Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 12, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 000-23661 | |
Entity Registrant Name | ROCKWELL MEDICAL, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 38-3317208 | |
Entity Address, Address Line One | 30142 S. Wixom Road | |
Entity Address, City or Town | Wixom | |
Entity Address, State or Province | MI | |
Entity Address, Postal Zip Code | 48393 | |
City Area Code | 248 | |
Local Phone Number | 960-9009 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, par value $0.0001 | |
Trading Symbol | RMTI | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding (in shares) | 93,966,381 | |
Entity Central Index Key | 0001041024 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
ASSETS | ||
Cash and Cash Equivalents | $ 23,390 | $ 48,682 |
Investments Available-for-Sale | 9,813 | 9,997 |
Accounts Receivable, net | 6,036 | 4,171 |
Inventory, net | 4,028 | 3,913 |
Prepaid and Other Current Assets | 2,815 | 2,706 |
Total Current Assets | 46,082 | 69,469 |
Property and Equipment, net | 2,507 | 2,642 |
Inventory, Non-Current | 1,526 | 1,176 |
Right of Use Assets, net | 6,934 | 2,911 |
Goodwill | 921 | 921 |
Other Non-Current Assets | 729 | 629 |
Total Assets | 58,699 | 77,748 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
Accounts Payable | 4,834 | 4,155 |
Accrued Liabilities | 4,371 | 5,013 |
Lease Liability - Current | 1,832 | 1,167 |
Deferred License Revenue - Current | 2,176 | 2,175 |
Term Loan - Net of Issuance Costs | 7,131 | 0 |
Insurance Financing Note Payable | 1,312 | 0 |
Customer Deposits | 100 | 152 |
Other Current Liability - Related Party | 0 | 131 |
Total Current Liabilities | 21,756 | 12,793 |
Lease Liability - Long-Term | 5,226 | 1,821 |
Term Loan, Net of Issuance Costs | 14,094 | 20,949 |
Deferred License Revenue - Long-Term | 6,529 | 8,015 |
Total Liabilities | 47,605 | 43,578 |
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 September 30, 2021 and December 31, 2020 | 0 | 0 |
Common Stock, $0.0001 par value; 170,000,000 shares authorized; 93,966,381 and 93,573,165 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 9 | 9 |
Additional Paid-in Capital | 372,168 | 371,510 |
Accumulated Deficit | (361,139) | (337,406) |
Accumulated Other Comprehensive Income | 56 | 57 |
Total Stockholders’ Equity | 11,094 | 34,170 |
Total Liabilities and Stockholders’ Equity | $ 58,699 | $ 77,748 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred shares, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred shares, shares authorized (in shares) | 2,000,000 | 2,000,000 |
Preferred shares, shares issued (in shares) | 0 | 0 |
Preferred shares, shares outstanding (in shares) | 0 | 0 |
Common shares, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common shares, shares authorized (in shares) | 170,000,000 | 170,000,000 |
Common shares, shares issued (in shares) | 93,966,381 | 93,573,165 |
Common shares, shares outstanding (in shares) | 93,966,381 | 93,573,165 |
UNAUDITED CONDENSED CONSOLIDATE
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Statement [Abstract] | ||||
Net Sales | $ 15,988 | $ 15,280 | $ 46,599 | $ 47,033 |
Cost of Sales | 16,317 | 14,934 | 46,788 | 44,693 |
Gross (Loss) Profit | (329) | 346 | (189) | 2,340 |
Research and Product Development | 1,221 | 1,745 | 5,445 | 5,183 |
Selling and Marketing | 1,541 | 1,669 | 4,860 | 5,738 |
General and Administrative | 3,881 | 3,622 | 11,483 | 11,767 |
Operating Loss | (6,972) | (6,690) | (21,977) | (20,348) |
Other (Expense) Income | ||||
Realized (Loss) Gain on Investments | 0 | 4 | (1) | 8 |
Warrant Modification Expense | 0 | 0 | 0 | (837) |
Interest Expense | (609) | (666) | (1,772) | (1,289) |
Interest Income | 0 | 2 | 17 | 239 |
Total Other Expense | (609) | (660) | (1,756) | (1,879) |
Net Loss | $ (7,581) | $ (7,350) | $ (23,733) | $ (22,227) |
Basic Net Loss per Share (in dollars per share) | $ (0.08) | $ (0.10) | $ (0.26) | $ (0.32) |
Diluted Net Loss per Share (in dollars per share) | $ (0.08) | $ (0.10) | $ (0.26) | $ (0.32) |
Basic Weighted Average Shares Outstanding (in shares) | 93,882,142 | 71,811,322 | 93,726,629 | 69,594,167 |
Diluted Weighted Average Shares Outstanding (in shares) | 93,882,142 | 71,811,322 | 93,726,629 | 69,594,167 |
UNAUDITED CONDENSED CONSOLIDA_2
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Statement of Comprehensive Income [Abstract] | ||||
Net Loss | $ (7,581) | $ (7,350) | $ (23,733) | $ (22,227) |
Unrealized Gain (Loss) on Available-for-Sale Debt Instrument Investments | 4 | 2 | (4) | (11) |
Foreign Currency Translation Adjustments | 0 | 1 | 3 | 8 |
Comprehensive Loss | $ (7,577) | $ (7,347) | $ (23,734) | $ (22,230) |
UNAUDITED CONDENSED CONSOLIDA_3
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Bought Deal | Public Offering | At-the-Market Offering | COMMON STOCK | COMMON STOCKBought Deal | COMMON STOCKPublic Offering | COMMON STOCKAt-the-Market Offering | ADDITIONAL PAID-IN CAPITAL | ADDITIONAL PAID-IN CAPITALBought Deal | ADDITIONAL PAID-IN CAPITALPublic Offering | ADDITIONAL PAID-IN CAPITALAt-the-Market Offering | ACCUMULATED DEFICIT | ACCUMULATED OTHER COMPREHENSIVE INCOME |
Beginning balance (in shares) at Dec. 31, 2019 | 65,378,890 | |||||||||||||
Beginning balance at Dec. 31, 2019 | $ 20,320 | $ 7 | $ 326,777 | $ (306,516) | $ 52 | |||||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||||
Net Loss | (7,984) | (7,984) | ||||||||||||
Unrealized Gain (Loss) on Available-for-Sale Debt Instrument Investments | (7) | (7) | ||||||||||||
Foreign Currency Translation Adjustments | 6 | 6 | ||||||||||||
Issuance of common stock, net of offering costs (in shares) | 3,670,212 | |||||||||||||
Issuance of common stock, net of offering costs | $ 8,003 | $ 8,003 | ||||||||||||
Issuance of Warrants related to Debt Financing | 501 | 501 | ||||||||||||
Stock-based Compensation expense | 935 | 935 | ||||||||||||
Ending balance (in shares) at Mar. 31, 2020 | 69,049,102 | |||||||||||||
Ending balance at Mar. 31, 2020 | 21,774 | $ 7 | 336,216 | (314,500) | 51 | |||||||||
Beginning balance (in shares) at Dec. 31, 2019 | 65,378,890 | |||||||||||||
Beginning balance at Dec. 31, 2019 | 20,320 | $ 7 | 326,777 | (306,516) | 52 | |||||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||||
Net Loss | (22,227) | |||||||||||||
Unrealized Gain (Loss) on Available-for-Sale Debt Instrument Investments | (11) | |||||||||||||
Foreign Currency Translation Adjustments | 8 | |||||||||||||
Ending balance (in shares) at Sep. 30, 2020 | 93,573,165 | |||||||||||||
Ending balance at Sep. 30, 2020 | 42,075 | $ 9 | 370,760 | (328,743) | 49 | |||||||||
Beginning balance (in shares) at Mar. 31, 2020 | 69,049,102 | |||||||||||||
Beginning balance at Mar. 31, 2020 | 21,774 | $ 7 | 336,216 | (314,500) | 51 | |||||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||||
Net Loss | (6,893) | (6,893) | ||||||||||||
Unrealized Gain (Loss) on Available-for-Sale Debt Instrument Investments | (6) | (6) | ||||||||||||
Foreign Currency Translation Adjustments | 1 | 1 | ||||||||||||
Issuance of common stock, net of offering costs (in shares) | 987,716 | |||||||||||||
Issuance of common stock, net of offering costs | $ 1,978 | $ 1,978 | ||||||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares) | 120,104 | |||||||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld | (19) | (19) | ||||||||||||
Warrant Modification Expense | 837 | 837 | ||||||||||||
Stock-based Compensation expense | (1,461) | (1,461) | ||||||||||||
Ending balance (in shares) at Jun. 30, 2020 | 70,156,922 | |||||||||||||
Ending balance at Jun. 30, 2020 | 16,211 | $ 7 | 337,551 | (321,393) | 46 | |||||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||||
Net Loss | (7,350) | (7,350) | ||||||||||||
Unrealized Gain (Loss) on Available-for-Sale Debt Instrument Investments | 2 | 2 | ||||||||||||
Foreign Currency Translation Adjustments | 1 | 1 | ||||||||||||
Issuance of common stock, net of offering costs (in shares) | 23,178,809 | 140,892 | ||||||||||||
Issuance of common stock, net of offering costs | $ 32,677 | $ 284 | $ 2 | $ 32,675 | $ 284 | |||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares) | 96,542 | |||||||||||||
Stock-based Compensation expense | 250 | 250 | ||||||||||||
Ending balance (in shares) at Sep. 30, 2020 | 93,573,165 | |||||||||||||
Ending balance at Sep. 30, 2020 | $ 42,075 | $ 9 | 370,760 | (328,743) | 49 | |||||||||
Beginning balance (in shares) at Dec. 31, 2020 | 93,573,165 | 93,573,165 | ||||||||||||
Beginning balance at Dec. 31, 2020 | $ 34,170 | $ 9 | 371,510 | (337,406) | 57 | |||||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||||
Net Loss | (7,752) | (7,752) | ||||||||||||
Unrealized Gain (Loss) on Available-for-Sale Debt Instrument Investments | (7) | (7) | ||||||||||||
Foreign Currency Translation Adjustments | 3 | 3 | ||||||||||||
Stock-based Compensation expense (in shares) | 26,354 | |||||||||||||
Stock-based Compensation expense | (236) | (236) | ||||||||||||
Ending balance (in shares) at Mar. 31, 2021 | 93,599,519 | |||||||||||||
Ending balance at Mar. 31, 2021 | $ 26,178 | $ 9 | 371,274 | (345,158) | 53 | |||||||||
Beginning balance (in shares) at Dec. 31, 2020 | 93,573,165 | 93,573,165 | ||||||||||||
Beginning balance at Dec. 31, 2020 | $ 34,170 | $ 9 | 371,510 | (337,406) | 57 | |||||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||||
Net Loss | (23,733) | |||||||||||||
Unrealized Gain (Loss) on Available-for-Sale Debt Instrument Investments | (4) | |||||||||||||
Foreign Currency Translation Adjustments | $ 3 | |||||||||||||
Ending balance (in shares) at Sep. 30, 2021 | 93,966,381 | 93,966,381 | ||||||||||||
Ending balance at Sep. 30, 2021 | $ 11,094 | $ 9 | 372,168 | (361,139) | 56 | |||||||||
Beginning balance (in shares) at Mar. 31, 2021 | 93,599,519 | |||||||||||||
Beginning balance at Mar. 31, 2021 | 26,178 | $ 9 | 371,274 | (345,158) | 53 | |||||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||||
Net Loss | (8,400) | (8,400) | ||||||||||||
Unrealized Gain (Loss) on Available-for-Sale Debt Instrument Investments | (1) | (1) | ||||||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares) | 211,862 | |||||||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld | (7) | (7) | ||||||||||||
Stock-based Compensation expense | 433 | 433 | ||||||||||||
Ending balance (in shares) at Jun. 30, 2021 | 93,811,381 | |||||||||||||
Ending balance at Jun. 30, 2021 | 18,203 | $ 9 | 371,700 | (353,558) | 52 | |||||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||||
Net Loss | (7,581) | (7,581) | ||||||||||||
Unrealized Gain (Loss) on Available-for-Sale Debt Instrument Investments | 4 | 4 | ||||||||||||
Foreign Currency Translation Adjustments | 0 | |||||||||||||
Issued shares for services (in shares) | 155,000 | |||||||||||||
Issued shares for services | 107 | 107 | ||||||||||||
Stock-based Compensation expense | $ 361 | 361 | ||||||||||||
Ending balance (in shares) at Sep. 30, 2021 | 93,966,381 | 93,966,381 | ||||||||||||
Ending balance at Sep. 30, 2021 | $ 11,094 | $ 9 | $ 372,168 | $ (361,139) | $ 56 |
UNAUDITED CONDENSED CONSOLIDA_4
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash Flows From Operating Activities: | ||
Net Loss | $ (23,733) | $ (22,227) |
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities: | ||
Depreciation and Amortization | 535 | 614 |
Stock-based Compensation | 558 | (276) |
Warrant Modification Expense | 0 | 837 |
Increase in Inventory Reserves | 89 | 305 |
Amortization of Right of Use Asset | 1,312 | 1,090 |
Amortization of Debt Financing Costs and Accretion of Debt Discount | 276 | 200 |
Loss on Disposal of Assets | 7 | 7 |
Realized Loss (Gain) on Sale of Investments Available-for-Sale | 1 | (8) |
Foreign Currency Translation Adjustment | 3 | 7 |
Changes in Assets and Liabilities: | ||
(Increase) Decrease in Accounts Receivable, net | (1,865) | 74 |
Increase in Inventory | (554) | (953) |
Decrease in Prepaid and Other Assets | 1,760 | 161 |
Increase in Accounts Payable | 679 | 1,172 |
Decrease in Settlement Payable | 0 | (104) |
Decrease in Lease Liability | (1,266) | (1,056) |
(Decrease) Increase in Other Liabilities | (825) | 423 |
Decrease in Deferred License Revenue | (1,485) | (1,338) |
Changes in Assets and Liabilities | (3,556) | (1,621) |
Cash Used In Operating Activities | (24,508) | (21,072) |
Cash Flows From Investing Activities: | ||
Purchase of Investments Available-for-Sale | (19,107) | (23,531) |
Sale of Investments Available-for-Sale | 19,286 | 27,076 |
Purchase of Equipment | (408) | (970) |
Cash (Used In) Provided By Investing Activities | (229) | 2,575 |
Cash Flows From Financing Activities: | ||
Proceeds from Term Loan | 0 | 22,500 |
Debt Issuance Costs | 0 | (1,343) |
Payments on Short Term Note Payable | (656) | (763) |
Proceeds from the Issuance of Common Stock for payment related to services provided | 107 | 0 |
Repurchase of Common Stock to Pay Employee Withholding Taxes | (6) | (18) |
Cash (Used In) Provided By Financing Activities | (555) | 63,317 |
(Decrease) Increase in Cash and Cash Equivalents | (25,292) | 44,820 |
Cash and Cash Equivalents at Beginning of Period | 48,682 | 11,794 |
Cash and Cash Equivalents at End of Period | 23,390 | 56,614 |
Supplemental Disclosure of Cash Flow Information: | ||
Cash Paid for Interest | 1,318 | 906 |
Supplemental Disclosure of Noncash Investing and Financing Activities: | ||
Change in Unrealized Loss on Marketable Securities Available-for-Sale | (4) | (11) |
Fair Value of Warrants issued related to Debt Financing | 0 | 501 |
Public Offering | ||
Cash Flows From Financing Activities: | ||
Proceeds from the Issuance of Common Stock | 0 | 43,148 |
Offering Costs from the Issuance of Common Stock | 0 | (2,469) |
At-the-Market Offering | ||
Cash Flows From Financing Activities: | ||
Proceeds from the Issuance of Common Stock | 0 | 2,325 |
Offering Costs from the Issuance of Common Stock | $ 0 | $ (63) |
Description of Business
Description of Business | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business Rockwell Medical, Inc. ("Rockwell Medical," "Rockwell", the "Company" or "We") is a commercial-stage, biopharmaceutical company developing and commercializing our next-generation parenteral iron technology platform, ferric pyrophosphate citrate (“FPC”), which we believe has the potential to lead to transformative treatments for iron deficiency in multiple disease states, 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. The Company has two novel, FDA approved therapies, Triferic and Triferic AVNU, which are the first two products developed from our FPC platform. The Company is target marketing both products to kidney dialysis centers for their patients receiving dialysis and working to find a commercial partner to expand our commercial efforts within the United States. In 2021, Rockwell has been working to advance our FPC platform strategy outside of dialysis by starting a Phase II trial for the treatment of iron deficiency anemia in patients, who are receiving long-term and or chronic intravenous medications for various therapeutic needs in the home infusion setting. In the Company's 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 trial in these patients in 2022. Rockwell Medical is the second largest supplier of hemodialysis concentrates in the United States generating approximately $60 million in annual revenue. The Company's reputation for excellent service, quality, and reliability is based on over 25 years of service to kidney dialysis centers. The Company's approximately 300 dedicated employees, as well as a management team with experience in manufacturing, logistics, pharmaceutical development and commercialization provides Rockwell with a solid foundation upon which to grow. |
Liquidity and Capital Resources
Liquidity and Capital Resources | 9 Months Ended |
Sep. 30, 2021 | |
Liquidity and Capital Resources [Abstract] | |
Liquidity and Capital Resources | Liquidity and Capital Resources Since inception, Rockwell has incurred significant net losses and has funded its operations primarily through revenue from commercial products, proceeds from the issuance of debt and equity securities and payments from partnerships. At September 30, 2021, Rockwell had an accumulated deficit of approximately $361.1 million and stockholders' equity of $11.1 million. As of September 30, 2021, Rockwell had approximately $33.2 million of cash, cash equivalents and investments available-for-sale, and working capital of $24.3 million. Net cash used in operating activities for the nine months ended September 30, 2021 was approximately $24.5 million. Based on the currently available working capital, the adjustments made to sales and marketing efforts for Triferic and Triferic AVNU and the implementation of key efficiency initiatives within our concentrates business, management believes the Company currently has sufficient funds to meet its operating requirements for at least the next twelve months from the date of the filing of this report. The Company expects it will require additional capital to sustain its operations and make the investments it needs to execute its strategic plan 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. Currently, because the Company's public float is less than $75 million, we are subject to the baby shelf limitations under our current registration statement on Form S-3, which limit the amount we may offer under our Form S-3. This could limit our ability to raise capital under this registration statement. Additionally, the Company has received a delisting notification letter from the Nasdaq Stock Market ("Nasdaq") regarding compliance with minimum bid requirements. The notification letter states that the Company has 180 calendar days, or until December 8, 2021, to regain compliance with Nasdaq Listing Rule 5450(a)(1). To regain compliance, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive business days at any time prior to December 8, 2021. In the event that the Company does not regain compliance by December 8, 2021, the Company may be eligible for additional time to reach compliance with the minimum bid price requirement. The Company is working on a plan to meet the minimum compliance requirements set forth by Nasdaq. Based on the above, 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 is in compliance with all covenants. (See Note 15 for further detail). The COVID-19 pandemic and resulting domestic and global disruptions in the supply chain and labor market, among other areas, have adversely affected Rockwell's business and operations, including, but not limited to, our sales and marketing efforts, research and development activities, our plant and transportation operations 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 continue to negatively impact Rockwell's business, including with regard to the Company’s manufacturing and transportation and remaining sales and marketing activities. The Company's international business development activities may also continue to be negatively impacted by COVID-19, especially with the recent surge in infections internationally, ongoing international travel restrictions and 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 continued evolving nature of the global situation, it is not possible to predict the extent to which these conditions could adversely affect the Company's liquidity and capital resources in the future. |
Basis of Presentation, Summary
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements | Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements The accompanying condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U. S. Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. The condensed consolidated balance sheet at September 30, 2021, condensed consolidated statements of operations for the three and nine months ended September 30, 2021 and 2020, condensed consolidated statements of comprehensive loss for the three and nine months ended September 30, 2021 and 2020, condensed consolidated statement of changes in stockholders' equity for the three and nine months ended September 30, 2021 and 2020, and condensed consolidated statements of cash flows for the nine months ended September 30, 2021 and 2020 are unaudited, but include all adjustments, consisting of normal recurring adjustments, that the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021 or for any future interim period. The condensed consolidated balance sheet at December 31, 2020 has been derived from audited financial statements, however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2020 and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 as filed with the SEC on March 31, 2021. The Company’s consolidated subsidiaries consisted of its wholly-owned subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited. The accompanying condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Leases The Company accounts for its leases under Accounting Standards Codification (“ASC”) 842, Leases . Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. Variable lease expenses, if any, are recorded when incurred. In calculating the right-of-use asset and lease liability, the Company elects to combine lease and non-lease components. The Company excludes short-term leases having initial terms of 12 months or less from the new guidance as an accounting policy election and recognizes rent expense on a straight-line basis over the lease term. Loss Per Share ASC 260, Earnings Per Share , requires dual presentation of basic and diluted earnings per share (“EPS”), with a reconciliation of the numerator and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. Basic EPS excludes dilution. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that are then sharing in the earnings of the entity. Basic net loss per share of common stock excludes dilution and is computed by dividing the net loss by the weighted average number of shares outstanding during the period. Diluted net loss per share of common stock reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity unless inclusion of such shares would be anti-dilutive. The Company has only incurred losses, therefore, basic and diluted net loss per share is the same. Securities that could potentially dilute net income per share in the future that were not included in the computation of diluted loss per share were as follows: As of September 30, 2021 2020 Options to purchase common stock 5,871,620 6,682,192 Unvested restricted stock awards 78,300 146,800 Unvested restricted stock units 342,271 245,405 Warrants to purchase common stock 26,426,863 26,426,863 Total 32,719,054 33,501,260 Adoption of Recent Accounting Pronouncements The Company continually assesses new accounting pronouncements to determine their applicability. When it is determined that a new accounting pronouncement affects the Company’s financial reporting, the Company undertakes a review to determine the consequences of the change to its consolidated financial statements and assures that there are sufficient controls in place to ascertain that the Company’s consolidated financial statements properly reflect the change. In April 2021, the Financial Accounting Standards Board ("FASB") recently issued Accounting Standards Update ("ASU") 2021-04 to codify the final consensus reached by the Emerging Issues Task Force (EITF) on how an issuer should account for modifications made to equity-classified written call options (hereafter referred to as a warrant to purchase the issuer’s common stock). The guidance in the ASU requires the issuer to treat a modification of an equity-classified warrant that does not cause the warrant to become liability-classified as an exchange of the original warrant for a new warrant. This guidance applies whether the modification is structured as an amendment to the terms and conditions of the warrant or as termination of the original warrant and issuance of a new warrant. The Company is evaluating the impact of this guidance on its condensed consolidated financial statements. |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | Revenue Recognition The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the new revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: • Step 1: Identify the contract with the customer • Step 2: Identify the performance obligations in the contract • Step 3: Determine the transaction price • Step 4: Allocate the transaction price to the performance obligations in the contract • Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue. Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer. Nature of goods and services The following is a description of principal activities from which the Company generates its revenue. Product sales – The Company accounts for individual products and services separately if they are distinct (i.e., if a product or service is separately identifiable from other items and if a customer can benefit from it on its own or with other resources that are readily available to the customer). The consideration, including any discounts, is allocated between separate products and services based on their stand-alone selling prices. The stand-alone selling prices are determined based on the cost plus margin approach. Drug and dialysis 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 five distribution and license agreements that have been deferred as a contract liability. The amounts received from Wanbang Biopharmaceuticals Co., Ltd. (“Wanbang”), Sun Pharmaceutical Industries Ltd. ("Sun Pharma"), Jeil Pharmaceutical Co., Ltd. ("Jeil Pharma") and Drogsan Pharmaceuticals ("Drogsan Pharma") are recognized as revenue over the estimated term of the applicable distribution and license agreement as regulatory approval was not received and the Company did not have sufficient experience in China, India 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 or receipt of the product. The amount of revenue recognized is based on the purchase order less returns and adjusted for any rebates, discounts, chargebacks or other amounts paid to customers. There were no such adjustments for the periods reported. Customers typically pay for the product based on customary business practices with payment terms averaging 30 days, while distributor payment terms average 45 days. Disaggregation of revenue Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition. In thousands of U.S. dollars ($) Three Months Ended September 30, 2021 Nine Months Ended September 30, 2021 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ 217 $ 217 $ — $ 656 $ 656 $ — License Fee – Over time 62 — 62 179 — 179 Total Drug Products 279 217 62 835 656 179 Concentrate Products Product Sales – Point-in-time 15,224 13,541 1,683 44,308 39,768 4,540 License Fee – Over time 485 485 — 1,456 1,456 — Total Concentrate Products 15,709 14,026 1,683 45,764 41,224 4,540 Net Revenue $ 15,988 $ 14,243 $ 1,745 $ 46,599 $ 41,880 $ 4,719 In thousands of U.S. dollars ($) Three Months Ended September 30, 2020 Nine Months Ended September 30, 2020 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ 228 $ 228 $ — $ 609 $ 609 $ — License Fee – Over time 56 — 56 167 — 167 Total Drug Products 284 228 56 776 609 167 Concentrate Products Product Sales – Point-in-time 14,506 13,470 1,036 44,786 40,295 4,491 License Fee – Over time 490 490 — 1,471 1,471 — Total Concentrate Products 14,996 13,960 1,036 46,257 41,766 4,491 Net Revenue $ 15,280 $ 14,188 $ 1,092 $ 47,033 $ 42,375 $ 4,658 Contract balances The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands of U.S. dollars ($) September 30, 2021 December 31, 2020 Receivables, which are included in "Trade and other receivables" $ 6,036 $ 4,171 Contract liabilities $ 8,705 $ 10,190 There were no material losses recognized related to any receivables arising from the Company’s contracts with customers for the three and nine months ended September 30, 2021 and 2020. For the three and nine months ended September 30, 2021 and September 30, 2020, the Company did not recognize any material bad-debt expense. There were no material contract assets recorded on the condensed consolidated balance sheet as of September 30, 2021 and December 31, 2020. The Company does not generally accept returns of its concentrate products and no material reserve for returns of concentrate products was established as of September 30, 2021 or December 31, 2020. The contract liabilities primarily relate to upfront payments and consideration received from customers that are received in advance of the customer assuming control of the related products Transaction price allocated to remaining performance obligations For the three and nine months ended September 30, 2021, revenue recognized from performance obligations related to prior periods was not material. |
Investments - Available-for-Sal
Investments - Available-for-Sale | 9 Months Ended |
Sep. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments - Available-for-Sale | Investments - Available-for-Sale Investments available-for-sale consisted of the following as of September 30, 2021 and December 31, 2020 (table in thousands): September 30, 2021 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Income Fair Value Available-for-Sale Securities Bonds $ 9,805 $ 1 $ — $ 7 $ 9,813 December 31, 2020 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Fair Value Available-for-Sale Securities Bonds $ 9,987 $ 3 $ — $ 7 $ 9,997 The fair value of investments available-for-sale are determined using quoted market prices from daily exchange-traded markets based on the closing price as of the balance sheet date and are classified as a Level 1 measurement under ASC 820 Fair Value Measurements. As of September 30, 2021 and December 31, 2020, the amortized cost and estimated fair value of our available-for-sale securities were due within one year. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Components of inventory, net of reserves, as of September 30, 2021 and December 31, 2020 are as follows (table in thousands): September 30, December 31, Raw Materials $ 3,507 $ 3,112 Work in Process 266 172 Finished Goods 1,781 1,805 Total $ 5,554 $ 5,089 As of September 30, 2021, the Company classified $1.5 million of inventory as non-current, all of which was related to Triferic or the active pharmaceutical ingredient and raw materials for Triferic. As of September 30, 2021, the total Triferic inventory net of reserve was $1.6 million. The $1.6 million net value of Triferic inventory consisted of $0.4 million of Triferic (dialysate) finished goods with expiration dates ranging from September 2021 to December 2023, $0.4 million of Triferic API with estimated remaining shelf life extending beyond 2022, and $0.9 million of raw materials for Triferic with estimated remaining shelf life extending beyond 2025. |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment As of September 30, 2021 and December 31, 2020, the Company’s property and equipment consisted of the following (table in thousands): September 30, December 31, Leasehold Improvements $ 1,196 $ 1,196 Machinery and Equipment 5,794 5,475 Information Technology & Office Equipment 1,846 1,831 Laboratory Equipment 676 676 9,512 9,178 Accumulated Depreciation (7,005) (6,536) Property and Equipment, net $ 2,507 $ 2,642 |
Accrued Liabilities
Accrued Liabilities | 9 Months Ended |
Sep. 30, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities as of September 30, 2021 and December 31, 2020 consisted of the following (table in thousands): September 30, December 31, Accrued Research & Development Expense $ 181 $ 232 Accrued Compensation and Benefits 2,193 2,500 Accrued Unvouchered Receipts 622 755 Accrued Workers Compensation 434 395 Other Accrued Liabilities 941 1,131 Total Accrued Liabilities $ 4,371 $ 5,013 |
Deferred Revenue
Deferred Revenue | 9 Months Ended |
Sep. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Deferred Revenue | Deferred Revenue In October 2014, the Company entered into the Baxter Agreement with Baxter and received an upfront fee of $20 million. The upfront fee was recorded as deferred revenue and is being recognized based on the proportion of product shipments to Baxter in each period, compared with total expected sales volume over the term of the Baxter Agreement, which expires in October 2024 and is subject to extension. The Company recognized revenue of approximately $0.5 million and $1.5 million for each of the three and nine months ended September 30, 2021 and 2020. Deferred revenue related to the Baxter Agreement totaled $5.7 million as of September 30, 2021 and $7.2 million as of December 31, 2020. If a “Refund Trigger Event” occurs under the Baxter Agreement prior to December 31, 2021, Rockwell would be obligated to repay 25% of the upfront fee. In 2016, the Company entered into a distribution and license agreement with Wanbang (the "Wanbang Agreement") and received an upfront fee of $4.0 million. The upfront fee was recorded as deferred revenue and is being recognized as revenue based on the agreement term. The Company recognized approximately $53,000 and $0.2 million revenue for each of the three and nine months ended September 30, 2021 and 2020. Deferred revenue related to the Wanbang Agreement totaled $2.6 million as of September 30, 2021 and $2.7 million as of December 31, 2020. In January 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 $2,500 and $7,500 for each of the three and nine months ended September 30, 2021 and 2020. Deferred revenue related to the Sun Pharma Agreement totaled $82,500 and $90,000 as of September 30, 2021 and December 31, 2020, respectively. In September 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 and nil for the three months ended September 30, 2021 and 2020, respectively, and $7,500 and nil for the nine months ended September 30, 2021 and 2020, respectively. Deferred revenue related to the Jeil Pharma Agreement totaled approximately $0.2 million as of September 30, 2021 and December 31, 2020. In June 2021, the Company entered into license and supply agreements with Drogsan Pharma (the "Drogsan Agreements"), for the rights to commercialize Triferic (dialysate) and Triferic AVNU in Turkey. Under the terms of the Drogsan Agreements, Drogsan Pharma will be the exclusive commercialization partner for Triferic (dialysate) and Triferic AVNU in Turkey. In consideration for the license, the Company received an upfront fee of $0.15 million, and will be eligible for milestone payment and royalties on net sales. A Joint Alliance Committee, comprised of members from the Company and Drogsan Pharma, will guide the execution for Triferic (dialysate) and Triferic AVNU in Turkey. Drogsan Pharma will be responsible for all regulatory approval and commercialization activities, and the Company will supply the product to Drogsan Pharma for Turkey. The upfront fee will be recorded as deferred revenue and will be recognized as revenue based on the agreement term. The Company recognized revenue of $3,750 for the three months ended September 30, 2021. Deferred revenue related to the Drogsan Agreements totaled approximately $0.15 million as of September 30, 2021. |
Stockholders_ Equity
Stockholders’ Equity | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Preferred Stock As of September 30, 2021 and December 31, 2020, 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 September 30, 2021 and December 31, 2020, there were 170,000,000 shares of common stock, $0.0001 par value per share, authorized and 93,966,381 and 93,573,165 shares issued and outstanding, respectively. Controlled Equity Offering (or "At the Market" Offering) On March 22, 2019, the Company entered into a sales agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (the “Agent”), pursuant to which the Company may offer and sell from time to time shares of the Company’s common stock through the Agent. The offering and sale of up to $40.0 million of the shares has been registered under the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the Company’s registration statement on Form S-3 (File No. 333-227363), which was originally filed with the SEC on September 14, 2018 and declared effective by the SEC on October 1, 2018, the base prospectus contained within the registration statement, and a prospectus supplement that was filed with the SEC on March 22, 2019. The registration statement on Form S-3 expired on October 1, 2021 and no further sales may be made under the Sales Agreement. During the three and nine months ended September 30, 2021, the Company has not sold shares of its common stock pursuant to the Sales Agreement. Approximately $32.3 million remained available for sale under this facility as of September 30, 2021. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation The Company recognized total stock-based compensation expense during the three and nine months ended September 30, 2021 and 2020 as follows (table in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Service-based awards: Restricted stock units $ 81 $ 9 $ 263 $ 243 Stock option awards 315 243 1,050 1,019 396 252 1,313 1,262 Performance-based awards: Restricted stock awards — — (391) — Restricted stock units — (123) — (1,148) Stock option awards (35) 121 (364) (390) (35) (2) (755) (1,538) Total $ 361 $ 250 $ 558 $ (276) Restricted Stock A summary of the Company’s restricted stock awards during the nine months ended September 30, 2021 is as follows: Number of Shares Weighted Average Unvested at January 1, 2021 146,800 $ 5.70 Forfeited (68,500) $ 5.70 Unvested at September 30, 2021 78,300 $ 5.70 A summary of the Company’s restricted stock awards during the nine months ended September 30, 2020 is as follows: Number of Shares Weighted Average Unvested at January 1, 2020 146,800 $ 5.70 Unvested at September 30, 2020 146,800 $ 5.70 The fair value of restricted stock awards are measured based on their fair value on the date of grant and amortized over the vesting period of 20 months. As of September 30, 2021, unvested restricted stock awards of 78,300 were related to performance-based awards. The forfeited performance-based restricted stock awards of 68,500 was due to the termination of the Company's former Chief Science Officer on January 19, 2021. These forfeited awards reduced stock-based compensation expense by $0.4 million. Service-Based Restricted Stock Units A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2021 is as follows: Number of Shares Weighted Average Unvested at January 1, 2021 265,494 $ 2.60 Granted 310,050 0.90 Vested (221,474) 2.38 Forfeited (11,799) 4.81 Unvested at September 30, 2021 342,271 $ 1.17 A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2020 is as follows: Number of Shares Weighted Average Unvested at January 1, 2020 463,786 $ 4.26 Granted 188,904 2.09 Vested (247,561) 4.30 Forfeited (159,724) 4.26 Unvested at September 30, 2020 245,405 $ 2.72 The fair value of service based restricted stock units are measured based on their fair value on the date of grant and amortized over the vesting period. The vesting periods range from 1 to 3 years. Stock-based compensation expense of $0.1 million and $0.3 million was recognized for the three and nine months ended September 30, 2021, respectively. Stock-based compensation expense of nil and $0.2 million was recognized for the three and nine months ended September 30, 2020, respectively. As of September 30, 2021, the unrecognized stock-based compensation expense was $0.2 million, which is expected to be recognized over an estimated weighted average remaining term of less than 1 year. Performance-Based Restricted Stock Units As of September 30, 2021, there were no outstanding performance-based restricted stock units. A summary of the Company’s performance-based restricted stock units during the nine months ended September 30, 2020 is as follows: Number of Shares Weighted Average Unvested at January 1, 2020 988,958 $ 4.48 Forfeited (988,958) 4.48 Unvested at Unvested at September 30, 2020 — $ — Service-Based Stock Options The fair value of the service-based stock options granted for the nine months ended September 30, 2021 were based on the following assumptions: September 30, Exercise price $0.61 - $1.73 Expected stock price volatility 75.8% - 77.7% Risk-free interest rate 0.47% - 1.06% Term (years) 5.5 - 6 A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2021 is as follows: Shares Weighted Weighted Aggregate Outstanding at January 1, 2021 5,717,956 $ 4.55 6.6 $ — Granted 1,872,162 0.89 6.0 — Forfeited (385,278) 2.30 — — Expired (1,333,220) 7.16 — — Outstanding at September 30, 2021 5,871,620 $ 2.95 7.7 $ — Exercisable at September 30, 2021 2,539,438 $ 4.96 5.8 $ — A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2020 is as follows: Shares Weighted Weighted Aggregate Outstanding at January 1, 2020 8,210,024 $ 7.06 5.1 $ 107,000 Granted 2,252,344 1.95 5.9 — Forfeited (440,026) 3.96 — — Expired (4,090,150) 8.24 — — Outstanding at September 30, 2020 5,932,192 $ 4.54 6.7 $ — Exercisable at September 30, 2020 2,889,218 $ 6.95 3.8 $ — The aggregate intrinsic value in the table above is calculated as the difference between the closing price of the Company's common stock and the exercise price of the stock options that had strike prices below the closing price. During the nine months ended September 30, 2021, the Company granted stock options to purchase up to 1,872,162 shares of common stock to certain employees. During the nine months ended September 30, 2021, 385,278 shares were forfeited and 1,333,220 shares expired. Forfeitures are recorded in the period of occurrence; compensation expense is adjusted accordingly. Stock-based compensation expense recognized for service-based stock options was $0.3 million and $1.0 million for the three and nine months ended September 30, 2021, respectively. Stock-based compensation expense recognized for service-based stock options was $0.2 million and $1.0 million for the three and nine months ended September 30, 2020, respectively. As of September 30, 2021, total stock-based compensation expense related to unvested options not yet recognized totaled approximately $1.7 million, which is expected to be recognized over an estimated weighted average remaining term of 3.0 years. Performance-Based Stock Options A summary of the performance-based stock options for the nine months ended September 30, 2021 is as follows: Number of Shares Weighted Average Outstanding at January 1, 2021 750,000 $ 2.20 Expired (750,000) 2.20 Outstanding at September 30, 2021 — $ — Exercisable at September 30, 2021 — $ — A summary of the performance-based stock options for the nine months ended September 30, 2020 is as follows: Number of Shares Weighted Average Outstanding at January 1, 2020 388,125 $ 4.70 Granted 750,000 $ 2.20 Forfeited (388,125) $ 4.70 Outstanding at September 30, 2020 750,000 $ 2.20 Exercisable at September 30, 2020 — $ — Stock-based compensation expense recognized for performance-based stock options was nil and $(0.4) million for the three and nine months ended September 30, 2021, respectively. Stock-based compensation expense recognized for performance-based stock options was $0.1 million and $(0.4) million for the three and nine months ended September 30, 2020, respectively. The increase in expired performance-based stock options and reduction in stock-based compensation expense was due to the performance criteria of certain performance-based options granted to officers of the Company becoming non-probable as of September 30, 2021. As of September 30, 2021, there was no unrecognized stock-based compensation expense related to unvested performance-based stock options. |
Licensing Agreements
Licensing Agreements | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Licensing Agreements | Licensing Agreements Product License Agreements The Company is a party to a Licensing Agreement with Charak, LLC ("Charak") dated January 7, 2002 (the "2002 Agreement") that grants the Company exclusive worldwide rights to certain patents and information related to our Triferic® product. On October 7, 2018, the Company entered into a Master Services and IP Agreement (the “Charak MSA”) with Charak and Dr. Ajay Gupta, a former Officer of the Company. Pursuant to the MSA, the parties entered into three additional agreements described below related to the license of certain soluble ferric pyrophosphate (“SFP”) intellectual property owned by Charak. The Charak MSA provided 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 had fulfilled its reimbursement obligation of certain legal expenses. As of September 30, 2021, the Company accrued $0.2 million relating to certain IP reimbursement expenses and certain sublicense royalty fees within accrued liabilities on the condensed consolidated balance sheet. Pursuant to the Charak MSA, the aforementioned parties entered into an Amendment, dated as of October 7, 2018 (the “Charak Amendment”), to the 2002 Agreement, under which Charak granted the Company an exclusive, worldwide, non-transferable license to commercialize SFP for the treatment of patients with renal failure. The Charak Amendment amends the royalty payments due to Charak under the 2002 Agreement such that the Company is liable to pay Charak royalties on net sales by the Company of products developed under the license, which includes the Company’s Triferic® product, at a specified rate until December 31, 2021 and thereafter at a reduced rate from January 1, 2022 until February 1, 2034. Additionally, the Company shall pay Charak a percentage of any sublicense income during the term of the agreement, which amount shall not be less than a minimum specified percentage of net sales of the licensed products by the sub-licensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and be no less than a lower rate of the net sales of the licensed products by the sub-licensee in jurisdictions where there exists no valid claim, on a country-by-country basis. Also pursuant to the Charak MSA, the Company and Charak entered into a Commercialization and Technology License Agreement I.V. Triferic® (now Triferic AVNU), dated as of October 7, 2018 (the “IV Agreement”), under which Charak granted the Company an exclusive, sub-licensable, royalty-bearing license to SFP for the purpose of commercializing certain intravenous-delivered products incorporating SFP for the treatment of iron disorders worldwide for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. The Company is liable to pay Charak royalties on net sales by the Company of products developed under the license at a specified rate until December 31, 2021. From January 1, 2022 until February 1, 2034, the Company is liable to pay Charak a base royalty at a reduced rate on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the IV Agreement, which amount shall not be less than a minimum specified percentage of net sales of the licensed products by the sub-licensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sub-licensee in jurisdictions where there exists no valid claim, on a country-by-country basis. Also pursuant to the Charak MSA, the Company and Charak entered into a Technology License Agreement TPN Triferic®, dated as of October 7, 2018 (the “TPN Agreement”), pursuant to which Charak granted the Company an exclusive, sublicensable, royalty-bearing license to SFP for the purpose of commercializing worldwide certain parenteral nutritional ("TPN”) products incorporating SFP. The license grant under the TPN Agreement continues for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. During the term of the TPN Agreement, the Company is liable to pay Charak a base royalty on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the TPN Agreement, which amount shall not be less than a minimum royalty on net sales of the licensed products by the sub-licensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sub-licensee in jurisdictions where there exists no valid claim, on a country-by-country basis. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
Leases | Leases The Company leases its production facilities and administrative offices as well as certain equipment used in our operations including leases on transportation equipment used in the delivery of its products. The lease terms range from monthly to five years. The Company occupies a 51,000 square foot facility and a 17,500 square foot facility in Wixom, Michigan under a lease expiring in August 2024. The Company also occupies two other manufacturing facilities, a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December 2025, and a 57,000 square foot facility in Greer, South Carolina under a lease expiring February 2023. In addition, the Company occupies 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. At September 30, 2021, the Company had operating and finance lease liabilities of $7.1 million and right-of-use assets of $6.9 million, which are included in the consolidated balance sheet. At December 31, 2020, the Company had operating lease liabilities of $3.0 million and right-of-use assets of $2.9 million, which are included in the consolidated balance sheet. The following summarizes quantitative information about the Company’s operating leases (table in thousands): Three Months Ended September 30, 2021 Three Months Ended September 30, 2020 Nine Months Ended September 30, 2021 Nine Months Ended September 30, 2020 Operating leases Operating lease cost $ 457 $ 382 $ 1,309 $ 1,228 Variable lease cost 94 90 286 403 Operating lease expense 551 472 1,595 1,631 Finance leases Amortization of right-of-use assets 73 — 184 — Interest on lease obligations 22 — 55 — Finance lease expense 95 — 239 — Short-term lease rent expense 4 4 12 12 Total rent expense $ 650 $ 476 $ 1,846 $ 1,643 Other information Operating cash flows from operating leases $ 444 $ 393 $ 1,298 $ 1,248 Operating cash flows from finance leases $ 22 $ — $ 56 $ — Financing cash flows from finance leases $ 59 $ — $ 152 $ — Right of use assets exchanged for operating lease liabilities $ 718 $ — $ 4,089 $ — Right of use assets exchanged for finance lease liabilities $ 588 $ — $ 1,365 $ — Weighted-average remaining lease term – operating leases 3.7 2.3 3.7 2.3 Weighted-average remaining lease term – finance leases 5.5 0.0 5.5 0.0 Weighted-average discount rate – operating leases 6.3 % 6.8 % 6.3 % 6.8 % Weighted-average discount rate – finance leases 5.9 % — % 5.9 % — % Future minimum rental payments under operating lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2021 (remaining) $ 470 $ 103 Year ending December 31, 2022 1,746 418 Year ending December 31, 2023 1,429 424 Year ending December 31, 2024 1,076 424 Year ending December 31, 2025 616 426 Remaining future payments 345 526 Total $ 5,682 $ 2,321 Less present value discount (607) (338) Operating and finance lease liabilities $ 5,075 $ 1,983 |
Leases | Leases The Company leases its production facilities and administrative offices as well as certain equipment used in our operations including leases on transportation equipment used in the delivery of its products. The lease terms range from monthly to five years. The Company occupies a 51,000 square foot facility and a 17,500 square foot facility in Wixom, Michigan under a lease expiring in August 2024. The Company also occupies two other manufacturing facilities, a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December 2025, and a 57,000 square foot facility in Greer, South Carolina under a lease expiring February 2023. In addition, the Company occupies 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. At September 30, 2021, the Company had operating and finance lease liabilities of $7.1 million and right-of-use assets of $6.9 million, which are included in the consolidated balance sheet. At December 31, 2020, the Company had operating lease liabilities of $3.0 million and right-of-use assets of $2.9 million, which are included in the consolidated balance sheet. The following summarizes quantitative information about the Company’s operating leases (table in thousands): Three Months Ended September 30, 2021 Three Months Ended September 30, 2020 Nine Months Ended September 30, 2021 Nine Months Ended September 30, 2020 Operating leases Operating lease cost $ 457 $ 382 $ 1,309 $ 1,228 Variable lease cost 94 90 286 403 Operating lease expense 551 472 1,595 1,631 Finance leases Amortization of right-of-use assets 73 — 184 — Interest on lease obligations 22 — 55 — Finance lease expense 95 — 239 — Short-term lease rent expense 4 4 12 12 Total rent expense $ 650 $ 476 $ 1,846 $ 1,643 Other information Operating cash flows from operating leases $ 444 $ 393 $ 1,298 $ 1,248 Operating cash flows from finance leases $ 22 $ — $ 56 $ — Financing cash flows from finance leases $ 59 $ — $ 152 $ — Right of use assets exchanged for operating lease liabilities $ 718 $ — $ 4,089 $ — Right of use assets exchanged for finance lease liabilities $ 588 $ — $ 1,365 $ — Weighted-average remaining lease term – operating leases 3.7 2.3 3.7 2.3 Weighted-average remaining lease term – finance leases 5.5 0.0 5.5 0.0 Weighted-average discount rate – operating leases 6.3 % 6.8 % 6.3 % 6.8 % Weighted-average discount rate – finance leases 5.9 % — % 5.9 % — % Future minimum rental payments under operating lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2021 (remaining) $ 470 $ 103 Year ending December 31, 2022 1,746 418 Year ending December 31, 2023 1,429 424 Year ending December 31, 2024 1,076 424 Year ending December 31, 2025 616 426 Remaining future payments 345 526 Total $ 5,682 $ 2,321 Less present value discount (607) (338) Operating and finance lease liabilities $ 5,075 $ 1,983 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies 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 |
Loans and Security Agreement
Loans and Security Agreement | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Loans and Security Agreement | Loan and Security Agreement In March 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 11.3%. 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 each of the three months ended September 30, 2021 and 2020, interest expense amounted to $0.6 million and $0.7 million, respectively. For the nine months ended September 30, 2021 and 2020, interest expense amounted to $1.8 million and $1.3 million, respectively. The Loan Agreement is secured by all assets of the Company and Rockwell Transportation, Inc. Proceeds are being used for working capital purposes. The Loan Agreement contains customary representations and warranties and covenants, subject to customary carve outs, and includes financial covenants related to liquidity and trailing twelve months sales of Triferic, with the latter beginning with the period ending December 31, 2020. The Company cannot assure you that we can maintain compliance with the covenants under our Loan Agreement, which may result in an event of default. The Company's ability to comply with these covenants may be adversely affected by events beyond its control. For example, the Loan Agreement contains certain financial covenants relating to sales and, as a result of the ongoing COVID-19 pandemic and its effect on the Company's sales activities, among other factors, the Company may not be able to satisfy such covenants in the future. If the Company is unable to comply with the covenants under the Loan Agreement, it would pursue all available cure options in order to regain compliance. The Company previously failed to satisfy a revenue covenant for the period ended December 31, 2020 and then subsequently agreed to an appropriate remedy during the applicable cure period. However, the Company may not be able to mutually agree with Innovatus on appropriate remedies to cure a future breach of a covenant, which could give rise to an event of default. If the Company is unable to avoid an event of default, any required repayments could have an adverse effect on its liquidity. As of September 30, 2021, the Company is in compliance with all the reporting and financial covenants. The financial statements for September 30, 2021 have been prepared with the assumption that the Company will be able to agree to an appropriate remedy during the applicable cure period for any future breaches of operating covenants. Based on the foregoing, the Company has classified amounts payable under the Loan Agreement as a current liability. If and when the Company reaches an agreement with Innovatus to avoid an event of default, the amounts payable under the Loan Agreement will be reevaluated for its classification and presentation. In connection with each funding of the Term Loans, the Company is required to issue to Innovatus a warrant (the “Warrants”) to purchase a number of shares of the Company’s common stock equal to 3.5% of the principal amount of the relevant Term Loan funded divided by the exercise price, which will be based on the lower of (i) the volume weighted average closing price of the Company’s stock for the 5-trading day period ending on the last trading day immediately preceding the execution of the Loan Agreement or (ii) the closing price on the last trading day immediately preceding the execution of the Loan Agreement (or for the second and third tranches only at the lower of (i) $1.65 per share or (ii) the volume weighted average closing price of the Company’s stock for the 5-trading day period ending on the last trading day immediately preceding the relevant Term Loan funding). The Warrants may be exercised on a cashless basis and are immediately exercisable through the seventh anniversary of the applicable funding date. The number of shares of common stock for which each Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Warrant. In connection with the first tranche of the Term Loans, the Company issued a Warrant to Innovatus, exercisable for an aggregate of 477,273 shares of the Company’s common stock at an exercise price of $1.65 per share. The Company evaluated the warrant under ASC 470, Debt, and recognized an additional debt discount of approximately $0.5 million based on the relative fair value of the base instruments and warrants. The Company calculated the fair value of the warrant using the Black-Scholes model. On September 24, 2021, the Company, entered into the First Amendment to Loan and Security Agreement (the “Amendment”) with Innovatus Life Sciences Lending Fund I, LP, which amended the Loan Agreement.. Pursuant to the Amendment, the Company (i) shall prepay an aggregate principal amount of $7.5 million in Term Loans (as defined in the Loan Agreement) in ten consecutive equal monthly installments commencing on December 1, 2021; (ii) shall pay an additional prepayment premium of 5% on prepaid amounts if the Company elects to prepay all outstanding Term Loans on or before September 24, 2023 and (iii) shall maintain minimum liquidity of no less than $5.0 million if the aggregate principal amount of Term Loans is greater than $15.0 million pursuant to the liquidity covenant in the Loan Agreement. As of September 30, 2021, the outstanding balance of the Term Loan was $21.2 million, net of unamortized issuance costs and unaccreted discount of $1.3 million. The following table reflects the schedule of principal payments on the Term Loan as of September 30, 2021 (in thousands): Principal Payments 2021 $ 1,500 2022 7,500 2023 6,000 2024 6,000 2025 1,500 $ 22,500 |
Insurance Financing Note Payabl
Insurance Financing Note Payable | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Insurance Financing Note Payable | Insurance Financing Note PayableOn July 3, 2021, the Company entered into a short-term note payable for $2.0 million, bearing interest at 3.93% per annum to finance various insurance policies. Principal and interest payments related to this note will begin on July 3, 2021 and are paid on a straight-line amortization over 9 months with the final payment due on March 3, 2022. As of September 30, 2021, the Company's insurance note payable balance was $1.3 million. |
Basis of Presentation, Summar_2
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The accompanying condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. |
Leases | Leases The Company accounts for its leases under Accounting Standards Codification (“ASC”) 842, Leases . Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. Variable lease expenses, if any, are recorded when incurred. |
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 issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that are then sharing in the earnings of the entity. |
Adoption of Recent Accounting Pronouncements | Adoption of Recent Accounting Pronouncements The Company continually assesses new accounting pronouncements to determine their applicability. When it is determined that a new accounting pronouncement affects the Company’s financial reporting, the Company undertakes a review to determine the consequences of the change to its consolidated financial statements and assures that there are sufficient controls in place to ascertain that the Company’s consolidated financial statements properly reflect the change. In April 2021, the Financial Accounting Standards Board ("FASB") recently issued Accounting Standards Update ("ASU") 2021-04 to codify the final consensus reached by the Emerging Issues Task Force (EITF) on how an issuer should account for modifications made to equity-classified written call options (hereafter referred to as a warrant to purchase the issuer’s common stock). The guidance in the ASU requires the issuer to treat a modification of an equity-classified warrant that does not cause the warrant to become liability-classified as an exchange of the original warrant for a new warrant. This guidance applies whether the modification is structured as an amendment to the terms and conditions of the warrant or as termination of the original warrant and issuance of a new warrant. The Company is evaluating the impact of this guidance on its condensed consolidated financial statements. |
Basis of Presentation, Summar_3
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Potentially Dilutive Securities | Securities that could potentially dilute net income per share in the future that were not included in the computation of diluted loss per share were as follows: As of September 30, 2021 2020 Options to purchase common stock 5,871,620 6,682,192 Unvested restricted stock awards 78,300 146,800 Unvested restricted stock units 342,271 245,405 Warrants to purchase common stock 26,426,863 26,426,863 Total 32,719,054 33,501,260 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregation of Revenue | Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition. In thousands of U.S. dollars ($) Three Months Ended September 30, 2021 Nine Months Ended September 30, 2021 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ 217 $ 217 $ — $ 656 $ 656 $ — License Fee – Over time 62 — 62 179 — 179 Total Drug Products 279 217 62 835 656 179 Concentrate Products Product Sales – Point-in-time 15,224 13,541 1,683 44,308 39,768 4,540 License Fee – Over time 485 485 — 1,456 1,456 — Total Concentrate Products 15,709 14,026 1,683 45,764 41,224 4,540 Net Revenue $ 15,988 $ 14,243 $ 1,745 $ 46,599 $ 41,880 $ 4,719 In thousands of U.S. dollars ($) Three Months Ended September 30, 2020 Nine Months Ended September 30, 2020 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ 228 $ 228 $ — $ 609 $ 609 $ — License Fee – Over time 56 — 56 167 — 167 Total Drug Products 284 228 56 776 609 167 Concentrate Products Product Sales – Point-in-time 14,506 13,470 1,036 44,786 40,295 4,491 License Fee – Over time 490 490 — 1,471 1,471 — Total Concentrate Products 14,996 13,960 1,036 46,257 41,766 4,491 Net Revenue $ 15,280 $ 14,188 $ 1,092 $ 47,033 $ 42,375 $ 4,658 |
Contract Balances | The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands of U.S. dollars ($) September 30, 2021 December 31, 2020 Receivables, which are included in "Trade and other receivables" $ 6,036 $ 4,171 Contract liabilities $ 8,705 $ 10,190 |
Investments - Available-for-S_2
Investments - Available-for-Sale (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments Available-for-Sale | Investments available-for-sale consisted of the following as of September 30, 2021 and December 31, 2020 (table in thousands): September 30, 2021 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Income Fair Value Available-for-Sale Securities Bonds $ 9,805 $ 1 $ — $ 7 $ 9,813 December 31, 2020 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Fair Value Available-for-Sale Securities Bonds $ 9,987 $ 3 $ — $ 7 $ 9,997 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule Components of Inventory | Components of inventory, net of reserves, as of September 30, 2021 and December 31, 2020 are as follows (table in thousands): September 30, December 31, Raw Materials $ 3,507 $ 3,112 Work in Process 266 172 Finished Goods 1,781 1,805 Total $ 5,554 $ 5,089 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Major Classes of Property and Equipment | As of September 30, 2021 and December 31, 2020, the Company’s property and equipment consisted of the following (table in thousands): September 30, December 31, Leasehold Improvements $ 1,196 $ 1,196 Machinery and Equipment 5,794 5,475 Information Technology & Office Equipment 1,846 1,831 Laboratory Equipment 676 676 9,512 9,178 Accumulated Depreciation (7,005) (6,536) Property and Equipment, net $ 2,507 $ 2,642 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities as of September 30, 2021 and December 31, 2020 consisted of the following (table in thousands): September 30, December 31, Accrued Research & Development Expense $ 181 $ 232 Accrued Compensation and Benefits 2,193 2,500 Accrued Unvouchered Receipts 622 755 Accrued Workers Compensation 434 395 Other Accrued Liabilities 941 1,131 Total Accrued Liabilities $ 4,371 $ 5,013 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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 three and nine months ended September 30, 2021 and 2020 as follows (table in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Service-based awards: Restricted stock units $ 81 $ 9 $ 263 $ 243 Stock option awards 315 243 1,050 1,019 396 252 1,313 1,262 Performance-based awards: Restricted stock awards — — (391) — Restricted stock units — (123) — (1,148) Stock option awards (35) 121 (364) (390) (35) (2) (755) (1,538) Total $ 361 $ 250 $ 558 $ (276) |
Restricted stock awards | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Schedule of Restricted Stock Awards | A summary of the Company’s restricted stock awards during the nine months ended September 30, 2021 is as follows: Number of Shares Weighted Average Unvested at January 1, 2021 146,800 $ 5.70 Forfeited (68,500) $ 5.70 Unvested at September 30, 2021 78,300 $ 5.70 A summary of the Company’s restricted stock awards during the nine months ended September 30, 2020 is as follows: Number of Shares Weighted Average Unvested at January 1, 2020 146,800 $ 5.70 Unvested at September 30, 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 Awards | A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2021 is as follows: Number of Shares Weighted Average Unvested at January 1, 2021 265,494 $ 2.60 Granted 310,050 0.90 Vested (221,474) 2.38 Forfeited (11,799) 4.81 Unvested at September 30, 2021 342,271 $ 1.17 A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2020 is as follows: Number of Shares Weighted Average Unvested at January 1, 2020 463,786 $ 4.26 Granted 188,904 2.09 Vested (247,561) 4.30 Forfeited (159,724) 4.26 Unvested at September 30, 2020 245,405 $ 2.72 |
Restricted stock units - performance based awards | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Schedule of Restricted Stock Awards | A summary of the Company’s performance-based restricted stock units during the nine months ended September 30, 2020 is as follows: Number of Shares Weighted Average Unvested at January 1, 2020 988,958 $ 4.48 Forfeited (988,958) 4.48 Unvested at Unvested at September 30, 2020 — $ — |
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 nine months ended September 30, 2021 were based on the following assumptions: September 30, Exercise price $0.61 - $1.73 Expected stock price volatility 75.8% - 77.7% Risk-free interest rate 0.47% - 1.06% Term (years) 5.5 - 6 |
Schedule of Stock Options Activity | A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2021 is as follows: Shares Weighted Weighted Aggregate Outstanding at January 1, 2021 5,717,956 $ 4.55 6.6 $ — Granted 1,872,162 0.89 6.0 — Forfeited (385,278) 2.30 — — Expired (1,333,220) 7.16 — — Outstanding at September 30, 2021 5,871,620 $ 2.95 7.7 $ — Exercisable at September 30, 2021 2,539,438 $ 4.96 5.8 $ — A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2020 is as follows: Shares Weighted Weighted Aggregate Outstanding at January 1, 2020 8,210,024 $ 7.06 5.1 $ 107,000 Granted 2,252,344 1.95 5.9 — Forfeited (440,026) 3.96 — — Expired (4,090,150) 8.24 — — Outstanding at September 30, 2020 5,932,192 $ 4.54 6.7 $ — Exercisable at September 30, 2020 2,889,218 $ 6.95 3.8 $ — |
Stock option awards - performance based awards | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Schedule of Stock Options Activity | A summary of the performance-based stock options for the nine months ended September 30, 2021 is as follows: Number of Shares Weighted Average Outstanding at January 1, 2021 750,000 $ 2.20 Expired (750,000) 2.20 Outstanding at September 30, 2021 — $ — Exercisable at September 30, 2021 — $ — A summary of the performance-based stock options for the nine months ended September 30, 2020 is as follows: Number of Shares Weighted Average Outstanding at January 1, 2020 388,125 $ 4.70 Granted 750,000 $ 2.20 Forfeited (388,125) $ 4.70 Outstanding at September 30, 2020 750,000 $ 2.20 Exercisable at September 30, 2020 — $ — |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
Summary of Lease Costs | The following summarizes quantitative information about the Company’s operating leases (table in thousands): Three Months Ended September 30, 2021 Three Months Ended September 30, 2020 Nine Months Ended September 30, 2021 Nine Months Ended September 30, 2020 Operating leases Operating lease cost $ 457 $ 382 $ 1,309 $ 1,228 Variable lease cost 94 90 286 403 Operating lease expense 551 472 1,595 1,631 Finance leases Amortization of right-of-use assets 73 — 184 — Interest on lease obligations 22 — 55 — Finance lease expense 95 — 239 — Short-term lease rent expense 4 4 12 12 Total rent expense $ 650 $ 476 $ 1,846 $ 1,643 Other information Operating cash flows from operating leases $ 444 $ 393 $ 1,298 $ 1,248 Operating cash flows from finance leases $ 22 $ — $ 56 $ — Financing cash flows from finance leases $ 59 $ — $ 152 $ — Right of use assets exchanged for operating lease liabilities $ 718 $ — $ 4,089 $ — Right of use assets exchanged for finance lease liabilities $ 588 $ — $ 1,365 $ — Weighted-average remaining lease term – operating leases 3.7 2.3 3.7 2.3 Weighted-average remaining lease term – finance leases 5.5 0.0 5.5 0.0 Weighted-average discount rate – operating leases 6.3 % 6.8 % 6.3 % 6.8 % Weighted-average discount rate – finance leases 5.9 % — % 5.9 % — % |
Operating Lease Maturities | Future minimum rental payments under operating lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2021 (remaining) $ 470 $ 103 Year ending December 31, 2022 1,746 418 Year ending December 31, 2023 1,429 424 Year ending December 31, 2024 1,076 424 Year ending December 31, 2025 616 426 Remaining future payments 345 526 Total $ 5,682 $ 2,321 Less present value discount (607) (338) Operating and finance lease liabilities $ 5,075 $ 1,983 |
Finance Lease Maturities | Future minimum rental payments under operating lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2021 (remaining) $ 470 $ 103 Year ending December 31, 2022 1,746 418 Year ending December 31, 2023 1,429 424 Year ending December 31, 2024 1,076 424 Year ending December 31, 2025 616 426 Remaining future payments 345 526 Total $ 5,682 $ 2,321 Less present value discount (607) (338) Operating and finance lease liabilities $ 5,075 $ 1,983 |
Loans and Security Agreement (T
Loans and Security Agreement (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Principal Payments on Term Loan | The following table reflects the schedule of principal payments on the Term Loan as of September 30, 2021 (in thousands): Principal Payments 2021 $ 1,500 2022 7,500 2023 6,000 2024 6,000 2025 1,500 $ 22,500 |
Description of Business (Detail
Description of Business (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021USD ($)employee | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)employee | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||
Net Revenue | $ | $ 15,988 | $ 15,280 | $ 46,599 | $ 47,033 | $ 60,000 |
Years of service | 25 years | ||||
Number of employees | employee | 300 | 300 |
Liquidity and Capital Resourc_2
Liquidity and Capital Resources (Details) $ / shares in Units, $ in Thousands | 5 Months Ended | 9 Months Ended | |||||||
Dec. 08, 2021businessDay$ / shares | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Liquidity and Capital Resources [Line Items] | |||||||||
Accumulated deficit | $ (361,139) | $ (337,406) | |||||||
Stockholders' equity | 11,094 | $ 42,075 | $ 18,203 | $ 26,178 | $ 34,170 | $ 16,211 | $ 21,774 | $ 20,320 | |
Cash, cash equivalents and investments available-for-sale | 33,200 | ||||||||
Working capital | 24,300 | ||||||||
Net cash used in operating activities | $ (24,508) | $ (21,072) | |||||||
Subsequent event | |||||||||
Liquidity and Capital Resources [Line Items] | |||||||||
Period to regain Nasdaq minimum bid requirements | 180 days | ||||||||
Common stock, closing bid price (at least) (in dollars per share) | $ / shares | $ (1) | ||||||||
Number of consecutive business days (minimum) | businessDay | 10 |
Basis of Presentation, Summar_4
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Summary of Potentially Dilutive Securities (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation (in shares) | 32,719,054 | 33,501,260 |
Options to purchase common stock | ||
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation (in shares) | 5,871,620 | 6,682,192 |
Unvested restricted stock awards | ||
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation (in shares) | 78,300 | 146,800 |
Unvested restricted stock units | ||
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation (in shares) | 342,271 | 245,405 |
Warrants to purchase common stock | ||
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation (in shares) | 26,426,863 | 26,426,863 |
Revenue Recognition - Nature of
Revenue Recognition - Nature of Goods and Services (Details) | 9 Months Ended |
Sep. 30, 2021agreement | |
Revenue from Contract with Customer [Abstract] | |
Number of distribution and license agreements | 5 |
Customers average payment term | 30 days |
Distributors average payment term | 45 days |
Revenue Recognition - Disaggreg
Revenue Recognition - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | $ 15,988 | $ 15,280 | $ 46,599 | $ 47,033 | $ 60,000 |
Drug products | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 279 | 284 | 835 | 776 | |
Concentrate Products | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 15,709 | 14,996 | 45,764 | 46,257 | |
U.S. | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 14,243 | 14,188 | 41,880 | 42,375 | |
U.S. | Drug products | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 217 | 228 | 656 | 609 | |
U.S. | Concentrate Products | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 14,026 | 13,960 | 41,224 | 41,766 | |
Rest of World | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 1,745 | 1,092 | 4,719 | 4,658 | |
Rest of World | Drug products | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 62 | 56 | 179 | 167 | |
Rest of World | Concentrate Products | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 1,683 | 1,036 | 4,540 | 4,491 | |
Product Sales – Point-in-time | Drug product sales | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 217 | 228 | 656 | 609 | |
Product Sales – Point-in-time | Concentrate product sales | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 15,224 | 14,506 | 44,308 | 44,786 | |
Product Sales – Point-in-time | U.S. | Drug product sales | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 217 | 228 | 656 | 609 | |
Product Sales – Point-in-time | U.S. | Concentrate product sales | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 13,541 | 13,470 | 39,768 | 40,295 | |
Product Sales – Point-in-time | Rest of World | Drug product sales | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 0 | 0 | 0 | 0 | |
Product Sales – Point-in-time | Rest of World | Concentrate product sales | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 1,683 | 1,036 | 4,540 | 4,491 | |
License Fee – Over time | Drug license fee | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 62 | 56 | 179 | 167 | |
License Fee – Over time | Concentrate product license fee | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 485 | 490 | 1,456 | 1,471 | |
License Fee – Over time | U.S. | Drug license fee | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 0 | 0 | 0 | 0 | |
License Fee – Over time | U.S. | Concentrate product license fee | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 485 | 490 | 1,456 | 1,471 | |
License Fee – Over time | Rest of World | Drug license fee | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | 62 | 56 | 179 | 167 | |
License Fee – Over time | Rest of World | Concentrate product license fee | |||||
Disaggregation of Revenue [Line Items] | |||||
Net Revenue | $ 0 | $ 0 | $ 0 | $ 0 |
Revenue Recognition - Contract
Revenue Recognition - Contract Balances (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Revenue from Contract with Customer [Abstract] | ||
Receivables, which are included in "Trade and other receivables" | $ 6,036 | $ 4,171 |
Contract liabilities | $ 8,705 | $ 10,190 |
Revenue Recognition - Narrative
Revenue Recognition - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Revenue Recognition [Line Items] | |||||
Impairment losses | $ 0 | $ 0 | $ 0 | $ 0 | |
Contract assets | 0 | 0 | $ 0 | ||
Revenue performance obligation | 8.7 | 8.7 | |||
Baxter Healthcare Organization | |||||
Revenue Recognition [Line Items] | |||||
Revenue performance obligation | 5.7 | 5.7 | |||
Concentrate Products | |||||
Revenue Recognition [Line Items] | |||||
Reserve for returns | $ 0 | $ 0 | $ 0 |
Investments - Available-for-S_3
Investments - Available-for-Sale (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Investments, Debt and Equity Securities [Abstract] | ||
Amortized Cost | $ 9,805 | $ 9,987 |
Unrealized Gain | 1 | 3 |
Unrealized Loss | 0 | 0 |
Accrued Interest Income | 7 | 7 |
Fair Value | $ 9,813 | $ 9,997 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Inventory [Line Items] | ||
Raw Materials | $ 3,507 | $ 3,112 |
Work in Process | 266 | 172 |
Finished Goods | 1,781 | 1,805 |
Total | 5,554 | 5,089 |
Inventory, noncurrent | 1,526 | 1,176 |
Inventory, net | 4,028 | $ 3,913 |
Triferic Inventory | ||
Inventory [Line Items] | ||
Raw Materials | 900 | |
Inventory, noncurrent | 1,500 | |
Inventory, net | 1,600 | |
Triferic Dialysate | ||
Inventory [Line Items] | ||
Finished Goods | 400 | |
Triferic API | ||
Inventory [Line Items] | ||
Inventory, net | $ 400 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Property and equipment | |||||
Gross property and equipment | $ 9,512 | $ 9,512 | $ 9,178 | ||
Accumulated Depreciation | (7,005) | (7,005) | (6,536) | ||
Property and Equipment, net | 2,507 | 2,507 | 2,642 | ||
Depreciation expense | 100 | $ 200 | 500 | $ 600 | |
Leasehold Improvements | |||||
Property and equipment | |||||
Gross property and equipment | 1,196 | 1,196 | 1,196 | ||
Machinery and Equipment | |||||
Property and equipment | |||||
Gross property and equipment | 5,794 | 5,794 | 5,475 | ||
Information Technology & Office Equipment | |||||
Property and equipment | |||||
Gross property and equipment | 1,846 | 1,846 | 1,831 | ||
Laboratory Equipment | |||||
Property and equipment | |||||
Gross property and equipment | $ 676 | $ 676 | $ 676 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued Research & Development Expense | $ 181 | $ 232 |
Accrued Compensation and Benefits | 2,193 | 2,500 |
Accrued Unvouchered Receipts | 622 | 755 |
Accrued Workers Compensation | 434 | 395 |
Other Accrued Liabilities | 941 | 1,131 |
Total Accrued Liabilities | $ 4,371 | $ 5,013 |
Deferred Revenue (Details)
Deferred Revenue (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Jun. 30, 2021 | Sep. 30, 2020 | Jan. 31, 2020 | Oct. 31, 2014 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2016 | Dec. 31, 2020 | |
Deferred Revenue Arrangement [Line Items] | ||||||||||
Deferred revenue | $ 8,705,000 | $ 8,705,000 | $ 10,190,000 | |||||||
Baxter Healthcare Organization | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Upfront payment | $ 20,000,000 | |||||||||
Recognized deferred revenue | 500,000 | $ 1,500,000 | 500,000 | $ 1,500,000 | ||||||
Deferred revenue | 5,700,000 | $ 5,700,000 | 7,200,000 | |||||||
Refund percentage | 25.00% | |||||||||
Wanbang Biopharmaceutical | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Upfront payment | $ 4,000,000 | |||||||||
Recognized deferred revenue | 53,000 | 200,000 | $ 53,000 | 200,000 | ||||||
Deferred revenue | 2,600,000 | 2,600,000 | 2,700,000 | |||||||
Sun Pharma Agreements | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Upfront payment | $ 100,000 | |||||||||
Recognized deferred revenue | 2,500 | 7,500 | 2,500 | 7,500 | ||||||
Deferred revenue | 82,500 | 82,500 | 90,000 | |||||||
Jeil Pharma Agreements | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Upfront payment | $ 200,000 | |||||||||
Recognized deferred revenue | 2,500 | $ 0 | 7,500 | $ 0 | ||||||
Deferred revenue | 200,000 | 200,000 | $ 200,000 | |||||||
Drogsan Agreements | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Upfront payment | $ 150,000 | |||||||||
Recognized deferred revenue | 3,750 | |||||||||
Deferred revenue | $ 150,000 | $ 150,000 |
Stockholders_ Equity (Details)
Stockholders’ Equity (Details) - USD ($) | Mar. 22, 2019 | Sep. 30, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | ||||
Preferred stock, authorized (in shares) | 2,000,000 | 2,000,000 | 2,000,000 | |
Preferred shares, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Preferred shares, shares issued (in shares) | 0 | 0 | 0 | |
Preferred shares, shares outstanding (in shares) | 0 | 0 | 0 | |
Common shares, shares authorized (in shares) | 170,000,000 | 170,000,000 | 170,000,000 | |
Common shares, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Common shares, shares issued (in shares) | 93,966,381 | 93,966,381 | 93,573,165 | |
Common shares, shares outstanding (in shares) | 93,966,381 | 93,966,381 | 93,573,165 | |
At-the-Market Offering | ||||
Class of Stock [Line Items] | ||||
Remaining amount available for sale | $ 32,300,000 | $ 32,300,000 | ||
At-the-Market Offering | Maximum | ||||
Class of Stock [Line Items] | ||||
Sales agreement, threshold sale of shares | $ 40,000,000 |
Stock-Based Compensation - Shar
Stock-Based Compensation - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share based compensation expense | $ 361 | $ 250 | $ 558 | $ (276) |
Service based awards | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share based compensation expense | 396 | 252 | 1,313 | 1,262 |
Restricted stock units - service based awards | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share based compensation expense | 81 | 9 | 263 | 243 |
Stock option awards - service based awards | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share based compensation expense | 315 | 243 | 1,050 | 1,019 |
Performance based awards | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share based compensation expense | (35) | (2) | (755) | (1,538) |
Restricted stock awards - performance based awards | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share based compensation expense | 0 | 0 | (391) | 0 |
Restricted stock units - performance based awards | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share based compensation expense | 0 | (123) | 0 | (1,148) |
Stock option awards - performance based awards | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share based compensation expense | $ (35) | $ 121 | $ (364) | $ (390) |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Awards (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Weighted Average Grant-Date Fair Value | ||||
Stock based compensation expenses | $ 361 | $ 250 | $ 558 | $ (276) |
Restricted stock awards | ||||
Number of Shares | ||||
Unvested at beginning of period (in shares) | 146,800 | 146,800 | ||
Forfeited (in shares) | (68,500) | |||
Unvested at end of period (in shares) | 78,300 | 146,800 | 78,300 | 146,800 |
Weighted Average Grant-Date Fair Value | ||||
Unvested at beginning of period (in dollars per share) | $ 5.70 | $ 5.70 | ||
Forfeited (in dollars per share) | 5.70 | |||
Unvested at end of period (in dollars per share) | $ 5.70 | $ 5.70 | $ 5.70 | $ 5.70 |
Vesting period | 20 months | |||
Unvested, number of shares (in shares) | 78,300 | 146,800 | 78,300 | 146,800 |
Forfeited (in shares) | (68,500) | |||
Restricted stock awards - performance based awards | ||||
Number of Shares | ||||
Forfeited (in shares) | (68,500) | |||
Unvested at end of period (in shares) | 78,300 | 78,300 | ||
Weighted Average Grant-Date Fair Value | ||||
Unvested, number of shares (in shares) | 78,300 | 78,300 | ||
Forfeited (in shares) | (68,500) | |||
Stock based compensation expenses | $ 0 | $ 0 | $ (391) | $ 0 |
Stock-Based Compensation - Serv
Stock-Based Compensation - Service Based and Performance Based Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Weighted Average Grant-Date Fair Value | ||||
Stock based compensation expenses | $ 361 | $ 250 | $ 558 | $ (276) |
Restricted stock units - service based awards | ||||
Number of Shares | ||||
Unvested at beginning of period (in shares) | 265,494 | 463,786 | ||
Granted (in shares) | 310,050 | 188,904 | ||
Vested (in shares) | (221,474) | (247,561) | ||
Forfeited (in shares) | (11,799) | (159,724) | ||
Unvested at end of period (in shares) | 342,271 | 245,405 | 342,271 | 245,405 |
Weighted Average Grant-Date Fair Value | ||||
Unvested at beginning of period (in dollars per share) | $ 2.60 | $ 4.26 | ||
Granted (in dollars per share) | 0.90 | 2.09 | ||
Vested (in dollars per share) | 2.38 | 4.30 | ||
Forfeited (in dollars per share) | 4.81 | 4.26 | ||
Unvested at end of period (in dollars per share) | $ 1.17 | $ 2.72 | $ 1.17 | $ 2.72 |
Stock based compensation expenses | $ 81 | $ 9 | $ 263 | $ 243 |
Unrecognized stock-based compensation expense | 200 | $ 200 | ||
Unrecognized stock-based compensation expense, weighted average remaining term (in years) (less than) | 1 year | |||
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 | |||
Restricted stock units - performance based awards | ||||
Number of Shares | ||||
Unvested at beginning of period (in shares) | 988,958 | |||
Forfeited (in shares) | (988,958) | |||
Unvested at end of period (in shares) | 0 | 0 | ||
Weighted Average Grant-Date Fair Value | ||||
Unvested at beginning of period (in dollars per share) | $ 4.48 | |||
Forfeited (in dollars per share) | 4.48 | |||
Unvested at end of period (in dollars per share) | $ 0 | $ 0 | ||
Stock based compensation expenses | $ 0 | $ (123) | $ 0 | $ (1,148) |
Outstanding performance-based restricted stock units (in shares) | 0 | 0 |
Stock-Based Compensation - Se_2
Stock-Based Compensation - Service Based Stock Options - Fair Value Assumptions (Details) - Stock option awards - service based awards | 9 Months Ended |
Sep. 30, 2021$ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected stock price volatility, minimum | 75.80% |
Expected stock price volatility, maximum | 77.70% |
Risk-free interest rate, minimum | 0.47% |
Risk-free interest rate, maximum | 1.06% |
Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price (in dollars per share) | $ 0.61 |
Term (years) | 5 years 6 months |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price (in dollars per share) | $ 1.73 |
Term (years) | 6 years |
Stock-Based Compensation - Se_3
Stock-Based Compensation - Service Based Stock Options (Details) - Stock option awards - service based awards - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Shares Underlying Options | ||||
Outstanding at the beginning of the period (in shares) | 5,717,956 | 8,210,024 | 8,210,024 | |
Granted (in shares) | 1,872,162 | 2,252,344 | ||
Forfeited (in shares) | (385,278) | (440,026) | ||
Expired (in shares) | (1,333,220) | (4,090,150) | ||
Outstanding at the end of the period (in shares) | 5,871,620 | 5,932,192 | 5,717,956 | 8,210,024 |
Exercisable at end of period (in shares) | 2,539,438 | 2,889,218 | ||
Weighted Average Exercise Price | ||||
Outstanding at the beginning of the period (in dollars per share) | $ 4.55 | $ 7.06 | $ 7.06 | |
Granted (in dollars per share) | 0.89 | 1.95 | ||
Forfeited (in dollars per share) | 2.30 | 3.96 | ||
Expired (in dollar per share) | 7.16 | 8.24 | ||
Outstanding at the end of the period (in dollars per share) | 2.95 | 4.54 | $ 4.55 | $ 7.06 |
Exercisable at end of the period (in dollars per share) | $ 4.96 | $ 6.95 | ||
Weighted Average Remaining Contractual Term | ||||
Outstanding | 7 years 8 months 12 days | 6 years 8 months 12 days | 6 years 7 months 6 days | 5 years 1 month 6 days |
Granted | 6 years | 5 years 10 months 24 days | ||
Exercisable at end of the period | 5 years 9 months 18 days | 3 years 9 months 18 days | ||
Aggregate Intrinsic Value | ||||
Outstanding | $ 0 | $ 0 | $ 0 | $ 107,000 |
Exercisable at end of the period | $ 0 | $ 0 |
Stock-Based Compensation - Se_4
Stock-Based Compensation - Service Based Stock Options - Others (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock based compensation expenses | $ 361 | $ 250 | $ 558 | $ (276) |
Stock option awards - service based awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Granted (in shares) | 1,872,162 | 2,252,344 | ||
Forfeited (in shares) | 385,278 | 440,026 | ||
Expirations (in shares) | 1,333,220 | 4,090,150 | ||
Stock based compensation expenses | 315 | $ 243 | $ 1,050 | $ 1,019 |
Unrecognized stock-based compensation expenses | $ 1,700 | $ 1,700 | ||
Unrecognized stock-based compensation expense, weighted average remaining term (in years) | 3 years |
Stock-Based Compensation - Perf
Stock-Based Compensation - Performance Based Stock Options (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Weighted Average Exercise Price | ||||
Stock based compensation expenses | $ 361,000 | $ 250,000 | $ 558,000 | $ (276,000) |
Stock option awards - performance based awards | ||||
Number of Shares | ||||
Outstanding at the beginning of the period (in shares) | 750,000 | 388,125 | ||
Expired (in shares) | (750,000) | |||
Granted (in shares) | 750,000 | |||
Forfeited (in shares) | (388,125) | |||
Outstanding at the end of the period (in shares) | 0 | 750,000 | 0 | 750,000 |
Exercisable at end of period (in shares) | 0 | 0 | 0 | 0 |
Weighted Average Exercise Price | ||||
Outstanding at the beginning of the period (in dollars per share) | $ 2.20 | $ 4.70 | ||
Expired (in dollar per share) | 2.20 | |||
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) | $ 0 | $ 2.20 | 0 | 2.20 |
Exercisable at end of the period (in dollars per share) | $ 0 | $ 0 | $ 0 | $ 0 |
Stock based compensation expenses | $ (35,000) | $ 121,000 | $ (364,000) | $ (390,000) |
Unrecognized stock-based compensation expenses | $ 0 | $ 0 |
Licensing Agreements (Details)
Licensing Agreements (Details) $ in Thousands | Oct. 07, 2018USD ($)installmentagreement | Dec. 31, 2019USD ($) | Sep. 30, 2021USD ($) | Jul. 15, 2019USD ($) | Apr. 15, 2019USD ($) | Jan. 15, 2019USD ($) | Oct. 15, 2018USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Number of additional agreements | agreement | 3 | ||||||
Collaborative arrangement, accrued reimbursement of IP expenses and sublicense royalty fees | $ 200 | ||||||
Executive vice president and chief scientific officer | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Total amount due | $ 1,000 | $ 250 | $ 250 | $ 250 | $ 250 | ||
Number of quarterly installment payments | installment | 4 | ||||||
Installment paid | $ 1,000 | ||||||
Collaborative arrangement, accrued reimbursement of legal expenses | $ 100 |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Thousands | Sep. 30, 2021USD ($)ft² | Dec. 31, 2020USD ($) |
Lessee, Lease, Description [Line Items] | ||
Operating lease and finance lease liabilities | $ | $ 7,100 | |
Operating lease and finance lease, right of use assets, net | $ | 6,934 | $ 2,911 |
Operating lease liabilities | $ | $ 5,075 | 3,000 |
Operating lease, right of use assets | $ | $ 2,900 | |
Wixom, Michigan | Wixom, Michigan Property One | ||
Lessee, Lease, Description [Line Items] | ||
Facility sqft. | 51,000 | |
Wixom, Michigan | Wixom, Michigan Property Two | ||
Lessee, Lease, Description [Line Items] | ||
Facility sqft. | 17,500 | |
Grapevine, Texas | ||
Lessee, Lease, Description [Line Items] | ||
Facility sqft. | 51,000 | |
Greer, South Carolina | ||
Lessee, Lease, Description [Line Items] | ||
Facility sqft. | 57,000 | |
Hackensack, New Jersey | ||
Lessee, Lease, Description [Line Items] | ||
Facility sqft. | 4,100 | |
Maximum | ||
Lessee, Lease, Description [Line Items] | ||
Lease term | 5 years |
Leases - Summary of Lease Costs
Leases - Summary of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Operating leases | ||||
Operating lease cost | $ 457 | $ 382 | $ 1,309 | $ 1,228 |
Variable lease cost | 94 | 90 | 286 | 403 |
Operating lease expense | 551 | 472 | 1,595 | 1,631 |
Finance leases | ||||
Amortization of right-of-use assets | 73 | 0 | 184 | 0 |
Interest on lease obligations | 22 | 0 | 55 | 0 |
Finance lease expense | 95 | 0 | 239 | 0 |
Short-term lease rent expense | 4 | 4 | 12 | 12 |
Total rent expense | 650 | 476 | 1,846 | 1,643 |
Other information | ||||
Operating cash flows from operating leases | 444 | 393 | 1,298 | 1,248 |
Operating cash flows from finance leases | 22 | 0 | 56 | 0 |
Financing cash flows from finance leases | 59 | 0 | 152 | 0 |
Right of use assets exchanged for operating lease liabilities | 718 | 0 | 4,089 | 0 |
Right of use assets exchanged for finance lease liabilities | $ 588 | $ 0 | $ 1,365 | $ 0 |
Weighted-average remaining lease term – operating leases | 3 years 8 months 12 days | 2 years 3 months 18 days | 3 years 8 months 12 days | 2 years 3 months 18 days |
Weighted-average remaining lease term – finance leases | 5 years 6 months | 0 years | 5 years 6 months | 0 years |
Weighted-average discount rate – operating leases | 6.30% | 6.80% | 6.30% | 6.80% |
Weighted-average discount rate – finance leases | 5.90% | 0.00% | 5.90% | 0.00% |
Leases - Finance Lease and Oper
Leases - Finance Lease and Operating Lease Maturities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Operating | ||
Year ending December 31, 2021 (remaining) | $ 470 | |
Year ending December 31, 2022 | 1,746 | |
Year ending December 31, 2023 | 1,429 | |
Year ending December 31, 2024 | 1,076 | |
Year ending December 31, 2025 | 616 | |
Remaining future payments | 345 | |
Total | 5,682 | |
Less present value discount | (607) | |
Operating lease liabilities | 5,075 | $ 3,000 |
Finance | ||
Year ending December 31, 2021 (remaining) | 103 | |
Year ending December 31, 2022 | 418 | |
Year ending December 31, 2023 | 424 | |
Year ending December 31, 2024 | 424 | |
Year ending December 31, 2025 | 426 | |
Remaining future payments | 526 | |
Total | 2,321 | |
Less present value discount | (338) | |
Finance lease liabilities | $ 1,983 |
Loans and Security Agreement -
Loans and Security Agreement - Narrative (Details) - Term loan | Sep. 24, 2021USD ($)installment | Mar. 16, 2020USD ($)$ / sharesshares | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Mar. 31, 2020USD ($) |
Term loan | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 7,500,000 | $ 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 | 11.30% | ||||||
Option to add interest rate amount to outstanding principal balance in lieu of paying such amount in cash, percentage | 1.00% | ||||||
Interest expense | $ 600,000 | $ 700,000 | $ 1,800,000 | $ 1,300,000 | |||
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% | ||||||
Warrant exercise price calculation, period immediately preceding execution of loan agreement, number of trading days | 5 days | ||||||
Number of monthly installments | installment | 10 | ||||||
Prepayment premium percentage | 5.00% | ||||||
Minimum liquidity floor | $ 5,000,000 | ||||||
Minimum principal amount pursuant to liquidity covenant | $ 15,000,000 | ||||||
Outstanding balance, net of unamortized issuance costs and unaccreted discount | 21,200,000 | 21,200,000 | |||||
Unamortized issuance costs and unaccreted discount | $ 1,300,000 | $ 1,300,000 | |||||
Term loan | Minimum | |||||||
Debt Instrument [Line Items] | |||||||
Period for which company is entitled to make interest-only payments | 30 months | ||||||
Term loan | Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Period for which company is entitled to make interest-only payments | 36 months | ||||||
Term loan, first tranche | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 22,500,000 | ||||||
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 | |||||||
Debt Instrument [Line Items] | |||||||
Warrant exercise price calculation, period immediately preceding relevant funding, number of trading days | 5 days | ||||||
Term loan, second and third tranches | Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 1.65 | ||||||
Term loan, second tranche | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 5,000,000 | ||||||
Term loan, third tranche | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 7,500,000 |
Loans and Security Agreement _2
Loans and Security Agreement - Schedule of Principal Payments on Term Loan (Details) - Term loan - Term loan $ in Thousands | Sep. 30, 2021USD ($) |
Debt Instrument [Line Items] | |
2021 | $ 1,500 |
2022 | 7,500 |
2023 | 6,000 |
2024 | 6,000 |
2025 | 1,500 |
Principal Payments | $ 22,500 |
Insurance Financing Note Paya_2
Insurance Financing Note Payable (Details) - USD ($) $ in Thousands | Jul. 03, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Short-term Debt [Line Items] | |||
Insurance Financing Note Payable | $ 1,312 | $ 0 | |
3.925% Note Payable | Notes Payable to Banks | |||
Short-term Debt [Line Items] | |||
Short-term note payable | $ 2,000 | ||
Interest rate, base percentage | 3.93% | ||
Amortization period (in months) | 9 months |