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United States
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
__________________________________________________
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2022
or
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)
Delaware38-3317208
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
30142 S. Wixom Road, Wixom, Michigan
48393
(Address of principal executive offices)(Zip Code)
(248) 960-9009
(Registrant’s telephone number, including area code)


(Former name, former address and former fiscal year,
if changed since last report)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.   Yes      No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes      No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filerAccelerated filer
Non-accelerated filerSmaller reporting company
 Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes 
  No
Securities registered pursuant to Section 12(b) of the Act:
Title of each class:Trading SymbolName of each exchange on which registered:
Common Stock, par value $0.0001RMTI
Nasdaq Capital Market
The number of shares of common stock outstanding as of November 11, 2022 was 11,632,673.



Rockwell Medical, Inc. and Subsidiaries
Index to Form 10-Q
Page
2


PART I – FINANCIAL INFORMATION
Item 1.  Financial Statements
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Dollars In Thousands)
September 30,
2022
December 31,
2021
(Unaudited)
ASSETS
Cash and Cash Equivalents$12,980 $13,280 
Investments Available-for-Sale14,584 9,158 
Accounts Receivable, net7,367 5,913 
Inventory, net5,020 4,076 
Prepaid and Other Current Assets2,407 2,861 
Total Current Assets42,358 35,288 
Property and Equipment, net2,264 2,486 
Inventory, Non-Current1,193 1,523 
Right of Use Assets, net6,928 7,737 
Goodwill921 921 
Other Non-Current Assets522 619 
Total Assets$54,186 $48,574 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts Payable$3,051 $3,739 
Accrued Liabilities5,887 5,090 
Lease Liability - Current1,992 2,004 
Deferred License Revenue - Current2,164 2,171 
Term Loan - Net of Issuance Costs5,131 7,381 
Insurance Financing Note Payable1,006 437 
Customer Deposits107 144 
Total Current Liabilities19,338 20,966 
Lease Liability - Long-Term5,171 5,887 
Term Loan, Net of Issuance Costs8,962 13,186 
Deferred License Revenue - Long-Term4,565 5,986 
Long Term Liability - Other14 14 
Total Liabilities38,050 46,039 
Stockholders’ Equity:
Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; 15,000 and nil shares issued and outstanding at September 30, 2022 and December 31, 2021
  
Common Stock, $0.0001 par value; 170,000,000 shares authorized; 11,152,673 and 8,544,225 shares issued and outstanding at September 30, 2022 and December 31, 2021
1 1 
Additional Paid-in Capital402,480 372,562 
Accumulated Deficit(386,399)(370,080)
Accumulated Other Comprehensive Income54 52 
Total Stockholders’ Equity16,136 2,535 
Total Liabilities and Stockholders’ Equity$54,186 $48,574 
The accompanying notes are an integral part of the condensed consolidated financial statements.
3


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Shares and Per Share Amounts)
Three Months Ended September 30, 2022Three Months Ended September 30, 2021Nine Months Ended September 30, 2022Nine Months Ended September 30, 2021
Net Sales$18,691 $15,988 $53,497 $46,599 
Cost of Sales17,914 16,317 51,760 46,788 
Gross Profit (Loss)777 (329)1,737 (189)
Research and Product Development469 1,221 2,963 5,445 
Selling and Marketing762 1,541 1,743 4,860 
General and Administrative3,254 3,881 11,845 11,483 
Operating Loss(3,708)(6,972)(14,814)(21,977)
Other (Expense) Income
Realized Gain on Investments  4 (1)
Interest Expense(476)(609)(1,497)(1,772)
Interest Income(6) (10)17 
Total Other Expense(482)(609)(1,503)(1,756)
Net Loss$(4,190)$(7,581)$(16,317)$(23,733)
Basic and Diluted Net Loss per Share$(0.40)$(0.89)$(1.75)$(2.79)
Basic and Diluted Weighted Average Shares Outstanding10,528,148 8,534,740 9,299,788 8,520,603 
The accompanying notes are an integral part of the condensed consolidated financial statements.
4


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In Thousands)
Three Months Ended September 30, 2022Three Months Ended September 30, 2021Nine Months Ended September 30, 2022Nine Months Ended September 30, 2021
Net Loss$(4,190)$(7,581)$(16,317)$(23,733)
Unrealized Gain (Loss) on Available-for-Sale Debt Instrument Investments5 4 5 (4)
Foreign Currency Translation Adjustments  (3)3 
Comprehensive Loss$(4,185)$(7,577)$(16,315)$(23,734)
The accompanying notes are an integral part of the condensed consolidated financial statements.
5


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
(Dollars in Thousands)
PREFERRED STOCKCOMMON STOCKADDITIONAL PAID-IN CAPITALACCUMULATED
DEFICIT
ACCUMULATED
OTHER
COMPREHENSIVE
INCOME
TOTAL
STOCKHOLDERS'
 (DEFICIT)
SHARESAMOUNTSHARESAMOUNT
Balance as of January 1, 2022 $ 8,544,225 $1 $372,562 $(370,080)$52 $2,535 
Net Loss— — — — — (7,162)— (7,162)
Foreign Currency Translation Adjustments— — — — — — (1)(1)
Stock-based Compensation— — — — (179)— — (179)
Balance as of March 31, 2022 $ 8,544,225 $1 $372,383 $(377,242)$51 $(4,807)
Net Loss— — — — — (4,967)— (4,967)
Foreign Currency Translation Adjustments— — — — — — (2)(2)
Issuance of common stock, net of offering costs/Public Offering— — 844,613 — 14,893 — — 14,893 
Issuance of common stock, net of offering costs/At-the-Market Offering— — 7,500 — 15 — — 15 
Issuance of preferred stock, net of offering costs15,000 — — — 14,916 — — 14,916 
Vesting of Restricted Stock Units Issued, net of taxes withheld— — 10,958 — — — — — 
Stock-based Compensation and modification expense— — — — 97 — — 97 
Balance as of June 30, 202215,000 $ 9,407,296 $1 $402,304 $(382,209)$49 $20,145 
Net Loss— — — — — (4,190)— (4,190)
Unrealized Gain on Available-for-Sale Investments— — — — — — 5 5 
Issuance of common stock, net of offering costs/Public Offering— 1,745,377 — — — — — 
Stock-based Compensation expense— — — — 176 — — 176 
Balance as of September 30, 202215,000 $ 11,152,673 $1 $402,480 $(386,399)$54 $16,136 

    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)
PREFERRED STOCKCOMMON STOCKADDITIONAL PAID-IN CAPITALACCUMULATED
DEFICIT
ACCUMULATED
OTHER
COMPREHENSIVE
INCOME
TOTAL
STOCKHOLDERS'
EQUITY
SHARESAMOUNTSHARESAMOUNT
Balance as of January 1, 2021 $ 8,506,651 $1 $371,518 $(337,406)$57 $34,170 
Net Loss— — — — — (7,752)— (7,752)
Unrealized Loss on Available-for-Sale Investments— — — — — — (7)(7)
Foreign Currency Translation Adjustments— — — — — — 3 3 
Stock-based Compensation— — 2,396 — (236)— — (236)
Balance as of March 31, 2021 $ 8,509,047 $1 $371,282 $(345,158)$53 $26,178 
Net Loss— — — — — (8,400)— (8,400)
Unrealized Loss on Available-for-Sale Investments— — — — — — (1)(1)
Vesting of Restricted Stock Units Issued, net of taxes withheld— — 19,260 — (7)— — (7)
Stock-based Compensation— — — — 433 — — 433 
Balance as of June 30, 2021 $ 8,528,307 $1 $371,708 $(353,558)$52 $18,203 
Net Loss— — — — — (7,581)— (7,581)
Unrealized Gain on Available-for-Sale Investments— — — — — — 4 4 
Issued shares for services— — 14,090 — 107 — — 107 
Stock-based Compensation— — — — 361 — — 361 
Balance as of September 30, 2021 $ 8,542,397 $1 $372,176 $(361,139)$56 $11,094 
The accompanying notes are an integral part of the condensed consolidated financial statements.

6


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Dollars in Thousands)
For the nine months ended September 30, 2022 and 2021
Nine Months Ended
September 30, 2022
Nine Months Ended
September 30, 2021
Cash Flows From Operating Activities:
Net Loss$(16,317)$(23,733)
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:
Depreciation and Amortization422 535 
Stock-based Compensation95 558 
Increase in Inventory Reserves307 89 
Amortization of Right of Use Asset1,518 1,312 
Amortization of Debt Financing Costs and Accretion of Debt Discount276 276 
(Gain) Loss on Disposal of Assets(3)7 
Realized (Gain) Loss on Sale of Investments Available-for-Sale(4)1 
Foreign Currency Translation Adjustment(3)3 
Changes in Assets and Liabilities:
Increase in Accounts Receivable, net(1,454)(1,865)
Increase in Inventory(921)(554)
Decrease in Prepaid and Other Assets2,058 1,760 
(Decrease) Increase in Accounts Payable(688)679 
Decrease in Lease Liability(1,435)(1,266)
Increase (Decrease) in Other Liabilities756 (825)
Decrease in Deferred License Revenue(1,427)(1,485)
Changes in Assets and Liabilities(3,111)(3,556)
Cash Used In Operating Activities(16,820)(24,508)
Cash Flows From Investing Activities:
Purchase of Investments Available-for-Sale(17,389)(19,107)
Sale of Investments Available-for-Sale11,972 19,286 
Purchase of Equipment(197)(408)
Cash Used In Investing Activities(5,614)(229)
Cash Flows From Financing Activities:
Payments on Debt(6,750) 
Payments on Short Term Note Payable(941)(656)
Proceeds from the Issuance of Common Stock15,016  
Offering Costs from the Issuance of Common Stock(106) 
Proceeds from the Issuance of Preferred Stock15,000  
Offering Costs from the Issuance of Preferred Stock(85) 
Proceeds from the Issuance of Common Stock for payment related to services provided 107 
Repurchase of Common Stock to Pay Employee Withholding Taxes (6)
Cash Provided by (Used In) Financing Activities22,134 (555)
Decrease in Cash and Cash Equivalents(300)(25,292)
Cash and Cash Equivalents at Beginning of Period13,280 48,682 
Cash and Cash Equivalents at End of Period$12,980 $23,390 
Supplemental Disclosure of Cash Flow Information:
Cash Paid for Interest$1,261 $1,318 
Supplemental Disclosure of Noncash Investing and Financing Activities:
Change in Unrealized Loss on Marketable Securities Available-for-Sale$5 $(4)
The accompanying notes are an integral part of the condensed consolidated financial statements.

7


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1.  Description of Business
Rockwell Medical, Inc. (“Rockwell Medical,” “Rockwell,” or the “Company”) is a commercial healthcare company focused on providing life-sustaining products for patients suffering from blood disorders and diseases associated with the kidney. Rockwell is a revenue-generating business and the second largest supplier of acid and bicarbonate concentrates for dialysis patients in the United States. Hemodialysis is the most common form of end-stage kidney disease treatment and is usually performed at a freestanding outpatient dialysis center, at a hospital-based outpatient center, or in a patient’s home. This represents a large market opportunity for which Rockwell's products are well-positioned to meet the needs of patients.
Rockwell manufactures hemodialysis concentrates under cGMP regulations at its three facilities in Michigan, Texas, and South Carolina totaling approximately 175,000 square feet, and manufactures mixers in its Iowa facility. Rockwell delivers the majority of its hemodialysis concentrates products and mixers to dialysis clinics throughout the United States and internationally utilizing its own delivery trucks and third-party carriers. Rockwell has developed a core expertise in manufacturing and delivering hemodialysis concentrates, and has built a longstanding reputation for reliability, quality, and excellent customer service.
Rockwell has a proprietary parenteral iron product, TRIFERIC® (ferric pyrophosphate citrate, "FPC"), which is indicated to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. The Company has established several international partnerships with companies seeking to develop and commercialize TRIFERIC® outside the United States and is working closely with these international partners to develop and commercialize TRIFERIC® in their respective regions.
Rockwell continues to evaluate the viability of its FPC platform and FPC's potential to treat iron deficiency and iron deficiency anemia and for acute heart failure.
Rockwell’s strategy is focused on growing the Company's revenue-generating business, which currently includes hemodialysis concentrates and international partnerships for TRIFERIC® and achieving profitability in 2024 to put the Company in a stronger and more stable financial position.
8


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
2.  Liquidity and Capital Resources
As of September 30, 2022, Rockwell had approximately $27.6 million of cash, cash equivalents and investments available-for-sale, and working capital of $23.0 million. Net cash used in operating activities for the nine months ended September 30, 2022 was approximately $16.8 million. Based on the currently available working capital and capital raises described below, management believes the Company currently has sufficient funds to meet its operating requirements for at least the next twelve months from the date of the filing of this report.
On April 6, 2022, the Company and DaVita, Inc. ("DaVita") entered into an amendment (the "Amendment") to the Products Purchase Agreement, dated July 1, 2019, under which the Company supplies DaVita with certain dialysis concentrates. Under the Amendment, the Company and DaVita agreed to certain price increases, effective May 1, 2022, as well as the pass-through of certain inflationary costs, determined on a quarterly basis. Certain costs are subject to a cap. The Amendment also requires the Company to implement certain cost containment and cost-cutting measures. The Amendment contains certain covenants with respect to the Company’s ongoing operations, including a minimum cash covenant of $10 million, or the Company will be in default under the Products Purchase Agreement. An event of default could result in termination of that agreement.
On April 6, 2022, the Company and DaVita entered into a Securities Purchase Agreement (the “SPA”), pursuant to which the Company issued $15 million of preferred stock to DaVita in two separate tranches. The Company initially issued 7,500 shares of a newly designated series of preferred stock, which is designated “Series X Convertible Preferred Stock” (the “Series X Preferred Stock”) for gross proceeds of $7.5 million. On June 15, 2022, the Company issued to DaVita an additional 7,500 shares of Series X Preferred Stock in a second closing (the “Second Tranche”) for an additional $7.5 million. The Second Tranche was conditioned upon the Company raising an additional $15 million in capital within a certain timeline, which took place on June 2, 2022.
On April 8, 2022, 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 $12,200,000 of shares of Company’s common stock through the Agent. The offering and sale of such shares has been registered under the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-259923) (the “Registration Statement”), which was originally filed with the Securities and Exchange Commission (“SEC”) on September 30, 2021 and declared effective by the SEC on October 8, 2021, the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed with the SEC on April 8, 2022. During the three months ended September 30, 2022, the Company did not make any sales pursuant to the Sales Agreement. Approximately $12.2 million remains available for sale under the ATM facility.
On May 30, 2022, the Company entered into a Securities Purchase Agreement (the “RD Purchase Agreement”) with the purchaser named therein (the “Purchaser”), pursuant to which the Company agreed to issue and sell, in a registered direct offering (the “Offering”), 844,613 shares of its common stock at price of $1.39 per share, and prefunded warrants to purchase up to an aggregate of 7,788,480 shares of common stock (the “Pre-Funded Warrants” and the shares of common stock underlying the Pre-Funded Warrants, the “Warrant Shares”). The purchase price of each Pre-Funded Warrant was equal to the price at which a share of common stock was sold to the public in the Offering, minus $0.0001, and the exercise price of each Pre-Funded Warrant is $0.0001 per share.
Also on May 30, 2022, concurrently with the Offering, the Company entered into a Securities Purchase Agreement with the Purchaser (the “PIPE Purchase Agreement”) relating to the offering and sale (the “Private Placement”) of warrants to purchase up to a total of 9,900,990 shares of common stock and pre-funded warrants to purchase up to a total of 1,267,897 shares of common stock (the “PIPE Warrants”). Each warrant was sold at a price of $0.125 per underlying warrant share and is exercisable at an exercise price of $1.39 per share. The purchase price of each Pre-Funded Warrant was equal to the price at which a share of common stock was sold to the public in the Offering, minus $0.0001, and the exercise price of each prefunded warrant is $0.0001 per share. The Offering and the Private Placement closed on June 2, 2022. The net proceeds to the Company from the Offering and the Private Placement were approximately $14.9 million, after deducting fees and expenses.
The Company may require additional capital to sustain its operations and make the investments it needs to execute its strategic plan. If the Company attempts to obtain additional debt or equity financing, the Company cannot assume such financing will be available on favorable terms, if at all.
Currently, because the Company's public float is less than $75 million, it is subject to the baby shelf limitations under its current registration statement on Form S-3, which limit the amount the Company may offer under the Form S-3. This could limit its ability to raise capital under this registration statement.

In addition, the Company is subject to certain covenants and cure provisions under its Loan Agreement with Innovatus. As of the date of this report, the Company is in compliance with all covenants (See Note 14 for further detail).

The COVID-19 pandemic and resulting domestic and global disruptions, particularly in the supply chain and labor market, among other areas, have adversely affected the Company's business and operations, including, but not limited to, its sales and marketing efforts and its research and development activities, its plant and transportation operations and the operations of third parties upon whom the Company relies. The Company's international business development activities may also continue to be negatively impacted by COVID-19.

The COVID-19 pandemic and the resulting global disruptions and recent inflationary pressures have caused significant volatility in financial and credit markets. Rockwell has utilized a range of financing methods to fund its operations in the past; however, current conditions in the financial and credit markets may limit the availability of funding, refinancing or increase the cost of funding. Due to the rapidly evolving nature of the global situation, it is not possible to predict the extent to which these conditions could adversely affect the Company's liquidity and capital resources in the future.
9


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
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 of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U. S. Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements.

The condensed consolidated balance sheet at September 30, 2022, condensed consolidated statements of operations for the three and nine months ended September 30, 2022 and 2021, condensed consolidated statements of comprehensive loss for the three and nine months ended September 30, 2022 and 2021, condensed consolidated statement of changes in stockholders' equity for the three and nine months ended September 30, 2022 and 2021, and condensed consolidated statements of cash flows for the nine months ended September 30, 2022 and 2021 are unaudited, but include all adjustments, consisting of normal recurring adjustments, the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 30, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022 or for any future interim period. The condensed consolidated balance sheet at December 31, 2021 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, 2021 and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 as filed with the SEC on April 8, 2022. 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.
Reverse Stock Split
On May 9, 2022, the stockholders of the Company authorized the Board of Directors to effect a reverse stock split of all outstanding shares of common stock. The Board of Directors subsequently approved the implementation of a reverse stock split as a ratio of one-for-eleven shares, which became effective on May 13, 2022. The Company’s outstanding stock options were also adjusted to reflect the one-for-eleven reverse stock split of the Company’s common stock. Outstanding stock options were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased. The reverse stock split resulted in an adjustment to the Series X convertible preferred stock conversion prices to reflect a proportional decrease in the number of shares of common stock to be issued upon conversion. All share and per share data in these condensed consolidated financial statements and related notes hereto have been retroactively adjusted to account for the effect of the reverse stock split for the three and nine month periods ended September 30, 2022 and 2021, respectively, and the balance sheet at September 30, 2022 and December 31, 2021.
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 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.
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 is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, common stock warrants, unvested restricted stock units and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive, and therefore, basic and diluted net loss per share were the same for all periods presented.
The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the nine months ended September 30, 2022 and 2021, respectively, because to do so would be anti-dilutive (in common equivalent shares):
As of September 30,
20222021
Options to purchase common stock1,311,691 533,784 
Unvested restricted stock awards891 7,118 
Unvested restricted stock units125,000 31,116 
Preferred stock conversion to common stock1,363,636  
Warrants to purchase common stock17,507,268 2,402,442 
Total20,308,486 2,974,460 
Adoption of Recent Accounting Pronouncements
The Company continually assesses new accounting pronouncements to determine their applicability. When it is determined a new accounting pronouncement affects the Company’s financial reporting, the Company undertakes a review to determine the consequences of the change to its consolidated financial statements and assures there are sufficient controls in place to ascertain the Company’s consolidated financial statements properly reflect the change.
In August 2020, the FASB issued ASU No. 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity”, which simplifies the accounting for convertible instruments by eliminating the requirement to separate embedded conversion features from the host contract when the conversion features are not required to be accounted for as derivatives under Topic 815, Derivatives and Hedging, or do not result in substantial premiums accounted for as paid-in capital. By removing the separation model, a convertible debt instrument will be reported as a single liability instrument with no separate accounting for embedded conversion features. This new standard also removes certain settlement conditions required for contracts to qualify for equity classification and simplifies the diluted earnings per share calculations by requiring an entity use the if-converted method and the effect of potential share settlement be included in diluted earnings per share calculations. This new standard will be effective for the Company for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently assessing the impact of adopting this standard on the consolidated financial statements.
10


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
4.  Revenue Recognition

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
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 concentrates 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 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 control of the product transfers to the customer.
The Company received upfront fees under five distribution and license agreements that have been deferred as a contract liability.  The amounts received from Wanbang Biopharmaceuticals Co., Ltd. (“Wanbang”), Sun Pharmaceutical Industries Ltd. ("Sun Pharma"), Jeil Pharmaceutical Co., Ltd. ("Jeil Pharma") and Drogsan Pharmaceuticals ("Drogsan Pharma") are recognized as revenue over the estimated term of the applicable distribution and license agreement as regulatory approval was not received and the Company did not have sufficient experience in China, India, South Korea and Turkey, respectively, to determine 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 the estimated product sales under the agreement occur. 
For the business under the Company’s 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 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.
In thousands of U.S. dollars ($) Three Months Ended September 30, 2022Nine Months Ended September 30, 2022
Products By Geographic AreaTotalU.S.Rest of WorldTotalU.S.Rest of World
Drug Revenues
Product Sales – Point-in-time$193 $193 $ $834 $561 $273 
License Fee – Over time65  65 192  192 
Total Drug Products258 193 65 1,026 561 465 
Concentrates Products
Product Sales – Point-in-time17,953 16,619 1,334 51,035 46,334 4,701 
License Fee – Over time480 480  1,436 1,436  
Total Concentrate Products18,433 17,099 1,334 52,471 47,770 4,701 
Net Revenue$18,691 $17,292 $1,399 $53,497 $48,331 $5,166 
In thousands of U.S. dollars ($)Three Months Ended September 30, 2021Nine Months Ended September 30, 2021
Products By Geographic AreaTotalU.S.Rest of WorldTotalU.S.Rest of World
Drug Revenues
Product Sales – Point-in-time$217 $217 $ $656 $656 $ 
License Fee – Over time62  62 179  179 
Total Drug Products279 217 62 835 656 179 
Concentrates Products
Product Sales – Point-in-time15,224 13,541 1,683 44,308 39,768 4,540 
License Fee – Over time485 485  1,456 1,456  
Total Concentrate Products15,709 14,026 1,683 45,764 41,224 4,540 
Net Revenue$15,988 $14,243 $1,745 $46,599 $41,880 $4,719 
Contract balances
The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers.
In thousands of U.S. dollars ($)September 30, 2022December 31, 2021
Receivables, which are included in "Trade and other receivables"$7,367 $5,913 
Contract liabilities$6,729 $8,157 
There were no impairment losses recognized related to any receivables arising from the Company’s contracts with customers for the three and nine months ended September 30, 2022 and 2021.
For the three and nine months ended September 30, 2022 and September 30, 2021, the Company did not recognize any material bad-debt expense. There were no material contract assets recorded on the condensed consolidated balance sheet as of September 30, 2022 and December 31, 2021.  The Company does not generally accept returns of its concentrates products and no material reserve for returns of concentrates products was established as of September 30, 2022 or December 31, 2021. 
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 months ended September 30, 2022, revenue recognized from performance obligations related to prior periods was not material.
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 $6.7 million as of September 30, 2022. The amount relates primarily to upfront payments and consideration received from customers 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 having 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 $3.8 million as of September 30, 2022, which is amortized ratably through expiration of the Baxter Agreement on October 2, 2024.
11


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
5.  Investments - Available-for-Sale
Investments available-for-sale consisted of the following as of September 30, 2022 and December 31, 2021 (table in thousands):
September 30, 2022
Amortized CostUnrealized GainUnrealized LossAccrued InterestFair Value
Available-for-Sale Securities
Bonds$14,578 $6 $(1)$1 $14,584 

December 31, 2021
Amortized CostUnrealized GainUnrealized LossAccrued InterestFair Value
Available-for-Sale Securities
Bonds$9,143 $1 $ $14 $9,158 
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 30, 2022 and December 31, 2021, 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 30, 2022 and December 31, 2021 are as follows (table in thousands):
September 30,
2022
December 31,
2021
Raw Materials$4,074 $3,434 
Work in Process336 201 
Finished Goods1,803 1,964 
Total$6,213 $5,599 
As of September 30, 2022, the Company classified $1.2 million of inventory as non-current, all of which was related to the active pharmaceutical ingredient and raw materials for TRIFERIC®. As of September 30, 2022, the total TRIFERIC® inventory net of reserve was $1.2 million.
The $1.2 million net value of TRIFERIC® inventory consisted of $0.3 million of TRIFERIC® API with an estimated useful life extending through 2023, and $0.9 million of raw materials for TRIFERIC® with an estimated useful life of 25 years.
12


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
7.  Property and Equipment
As of September 30, 2022 and December 31, 2021, the Company’s property and equipment consisted of the following (table in thousands):
September 30,
2022
December 31,
2021
Leasehold Improvements$1,257 $1,204 
Machinery and Equipment5,985 5,864 
Information Technology & Office Equipment1,845 1,845 
Laboratory Equipment660 676 
9,747 9,589 
Accumulated Depreciation(7,483)(7,103)
Property and Equipment, net$2,264 $2,486 
Depreciation expense for both the three months ended September 30, 2022 and 2021 was $0.1 million. Depreciation expense for nine months end September 30, 2022 and 2021 was $0.4 million and $0.5 million, respectively.
13


ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
8.  Accrued Liabilities
Accrued liabilities as of September 30, 2022 and December 31, 2021 consisted of the following (table in thousands):
September 30,
2022
December 31,
2021
Accrued Research & Development Expense$65 $366 
Accrued Compensation and Benefits3,006 1,791 
Accrued Unvouchered Receipts581 796 
Accrued Workers Compensation294 382 
Other Accrued Liabilities1,941 1,755 
Total Accrued Liabilities$5,887 $5,090 
9.  Deferred Revenue
In October 2014, the Company entered into the Baxter Agreement, which has a term of