Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 05, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
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 $0.0001 | |
Trading Symbol | RMTI | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding (in shares) | 31,030,218 | |
Entity Central Index Key | 0001041024 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 |
UNAUDITED CONDENSED CONSOLIDATE
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
ASSETS | ||
Cash and Cash Equivalents | $ 11,863 | $ 8,983 |
Investments Available-for-Sale | 0 | 1,952 |
Accounts Receivable, net | 10,840 | 10,901 |
Inventory, net | 5,883 | 5,871 |
Prepaid and Other Current Assets | 1,167 | 1,063 |
Total Current Assets | 29,753 | 28,770 |
Property and Equipment, net | 6,009 | 6,402 |
Inventory, Non-Current | 178 | 178 |
Right of Use Assets - Operating, net | 3,515 | 2,713 |
Right of Use Assets - Financing, net | 1,621 | 1,903 |
Intangible Assets, net | 10,483 | 10,759 |
Goodwill | 921 | 921 |
Other Non-Current Assets | 548 | 527 |
Total Assets | 53,028 | 52,173 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
Accounts Payable | 3,347 | 4,516 |
Accrued Liabilities | 6,168 | 7,149 |
Deferred Consideration - Current | 2,500 | 2,500 |
Lease Liabilities - Operating - Current | 1,458 | 1,381 |
Lease Liabilities - Financing - Current | 576 | 558 |
Deferred License Revenue - Current | 46 | 46 |
Insurance Financing Note Payable | 670 | 244 |
Customer Deposits | 126 | 243 |
Total Current Liabilities | 14,891 | 16,637 |
Lease Liabilities-Operating - Long-Term | 2,142 | 1,433 |
Lease Liabilities-Financing - Long-Term | 1,236 | 1,530 |
Term Loan - Long-Term, net of issuance costs | 8,295 | 8,293 |
Deferred License Revenue - Long-Term | 452 | 475 |
Deferred Consideration - Long-Term | 2,500 | 2,500 |
Long Term Liability - Other | 14 | 14 |
Total Liabilities | 29,530 | 30,882 |
Stockholders’ Equity: | ||
Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; 15,000 shares issued and outstanding at June 30, 2024 and December 31, 2023 | 0 | 0 |
Common Stock, $0.0001 par value; 170,000,000 shares authorized; 31,030,218 and 29,130,607 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 3 | 3 |
Additional Paid-in Capital | 422,086 | 418,487 |
Accumulated Deficit | (398,586) | (397,198) |
Accumulated Other Comprehensive Loss | (5) | (1) |
Total Stockholders’ Equity | 23,498 | 21,291 |
Total Liabilities and Stockholders’ Equity | $ 53,028 | $ 52,173 |
UNAUDITED CONDENSED CONSOLIDA_2
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 | Jun. 30, 2023 |
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) | 15,000 | 15,000 | |
Preferred shares, shares outstanding (in shares) | 15,000 | 15,000 | |
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) | 31,030,218 | 29,130,607 | |
Common shares, shares outstanding (in shares) | 31,030,218 | 29,130,607 | 16,795,673 |
UNAUDITED CONDENSED CONSOLIDA_3
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income Statement [Abstract] | ||||
Net Sales | $ 25,832 | $ 18,080 | $ 48,508 | $ 37,748 |
Cost of Sales | 21,282 | 17,047 | 40,894 | 34,116 |
Gross Profit | 4,550 | 1,033 | 7,614 | 3,632 |
Research and Product Development | 0 | 167 | 18 | 445 |
Selling and Marketing | 586 | 530 | 1,180 | 1,028 |
General and Administrative | 3,449 | 3,295 | 7,225 | 6,545 |
Operating Income (Loss) | 515 | (2,959) | (809) | (4,386) |
Other Expense: | ||||
Realized gain on Available-for-Sale Investments | 51 | 0 | 51 | 0 |
Interest Expense | (232) | (395) | (663) | (782) |
Interest Income | 9 | 49 | 33 | 113 |
Total Other Expense, net | (172) | (346) | (579) | (669) |
Net Income (Loss) | $ 343 | $ (3,305) | $ (1,388) | $ (5,055) |
Basic Net Income (Loss) per Share (in dollars per share) | $ 0.01 | $ (0.18) | $ (0.05) | $ (0.27) |
Diluted Net Income (Loss) per Share (in dollars per share) | $ 0.01 | $ (0.18) | $ (0.05) | $ (0.27) |
Basic Weighted Average Shares Outstanding (in shares) | 30,451,622 | 18,496,640 | 29,889,413 | 18,480,248 |
Diluted Weighted Average Shares Outstanding (in shares) | 32,033,776 | 18,496,640 | 29,889,413 | 18,480,248 |
UNAUDITED CONDENSED CONSOLIDA_4
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Statement of Comprehensive Income [Abstract] | ||||
Net Income (Loss) | $ 343 | $ (3,305) | $ (1,388) | $ (5,055) |
Reclassification of Realized Gain on Available-for-Sale Investments Included in Net Income | (25) | 0 | (25) | 0 |
Unrealized (Loss) Gain on Available-for-Sale Investments | 0 | (18) | 25 | (21) |
Foreign Currency Translation Adjustments | (4) | (1) | (4) | (4) |
Comprehensive Income (Loss) | $ 314 | $ (3,324) | $ (1,392) | $ (5,080) |
UNAUDITED CONDENSED CONSOLIDA_5
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | At-the-Market Offering | Public Offering | PREFERRED STOCK | COMMON STOCK | COMMON STOCK Pre-funded Warrants | COMMON STOCK At-the-Market Offering | COMMON STOCK Public Offering | ADDITIONAL PAID-IN CAPITAL | ADDITIONAL PAID-IN CAPITAL At-the-Market Offering | ACCUMULATED DEFICIT | ACCUMULATED OTHER COMPREHENSIVE (LOSS) INCOME |
Beginning balance (in shares) at Dec. 31, 2022 | 15,000 | |||||||||||
Beginning balance at Dec. 31, 2022 | $ 0 | |||||||||||
Beginning balance (in shares) at Dec. 31, 2022 | 12,163,673 | |||||||||||
Beginning balance at Dec. 31, 2022 | $ 14,106 | $ 1 | $ 402,701 | $ (388,759) | $ 163 | |||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||
Net Income (Loss) | (1,750) | (1,750) | ||||||||||
Unrealized (Loss) Gain on Available-for-Sale Investments | (3) | (3) | ||||||||||
Foreign Currency Translation Adjustments | (4) | (4) | ||||||||||
Issuance of Common Stock upon exercise of Pre-Funded Warrants (in shares) | 389,000 | |||||||||||
Stock-based Compensation | 193 | 193 | ||||||||||
Ending balance (in shares) at Mar. 31, 2023 | 15,000 | |||||||||||
Ending balance at Mar. 31, 2023 | $ 0 | |||||||||||
Ending balance (in shares) at Mar. 31, 2023 | 12,552,673 | |||||||||||
Ending balance at Mar. 31, 2023 | 12,542 | $ 1 | 402,894 | (390,509) | 156 | |||||||
Beginning balance (in shares) at Dec. 31, 2022 | 15,000 | |||||||||||
Beginning balance at Dec. 31, 2022 | $ 0 | |||||||||||
Beginning balance (in shares) at Dec. 31, 2022 | 12,163,673 | |||||||||||
Beginning balance at Dec. 31, 2022 | 14,106 | $ 1 | 402,701 | (388,759) | 163 | |||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||
Net Income (Loss) | (5,055) | |||||||||||
Reclassification of Realized Gains on Available-for-Sale Debt Instrument Investments Included in Net Income | 0 | |||||||||||
Foreign Currency Translation Adjustments | $ (4) | |||||||||||
Ending balance (in shares) at Jun. 30, 2023 | 15,000 | |||||||||||
Ending balance at Jun. 30, 2023 | $ 0 | |||||||||||
Ending balance (in shares) at Jun. 30, 2023 | 16,795,673 | 16,795,673 | ||||||||||
Ending balance at Jun. 30, 2023 | $ 9,528 | $ 2 | 403,203 | (393,814) | 137 | |||||||
Beginning balance (in shares) at Mar. 31, 2023 | 15,000 | |||||||||||
Beginning balance at Mar. 31, 2023 | $ 0 | |||||||||||
Beginning balance (in shares) at Mar. 31, 2023 | 12,552,673 | |||||||||||
Beginning balance at Mar. 31, 2023 | 12,542 | $ 1 | 402,894 | (390,509) | 156 | |||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||
Net Income (Loss) | (3,305) | (3,305) | ||||||||||
Unrealized (Loss) Gain on Available-for-Sale Investments | (18) | (18) | ||||||||||
Reclassification of Realized Gains on Available-for-Sale Debt Instrument Investments Included in Net Income | 0 | |||||||||||
Foreign Currency Translation Adjustments | (1) | (1) | ||||||||||
Issuance of Stock, net of offering costs/At-The-Market (in shares) | 4,118,000 | |||||||||||
Issuance of Common Stock, net of offering costs/At-The-Market | $ 1 | $ 1 | ||||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares) | 125,000 | |||||||||||
Stock-based Compensation | $ 309 | 309 | ||||||||||
Ending balance (in shares) at Jun. 30, 2023 | 15,000 | |||||||||||
Ending balance at Jun. 30, 2023 | $ 0 | |||||||||||
Ending balance (in shares) at Jun. 30, 2023 | 16,795,673 | 16,795,673 | ||||||||||
Ending balance at Jun. 30, 2023 | $ 9,528 | $ 2 | 403,203 | (393,814) | 137 | |||||||
Beginning balance (in shares) at Dec. 31, 2023 | 15,000 | 15,000 | ||||||||||
Beginning balance at Dec. 31, 2023 | $ 0 | $ 0 | ||||||||||
Beginning balance (in shares) at Dec. 31, 2023 | 29,130,607 | 29,130,607 | ||||||||||
Beginning balance at Dec. 31, 2023 | $ 21,291 | $ 3 | 418,487 | (397,198) | (1) | |||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||
Net Income (Loss) | (1,731) | (1,731) | ||||||||||
Unrealized (Loss) Gain on Available-for-Sale Investments | 25 | 25 | ||||||||||
Issuance of Stock, net of offering costs/At-The-Market (in shares) | 358,210 | |||||||||||
Issuance of Common Stock, net of offering costs/At-The-Market | $ 560 | $ 560 | ||||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares) | 67,657 | |||||||||||
Issuance of Warrant in connection with the Third Amendment (Note 11) | 247 | 247 | ||||||||||
Stock-based Compensation | 251 | 251 | ||||||||||
Ending balance (in shares) at Mar. 31, 2024 | 15,000 | |||||||||||
Ending balance at Mar. 31, 2024 | $ 0 | |||||||||||
Ending balance (in shares) at Mar. 31, 2024 | 29,556,474 | |||||||||||
Ending balance at Mar. 31, 2024 | $ 20,643 | $ 3 | 419,545 | (398,929) | 24 | |||||||
Beginning balance (in shares) at Dec. 31, 2023 | 15,000 | 15,000 | ||||||||||
Beginning balance at Dec. 31, 2023 | $ 0 | $ 0 | ||||||||||
Beginning balance (in shares) at Dec. 31, 2023 | 29,130,607 | 29,130,607 | ||||||||||
Beginning balance at Dec. 31, 2023 | $ 21,291 | $ 3 | 418,487 | (397,198) | (1) | |||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||
Net Income (Loss) | (1,388) | |||||||||||
Reclassification of Realized Gains on Available-for-Sale Debt Instrument Investments Included in Net Income | (25) | |||||||||||
Foreign Currency Translation Adjustments | $ (4) | |||||||||||
Issuance of Stock, net of offering costs/At-The-Market (in shares) | 1,708,379 | |||||||||||
Ending balance (in shares) at Jun. 30, 2024 | 15,000 | 15,000 | ||||||||||
Ending balance at Jun. 30, 2024 | $ 0 | $ 0 | ||||||||||
Ending balance (in shares) at Jun. 30, 2024 | 31,030,218 | 31,030,218 | ||||||||||
Ending balance at Jun. 30, 2024 | $ 23,498 | $ 3 | 422,086 | (398,586) | (5) | |||||||
Beginning balance (in shares) at Mar. 31, 2024 | 15,000 | |||||||||||
Beginning balance at Mar. 31, 2024 | $ 0 | |||||||||||
Beginning balance (in shares) at Mar. 31, 2024 | 29,556,474 | |||||||||||
Beginning balance at Mar. 31, 2024 | 20,643 | $ 3 | 419,545 | (398,929) | 24 | |||||||
Increase (Decrease) in Shareholders' Equity | ||||||||||||
Net Income (Loss) | 343 | 343 | ||||||||||
Reclassification of Realized Gains on Available-for-Sale Debt Instrument Investments Included in Net Income | (25) | (25) | ||||||||||
Foreign Currency Translation Adjustments | (4) | (4) | ||||||||||
Issuance of Stock, net of offering costs/At-The-Market (in shares) | 1,350,169 | |||||||||||
Issuance of Common Stock, net of offering costs/At-The-Market | $ 2,203 | $ 2,203 | ||||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares) | 123,575 | |||||||||||
Stock-based Compensation | $ 338 | 338 | ||||||||||
Ending balance (in shares) at Jun. 30, 2024 | 15,000 | 15,000 | ||||||||||
Ending balance at Jun. 30, 2024 | $ 0 | $ 0 | ||||||||||
Ending balance (in shares) at Jun. 30, 2024 | 31,030,218 | 31,030,218 | ||||||||||
Ending balance at Jun. 30, 2024 | $ 23,498 | $ 3 | $ 422,086 | $ (398,586) | $ (5) |
UNAUDITED CONDENSED CONSOLIDA_6
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash Flows From Operating Activities: | ||
Net Loss | $ (1,388) | $ (5,055) |
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities: | ||
Depreciation and Amortization | 1,094 | 330 |
Stock-based Compensation | 589 | 502 |
Non-cash Lease Expense from Right of Use Assets | 941 | 1,017 |
Amortization of Debt Financing Costs and Accretion of Debt Discount and Premium | 249 | 184 |
Realized Gain on Sale of Investments | (51) | 0 |
Changes in Operating Assets and Liabilities: | ||
Accounts Receivable, net | 61 | 848 |
Inventory | (12) | 0 |
Prepaid and Other Assets | 545 | 998 |
Accounts Payable | (1,169) | 1,874 |
Lease Liabilities | (676) | (744) |
Accrued and Other Liabilities | (1,098) | (3,968) |
Deferred License Revenue | (23) | (1,602) |
Net Cash Used In Operating Activities | (938) | (5,616) |
Cash Flows From Investing Activities: | ||
Purchase of Investments Available-for-Sale | 0 | (3,835) |
Sale of Investments Available-for-Sale | 2,003 | 9,298 |
Purchase of Equipment | (425) | (225) |
Net Cash Provided by Investing Activities | 1,578 | 5,238 |
Cash Flows From Financing Activities: | ||
Payments on Insurance Financing Note Payable | (244) | (503) |
Payments on Financing Lease Liabilities | (276) | (258) |
Proceeds from Issuance of Common Stock | 2,763 | 0 |
Net Cash Provided by (Used In) Financing Activities | 2,243 | (761) |
Effect of Exchange Rate Changes on Cash and Cash Equivalents | (3) | (4) |
Net Increase (Decrease) in Cash and Cash Equivalents | 2,880 | (1,143) |
Cash and Cash Equivalents at Beginning of Period | 8,983 | 10,102 |
Cash and Cash Equivalents at End of Period | 11,863 | 8,959 |
Supplemental Disclosure of Cash Flow Information: | ||
Cash Paid for Interest | 432 | 295 |
Supplemental Disclosure of Non-cash Investing and Financing Activities: | ||
Issuance of Warrant in connection with the Third Amendment as Debt Issuance Costs | 247 | 0 |
Right of Use Assets - Operating obtained in exchange for Lease Liabilities - Operating | 1,549 | 0 |
Change in Unrealized Gain (Loss) on Investments Available-for-Sale | 0 | (21) |
Increase in Prepaid Assets from Insurance Financing Note Payable | $ 670 | $ 733 |
Description of Business
Description of Business | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business Rockwell Medical, Inc. (the "Company", "Rockwell", "we", or "us") is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide. Rockwell is the largest supplier of liquid bicarbonate concentrates and the second largest supplier of acid and dry bicarbonate concentrates for dialysis patients in the United States. Hemodialysis is the most common form of end-stage kidney disease treatment and is usually performed at freestanding outpatient dialysis centers, at hospital-based outpatient centers, at skilled nursing facilities, or in a patient’s home. Rockwell manufactures hemodialysis concentrates at its facilities in Michigan, South Carolina, and Texas totaling approximately 175,000 square feet, and manufactures its dry acid concentrate mixers at its facility in Iowa. Additionally, in July 2023, the Company purchased customer relationships, equipment and inventory from Evoqua Water Technologies related to the manufacturing and sale of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization in Minnesota. Rockwell delivers the majority of its hemodialysis concentrates products and mixers to dialysis clinics throughout the United States and internationally utilizing its own delivery trucks and third-party carriers. The Company operates in a single segment. Rockwell was incorporated in the state of Michigan in 1996 and re-domiciled to the state of Delaware in 2019. Rockwell's headquarters is located at 30142 Wixom Road, Wixom, Michigan 48393. |
Liquidity and Capital Resources
Liquidity and Capital Resources | 6 Months Ended |
Jun. 30, 2024 | |
Liquidity and Capital Resources [Abstract] | |
Liquidity and Capital Resources | Liquidity and Capital Resources As of June 30, 2024, Rockwell had approximately $11.9 million of cash and cash equivalents, and working capital of $14.9 million. Net cash used in operating activities for the six months ended June 30, 2024 was approximately $0.9 million. Based on the currently available working capital along with the expectation of management of its ability to execute on its operational plans as discussed below, management believes the Company currently has sufficient funds to meet its operating requirements for at least the next twelve months from the date of the filing of this report. The Company continues to review its operational plans and execute on the acquisition of new customers, and has implemented cost containment activities. The Company may require additional capital to sustain its operations and make the investments it needs to execute its strategic plan. Additionally, the Company's operational plans include raising capital, if needed, by using the remaining $8.2 million available under its at-the-market ("ATM") facility or other methods or forms of financings, subject to existing limitations. If the Company attempts to obtain additional debt or equity financing, the Company cannot assume such financing will be available on favorable terms, if at all. The Company is subject to certain covenants and cure provisions under its Loan Agreement with Innovatus, which, on January 2, 2024, was amended to include, among other things, an interest-only period for 30 months, or up to 36 months if certain conditions are met, and to extend the maturity date to January 1, 2029 (See Note 15 for further detail). As of June 30, 2024, the Company is in compliance with all covenants. In addition, the global macroeconomic environment is uncertain, and could be negatively affected by, among other things, increased U.S. trade tariffs and trade disputes with other countries, instability in the global capital and credit markets, recent bank failures in the United States, supply chain weaknesses, and instability in the geopolitical environment, including as a result of the Russian invasion of Ukraine, the Israel-Hamas conflict and other political tensions, and the occurrence of natural disasters and public health crises. Such challenges have caused, and may continue to cause, recession fears, rising interest rates, foreign exchange volatility and inflationary pressures. At this time, the Company is unable to quantify the potential effects of this economic instability on our future operations. 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 or 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 | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements | Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements The accompanying condensed consolidated financial statements have been prepared in accordance with 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 June 30, 2024, and the condensed consolidated statements of operations, comprehensive income (loss), and changes in stockholders' equity, and cash flows for the three and six months ended June 30, 2024 and 2023 are unaudited, but include all adjustments, consisting of normal recurring adjustments the Company considers necessary for a fair presentation of the financial position, operating results, and cash flows for the periods presented. The results for the three and six months ended June 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024 or for any future interim period. The condensed consolidated balance sheet at December 31, 2023 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, 2023 and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 as filed with the SEC on March 21, 2024. The Company’s consolidated subsidiaries consist of its wholly-owned subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited. The accompanying condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Income (Loss) Per Share Basic and diluted net income (loss) per share for the three and six months ended June 30, 2024 and 2023 was calculated as follows: Three Months Ended Six Months Ended (In thousands, except share and per share amounts) 2024 2023 2024 2023 Numerator: Net Income (Loss) $ 343 $ (3,305) $ (1,388) $ (5,055) Less: Undistributed Earnings to Participating Securities (58) — — — Net Income (Loss) Attributable to Common Stockholders $ 285 $ (3,305) $ (1,388) $ (5,055) Denominator: Weighted Average Number of Shares of Common Stock Outstanding - Basic 30,451,622 18,496,640 29,889,413 18,480,248 Incremental Shares Attributable to the Assumed Exercise of Outstanding Options to Purchase Common Stock 35,185 — — — Incremental Shares Attributable to the Assumed Vesting of Unvested Restricted Stock Units 183,333 — — — Incremental Shares Attributable to the Assumed Conversion of Preferred Stock 1,363,636 — — — Weighted Average Number of Shares of Common Stock Outstanding - Diluted 32,033,776 18,496,640 29,889,413 18,480,248 Net Loss per Share Attributable to Common Stockholders - Basic $ 0.01 $ (0.18) $ (0.05) $ (0.27) Net Loss per Share Attributable to Common Stockholders - Diluted $ 0.01 $ (0.18) $ (0.05) $ (0.27) Income (loss) per share (“EPS”) is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period, excluding the effects of any potentially dilutive securities. Diluted EPS gives effect to the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock, using the more dilutive of the two- class method and the if-converted method in the period of earnings. The two class method is an earnings allocation method that determines income (loss) per share (when there are earnings) for common stock and participating securities. The if-converted method assumes all convertible securities are converted into common stock. Diluted EPS excludes all dilutive potential shares of common stock if their effect is anti-dilutive. Included within the weighted average shares of common stock outstanding for the three and six months ended June 30, 2023 are 1,793,000 shares of common stock issuable upon the exercise of certain pre-funded warrants, as the warrants were exercisable at any time for nominal consideration and, as such, the shares were considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders. There were no unexercised pre-funded warrants during each of the three and six months ended June 30, 2024. The Company’s potentially dilutive securities include stock options, restricted stock awards and units, convertible preferred stock and warrants. The following table includes the potential shares of common stock, presented based on amounts outstanding at each period end, that were excluded from the computation of diluted net income (loss) per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Three Months Ended Six Months Ended 2024 2023 2024 2023 Warrants to Purchase Common Stock 3,984,484 10,196,268 3,984,484 10,196,268 Options to Purchase Common Stock 342,331 1,570,599 1,895,031 1,570,599 Convertible Preferred Stock — 1,363,636 1,363,636 1,363,636 Unvested Restricted Stock Units — 313,065 534,309 313,065 Unvested Restricted Stock Awards 891 891 891 891 Total 4,327,706 13,444,459 7,778,351 13,444,459 Adoption of Recent Accounting Pronouncements The Company continually assesses new accounting pronouncements to determine their applicability. When it is determined a new accounting pronouncement affects the Company’s financial reporting, the Company undertakes a review to determine the consequences of the change to its consolidated financial statements and assures there are sufficient controls in place to ascertain the Company’s consolidated financial statements properly reflect the change. In November 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2023-07, Segment Reporting - Improvements to Reportable Segment Disclosures , which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. The amendments in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is in the process of determining the effect this ASU will have on the disclosures contained in the notes to the consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures , which updates income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This ASU also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in this ASU are effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is in the process of determining the effect this ASU will have on the disclosures contained in the notes to the consolidated financial statements. |
Asset Acquisition
Asset Acquisition | 6 Months Ended |
Jun. 30, 2024 | |
Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract] | |
Asset Acquisition | Asset Acquisition On July 10, 2023, the Company executed and consummated the transactions contemplated by an Asset Purchase Agreement (the “Purchase Agreement”) with Evoqua Water Technologies LLC ("Evoqua") (the "Evoqua Acquisition"). Subject to the terms and conditions of the Purchase Agreement, at the closing of the transaction (the “Closing”), the Company purchased customer relationships, equipment and inventory from Evoqua, which were related to its manufacturing and selling of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization. Pursuant to the Purchase Agreement, total consideration was $17.4 million, comprising a cash payment at Closing of $12.4 million (inclusive of transaction costs) and two $2.5 million deferred payments. On July 12, 2024, the Company and Evoqua executed an amendment to the Purchase Agreement (the "First Amendment"), which stipulated that the first deferred payment would be partially offset by $0.3 million to reimburse the Company for certain expenses incurred following the close of the Evoqua Acquisition and split the first deferred payment into four quarterly installments to be paid through April 2025. The First Amendment also split the second deferred payment into four quarterly installments to be paid from July 2025 through April 2026. The first deferred payment is included as Deferred Consideration - Current the Company's condensed consolidated balance sheets. The transaction was accounted for as an asset acquisition, as the acquired assets did not meet the definition of a business as defined by Accounting Standards Codification ("ASC") 805, Business Combinations . The purchase price was allocated, on a relative fair value basis, to the assets acquired at the July 10, 2023 acquisition date as follows (table in thousands): Consideration Cash Payment $ 12,233 Deferred Consideration 5,000 Transaction Costs 128 Total Consideration $ 17,361 Assets Acquired Customer Relationships Intangible Asset $ 11,035 Equipment 5,093 Inventory 1,233 Total Assets Acquired $ 17,361 The fair value of the customer relationships intangible asset was determined using a multi-period excess earnings method, a form of the income approach, which incorporates the estimated future cash flows to be generated from the customer base. Key assumptions included discounted cash flow, estimated life cycle and customer attrition rates. Customer relationships are being amortized over a period of 20 years. Given that the acquired equipment had been recently purchased and recorded at fair value, the Company determined the fair value of the equipment using a cost approach, which considered assumptions over the equipment's current replacement cost and useful life. Inventory was purchased directly from the contract manufacturer holding the inventory, which approximated fair value. During the three and six months ended June 30, 2024, the Company recorded amortization of its customer relationship intangible asset of $0.1 million and $0.3 million, respectively, resulting in a net intangible asset of $10.5 million as of June 30, 2024. Estimated future amortization expense on the Company's customer relationships intangible asset as of June 30, 2024 is as follows (table in thousands): Year ended December 31: 2024 (remainder of year) $ 276 2025 552 2026 552 2027 552 2028 552 Thereafter 7,999 Total $ 10,483 |
Revenue Recognition
Revenue Recognition | 6 Months Ended |
Jun. 30, 2024 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | Revenue Recognition The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers , issued by the FASB . The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: • Step 1: Identify the contract with the customer • Step 2: Identify the performance obligations in the contract • Step 3: Determine the transaction price • Step 4: Allocate the transaction price to the performance obligations in the contract • Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by Rockwell 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 Rockwell operates in one market segment, the hemodialysis market, which involves the manufacture, sale and distribution of hemodialysis products to hemodialysis clinics, including pharmaceutical, dialysis concentrates, dialysis kits and other ancillary products used in the dialysis process. Rockwell's customer mix is diverse, with most customer sales concentrations under 10% and one customer, DaVita, Inc. ("DaVita"), at approximately 44% and 50% of total net product sales for the six months ended June 30, 2024 and 2023, respectively, and 45% and 51% of total net product sales for the three months ended June 30, 2024 and 2023, respectively. Rockwell's accounts receivable from this customer were approximately 35% of the total net consolidated accounts receivable balance at each of June 30, 2024 and December 31, 2023. See below and Note 10 for additional information regarding the Company's contracts with DaVita. 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. 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 estimated at the time of sale. Customers typically pay for the product based on customary business practices with payment terms averaging 30 days, while a small subset of customers have payment terms averaging 60 days. Deferred License Revenue The Company received upfront fees under five distribution and license agreements that have been deferred as a contract liability and presented on the accompanying condensed consolidated balance sheets as deferred license revenue. 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”) were deferred and recognized as revenue at the point in time the estimated product sales under the agreement occurred. During the three months ended June 30, 2023, all remaining deferred revenue relating to the Baxter agreement was recognized as revenue. For additional information related to the Company's deferred license revenue, see Note 10. Product Purchase Agreements On September 18, 2023, the Company and its long-time partner, DaVita, Inc. ("DaVita"), a leading provider of kidney care, entered into an Amended and Restated Products Purchase Agreement (the "Amended Agreement"), which amends and restates the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates. Under the Amended Agreement, the Company and DaVita agreed to an increase in product pricing, effective September 1, 2023 and a one-time payment of $0.4 million to Rockwell on or after December 1, 2023, which was recorded as revenue recognized during the fourth quarter of 2023. The term of the Amended Agreement will expire on December 31, 2024. DaVita will have the right, in its sole discretion upon written notice to the Company given no later than September 30, 2024, to further extend the term through December 31, 2025. In the event of such an extension, product pricing will be increased for the extended term. In addition, DaVita is required to provide the Company with nine-month purchasing forecasts and a commitment to purchase at least the forecasted amounts. In the event that DaVita does not meet its forecasts, it is required to pay the Company for the amount forecasted or purchase additional product; otherwise, the Company may terminate the Amended Agreement. Upon expiration or termination of the Amended Agreement, and upon request by DaVita, the Company has agreed it would provide transition services to DaVita during a transition period. Disaggregation of revenue Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition. In thousands Three Months Ended June 30, 2024 Six Months Ended June 30, 2024 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues License Fee – Over time $ 12 $ — $ 12 $ 23 $ — $ 23 Total Drug Products 12 — 12 23 — 23 Concentrate Products Product Sales – Point-in-time 25,820 23,209 2,611 48,485 44,143 4,342 Total Concentrate Products 25,820 23,209 2,611 48,485 44,143 4,342 Net Revenue $ 25,832 $ 23,209 $ 2,623 $ 48,508 $ 44,143 $ 4,365 In thousands Three Months Ended June 30, 2023 Six Months Ended June 30, 2023 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues License Fee – Over time $ 65 $ — $ 65 $ 130 $ 130 Total Drug Products 65 — 65 130 — 130 Concentrate Products Product Sales – Point-in-time 18,015 16,125 1,890 36,146 32,585 3,561 License Fee – Over time — — — 1,472 1,472 — Total Concentrate Products 18,015 16,125 1,890 37,618 34,057 3,561 Net Revenue $ 18,080 $ 16,125 $ 1,955 $ 37,748 $ 34,057 $ 3,691 Contract balances The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands June 30, 2024 December 31, 2023 January 1, 2023 Accounts Receivable, net $ 10,840 $ 10,901 $ 6,259 Contract Liabilities, which are included in deferred license revenue $ 498 $ 521 $ 4,331 There were no other material contract assets recorded on the condensed consolidated balance sheets as of June 30, 2024 and December 31, 2023. The Company does not generally accept returns of its concentrate products and no material reserve for returns of concentrates products was established as of June 30, 2024 or December 31, 2023. The contract liabilities primarily relate to upfront fees under distribution and license agreements with Wanbang, Sun Pharma, Jeil Pharma, and Drogsan Pharma. Transaction price allocated to remaining performance obligations For the six months ended June 30, 2024 and 2023, the Company recognized an immaterial amount and $1.6 million as revenue from amounts classified as contract liabilities (i.e., deferred license revenue) as of December 31, 2023 and 2022, respectively. 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 $0.5 million as of June 30, 2024. 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 ASC 606, paragraph 606-10-50-14 and does not disclose information about remaining performance obligations that have original expected durations of one year or less. |
Investments - Available-for-Sal
Investments - Available-for-Sale | 6 Months Ended |
Jun. 30, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments - Available-for-Sale | Investments - Available-for-Sale Investments available-for-sale consisted of the following as of December 31, 2023 (table in thousands): December 31, 2023 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Fair Value Available-for-Sale Securities Debt securities $ 1,948 $ 4 $ — $ — $ 1,952 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, 2023, the Company's available-for-sale securities were all due within one year. During the three and six months ended June 30, 2024, the Company sold these investments for a realized gain of $0.1 million, which is included in realized gain on available-for-sale investments on the condensed consolidated statements of operations. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Components of inventory, net of reserves, as of June 30, 2024 and December 31, 2023 are as follows (table in thousands): June 30, December 31, Inventory - Current Portion Raw Materials $ 2,209 $ 2,250 Work in Process 225 351 Finished Goods 3,449 3,270 Total Current Inventory 5,883 5,871 Inventory - Long Term (1) 178 178 Total Inventory $ 6,061 $ 6,049 __________ 1. Represents inventory related to Triferic raw materials, which is expected to be utilized for the Company's international partnerships, net of a reserve of $1.1 million related to the termination of the development of Triferic in Wanbang in August 2023 as a result of the failure to demonstrate efficacy when compared with a placebo in its phase III clinical studies. |
Property and Equipment, net
Property and Equipment, net | 6 Months Ended |
Jun. 30, 2024 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment As of June 30, 2024 and December 31, 2023, the Company’s property and equipment consisted of the following (table in thousands): June 30, December 31, Leasehold Improvements $ 1,542 $ 1,423 Machinery and Equipment 11,438 11,131 Information Technology & Office Equipment 1,845 1,845 Laboratory Equipment 807 807 Total Property and Equipment 15,632 15,206 Accumulated Depreciation and Amortization (9,623) (8,804) Property and Equipment, net $ 6,009 $ 6,402 Depreciation and amortization expense for the three months ended June 30, 2024 and 2023 was $0.4 million and $0.2 million, respectively. Depreciation and amortization expense for the six months ended June 30, 2024 and 2023 was $0.8 million and $0.3 million. |
Accrued Liabilities
Accrued Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities as of June 30, 2024 and December 31, 2023 consisted of the following (table in thousands): June 30, December 31, Accrued Compensation and Benefits $ 1,629 $ 2,413 Accrued Unvouchered Receipts 1,325 1,663 Accrued Manufacturing Expense 902 1,064 Accrued Workers Compensation 408 254 Other Accrued Liabilities 1,904 1,755 Total Accrued Liabilities $ 6,168 $ 7,149 |
Deferred License Revenue
Deferred License Revenue | 6 Months Ended |
Jun. 30, 2024 | |
Revenue from Contract with Customer [Abstract] | |
Deferred License Revenue | Deferred License Revenue In October 2014, the Company entered into an exclusive distribution agreement with Baxter, which had a term of 10 years, The remaining agreements with Sun Pharma, Jeil Pharmaceutical, and Drogsan Pharmaceuticals comprise the current and long-term portions of deferred license revenue on the condensed consolidated balance sheets as of June 30, 2024 and December 31, 2023. |
Stockholders_ Equity
Stockholders’ Equity | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Preferred Stock On April 6, 2022, the Company and DaVita entered into the Securities Purchase Agreement (the "SPA"), which provided for the issuance by the Company of up to $15 million of preferred stock to DaVita. On April 6, 2022, the Company issued 7,500 shares of Series X Preferred Stock for gross proceeds of $7.5 million. On June 16, 2022, the Company issued an additional 7,500 shares of the Series X Preferred Stock to DaVita for gross proceeds of $7.5 million. The Series X Preferred Stock was issued for a price of $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. As of June 30, 2024, the Series X Preferred Stock accreted a total $0.2 million. The Series X Convertible Preferred Stock is convertible to common stock at a rate equal to the Face Amount, divided by a conversion price of $11.00 per share (subject to adjustment for future 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. 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. Additionally, the Series X Preferred Stock has a deemed liquidation event and redemption clause which could be triggered if the sale of all or substantially all of the Company's assets relating to the Company's dialysis concentrates business line. Since the Series X Preferred Stock may be redeemed if certain assets are sold at the option of the holder, but is not mandatorily redeemable and the sale of the assets that would allow for redemption is within the control of the Company, the preferred stock has been classified as permanent equity and initially recognized at fair value of $15 million (the proceeds on the date of issuance) less issuance costs of $0.1 million, resulting in an initial value of $14.9 million. The Company will assess at each reporting period whether conditions have changed to now meet the mandatory redemption definition which could trigger liability classification. As of each of June 30, 2024 and December 31, 2023, there were 2,000,000 shares of preferred stock, $0.0001 par value per share, authorized and 15,000 shares of preferred stock issued and outstanding. Common Stock As of June 30, 2024 and December 31, 2023, there were 170,000,000 shares of common stock, $0.0001 par value per share, authorized and 31,030,218 and 29,130,607 shares issued and outstanding, respectively. As of June 30, 2024 and 2023, the Company reserved for issuance the following shares of common stock related to the potential exercise of employee stock options, unvested restricted stock, convertible preferred stock, pre-funded warrants and all other warrants (collectively, "common stock equivalents"): As of June 30, Common Stock and Common Stock Equivalents: 2024 2023 Common Stock 31,030,218 16,795,673 Common Stock Issuable upon Exercise of Pre-funded Warrants — 1,793,000 Common Stock and Pre-funded Stock Warrants 31,030,218 18,588,673 Options to Purchase Common Stock 1,895,031 1,570,599 Unvested Restricted Stock Awards 891 891 Unvested Restricted Stock Units 534,309 313,065 Convertible Preferred Stock 1,363,636 1,363,636 Warrants to Purchase Common Stock 3,984,484 10,196,268 Total 38,808,569 32,033,132 During the three months ended June 30, 2024 and 2023, nil and 4,118,000 Pre-Funded Warrants were exercised, respectively. During the six months ended June 30, 2024 and 2023, nil and 4,507,000 Pre-Funded Warrants were exercised, respectively. During the three and six months ended June 30, 2024 and 2023, no vested employee stock options were exercised. Controlled Equity Offering On April 8, 2022, the Company entered into the Sales Agreement (the "ATM facility") with Cantor Fitzgerald & Co. as Agent, pursuant to which the Company may offer and sell from time to time up to $12.2 million 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. During the six months ended June 30, 2024, 1,708,379 shares were sold pursuant to the Sales Agreement for net proceeds of $2.8 million. Approximately $8.2 million remains available for sale under the ATM facility. Private Placement On July 10, 2023, the Company entered into a letter agreement (the “Letter Agreement”) with Armistice Capital Master Fund Ltd. (“Armistice”), which held a warrant (the “Prior Warrant”) to purchase 9,900,990 shares of common stock of the Company (the “Common Stock”) with an exercise price of $1.39 per share, offering Armistice the opportunity to exercise the Prior Warrant for cash, provided the Prior Warrant was exercised for cash on or prior to 5:00 P.M. Eastern Time on July 10, 2028 (the “End Date”). In addition, Armistice would receive a “reload” warrant (the “Reload Warrant”) to purchase 3,750,000 shares of Common Stock with an exercise price of $5.13 per share, the closing price as reported by the Nasdaq Capital Market on July 7, 2023. The terms of the Reload Warrant and Letter Agreement provide for customary resale registration rights. The Letter Agreement also provides that for a period of 45 days after the issuance of the Reload Warrant, the Company may not sell shares of Common Stock pursuant to its sales agreement with Cantor Fitzgerald & Co., dated as of April 8, 2022, at a price per share less than $6.25. The Reload Warrant may be exercised at all times prior to the 54 months anniversary of its issuance date. The Prior Warrant and the Reload Warrant both provide that a holder (together with its affiliates) may not exercise any portion of the Prior Warrant or the Reload Warrant to the extent that the holder would own more than 9.99% of the Company’s outstanding Common Stock immediately after exercise, as such percentage ownership is determined in accordance with the terms of such warrant. To the extent the exercise of the Prior Warrant would result in Armistice holding more than 9.99% of the Company’s outstanding Common Stock, such shares of Common Stock in excess of 9.99% will be held in abeyance. The Letter Agreement amended the Prior Warrant to extend the expiration date thereof to one year following the original expiration date set forth therein. Armistice exercised the Prior Warrant on July 10, 2023, and the Company received gross proceeds of approximately $13.8 million. Third Amendment In connection with the execution of the Third Amendment, as defined and described in Note 15 , on January 2, 2024, the Company issued to Innovatus a warrant to purchase 191,096 shares of the Company’s common stock with an exercise price of $1.83 per share. The warrant may be exercised on a cashless basis, and is immediately exercisable through January 2, 2029. The number of shares of common stock for which the warrant is exercisable and the exercise price are subject to certain proportional adjustments as set forth in the Third Amendment. The warrant is equity-classified with a fair value of approximately $0.2 million at issuance, which was treated as a debt issuance cost and will be amortized through interest expense over the remaining contractual term of the Term Loan. The fair value of the warrant at the issuance date was calculated using the Black-Scholes pricing model and include the following assumptions: Stock Price per Share $1.86 Expected Stock Price Volatility 85.00% Risk-free Interest Rate 3.93% Term (years) 5.0 Dividend Yield 0% |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation The Company recognized total stock-based compensation expense during the three and six months ended June 30, 2024 and 2023 as follows (table in thousands): Three Months Ended Six Months Ended 2024 2023 2024 2023 Service-based awards: Restricted Stock Units $ 159 $ 119 $ 277 $ 164 Stock Option Awards 179 190 312 338 Total $ 338 $ 309 $ 589 $ 502 Performance Based Restricted Stock Awards A summary of the Company’s performance based restricted stock awards during the six months ended June 30, 2024 is as follows: Performance Based Restricted Stock Awards Number of Shares Weighted Average Unvested at January 1, 2024 891 $ 62.70 Unvested at June 30, 2024 891 $ 62.70 Performance-based 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 June 30, 2024, there is no unrecognized stock-based compensation expense related to performance based restricted stock awards. Service Based Restricted Stock Units A summary of the Company’s service-based restricted stock units during the six months ended June 30, 2024 is as follows: Service Based Restricted Stock Units Number of Shares Weighted Average Unvested at January 1, 2024 258,885 $ 1.97 Granted 466,656 1.58 Vested (191,232) 2.18 Unvested at June 30, 2024 534,309 $ 1.48 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. As of June 30, 2024, the unrecognized stock-based compensation expense was $0.7 million, which is expected to be recognized over the next 1.7 years. Service Based Stock Option Awards The fair value of the service-based stock option awards granted for the six months ended June 30, 2024 and 2023 were based on the following assumptions: Six Months Ended June 30, 2024 Six Months Ended June 30, 2023 Exercise Price $1.39 - $1.80 $1.37 - $2.83 Expected Stock Price Volatility 81.8% 81.6% - 81.9% Risk-free Interest Rate 4.31% - 4.45% 3.41% - 3.55% Term (years) 5.61 - 5.62 4 - 6 A summary of the Company’s service-based stock option activity for the six months ended June 30, 2024 is as follows: Service Based Stock Option Awards Shares Weighted Weighted Aggregate Intrinsic Value (in $1,000's) Outstanding at January 1, 2024 1,328,621 $ 5.22 Granted 569,160 1.40 Forfeited (2,500) 2.29 Expired (250) 2.83 Outstanding at June 30, 2024 1,895,031 $ 4.08 8.5 $ 529,694 Exercisable at June 30, 2024 455,511 $ 11.57 7.2 $ 88,240 The aggregate intrinsic value is calculated as the difference between the closing price of the Company's common stock at the date indicated and the exercise price of the stock options that had strike prices below the closing price. The weighted average grant date fair value for service based stock option awards granted during the six months ended June 30, 2024 and 2023 was $0.99 and $1.03, respectively. As of June 30, 2024, total stock-based compensation expense related to unvested options not yet recognized totaled approximately $0.9 million, which is expected to be recognized over the next 3.2 years. |
License Agreements
License Agreements | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License Agreements | License 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 June 30, 2024 and December 31, 2023, the Company has accrued $87,900 relating to certain IP reimbursement expenses and certain sublicense royalty fees, which is included within accrued liabilities on the condensed consolidated balance sheets. 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 is required to pay Charak a percentage of any sublicense income during the term of the agreement, which cannot 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 can be no less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis. Also pursuant to the Charak MSA, the Company and Charak entered into a Commercialization and Technology License Agreement IV Triferic dated as of October 7, 2018 (the “IV Agreement”), under which Charak granted the Company an exclusive, sub-licensable, royalty-bearing license to SFP for the purpose of commercializing certain intravenous-delivered products incorporating SFP for the treatment of iron disorders worldwide for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. The Company was 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, sub-licensable, 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 as of June 30, 2024 and December 31, 2023. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2024 | |
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 six 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 2027. During the six months ended June 30, 2024, the lease for the Wixom facilities was extended by three years to August 2027, which was accounted for as a modification. As a result of the modification, the operating lease right of use asset and lease liabilities increased by $1.5 million. 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 2026. In addition, Rockwell occupied 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. The following summarizes quantitative information about the Company’s operating and finance leases (table in thousands): Three Months Ended June 30, 2024 Three Months Ended June 30, 2023 Six Months Ended June 30, 2024 Six Months Ended June 30, 2023 Operating Leases Operating Lease Cost $ 341 $ 455 $ 761 $ 859 Variable Lease Cost 128 109 250 224 Operating Lease Expense 469 564 1,011 1,083 Finance Leases Amortization of Right-of-use Assets 141 141 282 282 Interest on Lease Obligations 29 38 61 77 Finance Lease Expense 170 179 343 359 Short-term Lease Rent Expense 6 4 11 8 Total Rent Expense $ 645 $ 747 $ 1,365 $ 1,450 Other Information Operating Cash Flows from Operating Leases $ 426 $ 478 $ 863 $ 902 Operating Cash Flows from Finance Leases $ 29 $ 38 $ 61 $ 77 Financing Cash Flows from Finance Leases $ 138 $ 129 $ 276 $ 258 Weighted-average Remaining Lease Term – Operating Leases 2.6 2.7 2.6 2.7 Weighted-average Remaining Lease Term – Finance Leases 3.0 3.9 3.0 3.9 Weighted-average Discount Rate – Operating Leases 6.3 % 6.5 % 6.3 % 6.5 % Weighted-average Discount Rate – Finance Leases 6.4 % 6.4 % 6.4 % 6.4 % Future minimum rental payments under operating and finance lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2024 (remaining) $ 835 $ 334 Year ending December 31, 2025 1,587 676 Year ending December 31, 2026 946 666 Year ending December 31, 2027 525 311 Year ending December 31, 2028 2 — Total 3,895 1,987 Less Present Value Discount (295) (175) Operating and Finance Lease Liabilities $ 3,600 $ 1,812 |
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 six 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 2027. During the six months ended June 30, 2024, the lease for the Wixom facilities was extended by three years to August 2027, which was accounted for as a modification. As a result of the modification, the operating lease right of use asset and lease liabilities increased by $1.5 million. 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 2026. In addition, Rockwell occupied 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. The following summarizes quantitative information about the Company’s operating and finance leases (table in thousands): Three Months Ended June 30, 2024 Three Months Ended June 30, 2023 Six Months Ended June 30, 2024 Six Months Ended June 30, 2023 Operating Leases Operating Lease Cost $ 341 $ 455 $ 761 $ 859 Variable Lease Cost 128 109 250 224 Operating Lease Expense 469 564 1,011 1,083 Finance Leases Amortization of Right-of-use Assets 141 141 282 282 Interest on Lease Obligations 29 38 61 77 Finance Lease Expense 170 179 343 359 Short-term Lease Rent Expense 6 4 11 8 Total Rent Expense $ 645 $ 747 $ 1,365 $ 1,450 Other Information Operating Cash Flows from Operating Leases $ 426 $ 478 $ 863 $ 902 Operating Cash Flows from Finance Leases $ 29 $ 38 $ 61 $ 77 Financing Cash Flows from Finance Leases $ 138 $ 129 $ 276 $ 258 Weighted-average Remaining Lease Term – Operating Leases 2.6 2.7 2.6 2.7 Weighted-average Remaining Lease Term – Finance Leases 3.0 3.9 3.0 3.9 Weighted-average Discount Rate – Operating Leases 6.3 % 6.5 % 6.3 % 6.5 % Weighted-average Discount Rate – Finance Leases 6.4 % 6.4 % 6.4 % 6.4 % Future minimum rental payments under operating and finance lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2024 (remaining) $ 835 $ 334 Year ending December 31, 2025 1,587 676 Year ending December 31, 2026 946 666 Year ending December 31, 2027 525 311 Year ending December 31, 2028 2 — Total 3,895 1,987 Less Present Value Discount (295) (175) Operating and Finance Lease Liabilities $ 3,600 $ 1,812 |
Loans and Security Agreement
Loans and Security Agreement | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Loans and Security Agreement | Loan and Security Agreement On 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 additional tranches, which were tied to the achievement of certain milestones. Net draw down proceeds were $21.2 million with closing costs of $1.3 million. The Company also owes an additional fee equal to 4.375% of the funded amount of the Term Loans, or $1.0 million (such additional fee, the "Final Fee") at maturity. The Company is accreting up to this Final Fee premium with a charge against interest expense on the accompanying condensed consolidated statements of operations. In connection with each funding of the Term Loans, the Company was 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. 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 Warrant may be exercised on a cashless basis and is immediately exercisable through the seventh anniversary of the applicable funding date. The number of shares of common stock for which the Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Warrant. 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 Term Loan was scheduled to mature on March 16, 2025, and bore interest at the greater of (i) Prime Rate (as defined in the Loan Agreement) and (ii) 4.75%, plus 4.00%, with an initial interest rate of 8.75% per annum. The Company had the option, under certain circumstances, to add 1.00% of such interest rate amount to the then outstanding principal balance in lieu of paying such amount in cash. The Loan Agreement is secured by all assets of the Company and Rockwell Transportation, Inc. and contains customary representations and warranties and covenants, subject to customary carve outs, and initially included financial covenants related to liquidity and sales of Triferic. 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 $7.5 million 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 $5.0 million if the aggregate principal amount of Term Loans is greater than $15 million pursuant to the liquidity covenant in the Loan Agreement. On November 10, 2022, the Company entered into a Second Amendment to the Loan and Security Agreement (the “Second Amendment”) dated as of November 14, 2022 with Innovatus. Pursuant to the Second Amendment, the Company (i) prepaid an additional aggregate principal amount of $5.0 million in Term Loans in one installment on November 14, 2022; and (ii) paid interest only payments until September 2023, at which time it resumed scheduled debt payments. The financial covenant related to the sales of Triferic was replaced with the trailing 6 months revenue of the Company's concentrates products. On January 2, 2024, the Company entered into the Third Amendment to and Restatement of the Loan and Security Agreement (the "Third Amendment") with Innovatus, dated January 1, 2024. The Third Amendment provides for the continuation of term loans initially borrowed under the Loan Agreement amounting to $8.0 million as of January 1, 2024. The Company will make interest-only payments on the Term Loans for 30 months, or up to 36 months if certain conditions are met. The Term Loans will mature on January 1, 2029, unless earlier repaid. Effective on January 1, 2024, the Term Loans will bear interest equal to the sum of (i) the greater of (a) Prime Rate (as defined in the Third Amendment) and (b) 7.50% plus (ii) 3.50%. At the Company's option, 2.00% of the interest due on any applicable interest payment date during the interest-only period may be paid in-kind by adding such amount to the then outstanding principal balance of the Term Loans. The Term Loans may be voluntarily prepaid in full (but not partially) at any time, upon at least seven The Third Amendment contains various financial covenants and customary representations and warranties and affirmative and negative covenants, subject to exceptions as described in the Third Amendment. The Company's ability to comply with the covenants under the Third Amendment may be adversely affected by events beyond its control. If the Company is unable to comply with the covenants under the Third Amendment, 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. However, as of June 30, 2024, the Company was in compliance with all covenants under the Third Amendment. In connection with the execution of the Third Amendment, on January 2, 2024, the Company issued a warrant to purchase shares of the Company’s common stock. The warrant is equity-classified with a fair value of $0.2 million at issuance, which was treated as a debt issuance cost and will be amortized through interest expense over the remaining contractual term of the Term Loan. For additional information, see Note 11. The effective interest rate is 12.0% as of June 30, 2024. For the three months ended June 30, 2024 and 2023, interest expense amounted to $0.2 million and $0.3 million, respectively. For the six months ended June 30, 2024 and 2023, interest expense amounted to $0.5 million and $0.6 million, respectively. As of June 30, 2024, the outstanding balance of the Term Loan was $8.3 million, net of unamortized issuance costs and discount of $0.6 million, and including $0.8 million of premium accretion, $0.1 million related to a fee resulting from the Third Amendment, and paid-in-kind interest of $0.1 million. The following table reflects the schedule of principal payments on the Term Loan as of June 30, 2024 (in thousands): June 30, 2024 2024 (remaining) $ — 2025 — 2026 1,359 2027 3,262 2028 3,262 2029 (inclusive of Final Fee) 1,256 Total Debt Maturities 9,139 Unamortized Issuance Costs, Discount and Premium, net (844) Term Loan - Long-Term, net of issuance costs $ 8,295 |
Insurance Financing Note Payabl
Insurance Financing Note Payable | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Insurance Financing Note Payable | Insurance Financing Note Payable On June 3, 2023, the Company entered into a short-term note payable for $0.7 million, bearing interest at a rate of 9.59% per annum to finance various insurance policies. Principal and interest payments related to this note began on July 3, 2023 and were paid on a straight-line amortization over nine months with the final payment due on March 3, 2024. During the six months ended June 30, 2024, the Company's insurance financing note payable balance was paid in full. On June 24, 2024, the Company entered into a short-term note payable with a principal amount of $0.7 million, bearing interest at a rate of 7.89% per annum to finance various insurance policies, which required an upfront payment of $0.2 million. Principal and interest payments related to this note began on July 3, 2024 and will be paid in 10 equal monthly payments of $0.1 million, with the final payment due on April 3, 2025. As of June 30, 2024, the balance of the insurance financing note payable was $0.7 million. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ 343 | $ (1,731) | $ (3,305) | $ (1,750) | $ (1,388) | $ (5,055) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended | 6 Months Ended |
Jun. 30, 2024 shares | Jun. 30, 2024 shares | |
Trading Arrangements, by Individual | ||
Material Terms of Trading Arrangement | Director and executive officer trading arrangements The following table provides information concerning Rule 10b5-1 trading arrangements adopted during the three months ended June 30, 2024, by any director or any executive officer who is subject to the filing requirements of Section 16 of the Securities Exchange Act of 1934. These trading arrangements are intended to satisfy the affirmative defense of Rule 10b5-1(c). No non-Rule 10b5-1 trading arrangements were adopted by any director or executive officer during the second quarter of 2024. In addition, no Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were terminated by any director or executive officer in the second quarter of 2024. Name Title Adoption Date Duration (a) Number of shares to be sold Mark Strobeck President and CEO May 31, 2024 May 31, 2024 – October 2, 2025 25,104 Timothy Chole SVP and Chief Commercial Officer June 7, 2024 June 7, 2024 – October 2, 2025 10,606 a Subject to compliance with Rule 10b5-1, duration could cease earlier than the final date shown above to the extent that the aggregate number of shares to be sold under the trading arrangement have been sold. | |
Non-Rule 10b5-1 Arrangement Adopted | false | |
Rule 10b5-1 Arrangement Terminated | false | |
Non-Rule 10b5-1 Arrangement Terminated | false | |
Mark Strobeck [Member] | ||
Trading Arrangements, by Individual | ||
Name | Mark Strobeck | |
Title | President and CEO | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | May 31, 2024 | |
Expiration Date | October 2, 2025 | |
Arrangement Duration | 489 days | |
Aggregate Available | 25,104 | 25,104 |
Timothy Chole [Member] | ||
Trading Arrangements, by Individual | ||
Name | Timothy Chole | |
Title | SVP and Chief Commercial Officer | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | June 7, 2024 | |
Expiration Date | October 2, 2025 | |
Arrangement Duration | 482 days | |
Aggregate Available | 10,606 | 10,606 |
Basis of Presentation, Summar_2
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The accompanying condensed consolidated financial statements have been prepared in accordance with 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 June 30, 2024, and the condensed consolidated statements of operations, comprehensive income (loss), and changes in stockholders' equity, and cash flows for the three and six months ended June 30, 2024 and 2023 are unaudited, but include all adjustments, consisting of normal recurring adjustments the Company considers necessary for a fair presentation of the financial position, operating results, and cash flows for the periods presented. The results for the three and six months ended June 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024 or for any future interim period. The condensed consolidated balance sheet at December 31, 2023 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, 2023 and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 as filed with the SEC on March 21, 2024. The Company’s consolidated subsidiaries consist of its wholly-owned subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited. The accompanying condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | 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 revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Income (Loss) Per Share | The Company’s potentially dilutive securities include stock options, restricted stock awards and units, convertible preferred stock and warrants. |
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 a new accounting pronouncement affects the Company’s financial reporting, the Company undertakes a review to determine the consequences of the change to its consolidated financial statements and assures there are sufficient controls in place to ascertain the Company’s consolidated financial statements properly reflect the change. In November 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2023-07, Segment Reporting - Improvements to Reportable Segment Disclosures , which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. The amendments in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is in the process of determining the effect this ASU will have on the disclosures contained in the notes to the consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures , which updates income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This ASU also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in this ASU are effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is in the process of determining the effect this ASU will have on the disclosures contained in the notes to the consolidated financial statements. |
Revenue recognition | The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers , issued by the FASB . The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: • Step 1: Identify the contract with the customer • Step 2: Identify the performance obligations in the contract • Step 3: Determine the transaction price • Step 4: Allocate the transaction price to the performance obligations in the contract • Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by Rockwell 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. |
Basis of Presentation, Summar_3
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Basic and Diluted Net Loss Per Share | Basic and diluted net income (loss) per share for the three and six months ended June 30, 2024 and 2023 was calculated as follows: Three Months Ended Six Months Ended (In thousands, except share and per share amounts) 2024 2023 2024 2023 Numerator: Net Income (Loss) $ 343 $ (3,305) $ (1,388) $ (5,055) Less: Undistributed Earnings to Participating Securities (58) — — — Net Income (Loss) Attributable to Common Stockholders $ 285 $ (3,305) $ (1,388) $ (5,055) Denominator: Weighted Average Number of Shares of Common Stock Outstanding - Basic 30,451,622 18,496,640 29,889,413 18,480,248 Incremental Shares Attributable to the Assumed Exercise of Outstanding Options to Purchase Common Stock 35,185 — — — Incremental Shares Attributable to the Assumed Vesting of Unvested Restricted Stock Units 183,333 — — — Incremental Shares Attributable to the Assumed Conversion of Preferred Stock 1,363,636 — — — Weighted Average Number of Shares of Common Stock Outstanding - Diluted 32,033,776 18,496,640 29,889,413 18,480,248 Net Loss per Share Attributable to Common Stockholders - Basic $ 0.01 $ (0.18) $ (0.05) $ (0.27) Net Loss per Share Attributable to Common Stockholders - Diluted $ 0.01 $ (0.18) $ (0.05) $ (0.27) |
Summary of Potentially Dilutive Securities | The following table includes the potential shares of common stock, presented based on amounts outstanding at each period end, that were excluded from the computation of diluted net income (loss) per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Three Months Ended Six Months Ended 2024 2023 2024 2023 Warrants to Purchase Common Stock 3,984,484 10,196,268 3,984,484 10,196,268 Options to Purchase Common Stock 342,331 1,570,599 1,895,031 1,570,599 Convertible Preferred Stock — 1,363,636 1,363,636 1,363,636 Unvested Restricted Stock Units — 313,065 534,309 313,065 Unvested Restricted Stock Awards 891 891 891 891 Total 4,327,706 13,444,459 7,778,351 13,444,459 |
Asset Acquisition (Tables)
Asset Acquisition (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract] | |
Schedule of Purchase Price, on a Relative Fair Value Basis, to Assets Acquired | The purchase price was allocated, on a relative fair value basis, to the assets acquired at the July 10, 2023 acquisition date as follows (table in thousands): Consideration Cash Payment $ 12,233 Deferred Consideration 5,000 Transaction Costs 128 Total Consideration $ 17,361 Assets Acquired Customer Relationships Intangible Asset $ 11,035 Equipment 5,093 Inventory 1,233 Total Assets Acquired $ 17,361 |
Schedule of Future Amortization Expense | Estimated future amortization expense on the Company's customer relationships intangible asset as of June 30, 2024 is as follows (table in thousands): Year ended December 31: 2024 (remainder of year) $ 276 2025 552 2026 552 2027 552 2028 552 Thereafter 7,999 Total $ 10,483 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Revenue from Contract with Customer [Abstract] | |
Summary of Disaggregation of Revenue | Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition. In thousands Three Months Ended June 30, 2024 Six Months Ended June 30, 2024 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues License Fee – Over time $ 12 $ — $ 12 $ 23 $ — $ 23 Total Drug Products 12 — 12 23 — 23 Concentrate Products Product Sales – Point-in-time 25,820 23,209 2,611 48,485 44,143 4,342 Total Concentrate Products 25,820 23,209 2,611 48,485 44,143 4,342 Net Revenue $ 25,832 $ 23,209 $ 2,623 $ 48,508 $ 44,143 $ 4,365 In thousands Three Months Ended June 30, 2023 Six Months Ended June 30, 2023 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues License Fee – Over time $ 65 $ — $ 65 $ 130 $ 130 Total Drug Products 65 — 65 130 — 130 Concentrate Products Product Sales – Point-in-time 18,015 16,125 1,890 36,146 32,585 3,561 License Fee – Over time — — — 1,472 1,472 — Total Concentrate Products 18,015 16,125 1,890 37,618 34,057 3,561 Net Revenue $ 18,080 $ 16,125 $ 1,955 $ 37,748 $ 34,057 $ 3,691 |
Summary of Contract Balances | The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands June 30, 2024 December 31, 2023 January 1, 2023 Accounts Receivable, net $ 10,840 $ 10,901 $ 6,259 Contract Liabilities, which are included in deferred license revenue $ 498 $ 521 $ 4,331 |
Investments - Available-for-S_2
Investments - Available-for-Sale (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Investments Available-for-Sale | Investments available-for-sale consisted of the following as of December 31, 2023 (table in thousands): December 31, 2023 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Fair Value Available-for-Sale Securities Debt securities $ 1,948 $ 4 $ — $ — $ 1,952 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Summary of Components of Inventory | Components of inventory, net of reserves, as of June 30, 2024 and December 31, 2023 are as follows (table in thousands): June 30, December 31, Inventory - Current Portion Raw Materials $ 2,209 $ 2,250 Work in Process 225 351 Finished Goods 3,449 3,270 Total Current Inventory 5,883 5,871 Inventory - Long Term (1) 178 178 Total Inventory $ 6,061 $ 6,049 __________ 1. |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Property, Plant and Equipment [Abstract] | |
Summary of Major Classes of Property and Equipment | As of June 30, 2024 and December 31, 2023, the Company’s property and equipment consisted of the following (table in thousands): June 30, December 31, Leasehold Improvements $ 1,542 $ 1,423 Machinery and Equipment 11,438 11,131 Information Technology & Office Equipment 1,845 1,845 Laboratory Equipment 807 807 Total Property and Equipment 15,632 15,206 Accumulated Depreciation and Amortization (9,623) (8,804) Property and Equipment, net $ 6,009 $ 6,402 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Liabilities | Accrued liabilities as of June 30, 2024 and December 31, 2023 consisted of the following (table in thousands): June 30, December 31, Accrued Compensation and Benefits $ 1,629 $ 2,413 Accrued Unvouchered Receipts 1,325 1,663 Accrued Manufacturing Expense 902 1,064 Accrued Workers Compensation 408 254 Other Accrued Liabilities 1,904 1,755 Total Accrued Liabilities $ 6,168 $ 7,149 |
Stockholder's Equity (Tables)
Stockholder's Equity (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Summary of Common Stock Reserved for Issuance | As of June 30, 2024 and 2023, the Company reserved for issuance the following shares of common stock related to the potential exercise of employee stock options, unvested restricted stock, convertible preferred stock, pre-funded warrants and all other warrants (collectively, "common stock equivalents"): As of June 30, Common Stock and Common Stock Equivalents: 2024 2023 Common Stock 31,030,218 16,795,673 Common Stock Issuable upon Exercise of Pre-funded Warrants — 1,793,000 Common Stock and Pre-funded Stock Warrants 31,030,218 18,588,673 Options to Purchase Common Stock 1,895,031 1,570,599 Unvested Restricted Stock Awards 891 891 Unvested Restricted Stock Units 534,309 313,065 Convertible Preferred Stock 1,363,636 1,363,636 Warrants to Purchase Common Stock 3,984,484 10,196,268 Total 38,808,569 32,033,132 |
Summary of Assumptions Used In Calculating Fair Value of Warrant | The fair value of the warrant at the issuance date was calculated using the Black-Scholes pricing model and include the following assumptions: Stock Price per Share $1.86 Expected Stock Price Volatility 85.00% Risk-free Interest Rate 3.93% Term (years) 5.0 Dividend Yield 0% |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Summary of Total Stock-Based Compensation Expense | The Company recognized total stock-based compensation expense during the three and six months ended June 30, 2024 and 2023 as follows (table in thousands): Three Months Ended Six Months Ended 2024 2023 2024 2023 Service-based awards: Restricted Stock Units $ 159 $ 119 $ 277 $ 164 Stock Option Awards 179 190 312 338 Total $ 338 $ 309 $ 589 $ 502 |
Summary of Stock Options Activity | A summary of the Company’s service-based stock option activity for the six months ended June 30, 2024 is as follows: Service Based Stock Option Awards Shares Weighted Weighted Aggregate Intrinsic Value (in $1,000's) Outstanding at January 1, 2024 1,328,621 $ 5.22 Granted 569,160 1.40 Forfeited (2,500) 2.29 Expired (250) 2.83 Outstanding at June 30, 2024 1,895,031 $ 4.08 8.5 $ 529,694 Exercisable at June 30, 2024 455,511 $ 11.57 7.2 $ 88,240 |
Restricted stock awards - performance based awards | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Summary of Restricted Stock Awards | A summary of the Company’s performance based restricted stock awards during the six months ended June 30, 2024 is as follows: Performance Based Restricted Stock Awards Number of Shares Weighted Average Unvested at January 1, 2024 891 $ 62.70 Unvested at June 30, 2024 891 $ 62.70 |
Restricted stock units - service based awards | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Summary of Restricted Stock Awards | A summary of the Company’s service-based restricted stock units during the six months ended June 30, 2024 is as follows: Service Based Restricted Stock Units Number of Shares Weighted Average Unvested at January 1, 2024 258,885 $ 1.97 Granted 466,656 1.58 Vested (191,232) 2.18 Unvested at June 30, 2024 534,309 $ 1.48 |
Stock Option Awards | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Summary of Stock Option Assumptions | The fair value of the service-based stock option awards granted for the six months ended June 30, 2024 and 2023 were based on the following assumptions: Six Months Ended June 30, 2024 Six Months Ended June 30, 2023 Exercise Price $1.39 - $1.80 $1.37 - $2.83 Expected Stock Price Volatility 81.8% 81.6% - 81.9% Risk-free Interest Rate 4.31% - 4.45% 3.41% - 3.55% Term (years) 5.61 - 5.62 4 - 6 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Summary of Lease Costs | The following summarizes quantitative information about the Company’s operating and finance leases (table in thousands): Three Months Ended June 30, 2024 Three Months Ended June 30, 2023 Six Months Ended June 30, 2024 Six Months Ended June 30, 2023 Operating Leases Operating Lease Cost $ 341 $ 455 $ 761 $ 859 Variable Lease Cost 128 109 250 224 Operating Lease Expense 469 564 1,011 1,083 Finance Leases Amortization of Right-of-use Assets 141 141 282 282 Interest on Lease Obligations 29 38 61 77 Finance Lease Expense 170 179 343 359 Short-term Lease Rent Expense 6 4 11 8 Total Rent Expense $ 645 $ 747 $ 1,365 $ 1,450 Other Information Operating Cash Flows from Operating Leases $ 426 $ 478 $ 863 $ 902 Operating Cash Flows from Finance Leases $ 29 $ 38 $ 61 $ 77 Financing Cash Flows from Finance Leases $ 138 $ 129 $ 276 $ 258 Weighted-average Remaining Lease Term – Operating Leases 2.6 2.7 2.6 2.7 Weighted-average Remaining Lease Term – Finance Leases 3.0 3.9 3.0 3.9 Weighted-average Discount Rate – Operating Leases 6.3 % 6.5 % 6.3 % 6.5 % Weighted-average Discount Rate – Finance Leases 6.4 % 6.4 % 6.4 % 6.4 % |
Summary of Operating Lease Maturities | Future minimum rental payments under operating and finance lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2024 (remaining) $ 835 $ 334 Year ending December 31, 2025 1,587 676 Year ending December 31, 2026 946 666 Year ending December 31, 2027 525 311 Year ending December 31, 2028 2 — Total 3,895 1,987 Less Present Value Discount (295) (175) Operating and Finance Lease Liabilities $ 3,600 $ 1,812 |
Summary of Finance Lease Maturities | Future minimum rental payments under operating and finance lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2024 (remaining) $ 835 $ 334 Year ending December 31, 2025 1,587 676 Year ending December 31, 2026 946 666 Year ending December 31, 2027 525 311 Year ending December 31, 2028 2 — Total 3,895 1,987 Less Present Value Discount (295) (175) Operating and Finance Lease Liabilities $ 3,600 $ 1,812 |
Loans and Security Agreement (T
Loans and Security Agreement (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Summary of Principal Payments on Term Loan | The following table reflects the schedule of principal payments on the Term Loan as of June 30, 2024 (in thousands): June 30, 2024 2024 (remaining) $ — 2025 — 2026 1,359 2027 3,262 2028 3,262 2029 (inclusive of Final Fee) 1,256 Total Debt Maturities 9,139 Unamortized Issuance Costs, Discount and Premium, net (844) Term Loan - Long-Term, net of issuance costs $ 8,295 |
Description of Business (Detail
Description of Business (Details) | 6 Months Ended |
Jun. 30, 2024 ft² | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Operating space | 175,000 |
Liquidity and Capital Resourc_2
Liquidity and Capital Resources (Details) - USD ($) $ in Thousands | 6 Months Ended | |||
Jan. 02, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | Apr. 08, 2022 | |
Liquidity and Capital Resources [Abstract] | ||||
Cash and cash equivalents | $ 11,900 | |||
Working capital | 14,900 | |||
Net cash used in operating activities | 938 | $ 5,616 | ||
Cantor Fitzgerald & Co | At-the-Market Offering | ||||
Liquidity and Capital Resources [Abstract] | ||||
Sale of stock, aggregate consideration authorized | $ 8,200 | $ 12,200 | ||
Term loan | Term loan | ||||
Debt Instrument [Line Items] | ||||
Period for which company is entitled to make interest-only payments | 30 months | |||
Term loan | Term loan | Maximum | ||||
Debt Instrument [Line Items] | ||||
Period for which company is entitled to make interest-only payments | 36 months |
Basis of Presentation, Summar_4
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Summary of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Numerator: | ||||||
Net Income (Loss) | $ 343 | $ (1,731) | $ (3,305) | $ (1,750) | $ (1,388) | $ (5,055) |
Less: Undistributed Earnings to Participating Securities | (58) | 0 | 0 | 0 | ||
Net Income (Loss) Attributable to Common Stockholders basic | 285 | (3,305) | (1,388) | (5,055) | ||
Net Income (Loss) Attributable to Common Stockholders diluted | $ 285 | $ (3,305) | $ (1,388) | $ (5,055) | ||
Denominator: | ||||||
Weighted Average Number of Shares of Common Stock Outstanding - Basic (in shares) | 30,451,622 | 18,496,640 | 29,889,413 | 18,480,248 | ||
Incremental Shares Attributable to the Assumed Conversion of Preferred Stock (in shares) | 1,363,636 | 0 | 0 | 0 | ||
Weighted Average Number of Shares of Common Stock Outstanding - Diluted (in shares) | 32,033,776 | 18,496,640 | 29,889,413 | 18,480,248 | ||
Net Loss per Share Attributable to Common Stockholders - Basic (in dollars per share) | $ 0.01 | $ (0.18) | $ (0.05) | $ (0.27) | ||
Net Loss per Share Attributable to Common Stockholders - Diluted (in dollars per share) | $ 0.01 | $ (0.18) | $ (0.05) | $ (0.27) | ||
Options to Purchase Common Stock | ||||||
Denominator: | ||||||
Incremental common shares attributable to dilutive effect of share-based payment arrangements (in shares) | 35,185 | 0 | 0 | 0 | ||
Unvested Restricted Stock Units | ||||||
Denominator: | ||||||
Incremental common shares attributable to dilutive effect of share-based payment arrangements (in shares) | 183,333 | 0 | 0 | 0 |
Basis of Presentation, Summar_5
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Narrative (Details) - shares | Jun. 30, 2024 | Jun. 30, 2023 |
Pre-funded Warrants | ||
Finite-Lived Intangible Assets [Line Items] | ||
Common stock issuable upon exercise of pre-funded warrants (in shares) | 0 | 1,793,000 |
Basis of Presentation, Summar_6
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Summary of Potentially Dilutive Securities (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Net Earnings per Share | ||||
Securities excluded from diluted loss per share calculation (in shares) | 4,327,706 | 13,444,459 | 7,778,351 | 13,444,459 |
Warrants to Purchase Common Stock | ||||
Net Earnings per Share | ||||
Securities excluded from diluted loss per share calculation (in shares) | 3,984,484 | 10,196,268 | 3,984,484 | 10,196,268 |
Options to Purchase Common Stock | ||||
Net Earnings per Share | ||||
Securities excluded from diluted loss per share calculation (in shares) | 342,331 | 1,570,599 | 1,895,031 | 1,570,599 |
Convertible Preferred Stock | ||||
Net Earnings per Share | ||||
Securities excluded from diluted loss per share calculation (in shares) | 0 | 1,363,636 | 1,363,636 | 1,363,636 |
Unvested Restricted Stock Units | ||||
Net Earnings per Share | ||||
Securities excluded from diluted loss per share calculation (in shares) | 0 | 313,065 | 534,309 | 313,065 |
Unvested Restricted Stock Awards | ||||
Net Earnings per Share | ||||
Securities excluded from diluted loss per share calculation (in shares) | 891 | 891 | 891 | 891 |
Asset Acquisition - Narrative (
Asset Acquisition - Narrative (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jul. 12, 2024 USD ($) installment | Jul. 10, 2023 USD ($) payment | Jun. 30, 2024 USD ($) | Jun. 30, 2024 USD ($) | |
Customer Relationships | ||||
Asset Acquisition [Line Items] | ||||
Amortization of intangible assets | $ 100 | $ 300 | ||
Net intangible assets | $ 10,483 | $ 10,483 | ||
Evoqua Water Technologies LLC | ||||
Asset Acquisition [Line Items] | ||||
Total consideration | $ 17,361 | |||
Cash payment, including transaction cost | $ 12,400 | |||
Number of deferred payments | payment | 2 | |||
Milestone payments | $ 2,500 | |||
Evoqua Water Technologies LLC | Subsequent event | ||||
Asset Acquisition [Line Items] | ||||
Deferred payment | $ 300 | |||
Deferred payments, number of installments | installment | 4 | |||
Evoqua Water Technologies LLC | Customer Relationships | ||||
Asset Acquisition [Line Items] | ||||
Intangible asset, useful life | 20 years |
Asset Acquisition - Schedule of
Asset Acquisition - Schedule of Purchase Price, on a Relative Fair Value Basis, to Assets Acquired (Details) - Evoqua Water Technologies LLC $ in Thousands | Jul. 10, 2023 USD ($) |
Asset Acquisition [Line Items] | |
Cash Payment | $ 12,233 |
Deferred Consideration | 5,000 |
Transaction Costs | 128 |
Total Consideration | 17,361 |
Equipment | 5,093 |
Inventory | 1,233 |
Total Assets Acquired | 17,361 |
Customer Relationships | |
Asset Acquisition [Line Items] | |
Customer Relationships Intangible Asset | $ 11,035 |
Asset Acquisition - Schedule _2
Asset Acquisition - Schedule of Future Amortization Expense (Details) - Customer Relationships $ in Thousands | Jun. 30, 2024 USD ($) |
Asset Acquisition [Line Items] | |
2024 (remainder of year) | $ 276 |
2025 | 552 |
2026 | 552 |
2027 | 552 |
2028 | 552 |
Thereafter | 7,999 |
Total | $ 10,483 |
Revenue Recognition - Nature of
Revenue Recognition - Nature of Goods and Services (Details) $ in Millions | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2024 | Dec. 31, 2023 USD ($) | Jun. 30, 2023 | Jun. 30, 2024 agreement segment | Jun. 30, 2023 | Dec. 31, 2023 | |
Revenue Recognition [Line Items] | ||||||
Number of operating market segments | segment | 1 | |||||
Customers average payment term | 30 days | |||||
Distributors average payment term | 60 days | |||||
Number of distribution and license agreements | agreement | 5 | |||||
Da Vita Healthcare Partners Inc | ||||||
Revenue Recognition [Line Items] | ||||||
Product purchase agreement, one time payment from counterparty | $ | $ 0.4 | |||||
Da Vita Healthcare Partners Inc | Revenue Benchmark | Customer Concentration Risk | ||||||
Revenue Recognition [Line Items] | ||||||
Customer concentration, percentage | 45% | 51% | 44% | 50% | ||
Da Vita Healthcare Partners Inc | Accounts Receivable | Customer Concentration Risk | ||||||
Revenue Recognition [Line Items] | ||||||
Customer concentration, percentage | 35% | 35% |
Revenue Recognition - Summary o
Revenue Recognition - Summary of Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | $ 25,832 | $ 18,080 | $ 48,508 | $ 37,748 |
Drug products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 12 | 65 | 23 | 130 |
Concentrate Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 25,820 | 18,015 | 48,485 | 37,618 |
U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 23,209 | 16,125 | 44,143 | 34,057 |
U.S. | Drug products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 0 | 0 | 0 | 0 |
U.S. | Concentrate Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 23,209 | 16,125 | 44,143 | 34,057 |
Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 2,623 | 1,955 | 4,365 | 3,691 |
Rest of World | Drug products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 12 | 65 | 23 | 130 |
Rest of World | Concentrate Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 2,611 | 1,890 | 4,342 | 3,561 |
License Fee – Over time | Drug products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 12 | 65 | 23 | 130 |
License Fee – Over time | Concentrate Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 0 | 1,472 | ||
License Fee – Over time | U.S. | Drug products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 0 | 0 | 0 | |
License Fee – Over time | U.S. | Concentrate Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 0 | 1,472 | ||
License Fee – Over time | Rest of World | Drug products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 12 | 65 | 23 | 130 |
License Fee – Over time | Rest of World | Concentrate Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 0 | 0 | ||
Product Sales – Point-in-time | Concentrate Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 25,820 | 18,015 | 48,485 | 36,146 |
Product Sales – Point-in-time | U.S. | Concentrate Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 23,209 | 16,125 | 44,143 | 32,585 |
Product Sales – Point-in-time | Rest of World | Concentrate Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | $ 2,611 | $ 1,890 | $ 4,342 | $ 3,561 |
Revenue Recognition - Summary_2
Revenue Recognition - Summary of Contract Balances (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 | Jan. 01, 2023 |
Revenue from Contract with Customer [Abstract] | |||
Accounts Receivable, net | $ 10,840,000 | $ 10,901,000 | $ 6,259,000 |
Contract Liabilities, which are included in deferred license revenue | 498,000 | 521,000 | $ 4,331,000 |
Revenue Recognition [Line Items] | |||
Contract assets | 0 | 0 | |
Concentrate Products | |||
Revenue Recognition [Line Items] | |||
Reserve for returns | $ 0 | $ 0 |
Revenue Recognition - Transacti
Revenue Recognition - Transaction Price Allocated to Remaining Performance Obligations (Details) - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Revenue Recognition [Line Items] | ||
Contract liabilities, revenue recognized | $ 0 | $ 1.6 |
Revenue performance obligation | $ 0.5 |
Investments Available-for-Sale
Investments Available-for-Sale -Summary (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |||||
Amortized Cost | $ 1,948 | ||||
Unrealized Gain | 4 | ||||
Unrealized Loss | 0 | ||||
Accrued Interest | 0 | ||||
Fair Value | $ 1,952 | ||||
Realized gain on available-for-sale investments | $ 51 | $ 0 | $ 51 | $ 0 |
Inventory - Summary of Componen
Inventory - Summary of Components of Inventory (Details) - USD ($) $ in Thousands | 1 Months Ended | ||
Aug. 31, 2023 | Jun. 30, 2024 | Dec. 31, 2023 | |
Inventory - Current Portion | |||
Raw Materials | $ 2,209 | $ 2,250 | |
Work in Process | 225 | 351 | |
Finished Goods | 3,449 | 3,270 | |
Total Current Inventory | 5,883 | 5,871 | |
Inventory - Long Term | 178 | 178 | |
Total Inventory | $ 6,061 | $ 6,049 | |
Triferic Inventory | SEC Schedule, 12-09, Reserve, Inventory | |||
Inventory - Current Portion | |||
Inventory reserve, period increase (decrease) | $ 1,100 |
Inventory - Narrative (Details)
Inventory - Narrative (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Inventory | $ 5,883,000 | $ 5,871,000 |
Inventory, reserve | $ 25,000 | $ 25,000 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Property and equipment | |||||
Gross property and equipment | $ 15,632 | $ 15,632 | $ 15,206 | ||
Accumulated Depreciation and Amortization | (9,623) | (9,623) | (8,804) | ||
Property and Equipment, net | 6,009 | 6,009 | 6,402 | ||
Depreciation expense | 400 | $ 200 | 800 | $ 300 | |
Leasehold Improvements | |||||
Property and equipment | |||||
Gross property and equipment | 1,542 | 1,542 | 1,423 | ||
Machinery and Equipment | |||||
Property and equipment | |||||
Gross property and equipment | 11,438 | 11,438 | 11,131 | ||
Information Technology & Office Equipment | |||||
Property and equipment | |||||
Gross property and equipment | 1,845 | 1,845 | 1,845 | ||
Laboratory Equipment | |||||
Property and equipment | |||||
Gross property and equipment | $ 807 | $ 807 | $ 807 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Accrued Compensation and Benefits | $ 1,629 | $ 2,413 |
Accrued Unvouchered Receipts | 1,325 | 1,663 |
Accrued Manufacturing Expense | 902 | 1,064 |
Accrued Workers Compensation | 408 | 254 |
Other Accrued Liabilities | 1,904 | 1,755 |
Total Accrued Liabilities | $ 6,168 | $ 7,149 |
Deferred License Revenue (Detai
Deferred License Revenue (Details) $ in Millions | 1 Months Ended | 6 Months Ended | ||
Oct. 31, 2014 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Nov. 09, 2022 installment | |
Disaggregation of Revenue [Line Items] | ||||
Recognized deferred revenue | $ 0 | $ 1.6 | ||
Baxter Healthcare Organization | ||||
Disaggregation of Revenue [Line Items] | ||||
Term of agreement | 10 years | |||
Upfront payment | $ 20 | |||
Number of payment installments | installment | 2 | |||
Recognized deferred revenue | $ 1.5 |
Stockholders_ Equity - Narrativ
Stockholders’ Equity - Narrative (Details) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | |||||||||||
Jul. 10, 2023 USD ($) $ / shares shares | Jun. 16, 2022 USD ($) shares | Apr. 06, 2022 USD ($) $ / shares shares | Jun. 30, 2024 USD ($) $ / shares shares | Mar. 31, 2024 shares | Jun. 30, 2023 shares | Jun. 30, 2024 USD ($) $ / shares shares | Jun. 30, 2023 shares | Jan. 02, 2024 USD ($) $ / shares shares | Dec. 31, 2023 $ / shares shares | Mar. 31, 2023 shares | Dec. 31, 2022 shares | Apr. 08, 2022 USD ($) | |
Class of Stock [Line Items] | |||||||||||||
Preferred shares, shares authorized (in shares) | 2,000,000 | 2,000,000 | 2,000,000 | ||||||||||
Preferred shares, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||
Preferred shares, shares issued (in shares) | 15,000 | 15,000 | 15,000 | ||||||||||
Preferred shares, shares outstanding (in shares) | 15,000 | 15,000 | 15,000 | ||||||||||
Common shares, shares authorized (in shares) | 170,000,000 | 170,000,000 | 170,000,000 | ||||||||||
Common shares, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||
Common shares, shares outstanding (in shares) | 31,030,218 | 16,795,673 | 31,030,218 | 16,795,673 | 29,130,607 | ||||||||
Common shares, shares issued (in shares) | 31,030,218 | 31,030,218 | 29,130,607 | ||||||||||
Exercise of employee stock options, net of tax (in shares) | 0 | 0 | 0 | 0 | |||||||||
COMMON STOCK | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common shares, shares outstanding (in shares) | 31,030,218 | 29,556,474 | 16,795,673 | 31,030,218 | 16,795,673 | 29,130,607 | 12,552,673 | 12,163,673 | |||||
Term loan | Term loan | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock issuable upon exercise of pre-funded warrants (in shares) | 191,096 | ||||||||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 1.83 | ||||||||||||
Fair value of warrant | $ | $ 0.2 | ||||||||||||
PIPE Purchase Agreement Pre-Funded Warrant | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Warrants exercised (in shares) | 0 | 4,118,000 | 0 | 4,507,000 | |||||||||
Armistice Warrant Agreement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock issuable upon exercise of pre-funded warrants (in shares) | 9,900,990 | ||||||||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 1.39 | ||||||||||||
Proceeds from Issuance of Common Stock in connection with exercise of Prior Warrant and Pre-Funded Warrants | $ | $ 13.8 | ||||||||||||
Armistice Reload Warrant Agreement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock issuable upon exercise of pre-funded warrants (in shares) | 3,750,000 | ||||||||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 5.13 | ||||||||||||
Warrant expiration period | 54 months | ||||||||||||
Ownership limitation percentage | 0.0999 | ||||||||||||
Letter Agreement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Period after issuance, shares cannot be sold | 45 days | ||||||||||||
Minimum purchase price (in dollars per share) | $ / shares | $ 6.25 | ||||||||||||
Extended expiration date | 1 year | ||||||||||||
At-the-Market Offering | COMMON STOCK | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Issuance of common stock (in shares) | 1,350,169 | 358,210 | 1,708,379 | ||||||||||
Series X Convertible Preferred Stock | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Interest rate percentage | 1% | ||||||||||||
Common stock trading price (in dollars per share) | $ / shares | $ 22 | ||||||||||||
Common stock trading period | 30 days | ||||||||||||
Accreted amount | $ | $ 0.2 | $ 0.2 | |||||||||||
Conversion price (in dollars 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% | ||||||||||||
Maximum working capital line | $ | $ 5 | ||||||||||||
Consideration received | $ | 15 | ||||||||||||
Stock issuance costs | $ | 0.1 | ||||||||||||
Proceeds from sale of equity, net | $ | 14.9 | ||||||||||||
Da Vita Healthcare Partners Inc | Share Issuance, Tranche One | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Proceeds from issuance of convertible preferred stock | $ | $ 7.5 | 7.5 | |||||||||||
Da Vita Healthcare Partners Inc | Series X Convertible Preferred Stock | Private Placement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Sale of stock, aggregate consideration authorized | $ | $ 15 | ||||||||||||
Common stock trading price (in dollars per share) | $ / shares | $ 1,000 | ||||||||||||
Da Vita Healthcare Partners Inc | Series X Convertible Preferred Stock | Private Placement | Share Issuance, Tranche One | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Number of shares issued (in shares) | 7,500 | 7,500 | |||||||||||
Cantor Fitzgerald & Co | At-the-Market Offering | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Sale of stock, aggregate consideration authorized | $ | $ 8.2 | 8.2 | $ 12.2 | ||||||||||
Cantor Fitzgerald & Co | Controlled Equity Offering | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Consideration received | $ | $ 2.8 |
Stockholder's Equity - Summary
Stockholder's Equity - Summary of Common Stock Reserved for Issuance (Details) - shares | Jun. 30, 2024 | Dec. 31, 2023 | Jun. 30, 2023 |
Common Stock and Common Stock Equivalents: | |||
Common Stock (in shares) | 31,030,218 | 29,130,607 | 16,795,673 |
Common Stock and Pre-funded Stock Warrants (in shares) | 31,030,218 | 18,588,673 | |
Options to Purchase Common Stock (in shares) | 1,895,031 | 1,570,599 | |
Convertible Preferred Stock (in shares) | 1,363,636 | 1,363,636 | |
Total (in shares) | 38,808,569 | 32,033,132 | |
Warrants to Purchase Common Stock | |||
Common Stock and Common Stock Equivalents: | |||
Warrants to Purchase Common Stock (in shares) | 3,984,484 | 10,196,268 | |
Pre-funded Warrants | |||
Common Stock and Common Stock Equivalents: | |||
Common Stock Issuable upon Exercise of Pre-funded Warrants (in shares) | 0 | 1,793,000 | |
Unvested Restricted Stock Awards | |||
Common Stock and Common Stock Equivalents: | |||
Unvested restricted stock awards/units (in shares) | 891 | 891 | |
Unvested Restricted Stock Units | |||
Common Stock and Common Stock Equivalents: | |||
Unvested restricted stock awards/units (in shares) | 534,309 | 258,885 | 313,065 |
Stockholder's Equity - Summar_2
Stockholder's Equity - Summary of Assumptions Used In Calculating Fair Value of Warrant (Details) | Jun. 30, 2024 |
Stock Price per Share | |
FairValueAssetsAndLiabilitiesMeasuredOnRecurringAndNonrecurringBasisValuationTechniquesTable [Line Items] | |
Measurement input | 1.86 |
Expected Stock Price Volatility | |
FairValueAssetsAndLiabilitiesMeasuredOnRecurringAndNonrecurringBasisValuationTechniquesTable [Line Items] | |
Measurement input | 0.8500 |
Risk-free Interest Rate | |
FairValueAssetsAndLiabilitiesMeasuredOnRecurringAndNonrecurringBasisValuationTechniquesTable [Line Items] | |
Measurement input | 0.0393 |
Term (years) | |
FairValueAssetsAndLiabilitiesMeasuredOnRecurringAndNonrecurringBasisValuationTechniquesTable [Line Items] | |
Measurement input | 5 |
Dividend Yield | |
FairValueAssetsAndLiabilitiesMeasuredOnRecurringAndNonrecurringBasisValuationTechniquesTable [Line Items] | |
Measurement input | 0 |
Stock-Based Compensation - Shar
Stock-Based Compensation - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share based compensation expense | $ 338 | $ 309 | $ 589 | $ 502 |
Restricted Stock Units | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share based compensation expense | 159 | 119 | 277 | 164 |
Stock Option Awards | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share based compensation expense | $ 179 | $ 190 | $ 312 | $ 338 |
Stock-Based Compensation - Perf
Stock-Based Compensation - Performance Based Restricted Stock Awards (Details) - Restricted stock awards - performance based awards - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | |
Jun. 30, 2024 | Dec. 31, 2023 | |
Number of Shares | ||
Unvested, beginning (in shares) | 891 | 891 |
Unvested, ending (in shares) | 891 | 891 |
Weighted Average Grant-Date Fair Value | ||
Unvested, beginning (in dollars per share) | $ 62.70 | $ 62.70 |
Unvested, ending (in dollars per share) | $ 62.70 | $ 62.70 |
Vesting period | 20 months | |
Unrecognized stock-based compensation expense | $ 0 |
Stock-Based Compensation - Serv
Stock-Based Compensation - Service Based Restricted Stock Units (Details) - Unvested Restricted Stock Units $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2024 USD ($) $ / shares shares | |
Number of Shares | |
Outstanding beginning (in shares) | shares | 258,885 |
Granted (in shares) | shares | 466,656 |
Vested (in shares) | shares | (191,232) |
Outstanding ending (in shares) | shares | 534,309 |
Weighted Average Grant-Date Fair Value | |
Outstanding beginning (in dollars per share) | $ / shares | $ 1.97 |
Granted (in dollars per share) | $ / shares | 1.58 |
Vested (in dollars per share) | $ / shares | 2.18 |
Outstanding ending (in dollars per share) | $ / shares | $ 1.48 |
Unrecognized stock-based compensation expense | $ | $ 0.7 |
Unrecognized stock-based compensation expense, weighted average remaining term (in years) (less than) | 1 year 8 months 12 days |
Minimum | |
Weighted Average Grant-Date Fair Value | |
Vesting period | 1 year |
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 - $ / shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected Stock Price Volatility, minimum | 81.80% | |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price (in dollars per share) | $ 1.39 | $ 1.37 |
Expected Stock Price Volatility, minimum | 81.60% | |
Risk-free Interest Rate, minimum | 4.31% | 3.41% |
Term (years) | 5 years 7 months 9 days | 4 years |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price (in dollars per share) | $ 1.80 | $ 2.83 |
Expected Stock Price Volatility, minimum | 81.90% | |
Risk-free Interest Rate, minimum | 4.45% | 3.55% |
Term (years) | 5 years 7 months 13 days | 6 years |
Stock-Based Compensation - Se_3
Stock-Based Compensation - Service Based Stock Options (Details) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2024 USD ($) $ / shares shares | |
Shares Underlying Options | |
Outstanding at the end of the period (in shares) | 1,895,031 |
Stock Option Awards | |
Shares Underlying Options | |
Outstanding at the beginning of the period (in shares) | 1,328,621 |
Granted (in shares) | 569,160 |
Forfeited (in shares) | (2,500) |
Expired (in shares) | (250) |
Outstanding at the end of the period (in shares) | 1,895,031 |
Exercisable at end of period (in shares) | 455,511 |
Weighted Average Exercise Price | |
Outstanding at the beginning of the period (in dollars per share) | $ / shares | $ 5.22 |
Granted (in dollars per share) | $ / shares | 1.40 |
Forfeited (in dollars per share) | $ / shares | 2.29 |
Expired (in dollar per share) | $ / shares | 2.83 |
Outstanding at the end of the period (in dollars per share) | $ / shares | 4.08 |
Exercisable at end of the period (in dollars per share) | $ / shares | $ 11.57 |
Weighted Average Remaining Contractual Term | |
Outstanding | 8 years 6 months |
Exercisable at end of the period | 7 years 2 months 12 days |
Aggregate Intrinsic Value (in $1,000's) | |
Outstanding | $ | $ 529,694 |
Exercisable at end of the period | $ | $ 88,240 |
Stock-Based Compensation - Se_4
Stock-Based Compensation - Service Based Stock Options - Others (Details) - Stock Option Awards - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average grant date fair value (in dollars per share) | $ 0.99 | $ 1.03 |
Unrecognized stock-based compensation expenses | $ 0.9 | |
Unrecognized stock-based compensation expense, weighted average remaining term (in years) | 3 years 2 months 12 days |
License Agreements (Details)
License Agreements (Details) | Oct. 07, 2018 agreement | Jun. 30, 2024 USD ($) | Dec. 31, 2023 USD ($) |
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 | $ 87,900 | $ 87,900 | |
Milestone payments | $ 0 | $ 0 |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 USD ($) ft² facility | Jun. 30, 2023 USD ($) | |
Lessee, Lease, Description [Line Items] | ||
Operating lease right-of-use asset and lease liability increase | $ | $ 1,549 | $ 0 |
Wixom, Michigan | Wixom, Michigan Property One | ||
Lessee, Lease, Description [Line Items] | ||
Facility square footage | 51,000 | |
Wixom, Michigan | Wixom, Michigan Property Two | ||
Lessee, Lease, Description [Line Items] | ||
Facility square footage | 17,500 | |
Texas and South Carolina | ||
Lessee, Lease, Description [Line Items] | ||
Number of manufacturing facilities | facility | 2 | |
Grapevine, Texas | ||
Lessee, Lease, Description [Line Items] | ||
Facility square footage | 51,000 | |
Greer, South Carolina | ||
Lessee, Lease, Description [Line Items] | ||
Facility square footage | 57,000 | |
Hackensack, New Jersey | ||
Lessee, Lease, Description [Line Items] | ||
Facility square footage | 4,100 | |
Maximum | ||
Lessee, Lease, Description [Line Items] | ||
Lease term | 6 years |
Leases - Summary of Lease Costs
Leases - Summary of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Operating Leases | ||||
Operating Lease Cost | $ 341 | $ 455 | $ 761 | $ 859 |
Variable Lease Cost | 128 | 109 | 250 | 224 |
Operating Lease Expense | 469 | 564 | 1,011 | 1,083 |
Finance Leases | ||||
Amortization of Right-of-use Assets | 141 | 141 | 282 | 282 |
Interest on Lease Obligations | 29 | 38 | 61 | 77 |
Finance Lease Expense | 170 | 179 | 343 | 359 |
Short-term Lease Rent Expense | 6 | 4 | 11 | 8 |
Total Rent Expense | 645 | 747 | 1,365 | 1,450 |
Other Information | ||||
Operating Cash Flows from Operating Leases | 426 | 478 | 863 | 902 |
Operating Cash Flows from Finance Leases | 29 | 38 | 61 | 77 |
Financing Cash Flows from Finance Leases | $ 138 | $ 129 | $ 276 | $ 258 |
Weighted-average Remaining Lease Term – Operating Leases | 2 years 7 months 6 days | 2 years 8 months 12 days | 2 years 7 months 6 days | 2 years 8 months 12 days |
Weighted-average Remaining Lease Term – Finance Leases | 3 years | 3 years 10 months 24 days | 3 years | 3 years 10 months 24 days |
Weighted-average Discount Rate – Operating Leases | 6.30% | 6.50% | 6.30% | 6.50% |
Weighted-average Discount Rate – Finance Leases | 6.40% | 6.40% | 6.40% | 6.40% |
Leases - Summary of Finance Lea
Leases - Summary of Finance Lease and Operating Lease Maturities (Details) $ in Thousands | Jun. 30, 2024 USD ($) |
Operating | |
Year ending December 31, 2024 (remaining) | $ 835 |
Year ending December 31, 2025 | 1,587 |
Year ending December 31, 2026 | 946 |
Year ending December 31, 2027 | 525 |
Year ending December 31, 2028 | 2 |
Total | 3,895 |
Less Present Value Discount | (295) |
Operating Lease Liabilities | 3,600 |
Finance | |
Year ending December 31, 2024 (remaining) | 334 |
Year ending December 31, 2025 | 676 |
Year ending December 31, 2026 | 666 |
Year ending December 31, 2027 | 311 |
Year ending December 31, 2028 | 0 |
Total | 1,987 |
Less Present Value Discount | (175) |
Finance Lease Liabilities | $ 1,812 |
Loans and Security Agreement -
Loans and Security Agreement - Narrative (Details) - Term loan $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Jan. 02, 2024 USD ($) $ / shares shares | Mar. 16, 2020 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) installment | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Nov. 10, 2022 USD ($) | |
Term loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Aggregate principal amount | $ 8,000 | $ 35,000 | $ 7,500 | $ 5,000 | ||||
Calculation for number of shares of common stock able to be purchased by warrant, percentage of principal amount of relevant term loan funded | 3.50% | |||||||
Common stock issuable upon exercise of pre-funded warrants (in shares) | shares | 191,096 | |||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 1.83 | |||||||
Interest rate, base percentage | 7.50% | 4.75% | ||||||
Interest rate, additional percentage added to base percentage | 3.50% | 4% | ||||||
Initial interest rate percentage | 8.75% | |||||||
Option to add interest rate amount to outstanding principal balance in lieu of paying such amount in cash, percentage | 2% | 1% | ||||||
Number of monthly installments | installment | 10 | |||||||
Prepayment premium percentage | 5% | |||||||
Minimum liquidity floor | $ 5,000 | |||||||
Minimum principal amount pursuant to liquidity covenant | $ 15,000 | |||||||
Period for which company is entitled to make interest-only payments | 30 months | |||||||
Debt instrument, notice period (at least) | 7 days | |||||||
Debt instrument prepayment before first anniversary of loan agreement date | 6% | |||||||
Debt instrument, prepayment after first anniversary of loan agreement date but on or before second anniversary, percentage | 2% | |||||||
Debt instrument, prepayment after second anniversary of loan agreement date but on or before third anniversary, percentage | 1% | |||||||
Debt instrument, prepayment after third anniversary of loan agreement date through maturity, percentage | 0% | |||||||
Fair value of warrant | $ 200 | |||||||
Effective interest rate | 12% | 12% | ||||||
Interest expense | $ 200 | $ 300 | $ 500 | $ 600 | ||||
Term Loan - Long-Term, net of issuance costs | 8,295 | 8,295 | ||||||
Unamortized Issuance Costs, Discount and Premium, net | 600 | 600 | ||||||
Premium accretion | 844 | 844 | ||||||
Debt instrument, fee amount | 100 | 100 | ||||||
Paid-in-kind interest | $ 100 | $ 100 | ||||||
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 | |||||||
Net draw down proceeds | 21,200 | |||||||
Closing costs | $ 1,300 | |||||||
Debt instrument, additional fee at maturity, percentage | 4.375% | |||||||
Debt instrument, additional fee at maturity, amount | $ 1,000 | |||||||
Common stock issuable upon exercise of pre-funded warrants (in shares) | shares | 43,388 | |||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 18.15 | |||||||
Additional debt discount recognized | $ 500 |
Loans and Security Agreement _2
Loans and Security Agreement - Summary of Principal Payments on Term Loan (Details) - Term loan - Term loan $ in Thousands | Jun. 30, 2024 USD ($) |
Debt Instrument [Line Items] | |
2024 (remaining) | $ 0 |
2025 | 0 |
2026 | 1,359 |
2027 | 3,262 |
2028 | 3,262 |
2029 (inclusive of Final Fee) | 1,256 |
Total Debt Maturities | 9,139 |
Unamortized Issuance Costs, Discount and Premium, net | (844) |
Term Loan - Long-Term, net of issuance costs | $ 8,295 |
Insurance Financing Note Paya_2
Insurance Financing Note Payable (Details) $ in Thousands | Jun. 24, 2024 USD ($) payment | Jun. 03, 2023 USD ($) | Jun. 30, 2024 USD ($) | Dec. 31, 2023 USD ($) |
Short-term Debt [Line Items] | ||||
Insurance financing note payable | $ 670 | $ 244 | ||
9.59% Note Payable | Notes Payable to Banks | ||||
Short-term Debt [Line Items] | ||||
Short-term note payable | $ 700 | |||
Interest rate, base percentage | 9.59% | |||
Amortization period (in months) | 9 months | |||
7.89% Note Payable | Notes Payable to Banks | ||||
Short-term Debt [Line Items] | ||||
Short-term note payable | $ 700 | |||
Interest rate, base percentage | 7.89% | |||
Debt instrument, fee amount | $ 200 | |||
Number of installment payments | payment | 10 | |||
Note payabe, final payment | $ 100 | |||
Insurance financing note payable | $ 700 |