Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 29, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 000-23661 | ||
Entity Registrant Name | ROCKWELL MEDICAL, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 38-3317208 | ||
Entity Address, Address Line One | 30142 S. Wixom Road | ||
Entity Address, City or Town | Wixom | ||
Entity Address, State or Province | MI | ||
Entity Address, Postal Zip Code | 48393 | ||
City Area Code | 248 | ||
Local Phone Number | 960‑9009 | ||
Title of 12(b) Security | Common Stock, par value $.0001 | ||
Trading Symbol | RMTI | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 111,970,531 | ||
Entity Common Stock, Shares Outstanding | 93,585,780 | ||
Documents Incorporated by Reference | Portions of the Registrant’s definitive Proxy Statement pertaining to the 2021 Annual Meeting of Stockholders, which the Registrant intends to file pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after the Registrant’s fiscal year ended December 31, 2020, to be filed pursuant to Regulation 14A are herein incorporated by reference in Part III of this Annual Report on Form 10‑K. | ||
Entity Central Index Key | 0001041024 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
ASSETS | ||
Cash and Cash Equivalents | $ 48,682 | $ 11,795 |
Investments Available-for -Sale | 9,997 | 14,250 |
Accounts Receivable, net of a reserve of $9 for both 2020 and 2019 | 4,171 | 4,203 |
Inventory | 3,913 | 3,647 |
Prepaid and Other Current Assets | 2,706 | 2,979 |
Total Current Assets | 69,469 | 36,874 |
Property and Equipment, net | 2,642 | 2,433 |
Inventory, Non-Current | 1,176 | 441 |
Right of Use Assets, net | 2,911 | 3,213 |
Goodwill | 921 | 921 |
Other Non-current Assets | 629 | 435 |
Total Assets | 77,748 | 44,317 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
Accounts Payable | 4,155 | 3,018 |
Accrued Liabilities | 5,013 | 4,518 |
Settlement Payable | 0 | 104 |
Lease Liability - Current | 1,167 | 1,493 |
Deferred License Revenue | 2,175 | 2,234 |
Insurance Financing Note Payable | 0 | 763 |
Customer Deposits | 152 | 55 |
Other Current Liability - Related Party | 131 | 189 |
Total Current Liabilities | 12,793 | 12,374 |
Lease Liability - Long-Term | 1,821 | 1,781 |
Term Loan, Net of Issuance Costs | 20,949 | 0 |
Deferred License Revenue - Long-Term | 8,015 | 9,842 |
Total Liabilities | 43,578 | 23,997 |
Commitments and Contingencies (See Note 14) | ||
Stockholders’ Equity: | ||
Preferred Stock, $0.0001 par value, 2,000,000 shares authorized, no shares issued and outstanding at December 31, 2020 and 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 December 31, 2020 and 2019, respectively | 9 | 7 |
Additional Paid-in Capital | 371,510 | 326,777 |
Accumulated Deficit | (337,406) | (306,516) |
Accumulated Other Comprehensive Income | 57 | 52 |
Total Stockholders’ Equity | 34,170 | 20,320 |
Total Liabilities And Stockholders’ Equity | $ 77,748 | $ 44,317 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Allowance for reserve, accounts receivable (in dollars) | $ 9 | $ 9 |
Preferred shares, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred shares, shares authorized (in shares) | 2,000,000 | 2,000,000 |
Preferred shares, shares issued (in shares) | 0 | 0 |
Preferred shares, shares outstanding (in shares) | 0 | 0 |
Common shares, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock authorized (in shares) | 170,000,000 | 170,000,000 |
Common shares, shares issued (in shares) | 93,573,165 | 65,378,890 |
Common shares, shares outstanding (in shares) | 93,573,165 | 65,378,890 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement [Abstract] | ||
Net Sales | $ 62,197 | $ 61,303 |
Cost of Sales | 59,472 | 58,464 |
Gross Profit | 2,725 | 2,839 |
Research and Product Development | 7,092 | 6,886 |
Selling and Marketing | 7,871 | 9,050 |
General and Administrative | 16,182 | 20,998 |
Settlement Expense, net of Reimbursement | 0 | 430 |
Operating Loss | (28,420) | (34,525) |
Other Income (Expense) | ||
Realized Gain (Loss) on Investments | 8 | 30 |
Warrant Modification Expense | (837) | 0 |
Interest Expense | (1,879) | (25) |
Interest Income | 238 | 392 |
Total Other Income (Expense) | (2,470) | 397 |
Net Loss | $ (30,890) | $ (34,128) |
Basic and Diluted Net Loss per Share (in dollars per share) | $ (0.41) | $ (0.56) |
Basic and Diluted Weighted Average Shares Outstanding (in shares) | 75,621,674 | 60,918,544 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | ||
Net Loss | $ (30,890) | $ (34,128) |
Unrealized Loss on Available-for-Sale Investments | (3) | (10) |
Foreign Currency Translation Adjustments | 8 | (1) |
Comprehensive Loss | $ (30,885) | $ (34,139) |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY - USD ($) | Total | Public offering | At -the-market | COMMON STOCK | COMMON STOCKPublic offering | COMMON STOCKAt -the-market | ADDITIONAL PAID-IN CAPITAL | ADDITIONAL PAID-IN CAPITALPublic offering | ADDITIONAL PAID-IN CAPITALAt -the-market | ACCUMULATED DEFICIT | ACCUMULATED OTHER COMPREHENSIVE INCOME / (LOSS) |
Beginning balance (in shares) at Dec. 31, 2018 | 57,034,154 | ||||||||||
Beginning balance at Dec. 31, 2018 | $ 27,277,000 | $ 6,000 | $ 299,596,000 | $ (272,388,000) | $ 63,000 | ||||||
Increase (Decrease) in Shareholders' Equity | |||||||||||
Net Loss | (34,128,000) | (34,128,000) | |||||||||
Unrealized Loss on Available-for-Sale Investments | (10,000) | (10,000) | |||||||||
Foreign Currency Translation Adjustments | $ (1,000) | (1,000) | |||||||||
Issuance of Common Stock (in shares) | 30,000 | 30,000 | |||||||||
Issuance of Common Stock | $ 147,900 | 148,000 | |||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares) | 215,079 | ||||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld | (279,000) | (279,000) | |||||||||
Issuance of Common Stock, net of Issuance costs/Public offering (in shares) | 6,259,214 | 1,840,443 | |||||||||
Issuance of Common Stock, net of Issuance Costs/Public offering | $ 17,288,000 | $ 5,073,000 | $ 1,000 | $ 17,287,000 | $ 5,073,000 | ||||||
Stock-based Compensation | $ 4,952,000 | 4,952,000 | |||||||||
Ending balance (in shares) at Dec. 31, 2019 | 65,378,890 | 65,378,890 | |||||||||
Ending balance at Dec. 31, 2019 | $ 20,320,000 | $ 7,000 | 326,777,000 | (306,516,000) | 52,000 | ||||||
Increase (Decrease) in Shareholders' Equity | |||||||||||
Net Loss | (30,890,000) | (30,890,000) | |||||||||
Unrealized Loss on Available-for-Sale Investments | (3,000) | (3,000) | |||||||||
Foreign Currency Translation Adjustments | $ 8,000 | 8,000 | |||||||||
Issuance of Common Stock (in shares) | 0 | ||||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares) | 216,646 | ||||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld | $ (19,000) | (19,000) | |||||||||
Issuance of Common Stock, net of Issuance costs/Public offering (in shares) | 26,849,021 | 1,128,608 | |||||||||
Issuance of Common Stock, net of Issuance Costs/Public offering | $ 40,679,000 | $ 2,262,000 | $ 2,000 | $ 40,677,000 | $ 2,262,000 | ||||||
Issuance of Warrants related to Debt Financing | 501,000 | 501,000 | |||||||||
Warrant Modification Expense | 837,000 | 837,000 | |||||||||
Stock-based Compensation | $ 475,000 | 475,000 | |||||||||
Ending balance (in shares) at Dec. 31, 2020 | 93,573,165 | 93,573,165 | |||||||||
Ending balance at Dec. 31, 2020 | $ 34,170,000 | $ 9,000 | $ 371,510,000 | $ (337,406,000) | $ 57,000 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash Flows From Operating Activities: | ||
Net Loss | $ (30,890) | $ (34,128) |
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities: | ||
Depreciation and Amortization | 834 | 788 |
Stock-based Compensation | 475 | 4,952 |
Warrant Modification Expense | 837 | 0 |
Increase in Inventory Reserves | 305 | 1,271 |
Amortization of Right of Use Asset | 1,455 | 1,865 |
Amortization of Debt Financing Costs and Accretion of Debt Discount | 294 | 0 |
Loss on Disposal of Assets | 7 | 5 |
Realized Loss on Sale of Investments Available-for-Sale | (8) | (30) |
Foreign Currency Translation Adjustment | 8 | (1) |
Changes in Assets and Liabilities: | ||
Decrease in Insurance Receivable | 0 | 371 |
Decrease in Accounts Receivable, net | 32 | 2,777 |
(Increase) Decrease in Inventory | (1,306) | 317 |
Decrease in Other Assets | 76 | 934 |
Increase (Decrease) in Accounts Payable | 1,136 | (1,474) |
Decrease in Settlement Payable | (104) | (313) |
Decrease in Lease Liability | (1,439) | (1,803) |
Increase (Decrease) in Other Liabilities | 534 | (532) |
Decrease in Deferred License Revenue | (1,887) | (2,253) |
Changes in Assets and Liabilities | (2,958) | (1,976) |
Cash Used In Operating Activities | (29,641) | (27,254) |
Cash Flows From Investing Activities: | ||
Purchase of Investments Available-for-Sale | (29,307) | (41,678) |
Sale of Investments Available-for-Sale | 33,565 | 38,266 |
Purchase of Equipment | (1,046) | (588) |
Purchase of Research and Development Licenses (Related Party) | 0 | (750) |
Cash Provided By (Used in) Provided By Investing Activities | 3,212 | (4,750) |
Cash Flows From Financing Activities: | ||
Proceeds from Term Loan | 22,500 | 0 |
Debt Issuance Costs | (1,343) | 0 |
Payments on Short Term Note Payable | (763) | (1,145) |
Proceeds from the Exercise of Employee Stock Options, Net of Tax | 0 | 148 |
Repurchase of Common Stock to Pay Employee Withholding Taxes | (19) | (279) |
Cash Provided By Financing Activities | 63,316 | 21,085 |
Increase (Decrease) In Cash and Cash Equivalents | 36,887 | (10,919) |
Cash and Cash Equivalents At Beginning Of Period | 11,795 | 22,714 |
Cash and Cash Equivalents At End Of Period | 48,682 | 11,795 |
Supplemental Disclosure of Cash Flow Information: | ||
Cash Paid for Interest | 1,558 | 0 |
Supplemental Disclosure of Noncash Investing Activities: | ||
Change in Unrealized Loss on Marketable Securities Available-for-Sale | (3) | (10) |
Insurance Financing Note Payable | 0 | 763 |
Fair Value of Warrants issued related to Debt Financing | 501 | 0 |
Public offering | ||
Cash Flows From Financing Activities: | ||
Proceeds from the Issuance of Common Stock | 43,148 | 18,778 |
Offering Costs from the Issuance of Common Stock | (2,469) | (1,490) |
At -the-market | ||
Cash Flows From Financing Activities: | ||
Proceeds from the Issuance of Common Stock | 2,325 | 5,383 |
Offering Costs from the Issuance of Common Stock | $ (63) | $ (310) |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business Rockwell Medical, Inc. ("Rockwell Medical," "Rockwell" or the "Company") is a commercial-stage, biopharmaceutical company developing and commercializing our next-generation parenteral iron technology platform, ferric pyrophosphate citrate (“FPC”), which we believe has significant 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 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 by starting a Phase II trial for the treatment of iron deficiency anemia in patients outside of dialysis, who are receiving intravenous medications in the home infusion 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 II program in these patients in 2022. |
Liquidity and Capital Resources
Liquidity and Capital Resources | 12 Months Ended |
Dec. 31, 2020 | |
Liquidity and Capital Resources [Abstract] | |
Liquidity and Capital Resources | Liquidity and Capital Resources Since inception, Rockwell has incurred significant net losses and have funded its operations primarily through revenue from commercial products, proceeds from the issuance of debt and equity securities and payments from partnerships. At December 31, 2020, Rockwell had an accumulated deficit of approximately $337.4 million and stockholders' equity of $34.2 million. As of December 31, 2020, Rockwell had approximately $58.7 million of cash, cash equivalents and investments available-for-sale, and working capital of $56.7 million. Net cash used in operating activities for the year ended December 31, 2020 was approximately $29.6 million. Based on the currently available working capital, capital raise and debt financing noted 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. In February 2020, the Company sold 3,670,212 shares of its common stock for proceeds of $8.0 million, net of issuance costs. On March 16, 2020, the Company closed a debt financing transaction with net proceeds at closing of approximately $21.2 million, net of fees and expenses (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 11 for further detail). During the year ended December 31, 2020, the Company sold 1,128,608 shares of its common stock as part of its At-the-Market ("ATM") 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 11 for further detail. The Company expects it will require additional capital to sustain its operations and make the investments it needs to execute its strategic plan, including the commercialization of Triferic (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 for progressing our pipeline development program of new indications for its FPC platform. If the Company is unable to generate sufficient revenue from sales of its 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, 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 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 Rockwell is unable to avoid an event of default, any required repayments could have an adverse effect on its liquidity (See Note 15 for further detail). The COVID-19 pandemic and resulting domestic and global disruptions have adversely affected Rockwell's business and operations, including, but not limited to, its sales and marketing efforts and our research and development activities, and the operations of third parties upon whom the Company relies. Quarantines, shelter-in-place, executive and similar government orders and the recent surge in infections domestically may negatively impact Rockwell's sales and marketing activities, particularly if its sales representatives are unable to interact with current and potential customers to the same extent as before onset of the COVID-19 pandemic. The Company's international business development activities may also be negatively impacted by COVID-19, especially with the recent surge in infections and resulting quarantines or shelter-in-place orders. The COVID-19 pandemic, the domestic and international surge in infections and resulting global disruptions 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited. Rockwell Medical India Private Limited was formed in 2017 for the purpose of conducting certain commercial activities in India. All 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. Revenue Recognition The Company recognizes revenue under Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers. The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: • Step 1: Identify the contract with the customer • Step 2: Identify the performance obligations in the contract • Step 3: Determine the transaction price • Step 4: Allocate the transaction price to the performance obligations in the contract • Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by 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 four 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") and Jeil Pharmaceutical Co., Ltd. ("Jeil 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 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 US dollars ($) Year Ended December 31, 2020 Products By Geographic Area Total U.S. Rest of World Drug Revenues Product Sales - Point-in-time $ 910 $ 910 $ — License Fee – Over time 226 — 226 Total Drug Products 1,136 910 226 Concentrate Products Product Sales – Point-in-time 59,100 53,707 5,393 License Fee – Point-in-time 1,961 1,961 — Total Concentrate Products 61,061 55,668 5,393 Net Revenue $ 62,197 $ 56,578 $ 5,619 In thousands of US dollars ($) Year Ended December 31, 2019 Products By Geographic Area Total U.S. Rest of World Drug Revenues Product Sales - Point-in-time $ 272 $ 272 $ — License Fee – Over time 273 — 273 Total Drug Products 545 272 273 Concentrate Products Product Sales – Point-in-time 58,778 52,540 6,238 License Fee – Point-in-time 1,980 1,980 — Total Concentrate Products 60,758 54,520 6,238 Net Revenue $ 61,303 $ 54,792 $ 6,511 For the years ended December 31, 2020 and 2019, license fee revenue was $2.2 million and $2.3 million, respectively. For the years ended December 31, 2020 and 2019, product sales revenue was $60.0 million and $59.0 million, respectively. Contract balances The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands of US dollars ($) December 31, 2020 December 31, 2019 Receivables, which are included in "Trade and other receivables" $ 4,171 $ 4,203 Contract liabilities $ 10,190 $ 12,076 There were no impairment losses recognized related to any receivables arising from the Company’s contracts with customers for the years ended December 31, 2020 and 2019. For the years ended December 31, 2020 and 2019, the Company did not recognize material bad-debt expense and there were no material contract assets recorded on the consolidated balance sheets as of December 31, 2020 and 2019. The Company does not generally accept returns of its concentrate products and no reserve for returns of concentrate products was established as of December 31, 2020 or December 31, 2019. 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 year ended December 31, 2020, 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 $10.2 million and $12.1 million as of December 31, 2020 and 2019, respectively. 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. As of December 31, 2020 unfulfilled performance obligations related to the Baxter Agreement are product sales totaling $7.2 million, which will be amortized through expiration of the agreement on October 2, 2024. Use of Estimates The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“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 consolidated financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. The most significant accounting estimates inherent in the preparation of our financial statements include estimates associated with fair value and classification of warrants, revenue recognition, allowance for doubtful accounts, inventory reserves, accrued expenses, deferred license revenue, stock-based compensation, impairments of long-lived assets, and accounting for income taxes. Cash and Cash Equivalents The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents excluding items held in Investments - Available for Sale as noted below. Cash and cash equivalents include cash held in banks, money market mutual funds and unrestricted certificates of deposit. The Company’s cash and cash equivalents exceeds the Federal Deposit Insurance Corporation insured limits. The Company has not experienced any credit losses for amounts in excess of insured limits. Currently the Company does not reasonably believe a significant risk of credit loss exists. Fair Value Measurement The Company applies the guidance issued with ASC 820, Fair Value Measurements , which provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity ad values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. Investments – Available for Sale The Company has designated its short term investments as of each balance sheet date as available-for-sale securities and accounts for them at their respective fair values. Available-for-sale securities are measured at fair value, including accrued interest, with temporary unrealized gains and losses reported as a component of stockholders' equity until their disposition. We review all available-for-sale securities at each period end to determine if they remain available-for-sale based on our then current intent and ability to sell the security if required to do so. The cost of securities sold is based on the specific identification method. All of our investments available-for-sale are subject to periodic impairment review. We recognize an impairment charge when a decline in the fair value of our investments below the cost basis is judged to be other than temporary. Accounts Receivable Accounts receivable are stated at invoice amounts. The carrying amount of trade accounts receivable is reduced by an allowance for doubtful accounts that reflects our best estimate of accounts that may not be collected. We review outstanding trade accounts receivable balances and based on our assessment of expected collections, we estimate the portion, if any, of the balance that may not be collected as well as a general valuation allowance for other accounts receivable based primarily on historical experience. All accounts or portions thereof deemed to be uncollectible are written off to the allowance for doubtful accounts. Inventory Inventory is stated at the lower of cost or net realizable value. Cost is determined on the first‑in first‑out (FIFO) method. Inventory that is not expected to be converted to cash over the next year is classified as non-current. Our policy is to reserve for our drug product inventory that we determine is unlikely to be sold to, or if sold, unlikely to be utilized by our customers on or before its expiration date. Property and Equipment Property and equipment is recorded at cost and are depreciated using the straight‑line method over the useful lives of the assets, which range from three Impairment of Long-lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable. Impairment losses on long-lived assets, such as real estate and equipment, are recognized when events or changes in circumstances indicate that the undiscounted cash flows estimated to be generated by such assets are less than their carrying value and, accordingly, all or a portion of such carrying value may not be recoverable. Impairment losses are then measured by comparing the fair value of assets to their carrying amounts. For the years ended December 31, 2020 and 2019, there were no impairments of long-lived assets. Goodwill and Intangible Assets Goodwill is the excess of purchase price over the fair value of identified net assets of businesses acquired. Intangible assets with indefinite useful lives are measured at their respective fair values as of the acquisition date. Rockwell reviews goodwill and indefinite-lived intangible assets at least annually for possible impairment. Goodwill and indefinite-lived intangible assets are reviewed for possible impairment between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of the reporting unit or the indefinite-lived intangible assets below their carrying values. Intangible assets with definite lives are amortized over their estimated useful lives. Intangible assets subject to amortization are reviewed for potential impairment whenever events or circumstances indicate that carrying amounts may not be recoverable. Definite-lived intangible assets consist of our license fees related to the technology, intellectual property and marketing rights for Triferic covered under certain issued patents have been capitalized and are being amortized over the life of the related patents which is generally 17 years. Deferred Revenue In October 2014, the Company entered into a 10 year distribution 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 Distribution Agreement. The Company recognized revenue of approximately $2.0 million and $2.1 million for the years ended December 31, 2020 and 2019, respectively. Deferred revenue related to the Baxter agreement totaled $7.2 million and $9.1 million as of December 31, 2020 and 2019, respectively. If a “Refund Trigger Event” occurs prior to December 31, 2021, Rockwell would be obligated to repay 25% of the upfront fee. During the year ended December 31, 2016, the Company entered into a distribution agreement with Wanbang 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 $0.2 million and $0.3 million during the years ended December 31, 2020 and 2019, respectively. Deferred revenue related to the Wanbang agreement totaled $2.7 million and $2.9 million as of December 31, 2020 and 2019, respectively. On 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) (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) 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) in 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 $10,000 during the year ended December 31, 2020. Deferred revenue related to the Sun Pharma Agreement totaled $90,000 as of December 31, 2020. On 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) (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) 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) 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 during the year ended December 31, 2020. Deferred revenue related to the Jeil Pharma Agreement totaled $0.2 million as of December 31, 2020. Income Taxes We account for income taxes in accordance with the provisions of ASC 740‑10, Income Taxes. A current tax liability or asset is recognized for the estimated taxes payable or refundable on tax returns for the year. Deferred tax liabilities or assets are recognized for the estimated future tax effects of temporary differences between book and tax accounting and operating loss and tax credit carryforwards. A valuation allowance is established for deferred tax assets if we determine it to be more likely than not that the deferred tax asset will not be realized. The effects of tax positions are generally recognized in the financial statements consistent with amounts reflected in returns filed, or expected to be filed, with taxing authorities. For tax positions that the Company considers to be uncertain, current and deferred tax liabilities are recognized, or assets derecognized, when it is probable that an income tax liability has been incurred and the amount of the liability is reasonably estimable, or when it is probable that a tax benefit, such as a tax credit or loss carryforward, will be disallowed by a taxing authority. The amount of unrecognized tax benefits related to current tax positions is insignificant. The Company recognizes interest and penalties accrued related to unrecognized tax benefits as income tax expense. Research and Product Development The Company recognizes research and product development expenses as incurred. The Company incurred product development and research costs related to the commercial development, patent approval and regulatory approval of new products aggregating approximately $7.1 million and $6.9 million for the years ended December 31, 2020 and 2019, respectively. Stock-Based Compensation Service-Based Stock Unit Awards The Company expenses stock-based compensation to employees over the requisite service period based on the estimated grant-date fair value of the awards. For stock-based compensation awards to non-employees, the Company re-measures the fair value of the non-employee awards at each reporting period prior to vesting and finally at the vesting date of the award. Changes in the estimated fair value of these non-employee awards are recognized as compensation expense in the period of change. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. For the years ended December 31, 2020 and 2019, the Company recorded stock-based compensation expense on its options granted under the Company’s equity compensation plans to its directors and officers, and its employees (See Note 13). Market and Performance-Based Stock Unit Awards In addition to awards with service-based vesting conditions, the Company has granted performance share units with market and performance conditions, to certain of its executives. The fair value of awards with performance conditions are based on the fair value of the Company’s common stock on the date of grant. The fair value of awards with market conditions are based on a Monte Carlo simulation model. Assumptions and estimates utilized in the calculation of the fair value of the market awards include the risk-free interest rate, dividend yield, average closing price, expected volatility based on the historical volatility of the Company, and the remaining period of the award. The awards with performance conditions vest and result in issuance, at settlement, of common stock for each recipient based upon the recipient’s continued employment with the Company through the settlement date of the award and the Company’s achievement of specified milestones. The requisite service period of the awards with performance conditions is generally 1-2 years. In the case of awards with performance conditions, the Company recognizes stock-based compensation expense based on the grant date fair value of the award when achievement of the underlying performance-based targets become probable. The awards with market conditions vest and result in the issuance of common stock based upon the recipient’s continuing employment with the Company through the settlement date of the award related to the market capitalization criteria. The fair value related to the awards with market conditions is recorded as stock-based compensation expense over the period from date of grant to the settlement date regardless of whether the market capitalization is achieved. Commitments and Contingencies In the normal course of business, the Company may become subject to loss contingencies, such as legal proceedings and claims arising out of its business, including government investigations. An accrual for a loss contingency is recognized when it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated. The Company expenses legal costs associated with loss contingencies as they are incurred. 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 issued common stock were exercised or converted into common stock or resulted in the issuance of common stock that are then shared 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 are 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 loss per share in the future that were not included in the computation of diluted loss per share for the years ended December 31, 2020 and 2019 were as follows: As of December 31, 2020 2019 Options to purchase common stock 6,467,956 8,598,149 Unvested restricted stock awards 146,800 146,800 Unvested restricted stock units 265,494 1,452,744 Warrants to purchase common stock 26,426,863 2,770,781 33,307,113 12,968,474 Accumulated Other Comprehensive Income Accumulated other comprehensive income includes all changes in equity during a period except those that resulted from investments by or distributions to the Company’s stockholders. Accumulated other comprehensive income refers to revenues, expenses, gains and losses that are included in comprehensive income, but excluded from net income as these amounts are recorded directly as an adjustment to stockholders’ equity. Accumulated other comprehensive income consists of unrealized gains and losses on available‑for‑sale investment securities and foreign currency translation adjustments. 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 study to determine the consequences of the change to its consolidated financial statements and assures that there are proper controls in place to ascertain that the Company’s consolidated financial statements properly reflect the change. |
Investments - Available-for-Sal
Investments - Available-for-Sale | 12 Months Ended |
Dec. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments - Available-for-Sale | Investments - Available-for-SaleInvestments available-for-sale consisted of the following as of December 31, 2020 and 2019 (table in thousands): December 31, 2020 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Income Fair Value Available-for-Sale Securities Bonds $ 9,987 $ 3 $ — $ 7 $ 9,997 December 31, 2019 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Income Fair Value Available-for-Sale Securities Bonds $ 14,238 $ 13 $ (1) $ — $ 14,250 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 Level 1, as described in Note 3, Fair Value Measurement to our consolidated financial statements. As of December 31, 2020 and 2019, the amortized cost and estimated fair value of our available-for-sale securities were due in one year or less. |
Significant Market Segments And
Significant Market Segments And Customers | 12 Months Ended |
Dec. 31, 2020 | |
Segment Reporting [Abstract] | |
Significant Market Segments And Customers | Significant Market Segments and Customers We operate in one market segment, the hemodialysis market, which involves the manufacture, sale and distribution of hemodialysis products to hemodialysis clinics, including pharmaceutical, dialysis concentrates, dialysis kits and other ancillary products used in the dialysis process. One customer, DaVita, Inc. ("DaVita"), accounted for 50% of our sales in 2020 and 49% of our sales in 2019. Our accounts receivable from this customer were $1.1 million and $1.2 million as of December 31, 2020 and 2019, respectively. In October 2014, we entered into the Distribution Agreement with Baxter, which was amended in June 2017 and March 2020, pursuant to which Baxter received exclusive distribution rights for our concentrate products in the United States, a commitment by Rockwell to maintain a specified manufacturing capacity for Baxter, a cap upon the net amount of reimbursable transportation expenses and modified extension terms. Our domestic customer contracts for the supply of dialysis concentrate products that permitted assignment to Baxter without consent have been assigned to Baxter. As a result, for 2020 and 2019, our direct sales to Baxter aggregated approximately 25% and 27% of sales, respectively, and we had a receivable from Baxter of $1.6 million and $2.0 million as of December 31, 2020 and 2019, respectively. DaVita and Baxter and the accounts administered by Baxter are important to our business, financial condition and results of operations. The loss of any significant accounts could have a material adverse effect on our business, financial condition and results of operations. No other domestic customers accounted for more than 10% of our sales in any of the last two years. |
Distribution Agreement
Distribution Agreement | 12 Months Ended |
Dec. 31, 2020 | |
DISTRIBUTION AGREEMENT. | |
Distribution Agreement | Distribution AgreementIn October 2014, we entered into the Distribution Agreement with Baxter, pursuant to which Baxter became our exclusive agent for commercializing our hemodialysis concentrate and ancillary products in the United States and various foreign countries for an initial term of 10 years ending October 2, 2024. We retain sales, marketing and distribution rights for our hemodialysis concentrate products for our international customers and in those countries in which we have an established commercial presence. During the term of the Distribution Agreement, Baxter has agreed not to manufacture or sell any competitive concentrate products in the United States hemodialysis market, other than specified products. The Distribution Agreement does not include any of the Company’s drug products. In June 2017, we entered into the First Amendment to Exclusive Distribution Agreement with Baxter (the “Amendment”). The Amendment provides for, among other things, reduced pricing on certain accounts and incentives to Baxter to pursue new customers and increase future sales. In March 2020, we entered into the Second Amendment to the Exclusive Distribution Agreement with Baxter (the “Second Amendment”). The Second Amendment provides for, among other things, a commitment by Rockwell to maintain a specified manufacturing capacity for Baxter, a cap upon the net amount of reimbursable transportation expenses and modified extension terms. Under the Distribution Agreement, Baxter purchases concentrate-related products from us at pre-determined gross margin-based prices per unit adjusted each year during the term and subject to an annual true up. The Distribution Agreement also requires Baxter to meet minimum annual purchase levels, subject to a cure period and certain other relief, in order to maintain its exclusive distribution rights. The minimum purchase levels increase each year over the term of the Distribution Agreement. Purchases in any calendar year that exceed the minimum may be carried forward and applied to future years’ minimum requirements. The Distribution Agreement, as amended by the Second Amendment, also contains provisions regarding our obligations to maintain specified manufacturing capacity and quality levels. We continue to manage customer service, transportation and certain other functions for our current customers. For customer service, Baxter pays us an amount equal to our related costs plus a slight mark-up for these services. For transportation costs, Baxter pays us an amount equal to our related costs, subject to the defined caps contained within the Second Amendment, which are based upon defined percentages of liquid concentrate product being shipped. The Distribution Agreement also provides that, upon the mutual determination of us and Baxter, Baxter will pay us up to $10 million to build a new manufacturing facility in the Pacific time-zone that would serve customers in the western United States. The fee payable in connection with construction of the facility will be reduced to the extent that the facility is not operational within 12 months after the start of construction. Except for any leased components, we will own and operate the facility when completed. Either party may terminate the Distribution Agreement upon the insolvency or material breach of the other party or in the event of a force majeure. In addition, Baxter may also terminate the Distribution Agreement at any time upon 270 days’ prior written notice to us or if (i) prices increase beyond certain thresholds and notice is provided within 45 days after the true up payment is due for the year in which the price threshold is exceeded, (ii) a change of control of the Company occurs and 270 days’ notice is provided, or (iii) upon written notice that Baxter has been enjoined by a court of competent jurisdiction from selling in the United States any product covered by the Distribution Agreement due to a claim of intellectual property infringement or misappropriation relating to such product. If Baxter terminates the Distribution Agreement under the discretionary termination or the price increase provisions, it would be subject to a limited non-compete obligation in the United States with respect to certain products for a period of two years. Pursuant to the Distribution Agreement, we received an upfront fee of $20 million in October 2014. If a “Refund Trigger Event” occurs prior to December 31, 2021, we would be obligated to repay 25% of the upfront fee and any paid portion of the facility fee. A “Refund Trigger Event” means any of the following: (i) a change of control of the Company involving any of certain specified companies; (ii) a termination by Baxter due to the Company’s bankruptcy or breach, or due to price increases that exceed the stated thresholds; (iii) a termination by either party due to a force majeure; (iv) settlement or adjudication of any claim, action or litigation relating to a covered product that materially and adversely affects Baxter’s commercialization of the product; and (v) any regulatory action or ruling relating to a covered product that materially and adversely affects Baxter’s commercialization of the product. The Upfront Fee has been deferred and is being recognized as revenue based on the proportion of product shipments to Baxter in each period to total expected sales volume over the term of the Distribution Agreement. We recognized revenue associated with the Upfront Fee totaling $2.0 million and $2.1 million for the years ended December 31, 2020, and 2019, respectively. The Distribution Agreement may be extended for an additional five years by Baxter if Baxter achieves a specified sales target and pays an extension fee of $7.5 million. If the first extension occurs, the Distribution Agreement term may later be extended an additional five years at Baxter’s option at no additional cost. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Components of inventory, net of reserves as of December 31, 2020 and 2019 are as follows (table in thousands): December 31, December 31, Raw Materials $ 3,112 $ 2,471 Work in Process 172 185 Finished Goods 1,805 1,432 Total $ 5,089 $ 4,088 As of December 31, 2020 and 2019, we classified $1.2 million and $0.4 million, respectively, of inventory as non-current all of which was related to Triferic or the active pharmaceutical ingredient for Triferic. As of December 31, 2020 and 2019, we had total Triferic inventory aggregating $3.9 million and $3.5 million respectively, against which we had reserved $2.6 million and $2.8 million, respectively. For the year ended December 31, 2020, the Company’s inventory reserves and write-offs decreased overall by $0.1 million, which consisted primarily of an increase in inventory reserve of $0.3 million offset by a reduction to inventory reserve of $0.4 million related to destruction of Triferic inventory. For the year ended December 31, 2019, inventory reserves and write-offs increased by $1.3 million. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment As of December 31, 2020 and 2019, the Company’s property and equipment consisted of the following (table in thousands): 2020 2019 Leasehold Improvements $ 1,196 $ 1,162 Machinery and Equipment 5,475 4,673 Information Technology & Office Equipment 1,831 1,810 Laboratory Equipment 676 653 9,178 8,298 Accumulated Depreciation (6,536) (5,865) Net Property and Equipment $ 2,642 $ 2,433 Depreciation expense during the years ended December 31, 2020 and 2019 is as follows (table in thousands): 2020 2019 Depreciation expense $ 834 $ 788 |
Goodwill And Intangible Assets
Goodwill And Intangible Assets | 12 Months Ended |
Dec. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | Goodwill and Intangible AssetsTotal goodwill was $0.9 million at December 31, 2020 and 2019. We completed our annual impairment tests as of December 31, 2020 and 2019, and determined that no adjustment for impairment of goodwill was required during the years ended December 31, 2020 and 2019. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities as of December 31, 2020 and 2019 consisted of the following (table in thousands): 2020 2019 Accrued Research & Development Expense $ 232 $ 283 Accrued Compensation and Benefits 2,500 1,108 Accrued Unvouchered Receipts 755 1,901 Accrued Workers Compensation 395 195 Other Accrued Liabilities 1,131 1,031 Total Accrued Liabilities $ 5,013 $ 4,518 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Preferred Stock As of December 31, 2020 and 2019, there were 2,000,000 shares of preferred stock, $0.0001 par value per share, authorized and no shares of preferred stock issued or outstanding. Common Stock As of December 31, 2020 and 2019, there were 170,000,000 shares of common stock, $0.0001 par value per share, authorized and 93,573,165 and 65,378,890 shares issued and outstanding, respectively. During the year ended December 31, 2019, 30,000 vested employee stock options were exercised for net cash proceeds of $147,900 at a weighted average exercise price of $4.93 per share. During the year ended December 31, 2020, no vested employee stock options were exercised. Controlled Equity 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, 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 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 a “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 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 year ended December 31, 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. As of December 31, 2020, approximately $32.3 million remains available for sale under this facility. We are not required to sell any shares at any time during the term of the facility. Our ability to sell common stock under the facility may be limited by several factors including, among other things, the trading volume of our common stock and certain black-out periods that we may impose upon the facility, among other things. Public Offerings 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 23,178,809 shares of 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 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% of the aggregate gross proceeds raised in the offering, minus $0.4 million 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% 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 December 31, 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. Restricted Common Stock During the year ended December 31, 2020, 988,958 shares of performance-based restricted stock and 152,097 shares of time-based restricted stock were forfeited. Forfeitures of the performance-based and time-based restricted stock were related to the resignation of Stuart Paul, former CEO, and Angus Smith, former CFO. During the year ended December 31, 2020, 224,994 shares of common stock related to fully vested restricted stock units were delivered to officers and employees of the Company. The Company withheld 8,348 of these shares of common stock at a fair value of $18,950 to cover the employees and officer’s withholding taxes related to the vesting of restricted stock units. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation The Board of Directors adopted the Rockwell Medical, Inc., 2007 Long Term Incentive Plan (“2007 LTIP”) on April 11, 2007. The 2007 LTIP expired on April 11, 2017 and no equity awards were granted under the 2007 LTIP following its expiration. There were 11,500,000 shares of common stock reserved for issuance under the 2007 LTIP. The Board of Directors adopted the 2018 Long-Term Incentive Plan (“2018 LTIP”) on January 29, 2018 as a replacement for the 2007 LTIP. Initially there were 3,300,000 shares of common stock reserved for issuance under the 2018 LTIP. On May 18, 2020, at the Annual Meeting, the Company’s stockholders approved the amendment and restatement of the Rockwell Medical, Inc. 2018 Long Term Incentive Plan to increase the number of shares of common stock issuable thereunder by 2,900,000 shares bringing common stock reserve for issuance up to 6,200,000 under the 2018 LTIP. The Compensation Committee of the Board of Directors (the “Committee”) is responsible for the administration of the 2007 LTIP and 2018 LTIP, including the grant of stock based awards and other financial incentives including performance based incentives to employees, non‑employee directors and consultants. Our standard stock option agreement under the 2007 LTIP and 2018 LTIP allows for the payment of the exercise price of vested stock options either through cash remittance in exchange for newly issued shares, or through non‑cash exchange of previously issued shares held by the recipient for at least six months in exchange for our newly issued shares. The 2007 LTIP and 2018 LTIP also allow for the retention of shares in payment of the exercise price and income tax withholding. The latter method results in no cash being received by us, but also results in a lower number of total shares being outstanding subsequently as a direct result of this exchange of shares. Shares returned to us in this manner would be retired. The Company recognized total stock-based compensation expense during the years ended December 31, 2020 and 2019 as follows (table in thousands): Year Ended 2020 2019 Service based awards: Restricted stock awards $ — $ (33) Restricted stock units 372 1,600 Stock option awards 1,491 2,300 $ 1,863 $ 3,867 Performance based awards: Restricted stock units $ (1,148) $ 642 Stock option awards (240) 443 (1,388) 1,085 Total $ 475 $ 4,952 Restricted Stock Awards A summary of the Company’s restricted stock awards during the years ended December 31, 2020 and 2019 is as follows: Number of Shares Weighted Average Unvested at January 1, 2019 146,800 $ 5.70 Unvested at December 31, 2019 146,800 $ 5.70 Unvested at December 31, 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 December 31, 2020, unvested restricted stock awards of 146,800 were related to performance based awards. Stock-based compensation expense of nil was recognized for both the year ended December 31, 2020 and 2019, respectively. As of December 31, 2020, there is no unrecognized stock-based compensation expense related to restricted stock awards. Service Based Restricted Stock Units A summary of the Company’s service based restricted stock units during the year ended December 31, 2020 and 2019 is as follows: Number of Shares Weighted Average Unvested at January 1, 2019 472,959 $ 4.32 Granted 244,063 4.09 Forfeited (28,916) 4.32 Vested (224,320) 4.19 Unvested at December 31, 2019 463,786 4.26 Granted 208,993 2.00 Forfeited (159,724) 4.26 Vested (247,561) 4.30 Unvested at December 31, 2020 265,494 $ 2.60 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 1-3 years. Stock-based compensation expense of 0.4 million and $1.6 million was recognized during the year ended December 31, 2020 and 2019, respectively. As of December 31, 2020, the unrecognized stock-based compensation expense was $0.2 million over the next 12 months. Performance Based Restricted Stock Units A summary of the Company’s performance based restricted stock units during the year ended December 31, 2020 and 2019 is as follows: Number of Shares Weighted Average Unvested at January 1, 2020 988,958 $ 4.48 Forfeited (988,958) $ 4.48 Unvested at December 31, 2020 — $ — Number of Shares Weighted Average Unvested at January 1, 2019 988,958 $ 4.48 Unvested at December 31, 2019 988,958 $ 4.48 Stock-based compensation expense recognized for performance based restricted stock units was $(1.1) million and $0.6 million for the year ended December 31, 2020 and 2019, respectively. As of December 31, 2020, there was no 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, Stuart Paul, on April 17, 2020 and the resignation of the Company's former Chief Financial Officer, Angus Smith, effective July 3, 2020. These forfeited awards reduced stock-based compensation expense for the year ended December 31, 2020 by $1.4 million. Service Based Stock Options The fair value of the service based stock options granted for the years ended December 31, 2020 and 2019 were based on the following assumptions: December 31, 2020 2019 Exercise price $0.92 - $2.90 $1.91 - $6.55 Expected stock price volatility 68.2% - 75.8% 67.5% - 70.3% Risk-free interest rate 0.31% - 1.70% 1.40% - 2.60% Term (years) 5.5 - 6.0 3.4 - 6.5 A summary of the Company’s service based stock option activity for the years ended December 31, 2020 and 2019 is as follows: Shares Weighted Weighted Aggregate Intrinsic Value (in $1,000's) Outstanding at January 1, 2019 7,856,480 $ 7.50 5.2 $ — Granted 1,103,938 $ 3.37 9.0 107 Exercised (30,000) $ 4.93 — Forfeited (720,394) $ (6.24) — Outstanding at December 31, 2019 8,210,024 $ 7.06 5.1 $ 107 Granted 2,288,386 $ 1.94 9.0 — Exercised — $ — — Expired (4,249,596) $ (8.07) — Forfeited (530,858) $ (3.88) — Outstanding at December 31, 2020 5,717,956 $ 4.55 6.6 $ — Exercisable at December 31, 2020 2,898,104 $ 6.85 3.9 $ — The aggregate intrinsic value in the table above is calculated as the difference between the closing price of our common stock and the exercise price of the stock options that had strike prices below the closing price. During the year ended December 31, 2020 and 2019, the service based stock options granted consisted of 2,288,386 and 1,103,938 options granted to employees, respectively. As of December 31, 2020, 2,898,104 vested options were exercisable at a weighted average price of 6.85 per share. During the year ended December 31, 2020 and 2019, stock-based compensation expense of $1.5 million and $2.3 million was recognized, respectively. As of December 31, 2020, total stock-based compensation expense related to 2,819,582 unvested options not yet recognized totaled approximately $2.2 million over the next 2.2 years. Performance Based Stock Options A summary of the performance based stock options granted for the year ended December 31, 2020, is as follows: Number of Shares Weighted Average Outstanding at January 1, 2019 388,125 $ 4.70 Outstanding at December 31, 2019 388,125 $ 4.70 Granted 750,000 $ 2.20 Forfeited (388,125) $ (4.70) Outstanding at December 31, 2020 750,000 $ 2.20 Exercisable at December 31, 2020 — $ — Stock-based compensation expense recognized for performance-based stock options was $(0.2) million and $0.4 million for the year ended December 31, 2020 and 2019. As of December 31, 2020, the unrecognized stock-based compensation expense related to unvested performance-based stock options was $0.2 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, Stuart Paul, on April 17, 2020. These forfeited options reduced stock-based compensation expense by $0.7 million. A performance option may be comprised of either a performance based award or a market-based award. Performance based awards start vesting on the grant date through the probability date of the measured performance, and the fair value is the market price of one common share on the grant date. Evaluation of the expected vesting period is reviewed quarterly. Market-based awards vest upon the achievement of the market-based performance goal, provided the continued employment of the Company’s employee. The fair value of each market-based stock option was determined through the use of the Monte Carlo simulation method. Over the performance period, the number of shares expected to be issued is adjusted upward or downward based upon probability of achievement of performance targets. The ultimate number of shares issued and the related compensation cost recognized is based on a comparison of the final performance metrics to the specified targets. The fair value of the performance-based stock options granted for the year ended December 31, 2020 were based on the following assumptions: Expected stock price volatility 74.4% Risk-free interest rate 0.4% Dividend yield rate — Term (years) 5.7 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions Product License Agreements The Company is a party to a Licensing Agreement between the Company and Charak, LLC (“Charak”) dated January 7, 2002 (the “2002 Agreement”) that grants the Company exclusive worldwide rights to certain patents and information related to 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, a former Officer of the Company (see Note 18). Pursuant to the MSA, the parties entered into three additional agreements described below related to the license of certain soluble ferric pyrophosphate (“SFP”) intellectual property owned by Charak, as well as the Employment Agreement (defined below). The Charak MSA provides for a payment of $1.0 million to Dr. Gupta, payable in four 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 December 31, 2020, the Company has fulfilled its reimbursement obligation of certain legal expenses and accrued $0.1 million relating to certain IP reimbursement expenses and certain sublicense royalty fees as a related party payable 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 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 sublicensee 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 sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis. Also pursuant to the Charak MSA, the Company and Charak entered into a Commercialization and Technology License Agreement IV Triferic®, dated as of October 7, 2018 (the “IV Agreement”), under which Charak granted the Company an exclusive, sublicensable, 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 country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the IV Agreement, which amount shall not be less than a minimum specified percentage of net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis. Also pursuant to the Charak MSA, the Company and Charak entered into a Technology License Agreement TPN Triferic®, dated as of October 7, 2018 (the “TPN Agreement”), pursuant to which Charak granted the Company an exclusive, sublicensable, royalty-bearing license to SFP for the purpose of commercializing worldwide certain TPN products incorporating SFP. The license grant under the TPN Agreement continues for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. During the term of the TPN Agreement, the Company is liable to pay Charak a base royalty on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the TPN Agreement, which amount shall not be less than a minimum royalty on net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis. The potential milestone payments are not yet considered probable, and no milestone payments have been accrued at December 31, 2020. Director Compensation In 2019, the Company compensated non-employee directors with a cash retainer, which was approved by the Board of Directors, to serve on a special Advisory Committee of the Board, which committee was delegated to provide Board-level oversight of senior management and not have any management authority within the Company. Independent directors Lisa Colleran and John Cooper were appointed to the Advisory Committee. The aggregate compensation paid to the members of the advisory Committee for the year ended December 31, 2020 and 2019 was $225,000 and $202,500, respectively. The Advisory Committee disbanded in May 2020. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Leases We lease our 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 products. The lease terms range from monthly to seven years. We occupy a 51,000 square foot facility and a 17,500 square foot facility in Wixom, Michigan under a lease expiring in August 2021. We also occupy two other manufacturing facilities, a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December 2025, and a 57,000 square foot facility in Greer, South Carolina under a lease expiring February 2023. In addition, we occupy 4,100 square feet of office space in Hackensack, New Jersey under a lease expiring on July 1, 2024. This lease is currently being offered for sublease. The following summarizes quantitative information about the Company’s operating leases (dollars in thousands): For the year ended December 31, For the year ended December 31, 2020 2019 Operating leases Operating lease cost $ 1,609 $ 2,076 Variable lease cost 488 318 Operating lease expense 2,097 2,394 Finance leases Amortization of right-of-use assets 18 — Interest on lease obligations 5 — Finance lease expense 23 — Short-term lease rent expense 17 17 Total rent expense $ 2,137 $ 2,411 Other information Operating cash flows from operating leases $ 1,648 $ 2,015 Operating cash flows from finance leases $ 5 $ — Financing cash flows from finance leases $ 17 $ — Right of use assets exchanged for operating lease liabilities $ 268 $ 5,077 Right of use assets exchanged for finance lease liabilities $ 930 $ — Weighted-average remaining lease term - operating leases 2.3 1.9 Weighted-average remaining lease term – finance leases 5.8 0 Weighted-average discount rate - operating leases 6.4 % 6.8 % Weighted-average discount rate – finance leases 5.1 % — % Future minimum rental payments under operating lease agreements are as follows (table in thousands): Operating Finance Year ending December 31, 2021 $ 1,131 $ 176 Year ending December 31, 2022 668 179 Year ending December 31, 2023 314 181 Year ending December 31, 2024 118 178 Year Ended December 31, 2025 6 176 Year Ended December 31, 2026 — 163 Total 2,237 1,053 Less present value discount $ (162) $ (140) Operating and Finance lease liabilities. $ 2,075 $ 913 Insurance We evaluate various kinds of risk that we are exposed to in our business. In our evaluation of risk, we evaluate options and alternatives to mitigating such risks. For certain insurable risks, we may acquire insurance policies to protect against potential losses or to partially insure against certain risks. For our subsidiary, Rockwell Transportation, Inc., we maintain a partially self-insured workers' compensation policy. Under the policy, our self‑insurance retention is $350,000 per occurrence and $602,354 in aggregate coverage for the policy year ending July 1, 2021. The total amount at December 31, 2020 by which retention limits exceed the claims paid and accrued is approximately $479,000 for the policy year ending July 1, 2020. Estimated loss and additional future claims of approximately $395,000 have been reserved and accrued for the year ended December 31, 2020. As of December 31, 2020, approximately $0.3 million was held in cash collateral and escrow by the insurance carrier for workers’ compensation insurance. At December 31, 2020, amounts held in cash collateral and escrow are included in prepaid expenses and other non-current assets in the consolidated financial statements. Purchase Obligations We have contracts for anticipated future obligations through December 31, 2021 of approximately $25.5 million, which include $23.8 million for concentrate manufacturing and $1.7 million in ancillary supplies. 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 December 31, 2020, the Company has performed all required obligations 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 status for Triferic (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 December 31, 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. 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. |
Loan and Security Agreement
Loan and Security Agreement | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Loan and Security Agreement | Loan and Security Agreement 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 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 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 and an effective interest rate of 10.90%. 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. For the year ended December 31, 2020, interest expense amounted to $1.6 million. The Loan Agreement is secured by all assets of 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 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 Triferic sales for the year ended December 31, 2020, we did not satisfy this covenant as of December 31, 2020. The Company utilized the cure provision to regain compliance, which Innovatus accepted. As of December 31, 2020, the Company is in compliance with all the reporting and financial covenants. 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 December 31, 2020, the outstanding balance of the Term Loan was $20.9 million, net of unamortized issuance costs and unaccreted discount of $1.6 million. The following table reflects the schedule of principal payments on the Term Loan as of December 31, 2020 (in thousands): Year Principal Payments 2021 $ — 2022 2,250 2023 9,000 2024 9,000 2025 2,250 $ 22,500 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes A reconciliation of income tax expense at the statutory rate to income tax expense at our effective tax rate is as follows (dollars in thousands): 2020 2019 Tax Expense (Benefit) Computed at 22.67% and 22.79% of Pretax Income (Loss) $ (6,373) $ (7,780) Changes in Tax Laws — — Foreign Income Tax Expense — — Effect of Change in Valuation Allowance 6,373 7,780 Total Income Tax Expense $ — $ — The details of the net deferred tax asset are as follows (dollars in thousands): December 31, 2020 2019 Deferred tax assets: Net Operating Loss Carryforward $ 59,586 $ 52,935 Stock Based Compensation 7,582 7,514 Deferred Revenue 2,310 2,752 General Business Credit 6,872 6,872 Accrued Expenses 185 280 Inventories 666 866 Book over Tax Depreciation 25 18 Other Deferred Tax Assets 387 22 Total Deferred Tax Assets 77,613 71,259 Deferred Tax Liabilities: Goodwill & Intangible Assets 155 136 Prepaid Expenses 294 332 Total Deferred Tax Liabilities 449 468 Subtotal 77,164 70,791 Valuation Allowance (77,164) (70,791) Net Deferred Tax Asset $ — $ — The Tax Cuts and Jobs Act of 2017 ("TCJA") impacted how net operating losses are utilized. The Coronavirus Aid, Relief, and Economic Security Act ("CARES Act") temporarily suspends the TCJA limitation, allowing a net operating loss carryforward to fully offset taxable income in tax years beginning before January 1, 2021. The CARES Act also temporarily reinstated a carryback period for all net operating losses generated in years beginning after December 31, 2017 and before January 1, 2021. The carryback period for those years is five years under the CARES Act. Deferred tax assets result primarily from net operating loss carryforwards. For federal tax purposes, we have net operating loss carryforwards of approximately $262.9 million that expire between 2021 and 2037. In assessing the potential for realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized upon the generation of future taxable income during the periods in which those temporary differences become deductible. We recognized no income tax expense or benefit for the years ended December 31, 2020, and 2019. While we anticipate generating income within the next year or two, we expect to incur operating losses until our drug products are marketed and generating sufficient profits to offset our operating expenses. Considered together with our limited history of operating income and our net losses in 2020 and 2019, management has placed a full valuation allowance against the net deferred tax assets as of December 31, 2020 and 2019. The portion of the valuation allowance resulting from excess tax benefits on share based compensation that would be credited directly to contributed capital if recognized in subsequent periods is $4.2 million. We account for our uncertain tax positions in accordance with ASC 740‑10, Income Taxes |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent EventsEffective January 19, 2021, as authorized by the Board of Directors of Rockwell Medical, Inc., the Company terminated the employment of Ajay Gupta, M.D. as the Company’s Chief Scientific Officer. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited. Rockwell Medical India Private Limited was formed in 2017 for the purpose of conducting certain commercial activities in India. All 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. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue under Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers. The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: • Step 1: Identify the contract with the customer • Step 2: Identify the performance obligations in the contract • Step 3: Determine the transaction price • Step 4: Allocate the transaction price to the performance obligations in the contract • Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by 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 four 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") and Jeil Pharmaceutical Co., Ltd. ("Jeil 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 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 US dollars ($) Year Ended December 31, 2020 Products By Geographic Area Total U.S. Rest of World Drug Revenues Product Sales - Point-in-time $ 910 $ 910 $ — License Fee – Over time 226 — 226 Total Drug Products 1,136 910 226 Concentrate Products Product Sales – Point-in-time 59,100 53,707 5,393 License Fee – Point-in-time 1,961 1,961 — Total Concentrate Products 61,061 55,668 5,393 Net Revenue $ 62,197 $ 56,578 $ 5,619 In thousands of US dollars ($) Year Ended December 31, 2019 Products By Geographic Area Total U.S. Rest of World Drug Revenues Product Sales - Point-in-time $ 272 $ 272 $ — License Fee – Over time 273 — 273 Total Drug Products 545 272 273 Concentrate Products Product Sales – Point-in-time 58,778 52,540 6,238 License Fee – Point-in-time 1,980 1,980 — Total Concentrate Products 60,758 54,520 6,238 Net Revenue $ 61,303 $ 54,792 $ 6,511 For the years ended December 31, 2020 and 2019, license fee revenue was $2.2 million and $2.3 million, respectively. For the years ended December 31, 2020 and 2019, product sales revenue was $60.0 million and $59.0 million, respectively. Contract balances The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands of US dollars ($) December 31, 2020 December 31, 2019 Receivables, which are included in "Trade and other receivables" $ 4,171 $ 4,203 Contract liabilities $ 10,190 $ 12,076 There were no impairment losses recognized related to any receivables arising from the Company’s contracts with customers for the years ended December 31, 2020 and 2019. For the years ended December 31, 2020 and 2019, the Company did not recognize material bad-debt expense and there were no material contract assets recorded on the consolidated balance sheets as of December 31, 2020 and 2019. The Company does not generally accept returns of its concentrate products and no reserve for returns of concentrate products was established as of December 31, 2020 or December 31, 2019. 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 year ended December 31, 2020, 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 $10.2 million and $12.1 million as of December 31, 2020 and 2019, respectively. 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. As of December 31, 2020 unfulfilled performance obligations related to the Baxter Agreement are product sales totaling $7.2 million, which will be amortized through expiration of the agreement on October 2, 2024. Deferred Revenue In October 2014, the Company entered into a 10 year distribution 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 Distribution Agreement. The Company recognized revenue of approximately $2.0 million and $2.1 million for the years ended December 31, 2020 and 2019, respectively. Deferred revenue related to the Baxter agreement totaled $7.2 million and $9.1 million as of December 31, 2020 and 2019, respectively. If a “Refund Trigger Event” occurs prior to December 31, 2021, Rockwell would be obligated to repay 25% of the upfront fee. During the year ended December 31, 2016, the Company entered into a distribution agreement with Wanbang 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 $0.2 million and $0.3 million during the years ended December 31, 2020 and 2019, respectively. Deferred revenue related to the Wanbang agreement totaled $2.7 million and $2.9 million as of December 31, 2020 and 2019, respectively. On 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) (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) 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) in 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 $10,000 during the year ended December 31, 2020. Deferred revenue related to the Sun Pharma Agreement totaled $90,000 as of December 31, 2020. On 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) (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) 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) 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 |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“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 consolidated financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. The most significant accounting estimates inherent in the preparation of our financial statements include estimates associated with fair value and classification of warrants, revenue recognition, allowance for doubtful accounts, inventory reserves, accrued expenses, deferred license revenue, stock-based compensation, impairments of long-lived assets, and accounting for income taxes. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents excluding items held in Investments - Available for Sale as noted below. Cash and cash equivalents include cash held in banks, money market mutual funds and unrestricted certificates of deposit. The Company’s cash and cash equivalents exceeds the Federal Deposit Insurance Corporation insured limits. The Company has not experienced any credit losses for amounts in excess of insured limits. Currently the Company does not reasonably believe a significant risk of credit loss exists. |
Fair Value Measurement | Fair Value Measurement The Company applies the guidance issued with ASC 820, Fair Value Measurements , which provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity ad values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. |
Investments - Available for Sale | Investments – Available for Sale The Company has designated its short term investments as of each balance sheet date as available-for-sale securities and accounts for them at their respective fair values. Available-for-sale securities are measured at fair value, including accrued interest, with temporary unrealized gains and losses reported as a component of stockholders' equity until their disposition. We review all available-for-sale securities at each period end to determine if they remain available-for-sale based on our then current intent and ability to sell the security if required to do so. The cost of securities sold is based on the specific identification method. All of our investments available-for-sale are subject to periodic impairment review. We recognize an impairment charge when a decline in the fair value of our investments below the cost basis is judged to be other than temporary. |
Accounts Receivable | Accounts Receivable Accounts receivable are stated at invoice amounts. The carrying amount of trade accounts receivable is reduced by an allowance for doubtful accounts that reflects our best estimate of accounts that may not be collected. We review outstanding trade accounts receivable balances and based on our assessment of expected collections, we estimate the portion, if any, of the balance that may not be collected as well as a general valuation allowance for other accounts receivable based primarily on historical experience. All accounts or portions thereof deemed to be uncollectible are written off to the allowance for doubtful accounts. |
Inventory | InventoryInventory is stated at the lower of cost or net realizable value. Cost is determined on the first‑in first‑out (FIFO) method. Inventory that is not expected to be converted to cash over the next year is classified as non-current. Our policy is to reserve for our drug product inventory that we determine is unlikely to be sold to, or if sold, unlikely to be utilized by our customers on or before its expiration date. |
Property and Equipment | Property and Equipment Property and equipment is recorded at cost and are depreciated using the straight‑line method over the useful lives of the assets, which range from three |
Impairment of Long-lived Assets | Impairment of Long-lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable. Impairment losses on long-lived assets, such as real estate and equipment, are recognized when events or changes in circumstances indicate that the undiscounted cash flows estimated to be generated by such assets are less than their carrying value and, accordingly, all or a portion of such carrying value may not be recoverable. Impairment |
Goodwill and Intangible Assets | Goodwill and Intangible Assets Goodwill is the excess of purchase price over the fair value of identified net assets of businesses acquired. Intangible assets with indefinite useful lives are measured at their respective fair values as of the acquisition date. Rockwell reviews goodwill and indefinite-lived intangible assets at least annually for possible impairment. Goodwill and indefinite-lived intangible assets are reviewed for possible impairment between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of the reporting unit or the indefinite-lived intangible assets below their carrying values. Intangible assets with definite lives are amortized over their estimated useful lives. Intangible assets subject to amortization are reviewed for potential impairment whenever events or circumstances indicate that carrying amounts may not be recoverable. Definite-lived intangible assets consist of our license fees related to the technology, intellectual property and marketing rights for Triferic covered under certain issued patents have been capitalized and are being amortized over the life of the related patents which is generally 17 years. |
Deferred Revenue | Revenue Recognition The Company recognizes revenue under Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers. The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: • Step 1: Identify the contract with the customer • Step 2: Identify the performance obligations in the contract • Step 3: Determine the transaction price • Step 4: Allocate the transaction price to the performance obligations in the contract • Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by 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 four 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") and Jeil Pharmaceutical Co., Ltd. ("Jeil 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 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 US dollars ($) Year Ended December 31, 2020 Products By Geographic Area Total U.S. Rest of World Drug Revenues Product Sales - Point-in-time $ 910 $ 910 $ — License Fee – Over time 226 — 226 Total Drug Products 1,136 910 226 Concentrate Products Product Sales – Point-in-time 59,100 53,707 5,393 License Fee – Point-in-time 1,961 1,961 — Total Concentrate Products 61,061 55,668 5,393 Net Revenue $ 62,197 $ 56,578 $ 5,619 In thousands of US dollars ($) Year Ended December 31, 2019 Products By Geographic Area Total U.S. Rest of World Drug Revenues Product Sales - Point-in-time $ 272 $ 272 $ — License Fee – Over time 273 — 273 Total Drug Products 545 272 273 Concentrate Products Product Sales – Point-in-time 58,778 52,540 6,238 License Fee – Point-in-time 1,980 1,980 — Total Concentrate Products 60,758 54,520 6,238 Net Revenue $ 61,303 $ 54,792 $ 6,511 For the years ended December 31, 2020 and 2019, license fee revenue was $2.2 million and $2.3 million, respectively. For the years ended December 31, 2020 and 2019, product sales revenue was $60.0 million and $59.0 million, respectively. Contract balances The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands of US dollars ($) December 31, 2020 December 31, 2019 Receivables, which are included in "Trade and other receivables" $ 4,171 $ 4,203 Contract liabilities $ 10,190 $ 12,076 There were no impairment losses recognized related to any receivables arising from the Company’s contracts with customers for the years ended December 31, 2020 and 2019. For the years ended December 31, 2020 and 2019, the Company did not recognize material bad-debt expense and there were no material contract assets recorded on the consolidated balance sheets as of December 31, 2020 and 2019. The Company does not generally accept returns of its concentrate products and no reserve for returns of concentrate products was established as of December 31, 2020 or December 31, 2019. 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 year ended December 31, 2020, 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 $10.2 million and $12.1 million as of December 31, 2020 and 2019, respectively. 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. As of December 31, 2020 unfulfilled performance obligations related to the Baxter Agreement are product sales totaling $7.2 million, which will be amortized through expiration of the agreement on October 2, 2024. Deferred Revenue In October 2014, the Company entered into a 10 year distribution 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 Distribution Agreement. The Company recognized revenue of approximately $2.0 million and $2.1 million for the years ended December 31, 2020 and 2019, respectively. Deferred revenue related to the Baxter agreement totaled $7.2 million and $9.1 million as of December 31, 2020 and 2019, respectively. If a “Refund Trigger Event” occurs prior to December 31, 2021, Rockwell would be obligated to repay 25% of the upfront fee. During the year ended December 31, 2016, the Company entered into a distribution agreement with Wanbang 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 $0.2 million and $0.3 million during the years ended December 31, 2020 and 2019, respectively. Deferred revenue related to the Wanbang agreement totaled $2.7 million and $2.9 million as of December 31, 2020 and 2019, respectively. On 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) (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) 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) in 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 $10,000 during the year ended December 31, 2020. Deferred revenue related to the Sun Pharma Agreement totaled $90,000 as of December 31, 2020. On 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) (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) 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) 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 |
Income Taxes | Income Taxes We account for income taxes in accordance with the provisions of ASC 740‑10, Income Taxes. A current tax liability or asset is recognized for the estimated taxes payable or refundable on tax returns for the year. Deferred tax liabilities or assets are recognized for the estimated future tax effects of temporary differences between book and tax accounting and operating loss and tax credit carryforwards. A valuation allowance is established for deferred tax assets if we determine it to be more likely than not that the deferred tax asset will not be realized. The effects of tax positions are generally recognized in the financial statements consistent with amounts reflected in returns filed, or expected to be filed, with taxing authorities. For tax positions that the Company considers to be uncertain, current and deferred tax liabilities are recognized, or assets derecognized, when it is probable that an income tax liability has been incurred and the amount of the liability is reasonably estimable, or when it is probable that a tax benefit, such as a tax credit or loss carryforward, will be disallowed by a taxing authority. The amount of unrecognized tax benefits related to current tax positions is insignificant. The Company recognizes interest and penalties accrued related to unrecognized tax benefits as income tax expense. |
Research and Product Development | Research and Product Development The Company recognizes research and product development expenses as incurred. The Company incurred product development and research costs related to the commercial development, patent approval and regulatory approval of new products aggregating approximately $7.1 million and $6.9 million for the years ended December 31, 2020 and 2019, respectively. |
Stock-Based Compensation | Stock-Based Compensation Service-Based Stock Unit Awards The Company expenses stock-based compensation to employees over the requisite service period based on the estimated grant-date fair value of the awards. For stock-based compensation awards to non-employees, the Company re-measures the fair value of the non-employee awards at each reporting period prior to vesting and finally at the vesting date of the award. Changes in the estimated fair value of these non-employee awards are recognized as compensation expense in the period of change. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. For the years ended December 31, 2020 and 2019, the Company recorded stock-based compensation expense on its options granted under the Company’s equity compensation plans to its directors and officers, and its employees (See Note 13). Market and Performance-Based Stock Unit Awards In addition to awards with service-based vesting conditions, the Company has granted performance share units with market and performance conditions, to certain of its executives. The fair value of awards with performance conditions are based on the fair value of the Company’s common stock on the date of grant. The fair value of awards with market conditions are based on a Monte Carlo simulation model. Assumptions and estimates utilized in the calculation of the fair value of the market awards include the risk-free interest rate, dividend yield, average closing price, expected volatility based on the historical volatility of the Company, and the remaining period of the award. The awards with performance conditions vest and result in issuance, at settlement, of common stock for each recipient based upon the recipient’s continued employment with the Company through the settlement date of the award and the Company’s achievement of specified milestones. The requisite service period of the awards with performance conditions is generally 1-2 years. In the case of awards with performance conditions, the Company recognizes stock-based compensation expense based on the grant date fair value of the award when achievement of the underlying performance-based targets become probable. The awards with market conditions vest and result in the issuance of common stock based upon the recipient’s continuing employment with the Company through the settlement date of the award related to the market capitalization criteria. |
Commitments and Contingencies | Commitments and Contingencies In the normal course of business, the Company may become subject to loss contingencies, such as legal proceedings and claims arising out of its business, including government investigations. An accrual for a loss contingency is recognized when it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated. The Company expenses legal costs associated with loss contingencies as they are incurred. |
Loss Per Share | 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 issued common stock were exercised or converted into common stock or resulted in the issuance of common stock that are then shared in the earnings of the entity. |
Accumulated Other Comprehensive Income | Accumulated Other Comprehensive Income Accumulated other comprehensive income includes all changes in equity during a period except those that resulted from investments by or distributions to the Company’s stockholders. Accumulated other comprehensive income refers to revenues, expenses, gains and losses that are included in comprehensive income, but excluded from net income as these amounts are recorded directly as an adjustment to stockholders’ equity. Accumulated other comprehensive income consists of unrealized gains and losses on available‑for‑sale investment securities and foreign currency translation adjustments. |
Adoption of Recent Accounting Pronouncements | 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 study to determine the consequences of the change to its consolidated financial statements and assures that there are proper controls in place to ascertain that the Company’s consolidated financial statements properly reflect the change. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Disaggregation of revenue | Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition. In thousands of US dollars ($) Year Ended December 31, 2020 Products By Geographic Area Total U.S. Rest of World Drug Revenues Product Sales - Point-in-time $ 910 $ 910 $ — License Fee – Over time 226 — 226 Total Drug Products 1,136 910 226 Concentrate Products Product Sales – Point-in-time 59,100 53,707 5,393 License Fee – Point-in-time 1,961 1,961 — Total Concentrate Products 61,061 55,668 5,393 Net Revenue $ 62,197 $ 56,578 $ 5,619 In thousands of US dollars ($) Year Ended December 31, 2019 Products By Geographic Area Total U.S. Rest of World Drug Revenues Product Sales - Point-in-time $ 272 $ 272 $ — License Fee – Over time 273 — 273 Total Drug Products 545 272 273 Concentrate Products Product Sales – Point-in-time 58,778 52,540 6,238 License Fee – Point-in-time 1,980 1,980 — Total Concentrate Products 60,758 54,520 6,238 Net Revenue $ 61,303 $ 54,792 $ 6,511 |
Contract balances | The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands of US dollars ($) December 31, 2020 December 31, 2019 Receivables, which are included in "Trade and other receivables" $ 4,171 $ 4,203 Contract liabilities $ 10,190 $ 12,076 |
Summary of potentially dilutive securities | Securities that could potentially dilute loss per share in the future that were not included in the computation of diluted loss per share for the years ended December 31, 2020 and 2019 were as follows: As of December 31, 2020 2019 Options to purchase common stock 6,467,956 8,598,149 Unvested restricted stock awards 146,800 146,800 Unvested restricted stock units 265,494 1,452,744 Warrants to purchase common stock 26,426,863 2,770,781 33,307,113 12,968,474 |
Investments - Available-for-S_2
Investments - Available-for-Sale (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments available for sale | Investments available-for-sale consisted of the following as of December 31, 2020 and 2019 (table in thousands): December 31, 2020 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Income Fair Value Available-for-Sale Securities Bonds $ 9,987 $ 3 $ — $ 7 $ 9,997 December 31, 2019 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Income Fair Value Available-for-Sale Securities Bonds $ 14,238 $ 13 $ (1) $ — $ 14,250 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule components of inventory | Components of inventory, net of reserves as of December 31, 2020 and 2019 are as follows (table in thousands): December 31, December 31, Raw Materials $ 3,112 $ 2,471 Work in Process 172 185 Finished Goods 1,805 1,432 Total $ 5,089 $ 4,088 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment and depreciation expense | As of December 31, 2020 and 2019, the Company’s property and equipment consisted of the following (table in thousands): 2020 2019 Leasehold Improvements $ 1,196 $ 1,162 Machinery and Equipment 5,475 4,673 Information Technology & Office Equipment 1,831 1,810 Laboratory Equipment 676 653 9,178 8,298 Accumulated Depreciation (6,536) (5,865) Net Property and Equipment $ 2,642 $ 2,433 Depreciation expense during the years ended December 31, 2020 and 2019 is as follows (table in thousands): 2020 2019 Depreciation expense $ 834 $ 788 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities as of December 31, 2020 and 2019 consisted of the following (table in thousands): 2020 2019 Accrued Research & Development Expense $ 232 $ 283 Accrued Compensation and Benefits 2,500 1,108 Accrued Unvouchered Receipts 755 1,901 Accrued Workers Compensation 395 195 Other Accrued Liabilities 1,131 1,031 Total Accrued Liabilities $ 5,013 $ 4,518 |
Stock-Based Compensation - (Tab
Stock-Based Compensation - (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Schedule of total stock-based compensation expense | The Company recognized total stock-based compensation expense during the years ended December 31, 2020 and 2019 as follows (table in thousands): Year Ended 2020 2019 Service based awards: Restricted stock awards $ — $ (33) Restricted stock units 372 1,600 Stock option awards 1,491 2,300 $ 1,863 $ 3,867 Performance based awards: Restricted stock units $ (1,148) $ 642 Stock option awards (240) 443 (1,388) 1,085 Total $ 475 $ 4,952 |
Restricted stock awards | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Schedule of restricted stock award | A summary of the Company’s restricted stock awards during the years ended December 31, 2020 and 2019 is as follows: Number of Shares Weighted Average Unvested at January 1, 2019 146,800 $ 5.70 Unvested at December 31, 2019 146,800 $ 5.70 Unvested at December 31, 2020 146,800 $ 5.70 |
Restricted stock units - Service based awards | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Schedule of restricted stock award | A summary of the Company’s service based restricted stock units during the year ended December 31, 2020 and 2019 is as follows: Number of Shares Weighted Average Unvested at January 1, 2019 472,959 $ 4.32 Granted 244,063 4.09 Forfeited (28,916) 4.32 Vested (224,320) 4.19 Unvested at December 31, 2019 463,786 4.26 Granted 208,993 2.00 Forfeited (159,724) 4.26 Vested (247,561) 4.30 Unvested at December 31, 2020 265,494 $ 2.60 |
Restricted stock units - Performance based awards | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Schedule of restricted stock award | A summary of the Company’s performance based restricted stock units during the year ended December 31, 2020 and 2019 is as follows: Number of Shares Weighted Average Unvested at January 1, 2020 988,958 $ 4.48 Forfeited (988,958) $ 4.48 Unvested at December 31, 2020 — $ — Number of Shares Weighted Average Unvested at January 1, 2019 988,958 $ 4.48 Unvested at December 31, 2019 988,958 $ 4.48 |
Stock option awards - Service based awards | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Schedule of stock option assumptions | The fair value of the service based stock options granted for the years ended December 31, 2020 and 2019 were based on the following assumptions: December 31, 2020 2019 Exercise price $0.92 - $2.90 $1.91 - $6.55 Expected stock price volatility 68.2% - 75.8% 67.5% - 70.3% Risk-free interest rate 0.31% - 1.70% 1.40% - 2.60% Term (years) 5.5 - 6.0 3.4 - 6.5 |
Schedule of stock options activity | A summary of the Company’s service based stock option activity for the years ended December 31, 2020 and 2019 is as follows: Shares Weighted Weighted Aggregate Intrinsic Value (in $1,000's) Outstanding at January 1, 2019 7,856,480 $ 7.50 5.2 $ — Granted 1,103,938 $ 3.37 9.0 107 Exercised (30,000) $ 4.93 — Forfeited (720,394) $ (6.24) — Outstanding at December 31, 2019 8,210,024 $ 7.06 5.1 $ 107 Granted 2,288,386 $ 1.94 9.0 — Exercised — $ — — Expired (4,249,596) $ (8.07) — Forfeited (530,858) $ (3.88) — Outstanding at December 31, 2020 5,717,956 $ 4.55 6.6 $ — Exercisable at December 31, 2020 2,898,104 $ 6.85 3.9 $ — |
Stock option awards - Performance based awards | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Schedule of stock option assumptions | The fair value of the performance-based stock options granted for the year ended December 31, 2020 were based on the following assumptions: Expected stock price volatility 74.4% Risk-free interest rate 0.4% Dividend yield rate — Term (years) 5.7 |
Schedule of stock options activity | A summary of the performance based stock options granted for the year ended December 31, 2020, is as follows: Number of Shares Weighted Average Outstanding at January 1, 2019 388,125 $ 4.70 Outstanding at December 31, 2019 388,125 $ 4.70 Granted 750,000 $ 2.20 Forfeited (388,125) $ (4.70) Outstanding at December 31, 2020 750,000 $ 2.20 Exercisable at December 31, 2020 — $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of quantitative operating lease information | The following summarizes quantitative information about the Company’s operating leases (dollars in thousands): For the year ended December 31, For the year ended December 31, 2020 2019 Operating leases Operating lease cost $ 1,609 $ 2,076 Variable lease cost 488 318 Operating lease expense 2,097 2,394 Finance leases Amortization of right-of-use assets 18 — Interest on lease obligations 5 — Finance lease expense 23 — Short-term lease rent expense 17 17 Total rent expense $ 2,137 $ 2,411 Other information Operating cash flows from operating leases $ 1,648 $ 2,015 Operating cash flows from finance leases $ 5 $ — Financing cash flows from finance leases $ 17 $ — Right of use assets exchanged for operating lease liabilities $ 268 $ 5,077 Right of use assets exchanged for finance lease liabilities $ 930 $ — Weighted-average remaining lease term - operating leases 2.3 1.9 Weighted-average remaining lease term – finance leases 5.8 0 Weighted-average discount rate - operating leases 6.4 % 6.8 % Weighted-average discount rate – finance leases 5.1 % — % |
Schedule of future minimum rental payments under operating lease agreements | Future minimum rental payments under operating lease agreements are as follows (table in thousands): Operating Finance Year ending December 31, 2021 $ 1,131 $ 176 Year ending December 31, 2022 668 179 Year ending December 31, 2023 314 181 Year ending December 31, 2024 118 178 Year Ended December 31, 2025 6 176 Year Ended December 31, 2026 — 163 Total 2,237 1,053 Less present value discount $ (162) $ (140) Operating and Finance lease liabilities. $ 2,075 $ 913 |
Loan and Security Agreement (Ta
Loan and Security Agreement (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of principal payments on term loans | The following table reflects the schedule of principal payments on the Term Loan as of December 31, 2020 (in thousands): Year Principal Payments 2021 $ — 2022 2,250 2023 9,000 2024 9,000 2025 2,250 $ 22,500 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of reconciliation of income tax expense at the statutory rate to income tax expense at Entity's effective tax rate | A reconciliation of income tax expense at the statutory rate to income tax expense at our effective tax rate is as follows (dollars in thousands): 2020 2019 Tax Expense (Benefit) Computed at 22.67% and 22.79% of Pretax Income (Loss) $ (6,373) $ (7,780) Changes in Tax Laws — — Foreign Income Tax Expense — — Effect of Change in Valuation Allowance 6,373 7,780 Total Income Tax Expense $ — $ — |
Schedule of details of the net deferred tax asset | The details of the net deferred tax asset are as follows (dollars in thousands): December 31, 2020 2019 Deferred tax assets: Net Operating Loss Carryforward $ 59,586 $ 52,935 Stock Based Compensation 7,582 7,514 Deferred Revenue 2,310 2,752 General Business Credit 6,872 6,872 Accrued Expenses 185 280 Inventories 666 866 Book over Tax Depreciation 25 18 Other Deferred Tax Assets 387 22 Total Deferred Tax Assets 77,613 71,259 Deferred Tax Liabilities: Goodwill & Intangible Assets 155 136 Prepaid Expenses 294 332 Total Deferred Tax Liabilities 449 468 Subtotal 77,164 70,791 Valuation Allowance (77,164) (70,791) Net Deferred Tax Asset $ — $ — |
Description of Business - Narra
Description of Business - Narrative (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020USD ($)employee | Dec. 31, 2019USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Years of service | 25 years | |
Net revenue | $ | $ 62,197 | $ 61,303 |
Number of employees | employee | 300 |
Liquidity and Capital Resourc_2
Liquidity and Capital Resources (Details) - USD ($) $ in Thousands | Sep. 23, 2020 | Mar. 16, 2020 | Feb. 29, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Liquidity and Capital Resources [Line Items] | ||||||
Accumulated deficit | $ (337,406) | $ (306,516) | ||||
Stockholders' equity | 34,170 | 20,320 | $ 27,277 | |||
Cash and cash equivalents and investments available-for-sale | 58,700 | |||||
Working capital | 56,700 | |||||
Net cash used in operating activities | $ (29,641) | $ (27,254) | ||||
Common shares sold (in shares) | 23,178,809 | 3,670,212 | 1,128,608 | |||
Proceeds from issuance of common stock | $ 8,000 | |||||
Proceeds from issuance of common stock, net of stock issuance costs | $ 32,700 | $ 2,300 | ||||
Remaining amount available for sale | $ 32,300 | |||||
Innovatus Life Sciences Lending Fund I, LP | Term loan | ||||||
Liquidity and Capital Resources [Line Items] | ||||||
Net drawn down proceeds | $ 21,200 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) | Jan. 14, 2020USD ($) | Oct. 31, 2014USD ($) | Dec. 31, 2020USD ($)agreement | Dec. 31, 2019USD ($) | Dec. 31, 2016USD ($) |
Accounting Policies [Abstract] | |||||
Number of distribution and license agreements | agreement | 4 | ||||
Customers average payment term | 30 days | ||||
Distributors average payment term | 45 days | ||||
Summary of significant accounting policies | |||||
Net revenue | $ 62,197,000 | $ 61,303,000 | |||
Impairment losses | 0 | 0 | |||
Bad-debt expense | 0 | 0 | |||
Contract assets | 0 | 0 | |||
Revenue performance obligation | 10,200,000 | 12,100,000 | |||
Impairments of long-lived assets | $ 0 | 0 | |||
Finite-lived intangible asset useful life | 17 years | ||||
Contract liabilities | $ 10,190,000 | 12,076,000 | |||
Research and product development expense | 7,092,000 | 6,886,000 | |||
Baxter Healthcare Organization | |||||
Summary of significant accounting policies | |||||
Revenue performance obligation | 7,200,000 | ||||
Distribution agreement term | 10 years | ||||
Upfront payment | $ 20,000,000 | ||||
Deferred drug license revenue | 2,000,000 | 2,100,000 | |||
Contract liabilities | $ 7,200,000 | 9,100,000 | |||
Upfront payment benefit percent | 25.00% | ||||
Wanbang Biopharmaceutical | |||||
Summary of significant accounting policies | |||||
Upfront payment | $ 4,000,000 | ||||
Deferred drug license revenue | $ 200,000 | 300,000 | |||
Contract liabilities | 2,700,000 | 2,900,000 | |||
Sun Pharma Agreements | |||||
Summary of significant accounting policies | |||||
Upfront payment | $ 100,000 | ||||
Deferred drug license revenue | 10,000 | ||||
Contract liabilities | 90,000 | ||||
Jeil Pharma Agreements | |||||
Summary of significant accounting policies | |||||
Upfront payment | $ 200,000 | ||||
Deferred drug license revenue | 2,500 | ||||
Contract liabilities | $ 200,000 | ||||
Minimum | |||||
Summary of significant accounting policies | |||||
Property and equipment useful life | 3 years | ||||
Market and performance-based stock unit awards service period | 1 year | ||||
Maximum | |||||
Summary of significant accounting policies | |||||
Property and equipment useful life | 10 years | ||||
Market and performance-based stock unit awards service period | 2 years | ||||
License | |||||
Summary of significant accounting policies | |||||
Net revenue | $ 2,200,000 | 2,300,000 | |||
Product | |||||
Summary of significant accounting policies | |||||
Net revenue | 60,000,000 | 59,000,000 | |||
Concentrate Products | |||||
Summary of significant accounting policies | |||||
Net revenue | 61,061,000 | 60,758,000 | |||
Reserve for returns | $ 0 | $ 0 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation of Revenue [Line Items] | ||
Net revenue | $ 62,197 | $ 61,303 |
U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 56,578 | 54,792 |
Rest of World | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 5,619 | 6,511 |
Drug Revenues | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 1,136 | 545 |
Drug Revenues | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 910 | 272 |
Drug Revenues | Rest of World | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 226 | 273 |
Concentrate Products | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 61,061 | 60,758 |
Concentrate Products | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 55,668 | 54,520 |
Concentrate Products | Rest of World | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 5,393 | 6,238 |
Point-in-time | Drug Product Sales | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 910 | 272 |
Point-in-time | Drug Product Sales | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 910 | 272 |
Point-in-time | Drug Product Sales | Rest of World | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 0 | 0 |
Point-in-time | Concentrate Product Sales | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 59,100 | 58,778 |
Point-in-time | Concentrate Product Sales | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 53,707 | 52,540 |
Point-in-time | Concentrate Product Sales | Rest of World | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 5,393 | 6,238 |
Point-in-time | Concentrate Product License Fee | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 1,961 | 1,980 |
Point-in-time | Concentrate Product License Fee | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 1,961 | 1,980 |
Point-in-time | Concentrate Product License Fee | Rest of World | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 0 | 0 |
Over-time | Drug License Fee | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 226 | 273 |
Over-time | Drug License Fee | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 0 | 0 |
Over-time | Drug License Fee | Rest of World | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | $ 226 | $ 273 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Contract Balances (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||
Receivables, which are included in "Trade and other receivables" | $ 4,171 | $ 4,203 |
Contract liabilities | $ 10,190 | $ 12,076 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Loss Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation (in shares) | 33,307,113 | 12,968,474 |
Options to purchase common stock | ||
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation (in shares) | 6,467,956 | 8,598,149 |
Unvested restricted stock awards | ||
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation (in shares) | 146,800 | 146,800 |
Unvested restricted stock units | ||
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation (in shares) | 265,494 | 1,452,744 |
Warrants to purchase common stock | ||
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation (in shares) | 26,426,863 | 2,770,781 |
Investments - Available-for-S_3
Investments - Available-for-Sale (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Investments, Debt and Equity Securities [Abstract] | ||
Amortized Cost | $ 9,987 | $ 14,238 |
Unrealized Gain | 3 | 13 |
Unrealized Loss | 0 | (1) |
Accrued Interest Income | 7 | 0 |
Fair Value | $ 9,997 | $ 14,250 |
Significant Market Segments A_2
Significant Market Segments And Customers (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Significant market segments | ||
Accounts receivable | $ 4,171 | $ 4,203 |
Sales | International sales | ||
Significant market segments | ||
Direct sales percentage of sales | 9.00% | 11.00% |
Sales | DaVita | Customer concentration | ||
Significant market segments | ||
Direct sales percentage of sales | 50.00% | 49.00% |
Sales | Baxter | Customer concentration | ||
Significant market segments | ||
Direct sales percentage of sales | 25.00% | 27.00% |
Sales | Nipro Medical Corporation | ||
Significant market segments | ||
Direct sales percentage of sales | 7.00% | 9.00% |
Accounts receivable | DaVita | ||
Significant market segments | ||
Accounts receivable | $ 1,100 | $ 1,200 |
Accounts receivable | Baxter | ||
Significant market segments | ||
Accounts receivable | $ 1,600 | $ 2,000 |
Distribution Agreement (Details
Distribution Agreement (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2014 | Dec. 31, 2020 | Dec. 31, 2019 | |
Related Party Transaction [Line Items] | |||
Agreement Refund Trigger Event repayment percent first criteria | 25.00% | ||
Baxter | |||
Related Party Transaction [Line Items] | |||
Distribution agreement term | 10 years | ||
Maximum proceeds for manufacturing facility | $ 10 | ||
Period of time for facility to become operational before fee payable begins to be reduced | 12 months | ||
Agreement termination notice period | 270 days | ||
Agreement termination significant price increase notice period | 45 days | ||
Agreement termination limited non-compete period | 2 years | ||
Upfront fee | $ 20 | ||
Recognized revenue | $ 2 | $ 2.1 | |
Agreement extension period | 5 years | ||
Extension fee | $ 7.5 | ||
Baxter | Upfront Fee | |||
Related Party Transaction [Line Items] | |||
Recognized revenue | $ 2 | $ 2.1 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Inventory [Line Items] | ||
Raw Materials | $ 3,112 | $ 2,471 |
Work in Process | 172 | 185 |
Finished Goods | 1,805 | 1,432 |
Total | 5,089 | 4,088 |
Inventory, non-current | 1,176 | 441 |
Increase (decrease) in inventory reserves and write-offs, net | 1,300 | |
Inventory, net | 3,913 | 3,647 |
Triferic Inventory | ||
Inventory [Line Items] | ||
Raw Materials | 890 | |
Inventory, non-current | 1,200 | 400 |
Inventory, gross | 3,900 | 3,500 |
Inventory, reserve | 2,600 | $ 2,800 |
Increase (decrease) in inventory reserves and write-offs, net | (100) | |
Increase in inventory reserves and write offs | 300 | |
Decrease in inventory reserves and write offs | 400 | |
Inventory, net | $ 1,300 | |
Inventory, raw materials, useful life | 25 years | |
Triferic Dialysate | ||
Inventory [Line Items] | ||
Finished Goods | $ 100 | |
Triferic API | ||
Inventory [Line Items] | ||
Inventory, net | $ 300 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property and equipment | ||
Gross property and equipment | $ 9,178 | $ 8,298 |
Accumulated Depreciation | (6,536) | (5,865) |
Net Property and Equipment | 2,642 | 2,433 |
Depreciation expense | 834 | 788 |
Leasehold Improvements | ||
Property and equipment | ||
Gross property and equipment | 1,196 | 1,162 |
Machinery and Equipment | ||
Property and equipment | ||
Gross property and equipment | 5,475 | 4,673 |
Information Technology & Office Equipment | ||
Property and equipment | ||
Gross property and equipment | 1,831 | 1,810 |
Laboratory Equipment | ||
Property and equipment | ||
Gross property and equipment | $ 676 | $ 653 |
Goodwill And Intangible Assets
Goodwill And Intangible Assets (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Goodwill | $ 921,000 | $ 921,000 |
Impairment | $ 0 | $ 0 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Accrued Research & Development Expense | $ 232 | $ 283 |
Accrued Compensation and Benefits | 2,500 | 1,108 |
Accrued Unvouchered Receipts | 755 | 1,901 |
Accrued Workers Compensation | 395 | 195 |
Other Accrued Liabilities | 1,131 | 1,031 |
Total Accrued Liabilities | $ 5,013 | $ 4,518 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | Sep. 23, 2020 | Feb. 21, 2020 | Feb. 06, 2020 | Mar. 22, 2019 | Feb. 29, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Feb. 19, 2020 | Feb. 04, 2020 |
Class of Stock [Line Items] | |||||||||
Preferred shares, shares authorized (in shares) | 2,000,000 | 2,000,000 | |||||||
Preferred stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |||||||
Preferred shares, shares issued (in shares) | 0 | 0 | |||||||
Preferred shares, shares outstanding (in shares) | 0 | 0 | |||||||
Common stock authorized (in shares) | 170,000,000 | 170,000,000 | |||||||
Common stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |||||||
Common shares, shares issued (in shares) | 93,573,165 | 65,378,890 | |||||||
Common shares, shares outstanding (in shares) | 93,573,165 | 65,378,890 | |||||||
Common stock issued on exercise of stock options (in shares) | 0 | 30,000 | |||||||
Amount of common stock issued on exercise of stock options | $ 147,900 | ||||||||
Weighted average exercise price (in dollars per share) | $ 4.93 | ||||||||
Proceeds from issuance of common stock | $ 8,000,000 | ||||||||
Remaining amount available for sale | $ 32,300,000 | ||||||||
Amount allocated to common stock | $ 9,000 | $ 7,000 | |||||||
Restricted stock awards - performance based | |||||||||
Class of Stock [Line Items] | |||||||||
Restricted common stock forfeited (in shares) | 988,958 | ||||||||
Restricted stock awards - time based | |||||||||
Class of Stock [Line Items] | |||||||||
Restricted common stock forfeited (in shares) | 152,097 | ||||||||
Restricted stock units | |||||||||
Class of Stock [Line Items] | |||||||||
Restricted common stock vested (in shares) | 224,994 | ||||||||
Shares withheld for tax withholding (in shares) | 8,348 | ||||||||
Tax withholding amount | $ 18,950 | ||||||||
At-the-market offering | |||||||||
Class of Stock [Line Items] | |||||||||
Weighted average exercise price (in dollars per share) | $ 2.06 | $ 2.92 | |||||||
Issuance of common stock (in shares) | 1,128,608 | 1,840,443 | |||||||
Proceeds from issuance of common stock | $ 2,325,478 | $ 5,383,079 | |||||||
Stock issuance costs | 309,479 | ||||||||
Commission and offering fees paid | 63,000 | ||||||||
Remaining amount available for sale | 32,300,000 | ||||||||
At-the-market offering | Maximum | |||||||||
Class of Stock [Line Items] | |||||||||
Sales agreement, threshold sale of shares | $ 40,000,000 | ||||||||
Public offering | |||||||||
Class of Stock [Line Items] | |||||||||
Issuance of common stock (in shares) | 3,191,489 | ||||||||
Proceeds from issuance of common stock | $ 8,000,000 | 43,148,000 | 18,778,000 | ||||||
Stock issuance costs | $ 100,000 | 2,469,000 | $ 1,490,000 | ||||||
Common stock reserved for future issuance (up to) (in shares) | 3,670,212 | ||||||||
Share price (in USD per share) | $ 2.22 | $ 2.22 | |||||||
Over allotment option | |||||||||
Class of Stock [Line Items] | |||||||||
Common stock reserved for future issuance (up to) (in shares) | 478,723 | 478,723 | |||||||
Registered direct offering | |||||||||
Class of Stock [Line Items] | |||||||||
Stock issuance costs | $ 2,300,000 | ||||||||
Common stock reserved for future issuance (up to) (in shares) | 21,818,544 | ||||||||
Gross proceeds from issuance of common stock and warrants | $ 35,000,000 | ||||||||
Placement agent, cash fee, percentage of aggregate gross proceeds raised in Offering | 6.00% | ||||||||
Amount payable to financial advisory firm for services related to offering | $ 400,000 | ||||||||
Placement agent, cash fee, percentage of aggregate gross proceeds from cash exercise of warrants issued to investors | 6.00% | ||||||||
Placement agent, cash fee, percentage of aggregate gross proceeds from cash exercise of any warrants issued in the offering from the exercise of warrants during the remainder term of such warrants | 4.00% | ||||||||
Placement agent fee, non-accountable expenses | $ 50,000 | ||||||||
Placement agent fee, clearing fees | 12,900 | ||||||||
Amount allocated to common stock | $ 26,100,000 | ||||||||
Proceeds from issuance of warrants | $ 8,900,000 | ||||||||
Registered direct offering | Warrants | |||||||||
Class of Stock [Line Items] | |||||||||
Share price (in USD per share) | $ 1.51 | ||||||||
Number of shares of common stock for which warrant is exercisable (in shares) | 23,178,809 | ||||||||
Number of shares of common stock each warrant is exercisable for (in shares) | 1 | ||||||||
Exercise price of warrant (in dollars per share) | $ 1.80 | ||||||||
Maximum percentage of outstanding common stock able to be owned immediately after exercise of warrants | 9.99% | ||||||||
Maximum percentage of outstanding common stock able to be owned immediately after exercise of warrants, at holder's option upon issuance | 4.99% | ||||||||
Registered direct offering | Pre-Funded Warrants | |||||||||
Class of Stock [Line Items] | |||||||||
Number of shares of common stock for which warrant is exercisable (in shares) | 1,360,265,000,000 | ||||||||
Exercise price of warrant (in dollars per share) | $ 0.001 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - shares | May 18, 2020 | Dec. 31, 2020 | Dec. 31, 2020 | Jan. 29, 2018 | Apr. 11, 2017 |
Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Minimum period for non-cash exchange of previously issued shares in exchange for newly issued shares | 6 months | ||||
2007 LTIP | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Granted (in shares) | 0 | ||||
Common stock reserved for issuance (in shares) | 11,500,000 | ||||
2018 LTIP | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock reserved for issuance (in shares) | 6,200,000 | 3,300,000 | |||
Common stock, number of additional shares authorized for issuance (in shares) | 2,900,000 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-based compensation expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share-based compensation expense | $ 475 | $ 4,952 |
Service based awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share-based compensation expense | 1,863 | 3,867 |
Restricted stock awards - Service based awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share-based compensation expense | 0 | (33) |
Restricted stock units - Service based awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share-based compensation expense | 372 | 1,600 |
Stock option awards - Service based awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share-based compensation expense | 1,491 | 2,300 |
Performance based awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share-based compensation expense | (1,388) | 1,085 |
Restricted stock units - Performance based awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share-based compensation expense | (1,148) | 642 |
Stock option awards - Performance based awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share-based compensation expense | $ (240) | $ 443 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Awards (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2020 | |
Weighted Average Grant-Date Fair Value | |||
Stock based compensation expenses | $ 475,000 | $ 4,952,000 | |
Restricted stock awards | |||
Number of Shares | |||
Outstanding at beginning of period (in shares) | 146,800 | 146,800 | |
Outstanding at end of period (in shares) | 146,800 | 146,800 | |
Weighted Average Grant-Date Fair Value | |||
Outstanding at beginning of period (in dollars per share) | $ 5.70 | $ 5.70 | |
Outstanding at end of period (in dollars per share) | $ 5.70 | $ 5.70 | |
Vesting period | 20 months | ||
Unvested restricted stock awards (in shares) | 146,800 | 146,800 | 146,800 |
Stock based compensation expenses | $ 0 | $ 0 | |
Unrecognized stock-based compensation expenses | $ 0 | ||
Restricted stock awards - performance based | |||
Number of Shares | |||
Outstanding at end of period (in shares) | 146,800 | ||
Weighted Average Grant-Date Fair Value | |||
Unvested restricted stock awards (in shares) | 146,800 | 146,800 | |
Restricted stock awards - Service based awards | |||
Weighted Average Grant-Date Fair Value | |||
Stock based compensation expenses | $ 0 | $ (33,000) |
Stock-Based Compensation - Serv
Stock-Based Compensation - Service Based Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Weighted Average Grant-Date Fair Value | ||
Stock based compensation expenses | $ 475 | $ 4,952 |
Restricted stock units - Service based awards | ||
Number of Shares | ||
Outstanding at beginning of period (in shares) | 463,786 | 472,959 |
Granted (in shares) | 208,993 | 244,063 |
Forfeited (in shares) | (159,724) | (28,916) |
Vested (in shares) | (247,561) | (224,320) |
Outstanding at end of period (in shares) | 265,494 | 463,786 |
Weighted Average Grant-Date Fair Value | ||
Outstanding at beginning of period (in dollars per share) | $ 4.26 | $ 4.32 |
Granted (in dollars per share) | 2 | 4.09 |
Forfeited (in dollars per share) | 4.26 | 4.32 |
Vested (in dollars per share) | 4.30 | 4.19 |
Outstanding at end of period (in dollars per share) | $ 2.60 | $ 4.26 |
Stock based compensation expenses | $ 400 | $ 1,600 |
Unrecognized stock-based compensation expenses | $ 200 | |
Period of recognition for unrecognized stock-based compensation expenses | 12 months | |
Restricted stock units - Service based awards | Minimum | ||
Weighted Average Grant-Date Fair Value | ||
Vesting period | 1 year | |
Restricted stock units - Service based awards | Maximum | ||
Weighted Average Grant-Date Fair Value | ||
Vesting period | 3 years |
Stock-Based Compensation - Perf
Stock-Based Compensation - Performance Based Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | Apr. 17, 2020 | Dec. 31, 2020 | Dec. 31, 2019 |
Weighted Average Grant-Date Fair Value | |||
Stock based compensation expenses | $ 475 | $ 4,952 | |
Restricted stock units - Performance based awards | |||
Number of Shares | |||
Outstanding at beginning of period (in shares) | 988,958 | 988,958 | |
Forfeited (in shares) | (988,958) | ||
Outstanding at end of period (in shares) | 0 | 988,958 | |
Weighted Average Grant-Date Fair Value | |||
Outstanding at beginning of period (in dollars per share) | $ 4.48 | $ 4.48 | |
Forfeited (in dollars per share) | 4.48 | ||
Outstanding at end of period (in dollars per share) | $ 0 | $ 4.48 | |
Stock based compensation expenses | $ (1,148) | $ 642 | |
Forfeited (in shares) | 988,958 | ||
Restricted stock units - Performance based awards | President and Chief Executive Officer | |||
Number of Shares | |||
Forfeited (in shares) | (988,958) | ||
Weighted Average Grant-Date Fair Value | |||
Forfeited (in shares) | 988,958 | ||
Allocated share-based compensation expense, reduction due to forfeitures | $ 1,400 |
Stock-Based Compensation - Se_2
Stock-Based Compensation - Service Based Stock Options - Fair value assumptions (Details) - Stock option awards - Service based awards - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected stock price volatility - minimum | 68.20% | 67.50% |
Expected stock price volatility - maximum | 75.80% | 70.30% |
Risk-free interest rate - minimum | 0.31% | 1.40% |
Risk-free interest rate - maximum | 1.70% | 2.60% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise price (in USD per share) | $ 0.92 | $ 1.91 |
Term (years) | 5 years 6 months | 3 years 4 months 24 days |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise price (in USD per share) | $ 2.90 | $ 6.55 |
Term (years) | 6 years | 6 years 6 months |
Stock-Based Compensation - Se_3
Stock-Based Compensation - Service Based Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Shares Underlying Options | |||
Exercised (in shares) | 0 | (30,000) | |
Weighted Average Exercise Price | |||
Exercised (in dollars per share) | $ 4.93 | ||
Stock option awards - Service based awards | |||
Shares Underlying Options | |||
Outstanding at the beginning of the period (in shares) | 8,210,024 | 7,856,480 | |
Granted (in shares) | 2,288,386 | 1,103,938 | |
Exercised (in shares) | 0 | (30,000) | |
Expired (in shares) | (4,249,596) | ||
Forfeited (in shares) | (530,858) | (720,394) | |
Outstanding at the end of the period (in shares) | 5,717,956 | 8,210,024 | 7,856,480 |
Exercisable at end of period (in shares) | 2,898,104 | ||
Weighted Average Exercise Price | |||
Outstanding at the beginning of the period (in dollars per share) | $ 7.06 | $ 7.50 | |
Granted (in dollars per share) | 1.94 | 3.37 | |
Exercised (in dollars per share) | 0 | 4.93 | |
Expired (in dollars per share) | (8.07) | ||
Forfeited (in dollars per share) | (3.88) | (6.24) | |
Outstanding at the end of the period (in dollars per share) | 4.55 | $ 7.06 | $ 7.50 |
Exercise price (in dollars per share) | $ 6.85 | ||
Weighted Average Remaining Contractual Term | |||
Outstanding | 6 years 7 months 6 days | 5 years 1 month 6 days | 5 years 2 months 12 days |
Granted | 9 years | 9 years | |
Exercisable | 3 years 10 months 24 days | ||
Aggregate Intrinsic Value (in $1,000's) | |||
Outstanding | $ 0 | $ 107 | $ 0 |
Granted | 0 | $ 107 | |
Exercisable at end of period | $ 0 |
Stock-Based Compensation - Se_4
Stock-Based Compensation - Service Based Stock Options - Others (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock based compensation expenses | $ 475 | $ 4,952 |
Stock option awards - Service based awards | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted (in shares) | 2,288,386 | 1,103,938 |
Vested options, exercisable (in shares) | 2,898,104 | |
Vested options exercisable at an average price (in dollars per share) | $ 6.85 | |
Stock based compensation expenses | $ 1,491 | $ 2,300 |
Unvested options (in shares) | 2,819,582 | |
Unrecognized stock-based compensation expenses | $ 2,200 | |
Period of recognition for unrecognized stock-based compensation expenses | 2 years 2 months 12 days |
Stock-Based Compensation - Pe_2
Stock-Based Compensation - Performance Based Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands | Apr. 17, 2020 | Dec. 31, 2020 | Dec. 31, 2019 |
Fair value assumptions: | |||
Stock based compensation expenses | $ 475 | $ 4,952 | |
Stock option awards - Performance based awards | |||
Number of Shares | |||
Outstanding at the beginning of the period (in shares) | 388,125 | ||
Granted (in shares) | 750,000 | ||
Forfeited (in shares) | (388,125) | ||
Outstanding at the end of the period (in shares) | 750,000 | 388,125 | |
Exercisable at end of period (in shares) | 0 | ||
Weighted Average Exercise Price | |||
Outstanding at the beginning of the period (in dollars per share) | $ 4.70 | ||
Granted (in dollars per share) | 2.20 | ||
Forfeited (in dollars per share) | (4.70) | ||
Outstanding at the end of the period (in dollars per share) | 2.20 | $ 4.70 | |
Exercise price (in dollars per share) | $ 0 | ||
Fair value assumptions: | |||
Expected stock price volatility | 74.40% | ||
Risk-free interest rate | 0.40% | ||
Dividend yield rate | 0.00% | ||
Term (years) | 5 years 8 months 12 days | ||
Stock based compensation expenses | $ (240) | $ 443 | |
Unrecognized stock-based compensation expenses | $ 200 | ||
Forfeited performance-based stock options (in shares) | 388,125 | ||
Number of shares per unit | 1 | ||
Stock option awards - Performance based awards | President and Chief Executive Officer | |||
Number of Shares | |||
Forfeited (in shares) | (388,125) | ||
Fair value assumptions: | |||
Forfeited performance-based stock options (in shares) | 388,125 | ||
Allocated share-based compensation expense, reduction due to forfeitures | $ 700 |
Related Party Transactions (Det
Related Party Transactions (Details) | Oct. 07, 2018USD ($)installmentagreement | Dec. 31, 2019USD ($) | Dec. 31, 2020USD ($) | Jul. 15, 2019USD ($) | Apr. 15, 2019USD ($) | Jan. 15, 2019USD ($) | Oct. 15, 2018USD ($) |
Related Party Transaction [Line Items] | |||||||
Number of additional agreements | agreement | 3 | ||||||
Related party transactions, accrued reimbursement of IP expenses and sublicense royalty fees | $ 100,000 | ||||||
Cash compensation | $ 202,500 | 225,000 | |||||
Master services and IP agreements | |||||||
Related Party Transaction [Line Items] | |||||||
Milestone payments | $ 0 | ||||||
Executive Vice President and Chief Scientific Officer [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Total amount due | $ 1,000,000 | $ 250,000 | $ 250,000 | $ 250,000 | $ 250,000 | ||
Number of quarterly installment payments | installment | 4 | ||||||
Installment paid | 1,000,000 | ||||||
Related party transactions, accrued reimbursement of legal expenses | $ 100,000 |
Commitments and Contingencies -
Commitments and Contingencies - Leases (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020USD ($)ft² | Dec. 31, 2019USD ($) | |
Lease, Cost [Abstract] | ||
Operating lease cost | $ 1,609 | $ 2,076 |
Variable lease cost | 488 | 318 |
Operating lease expense | 2,097 | 2,394 |
Amortization of right-of-use assets | 18 | 0 |
Interest on lease obligations | 5 | 0 |
Finance lease expense | 23 | 0 |
Short-term lease rent expense | 17 | 17 |
Total rent expense | 2,137 | 2,411 |
Other information | ||
Operating cash flows from operating leases | 1,648 | 2,015 |
Operating cash flows from finance leases | 5 | 0 |
Financing cash flows from finance leases | 17 | 0 |
Right of use assets exchanged for operating lease liabilities | 268 | 5,077 |
Right of use assets exchanged for finance lease liabilities | $ 930 | $ 0 |
Weighted-average remaining lease term - operating leases | 2 years 3 months 18 days | 1 year 10 months 24 days |
Weighted-average remaining lease term – finance leases | 5 years 9 months 18 days | 0 years |
Weighted-average discount rate - operating leases | 6.40% | 6.80% |
Weighted-average discount rate – finance leases | 5.10% | 0.00% |
Operating | ||
Year ending December 31, 2021 | $ 1,131 | |
Year ending December 31, 2022 | 668 | |
Year ending December 31, 2023 | 314 | |
Year ending December 31, 2024 | 118 | |
Year Ended December 31, 2025 | 6 | |
Year Ended December 31, 2026 | 0 | |
Total | 2,237 | |
Less present value discount | (162) | |
Operating and Finance lease liabilities. | 2,075 | |
Finance | ||
Year ending December 31, 2021 | 176 | |
Year ending December 31, 2022 | 179 | |
Year ending December 31, 2023 | 181 | |
Year ending December 31, 2024 | 178 | |
Year Ended December 31, 2025 | 176 | |
Year Ended December 31, 2026 | 163 | |
Total | 1,053 | |
Less present value discount | (140) | |
Operating and Finance lease liabilities. | $ 913 | |
Texas | ||
LEASES | ||
Area occupied by entity (in square feet) | ft² | 51,000 | |
South Carolina | ||
LEASES | ||
Area occupied by entity (in square feet) | ft² | 57,000 | |
New Jersey | ||
LEASES | ||
Area occupied by entity (in square feet) | ft² | 4,100 | |
Maximum | ||
LEASES | ||
Lease term | 7 years | |
Wixom, Michigan Property One | Michigan | ||
LEASES | ||
Area occupied by entity (in square feet) | ft² | 51,000 | |
Wixom, Michigan Property Two | Michigan | ||
LEASES | ||
Area occupied by entity (in square feet) | ft² | 17,500 |
Commitments and Contingencies_2
Commitments and Contingencies - Insurance (Details) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Self insurance retention per occurrence | $ 350,000 |
Aggregate coverage | 602,354 |
Retention limit in excess of claims paid and accrued | 479,000 |
Estimated loss reserves and additional future claims | 395,000 |
Cash collateral and escrow held by insurance carrier for workers' compensation insurance | $ 300,000 |
Commitments and Contingencies_3
Commitments and Contingencies - Purchase Obligations (Details) $ in Millions | Dec. 31, 2020USD ($) |
Recorded Unconditional Purchase Obligation [Line Items] | |
Purchase obligation | $ 25.5 |
Concentrate manufacturing | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Purchase obligation | 23.8 |
Ancillary supplies | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Purchase obligation | $ 1.7 |
Commitments and Contingencies_4
Commitments and Contingencies - Demand Notice (Details) - USD ($) $ in Millions | Jul. 31, 2020 | Feb. 29, 2020 | Dec. 31, 2020 |
Commitments and Contingencies Disclosure [Abstract] | |||
Amount of penalties sought from supplier | $ 3 | ||
Percentage of raw materials to be paid | 50.00% | 50.00% |
Commitments and Contingencies_5
Commitments and Contingencies - Litigation (Details) - USD ($) $ in Thousands | Aug. 07, 2019 | Dec. 31, 2020 | Dec. 31, 2019 |
Loss Contingencies [Line Items] | |||
Settlement Expense, net of Reimbursement | $ 0 | $ 430 | |
Settlement agreement | |||
Loss Contingencies [Line Items] | |||
Litigation settlement amount | $ 3,700 | ||
Settlement Expense, net of Reimbursement | $ 100 |
Loan and Security Agreement (De
Loan and Security Agreement (Details) - Term loan | Mar. 16, 2020USD ($)day$ / sharesshares | Dec. 31, 2020USD ($) |
Term loan | ||
Loss Contingencies [Line Items] | ||
Aggregate principal amount | $ 35,000,000 | |
Interest rate, base percentage | 4.75% | |
Interest rate, additional percentage added to base percentage | 4.00% | |
Initial interest rate percentage | 8.75% | |
Effective interest rate | 10.90% | |
Option to add interest rate amount to outstanding principal balance in lieu of payment, percentage | 1.00% | |
Interest expense | $ 1,600,000 | |
Calculation for number of shares of common stock able to be purchased by warrant, percentage of principal amount of relevant term loan funded funded | 3.50% | |
Exercise price calculation, period immediately preceding execution of agreement, number of trading days | day | 5 | |
Outstanding balance, net of unamortized issuance costs and unaccreted discount | 20,900,000 | |
Unamortized issuance costs and unaccreted discount | $ 1,600,000 | |
Term loan | Minimum | ||
Loss Contingencies [Line Items] | ||
Period for which company is entitled to make interest-only payments | 30 months | |
Term loan | Maximum | ||
Loss Contingencies [Line Items] | ||
Period for which company is entitled to make interest-only payments | 36 months | |
Term loan, first tranche | ||
Loss Contingencies [Line Items] | ||
Aggregate principal amount | $ 22,500,000 | |
Net draw down proceeds | 21,200,000 | |
Closing costs | $ 1,300,000 | |
Exercise price of warrant (in dollars per share) | $ / shares | $ 1.65 | |
Number of shares of common stock for which warrant is exercisable (in shares) | shares | 477,273 | |
Additional debt discount recognized | $ 500,000 | |
Term loan, second and third tranches | ||
Loss Contingencies [Line Items] | ||
Warrant exercise price calculation, period immediately preceding relevant funding, number of trading days | day | 5 | |
Term loan, second and third tranches | Maximum | ||
Loss Contingencies [Line Items] | ||
Exercise price of warrant (in dollars per share) | $ / shares | $ 1.65 | |
Term loan, second tranche | ||
Loss Contingencies [Line Items] | ||
Aggregate principal amount | $ 5,000,000 | |
Term loan, third tranche | ||
Loss Contingencies [Line Items] | ||
Aggregate principal amount | $ 7,500,000 |
Loan and Security Agreement - S
Loan and Security Agreement - Schedule of Principal Payments on Term Loan (Details) - Term loan - Term loan $ in Thousands | Dec. 31, 2020USD ($) |
Debt Instrument [Line Items] | |
2021 | $ 0 |
2022 | 2,250 |
2023 | 9,000 |
2024 | 9,000 |
2025 | 2,250 |
Principal payments | $ 22,500 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Reconciliation of income tax expense at the statutory rate to income tax expense at Entity's effective tax rate | ||
Effective tax rate | 22.67% | 22.79% |
Tax Expense (Benefit) Computed at 22.67% and 22.79% of Pretax Income (Loss) | $ (6,373,000) | $ (7,780,000) |
Changes in Tax Laws | 0 | 0 |
Foreign Income Tax Expense | 0 | 0 |
Effect of Change in Valuation Allowance | 6,373,000 | 7,780,000 |
Total Income Tax Expense | 0 | 0 |
Deferred tax assets: | ||
Net Operating Loss Carryforward | 59,586,000 | 52,935,000 |
Stock Based Compensation | 7,582,000 | 7,514,000 |
Deferred Revenue | 2,310,000 | 2,752,000 |
General Business Credit | 6,872,000 | 6,872,000 |
Accrued Expenses | 185,000 | 280,000 |
Inventories | 666,000 | 866,000 |
Book over Tax Depreciation | 25,000 | 18,000 |
Other Deferred Tax Assets | 387,000 | 22,000 |
Total Deferred Tax Assets | 77,613,000 | 71,259,000 |
Deferred Tax Liabilities: | ||
Goodwill & Intangible Assets | 155,000 | 136,000 |
Prepaid Expenses | 294,000 | 332,000 |
Total Deferred Tax Liabilities | 449,000 | 468,000 |
Subtotal | 77,164,000 | 70,791,000 |
Valuation Allowance | (77,164,000) | (70,791,000) |
Net Deferred Tax Asset | 0 | 0 |
Net operating loss carryforwards | 262,900,000 | |
Income tax expense (benefit) | 0 | $ 0 |
Excess tax benefits on share based compensation that would be credited directly to contributed capital, if recognized | $ 4,200,000 |