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United States
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
__________________________________________________
(Mark One)
| | | | | |
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2023
or
| | | | | |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 000-23661
ROCKWELL MEDICAL, INC.
(Exact name of registrant as specified in its charter)
| | | | | | | | | | | |
Delaware | 38-3317208 |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
30142 S. Wixom Road, Wixom, Michigan | 48393 |
(Address of principal executive offices) | (Zip Code) |
(248) 960-9009
(Registrant’s telephone number, including area code)
(Former name, former address and former fiscal year,
if changed since last report)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| | | | | | | | | | | |
Large accelerated filer | ☐ | Accelerated filer | ☐ |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| | Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒
No
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | | | | | | | |
Title of each class: | | Trading Symbol | | Name of each exchange on which registered: |
Common Stock, par value $0.0001 | | RMTI | | Nasdaq Capital Market |
The number of shares of common stock outstanding as of November 10, 2023 was 28,489,663.
Rockwell Medical, Inc. and Subsidiaries
Index to Form 10-Q
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Dollars In Thousands, Except Par Value Amounts)
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
| | | |
ASSETS | | | |
Cash and Cash Equivalents | $ | 7,759 | | | $ | 10,102 | |
Investments Available-for-Sale | 3,971 | | | 11,390 | |
Accounts Receivable, net | 9,361 | | | 6,259 | |
| | | |
Inventory, net | 5,486 | | | 5,814 | |
Prepaid and Other Current Assets | 1,596 | | | 1,745 | |
Total Current Assets | 28,173 | | | 35,310 | |
Property and Equipment, net | 6,771 | | | 2,194 | |
Inventory, Non-Current | 178 | | | 1,276 | |
Right of Use Assets-Operating, net | 3,095 | | | 3,943 | |
Right of Use Assets-Financing, net | 2,044 | | | 2,468 | |
Intangible Asset, net | 10,897 | | | — | |
Goodwill | 921 | | | 921 | |
Other Non-Current Assets | 527 | | | 523 | |
Total Assets | $ | 52,606 | | | $ | 46,635 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | |
Accounts Payable | $ | 3,929 | | | $ | 4,053 | |
Accrued Liabilities | 6,708 | | | 7,702 | |
Deferred Consideration - Current | 2,500 | | | — | |
Lease Liabilities-Operating - Current | 1,529 | | | 1,483 | |
Lease Liabilities-Financing - Current | 550 | | | 522 | |
Deferred License Revenue - Current | 46 | | | 1,731 | |
Term Loan - Current - Net of Issuance Costs | 5,631 | | | 1,631 | |
Insurance Financing Note Payable | 488 | | | 503 | |
Customer Deposits | 27 | | | 66 | |
| | | |
Total Current Liabilities | 21,408 | | | 17,691 | |
| | | |
Lease Liabilities-Operating - Long-Term | 1,676 | | | 2,581 | |
Lease Liabilities-Financing - Long-Term | 1,672 | | | 2,088 | |
Term Loan - Long-Term, net of issuance costs | 3,331 | | | 7,555 | |
Deferred License Revenue - Long-Term | 487 | | | 2,600 | |
Deferred Consideration - Long-Term | 2,500 | | | — | |
Long Term Liability - Other | 14 | | | 14 | |
Total Liabilities | 31,088 | | | 32,529 | |
| | | |
| | | |
| | | |
| | | |
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Stockholders’ Equity: | | | |
Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; 15,000 shares issued and outstanding at September 30, 2023 and December 31, 2022 | — | | | — | |
Common Stock, $0.0001 par value; 170,000,000 shares authorized; 28,489,663 and 12,163,673 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 3 | | | 1 | |
Additional Paid-in Capital | 417,133 | | | 402,701 | |
Accumulated Deficit | (395,686) | | | (388,759) | |
Accumulated Other Comprehensive Income | 68 | | | 163 | |
Total Stockholders’ Equity | 21,518 | | | 14,106 | |
Total Liabilities and Stockholders’ Equity | $ | 52,606 | | | $ | 46,635 | |
The accompanying notes are an integral part of the condensed consolidated financial statements.
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Amounts)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, 2023 | | Three Months Ended September 30, 2022 | | Nine Months Ended September 30, 2023 | | Nine Months Ended September 30, 2022 |
| | | | | | | |
Net Sales | $ | 23,771 | | | $ | 18,691 | | | $ | 61,519 | | | $ | 53,497 | |
Cost of Sales | 21,569 | | | 17,914 | | | 55,685 | | | 51,760 | |
Gross Profit | 2,202 | | | 777 | | | 5,834 | | | 1,737 | |
Research and Product Development | 494 | | | 469 | | | 939 | | | 2,963 | |
Selling and Marketing | 556 | | | 762 | | | 1,584 | | | 1,743 | |
General and Administrative | 2,889 | | | 3,254 | | | 9,434 | | | 11,845 | |
| | | | | | | |
Operating Loss | (1,737) | | | (3,708) | | | (6,123) | | | (14,814) | |
| | | | | | | |
Other (Expense) Income | | | | | | | |
Realized Gain on Settlement of Investments | 220 | | | — | | | 220 | | | 4 | |
| | | | | | | |
Interest Expense | (411) | | | (476) | | | (1,193) | | | (1,497) | |
Interest and Other Income (Expense) - net | 56 | | | (6) | | | 169 | | | (10) | |
Total Other Expense, net | (135) | | | (482) | | | (804) | | | (1,503) | |
| | | | | | | |
Net Loss | $ | (1,872) | | | $ | (4,190) | | | $ | (6,927) | | | $ | (16,317) | |
| | | | | | | |
Basic and Diluted Net Loss per Share | $ | (0.07) | | | $ | (0.23) | | | $ | (0.32) | | | $ | (1.26) | |
Basic and Diluted Weighted Average Shares Outstanding * | 27,521,088 | | | 18,463,673 | | | 21,526,978 | | | 12,902,890 | |
* See Note 3 for more detail related to Basic and Diluted Weighted Average Shares Outstanding
The accompanying notes are an integral part of the condensed consolidated financial statements.
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In Thousands)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, 2023 | | Three Months Ended September 30, 2022 | | Nine Months Ended September 30, 2023 | | Nine Months Ended September 30, 2022 |
| | | | | | | |
Net Loss | $ | (1,872) | | | $ | (4,190) | | | $ | (6,927) | | | $ | (16,317) | |
Unrealized (Loss) Gain on Available-for-Sale Investments | (69) | | | 5 | | | (90) | | | 5 | |
Foreign Currency Translation Adjustments | — | | | — | | | (4) | | | (3) | |
Comprehensive Loss | $ | (1,941) | | | $ | (4,185) | | | $ | (7,021) | | | $ | (16,315) | |
The accompanying notes are an integral part of the condensed consolidated financial statements.
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
(Dollars in Thousands) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | 15,000 | | | $ | — | | | 12,163,673 | | | $ | 1 | | | $ | 402,701 | | | $ | (388,759) | | | $ | 163 | | | $ | 14,106 | |
Net Loss | — | | | — | | | — | | | — | | | — | | | (1,750) | | | — | | | (1,750) | |
Unrealized Loss on Available-for-Sale Investments | — | | | — | | | — | | | — | | | — | | | — | | | (3) | | | (3) | |
Foreign Currency Translation Adjustments | — | | | — | | | — | | | — | | | — | | | — | | | (4) | | | (4) | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
Issuance of Common Stock upon exercise of Pre-Funded Warrants | — | | | — | | | 389,000 | | | — | | | — | | | — | | | — | | | — | |
Stock-based Compensation | — | | | — | | | — | | | — | | | 193 | | | — | | | — | | | 193 | |
Balance as of March 31, 2023 | 15,000 | | | — | | | 12,552,673 | | | 1 | | | 402,894 | | | (390,509) | | | 156 | | | 12,542 | |
Net Loss | — | | | — | | | — | | | — | | | — | | | (3,305) | | | — | | | (3,305) | |
Unrealized Loss on Available-for-Sale Investments | — | | | — | | | — | | | — | | | — | | | — | | | (18) | | | (18) | |
Foreign Currency Translation Adjustments | — | | | — | | | — | | | — | | | — | | | — | | | (1) | | | (1) | |
Issuance of Common Stock upon exercise of Pre-Funded Warrants | — | | | — | | | 4,118,000 | | | 1 | | | — | | | — | | | — | | | 1 | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
Vesting of Restricted Stock Units Issued, net of taxes withheld | — | | | — | | | 125,000 | | | — | | | — | | | — | | | — | | | — | |
| | | | | | | | | | | | | | | |
Stock-based Compensation | — | | | — | | | — | | | — | | | 309 | | | — | | | — | | | 309 | |
Balance as of June 30, 2023 | 15,000 | | | — | | | 16,795,673 | | | 2 | | | 403,203 | | | (393,814) | | | 137 | | | 9,528 | |
Net Loss | — | | | — | | | — | | | — | | | — | | | (1,872) | | | — | | | (1,872) | |
Unrealized Loss on Available-for-Sale Investments | — | | | — | | | — | | | — | | | — | | | — | | | (69) | | | (69) | |
| | | | | | | | | | | | | | | |
Issuance of Common Stock in connection with exercise of Prior Warrant and Pre-Funded Warrants, net of offering costs | — | | | — | | | 11,693,990 | | | 1 | | | 13,718 | | | — | | | — | | | 13,719 | |
Stock-based Compensation | — | | | — | | | — | | | — | | | 212 | | | — | | | — | | | 212 | |
Balance as of September 30, 2023 | 15,000 | | | $ | — | | | 28,489,663 | | | $ | 3 | | | $ | 417,133 | | | $ | (395,686) | | | $ | 68 | | | $ | 21,518 | |
The accompanying notes are an integral part of the condensed consolidated financial statements.
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT)
(Dollars in Thousands)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | — | | | $ | — | | | 8,544,225 | | | $ | 1 | | | $ | 372,562 | | | $ | (370,080) | | | $ | 52 | | | $ | 2,535 | |
Net Loss | — | | | — | | | — | | | — | | | — | | | (7,162) | | | — | | | (7,162) | |
| | | | | | | | | | | | | | | |
Foreign Currency Translation Adjustments | — | | | — | | | — | | | — | | | — | | | — | | | (1) | | | (1) | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
Stock-based Compensation | — | | | — | | | — | | | — | | | (179) | | | — | | | — | | | (179) | |
Balance as of March 31, 2022 | — | | | — | | | 8,544,225 | | | 1 | | | 372,383 | | | (377,242) | | | 51 | | | (4,807) | |
Net Loss | — | | | — | | | — | | | — | | | — | | | (4,967) | | | — | | | (4,967) | |
| | | | | | | | | | | | | | | |
Foreign Currency Translation Adjustments | — | | | — | | | — | | | — | | | — | | | — | | | (2) | | | (2) | |
Issuance of Common Stock, net of offering costs/Public Offering | — | | | — | | | 844,613 | | | — | | | 14,893 | | | — | | | — | | | 14,893 | |
Issuance of Common Stock, net of offering costs/At-the-Market Offering | — | | | — | | | 7,500 | | | — | | | 15 | | | — | | | — | | | 15 | |
Issuance of Preferred Stock, net of offering costs | 15,000 | | | — | | | — | | | — | | | 14,916 | | | — | | | — | | | 14,916 | |
Vesting of Restricted Stock Units Issued, net of taxes withheld | — | | | — | | | 10,958 | | | — | | | — | | | — | | | — | | | — | |
| | | | | | | | | | | | | | | |
Stock-based Compensation | — | | | — | | | — | | | — | | | 97 | | | — | | | — | | | 97 | |
Balance as of June 30, 2022 | 15,000 | | | — | | | 9,407,296 | | | 1 | | | 402,304 | | | (382,209) | | | 49 | | | 20,145 | |
Net Loss | — | | | — | | | — | | | — | | | — | | | (4,190) | | | — | | | (4,190) | |
Unrealized Gain on Available-for-Sale Investments | — | | | — | | | — | | | — | | | — | | | — | | | 5 | | | 5 | |
| | | | | | | | | | | | | | | |
Issuance of Common Stock, net of offering costs/Public Offering | — | | | — | | | 1,745,377 | | | — | | | — | | | — | | | — | | | — | |
Stock-based Compensation | — | | | — | | | — | | | — | | | 176 | | | — | | | — | | | 176 | |
Balance as of September 30, 2022 | 15,000 | | | $ | — | | | 11,152,673 | | | $ | 1 | | | $ | 402,480 | | | $ | (386,399) | | | $ | 54 | | | $ | 16,136 | |
The accompanying notes are an integral part of the condensed consolidated financial statements.
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Dollars in Thousands)
| | | | | | | | | | | |
| Nine Months Ended September 30, 2023 | | Nine Months Ended September 30, 2022 |
| | | |
Cash Flows From Operating Activities: | | | |
Net Loss | $ | (6,927) | | | $ | (16,317) | |
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities: | | | |
Depreciation and Amortization | 894 | | | 422 | |
Stock-based Compensation | 714 | | | 95 | |
| | | |
Increase in Inventory Reserves | 1,098 | | | 307 | |
Non-cash Lease Expense from Right of Use Assets | 1,529 | | | 1,518 | |
Amortization of Debt Financing Costs and Accretion of Debt Discount | 276 | | | 276 | |
Loss (Gain) on Disposal of Assets | 1 | | | (3) | |
Realized Gain on Sale of Investments | (220) | | | (4) | |
Changes in Operating Assets and Liabilities: | | | |
Accounts Receivable, net | (3,102) | | | (1,454) | |
| | | |
Inventory | 1,561 | | | (921) | |
Prepaid and Other Assets | 875 | | | 2,058 | |
Accounts Payable | (124) | | | (688) | |
Lease Liabilities | (1,113) | | | (1,435) | |
Other Liabilities | (1,033) | | | 756 | |
Deferred License Revenue | (3,798) | | | (1,427) | |
Cash Used In Operating Activities | (9,369) | | | (16,817) | |
Cash Flows From Investing Activities: | | | |
Purchase of Investments Available-for-Sale | (3,752) | | | (17,389) | |
Sale of Investments Available-for-Sale | 11,301 | | | 11,972 | |
Purchase of Equipment | (241) | | | (197) | |
Cash Paid in Connection with Evoqua Asset Acquisition | (12,361) | | | — | |
Cash Used In Investing Activities | (5,053) | | | (5,614) | |
Cash Flows From Financing Activities: | | | |
| | | |
| | | |
Payments on Debt | (500) | | | (6,750) | |
Payments on Insurance Financing Note Payable | (748) | | | (941) | |
Payments on Financing Lease Liabilities | (388) | | | — | |
| | | |
| | | |
Proceeds from Issuance of Common Stock | 13,763 | | | 15,016 | |
Offering Costs from Issuance of Common Stock | (43) | | | (106) | |
Proceeds from Issuance of Preferred Stock | — | | | 15,000 | |
Offering Costs from Issuance of Preferred Stock | — | | | (85) | |
| | | |
| | | |
| | | |
Cash Provided by Financing Activities | 12,084 | | | 22,134 | |
| | | |
Effect of Exchange Rate Changes on Cash and Cash Equivalents | (5) | | | (3) | |
| | | |
Net Decrease in Cash and Cash Equivalents | (2,343) | | | (300) | |
Cash and Cash Equivalents at Beginning of Period | 10,102 | | | 13,280 | |
Cash and Cash Equivalents at End of Period | $ | 7,759 | | | $ | 12,980 | |
| | | |
Supplemental Disclosure of Cash Flow Information: | | | |
Cash Paid for Interest | $ | 929 | | | $ | 1,261 | |
| | | |
| | | |
| | | |
Supplemental Disclosure of Non-cash Operating, Investing and Financing Activities: | | | |
Change in Unrealized (Loss) Gain on Investments Available-for-Sale | $ | (90) | | | $ | 5 | |
Increase in Prepaid Assets from Insurance Financing Note Payable | $ | 733 | | | $ | — | |
Deferred Consideration from Evoqua Asset Acquisition | $ | 5,000 | | | $ | — | |
The accompanying notes are an integral part of the condensed consolidated financial statements.
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. 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 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, the Company executed and consummated the transactions contemplated by an Asset Purchase Agreement (the “Purchase Agreement”) with Evoqua Water Technologies LLC ("Evoqua") (the "Evoqua Acquisition"). Subject to the terms and conditions of the Purchase Agreement, at the closing of the transaction (the “Closing”), the Company purchased customer relationships, equipment and inventory from Evoqua, which were related to its manufacturing and selling of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization. See Note 4 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 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. During the third quarter of 2023, the ongoing Triferic development effort was terminated resulting in an acceleration of the corresponding deferred license revenue (see Note 10) and a reserve on the non-current inventory (see Note 7). 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.
2. Liquidity and Capital Resources
As of September 30, 2023, Rockwell had approximately $11.7 million of cash, cash equivalents and investments available-for-sale, and working capital of $6.8 million. Net cash used in operating activities for the nine months ended September 30, 2023 was approximately $9.4 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.
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.
In 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 15 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, Israel-Hamas conflict 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.
3. Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements
The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U. S. Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements.
The condensed consolidated balance sheet at September 30, 2023, and the condensed consolidated statements of operations, comprehensive loss, and changes in stockholders' equity for the three and nine months ended September 30, 2023 and cash flows for the nine months ended September 30, 2023 are unaudited, but include all adjustments, consisting of normal recurring adjustments the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 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. 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
Loss per share for the three and nine months ended September 30, 2022 have been recalculated and restated and is presented on a comparable basis with the three and nine months ended September 30, 2023. In the first quarter of 2023, the Company determined it should have included pre-funded warrants issued in the second quarter of 2022 in the earnings per share calculation in 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, the Company has recalculated and restated 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 September 30, 2023 and 2022 in the "Loss Per Share" section below.
| | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | | Nine Months Ended September 30, |
| | | 2022 | | | | 2022 |
As Previously Reported: | | | | | | | |
Net loss per share attributable to common stockholders - basic and diluted | | | $ | (0.40) | | | | | $ | (1.75) | |
Weighted average number of shares of common stock outstanding - basic and diluted | | | 10,528,148 | | | | | 9,299,788 | |
| | | | | | | |
As Restated: | | | | | | | |
Net loss per share attributable to common stockholders - basic and diluted | | | $ | (0.23) | | | | | $ | (1.26) | |
Weighted average number of shares of common stock outstanding - basic and diluted | | | 18,463,673 | | | | | 12,902,890 | |
Loss Per Share
Basic and diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, after giving effect to the restatement discussed above, was calculated as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
(In Thousands, Except Share and Per Share Amounts) | 2023 | | 2022 | | 2023 | | 2022 |
Numerator: | | | | | | | |
Net loss | $ | (1,872) | | | $ | (4,190) | | | $ | (6,927) | | | $ | (16,317) | |
Net loss attributable to common stockholders for basic and diluted loss per share | $ | (1,872) | | | $ | (4,190) | | | $ | (6,927) | | | $ | (16,317) | |
| | | | | | | |
Denominator: | | | | | | | |
Weighted average number of shares of common stock outstanding - basic and diluted | 27,521,088 | | | 18,463,673 | | | 21,526,978 | | | 12,902,890 | |
Net loss per share attributable to common stockholders - basic and diluted | $ | (0.07) | | | $ | (0.23) | | | $ | (0.32) | | | $ | (1.26) | |
Included within the weighted average shares of common stock outstanding for the three and nine months ended September 30, 2022 are 7,311,000 shares of common stock issuable upon the exercise of pre-funded warrants (See Note 11), 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 nine months ended September 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:
| | | | | | | | | | | |
| As of September 30, |
| 2023 | | 2022 |
Options to Purchase Common Stock | 1,367,493 | | | 1,311,691 | |
Unvested Restricted Stock Awards | 891 | | | 891 | |
Unvested Restricted Stock Units | 287,400 | | | 125,000 | |
Convertible Preferred Stock | 1,363,636 | | | 1,363,636 | |
Warrants to Purchase Common Stock | 4,045,278 | | 17,507,268 | |
Total | 7,064,698 | | 20,308,486 | |
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 related losses for trade accounts receivable, as well as available-for-sale debt securities, which are 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.
4. Asset Acquisition
On July 10, 2023, the Company completed the Evoqua Acquisition. At the Closing, the Company purchased customer relationships, equipment and inventory from Evoqua, which were related to manufacturing and selling of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization.
Pursuant to the Purchase Agreement, total consideration was $17.4 million, comprising a cash payment at Closing of $12.2 million (inclusive of transaction costs) and two $2.5 million deferred payments, the first to be paid on the one-year anniversary of the Closing, which is included as a current liability on the Company's condensed consolidated balance sheet, and the second to be paid on the second anniversary of the Closing (collectively, the “deferred consideration”).
The transaction was accounted for as an asset acquisition, as the acquired assets did not meet the definition of a business as defined by ASC 805, Business Combinations.
The purchase price was allocated, on a relative fair value basis, to the assets acquired at the July 10, 2023 acquisition date as follows (table in thousands):
| | | | | | | | |
| | |
Consideration | | |
Cash Payment | | $ | 12,233 | |
Deferred Consideration | | 5,000 | |
Transaction Costs | | 128 | |
Total Consideration | | $ | 17,361 | |
| | |
Assets Acquired | | |
Customer Relationships Intangible Asset | | $ | 11,035 | |
Equipment | | 5,093 | |
Inventory | | 1,233 | |
Total Assets Acquired | | $ | 17,361 | |
The fair value of the customer relationships intangible asset was determined using a multi-period excess earnings method, a form of the income approach, which incorporates the estimated future cash flows to be generated from the customer base. Key assumptions included discounted cash flow, estimated life cycle and customer attrition rates. Customer relationships are being amortized over a period of 20 years. Given the recency of the purchase of the equipment in which the assets were recorded at fair value, the Company determined the fair value of the equipment using a cost approach, which considered
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
assumptions over the equipment's current replacement cost and useful life. Inventory was purchased directly from the contract manufacturer holding the inventory, which approximated fair value.
During the three and nine months ended September 30, 2023, the Company recorded amortization of its customer relationship intangible asset of $0.1 million, resulting in a net intangible asset of $10.9 million as of September 30, 2023.
Estimated future amortization expense on the Company's customer relationships intangible asset as of September 30, 2023 is as follows (table in thousands):
| | | | | | | | | |
Year ended December 31: | | | |
2023 (remainder of year) | | | $ | 138 | |
2024 | | | 552 | |
2025 | | | 552 | |
2026 | | | 552 | |
2027 | | | 552 | |
Thereafter | | | 8,551 | |
Total | | | $ | 10,897 | |
5. Revenue Recognition
The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle:
•Step 1: Identify the contract with the customer
•Step 2: Identify the performance obligations in the contract
•Step 3: Determine the transaction price
•Step 4: Allocate the transaction price to the performance obligations in the contract
•Step 5: Recognize revenue when the company satisfies a performance obligation
Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue.
Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer.
Nature of goods and services
The following is a description of principal activities from which the Company generates its revenue.
The Company currently operates in one market segment, the hemodialysis market, which involves the manufacture, sale and distribution of hemodialysis products to hemodialysis clinics, including pharmaceutical, dialysis concentrates, dialysis kits and other ancillary products used in the dialysis process. Rockwell's customer mix is diverse, with most customer sales concentrations under 10% and one customer, DaVita, Inc. ("DaVita"), at approximately 50% of total net product sales for each of the three and nine months ended September 30, 2023. Rockwell's accounts receivable from this customer were approximately 31% and 30% of the total net consolidated accounts receivable balance at September 30, 2023 and December 31, 2022, respectively.
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. During the three months ended September 30, 2023, the amounts received from Wanbang were accelerated out of deferred license revenue and into revenue upon notice that the development effort was terminated (see Note 10).
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 U.S. 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 U.S. and around the world. For additional information, see Note 10.
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 September 30, 2023, all payments were completed.
On September 18, 2023, the Company and its long-time partner, DaVita, a leading provider of kidney care, entered into an Amended and Restated Products Purchase Agreement (the "Amended Agreement"), which amends and restates the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates. Under the Amended Agreement, the Company and DaVita agreed to an increase in product pricing, effective September 1, 2023 and a one-time payment to Rockwell on or after December 1, 2023. The term of the Amended Agreement will expire on December 31, 2024. DaVita will have the right, in its sole discretion upon written notice to the Company given no later than September 30, 2024, to further extend the term through December 31, 2025. In the event of such an extension, product pricing will be increased for the extended term. In addition, DaVita is required to provide the Company with nine-month purchasing forecasts and a commitment to purchase at least the forecasted amounts. In the event that DaVita does not meet its forecasts, it is required to pay the Company for the amount forecasted, purchase additional product, or the Company may terminate the Amended Agreement. Upon expiration or termination of the Amended Agreement, and upon request by DaVita, the Company has agreed to provide transition services to DaVita during a transition period.
Additionally during the third quarter of 2023, the Company entered into several long-term product purchase agreements, which include supply and purchasing commitments from certain parties.
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 estimated at the time of sale. 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.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
In thousands | Three Months Ended September 30, 2023 | | Nine Months Ended September 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 | 2,197 | | | — | | | 2,197 | | | 2,327 | | | — | | | 2,327 | |
Total Drug Products | 2,197 | | | — | | | 2,197 | | | 2,327 | | | — | | | 2,327 | |
Concentrates Products | | | | | | | | | | | |
Product Sales – Point-in-time | 21,574 | | | 19,741 | | | 1,833 | | | 57,720 | | | 52,326 | | | 5,394 | |
License Fee – Over time | — | | | — | | | — | | | 1,472 | | | 1,472 | | | — | |
Total Concentrate Products | 21,574 | | | 19,741 | | | 1,833 | | | 59,192 | | | 53,798 | | | 5,394 | |
Net Revenue | $ | 23,771 | | | $ | 19,741 | | | $ | 4,030 | | | $ | 61,519 | | | $ | 53,798 | | | $ | 7,721 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
In thousands | Three Months Ended September 30, 2022 | | Nine Months Ended September 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 | $ | 193 | | | $ | 193 | | | $ | — | | | $ | 834 | | | $ | 561 | | | $ | 273 | |
License Fee – Over time | 65 | | | — | | | 65 | | | 192 | | | — | | | 192 | |
Total Drug Products | 258 | | | 193 | | | 65 | | | 1,026 | | | 561 | | | 465 | |
Concentrates Products | | | | | | | | | | | |
Product Sales – Point-in-time | 17,953 | | | 16,619 | | | 1,334 | | | 51,035 | | | 46,334 | | | 4,701 | |
License Fee – Over time | 480 | | | 480 | | | — | | | 1,436 | | | 1,436 | | | — | |
Total Concentrate Products | 18,433 | | | 17,099 | | | 1,334 | | | 52,471 | | | 47,770 | | | 4,701 | |
Net Revenue | $ | 18,691 | | | $ | 17,292 | | | $ | 1,399 | | | $ | 53,497 | | | $ | 48,331 | | | $ | 5,166 | |
Contract balances
The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers.
| | | | | | | | | | | |
In thousands | September 30, 2023 | | December 31, 2022 |
Accounts Receivable, net | $ | 9,361 | | | $ | 6,259 | |
Contract Liabilities, which are included in deferred license revenue | $ | 533 | | | $ | 4,331 | |
There were no other material contract assets recorded on the condensed consolidated balance sheets as of September 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 September 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.
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
6. Investments - Available-for-Sale
Investments available-for-sale consisted of the following as of September 30, 2023 and December 31, 2022 (table in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2023 |
| Amortized Cost | | Unrealized Gain | | Unrealized Loss | | Accrued Interest | | Fair Value |
Available-for-Sale Securities | | | | | | | | | |
Debt securities | $ | 3,898 | | | $ | 73 | | | $ | — | | | $ | — | | | $ | 3,971 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| December 31, 2022 |
| Amortized Cost | | Unrealized Gain | | Unrealized Loss | | Accrued Interest | | Fair Value |
Available-for-Sale Securities | | | | | | | | | |
Debt securities | $ | 11,315 | | | $ | 75 | | | $ | — | | | $ | — | | | $ | 11,390 | |
The fair value of investments available-for-sale are determined using quoted market prices from daily exchange-traded markets based on the closing price as of the balance sheet date and are classified as a Level 1 measurement under ASC 820 Fair Value Measurements.
As of September 30, 2023 and December 31, 2022, all of our available-for-sale securities were all due within one year.
7. Inventory
Components of inventory, net of reserves, as of September 30, 2023 and December 31, 2022 are as follows (table in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Inventory - Current Portion | | | |
Raw Materials | $ | 2,335 | | | $ | 3,351 | |
Work in Process | 337 | | | 351 | |
Finished Goods | 2,814 | | | 2,112 | |
Total Current Inventory | 5,486 | | | 5,814 | |
Inventory - Long Term (1) | 178 | | | 1,276 | |
Total Inventory | $ | 5,664 | | | $ | 7,090 | |
| | | |
__________1.Represents inventory related to Triferic raw materials. This Triferic inventory will be utilized for the Company's international partnerships. In September 2022, the Company discontinued its New Drug Applications ("NDAs") for Triferic (dialysate) and Triferic AVNU in the United States. During the three months ended September 30, 2023, the Company reserved $1.1 million of long-term inventory as a result of the termination of the Wanbang development effort.
As of September 30, 2023 and December 31, 2022, Rockwell had total current concentrate inventory aggregating $5.5 million and $5.8 million, respectively, against which Rockwell had reserved $25,000 at both September 30, 2023 and December 31, 2022.
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
8. Property and Equipment, net
As of September 30, 2023 and December 31, 2022, the Company’s property and equipment consisted of the following (table in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Leasehold Improvements | $ | 1,423 | | | $ | 1,256 | |
Machinery and Equipment | 11,085 | | | 5,922 | |
Information Technology & Office Equipment | 1,845 | | | 1,845 | |
Laboratory Equipment | 807 | | | 807 | |
Total Property and Equipment | 15,160 | | | 9,830 | |
Accumulated Depreciation and Amortization | (8,389) | | | (7,636) | |
Property and Equipment, net | $ | 6,771 | | | $ | 2,194 | |
Depreciation and amortization expense for the three months ended September 30, 2023 and 2022 was $0.4 million and $0.1 million, respectively. Depreciation and amortization expense for the nine months ended September 30, 2023 and 2022 was $0.8 million and $0.4 million, respectively.
9. Accrued Liabilities
Accrued liabilities as of September 30, 2023 and December 31, 2022 consisted of the following (table in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Accrued Compensation and Benefits | $ | 2,240 | | | $ | 2,568 | |
Accrued Unvouchered Receipts | 1,947 | | | 585 | |
Accrued Manufacturing Expense | 732 | | | — | |
Accrued Workers Compensation | 202 | | | 306 | |
Accrued Research & Development Expense | — | | | 43 | |
Other Accrued Liabilities | 1,587 | | | 4,200 | |
Total Accrued Liabilities | $ | 6,708 | | | $ | 7,702 | |
10. Deferred License 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 license 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 license revenue and is being recognized as revenue based on the agreement term. On August 7, 2023, Rockwell was informed by Wanbang that the main efficacy results of Wanbang’s clinical trial for Triferic (dialysate) compared with placebo were not obtained and Wanbang will not bring the product forward to registration. As a result, the Company recognized all remaining revenue under the Wangbang Agreement of approximately $2.2 million during the third quarter of 2023. Additionally, in connection with these events, the Company
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
established a reserve for related Triferic long-term inventory of $1.1 million, resulting in a net increase in gross profit of $1.1 million.
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 license revenue and is being recognized as revenue based on the agreement term. The Company recognized revenue of approximately $2,500 and $7,500 for the three and nine months ended September 30, 2023 and 2022, respectively. Deferred license revenue related to the Sun Pharma Agreement totaled $62,500 and $70,000 as of September 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 license revenue and are being recognized as revenue based on the agreement term. The Company recognized revenue of $5,200 and $15,600 for the three and nine months ended September 30, 2023 and 2022, respectively. Deferred license revenue related to the Jeil Agreement totaled approximately $0.4 million as of both September 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 license revenue and will be recognized as revenue based on the agreement term. The Company recognized revenue of $3,750 and $11,250 for the three and nine months ended September 30, 2023 and 2022, respectively. Deferred license revenue related to the Drogsan Agreements totaled approximately $0.1 million as of each of September 30, 2023 and December 31, 2022. 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. Drogsan is responsible for all regulatory approval and commercialization activities.
11. 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 September 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 and the sale of the assets that would allow for redemption is within the control of the Company, the preferred stock has been classified as permanent equity and initially recognized at fair value of $15 million (the proceeds on the date of issuance) less issuance costs of $0.1 million, resulting in an initial value of $14.9 million. The Company will assess at each reporting period whether conditions have changed to now meet the mandatory redemption definition which could trigger liability classification.
As of both September 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 September 30, 2023 and December 31, 2022, there were 170,000,000 shares of common stock, $0.0001 par value per share, authorized and 28,489,663 and 12,163,673 shares issued and outstanding, respectively.
As of September 30, 2023 and 2022, the Company reserved for issuance the following shares of common stock related to the potential exercise of employee stock options, unvested restricted stock, convertible preferred stock, pre-funded warrants and all other warrants (collectively, "common stock equivalents"):
| | | | | | | | | | | |
| As of September 30, |
Common stock and common stock equivalents: | 2023 | | 2022 |
Common stock | 28,489,663 | | | 11,152,673 | |
Common stock issuable upon exercise of pre-funded warrants | — | | | 7,311,000 | |
Common stock and pre-funded stock warrants | 28,489,663 | | | 18,463,673 | |
Options to Purchase Common Stock | 1,367,493 | | | 1,311,691 | |
Unvested Restricted Stock Awards | 891 | | | 891 | |
Unvested Restricted Stock Units | 287,400 | | | 125,000 | |
Convertible Preferred Stock | 1,363,636 | | | 1,363,636 | |
| | | |
Warrants to Purchase Common Stock | 4,045,278 | | | 17,507,268 | |
Total | 35,554,361 | | 38,772,159 | |
During the three months ended September 30, 2023 and 2022, 1,793,000 and 477,480 pre-funded warrants were exercised, respectively. During the nine months ended September 30, 2023 and 2022, 6,300,000 and 477,480 pre-funded warrants were exercised, respectively.
During the three and nine months ended September 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 (the "ATM facility") with Cantor Fitzgerald & Co. as Agent, pursuant to which the Company may offer and sell from time to time up to $12.2 million of shares of Company’s common stock through the Agent. The offering and sale of such shares has been registered under the Securities Act of 1933, as amended.
During the quarter ended September 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 Registered Direct Purchase Agreement (the "Agreement") with the Purchaser, pursuant to which the Company issued and sold, 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 Agreement contains customary representations and warranties and agreements of the Company and the Purchaser and customary indemnification rights and obligations of the parties.
On July 5, 2023, all of the remaining Pre-Funded Warrants to purchase 1,793,000 shares of common stock 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.
Private Placement
Also on May 30, 2022, concurrent with the Offering, the Company entered into the private investment in public equity "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.
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.
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
12. Stock-Based Compensation
The Company recognized total stock-based compensation expense during the three and nine months ended September 30, 2023 and 2022 as follows (table in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Service-based awards: | | | | | | | |
| | | | | | | |
Restricted Stock Units | $ | 112 | | | $ | 46 | | | $ | 276 | | | $ | 84 | |
Stock Option Awards | 100 | | | 130 | | | 438 | | | 401 | |
Total Service Based Awards | 212 | | | 176 | | | 714 | | | 485 | |
Performance-based awards: | | | | | | | |
Restricted Stock Awards | — | | | — | | | — | | | (391) | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Total | $ | 212 | | | $ | 176 | | | $ | 714 | | | $ | 94 | |
Performance Based Restricted Stock
A summary of the Company’s restricted stock awards during the nine months ended September 30, 2023 is as follows:
| | | | | | | | | | | |
| Number of Shares | | Weighted Average Grant-Date Fair Value |
Unvested at January 1, 2023 | 891 | | | $ | 62.70 | |
| | | |
Unvested at September 30, 2023 | 891 | | | $ | 62.70 | |
A summary of the Company’s restricted stock awards during the nine months ended September 30, 2022 is as follows:
| | | | | | | | | | | |
| Number of Shares | | Weighted Average Grant-Date Fair Value |
Unvested at January 1, 2022 | 7,118 | | | $ | 62.70 | |
Forfeited (1) | (6,227) | | | $ | 62.70 | |
Unvested at September 30, 2022 | 891 | | | $ | 62.70 | |
__________
1.These forfeited awards were due to the resignation of the Company's Chief Development Officer on March 25, 2022 and reduced stock-based compensation expense by $0.4 million in 2022.
Restricted stock awards are measured based on their fair value on the date of grant and amortized over the vesting period of 20 months.
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Service-Based Restricted Stock Units
A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2023 is as follows:
| | | | | | | | | | | |
| Number of Shares | | Weighted Average Grant-Date Fair Value |
Unvested at January 1, 2023 | 125,000 | | | $ | 1.47 | |
Granted | 313,065 | | | 1.87 | |
Vested | (125,000) | | | 1.47 | |
Forfeited | (25,665) | | | 1.37 | |
Unvested at September 30, 2023 | 287,400 | | | $ | 1.85 | |
A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2022 is as follows:
| | | | | | | | | | | |
| Number of Shares | | Weighted Average Grant-Date Fair Value |
Unvested at January 1, 2022 | 29,289 | | | $ | 12.87 | |
Granted | 125,000 | | | 1.47 | |
Vested | (23,515) | | | 11.33 | |
Forfeited | (5,774) | | | 19.00 | |
| | | |
Unvested at September 30, 2022 | 125,000 | | | $ | 1.47 | |
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 $46,000 was recognized for the three months ended September 30, 2023 and 2022, respectively. Stock-based compensation expense of $0.3 million and $0.1 million was recognized for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, the unrecognized stock-based compensation expense was $0.4 million, which is expected to be recognized over an estimated weighted average remaining term of less than 1.4 years.
Service-Based Stock Options
The fair value of the service-based stock options granted for the nine months ended September 30, 2023 were based on the following assumptions:
| | | | | |
| Nine Months Ended September 30, 2023 |
Exercise price | $1.37 - $2.83 |
Expected stock price volatility | 81.6% - 81.8% |
Risk-free interest rate | 3.41% - 3.46% |
Term (years) | 5.6 - 6 |
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2023 is as follows:
| | | | | | | | | | | | | | | | | | | | | | | | |
| Shares Underlying Options | | Weighted Average Exercise Price | | Weighted Average Remaining Contractual Term | | Aggregate Intrinsic Value | |
| | | | | in years | | in thousands | |
Outstanding at January 1, 2023 | 1,206,905 | | | $ | 8.32 | | | | | | |
Granted | 382,745 | | | 1.48 | | | | | | |
| | | | | | | | |
Forfeited | (143,430) | | | 2.82 | | | | | | |
Expired | (78,727) | | | 26.74 | | | | | | |
Outstanding at September 30, 2023 | 1,367,493 | | | $ | 5.93 | | | 8.4 | | $ | 680 | | |
| | | | | | | | |
Exercisable at September 30, 2023 | 444,836 | | | $ | 14.64 | | | 7 | | $ | 114 | | |
A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2022 is as follows:
| | | | | | | | | | | | | | | | | | | | | |
| Shares Underlying Options | | Weighted Average Exercise Price | | Weighted Average Remaining Contractual Term | | |
| | | | | in years | | |
Outstanding at January 1, 2022 | 528,591 | | | $ | 32.01 | | | 7.5 | | |
Granted | 898,659 | | | 1.49 | | | 5.5 | | |
Forfeited | (30,093) | | | 15.11 | | | — | | | |
Expired | (85,466) | | | 82.09 | | | — | | | |
Outstanding at September 30, 2022 | 1,311,691 | | | $ | 8.23 | | | 9.1 | | |
| | | | | | | |
Exercisable at September 30, 2022 | 243,973 | | | $ | 29.31 | | | 6.9 | | |
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 as of September 30, 2022 was not significant.
Stock-based compensation expense recognized for service-based stock options was $0.1 million and $0.1 million for the three months ended September 30, 2023 and 2022, respectively. Stock-based compensation expense recognized for service-based stock options was $0.4 million and $0.4 million for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, total stock-based compensation expense related to unvested options not yet recognized totaled approximately $0.7 million, which is expected to be recognized over an estimated weighted average remaining term of 3.2 years. Forfeitures are recorded in the period of occurrence and compensation expense is adjusted accordingly.
13. 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 September 30, 2023 and December 31, 2022, the Company has accrued $85,400 relating to
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
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 is required to pay Charak a percentage of any sublicense income during the term of the agreement, which amount cannot be less than a minimum specified percentage of net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and 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 September 30, 2023 and December 31, 2022.
14. 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 September 30, 2023, the Company had operating and finance lease liabilities of $5.4 million and right-of-use assets of $5.1 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):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, 2023 | | Three Months Ended September 30, 2022 | | Nine Months Ended September 30, 2023 | | Nine Months Ended September 30, 2022 |
Operating leases | | | | | | | |
Operating lease cost | $ | 422 | | | $ | 410 | | | $ | 1,281 | | | $ | 1,289 | |
Variable lease cost | 112 | | | 101 | | | 336 | | | 287 | |
Operating lease expense | 534 | | | 511 | | | 1,617 | | | 1,576 | |
Finance leases | | | | | | | |
Non-cash lease expense from right-of-use assets | 142 | | | 141 | | | 424 | | | 424 | |
Interest on lease obligations | 36 | | | 44 | | | 113 | | | 136 | |
Finance lease expense | 178 | | | 185 | | | 537 | | | 560 | |
Short-term lease rent expense | 4 | | | 5 | | | 12 | | | 14 | |
Total lease expense | $ | 716 | | | $ | 701 | | | $ | 2,166 | | | $ | 2,150 | |
| | | | | | | |
Other information | | | | | | | |
Payments for principal from operating leases | $ | 461 | | | $ | 427 | | | $ | 1,363 | | | $ | 1,338 | |
Payments for interest from finance leases | $ | 37 | | | $ | 44 | | | $ | 114 | | | $ | 136 | |
Payments for principal from finance leases | $ | 130 | | | $ | 121 | | | $ | 388 | | | $ | 359 | |
| | | | | | | |
| | | | | | | |
Weighted-average remaining lease term – operating leases | 2.5 | | 3.2 | | 2.5 | | 3.2 |
Weighted-average remaining lease term – finance leases | 3.7 | | 4.7 | | 3.7 | | 4.7 |
Weighted-average discount rate – operating leases | 6.5 | % | | 6.4 | % | | 6.5 | % | | 6.4 | % |
Weighted-average discount rate – finance leases | 6.4 | % | | 6.4 | % | | 6.4 | % | | 6.4 | % |
Future minimum rental payments under operating and finance lease agreements are as follows (in thousands): | | | | | | | | | | | |
| Operating | | Finance |
Year ending December 31, 2023 (remaining) | $ | 439 | | | $ | 168 | |
Year ending December 31, 2024 | 1,511 | | | 672 | |
Year ending December 31, 2025 | 1,021 | | | 676 | |
Year ending December 31, 2026 | 362 | | | 666 | |
Year ending December 31, 2027 | 131 | | | 311 | |
| | | |
Total | 3,464 | | | 2,493 | |
Less present value discount | (259) | | | (271) | |
Operating and finance lease liabilities | $ | 3,205 | | | $ | 2,222 | |
15. Loan and Security Agreement
On March 16, 2020, the Company and Rockwell Transportation, Inc., as Borrowers, entered into a Loan and Security Agreement (the "Loan Agreement") with Innovatus Life Sciences Lending Fund I, LP ("Innovatus"), as collateral agent and the lenders party thereto, pursuant to which Innovatus, as a lender, agreed to make certain term loans to the Company in the aggregate principal amount of up to $35.0 million (the "Term Loans"). Funding of the first $22.5 million tranche was completed on March 16, 2020. The Company is no longer eligible to draw on additional tranches, which were tied to the achievement of certain milestones. Net draw down proceeds were $21.2 million with closing costs of $1.3 million.
In connection with each funding of the Term Loans, the Company was required to issue to Innovatus a warrant (the “Warrants”) to purchase a number of shares of the Company’s common stock equal to 3.5% of the principal amount of the relevant Term Loan funded divided by the exercise price. In connection with the first tranche of the Term Loans, the Company issued a Warrant to Innovatus, exercisable for an aggregate of 43,388 shares of the Company’s common stock at an exercise price of $18.15 per share. The Warrant may be exercised on a cashless basis and is immediately exercisable through the seventh anniversary of the applicable funding date. The number of shares of common stock for which the Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Warrant. The Company evaluated the warrant under ASC 470, Debt, and recognized an additional debt discount of approximately $0.5 million based on the relative fair value of the base instruments and warrants. The Company calculated the fair value of the warrant using the Black-Scholes model.
The Term Loans mature on March 16, 2025, and 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 12.5% as of September 30, 2023. 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 September 30, 2023 and 2022, interest expense amounted to $0.3 million and $0.4 million, respectively. For the nine months ended September 30, 2023 and 2022, interest expense amounted to $0.9 million and $1.2 million, respectively.
The Loan Agreement is secured by all assets of the Company and Rockwell Transportation, Inc. and contains customary representations and warranties and covenants, subject to customary carve outs, and initially included financial covenants related to liquidity and sales of Triferic.
In September 2021, the Company entered into an amendment to the Loan Agreement in which the Company, in exchange for Innovatus lowering the sales covenants, agreed to: (i) prepay an aggregate principal amount of $7.5 million in ten installments commencing on December 1, 2021; (ii) pay an additional prepayment premium of 5% on prepaid amounts if the Company elects to prepay all outstanding Term Loans on or before September 24, 2023 and (iii) maintain minimum liquidity of no less than $5.0 million if the aggregate principal amount of Term Loans is greater than $15 million pursuant to the liquidity covenant in the Loan Agreement.
On November 10, 2022, the Company entered into a Second Amendment to the Loan and Security Agreement (the “Second Amendment”) dated as of November 14, 2022 with Innovatus, which amended the Loan Agreement. Pursuant to the Second Amendment, the Company (i) prepaid an additional aggregate principal amount of $5.0 million in Term Loans in one installment on November 14, 2022; (ii) paid interest only payments until September 2023, at which time it resumed scheduled debt payments. The financial covenant related to the sales of Triferic was replaced with the trailing 6 months revenue of our concentrates products. 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 September 30, 2023, the Company was in compliance with all covenants under the Loan Agreement.
As of September 30, 2023, the outstanding balance of the Term Loan was $9.0 million, net of unamortized issuance costs and discount of $0.5 million.
The following table reflects the schedule of principal payments on the Term Loan as of September 30, 2023 (in thousands):
| | | | | |
| Principal Payments |
2023 (remaining) | $ | 1,500 | |
2024 | 6,000 | |
2025 | 2,000 | |
| |
| $ | 9,500 | |
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
16. Insurance Financing Note Payable
On 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 September 30, 2023, the outstanding balance was $0.5 million.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis should be read in conjunction with our condensed consolidated financial statements and related notes in “Item 1. Condensed Consolidated Financial Statements”. References in this report to “Rockwell,” the “Company,” “we,” “our” and “us” are references to Rockwell Medical, Inc. and its subsidiaries.
Forward-Looking Statements
We make forward-looking statements in this report and may make such statements in future filings with the Securities and Exchange Commission, or SEC. We may also make forward-looking statements in our press releases or other public or shareholder communications. Our forward-looking statements are subject to risks and uncertainties and include information about our current expectations and possible or assumed future results of our operations. When we use words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,” “plan,” “potential,” “predict,” “forecast,” “project,” “intend,” “is focused on” or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward-looking statements. Our forward looking statements also include, without limitation, statements about our liquidity and capital resources; our ability to continue as a going concern; our ability to successfully integrate acquisitions; our ability to develop Ferric Pyrophosphate Citrate (“FPC”) for other indications; our ability to successfully execute on our business strategy; our ability to raise additional capital; our ability to successfully implement certain cost containment and cost-cutting measures; our ability to achieve profitability and statements regarding our anticipated future financial condition, operating results, cash flows and business plans.
While we believe our forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements, which are based on information available to us on the date of this report or, if made elsewhere, as of the date made. Because these forward-looking statements are based on estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different. Factors that might cause such a difference include, without limitation, the risks and uncertainties discussed in this report, “Item 1A — Risk Factors” in our Form 10-K for the year ended December 31, 2022 and from time to time in our other reports filed with the SEC.
Other factors not currently anticipated may also materially and adversely affect our results of operations, cash flow and financial position. There can be no assurance future results will meet expectations. Forward-looking statements speak only as of the date of this report and we expressly disclaim any intent to update or alter any statements whether as a result of new information, future events or otherwise, except as may be required by applicable law.
Overview
Rockwell Medical 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. This represents a large market opportunity for which we believe Rockwell's products are well-positioned to meet the needs of patients.
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. In addition, the Company manufactures hemodialysis concentrates in Minnesota under a contract manufacturing agreement with a contract manufacturing organization. (See Note 4 of the accompanying condensed consolidated interim financial statements for further detail). 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. Rockwell has developed a core expertise in manufacturing and delivering hemodialysis concentrates, and has built a longstanding reputation for reliability, quality, and excellent customer service.
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 international partnerships with companies seeking to develop and commercialize Triferic outside the United States and is working 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’s strategy is focused on growing the Company's revenue-generating business, which currently includes hemodialysis concentrates and international partnerships for Triferic and achieving profitability to put the Company in a stronger and more stable financial position.
Hemodialysis Concentrates Business: Rockwell is the second largest supplier of life-sustaining hemodialysis concentrates products to dialysis clinics in the United States. Our hemodialysis concentrates products are used to sustain a patient's life by removing toxins and balancing electrolytes in a dialysis patient’s bloodstream. A key element of our dialysis business strategy going forward is to improve the strength of our concentrates business. According to an independent research report from L.E.K. Consulting LLC, which was commissioned by Rockwell in 2022, the hemodialysis concentrates market in the United States alone was valued at $380 million in 2022 and is anticipated to grow to approximately $500 million by 2026. We believe we can grow our business through the addition of new customers, expanding our territory coverage, increasing the efficiency of our production, and pricing our products appropriately to drive profitability.
On July 10, 2023, the Company executed and consummated the transactions contemplated by an Asset Purchase Agreement (the “Purchase Agreement”) with Evoqua Water Technologies LLC ("Evoqua") (the "Evoqua Acquisition"). Subject to the terms and conditions of the Purchase Agreement, at the closing of the transaction (the “Closing”), the Company purchased customer relationships, equipment and inventory from Evoqua, which were related to manufacturing and selling of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization. Total consideration was $17.4 million, comprising a cash payment at Closing of $12.4 million (inclusive of transaction costs) and two $2.5 million deferred payments, the first to be paid on the first anniversary and the second to be paid on the second anniversary of the Closing. See Note 4 for further detail.
On September 18, 2023, Rockwell and our long-time partner, DaVita, Inc. ("DaVita"), a leading provider of kidney care, entered into an Amended and Restated Products Purchase Agreement (the "Amended Agreement"), which amends and restates the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates. Under the Amended Agreement, the Company and DaVita agreed to an increase in product pricing, effective September 1, 2023 and a one-time payment to Rockwell on or after December 1, 2023. The term of the Amended Agreement will expire on December 31, 2024. DaVita will have the right, in its sole discretion upon written notice to the Company given no later than September 30, 2024, to further extend the term through December 31, 2025. In the event of such an extension, product pricing will be increased for the extended term. In addition, DaVita is required to provide the Company with nine-month purchasing forecasts and a commitment to purchase at least the forecasted amounts. In the event that DaVita does not meet its forecasts, it is required to pay the Company for the amount forecasted, purchase additional product, or the Company may terminate the Amended Agreement. Upon expiration or termination of the Amended Agreement, and upon request by DaVita, the Company has agreed to provide transition services to DaVita during a transition period.
In 2022, in connection with an amendment of the original Products Purchase Agreement, DaVita invested $15 million in the Company's preferred stock in two equal tranches. The first tranche of $7.5 million was funded on April 7, 2022. The second tranche of $7.5 million was funded on June 16, 2022.
Additionally, during the third quarter of 2023, Rockwell entered into several long-term product purchase agreements, which include supply and purchasing commitments from certain parties. These agreements include Sanderling Renal Services, Inc., a full-service provider of in-center, home dialysis and renal telemedicine services focusing on patients in rural and underserved communities across the United States; Centers for Dialysis Care, the largest non-profit, independent outpatient dialysis provider in Northeast Ohio; Houston Methodist, a leading health system and academic medical center; Dialyze Direct, a leading provider of home dialysis services in the skilled nursing facility setting; and Outset Medical (Nasdaq:OM), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis with its Tablo® Hemodialysis System, which is FDA-cleared for use from the hospital to the home.
On November 9, 2022, Rockwell reacquired its distribution rights to its hemodialysis concentrates products from Baxter and has agreed to terminate the exclusive distribution agreement dated October 2, 2014. Exclusivity and other provisions
associated with the distribution agreement terminated November 9, 2022 and the remaining operational elements of the agreement terminate December 31, 2022. Under the exclusive distribution agreement, Baxter distributed and commercialized Rockwell’s hemodialysis concentrates products in the United States and certain other countries. Rockwell manufactured all hemodialysis concentrates products and provided customer service and order delivery to nearly all U.S. customers. Following the reacquisition of these rights, Rockwell is able to sell its hemodialysis concentrates products directly to dialysis clinics throughout the United States and around the world. Additionally, Rockwell is able to independently price its products, eliminate costs associated with manufacturing covenants, improve manufacturing efficiencies, realize the full benefits from those improvements, and develop, in-license, or acquire new products to develop a broader kidney care products portfolio. This is expected to improve Rockwell's overall profitability and set the Company on a positive growth trajectory. Collectively, we believe this affords Rockwell the opportunity to expand its leadership position within a large market opportunity.
Triferic: Our first two branded products from our FPC platform, Triferic (dialysate) and Triferic AVNU, are indicated to maintain hemoglobin in patients undergoing hemodialysis. We began commercializing Triferic and Triferic AVNU in the United States in the second half of 2019 and in early 2021, respectively. In addition, Rockwell established six international partnerships to develop and commercialize Triferic in China, India, Korea, Turkey, Peru and Chile.
In 2022, Rockwell undertook a strategic review of Triferic's viability in the United States. Triferic was launched into a very competitive marketplace with well-entrenched products and a lack of consensus regarding unmet medical needs for dialysis patients with anemia. Due to its limited market adoption, unfavorable reimbursement, and absence of interest from other companies to license or acquire Triferic despite Rockwell's significant effort to partner the program, the Company discontinued its NDAs for Triferic and Triferic AVNU in the United States in the fourth quarter of 2022. Sustaining Triferic commercially in the United States resulted in annual losses to Rockwell. The decision to discontinue the NDAs was not made lightly as the Company realizes the direct impact this action had on patients using the products. Triferic and its approved presentations were not discontinued for safety reasons.
Rockwell continues to support its partners outside the United States that have exclusive license agreements to develop and commercialize Triferic in India, Korea, Turkey, Peru and Chile. Partnering in these regions allows us to better leverage the development, regulatory, commercial presence, and expertise of business partners to increase sales of our products throughout the world. Currently, India, Peru and Chile development work has been put on hold. However, we believe there is still potential opportunity for Triferic internationally and will work diligently to support our partners, which requires minimal financial commitment from Rockwell and provides us with potential for near- and long-term revenue.
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 and Wanbang will not will not bring the product forward to registration.
Research and Development Pipeline: FPC for Home Infusion is Rockwell's follow-up to Triferic and utilizes the FPC platform in the home infusion setting.
In late 2021, Rockwell filed an Investigational New Drug (“IND”) application with the United States Food and Drug Administration (“FDA”) for the treatment of iron deficiency anemia in patients, who are receiving medications in the home infusion setting. During the second quarter 2022, Rockwell provided the FDA with supplemental data to be used in Rockwell’s clinical studies and to clinically support the Company’s IND application for home infusion. The FDA placed this program on Clinical Hold and requested that additional data related to the microbiology and short-term stability of this formulation be provided to support the application. During the third quarter of 2022, Rockwell conducted a microbiological and short-term stability study of FPC for Home Infusion, in accordance with FDA guidance, to support the Company’s IND application. Preliminary results from the microbiology and short-term stability study indicated that the program would likely not meet the FDA’s requirements to support the IND application and would require significant capital expenditure and resources to support additional re-formulation work and conduct a Phase 2 trial. As a result, Rockwell has put development work associated with FPC for Home Infusion on hold.
Rockwell is also exploring FPC’s impact on the treatment of hospitalized acute heart failure patients, which affects more than one million people in the United States annually. Rockwell conducted a pre-IND meeting with the FDA in 2022 and will determine the path forward for FPC in acute heart failure as the Company works toward profitability.
Results of Operations for the Three Months Ended September 30, 2023 and 2022
The following table summarizes our operating results for the periods presented below (dollars in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| 2023 | | % of Revenue | | 2022 | | % of Revenue | | % Change |
| | | | | | | | | |
Net Sales | $ | 23,771 | | | | | $ | 18,691 | | | | | 27 | % |
Cost of Sales | 21,569 | | | 91 | % | | 17,914 | | | 96 | % | | 20 | % |
Gross Profit | 2,202 | | | 9 | % | | 777 | | | 4 | % | | 183 | % |
| | | | | | | | | |
Research and Product Development | 494 | | | 2 | % | | 469 | | | 3 | % | | 5 | % |
Selling and Marketing | 556 | | | 2 | % | | 762 | | | 4 | % | | (27) | % |
General and Administrative | 2,889 | | | 12 | % | | 3,254 | | | 17 | % | | (11) | % |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
Operating Loss | $ | (1,737) | | | (7) | % | | $ | (3,708) | | | (20) | % | | (53) | % |
Net Sales
During the three months ended September 30, 2023, our net sales were $23.8 million compared to net sales of $18.7 million during the three months ended September 30, 2022. The increase of $5.1 million was primarily due to the Evoqua Asset Acquisition (see Note 4) which, through the acquisition of customer lists, resulted in new revenue during the third quarter of 2023 of $3.4 million, and the recognition of deferred license revenue of $2.2 million related to the Wanbang Agreement (see Note 10 to the condensed consolidated financial statements included elsewhere in this Form 10-Q). Overall, product revenue for the three months ended September 30, 2023 was $21.6 million compared to product revenue of $18.1 million for the three months ended September 30, 2022.
Gross Profit
Cost of sales for the three months ended September 30, 2023 was $21.6 million, resulting in gross profit of $2.2 million for the three months ended September 30, 2023, compared to cost of sales of $17.9 million and a gross profit of $0.8 million for the three months ended September 30, 2022. Cost of sales for the three months ended September 30, 2023 included a $1.1 million increase to Triferic inventory reserves due to the decision by Wanbang not to pursue registration in China. Gross profit increased by $1.4 million primarily due to $1.1 million net impact of Wanbang revenue and inventory reserves, as well as lower distribution costs associated with the concentrates business.
Research and Product Development Expense
Research and product development expenses were $0.5 million for each of the three months ended September 30, 2023 and 2022. Employee compensation expense decreased as a result of lower headcount, but was offset by severance costs.
Selling and Marketing Expense
Selling and marketing expenses were $0.6 million and $0.8 million for the three months ended September 30, 2023 and 2022, respectively. We continue to evaluate marketing spend and focus on target opportunities for greater return on investments.
General and Administrative Expense
General and administrative expenses were $2.9 million for the three months ended September 30, 2023, compared with $3.3 million for the three months ended September 30, 2022. The decrease of $0.4 million was primarily due to lower employee compensation as a result of reduced headcount, decreased government fees related to Triferic and lower administrative costs.
Other Expense
Total other expense of $0.1 million and $0.5 million for the three months ended September 30, 2023 and 2022, respectively, was primarily driven by $0.4 million and $0.5 million of other expense for the three months ended September 30, 2023 and 2022, respectively, largely due to interest expense related to our debt facility (See Note 15 to the condensed consolidated financial statements included elsewhere in this Form 10-Q).
Results of Operations for the Nine Months Ended September 30, 2023 and 2022
The following table summarizes our operating results for the periods presented below (dollars in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | % of Revenue | | 2022 | | % of Revenue | | % Change |
| | | | | | | | | |
Net Sales | $ | 61,519 | | | | | $ | 53,497 | | | | | 15 | % |
Cost of Sales | 55,685 | | | 91 | % | | 51,760 | | | 97 | % | | 8 | % |
Gross Profit | 5,834 | | | 9 | % | | 1,737 | | | 3 | % | | 236 | % |
| | | | | | | | | |
Research and Product Development | 939 | | | 2 | % | | 2,963 | | | 6 | % | | (68) | % |
Selling and Marketing | 1,584 | | | 3 | % | | 1,743 | | | 3 | % | | (9) | % |
General and Administrative | 9,434 | | | 15 | % | | 11,845 | | | 22 | % | | (20) | % |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
Operating Loss | $ | (6,123) | | | (10) | % | | $ | (14,814) | | | (28) | % | | (59) | % |
Net Sales
During the nine months ended September 30, 2023, our net sales were $61.5 million compared to net sales of $53.5 million during the nine months ended September 30, 2022. The increase of $8.0 million was primarily due to the restructuring of our products purchase agreement with DaVita, the reacquired rights to commercialize and distribute our products, the asset acquisition of Evoqua, onboarding of new customers and increased pricing to other customers. Overall, product revenue for the nine months ended September 30, 2023 was $57.7 million compared to product revenue of $51.9 million for the nine months ended September 30, 2022, an increase of $5.8 million.
Gross Profit
Cost of sales during the nine months ended September 30, 2023 was $55.7 million, resulting in gross profit of $5.8 million during the nine months ended September 30, 2023, compared to cost of sales of $51.8 million and a gross profit of $1.7 million during the nine months ended September 30, 2022. Gross profit increased by $4.1 million primarily due to the restructuring of our supply contract with DaVita in 2022, recognition of the remaining deferred license revenue related to the termination of the Baxter distribution agreement (See Note 10 to the condensed condensed consolidated financial statements included elsewhere in this Form 10-Q), onboarding of new customers, increased pricing to other customers and net impact of Wanbang revenue and inventory reserves.
Research and Development Expense
Research and product development expenses were $0.9 million and $3.0 million for the nine months ended September 30, 2023 and 2022, respectively. Research and product development expenses decreased by $2.1 million due to a reduction in wages and project costs resulting from the decision to pause all research related to our FPC for Home Infusion program. Approximately 44% of research and development expenses for the nine months ended September 30, 2023 were comprised of severance costs.
Selling and Marketing Expense
Selling and marketing expenses were $1.6 million and $1.7 million for the nine months ended September 30, 2023, and 2022, respectively. We continue to evaluate marketing spend and focus on target opportunities for greater return on investments.
General and Administrative Expense
General and administrative expenses were $9.4 million during the nine months ended September 30, 2023, compared with $11.8 million during the nine months ended September 30, 2022. The decrease of $2.4 million is primarily driven by lower employee compensation as a result of reduced headcount, decreased government fees related to Triferic, reduced professional fees and lower administrative costs.
Other Expense
Total other expense of $0.8 million and $1.5 million for the nine months ended September 30, 2023 and 2022, respectively, was primarily driven by $1.2 million and $1.5 million of other expense for the nine months ended September 30, 2023 and 2022, respectively, largely due to interest expense related to our debt facility (See Note 15 to the condensed consolidated financial statements included elsewhere in this Form 10-Q).
Liquidity and Capital Resources
As of September 30, 2023, we had approximately $11.7 million of cash, cash equivalents and investments available-for-sale, and working capital of $6.8 million. Net cash used in operating activities for the nine months ended September 30, 2023 was approximately $9.4 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”) exercised its warrant to purchase 9,900,990 shares of common stock with an exercise price of $1.39 per share and the Company received gross proceeds of approximately $13.8 million (See Note 11 to the condensed consolidated financial statements included elsewhere in this Form 10-Q).
On July 10, 2023, the Company completed the Evoqua Acquisition. Total consideration was $17.4 million, comprising a cash payment at Closing of $12.2 million (inclusive of transaction costs) and two $2.5 million deferred payments, the first to be paid on the first anniversary and the second to be paid on the second anniversary of the Closing. See Note 4 for further detail.
The Company continues to review its operational plans and execute on the acquisition of new customers and 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 our 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. 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.
In 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 15 to the accompanying condensed consolidated interim financial statements).
The global macroeconomic environment is uncertain, and could be negatively affected by, among other things, increased U.S. trade tariffs and trade disputes with other countries, instability in the global capital and credit markets, recent bank failures in the United States, supply chain weaknesses, and instability in the geopolitical environment, including as a result of the Russian invasion of Ukraine, the Israel-Hamas conflict and other political tensions, and 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.
General
The actual amount of cash that we will need to execute our business strategy is subject to many factors, including, but not limited to the costs associated with our manufacturing and transportation operations related to our concentrate business.
We may elect to raise capital in the future through one or more of the following: (i) equity and debt raises through the equity and capital markets, though there can be no assurance we will be able to secure additional capital or funding on acceptable terms, or if at all; and (ii) strategic transactions, including potential alliances and collaborations focused on markets outside the United States, as well as potential combinations (including by merger or acquisition) or other corporate transactions.
We believe our ability to fund our activities in the long term will be highly dependent upon i) our ability to execute on the growth strategy of our hemodialysis concentrates business, ii) our ability to achieve profitability, and iii) our ability to identify, develop, in-license, or acquire new products in developing our renal care product portfolio. All of these strategies are subject to significant risks and uncertainties such that there can be no assurance we will be successful in achieving them. If we are unsuccessful in executing our business plan and we are unable to raise the required capital, we may be forced to curtail all of our activities and, ultimately, cease operations. Even if we are able to raise sufficient capital, such financings may only be available on unattractive terms, or result in significant dilution of stockholders’ interests and, in such event, the market price of our common stock may decline.
Cash Used in Operating Activities
Net cash used in operating activities was $9.4 million for the nine months ended September 30, 2023 compared to net cash used in operating activities of $16.8 million for the nine months ended September 30, 2022. The decrease in cash used from operating activities during the current period was primarily due to a decrease in net loss, offset by changes in current balance sheet accounts in the ordinary course of business of approximately $6.7 million, including a decrease in deferred license revenue of $3.8 million for recognition of the remaining deferred license revenue related to the termination of the Baxter distribution agreement, a decrease in net accounts receivable of $3.1 million, a decrease in other liabilities of $1.0 million and a decrease in prepaid and other assets of $0.9 million.
Cash Used In Investing Activities
Net cash used in investing activities was $5.1 million during the nine months ended September 30, 2023 compared to net cash used in investing activities of $5.6 million for the nine months ended September 30, 2022. Net cash used in investing activities during the nine months ended September 30, 2023 was primarily due to the cash paid in connection with the Evoqua Asset Acquisition of $12.4 million, partially offset by the net cash proceeds from sales and purchase of available-for-sale investments during the period of $7.4 million. Net cash used in investing activities during the nine months ended September 30, 2022 were primarily related to the purchase and sale of investments.
Cash Provided by Financing Activities
Net cash provided by financing activities was $12.1 million during the nine months ended September 30, 2023 compared to net cash provided by financing activities of $22.1 million for the nine months ended September 30, 2022. Net cash provided financing activities during the nine months ended September 30, 2023 was primarily due to the gross proceeds from the issuance of common stock in connection with the exercise of the Prior Warrant and Pre-Funded Warrants of $13.8 million. Net cash provided by financing activities for the nine months ended September 30, 2022 was primarily due to the gross proceeds from the issuance of common and preferred stock of $15.0 million each, offset by debt repayment of $6.8 million.
Contractual Obligations and Other Commitments
See Note 13 to the condensed consolidated financial statements included elsewhere in this Form 10-Q for additional disclosures. There have been no other material changes from the contractual obligations and other commitments disclosed in Note 14 to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022.
Critical Accounting Policies and Significant Judgments and Estimates
Our critical accounting policies and significant estimates are detailed in our Annual Report on Form 10-K for the year ended December 31, 2022. In addition, our critical accounting policies and significant estimates related to the Evoqua Asset Acquisition, including changes to our existing accounting policies, are detailed below.
Fair Value Measurements
Nonrecurring Valuations. The assets acquired through the Evoqua Asset Acquisition were recorded at relative fair value, which required the determination of the fair values of assets acquired as of the acquisition date. In making these fair value determinations, we were required to make estimates and assumptions that affected the recorded amounts, including, but not limited to, (i) for the customer relationships intangible asset, expected future cash flows, discount rates and remaining useful life and (ii) for the equipment, replacement cost. To assist us in making these fair value determinations, we engaged third-party valuation specialists. Our estimates of fair value are based upon assumptions we believe to be reasonable, but which are inherently uncertain.
Intangible Assets
Definite-lived intangible assets consist of our customer relationships intangible asset, which has been capitalized and is being amortized over 20 years.
Recently issued and adopted accounting pronouncements:
We have evaluated all recently issued accounting pronouncements and believe such pronouncements do not have a material effect our financial statements. See Note 3 to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Per §229.305 of Regulation S-K, the Company, designated a Smaller Reporting Company as defined in §229.10(f)(1) of Regulation S-K, is not required to provide the disclosure required by this Item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures designed to ensure material information required to be disclosed in our reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and such information is accumulated and communicated to our management, including our Chief Executive Officer as appropriate, to allow timely decisions regarding required financial disclosure. In designing and evaluating the disclosure controls and procedures, we recognized a control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. Management was required to apply its judgment in evaluating the cost‑benefit relationship of possible controls and procedures.
Under the supervision of and with the participation of our management, including the Company’s Chief Executive Officer, we evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2023. Based upon that evaluation, our Chief Executive Officer concluded our disclosure controls and procedures were effective as of September 30, 2023.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting in connection with the evaluation required by Rule 13a-15(d) of the Exchange Act that occurred during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
We may be involved in certain routine legal proceedings from time to time before various courts and governmental agencies. We cannot predict the final disposition of such proceedings. We regularly review legal matters and record provisions for claims considered probable of loss. The resolution of these pending proceedings is not expected to have a material effect on our operations or consolidated financial statements in the period in which they are resolved.
Item 1A. Risk Factors
Our business is subject to various risks, including those described in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2022. There have been no material changes to the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2022 under "Item 1A - Risk Factors" and subsequent quarterly report on Form 10-Q for the quarter ended June 30, 2023, except as noted below.
Our agreement with our largest customer in our concentrates business is set to expire on December 31, 2024 and our inability to negotiate a new agreement would have a material and adverse effect on our financial condition and results of operations.
Our Amended and Restated Products Purchase Agreement (the “Products Purchase Agreement”) with DaVita is set to expire on December 31, 2024. The Products Purchase Agreement is a fixed price agreement. In September 2023, we amended the original Products Purchase Agreement with DaVita to raise our prices in light of inflationary pressures and to remove certain provisions. The Products Purchase Agreement may be extended by DaVita for one year in its sole discretion. When the Products Purchase Agreement is again up for renewal, we may be unable to reach an agreement with DaVita on new terms that make economic sense for us. In that case, we would not expect to enter into a new agreement. This would result in the loss of approximately one-half of our current volume of concentrates products and would have a material and adverse effect on our financial condition and results of operations and would likely lead to the implementation of cost saving measures that would negatively impact our activities.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None.
Item 6. Exhibits
The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.
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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 September 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 | | |
+ | | Certain confidential portions of this exhibit were omitted by means of marking such portions with asterisks because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed. | | |
| | | | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| | | | | | | | | | | |
| | ROCKWELL MEDICAL, INC. |
| | (Registrant) |
| | | |
| Date: November 14, 2023 | | /s/ Mark Strobeck |
| | | Mark Strobeck, Ph.D. Chief Executive Officer (Principal Executive Officer and Interim Financial Officer) |
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| | | |
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Exhibit 10.1
AMENDED AND RESTATED PRODUCTS PURCHASE AGREEMENT
THIS AMENDED AND RESTATED PRODUCTS PURCHASE AGREEMENT (this "Agreement"), is entered into and effective as of the 18th day of September, 2023 (the "Effective Date"), by and between Rockwell Medical, Inc., a Delaware corporation ("Rockwell"), and DaVita Inc., a Delaware corporation ("DaVita") on behalf of itself and for the benefit of the DaVita Facilities (as defined in Recital B). Capitalized terms used herein and not otherwise defined herein shall have the meaning set forth in Article XVIII.
RECITALS
A.Rockwell is in the business of manufacturing and selling dialysis products and supplies, including the dialysis products and supplies set forth on Exhibit A attached hereto and incorporated herein by this reference (each, a "Product", and collectively, the "Products").
B.DaVita owns (in whole or in part) or manages dialysis and vascular access facilities, clinics, and units located throughout the United States and its territories (each, a "DaVita Facility", and collectively, the "DaVita Facilities").
C.Rockwell and DaVita entered into that certain Products Purchase Agreement, effective as of July 1, 2019, as amended (the "Original Agreement"), whereby Rockwell agreed to sell certain products to DaVita and the DaVita Facilities, subject to all of the terms and conditions of the Original Agreement.
D.Rockwell and DaVita desire to enter into this Agreement in order to (i) supersede and replace the Original Agreement, effective as of the Effective Date, and (ii) set forth the terms and conditions on which: (A) DaVita, on behalf of itself and the DaVita Facilities, will purchase and acquire the Products from Rockwell, and (B) Rockwell will supply and sell the Products to DaVita and the DaVita Facilities.
In consideration of the foregoing premises and mutual covenants, agreements, representations, and warranties contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending to be legally bound, agree as follows:
ARTICLE I
PURCHASE AND SALE OF PRODUCTS AND REPORTS
1.1Sale and Purchase. During the Term (as defined in Section 2.1) and subject to the terms and conditions of this Agreement:
(a)Rockwell shall be obligated to sell, supply, convey, transfer, assign, and deliver the Products to DaVita and the DaVita Facilities in such quantities as DaVita or the DaVita Facilities may order from time to time; provided, that the quantity of each Product ordered during any Measurement Period (as defined in Section 1.3) does not exceed [***] during the applicable Measurement Period (the “Supply Commitment”) unless otherwise agreed by the parties in writing; and
(b)during each Measurement Period, DaVita or the DaVita Facilities shall be required to purchase [***] for the applicable Measurement Period (the "Product Commitment"). Rockwell understands and acknowledges that the DaVita Facilities may purchase other products from other vendors and suppliers performing some or all of the same functions as the Products.
1.2Forecasts. DaVita will provide to Rockwell a binding forecast of DaVita’s Product purchase requirements: (i) [***], which is attached hereto as Exhibit E, (ii) [***] and (iii) [***] (each, a “Forecast”). Each such Forecast shall include Product types and volumes.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.3Measurement Periods. Each of the following periods of time shall be considered a “Measurement Period”: (a) [***]; (b) [***] and (c) [***].
1.4Shortfalls. If, during the applicable Measurement Period, [***]:
(a)Rockwell shall provide written notice of the amount of the shortfall, if any, together with reasonably detailed documentation supporting the shortfall calculation, within thirty (30) days after the end of each Measurement Period.
(b)DaVita will have fifteen (15) days after receipt to review the documentation. If DaVita disputes Rockwell’s calculations, it shall notify Rockwell within such fifteen (15) day period and the Parties agree to use good faith efforts to resolve any such dispute, provided that if such dispute is not resolved within ten (10) days of such notice then either Party may submit the dispute to an independent expert to determine the accuracy of Rockwell’s calculations, which determination shall be made by such expert within thirty (30) days of the submission of the dispute to such expert and which determination shall be binding upon the parties. Rockwell shall consider in good faith all DaVita records including, but not limited to, invoices, delivery receipts, purchase orders, and internal order reports, in resolving any disagreements related to the Product Commitment and/or shortfall.
(c)If DaVita does not provide notice of dispute within such fifteen (15) day period, or if the independent expert determines there is a shortfall, the shortfall shall be satisfied, as DaVita shall elect in writing, by: (i) [***], (ii) [***], or (iii) a combination of (i) and (ii), in each case no later than [***] thereafter. The remedy set forth in this Section 1.4(c) shall be Rockwell's sole and exclusive remedy against DaVita and the DaVita Facilities for any breach by DaVita and the DaVita Facilities of the Product Commitment, and Rockwell shall not be entitled to any other relief or remedy whatsoever, including any monetary damages, against DaVita or any of the DaVita Facilities; provided, that failure by DaVita to cure a shortfall within such [***] period as set forth above shall result in Rockwell’s ability to terminate the Agreement pursuant to Section 2.3(a) and shall not limit Rockwell’s other rights or remedies with respect to DaVita’s failure to cure.
(d)[***] coordinate the logistics for the timing of delivery to the delivery location specified by DaVita for any Products being purchased to satisfy a shortfall. For the avoidance of doubt, [***].
1.5Notice of Changes to Product Labeling. If, at any time during the Term, Rockwell or any applicable Governmental Authority determines that there must be an amendment, change, revision, or modification to the product labeling, safety information, or any other information relating to any particular Product (a "Product Labeling Event"), Rockwell shall within ten (10) Business Days of any such Product Labeling Event, deliver a written notice to DaVita which: (a) describes in reasonable detail any such Product Labeling Event, (b) explains in reasonable detail the reasons and the causes for any such Product Labeling Event, (c) includes a copy of such amendment, change, revision, or modification to the product labeling, safety information, or any other information relating to any such particular Product, (d) describes the potential effects of such Product Labeling Event on DaVita's or any DaVita Facilities' use of such Product, and (e) describes the effects of such Product Labeling Event on the inventory reserved by Rockwell for use by DaVita and the DaVita Facilities pursuant to Article VII of this Agreement, together with Rockwell's plan and timeline for ensuring that such reserved inventory is properly labeled (the "Product Label Change Notice"). Rockwell shall respond to any questions, inquiries, or requests for additional information that DaVita or any DaVita Facility may have with respect to any Product Label Change Notice and shall assist DaVita and the DaVita Facilities in understanding how, if at all, any Product Labeling Event may affect or have an impact on DaVita's or any DaVita Facilities' use of the Products.
ARTICLE II
TERM AND TERMINATION
2.1Term. This Agreement shall commence on the Effective Date, and shall continue in effect until December 31, 2024; provided, that DaVita shall have the right, in its sole discretion upon written notice to Rockwell given no later than September 30, 2024, to further extend the term through December 31, 2025 (the
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
"Term"), unless sooner terminated in accordance with the provisions of this Article II. No later than September 30, 2024, DaVita shall provide Rockwell with written notice confirming whether or not DaVita exercises its right to so extend the Term. If DaVita provides such written notice to Rockwell by September 30, 2024 to extend the Term, then the Term shall be extended through December 31, 2025. If DaVita provides written notice to Rockwell that it will not extend the Term or if DaVita fails to provide written notice to Rockwell by September 30, 2024 indicating whether or not DaVita exercises its right to extend the Term, then the Term shall end on December 31, 2024, and, if requested by DaVita, Rockwell will provide transition services pursuant to Section 2.5.
2.2DaVita Termination Rights. This Agreement may be terminated by DaVita as follows:
(a)Immediately in the event of a knowing and willful breach by Rockwell of any of its covenants or obligations set forth in Article VI or Article IX; or
(b)Upon thirty (30) days prior written notice to Rockwell, in the event of a material breach by Rockwell of any representation, warranty, covenant, or obligation of Rockwell contained in this Agreement (other than a knowing and willful breach of the covenants or obligations set forth in Article VI or Article IX), and Rockwell fails to cure such breach within thirty (30) days following the date of such notice; or
(c)Immediately upon the occurrence of any of the following: (i) Rockwell files a voluntary petition in bankruptcy seeking protection from creditors (a "Bankruptcy Filing"); or (ii) Rockwell fails to contest an involuntary Bankruptcy Filing made against it or, despite contesting such involuntary Bankruptcy Filing, fails to obtain its dismissal within one hundred twenty (120) days from its filing; or (iii) a trustee or custodian is appointed for a substantial portion of or all of the assets of Rockwell; or (iv) Rockwell fails to pay its debts as they become due or admits its inability to do so (each of the foregoing, an "Insolvency Event"); or
(d)Immediately in the event there is a change in Rockwell's status which excludes it from participation in any Federal health care program, as defined under 42 U.S.C. § 1320a-7b(f).
2.1Rockwell Termination Rights. This Agreement may be terminated by Rockwell as follows:
(a)Immediately in the event of (i) a knowing and willful breach by DaVita of any of its covenants or obligations set forth in Article IX, or (ii) a failure by DaVita to cure a shortfall under Section 1.4(c) within the cure period specified in Section 1.4(c); or
(b)Upon thirty (30) days prior written notice to DaVita, in the event of a material breach by DaVita of any representation, warranty, covenant, or obligation of DaVita contained in this Agreement (other than a knowing and willful breach of the covenants or obligations set forth in Article IX or the failure by DaVita to cure a shortfall under Section 1.4(c) within the cure period specified in Section 1.4(c)), and DaVita fails to cure such breach within thirty (30) days following the date of such notice; or
(c)Immediately upon the occurrence of an Insolvency Event with respect to DaVita; or
(d)Upon at least fourteen (14) months prior written notice to DaVita in the event that Rockwell decides to either: (i) [***] or (ii) [***] (each, a "Product Category") (collectively, a "Business Model Change"); provided that (x [***]; and (y) [***]; or
(e)Immediately in the event there is a change in DaVita's status which excludes it from participation in any Federal health care program, as defined under 42 U.S.C. § 1320a-7b(f).
For the avoidance of doubt, in the event of an alleged breach, claim, dispute, or other disagreement between the Parties, Rockwell shall continue to supply each Product to DaVita in accordance with the terms hereof, including, without limitation the Supply Commitment and Inventory Reserve covenants, during any cure periods and during the pendency of any third-party’s review of such claim, dispute or disagreement as contemplated herein.
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2.1Effect of Termination. The expiration of this Agreement or the earlier termination of this Agreement for any reason will not release either party hereto from any liability or obligation which, at the time of the expiration of this Agreement or the earlier termination of this Agreement for any reason, has already accrued or which thereafter may accrue in respect to any act or omission prior to the expiration of this Agreement or the earlier termination of this Agreement for any reason. Notwithstanding anything in the Agreement to the contrary, in the event the Agreement is terminated: (a) by DaVita due to a Force Majeure Event or Failure to Supply Event, DaVita shall have no liability or obligation to Rockwell for any Product Commitment or shortfall, regardless of when such liability or obligation accrued, or (b) for any reason other than a Force Majeure Event or Failure to Supply Event, DaVita shall be responsible to Rockwell for the Product Commitment and any shortfall with respect to the Product Commitment during the Measurement Period in which such termination occurs, on a pro rata basis based on the effective date of termination.
2.2Transition.
(a)Subject to the terms of this Section 2.5, if requested by DaVita, Rockwell shall provide transition services for up to ninety (90) days following the expiration date or termination date, as applicable (the “Transition Period”), to assist DaVita in transitioning from purchasing under this Agreement.
(b)At least (i) [***] or (ii) [***], DaVita may provide Rockwell with written notice electing transition services (the “Transition Notice”). Such notice shall include a written transition plan containing an estimated forecast of monthly purchase volumes and DaVita Facilities to be serviced by Rockwell during the Transition Period (the “Transition Plan”). Rockwell shall not be obligated to supply quantities of Products in any month of the Transition Period that are more than [***] of the monthly average quantity of Products supplied by Rockwell during [***] immediately preceding the Transition Period. The Parties will meet monthly during the Transition Period to discuss any changes to the Transition Plan, subject to the mutual agreement of the Parties. During the Transition Period, Rockwell shall continue to fulfill all orders for each Product submitted hereunder in accordance with the terms herein (including, without limitation, Sections 2.5(c) and 2.5(d), the Regulatory Costs provisions set forth in Section 3.5, and the Supply Commitment provisions set forth in Section 1.1) and provide transition assistance reasonably requested by DaVita to allow the successor supplier to continue without material interruption or adverse effect and to facilitate the orderly transfer of supplies to the appropriate parties and in compliance with applicable laws.
(c)Except as set forth in Section 2.5(d), the Purchase Price for any Product ordered during the Transition Period will be the Purchase Price applicable to such Product [***].
(d)No later than thirty (30) days following delivery of the Transition Notice, if Rockwell determines it would incur [***], Rockwell shall provide written notice to DaVita, together with reasonably detailed documentation supporting its [***] calculation. Rockwell agrees to reasonably cooperate with DaVita’s review and will provide DaVita with reasonable access to Rockwell’s books and records relating to such calculation during normal business hours. DaVita and Rockwell will, for a period of thirty (30) days after receipt by DaVita of Rockwell’s notice, use commercially reasonable efforts to reach an agreement on [***]. If DaVita and Rockwell are not able to agree on [***], then: (i) [***] and (ii) [***].
ARTICLE III
PURCHASE PRICE AND OTHER PRICING COVENANTS
3.1One-Time Payment. On or after December 1, 2023, Rockwell shall invoice DaVita for a one-time, non-creditable, non-refundable payment [***] and DaVita shall pay such payment to Rockwell within twenty (20) days from the date of receipt of Rockwell’s invoice by DaVita’s Accounts Payable Department; [***].
3.2Purchase Price. The purchase price(s) for orders placed on or after September 1, 2023 through December 31, 2024 for each Product are set forth on Exhibit A (each, a "Purchase Price" and collectively, the
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"Purchase Prices"), subject to Sections 3.4 and 3.5 below. In the event DaVita exercises its right to extend the Term through December 31, 2025, Purchase Prices shall increase by [***] for orders placed on or after January 1, 2025 through December 31, 2025 and during the Transition Period, if applicable. The Purchase Price includes [***] in the states set forth on Exhibit B attached hereto (the "Territory"). In the event that DaVita or any DaVita Facility requires any Product to be shipped outside of the Territory, DaVita and Rockwell shall [***]. All orders for each Product by DaVita or any DaVita Facility shall be subject to [***] set forth on Exhibit C attached hereto. In the event that DaVita or any DaVita Facility desires to order an amount of any Product [***].
3.3Taxes. Rockwell covenants and agrees that neither DaVita nor any DaVita Facility shall be liable for any taxes including any excise, gross receipts, gross earnings, gross value, property, income taxes measured on Rockwell's income, or other taxes, other than applicable sales taxes, with respect to the purchase and sale of the Products. [***].
3.4Pricing Covenant. Rockwell represents and warrants to DaVita that the Purchase Price for each Product and all other terms of sale offered to DaVita and the DaVita Facilities for each Product [***].
3.5Regulatory Costs. No more than [***] during calendar year 2023, [***] during calendar year 2024 and, if applicable, [***] during calendar year 2025, if an applicable Governmental Authority during any such calendar year has changed the designation of such Product from a medical device to a drug and such change has increased Rockwell’s manufacturing costs with respect to such Product (“Regulatory Costs”) by at least [***] percent over the manufacturing costs with respect to such Product for the most recent calendar year for such Product, the Purchase Price for such Product shall be increased by the amount of such Regulatory Costs, provided that in no event will the increase in Purchase Price for any Product attributable to Regulatory Costs exceed [***] in any calendar year. If Rockwell believes the Regulatory Costs for a Product would result in an increase to the Purchase Price of such Product, Rockwell may submit a written notice to DaVita requesting an increase in the Purchase Price of such Product, together with reasonably detailed documentation showing Rockwell’s calculation of the Regulatory Costs for the applicable calendar year for such Product and Rockwell’s Regulatory Costs for the most recent calendar year in which there was a Purchase Price increase for such Product. DaVita will have thirty (30) days after receipt by DaVita of such notice to review the documentation of Rockwell’s calculation of the Regulatory Costs for such Product. Rockwell agrees to reasonably cooperate with DaVita’s review and will provide DaVita with reasonable access to Rockwell’s books and records relating to such Regulatory Costs during normal business hours. If DaVita disagrees with Rockwell’s calculation of the Regulatory Costs for such Product, DaVita may deliver a notice setting forth its objections to Rockwell’s calculation of the Regulatory Costs. DaVita and Rockwell will use commercially reasonable efforts to reach an agreement on the calculation of the Regulatory Costs for such Product for a period of thirty (30) days after receipt by Rockwell of such notice. If DaVita and Rockwell are not able to agree on the calculation of the Regulatory Costs for such Product, the parties will retain a mutually acceptable independent accounting firm (using the procedures described in Article XVI) to determine the Regulatory Costs for such Product, during which time the Purchase Price for the Product(s) shall remain unchanged. The cost of such accountant will be borne equally by the Parties.
ARTICLE IV
PURCHASE ORDERS; DELIVERY; DEDICATED CUSTOMER SERVICE REPRESENTATIVE
4.1Purchase Orders and Delivery. Each Product shall be delivered by Rockwell to delivery locations specified by DaVita or to any DaVita Facility, as applicable, pursuant to the terms of each purchase order submitted by DaVita or any such DaVita Facility, as applicable. DaVita or any DaVita Facility may submit an order for the purchase of any of the Products via facsimile at [***]. Rockwell shall provide accurate and on-time deliveries of all orders placed, in accordance with any reasonable special instructions that may be included in the purchase order submitted by DaVita or any DaVita Facility, as applicable. DaVita and each DaVita Facility have established a delivery schedule with Rockwell's Customer Service Department, including a specific day of the week and time by which orders shall be made and a specific day of the week for deliveries of the Products. All orders that DaVita or a DaVita Facility places by [***] will be received by DaVita or such DaVita Facility no later than its first designated delivery day following such order. Changes to an order day or delivery day must be mutually agreed upon by DaVita or such DaVita Facility and Rockwell’s Customer Service Department. Freight costs shall [***] in the pricing for the Product(s) set forth in Exhibit A to this Agreement. For the purposes of
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this Agreement, title to the Product(s) shall transfer from Rockwell to DaVita upon [***]. Returns are subject to Rockwell Return Goods Policy (Section 4.3). Rockwell shall be responsible for providing inside delivery of the Products to DaVita or any DaVita Facility's designated storage area.
4.2Dedicated Customer Service Representatives. Rockwell hereby agrees and covenants that it shall provide DaVita with reasonable access to one or more dedicated customer service representatives (each, a "Service Representative") who shall be available to promptly respond to and address any issues that DaVita or any DaVita Facility may have with respect to any of the Products or any of Rockwell's obligations set forth in this Agreement (the "Customer Services"). Rockwell further agrees and covenants that each Service Representative shall perform the Customer Services in a professional manner.
4.3Return Goods Policy. Rockwell’s "Return Goods and Credit Policy" is set forth at https://www.rockwellmed.com/return-goods-policy/ (the "Return Goods Policy") to the extent such terms do not conflict with the terms of this Agreement. All returns and credits for Products shall be administered in accordance with the Return Goods Policy; provided, that for purposes of this Agreement, the “Required Notice” period set forth therein shall be [***]. Subject to the Return Goods Policy, DaVita or a DaVita Facility, as applicable, reserves the right to inspect all Products and to reject any or all of the Products which are, in DaVita's or a DaVita Facility's, as applicable, reasonable discretion, incorrectly shipped by Rockwell, defective, damaged, contaminated, or otherwise not in compliance with the warranties granted or assigned hereunder. Rockwell shall provide DaVita with at least thirty (30) days prior written notice of any changes to the Return Goods Policy.
ARTICLE V
PAYMENT TERMS
All purchases by DaVita or any DaVita Facility of Products pursuant to this Agreement shall be paid within [***] from the date of receipt of Rockwell’s invoice by DaVita’s Accounts Payable Department. DaVita or any DaVita Facility, as applicable, may withhold payment on the portion of any invoice for which DaVita or any such DaVita Facility, as applicable, has a bona fide dispute if it: (a) notifies Rockwell of such invoice dispute [***] of receipt of the invoice, and (b) provides to Rockwell a reconciliation of charges and any documentation necessary to support its claimed adjustment. The parties agree to use their commercially reasonable efforts to resolve any invoice dispute within thirty (30) days of Rockwell's receipt of any such invoice dispute notice from DaVita or any DaVita Facility, as applicable. [***] If DaVita or any DaVita Facility fails to pay any amount when due and such failure continues for at least [***] after DaVita’s receipt of notice from Rockwell of such non-payment (which notice shall be given by email to [***], such failure to pay any undisputed amount shall, in addition to other rights and remedies existing in Rockwell’s favor, be deemed a material breach of this Agreement subject to Rockwell’s termination right following the written notice and cure period set forth in Section 2.3(b).
ARTICLE VI
FAILURE TO SUPPLY
In the event of Rockwell's: (i) failure or inability to supply any Product(s) within and for the time period required by DaVita or any DaVita Facility, as applicable, as a result of an act of God, fire, casualty, flood, war, act of terrorism, strike, failure of public utilities, injunction, epidemic, riot, insurrection, embargo, or government order or regulation (a "Force Majeure Event"), and (ii) failure or inability to supply any Product(s) within the established time periods described in Section 4.1 for any reason other than a Force Majeure Event (a “Failure to Supply Event”), Rockwell covenants and agrees that it shall (a) give notice as promptly as is practicable under the circumstances, but in no event more than [***], to DaVita of such Force Majeure Event or Failure to Supply Event, unless an order of a regulatory agency or other action arising out of patient safety concerns requires the giving of shorter notice; (b) [***] minimize the effects of any such Force Majeure Event or Failure to Supply Event, and shall resume the performance of its obligations [***]. (c) allocate any available quantities of any such Product(s) affected by such Force Majeure Event or Failure to Supply Event (exclusive of the inventory of such Product(s) reserved by Rockwell for use by DaVita and the DaVita Facilities pursuant to Article VII, which inventory shall be solely for the use of DaVita and the DaVita Facilities) to DaVita and the DaVita Facilities, in accordance with the percentage of purchases of any such Product(s) made by DaVita and the DaVita Facilities
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from Rockwell during the [***] period immediately preceding such Force Majeure Event or Failure to Supply Event in proportion to the percentage of purchases made by all other purchasers of any such Product(s) from Rockwell during the [***] period immediately preceding such Force Majeure Event or Failure to Supply Event; (d) not intentionally discriminate against DaVita and the DaVita Facilities in its allocation of the available quantities of any such Product(s) affected by such Force Majeure Event or Failure to Supply Event by making its allocation decisions, in whole or in part, on the basis of the prices, discounts, or other financial terms offered to DaVita and the DaVita Facilities pursuant to the terms and conditions of this Agreement; (e) with respect to any Failure to Supply Event, in the event DaVita and the DaVita Facilities, [***]; and (f) continue to perform its other obligations hereunder that are not affected by such Force Majeure Event or Failure to Supply Event. Rockwell further covenants and agrees that during the period that a Force Majeure Event or Failure to Supply Event is occurring, none of the DaVita Facilities shall be subject to the Product Commitment, and following completion of the Failure to Supply Event, the Product Commitment shall be pro-rated to take into account such period.
ARTICLE VII
INVENTORY RESERVE COVENANTS
7.1Subject to the terms of this Article VII, Rockwell agrees and covenants to DaVita that it shall, at all times during the Term, to allow for the continuous and uninterrupted supply of each of the Products to DaVita and the DaVita Facilities: (a) maintain and reserve for use exclusively by DaVita and the DaVita Facilities an amount of total inventory of each Product equal to [***] for each such Product and (b) have outstanding purchase orders with its suppliers for raw materials and products in amount sufficient to allow Rockwell to manufacture an amount of each such Product equal to [***] of each Product (the “Inventory Reserve”).
7.2Subject to the terms of this Article VII, at any time during the Term at DaVita's request, a responsible officer of Rockwell will deliver a written certification to DaVita that Rockwell is in compliance with its obligations under this Article VII. No more frequently than once in any [***] period, DaVita may arrange to conduct an inventory of the Products during normal business hours and at a mutually agreeable time. If, at any time during the Term, Rockwell does not have the outstanding purchase orders described above [***], Rockwell will deliver a written notice to DaVita which describes the reasons for Rockwell's failure to have such outstanding purchase orders, together with Rockwell's plan and timeline, which timeline shall not exceed [***] from the date of the notice, for entering into and such purchase orders. For the avoidance of doubt, any failure by Rockwell to meet the obligations in this Article VII shall constitute a material breach of the Agreement.
ARTICLE VIII
ADDITIONAL PRODUCTS AND REPLACEMENT PRODUCTS
8.1Additional Products. Throughout the Term, Rockwell shall provide to DaVita and the DaVita Facilities the right to purchase or lease all current or new products manufactured, utilized, licensed, sold, or distributed by Rockwell or any of its Affiliates (including products and product lines acquired by Rockwell or any of its Affiliates as a result of an acquisition, merger, or other transaction involving Rockwell or any of its Affiliates) that are or that become Commercially Available and which are not already covered by this Agreement or by any other agreement, whether written or oral, between the parties hereto (such products are collectively referred to as "Additional Products" and individually as an "Additional Product"). Rockwell agrees to include DaVita in all of its and its Affiliates distributions of customer announcements regarding Rockwell's or its Affiliates' Additional Products. The purchase price for any Additional Product(s) shall be negotiated by the parties hereto in good faith and the agreed upon purchase price shall be memorialized in writing as a supplement or amendment to this Agreement. Rockwell covenants and agrees that it shall only make an offer for the sale of any Additional Product(s) to DaVita's Vice-President of Clinical Operations, Chief Medical Officer, or Group Vice-President Purchasing, and not to any DaVita Facility directly: provided that the purchase of any Additional Product(s) by DaVita or any DaVita Facility through a Rockwell product catalog made generally available to the dialysis community shall not be a breach by Rockwell of this Section 8.1. If Rockwell or any of its Affiliates
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acquires any Additional Product(s) as a result of an acquisition, merger, or other transaction involving Rockwell or any of its Affiliates with a Person with which DaVita or a DaVita Facility, as applicable, already has a purchase or rebate arrangement whether written or oral (a "Prior Agreement"), Rockwell or such Affiliate covenants and agrees that it shall continue to abide by all of the terms and conditions of such Prior Agreement or if DaVita requests, any such Additional Product(s) shall be included in this Agreement on terms to be negotiated and mutually acceptable to the parties hereto as provided in this Section 8.1.
8.2Replacement Products. If at any time during the Term, Rockwell or any of its Affiliates introduces a product or offering that is a replacement for an existing Product covered by this Agreement, whether developed by Rockwell or any of its Affiliates or acquired by Rockwell or any of its Affiliates in connection with any transaction (a "Replacement Product"), Rockwell will allow (or will cause its Affiliate to allow) DaVita or any DaVita Facility, as applicable, to purchase such Replacement Product at the same price as the Product it is replacing or is ultimately intended to replace.
8.3Modified Products. Unless required by a Governmental Authority, Rockwell shall not remove, discontinue, replace or change any Product unless Rockwell (i) provides DaVita with at least ninety (90) days' prior written notice of its intent to remove, discontinue, replace or materially change such Product, (ii) simultaneously notifies all of its customers who purchase such Product of Rockwell's intent to remove, discontinue, replace or materially change the Product, and (iii) replaces such Product with a substitute product that (a) in DaVita's reasonable discretion is clinically and functionally superior or equivalent to the Product being removed, discontinued, replaced or materially changed (the "Modified Product") and (b) is provided by Rockwell at a price equal to the Product. If DaVita determines that the proposed substitute product does not substantially match the clinical efficacy or functionality of the Modified Product, introduction of such substitute product shall in no way relieve Rockwell of any of its requirements and obligations in relation to the Modified Product under this Agreement.
ARTICLE IX
CONFIDENTIAL INFORMATION COVENANTS
9.1Confidential Information.
(a)No Disclosure of Confidential Information. The Non-Disclosing Party (as defined in Section 18.5) agrees that in connection with the transactions contemplated by this Agreement and the relationship of the parties hereto, it will have access to Confidential Information of the Disclosing Party (as defined in Section 18.5) and that such Confidential Information is vital, sensitive, confidential, and proprietary to the Disclosing Party. Therefore, the Non-Disclosing Party agrees that during the Term and for the longest time permitted under applicable law after the expiration of this Agreement or the earlier termination of this Agreement for any reason, that it will (i) use the Confidential Information solely for the purposes of performing its obligations or exercising its rights under this Agreement or for the purposes of using the Products, Additional Products or Replacement Products supplied pursuant to this Agreement (the "Purpose"), (ii) hold any Confidential Information delivered or communicated to it by the Disclosing Party in the strictest confidence, including taking all reasonable precautions to prevent the inadvertent disclosure of any such Confidential Information to any unauthorized third party or parties and (ii) not, at any time without the Disclosing Party's express written consent, which consent may be withheld by the Disclosing Party in its sole and absolute discretion (A) disclose, reproduce, display, perform, record, broadcast, transmit, distribute, modify, translate, combine with other information or materials, create derivative works based on, exploit commercially, or otherwise use any such Confidential Information in any manner or medium whatsoever except for the Purpose, (B) disclose or publicize any such Confidential Information or the terms of this Agreement to any third party or parties, or (C) discuss with or otherwise disclose
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or reveal to any third party or parties any information relating to the Disclosing Party's business or the Non-Disclosing Party's duties or responsibilities to the Disclosing Party, regardless of whether such information constitutes Confidential Information, except, in each case, that the Non-Disclosing Party may disclose the Confidential Information to its contractors, agents (including attorneys, financial advisors and accountants) and employees who have a need to know the Confidential Information in connection with the Purpose and who are bound by an obligation of confidentiality consistent with the terms of this Article IX. Notwithstanding anything to the contrary herein, the Non-Disclosing Party shall have the right to disclose (to the minimum extent necessary) any of the terms or provisions of this Agreement upon any determination by the Non-Disclosing Party's legal counsel in consultation with Disclosing Party's counsel that such disclosure is necessary in connection with the compliance by the Non-Disclosing Party with any legal requirement, including applicable obligations and requirements pursuant to federal and state securities laws and listing standards.
(b)Retention and Destruction of Confidential Information. The Non-Disclosing Party shall not use, take or retain any Confidential Information that is in written, email, computerized, model, sample, or other form capable of physical delivery, upon or after the expiration of this Agreement or the earlier termination of this Agreement for any reason without the prior written consent of the Disclosing Party, which consent may be withheld by the Disclosing Party in its sole and absolute discretion, provided that the Non-Disclosing Party may retain one copy of such Confidential Information for its legal archives, and the Non-Disclosing Party will not be required to destroy electronic files containing such Confidential Information that are made in the ordinary course of its business information back-up procedures pursuant to its electronic record retention and destruction practices that apply to its own general electronic files and information. At any time upon the request of the Disclosing Party, the Non-Disclosing Party shall promptly redeliver to the Disclosing Party or destroy all written materials containing or reflecting any information contained in the Confidential Information (including all copies, extracts, or other reproductions) and agree to destroy all documents, memoranda, notes, and other writings whatsoever (including all copies, extracts, or other reproductions), prepared by the Non-Disclosing Party based on the information contained in the Confidential Information. Notwithstanding the return or destruction of the Confidential Information, the Non-Disclosing Party will continue to abide by its obligations of confidentiality and other obligations hereunder.
(c)Exceptions to Confidential Information. Notwithstanding anything to the contrary herein, Confidential Information shall not include any information that (i) was already known to the Non Disclosing Party at the time of disclosure by the Disclosing Party free of any restriction, (ii) is generally available to the public or becomes publicly known through no wrongful act of the Non-Disclosing Party, or (iii) is received by the Non-Disclosing Party from a third-party who has a legal right to provide such information to the Non-Disclosing Party.
(d)Use of Trademarks and Other Intellectual Property. Each party hereto agrees not to internally or externally use, release, publish, or distribute any materials or information (including advertising and promotional materials) containing the names, tradenames, trademarks, or other intellectual property right of the other party hereto without the express prior written consent of such other party hereto or as set forth in Section 19.18.
(e)Disclosures of Confidential Information Required By Law. In the event that the Non- Disclosing Party is required by law (e.g., by oral questions, interrogatories, request for information or documents, subpoena, civil investigative demand, or any other similar process) to disclose any Confidential Information, the Non-Disclosing Party agrees that it shall, to the extent permitted by law, provide the Disclosing Party with prompt written notice of any such disclosure of any such Confidential Information that is required by law (prior to making such disclosure and in no event later than five (5) days after the receipt of such request(s)) and shall consult with
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the Disclosing Party as to the advisability of taking legally advisable steps to resist or narrow any such disclosure of any such Confidential Information that is required by law. If disclosure of any Confidential Information is required by law, the Non-Disclosing Party will (i) furnish only that portion of any such Confidential Information which, in the reasonable opinion of the Non-Disclosing Party's counsel, after consultation with the Disclosing Party's counsel, it is legally obligated to disclose and (ii) use its best efforts to obtain an order or other reliable assurances that confidential and non-public treatment will be accorded to any such Confidential Information that is required to be disclosed by law.
(f)Employees, Agents, Representatives, Etc. For purposes of this Section 9.1, any Confidential Information received by any director, officer, member, manager, partner, employee, agent, subcontractor, advisor, or representative of the Non-Disclosing Party pursuant to the terms and conditions of this Agreement shall be deemed received by the Non-Disclosing Party and any breach by such persons of this Section 9.1 shall be deemed a breach by the Non-Disclosing Party of this Agreement.
9.2Enforcement. The Non-Disclosing Party agrees that money damages would not be an adequate remedy for any breach of this Article IX. Therefore, in the event of a breach or threatened breach of the provisions of this Article IX by the Non-Disclosing Party, the Disclosing Party shall, in addition to other rights and remedies existing in its favor, be entitled to seek specific performance, injunctive relief, or any other relief in order to enforce or prevent any violation of the provisions of this Article IX (without proving monetary damages, posting a bond, or other security).
ARTICLE X
REPRESENTATIONS AND WARRANTIES OF ROCKWELL
Rockwell hereby represents and warrants to DaVita as follows:
10.1Standing and Authority. Rockwell has the requisite corporate power, right, and authority to enter into this Agreement and to consummate the transactions contemplated hereby. Rockwell's execution and delivery of this Agreement and the consummation of the transactions contemplated hereby have been duly and validly authorized by all necessary corporate action on the part of Rockwell.
10.2Execution; Delivery; Binding Effect. This Agreement has been duly executed and delivered by Rockwell, and constitutes the legal, valid, and binding obligation of Rockwell, enforceable against Rockwell in accordance with its terms.
10.3No Conflicts. Neither the execution, delivery, or performance of this Agreement by Rockwell nor the consummation of the transactions contemplated in this Agreement, shall (a) conflict with, contravene, or result in a breach of any statute or administrative regulation, or of any law, rule, regulation, ordinance, order, writ, injunction, judgment, or decree of any Governmental Authority or of any arbitration award to which Rockwell is a party or by which any of the properties or assets of Rockwell are or may be bound or (b) conflict with, contravene, or violate any agreement, understanding, or arrangement to which Rockwell is a party or by which any of the properties or assets of Rockwell are or may be bound.
10.4Title. Rockwell possesses good and marketable title to all of the Products free and clear of any and all liens, mortgages, charges, security interests, pledges, or other encumbrances or adverse claims of any nature, whether arising by agreement, operation of law, or otherwise (collectively, "Liens"). Rockwell has the right to convey and in connection with the transactions contemplated by this Agreement will convey to DaVita and the DaVita Facilities, as applicable, good and marketable title to all of the Products acquired hereunder, free and clear of any and all Liens.
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10.5Licenses, Permits, and Compliance with Laws. Rockwell has all rights, licenses, permits, and consents necessary to sell the Products to DaVita and the DaVita Facilities and to perform its obligations hereunder during the Term. Rockwell is and has at all times been in and during the Term shall be in compliance with all federal, state, and local laws, statutes, rules, and regulations applicable to its business and the performance of its obligations under this Agreement. No Product delivered hereunder during the Term is or will be adulterated or misbranded within the meaning of the FFDCA, or within the meaning of any applicable state or municipal law, or is or will be a product which may not be introduced into interstate commerce. During the Term, Rockwell shall immediately inform DaVita following its receipt of any information which states that the integrity or legal status of any Product provided hereunder has been called into question by any retailer, wholesaler, or state or federal authority, or that any such Product sold to DaVita or any DaVita Facility hereunder is suspected of being counterfeit, stolen, adulterated, misbranded, or otherwise an unlawful product and shall provide DaVita with prompt written confirmation of any such event, including copies of any and all documents related thereto. DaVita's and the DaVita Facilities' use of the Products in accordance with their intended use shall not infringe upon any ownership rights of any other Person or upon any patent, copyright, trademark, or other intellectual property or proprietary right or trade secret of any third party.
10.6Products. Each Product purchased during the Term (a) is and shall be manufactured in accordance with its packaging, (b) is and shall be manufactured, handled, stored, and transported in accordance with all applicable United States, state, and local laws and regulations pertaining thereto, including to the extent applicable, the FFDCA and implementing regulations and FDA approved Good Manufacturing Practices, (c) meets all specifications for effectiveness and safety as required by the FDA, (d) is fit for the indications described in its labeling, and (e) is labeled in compliance with all applicable laws. Each Product is and will (i) be of the kind and quantity specified herein, (ii) be of safe and merchantable quality, (iii) be free of defects in design, materials, manufacture, or workmanship when delivered, (iv) [***], and (v) conform to its specifications as written or published, unless otherwise agreed to by the parties hereto. In the event any Product or any component of a Product is not manufactured by Rockwell, Rockwell hereby assigns or agrees to assign (to the extent assignable) to DaVita all such manufacturer warranties, copies of which shall be provided by Rockwell to DaVita upon request.
10.7Expired Product. Rockwell will use its best efforts not to ship to DaVita or any DaVita Facility expired Product or Product [***], unless agreed to in writing by DaVita. In the event that Rockwell ships to DaVita or any DaVita Facility expired Product [***], DaVita shall have the right to return such Product to Rockwell and Rockwell shall replace such Product with Product [***], all at Rockwell's sole cost and expense.
10.8Health Care Programs. Neither Rockwell nor any of its Affiliates is currently (a) named on any of the following lists (i) HHS/OIG List of Excluded Individuals/Entities, (ii) GSA List of Parties Excluded from Federal Programs, or (iii) OFAC "SDN and Blocked Individuals" or (b) under investigation or otherwise aware of any circumstances which would result in Rockwell being excluded from participation in any Federal health care program, as defined under 42 U.S.C. §1320a-7b(f). Neither Rockwell nor any of its Affiliates or personnel has ever been either convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a) or excluded from the Medicare program or any state health care program. Further, neither Rockwell nor any of its Affiliates or personnel is subject to an action or investigation that reasonably could be expected to lead to the conviction of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a) or exclusion from the Medicare program or any state health care program. Rockwell shall promptly notify DaVita if an action or investigation arises that reasonably could be expected to result in the conviction of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), or the exclusion of it, or any of its Affiliates or personnel from the Medicare program, any state health care program or would otherwise result in it, its Affiliates or personnel being excluded as set forth in this Section 10.8. Failure to timely notify DaVita of any such action or investigation shall give DaVita the right to terminate this Agreement effective immediately upon written notice. In the event that Rockwell becomes excluded from the Medicare program, any state health care program or would otherwise result in it, its Affiliates or personnel being excluded as set forth in this Section 10.8, for any reason, during the Term of this Agreement, DaVita shall be entitled to terminate this Agreement, effective immediately upon written notice. Rockwell certifies that this Agreement is not intended to generate referrals for services or supplies for which payment may be made in whole or in part under any federal health care program.
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All warranties granted or assigned under this Article X will continue in full force and effect notwithstanding transfer of title to any Product to or by DaVita or any DaVita Facility to any other DaVita Facility. All warranties granted under this Agreement shall survive inspection, acceptance, and payment of the Products.
ARTICLE XI
REPRESENTATIONS AND WARRANTIES OF DAVITA
DaVita hereby represents and warrants to Rockwell as follows:
11.1Standing and Authority. DaVita has the requisite corporate power, right, and authority to enter into this Agreement and to consummate the transactions contemplated hereby. DaVita's execution and delivery of this Agreement and the consummation of the transactions contemplated hereby have been duly and validly authorized by all necessary corporate action on the part of DaVita.
11.2Execution; Delivery; Binding Effect. This Agreement has been duly executed and delivered by DaVita, and constitutes the legal, valid, and binding obligation of DaVita, enforceable against DaVita in accordance with its terms.
11.3No Conflicts. Neither the execution, delivery, or performance of this Agreement by DaVita nor the consummation of the transactions contemplated in this Agreement, shall (a) conflict with, contravene, or result in a breach of any statute or administrative regulation, or of any law, rule, regulation, ordinance, order, writ, injunction, judgment, decree of any Governmental Authority, or of any arbitration award to which DaVita is a party or by which any of the properties or assets of DaVita are or may be bound or (b) conflict with, contravene, or violate any provision of any agreement, understanding, or arrangement to which DaVita is a party or by which any of the properties or assets of DaVita are or may be bound.
11.4Compliance with Laws. DaVita has all rights, licenses, permits, and consents necessary to perform its obligations hereunder during the Term. DaVita is and has at all times been in and during the Term shall be in compliance with all federal, state, and local laws, statutes, rules, and regulations applicable to its business and the performance of its obligations under this Agreement.
11.5Health Care Programs. Neither DaVita nor any of its Affiliates is currently (a) named on any of the following lists (i) HHS/OIG List of Excluded Individuals/Entities, (ii) GSA List of Parties Excluded from Federal Programs, or (iii) OFAC "SDN and Blocked Individuals" or (b) under investigation or otherwise aware of any circumstances which would result in DaVita being excluded from participation in any Federal health care program, as defined under 42 U.S.C. §1320a-7b(f). Neither DaVita nor any of its Affiliates or personnel has ever been either convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a) or excluded from the Medicare program or any state health care program. Further, neither DaVita nor any of its Affiliates or personnel is subject to an action or investigation that reasonably could be expected to lead to the conviction of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a) or exclusion from the Medicare program or any state health care program. DaVita shall promptly notify Rockwell if an action or investigation arises that reasonably could be expected to result in the conviction of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), or the exclusion of it, or any of its Affiliates or personnel from the Medicare program, any state health care program or would otherwise result in it, its Affiliates or personnel being excluded as set forth in this Section 11.5. Failure to timely notify Rockwell of any such action or investigation shall give Rockwell the right to terminate this Agreement effective immediately upon written notice. In the event that DaVita becomes excluded from the Medicare program, any state health care program or would otherwise result in it, its Affiliates or personnel being excluded as set forth in this Section 11.5, for any reason, during the Term of this Agreement, Rockwell shall be entitled to terminate this Agreement, effective immediately upon written notice. DaVita certifies that this Agreement is not intended to generate referrals for services or supplies for which payment may be made in whole or in part under any federal health care program.
ARTICLE XII
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INDEMNIFICATION AND INSURANCE
12.1Indemnification of DaVita. Rockwell agrees to defend, indemnify, and hold DaVita, its Affiliates, and the DaVita Facilities and each of their respective directors, officers, members, managers, partners, employees, and agents (collectively, the "DaVita Indemnitees") harmless from and against any and all causes of action (at law or in equity), actions, claims, costs, suits, liabilities, judgments, settlements, demands, losses, damages, proceedings, or expenses of all kinds (including reasonable attorneys' fees, witnesses' fees, investigation expenses, and any other expenses incident thereto) (collectively, "Losses") that the DaVita lndemnitees may sustain or incur as a result of any claim, suit, action, or proceeding by any Person who is not a party hereto or an Affiliate of a party hereto (a "Third Party Claim") against a DaVita Indemnitee arising out of or resulting from: (a) any breach of any representation or warranty made by Rockwell in this Agreement or in materials furnished by Rockwell for DaVita's and the DaVita Facilities' use; (b) any breach by Rockwell of any of its covenants or obligations in this Agreement; (c) the use of any Product by DaVita or any DaVita Facility in accordance with any such Products' labeling and instructions for use; (d) any defect in the design or manufacture of any Product (including claims for property damage, loss of life, and bodily injury); (e) any Recall (as defined in Article XIII) with respect to any Product; or (f) any negligent, reckless, wanton, malicious, or other tortious conduct by Rockwell in connection with the transactions contemplated by this Agreement. Notwithstanding the foregoing, in no event shall Rockwell have an obligation to defend, indemnify, or hold any of the DaVita Indemnitees harmless hereunder to the extent any Losses were caused by the sole negligence or willful misconduct of any such DaVita Indemnitees.
12.2Indemnification of Rockwell. DaVita agrees to defend, indemnify, and hold Rockwell and its Affiliates and each of their respective directors, officers, members, managers, partners, employees, and agents (collectively, the "Rockwell Indemnitees") harmless from and against any and all Losses that the Rockwell lndemnitees may sustain or incur as a result of any Third Party Claim against a Rockwell Indemnitee arising out of or resulting from: (a) any breach of any representation or warranty made by DaVita in this Agreement; (b) any breach by DaVita of any of its covenants or obligations in this Agreement; (c) the use of any Product by DaVita or any DaVita Facility not in accordance with any such Products' labeling and instructions for use; (d) any DaVita Facilities' negligence or misconduct in the "Administration" of a Product to its patients; or (e) any negligent, reckless, wanton, malicious, or other tortious conduct by DaVita in connection with the transactions contemplated by this Agreement. For purposes of this Section 12.2, the "Administration" of a Product by a DaVita Facility shall mean the dispensing and handling by such DaVita Facility and its employees of such Product and the actual administration of such Product to patients by such DaVita Facility and its employees, but shall exclude physician prescriptions of such Product to patients. Notwithstanding the foregoing, in no event shall DaVita have an obligation to defend, indemnify, or hold any of the Rockwell Indemnitees harmless hereunder to the extent any Losses were caused by the sole negligence or willful misconduct of any such Rockwell Indemnitees.
12.3Indemnification Procedure for Third Party Claims. If any DaVita Indemnitee or any Rockwell Indemnitee entitled to indemnification under this Article XII (the "Indemnified Party") receives notice of the assertion of any Third Party Claim against such Indemnified Party, the Indemnified Party shall give written notice regarding such Third Party Claim to the party hereto that is required to provide indemnification under this Article XII (the "Indemnifying Party") within thirty (30) days after learning of such Third Party Claim. The Indemnifying Party shall have the right, upon written notice to the Indemnified Party (the "Defense Notice") within thirty (30) days after receipt from the Indemnified Party of notice of such Third Party Claim, which Defense Notice by the Indemnifying Party shall specify the counsel it will appoint to defend such Third Party Claim (the "Defense Counsel"), to conduct at its expense the defense against such Third Party Claim in its own name, or if necessary in the name of the Indemnified Party; provided, however, that: (a) the Indemnified Party shall have the right to approve the Defense Counsel, which approval shall not be unreasonably withheld, conditioned, or delayed by the Indemnified Party and (b) as a condition precedent to the Indemnifying Party's right to assume control of such defense, the Indemnifying Party must first enter into an agreement with the Indemnified Party (in form and substance reasonably satisfactory to the Indemnified Party) pursuant to which the Indemnifying Party agrees to be fully responsible for any and all Losses relating to such Third Party Claim and unconditionally guarantees the payment and performance of any and all Losses which may arise with respect to such Third Party Claim, subject to the terms and conditions set forth in this Section 12. The Indemnifying Party shall not have the right to assume control of, but may participate in, and the Indemnified Party shall have the sole right to assume control of any Third Party Claim, at its own expense which: (i) seeks a temporary restraining order, a preliminary or permanent injunction, or specific performance against the Indemnified Party, (ii) involves criminal or quasi-criminal allegations against the Indemnified Party, (iii) if unsuccessful would set a precedent that would materially
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interfere with, or have a material adverse effect on, the business or financial condition of the Indemnified Party, or (iv) imposes liability in the part of the Indemnified Party for substantially all of which the Indemnified Party is not entitled to indemnification under this Article XII. If the Indemnifying Party is permitted to assume and control the defense of any Third Party Claim and elects to do so, the Indemnified Party shall have the right to employ counsel separate from counsel employed by the Indemnifying Party in any such Third Party Claim and to participate in the defense thereof, but the fees and expenses of such counsel employed by the Indemnified Party shall be at the expense of the Indemnified Party unless (A) the employment thereof has been specifically authorized by the Indemnifying Party in writing, (B) the Indemnified Party has been advised by counsel that a conflict of interest exists between the Indemnifying Party and the Indemnified Party, or the Indemnifying Party has failed to assume the defense and employ counsel, in which case the fees and expenses of the Indemnified Party's counsel shall be paid by the Indemnifying Party. No Indemnifying Party shall consent to the entry of any judgment or enter into any settlement of any Third Party Claim without the prior written consent of the Indemnified Party if (w) such judgment or settlement would lead to liability or create any financial or other obligation on the part of the Indemnified Party for which the Indemnified Party is not entitled to indemnification hereunder, (x) such judgment or settlement would result in the finding or admission of any violation of any federal, state, or local law, statute, ordinance, or regulation, (y) such judgment or settlement does not include as an unconditional term thereof the giving by each claimant or plaintiff to each Indemnified Party of a release from all liability in respect to such Third Party Claim, or (z) as a result of such judgment or settlement, injunctive or other equitable relief would be imposed against the Indemnified Party. In the event that the Indemnifying Party fails to give the Defense Notice within thirty (30) days of receiving notice of a Third Party Claim from the Indemnified Party, it shall be deemed to have elected not to conduct the defense of such Third Party Claim, or in the event the Indemnifying Party does deliver a Defense Notice within thirty (30) days of receiving notice of such Third Party Claim from the Indemnified Party and thereby elects to not conduct the defense of such Third Party Claim, then in either such event the Indemnified Party shall have the right to conduct and control the defense of such Third Party Claim in good faith and to compromise and settle such Third Party Claim or consent to the entry of a judgment of such Third Party Claim in good faith without the prior consent of the Indemnifying Party. A failure by the Indemnified Party to give timely, complete, or accurate notice as provided in this Section 12.3 will not affect the rights or obligations of the Indemnifying Party except and only to the extent that, as a result of such failure, the Indemnifying Party entitled to receive such notice was deprived of its right to recover any payment under its applicable insurance coverage or was otherwise directly and materially damaged as a result of such failure to give timely notice.
12.4Insurance. Each party hereto agrees that it shall secure and maintain in full force and effect throughout the Term (and following the expiration of this Agreement or the earlier termination of this Agreement for any reason, to cover any claims or liabilities arising from this Agreement) the insurance coverage set forth in Exhibit D attached hereto. Any limits on either party's insurance coverage shall not be construed to create a limit on its liability with respect to any of its obligations hereunder. Each party hereto shall name the other party as an additional insured on such party's commercial general liability insurance policy. Such insurance policies shall provide at least thirty (30) days prior written notice to the other party hereto of the cancellation, non-renewal, or substantial modification thereof. Each party hereto shall supply certificates of insurance to the other party hereto upon the other party's request.
12.5Limitation of Liability and Remedies. UNDER NO CIRCUMSTANCES WILL EITHER PARTY HAVE ANY LIABILITY TO THE OTHER PARTY FOR, AND EACH PARTY HEREBY EXPRESSLY WAIVES, ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, WHETHER ARISING OUT OF WARRANTY OR CONTRACT, NEGLIGENCE OR OTHER TORT, OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, FORESEEABLE BUSINESS LOSSES, LOSS OF PROFITS AND RELIANCE DAMAGES; PROVIDED, THAT THE FOREGOING LIMITATION OF LIABILITY SHALL NOT APPLY TO, AFFECT, OR LIMIT: [***].
12.6No Implied Warranties. THE WARRANTIES IN THIS AGREEMENT SHALL BE IN LIEU OF ANY OTHER WARRANTY EXPRESSED OR IMPLIED OR STATUTORY, AND ROCKWELL MAKES NO IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE XIII
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RECALL
In the event the FDA initiates a mandatory recall (i.e., the correction or removal of a Product) or Rockwell believes in its sole discretion that it may be necessary to conduct a recall (i.e., the correction or removal of a Product), field market withdrawal, stock recovery, or other similar action with respect to any of the Products (a "Recall"), Rockwell shall immediately notify DaVita of such Recall. The parties hereto agree that the final decision as to and control of the handling of any Recall shall be in Rockwell's sole discretion; provided that Rockwell conducts any such Recall in accordance with any and all applicable legal requirements and general guidance issued by the FDA. In the event that Rockwell does not conduct a Recall, clearly and without dispute, in accordance with all applicable legal requirements and general guidance issued by the FDA, [***]. DaVita shall provide all reasonable assistance requested by Rockwell in connection with a Recall. In the event of a Recall with respect to any Product(s), Rockwell shall reimburse DaVita for: [***]. DaVita and Rockwell shall maintain records of all sales of the Products and customers who received such Products so as to enable Rockwell to adequately administer a Recall with respect to any of the Products in accordance with applicable legal requirements and general guidance issued by the FDA. In the event of a Recall, neither party hereto shall make any statement to the press or public concerning such Recall without first notifying the other party hereto and obtaining such other party's prior written approval of any such statement, which approval shall not be unreasonably withheld, conditioned, or delayed. Any return by DaVita or any DaVita Facility pursuant to this Article XIII shall be sent back to Rockwell, [***].
ARTICLE XIV
OPEN RECORDS AND DISCOUNTS
14.1Open Records. To the extent required by §1861(v)(1)(I) of the Social Security Act, the parties hereto will allow the U.S. Department of Health and Human Services, the U.S. Comptroller General, and their duly authorized representatives, access to this Agreement and any records necessary to verify the nature and extent of costs incurred pursuant to this Agreement during the Term and for four (4) years following the last date any Products are furnished by Rockwell to DaVita or any DaVita Facility under this Agreement. If Rockwell carries out its obligations under this Agreement through a subcontract worth Ten Thousand Dollars ($10,000) or more over a twelve (12) month period with a related organization, the subcontract shall also contain an access clause to permit access by the U.S. Department of Health and Human Services, the U.S. Comptroller General, and their duly authorized representatives to the related organization's books and records. Nothing in this Section 14.1 is intended to waive any right either party hereto may have under any applicable laws or regulations to retain in confidence information included in records so requested.
14.2Discounts. Any discounts, rebates, incentives, or other reductions in price issued by Rockwell to DaVita or any DaVita Facility under this Agreement may constitute a discount within the meaning of 42 U.S.C. §1320a-7b(b)(3)(A). DaVita and the DaVita Facilities may have an obligation to properly disclose and appropriately reflect any such discounts, rebates, incentives, or other reductions in price to any state or federal program that provides cost or charge based reimbursement to DaVita or any such DaVita Facility for the items to which such discounts, rebates, incentives, or other reductions in price apply. In order to assist DaVita's and the DaVita Facilities' compliance with any such obligations, Rockwell agrees that it shall fully and accurately report all discounts, rebates, incentives, or other reductions in price on the invoices, coupons, or statements submitted to DaVita or any DaVita Facility and inform DaVita or any such DaVita Facility of their obligations to report such discounts, rebates, incentives, or other reductions in price. In the event the value of any discounts, rebates, incentives, or other reductions in price are not known at the time of sale, Rockwell shall fully and accurately report the existence of such discounts, rebates, incentives, or other reductions in price on the invoices, coupons, or statements submitted to DaVita or any DaVita Facility, inform DaVita or any DaVita Facility of their obligations to report such discounts, rebates, incentives, or other reductions in price, and when the value of such discounts, rebates, incentives, or other reductions in price becomes known, provide DaVita or any DaVita Facility with
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documentation of the calculation of such discounts, rebates, incentives, or other reductions in price and identifying the specific Products purchased to which such discounts, rebates, incentives, or other reductions in price will be applied. Rockwell shall also provide to DaVita or any DaVita Facility any other information that DaVita or any DaVita Facility may request that is necessary for them to obtain in order to comply with any such obligations, and Rockwell shall refrain from doing anything which would impede DaVita or any DaVita Facility from meeting its obligations under this Section 14.2 or any Medicare regulation.
ARTICLE XV
ACCESS AND POLICIES AND PROCEDURES
Rockwell acknowledges, agrees, and covenants that: (a) all of DaVita's applicable vendor relations policies and procedures and any updates thereto (the "Policies and Procedures") that will be in effect during the Term will be available for viewing by Rockwell during the Term by going to https://www.davita.com/about/suppliers, and (b) Rockwell shall abide by the Policies and Procedures during the Term to the extent they do not conflict with the terms of this Agreement. Rockwell further acknowledges, agrees, and covenants that it must obtain DaVita' s prior written approval of: (i) all proposed educational, marketing, presentation, and promotional materials and (ii) all presentations that are in the case of subparagraphs (i) or (ii) related to any of the products or services offered by Rockwell, including the Products (the "Materials"), that are to be given or made by Rockwell to: (A) DaVita or any DaVita Facility or (B) any patient of DaVita or any DaVita Facility, which approval may only be given in writing by DaVita's Vice President, Clinical Operations or his or her authorized representative. DaVita' s Vice President, Clinical Operations or his or her authorized representative agrees to use his or her commercially reasonable efforts to notify Rockwell of his or her decision with respect to the approval of the Materials within ten (10) Business Days following the receipt of a request by Rockwell to approve the Materials; provided that if DaVita's Vice President, Clinical Operations or his or her authorized representative fails to notify Rockwell of his or her decision with respect to the approval of the Materials within such ten (10) Business Day period, such request to approve the Materials will be deemed denied. Rockwell further acknowledges, agrees, and covenants that absent a specific request from DaVita or any DaVita Facility, none of Rockwell's agents, representatives, or employees shall: (x) contact any patient of DaVita or any DaVita Facility or (y) be permitted access at any time to DaVita or any DaVita Facility; provided that nothing in this Article XV shall prohibit Rockwell from contacting any patient of DaVita or any patient of a DaVita Facility in a manner that is consistent with the Policies and Procedures or as required by any applicable federal, state, or local law.
ARTICLE XVI
AUDIT
If DaVita disagrees with any computation or statement delivered by Rockwell to DaVita or any DaVita Facility under this Agreement, DaVita may, within thirty (30) days after the receipt of such computation or statement, audit any such computation or statement. DaVita shall conduct any such audit during such times as may be mutually agreed to by the parties hereto. In the event that DaVita's audit results in a number different from that set forth in the computation or statement delivered by Rockwell to DaVita or any DaVita Facility, DaVita shall deliver a written notice (an "Objection Notice") to Rockwell setting forth in reasonable detail any and all items of disagreement related to such computation or statement. If DaVita does not deliver an Objection Notice within such thirty (30) day period, the calculations set forth in any such computation or statement shall be deemed final, conclusive, and binding on the parties hereto. Rockwell and DaVita will use their commercially reasonable efforts to resolve any disagreements relating to any computation or statement, but if they do not obtain a final resolution within thirty (30) days after Rockwell has received the Objection Notice, then either Rockwell or DaVita may refer the items in dispute to a nationally recognized firm of independent public accounts as to which DaVita and Rockwell mutually agree (the "Firm"), to resolve any remaining disagreements. Rockwell and DaVita
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will direct the Firm to render a determination within forty-five (45) days of its retention, and Rockwell and DaVita and their respective agents and employees will cooperate with the Firm during its engagement. The determination of the Firm will be conclusive and binding upon DaVita and Rockwell, and DaVita or Rockwell, as applicable, will make any payment owed to other party hereto within ten (10) Business Days of the Firm's determination. The Firm shall execute a confidentiality agreement in a form reasonably acceptable to Rockwell and DaVita. [***]
ARTICLE XVII
ADDITIONAL ACKNOWLEDGEMENTS AND AGREEMENTS OF THE PARTIES
17.1Business Model Change. Rockwell agrees to [***] and to use commercially reasonable efforts to [***]. DaVita acknowledges that in the event Rockwell wishes to [***] it will use its commercially reasonable efforts to [***]; provided that if DaVita uses its commercially reasonable efforts to [***] DaVita shall have no liability whatsoever to Rockwell, including any direct, indirect, consequential, exemplary, or punitive damages, [***].
17.2Mixer Training. Rockwell agrees to furnish, [***], complete and appropriate training regarding the use and maintenance of the DriSate® Acid Mixer used for mixing Dri-Sate® Dry Acid and CitraPure® Dry Acid, to such number of personnel of DaVita and the DaVita Facilities as DaVita shall designate. [***].
17.3Reporting. Until the date on which Rockwell’s quarterly report on Form 10-Q or annual report on Form 10-K filed with the Securities and Exchange Commission first reflects [***], Rockwell will provide to DaVita as soon as available, but no later than thirty (30) days after the last day of each fiscal month (other than the last fiscal month of any fiscal quarter, in which case as soon as available, but no later than forty-five (45) days after the last day of such fiscal quarter) a compliance certificate certified by an officer of Rockwell attaching a Rockwell prepared summary consolidated balance sheet and income statement covering the consolidated operations of Rockwell and its subsidiaries for such fiscal month. From and after the date on which [***], Rockwell’s obligations under this Section 17.3 shall terminate and this Section 17.3 shall have no further force or effect.
ARTICLE XVIII
CERTAIN DEFINED TERMS
The following terms as used herein have the following meaning:
18.1"Affiliate" means, with respect to a Person, any Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with such Person. The term "control", including the terms "controlling", "controlled by", and "under common control with" for the purposes of the definition of "Affiliate", means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract, or otherwise.
18.2[***].
18.3"Business Day" means a day other than Saturday, Sunday, or a public holiday on which banks are authorized or required to be closed under the laws of the State of Colorado.
18.4"Commercially Available" means any product that is approved by the FDA and manufactured, utilized, sold, or distributed anywhere in the United States by Rockwell or any of its Affiliates.
18.5"Confidential Information" means information not generally known outside the disclosing party or any of its Affiliates (collectively, the "Disclosing Party") (unless as a result of a breach of any of the non-disclosing party's or any of its Affiliates'(collectively, the "Non-Disclosing Party's") obligations imposed by this Agreement) or which is identified as confidential by the Disclosing Party to the Non Disclosing Party concerning the Disclosing Party's business and technical information, whether in written, computerized, oral, tangible or
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
intangible, or other form, including: (a) the terms and provisions of this Agreement, (b) any and all trade secrets concerning the business, customers, and affairs of the Disclosing Party, product specifications, data, know-how, formulae, compositions, processes, designs, sketches, photographs, graphs, drawings, samples, inventions and ideas, past, current, and planned research and development, current and planned manufacturing and distribution methods and processes, customer lists, current and anticipated customer requirements, price lists, market studies, business plans, clinical practices and patient protocols, computer software and programs (including object code and source code), database technologies, systems, improvements, devices, discoveries, concepts, methods, and information of the Disclosing Party and any other information of the Disclosing Party, however documented, that is a trade secret under applicable law, (c) any and all information concerning the business and affairs of the Disclosing Party, including historical financial statements, financial projections and budgets, rebates, discounts, payment terms, pricing, historical and projected sales, capital spending budgets and plans, contractual arrangements, the names and background of key personnel, contractors, agents, customers, suppliers, and potential suppliers, personnel training and techniques and materials, purchasing methods and techniques, however documented, (d) the names and addresses, records and charts, and any other information concerning the Disclosing Party's patients, and (e) any and all notes, analysis compilations, studies, summaries, and other materials prepared by or for the Disclosing Party containing or based, in whole or in part, upon any information included in the foregoing.
18.6[***].
18.7"FDA" means the United States Food and Drug Administration and any successor thereto.
18.8"FFDCA" means the United States Federal Food, Drug and Cosmetic Act of 1938 and all regulations promulgated thereunder.
18.9"Governmental Authority" means any multi-national, national, state, provincial, local, governmental, judicial, public, quasi-public, administrative, regulatory or self-regulatory authority, agency, commission, board, organization, or instrumentality.
18.10"Person" means any individual or any group of individuals or any general partnership, limited partnership, limited liability partnership, limited liability company, professional limited liability company, corporation, joint venture, trust, business trust, cooperative or association or any other organization that is not a natural person and any combination of any such entity or organization and any natural persons acting in concert, and the heirs, executors, administrators, legal representatives, successors and assigns of any "person" where the context so permits.
18.11"Sale of DaVita" means any transaction or series of transactions pursuant to which any Person or group of related Persons in the aggregate acquire(s): (a) securities of DaVita possessing the voting power to elect a majority of DaVita’s board of directors (whether by merger, consolidation, reorganization, combination, sale or transfer of DaVita's securities, security holder or voting agreement, power of attorney, or otherwise) or (b) all or substantially all of DaVita's assets.
18.12"Sale of Rockwell" means any transaction or series of transactions pursuant to which any Person or group of related Persons in the aggregate acquire(s): (a) securities of Rockwell possessing the voting power to elect a majority of Rockwell's board of directors (whether by merger, consolidation, reorganization, combination, sale or transfer of Rockwell's securities, security holder or voting agreement, proxy, power of attorney, or otherwise) or (b) all or substantially all of Rockwell's assets.
18.13[***].
18.14"Transfer" means (a) any Sale of Rockwell, (b) Sale of DaVita, or (c) any sale, transfer, assignment, pledge, mortgage, exchange, hypothecation, grant of a security interest, or other direct or indirect disposition or encumbrance of an interest (including by operation of law) or the rights thereof. The term "Transferred," and other forms of the word "Transfer" shall have correlative meanings.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
ARTICLE XIX
MISCELLANEOUS
19.1Entire Agreement; Amendments. This Agreement, including its recitals and exhibits, constitutes the entire agreement between the parties hereto and supersedes any and all prior representations, warranties, statements, promises, agreements, and understandings between the parties hereto, whether oral or written, relating to the subject matter hereof, and no party hereto shall be bound by nor charged with any written or oral representations, warranties, statements, promises, agreements, or understandings not specifically set forth in this Agreement. For avoidance of doubt, this Agreement restates and supersedes the Product Purchase Agreement, dated July 1, 2019, between the parties, as amended by Amendment One, dated April 6, 2022 (the “Amendment”). No amendments or modifications of the terms of this Agreement, including any conflicting or additional terms contained in any sales order, purchase order, acknowledgment form, or other written document submitted by either party hereto, shall be binding on either party hereto unless reduced to writing and signed by a duly authorized representative of each party hereto.
19.2Notices. Except as otherwise specified herein, all notices given pursuant to this Agreement shall be sent by: (a) certified mail, return receipt requested, in which case notice will be deemed delivered three (3) Business Days after deposit, postage prepaid in the United States mail; (b) a nationally recognized overnight courier, in which case notice will be deemed delivered one (1) Business Day after deposit with such courier; or (c) personal delivery, in which case notice will be deemed delivered upon delivery, at the following addresses:
If to Rockwell:
Rockwell Medical, Inc.
30142 Wixom Road
Wixom, Michigan 48393
Attention: Chief Executive Officer
With copies to:
Rockwell Medical, Inc.
30142 Wixom Road
Wixom, Michigan 48393
Attention: General Counsel
Email: [***]
and
Dechert LLP
1095 Avenue of the Americas
New York, New York 10036
Attention: Thomas Rayski
Email: [***]
If to DaVita:
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
DaVita Inc.
2000 16th Street
Denver, CO 80202
Attention: Vice President, Procurement
with a copy to:
DaVita Inc.
2000 16th Street
Denver, Colorado 80202
Attention: Legal Department – VP, Commercial Contracting
and, with an email copy to:
Email: [***]
The addresses in this Section 19.2 may be changed by written notice to the other party hereto, provided that no notice of a change of address will be effective until actual receipt of such notice.
19.3Choice of Law. All issues and questions concerning the construction, validity, enforcement, and interpretation of this Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to any choice of law or conflict of law rules or provisions (whether of the State of Delaware or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the laws of the State of Delaware.
19.4WAIVER OF JURY TRIAL. EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY OF ANY CLAIM OR CAUSE OF ACTION IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS OR EVENTS CONTEMPLATED HEREBY OR ANY COURSE OF CONDUCT, COURSE OF DEALING, STATEMENTS (WHETHER ORAL OR WRITTEN), OR ACTIONS OF ANY PARTY HERETO. THE PARTIES HERETO EACH AGREE THAT ANY AND ALL SUCH CLAIMS AND CAUSES OF ACTION SHALL BE TRIED BY THE COURT WITHOUT A JURY. EACH OF THE PARTIES HERETO FURTHER WAIVES ANY RIGHT TO SEEK TO CONSOLIDATE ANY SUCH LEGAL PROCEEDING IN WHICH A JURY TRIAL HAS BEEN WAIVED WITH ANY OTHER LEGAL PROCEEDINGS IN WHICH A JURY TRIAL CANNOT OR HAS NOT BEEN WAIVED.
19.5Attorneys Fees. In the event of any legal proceeding between the parties hereto with respect to this Agreement, the enforceability of any of its provisions, or any alleged or actual breach of this Agreement by any party hereto, the prevailing party shall be entitled to recover reasonable attorney's fees and all other costs and expenses incurred in connection with pursuing any action with respect thereto, in addition to any other relief to which such party may be entitled. The term "prevailing party" shall mean with respect to each claim asserted in a complaint the party in whose favor final judgment after appeal (if any) is rendered with respect to each such claim asserted in the complaint.
19.6Non-Limitation of Rights and Remedies. Except as otherwise expressly provided herein, the various rights and remedies provided herein shall be cumulative and in addition to any other rights and remedies the parties hereto may be entitled to pursue at law or equity, including specific performance. The exercise of one or more of such rights or remedies shall not impair the right of either party hereto to exercise any other right or remedy at law or equity.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
19.7Waiver. No waiver by any party hereto, whether express or implied, of its rights under any provision hereto shall constitute a waiver of the party's rights under such provisions at any other time or a waiver of the party's rights under any other provision hereto. No failure by any party hereto to take any action against any breach of this Agreement or default by another party hereto shall constitute a waiver of the former party's right to enforce any provision of this Agreement or to take action against any such breach or default or any subsequent breach or default by the other party hereto. To be effective any waiver must be in writing and signed by the waiving party.
19.8Severability. In the event that any provision of this Agreement shall be held to be invalid or unenforceable in any respect, such provision shall be enforced to the fullest extent permitted by law and the remaining provisions of this Agreement shall remain in full force and effect. If any such invalid portion constitutes a material term of this Agreement, the parties hereto shall meet and in good faith seek to mutually agree to modify this Agreement so as to retain, if possible, the overall essential terms of this Agreement.
19.9Conflicts. To the extent that any provision of any sales order, purchase order, invoice, or any other document, or the terms of any of Rockwell's general policies, terms and conditions, procedures or catalogs, conflict with or alter any term of this Agreement, this Agreement shall govern and control.
19.10Assignment and Transfer. This Agreement will be binding upon and inure to the benefit of the parties hereto. This Agreement may not be Transferred by any party hereto without the prior written consent of the other party hereto which consent shall not be unreasonably withheld, conditioned, or delayed, except as provided below: provided however that nothing in this Agreement shall or is intended to limit the ability of: (a) DaVita to Transfer this Agreement, in whole or in part, without the consent of Rockwell to: (i) any Affiliate of DaVita; (ii) any buyer in connection with a Sale of DaVita; or (iii) any lenders of DaVita as collateral for borrowings or (b) Rockwell to Transfer this Agreement, in whole or in part, without the consent of DaVita to: (i) any Affiliate of Rockwell; or (ii) any lenders of Rockwell as collateral for borrowings. Notwithstanding the above, [***].
19.11Relationship of the Parties. This Agreement is not intended to create and shall not be construed as creating between Rockwell and DaVita the relationship of Affiliate, principal and agent, joint venture, partnership, or any other similar relationship, the existence of which is hereby expressly denied. Neither party hereto shall have (nor shall it hold itself out as having) any right, power, or authority to make or incur any legally binding agreement, obligation, representation, warranty, or commitment on behalf of the other party hereto or to direct any action of, or activity by the other party hereto or any of its officers, directors, members, managers, employees, or agents.
19.12Counterparts; Facsimile/PDF Signatures. This Agreement may be executed in any number of counterparts and any party hereto may execute any such counterpart, each of which when executed and delivered shall be deemed to be an original and all of which counterparts taken together shall constitute but one and the same instrument. This Agreement shall become binding when one or more counterparts taken together shall have been executed and delivered by each of the parties hereto. It shall not be necessary in making proof of this Agreement or any counterpart hereof to produce or account for any of the other counterparts. The parties hereto agree that facsimile transmission or PDF of original signatures shall constitute and be accepted as original signatures.
19.13Headings and Interpretation. All Section and Article headings contained in this Agreement are for convenience of reference only, do not form a part of this Agreement, and shall not affect in any way the meaning or interpretation of this Agreement. Words used herein, regardless of the number and gender specifically used, shall be deemed and construed to include any other number, singular or plural, and any other gender, masculine, feminine, or neuter as the context requires. The words "include", "includes", and "including", and words of similar import, shall be deemed to be followed by the phrase "without limitation". Unless the context expressly by its
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
terms requires otherwise, (a) any reference to any law herein shall be construed as referring to such law as from time to time enacted, repealed, or amended, (b) any reference herein to any Person shall be construed to include such Person's permitted successors and assigns, (c) the words "herein", "hereof', and "hereunder", and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, and (d) all references herein to Sections, Articles, or Exhibits shall be construed to refer to Sections, Articles, or Exhibits of this Agreement.
19.14Joint Preparation. Each party hereto: (a) has participated in the preparation of this Agreement; (b) has read and understands this Agreement; and (c) has been represented by counsel of its own choice in the negotiation and preparation of this Agreement. Each party hereto represents that this Agreement is executed voluntarily and should not be construed against any party hereto solely because it drafted all or a portion hereof.
19.15Time of Essence. Rockwell's obligation to meet the delivery dates or any other time periods set forth herein is of the essence.
19.16Survival. Notwithstanding anything to the contrary that may be contained elsewhere in this Agreement, this Article XIX and Articles II, VI, IX, X, XI, XII, XIII, and XIV shall survive, and remain in full force and effect, following the expiration of this Agreement or the earlier termination of this Agreement for any reason.
19.17Business Day. If any payment is due or any time period for giving notice or taking action expires on a day that is not a Business Day, the payment shall be due and payable on and the time period for giving such notice or taking such action shall automatically be extended to the next succeeding Business Day.
19.18Public Announcements. Except as otherwise required pursuant to any applicable federal or state securities laws or stock listing requirements, no party hereto shall make any public announcement of any kind or any filing with respect to the other party hereto or any of the transactions provided for herein without the prior written consent of the other party hereto. The disclosing party shall give reasonable prior advance notice of the proposed text of any such announcement or filing to the other party for its prior review and approval, which review and approval shall not be unreasonably conditioned, withheld or delayed. The parties further agree that if either party is required to file this Agreement or any amendment hereto pursuant to any applicable federal or state securities laws or stock listing requirements, the disclosing party shall redact pricing and other competitively sensitive terms to the extent consistent with applicable interpretations and guidance of the staff of the Securities and Exchange Commission.
[SIGNATURE PAGE FOLLOWS]
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be effective as of the Effective Date.
ROCKWELL: DAVITA:
ROCKWELL MEDICAL, INC. DAVITA INC.
/s/ Mark Strobeck /s/ Javier J. Rodriguez
Name: Mark Strobeck, Ph.D. Name: Javier J. Rodriguez
Title: President and Chief Executive Officer Title: Chief Executive Officer
DAVITA INC.
/s/ Joel Ackerman
Name: Joel Ackerman
Title: Chief Financial Officer
Approved as to form:
DAVITA INC.
/s/ David Witek
Name: David Witek
Title: VP, Associate General Counsel
Exhibit 31.1
CERTIFICATION PURSUANT TO RULE 13a‑14(a)
I, Mark Strobeck, certify that:
1.have reviewed this quarterly report on Form 10‑Q of Rockwell Medical, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a‑15(e) and 15d‑15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a‑15(f) and 15d‑15(f)) for the registrant and have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| | | | | |
Date: | November 14, 2023 |
| |
| /s/ Mark Strobeck Mark Strobeck (Principal Executive Officer and Principal Financial Officer) |
EXHIBIT 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Rockwell Medical, Inc. (the “Company”) on Form 10‑Q for the quarter ending September 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Periodic Report”), each of the undersigned, in the capacities and on the dates indicated below, hereby certifies pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that based on my knowledge:
1.the Periodic Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.the information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| | | | | |
Date: November 14, 2023 | /s/ Mark Strobeck |
| Mark Strobeck (Principal Executive Officer and Principal Financial Officer) |
| |
| |
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v3.23.3
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
ASSETS |
|
|
Cash and Cash Equivalents |
$ 7,759
|
$ 10,102
|
Investments Available-for-Sale |
3,971
|
11,390
|
Accounts Receivable, net |
9,361
|
6,259
|
Inventory, net |
5,486
|
5,814
|
Prepaid and Other Current Assets |
1,596
|
1,745
|
Total Current Assets |
28,173
|
35,310
|
Property and Equipment, net |
6,771
|
2,194
|
Inventory, Non-Current |
178
|
1,276
|
Right of Use Assets-Operating, net |
3,095
|
3,943
|
Right of Use Assets-Financing, net |
2,044
|
2,468
|
Intangible Asset, net |
10,897
|
0
|
Goodwill |
921
|
921
|
Other Non-Current Assets |
527
|
523
|
Total Assets |
52,606
|
46,635
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
Accounts Payable |
3,929
|
4,053
|
Accrued Liabilities |
6,708
|
7,702
|
Deferred Consideration - Current |
2,500
|
0
|
Lease Liabilities-Operating - Current |
1,529
|
1,483
|
Lease Liabilities-Financing - Current |
550
|
522
|
Deferred License Revenue - Current |
46
|
1,731
|
Term Loan - Current - Net of Issuance Costs |
5,631
|
1,631
|
Insurance Financing Note Payable |
488
|
503
|
Customer Deposits |
27
|
66
|
Total Current Liabilities |
21,408
|
17,691
|
Lease Liabilities-Operating - Long-Term |
1,676
|
2,581
|
Lease Liabilities-Financing - Long-Term |
1,672
|
2,088
|
Term Loan - Long-Term, net of issuance costs |
3,331
|
7,555
|
Deferred License Revenue - Long-Term |
487
|
2,600
|
Deferred Consideration - Long-Term |
2,500
|
0
|
Long Term Liability - Other |
14
|
14
|
Total Liabilities |
31,088
|
32,529
|
Stockholders’ Equity: |
|
|
Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; 15,000 shares issued and outstanding at September 30, 2023 and December 31, 2022 |
0
|
0
|
Common Stock, $0.0001 par value; 170,000,000 shares authorized; 28,489,663 and 12,163,673 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively |
3
|
1
|
Additional Paid-in Capital |
417,133
|
402,701
|
Accumulated Deficit |
(395,686)
|
(388,759)
|
Accumulated Other Comprehensive Income |
68
|
163
|
Total Stockholders’ Equity |
21,518
|
14,106
|
Total Liabilities and Stockholders’ Equity |
$ 52,606
|
$ 46,635
|
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v3.23.3
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Sep. 30, 2022 |
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) |
28,489,663
|
12,163,673
|
|
Common shares, shares outstanding (in shares) |
28,489,663
|
12,163,673
|
11,152,673
|
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v3.23.3
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
|
Net Sales |
|
$ 23,771
|
$ 18,691
|
$ 61,519
|
$ 53,497
|
Cost of Sales |
|
21,569
|
17,914
|
55,685
|
51,760
|
Gross Profit |
|
2,202
|
777
|
5,834
|
1,737
|
Research and Product Development |
|
494
|
469
|
939
|
2,963
|
Selling and Marketing |
|
556
|
762
|
1,584
|
1,743
|
General and Administrative |
|
2,889
|
3,254
|
9,434
|
11,845
|
Operating Loss |
|
(1,737)
|
(3,708)
|
(6,123)
|
(14,814)
|
Other (Expense) Income |
|
|
|
|
|
Realized Gain on Settlement of Investments |
|
220
|
0
|
220
|
4
|
Interest Expense |
|
(411)
|
(476)
|
(1,193)
|
(1,497)
|
Interest and Other Income (Expense) - net |
|
56
|
(6)
|
169
|
(10)
|
Total Other Expense, net |
|
(135)
|
(482)
|
(804)
|
(1,503)
|
Net Loss |
|
$ (1,872)
|
$ (4,190)
|
$ (6,927)
|
$ (16,317)
|
Basic Net Loss per Share (in dollars per share) |
|
$ (0.07)
|
$ (0.23)
|
$ (0.32)
|
$ (1.26)
|
Diluted Net Loss per Share (in dollars per share) |
|
$ (0.07)
|
$ (0.23)
|
$ (0.32)
|
$ (1.26)
|
Basic Weighted Average Shares Outstanding (in shares) |
[1] |
27,521,088
|
18,463,673
|
21,526,978
|
12,902,890
|
Diluted Weighted Average Shares Outstanding (in shares) |
[1] |
27,521,088
|
18,463,673
|
21,526,978
|
12,902,890
|
|
|
X |
- DefinitionThe aggregate costs related to goods produced and sold and services rendered by an entity during the reporting period. This excludes costs incurred during the reporting period related to financial services rendered and other revenue generating activities.
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v3.23.3
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Statement of Comprehensive Income [Abstract] |
|
|
|
|
Net Loss |
$ (1,872)
|
$ (4,190)
|
$ (6,927)
|
$ (16,317)
|
Unrealized (Loss) Gain on Available-for-Sale Investments |
(69)
|
5
|
(90)
|
5
|
Foreign Currency Translation Adjustments |
0
|
0
|
(4)
|
(3)
|
Comprehensive Loss |
$ (1,941)
|
$ (4,185)
|
$ (7,021)
|
$ (16,315)
|
X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.
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v3.23.3
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands |
Total |
Public Offering |
At-the-Market Offering |
PREFERRED STOCK |
COMMON STOCK |
COMMON STOCK
Public Offering
|
COMMON STOCK
At-the-Market Offering
|
ADDITIONAL PAID-IN CAPITAL |
ADDITIONAL PAID-IN CAPITAL
Public Offering
|
ADDITIONAL PAID-IN CAPITAL
At-the-Market Offering
|
ACCUMULATED DEFICIT |
ACCUMULATED OTHER COMPREHENSIVE INCOME |
Beginning balance (in shares) at Dec. 31, 2021 |
|
|
|
0
|
|
|
|
|
|
|
|
|
Beginning balance at Dec. 31, 2021 |
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Beginning balance (in shares) at Dec. 31, 2021 |
|
|
|
|
8,544,225
|
|
|
|
|
|
|
|
Beginning balance at Dec. 31, 2021 |
$ 2,535
|
|
|
|
$ 1
|
|
|
$ 372,562
|
|
|
$ (370,080)
|
$ 52
|
Increase (Decrease) in Shareholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
(7,162)
|
|
|
|
|
|
|
|
|
|
(7,162)
|
|
Foreign Currency Translation Adjustments |
(1)
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Stock-based Compensation |
(179)
|
|
|
|
|
|
|
(179)
|
|
|
|
|
Ending balance (in shares) at Mar. 31, 2022 |
|
|
|
0
|
|
|
|
|
|
|
|
|
Ending balance at Mar. 31, 2022 |
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Ending balance (in shares) at Mar. 31, 2022 |
|
|
|
|
8,544,225
|
|
|
|
|
|
|
|
Ending balance at Mar. 31, 2022 |
(4,807)
|
|
|
|
$ 1
|
|
|
372,383
|
|
|
(377,242)
|
51
|
Beginning balance (in shares) at Dec. 31, 2021 |
|
|
|
0
|
|
|
|
|
|
|
|
|
Beginning balance at Dec. 31, 2021 |
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Beginning balance (in shares) at Dec. 31, 2021 |
|
|
|
|
8,544,225
|
|
|
|
|
|
|
|
Beginning balance at Dec. 31, 2021 |
2,535
|
|
|
|
$ 1
|
|
|
372,562
|
|
|
(370,080)
|
52
|
Increase (Decrease) in Shareholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
(16,317)
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized Gain (Loss) on Available-for-Sale Investments |
5
|
|
|
|
|
|
|
|
|
|
|
|
Foreign Currency Translation Adjustments |
$ (3)
|
|
|
|
|
|
|
|
|
|
|
|
Ending balance (in shares) at Sep. 30, 2022 |
|
|
|
15,000
|
|
|
|
|
|
|
|
|
Ending balance at Sep. 30, 2022 |
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Ending balance (in shares) at Sep. 30, 2022 |
11,152,673
|
|
|
|
11,152,673
|
|
|
|
|
|
|
|
Ending balance at Sep. 30, 2022 |
$ 16,136
|
|
|
|
$ 1
|
|
|
402,480
|
|
|
(386,399)
|
54
|
Beginning balance (in shares) at Mar. 31, 2022 |
|
|
|
0
|
|
|
|
|
|
|
|
|
Beginning balance at Mar. 31, 2022 |
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Beginning balance (in shares) at Mar. 31, 2022 |
|
|
|
|
8,544,225
|
|
|
|
|
|
|
|
Beginning balance at Mar. 31, 2022 |
(4,807)
|
|
|
|
$ 1
|
|
|
372,383
|
|
|
(377,242)
|
51
|
Increase (Decrease) in Shareholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
(4,967)
|
|
|
|
|
|
|
|
|
|
(4,967)
|
|
Foreign Currency Translation Adjustments |
(2)
|
|
|
|
|
|
|
|
|
|
|
(2)
|
Issuance of stock, net of offering costs (in shares) |
|
|
|
15,000
|
|
844,613
|
7,500
|
|
|
|
|
|
Issuance of stock, net of offering costs |
14,916
|
$ 14,893
|
$ 15
|
|
|
|
|
14,916
|
$ 14,893
|
$ 15
|
|
|
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares) |
|
|
|
|
10,958
|
|
|
|
|
|
|
|
Stock-based Compensation |
97
|
|
|
|
|
|
|
97
|
|
|
|
|
Ending balance (in shares) at Jun. 30, 2022 |
|
|
|
15,000
|
|
|
|
|
|
|
|
|
Ending balance at Jun. 30, 2022 |
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Ending balance (in shares) at Jun. 30, 2022 |
|
|
|
|
9,407,296
|
|
|
|
|
|
|
|
Ending balance at Jun. 30, 2022 |
20,145
|
|
|
|
$ 1
|
|
|
402,304
|
|
|
(382,209)
|
49
|
Increase (Decrease) in Shareholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
(4,190)
|
|
|
|
|
|
|
|
|
|
(4,190)
|
|
Unrealized Gain (Loss) on Available-for-Sale Investments |
5
|
|
|
|
|
|
|
|
|
|
|
5
|
Foreign Currency Translation Adjustments |
0
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of stock, net of offering costs (in shares) |
|
|
|
|
|
1,745,377
|
|
|
|
|
|
|
Issuance of stock, net of offering costs |
|
$ 0
|
|
|
|
$ 0
|
|
|
$ 0
|
|
|
|
Stock-based Compensation |
$ 176
|
|
|
|
|
|
|
176
|
|
|
|
|
Ending balance (in shares) at Sep. 30, 2022 |
|
|
|
15,000
|
|
|
|
|
|
|
|
|
Ending balance at Sep. 30, 2022 |
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Ending balance (in shares) at Sep. 30, 2022 |
11,152,673
|
|
|
|
11,152,673
|
|
|
|
|
|
|
|
Ending balance at Sep. 30, 2022 |
$ 16,136
|
|
|
|
$ 1
|
|
|
402,480
|
|
|
(386,399)
|
54
|
Beginning balance (in shares) at Dec. 31, 2022 |
15,000
|
|
|
15,000
|
|
|
|
|
|
|
|
|
Beginning balance at Dec. 31, 2022 |
$ 0
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Beginning balance (in shares) at Dec. 31, 2022 |
12,163,673
|
|
|
|
12,163,673
|
|
|
|
|
|
|
|
Beginning balance at Dec. 31, 2022 |
$ 14,106
|
|
|
|
$ 1
|
|
|
402,701
|
|
|
(388,759)
|
163
|
Increase (Decrease) in Shareholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
(1,750)
|
|
|
|
|
|
|
|
|
|
(1,750)
|
|
Unrealized Gain (Loss) on Available-for-Sale Investments |
(3)
|
|
|
|
|
|
|
|
|
|
|
(3)
|
Foreign Currency Translation Adjustments |
(4)
|
|
|
|
|
|
|
|
|
|
|
(4)
|
Issuance of Common Stock in connection with exercise of the Prior Warrant and Pre-Funded Warrants, net of offering costs (in shares) |
|
|
|
|
389,000
|
|
|
|
|
|
|
|
Stock-based Compensation |
193
|
|
|
|
|
|
|
193
|
|
|
|
|
Ending balance (in shares) at Mar. 31, 2023 |
|
|
|
15,000
|
|
|
|
|
|
|
|
|
Ending balance at Mar. 31, 2023 |
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Ending balance (in shares) at Mar. 31, 2023 |
|
|
|
|
12,552,673
|
|
|
|
|
|
|
|
Ending balance at Mar. 31, 2023 |
$ 12,542
|
|
|
|
$ 1
|
|
|
402,894
|
|
|
(390,509)
|
156
|
Beginning balance (in shares) at Dec. 31, 2022 |
15,000
|
|
|
15,000
|
|
|
|
|
|
|
|
|
Beginning balance at Dec. 31, 2022 |
$ 0
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Beginning balance (in shares) at Dec. 31, 2022 |
12,163,673
|
|
|
|
12,163,673
|
|
|
|
|
|
|
|
Beginning balance at Dec. 31, 2022 |
$ 14,106
|
|
|
|
$ 1
|
|
|
402,701
|
|
|
(388,759)
|
163
|
Increase (Decrease) in Shareholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
(6,927)
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized Gain (Loss) on Available-for-Sale Investments |
(90)
|
|
|
|
|
|
|
|
|
|
|
|
Foreign Currency Translation Adjustments |
$ (4)
|
|
|
|
|
|
|
|
|
|
|
|
Ending balance (in shares) at Sep. 30, 2023 |
15,000
|
|
|
15,000
|
|
|
|
|
|
|
|
|
Ending balance at Sep. 30, 2023 |
$ 0
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Ending balance (in shares) at Sep. 30, 2023 |
28,489,663
|
|
|
|
28,489,663
|
|
|
|
|
|
|
|
Ending balance at Sep. 30, 2023 |
$ 21,518
|
|
|
|
$ 3
|
|
|
417,133
|
|
|
(395,686)
|
68
|
Beginning balance (in shares) at Mar. 31, 2023 |
|
|
|
15,000
|
|
|
|
|
|
|
|
|
Beginning balance at Mar. 31, 2023 |
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Beginning balance (in shares) at Mar. 31, 2023 |
|
|
|
|
12,552,673
|
|
|
|
|
|
|
|
Beginning balance at Mar. 31, 2023 |
12,542
|
|
|
|
$ 1
|
|
|
402,894
|
|
|
(390,509)
|
156
|
Increase (Decrease) in Shareholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
(3,305)
|
|
|
|
|
|
|
|
|
|
(3,305)
|
|
Unrealized Gain (Loss) on Available-for-Sale Investments |
(18)
|
|
|
|
|
|
|
|
|
|
|
(18)
|
Foreign Currency Translation Adjustments |
(1)
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Issuance of Common Stock in connection with exercise of the Prior Warrant and Pre-Funded Warrants, net of offering costs (in shares) |
|
|
|
|
4,118,000
|
|
|
|
|
|
|
|
Issuance of Common Stock in connection with exercise of Prior Warrant and Pre-Funded Warrants, net of offering costs |
1
|
|
|
|
$ 1
|
|
|
|
|
|
|
|
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares) |
|
|
|
|
125,000
|
|
|
|
|
|
|
|
Stock-based Compensation |
309
|
|
|
|
|
|
|
309
|
|
|
|
|
Ending balance (in shares) at Jun. 30, 2023 |
|
|
|
15,000
|
|
|
|
|
|
|
|
|
Ending balance at Jun. 30, 2023 |
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Ending balance (in shares) at Jun. 30, 2023 |
|
|
|
|
16,795,673
|
|
|
|
|
|
|
|
Ending balance at Jun. 30, 2023 |
9,528
|
|
|
|
$ 2
|
|
|
403,203
|
|
|
(393,814)
|
137
|
Increase (Decrease) in Shareholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
(1,872)
|
|
|
|
|
|
|
|
|
|
(1,872)
|
|
Unrealized Gain (Loss) on Available-for-Sale Investments |
(69)
|
|
|
|
|
|
|
|
|
|
|
(69)
|
Foreign Currency Translation Adjustments |
0
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of Common Stock in connection with exercise of the Prior Warrant and Pre-Funded Warrants, net of offering costs (in shares) |
|
|
|
|
11,693,990
|
|
|
|
|
|
|
|
Issuance of Common Stock in connection with exercise of Prior Warrant and Pre-Funded Warrants, net of offering costs |
13,719
|
|
|
|
$ 1
|
|
|
13,718
|
|
|
|
|
Stock-based Compensation |
$ 212
|
|
|
|
|
|
|
212
|
|
|
|
|
Ending balance (in shares) at Sep. 30, 2023 |
15,000
|
|
|
15,000
|
|
|
|
|
|
|
|
|
Ending balance at Sep. 30, 2023 |
$ 0
|
|
|
$ 0
|
|
|
|
|
|
|
|
|
Ending balance (in shares) at Sep. 30, 2023 |
28,489,663
|
|
|
|
28,489,663
|
|
|
|
|
|
|
|
Ending balance at Sep. 30, 2023 |
$ 21,518
|
|
|
|
$ 3
|
|
|
$ 417,133
|
|
|
$ (395,686)
|
$ 68
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for option under share-based payment arrangement.
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v3.23.3
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Cash Flows From Operating Activities: |
|
|
Net Loss |
$ (6,927)
|
$ (16,317)
|
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities: |
|
|
Depreciation and Amortization |
894
|
422
|
Stock-based Compensation |
714
|
95
|
Increase in Inventory Reserves |
1,098
|
307
|
Non-cash Lease Expense from Right of Use Assets |
1,529
|
1,518
|
Amortization of Debt Financing Costs and Accretion of Debt Discount |
276
|
276
|
Loss (Gain) on Disposal of Assets |
1
|
(3)
|
Realized Gain on Sale of Investments |
(220)
|
(4)
|
Changes in Operating Assets and Liabilities: |
|
|
Accounts Receivable, net |
(3,102)
|
(1,454)
|
Inventory |
1,561
|
(921)
|
Prepaid and Other Assets |
875
|
2,058
|
Accounts Payable |
(124)
|
(688)
|
Lease Liabilities |
(1,113)
|
(1,435)
|
Other Liabilities |
(1,033)
|
756
|
Deferred License Revenue |
(3,798)
|
(1,427)
|
Cash Used In Operating Activities |
(9,369)
|
(16,817)
|
Cash Flows From Investing Activities: |
|
|
Purchase of Investments Available-for-Sale |
(3,752)
|
(17,389)
|
Sale of Investments Available-for-Sale |
11,301
|
11,972
|
Purchase of Equipment |
(241)
|
(197)
|
Cash Paid in Connection with Evoqua Asset Acquisition |
(12,361)
|
0
|
Cash Used In Investing Activities |
(5,053)
|
(5,614)
|
Cash Flows From Financing Activities: |
|
|
Payments on Debt |
(500)
|
(6,750)
|
Payments on Insurance Financing Note Payable |
(748)
|
(941)
|
Payments on Financing Lease Liabilities |
(388)
|
0
|
Proceeds from Issuance of Common Stock |
13,763
|
15,016
|
Offering Costs from Issuance of Common Stock |
(43)
|
(106)
|
Proceeds from Issuance of Preferred Stock |
0
|
15,000
|
Offering Costs from Issuance of Preferred Stock |
0
|
(85)
|
Cash Provided by Financing Activities |
12,084
|
22,134
|
Effect of Exchange Rate Changes on Cash and Cash Equivalents |
(5)
|
(3)
|
Net Decrease in Cash and Cash Equivalents |
(2,343)
|
(300)
|
Cash and Cash Equivalents at Beginning of Period |
10,102
|
13,280
|
Cash and Cash Equivalents at End of Period |
7,759
|
12,980
|
Supplemental Disclosure of Cash Flow Information: |
|
|
Cash Paid for Interest |
929
|
1,261
|
Supplemental Disclosure of Non-cash Operating, Investing and Financing Activities: |
|
|
Change in Unrealized (Loss) Gain on Investments Available-for-Sale |
(90)
|
5
|
Increase in Prepaid Assets from Insurance Financing Note Payable |
733
|
0
|
Deferred Consideration from Evoqua Asset Acquisition |
$ 5,000
|
$ 0
|
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v3.23.3
Description of Business
|
9 Months Ended |
Sep. 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 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, the Company executed and consummated the transactions contemplated by an Asset Purchase Agreement (the “Purchase Agreement”) with Evoqua Water Technologies LLC ("Evoqua") (the "Evoqua Acquisition"). Subject to the terms and conditions of the Purchase Agreement, at the closing of the transaction (the “Closing”), the Company purchased customer relationships, equipment and inventory from Evoqua, which were related to its manufacturing and selling of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization. See Note 4 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 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. During the third quarter of 2023, the ongoing Triferic development effort was terminated resulting in an acceleration of the corresponding deferred license revenue (see Note 10) and a reserve on the non-current inventory (see Note 7). 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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v3.23.3
Liquidity and Capital Resources
|
9 Months Ended |
Sep. 30, 2023 |
Liquidity and Capital Resources [Abstract] |
|
Liquidity and Capital Resources |
Liquidity and Capital Resources As of September 30, 2023, Rockwell had approximately $11.7 million of cash, cash equivalents and investments available-for-sale, and working capital of $6.8 million. Net cash used in operating activities for the nine months ended September 30, 2023 was approximately $9.4 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. 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. In 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 15 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, Israel-Hamas conflict 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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v3.23.3
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements
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9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
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Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements |
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U. S. Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements.
The condensed consolidated balance sheet at September 30, 2023, and the condensed consolidated statements of operations, comprehensive loss, and changes in stockholders' equity for the three and nine months ended September 30, 2023 and cash flows for the nine months ended September 30, 2023 are unaudited, but include all adjustments, consisting of normal recurring adjustments the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 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. 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 Loss per share for the three and nine months ended September 30, 2022 have been recalculated and restated and is presented on a comparable basis with the three and nine months ended September 30, 2023. In the first quarter of 2023, the Company determined it should have included pre-funded warrants issued in the second quarter of 2022 in the earnings per share calculation in 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, the Company has recalculated and restated 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 September 30, 2023 and 2022 in the "Loss Per Share" section below. | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | | Nine Months Ended September 30, | | | | 2022 | | | | 2022 | As Previously Reported: | | | | | | | | Net loss per share attributable to common stockholders - basic and diluted | | | $ | (0.40) | | | | | $ | (1.75) | | Weighted average number of shares of common stock outstanding - basic and diluted | | | 10,528,148 | | | | | 9,299,788 | | | | | | | | | | As Restated: | | | | | | | | Net loss per share attributable to common stockholders - basic and diluted | | | $ | (0.23) | | | | | $ | (1.26) | | Weighted average number of shares of common stock outstanding - basic and diluted | | | 18,463,673 | | | | | 12,902,890 | |
Loss Per Share Basic and diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, after giving effect to the restatement discussed above, was calculated as follows: | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | (In Thousands, Except Share and Per Share Amounts) | 2023 | | 2022 | | 2023 | | 2022 | Numerator: | | | | | | | | Net loss | $ | (1,872) | | | $ | (4,190) | | | $ | (6,927) | | | $ | (16,317) | | Net loss attributable to common stockholders for basic and diluted loss per share | $ | (1,872) | | | $ | (4,190) | | | $ | (6,927) | | | $ | (16,317) | | | | | | | | | | Denominator: | | | | | | | | Weighted average number of shares of common stock outstanding - basic and diluted | 27,521,088 | | | 18,463,673 | | | 21,526,978 | | | 12,902,890 | | Net loss per share attributable to common stockholders - basic and diluted | $ | (0.07) | | | $ | (0.23) | | | $ | (0.32) | | | $ | (1.26) | |
Included within the weighted average shares of common stock outstanding for the three and nine months ended September 30, 2022 are 7,311,000 shares of common stock issuable upon the exercise of pre-funded warrants (See Note 11), 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 nine months ended September 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: | | | | | | | | | | | | | As of September 30, | | 2023 | | 2022 | Options to Purchase Common Stock | 1,367,493 | | | 1,311,691 | | Unvested Restricted Stock Awards | 891 | | | 891 | | Unvested Restricted Stock Units | 287,400 | | | 125,000 | | Convertible Preferred Stock | 1,363,636 | | | 1,363,636 | | Warrants to Purchase Common Stock | 4,045,278 | | 17,507,268 | | Total | 7,064,698 | | 20,308,486 | |
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 related losses for trade accounts receivable, as well as available-for-sale debt securities, which are 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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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.23.3
Asset Acquisition
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9 Months Ended |
Sep. 30, 2023 |
Business Combination and Asset Acquisition [Abstract] |
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Asset Acquisition |
Asset Acquisition On July 10, 2023, the Company completed the Evoqua Acquisition. At the Closing, the Company purchased customer relationships, equipment and inventory from Evoqua, which were related to manufacturing and selling of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization. Pursuant to the Purchase Agreement, total consideration was $17.4 million, comprising a cash payment at Closing of $12.2 million (inclusive of transaction costs) and two $2.5 million deferred payments, the first to be paid on the one-year anniversary of the Closing, which is included as a current liability on the Company's condensed consolidated balance sheet, and the second to be paid on the second anniversary of the Closing (collectively, the “deferred consideration”). The transaction was accounted for as an asset acquisition, as the acquired assets did not meet the definition of a business as defined by ASC 805, Business Combinations. The purchase price was allocated, on a relative fair value basis, to the assets acquired at the July 10, 2023 acquisition date as follows (table in thousands): | | | | | | | | | | | | Consideration | | | Cash Payment | | $ | 12,233 | | Deferred Consideration | | 5,000 | | Transaction Costs | | 128 | | Total Consideration | | $ | 17,361 | | | | | Assets Acquired | | | Customer Relationships Intangible Asset | | $ | 11,035 | | Equipment | | 5,093 | | Inventory | | 1,233 | | Total Assets Acquired | | $ | 17,361 | |
The fair value of the customer relationships intangible asset was determined using a multi-period excess earnings method, a form of the income approach, which incorporates the estimated future cash flows to be generated from the customer base. Key assumptions included discounted cash flow, estimated life cycle and customer attrition rates. Customer relationships are being amortized over a period of 20 years. Given the recency of the purchase of the equipment in which the assets were recorded at fair value, the Company determined the fair value of the equipment using a cost approach, which considered assumptions over the equipment's current replacement cost and useful life. Inventory was purchased directly from the contract manufacturer holding the inventory, which approximated fair value. During the three and nine months ended September 30, 2023, the Company recorded amortization of its customer relationship intangible asset of $0.1 million, resulting in a net intangible asset of $10.9 million as of September 30, 2023. Estimated future amortization expense on the Company's customer relationships intangible asset as of September 30, 2023 is as follows (table in thousands): | | | | | | | | | | Year ended December 31: | | | | 2023 (remainder of year) | | | $ | 138 | | 2024 | | | 552 | | 2025 | | | 552 | | 2026 | | | 552 | | 2027 | | | 552 | | Thereafter | | | 8,551 | | Total | | | $ | 10,897 | |
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- DefinitionThe entire disclosure for asset acquisition.
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v3.23.3
Revenue Recognition
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9 Months Ended |
Sep. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
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Revenue Recognition |
Revenue Recognition The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle:
•Step 1: Identify the contract with the customer •Step 2: Identify the performance obligations in the contract •Step 3: Determine the transaction price •Step 4: Allocate the transaction price to the performance obligations in the contract •Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue. Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer. Nature of goods and services The following is a description of principal activities from which the Company generates its revenue. The Company currently operates in one market segment, the hemodialysis market, which involves the manufacture, sale and distribution of hemodialysis products to hemodialysis clinics, including pharmaceutical, dialysis concentrates, dialysis kits and other ancillary products used in the dialysis process. Rockwell's customer mix is diverse, with most customer sales concentrations under 10% and one customer, DaVita, Inc. ("DaVita"), at approximately 50% of total net product sales for each of the three and nine months ended September 30, 2023. Rockwell's accounts receivable from this customer were approximately 31% and 30% of the total net consolidated accounts receivable balance at September 30, 2023 and December 31, 2022, respectively. 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. During the three months ended September 30, 2023, the amounts received from Wanbang were accelerated out of deferred license revenue and into revenue upon notice that the development effort was terminated (see Note 10). 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 U.S. 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 U.S. and around the world. For additional information, see Note 10. 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 September 30, 2023, all payments were completed. On September 18, 2023, the Company and its long-time partner, DaVita, a leading provider of kidney care, entered into an Amended and Restated Products Purchase Agreement (the "Amended Agreement"), which amends and restates the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates. Under the Amended Agreement, the Company and DaVita agreed to an increase in product pricing, effective September 1, 2023 and a one-time payment to Rockwell on or after December 1, 2023. The term of the Amended Agreement will expire on December 31, 2024. DaVita will have the right, in its sole discretion upon written notice to the Company given no later than September 30, 2024, to further extend the term through December 31, 2025. In the event of such an extension, product pricing will be increased for the extended term. In addition, DaVita is required to provide the Company with nine-month purchasing forecasts and a commitment to purchase at least the forecasted amounts. In the event that DaVita does not meet its forecasts, it is required to pay the Company for the amount forecasted, purchase additional product, or the Company may terminate the Amended Agreement. Upon expiration or termination of the Amended Agreement, and upon request by DaVita, the Company has agreed to provide transition services to DaVita during a transition period. Additionally during the third quarter of 2023, the Company entered into several long-term product purchase agreements, which include supply and purchasing commitments from certain parties. 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 estimated at the time of sale. 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. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | In thousands | Three Months Ended September 30, 2023 | | Nine Months Ended September 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 | 2,197 | | | — | | | 2,197 | | | 2,327 | | | — | | | 2,327 | | Total Drug Products | 2,197 | | | — | | | 2,197 | | | 2,327 | | | — | | | 2,327 | | Concentrates Products | | | | | | | | | | | | Product Sales – Point-in-time | 21,574 | | | 19,741 | | | 1,833 | | | 57,720 | | | 52,326 | | | 5,394 | | License Fee – Over time | — | | | — | | | — | | | 1,472 | | | 1,472 | | | — | | Total Concentrate Products | 21,574 | | | 19,741 | | | 1,833 | | | 59,192 | | | 53,798 | | | 5,394 | | Net Revenue | $ | 23,771 | | | $ | 19,741 | | | $ | 4,030 | | | $ | 61,519 | | | $ | 53,798 | | | $ | 7,721 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | In thousands | Three Months Ended September 30, 2022 | | Nine Months Ended September 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 | $ | 193 | | | $ | 193 | | | $ | — | | | $ | 834 | | | $ | 561 | | | $ | 273 | | License Fee – Over time | 65 | | | — | | | 65 | | | 192 | | | — | | | 192 | | Total Drug Products | 258 | | | 193 | | | 65 | | | 1,026 | | | 561 | | | 465 | | Concentrates Products | | | | | | | | | | | | Product Sales – Point-in-time | 17,953 | | | 16,619 | | | 1,334 | | | 51,035 | | | 46,334 | | | 4,701 | | License Fee – Over time | 480 | | | 480 | | | — | | | 1,436 | | | 1,436 | | | — | | Total Concentrate Products | 18,433 | | | 17,099 | | | 1,334 | | | 52,471 | | | 47,770 | | | 4,701 | | Net Revenue | $ | 18,691 | | | $ | 17,292 | | | $ | 1,399 | | | $ | 53,497 | | | $ | 48,331 | | | $ | 5,166 | |
Contract balances The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. | | | | | | | | | | | | In thousands | September 30, 2023 | | December 31, 2022 | Accounts Receivable, net | $ | 9,361 | | | $ | 6,259 | | Contract Liabilities, which are included in deferred license revenue | $ | 533 | | | $ | 4,331 | |
There were no other material contract assets recorded on the condensed consolidated balance sheets as of September 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 September 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.
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v3.23.3
Investments - Available-for-Sale
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9 Months Ended |
Sep. 30, 2023 |
Investments, Debt and Equity Securities [Abstract] |
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Investments - Available-for-Sale |
Investments - Available-for-Sale Investments available-for-sale consisted of the following as of September 30, 2023 and December 31, 2022 (table in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | September 30, 2023 | | Amortized Cost | | Unrealized Gain | | Unrealized Loss | | Accrued Interest | | Fair Value | Available-for-Sale Securities | | | | | | | | | | Debt securities | $ | 3,898 | | | $ | 73 | | | $ | — | | | $ | — | | | $ | 3,971 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | December 31, 2022 | | Amortized Cost | | Unrealized Gain | | Unrealized Loss | | Accrued Interest | | Fair Value | Available-for-Sale Securities | | | | | | | | | | Debt securities | $ | 11,315 | | | $ | 75 | | | $ | — | | | $ | — | | | $ | 11,390 | |
The fair value of investments available-for-sale are determined using quoted market prices from daily exchange-traded markets based on the closing price as of the balance sheet date and are classified as a Level 1 measurement under ASC 820 Fair Value Measurements. As of September 30, 2023 and December 31, 2022, all of our available-for-sale securities were all due within one year.
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- DefinitionThe entire disclosure for cash, cash equivalents, investments in debt and equity instruments (including cost and equity investees and related income statement amounts), equity and cost method investments, investments in joint ventures and any other investment.
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v3.23.3
Inventory
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9 Months Ended |
Sep. 30, 2023 |
Inventory Disclosure [Abstract] |
|
Inventory |
Inventory Components of inventory, net of reserves, as of September 30, 2023 and December 31, 2022 are as follows (table in thousands): | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Inventory - Current Portion | | | | Raw Materials | $ | 2,335 | | | $ | 3,351 | | Work in Process | 337 | | | 351 | | Finished Goods | 2,814 | | | 2,112 | | Total Current Inventory | 5,486 | | | 5,814 | | Inventory - Long Term (1) | 178 | | | 1,276 | | Total Inventory | $ | 5,664 | | | $ | 7,090 | | | | | | __________1.Represents inventory related to Triferic raw materials. This Triferic inventory will be utilized for the Company's international partnerships. In September 2022, the Company discontinued its New Drug Applications ("NDAs") for Triferic (dialysate) and Triferic AVNU in the United States. During the three months ended September 30, 2023, the Company reserved $1.1 million of long-term inventory as a result of the termination of the Wanbang development effort. As of September 30, 2023 and December 31, 2022, Rockwell had total current concentrate inventory aggregating $5.5 million and $5.8 million, respectively, against which Rockwell had reserved $25,000 at both September 30, 2023 and December 31, 2022.
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- DefinitionThe entire disclosure for inventory. Includes, but is not limited to, the basis of stating inventory, the method of determining inventory cost, the classes of inventory, and the nature of the cost elements included in inventory.
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v3.23.3
Property and Equipment, net
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment, net |
Property and Equipment, net As of September 30, 2023 and December 31, 2022, the Company’s property and equipment consisted of the following (table in thousands): | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Leasehold Improvements | $ | 1,423 | | | $ | 1,256 | | Machinery and Equipment | 11,085 | | | 5,922 | | Information Technology & Office Equipment | 1,845 | | | 1,845 | | Laboratory Equipment | 807 | | | 807 | | Total Property and Equipment | 15,160 | | | 9,830 | | Accumulated Depreciation and Amortization | (8,389) | | | (7,636) | | Property and Equipment, net | $ | 6,771 | | | $ | 2,194 | |
Depreciation and amortization expense for the three months ended September 30, 2023 and 2022 was $0.4 million and $0.1 million, respectively. Depreciation and amortization expense for the nine months ended September 30, 2023 and 2022 was $0.8 million and $0.4 million, respectively.
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.23.3
Accrued Liabilities
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
Accrued Liabilities |
Accrued Liabilities Accrued liabilities as of September 30, 2023 and December 31, 2022 consisted of the following (table in thousands): | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Accrued Compensation and Benefits | $ | 2,240 | | | $ | 2,568 | | Accrued Unvouchered Receipts | 1,947 | | | 585 | | Accrued Manufacturing Expense | 732 | | | — | | Accrued Workers Compensation | 202 | | | 306 | | Accrued Research & Development Expense | — | | | 43 | | Other Accrued Liabilities | 1,587 | | | 4,200 | | Total Accrued Liabilities | $ | 6,708 | | | $ | 7,702 | |
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- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.23.3
Deferred License Revenue
|
9 Months Ended |
Sep. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Deferred License Revenue |
Deferred License Revenue In October 2014, the Company entered into an exclusive distribution agreement with Baxter, which had a term of 10 years and received an upfront fee of $20 million. The upfront fee was recorded as deferred license 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 license revenue and is being recognized as revenue based on the agreement term. On August 7, 2023, Rockwell was informed by Wanbang that the main efficacy results of Wanbang’s clinical trial for Triferic (dialysate) compared with placebo were not obtained and Wanbang will not bring the product forward to registration. As a result, the Company recognized all remaining revenue under the Wangbang Agreement of approximately $2.2 million during the third quarter of 2023. Additionally, in connection with these events, the Company established a reserve for related Triferic long-term inventory of $1.1 million, resulting in a net increase in gross profit of $1.1 million.
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 license revenue and is being recognized as revenue based on the agreement term. The Company recognized revenue of approximately $2,500 and $7,500 for the three and nine months ended September 30, 2023 and 2022, respectively. Deferred license revenue related to the Sun Pharma Agreement totaled $62,500 and $70,000 as of September 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 license revenue and are being recognized as revenue based on the agreement term. The Company recognized revenue of $5,200 and $15,600 for the three and nine months ended September 30, 2023 and 2022, respectively. Deferred license revenue related to the Jeil Agreement totaled approximately $0.4 million as of both September 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 license revenue and will be recognized as revenue based on the agreement term. The Company recognized revenue of $3,750 and $11,250 for the three and nine months ended September 30, 2023 and 2022, respectively. Deferred license revenue related to the Drogsan Agreements totaled approximately $0.1 million as of each of September 30, 2023 and December 31, 2022. 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. Drogsan is responsible for all regulatory approval and commercialization activities.
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v3.23.3
Stockholders’ Equity
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
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 September 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 and the sale of the assets that would allow for redemption is within the control of the Company, the preferred stock has been classified as permanent equity and initially recognized at fair value of $15 million (the proceeds on the date of issuance) less issuance costs of $0.1 million, resulting in an initial value of $14.9 million. The Company will assess at each reporting period whether conditions have changed to now meet the mandatory redemption definition which could trigger liability classification.
As of both September 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 September 30, 2023 and December 31, 2022, there were 170,000,000 shares of common stock, $0.0001 par value per share, authorized and 28,489,663 and 12,163,673 shares issued and outstanding, respectively. As of September 30, 2023 and 2022, the Company reserved for issuance the following shares of common stock related to the potential exercise of employee stock options, unvested restricted stock, convertible preferred stock, pre-funded warrants and all other warrants (collectively, "common stock equivalents"): | | | | | | | | | | | | | As of September 30, | Common stock and common stock equivalents: | 2023 | | 2022 | Common stock | 28,489,663 | | | 11,152,673 | | Common stock issuable upon exercise of pre-funded warrants | — | | | 7,311,000 | | Common stock and pre-funded stock warrants | 28,489,663 | | | 18,463,673 | | Options to Purchase Common Stock | 1,367,493 | | | 1,311,691 | | Unvested Restricted Stock Awards | 891 | | | 891 | | Unvested Restricted Stock Units | 287,400 | | | 125,000 | | Convertible Preferred Stock | 1,363,636 | | | 1,363,636 | | | | | | Warrants to Purchase Common Stock | 4,045,278 | | | 17,507,268 | | Total | 35,554,361 | | 38,772,159 | |
During the three months ended September 30, 2023 and 2022, 1,793,000 and 477,480 pre-funded warrants were exercised, respectively. During the nine months ended September 30, 2023 and 2022, 6,300,000 and 477,480 pre-funded warrants were exercised, respectively. During the three and nine months ended September 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 (the "ATM facility") with Cantor Fitzgerald & Co. as Agent, pursuant to which the Company may offer and sell from time to time up to $12.2 million of shares of Company’s common stock through the Agent. The offering and sale of such shares has been registered under the Securities Act of 1933, as amended.
During the quarter ended September 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 Registered Direct Purchase Agreement (the "Agreement") with the Purchaser, pursuant to which the Company issued and sold, 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 Agreement contains customary representations and warranties and agreements of the Company and the Purchaser and customary indemnification rights and obligations of the parties. On July 5, 2023, all of the remaining Pre-Funded Warrants to purchase 1,793,000 shares of common stock 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. Private Placement
Also on May 30, 2022, concurrent with the Offering, the Company entered into the private investment in public equity "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.
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.
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v3.23.3
Stock-Based Compensation
|
9 Months Ended |
Sep. 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 nine months ended September 30, 2023 and 2022 as follows (table in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Service-based awards: | | | | | | | | | | | | | | | | Restricted Stock Units | $ | 112 | | | $ | 46 | | | $ | 276 | | | $ | 84 | | Stock Option Awards | 100 | | | 130 | | | 438 | | | 401 | | Total Service Based Awards | 212 | | | 176 | | | 714 | | | 485 | | Performance-based awards: | | | | | | | | Restricted Stock Awards | — | | | — | | | — | | | (391) | | | | | | | | | | | | | | | | | | | | | | | | | | Total | $ | 212 | | | $ | 176 | | | $ | 714 | | | $ | 94 | |
Performance Based Restricted Stock A summary of the Company’s restricted stock awards during the nine months ended September 30, 2023 is as follows: | | | | | | | | | | | | | Number of Shares | | Weighted Average Grant-Date Fair Value | Unvested at January 1, 2023 | 891 | | | $ | 62.70 | | | | | | Unvested at September 30, 2023 | 891 | | | $ | 62.70 | |
A summary of the Company’s restricted stock awards during the nine months ended September 30, 2022 is as follows: | | | | | | | | | | | | | Number of Shares | | Weighted Average Grant-Date Fair Value | Unvested at January 1, 2022 | 7,118 | | | $ | 62.70 | | Forfeited (1) | (6,227) | | | $ | 62.70 | | Unvested at September 30, 2022 | 891 | | | $ | 62.70 | |
__________ 1.These forfeited awards were due to the resignation of the Company's Chief Development Officer on March 25, 2022 and reduced stock-based compensation expense by $0.4 million in 2022. Restricted stock awards are measured based on their fair value on the date of grant and amortized over the vesting period of 20 months. Service-Based Restricted Stock Units A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2023 is as follows: | | | | | | | | | | | | | Number of Shares | | Weighted Average Grant-Date Fair Value | Unvested at January 1, 2023 | 125,000 | | | $ | 1.47 | | Granted | 313,065 | | | 1.87 | | Vested | (125,000) | | | 1.47 | | Forfeited | (25,665) | | | 1.37 | | Unvested at September 30, 2023 | 287,400 | | | $ | 1.85 | |
A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2022 is as follows: | | | | | | | | | | | | | Number of Shares | | Weighted Average Grant-Date Fair Value | Unvested at January 1, 2022 | 29,289 | | | $ | 12.87 | | Granted | 125,000 | | | 1.47 | | Vested | (23,515) | | | 11.33 | | Forfeited | (5,774) | | | 19.00 | | | | | | Unvested at September 30, 2022 | 125,000 | | | $ | 1.47 | |
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 $46,000 was recognized for the three months ended September 30, 2023 and 2022, respectively. Stock-based compensation expense of $0.3 million and $0.1 million was recognized for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, the unrecognized stock-based compensation expense was $0.4 million, which is expected to be recognized over an estimated weighted average remaining term of less than 1.4 years. Service-Based Stock Options The fair value of the service-based stock options granted for the nine months ended September 30, 2023 were based on the following assumptions: | | | | | | | Nine Months Ended September 30, 2023 | Exercise price | $1.37 - $2.83 | Expected stock price volatility | 81.6% - 81.8% | Risk-free interest rate | 3.41% - 3.46% | Term (years) | 5.6 - 6 |
A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2023 is as follows: | | | | | | | | | | | | | | | | | | | | | | | | | | Shares Underlying Options | | Weighted Average Exercise Price | | Weighted Average Remaining Contractual Term | | Aggregate Intrinsic Value | | | | | | | in years | | in thousands | | Outstanding at January 1, 2023 | 1,206,905 | | | $ | 8.32 | | | | | | | Granted | 382,745 | | | 1.48 | | | | | | | | | | | | | | | | Forfeited | (143,430) | | | 2.82 | | | | | | | Expired | (78,727) | | | 26.74 | | | | | | | Outstanding at September 30, 2023 | 1,367,493 | | | $ | 5.93 | | | 8.4 | | $ | 680 | | | | | | | | | | | | Exercisable at September 30, 2023 | 444,836 | | | $ | 14.64 | | | 7 | | $ | 114 | | |
A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2022 is as follows: | | | | | | | | | | | | | | | | | | | | | | | Shares Underlying Options | | Weighted Average Exercise Price | | Weighted Average Remaining Contractual Term | | | | | | | | in years | | | Outstanding at January 1, 2022 | 528,591 | | | $ | 32.01 | | | 7.5 | | | Granted | 898,659 | | | 1.49 | | | 5.5 | | | Forfeited | (30,093) | | | 15.11 | | | — | | | | Expired | (85,466) | | | 82.09 | | | — | | | | Outstanding at September 30, 2022 | 1,311,691 | | | $ | 8.23 | | | 9.1 | | | | | | | | | | | Exercisable at September 30, 2022 | 243,973 | | | $ | 29.31 | | | 6.9 | | |
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 as of September 30, 2022 was not significant. Stock-based compensation expense recognized for service-based stock options was $0.1 million and $0.1 million for the three months ended September 30, 2023 and 2022, respectively. Stock-based compensation expense recognized for service-based stock options was $0.4 million and $0.4 million for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, total stock-based compensation expense related to unvested options not yet recognized totaled approximately $0.7 million, which is expected to be recognized over an estimated weighted average remaining term of 3.2 years. Forfeitures are recorded in the period of occurrence and compensation expense is adjusted accordingly.
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v3.23.3
Licensing Agreements
|
9 Months Ended |
Sep. 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 September 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 is required to pay Charak a percentage of any sublicense income during the term of the agreement, which amount cannot be less than a minimum specified percentage of net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and 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 September 30, 2023 and December 31, 2022.
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v3.23.3
Leases
|
9 Months Ended |
Sep. 30, 2023 |
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 September 30, 2023, the Company had operating and finance lease liabilities of $5.4 million and right-of-use assets of $5.1 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): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, 2023 | | Three Months Ended September 30, 2022 | | Nine Months Ended September 30, 2023 | | Nine Months Ended September 30, 2022 | Operating leases | | | | | | | | Operating lease cost | $ | 422 | | | $ | 410 | | | $ | 1,281 | | | $ | 1,289 | | Variable lease cost | 112 | | | 101 | | | 336 | | | 287 | | Operating lease expense | 534 | | | 511 | | | 1,617 | | | 1,576 | | Finance leases | | | | | | | | Non-cash lease expense from right-of-use assets | 142 | | | 141 | | | 424 | | | 424 | | Interest on lease obligations | 36 | | | 44 | | | 113 | | | 136 | | Finance lease expense | 178 | | | 185 | | | 537 | | | 560 | | Short-term lease rent expense | 4 | | | 5 | | | 12 | | | 14 | | Total lease expense | $ | 716 | | | $ | 701 | | | $ | 2,166 | | | $ | 2,150 | | | | | | | | | | Other information | | | | | | | | Payments for principal from operating leases | $ | 461 | | | $ | 427 | | | $ | 1,363 | | | $ | 1,338 | | Payments for interest from finance leases | $ | 37 | | | $ | 44 | | | $ | 114 | | | $ | 136 | | Payments for principal from finance leases | $ | 130 | | | $ | 121 | | | $ | 388 | | | $ | 359 | | | | | | | | | | | | | | | | | | Weighted-average remaining lease term – operating leases | 2.5 | | 3.2 | | 2.5 | | 3.2 | Weighted-average remaining lease term – finance leases | 3.7 | | 4.7 | | 3.7 | | 4.7 | Weighted-average discount rate – operating leases | 6.5 | % | | 6.4 | % | | 6.5 | % | | 6.4 | % | Weighted-average discount rate – finance leases | 6.4 | % | | 6.4 | % | | 6.4 | % | | 6.4 | % |
Future minimum rental payments under operating and finance lease agreements are as follows (in thousands): | | | | | | | | | | | | | Operating | | Finance | Year ending December 31, 2023 (remaining) | $ | 439 | | | $ | 168 | | Year ending December 31, 2024 | 1,511 | | | 672 | | Year ending December 31, 2025 | 1,021 | | | 676 | | Year ending December 31, 2026 | 362 | | | 666 | | Year ending December 31, 2027 | 131 | | | 311 | | | | | | Total | 3,464 | | | 2,493 | | Less present value discount | (259) | | | (271) | | Operating and finance lease liabilities | $ | 3,205 | | | $ | 2,222 | |
|
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 September 30, 2023, the Company had operating and finance lease liabilities of $5.4 million and right-of-use assets of $5.1 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): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, 2023 | | Three Months Ended September 30, 2022 | | Nine Months Ended September 30, 2023 | | Nine Months Ended September 30, 2022 | Operating leases | | | | | | | | Operating lease cost | $ | 422 | | | $ | 410 | | | $ | 1,281 | | | $ | 1,289 | | Variable lease cost | 112 | | | 101 | | | 336 | | | 287 | | Operating lease expense | 534 | | | 511 | | | 1,617 | | | 1,576 | | Finance leases | | | | | | | | Non-cash lease expense from right-of-use assets | 142 | | | 141 | | | 424 | | | 424 | | Interest on lease obligations | 36 | | | 44 | | | 113 | | | 136 | | Finance lease expense | 178 | | | 185 | | | 537 | | | 560 | | Short-term lease rent expense | 4 | | | 5 | | | 12 | | | 14 | | Total lease expense | $ | 716 | | | $ | 701 | | | $ | 2,166 | | | $ | 2,150 | | | | | | | | | | Other information | | | | | | | | Payments for principal from operating leases | $ | 461 | | | $ | 427 | | | $ | 1,363 | | | $ | 1,338 | | Payments for interest from finance leases | $ | 37 | | | $ | 44 | | | $ | 114 | | | $ | 136 | | Payments for principal from finance leases | $ | 130 | | | $ | 121 | | | $ | 388 | | | $ | 359 | | | | | | | | | | | | | | | | | | Weighted-average remaining lease term – operating leases | 2.5 | | 3.2 | | 2.5 | | 3.2 | Weighted-average remaining lease term – finance leases | 3.7 | | 4.7 | | 3.7 | | 4.7 | Weighted-average discount rate – operating leases | 6.5 | % | | 6.4 | % | | 6.5 | % | | 6.4 | % | Weighted-average discount rate – finance leases | 6.4 | % | | 6.4 | % | | 6.4 | % | | 6.4 | % |
Future minimum rental payments under operating and finance lease agreements are as follows (in thousands): | | | | | | | | | | | | | Operating | | Finance | Year ending December 31, 2023 (remaining) | $ | 439 | | | $ | 168 | | Year ending December 31, 2024 | 1,511 | | | 672 | | Year ending December 31, 2025 | 1,021 | | | 676 | | Year ending December 31, 2026 | 362 | | | 666 | | Year ending December 31, 2027 | 131 | | | 311 | | | | | | Total | 3,464 | | | 2,493 | | Less present value discount | (259) | | | (271) | | Operating and finance lease liabilities | $ | 3,205 | | | $ | 2,222 | |
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v3.23.3
Loans and Security Agreement
|
9 Months Ended |
Sep. 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 additional tranches, which were tied to the achievement of certain milestones. Net draw down proceeds were $21.2 million with closing costs of $1.3 million. In connection with each funding of the Term Loans, the Company was required to issue to Innovatus a warrant (the “Warrants”) to purchase a number of shares of the Company’s common stock equal to 3.5% of the principal amount of the relevant Term Loan funded divided by the exercise price. In connection with the first tranche of the Term Loans, the Company issued a Warrant to Innovatus, exercisable for an aggregate of 43,388 shares of the Company’s common stock at an exercise price of $18.15 per share. The Warrant may be exercised on a cashless basis and is immediately exercisable through the seventh anniversary of the applicable funding date. The number of shares of common stock for which the Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Warrant. The Company evaluated the warrant under ASC 470, Debt, and recognized an additional debt discount of approximately $0.5 million based on the relative fair value of the base instruments and warrants. The Company calculated the fair value of the warrant using the Black-Scholes model.
The Term Loans mature on March 16, 2025, and 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 12.5% as of September 30, 2023. 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 September 30, 2023 and 2022, interest expense amounted to $0.3 million and $0.4 million, respectively. For the nine months ended September 30, 2023 and 2022, interest expense amounted to $0.9 million and $1.2 million, respectively.
The Loan Agreement is secured by all assets of the Company and Rockwell Transportation, Inc. and contains customary representations and warranties and covenants, subject to customary carve outs, and initially included financial covenants related to liquidity and sales of Triferic.
In September 2021, the Company entered into an amendment to the Loan Agreement in which the Company, in exchange for Innovatus lowering the sales covenants, agreed to: (i) prepay an aggregate principal amount of $7.5 million in ten installments commencing on December 1, 2021; (ii) pay an additional prepayment premium of 5% on prepaid amounts if the Company elects to prepay all outstanding Term Loans on or before September 24, 2023 and (iii) maintain minimum liquidity of no less than $5.0 million if the aggregate principal amount of Term Loans is greater than $15 million pursuant to the liquidity covenant in the Loan Agreement. On November 10, 2022, the Company entered into a Second Amendment to the Loan and Security Agreement (the “Second Amendment”) dated as of November 14, 2022 with Innovatus, which amended the Loan Agreement. Pursuant to the Second Amendment, the Company (i) prepaid an additional aggregate principal amount of $5.0 million in Term Loans in one installment on November 14, 2022; (ii) paid interest only payments until September 2023, at which time it resumed scheduled debt payments. The financial covenant related to the sales of Triferic was replaced with the trailing 6 months revenue of our concentrates products. 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 September 30, 2023, the Company was in compliance with all covenants under the Loan Agreement.
As of September 30, 2023, the outstanding balance of the Term Loan was $9.0 million, net of unamortized issuance costs and discount of $0.5 million.
The following table reflects the schedule of principal payments on the Term Loan as of September 30, 2023 (in thousands): | | | | | | | Principal Payments | 2023 (remaining) | $ | 1,500 | | 2024 | 6,000 | | 2025 | 2,000 | | | | | $ | 9,500 | |
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v3.23.3
Insurance Financing Note Payable
|
9 Months Ended |
Sep. 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 September 30, 2023, the outstanding balance was $0.5 million.
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v3.23.3
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U. S. Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements.
The condensed consolidated balance sheet at September 30, 2023, and the condensed consolidated statements of operations, comprehensive loss, and changes in stockholders' equity for the three and nine months ended September 30, 2023 and cash flows for the nine months ended September 30, 2023 are unaudited, but include all adjustments, consisting of normal recurring adjustments the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 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 |
Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
|
Loss Per Share |
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 nine months ended September 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 related losses for trade accounts receivable, as well as available-for-sale debt securities, which are 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.
|
Revenue recognition |
The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle:
•Step 1: Identify the contract with the customer •Step 2: Identify the performance obligations in the contract •Step 3: Determine the transaction price •Step 4: Allocate the transaction price to the performance obligations in the contract •Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue. Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer.
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v3.23.3
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Loss Per Share Restated Amounts |
See the table presentation of loss per share calculations as of September 30, 2023 and 2022 in the "Loss Per Share" section below. | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | | Nine Months Ended September 30, | | | | 2022 | | | | 2022 | As Previously Reported: | | | | | | | | Net loss per share attributable to common stockholders - basic and diluted | | | $ | (0.40) | | | | | $ | (1.75) | | Weighted average number of shares of common stock outstanding - basic and diluted | | | 10,528,148 | | | | | 9,299,788 | | | | | | | | | | As Restated: | | | | | | | | Net loss per share attributable to common stockholders - basic and diluted | | | $ | (0.23) | | | | | $ | (1.26) | | Weighted average number of shares of common stock outstanding - basic and diluted | | | 18,463,673 | | | | | 12,902,890 | |
|
Schedule of Basic and Diluted Net Loss Per Share |
Basic and diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, after giving effect to the restatement discussed above, was calculated as follows: | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | (In Thousands, Except Share and Per Share Amounts) | 2023 | | 2022 | | 2023 | | 2022 | Numerator: | | | | | | | | Net loss | $ | (1,872) | | | $ | (4,190) | | | $ | (6,927) | | | $ | (16,317) | | Net loss attributable to common stockholders for basic and diluted loss per share | $ | (1,872) | | | $ | (4,190) | | | $ | (6,927) | | | $ | (16,317) | | | | | | | | | | Denominator: | | | | | | | | Weighted average number of shares of common stock outstanding - basic and diluted | 27,521,088 | | | 18,463,673 | | | 21,526,978 | | | 12,902,890 | | Net loss per share attributable to common stockholders - basic and diluted | $ | (0.07) | | | $ | (0.23) | | | $ | (0.32) | | | $ | (1.26) | |
|
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: | | | | | | | | | | | | | As of September 30, | | 2023 | | 2022 | Options to Purchase Common Stock | 1,367,493 | | | 1,311,691 | | Unvested Restricted Stock Awards | 891 | | | 891 | | Unvested Restricted Stock Units | 287,400 | | | 125,000 | | Convertible Preferred Stock | 1,363,636 | | | 1,363,636 | | Warrants to Purchase Common Stock | 4,045,278 | | 17,507,268 | | Total | 7,064,698 | | 20,308,486 | |
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v3.23.3
Asset Acquisition (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Business Combination and Asset Acquisition [Abstract] |
|
Schedule of Purchase Price, on a Relative Fair Value Basis, to Assets Acquired |
The purchase price was allocated, on a relative fair value basis, to the assets acquired at the July 10, 2023 acquisition date as follows (table in thousands): | | | | | | | | | | | | Consideration | | | Cash Payment | | $ | 12,233 | | Deferred Consideration | | 5,000 | | Transaction Costs | | 128 | | Total Consideration | | $ | 17,361 | | | | | Assets Acquired | | | Customer Relationships Intangible Asset | | $ | 11,035 | | Equipment | | 5,093 | | Inventory | | 1,233 | | Total Assets Acquired | | $ | 17,361 | |
|
Schedule of Future Amortization Expense |
Estimated future amortization expense on the Company's customer relationships intangible asset as of September 30, 2023 is as follows (table in thousands): | | | | | | | | | | Year ended December 31: | | | | 2023 (remainder of year) | | | $ | 138 | | 2024 | | | 552 | | 2025 | | | 552 | | 2026 | | | 552 | | 2027 | | | 552 | | Thereafter | | | 8,551 | | Total | | | $ | 10,897 | |
|
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v3.23.3
Revenue Recognition (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Disaggregation of Revenue |
Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | In thousands | Three Months Ended September 30, 2023 | | Nine Months Ended September 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 | 2,197 | | | — | | | 2,197 | | | 2,327 | | | — | | | 2,327 | | Total Drug Products | 2,197 | | | — | | | 2,197 | | | 2,327 | | | — | | | 2,327 | | Concentrates Products | | | | | | | | | | | | Product Sales – Point-in-time | 21,574 | | | 19,741 | | | 1,833 | | | 57,720 | | | 52,326 | | | 5,394 | | License Fee – Over time | — | | | — | | | — | | | 1,472 | | | 1,472 | | | — | | Total Concentrate Products | 21,574 | | | 19,741 | | | 1,833 | | | 59,192 | | | 53,798 | | | 5,394 | | Net Revenue | $ | 23,771 | | | $ | 19,741 | | | $ | 4,030 | | | $ | 61,519 | | | $ | 53,798 | | | $ | 7,721 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | In thousands | Three Months Ended September 30, 2022 | | Nine Months Ended September 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 | $ | 193 | | | $ | 193 | | | $ | — | | | $ | 834 | | | $ | 561 | | | $ | 273 | | License Fee – Over time | 65 | | | — | | | 65 | | | 192 | | | — | | | 192 | | Total Drug Products | 258 | | | 193 | | | 65 | | | 1,026 | | | 561 | | | 465 | | Concentrates Products | | | | | | | | | | | | Product Sales – Point-in-time | 17,953 | | | 16,619 | | | 1,334 | | | 51,035 | | | 46,334 | | | 4,701 | | License Fee – Over time | 480 | | | 480 | | | — | | | 1,436 | | | 1,436 | | | — | | Total Concentrate Products | 18,433 | | | 17,099 | | | 1,334 | | | 52,471 | | | 47,770 | | | 4,701 | | Net Revenue | $ | 18,691 | | | $ | 17,292 | | | $ | 1,399 | | | $ | 53,497 | | | $ | 48,331 | | | $ | 5,166 | |
|
Contract Balances |
The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. | | | | | | | | | | | | In thousands | September 30, 2023 | | December 31, 2022 | Accounts Receivable, net | $ | 9,361 | | | $ | 6,259 | | Contract Liabilities, which are included in deferred license revenue | $ | 533 | | | $ | 4,331 | |
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v3.23.3
Investments - Available-for-Sale (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Investments, Debt and Equity Securities [Abstract] |
|
Investments Available-for-Sale |
Investments available-for-sale consisted of the following as of September 30, 2023 and December 31, 2022 (table in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | September 30, 2023 | | Amortized Cost | | Unrealized Gain | | Unrealized Loss | | Accrued Interest | | Fair Value | Available-for-Sale Securities | | | | | | | | | | Debt securities | $ | 3,898 | | | $ | 73 | | | $ | — | | | $ | — | | | $ | 3,971 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | December 31, 2022 | | Amortized Cost | | Unrealized Gain | | Unrealized Loss | | Accrued Interest | | Fair Value | Available-for-Sale Securities | | | | | | | | | | Debt securities | $ | 11,315 | | | $ | 75 | | | $ | — | | | $ | — | | | $ | 11,390 | |
|
X |
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v3.23.3
Inventory (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Inventory Disclosure [Abstract] |
|
Schedule Components of Inventory |
Components of inventory, net of reserves, as of September 30, 2023 and December 31, 2022 are as follows (table in thousands): | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Inventory - Current Portion | | | | Raw Materials | $ | 2,335 | | | $ | 3,351 | | Work in Process | 337 | | | 351 | | Finished Goods | 2,814 | | | 2,112 | | Total Current Inventory | 5,486 | | | 5,814 | | Inventory - Long Term (1) | 178 | | | 1,276 | | Total Inventory | $ | 5,664 | | | $ | 7,090 | | | | | | __________ 1.Represents inventory related to Triferic raw materials. This Triferic inventory will be utilized for the Company's international partnerships. In September 2022, the Company discontinued its New Drug Applications ("NDAs") for Triferic (dialysate) and Triferic AVNU in the United States. During the three months ended September 30, 2023, the Company reserved $1.1 million of long-term inventory as a result of the termination of the Wanbang development effort.
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v3.23.3
Property and Equipment, net (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Major Classes of Property and Equipment |
As of September 30, 2023 and December 31, 2022, the Company’s property and equipment consisted of the following (table in thousands): | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Leasehold Improvements | $ | 1,423 | | | $ | 1,256 | | Machinery and Equipment | 11,085 | | | 5,922 | | Information Technology & Office Equipment | 1,845 | | | 1,845 | | Laboratory Equipment | 807 | | | 807 | | Total Property and Equipment | 15,160 | | | 9,830 | | Accumulated Depreciation and Amortization | (8,389) | | | (7,636) | | Property and Equipment, net | $ | 6,771 | | | $ | 2,194 | |
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v3.23.3
Accrued Liabilities (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Liabilities |
Accrued liabilities as of September 30, 2023 and December 31, 2022 consisted of the following (table in thousands): | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Accrued Compensation and Benefits | $ | 2,240 | | | $ | 2,568 | | Accrued Unvouchered Receipts | 1,947 | | | 585 | | Accrued Manufacturing Expense | 732 | | | — | | Accrued Workers Compensation | 202 | | | 306 | | Accrued Research & Development Expense | — | | | 43 | | Other Accrued Liabilities | 1,587 | | | 4,200 | | Total Accrued Liabilities | $ | 6,708 | | | $ | 7,702 | |
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v3.23.3
Stockholder's Equity (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
Summary of Common Stock Reserved for Issuance |
As of September 30, 2023 and 2022, the Company reserved for issuance the following shares of common stock related to the potential exercise of employee stock options, unvested restricted stock, convertible preferred stock, pre-funded warrants and all other warrants (collectively, "common stock equivalents"): | | | | | | | | | | | | | As of September 30, | Common stock and common stock equivalents: | 2023 | | 2022 | Common stock | 28,489,663 | | | 11,152,673 | | Common stock issuable upon exercise of pre-funded warrants | — | | | 7,311,000 | | Common stock and pre-funded stock warrants | 28,489,663 | | | 18,463,673 | | Options to Purchase Common Stock | 1,367,493 | | | 1,311,691 | | Unvested Restricted Stock Awards | 891 | | | 891 | | Unvested Restricted Stock Units | 287,400 | | | 125,000 | | Convertible Preferred Stock | 1,363,636 | | | 1,363,636 | | | | | | Warrants to Purchase Common Stock | 4,045,278 | | | 17,507,268 | | Total | 35,554,361 | | 38,772,159 | |
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v3.23.3
Stock-Based Compensation (Tables)
|
9 Months Ended |
Sep. 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 nine months ended September 30, 2023 and 2022 as follows (table in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Service-based awards: | | | | | | | | | | | | | | | | Restricted Stock Units | $ | 112 | | | $ | 46 | | | $ | 276 | | | $ | 84 | | Stock Option Awards | 100 | | | 130 | | | 438 | | | 401 | | Total Service Based Awards | 212 | | | 176 | | | 714 | | | 485 | | Performance-based awards: | | | | | | | | Restricted Stock Awards | — | | | — | | | — | | | (391) | | | | | | | | | | | | | | | | | | | | | | | | | | Total | $ | 212 | | | $ | 176 | | | $ | 714 | | | $ | 94 | |
|
Schedule of Stock Option Assumptions |
The fair value of the service-based stock options granted for the nine months ended September 30, 2023 were based on the following assumptions: | | | | | | | Nine Months Ended September 30, 2023 | Exercise price | $1.37 - $2.83 | Expected stock price volatility | 81.6% - 81.8% | Risk-free interest rate | 3.41% - 3.46% | Term (years) | 5.6 - 6 |
|
Schedule of Stock Options Activity |
A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2023 is as follows: | | | | | | | | | | | | | | | | | | | | | | | | | | Shares Underlying Options | | Weighted Average Exercise Price | | Weighted Average Remaining Contractual Term | | Aggregate Intrinsic Value | | | | | | | in years | | in thousands | | Outstanding at January 1, 2023 | 1,206,905 | | | $ | 8.32 | | | | | | | Granted | 382,745 | | | 1.48 | | | | | | | | | | | | | | | | Forfeited | (143,430) | | | 2.82 | | | | | | | Expired | (78,727) | | | 26.74 | | | | | | | Outstanding at September 30, 2023 | 1,367,493 | | | $ | 5.93 | | | 8.4 | | $ | 680 | | | | | | | | | | | | Exercisable at September 30, 2023 | 444,836 | | | $ | 14.64 | | | 7 | | $ | 114 | | |
A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2022 is as follows: | | | | | | | | | | | | | | | | | | | | | | | Shares Underlying Options | | Weighted Average Exercise Price | | Weighted Average Remaining Contractual Term | | | | | | | | in years | | | Outstanding at January 1, 2022 | 528,591 | | | $ | 32.01 | | | 7.5 | | | Granted | 898,659 | | | 1.49 | | | 5.5 | | | Forfeited | (30,093) | | | 15.11 | | | — | | | | Expired | (85,466) | | | 82.09 | | | — | | | | Outstanding at September 30, 2022 | 1,311,691 | | | $ | 8.23 | | | 9.1 | | | | | | | | | | | Exercisable at September 30, 2022 | 243,973 | | | $ | 29.31 | | | 6.9 | | |
|
Restricted stock awards |
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
Schedule of Restricted Stock Awards |
A summary of the Company’s restricted stock awards during the nine months ended September 30, 2023 is as follows: | | | | | | | | | | | | | Number of Shares | | Weighted Average Grant-Date Fair Value | Unvested at January 1, 2023 | 891 | | | $ | 62.70 | | | | | | Unvested at September 30, 2023 | 891 | | | $ | 62.70 | |
A summary of the Company’s restricted stock awards during the nine months ended September 30, 2022 is as follows: | | | | | | | | | | | | | Number of Shares | | Weighted Average Grant-Date Fair Value | Unvested at January 1, 2022 | 7,118 | | | $ | 62.70 | | Forfeited (1) | (6,227) | | | $ | 62.70 | | Unvested at September 30, 2022 | 891 | | | $ | 62.70 | |
__________ 1.These forfeited awards were due to the resignation of the Company's Chief Development Officer on March 25, 2022 and reduced stock-based compensation expense by $0.4 million in 2022.
|
Restricted stock units - service based awards |
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
Schedule of Restricted Stock Awards |
A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2023 is as follows: | | | | | | | | | | | | | Number of Shares | | Weighted Average Grant-Date Fair Value | Unvested at January 1, 2023 | 125,000 | | | $ | 1.47 | | Granted | 313,065 | | | 1.87 | | Vested | (125,000) | | | 1.47 | | Forfeited | (25,665) | | | 1.37 | | Unvested at September 30, 2023 | 287,400 | | | $ | 1.85 | |
A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2022 is as follows: | | | | | | | | | | | | | Number of Shares | | Weighted Average Grant-Date Fair Value | Unvested at January 1, 2022 | 29,289 | | | $ | 12.87 | | Granted | 125,000 | | | 1.47 | | Vested | (23,515) | | | 11.33 | | Forfeited | (5,774) | | | 19.00 | | | | | | Unvested at September 30, 2022 | 125,000 | | | $ | 1.47 | |
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v3.23.3
Leases (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Leases [Abstract] |
|
Summary of Lease Costs |
The following summarizes quantitative information about the Company’s operating and finance leases (table in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, 2023 | | Three Months Ended September 30, 2022 | | Nine Months Ended September 30, 2023 | | Nine Months Ended September 30, 2022 | Operating leases | | | | | | | | Operating lease cost | $ | 422 | | | $ | 410 | | | $ | 1,281 | | | $ | 1,289 | | Variable lease cost | 112 | | | 101 | | | 336 | | | 287 | | Operating lease expense | 534 | | | 511 | | | 1,617 | | | 1,576 | | Finance leases | | | | | | | | Non-cash lease expense from right-of-use assets | 142 | | | 141 | | | 424 | | | 424 | | Interest on lease obligations | 36 | | | 44 | | | 113 | | | 136 | | Finance lease expense | 178 | | | 185 | | | 537 | | | 560 | | Short-term lease rent expense | 4 | | | 5 | | | 12 | | | 14 | | Total lease expense | $ | 716 | | | $ | 701 | | | $ | 2,166 | | | $ | 2,150 | | | | | | | | | | Other information | | | | | | | | Payments for principal from operating leases | $ | 461 | | | $ | 427 | | | $ | 1,363 | | | $ | 1,338 | | Payments for interest from finance leases | $ | 37 | | | $ | 44 | | | $ | 114 | | | $ | 136 | | Payments for principal from finance leases | $ | 130 | | | $ | 121 | | | $ | 388 | | | $ | 359 | | | | | | | | | | | | | | | | | | Weighted-average remaining lease term – operating leases | 2.5 | | 3.2 | | 2.5 | | 3.2 | Weighted-average remaining lease term – finance leases | 3.7 | | 4.7 | | 3.7 | | 4.7 | Weighted-average discount rate – operating leases | 6.5 | % | | 6.4 | % | | 6.5 | % | | 6.4 | % | Weighted-average discount rate – finance leases | 6.4 | % | | 6.4 | % | | 6.4 | % | | 6.4 | % |
|
Operating Lease Maturities |
Future minimum rental payments under operating and finance lease agreements are as follows (in thousands): | | | | | | | | | | | | | Operating | | Finance | Year ending December 31, 2023 (remaining) | $ | 439 | | | $ | 168 | | Year ending December 31, 2024 | 1,511 | | | 672 | | Year ending December 31, 2025 | 1,021 | | | 676 | | Year ending December 31, 2026 | 362 | | | 666 | | Year ending December 31, 2027 | 131 | | | 311 | | | | | | Total | 3,464 | | | 2,493 | | Less present value discount | (259) | | | (271) | | Operating and finance lease liabilities | $ | 3,205 | | | $ | 2,222 | |
|
Finance Lease Maturities |
Future minimum rental payments under operating and finance lease agreements are as follows (in thousands): | | | | | | | | | | | | | Operating | | Finance | Year ending December 31, 2023 (remaining) | $ | 439 | | | $ | 168 | | Year ending December 31, 2024 | 1,511 | | | 672 | | Year ending December 31, 2025 | 1,021 | | | 676 | | Year ending December 31, 2026 | 362 | | | 666 | | Year ending December 31, 2027 | 131 | | | 311 | | | | | | Total | 3,464 | | | 2,493 | | Less present value discount | (259) | | | (271) | | Operating and finance lease liabilities | $ | 3,205 | | | $ | 2,222 | |
|
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v3.23.3
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Summary of Loss Per Share Restated Amounts (Details) - $ / shares
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Reclassification [Line Items] |
|
|
|
|
|
Net loss per share attributable to common stockholders - basic (in dollars per share) |
|
$ (0.07)
|
$ (0.23)
|
$ (0.32)
|
$ (1.26)
|
Net loss per share attributable to common stockholders - diluted (in dollars per share) |
|
$ (0.07)
|
$ (0.23)
|
$ (0.32)
|
$ (1.26)
|
Weighted average number of common shares outstanding - basic (in shares) |
[1] |
27,521,088
|
18,463,673
|
21,526,978
|
12,902,890
|
Weighted average number of common shares outstanding - diluted (in shares) |
[1] |
27,521,088
|
18,463,673
|
21,526,978
|
12,902,890
|
Previously Reported |
|
|
|
|
|
Reclassification [Line Items] |
|
|
|
|
|
Net loss per share attributable to common stockholders - basic (in dollars per share) |
|
|
$ (0.40)
|
|
$ (1.75)
|
Net loss per share attributable to common stockholders - diluted (in dollars per share) |
|
|
$ (0.40)
|
|
$ (1.75)
|
Weighted average number of common shares outstanding - basic (in shares) |
|
|
10,528,148
|
|
9,299,788
|
Weighted average number of common shares outstanding - diluted (in shares) |
|
|
10,528,148
|
|
9,299,788
|
|
|
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- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.23.3
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 |
9 Months Ended |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2022 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Numerator: |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ (1,872)
|
$ (3,305)
|
$ (1,750)
|
$ (4,190)
|
$ (4,967)
|
$ (7,162)
|
$ (6,927)
|
$ (16,317)
|
Net loss attributable to common stockholders for basic loss per share |
|
(1,872)
|
|
|
(4,190)
|
|
|
(6,927)
|
(16,317)
|
Net loss attributable to common stockholders for diluted loss per share |
|
$ (1,872)
|
|
|
$ (4,190)
|
|
|
$ (6,927)
|
$ (16,317)
|
Denominator: |
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding - basic (in shares) |
[1] |
27,521,088
|
|
|
18,463,673
|
|
|
21,526,978
|
12,902,890
|
Weighted average number of common shares outstanding - diluted (in shares) |
[1] |
27,521,088
|
|
|
18,463,673
|
|
|
21,526,978
|
12,902,890
|
Net loss per share attributable to common stockholders - basic (in dollars per share) |
|
$ (0.07)
|
|
|
$ (0.23)
|
|
|
$ (0.32)
|
$ (1.26)
|
Net loss per share attributable to common stockholders - diluted (in dollars per share) |
|
$ (0.07)
|
|
|
$ (0.23)
|
|
|
$ (0.32)
|
$ (1.26)
|
|
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.23.3
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Summary of Potentially Dilutive Securities (Details) - shares
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Net Earnings per Share |
|
|
Antidilutive securities (in shares) |
7,064,698
|
20,308,486
|
Common stock issuable upon exercise of pre-funded warrants |
|
|
Net Earnings per Share |
|
|
Warrants outstanding (in shares) |
0
|
7,311,000
|
Options to Purchase Common Stock |
|
|
Net Earnings per Share |
|
|
Antidilutive securities (in shares) |
1,367,493
|
1,311,691
|
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) |
287,400
|
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) |
4,045,278
|
17,507,268
|
X |
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v3.23.3
Asset Acquisition - Narrative (Details) $ in Thousands |
|
3 Months Ended |
9 Months Ended |
|
Jul. 10, 2023
USD ($)
payment
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
Asset Acquisition [Line Items] |
|
|
|
|
|
Cash Payment |
|
|
$ 12,361
|
$ 0
|
|
Amortization of intangible assets |
|
$ 100
|
100
|
|
|
Intangible Asset, net |
|
$ 10,897
|
$ 10,897
|
|
$ 0
|
Evoqua Water Technologies LLC |
|
|
|
|
|
Asset Acquisition [Line Items] |
|
|
|
|
|
Total Consideration |
$ 17,361
|
|
|
|
|
Cash Payment |
$ 12,233
|
|
|
|
|
Number of deferred payments | payment |
2
|
|
|
|
|
Milestone payments |
$ 2,500
|
|
|
|
|
Deferred payments, first payment period |
1 year
|
|
|
|
|
Evoqua Water Technologies LLC | Customer Relationships |
|
|
|
|
|
Asset Acquisition [Line Items] |
|
|
|
|
|
Intangible asset, useful life |
20 years
|
|
|
|
|
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v3.23.3
Asset Acquisition - Purchase Price, on a Relative Fair Value Basis, to Assets Acquired (Details) - USD ($) $ in Thousands |
|
9 Months Ended |
Jul. 10, 2023 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Asset Acquisition [Line Items] |
|
|
|
Cash Payment |
|
$ 12,361
|
$ 0
|
Deferred Consideration |
|
$ 5,000
|
$ 0
|
Evoqua Water Technologies LLC |
|
|
|
Asset Acquisition [Line Items] |
|
|
|
Cash Payment |
$ 12,233
|
|
|
Deferred Consideration |
5,000
|
|
|
Transaction Costs |
128
|
|
|
Total Consideration |
17,361
|
|
|
Equipment |
5,093
|
|
|
Inventory |
1,233
|
|
|
Total Assets Acquired |
17,361
|
|
|
Evoqua Water Technologies LLC | Customer Relationships |
|
|
|
Asset Acquisition [Line Items] |
|
|
|
Customer Relationships Intangible Asset |
$ 11,035
|
|
|
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Revenue Recognition - Disaggregation of Revenue (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
$ 23,771
|
$ 18,691
|
$ 61,519
|
$ 53,497
|
Drug products |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
2,197
|
258
|
2,327
|
1,026
|
Concentrates Products |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
21,574
|
18,433
|
59,192
|
52,471
|
U.S. |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
19,741
|
17,292
|
53,798
|
48,331
|
U.S. | Drug products |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
0
|
193
|
0
|
561
|
U.S. | Concentrates Products |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
19,741
|
17,099
|
53,798
|
47,770
|
Rest of World |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
4,030
|
1,399
|
7,721
|
5,166
|
Rest of World | Drug products |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
2,197
|
65
|
2,327
|
465
|
Rest of World | Concentrates Products |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
1,833
|
1,334
|
5,394
|
4,701
|
Product Sales – Point-in-time | Drug product sales |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
0
|
193
|
0
|
834
|
Product Sales – Point-in-time | Concentrates product sales |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
21,574
|
17,953
|
57,720
|
51,035
|
Product Sales – Point-in-time | U.S. | Drug product sales |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
0
|
193
|
0
|
561
|
Product Sales – Point-in-time | U.S. | Concentrates product sales |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
19,741
|
16,619
|
52,326
|
46,334
|
Product Sales – Point-in-time | Rest of World | Drug product sales |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
0
|
0
|
0
|
273
|
Product Sales – Point-in-time | Rest of World | Concentrates product sales |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
1,833
|
1,334
|
5,394
|
4,701
|
License Fee – Over time | Drug license fee |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
2,197
|
65
|
2,327
|
192
|
License Fee – Over time | Concentrates product license fee |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
0
|
480
|
1,472
|
1,436
|
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
|
1,436
|
License Fee – Over time | Rest of World | Drug license fee |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
2,197
|
65
|
2,327
|
192
|
License Fee – Over time | Rest of World | Concentrates product license fee |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Net Revenue |
$ 0
|
$ 0
|
$ 0
|
$ 0
|
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v3.23.3
Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands |
3 Months Ended |
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Inventory - Current Portion |
|
|
Raw Materials |
$ 2,335
|
$ 3,351
|
Work in Process |
337
|
351
|
Finished Goods |
2,814
|
2,112
|
Total Current Inventory |
5,486
|
5,814
|
Inventory - Long Term |
178
|
1,276
|
Total Inventory |
5,664
|
$ 7,090
|
Triferic Inventory | SEC Schedule, 12-09, Reserve, Inventory |
|
|
Inventory - Current Portion |
|
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Inventory reserve, period increase (decrease) |
$ 1,100
|
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v3.23.3
Property and Equipment, net (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Property and equipment |
|
|
|
|
|
Gross property and equipment |
$ 15,160
|
|
$ 15,160
|
|
$ 9,830
|
Accumulated Depreciation and Amortization |
(8,389)
|
|
(8,389)
|
|
(7,636)
|
Property and Equipment, net |
6,771
|
|
6,771
|
|
2,194
|
Depreciation expense |
400
|
$ 100
|
800
|
$ 400
|
|
Leasehold Improvements |
|
|
|
|
|
Property and equipment |
|
|
|
|
|
Gross property and equipment |
1,423
|
|
1,423
|
|
1,256
|
Machinery and Equipment |
|
|
|
|
|
Property and equipment |
|
|
|
|
|
Gross property and equipment |
11,085
|
|
11,085
|
|
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
|
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v3.23.3
Deferred License Revenue (Details) - USD ($)
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
12 Months Ended |
|
May 31, 2022 |
Jun. 30, 2021 |
Sep. 30, 2020 |
Jan. 31, 2020 |
Oct. 31, 2014 |
Sep. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2016 |
Dec. 31, 2022 |
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Contract Liabilities, which are included in deferred license revenue |
|
|
|
|
|
$ 533,000
|
|
|
$ 533,000
|
|
|
$ 4,331,000
|
Triferic Inventory | SEC Schedule, 12-09, Reserve, Inventory |
|
|
|
|
|
|
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Inventory reserve, period increase (decrease) |
|
|
|
|
|
1,100,000
|
|
|
|
|
|
|
Baxter Healthcare Organization |
|
|
|
|
|
|
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Term of agreement |
|
|
|
|
10 years
|
|
|
|
|
|
|
|
Upfront payment |
|
|
|
|
$ 20,000,000
|
|
|
|
|
|
|
|
Recognized deferred revenue |
|
|
|
|
|
|
$ 1,500,000
|
|
|
|
|
|
Wanbang Biopharmaceutical |
|
|
|
|
|
|
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Upfront payment |
|
|
|
|
|
|
|
|
|
|
$ 4,000,000
|
|
Recognized deferred revenue |
|
|
|
|
|
2,200,000
|
|
|
|
|
|
|
Wanbang Biopharmaceutical | Triferic Inventory |
|
|
|
|
|
|
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Inventory reserve, increase in gross profit |
|
|
|
|
|
1,100,000
|
|
|
|
|
|
|
Wanbang Biopharmaceutical | Triferic Inventory | SEC Schedule, 12-09, Reserve, Inventory |
|
|
|
|
|
|
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Inventory reserve, period increase (decrease) |
|
|
|
|
|
1,100,000
|
|
|
|
|
|
|
Sun Pharma Agreements |
|
|
|
|
|
|
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Upfront payment |
|
|
|
$ 100,000
|
|
|
|
|
|
|
|
|
Recognized deferred revenue |
|
|
|
|
|
2,500
|
|
$ 7,500
|
2,500
|
$ 7,500
|
|
|
Contract Liabilities, which are included in deferred license revenue |
|
|
|
|
|
62,500
|
|
|
62,500
|
|
|
70,000
|
Jeil Pharma Agreements |
|
|
|
|
|
|
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Upfront payment |
|
|
$ 200,000
|
|
|
|
|
|
|
|
|
|
Recognized deferred revenue |
|
|
|
|
|
5,200
|
|
15,600
|
5,200
|
15,600
|
|
|
Contract Liabilities, which are included in deferred license revenue |
|
|
|
|
|
400,000
|
|
|
400,000
|
|
|
400,000
|
Milestone consideration |
$ 200,000
|
|
|
|
|
|
|
|
|
|
|
|
Drogsan Agreements |
|
|
|
|
|
|
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Upfront payment |
|
$ 150,000
|
|
|
|
|
|
|
|
|
|
|
Recognized deferred revenue |
|
|
|
|
|
3,750
|
|
$ 11,250
|
3,750
|
$ 11,250
|
|
|
Contract Liabilities, which are included in deferred license revenue |
|
|
|
|
|
$ 100,000
|
|
|
$ 100,000
|
|
|
$ 100,000
|
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v3.23.3
Stockholders’ Equity - Narrative (Details)
|
|
|
|
|
|
|
3 Months Ended |
9 Months Ended |
|
|
Jul. 10, 2023
USD ($)
$ / shares
shares
|
Jul. 05, 2023
USD ($)
$ / shares
shares
|
May 23, 2023
shares
|
Jun. 16, 2022
USD ($)
shares
|
May 30, 2022
$ / shares
shares
|
Apr. 06, 2022
USD ($)
$ / shares
shares
|
Sep. 30, 2023
USD ($)
$ / shares
shares
|
Sep. 30, 2022
shares
|
Sep. 30, 2023
USD ($)
$ / shares
shares
|
Sep. 30, 2022
USD ($)
shares
|
Dec. 31, 2022
$ / shares
shares
|
Apr. 08, 2022
USD ($)
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Stock issuance costs | $ |
|
|
|
|
|
|
|
|
$ 43,000
|
$ 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) |
|
|
|
|
|
|
28,489,663
|
11,152,673
|
28,489,663
|
11,152,673
|
12,163,673
|
|
Common shares, shares issued (in shares) |
|
|
|
|
|
|
28,489,663
|
|
28,489,663
|
|
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
|
|
|
|
|
|
|
|
|
|
PIPE Purchase Agreement Pre-Funded Warrant |
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercised (in shares) |
|
1,793,000
|
|
|
|
|
1,793,000
|
477,480
|
6,300,000
|
477,480
|
|
|
Number of shares of common stock for which warrant is exercisable (in shares) |
|
|
|
|
1,267,897
|
|
|
|
|
|
|
|
Discount from stock price (in dollars per share) | $ / shares |
|
|
|
|
$ 0.0001
|
|
|
|
|
|
|
|
Exercise price of warrant (in dollars per share) | $ / shares |
|
$ 0.0001
|
|
|
$ 0.0001
|
|
|
|
|
|
|
|
Proceeds from Issuance of Common Stock in connection with exercise of Prior Warrant and Pre-Funded Warrants | $ |
|
$ 179
|
|
|
|
|
|
|
|
|
|
|
Common stock issuable upon exercise of pre-funded 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 (in dollars per share) | $ / shares |
|
|
|
|
$ 0.0001
|
|
|
|
|
|
|
|
Exercise price of warrant (in dollars per share) | $ / shares |
|
|
|
|
$ 0.0001
|
|
|
|
|
|
|
|
Ownership threshold |
|
|
|
|
9.99%
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
Warrant price (in dollars per share) | $ / shares |
|
|
|
|
$ 0.125
|
|
|
|
|
|
|
|
Armistice Warrant Agreement |
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from Issuance of Common Stock in connection with exercise of Prior Warrant and Pre-Funded Warrants | $ |
$ 13,800,000
|
|
|
|
|
|
|
|
|
|
|
|
Armistice Reload Warrant Agreement |
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares of common stock for which warrant is exercisable (in shares) |
3,750,000
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price of warrant (in dollars per share) | $ / shares |
$ 5.13
|
|
|
|
|
|
|
|
|
|
|
|
Warrant expiration period |
54 months
|
|
|
|
|
|
|
|
|
|
|
|
Ownership limitation percentage |
0.0999
|
|
|
|
|
|
|
|
|
|
|
|
Letter Agreement |
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Period after issuance, shares cannot be sold |
45 days
|
|
|
|
|
|
|
|
|
|
|
|
Minimum purchase price (in dollars per share) | $ / shares |
$ 6.25
|
|
|
|
|
|
|
|
|
|
|
|
Extended expiration date |
1 year
|
|
|
|
|
|
|
|
|
|
|
|
Registered Direct Offering |
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued (in shares) |
|
|
|
|
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 (in dollars per share) | $ / shares |
|
|
|
|
|
$ 22.00
|
|
|
|
|
|
|
Common stock trading period |
|
|
|
|
|
30 days
|
|
|
|
|
|
|
Accreted amount | $ |
|
|
|
|
|
|
$ 150,000
|
|
$ 150,000
|
|
|
|
Conversion price (in dollars 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 (in shares) |
|
|
|
7,500
|
|
7,500
|
|
|
|
|
|
|
Cantor Fitzgerald & Co | Controlled Equity Offering |
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Sale of stock, aggregate consideration authorized | $ |
|
|
|
|
|
|
$ 12,200,000
|
|
$ 12,200,000
|
|
|
$ 12,200,000
|
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v3.23.3
Stockholder's Equity - Summary of Common Stock Reserved for Issuance (Details) - shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Sep. 30, 2022 |
Dec. 31, 2021 |
Common stock and common stock equivalents: |
|
|
|
|
Common stock (in shares) |
28,489,663
|
12,163,673
|
11,152,673
|
|
Common stock and pre-funded stock warrants (in shares) |
28,489,663
|
|
18,463,673
|
|
Options to purchase common stock (in shares) |
1,367,493
|
|
1,311,691
|
|
Convertible preferred stock (in shares) |
1,363,636
|
|
1,363,636
|
|
Total (in shares) |
35,554,361
|
|
38,772,159
|
|
Common stock issuable upon exercise of pre-funded warrants |
|
|
|
|
Common stock and common stock equivalents: |
|
|
|
|
Warrants outstanding (in shares) |
0
|
|
7,311,000
|
|
Warrants to Purchase Common Stock |
|
|
|
|
Common stock and common stock equivalents: |
|
|
|
|
Warrants outstanding (in shares) |
4,045,278
|
|
17,507,268
|
|
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) |
287,400
|
125,000
|
125,000
|
29,289
|
X |
- DefinitionCommon Stock And Pre-Funded Warrants, Shares, Outstanding
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v3.23.3
Stock-Based Compensation - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
|
Total share based compensation expense |
$ 212
|
$ 176
|
$ 714
|
$ 94
|
|
Total Service Based Awards |
|
|
|
|
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
|
Total share based compensation expense |
212
|
176
|
714
|
485
|
|
Restricted Stock Units |
|
|
|
|
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
|
Total share based compensation expense |
112
|
46
|
276
|
84
|
|
Stock Option Awards |
|
|
|
|
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
|
Total share based compensation expense |
100
|
130
|
438
|
401
|
|
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)
|
$ 400
|
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v3.23.3
Stock-Based Compensation - Service Based Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Weighted Average Grant-Date Fair Value |
|
|
|
|
|
Stock based compensation expenses |
$ 212
|
$ 176
|
$ 714
|
$ 94
|
|
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) |
|
|
(25,665)
|
(5,774)
|
|
Unvested at end of period (in shares) |
287,400
|
125,000
|
287,400
|
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) |
|
|
1.37
|
19.00
|
|
Unvested at end of period (in dollars per share) |
$ 1.85
|
$ 1.47
|
$ 1.85
|
$ 1.47
|
$ 1.47
|
Stock based compensation expenses |
$ 112
|
$ 46
|
$ 276
|
$ 84
|
|
Unrecognized stock-based compensation expense |
$ 400
|
|
$ 400
|
|
|
Unrecognized stock-based compensation expense, weighted average remaining term (in years) (less than) |
|
|
1 year 4 months 24 days
|
|
|
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|
|
|
|
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|
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|
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|
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1 year
|
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|
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|
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|
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|
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3 years
|
|
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X |
- DefinitionAgreed-upon price for the exchange of the underlying asset relating to the share-based payment award.
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v3.23.3
Stock-Based Compensation - Service Based Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands |
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2021 |
Shares Underlying Options |
|
|
|
Outstanding at the end of the period (in shares) |
1,367,493
|
1,311,691
|
|
Stock Option Awards |
|
|
|
Shares Underlying Options |
|
|
|
Outstanding at the beginning of the period (in shares) |
1,206,905
|
528,591
|
|
Granted (in shares) |
382,745
|
898,659
|
|
Forfeited (in shares) |
(143,430)
|
(30,093)
|
|
Expired (in shares) |
(78,727)
|
(85,466)
|
|
Outstanding at the end of the period (in shares) |
1,367,493
|
1,311,691
|
528,591
|
Exercisable at end of period (in shares) |
444,836
|
243,973
|
|
Weighted Average Exercise Price |
|
|
|
Outstanding at the beginning of the period (in dollars per share) |
$ 8.32
|
$ 32.01
|
|
Granted (in dollars per share) |
1.48
|
1.49
|
|
Forfeited (in dollars per share) |
2.82
|
15.11
|
|
Expired (in dollar per share) |
26.74
|
82.09
|
|
Outstanding at the end of the period (in dollars per share) |
5.93
|
8.23
|
$ 32.01
|
Exercisable at end of the period (in dollars per share) |
$ 14.64
|
$ 29.31
|
|
Weighted Average Remaining Contractual Term |
|
|
|
Outstanding |
8 years 4 months 24 days
|
9 years 1 month 6 days
|
7 years 6 months
|
Granted |
|
5 years 6 months
|
|
Exercisable at end of the period |
7 years
|
6 years 10 months 24 days
|
|
Aggregate Intrinsic Value |
|
|
|
Outstanding |
$ 680
|
|
|
Exercisable at end of the period |
$ 114
|
|
|
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v3.23.3
Leases - Narrative (Details) $ in Millions |
Sep. 30, 2023
USD ($)
ft²
facility
|
Dec. 31, 2022
USD ($)
|
Lessee, Lease, Description [Line Items] |
|
|
Operating lease and finance lease liabilities | $ |
$ 5.4
|
$ 6.7
|
Operating lease and finance lease, right of use assets, net | $ |
$ 5.1
|
$ 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
|
|
Texas and South Carolina |
|
|
Lessee, Lease, Description [Line Items] |
|
|
Number of manufacturing facilities | facility |
2
|
|
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 |
|
|
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6 years
|
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v3.23.3
Leases - Summary of Lease Costs (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Operating leases |
|
|
|
|
Operating lease cost |
$ 422
|
$ 410
|
$ 1,281
|
$ 1,289
|
Variable lease cost |
112
|
101
|
336
|
287
|
Operating lease expense |
534
|
511
|
1,617
|
1,576
|
Finance leases |
|
|
|
|
Non-cash lease expense from right-of-use assets |
142
|
141
|
424
|
424
|
Interest on lease obligations |
36
|
44
|
113
|
136
|
Finance lease expense |
178
|
185
|
537
|
560
|
Short-term lease rent expense |
4
|
5
|
12
|
14
|
Total lease expense |
716
|
701
|
2,166
|
2,150
|
Other information |
|
|
|
|
Payments for principal from operating leases |
461
|
427
|
1,363
|
1,338
|
Payments for interest from finance leases |
37
|
44
|
114
|
136
|
Payments for principal from finance leases |
$ 130
|
$ 121
|
$ 388
|
$ 359
|
Weighted-average remaining lease term – operating leases |
2 years 6 months
|
3 years 2 months 12 days
|
2 years 6 months
|
3 years 2 months 12 days
|
Weighted-average remaining lease term – finance leases |
3 years 8 months 12 days
|
4 years 8 months 12 days
|
3 years 8 months 12 days
|
4 years 8 months 12 days
|
Weighted-average discount rate – operating leases |
6.50%
|
6.40%
|
6.50%
|
6.40%
|
Weighted-average discount rate – finance leases |
6.40%
|
6.40%
|
6.40%
|
6.40%
|
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v3.23.3
Leases - Finance Lease and Operating Lease Maturities (Details) $ in Thousands |
Sep. 30, 2023
USD ($)
|
Operating |
|
Year ending December 31, 2023 (remaining) |
$ 439
|
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 |
3,464
|
Less present value discount |
(259)
|
Operating lease liabilities |
3,205
|
Finance |
|
Year ending December 31, 2023 (remaining) |
168
|
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 |
2,493
|
Less present value discount |
(271)
|
Finance lease liabilities |
$ 2,222
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v3.23.3
Loans and Security Agreement - Narrative (Details) - Term loan
|
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
Mar. 16, 2020
USD ($)
$ / shares
shares
|
Sep. 30, 2021
USD ($)
installment
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 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 |
3.50%
|
|
|
|
|
|
|
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 |
|
|
12.50%
|
|
12.50%
|
|
|
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
|
$ 900,000
|
$ 1,200,000
|
|
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 |
|
|
9,000,000
|
|
9,000,000
|
|
|
Unamortized issuance costs and unaccreted discount |
|
|
$ 500,000
|
|
$ 500,000
|
|
|
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
|
|
|
|
|
|
|
Number of shares of common stock for which warrant is exercisable (in shares) | shares |
43,388
|
|
|
|
|
|
|
Exercise price of warrant (in dollars per share) | $ / shares |
$ 18.15
|
|
|
|
|
|
|
Additional debt discount recognized |
$ 500,000
|
|
|
|
|
|
|
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