Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 13, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
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 $0.0001 | |
Trading Symbol | RMTI | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding (in shares) | 8,532,478 | |
Entity Central Index Key | 0001041024 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
ASSETS | ||
Cash and Cash Equivalents | $ 9,914 | $ 13,280 |
Investments Available-for-Sale | 0 | 9,158 |
Accounts Receivable, net | 7,121 | 5,913 |
Inventory, net | 5,531 | 4,076 |
Prepaid and Other Current Assets | 2,231 | 2,861 |
Total Current Assets | 24,797 | 35,288 |
Property and Equipment, net | 2,377 | 2,486 |
Inventory, Non-Current | 1,523 | 1,523 |
Right of Use Assets, net | 7,200 | 7,737 |
Goodwill | 921 | 921 |
Other Non-Current Assets | 618 | 619 |
Total Assets | 37,436 | 48,574 |
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | ||
Accounts Payable | 4,224 | 3,739 |
Accrued Liabilities | 4,373 | 5,090 |
Lease Liability - Current | 1,983 | 2,004 |
Deferred License Revenue - Current | 2,163 | 2,171 |
Term Loan - Net of Issuance Costs | 6,631 | 7,381 |
Insurance Financing Note Payable | 0 | 437 |
Customer Deposits | 221 | 144 |
Total Current Liabilities | 19,595 | 20,966 |
Lease Liability - Long-Term | 5,400 | 5,887 |
Term Loan, Net of Issuance Costs | 11,778 | 13,186 |
Deferred License Revenue - Long-Term | 5,456 | 5,986 |
Long Term Liability - Other | 14 | 14 |
Total Liabilities | 42,243 | 46,039 |
Stockholders’ (Deficit) Equity: | ||
Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; no shares issued and outstanding at March 31, 2022 and December 31, 2021 | 0 | 0 |
Common Stock, $0.0001 par value; 170,000,000 shares authorized; 8,544,225 shares issued and outstanding at March 31, 2022 and December 31, 2021 | 1 | 1 |
Additional Paid-in Capital | 372,383 | 372,562 |
Accumulated Deficit | (377,242) | (370,080) |
Accumulated Other Comprehensive Income | 51 | 52 |
Total Stockholders’ (Deficit) Equity | (4,807) | 2,535 |
Total Liabilities and Stockholders’ Equity | $ 37,436 | $ 48,574 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
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) | 8,544,225 | 8,544,225 |
Common shares, shares outstanding (in shares) | 8,544,225 | 8,544,225 |
UNAUDITED CONDENSED CONSOLIDATE
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Statement [Abstract] | ||
Net Sales | $ 16,124 | $ 15,473 |
Cost of Sales | 16,910 | 15,072 |
Gross (Loss) Profit | (786) | 401 |
Research and Product Development | 1,567 | 1,809 |
Selling and Marketing | 455 | 1,851 |
General and Administrative | 3,818 | 3,923 |
Operating Loss | (6,626) | (7,182) |
Other (Expense) Income | ||
Realized Gain on Investments | 4 | 0 |
Interest Expense | (540) | (581) |
Interest Income | 0 | 11 |
Total Other Expense | (536) | (570) |
Net Loss | $ (7,162) | $ (7,752) |
Basic Net Loss per Share (in dollars per share) | $ (0.84) | $ (0.91) |
Diluted Net Loss per Share (in dollars per share) | $ (0.84) | $ (0.91) |
Basic Weighted Average Shares Outstanding (in shares) | 8,544,225 | 8,508,278 |
Diluted Weighted Average Shares Outstanding (in shares) | 8,544,225 | 8,508,278 |
UNAUDITED CONDENSED CONSOLIDA_2
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Net Loss | $ (7,162) | $ (7,752) |
Unrealized Gain (Loss) on Available-for-Sale Debt Instrument Investments | 0 | (7) |
Foreign Currency Translation Adjustments | (1) | 3 |
Comprehensive Loss | $ (7,163) | $ (7,756) |
UNAUDITED CONDENSED CONSOLIDA_3
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | COMMON STOCK | ADDITIONAL PAID-IN CAPITAL | ACCUMULATED DEFICIT | ACCUMULATED OTHER COMPREHENSIVE INCOME |
Beginning balance (in shares) at Dec. 31, 2020 | 8,506,651 | ||||
Beginning balance at Dec. 31, 2020 | $ 34,170 | $ 1 | $ 371,518 | $ (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) | 2,396 | ||||
Stock-based Compensation expense | (236) | (236) | |||
Ending balance (in shares) at Mar. 31, 2021 | 8,509,047 | ||||
Ending balance at Mar. 31, 2021 | $ 26,178 | $ 1 | 371,282 | (345,158) | 53 |
Beginning balance (in shares) at Dec. 31, 2021 | 8,544,225 | 8,544,225 | |||
Beginning balance at Dec. 31, 2021 | $ 2,535 | $ 1 | 372,562 | (370,080) | 52 |
Increase (Decrease) in Shareholders' Equity | |||||
Net Loss | (7,162) | (7,162) | |||
Unrealized Gain (Loss) on Available-for-Sale Debt Instrument Investments | 0 | ||||
Foreign Currency Translation Adjustments | (1) | (1) | |||
Stock-based Compensation expense (in shares) | 0 | ||||
Stock-based Compensation expense | $ (179) | (179) | |||
Ending balance (in shares) at Mar. 31, 2022 | 8,544,225 | 8,544,225 | |||
Ending balance at Mar. 31, 2022 | $ (4,807) | $ 1 | $ 372,383 | $ (377,242) | $ 51 |
UNAUDITED CONDENSED CONSOLIDA_4
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash Flows From Operating Activities: | ||
Net Loss | $ (7,162) | $ (7,752) |
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities: | ||
Depreciation and Amortization | 138 | 202 |
Stock-based Compensation | (179) | (236) |
Increase in Inventory Reserves | 0 | 71 |
Amortization of Right of Use Asset | 520 | 412 |
Amortization of Debt Financing Costs and Accretion of Debt Discount | 92 | 92 |
Loss on Disposal of Assets | 0 | 6 |
Realized Gain on Sale of Investments Available-for-Sale | (4) | 0 |
Foreign Currency Translation Adjustment | (1) | 3 |
Changes in Assets and Liabilities: | ||
Increase in Accounts Receivable, net | (1,208) | (2,426) |
Increase in Inventory | (1,455) | (424) |
Decrease in Prepaid and Other Assets | 630 | 317 |
Increase (Decrease) in Accounts Payable | 485 | (848) |
Decrease in Lease Liability | (490) | (410) |
Decrease in Other Liabilities | (640) | (958) |
Decrease in Deferred License Revenue | (538) | (544) |
Changes in Assets and Liabilities | (3,216) | (5,293) |
Cash Used In Operating Activities | (9,812) | (12,495) |
Cash Flows From Investing Activities: | ||
Purchase of Investments Available-for-Sale | (2,810) | (7,212) |
Sale of Investments Available-for-Sale | 11,972 | 6,738 |
Purchase of Equipment | (29) | (38) |
Cash Provided By (Used In) Investing Activities | 9,133 | (512) |
Cash Flows From Financing Activities: | ||
Payments on Debt | (2,250) | 0 |
Payments on Short Term Note Payable | (437) | 0 |
Cash Used In Financing Activities | (2,687) | 0 |
Decrease in Cash and Cash Equivalents | (3,366) | (13,007) |
Cash and Cash Equivalents at Beginning of Period | 13,280 | 48,682 |
Cash and Cash Equivalents at End of Period | 9,914 | 35,675 |
Supplemental Disclosure of Cash Flow Information: | ||
Cash Paid for Interest | 461 | 485 |
Supplemental Disclosure of Noncash Investing and Financing Activities: | ||
Change in Unrealized Loss on Marketable Securities Available-for-Sale | $ 0 | $ (7) |
Description of Business
Description of Business | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business Rockwell Medical, Inc. ("Rockwell Medical," "Rockwell", or the "Company") is a commercial-stage, biopharmaceutical company developing and commercializing our next-generation parenteral iron technology platform, ferric pyrophosphate citrate (“FPC”), which we believe has significant potential to lead to transformative treatments for iron deficiency in multiple disease states, that we believe could reduce healthcare costs and improve patients’ lives. We are also one of the two major suppliers of life saving hemodialysis concentrate products to kidney dialysis clinics in the United States. We have two novel, FDA approved therapies, Triferic and Triferic AVNU, which are the first two products developed from our FPC platform. We market both products to kidney dialysis centers for their patients receiving dialysis. In late 2021, we filed an IND with the United States Food and Drug Administration ("FDA") with the goal to advance our FPC platform strategy by conducting a Phase II trial for the treatment of iron deficiency anemia in patients outside of dialysis, who are receiving intravenous ("IV") medications in the home infusion setting. The trend toward providing medical care, including the delivery of infused medications, at home make the home infusion market a rapidly growing area of healthcare. We believe the home infusion setting is a natural path for expansion of our platform as many of the patients suffer from diseases associated with iron deficiency and anemia. In our R&D pipeline, we are also investigating FPC’s impact in the treatment of hospitalized patients with acute heart failure. We are the second largest supplier of hemodialysis concentrates in the United States, with a reputation for excellent service, quality, and reliability. We believe this reputation, which is based on over 25 years of service to kidney dialysis centers, combined with about $60 million in annual revenue, approximately 300 dedicated employees, expertise in manufacturing and logistics and the added expertise in pharmaceutical development and commercialization brought to the Company by recent additions to our management team, gives us a solid foundation on which to grow. |
Liquidity and Going Concern Con
Liquidity and Going Concern Considerations | 3 Months Ended |
Mar. 31, 2022 | |
Liquidity and Going Concern Considerations [Abstract] | |
Liquidity and Going Concern Considerations | Liquidity and Going Concern Considerations Since inception, the Company 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 March 31, 2022, Rockwell had an accumulated deficit of approximately $377.2 million and a stockholders' deficit of $4.8 million. As of March 31, 2022, Rockwell had approximately $9.9 million of cash and cash equivalents and working capital of $5.2 million. Net cash used in operating activities for the three months ended March 31, 2022 was approximately $9.8 million. The Company has experienced significant inflationary pressures in its dialysis concentrates business, particularly within the last six months, which have resulted in an accelerated operating loss associated with this business line. These factors raise substantial doubt about the Company’s ability to continue as a going concern and depend, in part, on the degree of success in the Company's ability to address inflationary pressures affecting the concentrates business, as well as the Company’s ability to contain costs, raise additional working capital and remain in compliance with financial and operating covenants under the Company’s secured loan. Managements plans are described below. On April 6, 2022, the Company entered into an amendment to one of its supply agreements to restructure the supply relationship, which management expects to result in improved financial performance of the Company's concentrate business. The Company also entered into an equity investment agreement with one of the contracting parties for an investment of up to $15 million in two tranches of $7.5 million each. The first tranche of $7.5 million was funded on April 7, 2022. The second $7.5 million tranche is to be funded subject to the Company raising $15 million in additional capital by June 30, 2022. On April 8, 2022, the Company entered into a sales agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (the “Agent”), pursuant to which the Company may offer and sell from time to time up to $12,200,000 of shares of Company’s common stock through the Agent. The offering and sale of such shares has been registered under the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-259923) (the “Registration Statement”), which was originally filed with the Securities and Exchange Commission (“SEC”) on September 30, 2021 and declared effective by the SEC on October 8, 2021, the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed with the SEC on April 8, 2022. The Company has started to implement cost cutting measures as noted in previous filings focusing mainly within sales and marketing. The Company expects it will require additional capital to sustain its operations and make the investments it needs to execute its strategic plan in developing FPC for iron deficiency anemia in patients undergoing home infusion and for progressing our pipeline development program of new indications for our FPC platform. If the Company is unable to generate sufficient cash flows from operations as described above or obtain additional equity or debt financing, the Company intends to implement further cost cutting measure which may include headcount reduction across multiple areas and reductions in general and administrative expenses. Based on these plans, Management believes the substantial doubt about the Company’s ability to continue as a going concern has been alleviated. 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. 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. As previously reported, on June 11, 2021, the Company received written notice (the "Notification Letter") from the Nasdaq Stock Market ("Nasdaq") notifying the Company that it is not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5450(a)(1) for continued listing on the Nasdaq Global Market. Nasdaq Listing Rule 5450(a)(1) requires listed securities maintain a minimum closing bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company's common stock for the 30 consecutive business days prior to the date of the Notification Letter, the Company did not meet the minimum closing bid price requirement. The Notification Letter provided for 180 calendar days, or until December 8, 2021, for the Company 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. The Company was not able to meet the minimum compliance requirements set forth by Nasdaq by December 8, 2021. On December 9, 2021, the Company received a written notice from Nasdaq indicating that the Company’s application to transfer its listing venue from The Nasdaq Global Market to The Nasdaq Capital Market for its common stock had been approved. The Company’s common stock commenced trading on The Nasdaq Capital Market at the opening of business on December 10, 2021 under the symbol “RMTI.” Also on December 9, 2021, the Company received written notice that Nasdaq has determined the Company is eligible for an additional 180-day extension, or until June 6, 2022, to regain compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. 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 June 6, 2022. On May 13, 2022, the Company effected a reverse stock split in order to regain compliance with the minimum bid price requirement (see Note 3 for further detail). In addition, the Company is subject to certain covenants and cure provisions under its Loan Agreement with Innovatus. As of the date of this report, the Company believes it will either be able to satisfy such covenants or, in the event of a breached covenant, exercise cure provisions to avoid an event of default. If Rockwell is unable to avoid an event of default, any required repayments could have an adverse effect on its liquidity (See Note 14 for further detail). The COVID-19 pandemic and resulting global disruptions, particularly in the supply chain and labor market, among other areas, have adversely affected our business and operations, including, but not limited to, our sales and marketing efforts and our research and development activities, our plant and transportation operations and the operations of third parties upon whom we rely. Further, any vaccine hesitancy among our labor force could disrupt our business if workers become ill or need to quarantine due to illness or exposure to the virus. The Company's international business development activities may also continue to be negatively impacted by COVID-19. The COVID-19 pandemic, the domestic and international surge in infections and resulting global disruptions have caused significant volatility in financial and credit markets. Rockwell has utilized a range of financing methods to fund its operations in the past; however, current conditions in the financial and credit markets may limit the availability of funding, refinancing or increase the cost of funding. Due to the rapidly evolving nature of the global situation, it is not possible to predict the extent to which these conditions could adversely affect the Company's liquidity and capital resources in the future. |
Basis of Presentation, Summary
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements | 3 Months Ended |
Mar. 31, 2022 | |
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 PronouncementsThe 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 March 31, 2022, condensed consolidated statements of operations for the three months ended March 31, 2022 and 2021, condensed consolidated statements of comprehensive loss for the three months ended March 31, 2022 and 2021, condensed consolidated statement of changes in stockholders' equity for the three months ended March 31, 2022 and 2021, and condensed consolidated statements of cash flows for the three months ended March 31, 2022 and 2021 are unaudited, but include all adjustments, consisting of normal recurring adjustments, the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three months ended March 31, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022 or for any future interim period. The condensed consolidated balance sheet at December 31, 2021 has been derived from audited financial statements, however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2021 and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 as filed with the SEC on April 8, 2022. The Company’s consolidated subsidiaries consisted of its wholly-owned subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited. The accompanying condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated in consolidation. Reverse Stock Split On May 9, 2022, the stockholders of the Company authorized our Board of Directors to effect a reverse stock split of all outstanding shares of common stock. The Board of Directors subsequently approved the implementation of a reverse stock split as a ratio of one-for-eleven shares, which became effective on May 13, 2022. The Company’s outstanding stock options were also adjusted to reflect the one-for-eleven reverse stock split of the Company’s common stock. Outstanding stock options were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased. The reverse stock split resulted in an adjustment to the Series X convertible preferred stock conversion prices to reflect a proportional decrease in the number of shares of common stock to be issued upon conversion. All share and per share data in these condensed consolidated financial statements and related notes hereto have been retroactively adjusted to the account for the effect of the reverse stock split for the three month periods ended March 31, 2022 and 2021, respectively, and the balance sheet at March 31, 2022 and December 31, 2021. Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Leases The Company accounts for its leases under Accounting Standards Codification (“ASC”) 842, Leases . Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. Variable lease expenses, if any, are recorded when incurred. In calculating the right-of-use asset and lease liability, the Company elects to combine lease and non-lease components. The Company excludes short-term leases having initial terms of 12 months or less from the new guidance as an accounting policy election and recognizes rent expense on a straight-line basis over the lease term. Loss Per Share ASC 260, Earnings Per Share , requires dual presentation of basic and diluted earnings per share (“EPS”), with a reconciliation of the numerator and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. Basic EPS excludes dilution. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that are then sharing in the earnings of the entity. Basic net loss per share 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 March 31, 2022 2021 Options to purchase common stock 511,117 558,417 Unvested restricted stock awards 891 7,118 Unvested restricted stock units 28,067 21,611 Warrants to purchase common stock 2,402,442 2,402,442 Total 2,942,517 2,989,588 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. |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2022 | |
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, South Korea and Turkey, respectively, to determine that regulatory approval was probable as of the execution of the agreement. The amounts received from Baxter Healthcare Corporation (“Baxter”) are recognized as revenue at the point in time that the estimated product sales under the agreement occur. For the business under the Company’s Distribution Agreement with Baxter (the “Baxter Agreement”) and for the majority of the Company’s international customers, the Company recognizes revenue at the shipping point, which is generally the Company’s plant or warehouse. For other business, the Company recognizes revenue based on when the customer takes control of the product. The amount of revenue recognized is based on the purchase order less returns and adjusted for any rebates, discounts, chargebacks or other amounts paid to customers. There were no such adjustments for the periods reported. Customers typically pay for the product based on customary business practices with payment terms averaging 30 days, while distributor payment terms average 45 days. Disaggregation of revenue Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition. In thousands of U.S. dollars ($) Three Months Ended March 31, 2022 Products By Geographic Area Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ 159 $ 159 $ — License Fee – Over time 62 — 62 Total Drug Products 221 159 62 Concentrate Products Product Sales – Point-in-time 15,427 13,810 1,617 License Fee – Over time 476 476 — Total Concentrate Products 15,903 14,286 1,617 Net Revenue $ 16,124 $ 14,445 $ 1,679 In thousands of U.S. dollars ($) Three Months Ended March 31, 2021 Products By Geographic Area Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ 225 $ 225 $ — License Fee – Over time 58 — 58 Total Drug Products 283 225 58 Concentrate Products Product Sales – Point-in-time 14,705 13,201 1,504 License Fee – Over time 485 485 — Total Concentrate Products 15,190 13,686 1,504 Net Revenue $ 15,473 $ 13,911 $ 1,562 Contract balances The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands of U.S. dollars ($) March 31, 2022 December 31, 2021 Receivables, which are included in "Trade and other receivables" $ 7,121 $ 5,913 Contract liabilities $ 7,619 $ 8,157 There were no impairment losses recognized related to any receivables arising from the Company’s contracts with customers for the three months ended March 31, 2022 and 2021. For the three months ended March 31, 2022 and March 31, 2021, the Company did not recognize any material bad-debt expense. There were no material contract assets recorded on the condensed consolidated balance sheet as of March 31, 2022 and December 31, 2021. The Company does not generally accept returns of its concentrate products and no material reserve for returns of concentrate products was established as of March 31, 2022 or December 31, 2021. The contract liabilities primarily relate to upfront payments and consideration received from customers that are received in advance of the customer assuming control of the related products Transaction price allocated to remaining performance obligations For the three months ended March 31, 2022, revenue recognized from performance obligations related to prior periods was not material. Revenue expected to be recognized in any future year related to remaining performance obligations, excluding revenue pertaining to contracts that have an original expected duration of one year or less, contracts where revenue is recognized as invoiced and contracts with variable consideration related to undelivered performance obligations, totaled $7.6 million as of March 31, 2022. The amount relates primarily to upfront payments and consideration received from customers that are received in advance of the customer assuming control of the related products. The Company applies the practical expedient in paragraph 606-10-50-14 and does not disclose information about remaining performance obligations that have original expected durations of one year or less. The Baxter Agreement includes minimum commitments of product sales over the duration of the agreement. Unfulfilled minimum commitments related to the Baxter Agreement are product sales of $4.8 million as of March 31, 2022, which is amortized ratably through expiration of the Baxter Agreement on October 2, 2024. |
Investments - Available-for-Sal
Investments - Available-for-Sale | 3 Months Ended |
Mar. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments - Available-for-Sale | Investments - Available-for-Sale As of March 31, 2022, all investment available-for-sale securities have been liquidated. Investments available-for-sale consisted of the following as of December 31, 2021 (table in thousands): December 31, 2021 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Fair Value Available-for-Sale Securities Bonds $ 9,143 $ 1 $ — $ 14 $ 9,158 The fair value of investments available-for-sale are determined using quoted market prices from daily exchange-traded markets based on the closing price as of the balance sheet date and are classified as a Level 1 measurement under ASC 820 Fair Value Measurements. As of December 31, 2021, the amortized cost and estimated fair value of our available-for-sale securities were due within one year. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Components of inventory, net of reserves, as of March 31, 2022 and December 31, 2021 are as follows (table in thousands): March 31, December 31, Raw Materials $ 4,312 $ 3,434 Work in Process 408 201 Finished Goods 2,334 1,964 Total $ 7,054 $ 5,599 As of March 31, 2022, 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 March 31, 2022, the total Triferic inventory net of reserve was $1.6 million. The $1.6 million net value of Triferic inventory consisted of $0.3 million of Triferic (dialysate) finished goods with expiration dates ranging from July 2022 to December 2023, $0.4 million of Triferic API with an estimated useful life extending through 2023, and $0.9 million of raw materials for Triferic with an estimated useful life of 25 years. |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment As of March 31, 2022 and December 31, 2021, the Company’s property and equipment consisted of the following (table in thousands): March 31, December 31, Leasehold Improvements $ 1,204 $ 1,204 Machinery and Equipment 5,867 5,864 Information Technology & Office Equipment 1,845 1,845 Laboratory Equipment 660 676 9,576 9,589 Accumulated Depreciation (7,199) (7,103) Property and Equipment, net $ 2,377 $ 2,486 |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Mar. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities as of March 31, 2022 and December 31, 2021 consisted of the following (table in thousands): March 31, December 31, Accrued Research & Development Expense $ 338 $ 366 Accrued Compensation and Benefits 1,158 1,791 Accrued Unvouchered Receipts 537 796 Accrued Workers Compensation 458 382 Other Accrued Liabilities 1,882 1,755 Total Accrued Liabilities $ 4,373 $ 5,090 |
Deferred Revenue
Deferred Revenue | 3 Months Ended |
Mar. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Deferred Revenue | Deferred Revenue In October 2014, the Company entered into the Baxter Agreement, which has a term of 10 years and received an upfront fee of $20 million. The upfront fee was recorded as deferred revenue and is being recognized based on the proportion of product shipments to Baxter in each period, compared with total expected sales volume over the term of the Distribution Agreement. The Company recognized revenue of approximately $0.5 million for each of the three months ended March 31, 2022 and 2021. Deferred revenue related to the Baxter Agreement totaled $4.8 million as of March 31, 2022 and $5.2 million as of December 31, 2021. In 2016, the Company entered into a distribution agreement with Wanbang (the "Wanbang Agreement") and received an upfront fee of $4.0 million. The upfront fee was recorded as deferred revenue and is being recognized as revenue based on the agreement term. The Company recognized revenue of approximately $0.1 million during each of the three months ended March 31, 2022 and 2021. Deferred revenue related to the Wanbang Agreement totaled $2.5 million as of March 31, 2022 and December 31, 2021. 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 for each of the three months ended March 31, 2022 and 2021. Deferred revenue related to the Sun Pharma Agreement totaled $77,500 and $80,000 as of March 31, 2022 and December 31, 2021, 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 for each of the three months ended March 31, 2022 and 2021. Deferred revenue related to the Jeil Pharma Agreement totaled approximately $0.2 million as of March 31, 2022 and December 31, 2021. 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 |
Stockholders_ Equity
Stockholders’ Equity | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Preferred Stock On April 6, 2022, the Company and DaVita Inc. ("DaVita") entered into a Securities Purchase Agreement (the "SPA"), pursuant to which the Company will issue up to $15 million of preferred stock to DaVita. On April 6, 2022, the Company issued 7,500 shares of a newly designated series of preferred stock, which is designated “Series X Convertible Preferred Stock” (the "Series X Preferred Stock") for gross proceeds of $7.5 million. The Company will issue an additional 7,500 shares of Series X Preferred Stock to DaVita in a second closing (the "Second Tranche") for an additional $7.5 million if the Company raises $15 million in additional capital by June 30, 2022. The Series X Preferred Stock will be issued for a price $1,000 per share (the "Face Amount"), subject to accretion at a rate of 1% per annum, compounded annually. If the Company’s common stock trades above $22.00 for a period of 30 calendar days, the accretion will thereafter cease. The Series X Convertible Preferred Stock is convertible to common stock at rate equal to the Face Amount, divided by a conversion price of $11.00 per share (subject to adjustment for stock splits, reverse stock splits and similar recapitalization events). As a result, each share of Series X Preferred Stock will initially convert into approximately 91 shares of common stock. DaVita’s right to convert to common stock is subject to a beneficial ownership limitation, which is initially set at 9.9% of the outstanding common stock, which limitation may be reset (not to exceed 19.9%) at DaVita’s option and upon providing prior written notice to the Company. The shares issued in the Second Tranche will have a lower conversion price if the Company raises capital through the issuance of convertible preferred stock prior to the closing of the Second Tranche and the conversion price of the securities sold in such preferred stock offerings is below $11.00 per share. In addition, any debt financing is limited by the terms of our Securities Purchase Agreement with DaVita. Specifically, until DaVita owns less than 50% of its investment, the Company may only incur additional debt in the form of a purchase money loan, a working capital line of up to $5 million or to refinance existing debt, unless DaVita consents. As of March 31, 2022 and December 31, 2021, there were 2,000,000 shares of preferred stock, $0.0001 par value per share, authorized and no shares of preferred stock issued and outstanding. Common Stock As of March 31, 2022 and December 31, 2021, there were 170,000,000 shares of common stock, $0.0001 par value per share, authorized and 8,544,225 and 8,544,225 shares issued and outstanding, respectively. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based CompensationThe Company recognized total stock-based compensation expense during the three months ended March 31, 2022 and 2021 as follows (table in thousands): Three Months Ended 2022 2021 Service-based awards: Restricted stock units $ 12 $ 104 Stock option awards 200 391 212 495 Performance-based awards: Restricted stock awards (391) (391) Stock option awards — (340) (391) (731) Total $ (179) $ (236) Restricted Stock A summary of the Company’s restricted stock awards during the three months ended March 31, 2022 is as follows: Number of Shares Weighted Average Unvested at January 1, 2022 7,118 $ 62.70 Forfeited (6,227) $ 62.70 Unvested at March 31, 2022 891 $ 62.70 A summary of the Company’s restricted stock awards during the three months ended March 31, 2021 is as follows: Number of Shares Weighted Average Unvested at January 1, 2021 13,345 $ 62.70 Forfeited (6,227) $ 62.70 Unvested at March 31, 2021 7,118 $ 62.70 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 March 31, 2022, unvested restricted stock awards of 891 were related to performance-based awards. The forfeited performance-based restricted stock awards of 6,227 was due to the resignation of the Company's Chief Development Officer on March 25, 2022. 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 three months ended March 31, 2022 is as follows: Number of Shares Weighted Average Unvested at January 1, 2022 29,289 $ 12.87 Forfeited (1,223) 52.91 Unvested at March 31, 2022 28,066 $ 11.11 A summary of the Company’s service-based restricted stock units during the three months ended March 31, 2021 is as follows: Number of Shares Weighted Average Unvested at January 1, 2021 24,136 $ 28.60 Granted 914 22.99 Vested (1,042) 52.91 Forfeited (2,396) 27.50 Unvested at March 31, 2021 21,612 $ 27.39 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 $12,000 and $104,000 was recognized for the three months ended March 31, 2022 and 2021, respectively. As of March 31, 2022, the unrecognized stock-based compensation expense was $0.1 million, which is expected to be recognized over an estimated weighted average remaining term of less than 1 year. Service-Based Stock Options The fair value of the service-based stock options granted for the three months ended March 31, 2022 were based on the following assumptions: March 31, Exercise price $4.12 Expected stock price volatility 76.2% Risk-free interest rate 1.98% Term (years) 6.5 A summary of the Company’s service-based stock option activity for the three months ended March 31, 2022 is as follows: Shares Weighted Weighted Aggregate Outstanding at January 1, 2022 528,591 $ 32.01 7.5 $ — Granted 909 4.07 9.9 — Forfeited (14,839) 17.49 — — Expired (3,545) 85.36 — — Outstanding at March 31, 2022 511,116 $ 32.01 7.0 $ 1 Exercisable at March 31, 2022 236,720 $ 52.14 5.0 $ — A summary of the Company’s service-based stock option activity for the three months ended March 31, 2021 is as follows: Shares Weighted Weighted Aggregate Outstanding at January 1, 2021 519,814 $ 50.05 6.6 $ — Granted 7,672 17.60 6.0 — Forfeited (16,721) 27.39 — — Expired (20,530) 84.26 — — Outstanding at March 31, 2021 490,235 $ 48.95 6.1 $ — Exercisable at March 31, 2021 251,180 $ 73.48 3.2 $ — 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 three months ended March 31, 2022, the Company granted stock options to purchase up to 909 shares of common stock to certain employees. During the three months ended March 31, 2022, 14,839 shares were forfeited and 3,545 shares expired. Forfeitures are recorded in the period of occurrence; compensation expense is adjusted accordingly. Stock-based compensation expense recognized for service-based stock options was $0.2 million and $0.4 million for the three months ended March 31, 2022 and 2021, respectively. As of March 31, 2022, total stock-based compensation expense related to unvested options not yet recognized totaled approximately $1.0 million, which is expected to be recognized over an estimated weighted average remaining term of 3.1 years. |
Licensing Agreements
Licensing Agreements | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Licensing Agreements | Licensing Agreements Product License Agreements The Company is a party to a Licensing Agreement between the Company and Charak, LLC ("Charak") dated January 7, 2002 (the "2002 Agreement") that grants the Company exclusive worldwide rights to certain patents and information related to 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. As of March 31, 2022, the Company has accrued $86,400 relating to certain IP reimbursement expenses and certain sublicense royalty fees and is included 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 sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and be no less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis. Also pursuant to the Charak MSA, the Company and Charak entered into a Commercialization and Technology License Agreement I.V. Triferic®, dated as of October 7, 2018 (the “IV Agreement”), under which Charak granted the Company an exclusive, sublicensable, royalty-bearing license to SFP for the purpose of commercializing certain intravenous-delivered products incorporating SFP for the treatment of iron disorders worldwide for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. The Company is liable to pay Charak royalties on net sales by the Company of products developed under the license at a specified rate until December 31, 2021. From January 1, 2022 until February 1, 2034, the Company is liable to pay Charak a base royalty at a reduced rate on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the IV Agreement, which amount shall not be less than a minimum specified percentage of net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis. Also pursuant to the Charak MSA, the Company and Charak entered into a Technology License Agreement TPN Triferic®, dated as of October 7, 2018 (the “TPN Agreement”), pursuant to which Charak granted the Company an exclusive, sublicensable, royalty-bearing license to SFP for the purpose of commercializing worldwide certain TPN products incorporating SFP. The license grant under the TPN Agreement continues for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. During the term of the TPN Agreement, the Company is liable to pay Charak a base royalty on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the TPN Agreement, which amount shall not be less than a minimum royalty on net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis. The potential milestone payments are not yet considered probable, and no milestone payments have been accrued at March 31, 2022. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Leases | Leases Rockwell leases its production facilities and administrative offices as well as certain equipment used in its operations including leases on transportation equipment used in the delivery of its products. The lease terms range from monthly to seven years. Rockwell occupies a 51,000 square foot facility and a 17,500 square foot facility in Wixom, Michigan under a lease expiring in August 2024. Rockwell also occupies two other manufacturing facilities, a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December 2025, and a 57,000 square foot facility in Greer, South Carolina under a lease expiring February 2023. In addition, Rockwell occupies 4,100 square feet of office space in Hackensack, New Jersey under a lease expiring on October 31, 2024. This lease was subleased on December 15, 2021 with an expiration date of October 31, 2024. At March 31, 2022, the Company had operating and finance lease liabilities of $7.4 million and right-of-use assets of $7.2 million, which are included in the consolidated balance sheet. At December 31, 2021, the Company had operating lease liabilities of $7.9 million and right-of-use assets of $7.7 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 March 31, 2022 Three Months Ended March 31, 2021 Operating leases Operating lease cost $ 449 $ 419 Variable lease cost 95 102 Operating lease expense 544 521 Finance leases Amortization of right-of-use assets 141 45 Interest on lease obligations 47 13 Finance lease expense 188 58 Short-term lease rent expense 4 4 Total rent expense $ 736 $ 583 Other information Operating cash flows from operating leases $ 464 $ 425 Operating cash flows from finance leases $ 47 $ 13 Financing cash flows from finance leases $ 118 $ 37 Right of use assets exchanged for operating lease liabilities $ — $ 1,896 Right of use assets exchanged for finance lease liabilities $ — $ 460 Weighted-average remaining lease term – operating leases 3.4 3.6 Weighted-average remaining lease term – finance leases 5.2 5.4 Weighted-average discount rate – operating leases 6.3 % 6.3 % Weighted-average discount rate – finance leases 6.4 % 5.4 % Future minimum rental payments under operating lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2022 (remaining) $ 1,307 $ 495 Year ending December 31, 2023 1,456 669 Year ending December 31, 2024 1,114 672 Year ending December 31, 2025 637 676 Year ending December 31, 2026 260 666 Remaining future payments 121 311 Total $ 4,895 $ 3,489 Less present value discount (485) (516) Operating and finance lease liabilities $ 4,410 $ 2,973 |
Leases | Leases Rockwell leases its production facilities and administrative offices as well as certain equipment used in its operations including leases on transportation equipment used in the delivery of its products. The lease terms range from monthly to seven years. Rockwell occupies a 51,000 square foot facility and a 17,500 square foot facility in Wixom, Michigan under a lease expiring in August 2024. Rockwell also occupies two other manufacturing facilities, a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December 2025, and a 57,000 square foot facility in Greer, South Carolina under a lease expiring February 2023. In addition, Rockwell occupies 4,100 square feet of office space in Hackensack, New Jersey under a lease expiring on October 31, 2024. This lease was subleased on December 15, 2021 with an expiration date of October 31, 2024. At March 31, 2022, the Company had operating and finance lease liabilities of $7.4 million and right-of-use assets of $7.2 million, which are included in the consolidated balance sheet. At December 31, 2021, the Company had operating lease liabilities of $7.9 million and right-of-use assets of $7.7 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 March 31, 2022 Three Months Ended March 31, 2021 Operating leases Operating lease cost $ 449 $ 419 Variable lease cost 95 102 Operating lease expense 544 521 Finance leases Amortization of right-of-use assets 141 45 Interest on lease obligations 47 13 Finance lease expense 188 58 Short-term lease rent expense 4 4 Total rent expense $ 736 $ 583 Other information Operating cash flows from operating leases $ 464 $ 425 Operating cash flows from finance leases $ 47 $ 13 Financing cash flows from finance leases $ 118 $ 37 Right of use assets exchanged for operating lease liabilities $ — $ 1,896 Right of use assets exchanged for finance lease liabilities $ — $ 460 Weighted-average remaining lease term – operating leases 3.4 3.6 Weighted-average remaining lease term – finance leases 5.2 5.4 Weighted-average discount rate – operating leases 6.3 % 6.3 % Weighted-average discount rate – finance leases 6.4 % 5.4 % Future minimum rental payments under operating lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2022 (remaining) $ 1,307 $ 495 Year ending December 31, 2023 1,456 669 Year ending December 31, 2024 1,114 672 Year ending December 31, 2025 637 676 Year ending December 31, 2026 260 666 Remaining future payments 121 311 Total $ 4,895 $ 3,489 Less present value discount (485) (516) Operating and finance lease liabilities $ 4,410 $ 2,973 |
Loans and Security Agreement
Loans and Security Agreement | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Loans and Security Agreement | Loan and Security AgreementOn March 16, 2020, the Company 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. 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) $18.15 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 43,388 shares of the Company’s common stock at an exercise price of $18.15 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. The Company is entitled to make interest-only payments for thirty months, or up to thirty-six months if certain conditions are met. The Term Loans will mature on March 16, 2025, and will bear interest at the greater of (i) Prime Rate (as defined in the Loan Agreement) and (ii) 4.75%, plus 4.00% with an initial interest rate of 8.75% per annum and an effective interest rate of 10.9%. The Company has the option, under certain circumstances, to add 1.00% of such interest rate amount to the then outstanding principal balance in lieu of paying such amount in cash. For the three months ended March 31, 2022 and 2021, interest expense amounted to $0.4 million and $0.6 million, respectively. The Loan Agreement is secured by all assets of the Company and Rockwell Transportation, Inc. Proceeds are 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. 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. In September 2021, the Company entered into an amendment to the Loan Agreement in which the Company, in exchange for Innovatus lowering the sales covenants, agreed to (i) prepay an aggregate principal amount of $7,500,000 in ten installments commencing on December 1, 2021; (ii) 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) maintain minimum liquidity of no less than $5,000,000 if the aggregate principal amount of Term Loans is greater than $15,000,000 pursuant to the liquidity covenant in the Loan Agreement. On March 31, 2022, the Collateral Agent and Lenders consented to the delivery to Collateral Agent and Lenders of its annual audited financial statements for the fiscal year 2021 by April 15, 2022 as opposed to within 90 days of December 31, 2021, as required pursuant to Loan Agreement. As of March 31, 2022, the Company was in compliance with all covenants under the Loan Agreement. As of March 31, 2022, the outstanding balance of the Term Loan was $18.4 million, net of unamortized issuance costs and discount of $1.1 million. The following table reflects the schedule of principal payments on the Term Loan as of March 31, 2022 (in thousands): Principal Payments 2022 $ 5,500 2023 6,000 2024 6,000 2025 2,000 $ 19,500 |
Insurance Financing Note Payabl
Insurance Financing Note Payable | 3 Months Ended |
Mar. 31, 2022 | |
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 began on July 3, 2021 and were paid on a straight-line amortization over 9 months with the final payment due on March 3, 2022. As of March 31, 2022, the Company's insurance note payable was paid in full. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Amended Supply Agreement The Company has been working to renegotiate certain terms of its supply contracts with the Company’s two largest customers in an effort to allow the Company to stabilize its concentrates business. On April 6, 2022, the Company and DaVita entered into an amendment (the "Amendment") to the Products Purchase Agreement, dated July 1, 2019 under which the Company supplies DaVita with certain dialysis concentrates. Under the Amendment, the Company and DaVita agreed to a price increase, effective May 1, 2022, as well as the pass-through of certain inflationary costs, determined on a quarterly basis. Certain costs are subject to a cap. The Amendment also requires the Company to implement certain cost containment and cost-cutting measures. The Amendment contains certain covenants with respect to the Company’s ongoing operations, including a minimum cash covenant, and the requirement to raise $15 million in additional capital by June 30, 2022. The Amendment also establishes a joint committee that will oversee certain efficiency and cost-savings activities to be undertaken by the Company. Certain cost savings that are realized by the Company will be shared with DaVita in the manner set forth in the Amendment. Controlled Equity Offering (or "At the Market" Offering) On April 8, 2022, the Company entered into a sales agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (the “Agent”), pursuant to which the Company may offer and sell from time to time up to $12,200,000 of shares of Company’s common stock through the Agent. The offering and sale of such shares has been registered under the Securities Act of 1933, as amended, pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-259923) (the “Registration Statement”), which was originally filed with the SEC on September 30, 2021 and declared effective by the SEC on October 8, 2021, the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed with the SEC on April 8, 2022. Reverse Stock Split On May 9, 2022, the Company's Board of Directors approved the reverse stock split at the ratio of 1-for-11 shares. The reverse stock split was approved by the Company's stockholders at the annual meeting of stockholders held on May 9, 2022 at a ratio ranging from 1-for-2 up to a ratio of 1-for-15, such ratio to be determined by the Board of Directors and included in a public announcement. The reverse stock split will became effective at 12:01 a.m. Eastern Time on May 13, 2022. Rockwell Medical's common stock is expected to begin trading on the Nasdaq Capital Market on a split-adjusted basis on May 13, 2022. |
Basis of Presentation, Summar_2
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
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. |
Reverse Stock Split | Reverse Stock Split On May 9, 2022, the stockholders of the Company authorized our Board of Directors to effect a reverse stock split of all outstanding shares of common stock. The Board of Directors subsequently approved the implementation of a reverse stock split as a ratio of one-for-eleven shares, which became effective on May 13, 2022. The Company’s outstanding stock options were also adjusted to reflect the one-for-eleven reverse stock split of the Company’s common stock. Outstanding stock options were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased. The reverse stock split resulted in an adjustment to the Series X convertible preferred stock conversion prices to reflect a proportional decrease in the number of shares of common stock to be issued upon conversion. All share and per share data in these condensed consolidated financial statements and related notes hereto have been retroactively adjusted to the account for the effect of the reverse stock split for the three month periods ended March 31, 2022 and 2021, respectively, and the balance sheet at March 31, 2022 and December 31, 2021. |
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. 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 | 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. |
Basis of Presentation, Summar_3
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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 March 31, 2022 2021 Options to purchase common stock 511,117 558,417 Unvested restricted stock awards 891 7,118 Unvested restricted stock units 28,067 21,611 Warrants to purchase common stock 2,402,442 2,402,442 Total 2,942,517 2,989,588 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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 March 31, 2022 Products By Geographic Area Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ 159 $ 159 $ — License Fee – Over time 62 — 62 Total Drug Products 221 159 62 Concentrate Products Product Sales – Point-in-time 15,427 13,810 1,617 License Fee – Over time 476 476 — Total Concentrate Products 15,903 14,286 1,617 Net Revenue $ 16,124 $ 14,445 $ 1,679 In thousands of U.S. dollars ($) Three Months Ended March 31, 2021 Products By Geographic Area Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ 225 $ 225 $ — License Fee – Over time 58 — 58 Total Drug Products 283 225 58 Concentrate Products Product Sales – Point-in-time 14,705 13,201 1,504 License Fee – Over time 485 485 — Total Concentrate Products 15,190 13,686 1,504 Net Revenue $ 15,473 $ 13,911 $ 1,562 |
Contract Balances | The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands of U.S. dollars ($) March 31, 2022 December 31, 2021 Receivables, which are included in "Trade and other receivables" $ 7,121 $ 5,913 Contract liabilities $ 7,619 $ 8,157 |
Investments - Available-for-S_2
Investments - Available-for-Sale (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments Available-for-Sale | Investments available-for-sale consisted of the following as of December 31, 2021 (table in thousands): December 31, 2021 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Fair Value Available-for-Sale Securities Bonds $ 9,143 $ 1 $ — $ 14 $ 9,158 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule Components of Inventory | Components of inventory, net of reserves, as of March 31, 2022 and December 31, 2021 are as follows (table in thousands): March 31, December 31, Raw Materials $ 4,312 $ 3,434 Work in Process 408 201 Finished Goods 2,334 1,964 Total $ 7,054 $ 5,599 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Major Classes of Property and Equipment | As of March 31, 2022 and December 31, 2021, the Company’s property and equipment consisted of the following (table in thousands): March 31, December 31, Leasehold Improvements $ 1,204 $ 1,204 Machinery and Equipment 5,867 5,864 Information Technology & Office Equipment 1,845 1,845 Laboratory Equipment 660 676 9,576 9,589 Accumulated Depreciation (7,199) (7,103) Property and Equipment, net $ 2,377 $ 2,486 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities as of March 31, 2022 and December 31, 2021 consisted of the following (table in thousands): March 31, December 31, Accrued Research & Development Expense $ 338 $ 366 Accrued Compensation and Benefits 1,158 1,791 Accrued Unvouchered Receipts 537 796 Accrued Workers Compensation 458 382 Other Accrued Liabilities 1,882 1,755 Total Accrued Liabilities $ 4,373 $ 5,090 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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 months ended March 31, 2022 and 2021 as follows (table in thousands): Three Months Ended 2022 2021 Service-based awards: Restricted stock units $ 12 $ 104 Stock option awards 200 391 212 495 Performance-based awards: Restricted stock awards (391) (391) Stock option awards — (340) (391) (731) Total $ (179) $ (236) |
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 three months ended March 31, 2022 is as follows: Number of Shares Weighted Average Unvested at January 1, 2022 7,118 $ 62.70 Forfeited (6,227) $ 62.70 Unvested at March 31, 2022 891 $ 62.70 A summary of the Company’s restricted stock awards during the three months ended March 31, 2021 is as follows: Number of Shares Weighted Average Unvested at January 1, 2021 13,345 $ 62.70 Forfeited (6,227) $ 62.70 Unvested at March 31, 2021 7,118 $ 62.70 |
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 three months ended March 31, 2022 is as follows: Number of Shares Weighted Average Unvested at January 1, 2022 29,289 $ 12.87 Forfeited (1,223) 52.91 Unvested at March 31, 2022 28,066 $ 11.11 A summary of the Company’s service-based restricted stock units during the three months ended March 31, 2021 is as follows: Number of Shares Weighted Average Unvested at January 1, 2021 24,136 $ 28.60 Granted 914 22.99 Vested (1,042) 52.91 Forfeited (2,396) 27.50 Unvested at March 31, 2021 21,612 $ 27.39 |
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 three months ended March 31, 2022 were based on the following assumptions: March 31, Exercise price $4.12 Expected stock price volatility 76.2% Risk-free interest rate 1.98% Term (years) 6.5 |
Schedule of Stock Options Activity | A summary of the Company’s service-based stock option activity for the three months ended March 31, 2022 is as follows: Shares Weighted Weighted Aggregate Outstanding at January 1, 2022 528,591 $ 32.01 7.5 $ — Granted 909 4.07 9.9 — Forfeited (14,839) 17.49 — — Expired (3,545) 85.36 — — Outstanding at March 31, 2022 511,116 $ 32.01 7.0 $ 1 Exercisable at March 31, 2022 236,720 $ 52.14 5.0 $ — A summary of the Company’s service-based stock option activity for the three months ended March 31, 2021 is as follows: Shares Weighted Weighted Aggregate Outstanding at January 1, 2021 519,814 $ 50.05 6.6 $ — Granted 7,672 17.60 6.0 — Forfeited (16,721) 27.39 — — Expired (20,530) 84.26 — — Outstanding at March 31, 2021 490,235 $ 48.95 6.1 $ — Exercisable at March 31, 2021 251,180 $ 73.48 3.2 $ — |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Summary of Lease Costs | The following summarizes quantitative information about the Company’s operating leases (table in thousands): Three Months Ended March 31, 2022 Three Months Ended March 31, 2021 Operating leases Operating lease cost $ 449 $ 419 Variable lease cost 95 102 Operating lease expense 544 521 Finance leases Amortization of right-of-use assets 141 45 Interest on lease obligations 47 13 Finance lease expense 188 58 Short-term lease rent expense 4 4 Total rent expense $ 736 $ 583 Other information Operating cash flows from operating leases $ 464 $ 425 Operating cash flows from finance leases $ 47 $ 13 Financing cash flows from finance leases $ 118 $ 37 Right of use assets exchanged for operating lease liabilities $ — $ 1,896 Right of use assets exchanged for finance lease liabilities $ — $ 460 Weighted-average remaining lease term – operating leases 3.4 3.6 Weighted-average remaining lease term – finance leases 5.2 5.4 Weighted-average discount rate – operating leases 6.3 % 6.3 % Weighted-average discount rate – finance leases 6.4 % 5.4 % |
Operating Lease Maturities | Future minimum rental payments under operating lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2022 (remaining) $ 1,307 $ 495 Year ending December 31, 2023 1,456 669 Year ending December 31, 2024 1,114 672 Year ending December 31, 2025 637 676 Year ending December 31, 2026 260 666 Remaining future payments 121 311 Total $ 4,895 $ 3,489 Less present value discount (485) (516) Operating and finance lease liabilities $ 4,410 $ 2,973 |
Finance Lease Maturities | Future minimum rental payments under operating lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2022 (remaining) $ 1,307 $ 495 Year ending December 31, 2023 1,456 669 Year ending December 31, 2024 1,114 672 Year ending December 31, 2025 637 676 Year ending December 31, 2026 260 666 Remaining future payments 121 311 Total $ 4,895 $ 3,489 Less present value discount (485) (516) Operating and finance lease liabilities $ 4,410 $ 2,973 |
Loans and Security Agreement (T
Loans and Security Agreement (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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 March 31, 2022 (in thousands): Principal Payments 2022 $ 5,500 2023 6,000 2024 6,000 2025 2,000 $ 19,500 |
Description of Business (Detail
Description of Business (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2022USD ($)employee | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Years of service | 25 years |
Revenue | $ | $ 60 |
Number of employees | employee | 300 |
Liquidity and Going Concern C_2
Liquidity and Going Concern Considerations (Details) | Apr. 08, 2022USD ($) | Apr. 07, 2022USD ($) | Jun. 30, 2022USD ($) | Mar. 31, 2022USD ($) | Mar. 31, 2021USD ($) | Dec. 08, 2021businessDay$ / shares | Apr. 06, 2022USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) |
Liquidity and Going Concern Considerations [Line Items] | |||||||||
Accumulated deficit | $ (377,242,000) | $ (370,080,000) | |||||||
Stockholders' equity | (4,807,000) | $ 26,178,000 | 2,535,000 | $ 34,170,000 | |||||
Cash and Cash Equivalents | 9,914,000 | $ 13,280,000 | |||||||
Working capital | 5,200,000 | ||||||||
Net cash used in operating activities | $ (9,812,000) | $ (12,495,000) | |||||||
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 | ||||||||
Subsequent event | |||||||||
Liquidity and Going Concern Considerations [Line Items] | |||||||||
Additional capital earned | $ 15,000,000 | $ 15,000,000 | |||||||
Subsequent event | Da Vita Healthcare Partners Inc | Share Issuance, Tranche One | |||||||||
Liquidity and Going Concern Considerations [Line Items] | |||||||||
Proceeds from issuance of convertible preferred stock | $ 7,500,000 | ||||||||
Subsequent event | Da Vita Healthcare Partners Inc | Forecast | Share Issuance, Tranche One | |||||||||
Liquidity and Going Concern Considerations [Line Items] | |||||||||
Proceeds from issuance of convertible preferred stock | $ 7,500,000 | ||||||||
Subsequent event | Da Vita Healthcare Partners Inc | Forecast | Share Issuance, Tranche Two | |||||||||
Liquidity and Going Concern Considerations [Line Items] | |||||||||
Proceeds from issuance of convertible preferred stock | 7,500,000 | ||||||||
Subsequent event | Da Vita Healthcare Partners Inc | Forecast | Series X Convertible Preferred Stock | Private Placement | |||||||||
Liquidity and Going Concern Considerations [Line Items] | |||||||||
Sale of stock, consideration received on transaction | $ 15,000,000 | ||||||||
Subsequent event | Cantor Fitzgerald & Co | |||||||||
Liquidity and Going Concern Considerations [Line Items] | |||||||||
Sales agreement, threshold sale of shares | $ 12,200,000 |
Basis of Presentation, Summar_4
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Summary of Potentially Dilutive Securities (Details) | May 09, 2022 | Mar. 31, 2022shares | Mar. 31, 2021shares |
Net Earnings per Share | |||
Securities excluded from diluted loss per share calculation (in shares) | 2,942,517 | 2,989,588 | |
Subsequent event | |||
Net Earnings per Share | |||
Reverse stock split | 0.09 | ||
Options to purchase common stock | |||
Net Earnings per Share | |||
Securities excluded from diluted loss per share calculation (in shares) | 511,117 | 558,417 | |
Unvested restricted stock awards | |||
Net Earnings per Share | |||
Securities excluded from diluted loss per share calculation (in shares) | 891 | 7,118 | |
Unvested restricted stock units | |||
Net Earnings per Share | |||
Securities excluded from diluted loss per share calculation (in shares) | 28,067 | 21,611 | |
Warrants to purchase common stock | |||
Net Earnings per Share | |||
Securities excluded from diluted loss per share calculation (in shares) | 2,402,442 | 2,402,442 |
Revenue Recognition - Nature of
Revenue Recognition - Nature of Goods and Services (Details) | 3 Months Ended |
Mar. 31, 2022agreement | |
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 | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||
Net Revenue | $ 16,124 | $ 15,473 |
Drug products | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 221 | 283 |
Concentrate Products | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 15,903 | 15,190 |
U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 14,445 | 13,911 |
U.S. | Drug products | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 159 | 225 |
U.S. | Concentrate Products | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 14,286 | 13,686 |
Rest of World | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 1,679 | 1,562 |
Rest of World | Drug products | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 62 | 58 |
Rest of World | Concentrate Products | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 1,617 | 1,504 |
Product Sales – Point-in-time | Drug product sales | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 159 | 225 |
Product Sales – Point-in-time | Concentrate product sales | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 15,427 | 14,705 |
Product Sales – Point-in-time | U.S. | Drug product sales | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 159 | 225 |
Product Sales – Point-in-time | U.S. | Concentrate product sales | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 13,810 | 13,201 |
Product Sales – Point-in-time | Rest of World | Drug product sales | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 0 | 0 |
Product Sales – Point-in-time | Rest of World | Concentrate product sales | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 1,617 | 1,504 |
License Fee – Over time | Drug license fee | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 62 | 58 |
License Fee – Over time | Concentrate product license fee | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 476 | 485 |
License Fee – Over time | U.S. | Drug license fee | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 0 | 0 |
License Fee – Over time | U.S. | Concentrate product license fee | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 476 | 485 |
License Fee – Over time | Rest of World | Drug license fee | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | 62 | 58 |
License Fee – Over time | Rest of World | Concentrate product license fee | ||
Disaggregation of Revenue [Line Items] | ||
Net Revenue | $ 0 | $ 0 |
Revenue Recognition - Contract
Revenue Recognition - Contract Balances (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Revenue from Contract with Customer [Abstract] | ||
Receivables, which are included in "Trade and other receivables" | $ 7,121 | $ 5,913 |
Contract liabilities | $ 7,619 | $ 8,157 |
Revenue Recognition - Narrative
Revenue Recognition - Narrative (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Revenue Recognition [Line Items] | |||
Impairment losses | $ 0 | $ 0 | |
Contract assets | 0 | $ 0 | |
Revenue performance obligation | 7,600,000 | ||
Baxter Healthcare Organization | |||
Revenue Recognition [Line Items] | |||
Revenue performance obligation | 4,800,000 | ||
Concentrate Products | |||
Revenue Recognition [Line Items] | |||
Reserve for returns | $ 0 | $ 0 |
Investments - Available-for-S_3
Investments - Available-for-Sale (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Investments, Debt and Equity Securities [Abstract] | ||
Amortized Cost | $ 9,143 | |
Unrealized Gain | 1 | |
Unrealized Loss | 0 | |
Accrued Interest | 14 | |
Fair Value | $ 0 | $ 9,158 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Dec. 31, 2021 | |
Inventory [Line Items] | ||
Raw Materials | $ 4,312 | $ 3,434 |
Work in Process | 408 | 201 |
Finished Goods | 2,334 | 1,964 |
Total | 7,054 | 5,599 |
Inventory, noncurrent | 1,523 | 1,523 |
Inventory, net | 5,531 | $ 4,076 |
Triferic Inventory | ||
Inventory [Line Items] | ||
Raw Materials | 900 | |
Inventory, noncurrent | 1,500 | |
Inventory, net | $ 1,600 | |
Useful life | 25 years | |
Triferic Dialysate | ||
Inventory [Line Items] | ||
Finished Goods | $ 300 | |
Triferic API | ||
Inventory [Line Items] | ||
Inventory, net | $ 400 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Property and equipment | |||
Gross property and equipment | $ 9,576 | $ 9,589 | |
Accumulated Depreciation | (7,199) | (7,103) | |
Property and Equipment, net | 2,377 | 2,486 | |
Depreciation expense | 100 | $ 200 | |
Leasehold Improvements | |||
Property and equipment | |||
Gross property and equipment | 1,204 | 1,204 | |
Machinery and Equipment | |||
Property and equipment | |||
Gross property and equipment | 5,867 | 5,864 | |
Information Technology & Office Equipment | |||
Property and equipment | |||
Gross property and equipment | 1,845 | 1,845 | |
Laboratory Equipment | |||
Property and equipment | |||
Gross property and equipment | $ 660 | $ 676 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued Research & Development Expense | $ 338 | $ 366 |
Accrued Compensation and Benefits | 1,158 | 1,791 |
Accrued Unvouchered Receipts | 537 | 796 |
Accrued Workers Compensation | 458 | 382 |
Other Accrued Liabilities | 1,882 | 1,755 |
Total Accrued Liabilities | $ 4,373 | $ 5,090 |
Deferred Revenue (Details)
Deferred Revenue (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Jun. 30, 2021 | Sep. 30, 2020 | Jan. 31, 2020 | Oct. 31, 2014 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2016 | Dec. 31, 2021 | |
Deferred Revenue Arrangement [Line Items] | ||||||||
Deferred revenue | $ 7,619,000 | $ 8,157,000 | ||||||
Baxter Healthcare Organization | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Term of agreement | 10 years | |||||||
Upfront payment | $ 20,000,000 | |||||||
Recognized deferred revenue | 500,000 | $ 500,000 | ||||||
Deferred revenue | 4,800,000 | 5,200,000 | ||||||
Wanbang Biopharmaceutical | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Upfront payment | $ 4,000,000 | |||||||
Recognized deferred revenue | 100,000 | |||||||
Deferred revenue | 2,500,000 | 2,500,000 | ||||||
Sun Pharma Agreements | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Upfront payment | $ 100,000 | |||||||
Recognized deferred revenue | 2,500 | 2,500 | ||||||
Deferred revenue | 77,500 | 80,000 | ||||||
Jeil Pharma Agreements | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Upfront payment | $ 200,000 | |||||||
Recognized deferred revenue | 2,500 | 2,500 | ||||||
Deferred revenue | 200,000 | 200,000 | ||||||
Drogsan Agreements | ||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||
Upfront payment | $ 150,000 | |||||||
Recognized deferred revenue | 3,750 | $ 0 | ||||||
Deferred revenue | $ 140,000 | $ 140,000 |
Stockholders_ Equity (Details)
Stockholders’ Equity (Details) | Apr. 07, 2022USD ($)shares | Apr. 06, 2022USD ($)$ / shares | Jun. 30, 2022USD ($)shares | Mar. 31, 2022$ / sharesshares | Dec. 31, 2021$ / sharesshares |
Class of Stock [Line Items] | |||||
Preferred stock, authorized (in shares) | 2,000,000 | 2,000,000 | |||
Preferred shares, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||
Preferred shares, shares issued (in shares) | 0 | 0 | |||
Preferred shares, shares outstanding (in shares) | 0 | 0 | |||
Common shares, shares authorized (in shares) | 170,000,000 | 170,000,000 | |||
Common shares, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||
Common shares, shares issued (in shares) | 8,544,225 | 8,544,225 | |||
Common shares, shares outstanding (in shares) | 8,544,225 | 8,544,225 | |||
Subsequent event | |||||
Class of Stock [Line Items] | |||||
Additional capital earned | $ | $ 15,000,000 | $ 15,000,000 | |||
Series X Convertible Preferred Stock | Subsequent event | |||||
Class of Stock [Line Items] | |||||
Interest rate percentage | 100.00% | ||||
Common stock trading price | $ / shares | $ 22 | ||||
Common stock trading period | 30 years | ||||
Conversion price (per share) | $ / shares | $ 11 | ||||
Convertible preferred stock (in shares) | 91 | ||||
Outstanding common stock, percentage | 9.90% | ||||
Outstanding common stock, not to exceed, percentage | 19.90% | ||||
Percentage of investment owned | 50.00% | ||||
Maximum working capital line | $ | $ 5,000,000 | ||||
Da Vita Healthcare Partners Inc | Subsequent event | Share Issuance, Tranche One | |||||
Class of Stock [Line Items] | |||||
Proceeds from issuance of convertible preferred stock | $ | $ 7,500,000 | ||||
Da Vita Healthcare Partners Inc | Forecast | Subsequent event | Share Issuance, Tranche One | |||||
Class of Stock [Line Items] | |||||
Proceeds from issuance of convertible preferred stock | $ | $ 7,500,000 | ||||
Da Vita Healthcare Partners Inc | Forecast | Subsequent event | Share Issuance, Tranche Two | |||||
Class of Stock [Line Items] | |||||
Proceeds from issuance of convertible preferred stock | $ | 7,500,000 | ||||
Private Placement | Da Vita Healthcare Partners Inc | Series X Convertible Preferred Stock | Subsequent event | |||||
Class of Stock [Line Items] | |||||
Common stock trading price (in dollars per share) | $ / shares | $ 1,000 | ||||
Private Placement | Da Vita Healthcare Partners Inc | Series X Convertible Preferred Stock | Subsequent event | Share Issuance, Tranche One | |||||
Class of Stock [Line Items] | |||||
Sale of Stock, number of shares issued in transaction | 7,500 | ||||
Private Placement | Da Vita Healthcare Partners Inc | Forecast | Series X Convertible Preferred Stock | Subsequent event | |||||
Class of Stock [Line Items] | |||||
Sale of stock, consideration received on transaction | $ | $ 15,000,000 | ||||
Private Placement | Da Vita Healthcare Partners Inc | Forecast | Series X Convertible Preferred Stock | Subsequent event | Share Issuance, Tranche Two | |||||
Class of Stock [Line Items] | |||||
Sale of Stock, number of shares issued in transaction | 7,500 |
Stock-Based Compensation - Shar
Stock-Based Compensation - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share based compensation expense | $ (179) | $ (236) |
Service based awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share based compensation expense | 212 | 495 |
Restricted stock units - service based awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share based compensation expense | 12 | 104 |
Stock option awards - service based awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share based compensation expense | 200 | 391 |
Performance based awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share based compensation expense | (391) | (731) |
Restricted stock awards - performance based awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share based compensation expense | (391) | (391) |
Stock option awards - performance based awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total share based compensation expense | $ 0 | $ (340) |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Awards (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Weighted Average Grant-Date Fair Value | ||
Stock based compensation expenses | $ (179) | $ (236) |
Restricted stock awards | ||
Number of Shares | ||
Unvested at beginning of period (in shares) | 7,118 | 13,345 |
Forfeited (in shares) | (6,227) | (6,227) |
Unvested at end of period (in shares) | 891 | 7,118 |
Weighted Average Grant-Date Fair Value | ||
Unvested at beginning of period (in dollars per share) | $ 62.70 | $ 62.70 |
Forfeited (in dollars per share) | 62.70 | 62.70 |
Unvested at end of period (in dollars per share) | $ 62.70 | $ 62.70 |
Vesting period | 20 months | |
Unvested, number of shares (in shares) | 891 | 7,118 |
Forfeited (in shares) | (6,227) | (6,227) |
Restricted stock awards - performance based awards | ||
Number of Shares | ||
Forfeited (in shares) | (6,227) | |
Weighted Average Grant-Date Fair Value | ||
Forfeited (in shares) | (6,227) | |
Stock based compensation expenses | $ (391) | $ (391) |
Stock-Based Compensation - Serv
Stock-Based Compensation - Service Based Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Weighted Average Grant-Date Fair Value | ||
Stock based compensation expenses | $ (179) | $ (236) |
Restricted stock units - service based awards | ||
Number of Shares | ||
Unvested at beginning of period (in shares) | 29,289 | 24,136 |
Granted (in shares) | 914 | |
Vested (in shares) | (1,042) | |
Forfeited (in shares) | (1,223) | (2,396) |
Unvested at end of period (in shares) | 28,066 | 21,612 |
Weighted Average Grant-Date Fair Value | ||
Unvested at beginning of period (in dollars per share) | $ 12.87 | $ 28.60 |
Granted (in dollars per share) | 22.99 | |
Vested (in dollars per share) | 52.91 | |
Forfeited (in dollars per share) | 52.91 | 27.50 |
Unvested at end of period (in dollars per share) | $ 11.11 | $ 27.39 |
Stock based compensation expenses | $ 12 | $ 104 |
Unrecognized stock-based compensation expense | $ 100 | |
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 |
Stock-Based Compensation - Se_2
Stock-Based Compensation - Service Based Stock Options - Fair Value Assumptions (Details) - Stock option awards - service based awards | 3 Months Ended |
Mar. 31, 2022$ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price (in dollars per share) | $ 4.12 |
Expected stock price volatility | 76.20% |
Risk-free interest rate | 1.98% |
Term (years) | 6 years 6 months |
Stock-Based Compensation - Se_3
Stock-Based Compensation - Service Based Stock Options (Details) - Stock option awards - service based awards - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Mar. 31, 2022 | Mar. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Shares Underlying Options | ||||||
Outstanding at the beginning of the period (in shares) | 528,591 | 519,814 | 519,814 | |||
Granted (in shares) | 909 | 7,672 | ||||
Forfeited (in shares) | (14,839) | (16,721) | ||||
Expired (in shares) | (3,545) | (20,530) | ||||
Outstanding at the end of the period (in shares) | 511,116 | 490,235 | ||||
Exercisable at end of period (in shares) | 236,720 | 251,180 | ||||
Weighted Average Exercise Price | ||||||
Outstanding at the beginning of the period (in dollars per share) | $ 32.01 | $ 50.05 | $ 50.05 | |||
Granted (in dollars per share) | 4.07 | 17.60 | ||||
Forfeited (in dollars per share) | 17.49 | 27.39 | ||||
Expired (in dollar per share) | 85.36 | 84.26 | ||||
Outstanding at the end of the period (in dollars per share) | 32.01 | 48.95 | ||||
Exercisable at end of the period (in dollars per share) | $ 52.14 | $ 73.48 | ||||
Weighted Average Remaining Contractual Term | ||||||
Outstanding | 7 years | 6 years 1 month 6 days | 7 years 6 months | 6 years 7 months 6 days | ||
Granted | 9 years 10 months 24 days | 6 years | ||||
Exercisable at end of the period | 5 years | 3 years 2 months 12 days | ||||
Aggregate Intrinsic Value | ||||||
Outstanding | $ 1 | $ 0 | $ 0 | $ 0 | ||
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 | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock based compensation expenses | $ (179) | $ (236) |
Stock option awards - service based awards | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted (in shares) | 909 | 7,672 |
Forfeited (in shares) | 14,839 | 16,721 |
Expirations (in shares) | 3,545 | 20,530 |
Stock based compensation expenses | $ 200 | $ 391 |
Unrecognized stock-based compensation expenses | $ 1,000 | |
Unrecognized stock-based compensation expense, weighted average remaining term (in years) | 3 years 1 month 6 days |
Licensing Agreements (Details)
Licensing Agreements (Details) | Oct. 07, 2018agreement | Mar. 31, 2022USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Number of additional agreements | agreement | 3 | |
Master Services And Ip Agreement | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Collaborative arrangement, accrued reimbursement of IP expenses and sublicense royalty fees | $ 86,400 | |
Milestone payments | $ 0 |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Thousands | Mar. 31, 2022USD ($)ft² | Dec. 31, 2021USD ($) |
Lessee, Lease, Description [Line Items] | ||
Operating lease and finance lease liabilities | $ | $ 7,400 | |
Operating lease and finance lease, right of use assets, net | $ | 7,200 | $ 7,737 |
Operating lease liabilities | $ | $ 4,410 | 7,900 |
Operating lease, right of use assets | $ | $ 7,700 | |
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 | 7 years |
Leases - Summary of Lease Costs
Leases - Summary of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating leases | ||
Operating lease cost | $ 449 | $ 419 |
Variable lease cost | 95 | 102 |
Operating lease expense | 544 | 521 |
Finance leases | ||
Amortization of right-of-use assets | 141 | 45 |
Interest on lease obligations | 47 | 13 |
Finance lease expense | 188 | 58 |
Short-term lease rent expense | 4 | 4 |
Total rent expense | 736 | 583 |
Other information | ||
Operating cash flows from operating leases | 464 | 425 |
Operating cash flows from finance leases | 47 | 13 |
Financing cash flows from finance leases | 118 | 37 |
Right of use assets exchanged for operating lease liabilities | 0 | 1,896 |
Right of use assets exchanged for finance lease liabilities | $ 0 | $ 460 |
Weighted-average remaining lease term – operating leases | 3 years 4 months 24 days | 3 years 7 months 6 days |
Weighted-average remaining lease term – finance leases | 5 years 2 months 12 days | 5 years 4 months 24 days |
Weighted-average discount rate – operating leases | 6.30% | 6.30% |
Weighted-average discount rate – finance leases | 6.40% | 5.40% |
Leases - Finance Lease and Oper
Leases - Finance Lease and Operating Lease Maturities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Operating | ||
Year ending December 31, 2022 (remaining) | $ 1,307 | |
Year ending December 31, 2023 | 1,456 | |
Year ending December 31, 2024 | 1,114 | |
Year ending December 31, 2025 | 637 | |
Year ending December 31, 2026 | 260 | |
Remaining future payments | 121 | |
Total | 4,895 | |
Less present value discount | (485) | |
Operating lease liabilities | 4,410 | $ 7,900 |
Finance | ||
Year ending December 31, 2022 (remaining) | 495 | |
Year ending December 31, 2023 | 669 | |
Year ending December 31, 2024 | 672 | |
Year ending December 31, 2025 | 676 | |
Year ending December 31, 2026 | 666 | |
Remaining future payments | 311 | |
Total | 3,489 | |
Less present value discount | (516) | |
Finance lease liabilities | $ 2,973 |
Loans and Security Agreement -
Loans and Security Agreement - Narrative (Details) - Term loan | Sep. 24, 2021USD ($)installment | Mar. 16, 2020USD ($)$ / sharesshares | Mar. 31, 2022USD ($) | Mar. 31, 2021USD ($) | Mar. 31, 2020USD ($) |
Term loan | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | $ 7,500,000 | $ 35,000,000 | |||
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 | ||||
Interest rate, base percentage | 4.75% | ||||
Interest rate, additional percentage added to base percentage | 4.00% | ||||
Initial interest rate percentage | 8.75% | ||||
Effective interest rate | 10.90% | ||||
Option to add interest rate amount to outstanding principal balance in lieu of paying such amount in cash, percentage | 1.00% | ||||
Interest expense | $ 400,000 | $ 600,000 | |||
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 | 18,400,000 | ||||
Unamortized issuance costs and unaccreted discount | $ 1,100,000 | ||||
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 | $ 18.15 | ||||
Number of shares of common stock for which warrant is exercisable (in shares) | shares | 43,388 | ||||
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 | $ 18.15 | ||||
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 | Mar. 31, 2022USD ($) |
Debt Instrument [Line Items] | |
2022 | $ 5,500 |
2023 | 6,000 |
2024 | 6,000 |
2025 | 2,000 |
Principal Payments | $ 19,500 |
Insurance Financing Note Paya_2
Insurance Financing Note Payable (Details) - 3.925% Note Payable - Notes Payable to Banks $ in Millions | Jul. 03, 2021USD ($) |
Short-term Debt [Line Items] | |
Short-term note payable | $ 2 |
Interest rate, base percentage | 3.93% |
Amortization period (in months) | 9 months |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent event | May 09, 2022 | Apr. 08, 2022USD ($) | Jun. 30, 2022USD ($) | Apr. 06, 2022USD ($)customer |
Subsequent Event [Line Items] | ||||
Largest customers | customer | 2 | |||
Additional capital earned | $ 15,000,000 | $ 15,000,000 | ||
Reverse stock split | 0.09 | |||
Minimum | ||||
Subsequent Event [Line Items] | ||||
Reverse stock split | 0.50 | |||
Maximum | ||||
Subsequent Event [Line Items] | ||||
Reverse stock split | 0.07 | |||
Cantor Fitzgerald & Co | ||||
Subsequent Event [Line Items] | ||||
Sales agreement, threshold sale of shares | $ 12,200,000 |