QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | ||||||||||
(Address of principal executive offices) | (Zip Code) |
Large accelerated filer | ☐ | Accelerated filer | ☐ | ||||||||
☒ | Smaller reporting company | ||||||||||
Emerging growth company |
Title of each class: | Trading Symbol | Name of each exchange on which registered: | ||||||||||||
Page | |||||
June 30, 2023 | December 31, 2022 | ||||||||||
(Unaudited) | |||||||||||
ASSETS | |||||||||||
Cash and Cash Equivalents | $ | $ | |||||||||
Investments Available-for-Sale | |||||||||||
Accounts Receivable, net | |||||||||||
Inventory | |||||||||||
Prepaid and Other Current Assets | |||||||||||
Total Current Assets | |||||||||||
Property and Equipment, net | |||||||||||
Inventory, Non-Current | |||||||||||
Right of Use Assets-Operating, net | |||||||||||
Right of Use Assets-Financing, net | |||||||||||
Goodwill | |||||||||||
Other Non-Current Assets | |||||||||||
Total Assets | $ | $ | |||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
Accounts Payable | $ | $ | |||||||||
Accrued Liabilities | |||||||||||
Lease Liability-Operating - Current | |||||||||||
Lease Liability-Financing - Current | |||||||||||
Deferred License Revenue - Current | |||||||||||
Term Loan - Net of Issuance Costs | |||||||||||
Insurance Financing Note Payable | |||||||||||
Customer Deposits | |||||||||||
Total Current Liabilities | |||||||||||
Lease Liability-Operating - Long-Term | |||||||||||
Lease Liability-Financing - Long-Term | |||||||||||
Term Loan, Net of Issuance Costs | |||||||||||
Deferred License Revenue - Long-Term | |||||||||||
Long Term Liability - Other | |||||||||||
Total Liabilities | |||||||||||
Stockholders’ Equity: | |||||||||||
Preferred Stock, $ | |||||||||||
Common Stock, $ | |||||||||||
Additional Paid-in Capital | |||||||||||
Accumulated Deficit | ( | ( | |||||||||
Accumulated Other Comprehensive Income | |||||||||||
Total Stockholders’ Equity | |||||||||||
Total Liabilities and Stockholders’ Equity | $ | $ |
Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | ||||||||||||||||||||
Net Sales | $ | $ | $ | $ | |||||||||||||||||||
Cost of Sales | |||||||||||||||||||||||
Gross Profit | |||||||||||||||||||||||
Research and Product Development | |||||||||||||||||||||||
Selling and Marketing | |||||||||||||||||||||||
General and Administrative | |||||||||||||||||||||||
Operating Loss | ( | ( | ( | ( | |||||||||||||||||||
Other (Expense) Income | |||||||||||||||||||||||
Realized Gain on Investments | |||||||||||||||||||||||
Interest Expense | ( | ( | ( | ( | |||||||||||||||||||
Interest Income | |||||||||||||||||||||||
Total Other Expense | ( | ( | ( | ( | |||||||||||||||||||
Net Loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Basic and Diluted Net Loss per Share | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Basic and Diluted Weighted Average Shares Outstanding * |
Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | ||||||||||||||||||||
Net Loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Unrealized Loss on Available-for-Sale Investments | ( | ( | |||||||||||||||||||||
Foreign Currency Translation Adjustments | ( | ( | ( | ( | |||||||||||||||||||
Comprehensive Loss | $ | ( | $ | ( | $ | ( | $ | ( |
PREFERRED STOCK | COMMON STOCK | ADDITIONAL PAID-IN CAPITAL | ACCUMULATED DEFICIT | ACCUMULATED OTHER COMPREHENSIVE INCOME | TOTAL STOCKHOLDERS' EQUITY | ||||||||||||||||||||||||||||||||||||||||||
SHARES | AMOUNT | SHARES | AMOUNT | ||||||||||||||||||||||||||||||||||||||||||||
Balance as of January 1, 2023 | $ | — | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||||||||||||
Net Loss | — | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||||||||||
Unrealized Loss on Available-for-Sale Investments | — | — | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||||||||||||
Foreign Currency Translation Adjustments | — | — | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||||||||||||
Issuance of Common Stock upon exercise of Pre-Funded Warrants | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
Stock-based Compensation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Balance as of March 31, 2023 | — | ( | |||||||||||||||||||||||||||||||||||||||||||||
Net Loss | — | — | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||||||||||||
Unrealized Loss on Available-for-Sale Investments | — | — | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||||||||||||
Foreign Currency Translation Adjustments | — | — | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||||||||||||
Issuance of Common Stock upon exercise of Pre-Funded Warrants | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
Stock-based Compensation expense | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Balance as of June 30, 2023 | $ | — | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||||||||||||
PREFERRED STOCK | COMMON STOCK | ADDITIONAL PAID-IN CAPITAL | ACCUMULATED DEFICIT | ACCUMULATED OTHER COMPREHENSIVE INCOME | TOTAL STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||||||||||||||||||||||||||||||||||||
SHARES | AMOUNT | SHARES | AMOUNT | ||||||||||||||||||||||||||||||||||||||||||||
Balance as of January 1, 2022 | — | $ | — | $ | $ | $ | ( | $ | $ | ||||||||||||||||||||||||||||||||||||||
Net Loss | — | — | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||||||||||||
Foreign Currency Translation Adjustments | — | — | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||||||||||||
Stock-based Compensation | — | — | — | — | ( | — | — | ( | |||||||||||||||||||||||||||||||||||||||
Balance as of March 31, 2022 | — | $ | ( | ( | |||||||||||||||||||||||||||||||||||||||||||
Net Loss | — | — | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||||||||||||
Foreign Currency Translation Adjustments | — | — | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||||||||||||
Issuance of common stock, net of offering costs/Public Offering | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock, net of offering costs/At-the-Market Offering | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Issuance of preferred stock, net of offering costs | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Vesting of Restricted Stock Units Issued, net of taxes withheld | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
Stock-based Compensation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Balance as of June 30, 2022 | $ | — | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||||||||||||
Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | ||||||||||
Cash Flows From Operating Activities: | |||||||||||
Net Loss | $ | ( | $ | ( | |||||||
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities: | |||||||||||
Depreciation and Amortization | |||||||||||
Stock-based Compensation | ( | ||||||||||
Increase in Inventory Reserves | |||||||||||
Non-cash lease expense from Right of Use Assets | |||||||||||
Amortization of Debt Financing Costs and Accretion of Debt Discount | |||||||||||
Loss on Disposal of Assets | ( | ||||||||||
Realized Gain on Sale of Investments Available-for-Sale | ( | ||||||||||
Changes in operating Assets and Liabilities: | |||||||||||
Accounts Receivable, net | ( | ||||||||||
Inventory | ( | ||||||||||
Prepaid and Other Assets | |||||||||||
Accounts Payable | ( | ||||||||||
Lease Liability | ( | ( | |||||||||
Other Liabilities | ( | ( | |||||||||
Deferred License Revenue | ( | ( | |||||||||
Changes in operating Assets and Liabilities | ( | ( | |||||||||
Cash Used In Operating Activities | ( | ( | |||||||||
Cash Flows From Investing Activities: | |||||||||||
Purchase of Investments Available-for-Sale | ( | ( | |||||||||
Sale of Investments Available-for-Sale | |||||||||||
Purchase of Equipment | ( | ( | |||||||||
Cash Provided by Investing Activities | |||||||||||
Cash Flows From Financing Activities: | |||||||||||
Payments on Debt | ( | ||||||||||
Payments on Insurance Financing Note Payable | ( | ( | |||||||||
Payment on Financing Lease Liabilities | ( | ||||||||||
Proceeds from the Issuance of Common Stock | |||||||||||
Offering Costs from the Issuance of Common Stock | ( | ||||||||||
Proceeds from the Issuance of Preferred Stock | |||||||||||
Offering Costs from the Issuance of Preferred Stock | ( | ||||||||||
Cash (Used In) Provided by Financing Activities | ( | ||||||||||
Effect of exchange rate changes on cash | ( | ( | |||||||||
(Decrease) Increase in Cash and Cash Equivalents | ( | ||||||||||
Cash and Cash Equivalents at Beginning of Period | |||||||||||
Cash and Cash Equivalents at End of Period | $ | $ | |||||||||
Supplemental Disclosure of Cash Flow Information: | |||||||||||
Cash Paid for Interest | $ | $ | |||||||||
Supplemental Disclosure of Noncash Investing and Financing Activities: | |||||||||||
Change in Unrealized Loss on Available-for-Sale Investments | $ | ( | $ | ||||||||
Insurance Financing Note Payable | $ | $ | |||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
2022 | 2022 | ||||||||||||||||
As Previously Reported: | |||||||||||||||||
Net loss per share attributable to common stockholders - basic and diluted | $ | ( | $ | ( | |||||||||||||
Weighted average number of shares of common stock outstanding - basic and diluted | |||||||||||||||||
As Restated: | |||||||||||||||||
Net loss per share attributable to common stockholders - basic and diluted | $ | ( | $ | ( | |||||||||||||
Weighted average number of shares of common stock outstanding - basic and diluted |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
(In Thousands, Except Shares and Per Share Amounts) | 2023 | 2022 | 2023 | 2022 | |||||||||||||||||||
Numerator: | |||||||||||||||||||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Net loss attributable to common stockholders for basic and diluted loss per share | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Denominator: | |||||||||||||||||||||||
Weighted average number of shares of common stock outstanding - basic and diluted | |||||||||||||||||||||||
Net loss per share attributable to common stockholders - basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( |
As of June 30, | |||||||||||
2023 | 2022 | ||||||||||
Options to purchase common stock | |||||||||||
Unvested restricted stock awards | |||||||||||
Unvested restricted stock units | |||||||||||
Convertible Preferred Stock | |||||||||||
Warrants to purchase common stock | |||||||||||
Total |
In thousands of U.S. dollars ($) | 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 | |||||||||||||||||||||||||||||||||||
Product Sales – Point-in-time | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||
License Fee – Over time | |||||||||||||||||||||||||||||||||||
Total Drug Products | |||||||||||||||||||||||||||||||||||
Concentrates Products | |||||||||||||||||||||||||||||||||||
Product Sales – Point-in-time | |||||||||||||||||||||||||||||||||||
License Fee – Over time | |||||||||||||||||||||||||||||||||||
Total Concentrate Products | |||||||||||||||||||||||||||||||||||
Net Revenue | $ | $ | $ | $ | $ | $ |
In thousands of U.S. dollars ($) | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2022 | |||||||||||||||||||||||||||||||||
Products By Geographic Area | Total | U.S. | Rest of World | Total | U.S. | Rest of World | |||||||||||||||||||||||||||||
Drug Revenues | |||||||||||||||||||||||||||||||||||
Product Sales – Point-in-time | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||
License Fee – Over time | |||||||||||||||||||||||||||||||||||
Total Drug Products | |||||||||||||||||||||||||||||||||||
Concentrates Products | |||||||||||||||||||||||||||||||||||
Product Sales – Point-in-time | |||||||||||||||||||||||||||||||||||
License Fee – Over time | |||||||||||||||||||||||||||||||||||
Total Concentrate Products | |||||||||||||||||||||||||||||||||||
Net Revenue | $ | $ | $ | $ | $ | $ |
In thousands of U.S. dollars ($) | June 30, 2023 | December 31, 2022 | |||||||||
Accounts Receivable, net | $ | $ | |||||||||
Contract liabilities, which are included in deferred revenue | $ | $ |
June 30, 2023 | |||||||||||||||||||||||||||||
Amortized Cost | Unrealized Gain | Unrealized Loss | Accrued Interest | Fair Value | |||||||||||||||||||||||||
Available-for-Sale Securities | |||||||||||||||||||||||||||||
Debt securities | $ | $ | $ | $ | $ |
December 31, 2022 | |||||||||||||||||||||||||||||
Amortized Cost | Unrealized Gain | Unrealized Loss | Accrued Interest | Fair Value | |||||||||||||||||||||||||
Available-for-Sale Securities | |||||||||||||||||||||||||||||
Debt securities | $ | $ | $ | $ | $ |
June 30, 2023 | December 31, 2022 | ||||||||||
Inventory - Current Portion | |||||||||||
Raw Materials | $ | $ | |||||||||
Work in Process | |||||||||||
Finished Goods | |||||||||||
Total Current Inventory | |||||||||||
Inventory - Long Term | |||||||||||
Total Inventory | $ | $ | |||||||||
June 30, 2023 | December 31, 2022 | ||||||||||
Leasehold Improvements | $ | $ | |||||||||
Machinery and Equipment | |||||||||||
Information Technology & Office Equipment | |||||||||||
Laboratory Equipment | |||||||||||
Total Property and Equipment | |||||||||||
Accumulated Depreciation | ( | ( | |||||||||
Property and Equipment, net | $ | $ |
June 30, 2023 | December 31, 2022 | ||||||||||
Accrued Research & Development Expense | $ | $ | |||||||||
Accrued Compensation and Benefits | |||||||||||
Accrued Unvouchered Receipts | |||||||||||
Accrued Workers Compensation | |||||||||||
Other Accrued Liabilities | |||||||||||
Total Accrued Liabilities | $ | $ |
As of June 30, | |||||||||||
Common stock and common stock equivalents: | 2023 | 2022 | |||||||||
Common stock | |||||||||||
Common stock issuable upon exercise of pre-funded warrants | |||||||||||
Common stock and pre-funded stock warrants | |||||||||||
Options to purchase common stock | |||||||||||
Unvested restricted stock awards | |||||||||||
Unvested restricted stock units | |||||||||||
Convertible Preferred Stock | |||||||||||
Warrants to purchase common stock | |||||||||||
Total |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Service-based awards: | |||||||||||||||||||||||
Restricted stock units | $ | $ | $ | $ | |||||||||||||||||||
Stock option awards | |||||||||||||||||||||||
Total Service Based Awards | |||||||||||||||||||||||
Performance-based awards: | |||||||||||||||||||||||
Restricted stock awards | ( | ||||||||||||||||||||||
Total | $ | $ | $ | $ | ( |
Number of Shares | Weighted Average Grant-Date Fair Value | ||||||||||
Unvested at January 1, 2023 | $ | ||||||||||
Unvested at June 30, 2023 | $ |
Number of Shares | Weighted Average Grant-Date Fair Value | ||||||||||
Unvested at January 1, 2022 | $ | ||||||||||
Forfeited | ( | $ | |||||||||
Unvested at June 30, 2022 | $ |
Number of Shares | Weighted Average Grant-Date Fair Value | ||||||||||
Unvested at January 1, 2023 | $ | ||||||||||
Granted | |||||||||||
Vested | ( | ||||||||||
Unvested at June 30, 2023 | $ |
Number of Shares | Weighted Average Grant-Date Fair Value | ||||||||||
Unvested at January 1, 2022 | $ | ||||||||||
Granted | |||||||||||
Vested | ( | ||||||||||
Forfeited | ( | ||||||||||
Unvested at June 30, 2022 | $ |
Six Months Ended June 30, 2023 | |||||
Exercise price | $ | ||||
Expected stock price volatility | |||||
Risk-free interest rate | |||||
Term (years) |
Shares Underlying Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term | ||||||||||||||||||
Outstanding at January 1, 2023 | $ | |||||||||||||||||||
Granted | ||||||||||||||||||||
Forfeited | ( | — | ||||||||||||||||||
Expired | ( | — | ||||||||||||||||||
Outstanding at June 30, 2023 | $ | |||||||||||||||||||
Exercisable at June 30, 2023 | $ |
Shares Underlying Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term | ||||||||||||||||||
Outstanding at January 1, 2022 | $ | |||||||||||||||||||
Granted | ||||||||||||||||||||
Forfeited | ( | — | ||||||||||||||||||
Expired | ( | — | ||||||||||||||||||
Outstanding at June 30, 2022 | $ | |||||||||||||||||||
Exercisable at June 30, 2022 | $ |
Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | ||||||||||||||||||||
Operating leases | |||||||||||||||||||||||
Operating lease cost | $ | $ | $ | $ | |||||||||||||||||||
Interest on lease obligations | |||||||||||||||||||||||
Variable lease cost | |||||||||||||||||||||||
Operating lease expense | |||||||||||||||||||||||
Finance leases | |||||||||||||||||||||||
Non-cash lease expense from right-of-use assets | |||||||||||||||||||||||
Interest on lease obligations | |||||||||||||||||||||||
Finance lease expense | |||||||||||||||||||||||
Short-term lease rent expense | |||||||||||||||||||||||
Total lease expense | $ | $ | $ | $ | |||||||||||||||||||
Other information | |||||||||||||||||||||||
Payments for principal from operating leases | $ | $ | $ | $ | |||||||||||||||||||
Payments for interest from finance leases | $ | $ | $ | $ | |||||||||||||||||||
Payments for principal from finance leases | $ | $ | $ | $ | |||||||||||||||||||
Weighted-average remaining lease term – operating leases | |||||||||||||||||||||||
Weighted-average remaining lease term – finance leases | |||||||||||||||||||||||
Weighted-average discount rate – operating leases | % | % | % | % | |||||||||||||||||||
Weighted-average discount rate – finance leases | % | % | % | % |
Operating | Finance | ||||||||||
Year ending December 31, 2023 (remaining) | $ | $ | |||||||||
Year ending December 31, 2024 | |||||||||||
Year ending December 31, 2025 | |||||||||||
Year ending December 31, 2026 | |||||||||||
Year ending December 31, 2027 | |||||||||||
Total | |||||||||||
Less present value discount | ( | ( | |||||||||
Operating and finance lease liabilities | $ | $ |
Principal Payments | |||||
2023 (remaining) | $ | ||||
2024 | |||||
2025 | |||||
$ |
For the Three Months Ended June 30, | |||||||||||||||||||||||||||||
2023 | % of Revenue | 2022 | % of Revenue | % Change | |||||||||||||||||||||||||
Net Sales | $ | 18,080 | $ | 18,682 | (3) | % | |||||||||||||||||||||||
Cost of Sales | 17,047 | 94 | % | 16,937 | 91 | % | 1 | ||||||||||||||||||||||
Gross Profit | 1,033 | 6 | 1,745 | 9 | (41) | ||||||||||||||||||||||||
Research and Product Development | 167 | 1 | 926 | 5 | (82) | ||||||||||||||||||||||||
Selling and Marketing | 530 | 3 | 526 | 3 | 1 | ||||||||||||||||||||||||
General and Administrative | 3,295 | 18 | 4,775 | 26 | (31) | ||||||||||||||||||||||||
Operating Loss | $ | (2,959) | (16) | % | $ | (4,482) | (24) | % | (34) | % |
For the Six Months Ended June 30, | |||||||||||||||||||||||||||||
2023 | % of Revenue | 2022 | % of Revenue | % Change | |||||||||||||||||||||||||
Net Sales | $ | 37,748 | $ | 34,806 | 8 | % | |||||||||||||||||||||||
Cost of Sales | 34,116 | 90 | % | 33,846 | 97 | % | 1 | ||||||||||||||||||||||
Gross Profit | 3,632 | 10 | 960 | 3 | 278 | ||||||||||||||||||||||||
Research and Product Development | 445 | 1 | 2,494 | 7 | (82) | ||||||||||||||||||||||||
Selling and Marketing | 1,028 | 3 | 981 | 3 | 5 | ||||||||||||||||||||||||
General and Administrative | 6,545 | 17 | 8,592 | 25 | (24) | ||||||||||||||||||||||||
Operating Loss | $ | (4,386) | (12) | % | $ | (11,107) | (32) | % | (61) | % |
EXHIBIT INDEX | ||||||||
Exhibit No. | Description | |||||||
4.1 * | ||||||||
10.1 * | ||||||||
10.2 * | ||||||||
10.3 * | ||||||||
31.1* | ||||||||
32.1** | ||||||||
101.INS* | XBRL Instance Document | |||||||
101.SCH* | XBRL Taxonomy Extension Schema | |||||||
101.CAL* | XBRL Taxonomy Extension Calculation Linkbase | |||||||
101.DEF* | XBRL Taxonomy Extension Definition Database | |||||||
101.LAB* | XBRL Taxonomy Extension Label Linkbase | |||||||
101.PRE* | XBRL Taxonomy Extension Presentation Linkbase | |||||||
104* | The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, formatted in Inline XBRL (included as Exhibit 101) | |||||||
* | Filed herewith | |||||||
** | Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act | |||||||
ROCKWELL MEDICAL, INC. | |||||||||||
(Registrant) | |||||||||||
Date: August 14, 2023 | /s/ Mark Strobeck | ||||||||||
Mark Strobeck, Ph.D. Chief Executive Officer (Principal Executive Officer and Interim Financial Officer) | |||||||||||
ROCKWELL MEDICAL, INC. | ||
By: /s/ Mark Strobeck__________ Name: Mark Strobeck Title: CEO |
Name: | |||||
(Please Print) | |||||
Address: | |||||
Phone Number: Email Address: | (Please Print) ______________________________________ ______________________________________ | ||||
Dated: _______________ __, ______ | |||||
Holder’s Signature: | |||||
Holder’s Address: |
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Number of Warrants Exercised | 9,900,990 | ||||
Aggregate Existing Warrant Exercise Price | $13,762,376.10 | ||||
New Warrants: | 3,750,000 | ||||
Beneficial Ownership Blocker: | 4.99% | ||||
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PURCHASER: ROCKWELL MEDICAL, INC. By:/s/ Mark Strobeck_________________________ Name: Title: | |||||
SELLER: EVOQUA WATER TECHNOLOGIES LLC By: /s/ Rodney Aulick Name: Rodney Aulick Title: EVP and Segment President, Integrated Sales Solutions and Services |
Date: | August 14, 2023 | ||||
/s/ Mark Strobeck Mark Strobeck (Principal Executive Officer and Principal Financial Officer) |
Date: August 14, 2023 | /s/ Mark Strobeck | ||||
Mark Strobeck (Principal Executive Officer and Principal Financial Officer) | |||||
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares |
Jun. 30, 2023 |
Dec. 31, 2022 |
Jun. 30, 2022 |
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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) | 16,795,673 | 12,163,673 | |
Common shares, shares outstanding (in shares) | 16,795,673 | 12,163,673 | 9,407,296 |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||||
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Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Income Statement [Abstract] | ||||||
Net Sales | $ 18,080 | $ 18,682 | $ 37,748 | $ 34,806 | ||
Cost of Sales | 17,047 | 16,937 | 34,116 | 33,846 | ||
Gross Profit | 1,033 | 1,745 | 3,632 | 960 | ||
Research and Product Development | 167 | 926 | 445 | 2,494 | ||
Selling and Marketing | 530 | 526 | 1,028 | 981 | ||
General and Administrative | 3,295 | 4,775 | 6,545 | 8,592 | ||
Operating Loss | (2,959) | (4,482) | (4,386) | (11,107) | ||
Other (Expense) Income | ||||||
Realized Gain on Investments | 0 | 0 | 0 | 4 | ||
Interest Expense | (395) | (485) | (782) | (1,025) | ||
Interest Income | 49 | 0 | 113 | 0 | ||
Total Other Expense | (346) | (485) | (669) | (1,021) | ||
Net Loss | $ (3,305) | $ (4,967) | $ (5,055) | $ (12,128) | ||
Basic Net Loss per Share (in dollars per share) | $ (0.18) | $ (0.43) | $ (0.27) | $ (1.20) | ||
Diluted Net Loss per Share (in dollars per share) | $ (0.18) | $ (0.43) | $ (0.27) | $ (1.20) | ||
Basic Weighted Average Shares Outstanding (in shares) | [1] | 18,496,640 | 11,591,768 | 18,480,248 | 10,076,415 | |
Diluted Weighted Average Shares Outstanding (in shares) | [1] | 18,496,640 | 11,591,768 | 18,480,248 | 10,076,415 | |
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UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Statement of Comprehensive Income [Abstract] | ||||
Net Loss | $ (3,305) | $ (4,967) | $ (5,055) | $ (12,128) |
Unrealized Loss on Available-for-Sale Investments | (18) | 0 | (21) | 0 |
Foreign Currency Translation Adjustments | (1) | (2) | (4) | (3) |
Comprehensive Loss | $ (3,324) | $ (4,969) | $ (5,080) | $ (12,131) |
Description of Business |
6 Months Ended |
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Jun. 30, 2023 | |
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 a revenue-generating business and the second largest supplier of liquid and powder acid and bicarbonate concentrates for dialysis patients in the United States. Hemodialysis is the most common form of end-stage kidney disease treatment and is typically performed at freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or in a patient’s home. Rockwell provides the hemodialysis community with products controlled by a Quality Management System regulated by the U.S. Food and Drug Administration ("FDA"). Rockwell is ISO 13485 Certified and adheres to current Good Manufacturing Practices ("cGMP") and Association for Advancement of Medical Instrumentation ("AAMI") standards. 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. 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. On July 10, 2023, Rockwell acquired the hemodialysis concentrates business from Evoqua Water Technologies LLC ("Evoqua"). This acquisition expands the Company's geographic footprint, customer base, and product offerings. In addition, this acquisition provides fully automated processing that potentially results in a lower cost to manufacture. As part of this acquisition, the Company now manufactures hemodialysis concentrates in Minnesota under a contract manufacturing agreement with a contract manufacturing organization. (See Note 16 for further detail). In addition to its primary focus on hemodialysis concentrates, Rockwell also has a proprietary parenteral iron product, Triferic® (ferric pyrophosphate citrate ("FPC")), which is indicated to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. While Rockwell has discontinued commercialization of Triferic in the United States, the Company has established several international partnerships with companies seeking to develop and commercialize Triferic outside the United States and is working closely with these international partners to develop and commercialize Triferic in their respective regions. Additionally, Rockwell continues to evaluate the viability of its FPC platform and FPC's potential to treat iron deficiency, iron deficiency anemia, and acute heart failure. 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.
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Liquidity and Capital Resources |
6 Months Ended |
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Jun. 30, 2023 | |
Liquidity and Capital Resources [Abstract] | |
Liquidity and Capital Resources | Liquidity and Capital Resources As of June 30, 2023, Rockwell had approximately $14.9 million of cash, cash equivalents and investments available-for-sale, and working capital of $10.1 million. Net cash used in operating activities for the six months ended June 30, 2023 was approximately $5.6 million. Based on the currently available working capital, management believes the Company currently has sufficient funds to meet its operating requirements for at least the next twelve months from the date of the filing of this report. On July 10, 2023, Armistice Capital Master Fund Ltd. (“Armistice”), which held a warrant to purchase 9,900,990 shares of common stock of the Company with an exercise price of $1.39 per share, exercised the warrant and the Company received gross proceeds of approximately $13.8 million (See Note 16 for further detail). Also on July 10, 2023, Rockwell acquired the hemodialysis concentrates business from Evoqua Water Technologies LLC ("Evoqua") for an aggregate purchase price, subject to certain adjustments pursuant to the terms of the Purchase Agreement, of $11.0 million in cash paid at closing and equal annual installments of $2.5 million payable on each of the first and second anniversaries of the closing. In addition, the Company purchased approximately $1.2 million of inventory. This acquisition expands the Company's geographic footprint, customer base, and product offerings. In addition, this acquisition provides fully automated processing that potentially results in a lower cost to manufacture. As part of this acquisition, the Company manufactures hemodialysis concentrates under a contract manufacturing agreement with a contract manufacturing organization. (See Note 16 for further detail). 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 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. As of June 30, 2023, the Company is no longer subject to the baby shelf limitations under Form S-3, which limit the amount the Company may offer pursuant to its registration statement on Form S-3. The Company is subject to certain covenants and cure provisions under its Loan Agreement with Innovatus. As of the date of this report, the Company is in compliance with all covenants (See Note 14 for further detail). 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 and other political tensions, and lingering effects of the COVID-19 pandemic. 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, 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.
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Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements | Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements The accompanying condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U. S. Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. The condensed consolidated balance sheet at June 30, 2023, and the condensed consolidated statements of operations, comprehensive loss, and changes in stockholders' equity for the three and six months ended June 30, 2023 and 2022 and cash flows for the six months ended June 30, 2023 and 2022 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, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023 or for any future interim period. The condensed consolidated balance sheet at December 31, 2022 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, 2022 and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 as filed with the SEC on March 30, 2023. 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. generally accepted accounting principles ("GAAP") requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Restatement of Loss Per Share Earnings per share for the three and six months ended June 30, 2022 have been recalculated and restated and is presented on a comparable basis with the three and six months ended June 30, 2023. In the first quarter of 2023, the Company determined it should have included pre-funded warrants issued in Q2 2022 in the earnings per share calculation accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC’) 260-10-45-13, which treats shares of common stock exercisable for little to no consideration as included in the denominator of both the basic and diluted earnings per share calculations. While the Company has determined the impact of including the pre-funded warrants in the earnings per share calculations does not have a material impact on previously issued financial statements and is correct to recalculate and restate amounts presented on a comparative and consistent basis with current period results. The table below summarizes previously reported and restated amounts on a comparative basis. See the table presentation of loss per share calculations as of June 30, 2023 and 2022 in the "Loss Per Share Including Restated Amounts" section below.
Loss Per Share Basic and diluted net loss per share for the three and six months ended June 30, 2023 and 2022, after giving effect to the restatement discussed above, was calculated as follows:
Included within the weighted average shares of common stock outstanding for the three and six months ended June 30, 2023 and 2022, are 1,793,000 and 9,056,377 shares of common stock issuable upon the exercise of the pre-funded warrants (See Note 10), as the warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders. The Company’s potentially dilutive securities include stock options, restricted stock awards and units, convertible preferred stock and warrants. These securities were excluded from the computations of diluted net loss per share for the three and six months ended June 30, 2023 and 2022, as the effect would be to reduce the net loss per share. 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 loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
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 June 2016, the FASB issued Accounting Standards Update ("ASU") 2016-13, "Financial Instruments - Credit Losses (Topic 326)," which introduced an impairment model that is based on expected credit losses, rather than incurred losses, to estimate credit losses on certain types of financial instruments (e.g., loan commitments). The expected credit losses should consider historical information, current information, and reasonable and supportable forecasts, including estimates of prepayments, over the contractual term. Financial instruments with similar risk characteristics may be grouped together when estimating expected credit losses. In addition, ASC 326 requires expected credit relates losses for available-for-sale debt securities to be recorded through an allowance for credit losses, while non-credit related losses will continue to be recognized through other comprehensive income. The Company adopted the new guidance, as of January 1, 2023, and it did not have a material impact on the Condensed Consolidated Financial Statements.
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Revenue Recognition |
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue Recognition | Revenue Recognition The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the new revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: •Step 1: Identify the contract with the customer •Step 2: Identify the performance obligations in the contract •Step 3: Determine the transaction price •Step 4: Allocate the transaction price to the performance obligations in the contract •Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue. Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer. Nature of goods and services The following is a description of principal activities from which the Company generates its revenue. We currently operate in one market segment, the hemodialysis market, which involves the manufacture, sale and distribution of hemodialysis products to hemodialysis clinics, including pharmaceutical, dialysis concentrates, dialysis kits and other ancillary products used in the dialysis process. Our customer mix is diverse with most customer sales concentrations under 10% and one customer, DaVita, Inc., at approximately 50% for the six months ended June 30, 2023. Our accounts receivable from this customer were approximately 33% of the total consolidated accounts receivable balance at June 30, 2023. Product sales – The Company accounts for individual products and services separately if they are distinct (i.e., if a product or service is separately identifiable from other items and if a customer can benefit from it on its own or with other resources that are readily available to the customer). The consideration, including any discounts, is allocated between separate products and services based on their stand-alone selling prices. The stand-alone selling prices are determined based on the cost plus margin approach. Drug and dialysis concentrates products are sold directly to dialysis clinics and to wholesale distributors in both domestic and international markets. Distribution and license agreements for which upfront fees are received are evaluated upon execution or modification of the agreement to determine if the agreement creates a separate performance obligation from the underlying product sales. For all existing distribution and license agreements, the distribution and license agreement is not a distinct performance obligation from the product sales. In instances where regulatory approval of the product has not been established and the Company does not have sufficient experience with the foreign regulatory body to conclude regulatory approval is probable, the revenue for the performance obligation is recognized over the term of the license agreement (over time recognition). Conversely, when regulatory approval already exists or is probable, revenue is recognized at the point in time control of the product transfers to the customer. The Company received upfront fees under five distribution and license agreements that have been deferred as a contract liability. The amounts received from Wanbang Biopharmaceuticals Co., Ltd. (“Wanbang”), Sun Pharmaceutical Industries Ltd. ("Sun Pharma"), Jeil Pharmaceutical Co., Ltd. ("Jeil Pharma") and Drogsan Pharmaceuticals ("Drogsan Pharma") are recognized as revenue over the estimated term of the applicable distribution and license agreement as regulatory approval was not received and the Company did not have sufficient experience in China, India, South Korea and Turkey, respectively, to determine regulatory approval was probable as of the execution of the agreement. The amounts received from Baxter Healthcare Corporation (“Baxter”) were deferred and recognized as revenue at the point in time the estimated product sales under the agreement occurred. In November 2022, Rockwell reacquired its distribution rights to its hemodialysis concentrates products from Baxter and terminated the exclusive distribution agreement. Under the exclusive distribution agreement, Baxter distributed and commercialized Rockwell’s hemodialysis concentrates products and provided customer service and order delivery to nearly all United States customers. Following the reacquisition of these rights, Rockwell is now unrestricted in its ability to sell its hemodialysis concentrates products to dialysis clinics throughout the United States and around the world. Rockwell agreed to pay Baxter a fee for the reacquisition of its distribution rights which was reflected as an expense at that time. This fee was payable in two equal installments on January 1, 2023 and April 1, 2023. As of June 30, 2023, all payments were completed. For the majority of the Company’s U.S. and international customers, the Company recognizes revenue at the shipping point, which is generally the Company’s plant or warehouse. For other business, the Company recognizes revenue based on when the customer takes control of the product. The amount of revenue recognized is based on the purchase order less returns and adjusted for any rebates, discounts, chargebacks or other amounts paid to customers. There were no such adjustments for the periods reported. Customers typically pay for the product based on customary business practices with payment terms averaging 30 days, while a small subset of customers have payment terms averaging 60 days. Disaggregation of revenue Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition.
Contract balances The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers.
There were no bad debt expenses recognized related to any receivables arising from the Company’s contracts with customers for the three and six months ended June 30, 2023 and 2022. There were no other material contract assets recorded on the condensed consolidated balance sheet as of June 30, 2023 and December 31, 2022. The Company does not generally accept returns of its concentrates products and no material reserve for returns of concentrates products was established as of June 30, 2023 or December 31, 2022. The contract liabilities primarily relate to upfront payments and consideration received from customers in advance of the customer assuming control of the related products. Transaction price allocated to remaining performance obligations 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 $2.7 million as of June 30, 2023. The amount relates primarily to upfront payments and consideration received from customers in advance of the customer assuming control of the related products. The Company applies the practical expedient in paragraph 606-10-50-14 and does not disclose information about remaining performance obligations that have original expected durations of one year or less.
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Investments - Available-for-Sale |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments - Available-for-Sale | Investments - Available-for-Sale Investments available-for-sale consisted of the following as of June 30, 2023 and December 31, 2022 (table in thousands):
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 June 30, 2023 and December 31, 2022, the amortized cost and estimated fair value of our available-for-sale securities were all due within one year.
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Inventory |
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Inventory | Inventory Components of inventory, net of reserves, as of June 30, 2023 and December 31, 2022 are as follows (table in thousands):
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Property and Equipment, net | Property and Equipment, net As of June 30, 2023 and December 31, 2022, the Company’s property and equipment consisted of the following (table in thousands):
Depreciation expense for the three months ended June 30, 2023 and 2022 was $0.2 million and $0.1 million, respectively. Depreciation expense for both the six months ended June 30, 2023 and 2022 was $0.3 million.
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Accrued Liabilities |
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Accrued Liabilities | Accrued Liabilities Accrued liabilities as of June 30, 2023 and December 31, 2022 consisted of the following (table in thousands):
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Deferred Revenue |
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Revenue from Contract with Customer [Abstract] | |
Deferred Revenue | Deferred Revenue In October 2014, the Company entered into an exclusive distribution agreement with Baxter, which had a term of 10 years and received an upfront fee of $20 million. The upfront fee was recorded as deferred revenue and was being recognized based on the proportion of product shipments to Baxter in each period, compared with total expected sales volume over the term of the distribution agreement. On November 9, 2022, Rockwell reacquired its distribution rights to its hemodialysis concentrates products from Baxter and terminated the distribution agreement. Exclusivity and other provisions associated with the distribution agreement terminated November 9, 2022 and the remaining operational elements of the agreement terminated December 31, 2022. Rockwell agreed to provide certain services to a group of Baxter's customers until March 31, 2023. Under the distribution agreement, Baxter distributed and commercialized Rockwell’s hemodialysis concentrates products and provided customer service and order delivery to nearly all United States customers. Following the reacquisition of these rights, Rockwell is now unrestricted in its ability to sell its hemodialysis concentrates products to dialysis clinics throughout the United States and around the world. The Company recognized the remaining revenue of $1.5 million during the three months ended March 31, 2023. In 2016, the Company entered into a distribution agreement with Wanbang (the "Wanbang Agreement") and received an upfront fee of $4.0 million. The upfront fee was recorded as deferred revenue and is being recognized as revenue based on the agreement term. The Company recognized revenue of approximately $53,000 and $0.1 million for each of the three and six months ended June 30, 2023 and 2022, respectively. Deferred revenue related to the Wanbang Agreement totaled $2.2 million as of June 30, 2023 and $2.3 million as of December 31, 2022. On August 7, 2023, Rockwell was informed by Wanbang, the Company’s commercialization partner in China for Triferic, that the main efficacy results of Wanbang’s clinical trial for Triferic (dialysate) compared with placebo were not obtained. The Company is working with Wanbang to determine next steps. In January 2020, the Company entered into license and supply agreements with Sun Pharma (the "Sun Pharma Agreements"), for the rights to commercialize Triferic (dialysate) in India. In consideration for the license, the Company received an upfront fee of $0.1 million. The upfront fee was recorded as deferred revenue and is being recognized as revenue based on the agreement term. The Company recognized revenue of approximately $2,500 and $5,000 for the three and six months ended June 30, 2023 and 2022, respectively. Deferred revenue related to the Sun Pharma Agreement totaled $65,000 and $70,000 as of June 30, 2023 and December 31, 2022, respectively. In September 2020, the Company entered into a license and supply agreements with Jeil Pharmaceutical (the "Jeil Agreements"), for the rights to commercialize Triferic (dialysate) in South Korea. In consideration for the license, the Company received an upfront fee of $0.2 million. In May 2022, Jeil Pharmaceutical obtained regulatory approval in South Korea and paid the Company $0.2 million in consideration of reaching the milestone. The upfront fee and milestone payments were recorded as deferred revenue and are being recognized as revenue based on the agreement term. The Company recognized revenue of $5,200 and $10,400 for the three and six months ended June 30, 2023 and 2022, respectively. Deferred revenue related to the Jeil Agreement totaled approximately $0.4 million as of both June 30, 2023 and December 31, 2022. In June 2021, the Company entered into license and supply agreements with Drogsan Pharmaceuticals (the "Drogsan Agreements"), for the rights to commercialize Triferic (dialysate) and Triferic AVNU in Turkey. In consideration for the license, the Company received an upfront fee of $0.15 million. The upfront fee was recorded as deferred revenue and will be recognized as revenue based on the agreement term. The Company recognized revenue of $3,750 and $7,500 for the three and six months ended June 30, 2023 and 2022, respectively. Deferred revenue related to the Drogsan Agreements totaled approximately $120,000 and $127,500 as of June 30, 2023 and December 31, 2022, respectively. In April 2023, Drogsan submitted a Marketing Authorization application and GMP application for Triferic AVNU to the Turkish Medicines and Medical Devices Agency, for which Drogsan received priority status and high priority status, respectively. Taking into consideration that Drogsan was granted an accelerated review for Triferic AVNU with the Turkish regulatory authority, Rockwell anticipates approval for Triferic AVNU in Turkey in 2024. Drogsan is responsible for all regulatory approval and commercialization activities.
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Stockholders’ Equity |
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Stockholders' Equity | Stockholders’ Equity The Company held its annual meeting of stockholders on May 23, 2023 (the “Annual Meeting”). At the Annual Meeting, the Company’s stockholders approved the amendment and restatement of the Rockwell Medical, Inc. 2018 Long Term Incentive Plan to increase the number of shares of common stock issuable thereunder by 1,600,000 shares (the “Amended 2018 Plan”). 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, 2023, the Series X Preferred Stock accreted a total $150,000. 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, 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 both June 30, 2023 and December 31, 2022, 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, 2023 and December 31, 2022, there were 170,000,000 shares of common stock, $0.0001 par value per share, authorized and 16,795,673 and 12,163,673 shares issued and outstanding, respectively. As of June 30, 2023 and 2022, the Company has 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"):
During the three months ended June 30, 2023 and 2022, 4,118,000 and nil pre-funded warrants were exercised, respectively. During the six months ended June 30, 2023 and 2022, 4,507,000 and nil pre-funded warrants were exercised, respectively. During the three and six months ended June 30, 2023 and 2022, no vested employee stock options were exercised. Controlled Equity Offering On April 8, 2022, the Company entered into the Sales Agreement with Cantor Fitzgerald & Co. as Agent, pursuant to which the Company may offer and sell from time to time up to $12,200,000 of shares of Company’s common stock through the Agent. The offering and sale of such shares has been registered under the Securities Act of 1933, as amended, pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-259923) (the “Registration Statement”), which was originally filed with the SEC on September 30, 2021 and declared effective by the SEC on October 8, 2021, the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed with the SEC on April 8, 2022. During the quarter ended June 30, 2023, no sales were made pursuant to the Sales Agreement. Approximately $12.2 million remains available for sale under the ATM facility. Registered Direct Offering On May 30, 2022, the Company entered into the RD Purchase Agreement with the Purchaser named therein, pursuant to which the Company agreed to issue and sell, in a registered direct offering (the “Offering”), 844,613 shares of its common stock at price of $1.39 per share, and pre-funded warrants to purchase up to an aggregate of 7,788,480 shares of common stock (the “Pre-Funded Warrants” and the shares of common stock underlying the Pre-Funded Warrants, the “Warrant Shares”). The purchase price of each Pre-Funded Warrant is equal to the price at which a share of common stock was sold to the public in the Offering, minus $0.0001, and the exercise price of each Pre-Funded Warrant is $0.0001 per share. A holder (together with its affiliates) may not exercise any portion of the Pre-Funded Warrants to the extent 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 the Pre-Funded Warrant. The RD Purchase Agreement contains customary representations and warranties and agreements of the Company and the Purchaser and customary indemnification rights and obligations of the parties. A total of 1,793,000 Pre-Funded Warrants remained outstanding as of June 30, 2023. On July 5, 2023, the remaining 1,793,000 Pre-Funded Warrants to purchase common stock were exercised. Private Placement Also on May 30, 2022, concurrently with the Offering, the Company entered into the PIPE Purchase Agreement relating to the offering and sale (the “Private Placement”) of warrants to purchase up to a total of 9,900,990 shares of common stock (the "PIPE Warrants") and pre-funded warrants to purchase up to a total of 1,267,897 shares of common stock (the “Pre- Funded PIPE Warrants”). Each warrant was sold at a price of $0.125 per underlying warrant share and is exercisable at an exercise price of $1.39 per share. The purchase price of each Pre-Funded Warrant was equal to the price at which a share of common stock was sold to the public in the Offering, minus $0.0001, and the exercise price of each Pre-Funded Warrant is $0.0001 per share. As of December 2022, all Pre-Funded PIPE Warrants have been exercised. As of June 30, 2023, 9,900,990 PIPE Warrants remained outstanding. On July 10, 2023, 9,900,990 PIPE Warrants were exercised for 9,900,990 shares of common stock (See Note 16 for further details).
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Stock-Based Compensation |
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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, 2023 and 2022 as follows (table in thousands):
Performance Based Restricted Stock A summary of the Company’s restricted stock awards during the six months ended June 30, 2023 is as follows:
A summary of the Company’s restricted stock awards during the six months ended June 30, 2022 is as follows:
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 both June 30, 2023 and 2022, unvested restricted stock awards of 891 were related to performance-based awards. The forfeited performance-based restricted stock awards of 6,227 was due to the resignation of the Company's Chief Development Officer on March 25, 2022. These forfeited awards reduced stock-based compensation expense by $0.4 million in 2022. Service-Based Restricted Stock Units A summary of the Company’s service-based restricted stock units during the six months ended June 30, 2023 is as follows:
A summary of the Company’s service-based restricted stock units during the six months ended June 30, 2022 is as follows:
Service based restricted stock units are measured based on their fair value on the date of grant and amortized over the vesting period. The vesting periods range from 1 to 3 years. Stock-based compensation expense of $0.1 million and $25,554 was recognized for the three months ended June 30, 2023 and 2022, respectively. Stock-based compensation expense of $0.2 million and $37 thousand was recognized for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, the unrecognized stock-based compensation expense was $0.5 million, which is expected to be recognized over an estimated weighted average remaining term of less than 1.7 years. Service-Based Stock Options The fair value of the service-based stock options granted for the six months ended June 30, 2022 were based on the following assumptions:
A summary of the Company’s service-based stock option activity for the six months ended June 30, 2023 is as follows:
A summary of the Company’s service-based stock option activity for the six months ended June 30, 2022 is as follows:
The aggregate intrinsic value is calculated as the difference between the closing price of the Company's common stock and the exercise price of the stock options that had strike prices below the closing price. The intrinsic value of the outstanding options were not significant for all periods presented. During the six months ended June 30, 2023, the Company granted 382,745 stock options to purchase shares of common stock. During the six months ended June 30, 2023, 13,447 shares were forfeited and 5,604 shares expired. Forfeitures are recorded in the period of occurrence and compensation expense is adjusted accordingly. Stock-based compensation expense recognized for service-based stock options was $0.2 million and $0.1 million for the three months ended June 30, 2023, and 2022 respectively. Stock-based compensation expense recognized for service-based stock options was $0.3 million and $0.3 million for the six months ended June 30, 2023, and 2022, respectively. As of June 30, 2023, total stock-based compensation expense related to unvested options not yet recognized totaled approximately $0.9 million, which is expected to be recognized over an estimated weighted average remaining term of 8.7 years.
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Licensing Agreements |
6 Months Ended |
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Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Licensing Agreements | Licensing Agreements Product License Agreements The Company is a party to a Licensing Agreement between the Company and Charak, LLC ("Charak") dated January 7, 2002 (the "2002 Agreement") that grants the Company exclusive worldwide rights to certain patents and information related to our Triferic product. On October 7, 2018, the Company entered into a Master Services and IP Agreement (the “Charak MSA”) with Charak and Dr. Ajay Gupta, a former Officer of the Company. Pursuant to the MSA, the parties entered into three additional agreements described below related to the license of certain soluble ferric pyrophosphate (“SFP”) intellectual property owned by Charak. As of June 30, 2023 and December 31, 2022, the Company has accrued $85,400 relating to certain IP reimbursement expenses and certain sublicense royalty fees, which is included within accrued liabilities on the condensed consolidated balance sheet. Pursuant to the Charak MSA, the aforementioned parties entered into an Amendment, dated as of October 7, 2018 (the “Charak Amendment”), to the 2002 Agreement, under which Charak granted the Company an exclusive, worldwide, non-transferable license to commercialize SFP for the treatment of patients with renal failure. The Charak Amendment amends the royalty payments due to Charak under the 2002 Agreement such that the Company is liable to pay Charak royalties on net sales by the Company of products developed under the license, which includes the Company’s Triferic product, at a specified rate until December 31, 2021 and thereafter at a reduced rate from January 1, 2022 until February 1, 2034. Additionally, the Company shall pay Charak a percentage of any sublicense income during the term of the agreement, which amount shall not be less than a minimum specified percentage of net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and be no less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis. Also pursuant to the Charak MSA, the Company and Charak entered into a Commercialization and Technology License Agreement I.V. Triferic dated as of October 7, 2018 (the “IV Agreement”), under which Charak granted the Company an exclusive, 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 sub-license milestone payments are not yet considered probable, and no milestone payments have been accrued as of June 30, 2023 and December 31, 2022.
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Leases |
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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 2024. Rockwell also occupies two other manufacturing facilities, a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December 2025, and a 57,000 square foot facility in Greer, South Carolina under a lease expiring February 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. At June 30, 2023, the Company had operating and finance lease liabilities of $5.9 million and right-of-use assets of $5.7 million, which are included in the condensed consolidated balance sheet. At December 31, 2022, the Company had operating and finance lease liabilities of $6.7 million and right-of-use assets of $6.4 million, which are included in the condensed consolidated balance sheet. The following summarizes quantitative information about the Company’s operating and finance leases (table in thousands):
Future minimum rental payments under operating and finance lease agreements are as follows (in thousands):
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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 2024. Rockwell also occupies two other manufacturing facilities, a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December 2025, and a 57,000 square foot facility in Greer, South Carolina under a lease expiring February 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. At June 30, 2023, the Company had operating and finance lease liabilities of $5.9 million and right-of-use assets of $5.7 million, which are included in the condensed consolidated balance sheet. At December 31, 2022, the Company had operating and finance lease liabilities of $6.7 million and right-of-use assets of $6.4 million, which are included in the condensed consolidated balance sheet. The following summarizes quantitative information about the Company’s operating and finance leases (table in thousands):
Future minimum rental payments under operating and finance lease agreements are as follows (in thousands):
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Loans and Security Agreement |
6 Months Ended | ||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||
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 a second tranche of $5.0 million or a third tranche of $7.5 million, which were tied to the achievement of certain milestones by a specific date. Net draw down proceeds were $21.2 million with closing costs of $1.3 million. In connection with each funding of the Term Loans, the Company 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, which was based on the lower of (i) the volume weighted average closing price of the Company’s stock for the 5-trading day period ending on the last trading day immediately preceding the execution of the Loan Agreement or (ii) the closing price on the last trading day immediately preceding the execution of the Loan Agreement (or for the second and third tranches only at the lower of (i) $18.15 per share or (ii) the volume weighted average closing price of the Company’s stock for the 5-trading day period ending on the last trading day immediately preceding the relevant Term Loan funding). The Warrants may be exercised on a cashless basis and are immediately exercisable through the seventh anniversary of the applicable funding date. The number of shares of common stock for which each Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Warrant. In connection with the first tranche of the Term Loans, the Company issued a Warrant to Innovatus, exercisable for an aggregate of 43,388 shares of the Company’s common stock at an exercise price of $18.15 per share. The Company evaluated the warrant under ASC 470, Debt, and recognized an additional debt discount of approximately $0.5 million based on the relative fair value of the base instruments and warrants. The Company calculated the fair value of the warrant using the Black-Scholes model. The Company is entitled to make interest-only payments for thirty months, or up to thirty-six months if certain conditions are met. The Term Loans will mature on March 16, 2025, and will bear interest at the greater of (i) Prime Rate (as defined in the Loan Agreement) and (ii) 4.75%, plus 4.00% with an initial interest rate of 8.75% per annum and an effective interest rate of 10.9%. The Company has the option, under certain circumstances, to add 1.00% of such interest rate amount to the then outstanding principal balance in lieu of paying such amount in cash. For the three months ended June 30, 2023 and 2022, interest expense amounted to $0.3 million and $0.4 million, respectively. For the six months ended June 30, 2023 and 2022, interest expense amounted to $0.6 million and $0.8 million, respectively. The Loan Agreement is secured by all assets of the Company and Rockwell Transportation, Inc. Proceeds are used for working capital purposes. The Loan Agreement contained customary representations and warranties and covenants, subject to customary carve outs, and included financial covenants related to liquidity and trailing twelve months sales of Triferic, with the latter beginning with the period ending December 31, 2020. 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, which amended the Loan Agreement. Pursuant to the Second Amendment, the Company (i) prepaid an aggregate principal amount of $5.0 million in Term Loans in one installment on November 14, 2022; (ii) shall pay interest only payments until September 2023 at which time will resume scheduled debt payments. Additionally, the financial covenants related to the trailing twelve months sales of Triferic was replaced with a trailing 6 months revenue of our concentrates products beginning with the period ending September 30, 2022. The Company cannot assure that it can maintain compliance with the covenants under our Loan Agreement, which may result in an event of default. The Company's ability to comply with these covenants may be adversely affected by events beyond its control. If the Company is unable to comply with the covenants under the Loan Agreement, it would pursue all available cure options in order to regain compliance. However, the Company may not be able to mutually agree with Innovatus on appropriate remedies to cure a future breach of a covenant, which could give rise to an event of default. If the Company is unable to avoid an event of default, any required repayments could have an adverse effect on its liquidity. As of June 30, 2023, the Company was in compliance with all covenants under the Loan Agreement. As of June 30, 2023, the outstanding balance of the Term Loan was $9.4 million, net of unamortized issuance costs and discount of $0.6 million. The following table reflects the schedule of principal payments on the Term Loan as of June 30, 2023 (in thousands):
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Insurance Financing Note Payable |
6 Months Ended |
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Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Insurance Financing Note Payable | Insurance Financing Note PayableOn June 3, 2023, the Company entered into a short-term note payable for $0.7 million, bearing interest at 9.59% per annum to finance various insurance policies. Principal and interest payments related to this note began on July 3, 2023 and will be paid on a straight-line amortization over nine months with the final payment due on March 3, 2024. As of June 30, 2023, the outstanding balance was $0.7 million. |
Subsequent Events |
6 Months Ended |
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Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events On July 5, 2023, all of the remaining Pre-Funded Warrants to purchase 1,793,000 shares of common stock issued on May 30, 2022 were exercised. The exercise price of each Pre-Funded Warrant was $0.0001 per share and resulted in gross proceeds to the Company of $179 (See Note 10 for more detail on the Pre-Funded Warrants). Asset Purchase Agreement On July 10, 2023, the Company executed and consummated the transactions contemplated by an Asset Purchase Agreement (the “Purchase Agreement”) with Evoqua. Subject to the terms and conditions of the Purchase Agreement, at the closing of the transaction (the “Closing”), the Company purchased from Evoqua substantially all of the assets of Evoqua that are related to its business of manufacturing, marketing, distributing, and selling hemodialysis concentrates products in powder and liquid form (the “Concentrates Business”) for an aggregate purchase price, subject to certain adjustments pursuant to the terms of the Purchase Agreement, of $11.0 million in cash paid at Closing and equal annual installments of $2.5 million payable on each of the first and second anniversaries of the Closing. The foregoing summary of the Purchase Agreement is subject to, and qualified in its entirety by reference to, the Purchase Agreement, which is filed as Exhibit 10.2 to this Quarterly Report on Form 10-Q. Warrant Exercise and Reload Warrants 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’s may not sell shares of Common Stock pursuant to its sales agreement with Cantor Fitzgerald & Co., dated as of April 8, 2022, at price per share less than $6.25. The Reload Warrant may be exercised at all times prior to the 54 months month 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 from the exercise of the Prior Warrant as a result of such exercise pursuant to the terms of the Letter Agreement. As of July 10, 2023, following the exercise of the Prior Warrant, the Company had 28,489,663 shares of common stock outstanding. The Letter Agreement and Reload Warrant were entered into pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, and Regulation D as promulgated thereunder. The foregoing summaries of the Reload Warrant and the Letter Agreement are subject to, and qualified in their entirety by reference to, the Reload Warrant and the Letter Agreement, which are filed as Exhibits 4.1 and 10.1 to this Quarterly Report on Form 10-Q, respectively. International Distribution Agreement On August 7, 2023, Rockwell was informed by Wanbang, the Company’s commercialization partner in China for Triferic, that the main efficacy results of Wanbang’s clinical trial for Triferic (dialysate) compared with placebo were not obtained. The Company is working with Wanbang to determine next steps.
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Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies) |
6 Months Ended |
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Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The accompanying condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U. S. Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. The condensed consolidated balance sheet at June 30, 2023, and the condensed consolidated statements of operations, comprehensive loss, and changes in stockholders' equity for the three and six months ended June 30, 2023 and 2022 and cash flows for the six months ended June 30, 2023 and 2022 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, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023 or for any future interim period. The condensed consolidated balance sheet at December 31, 2022 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, 2022 and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 as filed with the SEC on March 30, 2023. 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.
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Use of Estimates | Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. generally accepted accounting principles ("GAAP") requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
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Loss Per Share | Included within the weighted average shares of common stock outstanding for the three and six months ended June 30, 2023 and 2022, are 1,793,000 and 9,056,377 shares of common stock issuable upon the exercise of the pre-funded warrants (See Note 10), as the warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders.The Company’s potentially dilutive securities include stock options, restricted stock awards and units, convertible preferred stock and warrants. These securities were excluded from the computations of diluted net loss per share for the three and six months ended June 30, 2023 and 2022, as the effect would be to reduce the net loss per share. |
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 June 2016, the FASB issued Accounting Standards Update ("ASU") 2016-13, "Financial Instruments - Credit Losses (Topic 326)," which introduced an impairment model that is based on expected credit losses, rather than incurred losses, to estimate credit losses on certain types of financial instruments (e.g., loan commitments). The expected credit losses should consider historical information, current information, and reasonable and supportable forecasts, including estimates of prepayments, over the contractual term. Financial instruments with similar risk characteristics may be grouped together when estimating expected credit losses. In addition, ASC 326 requires expected credit relates losses for available-for-sale debt securities to be recorded through an allowance for credit losses, while non-credit related losses will continue to be recognized through other comprehensive income. The Company adopted the new guidance, as of January 1, 2023, and it did not have a material impact on the Condensed Consolidated Financial Statements.
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Revenue recognition | The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the new revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: •Step 1: Identify the contract with the customer •Step 2: Identify the performance obligations in the contract •Step 3: Determine the transaction price •Step 4: Allocate the transaction price to the performance obligations in the contract •Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue. Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer.
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Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
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Schedule of Basic and Diluted Net Loss Per Share | Basic and diluted net loss per share for the three and six months ended June 30, 2023 and 2022, after giving effect to the restatement discussed above, was calculated as follows:
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Summary of Loss Per Share Restated Amounts | See the table presentation of loss per share calculations as of June 30, 2023 and 2022 in the "Loss Per Share Including Restated Amounts" section below.
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Revenue Recognition (Tables) |
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disaggregation of Revenue | Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition.
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Contract Balances | The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers.
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Investments - Available-for-Sale (Tables) |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments Available-for-Sale | Investments available-for-sale consisted of the following as of June 30, 2023 and December 31, 2022 (table in thousands):
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Inventory (Tables) |
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Schedule Components of Inventory | Components of inventory, net of reserves, as of June 30, 2023 and December 31, 2022 are as follows (table in thousands):
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Property and Equipment, net (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Major Classes of Property and Equipment | As of June 30, 2023 and December 31, 2022, the Company’s property and equipment consisted of the following (table in thousands):
|
Accrued Liabilities (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Accrued Liabilities | Accrued liabilities as of June 30, 2023 and December 31, 2022 consisted of the following (table in thousands):
|
Stockholder's Equity (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Common Stock Reserved for Issuance | As of June 30, 2023 and 2022, the Company has 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"):
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Stock-Based Compensation (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Total Stock-Based Compensation Expense | The Company recognized total stock-based compensation expense during the three and six months ended June 30, 2023 and 2022 as follows (table in thousands):
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Schedule of Stock Option Assumptions | The fair value of the service-based stock options granted for the six months ended June 30, 2022 were based on the following assumptions:
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Restricted stock awards | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Restricted Stock Awards | A summary of the Company’s restricted stock awards during the six months ended June 30, 2023 is as follows:
A summary of the Company’s restricted stock awards during the six months ended June 30, 2022 is as follows:
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Restricted stock units - service based awards | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Restricted Stock Awards | A summary of the Company’s service-based restricted stock units during the six months ended June 30, 2023 is as follows:
A summary of the Company’s service-based restricted stock units during the six months ended June 30, 2022 is as follows:
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Stock option awards - service based awards | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Stock Options Activity | A summary of the Company’s service-based stock option activity for the six months ended June 30, 2023 is as follows:
A summary of the Company’s service-based stock option activity for the six months ended June 30, 2022 is as follows:
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Leases (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Lease Costs | The following summarizes quantitative information about the Company’s operating and finance leases (table in thousands):
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Operating Lease Maturities | Future minimum rental payments under operating and finance lease agreements are as follows (in thousands):
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Finance Lease Maturities | Future minimum rental payments under operating and finance lease agreements are as follows (in thousands):
|
Loans and Security Agreement (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||
Schedule of Principal Payments on Term Loan | The following table reflects the schedule of principal payments on the Term Loan as of June 30, 2023 (in thousands):
|
Description of Business (Details) |
6 Months Ended |
---|---|
Jun. 30, 2023
ft²
| |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Operating space | 175,000 |
Liquidity and Capital Resources (Details) - USD ($) $ / shares in Units, $ in Thousands |
6 Months Ended | ||
---|---|---|---|
Jul. 10, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Liquidity and Capital Resources [Line Items] | |||
Cash, cash equivalents and investments available-for-sale | $ 14,900 | ||
Working capital | 10,100 | ||
Net cash used in operating activities | $ (5,616) | $ (15,715) | |
Evoqua Water Technologies LLC | Subsequent event | |||
Liquidity and Capital Resources [Line Items] | |||
Cash paid | $ 11,000 | ||
Milestone payments | 2,500 | ||
Asset acquisition, inventory | $ 1,200 | ||
Armistice Warrant Agreement | Subsequent event | |||
Liquidity and Capital Resources [Line Items] | |||
Number of shares of common stock for which warrant is exercisable (in shares) | 9,900,990 | ||
Exercise price of warrant (in dollars per share) | $ 1.39 | ||
Gross proceeds | $ 13,800 |
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Schedule of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 6 Months Ended | ||||||
---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|||
Numerator: | ||||||||
Net loss | $ (3,305) | $ (1,750) | $ (4,967) | $ (7,162) | $ (5,055) | $ (12,128) | ||
Net loss attributable to common stockholders for basic loss per share | (3,305) | (4,967) | (5,055) | (12,128) | ||||
Net loss attributable to common stockholders for diluted loss per share | $ (3,305) | $ (4,967) | $ (5,055) | $ (12,128) | ||||
Denominator: | ||||||||
Weighted average number of common shares outstanding - basic (in shares) | [1] | 18,496,640 | 11,591,768 | 18,480,248 | 10,076,415 | |||
Weighted average number of common shares outstanding - diluted (in shares) | [1] | 18,496,640 | 11,591,768 | 18,480,248 | 10,076,415 | |||
Net loss per share attributable to common stockholders - diluted (in dollars per share) | $ (0.18) | $ (0.43) | $ (0.27) | $ (1.20) | ||||
Net loss per share attributable to common stockholders - basic (in dollars per share) | $ (0.18) | $ (0.43) | $ (0.27) | $ (1.20) | ||||
|
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Details) - shares |
6 Months Ended | |
---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Net Earnings per Share | ||
Antidilutive securities (in shares) | 13,444,459 | 14,216,276 |
Registered Direct Offering Warrants | ||
Net Earnings per Share | ||
Warrants outstanding (in shares) | 1,793,000 | 9,056,377 |
Options to purchase common stock | ||
Net Earnings per Share | ||
Antidilutive securities (in shares) | 1,570,599 | 423,317 |
Unvested restricted stock awards | ||
Net Earnings per Share | ||
Antidilutive securities (in shares) | 891 | 891 |
Unvested restricted stock units | ||
Net Earnings per Share | ||
Antidilutive securities (in shares) | 313,065 | 125,000 |
Convertible Preferred Stock | ||
Net Earnings per Share | ||
Antidilutive securities (in shares) | 1,363,636 | 1,363,636 |
Warrants to purchase common stock | ||
Net Earnings per Share | ||
Antidilutive securities (in shares) | 10,196,268 | 12,303,432 |
Revenue Recognition - Nature of Goods and Services (Details) |
6 Months Ended |
---|---|
Jun. 30, 2023
agreement
Segment
| |
Revenue Recognition [Line Items] | |
Number of operating market segments | Segment | 1 |
Number of distribution and license agreements | agreement | 5 |
Customers average payment term | 30 days |
Distributors average payment term | 60 days |
Da Vita Healthcare Partners Inc | Revenue Benchmark | Customer Concentration Risk | |
Revenue Recognition [Line Items] | |
Customer concentration, percentage | 50.00% |
Da Vita Healthcare Partners Inc | Accounts Receivable | Customer Concentration Risk | |
Revenue Recognition [Line Items] | |
Customer concentration, percentage | 33.00% |
Revenue Recognition - Disaggregation of Revenue (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | $ 18,080 | $ 18,682 | $ 37,748 | $ 34,806 |
Drug products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 65 | 547 | 130 | 768 |
Concentrates Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 18,015 | 18,135 | 37,618 | 34,038 |
U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 16,125 | 16,595 | 34,057 | 31,039 |
U.S. | Drug products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 0 | 209 | 0 | 368 |
U.S. | Concentrates Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 16,125 | 16,386 | 34,057 | 30,671 |
Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 1,955 | 2,087 | 3,691 | 3,767 |
Rest of World | Drug products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 65 | 338 | 130 | 400 |
Rest of World | Concentrates Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 1,890 | 1,749 | 3,561 | 3,367 |
Product Sales – Point-in-time | Drug product sales | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 0 | 482 | 0 | 641 |
Product Sales – Point-in-time | Concentrates product sales | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 18,015 | 17,655 | 36,146 | 33,082 |
Product Sales – Point-in-time | U.S. | Drug product sales | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 0 | 209 | 0 | 368 |
Product Sales – Point-in-time | U.S. | Concentrates product sales | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 16,125 | 15,906 | 32,585 | 29,715 |
Product Sales – Point-in-time | Rest of World | Drug product sales | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 0 | 273 | 0 | 273 |
Product Sales – Point-in-time | Rest of World | Concentrates product sales | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 1,890 | 1,749 | 3,561 | 3,367 |
License Fee – Over time | Drug license fee | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 65 | 65 | 130 | 127 |
License Fee – Over time | Concentrates product license fee | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 0 | 480 | 1,472 | 956 |
License Fee – Over time | U.S. | Drug license fee | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 0 | 0 | 0 | 0 |
License Fee – Over time | U.S. | Concentrates product license fee | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 0 | 480 | 1,472 | 956 |
License Fee – Over time | Rest of World | Drug license fee | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 65 | 65 | 130 | 127 |
License Fee – Over time | Rest of World | Concentrates product license fee | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | $ 0 | $ 0 | $ 0 | $ 0 |
Revenue Recognition - Contract Balances (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Revenue from Contract with Customer [Abstract] | ||
Accounts Receivable, net | $ 5,411 | $ 6,259 |
Contract liabilities, which are included in deferred revenue | $ 2,729 | $ 4,331 |
Revenue Recognition - Narrative (Details) - USD ($) |
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
|
Revenue Recognition [Line Items] | |||||
Impairment losses | $ 0 | $ 0 | $ 0 | $ 0 | |
Contract assets | 0 | 0 | $ 0 | ||
Revenue performance obligation | 2,700,000 | 2,700,000 | |||
Concentrates Products | |||||
Revenue Recognition [Line Items] | |||||
Reserve for returns | $ 0 | $ 0 | $ 0 |
Investments - Available-for-Sale (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Investments, Debt and Equity Securities [Abstract] | ||
Amortized Cost | $ 5,852 | $ 11,315 |
Unrealized Gain | 54 | 75 |
Unrealized Loss | 0 | 0 |
Accrued Interest | 0 | 0 |
Fair Value | $ 5,906 | $ 11,390 |
Inventory (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Inventory - Current Portion | ||
Raw Materials | $ 2,805 | $ 3,351 |
Work in Process | 411 | 351 |
Finished Goods | 2,598 | 2,112 |
Total Current Inventory | 5,814 | 5,814 |
Inventory - Long Term | 1,276 | 1,276 |
Total Inventory | 7,090 | 7,090 |
Triferic Inventory | ||
Inventory - Current Portion | ||
Inventory - Long Term | 1,300 | 1,300 |
Inventory, gross | 5,800 | 5,800 |
Inventory, reserve | $ 25 | $ 25 |
Property and Equipment, net (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
|
Property and equipment | |||||
Gross property and equipment | $ 10,056 | $ 10,056 | $ 9,830 | ||
Accumulated Depreciation | (7,963) | (7,963) | (7,636) | ||
Property and Equipment, net | 2,093 | 2,093 | 2,194 | ||
Depreciation expense | 200 | $ 100 | 300 | $ 300 | |
Leasehold Improvements | |||||
Property and equipment | |||||
Gross property and equipment | 1,398 | 1,398 | 1,256 | ||
Machinery and Equipment | |||||
Property and equipment | |||||
Gross property and equipment | 6,006 | 6,006 | 5,922 | ||
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) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Payables and Accruals [Abstract] | ||
Accrued Research & Development Expense | $ 0 | $ 43 |
Accrued Compensation and Benefits | 1,574 | 2,568 |
Accrued Unvouchered Receipts | 552 | 585 |
Accrued Workers Compensation | 173 | 306 |
Other Accrued Liabilities | 1,464 | 4,200 |
Total Accrued Liabilities | $ 3,763 | $ 7,702 |
Deferred Revenue (Details) - USD ($) |
1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
May 31, 2022 |
Jun. 30, 2021 |
Sep. 30, 2020 |
Jan. 31, 2020 |
Oct. 31, 2014 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2016 |
Dec. 31, 2022 |
|
Deferred Revenue Arrangement [Line Items] | ||||||||||||
Deferred revenue | $ 2,729,000 | $ 2,729,000 | $ 4,331,000 | |||||||||
Baxter Healthcare Organization | ||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||
Term of agreement | 10 years | |||||||||||
Upfront payment | $ 20,000,000 | |||||||||||
Recognized deferred revenue | $ 1,500,000 | |||||||||||
Wanbang Biopharmaceutical | ||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||
Upfront payment | $ 4,000,000 | |||||||||||
Recognized deferred revenue | 53,000 | $ 53,000 | 100,000 | $ 100,000 | ||||||||
Deferred revenue | 2,200,000 | 2,200,000 | 2,300,000 | |||||||||
Sun Pharma Agreements | ||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||
Upfront payment | $ 100,000 | |||||||||||
Recognized deferred revenue | 2,500 | 2,500 | 5,000 | 5,000 | ||||||||
Deferred revenue | 65,000 | 65,000 | 70,000 | |||||||||
Jeil Pharma Agreements | ||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||
Upfront payment | $ 200,000 | |||||||||||
Recognized deferred revenue | 5,200 | 5,200 | 10,400 | 10,400 | ||||||||
Deferred revenue | 400,000 | 400,000 | 400,000 | |||||||||
Milestone consideration | $ 200,000 | |||||||||||
Drogsan Agreements | ||||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||||
Upfront payment | $ 150,000 | |||||||||||
Recognized deferred revenue | 3,750 | $ 3,750 | 7,500 | $ 7,500 | ||||||||
Deferred revenue | $ 120,000 | $ 120,000 | $ 127,500 |
Stockholders’ Equity (Details) |
3 Months Ended | 6 Months Ended | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Jul. 10, 2023
shares
|
Jul. 05, 2023
$ / shares
shares
|
May 23, 2023
shares
|
Jun. 16, 2022
USD ($)
shares
|
May 30, 2022
$ / shares
shares
|
Apr. 06, 2022
USD ($)
$ / shares
shares
|
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Jun. 30, 2022
shares
|
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Jun. 30, 2022
USD ($)
shares
|
Dec. 31, 2022
$ / shares
shares
|
Apr. 08, 2022
USD ($)
|
|
Class of Stock [Line Items] | ||||||||||||
Stock issuance costs | $ | $ 0 | $ 106,000 | ||||||||||
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) | 16,795,673 | 9,407,296 | 16,795,673 | 9,407,296 | 12,163,673 | |||||||
Common shares, shares issued (in shares) | 16,795,673 | 16,795,673 | 12,163,673 | |||||||||
Exercise of Employee Stock Options, Net of Tax (in shares) | 0 | 0 | 0 | 0 | ||||||||
2018 Long Term Incentive Plan | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Additional common stock issuable (in shares) | 1,600,000 | |||||||||||
Subsequent event | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common shares, shares outstanding (in shares) | 28,489,663 | |||||||||||
PIPE Purchase Agreement Pre-Funded Warrant | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants exercised (in shares) | 4,118,000 | 0 | 4,507,000 | 0 | ||||||||
Number of shares of common stock for which warrant is exercisable (in shares) | 1,267,897 | |||||||||||
Discount from stock price (dollars per share) | $ / shares | $ 0.0001 | |||||||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||
PIPE Purchase Agreement Pre-Funded Warrant | Subsequent event | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants exercised (in shares) | 1,793,000 | |||||||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||
Registered Direct Offering Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of shares of common stock for which warrant is exercisable (in shares) | 7,788,480 | |||||||||||
Discount from stock price (dollars per share) | $ / shares | $ 0.0001 | |||||||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||
Ownership threshold | 9.99% | |||||||||||
Warrants outstanding (in shares) | 1,793,000 | 9,056,377 | 1,793,000 | 9,056,377 | ||||||||
PIPE Purchase Agreement Warrant | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of shares of common stock for which warrant is exercisable (in shares) | 9,900,990 | |||||||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 1.39 | |||||||||||
Warrants outstanding (in shares) | 9,900,990 | 9,900,990 | ||||||||||
Warrant price (dollars per share) | $ / shares | $ 0.125 | |||||||||||
PIPE Purchase Agreement Warrant | Subsequent event | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants exercised (in shares) | 9,900,990 | |||||||||||
Registered Direct Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of shares issued | 844,613 | |||||||||||
Common stock trading price (in dollars per share) | $ / shares | $ 1.39 | |||||||||||
Series X Convertible Preferred Stock | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Interest rate percentage | 1.00% | |||||||||||
Common stock trading price (per share) | $ / shares | $ 22.00 | |||||||||||
Accreted amount | $ | $ 150,000 | $ 150,000 | ||||||||||
Common stock trading period | 30 days | |||||||||||
Conversion price (per share) | $ / shares | $ 11.00 | |||||||||||
Convertible preferred stock (in shares) | 91 | |||||||||||
Outstanding common stock, percentage | 9.90% | |||||||||||
Outstanding common stock, not to exceed, percentage | 19.90% | |||||||||||
Percentage of investment owned | 50.00% | |||||||||||
Maximum working capital line | $ | $ 5,000,000 | |||||||||||
Consideration received | $ | 15,000,000 | |||||||||||
Stock issuance costs | $ | 100,000 | |||||||||||
Proceeds from sale of equity, net | $ | 14,900,000 | |||||||||||
Da Vita Healthcare Partners Inc | Share Issuance, Tranche One | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Proceeds from issuance of convertible preferred stock | $ | $ 7,500,000 | 7,500,000 | ||||||||||
Da Vita Healthcare Partners Inc | Series X Convertible Preferred Stock | Private Placement | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Sale of stock, aggregate consideration authorized | $ | $ 15,000,000 | |||||||||||
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 | 7,500 | 7,500 | ||||||||||
Cantor Fitzgerald & Co | Controlled Equity Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Sale of stock, aggregate consideration authorized | $ | $ 12,200,000 |
Stockholder's Equity - Summary of Common Stock Reserved for Issuance (Details) - shares |
Jun. 30, 2023 |
Dec. 31, 2022 |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|---|---|
Common stock and common stock equivalents: | ||||
Common shares, shares outstanding (in shares) | 16,795,673 | 12,163,673 | 9,407,296 | |
Common stock and pre-funded stock warrants (in shares) | 18,588,673 | 18,463,673 | ||
Options to purchase common stock (in shares) | 1,570,599 | 423,317 | ||
Convertible preferred stock (in shares) | 1,363,636 | 1,363,636 | ||
Total (in shares) | 32,033,132 | 30,572,785 | ||
Registered Direct Offering Warrants | ||||
Common stock and common stock equivalents: | ||||
Warrants outstanding (in shares) | 1,793,000 | 9,056,377 | ||
Private Placement Warrants | ||||
Common stock and common stock equivalents: | ||||
Warrants outstanding (in shares) | 10,196,268 | 10,196,268 | ||
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) | 313,065 | 125,000 | 125,000 | 29,289 |
Stock-Based Compensation - Share-Based Compensation Expense (Details) - USD ($) |
3 Months Ended | 6 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Total share based compensation expense | $ 309,000 | $ 98,000 | $ 502,000 | $ (82,000) | |
Service based awards | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Total share based compensation expense | 309,000 | 98,000 | 502,000 | 309,000 | |
Unvested restricted stock units | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Total share based compensation expense | 119,000 | 25,554 | 164,000 | 37,000 | |
Stock option awards - service based awards | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Total share based compensation expense | 190,000 | 72,000 | 338,000 | 272,000 | |
Restricted stock awards - performance based awards | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Total share based compensation expense | $ 0 | $ 0 | $ 0 | $ (391,000) | $ (400,000) |
Stock-Based Compensation - Restricted Stock Awards (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 6 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
|
Number of Shares | |||||
Forfeited (in shares) | (6,227) | ||||
Weighted Average Grant-Date Fair Value | |||||
Forfeited (in shares) | (6,227) | ||||
Stock based compensation expenses | $ 309 | $ 98 | $ 502 | $ (82) | |
Restricted stock awards | |||||
Number of Shares | |||||
Unvested at end of period (in shares) | 891 | 891 | 891 | 891 | |
Weighted Average Grant-Date Fair Value | |||||
Vesting period | 20 months | ||||
Unvested, number of shares (in shares) | 891 | 891 | 891 | 891 | |
Restricted stock awards - performance based awards | |||||
Number of Shares | |||||
Unvested at beginning of period (in shares) | 891 | 7,118 | 7,118 | ||
Forfeited (in shares) | (6,227) | ||||
Unvested at end of period (in shares) | 891 | 891 | 891 | 891 | 891 |
Weighted Average Grant-Date Fair Value | |||||
Unvested at beginning of period (in dollars per share) | $ 62.70 | $ 62.70 | $ 62.70 | ||
Forfeited (in dollars per share) | 62.70 | ||||
Unvested at end of period (in dollars per share) | $ 62.70 | $ 62.70 | $ 62.70 | $ 62.70 | $ 62.70 |
Unvested, number of shares (in shares) | 891 | 891 | 891 | 891 | 891 |
Forfeited (in shares) | (6,227) | ||||
Stock based compensation expenses | $ 0 | $ 0 | $ 0 | $ (391) | $ (400) |
Stock-Based Compensation - Service Based Restricted Stock Units (Details) - USD ($) |
3 Months Ended | 6 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
|
Number of Shares | |||||
Forfeited (in shares) | (6,227) | ||||
Weighted Average Grant-Date Fair Value | |||||
Stock based compensation expenses | $ 309,000 | $ 98,000 | $ 502,000 | $ (82,000) | |
Restricted stock units - service based awards | |||||
Number of Shares | |||||
Unvested at beginning of period (in shares) | 125,000 | 29,289 | 29,289 | ||
Granted (in shares) | 313,065 | 125,000 | |||
Vested (in shares) | (125,000) | (23,515) | |||
Forfeited (in shares) | (5,774) | ||||
Unvested at end of period (in shares) | 313,065 | 125,000 | 313,065 | 125,000 | 125,000 |
Weighted Average Grant-Date Fair Value | |||||
Unvested at beginning of period (in dollars per share) | $ 1.47 | $ 12.87 | $ 12.87 | ||
Granted (in dollars per share) | 1.87 | 1.47 | |||
Vested (in dollars per share) | 1.47 | 11.33 | |||
Forfeited (in dollars per share) | (19.00) | ||||
Unvested at end of period (in dollars per share) | $ 1.87 | $ 1.47 | $ 1.87 | $ 1.47 | $ 1.47 |
Stock based compensation expenses | $ 119,000 | $ 25,554 | $ 164,000 | $ 37,000 | |
Unrecognized stock-based compensation expense | $ 500,000 | $ 500,000 | |||
Unrecognized stock-based compensation expense, weighted average remaining term (in years) (less than) | 1 year 8 months 12 days | ||||
Restricted stock units - service based awards | Minimum | |||||
Weighted Average Grant-Date Fair Value | |||||
Vesting period | 1 year | ||||
Restricted stock units - service based awards | Maximum | |||||
Weighted Average Grant-Date Fair Value | |||||
Vesting period | 3 years |
Stock-Based Compensation - Service Based Stock Options (Details) - $ / shares |
6 Months Ended | 12 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
|
Shares Underlying Options | ||||
Outstanding at the end of the period (in shares) | 1,570,599 | 423,317 | ||
Stock option awards - service based awards | ||||
Shares Underlying Options | ||||
Outstanding at the beginning of the period (in shares) | 1,206,905 | 528,591 | 528,591 | |
Granted (in shares) | 382,745 | 909 | ||
Forfeited (in shares) | (13,447) | (24,488) | ||
Expired (in shares) | (5,604) | (81,695) | ||
Outstanding at the end of the period (in shares) | 1,570,599 | 423,317 | 1,206,905 | 528,591 |
Exercisable at end of period (in shares) | 301,986 | 227,412 | ||
Weighted Average Exercise Price | ||||
Outstanding at the beginning of the period (in dollars per share) | $ 8.32 | $ 32.01 | $ 32.01 | |
Granted (in dollars per share) | 1.48 | 4.07 | ||
Forfeited (in dollars per share) | 4.02 | 15.00 | ||
Expired (in dollar per share) | 19.01 | 83.32 | ||
Outstanding at the end of the period (in dollars per share) | 6.65 | 23.03 | $ 8.32 | $ 32.01 |
Exercisable at end of the period (in dollars per share) | $ 26.15 | $ 31.19 | ||
Weighted Average Remaining Contractual Term | ||||
Outstanding | 8 years 8 months 12 days | 7 years 9 months 18 days | 8 years 10 months 24 days | 7 years 6 months |
Granted | 5 years 6 months | 9 years 6 months | ||
Exercisable at end of the period | 6 years 6 months | 5 years 9 months 18 days |
Stock-Based Compensation - Service Based Stock Options - Others (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock based compensation expenses | $ 309 | $ 98 | $ 502 | $ (82) |
Stock option awards - service based awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Granted (in shares) | 382,745 | 909 | ||
Forfeited (in shares) | 13,447 | 24,488 | ||
Expirations (in shares) | 5,604 | 81,695 | ||
Stock based compensation expenses | 190 | $ 72 | $ 338 | $ 272 |
Unrecognized stock-based compensation expenses | $ 900 | $ 900 | ||
Unrecognized stock-based compensation expense, weighted average remaining term (in years) | 8 years 8 months 12 days |
Stock-Based Compensation - Service Based Stock Options - Fair Value Assumptions (Details) - Stock option awards - service based awards |
6 Months Ended |
---|---|
Jun. 30, 2023
$ / shares
| |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected stock price volatility, minimum | 81.64% |
Expected stock price volatility, maximum | 81.90% |
Risk-free interest rate, minimum | 3.41% |
Risk-free interest rate, maximum | 3.55% |
Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price (in dollars per share) | $ 1.37 |
Term (years) | 4 years |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price (in dollars per share) | $ 2.83 |
Term (years) | 6 years |
Licensing Agreements (Details) |
Oct. 07, 2018
agreement
|
Jun. 30, 2023
USD ($)
|
Dec. 31, 2022
USD ($)
|
---|---|---|---|
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 | $ 85,400 | $ 85,400 | |
Milestone payments | $ 0 | $ 0 |
Leases - Narrative (Details) $ in Millions |
Jun. 30, 2023
USD ($)
ft²
|
Dec. 31, 2022
USD ($)
|
---|---|---|
Lessee, Lease, Description [Line Items] | ||
Operating lease and finance lease liabilities | $ | $ 5.9 | $ 6.7 |
Operating lease and finance lease, right of use assets, net | $ | $ 5.7 | $ 6.4 |
Wixom, Michigan | Wixom, Michigan Property One | ||
Lessee, Lease, Description [Line Items] | ||
Facility sqft. | 51,000 | |
Wixom, Michigan | Wixom, Michigan Property Two | ||
Lessee, Lease, Description [Line Items] | ||
Facility sqft. | 17,500 | |
Grapevine, Texas | ||
Lessee, Lease, Description [Line Items] | ||
Facility sqft. | 51,000 | |
Greer, South Carolina | ||
Lessee, Lease, Description [Line Items] | ||
Facility sqft. | 57,000 | |
Hackensack, New Jersey | ||
Lessee, Lease, Description [Line Items] | ||
Facility sqft. | 4,100 | |
Maximum | ||
Lessee, Lease, Description [Line Items] | ||
Lease term | 6 years |
Leases - Summary of Lease Costs (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Operating leases | ||||
Operating lease cost | $ 391 | $ 366 | $ 735 | $ 745 |
Interest on lease obligations | 64 | 65 | 124 | 135 |
Variable lease cost | 109 | 92 | 224 | 187 |
Operating lease expense | 564 | 523 | 1,083 | 1,067 |
Finance leases | ||||
Non-cash lease expense from right-of-use assets | 141 | 141 | 282 | 282 |
Interest on lease obligations | 38 | 45 | 77 | 92 |
Finance lease expense | 179 | 186 | 359 | 374 |
Short-term lease rent expense | 4 | 4 | 8 | 8 |
Total lease expense | 747 | 713 | 1,450 | 1,449 |
Other information | ||||
Payments for principal from operating leases | 478 | 447 | 902 | 911 |
Payments for interest from finance leases | 38 | 45 | 77 | 92 |
Payments for principal from finance leases | $ 129 | $ 119 | $ 258 | $ 237 |
Weighted-average remaining lease term – operating leases | 2 years 8 months 12 days | 3 years 2 months 12 days | 2 years 8 months 12 days | 3 years 2 months 12 days |
Weighted-average remaining lease term – finance leases | 3 years 10 months 24 days | 4 years 10 months 24 days | 3 years 10 months 24 days | 4 years 10 months 24 days |
Weighted-average discount rate – operating leases | 6.50% | 6.30% | 6.50% | 6.30% |
Weighted-average discount rate – finance leases | 6.40% | 6.40% | 6.40% | 6.40% |
Leases - Finance Lease and Operating Lease Maturities (Details) $ in Thousands |
Jun. 30, 2023
USD ($)
|
---|---|
Operating | |
Year ending December 31, 2023 (remaining) | $ 875 |
Year ending December 31, 2024 | 1,511 |
Year ending December 31, 2025 | 1,021 |
Year ending December 31, 2026 | 362 |
Year ending December 31, 2027 | 131 |
Total | 3,900 |
Less present value discount | (318) |
Operating lease liabilities | 3,582 |
Finance | |
Year ending December 31, 2023 (remaining) | 335 |
Year ending December 31, 2024 | 672 |
Year ending December 31, 2025 | 676 |
Year ending December 31, 2026 | 666 |
Year ending December 31, 2027 | 311 |
Total | 2,660 |
Less present value discount | (308) |
Finance lease liabilities | $ 2,352 |
Loans and Security Agreement - Narrative (Details) - Term loan |
1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
---|---|---|---|---|---|---|---|
Mar. 16, 2020
USD ($)
$ / shares
shares
|
Sep. 30, 2021
USD ($)
installment
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Nov. 10, 2022
USD ($)
|
|
Term loan | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 35,000,000 | $ 7,500,000 | $ 5,000,000 | ||||
Calculation for number of shares of common stock able to be purchased by warrant, percentage of principal amount of relevant term loan funded funded | 3.50% | ||||||
Warrant exercise price calculation, period immediately preceding execution of loan agreement, number of trading days | 5 days | ||||||
Interest rate, base percentage | 4.75% | ||||||
Interest rate, additional percentage added to base percentage | 4.00% | ||||||
Initial interest rate percentage | 8.75% | ||||||
Effective interest rate | 10.90% | ||||||
Option to add interest rate amount to outstanding principal balance in lieu of paying such amount in cash, percentage | 1.00% | ||||||
Interest expense | $ 300,000 | $ 400,000 | $ 600,000 | $ 800,000 | |||
Number of monthly installments | installment | 10 | ||||||
Prepayment premium percentage | 5.00% | ||||||
Minimum liquidity floor | $ 5,000,000 | ||||||
Minimum principal amount pursuant to liquidity covenant | $ 15,000,000 | ||||||
Outstanding balance, net of unamortized issuance costs and unaccreted discount | 9,400,000 | 9,400,000 | |||||
Unamortized issuance costs and unaccreted discount | $ 600,000 | $ 600,000 | |||||
Term loan | Minimum | |||||||
Debt Instrument [Line Items] | |||||||
Period for which company is entitled to make interest-only payments | 30 months | ||||||
Term loan | Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Period for which company is entitled to make interest-only payments | 36 months | ||||||
Term loan, first tranche | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 22,500,000 | ||||||
Net draw down proceeds | 21,200,000 | ||||||
Closing costs | $ 1,300,000 | ||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 18.15 | ||||||
Number of shares of common stock for which warrant is exercisable (in shares) | shares | 43,388 | ||||||
Additional debt discount recognized | $ 500,000 | ||||||
Term loan, second and third tranches | |||||||
Debt Instrument [Line Items] | |||||||
Warrant exercise price calculation, period immediately preceding relevant funding, number of trading days | 5 days | ||||||
Term loan, second and third tranches | Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 18.15 | ||||||
Term loan, second tranche | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 5,000,000 | ||||||
Term loan, third tranche | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 7,500,000 |
Loans and Security Agreement - Schedule of Principal Payments on Term Loan (Details) - Term loan - Term loan $ in Thousands |
Jun. 30, 2023
USD ($)
|
---|---|
Debt Instrument [Line Items] | |
2023 (remaining) | $ 2,000 |
2024 | 6,000 |
2025 | 2,000 |
Principal Payments | $ 10,000 |
Insurance Financing Note Payable (Details) - 5.40% Note Payable - Notes Payable to Banks - USD ($) $ in Millions |
Jun. 03, 2023 |
Jun. 30, 2023 |
---|---|---|
Short-term Debt [Line Items] | ||
Short-term note payable | $ 0.7 | |
Interest rate, base percentage | 9.59% | |
Amortization period (in months) | 9 months | |
Outstanding amount | $ 0.7 |
Subsequent Events (Details) |
3 Months Ended | 6 Months Ended | ||||||
---|---|---|---|---|---|---|---|---|
Jul. 10, 2023
USD ($)
$ / shares
shares
|
Jul. 05, 2023
USD ($)
$ / shares
shares
|
Jun. 30, 2023
shares
|
Jun. 30, 2022
shares
|
Jun. 30, 2023
shares
|
Jun. 30, 2022
shares
|
Dec. 31, 2022
shares
|
May 30, 2022
$ / shares
shares
|
|
Subsequent Event [Line Items] | ||||||||
Common shares, shares outstanding (in shares) | 16,795,673 | 9,407,296 | 16,795,673 | 9,407,296 | 12,163,673 | |||
PIPE Purchase Agreement Pre-Funded Warrant | ||||||||
Subsequent Event [Line Items] | ||||||||
Warrants exercised (in shares) | 4,118,000 | 0 | 4,507,000 | 0 | ||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 0.0001 | |||||||
Number of shares of common stock for which warrant is exercisable (in shares) | 1,267,897 | |||||||
Subsequent event | ||||||||
Subsequent Event [Line Items] | ||||||||
Common shares, shares outstanding (in shares) | 28,489,663 | |||||||
Subsequent event | Evoqua Water Technologies LLC | ||||||||
Subsequent Event [Line Items] | ||||||||
Cash paid | $ | $ 11,000,000 | |||||||
Milestone payments | $ | $ 2,500,000 | |||||||
Subsequent event | PIPE Purchase Agreement Pre-Funded Warrant | ||||||||
Subsequent Event [Line Items] | ||||||||
Warrants exercised (in shares) | 1,793,000 | |||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 0.0001 | |||||||
Gross proceeds | $ | $ 179 | |||||||
Subsequent event | Armistice Warrant Agreement | ||||||||
Subsequent Event [Line Items] | ||||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 1.39 | |||||||
Gross proceeds | $ | $ 13,800,000 | |||||||
Number of shares of common stock for which warrant is exercisable (in shares) | 9,900,990 | |||||||
Subsequent event | Armistice Reload Warrant Agreement | ||||||||
Subsequent Event [Line Items] | ||||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 5.13 | |||||||
Number of shares of common stock for which warrant is exercisable (in shares) | 3,750,000 | |||||||
Warrant expiration period | 54 months | |||||||
Ownership limitation percentage | 0.0999 | |||||||
Subsequent event | Letter Agreement | ||||||||
Subsequent Event [Line Items] | ||||||||
Period after issuance, shares cannot be sold | 45 days | |||||||
Minimum purchase price (dollars per share) | $ / shares | $ 6.25 | |||||||
Extended expiration date | 1 year |
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