercised the Prior Warrant on July 10, 2023, and the Company received gross proceeds of approximately $13.8 million.

Third Amendment

The fair value of the warrant at the issuance date was calculated using the Black-Scholes pricing model and include the following assumptions:



Expected Stock Price Volatility			85.00%
Risk-free Interest Rate			3.93%
Term (years)			5.0
Dividend Yield			0%

Stock-Based Compensation

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

Stock-Based Compensation

The Company recognized total stock-based compensation expense during the three and nine months ended September 30, 2024 and 2023 as follows (table in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Service-based awards:

Restricted Stock Units	$	163	$	112	$	440	$	276
Stock Option Awards	158		100		470		438






Total	$	321	$	212	$	910	$	714

Performance Based Restricted Stock Awards

A summary of the Company’s performance based restricted stock awards during the nine months ended September 30, 2024 is as follows:


Performance Based Restricted Stock Awards	Number of Shares	Weighted Average Grant-Date Fair Value
Unvested at January 1, 2024	891	$	62.70

Unvested at September 30, 2024	891	$	62.70

Service Based Restricted Stock Units

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


Service Based Restricted Stock Units	Number of Shares	Weighted Average Grant-Date Fair Value
Unvested at January 1, 2024	258,885	$	1.97
Granted	466,656	1.58
Vested	(191,232)	2.18

Unvested at September 30, 2024	534,309	$	1.48

Service Based Stock Option Awards

The fair value of the service-based stock option awards granted for the nine months ended September 30, 2024 and 2023 were based on the following assumptions:


	Nine Months Ended September 30, 2024	Nine Months Ended September 30, 2023
Exercise Price	$1.39 - $1.80	$1.37 - $2.83
Expected Stock Price Volatility	81.8%	81.6% - 81.8%
Risk-free Interest Rate	4.31% - 4.45%	3.41% - 3.46%
Term (years)	5.61 - 5.62	5.6 - 6

A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2024 is as follows:


Service Based Stock Option Awards	Shares Underlying Options	Weighted Average Exercise Price		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value (in $1,000's)
Outstanding at January 1, 2024	1,328,621	$	5.22
Granted	569,160	1.40
Exercised	(6,042)	1.49
Forfeited	(15,073)	1.83
Expired	(1,937)	4.79
Outstanding at September 30, 2024	1,874,729	$	4.10	8.2	$	4,068

Exercisable at September 30, 2024	632,600	$	8.73	7.2	$	1,105

The weighted average grant date fair value for service based stock option awards granted during the nine months ended September 30, 2024 and 2023 was $0.99 and $1.03, respectively.

License Agreements	9 Months Ended
License Agreements	Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
License Agreements	License Agreements Product License Agreements The Company is a party to a Licensing Agreement between the Company and Charak, LLC ("Charak") dated January 7, 2002 (the "2002 Agreement") that grants the Company exclusive worldwide rights to certain patents and information related to its Triferic product. On October 7, 2018, the Company entered into a Master Services and IP Agreement (the “Charak MSA”) with Charak and Dr. Ajay Gupta, a former Officer of the Company. Pursuant to the MSA, the parties entered into three additional agreements described below related to the license of certain soluble ferric pyrophosphate (“SFP”) intellectual property owned by Charak. As of September 30, 2024 and December 31, 2023, the Company has accrued $0.1 million relating to certain IP reimbursement expenses and certain sublicense royalty fees, which is included within accrued liabilities on the condensed consolidated balance sheets. Pursuant to the Charak MSA, the aforementioned parties entered into an Amendment, dated as of October 7, 2018 (the “Charak Amendment”), to the 2002 Agreement, under which Charak granted the Company an exclusive, worldwide, non-transferable license to commercialize SFP for the treatment of patients with renal failure. The Charak Amendment amends the royalty payments due to Charak under the 2002 Agreement such that the Company is liable to pay Charak royalties on net sales by the Company of products developed under the license, which includes the Company’s Triferic product, at a specified rate until December 31, 2021 and thereafter at a reduced rate from January 1, 2022 until February 1, 2034. Additionally, the Company is required to pay Charak a percentage of any sublicense income during the term of the agreement, which cannot be less than a minimum specified percentage of net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and can be no 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. Also pursuant to the Charak MSA, the Company and Charak entered into a Commercialization and Technology License Agreement IV Triferic dated as of October 7, 2018 (the “IV Agreement”), under which Charak granted the Company an exclusive, sub-licensable, royalty-bearing license to SFP for the purpose of commercializing certain intravenous-delivered products incorporating SFP for the treatment of iron disorders worldwide for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. The Company was liable to pay Charak royalties on net sales by the Company of products developed under the license at a specified rate until December 31, 2021. From January 1, 2022 until February 1, 2034, the Company is liable to pay Charak a base royalty at a reduced rate on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the IV Agreement, which amount shall not be less than a minimum specified percentage of 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. Also pursuant to the Charak MSA, the Company and Charak entered into a Technology License Agreement TPN Triferic dated as of October 7, 2018 (the “TPN Agreement”), pursuant to which Charak granted the Company an exclusive, sub-licensable, royalty-bearing license to SFP for the purpose of commercializing worldwide certain TPN products incorporating SFP. The license grant under the TPN Agreement continues for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. During the term of the TPN Agreement, the Company is liable to pay Charak a base royalty on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. 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 yet considered probable, and no milestone payments have been accrued as of September 30, 2024 and December 31, 2023.

Leases

9 Months Ended

Sep. 30, 2024

Leases [Abstract]

Leases

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


	Three Months Ended September 30, 2024			Three Months Ended September 30, 2023			Nine Months Ended September 30, 2024			Nine Months Ended September 30, 2023
Operating Leases
Operating Lease Cost	$	418		$	422		$	1,179		$	1,281
Variable Lease Cost	126			112			376			336
Operating Lease Expense	544			534			1,555			1,617
Finance Leases
Amortization of Right-of-use Assets	139			142			421			424
Interest on Lease Obligations	28			36			89			113
Finance Lease Expense	167			178			510			537
Short-term Lease Rent Expense	5			4			16			12
Total Rent Expense	$	716		$	716		$	2,081		$	2,166

Other Information
Operating Cash Flows from Operating Leases	$	449		$	461		$	1,312		$	1,363
Operating Cash Flows from Finance Leases	$	28		$	37		$	89		$	114
Financing Cash Flows from Finance Leases	$	140		$	130		$	416		$	388


Weighted-average Remaining Lease Term – Operating Leases	2.6			2.5			2.6			2.5
Weighted-average Remaining Lease Term – Finance Leases	2.7			3.7			2.7			3.7
Weighted-average Discount Rate – Operating Leases	6.3		%	6.5		%	6.3		%	6.5		%
Weighted-average Discount Rate – Finance Leases	6.4		%	6.4		%	6.4		%	6.4		%

Future minimum rental payments under operating and finance lease agreements are as follows (in thousands):


	Operating		Finance
Year ending December 31, 2024 (remaining)	$	441	$	167
Year ending December 31, 2025	1,716		676
Year ending December 31, 2026	1,075		666
Year ending December 31, 2027	655		311
Year ending December 31, 2028	57		—

Total	3,944		1,820
Less Present Value Discount	(292)		(148)
Operating and Finance Lease Liabilities	$	3,652	$	1,672

Leases

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


	Three Months Ended September 30, 2024			Three Months Ended September 30, 2023			Nine Months Ended September 30, 2024			Nine Months Ended September 30, 2023
Operating Leases
Operating Lease Cost	$	418		$	422		$	1,179		$	1,281
Variable Lease Cost	126			112			376			336
Operating Lease Expense	544			534			1,555			1,617
Finance Leases
Amortization of Right-of-use Assets	139			142			421			424
Interest on Lease Obligations	28			36			89			113
Finance Lease Expense	167			178			510			537
Short-term Lease Rent Expense	5			4			16			12
Total Rent Expense	$	716		$	716		$	2,081		$	2,166

Other Information
Operating Cash Flows from Operating Leases	$	449		$	461		$	1,312		$	1,363
Operating Cash Flows from Finance Leases	$	28		$	37		$	89		$	114
Financing Cash Flows from Finance Leases	$	140		$	130		$	416		$	388


Weighted-average Remaining Lease Term – Operating Leases	2.6			2.5			2.6			2.5
Weighted-average Remaining Lease Term – Finance Leases	2.7			3.7			2.7			3.7
Weighted-average Discount Rate – Operating Leases	6.3		%	6.5		%	6.3		%	6.5		%
Weighted-average Discount Rate – Finance Leases	6.4		%	6.4		%	6.4		%	6.4		%

Future minimum rental payments under operating and finance lease agreements are as follows (in thousands):


	Operating		Finance
Year ending December 31, 2024 (remaining)	$	441	$	167
Year ending December 31, 2025	1,716		676
Year ending December 31, 2026	1,075		666
Year ending December 31, 2027	655		311
Year ending December 31, 2028	57		—

Total	3,944		1,820
Less Present Value Discount	(292)		(148)
Operating and Finance Lease Liabilities	$	3,652	$	1,672

Loans and Security Agreement

9 Months Ended

Sep. 30, 2024

Debt Disclosure [Abstract]

Loans and Security Agreement

Loan and Security Agreement

The following table reflects the schedule of principal payments on the Term Loan as of September 30, 2024 (in thousands):


	September 30, 2024
2024 (remaining)	$	—
2025	—
2026	1,366
2027	3,279
2028	3,279
2029 (inclusive of Final Fee)	1,256
Total Debt Maturities	9,180
Unamortized Issuance Costs, Discount and Premium, net	(797)
Term Loan - Long-Term, net of issuance costs	$	8,383

Insurance Financing Note Payable	9 Months Ended
Insurance Financing Note Payable	Sep. 30, 2024
Debt Disclosure [Abstract]
Insurance Financing Note Payable	Insurance Financing Note Payable On June 3, 2023, the Company entered into a short-term note payable for $0.7 million, bearing interest at a rate of 9.59% per annum to finance various insurance policies. Principal and interest payments related to this note began on July 3, 2023 and were paid on a straight-line amortization over nine months with the final payment due on March 3, 2024. During the nine months ended September 30, 2024, the Company's insurance financing note payable balance was paid in full. On June 24, 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 will be paid in 10 equal monthly payments of $0.1 million, with the final payment due on April 3, 2025. As of September 30, 2024, the balance of the insurance financing note payable was $0.5 million.

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies)	9 Months Ended
	Sep. 30, 2024
Accounting Policies [Abstract]
Basis of Presentation	The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U. S. 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 September 30, 2024, and the condensed consolidated statements of operations, comprehensive income (loss), changes in stockholders' equity, and cash flows for the three and nine months ended September 30, 2024 and 2023 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, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024 or for any future interim period. The condensed consolidated balance sheet at December 31, 2023 has been derived from audited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2023 and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 as filed with the SEC on March 21, 2024. The Company’s consolidated subsidiaries consist of its wholly-owned subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited. The accompanying condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates	Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Income (Loss) Per Share	The Company’s potentially dilutive securities include stock options, restricted stock awards and units, convertible preferred stock and warrants.
Adoption of Recent Accounting Pronouncements	Adoption of Recent Accounting Pronouncements The Company continually assesses new accounting pronouncements to determine their applicability. When it is determined a new accounting pronouncement affects the Company’s financial reporting, the Company undertakes a review to determine the consequences of the change to its consolidated financial statements and assures there are sufficient controls in place to ascertain the Company’s consolidated financial statements properly reflect the change. In November 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2023-07, Segment Reporting - Improvements to Reportable Segment Disclosures, which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. The amendments in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is in the process of determining the effect this ASU will have on the disclosures contained in the notes to the consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which updates income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This ASU also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in this ASU are effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is in the process of determining the effect this ASU will have on the disclosures contained in the notes to the consolidated financial statements. In November 2024, the FASB issued ASC 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, 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. This new standard is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the consolidated financial statements. The Company is currently assessing the impact this ASU will have on the consolidated financial statements and footnote disclosures.
Revenue Recognition	The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers, issued by the FASB. The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: •Step 1: Identify the contract with the customer •Step 2: Identify the performance obligations in the contract •Step 3: Determine the transaction price •Step 4: Allocate the transaction price to the performance obligations in the contract •Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by Rockwell from a customer, are excluded from revenue. Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer.

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables)

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Summary of Basic and Diluted Net Loss Per Share

Basic and diluted net income (loss) per share for the three and nine months ended September 30, 2024 and 2023 was calculated as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(In thousands, except share and per share amounts)	2024		2023		2024		2023
Numerator:
Net Income (Loss)	$	1,664	$	(1,872)	$	276	$	(6,927)

Less: Undistributed Earnings to Participating Securities	(233)		—		(40)		—
Net Income (Loss) Attributable to Common Stockholders	$	1,431	$	(1,872)	$	236	$	(6,927)

Denominator:
Basic Weighted Average Number of Shares of Common Stock Outstanding	31,551,805		27,521,088		30,447,588		21,526,978
Incremental Shares Attributable to the Assumed Exercise of Outstanding Options to Purchase Common Stock	489,193		—		271,382		—
Incremental Shares Attributable to the Assumed Vesting of Unvested Restricted Stock Units	318,046		—		282,340		—
Incremental Shares Attributable to the Assumed Exercise of Warrants	61,124		—		12,154		—

Diluted Weighted Average Number of Shares of Common Stock Outstanding	32,420,168		27,521,088		31,013,464		21,526,978
Basic Net Income (Loss) per Share Attributable to Common Stockholders	$	0.05	$	(0.07)	$	0.01	$	(0.32)
Diluted Net Income (Loss) per Share Attributable to Common Stockholders	$	0.04	$	(0.07)	$	0.01	$	(0.32)

Summary of Potentially Dilutive Securities

The following table includes the potential shares of common stock that were excluded from the computation of diluted EPS per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2024	2023	2024	2023
Warrants to Purchase Common Stock	3,793,388	4,045,278	3,793,388	4,045,278
Options to Purchase Common Stock	268,978	1,367,493	284,296	1,367,493
Convertible Preferred Stock	—	1,363,636	—	1,363,636
Unvested Restricted Stock Units	—	287,400	—	287,400
Unvested Restricted Stock Awards	891	891	891	891
Total	4,063,257	7,064,698	4,078,575	7,064,698

Asset Acquisition (Tables)

9 Months Ended

Sep. 30, 2024

Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract]

Schedule of Purchase Price, on a Relative Fair Value Basis, to Assets Acquired

The purchase price was allocated, on a relative fair value basis, to the assets acquired at the July 10, 2023 acquisition date as follows (table in thousands):



Consideration
Cash Payment	$	12,233
Deferred Consideration	5,000
Transaction Costs	128
Total Consideration	$	17,361

Assets Acquired
Customer Relationships Intangible Asset	$	11,035
Equipment	5,093
Inventory	1,233
Total Assets Acquired	$	17,361

Schedule of Future Amortization Expense

Estimated future amortization expense on the Company's customer relationships intangible asset as of September 30, 2024 is as follows (table in thousands):


Year ending December 31:
2024 (remainder of year)	$	138
2025	552
2026	552
2027	552
2028	552
Thereafter	7,999
Total	$	10,345

Revenue Recognition (Tables)

9 Months Ended

Sep. 30, 2024

Revenue from Contract with Customer [Abstract]

Summary of Disaggregation of Revenue

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


In thousands	Three Months Ended September 30, 2024						Nine Months Ended September 30, 2024
Products By Geographic Area	Total		U.S.		Rest of World		Total		U.S.		Rest of World
Drug Revenues

License Fee – Over time	$	11	$	—	$	11	$	34	$	—	$	34
Total Drug Products	11		—		11		34		—		34
Concentrate Products
Product Sales – Point-in-time	28,305		26,247		2,058		76,790		70,390		6,400

Total Concentrate Products	28,305		26,247		2,058		76,790		70,390		6,400
Net Revenue	$	28,316	$	26,247	$	2,069	$	76,824	$	70,390	$	6,434


In thousands	Three Months Ended September 30, 2023						Nine Months Ended September 30, 2023
Products By Geographic Area	Total		U.S.		Rest of World		Total		U.S.		Rest of World
Drug Revenues

License Fee – Over time	$	2,197	$	—	$	2,197	$	2,327	$	—	$	2,327
Total Drug Products	2,197		—		2,197		2,327		—		2,327
Concentrate Products
Product Sales – Point-in-time	21,574		19,741		1,833		57,720		52,326		5,394
License Fee – Over time	—		—		—		1,472		1,472		—
Total Concentrate Products	21,574		19,741		1,833		59,192		53,798		5,394
Net Revenue	$	23,771	$	19,741	$	4,030	$	61,519	$	53,798	$	7,721

Summary of Contract Balances

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


In thousands	September 30, 2024		December 31, 2023		January 1, 2023
Accounts Receivable, net	$	8,886	$	10,901	$	6,259
Contract Liabilities, which are included in deferred license revenue	$	487	$	521	$	4,331

Investments - Available-for-Sale (Tables)

9 Months Ended

Sep. 30, 2024

Investments, Debt and Equity Securities [Abstract]

Summary of Investments Available-for-Sale

Investments available-for-sale consisted of the following as of September 30, 2024 and December 31, 2023 (table in thousands):


	September 30, 2024
	Amortized Cost		Unrealized Gain		Unrealized Loss		Accrued Interest		Fair Value
Available-for-Sale Securities
Debt securities	$	5,921	$	13	$	—	$	—	$	5,934


	December 31, 2023
	Amortized Cost		Unrealized Gain		Unrealized Loss		Accrued Interest		Fair Value
Available-for-Sale Securities
Debt securities	$	1,948	$	4	$	—	$	—	$	1,952

Inventory (Tables)

9 Months Ended

Sep. 30, 2024

Inventory Disclosure [Abstract]

Summary of Components of Inventory

Components of inventory, net of reserves, as of September 30, 2024 and December 31, 2023 were as follows (table in thousands):


	September 30, 2024		December 31, 2023
Inventory - Current Portion
Raw Materials	$	2,152	$	2,250
Work in Process	319		351
Finished Goods	3,417		3,270
Total Current Inventory	5,888		5,871
Inventory - Long Term (1)	178		178
Total Inventory	$	6,066	$	6,049

__________

Property and Equipment (Tables)

9 Months Ended

Sep. 30, 2024

Property, Plant and Equipment [Abstract]

Summary of Major Classes of Property and Equipment

As of September 30, 2024 and December 31, 2023, the Company’s property and equipment consisted of the following (table in thousands):


	September 30, 2024		December 31, 2023
Machinery and Equipment	$	11,598	$	11,131
Information Technology & Office Equipment	1,845		1,845
Leasehold Improvements	1,542		1,423
Laboratory Equipment	807		807
Total Property and Equipment	15,792		15,206
Accumulated Depreciation and Amortization	(9,997)		(8,804)
Property and Equipment, net	$	5,795	$	6,402

Accrued Liabilities (Tables)

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

Summary of Accrued Liabilities

Accrued liabilities as of September 30, 2024 and December 31, 2023 consisted of the following (table in thousands):


	September 30, 2024		December 31, 2023
Accrued Compensation and Benefits	$	2,654	$	2,413
Accrued Unvouchered Receipts	2,214		1,663
Accrued Workers Compensation	340		254
Accrued Manufacturing Expense	—		1,064
Other Accrued Liabilities	1,082		1,755
Total Accrued Liabilities	$	6,290	$	7,149

Stockholder's Equity (Tables)

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

Summary of Common Stock Reserved for Issuance


	As of September 30,
Common Stock and Common Stock Equivalents:	2024	2023
Common Stock	32,318,806	28,489,663
Common Stock Issuable upon Exercise of Pre-funded Warrants	—	—
Common Stock and Pre-funded Stock Warrants	32,318,806	28,489,663
Options to Purchase Common Stock	1,874,729	1,367,493
Unvested Restricted Stock Awards	891	891
Unvested Restricted Stock Units	534,309	287,400
Convertible Preferred Stock	1,391,045	1,363,636

Warrants to Purchase Common Stock	3,984,484	4,045,278
Total	40,104,264	35,554,361

Summary of Assumptions Used In Calculating Fair Value of Warrant

The fair value of the warrant at the issuance date was calculated using the Black-Scholes pricing model and include the following assumptions:



Expected Stock Price Volatility			85.00%
Risk-free Interest Rate			3.93%
Term (years)			5.0
Dividend Yield			0%

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2024

Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]

Summary of Total Stock-Based Compensation Expense

The Company recognized total stock-based compensation expense during the three and nine months ended September 30, 2024 and 2023 as follows (table in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Service-based awards:

Restricted Stock Units	$	163	$	112	$	440	$	276
Stock Option Awards	158		100		470		438






Total	$	321	$	212	$	910	$	714

Summary of Stock Options Activity

A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2024 is as follows:


Service Based Stock Option Awards	Shares Underlying Options	Weighted Average Exercise Price		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value (in $1,000's)
Outstanding at January 1, 2024	1,328,621	$	5.22
Granted	569,160	1.40
Exercised	(6,042)	1.49
Forfeited	(15,073)	1.83
Expired	(1,937)	4.79
Outstanding at September 30, 2024	1,874,729	$	4.10	8.2	$	4,068

Exercisable at September 30, 2024	632,600	$	8.73	7.2	$	1,105

Restricted stock awards - performance based awards

Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]

Summary of Restricted Stock Awards

A summary of the Company’s performance based restricted stock awards during the nine months ended September 30, 2024 is as follows:


Performance Based Restricted Stock Awards	Number of Shares	Weighted Average Grant-Date Fair Value
Unvested at January 1, 2024	891	$	62.70

Unvested at September 30, 2024	891	$	62.70

Restricted stock units - service based awards

Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]

Summary of Restricted Stock Awards

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


Service Based Restricted Stock Units	Number of Shares	Weighted Average Grant-Date Fair Value
Unvested at January 1, 2024	258,885	$	1.97
Granted	466,656	1.58
Vested	(191,232)	2.18

Unvested at September 30, 2024	534,309	$	1.48

Stock Option Awards

Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]

Summary of Stock Option Assumptions

The fair value of the service-based stock option awards granted for the nine months ended September 30, 2024 and 2023 were based on the following assumptions:


	Nine Months Ended September 30, 2024	Nine Months Ended September 30, 2023
Exercise Price	$1.39 - $1.80	$1.37 - $2.83
Expected Stock Price Volatility	81.8%	81.6% - 81.8%
Risk-free Interest Rate	4.31% - 4.45%	3.41% - 3.46%
Term (years)	5.61 - 5.62	5.6 - 6

Leases (Tables)

9 Months Ended

Sep. 30, 2024

Leases [Abstract]

Summary of Lease Costs

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


	Three Months Ended September 30, 2024			Three Months Ended September 30, 2023			Nine Months Ended September 30, 2024			Nine Months Ended September 30, 2023
Operating Leases
Operating Lease Cost	$	418		$	422		$	1,179		$	1,281
Variable Lease Cost	126			112			376			336
Operating Lease Expense	544			534			1,555			1,617
Finance Leases
Amortization of Right-of-use Assets	139			142			421			424
Interest on Lease Obligations	28			36			89			113
Finance Lease Expense	167			178			510			537
Short-term Lease Rent Expense	5			4			16			12
Total Rent Expense	$	716		$	716		$	2,081		$	2,166

Other Information
Operating Cash Flows from Operating Leases	$	449		$	461		$	1,312		$	1,363
Operating Cash Flows from Finance Leases	$	28		$	37		$	89		$	114
Financing Cash Flows from Finance Leases	$	140		$	130		$	416		$	388


Weighted-average Remaining Lease Term – Operating Leases	2.6			2.5			2.6			2.5
Weighted-average Remaining Lease Term – Finance Leases	2.7			3.7			2.7			3.7
Weighted-average Discount Rate – Operating Leases	6.3		%	6.5		%	6.3		%	6.5		%
Weighted-average Discount Rate – Finance Leases	6.4		%	6.4		%	6.4		%	6.4		%

Summary of Operating Lease Maturities

Future minimum rental payments under operating and finance lease agreements are as follows (in thousands):


	Operating		Finance
Year ending December 31, 2024 (remaining)	$	441	$	167
Year ending December 31, 2025	1,716		676
Year ending December 31, 2026	1,075		666
Year ending December 31, 2027	655		311
Year ending December 31, 2028	57		—

Total	3,944		1,820
Less Present Value Discount	(292)		(148)
Operating and Finance Lease Liabilities	$	3,652	$	1,672

Summary of Finance Lease Maturities

Future minimum rental payments under operating and finance lease agreements are as follows (in thousands):


	Operating		Finance
Year ending December 31, 2024 (remaining)	$	441	$	167
Year ending December 31, 2025	1,716		676
Year ending December 31, 2026	1,075		666
Year ending December 31, 2027	655		311
Year ending December 31, 2028	57		—

Total	3,944		1,820
Less Present Value Discount	(292)		(148)
Operating and Finance Lease Liabilities	$	3,652	$	1,672

Loans and Security Agreement (Tables)

9 Months Ended

Sep. 30, 2024

Debt Disclosure [Abstract]

Summary of Principal Payments on Term Loan

The following table reflects the schedule of principal payments on the Term Loan as of September 30, 2024 (in thousands):


	September 30, 2024
2024 (remaining)	$	—
2025	—
2026	1,366
2027	3,279
2028	3,279
2029 (inclusive of Final Fee)	1,256
Total Debt Maturities	9,180
Unamortized Issuance Costs, Discount and Premium, net	(797)
Term Loan - Long-Term, net of issuance costs	$	8,383

Description of Business (Details) ft² in Thousands	9 Months Ended
Description of Business (Details) ft² in Thousands	Sep. 30, 2024 ft²
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Operating space	175

Liquidity and Capital Resources (Details) - USD ($) $ in Thousands		9 Months Ended
	Jan. 02, 2024	Sep. 30, 2024	Sep. 30, 2023	Apr. 08, 2022
Liquidity and Capital Resources [Abstract]
Cash and cash equivalents		$ 18,300
Working capital		20,000
Net cash used in operating activities		(3,337)	$ 9,369
Cantor Fitzgerald & Co \| At-the-Market Offering
Liquidity and Capital Resources [Abstract]
Sale of stock, aggregate consideration authorized		$ 4,500		$ 12,200
Term loan \| Term loan
Debt Instrument [Line Items]
Period for which company is entitled to make interest-only payments	30 months
Term loan \| Term loan \| Maximum
Debt Instrument [Line Items]
Period for which company is entitled to make interest-only payments	36 months

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Summary of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Numerator:
Net Income (Loss)	$ 1,664	$ 343	$ (1,731)	$ (1,872)	$ (3,305)	$ (1,750)	$ 276	$ (6,927)
Less: Undistributed Earnings to Participating Securities	(233)			0			(40)	0
Net Income (Loss) Attributable to Common Stockholders basic	1,431			(1,872)			236	(6,927)
Net Income (Loss) Attributable to Common Stockholders diluted	$ 1,431			$ (1,872)			$ 236	$ (6,927)
Denominator:
Basic Weighted Average Number of Shares of Common Stock Outstanding (in shares)	31,551,805			27,521,088			30,447,588	21,526,978
Incremental Shares Attributable to the Assumed Exercise of Warrants (in shares)	61,124			0			12,154	0
Diluted Weighted Average Number of Shares of Common Stock Outstanding (in shares)	32,420,168			27,521,088			31,013,464	21,526,978
Basic Net Income (Loss) per Share Attributable to Common Stockholders (in dollars per share)	$ 0.05			$ (0.07)			$ 0.01	$ (0.32)
Diluted Net Income (Loss) per Share Attributable to Common Stockholders (in dollars per share)	$ 0.04			$ (0.07)			$ 0.01	$ (0.32)
Options to Purchase Common Stock
Denominator:
Incremental common shares attributable to dilutive effect of share-based payment arrangements (in shares)	489,193			0			271,382	0
Unvested Restricted Stock Units
Denominator:
Incremental common shares attributable to dilutive effect of share-based payment arrangements (in shares)	318,046			0			282,340	0

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Summary of Potentially Dilutive Securities (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Net Earnings per Share
Securities excluded from diluted loss per share calculation (in shares)	4,063,257	7,064,698	4,078,575	7,064,698
Warrants to Purchase Common Stock
Net Earnings per Share
Securities excluded from diluted loss per share calculation (in shares)	3,793,388	4,045,278	3,793,388	4,045,278
Options to Purchase Common Stock
Net Earnings per Share
Securities excluded from diluted loss per share calculation (in shares)	268,978	1,367,493	284,296	1,367,493
Convertible Preferred Stock
Net Earnings per Share
Securities excluded from diluted loss per share calculation (in shares)	0	1,363,636	0	1,363,636
Unvested Restricted Stock Units
Net Earnings per Share
Securities excluded from diluted loss per share calculation (in shares)	0	287,400	0	287,400
Unvested Restricted Stock Awards
Net Earnings per Share
Securities excluded from diluted loss per share calculation (in shares)	891	891	891	891

Asset Acquisition - Narrative (Details) $ in Thousands			3 Months Ended		9 Months Ended
Asset Acquisition - Narrative (Details) $ in Thousands	Jul. 12, 2024 USD ($) installment	Jul. 10, 2023 USD ($) payment	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)
Asset Acquisition [Line Items]
Installment payment for deferred consideration					$ 976	$ 0
Deferred consideration, installment payment period					12 months
Customer Relationships
Asset Acquisition [Line Items]
Amortization of intangible assets			$ 100	$ 100	$ 400	$ 100
Net intangible assets			10,345		10,345
Evoqua Water Technologies LLC
Asset Acquisition [Line Items]
Total consideration		$ 17,361
Cash payment, including transaction cost		$ 12,400
Number of deferred payments \| payment		2
Milestone payments		$ 2,500
Deferred payment	$ 300
Deferred payments, number of installments \| installment	4
Installment payment for deferred consideration			$ 600		$ 600
Evoqua Water Technologies LLC \| Customer Relationships
Asset Acquisition [Line Items]
Intangible asset, useful life		20 years

Asset Acquisition - Schedule of Purchase Price, on a Relative Fair Value Basis, to Assets Acquired (Details) - USD ($) $ in Thousands		9 Months Ended
	Jul. 10, 2023	Sep. 30, 2024	Sep. 30, 2023
Asset Acquisition [Line Items]
Cash Payment		$ 616	$ 241
Evoqua Water Technologies LLC
Asset Acquisition [Line Items]
Cash Payment	$ 12,233
Deferred Consideration	5,000
Transaction Costs	128
Total Consideration	17,361
Equipment	5,093
Inventory	1,233
Total Assets Acquired	17,361
Evoqua Water Technologies LLC \| Customer Relationships
Asset Acquisition [Line Items]
Customer Relationships Intangible Asset	$ 11,035

Asset Acquisition - Schedule of Future Amortization Expense (Details) - Customer Relationships $ in Thousands	Sep. 30, 2024 USD ($)
Asset Acquisition [Line Items]
2024 (remainder of year)	$ 138
2025	552
2026	552
2027	552
2028	552
Thereafter	7,999
Total	$ 10,345

Revenue Recognition - Nature of Goods and Services (Details) $ in Millions	1 Months Ended	3 Months Ended			9 Months Ended		12 Months Ended
	Sep. 30, 2024	Sep. 30, 2024	Dec. 31, 2023 USD ($)	Sep. 30, 2023	Sep. 30, 2024 agreement segment	Sep. 30, 2023	Dec. 31, 2023
Revenue Recognition [Line Items]
Number of operating market segments \| segment					1
Customers average payment term					30 days
Distributors average payment term					60 days
Number of distribution and license agreements \| agreement					5
Da Vita Healthcare Partners Inc
Revenue Recognition [Line Items]
Product purchase agreement, one time payment from counterparty \| $			$ 0.4
Product purchase agreement, binding forecast period due from counterparty	12 months
Da Vita Healthcare Partners Inc \| Revenue Benchmark \| Customer Concentration Risk
Revenue Recognition [Line Items]
Customer concentration, percentage		52.00%		50.00%	47.00%	50.00%
Da Vita Healthcare Partners Inc \| Accounts Receivable \| Customer Concentration Risk
Revenue Recognition [Line Items]
Customer concentration, percentage					40.00%		40.00%

Revenue Recognition - Summary of Disaggregation of Revenue (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Disaggregation of Revenue [Line Items]
Net Revenue	$ 28,316	$ 23,771	$ 76,824	$ 61,519
Drug products
Disaggregation of Revenue [Line Items]
Net Revenue	11	2,197	34	2,327
Concentrate Products
Disaggregation of Revenue [Line Items]
Net Revenue	28,305	21,574	76,790	59,192
U.S.
Disaggregation of Revenue [Line Items]
Net Revenue	26,247	19,741	70,390	53,798
U.S. \| Drug products
Disaggregation of Revenue [Line Items]
Net Revenue	0	0	0	0
U.S. \| Concentrate Products
Disaggregation of Revenue [Line Items]
Net Revenue	26,247	19,741	70,390	53,798
Rest of World
Disaggregation of Revenue [Line Items]
Net Revenue	2,069	4,030	6,434	7,721
Rest of World \| Drug products
Disaggregation of Revenue [Line Items]
Net Revenue	11	2,197	34	2,327
Rest of World \| Concentrate Products
Disaggregation of Revenue [Line Items]
Net Revenue	2,058	1,833	6,400	5,394
License Fee – Over time \| Drug products
Disaggregation of Revenue [Line Items]
Net Revenue	11	2,197	34	2,327
License Fee – Over time \| Concentrate Products
Disaggregation of Revenue [Line Items]
Net Revenue		0		1,472
License Fee – Over time \| U.S. \| Drug products
Disaggregation of Revenue [Line Items]
Net Revenue	0	0	0	0
License Fee – Over time \| U.S. \| Concentrate Products
Disaggregation of Revenue [Line Items]
Net Revenue		0		1,472
License Fee – Over time \| Rest of World \| Drug products
Disaggregation of Revenue [Line Items]
Net Revenue	11	2,197	34	2,327
License Fee – Over time \| Rest of World \| Concentrate Products
Disaggregation of Revenue [Line Items]
Net Revenue		0		0
Product Sales – Point-in-time \| Concentrate Products
Disaggregation of Revenue [Line Items]
Net Revenue	28,305	21,574	76,790	57,720
Product Sales – Point-in-time \| U.S. \| Concentrate Products
Disaggregation of Revenue [Line Items]
Net Revenue	26,247	19,741	70,390	52,326
Product Sales – Point-in-time \| Rest of World \| Concentrate Products
Disaggregation of Revenue [Line Items]
Net Revenue	$ 2,058	$ 1,833	$ 6,400	$ 5,394

Revenue Recognition - Summary of Contract Balances (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023	Jan. 01, 2023
Revenue from Contract with Customer [Abstract]
Accounts Receivable, net	$ 8,886,000	$ 10,901,000	$ 6,259,000
Contract Liabilities, which are included in deferred license revenue	487,000	521,000	$ 4,331,000
Revenue Recognition [Line Items]
Contract assets	0	0
Concentrate Products
Revenue Recognition [Line Items]
Reserve for returns	$ 0	$ 0

Revenue Recognition - Transaction Price Allocated to Remaining Performance Obligations (Details) - USD ($) $ in Millions	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Revenue Recognition [Line Items]
Contract liabilities, revenue recognized	$ 0.0	$ 3.8
Revenue performance obligation	$ 0.5

Investments - Available-for-Sale - Summary (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Investments, Debt and Equity Securities [Abstract]
Amortized Cost	$ 5,921		$ 5,921		$ 1,948
Unrealized Gain	13		13		4
Unrealized Loss	0		0		0
Accrued Interest	0		0		0
Fair Value	5,934		5,934		$ 1,952
Realized gain on available-for-sale investments	$ 0	$ 220	$ 51	$ 220

Inventory - Summary of Components of Inventory (Details) - USD ($) $ in Thousands	1 Months Ended
	Aug. 31, 2023	Sep. 30, 2024	Dec. 31, 2023
Inventory - Current Portion
Raw Materials		$ 2,152	$ 2,250
Work in Process		319	351
Finished Goods		3,417	3,270
Total Current Inventory		5,888	5,871
Inventory - Long Term		178	178
Total Inventory		$ 6,066	$ 6,049
Triferic Inventory \| SEC Schedule, 12-09, Reserve, Inventory
Inventory - Current Portion
Inventory reserve, period increase (decrease)	$ 1,100

Inventory - Narrative (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Inventory Disclosure [Abstract]
Inventory	$ 6,200	$ 5,900
Inventory, reserve	$ 300	$ 25

Property and Equipment (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Property and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Property and equipment
Gross Property and Equipment	$ 15,792		$ 15,792		$ 15,206
Accumulated Depreciation and Amortization	(9,997)		(9,997)		(8,804)
Property and Equipment, net	5,795		5,795		6,402
Depreciation expense	400	$ 400	1,200	$ 800
Machinery and Equipment
Property and equipment
Gross Property and Equipment	11,598		11,598		11,131
Information Technology & Office Equipment
Property and equipment
Gross Property and Equipment	1,845		1,845		1,845
Leasehold Improvements
Property and equipment
Gross Property and Equipment	1,542		1,542		1,423
Laboratory Equipment
Property and equipment
Gross Property and Equipment	$ 807		$ 807		$ 807

Accrued Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Accrued Compensation and Benefits	$ 2,654	$ 2,413
Accrued Unvouchered Receipts	2,214	1,663
Accrued Workers Compensation	340	254
Accrued Manufacturing Expense	0	1,064
Other Accrued Liabilities	1,082	1,755
Total Accrued Liabilities	$ 6,290	$ 7,149

Deferred License Revenue (Details) $ in Millions	1 Months Ended	9 Months Ended
Deferred License Revenue (Details) $ in Millions	Oct. 31, 2014 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Nov. 09, 2022 installment
Disaggregation of Revenue [Line Items]
Recognized deferred revenue		$ 0.0	$ 3.8
Baxter Healthcare Organization
Disaggregation of Revenue [Line Items]
Term of agreement	10 years
Upfront payment	$ 20.0
Number of payment installments \| installment				2
Recognized deferred revenue			$ 1.5

Stockholders’ Equity - Narrative (Details) $ / shares in Units, $ in Thousands				3 Months Ended				9 Months Ended
	Jul. 10, 2023 USD ($) $ / shares shares	Jun. 16, 2022 USD ($) shares	Apr. 06, 2022 USD ($) $ / shares shares	Sep. 30, 2024 USD ($) $ / shares shares	Jun. 30, 2024 shares	Mar. 31, 2024 shares	Sep. 30, 2023 shares	Sep. 30, 2024 USD ($) $ / shares shares	Sep. 30, 2023 USD ($) shares	Jan. 02, 2024 USD ($) $ / shares shares	Dec. 31, 2023 $ / shares shares	Apr. 08, 2022 USD ($)
Class of Stock [Line Items]
Stock issuance costs								$ 0	$ 43
Preferred shares, shares authorized (in shares) \| shares				2,000,000				2,000,000			2,000,000
Preferred shares, par value (in dollars per share) \| $ / shares				$ 0.0001				$ 0.0001			$ 0.0001
Preferred shares, shares issued (in shares) \| shares				15,000				15,000			15,000
Preferred shares, shares outstanding (in shares) \| shares				15,000				15,000			15,000
Term loan \| Term loan
Class of Stock [Line Items]
Common stock issuable upon exercise of pre-funded warrants (in shares) \| shares										191,096
Exercise price of warrant (in dollars per share) \| $ / shares										$ 1.83
Fair value of warrant										$ 200
PIPE Purchase Agreement Pre-Funded Warrant
Class of Stock [Line Items]
Warrants exercised (in shares) \| shares				0			1,793,000	0	6,300,000
Armistice Warrant Agreement
Class of Stock [Line Items]
Common stock issuable upon exercise of pre-funded warrants (in shares) \| shares	9,900,990
Exercise price of warrant (in dollars per share) \| $ / shares	$ 1.39
Proceeds from Issuance of Common Stock in connection with exercise of Prior Warrant and Pre-Funded Warrants	$ 13,800
Armistice Reload Warrant Agreement
Class of Stock [Line Items]
Common stock issuable upon exercise of pre-funded warrants (in shares) \| shares	3,750,000
Exercise price of warrant (in dollars per share) \| $ / shares	$ 5.13
Warrant expiration period	54 months
Ownership limitation percentage	0.0999
At-the-Market Offering \| COMMON STOCK
Class of Stock [Line Items]
Issuance of common stock (in shares) \| shares				1,282,546	1,350,169	358,210		2,990,925
Series X Convertible Preferred Stock
Class of Stock [Line Items]
Interest rate percentage			1.00%
Common stock trading price (in dollars per share) \| $ / shares			$ 22.00
Common stock trading period			30 days
Accreted amount				$ 300				$ 300
Conversion price (in dollars per share) \| $ / shares			$ 11.00
Convertible preferred stock (in shares)			91
Outstanding common stock, percentage			9.90%
Outstanding common stock, not to exceed, percentage			19.90%
Percentage of investment owned			50.00%
Maximum working capital line			$ 5,000
Consideration received			15,000
Stock issuance costs			100
Proceeds from sale of equity, net			14,900
Da Vita Healthcare Partners Inc \| Share Issuance, Tranche One
Class of Stock [Line Items]
Proceeds from issuance of convertible preferred stock		$ 7,500	7,500
Da Vita Healthcare Partners Inc \| Series X Convertible Preferred Stock \| Private Placement
Class of Stock [Line Items]
Sale of stock, aggregate consideration authorized			$ 15,000
Common stock trading price (in dollars per share) \| $ / shares			$ 1,000
Da Vita Healthcare Partners Inc \| Series X Convertible Preferred Stock \| Private Placement \| Share Issuance, Tranche One
Class of Stock [Line Items]
Number of shares issued (in shares) \| shares		7,500	7,500
Cantor Fitzgerald & Co \| At-the-Market Offering
Class of Stock [Line Items]
Sale of stock, aggregate consideration authorized				$ 4,500				4,500				$ 12,200
Consideration received								$ 6,400

Stockholder's Equity - Summary of Common Stock Reserved for Issuance (Details) - shares	Sep. 30, 2024	Dec. 31, 2023	Sep. 30, 2023
Common Stock and Common Stock Equivalents:
Common Stock (in shares)	32,318,806	29,130,607	28,489,663
Common Stock and Pre-funded Stock Warrants (in shares)	32,318,806		28,489,663
Options to Purchase Common Stock (in shares)	1,874,729		1,367,493
Convertible Preferred Stock (in shares)	1,391,045		1,363,636
Total (in shares)	40,104,264		35,554,361
Unvested Restricted Stock Awards
Common Stock and Common Stock Equivalents:
Unvested restricted stock awards/units (in shares)	891		891
Unvested Restricted Stock Units
Common Stock and Common Stock Equivalents:
Unvested restricted stock awards/units (in shares)	534,309	258,885	287,400
Pre-funded Warrants
Common Stock and Common Stock Equivalents:
Common Stock Issuable upon Exercise of Pre-funded Warrants (in shares)	0		0
Warrants to Purchase Common Stock
Common Stock and Common Stock Equivalents:
Warrants to Purchase Common Stock (in shares)	3,984,484		4,045,278

Stockholder's Equity - Summary of Assumptions Used In Calculating Fair Value of Warrant (Details)	Sep. 30, 2024
Expected Stock Price Volatility
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis, Valuation Techniques [Line Items]
Measurement input	0.8500
Risk-free Interest Rate
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis, Valuation Techniques [Line Items]
Measurement input	0.0393
Term (years)
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis, Valuation Techniques [Line Items]
Measurement input	5.0
Dividend Yield
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis, Valuation Techniques [Line Items]
Measurement input	0

Stock-Based Compensation - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total share based compensation expense	$ 321	$ 212	$ 910	$ 714
Restricted Stock Units
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total share based compensation expense	163	112	440	276
Stock Option Awards
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total share based compensation expense	$ 158	$ 100	$ 470	$ 438

Stock-Based Compensation - Performance Based Restricted Stock Awards (Details) - Restricted stock awards - performance based awards - USD ($) $ / shares in Units, $ in Millions	9 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Number of Shares
Unvested, beginning (in shares)	891	891
Unvested, ending (in shares)	891	891
Weighted Average Grant-Date Fair Value
Unvested, beginning (in dollars per share)	$ 62.70	$ 62.70
Unvested, ending (in dollars per share)	$ 62.70	$ 62.70
Vesting period	20 months
Unrecognized stock-based compensation expense	$ 0.0

Stock-Based Compensation - Service Based Restricted Stock Units (Details) - Unvested Restricted Stock Units $ / shares in Units, $ in Millions	9 Months Ended
	Sep. 30, 2024 USD ($) $ / shares shares
Number of Shares
Outstanding beginning (in shares) \| shares	258,885
Granted (in shares) \| shares	466,656
Vested (in shares) \| shares	(191,232)
Outstanding ending (in shares) \| shares	534,309
Weighted Average Grant-Date Fair Value
Outstanding beginning (in dollars per share) \| $ / shares	$ 1.97
Granted (in dollars per share) \| $ / shares	1.58
Vested (in dollars per share) \| $ / shares	2.18
Outstanding ending (in dollars per share) \| $ / shares	$ 1.48
Unrecognized stock-based compensation expense \| $	$ 0.5
Unrecognized stock-based compensation expense, weighted average remaining term (in years) (less than)	1 year 4 months 24 days
Minimum
Weighted Average Grant-Date Fair Value
Vesting period	1 year
Maximum
Weighted Average Grant-Date Fair Value
Vesting period	3 years

Stock-Based Compensation - Service Based Stock Options - Fair Value Assumptions (Details) - Stock Option Awards - $ / shares	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected Stock Price Volatility	81.80%
Risk-free Interest Rate, minimum	4.31%	3.41%
Risk-free Interest Rate, maximum	4.45%	3.46%
Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Exercise Price (in dollars per share)	$ 1.39	$ 1.37
Expected Stock Price Volatility		81.60%
Term (years)	5 years 7 months 9 days	5 years 7 months 6 days
Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Exercise Price (in dollars per share)	$ 1.80	$ 2.83
Expected Stock Price Volatility		81.80%
Term (years)	5 years 7 months 13 days	6 years

Stock-Based Compensation - Service Based Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended
	Sep. 30, 2024
Shares Underlying Options
Outstanding at the end of the period (in shares)	1,874,729
Stock Option Awards
Shares Underlying Options
Outstanding at the beginning of the period (in shares)	1,328,621
Granted (in shares)	569,160
Exercised (in shares)	(6,042)
Forfeited (in shares)	(15,073)
Expired (in shares)	(1,937)
Outstanding at the end of the period (in shares)	1,874,729
Exercisable at end of period (in shares)	632,600
Weighted Average Exercise Price
Outstanding at the beginning of the period (in dollars per share)	$ 5.22
Granted (in dollars per share)	1.40
Exercised (in dollars per share)	1.49
Forfeited (in dollars per share)	1.83
Expired (in dollar per share)	4.79
Outstanding at the end of the period (in dollars per share)	4.10
Exercisable at end of the period (in dollars per share)	$ 8.73
Weighted Average Remaining Contractual Term
Outstanding	8 years 2 months 12 days
Exercisable at end of the period	7 years 2 months 12 days
Aggregate Intrinsic Value (in $1,000's)
Outstanding	$ 4,068
Exercisable at end of the period	$ 1,105

Stock-Based Compensation - Service Based Stock Options - Others (Details) - Stock Option Awards - USD ($) $ / shares in Units, $ in Millions	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average grant date fair value (in dollars per share)	$ 0.99	$ 1.03
Unrecognized stock-based compensation expenses	$ 0.7
Unrecognized stock-based compensation expense, weighted average remaining term (in years)	2 years 10 months 24 days

License Agreements (Details)	Oct. 07, 2018 agreement	Sep. 30, 2024 USD ($)	Dec. 31, 2023 USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of additional agreements \| agreement	3
Master Services and IP Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, accrued reimbursement of IP expenses and sublicense royalty fees		$ 100,000	$ 100,000
Milestone payments		$ 0	$ 0

Leases - Narrative (Details) $ in Thousands	9 Months Ended
Leases - Narrative (Details) $ in Thousands	Sep. 30, 2024 USD ($) ft² facility	Sep. 30, 2023 USD ($)
Lessee, Lease, Description [Line Items]
Operating lease right-of-use asset and lease liability increase \| $	$ 1,984	$ 0
Wixom, Michigan
Lessee, Lease, Description [Line Items]
Lessee, operating lease, modification, extension, term	3 years
Wixom, Michigan \| Wixom, Michigan Property One
Lessee, Lease, Description [Line Items]
Facility square footage	51,000
Wixom, Michigan \| Wixom, Michigan Property Two
Lessee, Lease, Description [Line Items]
Facility square footage	17,500
Operating lease right-of-use asset and lease liability increase \| $	$ 1,500
Texas and South Carolina
Lessee, Lease, Description [Line Items]
Number of manufacturing facilities \| facility	2
Grapevine, Texas
Lessee, Lease, Description [Line Items]
Facility square footage	51,000
Greer, South Carolina
Lessee, Lease, Description [Line Items]
Facility square footage	57,000
Hackensack, New Jersey
Lessee, Lease, Description [Line Items]
Facility square footage	4,100
Maximum
Lessee, Lease, Description [Line Items]
Lease term	6 years

Leases - Summary of Lease Costs (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Operating Leases
Operating Lease Cost	$ 418	$ 422	$ 1,179	$ 1,281
Variable Lease Cost	126	112	376	336
Operating Lease Expense	544	534	1,555	1,617
Finance Leases
Amortization of Right-of-use Assets	139	142	421	424
Interest on Lease Obligations	28	36	89	113
Finance Lease Expense	167	178	510	537
Short-term Lease Rent Expense	5	4	16	12
Total Rent Expense	716	716	2,081	2,166
Other Information
Operating Cash Flows from Operating Leases	449	461	1,312	1,363
Operating Cash Flows from Finance Leases	28	37	89	114
Financing Cash Flows from Finance Leases	$ 140	$ 130	$ 416	$ 388
Weighted-average Remaining Lease Term – Operating Leases	2 years 7 months 6 days	2 years 6 months	2 years 7 months 6 days	2 years 6 months
Weighted-average Remaining Lease Term – Finance Leases	2 years 8 months 12 days	3 years 8 months 12 days	2 years 8 months 12 days	3 years 8 months 12 days
Weighted-average Discount Rate – Operating Leases	6.30%	6.50%	6.30%	6.50%
Weighted-average Discount Rate – Finance Leases	6.40%	6.40%	6.40%	6.40%

Leases - Summary of Finance Lease and Operating Lease Maturities (Details) $ in Thousands	Sep. 30, 2024 USD ($)
Operating
Year ending December 31, 2024 (remaining)	$ 441
Year ending December 31, 2025	1,716
Year ending December 31, 2026	1,075
Year ending December 31, 2027	655
Year ending December 31, 2028	57
Total	3,944
Less Present Value Discount	(292)
Operating Lease Liabilities	3,652
Finance
Year ending December 31, 2024 (remaining)	167
Year ending December 31, 2025	676
Year ending December 31, 2026	666
Year ending December 31, 2027	311
Year ending December 31, 2028	0
Total	1,820
Less Present Value Discount	(148)
Finance Lease Liabilities	$ 1,672

Loans and Security Agreement - Narrative (Details) - Term loan $ / shares in Units, $ in Thousands				1 Months Ended	3 Months Ended		9 Months Ended
	Jan. 02, 2024 USD ($) $ / shares shares	Nov. 10, 2022 USD ($) installment	Mar. 16, 2020 USD ($) $ / shares shares	Sep. 30, 2021 USD ($) installment	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)
Term loan
Debt Instrument [Line Items]
Aggregate principal amount	$ 8,000	$ 5,000	$ 35,000	$ 7,500
Calculation for number of shares of common stock able to be purchased by warrant, percentage of principal amount of relevant term loan funded			3.50%
Common stock issuable upon exercise of pre-funded warrants (in shares) \| shares	191,096
Exercise price of warrant (in dollars per share) \| $ / shares	$ 1.83
Interest rate, base percentage	7.50%		4.75%
Interest rate, additional percentage added to base percentage	3.50%		4.00%
Initial interest rate percentage			8.75%
Option to add interest rate amount to outstanding principal balance in lieu of paying such amount in cash, percentage	2.00%		1.00%
Number of monthly installments \| installment				10
Prepayment premium percentage				5.00%
Minimum liquidity floor				$ 5,000
Minimum principal amount pursuant to liquidity covenant				$ 15,000
Prepaid installment \| installment		1
Financial covenant, trailing revenue period		6 months
Period for which company is entitled to make interest-only payments	30 months
Debt instrument, interest, extended period	36 months
Debt instrument, notice period (at least)	7 days
Debt instrument prepayment before first anniversary of loan agreement date	6.00%
Debt instrument, prepayment after first anniversary of loan agreement date but on or before second anniversary, percentage	2.00%
Debt instrument, prepayment after second anniversary of loan agreement date but on or before third anniversary, percentage	1.00%
Debt instrument, prepayment after third anniversary of loan agreement date through maturity, percentage	0.00%
Fair value of warrant	$ 200
Effective interest rate					11.50%		11.50%
Interest expense					$ 200	$ 300	$ 700	$ 900
Term Loan - Long-Term, net of issuance costs					8,383		8,383
Unamortized Issuance Costs, Discount and Premium, net					600		600
Premium accretion					797		797
Debt instrument, fee amount					100		100
Paid-in-kind interest					$ 100		$ 100
Term loan \| Maximum
Debt Instrument [Line Items]
Period for which company is entitled to make interest-only payments	36 months
Term loan, first tranche
Debt Instrument [Line Items]
Aggregate principal amount			$ 22,500
Net draw down proceeds			21,200
Closing costs			$ 1,300
Debt instrument, additional fee at maturity, percentage			4.375%
Debt instrument, additional fee at maturity, amount			$ 1,000
Common stock issuable upon exercise of pre-funded warrants (in shares) \| shares			43,388
Exercise price of warrant (in dollars per share) \| $ / shares			$ 18.15
Additional debt discount recognized			$ 500

Loans and Security Agreement - Summary of Principal Payments on Term Loan (Details) - Term loan - Term loan $ in Thousands	Sep. 30, 2024 USD ($)
Debt Instrument [Line Items]
2024 (remaining)	$ 0
2025	0
2026	1,366
2027	3,279
2028	3,279
2029 (inclusive of Final Fee)	1,256
Total Debt Maturities	9,180
Unamortized Issuance Costs, Discount and Premium, net	(797)
Term Loan - Long-Term, net of issuance costs	$ 8,383

Insurance Financing Note Payable (Details) $ in Thousands	Jun. 24, 2024 USD ($) payment	Jun. 03, 2023 USD ($)	Sep. 30, 2024 USD ($)	Dec. 31, 2023 USD ($)
Short-term Debt [Line Items]
Insurance financing note payable			$ 469	$ 244
9.59% Note Payable \| Notes Payable to Banks
Short-term Debt [Line Items]
Short-term note payable		$ 700
Interest rate, base percentage		9.59%
Amortization period (in months)		9 months
7.89% Note Payable \| Notes Payable to Banks
Short-term Debt [Line Items]
Short-term note payable	$ 700
Interest rate, base percentage	7.89%
Debt instrument, fee amount	$ 200
Number of installment payments \| payment	10
Note payable, final payment	$ 100
Insurance financing note payable	$ 500