Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 22, 2023 | Jun. 30, 2022 | |
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 001-35814 | ||
Entity Registrant Name | HARROW HEALTH, INC. | ||
Entity Central Index Key | 0001360214 | ||
Entity Tax Identification Number | 45-0567010 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 102 Woodmont Blvd. | ||
Entity Address, Address Line Two | Suite 610 | ||
Entity Address, City or Town | Nashville | ||
Entity Address, State or Province | TN | ||
Entity Address, Postal Zip Code | 37205 | ||
City Area Code | (615) | ||
Local Phone Number | 733-4730 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 159 | ||
Entity Common Stock, Shares Outstanding | 29,967,749 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive Proxy Statement for its 2023 Annual Meeting of Stockholders to be held on June 21, 2023 are incorporated by reference in Part III of this Annual Report on Form 10-K, to the extent stated herein | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Firm ID | 170 | ||
Auditor Name | KMJ Corbin & Company LLP | ||
Auditor Location | Irvine, California | ||
Common Stock, $0.001 par value per share | |||
Title of 12(b) Security | Common Stock, $0.001 par value per share | ||
Trading Symbol | HROW | ||
Security Exchange Name | NASDAQ | ||
8.625% Senior Notes due 2026 | |||
Title of 12(b) Security | 8.625% Senior Notes due 2026 | ||
Trading Symbol | HROWL | ||
Security Exchange Name | NASDAQ | ||
11.875% Senior Notes due 2027 | |||
Title of 12(b) Security | 11.875% Senior Notes due 2027 | ||
Trading Symbol | HROWM | ||
Security Exchange Name | NASDAQ |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 96,270,000 | $ 42,167,000 |
Investment in Eton Pharmaceuticals | 5,589,000 | 8,503,000 |
Accounts receivable, net | 6,249,000 | 4,470,000 |
Inventories | 6,541,000 | 4,217,000 |
Prepaid expenses and other current assets | 3,611,000 | 1,305,000 |
Total current assets | 118,260,000 | 60,662,000 |
Property, plant and equipment, net | 3,486,000 | 3,141,000 |
Capitalized software costs, net | 2,112,000 | 1,313,000 |
Deferred financing costs | 1,950,000 | |
Operating lease right-of-use assets, net | 7,513,000 | 5,935,000 |
Intangible assets, net | 23,725,000 | 15,813,000 |
Investment in Melt Pharmaceuticals | 11,133,000 | |
Goodwill | 332,000 | 332,000 |
TOTAL ASSETS | 157,378,000 | 98,329,000 |
Current liabilities | ||
Accounts payable and accrued expenses | 13,771,000 | 6,337,000 |
Accrued payroll and related liabilities | 4,025,000 | 3,089,000 |
Deferred revenue and customer deposits | 113,000 | 16,000 |
Current portion of operating lease obligations | 723,000 | 272,000 |
Current portion of finance lease obligations | 8,000 | |
Total current liabilities | 18,632,000 | 9,722,000 |
Operating lease obligations, net of current portion | 7,332,000 | 6,012,000 |
Finance lease obligations, net of current portion | 10,000 | |
Notes payable, net of unamortized debt discount | 104,174,000 | 71,654,000 |
TOTAL LIABILITIES | 130,138,000 | 87,398,000 |
Commitments and contingencies | ||
STOCKHOLDERS’ EQUITY | ||
Common stock, $0.001 par value, 50,000,000 shares authorized, 29,901,530 and 26,902,763 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | 30,000 | 27,000 |
Additional paid-in capital | 137,058,000 | 106,666,000 |
Accumulated deficit | (109,493,000) | (95,407,000) |
TOTAL HARROW HEALTH STOCKHOLDERS’ EQUITY | 27,595,000 | 11,286,000 |
Noncontrolling interests | (355,000) | (355,000) |
TOTAL STOCKHOLDERS’ EQUITY | 27,240,000 | 10,931,000 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 157,378,000 | $ 98,329,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 29,901,530 | 26,902,763 |
Common stock, shares outstanding | 29,901,530 | 26,902,763 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenues: | ||
Total revenues | $ 88,595,000 | $ 72,476,000 |
Cost of sales | (25,383,000) | (18,214,000) |
Gross profit | 63,212,000 | 54,262,000 |
Operating expenses: | ||
Selling, general and administrative | 58,243,000 | 41,315,000 |
Research and development | 3,050,000 | 11,084,000 |
Impairment of long-lived assets | 249,000 | |
Total operating expenses | 61,293,000 | 52,648,000 |
Income from operations | 1,919,000 | 1,614,000 |
Other income (expense): | ||
Interest expense, net | (7,244,000) | (5,436,000) |
Equity in losses of unconsolidated entities | (11,133,000) | (5,334,000) |
Investment loss from Eton Pharmaceuticals | (2,914,000) | (10,126,000) |
Loss on early extinguishment of debt | (756,000) | |
Gain on forgiveness of PPP loan | 1,967,000 | |
Gain on sale of non-ophthalmology assets | 5,259,000 | |
Other income, net | 102,000 | 197,000 |
Total other expense, net | (15,930,000) | (19,488,000) |
Loss before income tax provision | (14,011,000) | (17,874,000) |
Income tax provision | (75,000) | (133,000) |
Net loss | (14,086,000) | (18,007,000) |
Preferred dividends and accretion of preferred stock issuance costs | (472,000) | |
Net loss attributable to common stockholders | $ (14,086,000) | $ (18,479,000) |
Basic and diluted net loss per share of common stock | $ (0.51) | $ (0.69) |
Weighted average number of shares of common stock outstanding, basic and diluted | 27,460,968 | 26,757,451 |
Product Sales Net [Member] | ||
Revenues: | ||
Total revenues | $ 83,524,000 | $ 69,104,000 |
Other Revenues [Member] | ||
Revenues: | ||
Total revenues | $ 5,071,000 | $ 3,372,000 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total Harrow Health, Inc. Stockholders' Equity [Member] | Noncontrolling Interest [Member] | Total |
Beginning balance at Dec. 31, 2020 | $ 26,000 | $ 104,557,000 | $ (77,400,000) | $ 27,183,000 | $ (355,000) | $ 26,828,000 | |
Beginning balance, shares at Dec. 31, 2020 | 25,749,875 | ||||||
Exercise of employee stock-based options | 65,000 | 65,000 | 65,000 | ||||
Exercise of employee stock-based options, shares | 25,480 | ||||||
Exercise of warrants | |||||||
Exercise of warrants, shares | 311,369 | ||||||
Vesting of RSUs | $ 1,000 | (1,000) | |||||
Vesting of RSUs, shares | 1,207,500 | ||||||
Shares withheld related to net share settlement of equity awards | (3,228,000) | (3,228,000) | (3,228,000) | ||||
Shares withheld related to net share settlement of equity awards, shares | (391,461) | ||||||
Issuance of preferred shares, net of discounts and issuance costs | 10,655,000 | 10,655,000 | 10,655,000 | ||||
Issuance of preferred shares, net of discount and issuance costs, shares | 440,000 | ||||||
Redemption of preferred shares | (11,000,000) | (11,000,000) | (11,000,000) | ||||
Redemption of preferred shares, shares | (440,000) | ||||||
Payment of preferred dividends | (127,000) | (127,000) | (127,000) | ||||
Stock-based compensation expense | 5,745,000 | 5,745,000 | 5,745,000 | ||||
Net loss | (18,007,000) | (18,007,000) | (18,007,000) | ||||
Ending balance at Dec. 31, 2021 | $ 27,000 | 106,666,000 | (95,407,000) | 11,286,000 | (355,000) | 10,931,000 | |
Ending balance, shares at Dec. 31, 2021 | 26,902,763 | ||||||
Exercise of employee stock-based options | $ 1,000 | 586,000 | 587,000 | 587,000 | |||
Exercise of employee stock-based options, shares | 221,086 | ||||||
Exercise of warrants | |||||||
Exercise of warrants, shares | 306,347 | ||||||
Vesting of RSUs | $ 1,000 | (1,000) | |||||
Vesting of RSUs, shares | 185,000 | ||||||
Shares withheld related to net share settlement of equity awards | $ (1,000) | (875,000) | (876,000) | (876,000) | |||
Shares withheld related to net share settlement of equity awards, shares | (109,771) | ||||||
Stock-based compensation expense | 7,974,000 | 7,974,000 | 7,974,000 | ||||
Net loss | (14,086,000) | (14,086,000) | (14,086,000) | ||||
Exercise of consultant stock-based options | 55,000 | 55,000 | 55,000 | ||||
Exercise of consultant stock based options, shares | 19,679 | ||||||
Issuance of common shares from public offering, net of offering costs | $ 2,000 | 22,653,000 | 22,655,000 | 22,655,000 | |||
Issuance of common shares from public offering, net of offering costs, shares | 2,376,426 | ||||||
Ending balance at Dec. 31, 2022 | $ 30,000 | $ 137,058,000 | $ (109,493,000) | $ 27,595,000 | $ (355,000) | $ 27,240,000 | |
Ending balance, shares at Dec. 31, 2022 | 29,901,530 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (14,086,000) | $ (18,007,000) |
Adjustments to reconcile net loss to net cash provided by operating activities: | ||
Depreciation and amortization of property, plant and equipment | 1,477,000 | 1,717,000 |
Amortization of intangible assets | 1,578,000 | 161,000 |
Amortization of operating lease right-of-use assets | 610,000 | 518,000 |
Provision for bad debt expense | 81,000 | 35,000 |
Amortization of debt issuance costs and discount | 782,000 | 677,000 |
Gain on forgiveness of PPP loan | (1,967,000) | |
Investment loss from Eton Pharmaceuticals | 2,914,000 | 10,126,000 |
Equity in losses of unconsolidated entities | 11,133,000 | 5,334,000 |
Loss on disposal of equipment | 69,000 | 41,000 |
Loss on early extinguishment of loan | 706,000 | |
Impairment of long-lived assets | 249,000 | |
Stock-based compensation | 7,974,000 | 5,745,000 |
Gain on sale of non-ophthalmology assets | (5,259,000) | |
Changes in assets and liabilities: | ||
Accounts receivable | (1,860,000) | (1,831,000) |
Inventories | (2,324,000) | (255,000) |
Prepaid expenses and other current assets | (4,256,000) | (621,000) |
Accounts payable and accrued expenses | 1,839,000 | 1,730,000 |
Accrued payroll and related liabilities | 936,000 | 774,000 |
Deferred revenue and customer deposits | 97,000 | (50,000) |
NET CASH PROVIDED BY OPERATING ACTIVITIES | 1,705,000 | 5,082,000 |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Net proceeds from sale of investments | 9,826,000 | |
Issuance of note receivable, Melt Pharmaceuticals | (12,592,000) | |
Proceeds from sale of non-ophthalmology assets | 6,000,000 | |
Proceeds from sale of property, plant and equipment | 30,000 | |
Investment in patent and trademark assets | (176,000) | (84,000) |
Purchase of licenses, product NDAs and patents | (5,000,000) | (14,050,000) |
Purchases of property, plant and equipment | (2,597,000) | (1,786,000) |
NET CASH USED IN INVESTING ACTIVITIES | (1,743,000) | (18,686,000) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Payments on finance lease obligations | (18,000) | (7,000) |
Proceeds from 8.625% notes payable, net of costs | 71,073,000 | |
Proceeds from 11.875% notes payable, net of costs | 31,738,000 | |
Principal and exit fee payments on SWK loan | (15,961,000) | |
Proceeds from common stock, net of offering costs | 22,655,000 | |
Payment of taxes upon vesting of RSUs | (876,000) | (3,228,000) |
Proceeds from exercise of stock options | 642,000 | 65,000 |
Sale of preferred stock, net of discount and issuance costs | 10,655,000 | |
Repayment of preferred stock | (11,000,000) | |
Payment of preferred stock dividends | (127,000) | |
NET CASH PROVIDED BY FINANCING ACTIVITIES | 54,141,000 | 51,470,000 |
NET CHANGE IN CASH AND CASH EQUIVALENTS | 54,103,000 | 37,866,000 |
CASH AND CASH EQUIVALENTS, beginning of year | 42,167,000 | 4,301,000 |
CASH AND CASH EQUIVALENTS, end of year | 96,270,000 | 42,167,000 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | ||
Cash paid for income taxes | 75,000 | 11,000 |
Cash paid for interest | 6,480,000 | 4,823,000 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING | ||
Purchase of property, plant and equipment included in accounts payable and accrued expenses | 123,000 | 123,000 |
Purchase of intangible asset included in accounts payable and accrued expenses | 5,000,000 | |
Right-of-use assets obtained in exchange for new operating lease obligations | 2,188,000 | |
Net reduction in right-of-use assets and lease obligations due to modification | 346,000 | |
Melt accounts receivable transferred to note receivable | $ 908,000 |
ORGANIZATION
ORGANIZATION | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION | NOTE 1. ORGANIZATION Harrow Health, Inc. (together with its subsidiaries, partially owned companies and royalty arrangements unless the context indicates or otherwise requires, the “Company” or “Harrow”) is an eyecare pharmaceutical company exclusively focused on the discovery, development, and commercialization of innovative ophthalmic therapies that are accessible and affordable. The Company owns non-controlling equity positions in Surface Ophthalmics, Inc. (“Surface”) and Melt Pharmaceuticals, Inc. (“Melt”), both companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in various drug candidates being developed by Surface and Melt. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation Harrow has prepared the accompanying consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying consolidated financial statements include the accounts of the Company and its wholly owned and majority-owned subsidiaries. Harrow consolidates entities in which it has a controlling financial interest. The Company assesses control under the variable interest entity (“VIE”) model to determine whether the Company is the primary beneficiary of that entity’s operations. The Company consolidates (i) entities in which it holds and/or controls, directly or indirectly, more than 50% of the voting rights Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting periods. Significant estimates made by management are, among others, allowance for doubtful accounts, variable consideration determined based on accruals for chargebacks, administrative fees and rebates, government rebates, returns and other allowances, renewal periods and discount rates for leases, realizability of inventories, recoverability of investments, realizability of deferred taxes, goodwill and intangible assets, recoverability of long-lived assets and goodwill, fair value of loans payable, and valuation of stock-based transactions with employees and non-employees. Actual results could differ from those estimates. Risks, Uncertainties and Liquidity The Company is subject to certain regulatory standards, approvals, guidelines and inspections which could impact the Company’s ability to make, dispense, and sell certain products. If the Company was required to cease compounding and selling certain products as a result of regulatory guidelines or inspections, this may have a material impact on the Company’s financial condition, liquidity and results of operations. Noncontrolling Interests The Company recognizes any noncontrolling interest as a separate line item in equity in the consolidated financial statements. A noncontrolling interest represents the portion of equity ownership in a less-than-wholly-owned subsidiary not attributable to the Company. Generally, any interest that holds less than 50% of the outstanding voting shares is deemed to be a noncontrolling interest; however, there are other factors that are considered as well, such as decision-making rights The Company provides in the consolidated statements of stockholders’ equity a reconciliation at the beginning and the end of the period of the carrying amount of total equity, equity attributable to the parent, and equity attributable to the noncontrolling interests that separately discloses: 1. net income or loss; 2. transactions with owners acting in their capacity as owners, showing separately contributions from and distributions to owners; and 3. each component of other income or loss The noncontrolling interests in the consolidated balance sheets as of December 31, 2022 and 2021, relate to consolidated subsidiaries that the Company owns a controlling stake in, but not 100 Segments As a result of shifts in the Company’s strategic plans to further focus on growing the Company’s ImprimisRx business and suspension of activities related to starting up development-stage pharmaceutical companies, along with changes to the Company’s organizational and internal reporting structure, beginning in January 2022, management no longer evaluates the Company’s business in two segments and instead focuses on the performance of the business as a single operating business. Revenue Recognition and Deferred Revenue The Company recognizes revenue at the time of 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 (see Note 3). Cost of Sales Cost of sales includes direct and indirect costs to manufacture formulations and other products sold, including active pharmaceutical ingredients, personnel costs, packaging, storage, royalties, shipping and handling costs, depreciation and amortization of certain intangible assets and the write-off of obsolete inventory. Research and Development Research and development (“R&D”) expenses consist of expenses incurred in performing research and development activities, including salaries and benefits, other overhead expenses, and costs related to clinical trials, contract services and outsourced contracts. We expense all costs related to R&D as they are incurred. Upfront and milestone payments related to the acquisition and licensing of technology for drug and product candidates that are not yet approved by the FDA are considered acquisition of in process R&D and expensed as R&D in the period in which the expense occurs. Debt Issuance Costs and Debt Discount Debt issuance costs and the debt discount are recorded net of loans payable in the consolidated balance sheets. Amortization of debt issuance costs and the debt discount is calculated using the effective interest method over the term of the related debt and is recorded in interest expense in the accompanying consolidated statements of operations. At December 31, 2022, the Company recorded deferred financing costs of $ 1,950,000 Intellectual Property The costs of acquiring intellectual property rights to be used in the research and development process, including licensing fees and milestone payments, are charged to research and development expense as incurred in situations where the Company has not identified an alternative future use for the acquired rights, and are capitalized in situations where we have identified an alternative future use for the acquired rights. Patents and trademarks are recorded at cost and capitalized at a time when the future economic benefits of such patents and trademarks become more certain (see “—Goodwill and Intangible Assets” below). If costs are not capitalized they are expensed as incurred. Income Taxes As part of the process of preparing the Company’s consolidated financial statements, the Company must estimate the actual current tax assets and liabilities and assess permanent and temporary differences that result from differing treatment of items for tax and accounting purposes. The temporary differences result in deferred tax assets and liabilities, which are included within the consolidated balance sheets. The Company must assess the likelihood that the deferred tax assets will be recovered from future taxable income and, to the extent the Company believes that recovery is not more likely than not, a valuation allowance must be established which reduces the amount of deferred tax assets recorded on the consolidated balance sheets. To the extent the Company establishes a valuation allowance or increase or decrease this allowance in a period, the impact will be included in income tax expense in the consolidated statements of operations. The Company accounts for income taxes under the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 740, Income Taxes Cash and Cash Equivalents Cash equivalents include short-term, highly liquid investments with maturities of three months or less at the time of acquisition. Concentrations of Credit Risk The Company places its cash with financial institutions deemed by management to be of high credit quality. The Federal Deposit Insurance Corporation (“FDIC”) provides basic deposit coverage with limits up to $ 250,000 Investment in Eton Pharmaceuticals, Inc. – Related Party The Company’s investment in Eton Pharmaceuticals, Inc. (“Eton”) consists of common stock with a readily determinable fair value which is carried at fair value with changes in fair value recognized in earnings. In accordance with the Accounting Standards Update (“ASU”) 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities 2,914,000 8,720,000 During the year ended December 31, 2021, the Company sold 1,518,000 underwritten public offering at a public offering price of $ 7.00 10,626,000 799,000 1,406,000 1,982,000 10 2.82 5,589,000 8,503,000 Accounts Receivable Accounts receivable are stated net of allowances for doubtful accounts and contractual adjustments. The accounts receivable balance primarily includes amounts due from customers the Company has invoiced or from third-party providers (e.g., insurance companies and governmental agencies), but for which payment has not been received. Charges to bad debt are based on both historical write-offs and specifically identified receivables. Accounts receivable are presented net of allowances for doubtful accounts and contractual adjustments in the amount of $ 779,000 40,000 Inventories Inventories are stated at the lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. The Company evaluates the carrying value of inventories on a regular basis, based on the price expected to be obtained for products in their respective markets compared with historical cost. Write-downs of inventories are considered to be permanent reductions in the cost basis of inventories. The Company also regularly evaluates its inventories for excess quantities and obsolescence (expiration), taking into account such factors as historical and anticipated future sales or use in production compared to quantities on hand and the remaining shelf life of products and active pharmaceutical ingredients on hand. The Company establishes reserves for excess and obsolete inventories as required based on its analyses. Investment in Melt Pharmaceuticals, Inc. – Related Party The Company owns 3,500,000 46 0 100 0 100 The following table summarizes the Company’s investments in Melt as of December 31, 2022: SCHEDULE OF INVESTMENT Cost Share of Equity Method Losses Paid-in-Kind In-substance Capital Contributions Net Carrying value Common stock $ 5,810,000 $ (5,810,000 ) $ - $ - $ - Loan 13,500,000 (13,500,000 ) 2,484,000 (2,484,000 ) - $ 19,310,000 $ (19,310,000 ) $ 2,484,000 $ (2,484,000 ) $ - The following table summarizes the Company’s investments in Melt as of December 31, 2021: Cost Basis Share of Equity Method Losses Paid-in-Kind Interest In-substance Capital Contributions Net Carrying value Common stock $ 5,810,000 $ (5,810,000 ) $ - $ - $ - Loan 13,500,000 (2,367,000 ) 576,000 (576,000 ) 11,133,000 $ 19,310,000 $ (8,177,000 ) $ 576,000 $ (576,000 ) $ 11,133,000 At December 31, 2022 and 2021, the Company recorded $ 139,000 48,000 See Note 5 for more information and related party disclosure regarding Melt. Investment in Surface Ophthalmics, Inc. – Related Party The Company owns 3,500,000 20 0 The following table summarizes the Company’s investment in Surface as of December 31, 2022 and 2021: SCHEDULE OF INVESTMENT Cost Basis Share of Equity Method Losses Net Carrying value Common stock $ 5,320,000 $ (5,320,000 ) $ - See Note 6 for more information and related party disclosure regarding Surface. Impairment of Equity Method Investment and Note Receivable On a quarterly basis, management assesses whether there are any indicators that the carrying value of the Company’s equity method investments and note receivable may be other than temporarily impaired. Indicators include financial condition, operating performance, and near-term prospects of the investee. To the extent indicators suggest that a loss in value may have occurred, the Company will evaluate both quantitative and qualitative factors to determine if the loss in value is other than temporary. If a potential loss in value is determined to be other than temporary, the Company will recognize an impairment loss based on the estimated fair value of the equity method investments and note receivable. At December 31, 2022 and December 31, 2021, no indicators of impairment existed. Property, Plant and Equipment Property, plant and equipment is stated at cost less accumulated depreciation and amortization. Depreciation and amortization is calculated using the straight-line method over the estimated useful life of the asset. Leasehold improvements and capital lease equipment are amortized over the estimated useful life or remaining lease term, whichever is shorter. Computer hardware and furniture and equipment are depreciated over three five years Capitalized Software Costs The Company capitalizes certain costs related to the development of internal-use software. Costs incurred during the application development phase are capitalized only when the Company believes it is probable the development will result in new or additional functionality. The types of costs capitalized during the application development phase include consulting fees for third-party developers working on these projects. Costs related to the preliminary project stage and post-implementation activities are expensed as incurred. Internal-use software is amortized on a straight-line basis over the estimated useful life of the asset, which ranges from two five years Goodwill and Intangible Assets Patents and trademarks are recorded at cost and capitalized at a time when the future economic benefits of such patents and trademarks become more certain. At that time, the Company capitalizes third-party legal costs and filing fees associated with obtaining and prosecuting claims related to its patents and trademarks. Once the patents have been issued, the Company amortizes these costs over the shorter of the legal life of the patent or its estimated economic life, generally 20 10 The Company reviews its goodwill and indefinite-lived intangible assets for impairment as of January 1 of each year and when an event or a change in circumstances indicates the fair value of a reporting unit may be below its carrying amount. Events or changes in circumstances considered as impairment indicators include but are not limited to the following: ● significant underperformance of the Company’s business relative to expected operating results; ● significant adverse economic and industry trends; ● significant decline in the Company’s market capitalization for an extended period of time relative to net book value; and ● expectations that a reporting unit will be sold or otherwise disposed. The goodwill impairment test consists of a two-step process as follows: Step 1. The Company compares the fair value of each reporting unit to its carrying amount, including the existing goodwill. The fair value of each reporting unit is determined using a discounted cash flow valuation analysis. The carrying amount of each reporting unit is determined by specifically identifying and allocating the assets and liabilities to each reporting unit based on headcount, relative revenues or other methods as deemed appropriate by management. If the carrying amount of a reporting unit exceeds its fair value, an indication exists that the reporting unit’s goodwill may be impaired and the Company then performs the second step of the impairment test. If the fair value of a reporting unit exceeds its carrying amount, no further analysis is required. Step 2. If further analysis is required, the Company compares the implied fair value of the reporting unit’s goodwill, determined by allocating the reporting unit’s fair value to all of its assets and its liabilities in a manner similar to a purchase price allocation, to its carrying amount. If the carrying amount of the reporting unit’s goodwill exceeds its fair value, an impairment loss will be recognized in an amount equal to the excess. Impairment of Long-Lived Assets Long-lived assets, such as property, plant and equipment, purchased intangibles subject to amortization and patents and trademarks, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized in the amount by which the carrying amount of the asset exceeds the fair value of the asset. Assets to be disposed of would be separately presented in the consolidated balance sheet and reported at the lower of the carrying amount or fair value less costs to sell, and are no longer depreciated. The assets and liabilities of a disposal group classified as held-for-sale would be presented separately in the appropriate asset and liability sections of the consolidated balance sheet, if material. Leases At the inception of a contract the Company determines if the arrangement is, or contains, a lease. Operating lease right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Rent expense is recognized on a straight-line basis over the lease term. The Company has made certain accounting policy elections whereby it (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12-months of less) and (ii) combines lease and non-lease elements of its operating leases. As of December 31, 2022, the Company did not have any finance leases. Fair Value Measurements Fair value measurements are determined based on the assumptions that market participants would use in pricing an asset or liability. GAAP establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. The established fair value hierarchy prioritizes the use of inputs used in valuation methodologies into the following three levels: ● Level 1: Applies to assets or liabilities for which there are quoted prices (unadjusted) for identical assets or liabilities in active markets. A quoted price in an active market provides the most reliable evidence of fair value and must be used to measure fair value whenever available. ● Level 2: Applies to assets or liabilities for which there are significant other observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data. ● Level 3: Applies to assets or liabilities for which there are significant unobservable inputs that reflect a reporting entity’s own assumptions about the assumptions that market participants would use in pricing an asset or liability. For example, Level 3 inputs would relate to forecasts of future earnings and cash flows used in a discounted future cash flows method. At December 31, 2022 and 2021, the Company measured its investment in Eton on a recurring basis. The Company’s investment in Eton is classified as Level 1 as the fair value is determined using quoted market prices in active markets for the same securities. As of December 31, 2022 and 2021, the fair market value of the Company’s investment in Eton was $ 5,589,000 8,503,000 The Company carries the 2026 Notes at face value, including the unamortized premium, less unamortized debt issuance costs, and the 2027 Notes are carried at face value less unamortized debt issuance costs on the consolidated balance sheets and presents fair value for disclosure purposes only. The 2026 Notes and 2027 Notes are classified as Level 1 instruments as the fair value is determined using quoted market prices in active markets for the same securities. The following table presents the estimated fair values and the carrying values: SCHEDULE OF ESTIMATED FAIR VALUE December 31, 2022 2021 Carrying Value Fair Value Carrying Value Fair Value 2026 Notes $ 72,436,000 $ 71,550,000 $ 71,654,000 $ 78,810,000 2027 Notes $ 31,738,000 $ 35,112,000 $ - $ - The Company’s other financial instruments include cash and cash equivalents, accounts receivable, accounts payable and accrued expenses, accrued payroll and related liabilities, deferred revenue and customer deposits and operating and finance lease liabilities. The carrying amount of these financial instruments, except for operating and finance lease liabilities, approximates fair value due to the short-term maturities of these instruments. Based on borrowing rates currently available to the Company, the carrying values of the operating and finance lease liabilities approximate their respective fair values. Stock-Based Compensation All stock-based payments to employees, directors and consultants, including grants of stock options, warrants, restricted stock units (“RSUs”) and restricted stock, are recognized in the consolidated financial statements based upon their estimated fair values. The Company uses the Black-Scholes-Merton option pricing model and Monte Carlo simulation model to estimate the fair value of stock-based awards. The estimated fair value is determined at the date of grant. The financial statement effect of forfeitures is estimated at the time of grant and revised, if necessary, if the actual effect differs from those estimates. Basic and Diluted Net Loss per Common Share Basic net loss per common share is computed by dividing net loss attributable to common stockholders for the period by the weighted average number of common shares outstanding during the period. Diluted income per share is computed by dividing the income attributable to common stockholders for the period by the weighted average number of common and common equivalent shares, such as stock options and warrants, outstanding during the period. Basic and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period. Common stock equivalents (using the treasury stock or “if converted” method) from stock options, unvested restricted stock units (“RSUs”) and warrants were 5,089,420 5,646,594 319,859 267,761 The following table shows the computation of basic net loss per share of common stock for the years ended December 31, 2022 and 2021: SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE 2022 2021 For the Years Ended December 31, 2022 2021 Numerator – net loss attributable to Harrow Health, Inc. common stockholders $ (14,086,000 ) $ (18,479,000 ) Denominator – weighted average number of shares outstanding, basic 27,460,968 26,757,451 Net loss per share, basic and diluted $ (0.51 ) $ (0.69 ) Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments In March 2022, the FASB issued ASU 2022-02, Financial Instruments-Credit Losses (Topic 326): Troubled Debt Restructurings and Vintage Disclosures Reclassifications Certain prior period items and amounts have been reclassified to conform to the classifications used to prepare the consolidated financial statements for the current period. These reclassifications had no material impact on the Company’s consolidated financial position, results of operations, or cash flows as previously reported. |
REVENUES
REVENUES | 12 Months Ended |
Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
REVENUES | NOTE 3. REVENUES The Company accounts for contracts with customers in accordance with ASC 606, Revenues from Contracts with Customers Product Revenues The Company sells prescription medications directly through its pharmacy, outsourcing facility and 3PL partner. Revenue from the Company’s pharmacy services includes: (i) the portion of the price the client pays directly to the Company, net of any volume-related or other discounts paid back to the client, (ii) the price paid to the Company by individuals, and (iii) customer copayments made directly to the pharmacy network. Sales taxes are not included in revenue. Following the core principles of ASC 606, the Company has identified the following: 1. Identify the contract(s) with a customer 2. Identify the performance obligations in the contract 3. Determine the transaction price 4. Allocate the transaction price to the performance obligations in the contract 5. Recognize revenue when (or as) the entity satisfies a performance obligation Commission Revenues The Company has entered into an agreement whereby it is paid a fee calculated based on sales the Company generates from a pharmaceutical product that is owned by a third party. The revenue earned from this arrangement is recognized, at which point there is no future performance obligation required by the Company and no consequential continuing involvement on the Company’s part to recognize the associated revenue. Revenues From Transfer of Acquired Product Profit The Company entered into an agreement whereby it purchased the exclusive commercial rights to assets associated with certain ophthalmic products from another pharmaceutical company (the “Seller”). During a temporary, six month transition period, the Seller continued Intellectual Property License Revenues The Company currently holds five intellectual property licenses and related agreements pursuant to which the Company has agreed to license or sell to a customer with the right to access the Company’s intellectual property. License arrangements may consist of non-refundable upfront license fees, data transfer fees, research reimbursement payments, exclusive license rights to patented or patent pending compounds, technology access fees, and various performance or sales milestones. These arrangements can be multiple-element arrangements, the revenue of which is recognized at the point in time that the performance obligation is met. Non-refundable fees that are not contingent on any future performance by the Company and require no consequential continuing involvement on the part of the Company are recognized as revenue when the license term commences and the licensed data, technology, compounded drug preparation and/or other deliverable is delivered. Such deliverables may include physical quantities of compounded drug preparations, design of the compounded drug preparations and structure-activity relationships, the conceptual framework and mechanism of action, and rights to the patents or patent applications for such compounded drug preparations. The Company defers recognition of non-refundable fees if it has continuing performance obligations without which the technology, right, product or service conveyed in conjunction with the non-refundable fee has no utility to the licensee and that are separate and independent of the Company’s performance under the other elements of the arrangement. In addition, if the Company’s continued involvement is required, through research and development services that are related to its proprietary know-how and expertise of the delivered technology or can only be performed by the Company, then such non-refundable fees are deferred and recognized over the period of continuing involvement. Guaranteed minimum annual royalties are recognized on a straight-line basis over the applicable term. Revenue disaggregated by revenue source for the years ended December 31, 2022 and 2021, consists of the following: SCHEDULE OF DISAGGREGATED REVENUE 2022 2021 For the Years Ended December 31, 2022 2021 Product sales, net $ 83,524,000 $ 69,104,000 Commissions 3,866,000 3,253,000 Transfer of profit 1,205,000 99,000 License - 20,000 Total revenues $ 88,595,000 $ 72,476,000 Deferred revenue and customer deposits at December 31, 2022 and 2021, were $ 113,000 16,000 |
RECENT PRODUCT ACQUISITIONS, LI
RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES | 12 Months Ended |
Dec. 31, 2022 | |
Recent Product Acquisitions Licenses And Divestitures | |
RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES | NOTE 4. RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES Acquisition of ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE In December 2022, the Company entered into an Asset Purchase Agreement (the “Fab 5 APA”) with Novartis Technology, LLC and Novartis Innovative Therapies AG (together, “Novartis”), pursuant to which the Company agreed to purchase from Novartis the exclusive commercial rights to assets associated with the following ophthalmic products (collectively the “Fab 5 Products”) in the U.S. (the “Fab 5 Acquisition”): ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE. Subsequent to December 31, 2022, the Company closed the Fab 5 Acquisition in January 2023 (see Note 20). Under the terms of the Fab 5 APA, the Company made a one-time payment of $ 130,000,000 45,000,000 Divestiture of Non-Ophthalmic Assets In October 2022, wholly-owned subsidiaries of the Company (“Imprimis”) entered into an Asset Purchase Agreement (the “RPC Agreement”) with Innovation Compounding Pharmacy, LLC (the “Buyer”). Under the terms of the RPC Agreement, Imprimis agreed to sell substantially all of its assets associated with its non-ophthalmology related compounding product line, including but not limited to, certain intellectual property rights, customer lists, databases, and formulations (the “RPC Assets”). The Buyer agreed to make offers of employment to six of the Company’s employees that were responsible for the sales activities associated with the RPC Assets. Under the terms of the RPC Agreement, the Buyer paid Imprimis an aggregate cash amount of $ 6,000,000 4,500,000 In connection with the RPC Agreement, Imprimis entered into a separate transition services agreement with the Buyer related to providing on going services associated with the RPC Assets, such as procuring and dispensing prescription orders, providing accounting and billing services and collecting accounts receivable. The Company expects Imprimis to provide transition services to the Buyer for up to six to nine months following the effective date of the RPC Agreement. The Company collected and will continue to collect cash on behalf of the Buyer for revenue generated by sales of RPC Assets from October 2022 through the transition period and the Company is obligated to transfer cash generated by such sales to the Buyer. The Company’s consolidated balance sheet as of December 31, 2022 reflected $ 579,000 128,000 The amount due from the Buyer for reimbursement of services performed under the transition services agreement was $ 254,000 453,000 102,000 The Company determined that the disposal of the related net assets does not qualify for reporting as discontinued operations because it does not represent a strategic shift that has or will have a major effect on the Company’s operations and financial results. During the year ended December 31, 2022, the Company recognized a net gain on the sale of the non-ophthalmology related compounding assets as follows: SCHEDULE OF NET GAIN ON SALE OF ASSETS Gross consideration $ 6,000,000 Closing and transaction costs 55,000 Net proceeds 5,945,000 Book value of assets transferred: Customer relations intangible asset 686,000 Gain on sale of non-ophthalmology assets $ 5,259,000 Acquisition of IOPIDINE, MAXITROL and MOXEZA In December 2021, the Company entered into an Asset Purchase Agreement (the “NVS Agreement”) with Novartis Technology, LLC and Novartis Ophthalmics AG (together, “NVS”), pursuant to which the Company purchased from NVS the exclusive commercial rights, including the NDAs, to assets associated with ophthalmic products Moxeza, Iopidine 1% and 0.5%, and Maxitrol eyedrops suspension (collectively the “NVS Products”) in the United States of America (“U.S.”) 14,050,000 Pursuant to the NVS NVS NVS NVS NVS NVS NVS NVS The Company accounted for this transaction as an asset acquisition, as the Company only acquired the rights and related intellectual property for the NVS Products and the cost was allocated to the acquired patents and NDAs based on their relative fair values. License and Supply Agreement for IHEEZO In July 2021, the Company entered into a License and Supply Agreement (the “Sintetica Agreement”) with Sintetica S.A. (“Sintetica”), pursuant to which Sintetica granted the Company the exclusive license and marketing rights to its patented ophthalmic drug candidate (“IHEEZO”) in the U.S. and Canada. Pursuant to the Sintetica Agreement, the Company agreed to pay Sintetica a per unit transfer price to supply IHEEZO, along with a per unit royalty for units sold. The Company is required to pay Sintetica up to $ 18,000,000 5,000,000 3,117,000 10,000,000 Subject to certain limitations, the Sintetica Agreement has a ten-year term, and allows for a ten-year extension if certain sales thresholds are met. License and Purchase of MAQ-100 In August 2021, the Company entered into a License Agreement and a Basic Sale and Purchase Agreement (together, the “Wakamoto Agreements”) with Wakamoto Pharmaceutical Co., Ltd. (“Wakamoto”), pursuant to which Wakamoto granted the Company the exclusive license and marketing rights to its ophthalmic drug candidate (“MAQ-100”) in the U.S. and Canada. Pursuant to the Wakamoto 2,000,000 6,200,000 Subject to certain limitations, the term of the Wakamoto Agreements is for five years from the date of the FDA’s market approval of MAQ-100 and allows for a five-year extension if certain unit sales thresholds are met. |
INVESTMENT IN MELT PHARMACEUTIC
INVESTMENT IN MELT PHARMACEUTICALS, INC. AND AGREEMENTS - RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
INVESTMENT IN MELT PHARMACEUTICALS, INC. AND AGREEMENTS - RELATED PARTY TRANSACTIONS | NOTE 5. INVESTMENT IN MELT PHARMACEUTICALS, INC. AND AGREEMENTS - RELATED PARTY TRANSACTIONS In December 2018, the Company entered into an asset purchase agreement with Melt (the “Melt Asset Purchase Agreement”). Pursuant to the terms of the Melt Asset Purchase Agreement, Melt was assigned certain intellectual property and related rights from the Company to develop, formulate, make, sell, and sub-license certain Company conscious sedation and analgesia related formulations (collectively, the “Melt Products”). Under the terms of the Melt Asset Purchase Agreement, Melt is required to make mid-single digit royalty payments to the Company on net sales of the Melt Products while any patent rights remain outstanding, as well as other conditions. In February 2019, the Company and Melt entered into a Management Service Agreement between the Company and Melt (the “Melt MSA”), whereby the Company provides to Melt certain administrative services and support, including bookkeeping, web services and human resources related activities, and Melt is required to pay the Company a monthly amount of $ 10,000 During the year ended December 31, 2022, the Company recorded $ 91,000 As of December 31, 2022 and December 31, 2021, the Company was due $ 139,000 48,000 The Company’s Chief Executive Officer, Mark L. Baum, was previously a member of the Melt board of directors until his resignation during the year ended December 31, 2021. Following Mr. Baum’s departure, the Company did not have any representation on Melt’s board of directors until January 2023, when The unaudited condensed results of operations information of Melt is summarized below: SCHEDULE OF CONDENSED INCOME STATEMENT 2022 2021 For the Years Ended December 31, 2022 2021 Revenues, net $ - $ - Loss from operations $ 12,443,000 $ 6,069,000 Net loss $ (14,446,000 ) $ (6,655,000 ) The unaudited condensed balance sheet information of Melt is summarized below: SCHEDULE OF CONDENSED BALANCE SHEET 2022 2021 December 31, 2022 2021 Current assets $ 655,000 $ 11,278,000 Non-current assets 107,000 - Total assets $ 762,000 $ 11,278,000 Total liabilities $ 19,056,000 $ 15,732,000 Total preferred stock and stockholders’ deficit (18,294,000 ) (4,454,000 ) Total liabilities and stockholders’ equity $ 762,000 $ 11,278,000 Melt Note Receivable On September 1, 2021, the Company entered into a loan and security agreement in the principal amount of $ 13,500,000 12.50 10,000,000 Melt has granted the Company a security interest in substantially all of its personal property, rights and assets, including intellectual property rights, to secure the payment of all amounts owed under the Melt Loan Agreement. The Melt Loan Agreement contains customary representations, warranties and covenants, including covenants by Melt limiting additional indebtedness, liens, mergers and acquisitions, dispositions, investments, distributions, subordinated debt, and transactions with affiliates. The Melt Loan Agreement includes customary events of default, and upon the occurrence of an event of default (subject to cure periods for certain events of default), all amounts owed by Melt thereunder may be declared immediately due and payable by the Company, and the interest rate on the loan may be increased by 3 In connection with the Melt Loan Agreement, the Company and Melt entered into a Right of First Refusal Agreement providing the Company with the right, but not the obligation, to match any offer received by Melt associated with the commercial rights to any of Melt’s drug candidates for a period of five years following the effective date of the Melt Loan Agreement. The net funds received by Melt excluded $ 908,000 15,984,000 14,076,000 Investments – Equity Method and Joint Ventures |
INVESTMENT IN SURFACE OPHTHALMI
INVESTMENT IN SURFACE OPHTHALMICS, INC. AND AGREEMENTS - RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2022 | |
Investment In Surface Ophthalmics Inc. And Agreements - Related Party Transactions | |
INVESTMENT IN SURFACE OPHTHALMICS, INC. AND AGREEMENTS - RELATED PARTY TRANSACTIONS | NOTE 6. INVESTMENT IN SURFACE OPHTHALMICS, INC. AND AGREEMENTS - RELATED PARTY TRANSACTIONS The Company entered into an asset purchase and license agreement with Surface in 2017 and amended it in April 2018 (the “Surface License Agreements”). Pursuant to the terms of the Surface License Agreements, the Company assigned and licensed to Surface certain intellectual property and related rights associated with Surface’s drug candidates (collectively, the “Surface Products”). Surface is required to make mid-single digit royalty payments to the Company on net sales of the Surface Products while any patent rights remain outstanding. As of December 31, 2022, the Company owned 3,500,000 The unaudited condensed results of operations information of Surface is summarized below: SUMMARY OF CONDENSED INCOME STATEMENT 2022 2021 For the Years Ended December 31, 2022 2021 Revenues, net $ - $ - Loss from operations $ (6,719,000 ) $ 10,468,000 Net loss $ (6,579,000 ) $ (10,143,000 ) The unaudited condensed balance sheet information of Surface is summarized below: SUMMARY OF CONDENSED BALANCE SHEET 2022 2021 December 31, 2022 2021 Current assets $ 15,350,000 $ 21,731,000 Non-current assets 652,000 412,000 Total assets $ 16,002,000 $ 22,143,000 Total liabilities $ 1,586,000 $ 1,514,000 Total stockholders’ equity 14,416,000 20,629,000 Total liabilities and stockholders’ equity $ 16,002,000 $ 22,143,000 |
INVENTORIES
INVENTORIES | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
INVENTORIES | NOTE 7. INVENTORIES Inventories are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, commercial pharmaceutical products, related laboratory supplies and active pharmaceutical ingredients. The composition of inventories as of December 31, 2022 and 2021 was as follows: SCHEDULE OF INVENTORIES 2022 2021 December 31, 2022 2021 Raw materials $ 3,707,000 $ 2,441,000 Work in progress 38,000 - Finished goods 2,796,000 1,776,000 Total inventories $ 6,541,000 $ 4,217,000 |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 12 Months Ended |
Dec. 31, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | NOTE 8. PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consisted of the following: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS 2022 2021 December 31, 2022 2021 Prepaid insurance $ 858,000 $ 728,000 Prepaid computer software related expenses 1,165,000 248,000 Other prepaid expenses 1,331,000 189,000 Receivable due from Melt 139,000 48,000 Deposits and other current assets 118,000 92,000 Total prepaid expenses and other current assets $ 3,611,000 $ 1,305,000 |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT | NOTE 9. PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment, net at December 31, 2022 and 2021 consisted of the following: SCHEDULE OF PROPERTY,PLANT AND EQUIPMENT 2022 2021 December 31, 2022 2021 Property, plant and equipment, net: Computer hardware $ 979,000 $ 772,000 Furniture and equipment 860,000 443,000 Lab and pharmacy equipment 4,259,000 4,056,000 Leasehold improvements 6,449,000 5,703,000 Property, plant and equipment, gross 12,547,000 10,974,000 Accumulated depreciation and amortization (9,061,000 ) (7,833,000 ) Property, plant and equipment, net $ 3,486,000 $ 3,141,000 During the years ended December 31, 2022 and 2021, the Company disposed of property, plant and equipment with a net book value of $ 99,000 41,000 150,000 1,253,000 1,580,000 During the year ended December 31, 2021, the Company purchased lab and pharmacy equipment at a cost of $ 753,000 |
CAPITALIZED SOFTWARE COSTS
CAPITALIZED SOFTWARE COSTS | 12 Months Ended |
Dec. 31, 2022 | |
Capitalized Software Costs | |
CAPITALIZED SOFTWARE COSTS | NOTE 10. CAPITALIZED SOFTWARE COSTS Capitalized software costs at December 31, 2022 and 2021 consisted of the following: SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS 2022 2021 December 31, 2022 2021 Capitalized software costs Capitalized internal-use software development costs $ 1,413,000 $ 942,000 Acquired third-party software license for internal-use 159,000 159,000 Total gross capitalized software for internal-use 1,572,000 1,101,000 Accumulated amortization (793,000 ) (569,000 ) Capitalized internal-use software in process 1,333,000 781,000 Total finite lived intangible assets net $ 2,112,000 $ 1,313,000 The Company recorded amortization expense of $ 224,000 137,000 |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS AND GOODWILL | NOTE 11. INTANGIBLE ASSETS AND GOODWILL The Company’s intangible assets at December 31, 2022 consisted of the following: SCHEDULE OF INTANGIBLE ASSETS Amortization Net periods Accumulated Carrying (in years) Cost amortization Sold value Patents 7 19 years Indefinite $ 980,000 $ (161,000 ) $ - $ 819,000 Licenses 20 years 100,000 (23,000 ) - 77,000 Trademarks Indefinite 267,000 - - 267,000 Acquired NDAs 10 years 23,720,000 (1,363,000 ) - 22,357,000 Customer relationships 3 15 years 1,519,000 (759,000 ) (626,000 ) 134,000 Trade name 5 years 75,000 (5,000 ) - 70,000 Non-competition clause 3 4 years 50,000 (50,000 ) - - State pharmacy licenses 25 years 8,000 (7,000 ) - 1,000 $ 26,719,000 $ (2,368,000 ) $ (626,000 ) $ 23,725,000 During the year ended December 31, 2022, the Company recorded a net reduction to customer relationships intangible assets of $ 626,000 The Company’s intangible assets at December 31, 2021 consisted of the following: Amortization Net periods Accumulated Carrying (in years) Cost amortization Impairment value Patents 7 19 years $ 966,000 $ (75,000 ) $ - $ 891,000 Licenses 20 100,000 (7,000 ) - 93,000 Trademarks Indefinite 359,000 - (99,000 ) 260,000 Acquired NDAs 10 13,635,000 - - 13,635,000 Customer relationships 3 15 years 1,519,000 (586,000 ) - 933,000 Trade name 5 5,000 (5,000 ) - - Non-competition clause 3 4 years 50,000 (50,000 ) - - State pharmacy licenses 25 years 8,000 (7,000 ) - 1,000 $ 16,642,000 $ (730,000 ) $ (99,000 ) $ 15,813,000 During the year ended December 31, 2021, the Company recorded impairment charges of $ 99,000 See Note 4 related to intangible assets acquired and divested during the years ended December 31, 2022 and 2021. Amortization expense for intangible assets for the years ended December 31, 2022 and 2021 were as follows: SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS 2022 2021 For the Years Ended December 31, 2022 2021 Patents $ 86,000 $ 26,000 Licenses 16,000 2,000 Acquired NDAs 1,363,000 - Customer relationships 113,000 133,000 Amortization of intangible assets $ 1,578,000 $ 161,000 Estimated future amortization expense for the Company’s intangible assets at December 31, 2022 is as follows: SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE Years ending December 31, 2023 2,521,000 2024 2,521,000 2025 2,521,000 2026 2,521,000 2027 2,521,000 Thereafter 10,853,000 Intangible assets $ 23,458,000 There were no |
ACCOUNTS PAYABLE AND ACCRUED EX
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | NOTE 12. ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses at December 31, 2022 and 2021 consisted of the following: SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES 2022 2021 December 31, 2022 2021 Accounts payable $ 6,440,000 $ 5,174,000 Accrued insurance premium 575,000 - Accrued IHEEZO milestone payments (see Note 4) 5,000,000 - Accrued RPC transition payments (see Note 4) 453,000 - Accrued litigation settlements 49,000 49,000 Accrued interest (see Note 13) 1,254,000 1,114,000 Total accounts payable and accrued expenses $ 13,771,000 $ 6,337,000 |
DEBT
DEBT | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
DEBT | NOTE 13. DEBT See Note 20 related to debt transactions that occurred subsequent to December 31, 2022. 11.875% Senior Notes Due 2027 In December 2022, the Company closed an offering of $ 35,000,000 25.00 31,738,000 3,626,000 The 2027 Notes are senior unsecured obligations of the Company and rank equally in right of payment with all of the Company’s other existing and future senior unsecured and unsubordinated indebtedness. The 2027 Notes are effectively subordinated in right of payment to all of the Company’s existing and future secured indebtedness and structurally subordinated to all existing and future indebtedness of the Company’s subsidiaries, including trade payables. The 2027 Notes bear interest at the rate of 11.875% December 31, 2027 At any time prior to December 31, 2024, the Company may, at its option, redeem the 2027 Notes, in whole at any time or in part from time to time, at a redemption price equal to 100% of the principal amount of the 2027 Notes to be redeemed, plus a make-whole amount, if any, plus accrued and unpaid interest to, but excluding, the date of redemption. The Company may redeem the 2027 Notes for cash in whole or in part at any time at its option (i) on or after December 31, 2024 and prior to December 31, 2025, at a price equal to $25.50 per note, plus accrued and unpaid interest to, but excluding, the date of redemption, (ii) on or after December 31, 2025 and prior to December 31, 2026, at a price equal to $25.25 per note, plus accrued and unpaid interest to, but excluding, the date of redemption, and (iii) on or after December 31, 2026 and prior to maturity, at a price equal to 100% of their principal amount, plus accrued and unpaid interest to, but excluding, the date of redemption. In addition, the Company is required to redeem the 2027 Notes, for cash, in whole but not in part, at the price of $25.50 per note 8.625% Senior Notes Due 2026 In April 2021, the Company closed an offering of $ 50,000,000 5,000,000 25.00 51,909,000 3,091,000 20,000,000 25.75 278,000 19,164,000 1,158,000 322,000 T 8.625% April 30, 2026 issuance costs were recorded as a debt discount and are being amortized as interest expense, net of the amortization of the premium on note issuance, over the term of the 2026 Notes using the effective interest rate method. Prior to February 1, 2026, the Company may, at its option, redeem the 2026 Notes, in whole at any time or in part from time to time, at a redemption price equal to 100% of the principal amount of the 2026 Notes to be redeemed Interest expense related to the 2026 Notes and 2027 Notes totaled $ 7,378,000 5,132,000 782,000 581,000 B. Riley Loan and Security Agreement On December 14, 2022 (the “Effective Date”), the Company entered into a Loan and Security Agreement (the “BR Loan”) with B. Riley Commercial Capital, LLC, as Administrative Agent for the Lenders. The BR Loan provided for a loan facility of up to $ 100,000,000 December 14, 2025 10.875% The BR Loan is secured by an intellectual property security agreement entered into in connection with the BR Loan, and by all assets of the Company and its material subsidiaries. The outstanding balance of the BR Loan is due in full on the Maturity Date. The BR Loan provides for voluntary prepayment subject to a prepayment fee of $ 0 3.00% The BR Loan also provides for mandatory and customary prepayments, along with customary representations and warranties, covenants and events of default. The covenants set forth in the BR Loan included certain affirmative and negative operational and financial covenants, including, among other things, restrictions on the Company’s ability to incur certain liens, make fundamental changes to its business or engage in transactions with affiliates. No amounts were outstanding under the BR Loan as of December 31, 2022. In January 2023, $ 59,750,000 SWK Senior Note – Paid in April 2021 In July 2017, the Company and several of its wholly owned subsidiaries entered into a term loan and security agreement in the principal amount of $ 16,000,000 (the “SWK Loan Agreement” or “SWK Loan”) with SWK Funding LLC and its partners (collectively, “SWK”), as lender and collateral agent. The SWK Loan Agreement was fully funded at closing with a five-year term; however, such term could be reduced to four years if certain revenue requirements were not achieved. The SWK Loan was secured by substantially all of the Company’s assets, including its intellectual property rights. The SWK Loan was subsequently amended in May 2019 and again in April 2020. The SWK Loan bore an interest rate equal to the three-month London Inter-Bank Offered Rate (subject to a minimum of 2.00% ), plus an applicable margin of 10.00% (the “Margin Rate”); provided that, if, two days prior to a payment date, the Company provided SWK evidence that the Company has achieved a leverage ratio as of such date of less than 4.00:1:00, the Margin Rate shall equal 9.00%; and if the Company had achieved a leverage ratio as of such date of less than 3.00:1:00, the Margin Rate shall equal 7.00% . The leverage ratio means, as of any date of determination, the ratio of: (a) indebtedness as of such date to (b) EBITDA (as defined in the SWK Loan), of the Company for the immediately preceding 12 month period, adding-back (i) actual litigation expenses for the immediately preceding 12 month period, minus (ii) actual litigation expenses for the immediately preceding 3 month period multiplied by 4. A summary of the material changes contained in the amendment entered into with SWK in April 2020 was as follows: ● SWK agreed to make available to the Company, and the Company drew down on, an additional principal amount of $ 1,000,000 ● The definition of the first amortization date was changed to August 14, 2020, permitting the Company to pay interest only on the principal amount loaned for the next payment (payments are due on a quarterly basis) following the SWK Second Amendment; and ● The interest payment of $ 358,000 Interest expense related to the SWK Loan Agreement, as amended, amounted to $ 647,000 96,000 In April 2021, the Company paid $ 15,540,000 756,000 Paycheck Protection Program Loan – Forgiven in March 2021 In April 2020, the Company entered into an unsecured promissory note and related Business Loan Agreement with Renasant Bank, as lender, for a loan (the “PPP Loan”) in the principal amount of $ 1,967,000 1,967,000 At December 31, 2022, future minimum payments under the Company’s debt were as follows (excluding debt transactions that occurred subsequent to December 31, 2022): SCHEDULE OF FUTURE MINIMUM PAYMENTS UNDER NOTES PAYABLES Amount 2023 $ 10,053,000 2024 10,625,000 2025 10,625,000 2026 81,314,000 2027 39,156,000 Total minimum payments 151,773,000 Less: amount representing interest payments (41,773,000 ) Notes payable, gross 110,000,000 Less: unamortized discount, net of premium (5,826,000 ) Notes payable, net of unamortized discount $ 104,174,000 |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2022 | |
Leases | |
LEASES | NOTE 14. LEASES The Company leases office and laboratory space under the non-cancelable operating leases listed below. These lease agreements have remaining terms between one five years ● An operating lease for 5,789 March 2025, with an option to extend the term through March 2028 ● An operating lease for 35,326 July 2026 1,400 8,900 ● An operating lease for 5,500 December 2024 ● An operating lease for 11,552 June 2027 At December 31, 2022 and 2021, the weighted-average discount rate and the weighted-average remaining lease term for the operating leases held by the Company were 6.6% and 6.3% and 10.9 and 14.6 years, respectively. During the years ended December 31, 2022 and 2021, cash paid for amounts included for the operating lease liabilities was $ 925,000 1,000,000 1,117,000 912,000 Future lease payments under operating leases as of December 31, 2022 were as follows : SCHEDULE OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES Operating Leases 2023 $ 1,231,000 2024 1,262,000 2025 1,093,000 2026 1,114,000 2027 972,000 Thereafter 5,829,000 Total minimum lease payments 11,501,000 Less: amount representing interest payments (3,446,000 ) Total operating lease liabilities 8,055,000 Less: current portion, operating lease liabilities (723,000 ) Operating lease liabilities, net of current portion $ 7,332,000 |
STOCKHOLDERS_ EQUITY AND STOCK-
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION | NOTE 15. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION Preferred Stock At December 31, 2022 and 2021, the Company had 5,000,000 0.001 no Series B Cumulative Preferred Stock – Redeemed in June 2021 In May 2021, the Company sold 440,000 0.001 25.00 10,655,000 Series B Preferred Stock was not convertible into our common stock, had no voting rights 9.50% 25.00 In June 2021, the Company redeemed all of the outstanding shares of the Series B Preferred Stock. The redemption price for the 440,000 25.00 11,127,000 472,000 Common Stock At each of December 31, 2022 and 2021, the Company had 50,000,000 0.001 Issuances During the Year Ended December 31, 2022 During the year ended December 31, 2022: ● the Company issued 53,594 125,000 2.40 36,014 35,392 295,000 ● the Company issued 306,347 373,847 2.08 ● the Company issued 4,054 15,995 7.07 11,941 ; ● the Company issued 15,625 55,000 15,625 3.50 ; ● the Company issued 132,100 587,000 132,100 1.70 8.40 ; ● 185,000 110,621 74,379 581,000 and ● 35,693 . Issuances During the Year Ended December 31, 2021 During the year ended December 31, 2021: ● the Company issued 311,369 406,539 1.79 3.75 ● the Company issued 25,480 65,000 25,480 1.70 4.29 ● the Company issued 715,871 1,050,000 334,129 2,760,000 ● the Company issued 100,168 157,500 57,332 468,000 ● 67,297 Stock Option Plan On September 17, 2007, the Company’s Board of Directors and stockholders adopted the Company’s 2007 Incentive Stock and Awards Plan, which was subsequently amended on November 5, 2008, February 26, 2012, July 18, 2012, May 2, 2013 and September 27, 2013 (as amended, the “2007 Plan”). The 2007 Plan reached its term in September 2017, and we can no longer issue additional awards under this plan, however, options previously issued under the 2007 Plan will remain outstanding until they are exercised, reach their maturity or are otherwise cancelled/forfeited. On June 13, 2017, the Company’s Board of Directors and stockholders adopted the Company’s 2017 Incentive Stock and Awards Plan which was subsequently amended on June 3, 2021 (as amended, the “2017 Plan” together with the 2007 Plan, the “Plans”). As of December 31, 2021, the 2017 Plan provides for the issuance of a maximum of 6,000,000 2,057,155 Stock Options A summary of stock option activity under the Plan for the year ended December 31, 2022 is as follows: SCHEDULE OF STOCK OPTION PLAN ACTIVITY Number of shares Weighted Avg. Exercise Price Weighted Avg. Remaining Contractual Life Aggregate Intrinsic Value Options outstanding – January 1, 2022 3,039,546 $ 5.52 Options granted 351,250 $ 7.71 Options exercised (288,720 ) $ 3.65 Options cancelled/forfeited (74,375 ) $ 7.46 Options outstanding – December 31, 2022 3,027,701 $ 5.90 4.48 $ 26,822,000 Options exercisable 2,457,769 $ 5.51 3.97 $ 22,731,000 Options vested and expected to vest 3,026,942 $ 5.90 4.48 $ 26,817,000 The aggregate intrinsic value in the table above represents the total pre-tax amount of the proceeds, net of exercise price, which would have been received by option holders if all option holders had exercised and immediately sold all options with an exercise price lower than the market price on December 31, 2022, based on the closing price of the Company’s common stock of $ 14.76 The intrinsic value of the options exercised in 2022 was $ 2,008,000 During the year ended December 31, 2022, the Company granted stock options to certain employees and a consultant. The stock options were granted with an exercise price equal to the current market price of the Company’s common stock, as reported by the securities exchange on which the common stock was then listed, at the grant date and have contractual terms of 10 Vesting terms for options granted to employees and consultants during the year ended December 31, 2022 generally included one of the following vesting schedules: 25% of the shares subject to the option vest and become exercisable on the first anniversary of the grant date and the remaining 75% of the shares subject to the option vest and become exercisable quarterly in equal installments thereafter over three years On July 31, 2015, the Company granted to its Chief Executive Officer, Mark Baum, an option (the “Baum Performance Option”) to purchase 600,000 7.87 9 15 5 1,876,000 five-year 70% 0.40% With the exception of the Baum Performance Option, the fair value of each option award is estimated on the date of grant using the Black-Scholes-Merton option pricing model. Beginning on April 1, 2019, the Company began calculating expected volatility based solely on the historical volatilities of the common stock of the Company. Prior to April 1, 2019, the expected volatility was based on the historical volatilities of the common stock of the Company and comparable publicly traded companies. The Company previously utilized this methodology based on its estimate that it had limited relevant historical data regarding the volatility of its stock price on which to base a meaningful estimate of expected volatility. The expected term of options granted was determined in accordance with the “simplified approach,” as the Company has limited, relevant, historical data on employee exercises and post-vesting employment termination behavior. The expected risk-free interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The financial statement effect of forfeitures is estimated at the time of grant and revised, if necessary, if the actual effect differs from those estimates. For option grants to employees and directors, the Company assigns a forfeiture factor of 10% The table below illustrates the fair value per share determined using the Black-Scholes-Merton option pricing model with the following assumptions used for valuing options granted to employees: SCHEDULE OF FAIR VALUE ASSUMPTIONS 2022 2021 Weighted-average fair value of options granted $ 4.72 $ 4.97 Expected terms (in years) 6.11 5.00 6.11 Expected volatility 68 72% 69 74% Risk-free interest rate 1.54 3.70% 0.39 0.45% Dividend yield - - The following table summarizes information about stock options outstanding and exercisable at December 31, 2022: SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE Options Outstanding Options Exercisable Range of Exercise Prices Number Weighted Weighted Price Number Weighted Price $ 1.47 2.23 583,112 4.53 $ 1.97 583,112 $ 1.97 $ 2.40 3.50 33,443 4.92 $ 2.84 25,631 $ 2.64 $ 3.95 310,000 3.25 $ 3.95 310,000 $ 3.95 $ 4.08 6.30 550,850 5.11 $ 5.84 518,417 $ 5.90 $ 6.75 7.30 405,000 7.67 $ 7.18 257,625 $ 7.29 $ 7.37 7.79 269,623 5.53 $ 7.54 138,249 $ 7.47 $ 7.87 600,000 2.58 $ 7.87 400,000 $ 7.87 $ 7.89 8.98 68,173 6.84 $ 8.24 44,735 $ 8.27 $ 8.99 180,000 0.33 $ 8.99 180,000 $ 8.99 $ 12.38 27,500 9.84 $ 12.38 - $ - $ 1.47 12.38 3,027,701 4.48 $ 5.90 2,457,769 $ 5.51 As of December 31, 2022, there was approximately $ 1,560,000 4.88 1,130,000 1,636,000 Restricted Stock Units/Performance Stock Units RSU awards are granted subject to certain vesting requirements and other restrictions, including performance and market-based vesting criteria. The grant date fair value of the RSUs, which has been determined based upon the market value of the Company’s common stock on the grant date, is expensed over the vesting period of the RSUs. Grants During the Year Ended December 31, 2022 During the year ended December 31, 2022, the Company’s board of directors were granted 65,615 500,000 A summary of the Company’s RSU activity and related information for the year ended December 31, 2022 is as follows: SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY Number of RSUs Weighted Average Grant Date Fair Value RSUs unvested – January 1, 2022 2,233,202 $ 6.78 RSUs granted 65,615 $ 7.62 RSUs vested (237,098 ) $ 6.70 RSUs cancelled/forfeit - RSUs unvested at December 31, 2022 2,061,719 $ 6.82 As of December 31, 2022, the total unrecognized compensation expense related to unvested RSUs was approximately $ 4,205,000 0.60 6,844,000 4,022,000 Grants During the Year Ended December 31, 2021 During the year ended December 31, 2021, 300,000 2,670,000 During the year ended December 31, 2021, the Company’s board of directors were granted 38,576 400,000 During the year ended December 31, 2021, the Company granted 1,567,913 SCHEDULE OF SHARE BASED COMPENSATION PERFORMANCE STOCK UNITS AWARD ACTIVITY Tranche Number of Shares TSR Target Share Price* Tranche 1 223,988 50% or greater $ 11.70 Tranche 2 335,981 100% or greater $ 15.60 Tranche 3 447,975 150% or greater $ 19.50 Tranche 4 559,969 175% or greater $ 21.45 * Target Share Price assumes that no dividends or like distributions are made to shareholders of the Company. If such distributions are made, the Target Share Price would decrease accordingly, to the benefit of the employee, to account for the dividend/distribution as a part of TSR. The fair value of the 2021 PSUs was $ 10,113,000 five-year 75% 0.72% A summary of the Company’s RSU activity and related information for the year ended December 31, 2021 is as follows: Number of RSUs Weighted Average Grant Date Fair Value RSUs unvested - January 1, 2021 1,601,509 $ 3.14 RSUs granted 1,906,490 $ 6.91 RSUs vested (1,274,797 ) $ 2.40 RSUs cancelled/forfeit - RSUs unvested at December 31, 2021 2,233,202 $ 6.78 Subsidiary Stock-Based Transactions The Company recognized $ 0 87,000 The Company recorded stock-based compensation (including issuance of common stock for services and accrual for stock-based compensation) related to equity instruments granted to employees, directors and consultants as follows: SCHEDULE OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES DIRECTORS CONSULTANTS 2022 2021 For the Year Ended December 31, 2022 2021 Employees – selling, general and administrative $ 6,669,000 $ 4,800,000 Employees – R&D 689,000 527,000 Directors – selling, general and administrative 462,000 418,000 Consultants – selling, general and administrative 154,000 - Total $ 7,974,000 $ 5,745,000 Stock-based compensation $ 7,974,000 $ 5,745,000 Warrants From time to time, the Company has issued warrants to purchase shares of the Company’s common stock to investors, lenders, underwriters and other non-employees for services rendered or to be rendered in the future. A summary of warrant activity during the year ended December 31, 2022 is as follows: SCHEDULE OF WARRANTS ACTIVITY Number of Shares Subject to Warrants Outstanding Weighted Avg. Exercise Price Warrants outstanding - January 1, 2022 373,847 $ 2.08 Granted - Exercised (373,847 ) 2.08 Expired - - Warrants outstanding - December 31, 2022 - $ - |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 16. INCOME TAXES The Company is subject to taxation in the United States, California, Florida, Georgia, Illinois, New Jersey, New York, Tennessee and Wisconsin. The Company’s income tax provision consists of the following for the years ended December 31, 2022 and 2021 are summarized below: SCHEDULE OF PROVISION FOR INCOME TAXES 2022 2021 December 31, 2022 2021 Current: Federal $ - $ - State 75,000 133,000 Total current $ 75,000 $ 133,000 Deferred: Federal $ 871,000 $ (425,000 ) State 312,000 (1,944,000 ) Change in valuation allowance (1,182,000 ) 2,369,000 Total deferred - - Income tax provision $ 75,000 $ 133,000 A reconciliation of income taxes computed by applying the statutory U.S. income tax rate to the Company’s loss before income taxes to the income tax provision is as follows: SCHEDULE OF INCOME TAX RECONCILIATION 2022 2021 December 31, 2022 2021 U.S. federal statutory tax rate 21.00 % 21.00 % State tax benefit, net (2.82 )% (3.24 )% Employee stock-based compensation 1.34 % 7.95 % Excess Employee Remuneration (28.15 )% (9.84 )% Other 1.98 % 2.31 % W/O of IRC Sec 382 Limited NOLs - % (14.77 )% W/O of IRC Sec 383 Limited Credits - % (1.71 )% Reduction of VA for IRC Sec 382 and 383 W/O - % 16.48 % Valuation allowance 6.22 % (18.92 )% Effective income tax rate (0.43 )% (0.74 )% Deferred tax assets and liabilities reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets are as follows: SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES 2022 2021 December 31, 2022 2021 Deferred tax assets (liabilities): NOL $ 9,401,000 $ 12,337,000 Depreciation and amortization 236,000 680,000 Other 349,000 59,000 Research and development credits 90,000 90,000 Deferred stock compensation 945,000 4,642,000 Basis Difference in Eton (1,684,000 ) (2,511,000 ) Sintetica License Agreement 2,162,000 2,329,000 Sparcs License Agreement 2,000 (1,000 ) Novartis License Agreement (13,000 ) (138,000 ) Basis difference in Melt Loan Value 4,240,000 869,000 Park stock purchase identifiable intangibles - (255,000 ) Limitation Under 163(j) 536,000 - Section 174 Capital Expenses 594,000 - ASC 842 Lease Liability 2,427,000 1,856,000 ASC 842 ROU Asset (2,263,000 ) (1,753,000 ) Total deferred tax assets, net 17,022,000 18,204,000 Valuation allowance (17,022,000 ) (18,204,000 ) Net deferred tax liabilities $ - $ - Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. The valuation allowance decreased by approximately $ 1,182,000 2,369,000 As of December 31, 2022, the Company had federal and state net operating loss carryforwards of approximately $ 23,900,000 45,000,000 2027 In addition, the Company has federal net operating loss carryforward of $3,900,000 generated after 2017 that can be carried over indefinitely and may be used to offset up to 80% of federal taxable income As of December 31, 2022 the Company had federal and state research and development credit carryforwards of approximately $ 47,000 54,000 2026 Utilization of the net operating losses and research and development carryforwards may be subject to a substantial annual limitation due to ownership change limitations that might have occurred or that could occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), as well as similar state and foreign provisions. These ownership changes may limit the amount of NOL and R&D credit carryforward that can be utilized annually to offset future taxable income and tax. Respectively. In general, an “ownership change” as defined by Section 382 of the Code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage points of the outstanding stock of a company by certain stockholders or public groups. Since the Company’s formation, the Company has raised capital through the issuance of capital stock on several occasions which, combined with the purchasing stockholders’ subsequent disposition of those shares, may have resulted in such an ownership change, or could result in an ownership change in the future upon subsequent disposition. As of December 31, 2022, the Company determined that it had net operating loss carryforwards of approximately $ 12,500,000 9,400 300,000 300,000 The Company did not have any unrecognized tax benefits as of December 31, 2022 and 2021. These unrecognized tax benefits, if recognized, would not affect the effective tax rate. There was no A reconciliation of the change in the UTB balance from January 1, 2022 to December 31, 2022 is as follows: SCHEDULE OF UNRECOGNIZED TAX BENEFITS Fed & State Tax Balance at January 1, 2022 $ - Additions for tax positions related to current year - Additions/(reductions) for tax positions related to prior years - Balance at December 31, 2022 $ - Total unrecognized tax benefits as of December 31, 2022 $ - The Tax Cuts and Jobs Act of 2017 (TCJA) included changes to the treatment of research and development expenses under IRC Section 174. Formerly, a company could deduct research and development expenses under IRC Section 174 as incurred. Effective for tax years beginning after December 31, 2021, research and development expenses under IRC Section 174 are required to be capitalized, with an amortization period of five years 15 2,191,000 |
EMPLOYEE SAVINGS PLAN
EMPLOYEE SAVINGS PLAN | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
EMPLOYEE SAVINGS PLAN | NOTE 17. EMPLOYEE SAVINGS PLAN The Company has established an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code, effective January 1, 2014. The plan allows participating employees to deposit into tax deferred investment accounts up to 100% 4% 397,000 282,000 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 18. COMMITMENTS AND CONTINGENCIES Legal General and Other In the ordinary course of business, the Company is involved in various legal proceedings, government investigations and other matters that are complex in nature and have outcomes that are difficult to predict. See also Part I, Item 1A. Risk Factors . The Company records accruals for loss contingencies to the extent that it concludes it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. The Company evaluates, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of a liability that has been accrued previously. The Company’s legal proceedings involve various aspects of its business and a variety of claims, some of which present novel factual allegations and/or unique legal theories. Typically, a number of the matters pending against the Company are at early stages of the legal process, which in complex proceedings of the sort the Company face often extend for several years. While it is not possible to accurately predict or determine the eventual outcomes of matters that have not concluded, an adverse determination in one or more of matter (whether discussed in this footnote or not) currently pending may have a material adverse effect on the Company’s consolidated results of operations, financial position or cash flows. Certain recent developments concerning the Company’s legal proceedings it believes are or were material to its business and other matters are discussed below: Novel Drug Solutions et al. In April 2018, Novel Drug Solutions, LLC and Eyecare Northwest, PA (collectively “NDS”) filed a lawsuit against the Company in the U.S. District Court for the District of Delaware asserting various claims, including breach of contract. The claims stem from an asset purchase agreement between the Company and NDS entered into in 2013. In July 2019, NDS filed a second amended complaint which added claims related to its purported termination of the asset purchase agreement. In October 2019, NDS voluntarily dismissed all but two claims, leaving only claims related to the scope and performance of the post-termination obligations to be litigated. On November 8, 2021, following a jury trial, the Company and NDS entered into a voluntary settlement agreement (the “Settlement Agreement”) to resolve all claims and pending matters related to this lawsuit. During the year ended December 31, 2021, the Company recorded $ 1,500,000 1,500,000 Product and Professional Liability Product and professional liability litigation represents an inherent risk to all firms in the pharmaceutical and pharmacy industry. We utilize traditional third-party insurance policies with regard to our product and professional liability claims. Such insurance coverage at any given time reflects current market conditions, including cost and availability, when the policy is written. John Erick et al. In January 2018, John Erick and Deborah Ferrell, successors-in-interest and heirs of Jade Erick, (collectively “Erick”) filed a lawsuit in the San Diego County Superior Court against Kim Kelly, ND, MPH asserting claims related to the death of Jade Erick. In April 2018, Erick filed an amendment to the lawsuit, naming the Company as a co-defendant. In September 2018, co-defendant Dr. Kelly filed a cross-complaint against the Company and various entities affiliated with Spectrum Laboratory Products, Inc., Spectrum Chemical Manufacturing Corp. and Spectrum Pharmacy Products, Inc. (collectively “Spectrum”). The cross-complaint sought indemnity and contribution from the Company and Spectrum. In November 2021, the lawsuit involving the Company was resolved. There was no impact to the Company’s consolidated financial position and results of operations as a result of the resolution of this matter. Indemnities In addition to the indemnification provisions contained in the Company’s charter documents, the Company generally enters into separate indemnification agreements with each of the Company’s directors and officers. These agreements require the Company, among other things, to indemnify the director or officer against specified expenses and liabilities, such as attorneys’ fees, judgments, fines and settlements, paid by the individual in connection with any action, suit or proceeding arising out of the individual’s status or service as the Company’s director or officer, other than liabilities arising from willful misconduct or conduct that is knowingly fraudulent or deliberately dishonest, and to advance expenses incurred by the individual in connection with any proceeding against the individual with respect to which the individual may be entitled to indemnification by the Company. The Company also indemnifies its lessors in connection with its facility leases for certain claims arising from the use of the facilities. These indemnities do not provide for any limitation of the maximum potential future payments the Company could be obligated to make. Historically, the Company has not incurred any payments for these obligations and, therefore, no liabilities have been recorded for these indemnities in the accompanying consolidated balance sheets. Sales and Marketing Agreements The Company has entered various sales and marketing agreements with certain organizations, to provide sales and marketing representation services to ImprimisRx in select geographies in the U.S., in connection with the Company’s ophthalmic compounded formulations. Under the terms of the sales and marketing agreements, the Company is required to make commission payments generally equal to 10 14 4,274,000 3,640,000 Other Asset Purchase, License and Related Agreements The Company has acquired and sourced intellectual property rights related to certain proprietary innovations from certain inventors and related parties (the “Inventors”) through multiple asset purchase agreements, license agreements, strategic agreements and commission agreements. In general, these agreements provide that the Inventors will cooperate with the Company in obtaining patent protection for the acquired intellectual property and that the Company will use commercially reasonable efforts to research, develop and commercialize a product based on the acquired intellectual property. In addition, the Company has acquired a right of first refusal on additional intellectual property and drug development opportunities presented by these Inventors. In consideration for the acquisition of the intellectual property rights, the Company is obligated to make payments to the Inventors based on the completion of certain milestones, generally consisting of: (1) a payment payable within 30 days after the issuance of the first patent in the United States arising from the acquired intellectual property (if any); (2) a payment payable within 30 days after the Company files the first investigational new drug application (“IND”) with the U.S. Food and Drug Administration (“FDA”) for the first product arising from the acquired intellectual property (if any); (3) for certain of the Inventors, a payment payable within 30 days after the Company files the first new drug application with the FDA for the first product arising from the acquired intellectual property (if any); and (4) certain royalty payments based on the net receipts received by the Company in connection with the sale or licensing of any product based on the acquired intellectual property (if any), after deducting (among other things) the Company’s development costs associated with such product. If, following five years after the date of the applicable asset purchase agreement, the Company either (a) for certain of the Inventors, has not filed an IND or, for the remaining Inventors, has not initiated a study where data is derived, or (b) has failed to generate royalty payments to the Inventors for any product based on the acquired intellectual property, the Inventors may terminate the applicable asset purchase agreement and request that the Company re-assign the acquired technology to the Inventors. At December 31, 2022 and 2021, $ 228,000 251,000 910,000 991,000 Klarity License Agreement – Related Party In April 2017, the Company entered into a license agreement (the “Klarity License Agreement”) with Richard L. Lindstrom, M.D., a member of its Board of Directors. Pursuant to the terms of the Klarity License Agreement, the Company licensed certain intellectual property and related rights from Dr. Lindstrom to develop, formulate, make, sell, and sub-license the topical ophthalmic solution Klarity designed to protect and rehabilitate the ocular surface (the “Klarity Product”). Under the terms of the Klarity License Agreement, the Company is required to make royalty payments to Dr. Lindstrom ranging from 3% to 6% of net sales, dependent upon the final formulation of the Klarity Product sold 50,000 50,000 50,000 50,000 100,000 274,000 165,000 71,000 30,000 315,000 160,000 Injectable Asset Purchase Agreement – Related Party In December 2019, the Company entered into an asset purchase agreement (the “Lindstrom APA”) with Dr. Lindstrom, a member of its Board of Directors. Pursuant to the terms of the Lindstrom APA, the Company acquired certain intellectual property and related rights from Dr. Lindstrom to develop, formulate, make, sell, and sub-license an ophthalmic injectable product (the “Lindstrom Product”). Under the terms of the Lindstrom APA, the Company is required to make royalty payments to Dr. Lindstrom ranging from 2% to 3% of net sales, dependent upon the final formulation and patent protection of the Lindstrom Product sold 33,000 32,000 28,000 9,000 8,000 33,000 29,000 Presbyopia Asset Purchase Agreement – Related Party In December 2019, the Company entered into an asset purchase agreement (the “Presbyopia APA”) with Richard L. Lindstrom, M.D., a member of its Board of Directors. Pursuant to the terms of the Presbyopia APA, the Company acquired certain intellectual property and related rights from Dr. Lindstrom to develop, formulate, make, sell, and sub-license an ophthalmic topical product to treat presbyopia (the “Presbyopia Product”). Under the terms of the Presbyopia Product, the Company is required to make royalty payments to Dr. Lindstrom ranging from 2% to 4% of net sales, dependent upon the final formulation and patent protection of the Presbyopia Product sold. 0 0 0 Eyepoint Commercial Alliance Agreement - Terminated In August 2020, the Company, through its wholly owned subsidiary ImprimisRx, LLC, entered into a Commercial Alliance Agreement (the “Dexycu Agreement”) with Eyepoint Pharmaceuticals, Inc. (“Eyepoint”), pursuant to which Eyepoint granted the Company the non-exclusive right to co-promote DEXYCU ® Pursuant to the Dexycu Agreement Dexycu Agreement Pursuant to a mutual termination agreement entered into on October 7, 2022 the Dexycu Agreement Following the preliminary Hospital Outpatient Prospective Payment System (HOPPS) rule proposed by the Centers for Medicare & Medicaid Services (CMS) in July of 2022, which did not contain an extension of the pass-through payment period for Dexycu beyond December 31, 2022, the Company entered into a Mutual Termination Agreement (the “Termination Agreement”) with Eyepoint on October 7, 2022, pursuant to which Eyepoint and the Company agreed (a) that the Company will continue to support the sale of Dexycu through the fourth quarter of 2022, consistent with the Company’s level of effort during the January through June 2022 period, (b) to decrease the required minimum quarterly sales levels based on Dexycu unit demand for the fourth quarter of 2022, and (c) to terminate the Dexycu Agreement, along with ancillary letter agreements, effective January 1, 2023. During the years ended December 31, 2022 and 2021, the Company recorded $ 3,866,000 3,253,000 Mayfield Pharmaceuticals MAY-66 License Termination In May 2021, Mayfield terminated the License Agreement (the “TGV License”) with TGV-Health, LLC and affiliated entities (collectively, “TGV”), pursuant to which it acquired intellectual property rights for use in the women’s health field, related to Mayfield’s proprietary drug candidate MAY-66. Concurrent with the termination, TGV returned to Mayfield 300,000 Mayfield Pharmaceuticals MAY-44 APA Termination In May 2021, Mayfield and Harrow terminated their asset purchase agreement dated January 2020 (the “MAY-44 APA”) for intellectual property rights associated with Mayfield’s drug candidate MAY-44 with Elle Pharmaceutical LLC (“Elle”). As part of the termination, Mayfield re-acquired 350,000 Stowe License Termination In May 2021, Stowe terminated the License Agreement (the “Stowe License”) with TGV, pursuant to which it acquired intellectual property rights for use in the ophthalmic field, related to Stowe’s proprietary drug candidate STE-006. Concurrent with the termination, TGV returned to Stowe 1,750,000 |
SEGMENTS AND CONCENTRATIONS
SEGMENTS AND CONCENTRATIONS | 12 Months Ended |
Dec. 31, 2022 | |
Segment Reporting [Abstract] | |
SEGMENTS AND CONCENTRATIONS | NOTE 19. SEGMENTS AND CONCENTRATIONS Management evaluated the Company’s 2021 performance based on operating segments. Segment performance for its two ● Operating expenses within selling, general and administrative expenses that result from the impact of corporate initiatives. Corporate initiatives primarily include integration, restructuring, acquisition and other shared costs; ● Selling, general and administrative expenses that result from shared infrastructure, including certain expenses associated with legal matters, our board of directors and principal executive officers, investor relations and other like shared expenses; ● Other select revenues and operating expenses including R&D expenses, amortization, and asset sales and impairments, net as not all such information has been accounted for at the segment level, or such information has not been used by both segments; and ● Total assets including capital expenditures. Management defined segment net revenues as pharmaceutical compounded drug sales, revenues from licenses and other revenues derived from related agreements. Cost of sales within segment contribution includes direct and indirect costs to manufacture formulations and sell products, including active pharmaceutical ingredients, personnel costs, packaging, storage, royalties, shipping and handling costs, manufacturing equipment and tenant improvements depreciation, the write-off of obsolete inventory and other related expenses. Selling, general and administrative expenses consisted mainly of personnel-related costs, marketing and promotion costs, distribution costs, professional service costs, insurance, depreciation, facilities costs, transaction costs, and professional services costs, which are general in nature and attributable to the segment. SCHEDULE OF SEGMENT NET REVENUES, SEGMENT OPERATING EXPENSES AND SEGMENT CONTRIBUTION For the Year Ended December 31, 2021 Pharmaceutical Pharmaceutical Compounding Drug Development Total Net revenues $ 72,476,000 $ - $ 72,476,000 Cost of sales (18,214,000 ) - (18,214,000 ) Gross profit 54,262,000 - 54,262,000 Operating expenses: Selling, general and administrative 27,465,000 - 27,465,000 Research and development 1,088,000 8,674,000 9,762,000 Segment contribution 25,709,000 (8,674,000 ) 17,035,000 Corporate (13,689,000 ) Research and development (1,322,000 ) Amortization (161,000 ) Asset sales and impairments, net (249,000 ) Operating income $ 1,614,000 Beginning in 2022, due to shifts in the Company’s strategic plans and its organizational structure, management no longer evaluates the Company’s business in two segments and instead focuses on the performance of the business as a single operating business. Concentrations The Company has two products that each comprised more than 10% of total revenues during the quarter. These products collectively accounted for 34% 35% The Company sells its compounded formulations to a large number of customers. There were no customers who comprised more than 10% of the Company’s total pharmacy sales for the years ended December 31, 2022 and 2021 , respectively 61 74 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 20. SUBSEQUENT EVENTS In January 2023, 23,000 13,398 9,602 142,000 In January 2023, 88,000 52,821 35,179 519,000 Closing of BR Loan and Fab 5 Acquisition - ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE In January 2023, the Company closed the Fab 5 Acquisition. At the time of closing the Company made a one-time payment of $ 130,000,000 45,000,000 The Company funded the initial purchase price payable at closing of the Fab 5 Acquisition with (i) proceeds of a $ 59,750,000 Overallotment Exercise of 2027 Notes In January 2023, the Company issued an additional $ 5,250,000 40,250,000 The Company has performed an evaluation of events occurring subsequent to December 31, 2022 through the filing date of this Annual Report and determined that no subsequent events have occurred that would require recognition in the consolidated financial statements or disclosures in the notes thereto, other than as disclosed in the accompanying notes. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation Harrow has prepared the accompanying consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying consolidated financial statements include the accounts of the Company and its wholly owned and majority-owned subsidiaries. Harrow consolidates entities in which it has a controlling financial interest. The Company assesses control under the variable interest entity (“VIE”) model to determine whether the Company is the primary beneficiary of that entity’s operations. The Company consolidates (i) entities in which it holds and/or controls, directly or indirectly, more than 50% of the voting rights |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting periods. Significant estimates made by management are, among others, allowance for doubtful accounts, variable consideration determined based on accruals for chargebacks, administrative fees and rebates, government rebates, returns and other allowances, renewal periods and discount rates for leases, realizability of inventories, recoverability of investments, realizability of deferred taxes, goodwill and intangible assets, recoverability of long-lived assets and goodwill, fair value of loans payable, and valuation of stock-based transactions with employees and non-employees. Actual results could differ from those estimates. |
Risks, Uncertainties and Liquidity | Risks, Uncertainties and Liquidity The Company is subject to certain regulatory standards, approvals, guidelines and inspections which could impact the Company’s ability to make, dispense, and sell certain products. If the Company was required to cease compounding and selling certain products as a result of regulatory guidelines or inspections, this may have a material impact on the Company’s financial condition, liquidity and results of operations. |
Noncontrolling Interests | Noncontrolling Interests The Company recognizes any noncontrolling interest as a separate line item in equity in the consolidated financial statements. A noncontrolling interest represents the portion of equity ownership in a less-than-wholly-owned subsidiary not attributable to the Company. Generally, any interest that holds less than 50% of the outstanding voting shares is deemed to be a noncontrolling interest; however, there are other factors that are considered as well, such as decision-making rights The Company provides in the consolidated statements of stockholders’ equity a reconciliation at the beginning and the end of the period of the carrying amount of total equity, equity attributable to the parent, and equity attributable to the noncontrolling interests that separately discloses: 1. net income or loss; 2. transactions with owners acting in their capacity as owners, showing separately contributions from and distributions to owners; and 3. each component of other income or loss The noncontrolling interests in the consolidated balance sheets as of December 31, 2022 and 2021, relate to consolidated subsidiaries that the Company owns a controlling stake in, but not 100 |
Segments | Segments As a result of shifts in the Company’s strategic plans to further focus on growing the Company’s ImprimisRx business and suspension of activities related to starting up development-stage pharmaceutical companies, along with changes to the Company’s organizational and internal reporting structure, beginning in January 2022, management no longer evaluates the Company’s business in two segments and instead focuses on the performance of the business as a single operating business. |
Revenue Recognition and Deferred Revenue | Revenue Recognition and Deferred Revenue The Company recognizes revenue at the time of 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 (see Note 3). |
Cost of Sales | Cost of Sales Cost of sales includes direct and indirect costs to manufacture formulations and other products sold, including active pharmaceutical ingredients, personnel costs, packaging, storage, royalties, shipping and handling costs, depreciation and amortization of certain intangible assets and the write-off of obsolete inventory. |
Research and Development | Research and Development Research and development (“R&D”) expenses consist of expenses incurred in performing research and development activities, including salaries and benefits, other overhead expenses, and costs related to clinical trials, contract services and outsourced contracts. We expense all costs related to R&D as they are incurred. Upfront and milestone payments related to the acquisition and licensing of technology for drug and product candidates that are not yet approved by the FDA are considered acquisition of in process R&D and expensed as R&D in the period in which the expense occurs. |
Debt Issuance Costs and Debt Discount | Debt Issuance Costs and Debt Discount Debt issuance costs and the debt discount are recorded net of loans payable in the consolidated balance sheets. Amortization of debt issuance costs and the debt discount is calculated using the effective interest method over the term of the related debt and is recorded in interest expense in the accompanying consolidated statements of operations. At December 31, 2022, the Company recorded deferred financing costs of $ 1,950,000 |
Intellectual Property | Intellectual Property The costs of acquiring intellectual property rights to be used in the research and development process, including licensing fees and milestone payments, are charged to research and development expense as incurred in situations where the Company has not identified an alternative future use for the acquired rights, and are capitalized in situations where we have identified an alternative future use for the acquired rights. Patents and trademarks are recorded at cost and capitalized at a time when the future economic benefits of such patents and trademarks become more certain (see “—Goodwill and Intangible Assets” below). If costs are not capitalized they are expensed as incurred. |
Income Taxes | Income Taxes As part of the process of preparing the Company’s consolidated financial statements, the Company must estimate the actual current tax assets and liabilities and assess permanent and temporary differences that result from differing treatment of items for tax and accounting purposes. The temporary differences result in deferred tax assets and liabilities, which are included within the consolidated balance sheets. The Company must assess the likelihood that the deferred tax assets will be recovered from future taxable income and, to the extent the Company believes that recovery is not more likely than not, a valuation allowance must be established which reduces the amount of deferred tax assets recorded on the consolidated balance sheets. To the extent the Company establishes a valuation allowance or increase or decrease this allowance in a period, the impact will be included in income tax expense in the consolidated statements of operations. The Company accounts for income taxes under the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 740, Income Taxes |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash equivalents include short-term, highly liquid investments with maturities of three months or less at the time of acquisition. |
Concentrations of Credit Risk | Concentrations of Credit Risk The Company places its cash with financial institutions deemed by management to be of high credit quality. The Federal Deposit Insurance Corporation (“FDIC”) provides basic deposit coverage with limits up to $ 250,000 |
Investment in Eton Pharmaceuticals, Inc. – Related Party | Investment in Eton Pharmaceuticals, Inc. – Related Party The Company’s investment in Eton Pharmaceuticals, Inc. (“Eton”) consists of common stock with a readily determinable fair value which is carried at fair value with changes in fair value recognized in earnings. In accordance with the Accounting Standards Update (“ASU”) 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities 2,914,000 8,720,000 During the year ended December 31, 2021, the Company sold 1,518,000 underwritten public offering at a public offering price of $ 7.00 10,626,000 799,000 1,406,000 1,982,000 10 2.82 5,589,000 8,503,000 |
Accounts Receivable | Accounts Receivable Accounts receivable are stated net of allowances for doubtful accounts and contractual adjustments. The accounts receivable balance primarily includes amounts due from customers the Company has invoiced or from third-party providers (e.g., insurance companies and governmental agencies), but for which payment has not been received. Charges to bad debt are based on both historical write-offs and specifically identified receivables. Accounts receivable are presented net of allowances for doubtful accounts and contractual adjustments in the amount of $ 779,000 40,000 |
Inventories | Inventories Inventories are stated at the lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. The Company evaluates the carrying value of inventories on a regular basis, based on the price expected to be obtained for products in their respective markets compared with historical cost. Write-downs of inventories are considered to be permanent reductions in the cost basis of inventories. The Company also regularly evaluates its inventories for excess quantities and obsolescence (expiration), taking into account such factors as historical and anticipated future sales or use in production compared to quantities on hand and the remaining shelf life of products and active pharmaceutical ingredients on hand. The Company establishes reserves for excess and obsolete inventories as required based on its analyses. |
Investment in Melt Pharmaceuticals, Inc. – Related Party | Investment in Melt Pharmaceuticals, Inc. – Related Party The Company owns 3,500,000 46 0 100 0 100 The following table summarizes the Company’s investments in Melt as of December 31, 2022: SCHEDULE OF INVESTMENT Cost Share of Equity Method Losses Paid-in-Kind In-substance Capital Contributions Net Carrying value Common stock $ 5,810,000 $ (5,810,000 ) $ - $ - $ - Loan 13,500,000 (13,500,000 ) 2,484,000 (2,484,000 ) - $ 19,310,000 $ (19,310,000 ) $ 2,484,000 $ (2,484,000 ) $ - The following table summarizes the Company’s investments in Melt as of December 31, 2021: Cost Basis Share of Equity Method Losses Paid-in-Kind Interest In-substance Capital Contributions Net Carrying value Common stock $ 5,810,000 $ (5,810,000 ) $ - $ - $ - Loan 13,500,000 (2,367,000 ) 576,000 (576,000 ) 11,133,000 $ 19,310,000 $ (8,177,000 ) $ 576,000 $ (576,000 ) $ 11,133,000 At December 31, 2022 and 2021, the Company recorded $ 139,000 48,000 See Note 5 for more information and related party disclosure regarding Melt. |
Investment in Surface Ophthalmics, Inc. – Related Party | Investment in Surface Ophthalmics, Inc. – Related Party The Company owns 3,500,000 20 0 The following table summarizes the Company’s investment in Surface as of December 31, 2022 and 2021: SCHEDULE OF INVESTMENT Cost Basis Share of Equity Method Losses Net Carrying value Common stock $ 5,320,000 $ (5,320,000 ) $ - See Note 6 for more information and related party disclosure regarding Surface. |
Impairment of Equity Method Investment and Note Receivable | Impairment of Equity Method Investment and Note Receivable On a quarterly basis, management assesses whether there are any indicators that the carrying value of the Company’s equity method investments and note receivable may be other than temporarily impaired. Indicators include financial condition, operating performance, and near-term prospects of the investee. To the extent indicators suggest that a loss in value may have occurred, the Company will evaluate both quantitative and qualitative factors to determine if the loss in value is other than temporary. If a potential loss in value is determined to be other than temporary, the Company will recognize an impairment loss based on the estimated fair value of the equity method investments and note receivable. At December 31, 2022 and December 31, 2021, no indicators of impairment existed. |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment is stated at cost less accumulated depreciation and amortization. Depreciation and amortization is calculated using the straight-line method over the estimated useful life of the asset. Leasehold improvements and capital lease equipment are amortized over the estimated useful life or remaining lease term, whichever is shorter. Computer hardware and furniture and equipment are depreciated over three five years |
Capitalized Software Costs | Capitalized Software Costs The Company capitalizes certain costs related to the development of internal-use software. Costs incurred during the application development phase are capitalized only when the Company believes it is probable the development will result in new or additional functionality. The types of costs capitalized during the application development phase include consulting fees for third-party developers working on these projects. Costs related to the preliminary project stage and post-implementation activities are expensed as incurred. Internal-use software is amortized on a straight-line basis over the estimated useful life of the asset, which ranges from two five years |
Goodwill and Intangible Assets | Goodwill and Intangible Assets Patents and trademarks are recorded at cost and capitalized at a time when the future economic benefits of such patents and trademarks become more certain. At that time, the Company capitalizes third-party legal costs and filing fees associated with obtaining and prosecuting claims related to its patents and trademarks. Once the patents have been issued, the Company amortizes these costs over the shorter of the legal life of the patent or its estimated economic life, generally 20 10 The Company reviews its goodwill and indefinite-lived intangible assets for impairment as of January 1 of each year and when an event or a change in circumstances indicates the fair value of a reporting unit may be below its carrying amount. Events or changes in circumstances considered as impairment indicators include but are not limited to the following: ● significant underperformance of the Company’s business relative to expected operating results; ● significant adverse economic and industry trends; ● significant decline in the Company’s market capitalization for an extended period of time relative to net book value; and ● expectations that a reporting unit will be sold or otherwise disposed. The goodwill impairment test consists of a two-step process as follows: Step 1. The Company compares the fair value of each reporting unit to its carrying amount, including the existing goodwill. The fair value of each reporting unit is determined using a discounted cash flow valuation analysis. The carrying amount of each reporting unit is determined by specifically identifying and allocating the assets and liabilities to each reporting unit based on headcount, relative revenues or other methods as deemed appropriate by management. If the carrying amount of a reporting unit exceeds its fair value, an indication exists that the reporting unit’s goodwill may be impaired and the Company then performs the second step of the impairment test. If the fair value of a reporting unit exceeds its carrying amount, no further analysis is required. Step 2. If further analysis is required, the Company compares the implied fair value of the reporting unit’s goodwill, determined by allocating the reporting unit’s fair value to all of its assets and its liabilities in a manner similar to a purchase price allocation, to its carrying amount. If the carrying amount of the reporting unit’s goodwill exceeds its fair value, an impairment loss will be recognized in an amount equal to the excess. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets, such as property, plant and equipment, purchased intangibles subject to amortization and patents and trademarks, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized in the amount by which the carrying amount of the asset exceeds the fair value of the asset. Assets to be disposed of would be separately presented in the consolidated balance sheet and reported at the lower of the carrying amount or fair value less costs to sell, and are no longer depreciated. The assets and liabilities of a disposal group classified as held-for-sale would be presented separately in the appropriate asset and liability sections of the consolidated balance sheet, if material. |
Leases | Leases At the inception of a contract the Company determines if the arrangement is, or contains, a lease. Operating lease right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Rent expense is recognized on a straight-line basis over the lease term. The Company has made certain accounting policy elections whereby it (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12-months of less) and (ii) combines lease and non-lease elements of its operating leases. As of December 31, 2022, the Company did not have any finance leases. |
Fair Value Measurements | Fair Value Measurements Fair value measurements are determined based on the assumptions that market participants would use in pricing an asset or liability. GAAP establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. The established fair value hierarchy prioritizes the use of inputs used in valuation methodologies into the following three levels: ● Level 1: Applies to assets or liabilities for which there are quoted prices (unadjusted) for identical assets or liabilities in active markets. A quoted price in an active market provides the most reliable evidence of fair value and must be used to measure fair value whenever available. ● Level 2: Applies to assets or liabilities for which there are significant other observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data. ● Level 3: Applies to assets or liabilities for which there are significant unobservable inputs that reflect a reporting entity’s own assumptions about the assumptions that market participants would use in pricing an asset or liability. For example, Level 3 inputs would relate to forecasts of future earnings and cash flows used in a discounted future cash flows method. At December 31, 2022 and 2021, the Company measured its investment in Eton on a recurring basis. The Company’s investment in Eton is classified as Level 1 as the fair value is determined using quoted market prices in active markets for the same securities. As of December 31, 2022 and 2021, the fair market value of the Company’s investment in Eton was $ 5,589,000 8,503,000 The Company carries the 2026 Notes at face value, including the unamortized premium, less unamortized debt issuance costs, and the 2027 Notes are carried at face value less unamortized debt issuance costs on the consolidated balance sheets and presents fair value for disclosure purposes only. The 2026 Notes and 2027 Notes are classified as Level 1 instruments as the fair value is determined using quoted market prices in active markets for the same securities. The following table presents the estimated fair values and the carrying values: SCHEDULE OF ESTIMATED FAIR VALUE December 31, 2022 2021 Carrying Value Fair Value Carrying Value Fair Value 2026 Notes $ 72,436,000 $ 71,550,000 $ 71,654,000 $ 78,810,000 2027 Notes $ 31,738,000 $ 35,112,000 $ - $ - The Company’s other financial instruments include cash and cash equivalents, accounts receivable, accounts payable and accrued expenses, accrued payroll and related liabilities, deferred revenue and customer deposits and operating and finance lease liabilities. The carrying amount of these financial instruments, except for operating and finance lease liabilities, approximates fair value due to the short-term maturities of these instruments. Based on borrowing rates currently available to the Company, the carrying values of the operating and finance lease liabilities approximate their respective fair values. |
Stock-Based Compensation | Stock-Based Compensation All stock-based payments to employees, directors and consultants, including grants of stock options, warrants, restricted stock units (“RSUs”) and restricted stock, are recognized in the consolidated financial statements based upon their estimated fair values. The Company uses the Black-Scholes-Merton option pricing model and Monte Carlo simulation model to estimate the fair value of stock-based awards. The estimated fair value is determined at the date of grant. The financial statement effect of forfeitures is estimated at the time of grant and revised, if necessary, if the actual effect differs from those estimates. |
Basic and Diluted Net Loss per Common Share | Basic and Diluted Net Loss per Common Share Basic net loss per common share is computed by dividing net loss attributable to common stockholders for the period by the weighted average number of common shares outstanding during the period. Diluted income per share is computed by dividing the income attributable to common stockholders for the period by the weighted average number of common and common equivalent shares, such as stock options and warrants, outstanding during the period. Basic and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period. Common stock equivalents (using the treasury stock or “if converted” method) from stock options, unvested restricted stock units (“RSUs”) and warrants were 5,089,420 5,646,594 319,859 267,761 The following table shows the computation of basic net loss per share of common stock for the years ended December 31, 2022 and 2021: SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE 2022 2021 For the Years Ended December 31, 2022 2021 Numerator – net loss attributable to Harrow Health, Inc. common stockholders $ (14,086,000 ) $ (18,479,000 ) Denominator – weighted average number of shares outstanding, basic 27,460,968 26,757,451 Net loss per share, basic and diluted $ (0.51 ) $ (0.69 ) |
Recent Accounting Pronouncements Not Yet Adopted | Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments In March 2022, the FASB issued ASU 2022-02, Financial Instruments-Credit Losses (Topic 326): Troubled Debt Restructurings and Vintage Disclosures |
Reclassifications | Reclassifications Certain prior period items and amounts have been reclassified to conform to the classifications used to prepare the consolidated financial statements for the current period. These reclassifications had no material impact on the Company’s consolidated financial position, results of operations, or cash flows as previously reported. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
SCHEDULE OF ESTIMATED FAIR VALUE | The following table presents the estimated fair values and the carrying values: SCHEDULE OF ESTIMATED FAIR VALUE December 31, 2022 2021 Carrying Value Fair Value Carrying Value Fair Value 2026 Notes $ 72,436,000 $ 71,550,000 $ 71,654,000 $ 78,810,000 2027 Notes $ 31,738,000 $ 35,112,000 $ - $ - |
SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE | The following table shows the computation of basic net loss per share of common stock for the years ended December 31, 2022 and 2021: SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE 2022 2021 For the Years Ended December 31, 2022 2021 Numerator – net loss attributable to Harrow Health, Inc. common stockholders $ (14,086,000 ) $ (18,479,000 ) Denominator – weighted average number of shares outstanding, basic 27,460,968 26,757,451 Net loss per share, basic and diluted $ (0.51 ) $ (0.69 ) |
Melt Pharmaceuticals, Inc. [Member] | |
SCHEDULE OF INVESTMENT | The following table summarizes the Company’s investments in Melt as of December 31, 2022: SCHEDULE OF INVESTMENT Cost Share of Equity Method Losses Paid-in-Kind In-substance Capital Contributions Net Carrying value Common stock $ 5,810,000 $ (5,810,000 ) $ - $ - $ - Loan 13,500,000 (13,500,000 ) 2,484,000 (2,484,000 ) - $ 19,310,000 $ (19,310,000 ) $ 2,484,000 $ (2,484,000 ) $ - The following table summarizes the Company’s investments in Melt as of December 31, 2021: Cost Basis Share of Equity Method Losses Paid-in-Kind Interest In-substance Capital Contributions Net Carrying value Common stock $ 5,810,000 $ (5,810,000 ) $ - $ - $ - Loan 13,500,000 (2,367,000 ) 576,000 (576,000 ) 11,133,000 $ 19,310,000 $ (8,177,000 ) $ 576,000 $ (576,000 ) $ 11,133,000 |
Surface Ophthalmics Inc [Member] | |
SCHEDULE OF INVESTMENT | The following table summarizes the Company’s investment in Surface as of December 31, 2022 and 2021: SCHEDULE OF INVESTMENT Cost Basis Share of Equity Method Losses Net Carrying value Common stock $ 5,320,000 $ (5,320,000 ) $ - |
REVENUES (Tables)
REVENUES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
SCHEDULE OF DISAGGREGATED REVENUE | Revenue disaggregated by revenue source for the years ended December 31, 2022 and 2021, consists of the following: SCHEDULE OF DISAGGREGATED REVENUE 2022 2021 For the Years Ended December 31, 2022 2021 Product sales, net $ 83,524,000 $ 69,104,000 Commissions 3,866,000 3,253,000 Transfer of profit 1,205,000 99,000 License - 20,000 Total revenues $ 88,595,000 $ 72,476,000 |
RECENT PRODUCT ACQUISITIONS, _2
RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Recent Product Acquisitions Licenses And Divestitures | |
SCHEDULE OF NET GAIN ON SALE OF ASSETS | The Company determined that the disposal of the related net assets does not qualify for reporting as discontinued operations because it does not represent a strategic shift that has or will have a major effect on the Company’s operations and financial results. During the year ended December 31, 2022, the Company recognized a net gain on the sale of the non-ophthalmology related compounding assets as follows: SCHEDULE OF NET GAIN ON SALE OF ASSETS Gross consideration $ 6,000,000 Closing and transaction costs 55,000 Net proceeds 5,945,000 Book value of assets transferred: Customer relations intangible asset 686,000 Gain on sale of non-ophthalmology assets $ 5,259,000 |
INVESTMENT IN MELT PHARMACEUT_2
INVESTMENT IN MELT PHARMACEUTICALS, INC. AND AGREEMENTS - RELATED PARTY TRANSACTIONS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
SCHEDULE OF CONDENSED INCOME STATEMENT | The unaudited condensed results of operations information of Melt is summarized below: SCHEDULE OF CONDENSED INCOME STATEMENT 2022 2021 For the Years Ended December 31, 2022 2021 Revenues, net $ - $ - Loss from operations $ 12,443,000 $ 6,069,000 Net loss $ (14,446,000 ) $ (6,655,000 ) |
SCHEDULE OF CONDENSED BALANCE SHEET | The unaudited condensed balance sheet information of Melt is summarized below: SCHEDULE OF CONDENSED BALANCE SHEET 2022 2021 December 31, 2022 2021 Current assets $ 655,000 $ 11,278,000 Non-current assets 107,000 - Total assets $ 762,000 $ 11,278,000 Total liabilities $ 19,056,000 $ 15,732,000 Total preferred stock and stockholders’ deficit (18,294,000 ) (4,454,000 ) Total liabilities and stockholders’ equity $ 762,000 $ 11,278,000 |
INVESTMENT IN SURFACE OPHTHAL_2
INVESTMENT IN SURFACE OPHTHALMICS, INC. AND AGREEMENTS - RELATED PARTY TRANSACTIONS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investment In Surface Ophthalmics Inc. And Agreements - Related Party Transactions | |
SUMMARY OF CONDENSED INCOME STATEMENT | The unaudited condensed results of operations information of Surface is summarized below: SUMMARY OF CONDENSED INCOME STATEMENT 2022 2021 For the Years Ended December 31, 2022 2021 Revenues, net $ - $ - Loss from operations $ (6,719,000 ) $ 10,468,000 Net loss $ (6,579,000 ) $ (10,143,000 ) |
SUMMARY OF CONDENSED BALANCE SHEET | The unaudited condensed balance sheet information of Surface is summarized below: SUMMARY OF CONDENSED BALANCE SHEET 2022 2021 December 31, 2022 2021 Current assets $ 15,350,000 $ 21,731,000 Non-current assets 652,000 412,000 Total assets $ 16,002,000 $ 22,143,000 Total liabilities $ 1,586,000 $ 1,514,000 Total stockholders’ equity 14,416,000 20,629,000 Total liabilities and stockholders’ equity $ 16,002,000 $ 22,143,000 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORIES | Inventories are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, commercial pharmaceutical products, related laboratory supplies and active pharmaceutical ingredients. The composition of inventories as of December 31, 2022 and 2021 was as follows: SCHEDULE OF INVENTORIES 2022 2021 December 31, 2022 2021 Raw materials $ 3,707,000 $ 2,441,000 Work in progress 38,000 - Finished goods 2,796,000 1,776,000 Total inventories $ 6,541,000 $ 4,217,000 |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS | Prepaid expenses and other current assets consisted of the following: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS 2022 2021 December 31, 2022 2021 Prepaid insurance $ 858,000 $ 728,000 Prepaid computer software related expenses 1,165,000 248,000 Other prepaid expenses 1,331,000 189,000 Receivable due from Melt 139,000 48,000 Deposits and other current assets 118,000 92,000 Total prepaid expenses and other current assets $ 3,611,000 $ 1,305,000 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF PROPERTY,PLANT AND EQUIPMENT | Property, plant and equipment, net at December 31, 2022 and 2021 consisted of the following: SCHEDULE OF PROPERTY,PLANT AND EQUIPMENT 2022 2021 December 31, 2022 2021 Property, plant and equipment, net: Computer hardware $ 979,000 $ 772,000 Furniture and equipment 860,000 443,000 Lab and pharmacy equipment 4,259,000 4,056,000 Leasehold improvements 6,449,000 5,703,000 Property, plant and equipment, gross 12,547,000 10,974,000 Accumulated depreciation and amortization (9,061,000 ) (7,833,000 ) Property, plant and equipment, net $ 3,486,000 $ 3,141,000 |
CAPITALIZED SOFTWARE COSTS (Tab
CAPITALIZED SOFTWARE COSTS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Capitalized Software Costs | |
SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS | Capitalized software costs at December 31, 2022 and 2021 consisted of the following: SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS 2022 2021 December 31, 2022 2021 Capitalized software costs Capitalized internal-use software development costs $ 1,413,000 $ 942,000 Acquired third-party software license for internal-use 159,000 159,000 Total gross capitalized software for internal-use 1,572,000 1,101,000 Accumulated amortization (793,000 ) (569,000 ) Capitalized internal-use software in process 1,333,000 781,000 Total finite lived intangible assets net $ 2,112,000 $ 1,313,000 |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
SCHEDULE OF INTANGIBLE ASSETS | The Company’s intangible assets at December 31, 2022 consisted of the following: SCHEDULE OF INTANGIBLE ASSETS Amortization Net periods Accumulated Carrying (in years) Cost amortization Sold value Patents 7 19 years Indefinite $ 980,000 $ (161,000 ) $ - $ 819,000 Licenses 20 years 100,000 (23,000 ) - 77,000 Trademarks Indefinite 267,000 - - 267,000 Acquired NDAs 10 years 23,720,000 (1,363,000 ) - 22,357,000 Customer relationships 3 15 years 1,519,000 (759,000 ) (626,000 ) 134,000 Trade name 5 years 75,000 (5,000 ) - 70,000 Non-competition clause 3 4 years 50,000 (50,000 ) - - State pharmacy licenses 25 years 8,000 (7,000 ) - 1,000 $ 26,719,000 $ (2,368,000 ) $ (626,000 ) $ 23,725,000 The Company’s intangible assets at December 31, 2021 consisted of the following: Amortization Net periods Accumulated Carrying (in years) Cost amortization Impairment value Patents 7 19 years $ 966,000 $ (75,000 ) $ - $ 891,000 Licenses 20 100,000 (7,000 ) - 93,000 Trademarks Indefinite 359,000 - (99,000 ) 260,000 Acquired NDAs 10 13,635,000 - - 13,635,000 Customer relationships 3 15 years 1,519,000 (586,000 ) - 933,000 Trade name 5 5,000 (5,000 ) - - Non-competition clause 3 4 years 50,000 (50,000 ) - - State pharmacy licenses 25 years 8,000 (7,000 ) - 1,000 $ 16,642,000 $ (730,000 ) $ (99,000 ) $ 15,813,000 |
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS | Amortization expense for intangible assets for the years ended December 31, 2022 and 2021 were as follows: SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS 2022 2021 For the Years Ended December 31, 2022 2021 Patents $ 86,000 $ 26,000 Licenses 16,000 2,000 Acquired NDAs 1,363,000 - Customer relationships 113,000 133,000 Amortization of intangible assets $ 1,578,000 $ 161,000 |
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE | Estimated future amortization expense for the Company’s intangible assets at December 31, 2022 is as follows: SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE Years ending December 31, 2023 2,521,000 2024 2,521,000 2025 2,521,000 2026 2,521,000 2027 2,521,000 Thereafter 10,853,000 Intangible assets $ 23,458,000 |
ACCOUNTS PAYABLE AND ACCRUED _2
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES | Accounts payable and accrued expenses at December 31, 2022 and 2021 consisted of the following: SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES 2022 2021 December 31, 2022 2021 Accounts payable $ 6,440,000 $ 5,174,000 Accrued insurance premium 575,000 - Accrued IHEEZO milestone payments (see Note 4) 5,000,000 - Accrued RPC transition payments (see Note 4) 453,000 - Accrued litigation settlements 49,000 49,000 Accrued interest (see Note 13) 1,254,000 1,114,000 Total accounts payable and accrued expenses $ 13,771,000 $ 6,337,000 |
DEBT (Tables)
DEBT (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF FUTURE MINIMUM PAYMENTS UNDER NOTES PAYABLES | At December 31, 2022, future minimum payments under the Company’s debt were as follows (excluding debt transactions that occurred subsequent to December 31, 2022): SCHEDULE OF FUTURE MINIMUM PAYMENTS UNDER NOTES PAYABLES Amount 2023 $ 10,053,000 2024 10,625,000 2025 10,625,000 2026 81,314,000 2027 39,156,000 Total minimum payments 151,773,000 Less: amount representing interest payments (41,773,000 ) Notes payable, gross 110,000,000 Less: unamortized discount, net of premium (5,826,000 ) Notes payable, net of unamortized discount $ 104,174,000 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases | |
SCHEDULE OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES | Future lease payments under operating leases as of December 31, 2022 were as follows : SCHEDULE OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES Operating Leases 2023 $ 1,231,000 2024 1,262,000 2025 1,093,000 2026 1,114,000 2027 972,000 Thereafter 5,829,000 Total minimum lease payments 11,501,000 Less: amount representing interest payments (3,446,000 ) Total operating lease liabilities 8,055,000 Less: current portion, operating lease liabilities (723,000 ) Operating lease liabilities, net of current portion $ 7,332,000 |
STOCKHOLDERS_ EQUITY AND STOC_2
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
SCHEDULE OF STOCK OPTION PLAN ACTIVITY | A summary of stock option activity under the Plan for the year ended December 31, 2022 is as follows: SCHEDULE OF STOCK OPTION PLAN ACTIVITY Number of shares Weighted Avg. Exercise Price Weighted Avg. Remaining Contractual Life Aggregate Intrinsic Value Options outstanding – January 1, 2022 3,039,546 $ 5.52 Options granted 351,250 $ 7.71 Options exercised (288,720 ) $ 3.65 Options cancelled/forfeited (74,375 ) $ 7.46 Options outstanding – December 31, 2022 3,027,701 $ 5.90 4.48 $ 26,822,000 Options exercisable 2,457,769 $ 5.51 3.97 $ 22,731,000 Options vested and expected to vest 3,026,942 $ 5.90 4.48 $ 26,817,000 |
SCHEDULE OF FAIR VALUE ASSUMPTIONS | The table below illustrates the fair value per share determined using the Black-Scholes-Merton option pricing model with the following assumptions used for valuing options granted to employees: SCHEDULE OF FAIR VALUE ASSUMPTIONS 2022 2021 Weighted-average fair value of options granted $ 4.72 $ 4.97 Expected terms (in years) 6.11 5.00 6.11 Expected volatility 68 72% 69 74% Risk-free interest rate 1.54 3.70% 0.39 0.45% Dividend yield - - |
SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE | The following table summarizes information about stock options outstanding and exercisable at December 31, 2022: SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE Options Outstanding Options Exercisable Range of Exercise Prices Number Weighted Weighted Price Number Weighted Price $ 1.47 2.23 583,112 4.53 $ 1.97 583,112 $ 1.97 $ 2.40 3.50 33,443 4.92 $ 2.84 25,631 $ 2.64 $ 3.95 310,000 3.25 $ 3.95 310,000 $ 3.95 $ 4.08 6.30 550,850 5.11 $ 5.84 518,417 $ 5.90 $ 6.75 7.30 405,000 7.67 $ 7.18 257,625 $ 7.29 $ 7.37 7.79 269,623 5.53 $ 7.54 138,249 $ 7.47 $ 7.87 600,000 2.58 $ 7.87 400,000 $ 7.87 $ 7.89 8.98 68,173 6.84 $ 8.24 44,735 $ 8.27 $ 8.99 180,000 0.33 $ 8.99 180,000 $ 8.99 $ 12.38 27,500 9.84 $ 12.38 - $ - $ 1.47 12.38 3,027,701 4.48 $ 5.90 2,457,769 $ 5.51 |
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY | A summary of the Company’s RSU activity and related information for the year ended December 31, 2022 is as follows: SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY Number of RSUs Weighted Average Grant Date Fair Value RSUs unvested – January 1, 2022 2,233,202 $ 6.78 RSUs granted 65,615 $ 7.62 RSUs vested (237,098 ) $ 6.70 RSUs cancelled/forfeit - RSUs unvested at December 31, 2022 2,061,719 $ 6.82 Number of RSUs Weighted Average Grant Date Fair Value RSUs unvested - January 1, 2021 1,601,509 $ 3.14 RSUs granted 1,906,490 $ 6.91 RSUs vested (1,274,797 ) $ 2.40 RSUs cancelled/forfeit - RSUs unvested at December 31, 2021 2,233,202 $ 6.78 |
SCHEDULE OF SHARE BASED COMPENSATION PERFORMANCE STOCK UNITS AWARD ACTIVITY | SCHEDULE OF SHARE BASED COMPENSATION PERFORMANCE STOCK UNITS AWARD ACTIVITY Tranche Number of Shares TSR Target Share Price* Tranche 1 223,988 50% or greater $ 11.70 Tranche 2 335,981 100% or greater $ 15.60 Tranche 3 447,975 150% or greater $ 19.50 Tranche 4 559,969 175% or greater $ 21.45 * Target Share Price assumes that no dividends or like distributions are made to shareholders of the Company. If such distributions are made, the Target Share Price would decrease accordingly, to the benefit of the employee, to account for the dividend/distribution as a part of TSR. |
SCHEDULE OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES DIRECTORS CONSULTANTS | The Company recorded stock-based compensation (including issuance of common stock for services and accrual for stock-based compensation) related to equity instruments granted to employees, directors and consultants as follows: SCHEDULE OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES DIRECTORS CONSULTANTS 2022 2021 For the Year Ended December 31, 2022 2021 Employees – selling, general and administrative $ 6,669,000 $ 4,800,000 Employees – R&D 689,000 527,000 Directors – selling, general and administrative 462,000 418,000 Consultants – selling, general and administrative 154,000 - Total $ 7,974,000 $ 5,745,000 Stock-based compensation $ 7,974,000 $ 5,745,000 |
SCHEDULE OF WARRANTS ACTIVITY | A summary of warrant activity during the year ended December 31, 2022 is as follows: SCHEDULE OF WARRANTS ACTIVITY Number of Shares Subject to Warrants Outstanding Weighted Avg. Exercise Price Warrants outstanding - January 1, 2022 373,847 $ 2.08 Granted - Exercised (373,847 ) 2.08 Expired - - Warrants outstanding - December 31, 2022 - $ - |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
SCHEDULE OF PROVISION FOR INCOME TAXES | The Company is subject to taxation in the United States, California, Florida, Georgia, Illinois, New Jersey, New York, Tennessee and Wisconsin. The Company’s income tax provision consists of the following for the years ended December 31, 2022 and 2021 are summarized below: SCHEDULE OF PROVISION FOR INCOME TAXES 2022 2021 December 31, 2022 2021 Current: Federal $ - $ - State 75,000 133,000 Total current $ 75,000 $ 133,000 Deferred: Federal $ 871,000 $ (425,000 ) State 312,000 (1,944,000 ) Change in valuation allowance (1,182,000 ) 2,369,000 Total deferred - - Income tax provision $ 75,000 $ 133,000 |
SCHEDULE OF INCOME TAX RECONCILIATION | A reconciliation of income taxes computed by applying the statutory U.S. income tax rate to the Company’s loss before income taxes to the income tax provision is as follows: SCHEDULE OF INCOME TAX RECONCILIATION 2022 2021 December 31, 2022 2021 U.S. federal statutory tax rate 21.00 % 21.00 % State tax benefit, net (2.82 )% (3.24 )% Employee stock-based compensation 1.34 % 7.95 % Excess Employee Remuneration (28.15 )% (9.84 )% Other 1.98 % 2.31 % W/O of IRC Sec 382 Limited NOLs - % (14.77 )% W/O of IRC Sec 383 Limited Credits - % (1.71 )% Reduction of VA for IRC Sec 382 and 383 W/O - % 16.48 % Valuation allowance 6.22 % (18.92 )% Effective income tax rate (0.43 )% (0.74 )% |
SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES | Deferred tax assets and liabilities reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets are as follows: SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES 2022 2021 December 31, 2022 2021 Deferred tax assets (liabilities): NOL $ 9,401,000 $ 12,337,000 Depreciation and amortization 236,000 680,000 Other 349,000 59,000 Research and development credits 90,000 90,000 Deferred stock compensation 945,000 4,642,000 Basis Difference in Eton (1,684,000 ) (2,511,000 ) Sintetica License Agreement 2,162,000 2,329,000 Sparcs License Agreement 2,000 (1,000 ) Novartis License Agreement (13,000 ) (138,000 ) Basis difference in Melt Loan Value 4,240,000 869,000 Park stock purchase identifiable intangibles - (255,000 ) Limitation Under 163(j) 536,000 - Section 174 Capital Expenses 594,000 - ASC 842 Lease Liability 2,427,000 1,856,000 ASC 842 ROU Asset (2,263,000 ) (1,753,000 ) Total deferred tax assets, net 17,022,000 18,204,000 Valuation allowance (17,022,000 ) (18,204,000 ) Net deferred tax liabilities $ - $ - |
SCHEDULE OF UNRECOGNIZED TAX BENEFITS | A reconciliation of the change in the UTB balance from January 1, 2022 to December 31, 2022 is as follows: SCHEDULE OF UNRECOGNIZED TAX BENEFITS Fed & State Tax Balance at January 1, 2022 $ - Additions for tax positions related to current year - Additions/(reductions) for tax positions related to prior years - Balance at December 31, 2022 $ - Total unrecognized tax benefits as of December 31, 2022 $ - |
SEGMENTS AND CONCENTRATIONS (Ta
SEGMENTS AND CONCENTRATIONS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Segment Reporting [Abstract] | |
SCHEDULE OF SEGMENT NET REVENUES, SEGMENT OPERATING EXPENSES AND SEGMENT CONTRIBUTION | SCHEDULE OF SEGMENT NET REVENUES, SEGMENT OPERATING EXPENSES AND SEGMENT CONTRIBUTION For the Year Ended December 31, 2021 Pharmaceutical Pharmaceutical Compounding Drug Development Total Net revenues $ 72,476,000 $ - $ 72,476,000 Cost of sales (18,214,000 ) - (18,214,000 ) Gross profit 54,262,000 - 54,262,000 Operating expenses: Selling, general and administrative 27,465,000 - 27,465,000 Research and development 1,088,000 8,674,000 9,762,000 Segment contribution 25,709,000 (8,674,000 ) 17,035,000 Corporate (13,689,000 ) Research and development (1,322,000 ) Amortization (161,000 ) Asset sales and impairments, net (249,000 ) Operating income $ 1,614,000 |
SCHEDULE OF INVESTMENT (Details
SCHEDULE OF INVESTMENT (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Melt Pharmaceuticals, Inc. [Member] | ||
Net Investment Income [Line Items] | ||
Cost Basis | $ 19,310,000 | $ 19,310,000 |
Share of Equity Method Losses | (19,310,000) | (8,177,000) |
Paid in Kind Interest | 2,484,000 | 576,000 |
In Substance Capital Contributions | (2,484,000) | (576,000) |
Net carrying value | 11,133,000 | |
Common Stock [Member] | Melt Pharmaceuticals, Inc. [Member] | ||
Net Investment Income [Line Items] | ||
Cost Basis | 5,810,000 | 5,810,000 |
Share of Equity Method Losses | (5,810,000) | (5,810,000) |
Paid in Kind Interest | ||
Common Stock [Member] | Surface Ophthalmics Inc [Member] | ||
Net Investment Income [Line Items] | ||
Cost Basis | 5,320,000 | |
Share of Equity Method Losses | (5,320,000) | |
Net carrying value | ||
Loan [Member] | Melt Pharmaceuticals, Inc. [Member] | ||
Net Investment Income [Line Items] | ||
Cost Basis | 13,500,000 | 13,500,000 |
Share of Equity Method Losses | (13,500,000) | (2,367,000) |
Paid in Kind Interest | 2,484,000 | 576,000 |
In Substance Capital Contributions | (2,484,000) | (576,000) |
Net carrying value | $ 11,133,000 |
SCHEDULE OF ESTIMATED FAIR VALU
SCHEDULE OF ESTIMATED FAIR VALUE (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Defined Benefit Plan Disclosure [Line Items] | ||
Carrying value | $ 110,000,000 | |
Fair Value, Inputs, Level 1 [Member] | 2016 Notes [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Carrying value | 72,436,000 | $ 71,654,000 |
Fair value | 71,550,000 | 78,810,000 |
Fair Value, Inputs, Level 1 [Member] | 2027 Notes [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Carrying value | 31,738,000 | |
Fair value | $ 35,112,000 |
SCHEDULE OF BASIC AND DILUTED E
SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Accounting Policies [Abstract] | ||
Numerator – net loss attributable to Harrow Health, Inc. common stockholders | $ (14,086,000) | $ (18,479,000) |
Denominator – weighted average number of shares outstanding, basic | 27,460,968 | 26,757,451 |
Net loss per share, basic and diluted | $ (0.51) | $ (0.69) |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Jul. 31, 2021 | |
Property, Plant and Equipment [Line Items] | |||
Consolidation basis description | entities in which it holds and/or controls, directly or indirectly, more than 50% of the voting rights | ||
Noncontrolling interest, description | Generally, any interest that holds less than 50% of the outstanding voting shares is deemed to be a noncontrolling interest; however, there are other factors that are considered as well, such as decision-making rights | ||
Equity interest percentage | 100% | ||
Deferred financing costs | $ 1,950,000 | ||
Cash, FDIC Insured Amount | 250,000 | ||
Accounts Receivable, after Allowance for Credit Loss | 779,000 | 40,000 | |
Due from related parties | $ 139,000 | $ 48,000 | |
Estimated useful life | 20 years | ||
Restricted Stock Units (RSUs) [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Vested RSU | 319,859 | 267,761 | |
Stock Options, Unvested RSUs and Warrants [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Unvested RSU warrants | 5,089,420 | 5,646,594 | |
New Drug Applications [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful life | 10 years | 10 years | |
Minimum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Useful Life | 3 years | ||
Estimated useful life | 2 years | ||
Maximum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Useful Life | 5 years | ||
Estimated useful life | 5 years | ||
Eton Pharmaceuticals, Inc. [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Number of stock sold | 1,518,000 | ||
Gross proceeds from sale of stock | $ 10,626,000 | ||
Payments for commissions | 799,000 | ||
Realized loss on investments | $ 1,406,000 | ||
Investment owned balance shares | 1,982,000 | ||
Ownership percentage | 10% | ||
Price per share | $ 2.82 | ||
Investment owned at fair value | $ 5,589,000 | $ 8,503,000 | |
Melt Pharmaceuticals, Inc. [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Investment owned balance shares | 3,500,000 | ||
Ownership percentage | 46% | ||
Reduction in common stock investment | $ 0 | 0 | |
Investment interest rate | 100% | ||
Surface Ophthalmics Inc [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Investment owned balance shares | 3,500,000 | ||
Ownership percentage | 20% | ||
Reduction in common stock investment | 0 | ||
Eton Pharmaceuticals, Inc. [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Unrealized gain loss on investments | $ 2,914,000 | $ 8,720,000 | |
Share price | $ 7 | ||
Investment owned at fair value | 5,589,000 | $ 8,503,000 | |
Melt Pharmaceuticals, Inc. [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Due from related parties | $ 139,000 | $ 48,000 |
SCHEDULE OF DISAGGREGATED REVEN
SCHEDULE OF DISAGGREGATED REVENUE (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ 88,595,000 | $ 72,476,000 |
Product Sales Net [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 83,524,000 | 69,104,000 |
Commissions [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 3,866,000 | 3,253,000 |
Transfer of Profit [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | 1,205,000 | 99,000 |
License [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenues | $ 20,000 |
REVENUES (Details Narrative)
REVENUES (Details Narrative) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Revenue from Contract with Customer [Abstract] | ||
Contract with customer liability current | $ 113,000 | $ 16,000 |
SCHEDULE OF NET GAIN ON SALE OF
SCHEDULE OF NET GAIN ON SALE OF ASSETS (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Recent Product Acquisitions Licenses And Divestitures | |
Gross consideration | $ 6,000,000 |
Closing and transaction costs | 55,000 |
Net proceeds | 5,945,000 |
Customer relations intangible asset | 686,000 |
Gain on sale of non-ophthalmology assets | $ 5,259,000 |
RECENT PRODUCT ACQUISITIONS, _3
RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Jan. 31, 2023 | Oct. 30, 2022 | Aug. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Accounts receivable | $ 6,249,000 | $ 4,470,000 | ||||
Accrued expense | $ 5,000,000 | |||||
Asset Purchase Agreement [Member] | ||||||
Proceeds from related party | $ 6,000,000 | |||||
Milestones receivable based on agreed revenues | $ 4,500,000 | |||||
Asset Purchase Agreement [Member] | Novartis Technology LLC and Novartis Opthalmics AG [Member] | ||||||
Asset acquisition description of acquired entity | the Company purchased from NVS the exclusive commercial rights, including the NDAs, to assets associated with ophthalmic products Moxeza, Iopidine 1% and 0.5%, and Maxitrol eyedrops suspension (collectively the “NVS Products”) in the United States of America (“U.S.”) | |||||
Asset Acquisition, Consideration Transferred | 14,050,000 | |||||
RPC Agreement [Member] | ||||||
Cash | $ 579,000 | |||||
RPC Agreement [Member] | Cash [Member] | ||||||
Accounts receivable | 128,000 | |||||
Transition Services Agreement [Member] | ||||||
Due from reimbursement of services amount | 254,000 | |||||
Accrued expenses | 453,000 | |||||
Other income | 102,000 | |||||
Sintetica Agreement [Member] | Research and Development Expense [Member] | ||||||
Payment for royalties | $ 3,117,000 | |||||
Sintetica Arrangement [Member] | ||||||
Accrued expense | $ 10,000,000 | |||||
Wakamoto Agreement [Member] | ||||||
Payment for royalties | $ 2,000,000 | |||||
Commercial payments for royalties | $ 6,200,000 | |||||
One Time Payment [Member] | Maximum [Member] | Sintetica Agreement [Member] | ||||||
Milestone payment | $ 18,000,000 | |||||
One Time Payment [Member] | Subsequent Event [Member] | ||||||
Milestone payment | $ 130,000,000 | |||||
One Time Payment [Member] | Subsequent Event [Member] | Maximum [Member] | ||||||
Milestone payment | $ 45,000,000 | |||||
Upfront Payment [Member] | Sintetica Agreement [Member] | ||||||
Milestone payment | $ 5,000,000 |
SCHEDULE OF CONDENSED INCOME ST
SCHEDULE OF CONDENSED INCOME STATEMENT (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenues, net | $ 88,595,000 | $ 72,476,000 |
Loss from operations | 1,919,000 | 1,614,000 |
Net loss | (14,086,000) | (18,007,000) |
Melt Pharmaceuticals, Inc. [Member] | ||
Revenues, net | ||
Loss from operations | 12,443,000 | 6,069,000 |
Net loss | $ (14,446,000) | $ (6,655,000) |
SCHEDULE OF CONDENSED BALANCE S
SCHEDULE OF CONDENSED BALANCE SHEET (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | $ 118,260,000 | $ 60,662,000 |
Total assets | 157,378,000 | 98,329,000 |
Total liabilities | 130,138,000 | 87,398,000 |
Total preferred stock and stockholders’ deficit | 27,595,000 | 11,286,000 |
Total liabilities and stockholders’ equity | 157,378,000 | 98,329,000 |
Melt Pharmaceuticals, Inc. [Member] | ||
Current assets | 655,000 | 11,278,000 |
Non-current assets | 107,000 | |
Total assets | 762,000 | 11,278,000 |
Total liabilities | 19,056,000 | 15,732,000 |
Total preferred stock and stockholders’ deficit | (18,294,000) | (4,454,000) |
Total liabilities and stockholders’ equity | $ 762,000 | $ 11,278,000 |
INVESTMENT IN MELT PHARMACEUT_3
INVESTMENT IN MELT PHARMACEUTICALS, INC. AND AGREEMENTS - RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Feb. 28, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | Sep. 01, 2021 | |
Due from related parties | $ 139,000 | $ 48,000 | |||
Rreimbursable expenses | 908,000 | ||||
Melt Loan Agreement [Member] | |||||
Loan amount | $ 13,500,000 | ||||
Debt instrument interest rate stated percentage | 12.50% | ||||
Increase in interest rate | 3% | ||||
Melt Loan Agreement [Member] | Third Party Investor [Member] | |||||
Loan amount | $ 10,000,000 | ||||
Melt Pharmaceuticals, Inc. [Member] | |||||
Reimbursable expenses | 91,000 | ||||
Due from related parties | 139,000 | 48,000 | |||
Melt Pharmaceuticals, Inc. [Member] | Management Services Agreement [Member] | |||||
Administrative fees expense | $ 10,000 | ||||
Due from related parties | 139,000 | 48,000 | |||
Notes receivable related parties | $ 15,984,000 | $ 14,076,000 |
SUMMARY OF CONDENSED INCOME STA
SUMMARY OF CONDENSED INCOME STATEMENT (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenues, net | $ 88,595,000 | $ 72,476,000 |
Loss from operations | 1,919,000 | 1,614,000 |
Net loss | (14,086,000) | (18,007,000) |
Surface Pharmaceuticals Inc [Member] | ||
Revenues, net | ||
Loss from operations | (6,719,000) | 10,468,000 |
Net loss | $ (6,579,000) | $ (10,143,000) |
SUMMARY OF CONDENSED BALANCE SH
SUMMARY OF CONDENSED BALANCE SHEET (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | $ 118,260,000 | $ 60,662,000 |
Total assets | 157,378,000 | 98,329,000 |
Total liabilities | 130,138,000 | 87,398,000 |
Total stockholders’ equity | 27,595,000 | 11,286,000 |
Total liabilities and stockholders’ equity | 157,378,000 | 98,329,000 |
Surface Pharmaceuticals Inc [Member] | ||
Current assets | 15,350,000 | 21,731,000 |
Non-current assets | 652,000 | 412,000 |
Total assets | 16,002,000 | 22,143,000 |
Total liabilities | 1,586,000 | 1,514,000 |
Total stockholders’ equity | 14,416,000 | 20,629,000 |
Total liabilities and stockholders’ equity | $ 16,002,000 | $ 22,143,000 |
INVESTMENT IN SURFACE OPHTHAL_3
INVESTMENT IN SURFACE OPHTHALMICS, INC. AND AGREEMENTS - RELATED PARTY TRANSACTIONS (Details Narrative) | Dec. 31, 2022 shares |
Surface Pharmaceuticals Inc [Member] | |
Shares, outstanding | 3,500,000 |
SCHEDULE OF INVENTORIES (Detail
SCHEDULE OF INVENTORIES (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 3,707,000 | $ 2,441,000 |
Work in progress | 38,000 | |
Finished goods | 2,796,000 | 1,776,000 |
Total inventories | $ 6,541,000 | $ 4,217,000 |
SCHEDULE OF PREPAID EXPENSES AN
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid insurance | $ 858,000 | $ 728,000 |
Prepaid computer software related expenses | 1,165,000 | 248,000 |
Other prepaid expenses | 1,331,000 | 189,000 |
Receivable due from Melt | 139,000 | 48,000 |
Deposits and other current assets | 118,000 | 92,000 |
Total prepaid expenses and other current assets | $ 3,611,000 | $ 1,305,000 |
SCHEDULE OF PROPERTY,PLANT AND
SCHEDULE OF PROPERTY,PLANT AND EQUIPMENT (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Abstract] | ||
Computer hardware | $ 979,000 | $ 772,000 |
Furniture and equipment | 860,000 | 443,000 |
Lab and pharmacy equipment | 4,259,000 | 4,056,000 |
Leasehold improvements | 6,449,000 | 5,703,000 |
Property, plant and equipment, gross | 12,547,000 | 10,974,000 |
Accumulated depreciation and amortization | (9,061,000) | (7,833,000) |
Property, plant and equipment, net | $ 3,486,000 | $ 3,141,000 |
PROPERTY, PLANT AND EQUIPMENT_2
PROPERTY, PLANT AND EQUIPMENT (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Gain loss on disposition of assets | $ 99,000 | $ 41,000 |
Impairment of charges | 150,000 | |
Depreciation and amortization expenses | $ 1,253,000 | 1,580,000 |
Purchase of lab and pharmacy equipment | $ 753,000 |
SCHEDULE OF FINITE LIVED INTANG
SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Finite-Lived Intangible Assets [Line Items] | ||
Total gross capitalized software for internal-use | $ 1,572,000 | $ 1,101,000 |
Accumulated amortization | (793,000) | (569,000) |
Capitalized internal-use software in process | 1,333,000 | 781,000 |
Total finite lived intangible assets net | 2,112,000 | 1,313,000 |
Capitalized Internal-use Software Development Costs [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Total gross capitalized software for internal-use | 1,413,000 | 942,000 |
Third Party Software License [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Total gross capitalized software for internal-use | $ 159,000 | $ 159,000 |
CAPITALIZED SOFTWARE COSTS (Det
CAPITALIZED SOFTWARE COSTS (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Capitalized Software Development Costs [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Amortization expenses | $ 224,000 | $ 137,000 |
SCHEDULE OF INTANGIBLE ASSETS (
SCHEDULE OF INTANGIBLE ASSETS (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Useful life | 20 years | |
Intangible assets, Cost | $ 26,719,000 | $ 16,642,000 |
Intangible assets, Accumulated amortization | (2,368,000) | (730,000) |
Intangible assets, Impairment | (626,000) | (99,000) |
Intangible assets, Net Carrying value | 23,725,000 | 15,813,000 |
Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Cost | 980,000 | 966,000 |
Intangible assets, Accumulated amortization | (161,000) | (75,000) |
Intangible assets, Impairment | ||
Intangible assets, Net Carrying value | $ 819,000 | $ 891,000 |
Trademarks [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life, description | Indefinite | Indefinite |
Intangible assets, Cost | $ 267,000 | $ 359,000 |
Intangible assets, Accumulated amortization | ||
Intangible assets, Impairment | (99,000) | |
Intangible assets, Net Carrying value | $ 267,000 | $ 260,000 |
Licenses [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Useful life | 20 years | 20 years |
Intangible assets, Cost | $ 100,000 | $ 100,000 |
Intangible assets, Accumulated amortization | (23,000) | (7,000) |
Intangible assets, Impairment | ||
Intangible assets, Net Carrying value | $ 77,000 | $ 93,000 |
New Drug Applications [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Useful life | 10 years | 10 years |
Intangible assets, Cost | $ 23,720,000 | $ 13,635,000 |
Intangible assets, Accumulated amortization | (1,363,000) | |
Intangible assets, Impairment | ||
Intangible assets, Net Carrying value | 22,357,000 | 13,635,000 |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Cost | 1,519,000 | 1,519,000 |
Intangible assets, Accumulated amortization | (759,000) | (586,000) |
Intangible assets, Impairment | (626,000) | |
Intangible assets, Net Carrying value | $ 134,000 | $ 933,000 |
Trade Names [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Useful life | 5 years | 5 years |
Intangible assets, Cost | $ 75,000 | $ 5,000 |
Intangible assets, Accumulated amortization | (5,000) | (5,000) |
Intangible assets, Impairment | ||
Intangible assets, Net Carrying value | 70,000 | |
Non-Competition Clause [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Cost | 50,000 | 50,000 |
Intangible assets, Accumulated amortization | (50,000) | (50,000) |
Intangible assets, Impairment | ||
Intangible assets, Net Carrying value | ||
State Pharmacy Licenses [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Useful life | 25 years | 25 years |
Intangible assets, Cost | $ 8,000 | $ 8,000 |
Intangible assets, Accumulated amortization | (7,000) | (7,000) |
Intangible assets, Impairment | ||
Intangible assets, Net Carrying value | $ 1,000 | $ 1,000 |
Minimum [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Useful life | 2 years | |
Minimum [Member] | Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Useful life | 7 years | 7 years |
Minimum [Member] | Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Useful life | 3 years | 3 years |
Minimum [Member] | Non-Competition Clause [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Useful life | 3 years | 3 years |
Maximum [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Useful life | 5 years | |
Maximum [Member] | Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Useful life | 19 years | 19 years |
Maximum [Member] | Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Useful life | 15 years | 15 years |
Maximum [Member] | Non-Competition Clause [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, Useful life | 4 years | 4 years |
SCHEDULE OF AMORTIZATION EXPENS
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets [Line Items] | ||
Amortization of intangible assets | $ 1,578,000 | $ 161,000 |
Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Amortization of intangible assets | 86,000 | 26,000 |
Licenses [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Amortization of intangible assets | 16,000 | 2,000 |
New Drug Applications [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Amortization of intangible assets | 1,363,000 | |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Amortization of intangible assets | $ 113,000 | $ 133,000 |
SCHEDULE OF ESTIMATED FUTURE AM
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2023 | $ 2,521,000 |
2024 | 2,521,000 |
2025 | 2,521,000 |
2026 | 2,521,000 |
2027 | 2,521,000 |
Thereafter | 10,853,000 |
Intangible assets | $ 23,458,000 |
INTANGIBLE ASSETS AND GOODWIL_2
INTANGIBLE ASSETS AND GOODWILL (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets [Line Items] | ||
Impairment | $ 626,000 | $ 99,000 |
Carrying value of ggodwill | 0 | 0 |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Impairment | 626,000 | |
Trademarks [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Impairment | $ 99,000 |
SCHEDULE OF ACCOUNTS PAYABLE AN
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 6,440,000 | $ 5,174,000 |
Accrued insurance premium | 575,000 | |
Accrued IHEEZO milestone payments (see Note 4) | 5,000,000 | |
Accrued RPC transition payments (see Note 4) | 453,000 | |
Accrued litigation settlements | 49,000 | 49,000 |
Accrued interest (see Note 13) | 1,254,000 | 1,114,000 |
Total accounts payable and accrued expenses | $ 13,771,000 | $ 6,337,000 |
SCHEDULE OF FUTURE MINIMUM PAYM
SCHEDULE OF FUTURE MINIMUM PAYMENTS UNDER NOTES PAYABLES (Details) | Dec. 31, 2022 USD ($) |
Debt Disclosure [Abstract] | |
2023 | $ 10,053,000 |
2024 | 10,625,000 |
2025 | 10,625,000 |
2026 | 81,314,000 |
2027 | 39,156,000 |
Total minimum payments | 151,773,000 |
Less: amount representing interest payments | (41,773,000) |
Notes payable, gross | 110,000,000 |
Less: unamortized discount, net of premium | (5,826,000) |
Notes payable, net of unamortized discount | $ 104,174,000 |
DEBT (Details Narrative)
DEBT (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||||
Dec. 14, 2022 | Dec. 31, 2022 | Jun. 30, 2021 | May 31, 2021 | Apr. 30, 2021 | Apr. 30, 2020 | Jul. 31, 2017 | Dec. 31, 2022 | Dec. 31, 2021 | Jan. 31, 2023 | |
Debt Instrument [Line Items] | ||||||||||
Amortization of debt issuance costs and discount | $ 782,000 | $ 677,000 | ||||||||
PPP loan balance | 1,967,000 | |||||||||
Subsequent Event [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt principal amount | $ 5,250,000 | |||||||||
Loan and Security Agreement [Member] | BR Loan [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt principal amount | $ 100,000,000 | |||||||||
Debt instrument maturity date | Dec. 14, 2025 | |||||||||
Interest rate | 10.875% | |||||||||
Prepayment fee | $ 0 | |||||||||
Interest rate | 3% | |||||||||
Loan and Security Agreement [Member] | BR Loan [Member] | Subsequent Event [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt principal amount | $ 59,750,000 | |||||||||
Term Loan and Security Agreement [Member] | SWK Funding LLC [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt principal amount | $ 16,000,000 | |||||||||
Interest expense, debt | 647,000 | |||||||||
Amortization of debt issuance costs and discount | 96,000 | |||||||||
Debt instrument interest rate description | Company provided SWK evidence that the Company has achieved a leverage ratio as of such date of less than 4.00:1:00, the Margin Rate shall equal 9.00%; and if the Company had achieved a leverage ratio as of such date of less than 3.00:1:00, the Margin Rate shall equal 7.00% | |||||||||
Debt instrument, additional principal amount | $ 1,000,000 | |||||||||
Interest paid-in-kind | 358,000 | |||||||||
Debt issuance expenses | $ 15,540,000 | |||||||||
Extinguishment of debt | 756,000 | |||||||||
Term Loan and Security Agreement [Member] | SWK Funding LLC [Member] | Base Rate [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Interest rate | 10% | |||||||||
Term Loan and Security Agreement [Member] | SWK Funding LLC [Member] | Minimum [Member] | London Interbank Offered Rate (LIBOR) [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Interest rate | 2% | |||||||||
Business Loan Agreement [Member] | Paycheck Protection Program Loan [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt principal amount | $ 1,967,000 | |||||||||
PPP loan balance | 1,967,000 | |||||||||
Senior Notes Due 2027 [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt principal amount | $ 35,000,000 | $ 35,000,000 | ||||||||
Shares issued price per share | $ 25 | $ 25 | ||||||||
Proceeds from issuance of debt | $ 31,738,000 | |||||||||
Deducting underwriting discounts and commissions and expenses | $ 3,626,000 | $ 3,626,000 | ||||||||
Interest rate, during period | 11.875% | |||||||||
Debt instrument maturity date | Dec. 31, 2027 | |||||||||
Redemption description | redemption price equal to 100% of the principal amount of the 2027 Notes to be redeemed, plus a make-whole amount, if any, plus accrued and unpaid interest to, but excluding, the date of redemption. The Company may redeem the 2027 Notes for cash in whole or in part at any time at its option (i) on or after December 31, 2024 and prior to December 31, 2025, at a price equal to $25.50 per note, plus accrued and unpaid interest to, but excluding, the date of redemption, (ii) on or after December 31, 2025 and prior to December 31, 2026, at a price equal to $25.25 per note, plus accrued and unpaid interest to, but excluding, the date of redemption, and (iii) on or after December 31, 2026 and prior to maturity, at a price equal to 100% of their principal amount, plus accrued and unpaid interest to, but excluding, the date of redemption. In addition, the Company is required to redeem the 2027 Notes, for cash, in whole but not in part, at the price of $25.50 per note | |||||||||
8.625% Senior Notes Due 2026 [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt principal amount | $ 50,000,000 | |||||||||
Deducting underwriting discounts and commissions and expenses | $ 1,158,000 | |||||||||
Interest rate, during period | 8.625% | |||||||||
Debt instrument maturity date | Apr. 30, 2026 | |||||||||
Redemption description | redemption price equal to 100% of the principal amount of the 2026 Notes to be redeemed | |||||||||
Debt instrument increase decrease for period net | $ 5,000,000 | |||||||||
Debt instrument unamortized premium | $ 322,000 | |||||||||
Interest expense other than long term debt | 7,378,000 | 5,132,000 | ||||||||
Amortization of debt issuance costs and discount | $ 782,000 | $ 581,000 | ||||||||
8.625% Senior Notes Due 2026 [Member] | Investor [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Shares issued price per share | $ 25.75 | $ 25 | ||||||||
Proceeds from issuance of debt | $ 19,164,000 | $ 51,909,000 | ||||||||
Deducting underwriting discounts and commissions and expenses | $ 3,091,000 | |||||||||
Debt instrument increase decrease for period net | 20,000,000 | |||||||||
Interest expense, debt | $ 278,000 |
SCHEDULE OF FUTURE LEASE PAYMEN
SCHEDULE OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Leases | ||
2023 | $ 1,231,000 | |
2024 | 1,262,000 | |
2025 | 1,093,000 | |
2026 | 1,114,000 | |
2027 | 972,000 | |
Thereafter | 5,829,000 | |
Total minimum lease payments | 11,501,000 | |
Less: amount representing interest payments | (3,446,000) | |
Total operating lease liabilities | 8,055,000 | |
Less: current portion, operating lease liabilities | (723,000) | $ (272,000) |
Operating lease liabilities, net of current portion | $ 7,332,000 | $ 6,012,000 |
LEASES (Details Narrative)
LEASES (Details Narrative) | 12 Months Ended | |
Dec. 31, 2022 USD ($) ft² | Dec. 31, 2021 USD ($) | |
Discount percent | 6.60% | 6.30% |
Lease term | 10 years 10 months 24 days | 14 years 7 months 6 days |
Operating lease payments | $ | $ 925,000 | $ 1,000,000 |
Operating lease expense | $ | $ 1,117,000 | $ 912,000 |
Carlsbad [Member] | ||
Area of land | 5,789 | |
Lease expiration date, description | March 2025, with an option to extend the term through March 2028 | |
Ledgewood [Member] | ||
Area of land | 35,326 | |
Lease expiration date, description | July 2026 | |
Additional area of land | 1,400 | |
Ledgewood [Member] | Lease Amendment [Member] | ||
Additional area of land | 8,900 | |
Nashville [Member] | ||
Area of land | 5,500 | |
Lease expiration date, description | December 2024 | |
Nashville 1 [Member] | ||
Area of land | 11,552 | |
Lease expiration date, description | June 2027 | |
Minimum [Member] | Office and Laboratory Space [Member] | ||
Lease term | 1 year | |
Maximum [Member] | Office and Laboratory Space [Member] | ||
Lease term | 5 years |
SCHEDULE OF STOCK OPTION PLAN A
SCHEDULE OF STOCK OPTION PLAN ACTIVITY (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Aggregate intrinsic value, options exercisable | $ | $ 2,008,000 |
Stock Option Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of shares, outstanding, beginning balance | shares | 3,039,546 |
Weighted average exercise price, outstanding, beginning balance | $ / shares | $ 5.52 |
Number of shares, options granted | shares | 351,250 |
Weighted average exercise price, options granted | $ / shares | $ 7.71 |
Number of shares, options exercised | shares | (288,720) |
Weighted average exercise price, options exercised | $ / shares | $ 3.65 |
Number of shares, options cancelled/forfeited | shares | (74,375) |
Weighted average exercise price, options cancelled/forfeited | $ / shares | $ 7.46 |
Number of shares, outstanding, ending balance | shares | 3,027,701 |
Weighted average exercise price, outstanding, ending balance | $ / shares | $ 5.90 |
Weighted average. remaining contractual life, options outstanding | 4 years 5 months 23 days |
Aggregate intrinsic value, options outstanding | $ | $ 26,822,000 |
Number of shares, options exercisable | shares | 2,457,769 |
Weighted average exercise price, options exercisable | $ / shares | $ 5.51 |
Weighted average. remaining contractual life, options exercisable | 3 years 11 months 19 days |
Aggregate intrinsic value, options exercisable | $ | $ 22,731,000 |
Number of shares, options vested and expected to vest | shares | 3,026,942 |
Weighted average exercise price, options vested and expected to vest | $ / shares | $ 5.90 |
Weighted average. remaining contractual life, options vested and expected to vest | 4 years 5 months 23 days |
Aggregate intrinsic value, options vested and expected to vest | $ | $ 26,817,000 |
SCHEDULE OF FAIR VALUE ASSUMPTI
SCHEDULE OF FAIR VALUE ASSUMPTIONS (Details) - Options Employees [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Weighted-average fair value of options granted | $ 4.72 | $ 4.97 |
Expected terms (in years) | 6 years 1 month 9 days | |
Dividend yield | ||
Minimum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected terms (in years) | 5 years | |
Expected volatility | 68% | 69% |
Risk-free interest rate | 1.54% | 0.39% |
Maximum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected terms (in years) | 6 years 1 month 9 days | |
Expected volatility | 72% | 74% |
Risk-free interest rate | 3.70% | 0.45% |
SCHEDULE OF STOCK OPTION OUTSTA
SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, minimum | $ 1.47 |
Range of Exercise Prices, maximum | $ 12.38 |
Number of Options Outstanding | shares | 3,027,701 |
Weighted Average Remaining Contractual Life in Years | 4 years 5 months 23 days |
Weighted Average Exercise Price | $ 5.90 |
Number Exercisable | shares | 2,457,769 |
Weighted Average Exercisable Exercise Price | $ 5.51 |
Range One [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, minimum | 1.47 |
Range of Exercise Prices, maximum | $ 2.23 |
Number of Options Outstanding | shares | 583,112 |
Weighted Average Remaining Contractual Life in Years | 4 years 6 months 10 days |
Weighted Average Exercise Price | $ 1.97 |
Number Exercisable | shares | 583,112 |
Weighted Average Exercisable Exercise Price | $ 1.97 |
Range Two [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, minimum | 2.40 |
Range of Exercise Prices, maximum | $ 3.50 |
Number of Options Outstanding | shares | 33,443 |
Weighted Average Remaining Contractual Life in Years | 4 years 11 months 1 day |
Weighted Average Exercise Price | $ 2.84 |
Number Exercisable | shares | 25,631 |
Weighted Average Exercisable Exercise Price | $ 2.64 |
Range Three [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, maximum | $ 3.95 |
Number of Options Outstanding | shares | 310,000 |
Weighted Average Remaining Contractual Life in Years | 3 years 3 months |
Weighted Average Exercise Price | $ 3.95 |
Number Exercisable | shares | 310,000 |
Weighted Average Exercisable Exercise Price | $ 3.95 |
Range Four [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, minimum | 4.08 |
Range of Exercise Prices, maximum | $ 6.30 |
Number of Options Outstanding | shares | 550,850 |
Weighted Average Remaining Contractual Life in Years | 5 years 1 month 9 days |
Weighted Average Exercise Price | $ 5.84 |
Number Exercisable | shares | 518,417 |
Weighted Average Exercisable Exercise Price | $ 5.90 |
Range Five [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, minimum | 6.75 |
Range of Exercise Prices, maximum | $ 7.30 |
Number of Options Outstanding | shares | 405,000 |
Weighted Average Remaining Contractual Life in Years | 7 years 8 months 1 day |
Weighted Average Exercise Price | $ 7.18 |
Number Exercisable | shares | 257,625 |
Weighted Average Exercisable Exercise Price | $ 7.29 |
Range Six [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, minimum | 7.37 |
Range of Exercise Prices, maximum | $ 7.79 |
Number of Options Outstanding | shares | 269,623 |
Weighted Average Remaining Contractual Life in Years | 5 years 6 months 10 days |
Weighted Average Exercise Price | $ 7.54 |
Number Exercisable | shares | 138,249 |
Weighted Average Exercisable Exercise Price | $ 7.47 |
Range Seven [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, maximum | $ 7.87 |
Number of Options Outstanding | shares | 600,000 |
Weighted Average Remaining Contractual Life in Years | 2 years 6 months 29 days |
Weighted Average Exercise Price | $ 7.87 |
Number Exercisable | shares | 400,000 |
Weighted Average Exercisable Exercise Price | $ 7.87 |
Range Eight [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, minimum | 7.89 |
Range of Exercise Prices, maximum | $ 8.98 |
Number of Options Outstanding | shares | 68,173 |
Weighted Average Remaining Contractual Life in Years | 6 years 10 months 2 days |
Weighted Average Exercise Price | $ 8.24 |
Number Exercisable | shares | 44,735 |
Weighted Average Exercisable Exercise Price | $ 8.27 |
Range Nine [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, maximum | $ 8.99 |
Number of Options Outstanding | shares | 180,000 |
Weighted Average Remaining Contractual Life in Years | 3 months 29 days |
Weighted Average Exercise Price | $ 8.99 |
Number Exercisable | shares | 180,000 |
Weighted Average Exercisable Exercise Price | $ 8.99 |
Range Ten [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, maximum | $ 12.38 |
Number of Options Outstanding | shares | 27,500 |
Weighted Average Remaining Contractual Life in Years | 9 years 10 months 2 days |
Weighted Average Exercise Price | $ 12.38 |
Number Exercisable | shares | |
Weighted Average Exercisable Exercise Price |
SCHEDULE OF RESTRICTED STOCK UN
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of RSUs unvested, outstanding, beginning balance | 2,233,202 | 1,601,509 |
Weighted average grant date fair value, beginning balance | $ 6.78 | $ 3.14 |
Number of RSUs granted | 65,615 | 1,906,490 |
Weighted average grant date fair value, RSUs granted | $ 7.62 | $ 6.91 |
Number of RSUs vested | (237,098) | (1,274,797) |
Weighted average grant date fair value, RSUs vested | $ 6.70 | $ 2.40 |
Number of RSUs cancelled/forfeited | ||
Number of RSUs unvested, outstanding, ending balance | 2,061,719 | 2,233,202 |
Weighted average grant date fair value, ending balance | $ 6.82 | $ 6.78 |
SCHEDULE OF SHARE BASED COMPENS
SCHEDULE OF SHARE BASED COMPENSATION PERFORMANCE STOCK UNITS AWARD ACTIVITY (Details) | Dec. 31, 2022 $ / shares shares | |
Share-Based Payment Arrangement, Tranche One [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Shares | shares | 223,988 | |
Target Share Price | $ / shares | $ 11.70 | [1] |
Share-Based Payment Arrangement, Tranche Two [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Shares | shares | 335,981 | |
Target Share Price | $ / shares | $ 15.60 | [1] |
Share-Based Payment Arrangement, Tranche Three [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Shares | shares | 447,975 | |
Target Share Price | $ / shares | $ 19.50 | [1] |
Share-based Payment Arrangement, Tranche Four [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Shares | shares | 559,969 | |
Target Share Price | $ / shares | $ 21.45 | [1] |
[1]Target Share Price assumes that no dividends or like distributions are made to shareholders of the Company. If such distributions are made, the Target Share Price would decrease accordingly, to the benefit of the employee, to account for the dividend/distribution as a part of TSR. |
SCHEDULE OF STOCK BASED COMPENS
SCHEDULE OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES DIRECTORS CONSULTANTS (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock-based compensation | $ 7,974,000 | $ 5,745,000 |
Selling, General and Administrative Expenses [Member] | Employees [Member] | ||
Stock-based compensation | 6,669,000 | 4,800,000 |
Selling, General and Administrative Expenses [Member] | Director [Member] | ||
Stock-based compensation | 462,000 | 418,000 |
Selling, General and Administrative Expenses [Member] | Consultant [Member] | ||
Stock-based compensation | 154,000 | |
Research and Development Expense [Member] | Employees [Member] | ||
Stock-based compensation | $ 689,000 | $ 527,000 |
SCHEDULE OF WARRANTS ACTIVITY (
SCHEDULE OF WARRANTS ACTIVITY (Details) - Warrant [Member] | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Class of Warrant or Right [Line Items] | |
Number of Shares Warrants Outstanding, beginning balance | 373,847 |
Weighted Avg. Exercise Price, Outstanding, beginning balance | $ / shares | $ 2.08 |
Number of Shares Warrants Outstanding, Granted | |
Number of Shares Warrants Outstanding, Exercised | (373,847) |
Weighted Avg. Exercise Price, Exercised | $ / shares | $ 2.08 |
Number of Shares Warrants Outstanding, Expirations | |
Weighted Avg. Exercise Price, Expired | $ / shares | |
Number of Shares Warrants Outstanding, ending balance | |
Weighted Avg. Exercise Price, Outstanding,ending balance | $ / shares |
STOCKHOLDERS_ EQUITY AND STOC_3
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION (Details Narrative) - USD ($) | 1 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 04, 2020 | Jul. 31, 2015 | May 31, 2021 | Jun. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Class of Stock [Line Items] | ||||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | ||||
Preferred stock, par value | $ 0.001 | $ 0.001 | ||||
Preferred stock, shares issued | 0 | 0 | ||||
Preferred stock, shares outstanding | 0 | 0 | ||||
Common stock, par value | 50,000,000 | 50,000,000 | ||||
Common stock, par or stated value per share | $ 0.001 | $ 0.001 | ||||
Common stock withheld for payroll tax withholdings, value | $ (876,000) | $ (3,228,000) | ||||
Net proceeds from common stock | 22,655,000 | |||||
Intrinsic value | 2,008,000 | |||||
Stock-based compensation | 7,974,000 | 5,745,000 | ||||
Fair value of restricted common stock issued | ||||||
Baum Performance Option [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares, options granted | 600,000 | |||||
Exercise price of options | $ 7.87 | |||||
Weighted avg. remaining contractual life, options outstanding | 5 years | |||||
Fair value of vested options | $ 1,876,000 | |||||
Expected term | 5 years | |||||
Volatility rate | 70% | |||||
Risk-free interest rate | 0.40% | |||||
2017 Incentive Stock and Awards Plan [Member] | ||||||
Class of Stock [Line Items] | ||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 6,000,000 | |||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 2,057,155 | |||||
Minimum [Member] | Baum Performance Option [Member] | ||||||
Class of Stock [Line Items] | ||||||
Average stock price | 9 | |||||
Maximum [Member] | Baum Performance Option [Member] | ||||||
Class of Stock [Line Items] | ||||||
Average stock price | $ 15 | |||||
Consultant [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares of common stock | 4,054 | |||||
Cashless exercise of options, shares | 15,995 | |||||
Warrants exercise price | $ 7.07 | |||||
Common stock withheld for payroll tax withholdings, shares | 11,941 | |||||
Consultant One [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares of common stock | 15,625 | |||||
Cashless exercise of options, shares | 15,625 | |||||
Warrants exercise price | $ 3.50 | |||||
Net proceeds from common stock | $ 55,000 | |||||
Consultant Two [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares of common stock | 132,100 | 25,480 | ||||
Cashless exercise of options, shares | 132,100 | 25,480 | ||||
Net proceeds from common stock | $ 587,000 | $ 65,000 | ||||
Consultant Two [Member] | Minimum [Member] | ||||||
Class of Stock [Line Items] | ||||||
Warrants exercise price | $ 1.70 | $ 1.70 | ||||
Consultant Two [Member] | Maximum [Member] | ||||||
Class of Stock [Line Items] | ||||||
Warrants exercise price | $ 8.40 | $ 4.29 | ||||
Employees [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares of common stock | 110,621 | |||||
Common stock withheld for payroll tax withholdings, shares | 74,379 | |||||
Common stock withheld for payroll tax withholdings, value | $ 581,000 | |||||
Number of RSUs granted | 185,000 | |||||
Warrant [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares of common stock | 306,347 | 311,369 | ||||
Number of securities called by warrants | 373,847 | 406,539 | ||||
Warrants exercise price | $ 2.08 | |||||
Warrant [Member] | Minimum [Member] | ||||||
Class of Stock [Line Items] | ||||||
Warrants exercise price | $ 1.79 | |||||
Warrant [Member] | Maximum [Member] | ||||||
Class of Stock [Line Items] | ||||||
Warrants exercise price | $ 3.75 | |||||
Restricted Stock Units (RSUs) [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of RSUs granted | 65,615 | 1,906,490 | ||||
Number of restricted shares vested | 319,859 | 267,761 | ||||
Number of RSUs unvested, outstanding, beginning balance | 1,601,509 | 2,233,202 | 1,601,509 | |||
Weighted average grant date fair value, beginning balance | $ 3.14 | $ 6.78 | $ 3.14 | |||
Weighted Average Grant Date Fair Value, RSUs granted | $ 7.62 | $ 6.91 | ||||
Number of RSUs vested | (237,098) | (1,274,797) | ||||
Weighted Average Grant Date Fair Value, RSUs vested | $ 6.70 | $ 2.40 | ||||
Number of RSUs cancelled/forfeited | ||||||
Number of RSUs unvested, outstanding, ending balance | 2,061,719 | 2,233,202 | ||||
Weighted average grant date fair value, ending balance | $ 6.82 | $ 6.78 | ||||
Restricted Stock Units (RSUs) [Member] | Employees [Member] | ||||||
Class of Stock [Line Items] | ||||||
Shares issued of restricted common stock, shares | 300,000 | |||||
Fair value of restricted common stock issued | $ 2,670,000 | |||||
Restricted Stock Units (RSUs) [Member] | Director [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of restricted shares vested | 35,693 | 67,297 | ||||
Restricted Stock Units (RSUs) [Member] | Board of Directors [Member] | ||||||
Class of Stock [Line Items] | ||||||
Shares issued of restricted common stock, shares | 65,615 | 38,576 | ||||
Fair value of restricted common stock issued | $ 500,000 | $ 400,000 | ||||
Stock Option Plan [Member] | ||||||
Class of Stock [Line Items] | ||||||
Closing price of common stock price per share | $ 14.76 | |||||
Forfeiture factor, percentage | 10% | |||||
Unrecognized compensation expense related to unvested stock options granted under the plan | $ 1,560,000 | |||||
Expense expected to recognize over the weighted-average remaining vesting period | 4 years 10 months 17 days | |||||
Stock-based compensation | $ 1,130,000 | 1,636,000 | ||||
Stock Option Plan [Member] | Employees and Consultant [Member] | ||||||
Class of Stock [Line Items] | ||||||
Weighted avg. remaining contractual life, options exercisable | 10 years | |||||
Vesting term description | Vesting terms for options granted to employees and consultants during the year ended December 31, 2022 generally included one of the following vesting schedules: 25% of the shares subject to the option vest and become exercisable on the first anniversary of the grant date and the remaining 75% of the shares subject to the option vest and become exercisable quarterly in equal installments thereafter over three years | |||||
Unvested RSUs [Member] | ||||||
Class of Stock [Line Items] | ||||||
Unrecognized compensation expense related to unvested stock options granted under the plan | $ 4,205,000 | |||||
Expense expected to recognize over the weighted-average remaining vesting period | 7 months 6 days | |||||
Stock-based compensation | $ 6,844,000 | $ 4,022,000 | ||||
Performance Shares [Member] | Board of Directors [Member] | ||||||
Class of Stock [Line Items] | ||||||
Shares issued of restricted common stock, shares | 1,567,913 | |||||
Performance Stock Units PSU [Member] | Employees [Member] | ||||||
Class of Stock [Line Items] | ||||||
Fair value of vested options | $ 10,113,000 | |||||
Expected term | 5 years | |||||
Volatility rate | 75% | |||||
Risk-free interest rate | 0.72% | |||||
Mark L. Baum [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares of common stock | 53,594 | 715,871 | ||||
Cashless exercise of options, shares | 125,000 | |||||
Warrants exercise price | $ 2.40 | |||||
Common stock withheld on cashless exercise | 36,014 | |||||
Common stock withheld for payroll tax withholdings, shares | 35,392 | 334,129 | ||||
Common stock withheld for payroll tax withholdings, value | $ 295,000 | $ 2,760,000 | ||||
Shares issued of restricted common stock, shares | 1,050,000 | |||||
Andrew R. Boll [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares of common stock | 100,168 | |||||
Common stock withheld for payroll tax withholdings, shares | 57,332 | |||||
Common stock withheld for payroll tax withholdings, value | $ 468,000 | |||||
Shares issued of restricted common stock, shares | 157,500 | |||||
Mayfield Pharmaceuticals Inc [Member] | Subsidiary Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Stock-based compensation | $ 0 | $ 87,000 | ||||
Series B Cumulative Preferred Stock Redeemed [Member] | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock, par value | $ 0.001 | |||||
Number of sale of stock | 440,000 | 440,000 | ||||
Preferred stock, liquidation preference per share | $ 25 | $ 25 | ||||
Payments of Stock Issuance Costs | $ 10,655,000 | |||||
Preferred Stock, Voting Rights | Series B Preferred Stock was not convertible into our common stock, had no voting rights | |||||
Preferred Stock, Dividend Rate, Percentage | 9.50% | |||||
Accrued and unpaid dividends | $ 11,127,000 | |||||
Preferred stock, cash dividends | $ 472,000 |
SCHEDULE OF PROVISION FOR INCOM
SCHEDULE OF PROVISION FOR INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Current: | ||
Federal | ||
State | 75,000 | 133,000 |
Total current | 75,000 | 133,000 |
Deferred: | ||
Federal | 871,000 | (425,000) |
State | 312,000 | (1,944,000) |
Change in valuation allowance | (1,182,000) | 2,369,000 |
Total deferred | ||
Income tax provision | $ 75,000 | $ 133,000 |
SCHEDULE OF INCOME TAX RECONCIL
SCHEDULE OF INCOME TAX RECONCILIATION (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
U.S. federal statutory tax rate | 21% | 21% |
State tax benefit, net | (2.82%) | (3.24%) |
Employee stock-based compensation | 1.34% | 7.95% |
Excess Employee Remuneration | (28.15%) | (9.84%) |
Other | 1.98% | 2.31% |
W/O of IRC Sec 382 Limited NOLs | (14.77%) | |
W/O of IRC Sec 383 Limited Credits | (1.71%) | |
Reduction of VA for IRC Sec 382 and 383 W/O | 16.48% | |
Valuation allowance | 6.22% | (18.92%) |
Effective income tax rate | (0.43%) | (0.74%) |
SCHEDULE OF DEFERRED TAX ASSETS
SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | ||
NOL | $ 9,401,000 | $ 12,337,000 |
Depreciation and amortization | 236,000 | 680,000 |
Other | 349,000 | 59,000 |
Research and development credits | 90,000 | 90,000 |
Deferred stock compensation | 945,000 | 4,642,000 |
Basis Difference in Eton | (1,684,000) | (2,511,000) |
Sintetica License Agreement | 2,162,000 | 2,329,000 |
Sparcs License Agreement | 2,000 | (1,000) |
Novartis License Agreement | (13,000) | (138,000) |
Basis difference in Melt Loan Value | 4,240,000 | 869,000 |
Park stock purchase identifiable intangibles | (255,000) | |
Limitation Under 163(j) | 536,000 | |
Section 174 Capital Expenses | 594,000 | |
ASC 842 Lease Liability | 2,427,000 | 1,856,000 |
ASC 842 ROU Asset | (2,263,000) | (1,753,000) |
Total deferred tax assets, net | 17,022,000 | 18,204,000 |
Valuation allowance | (17,022,000) | (18,204,000) |
Net deferred tax liabilities |
SCHEDULE OF UNRECOGNIZED TAX BE
SCHEDULE OF UNRECOGNIZED TAX BENEFITS (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Income Tax Disclosure [Abstract] | |
Balance at January 1, 2022 | |
Additions for tax positions related to current year | |
Additions/(reductions) for tax positions related to prior years | |
Balance at December 31, 2022 | |
Total unrecognized tax benefits as of December 31, 2021 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | ||
Increased valuation allowance | $ 1,182,000 | $ 2,369,000 |
Net operating loss carryforwards | 23,900,000 | |
State operating loss carryforwards | $ 45,000,000 | |
State net operating loss expiration date | 2027 | |
Federal net operating loss carryforward description | In addition, the Company has federal net operating loss carryforward of $3,900,000 generated after 2017 that can be carried over indefinitely and may be used to offset up to 80% of federal taxable income | |
Income tax examination penalties and interest accrued | $ 0 | 0 |
Research and development costs | $ 3,050,000 | $ 11,084,000 |
Reasearch and Development [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Federal and state research and development tax credits expiration date | 2026 | |
Domestic Tax Authority [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Research and development tax credits | $ 47,000 | |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Research and development tax credits | 54,000 | |
Internal Revenue Service (IRS) [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 12,500,000 | |
State operating loss carryforwards | 9,400 | |
Federal credit | 300,000 | |
State credits | $ 300,000 | |
US Jurisdiction [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Research and development amortization period | 5 years | |
Research and development costs | $ 2,191,000 | |
Non-US Jurisdiction [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Research and development amortization period | 15 years |
EMPLOYEE SAVINGS PLAN (Details
EMPLOYEE SAVINGS PLAN (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Retirement Benefits [Abstract] | ||
Percentage of salary deposits in tax deferred investment account | 100% | |
Percentage of contributions made by the company | 4% | |
Contributions by the company | $ 397,000 | $ 282,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Nov. 08, 2021 | May 31, 2021 | Dec. 31, 2019 | Apr. 30, 2017 | Dec. 31, 2022 | Dec. 31, 2021 | |
Loss Contingencies [Line Items] | ||||||
Litigation settlement agreement, description | On November 8, 2021, following a jury trial, the Company and NDS entered into a voluntary settlement agreement (the “Settlement Agreement”) to resolve all claims and pending matters related to this lawsuit. During the year ended December 31, 2021, the Company recorded $1,500,000 in selling, general and administrative expenses related to the Settlement Agreement. Except for the one-time payment of $1,500,000 the Company does not expect the Settlement Agreement will have any future material impact on the Company’s consolidated cash flows, financial position, and results of operations. | |||||
Estimated one-time payment | $ 1,500,000 | |||||
Sales and Marketing Agreements [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Description for commission payments | Under the terms of the sales and marketing agreements, the Company is required to make commission payments generally equal to 10% to 14% of net sales for products above and beyond the initial existing sales amounts | |||||
Commission expenses | $ 4,274,000 | $ 3,640,000 | ||||
Sales and Marketing Agreements [Member] | Minimum [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Commission payments percentage | 10% | |||||
Sales and Marketing Agreements [Member] | Maximum [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Commission payments percentage | 14% | |||||
Asset Purchase, License and Related Agreements [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Accounts payable and other accrued liabilities | $ 228,000 | 251,000 | ||||
Royalty expense | 910,000 | 991,000 | ||||
Klarity License Agreement [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Royalty expense | 315,000 | 160,000 | ||||
Milestone payment in cash | 274,000 | 165,000 | ||||
Additional milestone payment in cash | 71,000 | 30,000 | ||||
Klarity License Agreement [Member] | Richard L. Lindstrom, M.D [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Royalty payment description | Under the terms of the Klarity License Agreement, the Company is required to make royalty payments to Dr. Lindstrom ranging from 3% to 6% of net sales, dependent upon the final formulation of the Klarity Product sold | |||||
Klarity License Agreement [Member] | Richard L. Lindstrom, M.D [Member] | Initial Payment [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Royalty expense | $ 50,000 | |||||
Klarity License Agreement [Member] | Richard L. Lindstrom, M.D [Member] | Second Payment [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Royalty expense | 50,000 | |||||
Net sales | 50,000 | |||||
Klarity License Agreement [Member] | Richard L. Lindstrom, M.D [Member] | Final Payment [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Royalty expense | 50,000 | |||||
Net sales | $ 100,000 | |||||
Injectable Asset Purchase Agreement [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Royalty expense | 9,000 | 8,000 | ||||
Milestone payment in cash | 32,000 | 28,000 | ||||
Injectable Asset Purchase Agreement [Member] | Richard L. Lindstrom, M.D [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Royalty payment description | Under the terms of the Lindstrom APA, the Company is required to make royalty payments to Dr. Lindstrom ranging from 2% to 3% of net sales, dependent upon the final formulation and patent protection of the Lindstrom Product sold | |||||
Initial milestone payment | $ 33,000 | |||||
Lindstrom Agreement [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Royalty expense | 33,000 | 29,000 | ||||
Presbyopia Asset Purchase Agreement [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Royalty expense | 0 | 0 | ||||
Milestone payment in cash | 0 | 0 | ||||
Milestone payment due | 0 | 0 | ||||
Presbyopia Asset Purchase Agreement [Member] | Richard L. Lindstrom, M.D [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Royalty payment description | Under the terms of the Presbyopia Product, the Company is required to make royalty payments to Dr. Lindstrom ranging from 2% to 4% of net sales, dependent upon the final formulation and patent protection of the Presbyopia Product sold. | |||||
Dexycu Agreement [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Commission revenues | $ 3,866,000 | 3,253,000 | ||||
License Agreement [Member] | Mayfield Pharmaceuticals [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Shares returned | 300,000 | |||||
Asset Purchase Agreement [Member] | Mayfield Pharmaceuticals [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Shares returned | 350,000 | |||||
Stowe License Agreement [Member] | Mayfield Pharmaceuticals [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Shares returned | 1,750,000 | |||||
Selling, General and Administrative Expenses [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Estimated litigation settlement expense | $ 1,500,000 |
SCHEDULE OF SEGMENT NET REVENUE
SCHEDULE OF SEGMENT NET REVENUES, SEGMENT OPERATING EXPENSES AND SEGMENT CONTRIBUTION (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Segment Reporting Information [Line Items] | ||
Net Revenues | $ 88,595,000 | $ 72,476,000 |
Cost of sales | (25,383,000) | (18,214,000) |
Gross profit | 63,212,000 | 54,262,000 |
Selling, general and administrative | 58,243,000 | 41,315,000 |
Research and development | 3,050,000 | 11,084,000 |
Operating income (loss) | $ 1,919,000 | 1,614,000 |
Operating Segments [Member] | ||
Segment Reporting Information [Line Items] | ||
Net Revenues | 72,476,000 | |
Cost of sales | (18,214,000) | |
Gross profit | 54,262,000 | |
Selling, general and administrative | 27,465,000 | |
Research and development | 9,762,000 | |
Segment contribution | 17,035,000 | |
Operating income (loss) | 1,614,000 | |
Amortization | (161,000) | |
Asset sales and impairments, net | (249,000) | |
Operating Segments [Member] | Research and Development Expense [Member] | ||
Segment Reporting Information [Line Items] | ||
Operating income (loss) | (1,322,000) | |
Operating Segments [Member] | Pharmaceutical Compounding [Member] | ||
Segment Reporting Information [Line Items] | ||
Net Revenues | 72,476,000 | |
Cost of sales | (18,214,000) | |
Gross profit | 54,262,000 | |
Selling, general and administrative | 27,465,000 | |
Research and development | 1,088,000 | |
Segment contribution | 25,709,000 | |
Operating Segments [Member] | Pharmaceutical Drug Development [Member] | ||
Segment Reporting Information [Line Items] | ||
Net Revenues | ||
Cost of sales | ||
Gross profit | ||
Selling, general and administrative | ||
Research and development | 8,674,000 | |
Segment contribution | (8,674,000) | |
Corporate, Non-Segment [Member] | ||
Segment Reporting Information [Line Items] | ||
Operating income (loss) | $ (13,689,000) |
SEGMENTS AND CONCENTRATIONS (De
SEGMENTS AND CONCENTRATIONS (Details Narrative) - Segment | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue, Major Customer [Line Items] | ||
Number of operating segments | 2 | |
Cost of Goods and Service, Product and Service Benchmark [Member] | Supplier Concentration Risk [Member] | Three Main Suppliers [Member] | ||
Revenue, Major Customer [Line Items] | ||
Concentration risk percentage | 61% | 74% |
Two Product Concentration Risk [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | ||
Revenue, Major Customer [Line Items] | ||
Concentration risk percentage | 34% | 35% |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |
Jan. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Subsequent Event [Line Items] | |||
Common stock withheld for payroll tax withholdings, value | $ (876,000) | $ (3,228,000) | |
Milestone payment | $ 15,961,000 | ||
Andrew R. Boll [Member] | |||
Subsequent Event [Line Items] | |||
Number of shares of common stock | 100,168 | ||
Common stock withheld for payroll tax withholdings, shares | 57,332 | ||
Common stock withheld for payroll tax withholdings, value | $ 468,000 | ||
Mark L. Baum [Member] | |||
Subsequent Event [Line Items] | |||
Number of shares of common stock | 53,594 | 715,871 | |
Common stock withheld for payroll tax withholdings, shares | 35,392 | 334,129 | |
Common stock withheld for payroll tax withholdings, value | $ 295,000 | $ 2,760,000 | |
Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Face amount | $ 5,250,000 | ||
Note payable | 40,250,000 | ||
Subsequent Event [Member] | FAB Five [Member] | |||
Subsequent Event [Line Items] | |||
Face amount | 59,750,000 | ||
Subsequent Event [Member] | One Time Payment [Member] | |||
Subsequent Event [Line Items] | |||
Milestone payment | 130,000,000 | ||
Subsequent Event [Member] | Milestone Payment [Member] | |||
Subsequent Event [Line Items] | |||
Milestone payment | $ 45,000,000 | ||
Subsequent Event [Member] | Andrew R. Boll [Member] | |||
Subsequent Event [Line Items] | |||
Number of granted, sharess | 23,000 | ||
Number of shares of common stock | 13,398 | ||
Common stock withheld for payroll tax withholdings, shares | 9,602 | ||
Common stock withheld for payroll tax withholdings, value | $ 142,000 | ||
Subsequent Event [Member] | Mark L. Baum [Member] | |||
Subsequent Event [Line Items] | |||
Number of granted, sharess | 88,000 | ||
Number of shares of common stock | 52,821 | ||
Common stock withheld for payroll tax withholdings, shares | 35,179 | ||
Common stock withheld for payroll tax withholdings, value | $ 519,000 |