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~~June 30, ~~2020~~2021


☐			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)

~~411 Hackensack Avenue, Suite 501~~

~~Hackensack, NJ 07601~~

(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 ☒

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 Global Market

The number of shares of common stock outstanding as of ~~November 6, 2020~~August 13, 2021 was ~~93,573,165.~~93,888,881.

Rockwell Medical, Inc. and Subsidiaries

Index to Form 10-Q


			Page
Part I — Financial Information (unaudited)

Item 1 - Financial Statements

Condensed Consolidated Balance Sheets as of ~~September~~ June 30, ~~2020~~2021 and December 31, ~~2019~~2020			3

Condensed Consolidated Statements of Operations for the Three and ~~Nine~~Six Months Ended ~~September~~June 30, ~~2020~~2021 and ~~2019~~2020			4

Condensed Consolidated Statements of Comprehensive Loss for the Three and N ~~ine~~Six Months Ended~~September~~June 30, ~~2020~~2021 and ~~2019~~2020			5

Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and ~~Nine~~Six Months Ended ~~September~~June 30, ~~2020~~2021 and ~~2019~~2020			6

Condensed Consolidated Statements of Cash Flows for the ~~Nine~~Six Months Ended ~~September~~June 30, ~~2020~~2021 and ~~2019~~2020			7

Notes to Condensed Consolidated Financial Statements			8

Item 2 - Management’s Discussion and Analysis of Financial Condition and Results of Operations			27

Item 3 - Quantitative and Qualitative Disclosures about Market Risk			36

Item 4 - Controls and Procedures			36

Part II — Other Information

Item 1 - Legal Proceedings			37

Item 1A - Risk Factors			37

Item 6 - Exhibits			44

Signatures			45

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Dollars in Thousands)


		September 30, 2020		December 31, 2019			June 30, 2021		December 31, 2020
		(Unaudited)					(Unaudited)
ASSETS	ASSETS					ASSETS
Cash and Cash Equivalents	Cash and Cash Equivalents	$	56,614	$	11,794	Cash and Cash Equivalents	$	32,378	$	48,682
Investments Available-for-Sale	Investments Available-for-Sale	10,702		14,250		Investments Available-for-Sale	8,574		9,997
Accounts Receivable, net	Accounts Receivable, net	4,129		4,203		Accounts Receivable, net	5,357		4,171

Inventory, net	Inventory, net	3,877		3,647		Inventory, net	4,677		3,913
Prepaid and Other Current Assets	Prepaid and Other Current Assets	2,621		2,980		Prepaid and Other Current Assets	1,413		2,706
Total Current Assets	Total Current Assets	77,943		36,874		Total Current Assets	52,399		69,469
Property and Equipment, net	Property and Equipment, net	2,785		2,433		Property and Equipment, net	2,529		2,642
Inventory, Non-Current	Inventory, Non-Current	859		441		Inventory, Non-Current	1,122		1,176
Right of Use Assets, net	Right of Use Assets, net	2,099		3,213		Right of Use Assets, net	6,085		2,911
Goodwill	Goodwill	921		921		Goodwill	921		921
Other Non-Current Assets	Other Non-Current Assets	629		435		Other Non-Current Assets	628		629
Total Assets	Total Assets	$	85,236	$	44,317	Total Assets	$	63,684	$	77,748
LIABILITIES AND STOCKHOLDERS’ EQUITY	LIABILITIES AND STOCKHOLDERS’ EQUITY					LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts Payable	Accounts Payable	$	4,190	$	3,018	Accounts Payable	$	4,932	$	4,155
Accrued Liabilities	Accrued Liabilities	4,968		4,518		Accrued Liabilities	3,993		5,013
Settlement Payable		0		104

Lease Liability - Current	Lease Liability - Current	1,155		1,493		Lease Liability - Current	1,674		1,167
Deferred License Revenue - Current	Deferred License Revenue - Current	2,180		2,234		Deferred License Revenue - Current	2,166		2,175
Insurance Financing Note Payable		0		763
Term Loan - Net of Issuance Costs						Term Loan - Net of Issuance Costs	21,133		0

Customer Deposits	Customer Deposits	73		55		Customer Deposits	140		152
Other Current Liability - Related Party	Other Current Liability - Related Party	142		188		Other Current Liability - Related Party	0		131
Total Current Liabilities	Total Current Liabilities	12,708		12,373		Total Current Liabilities	34,038		12,793

Lease Liability - Long-Term	Lease Liability - Long-Term	1,039		1,781		Lease Liability - Long-Term	4,506		1,821
Term Loan, Net of Issuance Costs	Term Loan, Net of Issuance Costs	20,856		0		Term Loan, Net of Issuance Costs	0		20,949
Deferred License Revenue - Long-Term	Deferred License Revenue - Long-Term	8,558		9,843		Deferred License Revenue - Long-Term	6,937		8,015
Total Liabilities	Total Liabilities	43,161		23,997		Total Liabilities	45,481		43,578

Commitments and Contingencies (See Note 14)	Commitments and Contingencies (See Note 14)					Commitments and Contingencies (See Note 14)	0		0

Stockholders’ Equity:	Stockholders’ Equity:					Stockholders’ Equity:
Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; 0 shares issued and outstanding at September 30, 2020 and December 31, 2019		0		0
Common Stock, $0.0001 par value; 170,000,000 shares authorized; 93,573,165 and 65,378,890 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively		9		7
Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; 0 shares issued and outstanding at June 30, 2021 and December 31, 2020						Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; 0 shares issued and outstanding at June 30, 2021 and December 31, 2020	0		0
Common Stock, $0.0001 par value; 170,000,000 shares authorized; 93,811,381 and 93,573,165 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively						Common Stock, $0.0001 par value; 170,000,000 shares authorized; 93,811,381 and 93,573,165 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively	9		9
Additional Paid-in Capital	Additional Paid-in Capital	370,760		326,777		Additional Paid-in Capital	371,700		371,510
Accumulated Deficit	Accumulated Deficit	(328,743)		(306,516)		Accumulated Deficit	(353,558)		(337,406)
Accumulated Other Comprehensive Income	Accumulated Other Comprehensive Income	49		52		Accumulated Other Comprehensive Income	52		57
Total Stockholders’ Equity	Total Stockholders’ Equity	42,075		20,320		Total Stockholders’ Equity	18,203		34,170
Total Liabilities and Stockholders’ Equity	Total Liabilities and Stockholders’ Equity	$	85,236	$	44,317	Total Liabilities and Stockholders’ Equity	$	63,684	$	77,748

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

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Dollars in Thousands, Except Per Share Amounts)


		Three Months Ended September 30, 2020		Three Months Ended September 30, 2019		Nine Months Ended September 30, 2020		Nine Months Ended September 30, 2019			Three Months Ended June 30, 2021		Three Months Ended June 30, 2020		Six Months Ended June 30, 2021		Six Months Ended June 30, 2020

Net Sales	Net Sales	$	15,280	$	15,407	$	47,033	$	45,812	Net Sales	$	15,137	$	15,896	$	30,611	$	31,753
Cost of Sales	Cost of Sales	14,934		15,424		44,693		44,085		Cost of Sales	15,399		15,015		30,471		29,759
Gross Profit	Gross Profit	346		(17)		2,340		1,727		Gross Profit	(262)		881		140		1,994
Research and Product Development										Research and Product Development	2,416		1,616		4,224		3,438
Selling and Marketing	Selling and Marketing	1,669		1,827		5,738		7,149		Selling and Marketing	1,468		1,997		3,319		4,069
General and Administrative	General and Administrative	3,622		4,623		11,767		16,341		General and Administrative	3,677		2,871		7,602		8,145
Settlement Expense		0		0		0		430
Research and Product Development		1,745		1,475		5,183		4,930

Operating Loss	Operating Loss	(6,690)		(7,942)		(20,348)		(27,123)		Operating Loss	(7,823)		(5,603)		(15,005)		(13,658)

Other Income (Expense)
Realized Gain on Investments		4		6		8		24
Other (Expense) Income										Other (Expense) Income
Realized (Loss) Gain on Investments										Realized (Loss) Gain on Investments	(1)		2		(1)		4
Warrant Modification Expense	Warrant Modification Expense	0		0		(837)		0		Warrant Modification Expense	0		(837)		0		(837)
Interest Expense	Interest Expense	(666)		(16)		(1,289)		(16)		Interest Expense	(583)		(521)		(1,164)		(623)
Interest Income	Interest Income	2		97		239		289		Interest Income	7		67		18		238
Total Other Income (Expense)		(660)		87		(1,879)		297
Total Other Expense										Total Other Expense	(577)		(1,289)		(1,147)		(1,218)

Net Loss	Net Loss	$	(7,350)	$	(7,855)	$	(22,227)	$	(26,826)	Net Loss	$	(8,400)	$	(6,892)	$	(16,152)	$	(14,876)

Basic and Diluted Net Loss per Share	Basic and Diluted Net Loss per Share	$	(0.10)	$	(0.12)	$	(0.32)	$	(0.45)	Basic and Diluted Net Loss per Share	$	(0.09)	$	(0.10)	$	(0.17)	$	(0.22)
Basic and Diluted Weighted Average Shares Outstanding	Basic and Diluted Weighted Average Shares Outstanding	71,811,322		63,796,723		69,594,167		59,728,446		Basic and Diluted Weighted Average Shares Outstanding	93,703,492		69,428,574		93,647,583		68,473,407

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

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Dollars in Thousands)


		Three Months Ended September 30, 2020		Three Months Ended September 30, 2019		Nine Months Ended September 30, 2020		Nine Months Ended September 30, 2019			Three Months Ended June 30, 2021		Three Months Ended June 30, 2020		Six Months Ended June 30, 2021		Six Months Ended June 30, 2020

Net Loss	Net Loss	$	(7,350)	$	(7,855)	$	(22,227)	$	(26,826)	Net Loss	$	(8,400)	$	(6,892)	$	(16,152)	$	(14,876)
Unrealized Gain (Loss) on Available-for-Sale Debt Instrument Investments		2		6		(11)		10
Unrealized Loss on Available-for-Sale Debt Instrument Investments										Unrealized Loss on Available-for-Sale Debt Instrument Investments	(1)		(6)		(8)		(13)
Foreign Currency Translation Adjustments	Foreign Currency Translation Adjustments	1		(1)		8		(1)		Foreign Currency Translation Adjustments	0		1		3		7
Comprehensive Loss	Comprehensive Loss	$	(7,347)	$	(7,850)	$	(22,230)	$	(26,817)	Comprehensive Loss	$	(8,401)	$	(6,897)	$	(16,157)	$	(14,882)

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

(Dollars in Thousands)


		COMMON STOCK			ADDITIONAL PAID-IN CAPITAL		ACCUMULATED DEFICIT		ACCUMULATED OTHER COMPREHENSIVE INCOME		TOTAL STOCKHOLDERS' EQUITY			COMMON STOCK			ADDITIONAL PAID-IN CAPITAL		ACCUMULATED DEFICIT		ACCUMULATED OTHER COMPREHENSIVE INCOME		TOTAL STOCKHOLDERS' EQUITY
		SHARES	AMOUNT											SHARES	AMOUNT
Balance as of January 1, 2020		65,378,890	$	7	$	326,777	$	(306,516)	$	52	$	20,320
Balance as of January 1, 2021													Balance as of January 1, 2021	93,573,165	$	9	$	371,510	$	(337,406)	$	57	$	34,170
Net Loss	Net Loss	—	—		—		(7,984)		—		(7,984)		Net Loss	—	—		—		(7,752)		—		(7,752)
Unrealized Loss on Available-for-Sale Investments	Unrealized Loss on Available-for-Sale Investments	—	—		—		—		(7)		(7)		Unrealized Loss on Available-for-Sale Investments	—	—		—		—		(7)		(7)
Foreign Currency Translation Adjustments	Foreign Currency Translation Adjustments	—	—		—		—		6		6		Foreign Currency Translation Adjustments	—	—		—		—		3		3
Issuance of common stock, net of offering costs/Public Offering		3,670,212	0		8,003		—		—		8,003
Issuance of Warrants related to Debt Financing		—	—		501		—		—		501

Stock-based Compensation	Stock-based Compensation	—	—		935		—		—		935		Stock-based Compensation	26,354	—		(236)		—		—		(236)
Balance as of March 31, 2020		69,049,102	$	7	$	336,216	$	(314,500)	$	51	$	21,774
Balance as of March 31, 2021													Balance as of March 31, 2021	93,599,519	$	9	$	371,274	$	(345,158)	$	53	$	26,178
Net Loss	Net Loss	—	—		—		(6,893)		—		(6,893)		Net Loss	—	—		—		(8,400)		—		(8,400)
Unrealized Loss on Available-for-Sale Investments	Unrealized Loss on Available-for-Sale Investments	—	—		—		—		(6)		(6)		Unrealized Loss on Available-for-Sale Investments	—	—		—		—		(1)		(1)
Foreign Currency Translation Adjustments		—	—		—		—		1		1
Issuance of common stock, net of offering costs/At-the-Market Offering		987,716	0		1,978		—		—		1,978

Vesting of Restricted Stock Units Issued, net of taxes withheld	Vesting of Restricted Stock Units Issued, net of taxes withheld	120,104	0		(19)		—		—		(19)		Vesting of Restricted Stock Units Issued, net of taxes withheld	211,862	—		(7)		—		—		(7)
Warrant Modification Expense		—	—		837		—		—		837

Stock-based Compensation expense	Stock-based Compensation expense	—	—		(1,461)		—		—		(1,461)		Stock-based Compensation expense	—	—		433		—		—		433
Balance as of June 30, 2020		70,156,922	$	7	$	337,551	$	(321,393)	$	46	$	16,211
Net Loss		—	—		—		(7,350)		—		(7,350)
Unrealized Gain on Available-for-Sale Investments		—	—		—		—		2		2
Foreign Currency Translation Adjustments		—	—		—		—		1		1
Issuance of common stock, net of offering costs/Public Offering		23,178,809	2		32,675		—		—		32,677
Issuance of common stock, net of offering costs/At-the-Market Offering		140,892	0		284		—		—		284
Vesting of Restricted Stock Units Issued, net of taxes withheld		96,542	0		—		—		—		0
Stock-based Compensation expense		—	—		250		—		—		250
Balance as of September 30, 2020		93,573,165	$	9	$	370,760	$	(328,743)	$	49	$	42,075
Balance as of June 30, 2021													Balance as of June 30, 2021	93,811,381	$	9	$	371,700	$	(353,558)	$	52	$	18,203

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

(Dollars in Thousands)


		COMMON STOCK			ADDITIONAL PAID-IN CAPITAL		ACCUMULATED DEFICIT		ACCUMULATED OTHER COMPREHENSIVE INCOME		TOTAL STOCKHOLDERS' EQUITY			COMMON STOCK			ADDITIONAL PAID-IN CAPITAL		ACCUMULATED DEFICIT		ACCUMULATED OTHER COMPREHENSIVE INCOME		TOTAL STOCKHOLDERS' EQUITY
		SHARES	AMOUNT											SHARES	AMOUNT
Balance as of January 1, 2019		57,034,154	$	6	$	299,596	$	(272,388)	$	63	$	27,277
Balance as of January 1, 2020													Balance as of January 1, 2020	65,378,890	$	7	$	326,777	$	(306,516)	$	52	$	20,320
Net Loss	Net Loss	—	—		—		(8,679)		—		(8,679)		Net Loss	—	—		—		(7,984)		—		(7,984)
Unrealized Loss on Available-for-Sale Investments	Unrealized Loss on Available-for-Sale Investments	—	—		—		—		(7)		(7)		Unrealized Loss on Available-for-Sale Investments	—	—		—		—		(7)		(7)
Foreign Currency Translation Adjustments	Foreign Currency Translation Adjustments	—	—		—		—		0		0		Foreign Currency Translation Adjustments	—	—		—		—		6		6
Exercise of Employee Stock Options, Net of Tax		30,000	0		148		—		—		148
Delivery of common stock underlying restricted stock units, net of tax		64,173	0		(95)		—		—		(95)
Issuance of common stock, net of offering costs/Bought Deal													Issuance of common stock, net of offering costs/Bought Deal	3,670,212	—		8,003		—		—		8,003
Issuance of Warrants related to Debt Financing													Issuance of Warrants related to Debt Financing	—	—		501		—		—		501
Stock-based Compensation	Stock-based Compensation	—	—		1,517		—		—		1,517		Stock-based Compensation	—	—		935		—		—		935
Balance as of March 31, 2019		57,128,327	$	6	$	301,166	$	(281,067)	$	56	$	20,161
Balance as of March 31, 2020													Balance as of March 31, 2020	69,049,102	$	7	$	336,216	$	(314,500)	$	51	$	21,774
Net Loss	Net Loss	—	—		—		(10,292)		—		(10,292)		Net Loss	—	—		—		(6,892)		—		(6,892)
Unrealized Gain on Available-for-Sale Investments		—	—		—		—		12		12
Unrealized Loss on Available-for-Sale Investments													Unrealized Loss on Available-for-Sale Investments	—	—		—		—		(6)		(6)
Foreign Currency Translation Adjustments	Foreign Currency Translation Adjustments	—	—		—		—		0		0		Foreign Currency Translation Adjustments	—	—		—		—		1		1
Issuance of common stock, net of offering costs/Public Offering	Issuance of common stock, net of offering costs/Public Offering	5,833,334	0		16,120		—		—		16,120		Issuance of common stock, net of offering costs/Public Offering	987,716	—		1,978		—		—		1,978
Issuance of common stock, net of offering costs/At-the-Market Offering		437,043	0		2,089		—		—		2,089
Vesting of Restricted Stock Units Issued, net of taxes withheld													Vesting of Restricted Stock Units Issued, net of taxes withheld	120,104	—		(19)		—		—		(19)
Warrant Modification Expense													Warrant Modification Expense	—	—		837		—		—		837
Stock-based Compensation	Stock-based Compensation	—	—		1,502		—		—		1,502		Stock-based Compensation	—	—		(1,461)		—		—		(1,461)
Balance as of June 30, 2019		63,398,704	$	6	$	320,877	$	(291,359)	$	68	$	29,592
Net Loss		—	—		—		(7,855)		—		(7,855)
Unrealized Gain on Available-for-Sale Investments		—	—		—		—		6		6
Foreign Currency Translation Adjustments		—	—		—		—		(1)		(1)
Delivery of common stock underlying restricted stock units, net of tax		62,800	0		(85)		—		—		(85)
Issuance of common stock, net of offering costs/Public Offering		425,880	0		1,169		—		—		1,169
Stock-based Compensation		—	—		876		—		—		876
Balance as of September 30, 2019		63,887,384	$	6	$	322,837	$	(299,214)	$	73	$	23,702
Balance as of June 30, 2020													Balance as of June 30, 2020	70,156,922	$	7	$	337,551	$	(321,392)	$	46	$	16,212

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

(Dollars in Thousands)

For the ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 and ~~2019~~2020


		2020		2019			2021		2020

Cash Flows From Operating Activities:	Cash Flows From Operating Activities:					Cash Flows From Operating Activities:
Net Loss	Net Loss	$	(22,227)	$	(26,826)	Net Loss	$	(16,152)	$	(14,876)
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:	Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:					Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:
Depreciation and Amortization	Depreciation and Amortization	614		582		Depreciation and Amortization	385		408
Stock-based Compensation	Stock-based Compensation	(276)		3,895		Stock-based Compensation	197		(526)
Warrant Modification Expense	Warrant Modification Expense	837		0		Warrant Modification Expense	0		837
Increase in Inventory Reserves	Increase in Inventory Reserves	305		1,271		Increase in Inventory Reserves	89		12
Amortization of Right of Use Asset	Amortization of Right of Use Asset	1,090		1,430		Amortization of Right of Use Asset	857		748
Amortization of Debt Financing Costs and Accretion of Debt Discount	Amortization of Debt Financing Costs and Accretion of Debt Discount	200		0		Amortization of Debt Financing Costs and Accretion of Debt Discount	184		108
Loss (Gain) on Disposal of Assets		7		(1)
Realized (Gain) on Sale of Investments Available-for-Sale		(8)		(24)
Loss on Disposal of Assets						Loss on Disposal of Assets	8		6
Realized Loss (Gain) on Sale of Investments Available-for-Sale						Realized Loss (Gain) on Sale of Investments Available-for-Sale	1		(4)
Foreign Currency Translation Adjustment	Foreign Currency Translation Adjustment	7		0		Foreign Currency Translation Adjustment	3		6
Changes in Assets and Liabilities:	Changes in Assets and Liabilities:					Changes in Assets and Liabilities:
Decrease in Accounts Receivable, net		74		1,857
Decrease in Insurance Receivable		0		371
(Increase) Decrease in Inventory		(953)		293
Decrease in Prepaid and Other Assets		161		931
Increase (Decrease) in Accounts Payable		1,172		(1,298)
(Increase) Decrease in Accounts Receivable, net						(Increase) Decrease in Accounts Receivable, net	(1,186)		637

Increase in Inventory						Increase in Inventory	(799)		(1,302)
Decrease (Increase) in Prepaid and Other Assets						Decrease (Increase) in Prepaid and Other Assets	1,293		(608)
Increase in Accounts Payable						Increase in Accounts Payable	777		295
Decrease in Settlement Payable	Decrease in Settlement Payable	(104)		(147)		Decrease in Settlement Payable	0		(104)
Decrease in Lease Liability	Decrease in Lease Liability	(1,056)		(1,369)		Decrease in Lease Liability	(839)		(703)
Increase (Decrease) in Other Liabilities		423		(1,229)
Decrease in Other Liabilities						Decrease in Other Liabilities	(1,163)		(96)
Decrease in Deferred License Revenue	Decrease in Deferred License Revenue	(1,338)		(1,690)		Decrease in Deferred License Revenue	(1,088)		(992)
Changes in Assets and Liabilities	Changes in Assets and Liabilities	(1,621)		(2,281)		Changes in Assets and Liabilities	(3,005)		(2,873)
Cash Used In Operating Activities	Cash Used In Operating Activities	(21,072)		(21,954)		Cash Used In Operating Activities	(17,433)		(16,154)
Cash Flows From Investing Activities:	Cash Flows From Investing Activities:					Cash Flows From Investing Activities:
Purchase of Investments Available-for-Sale	Purchase of Investments Available-for-Sale	(23,531)		(34,202)		Purchase of Investments Available-for-Sale	(13,765)		(16,514)
Sale of Investments Available-for-Sale	Sale of Investments Available-for-Sale	27,076		30,479		Sale of Investments Available-for-Sale	15,181		17,497
Purchase of Equipment	Purchase of Equipment	(970)		(449)		Purchase of Equipment	(281)		(283)
Purchase of Research and Development Licenses (Related Party)		0		(750)
Cash Provided By (Used In) Investing Activities		2,575		(4,922)

Cash Provided By Investing Activities						Cash Provided By Investing Activities	1,135		700
Cash Flows From Financing Activities:	Cash Flows From Financing Activities:					Cash Flows From Financing Activities:
Proceeds from Term Loan	Proceeds from Term Loan	22,500		0		Proceeds from Term Loan	0		22,500
Debt Issuance Costs	Debt Issuance Costs	(1,343)		0		Debt Issuance Costs	0		(1,343)
Payments on Short Term Note Payable	Payments on Short Term Note Payable	(763)		(763)		Payments on Short Term Note Payable	0		(763)
Proceeds from the Issuance of Common Stock / Public Offering	Proceeds from the Issuance of Common Stock / Public Offering	43,148		18,777		Proceeds from the Issuance of Common Stock / Public Offering	0		8,148
Offering Costs from the Issuance of Common Stock / Public Offering	Offering Costs from the Issuance of Common Stock / Public Offering	(2,469)		(1,488)		Offering Costs from the Issuance of Common Stock / Public Offering	0		(144)
Proceeds from the Issuance of Common Stock / At-the-Market Offering	Proceeds from the Issuance of Common Stock / At-the-Market Offering	2,325		2,296		Proceeds from the Issuance of Common Stock / At-the-Market Offering	0		2,034
Offering Costs from the Issuance of Common Stock / At-the-Market Offering	Offering Costs from the Issuance of Common Stock / At-the-Market Offering	(63)		(207)		Offering Costs from the Issuance of Common Stock / At-the-Market Offering	0		(56)
Proceeds from the Exercise of Employee Stock Options		0		148

Repurchase of Common Stock to Pay Employee Withholding Taxes	Repurchase of Common Stock to Pay Employee Withholding Taxes	(18)		(180)		Repurchase of Common Stock to Pay Employee Withholding Taxes	(6)		(19)
Cash Provided By Financing Activities		63,317		18,583
Cash (Used In) Provided By Financing Activities						Cash (Used In) Provided By Financing Activities	(6)		30,357

Increase (Decrease) in Cash and Cash Equivalents		44,820		(8,293)
(Decrease) Increase in Cash and Cash Equivalents						(Decrease) Increase in Cash and Cash Equivalents	(16,304)		14,903
Cash and Cash Equivalents at Beginning of Period	Cash and Cash Equivalents at Beginning of Period	11,794		22,714		Cash and Cash Equivalents at Beginning of Period	48,682		11,794
Cash and Cash Equivalents at End of Period	Cash and Cash Equivalents at End of Period	$	56,614	$	14,421	Cash and Cash Equivalents at End of Period	$	32,378	$	26,697

Supplemental Disclosure of Cash Flow Information:	Supplemental Disclosure of Cash Flow Information:					Supplemental Disclosure of Cash Flow Information:
Cash Paid for Interest	Cash Paid for Interest	$	906	$	0	Cash Paid for Interest	$	982	$	410
Supplemental Disclosure of Noncash Investing and Financing Activities:	Supplemental Disclosure of Noncash Investing and Financing Activities:					Supplemental Disclosure of Noncash Investing and Financing Activities:
Change in Unrealized Loss on Marketable Securities Available-for-Sale	Change in Unrealized Loss on Marketable Securities Available-for-Sale	$	(11)	$	0	Change in Unrealized Loss on Marketable Securities Available-for-Sale	$	(7)	$	(12)

Insurance Financing Note Payable		$	0	$	1,145

Fair Value of Warrants issued related to Debt Financing	Fair Value of Warrants issued related to Debt Financing	$	501	$	0	Fair Value of Warrants issued related to Debt Financing	$	0	$	501

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. ~~and subsidiaries (collectively, “we”, “our”, “us”,~~("Rockwell Medical," "Rockwell" or the ~~“Company”~~"Company"), is a commercial-stage, biopharmaceutical company ~~dedicated to improving outcomes for patients with~~developing and commercializing our next-generation parenteral iron ~~deficiency and iron-deficiency anemia,with an initial focus on patients with end-stage kidney disease (ESKD) and on dialysis. The Company is focused on developing its proprietary~~technology platform, ferric pyrophosphate citrate (“FPC”) ~~therapeutic platform. The~~, which we believe has the potential to lead to transformative treatments for iron deficiency in multiple disease states, that we believe could reduce healthcare costs and improve patients’ lives. We are also one of the two major suppliers of life saving hemodialysis concentrate products to kidney dialysis clinics in the United States.

We have two novel, FDA approved therapies, Triferic and Triferic AVNU, which are the first ~~product~~two products developed from ~~this platform is Triferic, the first-FDA approved product~~our FPC platform. We are marketing both products to kidney dialysis centers for the replacement of iron and maintenance of hemoglobin in adult hemodialysis patients. We initiated commercial sales of Triferic Dialysate during the second quarter of 2019 and received approval by the U.S. Food and Drug Administration ("FDA") for the intravenous formulation of Triferic, Triferic AVNU, on March 27, 2020. We plantheir patients receiving dialysis. In 2021, we intend to ~~leverage our experience with Triferic to develop~~advance our FPC platform ~~for iron deficiency and iron deficiency anemia in other disease states. Our lead indication is developing FPC~~strategy outside of dialysis by starting a Phase II trial for the treatment of iron deficiency anemia in patients ~~undergoing~~outside of dialysis, who are receiving long-term and or chronic intravenous medications for various therapeutic needs in the home infusion ~~therapy.~~ setting. In our R&D pipeline, we are also exploring FPC’s impact in the treatment of hospitalized patients with acute heart failure, with the potential to begin another Phase 2 trial in these patients in 2022.

We are ~~also a manufacturer~~the second largest supplier of hemodialysis concentrates ~~for dialysis providers and distributors~~ in the United States generating approximately $60 million in annual revenue. The Company's reputation for excellent service, quality, and ~~abroad. We supply the domestic market~~reliability is based on over 25 years of service to kidney dialysis centers. Our approximately 300 dedicated employees, as well as a management team with ~~dialysis concentrates~~experience in manufacturing, logistics, pharmaceutical development and ~~we also supply dialysis concentrates~~commercialization gives us a solid foundation upon which to ~~distributors serving a number of foreign countries, primarily in the Americas and the Pacific Rim.~~

Our mission is to transform anemia management in a wide variety of disease states across the globe, while improving patients’ lives. Accordingly, we are building the foundation to become a leading medical and commercial organization in the field of iron deficiency.

~~Triferic® is a registered trademark of Rockwell Medical, Inc.~~grow.

2. Liquidity and Capital Resources

AsSince inception, Rockwell has incurred significant net losses and has funded its operations primarily through revenue from commercial products, proceeds from the issuance of ~~September~~debt and equity securities and payments from partnerships. At June 30, ~~2020, the Company~~2021, Rockwell had ~~approximately $56.6 million of cash and cash equivalents, $10.7 million of investments available-for-sale, working capital of $65.2 million and~~ an accumulated deficit of ~~$328.7~~approximately $353.6 million and stockholders' equity of $18.2 million. As of June 30, 2021, Rockwell had approximately $41.0 million of cash, cash equivalents and investments available-for-sale, and working capital of $18.4 million. Net cash used in operating activities for the ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 was approximately ~~$21.1~~$17.4 million. ~~Management evaluated~~

The Company is subject to certain covenants and cure provisions under its Loan Agreement with Innovatus. As of the ~~Company’s ability~~date of this report, the Company is in compliance with all covenants. As a result of the ongoing COVID-19 pandemic and its effect on the Company's sales activities, among other factors, the Company may not be able to ~~continue as going concern for at least~~satisfy such covenants over the next 12 ~~months from the filing of this report. Based~~months. However, based on the ~~currently available working capital, capital raise and debt financing described below, management believes~~foregoing, the Company ~~currently~~ has ~~sufficient funds to meet its operating requirements for at least~~classified amounts payable under the ~~next twelve months from the date of the filing of this report.~~

~~In February 2020,~~Loan Agreement as a current liability. If and when the Company ~~sold 3,670,212 shares~~reaches an agreement with Innovatus to avoid an event of ~~its common stock~~default, the amounts payable under the Loan Agreement will be reclassified. The financial statements for ~~proceeds of $8.0 million, net of issuance costs. On March 16, 2020,~~June 30, 2021, have been prepared with the assumption that the Company ~~closed a debt financing transaction~~will be able to agree to an appropriate remedy during the applicable cure period for any future breaches of operating covenants. If the Company is unable to comply with ~~net proceeds at closing of approximately $21.2 million, net of fees and expenses~~the covenants under the Loan Agreement, it would pursue all available cure options in order to regain compliance (See Note 15 for further detail). ~~On September 23, 2020, the Company sold 23,178,809 shares of its common stock for proceeds of $32.7 million, net of issuance costs (see Note 10 for further detail).~~

During the nine months ended September 30, 2020, the Company sold 1,128,608 shares of its common stock as part of its sales agreement with Cantor Fitzgerald & Co. for proceeds of $2.3 million, net of issuance costs. Approximately $32.3 million remains available for sale under this facility. See Note 10 for further detail.

The Company expects it will require additional capital to sustain its operations and make the investments it needs to execute ~~upon~~ its ~~longer-term business~~strategic plan, including the commercialization of Triferic ~~Dialysate~~(dialysate) and Triferic AVNU ~~executing upon our plans for enhancing Triferic's medical capabilities,~~in dialysis, generating additional data for Triferic in dialysis, developing FPC for iron deficiency anemia in patients undergoing home infusion and ~~developing Triferic~~ for progressing our pipeline development program of new ~~therapeutic indications.~~indications for its FPC platform. If the Company is unable to generate sufficient revenue from sales of its ~~existing long-term business plan,~~commercial products and from partnerships, the Company will need to obtain additional equity or debt financing. If the Company attempts to obtain additional debt or equity financing, the Company cannot assume that such financing will be available on favorable terms, if at all.

~~In addition,~~Based on the currently available working capital and managements assumption that the Company ~~is subject~~will be able to ~~certain covenants and cure provisions under our Loan Agreement with Innovatus. As of~~agree to an appropriate remedy, 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 believes that it will either be able to satisfy such covenants or, in the event of a breached covenant, exercise cure provisions to avoid an event of default. If we are unable to avoid an event of default, any required repayments could have an adverse effect on our liquidity (See Note 15 for further detail).report.

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

The COVID-19 pandemic and resulting domestic and global disruptions have adversely affected ~~our~~Rockwell's business and operations, including, but not limited to, our sales and marketing efforts, ~~and our~~ research and development activities, and the operations of third parties upon whom ~~we rely.~~the Company relies. Quarantines, shelter-in-place, executive and similar government orders and the recent surge in infections domestically may continue to negatively impact ~~our~~Rockwell's sales and marketing activities, particularly if ~~our~~its sales representatives are unable to interact with current and potential customers to the same extent as before onset of the COVID-19 pandemic. ~~Our~~The Company's international business development activities may also continue to be negatively impacted by COVID-19, especially with the recent surge in infections internationally, ongoing international travel restrictions and ~~resulting~~ quarantines or shelter-in-place orders. ~~Depending on the severity of the impact on our sales and marketing efforts, the timing of our commercial launch of Triferic AVNU could be delayed.~~

The COVID-19 pandemic, the ~~recent~~ domestic and international surge in infections and resulting global disruptions have caused significant volatility in financial and credit markets. ~~We have~~Rockwell has utilized a range of financing methods to fund ~~our~~its operations in the past; however, current conditions in the financial and credit markets may limit the availability of funding, 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 ~~our~~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 the accounting principles generally accepted in the United States ~~(“U.S.”)~~ 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~~June 30, ~~2020,~~2021, condensed consolidated statements of operations for the three and ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 and ~~2019,~~2020, condensed consolidated statements of comprehensive loss for the three and ~~nine~~six months ended ~~September~~June 30, 2021 and 2020, condensed consolidated statement of changes in stockholders' equity for the three and six months ended June 30, 2021 and 2020, and ~~2019,~~ condensed consolidated statements of cash flows for the ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 and ~~2019, and condensed consolidated statement of changes in shareholder’s equity for the three and nine months ended September 30,~~ 2020 ~~and 2019~~ are unaudited, but include all adjustments, consisting of normal recurring adjustments, that 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~~six months ended ~~September~~June 30, ~~2020~~2021 are not necessarily indicative of results to be expected for the year ending December 31, ~~2020~~2021 or for any future interim period. The condensed consolidated balance sheet at December 31, ~~2019~~2020 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, ~~2019~~2020 and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, ~~2019~~2020 as filed with the SEC on ~~Form 10-K on~~ March ~~17, 2020.~~31, 2021. The Company’s consolidated subsidiaries consisted 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.

~~Certain reclassifications have been made to the 2019 financial statements and notes to conform to the 2020 presentation.~~

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 expenses during the reporting period. Actual results could differ from those estimates.

Leases

The Company accounts for its leases under Accounting Standards Codification (“ASC”) 842, Leases. Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by

~~ROCKWELL MEDICAL, INC. AND SUBSIDIARIES~~

~~Notes to Condensed Consolidated Financial Statements~~

~~(Unaudited)~~

interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. Variable lease expenses, if any, are recorded when incurred.

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

In calculating the right-of-use asset and lease liability, the Company elects to combine lease and non-lease components. The Company excludes short-term leases having initial terms of 12 months or less from the new guidance as an accounting policy election and recognizes rent expense on a straight-line basis over the lease term.

Loss Per Share

ASC 260, Earnings Per Share, requires dual presentation of basic and diluted earnings per share (“EPS”), with a reconciliation of the numerator and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. Basic EPS excludes dilution. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that are then sharing in the earnings of the entity.

Basic net loss per share of common stock excludes dilution and is computed by dividing the net loss by the weighted average number of shares outstanding during the period. Diluted net loss per share of common stock reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity unless inclusion of such shares would be anti-dilutive. The Company has only incurred losses, therefore, basic and diluted net loss per share is the same. Securities that could potentially dilute net income per share in the future that were not included in the computation of diluted loss per share were as follows:


		As of September 30,			As of June 30,
		2020	2019		2021	2020
Options to purchase common stock	Options to purchase common stock	6,682,192	8,170,382	Options to purchase common stock	6,070,801	6,225,562
Unvested restricted stock awards	Unvested restricted stock awards	146,800	146,800	Unvested restricted stock awards	78,300	146,800
Unvested restricted stock units	Unvested restricted stock units	245,405	1,324,172	Unvested restricted stock units	342,604	503,395
Warrants to purchase common stock	Warrants to purchase common stock	26,426,863	2,770,781	Warrants to purchase common stock	26,426,863	3,248,054
		33,501,260	12,412,135
Total				Total	32,918,568	10,123,811

Adoption of Recent Accounting Pronouncements

The Company continually assesses ~~any~~ new accounting pronouncements to determine their applicability. When it is determined that 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 that there are sufficient controls in place to ascertain that the Company’s consolidated financial statements properly reflect the change.

In ~~July 2017,~~April 2021, the ~~FASB~~Financial Accounting Standards Board ("FASB") recently issued ~~ASU No. 2017-11, “Earnings Per Share (Topic 260) and Derivatives and Hedging (Topic 815)-~~ Accounting Standards Update ("ASU") 2021-04 to codify the final consensus reached by the Emerging Issues Task Force (EITF) on how an issuer should account for Certain Financial Instruments with Down Round Features” (“ASU 2017-11”). Equity-linked instruments, such as warrants and convertible instruments may contain down round features that result in the strike price being reduced on the basis of the pricing of future equity offerings. Under ASU 2017-11, a down round feature will no longer require a freestanding equity-linked instrument (or embedded conversion option)modifications made to ~~be classified~~equity-classified written call options (hereafter referred to as a ~~liability that is remeasured at fair value through~~warrant to purchase the ~~income statement (i.e. marked-to-market)~~issuer’s common stock). However, other features of the equity-linked instrument (or embedded conversion option) must still be evaluated to determine whether liability or equity classification is appropriate. Equity classified instruments are not marked-to-market. For earnings per share ("EPS") reporting,The guidance in the ASU requires ~~companies~~the issuer to ~~recognize~~treat a modification of an equity-classified warrant that does not cause the ~~effect~~warrant to become liability-classified as an exchange of the ~~down round feature only when it~~original warrant for a new warrant. This guidance applies whether the modification is ~~triggered by treating it~~structured as an amendment to the terms and conditions of the warrant or as termination of the original warrant and issuance of a ~~dividend and as a reduction~~new warrant. The Company is evaluating the impact of ~~income available to common shareholders in basic EPS. The amendments in~~ this ~~ASU are effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. This standard, which the Company as adopted~~guidance on ~~January 1, 2020, and did not have a material impact on the Company’s~~its condensed consolidated financial ~~position, results of operations or cash flows.~~statements.

4. Revenue Recognition

~~ROCKWELL MEDICAL, INC. AND SUBSIDIARIES~~

~~Notes to Condensed Consolidated Financial Statements~~

~~(Unaudited)~~

The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the new 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

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

•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 us 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

The following is a description of principal activities from which the Company generates its revenue.

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.

The Company received upfront fees under 45 distribution and license agreements that have been deferred as a contract liability. The amounts received from Wanbang Biopharmaceuticals Co., Ltd. (“Wanbang”) ~~and~~, Sun Pharmaceutical Industries Ltd. ("Sun Pharma") ~~and amounts to be received~~, 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 and South Korea, respectively, to determine that regulatory approval was probable as of the execution of the agreement. The amounts received from Baxter Healthcare Corporation (“Baxter”), are recognized as revenue at the point in time that the estimated product sales under the agreement occur.

For the business under the Company’s ~~distribution agreement~~Distribution Agreement with Baxter (the “Baxter Agreement”), and 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 or receipt 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. There were no such adjustments for the periods reported. Customers typically pay for the product based on customary business practices with payment terms averaging 30 days, while distributor payment terms average 45 days.

Disaggregation of revenue

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

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)


In thousands of U.S. dollars ($)	In thousands of U.S. dollars ($)	Three Months Ended September 30, 2020						Nine Months Ended September 30, 2020						In thousands of U.S. dollars ($)	Three Months Ended June 30, 2021						Six Months Ended June 30, 2021
Products By Geographic Area	Products By Geographic Area	Total		U.S.		Rest of World		Total		U.S.		Rest of World		Products By Geographic Area	Total		U.S.		Rest of World		Total		U.S.		Rest of World
Drug Revenues	Drug Revenues													Drug Revenues
Product Sales – Point-in-time	Product Sales – Point-in-time	$	228	$	228	$	0	$	609	$	609	$	0	Product Sales – Point-in-time	$	215	$	215	$	0	$	439	$	439	$	0
License Fee – Over time	License Fee – Over time	56		0		56		167		0		167		License Fee – Over time	58		0		58		117		0		117
Total Drug Products	Total Drug Products	284		228		56		776		609		167		Total Drug Products	273		215		58		556		439		117
Concentrate Products	Concentrate Products													Concentrate Products
Product Sales – Point-in-time	Product Sales – Point-in-time	14,506		13,470		1,036		44,786		40,295		4,491		Product Sales – Point-in-time	14,379		13,026		1,353		29,084		26,227		2,857
License Fee – Over time	License Fee – Over time	490		490		0		1,471		1,471		0		License Fee – Over time	485		485		0		971		971		0
Total Concentrate Products	Total Concentrate Products	14,996		13,960		1,036		46,257		41,766		4,491		Total Concentrate Products	14,864		13,511		1,353		30,055		27,198		2,857
Net Revenue	Net Revenue	$	15,280	$	14,188	$	1,092	$	47,033	$	42,375	$	4,658	Net Revenue	$	15,137	$	13,726	$	1,411	$	30,611	$	27,637	$	2,974


In thousands of U.S. dollars ($)	In thousands of U.S. dollars ($)	Three Months Ended September 30, 2019						Nine Months Ended September 30, 2019						In thousands of U.S. dollars ($)	Three Months Ended June 30, 2020						Six Months Ended June 30, 2020
Products By Geographic Area	Products By Geographic Area	Total		U.S.		Rest of World		Total		U.S.		Rest of World		Products By Geographic Area	Total		U.S.		Rest of World		Total		U.S.		Rest of World
Drug Revenues	Drug Revenues													Drug Revenues
Product Sales – Point-in-time	Product Sales – Point-in-time	$	98	$	98	$	0	$	112	$	112	$	0	Product Sales – Point-in-time	$	182	$	182	$	0	$	381	$	381	$	0
License Fee – Over time	License Fee – Over time	$	68	$	0	68		205		0		205		License Fee – Over time	56		0		56		112		0		112
Total Drug Products	Total Drug Products	166		98		68		317		112		205		Total Drug Products	238		182		56		493		381		112
Concentrate Products	Concentrate Products													Concentrate Products
Product Sales – Point-in-time	Product Sales – Point-in-time	14,746		13,353		1,393		44,010		39,100		4,910		Product Sales – Point-in-time	15,168		13,319		1,849		30,280		26,826		3,454
License Fee – Over time	License Fee – Over time	495		495		0		1,485		1,485		0		License Fee – Over time	490		490		0		980		980		0
Total Concentrate Products	Total Concentrate Products	15,241		13,848		1,393		45,495		40,585		4,910		Total Concentrate Products	15,658		13,809		1,849		31,260		27,806		3,454
Net Revenue	Net Revenue	$	15,407	$	13,946	$	1,461	$	45,812	$	40,697	$	5,115	Net Revenue	$	15,896	$	13,991	$	1,905	$	31,753	$	28,187	$	3,566

Contract balances

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


In thousands of U.S. dollars ($)	In thousands of U.S. dollars ($)	September 30, 2020		December 31, 2019		In thousands of U.S. dollars ($)	June 30, 2021		December 31, 2020
Receivables, which are included in "Trade and other receivables"	Receivables, which are included in "Trade and other receivables"	$	4,129	$	4,203	Receivables, which are included in "Trade and other receivables"	$	5,357	$	4,171
Contract liabilities	Contract liabilities	$	10,738	$	12,076	Contract liabilities	$	9,103	$	10,190

There were 0 material losses recognized related to any receivables arising from the Company’s contracts with customers for the three and ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 and ~~2019.~~2020.

For the three and ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 and ~~September~~June 30, ~~2019,~~2020, the Company did not recognize any material bad-debt expense. There were 0 material contract assets recorded on the condensed consolidated balance sheet as of ~~September~~June 30, ~~2020~~2021 and December 31, ~~2019.~~2020. The Company does not generally accept returns of its concentrate products and 0 material reserve for returns of concentrate products was established as of ~~September~~June 30, ~~2020~~2021 or December 31, ~~2019.~~2020.

The contract liabilities primarily relate to upfront payments and consideration received from customers that are received in advance of the customer assuming control of the related products

Transaction price allocated to remaining performance obligations

For the three and ~~nine~~six months ended ~~September~~June 30, ~~2020,~~2021, revenue recognized from performance obligations related to prior periods was not material.

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

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 ~~$10.7~~$9.1 million as of ~~September~~June 30, ~~2020.~~2021. 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 paragraph 606-10-50-14 and does not disclose information about remaining performance obligations that have original expected durations of one year or less. The Baxter Agreement includes minimum commitments of product sales over the duration of the agreement. Unfulfilled minimum commitments related to the Baxter Agreement are product sales of ~~$7.7~~$6.2 million as of ~~September~~June 30, ~~2020,~~2021, which is ~~being~~ amortized ratably through expiration of the Baxter Agreement on October 2, 2024.

5. Investments - Available-for-Sale

Investments available-for-sale consisted of the following as of ~~September~~June 30, ~~2020~~2021 and December 31, ~~2019~~2020 (table in thousands):


		September 30, 2020											June 30, 2021
		Amortized Cost		Unrealized Gain		Unrealized Loss		Accrued Interest Income		Fair Value			Amortized Cost		Unrealized Gain		Unrealized Loss		Accrued Interest Income		Fair Value
Available-for-Sale Securities	Available-for-Sale Securities											Available-for-Sale Securities
Bonds	Bonds	$	10,679	$	3	$	(1)	$	21	$	10,702	Bonds	$	8,558	$	1	$	0	$	15	$	8,574


		December 31, 2019											December 31, 2020
		Amortized Cost		Unrealized Gain		Unrealized Loss		Accrued Interest		Fair Value			Amortized Cost		Unrealized Gain		Unrealized Loss		Accrued Interest		Fair Value
Available-for-Sale Securities	Available-for-Sale Securities											Available-for-Sale Securities
Bonds	Bonds	$	14,238	$	13	$	(1)	$	0	$	14,250	Bonds	$	9,987	$	3	$	0	$	7	$	9,997

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.

As of ~~September~~June 30, ~~2020~~2021 and December 31, ~~2019,~~2020, the amortized cost and estimated fair value of our available-for-sale securities were due within one year.

6. Inventory

Components of inventory, net of reserves, as of ~~September~~June 30, ~~2020~~2021 and December 31, ~~2019~~2020 are as follows (table in thousands):


		September 30, 2020		December 31, 2019			June 30, 2021		December 31, 2020
Raw Materials	Raw Materials	$	2,794	$	2,471	Raw Materials	$	3,598	$	3,112
Work in Process	Work in Process	329		185		Work in Process	265		172
Finished Goods	Finished Goods	1,613		1,432		Finished Goods	1,936		1,805
Total	Total	$	4,736	$	4,088	Total	$	5,799	$	5,089

As of ~~September~~June 30, ~~2020, we~~2021, the Company classified ~~$0.9~~$1.1 million of inventory as non-current, all of which was related to Triferic or the active pharmaceutical ingredient and raw materials for Triferic. As of ~~September~~June 30, ~~2020,~~2021, the total Triferic inventory net of reserve was ~~$3.8 million, against which we had reserved $2.7~~$1.7 million.

The ~~$1.1~~$1.7 million net value of Triferic inventory consisted of ~~$0.1~~$0.3 million of Triferic ~~Dialysate~~(dialysate) finished goods with expiration dates ranging from September 2021 to December ~~2020 to May 2021, $0.3~~2023, $0.5 million of Triferic API with estimated remaining shelf life extending ~~through~~beyond 2021, and ~~$0.7~~$0.9 million of raw materials for Triferic with estimated remaining shelf life extending beyond 2025.

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

7. Property and Equipment

As of ~~September~~June 30, ~~2020~~2021 and December 31, ~~2019,~~2020, the Company’s property and equipment consisted of the following (table in thousands):


		September 30, 2020		December 31, 2019			June 30, 2021		December 31, 2020
Leasehold Improvements	Leasehold Improvements	$	1,176	$	1,162	Leasehold Improvements	$	1,196	$	1,196
Machinery and Equipment	Machinery and Equipment	5,454		4,673		Machinery and Equipment	5,684		5,475
Information Technology & Office Equipment	Information Technology & Office Equipment	1,822		1,810		Information Technology & Office Equipment	1,847		1,831
Laboratory Equipment	Laboratory Equipment	653		653		Laboratory Equipment	676		676
		9,105		8,298			9,403		9,178
Accumulated Depreciation	Accumulated Depreciation	(6,320)		(5,865)		Accumulated Depreciation	(6,874)		(6,536)
Property and Equipment, net	Property and Equipment, net	$	2,785	$	2,433	Property and Equipment, net	$	2,529	$	2,642

Depreciation expense for each of the three and six months ended ~~September~~June 30, ~~2020~~2021 and ~~2019~~2020 totaled $0.2 ~~million. Depreciation expense for the nine months ended September 30, 2020~~million and ~~2019 totaled $0.6~~$0.4 million.

8. Accrued Liabilities

Accrued liabilities as of ~~September~~June 30, ~~2020~~2021 and December 31, ~~2019~~2020 consisted of the following (table in thousands):


		September 30, 2020		December 31, 2019			June 30, 2021		December 31, 2020
Accrued Research & Development Expense	Accrued Research & Development Expense	$	258	$	283	Accrued Research & Development Expense	$	315	$	232
Accrued Compensation and Benefits	Accrued Compensation and Benefits	2,584		1,018		Accrued Compensation and Benefits	1,420		2,500
Accrued Legal Expenses		172		182
Accrued Marketing Expenses		100		61
Accrued Unvouchered Receipts						Accrued Unvouchered Receipts	647		755
Accrued Workers Compensation						Accrued Workers Compensation	531		395
Other Accrued Liabilities	Other Accrued Liabilities	1,854		2,974		Other Accrued Liabilities	1,080		1,131
Total Accrued Liabilities	Total Accrued Liabilities	$	4,968	$	4,518	Total Accrued Liabilities	$	3,993	$	5,013

9. Deferred Revenue

In October 2014, the Company entered into the Baxter Agreement with Baxter and received an upfront fee of $20 million. The upfront fee was recorded as deferred revenue and is 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 Baxter Agreement, which expires in October 2024. The Company recognized revenue of approximately $0.5 million and ~~$1.5~~$1.0 million for each of the three and ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 and ~~2019, respectively.~~2020. Deferred revenue related to the Baxter Agreement totaled ~~$7.7~~$6.2 million as of ~~September~~June 30, ~~2020~~2021 and ~~$9.1~~$7.2 million as of December 31, ~~2019.~~2020.

If a “Refund Trigger Event” occurs under the Baxter Agreement weprior to December 31, 2021, Rockwell would be obligated to repay ~~a portion~~25% of the upfront ~~fee and any paid portion of the facility~~ fee. In the event of a Refund Trigger Event occurring from October 1, 2020 to December 31, 2021, Baxter would be eligible for a 25% refund of the Baxter Agreement’s upfront fee. In addition, if Baxter terminates the Baxter Agreement because Baxter has been enjoined by a court of competent jurisdiction from selling in the United States any product covered by the Baxter Agreement due to a claim of intellectual property infringement or misappropriation relating to such product prior to the end of 2020, Baxter would be eligible for a partial refund of the upfront fee of $5.0 million. In no event does the Baxter Agreement require more than one refund be paid.

In 2016, the Company entered into a distribution and license agreement with Wanbang (the "Wanbang Agreement") and received an upfront fee of $4.0 million. The upfront fee was recorded as deferred revenue and is being recognized as revenue based on the agreement term. The Company recognized ~~revenue of~~ approximately $53,000 and ~~$0.2~~$0.1 million revenue for each of the three and ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 and ~~2019, respectively.~~2020. Deferred revenue related to the Wanbang Agreement totaled ~~$2.8~~$2.6 million as of ~~September~~June 30, ~~2020~~2021 and ~~$3.0~~$2.7 million as of December 31, ~~2019.~~2020.

~~ROCKWELL MEDICAL, INC. AND SUBSIDIARIES~~

~~Notes to Condensed Consolidated Financial Statements~~

~~(Unaudited)~~

OnIn January ~~14,~~ 2020, the Company entered into license and supply agreements with Sun Pharma (the "Sun Pharma Agreements"), for the rights to commercialize Triferic ~~Dialysate~~(dialysate) (ferric pyrophosphate citrate) in India. Under the terms of the Sun Pharma Agreements, Sun Pharma will be the exclusive development and commercialization partner for Triferic ~~Dialysate~~(dialysate) in India, and the Company will supply the product to Sun Pharma. In consideration for the license, the Company received an upfront fee of $0.1 million, and will be eligible for milestone payments and royalties on net sales. A Joint Alliance Committee, comprised of members from the Company and Sun Pharma, will guide the development and execution for Triferic ~~Dialysate~~(dialysate) in

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

India. Sun Pharma will be responsible for all clinical and regulatory approval, as well as commercialization activities. The upfront fee was recorded as deferred revenue and is being recognized as revenue based on the agreement term. The Company recognized revenue of approximately $2,500 and ~~$7,500 during~~$5,000 for each of the three and ~~nine~~six months ended ~~September~~June 30, ~~2020, respectively.~~2021 and 2020. Deferred revenue related to the Sun Pharma Agreement totaled ~~$92,500~~$85,000 and $90,000 as of ~~September~~June 30, ~~2020.~~2021 and December 31, 2020, respectively.

OnIn September 7, 2020, the Company entered into a license and supply agreements with Jeil Pharma (the "Jeil Pharma Agreements"), for the rights to commercialize Triferic ~~Dialysate~~(dialysate) (ferric pyrophosphate citrate) in South Korea. Under the terms of the Jeil Pharma Agreements, Jeil Pharma will be the exclusive development and commercialization partner for Triferic ~~Dialysate~~(dialysate) in South Korea, and the Company will supply the product to Jeil Pharma. In consideration for the license, the Company received an upfront fee of $0.2 million, and will be eligible for milestone payments and royalties on net sales. A Joint Alliance Committee, comprised of members from the Company and Jeil Pharma, will guide the development and execution for Triferic ~~Dialysate~~(dialysate) in South Korea. Jeil Pharma will be responsible for all clinical and regulatory approval, as well as commercialization activities. The upfront fee was recorded as deferred revenue and is being recognized as revenue based on the agreement term. The Company recognized revenue of $2,500 and NaN ~~during~~for the three ~~and nine~~ months ended ~~September~~June 30, 2021 and 2020, respectively, and $5,000 and NaN for the six months ended June 30, 2021 and 2020, respectively. Deferred revenue related to the Jeil Pharma Agreement totaled approximately $0.2 million as of June 30, 2021 and December 31, 2020.

In June 2021, the Company entered into license and supply agreements with Drogsan Pharma (the "Drogsan Agreements"), for the rights to commercialize Triferic (dialysate) and Triferic AVNU in Turkey. Under the terms of the Drogsan Agreements, Drogsan Pharma will be the exclusive commercialization partner for Triferic (dialysate) and Triferic AVNU in Turkey. In consideration for the license, the Company is due to receive an upfront fee of $0.2 million, and will be eligible for milestone payment and royalties on net sales. A Joint Alliance Committee, comprised of members from the Company and Drogsan Pharma, will guide the execution for Triferic (dialysate) and Triferic AVNU in Turkey. Drogsan Pharma will be responsible for all regulatory approval and commercialization activities, and the Company will supply the product to Drogsan Pharma for Turkey. The upfront fee will be recorded as deferred revenue and will be recognized as revenue based on the agreement term.

10. Stockholders’ Equity

Preferred Stock

As of ~~September~~June 30, ~~2020~~2021 and December 31, ~~2019,~~2020, there were 2,000,000 shares of preferred stock, $0.0001 par value per share, authorized and 0 shares of preferred stock issued or outstanding.

Common Stock

As of ~~September~~June 30, ~~2020~~2021 and December 31, ~~2019,~~2020, there were 170,000,000 shares of common stock, $0.0001 par value per share, authorized and ~~93,573,165~~93,811,381 and ~~65,378,890~~93,573,165 shares issued and outstanding, respectively.

Controlled Equity Offering (or "At the Market" Offering)

On March 22, 2019, the Company entered into a sales agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (the “Agent”), pursuant to which the Company may offer and sell from time to time shares of the Company’s common stock through the Agent. The offering and sale of up to $40.0 million of the shares has been registered under the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the Company’s registration statement on Form S-3 (File No. 333-227363), which was originally filed with the SEC on September 14, 2018 and declared effective by the SEC on October 1, 2018, the base prospectus contained within the registration statement, and a prospectus supplement that was filed with the SEC on March 22, 2019.

Sales of the shares, if any, pursuant to the Sales Agreement, may be made in sales deemed to be an “at the market" offering as defined in Rule 415(a) of the Securities Act, including sales made directly through the Nasdaq Global Market or on any other existing trading market for the Company’s common stock. The Company intends to use the proceeds from the offering for working capital and other general corporate purposes. The Company may suspend or terminate the Sales Agreement at any time.

During the year ended December 31, 2019, the Company sold 1,840,443 of shares of its common stock pursuant to the Sales Agreement for gross proceeds of $5,383,079, at a weighted average selling price of approximately $2.92. The Company paid $309,479 in commissions and offering fees related to the sale of the common stock. For the nine months ended September 30, 2020, the Company sold 1,128,608 of shares of its common stock pursuant to the Sales Agreement for gross proceeds of $2,325,478, at a weighted average selling price of approximately $2.06. The Company paid $63,000 in commissions and offering fees related to the sale of common stock. Approximately $32.3 million remains available for sale under this facility.

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

During the three and six months ended June 30, 2021, the Company has not sold shares of its common stock pursuant to the Sales Agreement. Approximately $32.3 million remains available for sale under this facility.

~~We are~~The Company is not required to sell any shares at any time during the term of the facility. ~~Our~~The Company's ability to sell common stock under the facility may be limited by several factors including, among other things, the trading volume of ~~our~~its common stock and certain black-out periods that wethe Company may impose upon the facility, among other things.

~~Public Offering of Common Stock~~

On February 4, 2020, the Company entered into an underwriting agreement with Cantor Fitzgerald & Co., as underwriter, pursuant to which the Company agreed to issue and sell an aggregate of up to 3,670,212 shares of its common stock, which included 478,723 optional shares that may be sold pursuant to an over-allotment option granted to the underwriters. On February 6, 2020, the Company closed the sale of 3,191,489 shares of its common stock at the public offering price of $2.22 per share (the "Offering").

On February 19, 2020, the underwriter exercised its over-allotment option to purchase an additional 478,723 shares at a price of $2.22 per share, which closed on February 21, 2020. The Company raised a total of $8.0 million, net of issuance costs of $0.1 million, relating to the sale of the common stock in the Offering. The Offering was made pursuant to the Company’s effective Registration Statement on Form S-3 (File No. 333-227363), which was previously filed with the SEC.

On September 23, 2020, the Company entered into a Securities Purchase Agreement (the “2020 Purchase Agreement”) with certain purchasers named therein, pursuant to which the Company agreed to issue and sell to several institutional and accredited investors in a registered direct offering, 21,818,544 shares of common stock and warrants to purchase up to 23,178,509 shares of common stock (the “Warrants”) at a combined purchase price equal to $1.51 per share. Each Warrant is exercisable for 1 share of common stock at an exercise price of $1.80 per share. The Warrants are immediately exercisable and will expire on September 25, 2022.

The Company also offered to certain purchasers pre-funded warrants to purchase up to an aggregate of 1,360,265 shares of common stock (the “Pre-Funded Warrants”), in lieu of shares of common stock. The purchase price of each Pre-Funded Warrant is equal to the price at which a share of common stock is sold to the public in the offering, minus $0.001, and the exercise price of each Pre-Funded Warrant is $0.001 per share. The Pre-Funded Warrants were exercised in conjunction with the issuance of common stock under the Securities Purchase Agreement. The Company received gross proceeds of approximately $35.0 million in connection with the offering, before deducting placement agent fees and related offering expenses of approximately $2.3 million.

A holder (together with its affiliates) may not exercise any portion of the Warrant to the extent that the holder would own more than 9.99% (or, at the holder’s option upon issuance, 4.99%) of the Company’s outstanding common stock immediately after exercise, as such percentage ownership is determined in accordance with the terms of the Warrant or Pre-Funded Warrant.

The Company agreed to pay H.C. Wainwright & Co., LLC (the "Placement Agent") a cash fee of 6.0% of the aggregate gross proceeds raised in the offering, minus $420,000 payable by the Company to a financial advisory firm for services related to the offering.

In addition, the Company agreed to pay the Placement Agent (i) 6.0% of the aggregate gross proceeds to be received, if any, from the cash exercise of any Warrants through December 25, 2021 and (ii) 4.0% of the aggregate gross proceeds to be received, if any, from the cash exercise of any Warrants subsequent to December 25, 2021. The Company also agreed to pay the Placement Agent non-accountable expenses of $50,000 as well as $12,900 for the clearing fees of the Placement Agent in connection with the offering.

The Company has accounted for the common stock for the 2020 Purchase Agreement as equity on the accompanying consolidated balance sheets as of September 30, 2020. The amount allocated to common stock was $26.1 million. This allocation is equal to the total proceeds of $35.0 million less the amount allocated to Warrants of $8.9 million and is also net of the direct and incremental costs associated with the 2020 Purchase Agreement of $2.3 million. The Black-Scholes pricing model was used to calculate the value of Warrants relating to the 2020 Purchase Agreement.

~~ROCKWELL MEDICAL, INC. AND SUBSIDIARIES~~

~~Notes to Condensed Consolidated Financial Statements~~

~~(Unaudited)~~

11. Stock-Based Compensation

The Company recognized total stock-based compensation expense during the three and ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 and ~~2019~~2020 as follows (table in thousands):


		Three Months Ended September 30,				Nine Months Ended September 30,					Three Months Ended June 30,				Six Months Ended June 30,
		2020		2019		2020		2019			2021		2020		2021		2020
Service-based awards:	Service-based awards:									Service-based awards:

Restricted stock units	Restricted stock units	$	9	$	502	$	243	$	1,274	Restricted stock units	$	78	$	(4)	$	182	$	234
Stock option awards	Stock option awards	243		597		1,019		1,796		Stock option awards	344		336		735		776
		252		1,099		1,262		3,070			422		332		917		1,010
Performance-based awards:	Performance-based awards:									Performance-based awards:
Restricted stock awards										Restricted stock awards	0		0		(390)		0
Restricted stock units	Restricted stock units	(123)		(332)		(1,148)		469		Restricted stock units	0		(1,197)		0		(1,025)
Stock option awards	Stock option awards	121		110		(390)		357		Stock option awards	11		(596)		(330)		(511)
		(2)		(222)		(1,538)		825			11		(1,793)		(720)		(1,536)
Total	Total	$	250	$	877	$	(276)	$	3,895	Total	$	433	$	(1,461)	$	197	$	(526)

Restricted Stock

A summary of the Company’s restricted stock awards during the ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 is as follows:

Number of Shares Weighted Average
Grant-Date
Fair Value
Unvested at January 1, 2020 146,800 $ 5.70
Unvested at September 30, 2020 146,800 $ 5.70


	Number of Shares	Weighted Average Grant-Date Fair Value
Unvested at January 1, 2021	146,800	$	5.70
Forfeited	(68,500)	$	5.70
Unvested at June 30, 2021	78,300	$	5.70

A summary of the Company’s restricted stock awards during the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020 is as follows:

Number of Shares Weighted Average
Grant-Date
Fair Value
Unvested at January 1, 2019 146,800 $ 5.70
Unvested at September 30, 2019 146,800 $ 5.70


	Number of Shares	Weighted Average Grant-Date Fair Value
Unvested at January 1, 2020	146,800	$	5.70
Unvested at June 30, 2020	146,800	$	5.70

The fair value of 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~~June 30, ~~2020,~~2021, unvested restricted stock awards of ~~146,800~~78,300 were related to performance-based awards. The forfeited performance-based restricted stock awards of 68,500 was due to the termination of the Company's former Chief Science Officer on January 19, 2021. These forfeited awards reduced stock-based compensation expense by $0.4 million.

1716

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Service-Based Restricted Stock Units

A summary of the Company’s service-based restricted stock units during the ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 is as follows:


		Number of Shares	Weighted Average Grant-Date Fair Value			Number of Shares	Weighted Average Grant-Date Fair Value
Unvested at January 1, 2020		463,786	$	4.26
Unvested at January 1, 2021					Unvested at January 1, 2021	265,494	$	2.60
Granted	Granted	188,904	2.09		Granted	310,050	0.90
Vested	Vested	(247,561)	4.30		Vested	(221,474)	2.38
Forfeited	Forfeited	(159,724)	4.26		Forfeited	(11,466)	4.81
Unvested at September 30, 2020		245,405	$	2.72
Unvested at June 30, 2021					Unvested at June 30, 2021	342,604	$	1.17

A summary of the Company’s service-based restricted stock units during the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020 is as follows:


		Number of Shares	Weighted Average Grant-Date Fair Value			Number of Shares	Weighted Average Grant-Date Fair Value
Unvested at January 1, 2019		472,959	$	4.32
Unvested at January 1, 2020					Unvested at January 1, 2020	463,786	$	4.26
Granted	Granted	222,497	4.26		Granted	188,904	2.09
Vested					Vested	(104,168)	4.66
Forfeited	Forfeited	(4,950)	4.81		Forfeited	(128,460)	4.30
Vested		(96,542)	4.70
Unvested at September 30, 2019		593,964	$	4.23

Unvested at June 30, 2020					Unvested at June 30, 2020	420,062	$	3.27

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. Stock-based compensation expense of $0.1 million and $0.2 million was recognized for the three and six months ended June 30, 2021, respectively. Stock-based compensation expense of NaN and $0.2 million was recognized ~~during~~for the three and ~~nine~~six months ended ~~September~~June 30, 2020, respectively. ~~Stock-based compensation expense of $0.5 million and $1.3 million was recognized during the three and nine months ended September 30, 2019, respectively.~~ As of ~~September~~June 30, ~~2020,~~2021, the unrecognized stock-based compensation expense was $0.3 million, which is expected to be recognized over an estimated weighted average remaining term of less than 1 year. Included in the forfeited service-based restricted stock units are 96,541 and 55,556 units related to the resignation of the Company's former President and Chief Executive Officer on April 17, 2020 and the former Chief Financial Officer on July 3, 2020, respectively. These forfeited awards reduced stock-based compensation expense by $0.4 million.

Performance-Based Restricted Stock Units

As of June 30, 2021, there were 0 outstanding performance-based restricted stock units.

A summary of the Company’s performance-based restricted stock units during the ~~nine~~six months ended ~~September~~June 30, 2020 is as follows:


		Number of Shares	Weighted Average Grant-Date Fair Value			Number of Shares	Weighted Average Grant-Date Fair Value
Unvested at January 1, 2020	Unvested at January 1, 2020	988,958	$	4.48	Unvested at January 1, 2020	988,958	$	4.48
Forfeited	Forfeited	(988,958)	4.48		Forfeited	(905,625)	4.61
Unvested at September 30, 2020		0	$	0
Unvested at June 30, 2020					Unvested at June 30, 2020	83,333	$	3.09

Service-Based Stock Options

1817

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

~~A summary of the Company’s performance-based restricted stock units during the nine months ended September 30, 2019 is as follows:~~

Number of Shares Weighted Average
Grant-Date
Fair Value
Unvested at January 1, 2019 988,958 $ 4.48
Unvested at September 30, 2019 988,958 $ 4.48

Stock-based compensation expense recognized for performance-based restricted stock units was ($0.1) million and ($1.1) million during the three and nine months ended September 30, 2020 and ($0.3) million and $0.5 million for the three and nine months ended September 30, 2019, respectively. As of September 30, 2020, there was 0 unrecognized stock-based compensation expense related to performance-based restricted stock units. The forfeited performance-based restricted stock awards of 988,958 is due to the resignation of the Company's former President and Chief Executive Officer on April 17, 2020 and the resignation of the Company's former Chief Financial Officer effective July 3, 2020. These forfeited awards reduced stock-based compensation expense for the three and nine months ended September 30, 2020 by $0.1 million and $1.4 million, respectively.

~~Service-Based Stock Options~~

The fair value of the service-based stock options granted for the ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 were based on the following assumptions:


			~~September~~June 30, ~~2020~~2021
Exercise price			$~~1.17~~0.90 - ~~$2.90~~$0.94
Expected stock price volatility			~~68.2%~~75.8% - ~~75.0%~~77.7%
Risk-free interest rate			~~0.31%~~0.47% - ~~1.65%~~1.06%
Term (years)			5.5 - ~~6.0~~6

A summary of the Company’s service-based stock option activity for the ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 is as follows:

Shares
Underlying
Options Weighted
Average Exercise
Price Weighted
Average
Remaining
Contractual
Term Aggregate
Intrinsic
Value
Outstanding at January 1, 2020 8,210,024 $ 7.06 5.1 $ 107,150
Granted 2,252,344 1.95 5.9 —
Forfeited (440,026) 3.96 — —
Expired (4,090,150) 8.24 — —
Outstanding at September 30, 2020 5,932,192 $ 4.54 6.7 $ 0
Exercisable at September 30, 2020 2,889,218 $ 6.95 3.8 $ 0

~~ROCKWELL MEDICAL, INC. AND SUBSIDIARIES~~

~~Notes to Condensed Consolidated Financial Statements~~

~~(Unaudited)~~


	Shares Underlying Options	Weighted Average Exercise Price		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value
Outstanding at January 1, 2021	5,717,956	$	4.55	6.6	$	0
Granted	1,522,162	0.96		6.0	—

Forfeited	(277,764)	2.52		—	—
Expired	(1,266,553)	7.35		—	—
Outstanding at June 30, 2021	5,695,801	$	3.07	7.8	$	5,000

Exercisable at June 30, 2021	2,387,440	$	5.25	5.8	$	0

A summary of the Company’s service-based stock option activity for the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020 is as follows:

Shares
Underlying
Options Weighted
Average Exercise
Price Weighted
Average
Remaining
Contractual
Term Aggregate
Intrinsic
Value
Outstanding at January 1, 2019 7,856,480 $ 7.50 5.2 $ 0
Granted 576,477 4.17 9.7 12,074
Exercised (30,000) 4.93 — —
Forfeited (620,700) 6.34 — —
Outstanding at September 30, 2019 7,782,257 $ 7.35 5.1 $ 12,074
Exercisable at September 30, 2019 6,340,901 $ 8.07 4.2 $ 0


	Shares Underlying Options	Weighted Average Exercise Price		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value
Outstanding at January 1, 2020	8,210,024	$	7.06	5.1	$	107,000
Granted	1,610,344	2.24		5.9	—
Forfeited	(211,471)	4.41		—	—
Expired	(3,983,335)	8.30		—	—
Outstanding at June 30, 2020	5,625,562	$	4.90	6.7	$	1,000

Exercisable at June 30, 2020	2,809,954	$	7.09	4.3	$	0

The aggregate intrinsic value in the table above is calculated as the difference between the closing price of ~~our~~the Company's common stock and the exercise price of the stock options that had strike prices below the closing price.

During the ~~nine~~six months ended ~~September~~June 30, ~~2020,~~2021, the Company granted stock options to purchase up to ~~2,252,344~~1,522,162 shares of common stock to certain employees. During the ~~nine~~six months ended ~~September~~June 30, ~~2020, 440,026~~2021, 277,764 shares were ~~forfeited.~~forfeited and 1,266,553 shares expired. Forfeitures are recorded in the period of occurrence; compensation expense is adjusted accordingly.

Stock-based compensation expense recognized for service-based stock options was ~~$0.2~~$0.3 million and ~~$1.0~~$0.7 million for the three and ~~nine~~six months ended ~~September~~June 30, ~~2020,~~2021, respectively. Stock-based compensation expense recognized for service-based stock options was ~~$0.6~~$0.3 million and ~~$1.8~~$0.8 million for the three and ~~nine~~six months ended ~~September~~June 30, ~~2019,~~2020, respectively. As of ~~September~~June 30, ~~2020,~~2021, total stock-based compensation expense related to unvested options not yet recognized totaled approximately ~~$2.8~~$2.0 million, which is expected to be recognized over an estimated weighted average remaining term of ~~2.4~~3.0 years. Included in the forfeited service-based stock options are 129,375 unvested options related to the resignation of the Company's former President and Chief Executive Officer on April 17, 2020 and 222,222 unvested options related to the resignation of the Company's former Chief Financial Officer effective July 3, 2020. These forfeited awards reduced stock-based compensation expense by $0.5 million. Included in the expired service-based stock options are 3,783,335 options related to the settlement with the former Chief Executive Officer, Robert Chioini, former Chief Financial Officer, Thomas Klema, and a former and then current director. See Note 14 for further details.

Performance-Based Stock Options

~~A summary of the performance-based stock options for the nine months ended September 30, 2020 is as follows:~~

Number of Shares Weighted Average
Exercise
Price
Outstanding at January 1, 2020 388,125 $ 4.70
Granted 750,000 2.20
Forfeited (388,125) 4.70
Outstanding at September 30, 2020 750,000 $ 2.20
Exercisable at September 30, 2020 0 $ 0

2018

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

A summary of the performance-based stock options for the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2021 is as follows:

Number of Shares Weighted Average
Exercise
Price
Outstanding at January 1, 2019 388,125 $ 4.70
Outstanding at September 30, 2019 388,125 $ 4.70
Exercisable at September 30, 2019 0 $ 0


	Number of Shares	Weighted Average Exercise Price
Outstanding at January 1, 2021	750,000	$	2.20

Expired	(375,000)	2.20
Outstanding at June 30, 2021	375,000	$	2.20

Exercisable at June 30, 2021	0	$	0

A summary of the performance-based stock options for the six months ended June 30, 2020 is as follows:


	Number of Shares	Weighted Average Exercise Price
Outstanding at January 1, 2020	388,125	$	4.70
Granted	600,000	$	2.45
Forfeited	(388,125)	$	4.70
Outstanding at June 30, 2020	600,000	$	2.45

Exercisable at June 30, 2020	0	$	0

Stock-based compensation expense recognized for performance-based stock options was ~~$0.1 million~~NaN and ~~($0.4)~~$(0.3) million for the three and ~~nine~~six months ended ~~September~~June 30, ~~2020.~~2021, respectively. Stock-based compensation expense recognized for performance-based stock options was ~~$0.1~~$(0.6) million and ~~$0.4~~$(0.5) million ~~during~~for the three and ~~nine~~six months ended ~~September~~June 30, ~~2019.~~2020, respectively. The reduction in stock-based compensation expense was due to the performance criteria of certain performance-based options granted to officers of the Company becoming non-probable as of March 31, 2021. The Company will continue to assess the probability of the performance criteria until such time the criteria becomes probable and the performance-based stock option vests or continues to be non-probable and the performance-based stock option expires. As of ~~September~~June 30, ~~2020, the~~2021, there was 0 unrecognized stock-based compensation expense related to unvested performance-based stock options was $0.4 million. The forfeited unvested performance-based stock options of 388,125 is due to the resignation of the Company's former President and Chief Executive Officer on April 17, 2020. These forfeited options reduced stock-based compensation expense by $0.7 million.options.

12. ~~Related Party Transactions~~Licensing Agreements

Product License Agreements

The Company is a party to a Licensing Agreement with Charak, LLC ("Charak") dated January 7, 2002 (the "2002 Agreement") that grants the Company exclusive worldwide rights to certain patents and information related to our 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, ~~who serves as Executive Vice President and Chief Scientific~~a former Officer of the Company. Pursuant to the MSA, the parties entered into 3 additional agreements described below related to the license of certain soluble ferric pyrophosphate (“SFP”) intellectual property owned by ~~Charak, as well as the Employment Agreement (defined below).~~Charak. The Charak MSA provided for a payment of $1.0 million to Dr. Gupta, payable in 4 quarterly installments of $250,000 each on October 15, 2018, January 15, 2019, April 15, 2019 and July 15, 2019, and reimbursement for certain legal fees incurred in connection with the Charak MSA. The Company paid all four of the quarterly installments totaling $1.0 million and accrued $0.1 million for the reimbursement of certain legal expenses during the year ended December 31, 2019. As of ~~September 30,~~December 31, 2020, the Company ~~has~~had fulfilled its reimbursement obligation of certain legal ~~expenses and~~expenses. As of June 30, 2021, the Company accrued ~~$0.1~~$0.2 million relating to certain IP reimbursement expenses and certain sublicense royalty fees ~~as a related party payable~~within accrued liabilities on the condensed consolidated balance sheet.

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

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

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 shall pay Charak a percentage of any sublicense income during the term of the agreement, which amount shall not be less than a minimum specified percentage of net sales of the licensed products by the sub-licensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and be no less than a lower rate of the net sales of the licensed products by the sub-licensee 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 I.V. Triferic® (now Triferic AVNU), 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 is 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

~~ROCKWELL MEDICAL, INC. AND SUBSIDIARIES~~

~~Notes to Condensed Consolidated Financial Statements~~

~~(Unaudited)~~

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 sub-licensee 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 sub-licensee 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, sublicensable, royalty-bearing license to SFP for the purpose of commercializing worldwide certain parenteral nutritional ("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 sub-licensee 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 sub-licensee in jurisdictions where there exists no valid claim, on a country-by-country basis.

~~The transaction was accounted for as an asset acquisition pursuant to ASU 2017-1,~~ ~~Business Combinations~~ ~~(Topic 805), Clarifying the Definition of a Business,~~ as the majority of the fair value of the assets acquired was concentrated in a group of similar assets, and the acquired assets did not have outputs or employees. The assets acquired under the Charak MSA include a license of SFP. Because SFP has not yet received regulatory approval, the $1.1 million purchase price paid and accrued for these assets has been expensed in the Company’s statement of operations for the year ended December 31, 2018. In addition, because the potential milestone payments are not yet considered probable, 0 milestone payments have been accrued at September 30, 2020.

13. Leases

~~We lease our~~The Company leases its production facilities and administrative offices as well as certain equipment used in our operations including leases on transportation equipment used in the delivery of ~~our~~its products. The lease terms range from monthly to five years. ~~We occupy~~The Company occupies a 51,000 square foot facility and a 17,500 square foot facility in Wixom, Michigan under a lease expiring in August ~~2021. We~~2024. The Company also ~~occupy~~occupies two other manufacturing facilities, a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December ~~2020,~~2025, and a 57,000 square foot facility in Greer, South Carolina under a lease expiring February 2023. In addition, ~~we occupy a 1,408 square foot office space in Greer, South Carolina under a lease expiring April 2021. Finally, we executed a lease for~~the Company occupies 4,100 square feet of office space in Hackensack, New Jersey ~~with~~under a lease ~~term beginning on April 1, 2019 and~~ expiring on July 1, 2024. This lease is currently being offered for sublease.

At ~~September~~June 30, 2021, the Company had operating and finance lease liabilities of $6.2 million and right-of-use assets of $6.1 million, which are included in the consolidated balance sheet.

At December 31, 2020, the Company had operating lease liabilities of ~~$2.2~~$3.0 million and right-of-use assets of ~~$2.1~~$2.9 million, which are included in the consolidated balance sheet.

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

2220

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)


		Three Months Ended September 30, 2020			Three Months Ended September 30, 2019			Nine Months Ended September 30, 2020			Nine Months Ended September 30, 2019				Three Months Ended June 30, 2021			Three Months Ended June 30, 2020			Six Months Ended June 30, 2021			Six Months Ended June 30, 2020
Operating leases	Operating leases													Operating leases
Operating lease cost	Operating lease cost	$	382		$	532		$	1,228		$	1,592		Operating lease cost	$	432		$	403		$	851		$	846
Variable lease cost	Variable lease cost	90			90			403			258			Variable lease cost	90			123			192			312
Operating lease expense	Operating lease expense	472			622			1,631			1,850			Operating lease expense	522			526			1,043			1,158
Finance leases														Finance leases
Amortization of right-of-use assets														Amortization of right-of-use assets	67			0			112			0
Interest on lease obligations														Interest on lease obligations	20			0			33			0
Finance lease expense														Finance lease expense	87			0			145			0
Short-term lease rent expense	Short-term lease rent expense	4			4			12			12			Short-term lease rent expense	4			4			8			8
Total rent expense	Total rent expense	$	476		$	626		$	1,643		$	1,862		Total rent expense	$	613		$	530		$	1,196		$	1,166

Other information	Other information													Other information
Operating cash flows from operating leases	Operating cash flows from operating leases	$	393		$	494		$	1,248		$	1,532		Operating cash flows from operating leases	$	428		$	410		$	853		$	855
Operating cash flows from finance leases														Operating cash flows from finance leases	$	21		$	0		$	34		$	0
Financing cash flows from finance leases														Financing cash flows from finance leases	$	56		$	0		$	93		$	0
Right of use assets exchanged for operating lease liabilities	Right of use assets exchanged for operating lease liabilities	$	0		$	136		$	0		$	4,442		Right of use assets exchanged for operating lease liabilities	$	1,476		$	0		$	3,371		$	0
Right of use assets exchanged for finance lease liabilities														Right of use assets exchanged for finance lease liabilities	$	316		$	0		$	777		$	0
Weighted-average remaining lease term – operating leases	Weighted-average remaining lease term – operating leases	2.3			1.8			2.3			1.8			Weighted-average remaining lease term – operating leases	3.5			2.4			3.5			2.4
Weighted-average remaining lease term – finance leases														Weighted-average remaining lease term – finance leases	5.5			0.0			5.5			0
Weighted-average discount rate – operating leases	Weighted-average discount rate – operating leases	6.8		%	6.8		%	6.8		%	6.8		%	Weighted-average discount rate – operating leases	6.2		%	6.8		%	6.2		%	6.8		%
Weighted-average discount rate – finance leases														Weighted-average discount rate – finance leases	5.5		%	0		%	5.5		%	0		%

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


~~Year ending December 31, 2020 (remaining)~~	$	~~387~~
~~Year ending December 31, 2021~~	~~1,055~~
~~Year ending December 31, 2022~~	~~592~~
~~Year ending December 31, 2023~~	~~234~~
~~Year ending December 31, 2024~~	98

~~Total~~	$	~~2,366~~
~~Less present value discount~~	~~(172)~~
~~Operating lease liabilities~~	$	~~2,194~~


	Operating		Finance
Year ending December 31, 2021 (remaining)	$	865	$	148
Year ending December 31, 2022	1,603		300
Year ending December 31, 2023	1,285		305
Year ending December 31, 2024	930		305
Year ending December 31, 2025	468		305
Remaining future payments	97		319
Total	$	5,248	$	1,682
Less present value discount	(522)		(228)
Operating and finance lease liabilities	$	4,726	$	1,454

14. Commitments and Contingencies

~~Demand Notice~~

In February 2020, the Company received a letter from a supplier relating to a supply agreement entered into with the Company in 2015. The supplier alleged the Company did not meet certain annual minimums under the supply agreement, and has requested $3.0 million in penalties, plus payment of the cost for certain raw materials. While the Company believed it had several defenses to the supplier's claim, the Company and the supplier negotiated an amicable resolution of the dispute. On July 31, 2020, the Company and the supplier entered into a settlement agreement, which released the Company from any penalties relating to annual minimums under the 2015 agreement, established new minimums under an amended supply agreement and required the Company to pay for certain raw materials with 50% of the cost to be paid upon execution of the settlement agreement and the remaining 50% to be paid no later than December 31, 2020. As of September 30, 2020, the Company has purchased 50% of the required raw materials under the settlement agreement.

Litigation

SEC Investigation

As a follow up to certain prior inquiries, the Company received a subpoena from the SEC during the Company’s quarter ended September 30, 2018 requesting, among other things, certain information and documents relating to the status of the Company’s request to the Centers for Medicare & Medicaid Services (the "CMS") for separate reimbursement

2321

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

~~the status of the Company’s request to the Centers for Medicare & Medicaid Services (the "CMS") for separate reimbursement~~ status for Triferic ~~Dialysate,~~(dialysate), the Company’s reserving methodology for expiring Triferic inventory, and the basis for the Board’s termination of the former Chief Executive Officer, Robert Chioini, and former Chief Financial Officer, Thomas Klema, in 2018. The Company is cooperating with the SEC and is responding to the SEC’s requests for documents and information.

~~Shareholder Class Action Lawsuits~~

On July 27, 2018, Plaintiff Ah Kit Too filed a putative class action lawsuit in the United States District Court in the Eastern District of New York against the Company and former officers, Robert Chioini and Thomas Klema (the "Too Complaint"). The Too Complaint is a federal securities class action purportedly brought on behalf of a class consisting of all persons and entities, other than Defendants, who purchased or otherwise acquired the publicly traded securities of the Company between March 16, 2018 and June 26, 2018. The Too Complaint alleges that the Company and Messrs. Chioini and Klema violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”). Specifically, the Too Complaint alleges that defendants filed reports with the SEC that contained purported inaccurate and misleading statements regarding the potential for the Company’s drug, Triferic, to quality for separate reimbursement status by the CMS.

On September 4, 2018, Plaintiff Robert Spock filed a similar putative class action lawsuit in the United States District Court in the Eastern District of New York against the Company and Messrs. Chioini and Klema (the "Spock Complaint"). The Spock Complaint is a federal securities class action purportedly brought on behalf of a class consisting of persons who purchased the Company’s securities between November 8, 2017 and June 26, 2018. This complaint alleges that the Company and Messrs. Chioini and Klema violated the Exchange Act in that the Company was aware the CMS would not pursue the Company’s proposal for separate reimbursement for Triferic; misstated reserves in the Company’s quarterly report for the first quarter of 2018; had a material weakness its internal controls over financial reporting, which rendered those controls ineffective; Mr. Chioini withheld material information regarding Triferic from the Company’s auditor, corporate counsel, and independent directors of the Board; and, as a result of these alleged issues, statements about the Company’s business were materially false and misleading.

~~On September 25, 2018, four Company stockholders filed motions to appoint lead plaintiffs, lead counsel, and to consolidate the~~ ~~Ah Kit Too v. Rockwell~~ ~~securities class action with the~~ ~~Spock v. Rockwell~~ securities class action. On October 10, 2018, the court issued an order consolidating the two actions, appointing co-lead plaintiffs and co-lead counsel. On December 10, 2018, lead Plaintiffs filed a consolidated amended complaint, which included the same allegations as the initial complaints and asserted claims on behalf of a putative class consisting of person who purchased the Company’s securities between November 8, 2017 and June 26, 2018. On February 18, 2019, the Company answered the consolidated amended complaint.

On August 7, 2019, all parties to the class action entered into a settlement of the consolidated class action. Pursuant to the terms and conditions of the settlement agreement, the Company will pay the Plaintiffs $3.7 million (the “Settlement Amount") in exchange for a full release of all liability as to all defendants. This resulted in a settlement expense of approximately $0.4 million for the year ended December 31, 2019. Of the Settlement Amount, the Company contributed approximately $0.1 million, which represented the remaining retention amount under the Company’s director and officer liability insurance policy as of September 30, 2020. The remainder of the settlement amount was funded by the Company’s director and officer insurance carrier. The settlement was approved by the court on February 26, 2020.

~~Shareholder Derivative Actions~~

Plaintiff Bill Le Clair filed a Verified Stockholder Derivative Complaint on April 23, 2019 in Case No. 1:19-cv-02373, and Plaintiff John Post filed a Verified Stockholder Derivative Complaint on May 10, 2019 in Case No. 1:19-cv-02774 (the “Derivative Complaints”) in the United States District Court in the Eastern District of New York, purportedly on behalf of the Company (as nominal defendant) and against certain of the Company’s current and former directors (the “Individual Defendants”). The Derivative Complaints assert causes of actions against the Individual Defendants for breach of fiduciary duty, waste of corporate assets, and unjust enrichment. The Derivative Complaints allege the Individual Defendants breached duties by, among other things, permitting alleged misstatements to be made in public filings regarding the status of separate reimbursement for Triferic from CMS, the adequacy of the Company's reserves and internal controls. The Derivative Complaints demand a jury trial, seeking monetary damages, corporate governance and internal procedure reform, injunctive relief on the Individual Directors’ trading activities, restitution, and attorneys’ fees. The cases were consolidated.

~~ROCKWELL MEDICAL, INC. AND SUBSIDIARIES~~

~~Notes to Condensed Consolidated Financial Statements~~

~~(Unaudited)~~

The Company tendered the above shareholder derivative actions to its director and officer insurance carrier(s) for defense and indemnity under its applicable insurance policies. On May 18, 2020, the Company, the Individual Defendants and the Plaintiffs (the "Settling Parties") entered into a formal Stipulation of Settlement, which memorializes the terms of the Settling Parties' settlement of the Derivative Complaints. A hearing occurred before the court on August 10, 2020 and the court issued a final order approving the settlement.~~The Company's director and officer insurance carrier has funded the settlement on behalf of the Company.~~

15. Loan and Security Agreement

OnIn March ~~16,~~ 2020, Rockwell Medical, Inc. and Rockwell Transportation, Inc., as Borrowers, entered into a Loan and Security Agreement (the "Loan Agreement") with Innovatus Life Sciences Lending Fund I, LP ("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 a second tranche of $5.0 million, which was tied to the achievement of certain milestones by a specific date. The Company may be eligible to draw on a third tranche of $7.5 million upon the achievement of certain additional milestones, including the achievement of certain Triferic sales thresholds. Net draw down proceeds were $21.2 million with closing costs of $1.3 million.

The Loan Agreement is secured by all assets of the Company and Rockwell Transportation, Inc. Proceeds ~~will be~~are being used for working capital purposes. The Loan Agreement contains customary representations and warranties and covenants, subject to customary carve outs, and includes financial covenants related to liquidity and trailing twelve months sales of Triferic, with the latter beginning with the period ending December 31, 2020. WeThe Company cannot assure you that we can maintain compliance with the covenants under our Loan Agreement, which may result in an event of default. ~~Our~~The Company's ability to comply with these covenants may be adversely affected by events beyond ~~our~~its control. For example, the Loan Agreement contains certain financial covenants relating to sales and, as a result of the ongoing COVID-19 pandemic and its effect on ~~our~~the Company's sales activities, among other factors, wethe Company may not be able to satisfy such covenants in the future. ~~Based on our annualized Triferic sales through September 30, 2020, we may not satisfy this covenant as of December 31, 2020.~~ If ~~we are~~the Company is unable to comply with the covenants under ~~our~~the Loan Agreement, ~~we intend to~~it would pursue all available cure options in order to regain compliance. The Company previously failed to satisfy a revenue covenant for the period ended December 31, 2020 and then subsequently agreed to an appropriate remedy during the applicable cure period. However, wethe 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. If ~~we are~~the Company is unable to avoid an event of default, any required repayments could have an adverse effect on ~~our~~its liquidity. As of ~~September~~June 30, ~~2020,~~2021, the Company is in compliance with all the reporting and financial covenants. The financial statements for June 30, 2021 have been prepared with the assumption that the Company will be able to agree to an appropriate remedy during the applicable cure period for any future breaches of operating covenants. Based on the foregoing, the Company has classified amounts payable under the Loan Agreement as a current liability.If and when the Company reaches an agreement with Innovatus to avoid an event of default, the amounts payable under the Loan Agreement will be reevaluated for its classification and presentation.

In connection with each funding of the Term Loans, the Company is 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, which will be based on the lower of (i) the volume weighted average closing price of the Company’s stock for the 5-trading day period ending on the last trading day immediately preceding the execution of the Loan Agreement or (ii) the closing price on the last trading day immediately preceding the execution of the Loan Agreement (or for the second and third tranches only at the lower of (i) $1.65 per share or (ii) the volume weighted average closing price of the Company’s stock for the 5-trading day period ending on the last trading day immediately preceding the relevant Term Loan funding). The Warrants may be exercised on a cashless basis and are immediately exercisable through the seventh anniversary of the applicable funding date. The number of shares of common stock for which each Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Warrant. In connection with the first tranche of the Term Loans, the Company issued a Warrant to Innovatus, exercisable for an aggregate of 477,273 shares of the Company’s common stock at an exercise price of $1.65 per share. 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.

~~As of September 30, 2020, the outstanding balance of the Term Loan was $20.9 million, net of unamortized issuance costs and unaccreted discount of $1.6 million.~~

2522

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

As of June 30, 2021, the outstanding balance of the Term Loan was $21.1 million, net of unamortized issuance costs and unaccreted discount of $1.4 million.

The following table reflects the schedule of principal payments on the Term Loan as of ~~September~~June 30, ~~2020~~2021 (in thousands):


		Principal Payments			Principal Payments
2020		$	0

2021	2021	0		2021	$	0
2022	2022	2,250		2022	2,250
2023	2023	9,000		2023	9,000
2024	2024	9,000		2024	9,000
2025	2025	2,250		2025	2,250
		$	22,500		$	22,500

16. Subsequent Events

On July 3, 2021, the Company entered into a short-term note payable for $2.0 million, bearing interest at 3.925% per annum to finance various insurance policies. Principal and interest payments related to this note will begin on July 3, 2021 and are paid on a straight-line amortization over a 9-month period with the final payment due on March 3, 2022.

2623

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 Securities and Exchange Commission, or 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 expectations and possible or assumed future results of our operations. When we use words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,” “plan,” “potential,” “predict,” “forecast,” “project,” “intend,” or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward-looking statements. Our forward looking statements also include, without limitation, statements about our liquidity and capital resources; our plans and ability to successfully commercialize our products; our ability to successfully launch FDA-approved Triferic AVNU; our ability to develop FPC for other indications; our ability to successfully execute on our business strategy and development of new indications; and statements regarding our anticipated future financial condition, operating results, cash flows and business plans.

While we believe that 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 Form 10-K for the year ended December 31, ~~2019~~2020 and from time to time in our other reports filed with the SEC, including in this Form 10-Q.

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 that 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 and Recent Developments

Rockwell ~~Medical, Inc. and subsidiaries (collectively, “we”, “our”, “us”, or the “Company”),~~ is a commercial-stage, biopharmaceutical company ~~dedicated~~developing and commercializing our next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate ("FPC"), which we believe has the potential to ~~improving outcomes~~lead to transformative treatments for iron deficiency in multiple disease states, that we believe could reduce healthcare costs and improve patients’ lives. We are also one of the two major suppliers of life-saving hemodialysis concentrate products to kidney dialysis clinics in the United States.

We have two novel, FDA approved therapies, Triferic and Triferic AVNU, which are the first two products developed from our FPC platform. We are marketing both products to kidney dialysis centers for their patients receiving dialysis. In 2021, we intend to advance our FPC platform strategy outside of dialysis by starting a Phase 2 trial for the treatment of iron deficiency anemia in patients who are receiving long-term and or chronic intravenous(“IV”) medications for various therapeutic needs in the home infusion setting.. The trend toward providing medical care, including the delivery of medicines, at home make the home infusion market a rapidly growing area of healthcare. We believe that the home infusion setting is a natural path for expansion of our platform as many of the patients suffer from chronic diseases that are associated with iron deficiency and ~~iron-deficiency anemia,~~anemia. We are currently seeking additional FDA feedback and clarification regarding the clinical development plan for FPC in the home-infusion setting. Our expectations regarding the commencement of a Phase 2 trial in 2021 is based on the assumption that the FDA agrees with ~~an initial focus~~the development plan as we have proposed. In our R&D pipeline, we are also investigating FPC’s impact on iron deficiency in the treatment of hospitalized patients with acute heart failure, with the potential to begin another Phase 2 trial in these patients in 2022.

We are the second largest supplier of hemodialysis concentrates in the United States, with a reputation for excellent service, quality, and reliability. We believe that this reputation, which is based on over 25 years of service to the kidney

dialysis centers, combined with about $60 million in annual revenue, approximately 300 dedicated employees, expertise in manufacturing and logistics and the added expertise in pharmaceutical development and commercialization brought to the Company by recent additions to our management team, gives us a solid foundation on which to grow.

At Rockwell Medical, we are dedicated to replacing the currently inadequate standard of care for treatment of iron deficiency in acute and chronic disease by leveraging our proprietary FPC platform technology. We believe that our proprietary drug platform, FPC, is a next-generation parenteral iron therapeutic that has several advantages over other parenteral iron therapies. Importantly, it provides iron that is immediately bioavailable for critical body processes once it is administered. It has been demonstrated to be safe and well-tolerated, with a safety profile similar to placebo.

Iron deficiency, which is often overlooked and undertreated in several illnesses because of the difficulty in treating them, can develop into a serious medical condition when left untreated. It is a common comorbidity in many disease states, such as end-stage kidney disease, ~~(ESKD)~~chronic kidney disease, acute heart failure, cancer and multiple chronic gastrointestinal conditions. Iron deficiency impacts patients’ health in many ways, including anemia, organ dysfunction, slower recovery, diminished energy and reduced quality of life.

Strategy Evolution and Overview

Rockwell Medical has evolved its strategy over the past year to develop into a more medically-, scientifically- and data-driven company. We believe future clinical, regulatory and commercial success require the right people with the right experience to navigate us to the right data. There has been an evolution of both our management and board, providing us with greater relevant experience. In particular, we have added board members and employees with significant medical and commercial experience in iron deficiency anemia and the dialysis sector, drug development and commercialization, small-cap public company finance and management and clinical nurse educator patient support. We believe these changes support an improved execution of our strategy to generate data that will support future commercial growth, fair reimbursement and regulatory approvals.

Our strategy is to accelerate Rockwell’s growth by creating and developing pharmaceutical products based on ~~dialysis. The Company is focused~~our FPC technology for disease states where patients can benefit the most from an effective treatment for iron deficiency or iron deficiency anemia, while concurrently refining our dialysis business to drive incremental growth and efficiencies. We plan to leverage and build on the foundation provided by our current dialysis business serving kidney dialysis centers by developing ~~its proprietary ferric pyrophosphate citrate (“FPC”) therapeutic platform. The~~a pipeline of additional potential drug therapies in multiple disease states outside of nephrology. We have preliminarily identified three disease states where we believe FPC may have the biggest impact.

Dialysis Business: We are the second largest supplier, and one of the two major suppliers of hemodialysis concentrates in the United States. We manufacture, sell and deliver hemodialysis concentrates, which are used to maintain human life by removing toxins and balancing electrolytes in the dialysis patient’s bloodstream. We have core capabilities in manufacturing hemodialysis concentrates in three facilities, totaling 159,000 square feet, located in Michigan, Texas and South Carolina. We also have core capabilities in the logistics of delivering these products to dialysis clinics throughout most of the United States.

Our first ~~product developed~~two branded products from ~~this~~our FPC platform, isTriferic® (dialysate) and Triferic AVNU® (IV), are used to maintain hemoglobin in patients undergoing hemodialysis. We are building on our reputation and industry presence by commercializing then to medium and small dialysis organizations. We began commercializing Triferic and Triferic AVNU in the ~~first-FDA approved product~~United States in the second half of 2019 and in early 2021, respectively. In April 2021, we received marketing approval for Triferic AVNU from Health Canada for the replacement of iron ~~and maintenance of~~to maintain hemoglobin in adult ~~hemodialysis patients.~~patients with hemodialysis-dependent chronic kidney disease, which is the first international regulatory approval for our intravenous therapy. We ~~initiated commercial sales~~expect Triferic AVNU to become commercially available in Canada during 2022. Our strategy for increasing Triferic adoption is to continue to generate data in clinics showing the benefits of Triferic ~~Dialysate during~~in real world protocols. In addition, we expect to study Triferic use with the ~~second quarter~~innovations that we believe have the potential to change future medical practices (e.g. introduction and adoption of ~~2019~~HIF-PHIs), subject to FDA approval. We believe that positive data from these studies would better position Triferic for long-term growth. We are developing strategic alliance partners for development, regulatory approval and ~~received approval by the U.S. Food and Drug Administration ("FDA") for the intravenous formulation~~commercialization of Triferic ~~Triferic AVNU, on March 27, 2020.~~outside of the United States.

Home Infusion Program: We plan to ~~leverage our experience with Triferic to develop our FPC platform for iron deficiency and iron deficiency anemia in other disease states. Our lead indication is developing~~initiate a clinical trial program of FPC for the treatment of iron deficiency anemia in ~~patients undergoing~~the home-infusion setting. Many patient groups requiring home infusion therapy. We are also a manufacturer of hemodialysis concentrates for dialysis providers and distributors in the United States and abroad. We supply the domestic market with dialysis concentrates and we also supply dialysis concentrates to distributors serving a number of foreign countries, primarily in the Americas and the Pacific Rim.therapies suffer from chronic diseases that

Substantially all of our sales have been concentrate products and ancillary items, though we initiated commercial sales of our proprietary therapeutic, Triferic Dialysate, during the second quarter of 2019.

~~Triferic~~

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~~Triferic is~~are associated with a high incidence of iron deficiency and anemia. Home infusion represents a large and rapidly-growing segment of healthcare where we believe FPC may have distinct advantages over currently available iron replacement therapy options.

Pipeline Development: We are investigating the ~~Company’s first proprietary~~use of our FPC platform for the treatment of iron ~~therapy from~~deficiency in hospitalized patients with acute heart failure. We believe that FPC may deliver rapidly bioavailable iron to the ~~FPC therapeutic platform that replaces iron~~heart and ~~maintains hemoglobin~~improve cardiac energetics. This effect could help patients recover faster, resulting in ~~dialysis patients without increasing iron stores. Triferic Dialysate was the first FDA approved product indicated to replace iron~~shorter hospital stays and ~~maintain hemoglobin concentration in adult HDD-CKD hemodialysis patients. On March 27, 2020, the FDA approved Triferic AVNU, a novel intravenous formulation of Triferic that~~fewer 30-day re-admissions, which would be a meaningful reduction healthcare costs and human suffering.

Our Growth Strategy

We plan to accelerate our growth by combining the solid foundation, strength and reputation of our dialysis business with the high-growth potential from therapeutics derived (or generated) from our FPC platform in multiple disease states where patients can benefit the most from an effective treatment for iron deficiency. In parallel with continually seeking to drive incremental growth and efficiencies in our dialysis business unit, our strategy is to accelerate the growth of our business in large, higher-margin markets by creating and developing pharmaceutical products based on our proprietary FPC technology that address iron deficiency in patients who are currently under-treated.

Dialysis Business

We are one of the two major suppliers of hemodialysis concentrates in the United States. Over the past 25 years we have developed a core expertise in manufacturing and delivering hemodialysis concentrates. Because these concentrates are used to maintain human life by removing toxins and balancing electrolytes in the dialysis patient’s bloodstream, we manufacture them under cGMP regulations as described below. Our concentrates are manufactured in three facilities, totaling 159,000 square feet, located in Michigan, Texas and South Carolina, from which we deliver these products to dialysis clinics throughout most of the United States. We utilize our own delivery fleet as well as third parties. We employ approximately 300 people in the concentrates unit of our dialysis business.

The “Rockwell Medical” name has earned a reputation for dependability, quality and service within our customer base. This reputation was further strengthened during the ~~same indication. Descriptions~~recent challenges presented, not only by the COVID-19 pandemic, but also by the multitude of recent natural disasters where our team has been challenged by hurricanes, flooding and freezing, while still meeting production demands.

Our dialysis business in concentrates and our growth opportunities with FPC technology are synergistic. We are leveraging our leadership position in the dialysis sector to commercialize our first two FPC-based products, Triferic ~~Dialysate~~ and Triferic AVNU, which are ~~set forth below.~~

~~TrifericDialysate~~

~~Triferic Dialysate, our dialysate formulation~~indicated for the replacement of ~~Triferic, received FDA approval in 2015 and remains the first FDA-approved therapy indicated~~iron to ~~replace iron and~~ maintain hemoglobin in adult ~~hemodialysis patients.~~patients with hemodialysis-dependent chronic kidney disease. We commercialize the Triferic Dialysate received a reimbursement J-code on January 1, 2016 from the Centers for Medicare & Medicaid Services (the "CMS"), providing that Triferic Dialysate would be reimbursed for administration to dialysis patients within the existing fixed-price “bundle” of payments that CMS provides to dialysis providers. On April 26, 2019, pursuant to a request we submitted earlier in 2019, we were notified of a preliminary recommendation by CMS to grant our powder packet formulation of Triferic Dialysate a separate J-Code, which became effective on July 1, 2019. As a result, the Company changed its commercialization strategy to plan for the commercial launch of Triferic Dialysate with reimbursement within the bundle of payments to dialysis providers, while continuing to develop Triferic AVNU (discussed below). We commercially launched Triferic Dialysate in May 2019.

In June 2018, the Company determined, based on feedback provided from CMMI, that Triferic Dialysate was unlikely to obtain add-on reimbursement in the near term. As a result, the Company changed its commercialization strategy to plan for the commercial launch of Triferic Dialysate with reimbursement within the bundle of payments to dialysis providers, while continuing to develop Triferic AVNU (discussed below). We commercially launched Triferic Dialysate in May 2019.

~~Triferic AVNU (formerly I.V. Triferic)~~

We have also developed Triferic AVNU, an intravenous injection formulation of Triferic, for use by hemodialysis clinics in the United States as well as international markets. On March 27, 2020, we received FDA approval for Triferic AVNU, with the same indications as the dialysate formulation (indicated to replace iron and maintain hemoglobin concentration in adult HDD-CKD hemodialysis patients) and we began recruiting clinics for participation in a sample evaluation program for Triferic AVNU during the third quarter of 2020. Due to a minor scheduling delay in the production of packaging for salable product, commercialization will likely be postponed until the first quarter of 2021. Like Triferic Dialysate, Triferic AVNU will be reimbursed within the existing fixed-price bundle of payments that CMS provides to dialysis providers.

~~While we intend to market and sell Triferic Dialysate and Triferic AVNU directly in the United States, our international strategy is to partner with and license these~~ products to established companies in other regions of the world to assist in the further development (primarily clinical trials and regulatory activities), if necessary, and commercialize in those regions. We continue to pursue international licensing opportunities in a number of countries and specific regions.

~~Dialysis Concentrates~~

We manufacture, sell, deliver and distribute hemodialysis concentrates, along with a line of ancillary dialysis products abroad. We sell directly to DaVita, Inc. and use Baxter as our exclusive marketer and distributorourselves in the United States, and ~~in select foreign markets. Dialysate concentrates accounted for approximately 96% of our revenues~~are partnering with established local pharmaceutical companies for the ~~nine months September 30, 2020,~~regulatory approval and commercialization outside of the United States.

Although we have an excellent reputation for dependability and service within the dialysis sector, with ~~ancillary products~~concentrates and Triferic, ~~accounting~~our growth opportunities for ~~most of the remainder. We receive a pre-defined gross profit margin on our concentrate products sold pursuant to the Baxter Agreement, subject to an annual true-up of costs.~~

~~Clinical Development~~

~~Although Triferic is approved for commercial sale~~both in the United States ~~it is~~dialysis market are challenged by the consolidated ownership of dialysis clinics, a capitated reimbursement model and the demographics of the patient population. The two largest dialysis organizations treat approximately 73% of the patients in the United States. One manufactures its own concentrates and IV iron and we already supply concentrates to the other. Through our partnership with Baxter International, we currently supply concentrates to a significant percentage of the small and medium sized dialysis organizations. In a sector, such as kidney dialysis, with capitated reimbursement for the dialysis procedure and all included inputs, new product success depends on compelling data demonstrating improved patient outcomes and/or pharmacoeconomics versus the current standard of care in practice in the clinics. Once Medicare determined that Triferic and Triferic AVNU would be reimbursed under the fixed bundled rate, market adoption became more dependent on the generation of these data, which were not ~~approved~~required for ~~sale in other major markets globally. We have received regulatory guidance~~the drug's approval from the ~~European Medicines Agency ("EMA") regarding~~FDA.

Notwithstanding the ~~clinical studies~~growth limitations mentioned above, we have made progress and continue to be confident that ~~are needed~~Triferic has the potential to ~~file~~be the treatment of choice for ~~approval~~the maintenance of hemoglobin in dialysis patients. Toward this end, we have increased our efforts in generating real world data in clinics with current protocols, which we believe will help with the adoption of Triferic and Triferic AVNU ~~in Europe. At the present time, we do not intend to commence~~as these clinical studies without a development partner in Europe. In conjunction with our licensee in China, Wanbang Biopharmaceutical, Co., Ltd. ("Wanbang"), we completed two clinical pharmacology studies in China during 2019. We expect Wanbang to initiate an additional, pivotal, clinical study that is required to support a submission for regulatory approval in China.results are developed and disseminated over time. In addition, ~~pursuant~~we believe the hemodialysis industry may experience a great deal of change over the next several years. We plan to take the licensing agreement with Sun Pharmaceutical Industries Ltd. ("Sun Pharma"), our licensee in India, meetings between Sun Pharma and the regulatory authorities in India have been initiated. Sun Pharma continuessteps necessary to ~~follow~~

2826

upgenerate the data necessary to potentially allow Triferic and Triferic AVNU to benefit from these new innovations, such as the potential approval of a class of drugs, known as hypoxia-inducible factor prolyl hydroxylase inhibitors ("HIF-PHIs"), as well as the new, solid-state dialysis equipment in development. We are planning to study Triferic in combination with these potential new innovations as they become available.

A key element of our dialysis business strategy is to also improve the strength of our concentrates business by creating efficiencies and enhancing our manufacturing and transportation operations. We have launched projects to identify ways to improve the overall profitability of these core operations. Specifically, we are reviewing our entire supply chain to identify opportunities for improvement, prioritizing initiatives that will have the largest impact on long-term efficiency, profitability and growth.

Home Infusion

Our growth strategy is to go beyond our foundational business in dialysis by leveraging the pre-clinical, clinical pharmacology and safety data from Triferic. We are planning to develop an FPC-based therapeutic for iron deficiency to be given in the home infusion setting. According to the National Home Infusion Association, the number of patients served by home infusion therapy has grown from approximately 800,000 in 2010 to over 3,000,000 in 2019. The home infusion setting is expected to continue to expand, which has been further accelerated by the COVID-19 pandemic and the desire to reduce or eliminate hospital and or clinic exposure. Many patient groups requiring home infusion therapies suffer from diseases that are associated with an incidence of iron deficiency and anemia. For example, it is estimated that 40% to 55% of all home parenteral nutrition patients are iron deficient. We believe, based on our data with hemodialysis patients, FPC as a home infusion therapy for iron deficiency anemia may have distinct advantages over currently available iron replacement therapy options.

We plan on initiating a Phase 2 clinical study in home infusion patients with iron deficient anemia during the second half of 2021 to confirm the dose and duration of FPC treatment. We expect data from the trial in the second half of 2022. Prior to commencing this study, the company is planning to further review and discuss this clinical plan with the ~~Indian regulatory authorities to determine~~FDA. After reviewing the requirements for approval of Triferic in India. Lastly, pursuant to the licensing agreement with Jeil Pharmaceutical Co., Ltd ("Jeil Pharma"), our licensee in South Korea, meetings between Jeil Pharma and the regulatory authorities in South Korea will be initiated. Jeil Pharma has informed us they do not believe they would need to perform a clinical trial in advance of approval. We anticipate sales in South Korea to begin in early 2022. See "Item 1A — Risk Factors" below for a discussion of the potential impact of COVID-19 our overall business and such clinical studies.

As a post-approval requirement under the Pediatric Research Equity Act, we are required to conduct a further clinical study of the effectiveness of Triferic in a pediatric patient population. We have reached agreementdevelopment plan with the FDA, and ~~EMA on~~subject to clarifying expected clinical development requirements, we expect to initiate the ~~design of this study. We have engaged a contract research organization and are in process of selecting sites~~trial in the ~~United States and selected EU countries. We expect the data from this study could be used as part~~second half of ~~the overall clinical data package to support approval by the EMA, if and when~~2021.

Pipeline Development

In our R&D pipeline, we are ~~able to complete the other clinical trials needed to support making such a filing. See "Item 1A — Risk Factors" below for a discussion of the potential~~also exploring FPC’s impact ~~of COVID-19 on such clinical studies.~~

~~Growth Opportunities~~

~~In the third Quarter of 2020 we initiated our plan to leverage our development and regulatory experience with our FPC platform for use~~ in ~~other indications. We plan to meet with the FDA for a Type C meeting to discuss our plan for developing FPC for~~ the treatment of iron deficiency anemia in patients undergoing home infusion therapy. Over 3.2 million patients are treated annually using home infusion therapy. The incidence of iron deficiency is estimated to be as high as 60% in this patient population.

Iron deficiency anemia is largely undertreated in part due to limitations of the currently available iron replacement drugs. Due to concerns about hypersensitivity reactions, IV iron is infrequently prescribed as a home infusion therapy. This means that patients need to visit a physician office for an infusion which is costly and inconvenient. As a result, physicians are often hesitant to proactively treat iron deficiency and the majority of patients are left to deal with the disease on their own. Those who become severely anemic are reactively given blood transfusions, which comes with significant risk.

~~We also plan to meet with FDA in 2021 to discuss our development plans for FPC to improve cardiac function~~ in hospitalized ~~acute congestive~~ heart failure patients. More than aone million ~~patients~~people in the United States are hospitalized each year ~~with~~for acute ~~decompensated~~ heart failure. ~~Iron deficiency is a common co-morbidity~~Clinical improvement in ~~50% to 70% of these patients.~~

~~While there is increasing evidence regarding the positive impact~~heart failure has already been demonstrated with older first-generation forms of IV iron ~~replacement therapy~~in clinical trials in the chronic ambulatory heart failure patient, the evidence in the acute population is scarce. One limitation of currently available parenteral iron products is that the iron must be processed and stored in the liver before it is released and becomes available as a fuel for cardiac muscle energetics.outpatient setting. We believe that FPC may ~~be a significant advantage for the acute heart failure patient due~~deliver rapidly bioavailable iron to the ~~fact that it provides 100% immediately bioavailable iron, which may mean it is~~heart and improve cardiac energetics during hospitalization. This effect could help patients recover faster ~~acting~~resulting in improved function, shorter hospital stays and ~~could make~~fewer 30-day re-admissions. If so, these outcomes would translate into a meaningful ~~impact within~~reduction in healthcare costs and human suffering. We expect to communicate with the ~~context~~FDA in 2021 regarding a development pathway for this indication.

We continue exploring other potential patient populations for application of our technology. We are considering disease states where patients can benefit the ~~hospital stay.~~most from an effective treatment for iron deficiency, and where the development path, cost estimates and reimbursement are the most favorable.

2927

Results of Operations for the ~~three months ended September~~Three Months Ended June 30, ~~2020~~2021 and ~~2019~~2020

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


		For the Three Months Ended September 30,											For the Three Months Ended June 30,
		2020		% of Revenue		2019		% of Revenue		% Change			2021		% of Revenue		2020		% of Revenue		% Change

Net Sales	Net Sales	$	15,280			$	15,407			(0.8)	%	Net Sales	$	15,137			$	15,896			(4.8)	%
Cost of Sales	Cost of Sales	14,934		97.7	%	15,424		100.1	%	(3.2)		Cost of Sales	15,399		101.7	%	15,015		94.5	%	2.6
Gross Profit (Loss)		346		2.3		(17)		(0.1)		(2,135.3)
Gross (Loss) Profit												Gross (Loss) Profit	(262)		(1.7)		881		5.5		(129.7)

Research and Product Development												Research and Product Development	2,416		16.0		1,616		10.2		49.5
Selling and Marketing	Selling and Marketing	1,669		10.9		1,827		11.9		(8.6)		Selling and Marketing	1,468		9.7		1,997		12.6		(26.5)
General and Administrative	General and Administrative	3,622		23.7		4,623		30.0		(21.7)		General and Administrative	3,677		24.3		2,871		18.1		28.1

Research and Product Development		1,745		11.4		1,475		9.6		18.3

Operating Loss	Operating Loss	$	(6,690)	(43.8)	%	$	(7,942)	(51.5)	%	(15.8)	%	Operating Loss	$	(7,823)	(51.7)	%	$	(5,603)	(35.2)	%	39.6	%

Net Sales

During the three months ended ~~September~~June 30, ~~2020,~~2021, our net sales were ~~$15.3~~$15.1 million compared to net sales of ~~$15.4~~$15.9 million during the three months ended ~~September~~June 30, ~~2019.~~2020. The decrease of ~~$0.1~~$0.8 million was primarily due to a decrease in ~~international~~ sales of dialysis concentrates products. ~~Triferic Dialysate net sales for the three months ended September 30, 2020 included approximately $0.2 million of Triferic Dialysate product sales to United States customers.~~

Gross Profit

Cost of sales during the three months ended ~~September~~June 30, ~~2020~~2021 was ~~$14.9~~$15.4 million, resulting in gross ~~profit~~loss of ~~$0.4~~$0.3 million during the three months ended ~~September~~June 30, ~~2020,~~2021, compared to cost of sales of a ~~$15.4~~$15.0 million and a gross ~~loss~~profit of ~~$17,000~~$0.9 million during the three months ended ~~September~~June 30, ~~2019.~~2020. Gross profit ~~increased~~decreased by ~~$0.4~~$1.2 million ~~in the third quarter of 2020 compared to the third quarter of 2019,~~mainly due ~~primarily~~ to a ~~large inventory reserved of $1.1 million recorded~~decrease in ~~the third quarter of 2019 compared to $0.3 million inventory reserve recorded in the third quarter of 2020; offset by~~concentrate sales and an increase in ~~labor and material~~ costs ~~$0.3 million~~related to ~~address~~ protocols ~~put in place from~~implemented because of the ongoing COVID-19 ~~pandemic. Gross profits are~~pandemic, shipping, fuel and labor.

Research and Product Development Expense

Research and product development expenses were $2.4 million for the three months ended June 30, 2021, compared with $1.6 million during the three months ended June 30, 2020. The increase of $0.8 million was primarily ~~related~~due to the Company continuing to invest in its medical and scientific programs to support the continued advancement of our ~~concentrates business at this time. The Company anticipates that potential future sales of Triferic will impact the mix of future gross profits.~~FPC technology platform.

Selling and Marketing Expense

Selling and marketing expenses were ~~$1.7~~$1.5 million during the three months ended ~~September~~June 30, ~~2020,~~2021, compared with ~~$1.8~~$2.0 million during the three months ended ~~September~~June 30, ~~2019.~~2020. The decrease of ~~$0.1~~$0.5 million is primarily due to a decrease in marketing costs related to Triferic ~~Dialysate~~(dialysate) partially offset by ana slight increase in costs associated with the launch of Triferic ~~AVNU, our new FDA-approved intravenous formula.~~AVNU.

General and Administrative Expense

General and administrative expenses were ~~$3.6~~$3.7 million during the three months ended ~~September~~June 30, ~~2020,~~2021, compared with ~~$4.6~~$2.9 million during the three months ended ~~September~~June 30, ~~2019.~~2020. The ~~decrease~~increase of ~~$1.0~~$0.8 million is due primarily to ~~a decrease~~an increase in stock compensation of ~~$0.6~~$1.9 million, ~~relating to~~which was a decrease in incentive compensation in Q2 2020 of $1.5 million from forfeited equity awards ~~associated with~~of the ~~departure of our~~ former President and Chief Financial in July 2020; a decrease in consulting expense of $0.3 million, relating to strategic development; a decrease in accounting costs of $0.2 million , relating to a decrease in internal audit fees; and a decrease in legal expense of $0.1 million, relating to previous litigation that has since been resolved;Executive Officer; partially offset by ~~an increase~~a decrease of ~~$0.3~~$0.8 million for ~~increased training cost and~~the reduction of severance ~~pay~~costs related to our former President and Chief Executive Officer.

Other Income (Expense)

Other income for the three months ended June 30, 2021 was $7,000, consisting primarily of interest income. Other income for the three months ended June 30, 2020 was $0.1 million, consisting primarily of interest income. Other expense for the three months ended June 30, 2021 was $0.6 million of interest expense related to our debt facility (see Note 15 for more

information on our debt facility). Other expense for the three months ended June 30, 2020 was $1.4 million, consisting of interest expense of $0.5 million related to our debt facility and warrant modification expense of $0.8 million.

Results of Operations for the Six Months Ended June 30, 2021 and 2020

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


	For the Six Months Ended June 30,
	2021		% of Revenue		2020		% of Revenue		% Change

Net Sales	$	30,611			$	31,753			(3.6)	%
Cost of Sales	30,471		99.5	%	29,759		93.7	%	2.4
Gross Profit	140		0.5		1,994		6.3		(93.0)

Research and Product Development	4,224		13.8		3,438		10.8		22.9
Selling and Marketing	3,319		10.8		4,069		12.8		(18.4)
General and Administrative	7,602		24.8		8,145		25.7		(6.7)



Operating Loss	$	(15,005)	(49.0)	%	$	(13,658)	(43.0)	%	9.9	%

Net Sales

During the six months ended June 30, 2021, our net sales were $30.6 million compared to net sales of $31.8 million during the six months ended June 30, 2020. The decrease of $1.2 million was primarily due to a decrease in sales of dialysis concentrates products.

Gross Profit

Cost of sales during the six months ended June 30, 2021 was $30.5 million, resulting in gross profit of $0.1 million during the six months ended June 30, 2021, compared to cost of sales of a $29.8 million and a gross profit of $2.0 million during the six months ended June 30, 2020. Gross profit decreased by $1.9 million mainly due to a decrease in concentrate sales and an increase in costs related to protocols implemented because of the ongoing COVID-19 pandemic, shipping and fuel costs and labor.

Research and Product Development Expense

Research and product development expenses were ~~$1.7~~$4.2 million for the ~~three~~six months ended ~~September~~June 30, ~~2020,~~2021, compared with ~~$1.5~~$3.4 million during the ~~three~~six months ended ~~September~~June 30, ~~2019. The~~2020. This increase of ~~$0.2~~$0.8 million ~~was~~is primarily due ~~primarily~~

to ~~increase in costs relating to our scientific programs. The~~continued investments the Company is ~~continuing to invest~~making in its medical and scientific programs to support the ~~global launch of Triferic and the~~continued advancement of our FPC technology platform.

Selling and Marketing Expense

Selling and marketing expenses were $3.3 million during the six months ended June 30, 2021, compared with $4.1 million during the six months ended June 30, 2020. The decrease of $0.8 million is primarily due to a decrease in marketing costs related to Triferic (dialysate) partially offset by a slight increase in costs associated with the launch of Triferic AVNU.

General and Administrative Expense

General and administrative expenses were $7.6 million during the six months ended June 30, 2021, compared with $8.1 million during the six months ended June 30, 2020. The decrease of $0.5 million is due primarily to a decrease of $0.8 million from the completion of severance pay related to our former President and Chief Executive Officer (CEO); a decrease in legal costs of $0.3 million, relating to previous litigation that has since been resolved; and a decrease in insurance and accounting costs of $0.2 million, relating to reduced premiums; partially offset by an increase of $0.7 million for stock compensation, relating to a decrease in Q2 2020 incentive compensation from forfeited equity awards related to our former President and CEO.

Other Income (Expense)

Other income for the ~~three~~six months ended ~~September~~June 30, ~~2020~~2021 was ~~$5,861,~~$18,000, consisting primarily of interest ~~income of $1,767 and $4,094 of realized gains on investments.~~income. Other income for the ~~three~~six months ended ~~September~~June 30, ~~2019~~2020 was ~~$103,386,~~$0.2 million, consisting ~~of $97,100~~primarily of interest ~~income and $6,268 of realized gains on investments.~~income. Other expense for the ~~three~~six months ended ~~September~~June 30, ~~2020~~2021 was ~~$0.7~~$1.2 million of interest expense related to our debt facility (see Note 15 for more information on our debt facility). Other expense for the ~~three~~six months ended ~~September 30, 2019 was $16,365 of interest expense.~~

~~Results of Operations for the nine months ended September 30, 2020 and 2019~~

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

For the Nine Months Ended September 30,
2020 % of Revenue 2019 % of Revenue % Change
Net Sales $ 47,033 $ 45,812 2.7 %
Cost of Sales 44,693 95.0 % 44,085 96.2 % 1.4
Gross Profit 2,340 5.0 1,727 3.8 35.5
Selling and Marketing 5,738 12.2 7,149 15.6 (19.7)
General and Administrative 11,767 25.0 16,341 35.7 (28.0)
Settlement Expense, net of Reimbursement — — 430 0.9 (100.0)
Research and Product Development 5,183 11.0 4,930 10.8 5.1
Operating Loss $ (20,348) (43.3) % $ (27,123) (59.2) % (25.0) %

~~Net Sales~~

During the nine months ended September 30, 2020, our net sales were $47.0 million compared to net sales of $45.8 million during the nine months ended September 30, 2019. The increase of $1.2 million was primarily due to higher domestic dialysis concentrate sales of $0.8 million and an increase in Triferic Dialysate sales of approximately $0.4 million compared to the nine months ended September 30, 2019. Triferic was launched in the third quarter of 2019 via the sample evaluation program and there were nominal revenues for the same period in 2019.

~~Gross Profit~~

~~Cost of sales during the nine months ended September~~June 30, 2020 was $44.7 million, resulting in gross profit of $2.3 million during the nine months ended September 30, 2020, compared to cost of sales of $44.1 million and a gross profit of $1.7 million during the nine months ended September 30, 2019. Gross profit increased by $0.6 million during the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019. The increase was due primarily to a gross margin increase of $0.3 million in our Triferic Dialysate product in 2020. In comparison, the launch and sales of Triferic Dialysate occurred in the third quarter of 2019 and had no to minimal impact during the nine months ended September 30, 2019. Gross profits are primarily related to our concentrates business at this time. The Company anticipates that potential future sales of Triferic will impact the mix of future gross profits.

~~Selling and Marketing Expense~~

Selling and marketing expenses were $5.7 million during the nine months ended September 30, 2020, compared with $7.1 million during the nine months ended September 30, 2019. The decrease of $1.4 million is due primarily to the decrease in marketing costs of $2.2 million, partially offset by an increase in costs associated with hiring, training and educating new employees of $0.8 million. The fluctuation in these costs are mainly due to the timing of the Triferic Dialysate launch in the third quarter of 2019. We expect those costs to continue to level off quarter over quarter going forward.

~~General and Administrative Expense~~

General and administrative expenses were $11.8 million during the nine months ended September 30, 2020, compared with $16.3 million during the nine months ended September 30, 2019. The $4.5 million decrease was driven primarily by decreases to stock compensation, legal, recruiting and consulting fees, partially offset by an increase in labor costs. The decrease in stock compensation primarily relate to the resignation of our former President and Chief Executive Officer in April 2020 and former Chief Financial Officer effective July 2020.

~~Research and Product Development Expense~~

Research and product development expenses was $5.2 million for the nine months ended September 30, 2020, compared with $4.9 million during the nine months ended September 30, 2019, an increase of $0.3 million. Research and product development expenses for the nine months ended September 30, 2020 included clinical trials and other product development expenses of $1.8 million for Triferic, compared to $1.4 million during the nine months ended September 30, 2019. The Company is continuing to invest in its medical and scientific programs to support the global launch of Triferic and the advancement of our FPC technology platform.

~~Settlement Expense, net of Reimbursement~~

Settlement expense was nil for the nine months ended September 30, 2020, compared to $0.4 million in for the nine months ended September 30, 2019. Settlement expense for the nine months ended September 30, 2019 reflected the terms of the confidential settlement agreement and mutual release entered into in August 2018 relating to the Company’s former Chief Executive Officer, Robert Chioini, former Chief Financial Officer, Thomas Klema, and a former and then current director.

~~Other Income (Expense)~~

Other income for the nine months ended September 30, 2020 was $247,682, consisting of interest income of $239,594 and $8,088 of realized gains on investments. Other income for the nine months ended September 30, 2019 was $313,393, consisting of $289,101 of interest income and $24,292 of realized gains on investments. Other expense for the nine months ended September 30, 2020 was $2.1$1.5 million, consisting of warrant modification expense of $0.8 million and interest expense of ~~$1.3~~$0.6 million related to our debt ~~facility (see Note 15 for more information on our debt facility). Other expense for the nine months ended September 30, 2019 was $16,365 of interest expense.~~facility.

3230

Liquidity and Capital Resources

Since inception, Rockwell has incurred significant net losses and has funded its operations primarily through revenue from commercial products, proceeds from the issuance of debt and equity securities and payments from partnerships. At June 30, 2021, Rockwell had an accumulated deficit of approximately $353.6 million and stockholders' equity of $18.2 million. As of ~~September~~June 30, ~~2020, we~~2021, Rockwell had approximately ~~$67.3~~$41.0 million of cash, cash equivalents and investments available-for-sale, and working capital of ~~$65.2~~$18.4 million. Net cash used in operating activities for the ~~nine~~six months ended ~~September~~June 30, ~~2020~~2021 was approximately ~~$21.1~~$17.4 million.

On March 22, 2019, the Company entered into a sales agreement with Cantor Fitzgerald & Co. (the “Agent”), pursuant to which the Company may offer and sell from time to time shares of the Company’s common stock through the Agent up to $40.0 million. As of December 31, 2019, the Company sold 1,840,443 shares of its common stock pursuant to the Sales Agreement for gross proceeds of approximately $5.4 million, at a weighted average selling price of approximately $2.92. The Company paid approximately $0.3 million in commissions and offering fees related to the sale of the common stock.

During the nine months ended September 30, 2020, the Company sold 1,128,608 of shares of its common stock pursuant to the Sales Agreement with the Agent for proceeds of $2.3 million, net of issuance costs. As of September 30, 2020, approximately $32.3 million remains available for sale under this facility.

On February 4, 2020, the Company entered into an underwriting agreement with Cantor Fitzgerald & Co., as underwriter, pursuant to which the Company agreed to issue and sell up to 3,670,212 shares of its common stock, which included 478,723 shares optional shares that may be sold pursuant to an over-allotment option granted to the underwriters. On February 6, 2020, the Company closed the sale of 3,191,489 shares of its common stock at the public offering price of $2.22 per share. On February 19, 2020, the underwriter exercised its over-allotment option to purchase an additional 478,723 shares at a price of $2.22 per share, which closed on February 21, 2020. The Company raised a total of $8.0 million, net of issuance costs of $0.1 million, relating to the sale of the common stock in the offering. The offering was made pursuant to the Company’s effective Registration Statement on Form S-3 (File No. 333-227363), which was previously filed with the SEC.

On March 16, 2020, Rockwell Medical, Inc. and Rockwell Transportation, Inc., as Borrowers, entered into a Loan and Security Agreement (the "Loan Agreement") with Innovatus Life Sciences Lending Fund I, LP (“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 a second tranche of $5.0 million, which was tied to the achievement of certain milestones by a specified date. The Company may be eligible to draw on a third tranche of $7.5 million upon the achievement of certain additional milestones, including the achievement of certain Triferic sales thresholds. Net draw down proceeds were $21.2 million with closing costs of $1.3 million.

The Company is ~~entitled~~subject to ~~make interest-only payments for thirty months, or up to thirty-nine months if~~ certain ~~conditions are met. The Term Loans will mature on March 16, 2025~~covenants and ~~will bear 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 has the option,~~cure provisions 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. For the nine months ended September 30, 2020 and 2019, interest expense amounted to $1.3 million and $16,000, respectively.

~~The~~its Loan Agreement ~~is secured by all assets~~with Innovatus. As of the date of this report, the Company and Rockwell Transportation, Inc. Proceeds will be used for working capital purposes. The Loan Agreement contains customary representations and warranties and covenants, subject to customary carve outs, and includes financial covenants related to liquidity and trailing twelve months sales of Triferic, with the latter beginning with the period ending December 31, 2020. We cannot assure you that we can maintainis in compliance with the covenants under our Loan Agreement, which may result in an event of default. Our ability to comply with these covenants may be adversely affected by events beyond our control. For example, the Loan Agreement contains certain financial covenants relating to sales and, asall covenants. As a result of the ongoing COVID-19 pandemic and its effect on ~~our~~the Company's sales activities, among other factors, wethe Company may not be able to satisfy such covenants inover the ~~future. Based~~next 12 months. However, based on ~~our annualized Triferic sales through September~~the foregoing, the Company has classified amounts payable under the Loan Agreement as a current liability. If and when the Company reaches an agreement with Innovatus to avoid an event of default, the amounts payable under the Loan Agreement will be reclassified. The financial statements for June 30, ~~2020, we may not satisfy this covenant as~~2021, have been prepared with the assumption that the Company will be able to agree to an appropriate remedy during the applicable cure period for any future breaches of ~~December 31, 2020.~~operating covenants. If ~~we are~~the Company is unable to comply with the covenants under ~~our~~the Loan Agreement, ~~we intend to~~it would pursue all available cure options in order to regain compliance. However, we may not be able to mutually agree with Innovatus on appropriate remedies to cure a breach of a covenant, which could give rise to an event of default. If we are unable to avoid an event of default, any required repayments could have an adverse effect on our liquidity. As of September 30, 2020, the Company was in compliance ~~with all the reporting and financial covenants.~~

If the Company is unable to maintain compliance with the reporting and financial covenants in the future, the Company could experience an event of default under the Loan Agreement, which would negatively impact the Company’s liquidity. For more information, see the risk factor entitled “Our Loan Agreement with Innovatus contains certain covenants that could adversely affect our operations and, if an event of default were to occur, we could be forced to repay the outstanding indebtedness sooner than planned and possibly at a time when we do not have sufficient capital to meet this obligation. The occurrence of any of these events could cause a significant adverse impact on our business, prospects and share price.” in “Item 1A — Risk Factors.”

On September 23, 2020, the Company entered into a Securities Purchase Agreement with certain purchasers named therein, pursuant to which the Company agreed to issue and sell to several institutional and accredited investors in a registered direct offering 21,818,544 shares of common stock and warrants to purchase up to 23,178,809 shares of common stock (the “Warrants”) at a combined purchase price equal to $1.51 per share. Each Warrant is exercisable(See Note 15 for ~~one share of common stock at an exercise price of $1.80 per share. The Warrants are immediately exercisable and will expire on September 25, 2022.~~further detail).

Based on the equity and debt financing described above, 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~~expects it will require additional capital to sustain its operations and make the investments it needs to execute ~~upon~~ its ~~longer-term business~~strategic plan, including the ~~commercial launch and medical education programs~~commercialization of Triferic ~~Dialysate~~(dialysate) and Triferic AVNU in dialysis, generating additional data for Triferic in dialysis, developing FPC for iron deficiency anemia in patients undergoing home infusion and ~~the further~~for progressing our pipeline development program of ~~our~~new indications for its FPC ~~pipeline programs.~~platform. If the Company is unable to generate sufficient revenue from sales of its ~~existing long-term business plan,~~commercial products and from partnerships, the Company will need to obtain additional equity or debt financing. If the Company attempts to obtain additional debt or equity financing, the Company cannot assume that such financing will be available on favorable terms, if at all.

Based on the currently available working capital and managements assumption that the Company will be able to agree to an appropriate remedy, 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.

General

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 expenses and revenue associated with the commercial ~~launch of Triferic Dialysate~~operations in the United States and ~~Triferic AVNU;~~internationally (with partners); the timing and magnitude of cash received from drug product sales; ~~and~~ the timing and expenditures associated with the development of Triferic for international markets; the timing and expenditures associated with the development of further innovative administration techniques of Triferic for dialysis patients; the timing and expenditures associated with the development ofprograms including our FPC technology for ~~patients with iron-deficiency anemia in other disease states;~~home infusion and potentially acute heart failure; the costs associated with ~~ongoing litigation~~our manufacturing and ~~investigatory matters.~~ transportation operations related to our concentrate business; any potential accelerated amortization under the Loan Agreement in the event of a failure to satisfy operating covenants..

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 that we will be able to secure additional capital or funding on acceptable terms, ofor if at all; and (ii) strategic transactions, including potential alliances and collaborations focused on markets outside the ~~U.S.,~~United States, as well as potential combinations (including by merger or acquisition) or other corporate transactions. In particular, our Baxter Agreement prohibits us from entering into a contract that would encumber the assets used in our concentrate business without the prior written consent of Baxter. Due to the fact that the assets used in our concentrate business currently constitute a substantial portion of the tangible assets we own other than our drug inventory, we may not be able to, or we may find it difficult, to obtain secured debt financing without the consent of Baxter.

We believe that our ability to fund our activities in the long term will be highly dependent upon 1) our ability to ~~successfully launch~~execute on the development of the FPC platform for new therapies, and 2) our ability to commercialize and increase adaptation of Triferic ~~Dialysate~~(dialysate) and Triferic AVNU. ~~Our commercialization~~Both of ~~Triferic Dialysate and Triferic AVNU~~these strategies is subject to significant risks and uncertainties ~~including risks~~such that there can be no assurance that we will be successful is achieving approval of FPC in ~~the commercialization of~~a new therapeutic area or that we will be able to have sustained commercial success with Triferic ~~in accordance with~~(dialysate) and Triferic AVNU. If our ~~plans. If~~planned clinical program is delayed or fails or if our commercialization of Triferic ~~Dialysate~~(dialysate) and/or Triferic AVNU should ~~be delayed for any reason or not proceed in accordance with our plans,~~fail to increase sales, we may be forced to implement cost-saving measures that may potentially have a negative impact on our activities and potentially the results of our research and development programs. ~~If our launch~~Even though we began commercialization of Triferic ~~Dialysate and/or~~(dialysate) and Triferic AVNU ~~is unsuccessful or our commercial launch does not proceed~~ as planned, if the results are unsuccessful, we may be unable to secure the additional capital that we will require to continue our

research and development activities and operations, which could have a material adverse effect on our business. If we are unable to raise the required capital, we may be ~~required~~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.

Cash Used in Operating Activities

Net cash used in operating activities was ~~$21.1~~$17.4 million for the ~~nine~~six months ended ~~September~~June 30, ~~2020. The net loss for this period was higher than~~2021 compared to net cash used in operating activities ~~by $1.1 million, which was primarily attributable to non-cash expenses~~ of $2.8 million, consisting primarily of $1.1 million of amortization of the right to use assets, $0.8 million of warrant modification expense, $0.6 million of depreciation and amortization, ($0.3) million of stock-based compensation and a ($1.6) million net change in assets and liabilities.

~~Net cash used in operating activities was $22.0~~$16.2 million for the ~~nine~~six months ended ~~September~~June 30, ~~2019.~~2020. The ~~net loss for this~~increase in cash used from operating activities during the current period was ~~higher than~~primarily due to changes in current balance sheet accounts in the ordinary course of business of approximately $3.0 million, including an increase in net ~~cash used in operating activities by $4.9~~accounts receivable of $1.2 million which was primarily attributable to non-cash expenses of $7.2 million, consisting of $3.9 million of stock-based compensation, $1.4 million of amortization of the right to use assets, $0.6 million of depreciation and amortization, and a ~~($2.3) million net change~~reduction in ~~assets~~accounts payable and ~~liabilities.~~accrued expense of approximately $0.4 million. Overall, our cash burn for the six months ended June 30, 2021 was in line with our expectations, and we continue to expect, in aggregate, 2021 cash burn to be lower than 2020 cash burn.

Cash Provided by ~~(Used In)~~ Investing Activities

Net cash provided by investing activities was ~~$2.6~~$1.1 million during the ~~nine~~six months ended ~~September~~June 30, 2021 compared to net cash provided by investing activities of $0.7 million for the six months ended June 30, 2020. The net cash provided by investing activities during the six months ended June 30, 2021 was primarily due to ~~the~~ sales and purchase of ~~our~~ available-for-sale investments ~~of $27.1 million, offset by $23.5 million used for the purchase of investments available-for-sale and $1.0 million for the purchase of equipment.~~

~~Net used in investing activities was $4.9 million~~ during the nine months ended September 30, 2019. The cash used was primarily due to the purchase of our available-for-sale investments of $30.5 million, offset by $34.2 million provided by the sale of investments available-for-sale, $0.8 million for the purchase of research and development licenses acquired from a related party and $0.4 million for the purchase of equipment.quarter.

Cash (Used in) Provided by Financing Activities

Net cash used in financing activities was $6,000 during the six months ended June 30, 2021 compared to the net cash provided by financing activities ~~was $63.3~~of $30.4 million ~~during~~for the ~~nine~~six months ended ~~September~~June 30, 2020. The net cash provided during the six months ended June 30, 2020 was primarily due to net proceeds of $21.2 million related to ~~the Loan Agreement and $40.7 million and $2.3 million~~proceeds from the ~~sale of our common stock, related to our public offerings~~debt facility and ~~our at-the market offering, respectively.~~

~~Net cash provided by financing activities was $18.6 million during the nine months ended September 30, 2019. The net cash provided was primarily due to net proceeds of $17.3 million and $2.1~~$8.0 million from the sale of our common stock, related to our public offering, ~~and our at-the market offering, respectively.~~offset by $0.8 million for payments on short term notes.

COVID-19 Impact

The COVID-19 pandemic and resulting global disruptions have adversely affected our business and operations, including, but not limited to, our sales and marketing efforts and our research and development activities, and the operations of third parties upon whom we rely. Quarantines, shelter-in-place, executive and similar government orders may negatively impact our sales and marketing activities, particularly if our sales representatives are unable to interact with current and potential customers to the same extent as before onset of the COVID-19 pandemic. ~~Depending on~~The Company's international business development activities may also continue to be negatively impacted by COVID-19, especially with the ~~severity of the impact on our sales~~recent surge in infections internationally, ongoing international travel restrictions and ~~marketing efforts, the timing of our commercial launch of Triferic AVNU could be adjusted.~~quarantines or shelter-in-place orders.

The COVID-19 pandemic and resulting global disruptions have caused significant volatility in financial and credit markets. We have utilized a range of financing methods to fund our operations in the past; however, current conditions in the financial and credit markets may limit the availability of funding 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 our liquidity and capital resources in the future.

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, ~~2019.~~2020. Our critical accounting policies and significant estimates have not changed from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, ~~2019, except for those subjects mentioned in the section of the notes to the condensed consolidated financial statements titled Adoption of Recent Accounting Pronouncements.~~2020.

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 of the condensed consolidated financial statements at ~~September~~June 30, ~~2020.~~2021.

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

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 that are designed to ensure material information required to be disclosed in our reports that 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 that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required financial disclosure. In designing and evaluating the disclosure controls and procedures, we recognized that a control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that 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 necessarily 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 and Chief Financial 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~~June 30, ~~2020.~~2021. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were ~~not~~ effective as of ~~September~~June 30, ~~2020.~~

The material weaknesses related to change management and third-party management controls, user access security and segregation of duties as it relates to user access controls in our Information Technology General Controls ("ITGC"), described in our Annual Report on Form 10-K for the year ended December 31, 2019, have been remediated. The Company is still evaluating the design, implementation and operating effectiveness of the pervasive effect on other ITGC dependent business activity level internal control cycles, which has not been remediated. Notwithstanding the material weaknesses, the Company’s management, including the Chief Executive Officer and Chief Financial Officer (Principal Financial Officer), have concluded that the condensed consolidated financial statements as of September 30, 2020, are fairly stated, in all material respects, in accordance with generally accepted accounting principles in the United States for each of the periods presented herein.

In connection with the pervasive effect of the ITGC material weaknesses, management has taken a number of steps with the intention of remediating the above control deficiencies. We continue to implement enhanced procedures and controls to remediate the pervasive impact of our material weaknesses in internal control over financial reporting. 2021.

Changes in Internal Control over Financial Reporting

~~Our management is responsible for establishing and maintaining adequate internal control over financial reporting. We maintain~~There were no changes in our internal control over financial reporting designed to provide reasonable, but not absolute, assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.

We continue to make further improvements to our internal controls over financial reporting, in addition to the improvements developed in 2019. During the quarter ended June 30, 2020, the Company remediated the ITGC control deficiencies in connection with change management and third-party management and enhanced evidentiary review and documentation of key ITGC controls and implemented new programs and policies to provide improved control over change management and third-party management controls to the ~~ERP system.~~

~~During the quarter ended September 30, 2020, we continued our improvements~~evaluation required by ~~remediating the ITGC control deficiencies in connection with user access security and segregation of duties as it relates to user access controls.~~

~~We also continued to make progress on our 2020 audit program, utilizing a National Audit firm as our internal audit partner, which includes in-house remediation testing~~Rule 13a-15(d) of the ~~pervasive impact~~Exchange Act that occurred during the period covered by this Quarterly Report on ~~other ITGC dependent business activity level internal control cycles.~~

~~The remediation of the material weaknesses is among~~Form 10-Q that have materially affected, or are reasonably likely to materially affect, our highest priorities. Our Audit Committee continually assesses the progress and sufficiency of these initiatives and make adjustments as and when necessary. As of the date of this report, our management believes that our efforts, when completed, will remediate the material weaknesses in internal control over financial reporting. However, there can be no assurance that our efforts will result in remediation of the material weaknesses in internal control over financial reporting.

PART II – OTHER INFORMATION

Item 1. Legal Proceedings

The disclosure set forth above in Note 14 (Commitments and Contingencies – Litigation) to our unaudited condensed consolidated financial statements is incorporated herein by reference.

Additionally, we ~~are~~may be involved in certain ~~other~~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 that are 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

~~Other than those set forth below, there~~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, ~~2019~~2020 under “Item 1A — Risk Factors.”

~~We have limited capital resources and will likely need additional funding before we are able to achieve profitability~~. ~~If we are unable to raise additional capital on attractive terms, or at all, we may be unable to sustain our operations.~~

We have limited capital resources, a cumulative deficit of approximately $328.7 million since inception and expect to incur further losses for the foreseeable future. As of September 30, 2020, we had approximately $67.3 million of cash, cash equivalents and investments available-for-sale, and working capital of $65.2 million. Net cash used in operating activities for the nine months ended September 30, 2020 was approximately $21.1 million.

On March 22, 2019, the Company entered into a sales agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (the “Agent”), pursuant to which the Company may offer and sell from time to time up to $40.0 million of shares of the Company’s common stock through the Agent. As of December 31, 2019, the Company sold 1,840,443 shares of its common stock pursuant to the Sales Agreement for gross proceeds of $5.4 million, at a weighted average selling price of approximately $2.92. The Company paid $0.3 million in commissions and offering fees related to the sales. During the nine months ended September 30, 2020, the Company sold 1,128,608 of shares of its common stock pursuant to the Sales Agreement with the Agent for proceeds of $2.3 million, net of issuance costs. As of September 30, 2020, approximately $32.3 million remains available for sale under this facility.

stock, which included 478,723 optional shares that may be sold pursuant to an over-allotment option granted to the underwriters. On February 6, 2020, the Company closed the sale of 3,191,489 shares of its common stock at the public offering price of $2.22 per share (the “Offering”). On February 19, 2020, the underwriter exercised its over-allotment option to purchase an additional 478,723 shares at a price of $2.22 per share, which closed on February 21, 2020. The Company raised a total of $8.0 million, net of issuance costs of $0.1 million, relating to the sale of the common stock in the Offering.

On March 16, 2020, Rockwell Medical, Inc. and Rockwell Transportation, Inc., as Borrowers, entered into a Loan and Security Agreement (the "Loan Agreement") with Innovatus Life Sciences Lending Fund I, LP, 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 a second tranche of $5.0 million, which was tied to the achievement of certain milestones by a specified date. The Company may be eligible to draw on a third tranche of $7.5 million upon the achievement of certain additional milestones, including the achievement of certain Triferic sales thresholds. Net draw down proceeds were $21.2 million with closing costs of $1.3 million.

The Company is entitled to make interest-only payments for thirty months, or up to thirty-six months if certain conditions are met. The Term Loans will mature on March 16, 2025, and will bear 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 has 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. 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 includes financial covenants related to liquidity and trailing twelve months sales of Triferic, with the latter beginning with the period ending December 31, 2020. We cannot assure you that we can maintain compliance with the covenants under our Loan Agreement, which may result in an event of default. Our ability to comply with these covenants may be adversely affected by events beyond our control. For example, the Loan Agreement contains certain financial covenants relating to sales and, as a result of the ongoing COVID-19 pandemic and its effect on our sales activities, among other factors, we may not be able to satisfy such covenants in the future. Based on our annualized Triferic sales through September 30, 2020, we may not satisfy this covenant as of December 31, 2020. If we are unable to comply with the covenants under our Loan Agreement, we intend to pursue all available cure options in order to regain compliance. However, we may not be able to mutually agree with Innovatus on appropriate remedies to cure a breach of a covenant, which could give rise to an event of default. If we are unable to avoid an event of default, any required repayments could have an adverse effect on our liquidity. As of September 30, 2020, the Company was in compliance with all reporting and financial covenants.

On September 23, 2020, the Company entered into a Securities Purchase Agreement with certain purchasers named therein, pursuant to which the Company agreed to issue and sell to several institutional and accredited investors in a registered direct offering 21,818,544 shares of its common stock and warrants to purchase up to 23,178,809 shares of its common stock (the “Warrants”) at a combined purchase price equal to $1.51 per share. Each Warrant is exercisable for one share of common stock at an exercise price of $1.80 per share. The Warrants are immediately exercisable and will expire on September 25, 2022.

The Company also offered to certain purchasers pre-funded warrants to purchase up to an aggregate of 1,360,265 shares of common stock (the “Pre-Funded Warrants”), in lieu of shares of common stock. The purchase price of each Pre-Funded Warrant is equal to the price at which a share of common stock is sold to the public in the offering, minus $0.001, and the exercise price of each Pre-Funded Warrant is $0.001 per share. The Pre-Funded Warrants were exercised at the same time as the issuance of common stock under the Securities Purchase Agreement. The Company received gross proceeds of approximately $35.0 million in connection with the offering, before deducting placement agent fees and related offering expenses of approximately $2.3 million.

Based on the equity offerings and the Loan Agreement described above, 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 will require additional capital to sustain its operations and make the investments it needs to execute upon its longer-term business plan, including the current launch of Triferic Dialysate and Triferic AVNU. If the Company is unable to generate sufficient revenue from its existing long-term business plan, the Company will need to obtain additional equity or debt financing. If the Company attempts to obtain additional debt or equity financing, the Company cannot assume that such financing will be available on favorable terms, if at all.

Our near-term success depends substantially on the commercialization of Triferic Dialysate and Triferic AVNU. Although Triferic Dialysate and Triferic AVNU have been approved by the FDA, we may not be able to commercialize either product successfully.

Triferic Dialysate launched commercially in the United States in May 2019 and Triferic AVNU was approved by the FDA in March 2020; however, it is possible that either version of Triferic will not gain market acceptance and that we will not be successful in the commercialization of these products. We do not know whether we will be able to successfully implement our commercialization strategy for Triferic Dialysate and Triferic AVNU or whether our new business strategy will ultimately be successful.

Both formulations of Triferic will be reimbursed “within the bundle,” which means that dialysis providers will not receive any additional amount of reimbursement from Medicare or Medicaid to compensate them for the cost of purchasing and administering Triferic. This reimbursement status may result in a slower rate of commercial adoption, as we must work to show dialysis providers that improved patient outcomes, the reduction of utilization in other therapies and the resulting savings offset the costs associated with Triferic. Additionally, Triferic competes against current anemia therapies (including intravenous iron and the ESA class of drugs) and possibly other future products. Additionally, it may be difficult to gain market acceptance from dialysis chains, anemia managers and nephrologists and such acceptance may be slower than expected, if at all.

Market acceptance will depend on a number of factors, such as demonstration of Triferic Dialysate’s safety and efficacy, cost-effectiveness, and advantages over existing products. Other factors that may impact the commercial success and ultimate profitability of Triferic include:

•~~the rate of adoption of Triferic Dialysate and Triferic AVNU relative to the shelf life of the existing inventory that we have on hand and whether we can sell our existing inventory before it expires;~~

•~~our ability to manage inventory available for commercial sale;~~

•~~the effectiveness of our marketing, sales and distribution strategies and operations for development and commercialization;~~

•~~the impact of Triferic Dialysate and Triferic AVNU on established customer protocols, formularies, administration methods and operational practices;~~

•~~The ability and willingness of dialysis centers to adopt their protocols and utilize the drugs in a manner consistent with state regulatory agencies.~~

•~~reimbursement of either formulation of Triferic by government and commercial payors;~~

•~~our ability to execute our marketing strategy without significant additional expenditures;~~

•~~our competitors’ activities, including aggressive marketing and pricing practices and other tactics to retain their market share;~~

•~~our ability to successfully assert our patents against potential competitors who may seek to introduce generic versions of either formulation of Triferic;~~

•our ability to comply with ongoing regulatory requirements applicable to either formulation of Triferic and the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping applicable to Triferic;

•~~the impact of certain royalties related to our sale of either formulation of Triferic paid by us based on the profitability of either formulation of Triferic;~~

•~~our ability to avoid third party patent interference or patent infringement claims;~~

•~~our ability to maintain a continued acceptable safety profile of either formulation of Triferic;~~

•the discovery of previously unknown problems with either formulation of Triferic or with any third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements; and

•~~the ability to successfully manufacture enough commercial product and successfully complete our commercialization planning to enable a launch of Triferic AVNU in 2020.~~

An adverse development with respect to any of the foregoing may have a material adverse effect on our ability to manufacture and market either formulation of Triferic. We cannot assure you that we will be able to generate meaningful and sustained revenues through the sale of either formulation of Triferic. If we are not successful in commercializing either formulation of Triferic, or are significantly delayed in doing so, our entire investment in Triferic may be of no value, our inventory of finished product may expire or become obsolete (resulting in write-offs of such inventory), our licensing rights could be materially adversely affected and the price of our common stock could substantially decline. Even if we are successful in commercializing either formulation of Triferic, since the market is highly concentrated with two significant suppliers, our continued success may depend on adoption of Triferic Dialysate by the limited number of existing dialysis providers.

The ongoing COVID-19 pandemic may result in significant disruptions to our business operations, including the commercial launch of our Triferic products and our clinical trials, which could have a material adverse effect on our business.

Our business and its operations, including but not limited to our sales and marketing efforts and our research and development activities, could be adversely affected by health epidemics in regions where we have business operations, and such health epidemics could cause significant disruption in the operations of third parties upon whom we rely. In December 2019, a novel strain of coronavirus, SARS-CoV-2, causing a disease referred to as COVID-19, was reported to have surfaced in Wuhan, China. Since then, COVID-19 has spread to other countries, including the United States, and has been declared a pandemic by the World Health Organization. In response to public health directives and orders related to COVID-19, we have implemented work-from-home policies for substantially all employees, excluding our essential manufacturing and distribution employees. The effects of executive and similar government orders, shelter-in-place orders and our work-from-home policies may negatively impact our growth and productivity, disrupt our business, including our sales and marketing activities, and delay our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition.

Quarantines, shelter-in-place, executive and similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could occur, related to COVID-19 or other infectious diseases, may impact personnel at our manufacturing facilities and third-party manufacturing facilities in the United States, Europe and other countries, or the availability or cost of materials we use or require to conduct our business, including product development, which would disrupt our supply chain. If the COVID-19 pandemic were to negatively affect our manufacturing facilities, the costs related to such manufacturing may increase and the productivity of our facilities may decrease. Furthermore, some of our manufacturers and suppliers are in Europe and may be impacted by port closures and other restrictions resulting from the COVID-19 pandemic, which may disrupt our supply chain or limit our ability to obtain sufficient materials for our drug products.

We commercially launched Triferic Dialysate in the United States in May 2019 and we began recruiting clinics to participate in a sample evaluation program for Triferic AVNU during the third quarter of 2020 in order to prepare for a commercial launch. Quarantines, shelter-in-place, executive and similar government orders, or changes in prospective customer practices in response to the COVID-19 outbreak, may negatively impact our sales and marketing activities, particularly if our sales representatives are unable to interact with current and potential customers to the same extent as before onset of the COVID-19 pandemic. Depending on the severity of the impact on our sales and marketing efforts, the commercial launch of Triferic AVNU could be delayed.

In addition, we may face decreased demand if our dialysis patients are unable to travel to dialysis clinics or if dialysis clinics are unable to make additional protocol changes that are required for Triferic. In order to ensure the safety of patients and staff at the dialysis clinics that use our Triferic products, we expect the dialysis clinics will implement a number of changes to their safety procedures. In addition, the dialysis clinics may face challenges related to decreased staffing, if staff members are affected by COVID-19. Changes to safety procedures and/or staffing issues may impede the clinics’ ability to make additional protocol changes that are required for Triferic.

In addition, our clinical trials and our partners’ clinical trials have been and may continue to be affected by the COVID-19 pandemic. For example, Wanbang is our commercialization partner for both Triferic Dialysate and Triferic AVNU in China and we currently expect Wanbang to initiate additional clinical studies during 2020 that are necessary to support a submission for regulatory approval in China. Such clinical studies may be delayed to later in 2020 than previously expected. In addition, meetings between Sun Pharma and the regulatory authorities in India related to our Triferic products have been postponed due to government restrictions in India. Lastly, meetings between Jeil Pharma and the regulatory authorities in South Korea could be postponed due to potential government restrictions in South Korea. If COVID-19 continues to spread in the United States and elsewhere, we or our partners may experience additional disruptions that could severely impact our business and clinical trials, including:

•~~delays in receiving authorization from local regulatory authorities to initiate our planned clinical trials;~~

•~~delays in receiving legalization documents from foreign embassies, which are required to allow our partners to direct activities on behalf of the Company in local markets;~~

•~~delays or difficulties in enrolling patients in our clinical trials;~~

•~~delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;~~

•delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials, including interruption in global shipping that may affect the transport of clinical trial materials;

•changes in local regulations as part of a response to the COVID-19 pandemic which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;

•diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

•interruption of key clinical trial activities, such as clinical trial site monitoring and data entry and verification, due to limitations on travel imposed or recommended by federal or state governments, employers and others, or interruption of clinical trial subject visits and study procedures, the occurrence of which could affect the completeness and integrity of clinical trial data and, as a result, determine the outcomes of the trial;

•risk that participants enrolled in our clinical trials will acquire COVID-19 while the clinical trial is ongoing, which could impact the results of the clinical trial, including by increasing the number of observed adverse events;

•~~risk that participants enrolled in our clinical trials will not be able to travel to our clinical trial sites as a result of quarantines or other restrictions resulting from COVID-19;~~

•~~risk that participants enrolled in our clinical trials will not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services;~~

•~~interruptions or delays in preclinical studies due to restricted or limited operations at our research and development laboratory facilities;~~

•delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;

•limitations in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;

•~~refusal of the FDA to accept data from clinical trials in affected geographies; and~~

•~~interruption or delays to our clinical activities.~~

The spread of COVID-19, which has caused a broad impact globally, may materially affect us economically. While the potential economic impact brought by COVID-19, and the duration of such impact, may be difficult to assess or predict, the widespread pandemic has resulted in significant disruption of global financial markets, which could reduce our ability to access capital and negatively affect our future liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 and related government orders and restrictions could materially affect our business and the value of our common stock.

The COVID-19 pandemic continues to evolve rapidly. The ultimate impact of the COVID-19 pandemic or a similar public health emergency is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, our clinical trials, healthcare systems, or the global economy as a whole. However, any one or a combination of these events could have an adverse effect on the operation of and results from our clinical trials and on our other business operations, which could negatively impact our business, operating results and financial condition.

The risks related to the ongoing COVID-19 pandemic may amplify the other risk factors described in this “Item 1A — Risk Factors” and in the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019.

Our Loan Agreement with Innovatus contains certain covenants that could adversely affect our operations and, if an event of default were to occur, we could be forced to repay the outstanding indebtedness sooner than planned and possibly at a time when we do not have sufficient capital to meet this obligation. The occurrence of any of these events could cause a significant adverse impact on our business, prospects and share price.

Pursuant to the Loan Agreement, we have pledged substantially all of our assets and the assets of our subsidiary, Rockwell Transportation, Inc., and have agreed that we may not sell or assign rights to our patents and other intellectual property without the prior consent of Innovatus. Additionally, the Loan Agreement contains affirmative, including financial covenants related to liquidity and trailing twelve months sales of Triferic, and negative covenants that, among other things, restrict our ability to:

•~~incur additional indebtedness;~~

•~~grant liens;~~

•~~make distributions, including dividends;~~

•~~enter into a merger or consolidation;~~

•~~alter the business of the Company; or~~

•~~sell all or a portion of the Company’s property, business or assets.~~

These terms of the Loan Agreement could prevent us from taking certain actions without the consent of our lenders, which may limit our flexibility in operating our business and our ability to take actions that might be advantageous to us and our stockholders, placing us at a competitive disadvantage compared to our competitors who have less leverage and who therefore may be able to take advantage of opportunities that our leverage prevents us from exploiting. These covenants could also limit our ability to make needed capital expenditures or otherwise conduct necessary or desirable business activities.

We cannot assure you that we can maintain compliance with the covenants under our Loan Agreement, which may result in an event of default. Our ability to comply with these covenants may be adversely affected by events beyond our control. For example, the Loan Agreement contains certain financial covenants relating to sales and, as a result of the ongoing

COVID-19 pandemic and its effect on our sales activities, among other factors, we may not be able to satisfy such covenants in the future. Based on our annualized Triferic sales through September 30, 2020, we may not satisfy this covenant as of December 31, 2020. If we are unable to comply with the covenants under our Loan Agreement, we intend to pursue all available cure options in order to regain compliance. However, we may not be able to mutually agree with Innovatus on appropriate remedies to cure a breach of a covenant, which could give rise to an event of default.

The Loan Agreement also includes customary events of default, including, among other things, a change of control or a failure to comply with certain of the covenants in the Loan Agreement. Upon the occurrence and continuation of an event of default, all amounts due under the Loan Agreement become (in the case of a bankruptcy event), or may become (in the case of all other events of default and at the option of Innovatus), immediately due and payable.

If an event of default under the Loan Agreement should occur, we could be required to immediately repay the outstanding indebtedness. If we are unable to repay this debt, the lenders would be able to foreclose on the secured collateral, including our cash accounts, and take other remedies permitted under the Loan Agreement. Even if we are able to repay the indebtedness on an event of default, the repayment of these sums may significantly reduce our working capital and impair our ability to operate as planned. The occurrence of any of these events could cause a significant adverse impact on our business and financial condition.

~~We do not anticipate paying dividends in the foreseeable future.~~

Since inception, we have not paid any cash dividends on our common stock and do not anticipate paying such dividends in the foreseeable future. In addition, the terms of our Loan Agreement with Innovatus restrict our ability to pay dividends to limited circumstances. As a result, investors in our common stock may only receive a return if the market price of our common stock increases.

The payment of dividends is within the discretion of our Board of Directors, subject to the restrictions in the Loan Agreement, and depends upon our earnings, capital requirements, financial condition and requirements, future prospects, restrictions in future financing agreements, business conditions and other factors deemed relevant by the Board. We intend to retain earnings and any cash resources to finance our operations. Therefore, it is highly unlikely we will pay cash dividends.

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

None.

Item 3. Defaults Upon Senior Securities.

ROCKWELL MEDICAL, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

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

~~4.1~~						~~Form of Warrant (filed with the SEC as Exhibit 4.1 to the Company's Form 8-K filed on September 25, 2020)~~

~~4.2~~						~~Form of Pre-Funded Warrant (filed with the SEC as Exhibit 4.2 to the Company's Form 8-K filed on September 25, 2020)~~

~~10.1#~~						~~Russell Skibsted Employment Agreement, dated September 15, 2020 (filed with the SEC as Exhibit 10.1 to the Company’s Form 8-K filed on September 16, 2020)~~

~~10.2#~~						~~Securities Purchase Agreement dated September 23, 2020 (filed with the SEC as Exhibit 10.1 to the Company’s Form 8-K filed on September 25, 2020)~~

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

31.2*						Certification of Chief Financial Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934

32.1#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~~June 30, ~~2020,~~2021, 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
#						~~Indicates management contracts or compensatory plans or arrangements.~~

4434

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 9, 2020~~August 16, 2021		/s/ Russell Ellison
		Russell Ellison Chief Executive Officer (Principal Executive Officer)


Date: ~~November 9, 2020~~August 16, 2021		/s/ Russell Skibsted
		Russell Skibsted Chief Financial Officer (Principal Financial Officer)

4535


	Number of Shares	Weighted Average Exercise Price
Outstanding at January 1, 2019	388,125	$	4.70
Outstanding at September 30, 2019	388,125	$	4.70

Exercisable at September 30, 2019	0	$	0


	For the Nine Months Ended September 30,
	2020		% of Revenue		2019		% of Revenue		% Change

Net Sales	$	47,033			$	45,812			2.7	%
Cost of Sales	44,693		95.0	%	44,085		96.2	%	1.4
Gross Profit	2,340		5.0		1,727		3.8		35.5

Selling and Marketing	5,738		12.2		7,149		15.6		(19.7)
General and Administrative	11,767		25.0		16,341		35.7		(28.0)
Settlement Expense, net of Reimbursement	—		—		430		0.9		(100.0)
Research and Product Development	5,183		11.0		4,930		10.8		5.1

Operating Loss	$	(20,348)	(43.3)	%	$	(27,123)	(59.2)	%	(25.0)	%