Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 13, 2023 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-35814 | |
Entity Registrant Name | Harrow, 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 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 Common Stock, Shares Outstanding | 35,117,746 | |
Common Stock, $0.001 par value per share | ||
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Trading Symbol | HROW | |
Security Exchange Name | NASDAQ | |
8.625% Senior Notes due 2026 | ||
Title of 12(b) Security | 8.625% Senior Notes due 2026 | |
Trading Symbol | HROWL | |
Security Exchange Name | NASDAQ | |
11.875% Senior Notes due 2027 | ||
Title of 12(b) Security | 11.875% Senior Notes due 2027 | |
Trading Symbol | HROWM | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 65,610,000 | $ 96,270,000 |
Investment in Eton Pharmaceuticals | 8,265,000 | 5,589,000 |
Accounts receivable, net | 18,468,000 | 6,249,000 |
Inventories | 8,924,000 | 6,541,000 |
Prepaid expenses and other current assets | 9,011,000 | 3,611,000 |
Total current assets | 110,278,000 | 118,260,000 |
Property, plant and equipment, net | 3,629,000 | 3,486,000 |
Capitalized software costs, net | 2,151,000 | 2,112,000 |
Deferred financing costs | 1,950,000 | |
Operating lease right-of-use assets, net | 6,972,000 | 7,513,000 |
Intangible assets, net | 162,703,000 | 23,725,000 |
Goodwill | 332,000 | 332,000 |
TOTAL ASSETS | 286,065,000 | 157,378,000 |
Current liabilities | ||
Accounts payable and accrued expenses | 12,772,000 | 13,771,000 |
Accrued payroll and related liabilities | 5,319,000 | 4,025,000 |
Deferred revenue and customer deposits | 153,000 | 113,000 |
Current portion of operating lease obligations | 785,000 | 723,000 |
Total current liabilities | 19,029,000 | 18,632,000 |
Operating lease obligations, net of current portion | 6,735,000 | 7,332,000 |
Accrued expenses, net of current portion | 2,713,000 | |
Notes payable, net of unamortized debt discount | 182,186,000 | 104,174,000 |
TOTAL LIABILITIES | 210,663,000 | 130,138,000 |
Commitments and contingencies | ||
STOCKHOLDERS’ EQUITY | ||
Common stock, $0.001 par value, 50,000,000 shares authorized, 35,117,621 and 29,901,530 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 35,000 | 30,000 |
Additional paid-in capital | 200,478,000 | 137,058,000 |
Accumulated deficit | (124,756,000) | (109,493,000) |
TOTAL HARROW, INC. STOCKHOLDERS’ EQUITY | 75,757,000 | 27,595,000 |
Noncontrolling interests | (355,000) | (355,000) |
TOTAL STOCKHOLDERS’ EQUITY | 75,402,000 | 27,240,000 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 286,065,000 | $ 157,378,000 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
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 | 35,117,621 | 29,901,530 |
Common stock, shares outstanding | 35,117,621 | 29,901,530 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues: | ||||
Total revenues | $ 34,265,000 | $ 22,823,000 | $ 93,838,000 | $ 68,266,000 |
Cost of sales | (10,067,000) | (6,721,000) | (28,338,000) | (19,218,000) |
Gross profit | 24,198,000 | 16,102,000 | 65,500,000 | 49,048,000 |
Operating expenses: | ||||
Selling, general and administrative | 21,033,000 | 15,421,000 | 56,878,000 | 43,004,000 |
Research and development | 1,421,000 | 775,000 | 3,316,000 | 2,347,000 |
Total operating expenses | 22,454,000 | 16,196,000 | 60,194,000 | 45,351,000 |
Income (loss) from operations | 1,744,000 | (94,000) | 5,306,000 | 3,697,000 |
Other (expense) income: | ||||
Interest expense, net | (5,749,000) | (1,800,000) | (16,200,000) | (5,386,000) |
Equity in losses of unconsolidated entities | (3,504,000) | (9,036,000) | ||
Investment gain (loss) from Eton Pharmaceuticals | 1,348,000 | (1,031,000) | 2,676,000 | (4,341,000) |
Loss on extinguishment of debt | (5,465,000) | |||
Other expense, net | (195,000) | (344,000) | ||
Total other expense, net | (4,596,000) | (6,335,000) | (19,333,000) | (18,763,000) |
Loss before income taxes | (2,852,000) | (6,429,000) | (14,027,000) | (15,066,000) |
Income tax expense | (1,539,000) | (35,000) | (1,236,000) | (75,000) |
Net loss attributable to Harrow, Inc. | $ (4,391,000) | $ (6,464,000) | $ (15,263,000) | $ (15,141,000) |
Basic net loss per share of common stock | $ (0.13) | $ (0.24) | $ (0.48) | $ (0.55) |
Diluted net loss per share of common stock | $ (0.13) | $ (0.24) | $ (0.48) | $ (0.55) |
Weighted average number of shares of common stock outstanding, basic | 34,255,197 | 27,349,642 | 31,689,947 | 27,293,756 |
Weighted average number of shares of common stock outstanding, diluted | 34,255,197 | 27,349,642 | 31,689,947 | 27,293,756 |
Product Sales Net [Member] | ||||
Revenues: | ||||
Total revenues | $ 31,809,000 | $ 21,575,000 | $ 81,804,000 | $ 63,433,000 |
Other Revenues [Member] | ||||
Revenues: | ||||
Total revenues | $ 2,456,000 | $ 1,248,000 | $ 12,034,000 | $ 4,833,000 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total Harrow Health Inc Stockholders Equity [Member] | Noncontrolling Interest [Member] | Total |
Beginning balance, value at Dec. 31, 2021 | $ 27,000 | $ 106,666,000 | $ (95,407,000) | $ 11,286,000 | $ (355,000) | $ 10,931,000 |
Beginning balance, shares at Dec. 31, 2021 | 26,902,763 | |||||
Exercise of consultant stock-based options | ||||||
Exercise of consultant stock based options, shares | 4,054 | |||||
Exercise of employee stock-based options | 7,000 | 7,000 | 7,000 | |||
Exercise of employee stock-based options, shares | 92,261 | |||||
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 | 5,941,000 | 5,941,000 | 5,941,000 | |||
Net loss | (15,141,000) | (15,141,000) | (15,141,000) | |||
Ending balance, value at Sep. 30, 2022 | $ 27,000 | 111,738,000 | (110,548,000) | 1,217,000 | (355,000) | 862,000 |
Ending balance, shares at Sep. 30, 2022 | 27,074,307 | |||||
Beginning balance, value at Jun. 30, 2022 | $ 27,000 | 109,806,000 | (104,084,000) | 5,749,000 | (355,000) | 5,394,000 |
Beginning balance, shares at Jun. 30, 2022 | 27,069,978 | |||||
Exercise of consultant stock-based options | ||||||
Exercise of consultant stock based options, shares | 4,054 | |||||
Exercise of employee stock-based options | ||||||
Exercise of employee stock-based options, shares | 275 | |||||
Stock-based compensation expense | 1,932,000 | 1,932,000 | 1,932,000 | |||
Net loss | (6,464,000) | (6,464,000) | (6,464,000) | |||
Ending balance, value at Sep. 30, 2022 | $ 27,000 | 111,738,000 | (110,548,000) | 1,217,000 | (355,000) | 862,000 |
Ending balance, shares at Sep. 30, 2022 | 27,074,307 | |||||
Beginning balance, value at Dec. 31, 2022 | $ 30,000 | 137,058,000 | (109,493,000) | 27,595,000 | (355,000) | 27,240,000 |
Beginning balance, shares at Dec. 31, 2022 | 29,901,530 | |||||
Exercise of consultant stock-based options | 85,000 | 85,000 | 85,000 | |||
Exercise of consultant stock based options, shares | 10,000 | |||||
Exercise of employee stock-based options | 270,000 | 270,000 | 270,000 | |||
Exercise of employee stock-based options, shares | 219,246 | |||||
Shares withheld related to net share settlement of equity awards | $ (1,000) | (12,970,000) | (12,971,000) | (12,971,000) | ||
Shares withheld related to net share settlement of equity awards, shares | (711,152) | |||||
Stock-based compensation expense | 11,521,000 | 11,521,000 | 11,521,000 | |||
Net loss | (15,263,000) | (15,263,000) | (15,263,000) | |||
Public offering, net of offering costs | $ 4,000 | 64,516,000 | 64,520,000 | 64,520,000 | ||
Public offering, net of offering costs, shares | 3,887,324 | |||||
Vesting of RSUs and PSUs | $ 2,000 | (2,000) | ||||
Vesting of RSUs and PSUs, shares | 1,810,673 | |||||
Ending balance, value at Sep. 30, 2023 | $ 35,000 | 200,478,000 | (124,756,000) | 75,757,000 | (355,000) | 75,402,000 |
Ending balance, shares at Sep. 30, 2023 | 35,117,621 | |||||
Beginning balance, value at Jun. 30, 2023 | $ 30,000 | 142,742,000 | (120,365,000) | 22,407,000 | (355,000) | 22,052,000 |
Beginning balance, shares at Jun. 30, 2023 | 30,276,938 | |||||
Exercise of employee stock-based options | 18,000 | 18,000 | 18,000 | |||
Exercise of employee stock-based options, shares | 2,430 | |||||
Shares withheld related to net share settlement of equity awards | $ (1,000) | (11,272,000) | (11,273,000) | (11,273,000) | ||
Shares withheld related to net share settlement of equity awards, shares | (616,984) | |||||
Stock-based compensation expense | 4,476,000 | 4,476,000 | 4,476,000 | |||
Net loss | (4,391,000) | (4,391,000) | (4,391,000) | |||
Public offering, net of offering costs | 4,000 | 64,516,000 | 64,520,000 | 64,520,000 | ||
Vesting of PSUs | $ 2,000 | (2,000) | ||||
Vesting of PSUs, shares | 1,567,913 | |||||
Ending balance, value at Sep. 30, 2023 | $ 35,000 | $ 200,478,000 | $ (124,756,000) | $ 75,757,000 | $ (355,000) | $ 75,402,000 |
Ending balance, shares at Sep. 30, 2023 | 35,117,621 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (15,263,000) | $ (15,141,000) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | ||
Depreciation and amortization of property, plant and equipment, and software development costs | 1,095,000 | 1,090,000 |
Amortization of intangible assets | 7,634,000 | 1,200,000 |
Amortization of operating lease right-of-use assets | 541,000 | 435,000 |
Provision for credit losses | 68,000 | 36,000 |
Amortization of debt issuance costs and debt discount | 2,568,000 | 585,000 |
Investment (gain) loss from investment in Eton | (2,676,000) | 4,341,000 |
Equity in losses of unconsolidated entities | 9,036,000 | |
Loss on extinguishment of debt | 5,465,000 | |
Loss on disposal of intangible assets | 22,000 | |
Stock-based compensation | 11,521,000 | 5,941,000 |
Changes in assets and liabilities: | ||
Accounts receivable | (12,287,000) | (2,309,000) |
Inventories | (2,383,000) | (1,066,000) |
Prepaid expenses and other current assets | (4,079,000) | (716,000) |
Accounts payable and accrued expenses | 1,584,000 | 1,534,000 |
Accrued payroll and related liabilities | 1,294,000 | 352,000 |
Deferred revenue and customer deposits | 40,000 | 99,000 |
NET CASH (USED IN) PROVIDED BY OPERATING ACTIVITIES | (4,856,000) | 5,417,000 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Investment in patent and trademark assets | (19,000) | |
Purchase of product NDAs, marketing authorizations and patents | (151,084,000) | |
Purchases of property, plant and equipment | (1,266,000) | (1,719,000) |
NET CASH USED IN INVESTING ACTIVITIES | (152,350,000) | (1,738,000) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from 11.875% notes payable, net of costs | 4,961,000 | |
Proceeds from Oaktree Loan, net of costs | 73,552,000 | |
Payment of payroll taxes upon vesting of PSUs, RSUs and exercise of stock options | (12,971,000) | (876,000) |
Proceeds from exercise of stock options | 355,000 | 7,000 |
Proceeds from B. Riley senior secured note, net of costs | 55,879,000 | |
Repayment of B. Riley senior secured note | (59,750,000) | |
Proceeds from public offering of common stock, net of costs | 64,520,000 | |
Payments on finance lease obligations | (18,000) | |
NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES | 126,546,000 | (887,000) |
NET CHANGE IN CASH AND CASH EQUIVALENTS | (30,660,000) | 2,792,000 |
CASH AND CASH EQUIVALENTS, beginning of period | 96,270,000 | 42,167,000 |
CASH AND CASH EQUIVALENTS, end of period | 65,610,000 | 44,959,000 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | ||
Cash paid for income taxes | 75,000 | |
Cash paid for interest | 12,279,000 | 4,851,000 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Reclassification of deferred financing costs | 1,950,000 | |
Accrual of exit fee related to Oaktree Loan | 2,713,000 | |
Insurance premium financed | 1,321,000 | 906,000 |
Purchase of intangible asset included in accounts payable and accrued expenses | 5,000,000 | |
Purchase of property, plant and equipment included in accounts payable and accrued expenses | 11,000 | 86,000 |
Right-of-use assets obtained in exchange for new operating lease obligations | $ 2,188,000 |
DESCRIPTION OF BUSINESS AND BAS
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION | NOTE 1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION Company and Background Harrow, Inc. (together with its consolidated subsidiaries, unless the context indicates or otherwise requires, the “Company” or “Harrow”) is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the U.S. market. Harrow helps U.S. eyecare professionals preserve the gift of sight by making its comprehensive portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of Americans each year. The Company owns commercial rights to one of the largest portfolios of branded ophthalmic pharmaceutical products in the U.S. that are marketed under its Harrow name. The Company also owns and operates ImprimisRx, one of the nation’s leading ophthalmology-focused pharmaceutical-compounding businesses. The Company owns non-controlling equity interests 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. Effective September 29, 2023, the Company changed its corporate name from Harrow Health, Inc. to Harrow, Inc. pursuant to a Certificate of Amendment to the Company’s Amended and Restated Certificate of Incorporation filed with the Secretary of State of the State of Delaware. Basis of Presentation The Company has prepared the accompanying unaudited condensed consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and in accordance with the rules and regulations of the U.S. Securities and Exchange Commission. Accordingly, they do not include all of the information and footnotes required by GAAP for audited financial statements. In the opinion of management, all adjustments (consisting of only normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023 or for any other period. For further information, refer to the Company’s audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. The accompanying unaudited condensed 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. The Company consolidates (i) entities in which it holds and/or controls, directly or indirectly, more than 50% of the voting rights |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The following represents an update for the three and nine months ended September 30, 2023 to the significant accounting policies described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. 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. Credit Losses The Company estimates and records a provision for its expected credit losses related to its financial instruments, including its trade receivables. Management considers historical collection rates, the current financial status of the Company’s customers, macroeconomic factors, and other industry-specific factors when evaluating for current expected credit losses. Forward-looking information is also considered in the evaluation of current expected credit losses. However, because of the short time to the expected receipt of accounts receivable, management believes that the carrying value, net of expected losses, approximates fair value and therefore, relies more on historical and current analysis of such financial instruments, including its trade receivables. To determine the provision for credit losses for accounts receivable, the Company has disaggregated its accounts receivable by class of customer at the business component level, as management determined that risk profile of the Company’s customers is consistent based on the type and industry in which they operate, mainly in the pharmaceuticals industry. Each business component is analyzed for estimated credit losses individually. In doing so, the Company establishes a historical loss matrix, based on the previous collections of accounts receivable by the age of such receivables, and evaluates the current and forecasted financial position of its customers, as available. Further, the Company considers macroeconomic factors and the status of the pharmaceuticals industry to estimate if there are current expected credit losses within its trade receivables based on the trends of the Company’s expectation of the future status of such economic and industry-specific factors. Also, specific allowance amounts are established based on review of outstanding invoices to record the appropriate provision for customers that have a higher probability of default. The accounts receivable balance on the Company’s condensed consolidated balance sheet as of September 30, 2023 was $ 18,468,000 108,000 SCHEDULE OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS Balance at January 1, 2023 $ 73,000 Change in expected credit losses 68,000 Write-offs, net of recoveries (33,000 ) Balance at September 30, 2023 $ 108,000 Business Combinations and Asset Acquisitions The Company evaluates acquisitions of assets and other similar transactions to assess whether the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether the Company has acquired inputs, process, and output, which would meet the requirements of a business. If determined to be a business combination, the Company accounts for the transaction under the acquisition method of accounting as indicated in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”). ASC 805, Business Combinations The consideration for the Company’s business acquisitions may include future payments that are contingent upon the occurrence of a particular event or events. The obligation for such contingent consideration payments are recorded at fair value on the acquisition date. The contingent consideration obligations are then evaluated each reporting period. Changes in the fair value of contingent consideration, other than changes due to payments, would be recognized as a gain or loss and recorded in the condensed consolidated statement of operations. If determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, Business Combinations – Related Issues 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 for substantially the full term of the assets or liabilities. ● 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 September 30, 2023 and December 31, 2022, the Company measured its investment in Eton Pharmaceuticals, Inc. (“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 September 30, 2023 and December 31, 2022, the fair market value of the Company’s investment in Eton was $ 8,265,000 5,589,000 The Company’s 2026 Notes (as defined in Note 13) are carried at face value, including the unamortized premium, less unamortized debt issuance costs, the 2027 Notes (as described in Note 13) are carried at face value less unamortized debt issuance costs, and the Oaktree Loan (as defined in Note 13) is carried at face value less the original issue discount and unamortized debt issuance costs on the condensed consolidated balance sheets and the Company 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 Oaktree Loan is classified as a Level 2 instrument and its fair value is determined through an income approach that considers collateral coverage, yield calibration, yield analysis and any adjustments to implied yield associated with the Company’s fundamental measures. The following table presents the estimated fair values and the carrying values: SCHEDULE OF ESTIMATED FAIR VALUE September 30, 2023 December 31, 2022 Carrying Value Fair Value Carrying Value Fair Value 2026 Notes $ 73,020,000 $ 71,760,000 $ 72,436,000 $ 71,550,000 2027 Notes $ 37,234,000 $ 41,297,000 $ 31,738,000 $ 35,112,000 Oaktree Loan $ 71,932,000 $ 75,973,000 $ - $ - 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 lease liabilities. The carrying amount of these financial instruments, except for operating 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 value of the operating lease liabilities approximate their respective fair values. 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 net loss per share is computed by dividing the net loss attributable to common stockholders for the period by the weighted average number of common and common equivalent shares, such as stock options, restricted stock units (“RSUs”), performance stock units (“PSUs”), and warrants, outstanding during the period. Common equivalent shares (using the treasury stock method) from stock options, unvested RSUs, unvested PSUs and warrants were 4,588,982 5,622,997 244,352 303,454 The following table shows the computation of basic net loss per share of common stock for the three and nine months ended September 30, 2023 and 2022: SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE 2023 2022 2023 2022 For the Three Months Ended September 30, For the Nine Months Ended September 30, 2023 2022 2023 2022 Numerator – net loss $ (4,391,000 ) $ (6,464,000 ) $ (15,263,000 ) $ (15,141,000 ) Denominator – weighted average number of shares outstanding, basic and diluted 34,255,197 27,349,642 31,689,947 27,293,756 Net loss per share, basic and diluted $ (0.13 ) $ (0.24 ) $ (0.48 ) $ (0.55 ) Income Taxes The Company’s effective tax rate was (8.81) (0.50) 21 The Company’s effective tax rate was (53.96) (0.54) 21 As of September 30, 2023 and December 31, 2022, there were no Investment in Eton Pharmaceuticals, Inc As of September 30, 2023, the Company owned 1,982,000 10 4.17 Investments — Equity Securities 1,348,000 2,676,000 (1,031,000) (4,341,000) 8,265,000 Investment in Melt Pharmaceuticals, Inc. – Related Party As of September 30, 2023, the Company owns 3,500,000 36 0 100 0 100 The following table summarizes the Company’s investments in Melt as of September 30, 2023: SCHEDULE OF INVESTMENT Cost Share of Equity Method Paid-in-Kind In-substance Capital Net Carrying Basis Losses Interest Contributions Value Common stock $ 5,810,000 $ (5,810,000 ) $ - $ $ - Note receivable 13,500,000 (13,500,000 ) 4,265,000 (4,265,000 ) - $ 19,310,000 $ (19,310,000 ) $ 4,265,000 $ (4,265,000 ) $ - See Note 5 for more information and related party disclosure regarding Melt. Investment in Surface Ophthalmics, Inc. – Related Party As of September 30, 2023, the Company owned 3,500,000 20 0 The following table summarizes the Company’s investment in Surface as of September 30, 2023: SCHEDULE OF INVESTMENT Cost Share of Equity Net Carrying Basis Method Losses Value Common stock $ 5,320,000 $ (5,320,000 ) $ - See Note 6 for more information and related party disclosure regarding Surface. Recently Adopted Accounting Pronouncements In September 2016, FASB issued Accounting Standards Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments Accounting Guidance Issued but Not Adopted at September 30, 2023 In August 2023, FASB issued ASU 2023-05, Business Combinations—Joint Venture Formations (Subtopic 805-60): Recognition and Initial Measurement |
REVENUES
REVENUES | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
REVENUES | NOTE 3. REVENUES The Company accounts for contracts with customers in accordance with ASC 606, Revenue 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 had entered into an agreement whereby it was 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 was recognized, at which point there was 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 Sales and Profits The Company has entered into agreements whereby it purchased the exclusive commercial rights to assets associated with certain ophthalmic products from other pharmaceutical companies (the “Sellers”). During a temporary, transition period, the Sellers continue to manufacture and market these products and transfer the net profit from the sale of the products to the Company. The revenue recognized by the Company from the transfer of net profit was recognized at the time profit from the product sales were calculated by the Sellers and confirmed by the Company, typically on a monthly basis, 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. On a quarterly basis, the Sellers invoice the Company for all credits and reimbursements (“Chargebacks”) made to customers related to the products. The Company uses historical actual experience to estimate Chargebacks associated with the net sales and profit transferred. The estimated Chargebacks are recorded as a reduction in revenues from transfer of acquired product sales and profits in the Company’s condensed consolidated statements of operations, and recorded as a reduction to accounts receivable in the condensed consolidated balance sheets, at the time the revenue is recognized. 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 deliverables are 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 three and nine months ended September 30, 2023 and 2022 consisted of the following: SCHEDULE OF DISAGGREGATED REVENUE 2023 2022 2023 2022 For the Three Months Ended For the Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Product sales, net $ 31,809,000 $ 21,575,000 $ 81,804,000 $ 63,433,000 Commission revenues - 1,044,000 - 3,576,000 Transfer of acquired product sales/profit 2,456,000 204,000 12,034,000 1,257,000 Total revenues $ 34,265,000 $ 22,823,000 $ 93,838,000 $ 68,266,000 Deferred revenue and customer deposits at September 30, 2023 and December 31, 2022 were $ 153,000 113,000 |
RECENT PRODUCT ACQUISITIONS, LI
RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES | 9 Months Ended |
Sep. 30, 2023 | |
Recent Product Acquisitions Licenses And Divestitures | |
RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES | NOTE 4. RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES Acquisition of VEVYE TM In July 2023, the Company acquired commercial rights of VEVYE (cyclosporine ophthalmic solution) 0.1 8,000,000 The Company accounted for the VEVYE Acquisition as an acquisition of assets and capitalized the initial payments of $ 8,000,000 70,000 Acquisition of Certain U.S. and Canadian Commercial Rights to Santen and Eyevance Products In July 2023, the Company entered into an Asset Purchase Agreement with Eyevance Pharmaceuticals, LLC and a License Agreement with Santen S.A.S. (collectively, the “Santen Agreements”), each a subsidiary of Santen Pharmaceuticals Co., Ltd. (collectively, “Santen”). Pursuant to the Santen Agreements, the Company acquired the exclusive commercial rights to assets associated with the following ophthalmic products (collectively, the “Santen Products”): FLAREX, NATACYN, ZERVIATE, VERKAZIA and FRESHKOTE in the US, and VERKAZIA and CATIONORM PLUS in Canada. The transactions pursuant to the Santen Agreements are referred to in these notes as the “Santen Products Acquisition.” Under the terms of the Santen Agreements, the Company made an initial one-time payment of $ 8,000,000 The assets acquired in the Santen Products Acquisition are identifiable intangible asset groups in similar asset classes and all directly related to the product NDAs and marketing authorizations acquired. The developed technology is within one major intangible asset class. No workforce/employees were included in the Santen Products Acquisition and the Company is required to utilize its own business inputs/processes to transfer and commercialize the Santen Products. The Company incurred $ 139,000 8,000,000 500,000 8,639,000 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. Under the terms of the Fab 5 APA, the Company made a one-time payment of $ 130,000,000 45,000,000 The assets acquired in the Fab 5 Acquisition are identifiable intangible asset groups in similar asset classes and all directly related to the five product NDAs acquired. The developed technology is within one major intangible asset class. No workforce/employees were included in the Fab 5 Acquisition and the Company is required to utilize its own business inputs/processes to transfer and commercialize the Fab 5 Products and NDAs. The Company incurred $ 558,000 130,000,000 130,558,000 Research and Development Divestiture of Non-Ophthalmic Assets In October 2022, wholly-owned subsidiaries of the Company (collectively, “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 nine 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 (the “RPC TSA”) with the Buyer related to providing ongoing services associated with the RPC Assets, such as procuring and dispensing prescription orders, providing accounting and billing services and collecting accounts receivable. Imprimis provided transition services to the Buyer for approximately nine months following the effective date of the RPC Agreement and expects to wind down transition services in subsequent periods. 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 condensed consolidated balance sheet as of September 30, 2023 includes accounts receivable of $ 59,000 There were no amount due from the Buyer for reimbursement of services performed under the RPC TSA as of September 30, 2023. The receivable amount of $ 59,000 159,000 330,000 |
INVESTMENT IN AND NOTE RECEIVAB
INVESTMENT IN AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC. - RELATED PARTY TRANSACTIONS | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
INVESTMENT IN AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC. - RELATED PARTY TRANSACTIONS | NOTE 5. INVESTMENT IN AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC. - RELATED PARTY TRANSACTIONS In December 2018, the Company entered into an asset purchase agreement (the “Melt APA”) with Melt. Pursuant to the terms of the Melt APA, 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 APA, 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 entered into a Management Service Agreement with Melt (the “Melt MSA”), whereby the Company provided to Melt certain administrative services and support, including bookkeeping, web services and human resources related activities, and Melt was required to pay the Company a monthly amount of $ 10,000 0 89,000 30,000 100,000 228,000 139,000 500,000 500,000 During the nine months ended September 30, 2023, Melt sold approximately 2,000,000 17,000,000 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. Mr. Baum re-joined the Melt board of directors in January 2023. At the time Mr. Baum re-joined, the Melt board of directors consisted of five members, including Mr. Baum, who is the only representative of the Company on Melt’s board of directors. The unaudited condensed results of operations information of Melt is summarized below: SCHEDULE OF CONDENSED INCOME STATEMENT 2023 2022 For the Nine Months Ended September 30, 2023 2022 Revenues, net $ - $ - Loss from operations $ (3,663,000 ) $ (9,064,000 ) Net loss $ (5,407,000 ) $ (10,562,000 ) The unaudited condensed balance sheet information of Melt is summarized below: SCHEDULE OF CONDENSED BALANCE SHEET 2023 2022 At September 30, At December 31, 2023 2022 Current assets $ 13,011,000 $ 655,000 Non-current assets 31,000 107,000 Total assets $ 13,042,000 $ 762,000 Total liabilities $ 20,733,000 $ 19,056,000 Total preferred stock and stockholders’ deficit (7,691,000 ) (18,294,000 ) Total liabilities and stockholders’ deficit $ 13,042,000 $ 762,000 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 17,765,000 15,984,000 Investments – Equity Method and Joint Ventures |
INVESTMENT IN SURFACE OPHTHALMI
INVESTMENT IN SURFACE OPHTHALMICS, INC. - RELATED PARTY TRANSACTIONS | 9 Months Ended |
Sep. 30, 2023 | |
Investment In Surface Ophthalmics Inc. - Related Party Transactions | |
INVESTMENT IN SURFACE OPHTHALMICS, INC. - RELATED PARTY TRANSACTIONS | NOTE 6. INVESTMENT IN SURFACE OPHTHALMICS, INC. - RELATED PARTY TRANSACTIONS The Company entered into an asset purchase and license agreement with Surface in 2017 and amended it in April 2018 (together, 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 September 30, 2023, the Company owned 3,500,000 The unaudited condensed results of operations information of Surface is summarized below: SUMMARY OF CONDENSED INCOME STATEMENT 2023 2022 For the Nine Months Ended 2023 2022 Revenues, net $ - $ - Loss from operations $ (4,723,000 ) $ (5,338,000 ) Net loss $ (4,463,000 ) $ (5,338,000 ) The unaudited condensed balance sheet information of Surface is summarized below: SUMMARY OF CONDENSED BALANCE SHEET At September 30, At December 31, 2023 2022 Current assets $ 11,140,000 $ 15,350,000 Non-current assets 780,000 652,000 Total assets $ 11,920,000 $ 16,002,000 Total liabilities $ 1,392,000 $ 1,586,000 Total preferred stock and stockholders’ equity 10,528,000 14,416,000 Total liabilities and stockholders’ equity $ 11,920,000 $ 16,002,000 |
INVENTORIES
INVENTORIES | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
INVENTORIES | NOTE 7. INVENTORIES Inventories are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, branded pharmaceutical products, including those held at the Company’s 3PL partner, related laboratory supplies and active pharmaceutical ingredients. The composition of inventories as of September 30, 2023 and December 31, 2022 was as follows: SCHEDULE OF INVENTORIES September 30, 2023 December 31, 2022 Raw materials $ 5,289,000 $ 3,707,000 Work in progress 113,000 38,000 Finished goods 3,522,000 2,796,000 Total inventories $ 8,924,000 $ 6,541,000 |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 9 Months Ended |
Sep. 30, 2023 | |
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 at September 30, 2023 and December 31, 2022 consisted of the following: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS September 30, 2023 December 31, 2022 Prepaid insurance $ 1,817,000 $ 858,000 Prepaid computer software licenses and related expenses 768,000 1,165,000 Due from Melt Pharmaceuticals 228,000 139,000 Other prepaid expenses 1,766,000 937,000 Prepaid Prescription Drug User fees 4,314,000 394,000 Deposits and other current assets 118,000 118,000 Total prepaid expenses and other current assets $ 9,011,000 $ 3,611,000 |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT | NOTE 9. PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment at September 30, 2023 and December 31, 2022 consisted of the following: SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT September 30, 2023 December 31, 2022 Property, plant and equipment, net: Computer hardware $ 1,228,000 $ 979,000 Furniture and equipment 915,000 860,000 Lab and pharmacy equipment 4,636,000 4,259,000 Leasehold improvements 6,654,000 6,449,000 Property, plant and equipment, gross 13,433,000 12,547,000 Accumulated depreciation (9,804,000 ) (9,061,000 ) Property, plant and equipment, net $ 3,629,000 $ 3,486,000 For the three and nine months ended September 30, 2023, depreciation related to the property, plant and equipment was $ 290,000 743,000 171,000 928,000 |
CAPITALIZED SOFTWARE COSTS
CAPITALIZED SOFTWARE COSTS | 9 Months Ended |
Sep. 30, 2023 | |
Capitalized Software Costs | |
CAPITALIZED SOFTWARE COSTS | NOTE 10. CAPITALIZED SOFTWARE COSTS Capitalized software costs at September 30, 2023 and December 31, 2022 consisted of the following: SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS September 30, 2023 December 31, 2022 Capitalized software costs Capitalized internal-use software development costs $ 2,746,000 $ 1,413,000 Acquired third-party software license for internal-use 159,000 159,000 Total gross capitalized software for internal-use 2,905,000 1,572,000 Accumulated amortization (1,145,000 ) (793,000 ) Capitalized internal-use software in process 391,000 1,333,000 Total finite lived intangible assets net $ 2,151,000 $ 2,112,000 The Company recorded amortization expense of $ 115,000 352,000 76,000 162,000 |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS AND GOODWILL | NOTE 11. INTANGIBLE ASSETS AND GOODWILL The Company’s intangible assets at September 30, 2023 consisted of the following: SCHEDULE OF INTANGIBLE ASSETS Amortization Periods (in years) Cost Accumulated Amortization Disposal Net Carrying Value Patents 17 19 $ 980,000 $ (226,000 ) $ - $ 754,000 Licenses 20 100,000 (30,000 ) (22,000 ) 48,000 Trademarks Indefinite 268,000 - - 268,000 Acquired NDAs 4 15 170,353,000 (8,889,000 ) - 161,464,000 Customer relationships 3 15 596,000 (498,000 ) - 98,000 Trade name 5 75,000 (5,000 ) - 70,000 Non-competition clause 3 4 50,000 (50,000 ) - - State pharmacy licenses 25 8,000 (7,000 ) - 1,000 $ 172,430,000 $ (9,705,000 ) $ (22,000 ) $ 162,703,000 Amortization expense for intangible assets for the three and nine months ended September 30, 2023 and 2022 was as follows: SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS 2023 2022 2023 2022 For the Three Months Ended For the Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Patents $ 22,000 $ 22,000 $ 65,000 $ 65,000 Licenses 2,000 2,000 7,000 13,000 Acquired NDAs 2,551,000 341,000 7,526,000 1,023,000 Customer relationships 9,000 33,000 36,000 99,000 Amortization of intangible assets $ 2,584,000 $ 398,000 $ 7,634,000 $ 1,200,000 Estimated future amortization expense for the Company’s intangible assets at September 30, 2023 was as follows: SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE Remainder of 2023 $ 2,458,000 2024 13,792,000 2025 13,792,000 2026 13,792,000 2027 13,501,000 Thereafter 105,100,000 Intangible assets $ 162,435,000 There were no changes to the carrying value of the Company’s goodwill during the three and nine months ended September 30, 2023 and 2022. |
ACCOUNTS PAYABLE AND ACCRUED EX
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | NOTE 12. ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses at September 30, 2023 and December 31, 2022 consisted of the following: SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES September 30, December 31, 2023 2022 Accounts payable $ 6,025,000 $ 6,440,000 Income tax payable 1,221,000 - Accrued insurance premium 1,321,000 575,000 Accrued IHEEZO milestone payments - 5,000,000 Accrued litigation settlements 49,000 49,000 Accrued RPC transition payments (see Note 4) 59,000 453,000 Accrued managed care commercial rebates 2,118,000 - Accrued interest (see Note 13) 1,979,000 1,254,000 Accrued exit fee for note payable (see Note 13) 2,713,000 - Total accounts payable and accrued expenses $ 15,485,000 $ 13,771,000 Less: current portion (12,772,000 ) (13,771,000 ) Non-current total accrued expenses $ 2,713,000 $ - The Company financed all insurance policies for the policy terms of August 17, 2022 through August 16, 2023 and August 17, 2023 through August 16, 2024. The financing agreements have an interest rate of 4.13 7.48 114,000 169,000 |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
DEBT | NOTE 13. DEBT Oaktree Loan Due 2026 In March 2023, the Company entered into a Credit Agreement and Guaranty, (the “Oaktree Loan”) with Oaktree Fund Administration, LLC, as administrative agent for the lenders (together, “Oaktree”), providing for a senior secured term loan facility to the Company with a principal amount of up to $ 100,000,000 65,000,000 B. Riley Loan and Security Agreement – Paid in Full 35,000,000 30,000,000 The Oaktree Loan is secured by nearly all of the assets, including intellectual property, of the Company and its material subsidiaries. The Oaktree Loan has a maturity date of January 19, 2026 6.5 11.90 3,415,000 3.5 2,275,000 In July 2023, the Company entered into the First Amendment to Credit Agreement and Guaranty and Consent (the “Oaktree Amendment”) to the Oaktree Loan. Under the Oaktree Amendment, the overall credit facility size was increased from $ 100,000,000 112,500,000 12,500,000 77,500,000 35,000,000 2,275,000 2,713,000 3.50 438,000 The Oaktree Loan contains customary guarantees and covenants, including financial covenants related to minimum liquidity and minimum net revenues. At September 30, 2023, the Company was in compliance with these covenants. As of the end of the fiscal quarter ending December 31, 2024, if the Company’s Total Leverage Ratio (as defined in the Oaktree Loan) is greater than or equal to five times, but less than seven times, the Company will be required to issue to Oaktree warrants to purchase 375,000 375,000 750,000 Interest expense related to the Oaktree Loan totaled $ 2,995,000 5,660,000 567,000 1,093,000 HROWM - 11.875% Senior Notes Due 2027 In December 2022 and in January 2023, the Company closed an offering of $ 35,000,000 5,250,000 11.875 25.00 36,699,000 3,551,000 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, Interest expense related to the 2027 Notes totaled $ 1,375,000 4,141,000 180,000 556,000 Our Chief Executive Officer, Mark L. Baum, Chief Financial Officer, Andrew R. Boll, and former directors R. Lawrence Van Horn and Dr. Richard Lindstrom, in the aggregate, purchased $ 950,000 HROWL – 8.625% Senior Notes Due 2026 In April 2021, the Company closed an offering of $ 50,000,000 8.625 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 8.625 April 30, 2026 . 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 totaled $ 1,814,000 5,436,000 1,814,000 5,436,000 197,000 585,000 197,000 585,000 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 was 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 was due in full on the Maturity Date. The BR Loan provided for voluntary prepayment subject to no prepayment fee if no loan amount had been funded or the prepayment or repayment occurred (other than as a result of acceleration of the BR Loan) on or prior to the date that was 90 days following the Effective Date and up to 3.00 In January 2023, $ 59,750,000 Interest expense related to the BR Loan totaled $ 1,565,000 356,000 5,465,000 A summary of the Company’s debt at September 30, 2023 and December 31, 2022 is described as follows: SCHEDULE OF LONG TERM DEBT September 30, December 31, 2023 2022 8.625% Senior Notes, due April 2026 $ 75,000,000 $ 75,000,000 11.875% Senior Notes, due December 2027 40,250,000 35,000,000 Oaktree Loan, due January 2026 77,500,000 - Notes payable gross 192,750,000 110,000,000 Less: Unamortized debt issuance costs (10,564,000 ) (5,826,000 ) Notes payable net $ 182,186,000 $ 104,174,000 For the three and nine months ended September 30, 2023, the total effective interest rate of the Company’s debt was 10.78 10.91 8.88 8.96 . At September 30, 2023, future minimum payments under the Company’s debt were as follows: SCHEDULE OF FUTURE MINIMUM PAYMENT UNDER NOTES PAYABLES Amount Remainder of 2023 $ 5,347,000 2024 21,159,000 2025 20,550,000 2026 159,894,000 2027 45,030,000 Total minimum payments 251,980,000 Less: amount representing interest payments (59,230,000 ) Notes payable, gross principal amount due 192,750,000 Less: unamortized debt issuance costs, net of premium (10,564,000 ) Notes payable, net of unamortized debt issuance costs $ 182,186,000 |
LEASES
LEASES | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
LEASES | NOTE 14. LEASES The Company leases office and laboratory space under non-cancelable operating leases listed below. These lease agreements have remaining terms between one five years ● An operating lease for 5,789 March 2025 ● An operating lease for 35,326 July 2027 1,400 8,900 ● An operating lease for 5,500 December 2024 ● An operating lease for 11,552 September 2027 At September 30, 2023, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases held by the Company were 6.60 10.54 During the three and nine months ended September 30, 2023, cash paid for amounts included for the operating lease liabilities was $ 310,000 921,000 249,000 622,000 309,000 926,000 309,000 809,000 Future lease payments under operating leases as of September 30, 2023 were as follows : SCHEDULE OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES Operating Leases Remainder of 2023 $ 310,000 2024 1,262,000 2025 1,093,000 2026 1,114,000 2027 972,000 Thereafter 5,829,000 Total minimum lease payments 10,580,000 Less: amount representing interest payments (3,060,000 ) Total operating lease obligations 7,520,000 Less: current portion, operating lease obligations (785,000 ) Operating lease obligations, net of current portion $ 6,735,000 |
STOCKHOLDERS_ EQUITY AND STOCK-
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION | NOTE 15. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION Common Stock In July 2023, the Company closed a public offering of shares of its common stock at an offering price of $ 17.75 3,887,324 64,520,000 4,480,000 In July 2023, the Company settled 1,567,913 50 175 616,984 11,273,000 During the nine months ended September 30, 2023, the Company issued 131,760 13,123 During the nine months ended September 30, 2023, the Company issued 61,934 355,000 61,934 1.70 8.50 During the nine months ended September 30, 2023, the Company issued 62,367 180,000 8.99 77,167 40,466 849,000 During the nine months ended September 30, 2023, the Company issued 55,558 90,000 6.00 25,521 8,921 189,000 During the nine months ended September 30, 2023, upon vesting of 23,000 13,398 9,602 142,000 During the nine months ended September 30, 2023, upon vesting of 88,000 52,821 35,179 519,000 During the nine months ended September 30, 2023, 43,130 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 September 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 September 3, 2021 (as amended, the “2017 Plan” and together with the 2007 Plan, the “Plans”). As of September 30, 2023, the 2017 Plan provided for the issuance of a maximum of 6,000,000 490,493 . Stock Options A summary of stock option activity under the Plans for the nine months ended September 30, 2023 is as follows: SCHEDULE OF STOCK OPTION PLAN ACTIVITY Number of Shares Weighted Average Price Weighted Average Remaining Contractual Life Aggregate Intrinsic Value Options outstanding – January 1, 2023 3,027,701 $ 5.90 Options granted 95,500 $ 19.54 Options exercised (331,934 ) $ 7.55 Options cancelled/forfeited (76,175 ) $ 6.85 Options outstanding – September 30, 2023 2,715,092 $ 6.15 4.18 $ 32,347,000 Options exercisable 2,436,946 $ 5.51 3.65 $ 30,441,000 Options vested and expected to vest 2,676,550 $ 6.06 4.11 $ 32,114,000 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 shares underlying options with an exercise price lower than the market price on September 30, 2023, based on the closing price of the Company’s common stock of $ 14.37 During the nine months ended September 30, 2023, the Company granted stock options to certain employees. 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 ten years. Vesting terms for options granted to employees during the nine months ended September 30, 2023 included the following vesting schedule: 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. The fair value of each option award is estimated on the date of grant using the Black-Scholes-Merton option pricing model. The expected term of options granted to employees and directors 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 2023 2022 Weighted-average fair value of options granted $ 11.89 $ 4.49 Expected terms (in years) 5.50 6.11 6.11 Expected volatility 68 70 % 68 70 % Risk-free interest rate 3.59 4.14 % 1.54 3.19 % Dividend yield - - The following table summarizes information about stock options outstanding and exercisable at September 30, 2023: SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE Options Outstanding Options Exercisable Range of Exercise Prices Number Outstanding Weighted Average Remaining Contractual Life in Years Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $ 1.47 1.73 295,852 4.20 $ 1.72 295,852 $ 1.72 $ 2.23 285,000 3.34 $ 2.23 285,000 $ 2.23 $ 2.40 2.60 24,068 3.27 $ 2.58 24,068 $ 2.58 $ 3.95 310,000 2.50 $ 3.95 310,000 $ 3.95 $ 4.08 5.72 123,225 4.67 $ 5.28 115,475 $ 5.25 $ 6.30 285,000 5.39 $ 6.30 285,000 $ 6.30 $ 6.75 7.26 105,062 8.32 $ 6.96 33,720 $ 6.96 $ 7.30 274,500 6.26 $ 7.30 274,500 $ 7.30 $ 7.37 7.79 238,712 4.43 $ 7.53 170,155 $ 7.50 $ 7.87 25.86 773,673 3.28 $ 9.43 643,176 $ 7.89 $ 1.47 25.86 2,715,092 4.18 $ 6.15 2,436,946 $ 5.51 As of September 30, 2023, there was approximately $ 1,781,000 2.82 154,000 617,000 241,000 771,000 The intrinsic value of options exercised during the nine months ended September 30, 2023 was $ 4,399,000 Restricted Stock Units RSU awards are granted subject to certain vesting requirements and other restrictions, including time-based 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. During the nine months ended September 30, 2023, the Company’s board of directors were granted an aggregate 41,301 800,000 A summary of the Company’s RSU activity and related information for the nine months ended September 30, 2023 is as follows: SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY Number of Shares Weighted Average Grant Date Fair Value RSUs unvested - January 1, 2023 493,806 $ 7.99 RSUs granted 54,424 $ 16.54 RSUs vested (167,253 ) $ 8.13 RSUs cancelled/forfeited (75,000 ) $ 5.83 RSUs unvested - September 30, 2023 305,977 $ 9.96 As of September 30, 2023, the total unrecognized compensation expense related to unvested RSUs was approximately $ 1,041,000 0.40 374,000 789,000 427,000 1,378,000 Performance Stock Units In April 2023, the Company granted an aggregate of 1,567,913 25.00 50.00 SCHEDULE OF PERFORMANCE STOCK UNITS Tranche Number of Shares Target Share Price* Tranche 1 223,988 $ 25.00 Tranche 2 335,981 $ 35.00 Tranche 3 447,975 $ 45.00 Tranche 4 559,969 $ 50.00 * Target Share Price assumes that no dividends or like distributions are made to stockholders 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 the Target Share Price. The aggregate fair value of the 2023 PSUs was $ 29,106,000 65 10.34 A summary of the Company’s PSU activity and related information for the nine months ended September 30, 2023 is as follows: SCHEDULE OF PERFORMANCE STOCK UNITS ACTIVITY Number of Shares Weighted Average Grant Date Fair Value PSUs unvested – January 1, 2023 1,567,913 $ 6.45 PSUs granted 1,567,913 $ 18.56 PSUs vested (1,567,913 ) $ 6.45 PSUs cancelled/forfeited - $ - PSUs unvested – September 30, 2023 1,567,913 $ 18.56 As of September 30, 2023, the total unrecognized compensation expense related to unvested PSUs was approximately $ 21,829,000 1.51 3,948,000 10,115,000 1,264,000 3,792,000 Stock-Based Compensation Summary The Company recorded 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 2023 2022 2023 2022 For the Three Months Ended September 30, For the Nine Months Ended September 30, 2023 2022 2023 2022 Employees – selling, general and administrative $ 3,784,000 $ 1,611,000 $ 9,719,000 $ 4,942,000 Employees – research and development 475,000 163,000 1,224,000 525,000 Directors – selling, general and administrative 200,000 125,000 528,000 337,000 Consultants – selling, general and administrative 17,000 33,000 50,000 137,000 Total $ 4,476,000 $ 1,932,000 $ 11,521,000 $ 5,941,000 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 16. 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. The Company describes legal proceedings and other matters that are/were significant or that it believes could become significant in this footnote. 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 faces 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 the matters (whether discussed in this footnote or not) currently pending may have a material adverse effect on the Company’s condensed consolidated results of operations, financial position or cash flows. Ocular Science, Inc. et. al In July 2021, ImprimisRx, LLC, a subsidiary of the Company, filed a lawsuit against Ocular Science, Inc. and OSRX, Inc. (together, “OSRX”) in the U.S. District Court for the Southern District of California, asserting claims for copyright infringement, trademark infringement, unfair competition and false advertising (Lanham Act). ImprimisRx is seeking damages from OSRX. Since July 2021, the complaint has been amended and OSRX added counterclaims alleging ImprimisRx, LLC is violating the Lanham Act with false advertising. Both parties are seeking damages from the other. The Company expects the trial to take place in 2024. 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. Indemnities In addition to the indemnification provisions contained in the Company’s governing 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 indemnifies Oaktree for certain claims and losses associated with the Oaktree Loan. 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 condensed consolidated balance sheets. Klarity License Agreement – Related Party The Company entered into a license agreement in April 2017, as amended in April 2018 (the “Klarity License Agreement”), with Richard L. Lindstrom, M.D., a former 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 0 146,000 77,000 199,000 71,000 220,000 67,000 244,000 Injectable Asset Purchase Agreement – Related Party In December 2019, the Company entered into an asset purchase agreement (the “Lindstrom APA”) with Dr. Lindstrom, a former 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 0 17,000 8,000 23,000 9,000 26,000 9,000 24,000 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. During the three and nine months ended September 30, 2023, $ 220,000 705,000 185,000 695,000 Sintetica Agreement 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 In August 2023, the Company amended the Sintetica Agreement to allow for early payment of previously accrued amounts for commercial related milestones associated with sales of IHEEZO in exchange for a $ 550,000 550,000 4,450,000 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. Wakamoto Agreement 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 Agreements, Wakamoto will supply MAQ-100 to the Company, and the Company will pay Wakamoto a per unit transfer price to supply MAQ-100. In addition, the Company is required to pay Wakamoto various one-time milestone payments totaling up to $ 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 may be extended for a five-year period if certain unit sales thresholds are met. 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 a mutual termination agreement entered into on October 7, 2022, the Dexycu Agreement terminated on January 1, 2023. 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 would 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 September 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 three and nine months ended September 30, 2022, the Company recorded $ 1,044,000 3,576,000 Sales and Marketing Agreements The Company had entered various sales and marketing agreements with certain organizations to provide exclusive and non-exclusive sales and marketing representation services to Harrow in select geographies in the U.S. in connection with the Company’s ophthalmic pharmaceutical compounded formulations or related products. Under the terms of the sales and marketing agreements, the Company was generally required to make commission payments equal to 10% to 14% of net sales for products above and beyond the initial existing sales amounts. 0 130,000 1,041,000 3,188,000 |
SEGMENTS AND CONCENTRATIONS
SEGMENTS AND CONCENTRATIONS | 9 Months Ended |
Sep. 30, 2023 | |
Segment Reporting [Abstract] | |
SEGMENTS AND CONCENTRATIONS | NOTE 17. SEGMENTS AND CONCENTRATIONS The Company operates its business on the basis of a single reportable segment, which is the business of discovery, development, and commercialization of innovative ophthalmic therapies. The Company’s chief operating decision-maker is the Chief Executive Officer, who evaluates the Company as a single operating segment. The Company has two products that each accounted for more than 10% of total revenues during the three and nine months ended September 30, 2023. The Company had two and three products that each accounted for more than 10% of total revenues during the three and nine months ended September 30, 2022, respectively. These products collectively accounted for 32 35 34 33 As of September 30, 2023 and December 31, 2022, accounts receivable from a single customer accounted for 48 0 35 23 The Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 96 79 52 66 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 18. SUBSEQUENT EVENTS The Company has performed an evaluation of events occurring subsequent to September 30, 2023 through the filing date of this Quarterly Report on Form 10-Q. Based on its evaluation, no events other than those described below need to be disclosed. In November 2023, the Company issued 125 1,000 125 6.75 In October 2023, the Company transferred the NDAs and marketing authorizations for all of the Santen Products in the U.S. The Company expects Santen to transfer the Canadian marketing authorizations for VERKAZIA and CATIONORM PLUS by March 31, 2024. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
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. |
Credit Losses | Credit Losses The Company estimates and records a provision for its expected credit losses related to its financial instruments, including its trade receivables. Management considers historical collection rates, the current financial status of the Company’s customers, macroeconomic factors, and other industry-specific factors when evaluating for current expected credit losses. Forward-looking information is also considered in the evaluation of current expected credit losses. However, because of the short time to the expected receipt of accounts receivable, management believes that the carrying value, net of expected losses, approximates fair value and therefore, relies more on historical and current analysis of such financial instruments, including its trade receivables. To determine the provision for credit losses for accounts receivable, the Company has disaggregated its accounts receivable by class of customer at the business component level, as management determined that risk profile of the Company’s customers is consistent based on the type and industry in which they operate, mainly in the pharmaceuticals industry. Each business component is analyzed for estimated credit losses individually. In doing so, the Company establishes a historical loss matrix, based on the previous collections of accounts receivable by the age of such receivables, and evaluates the current and forecasted financial position of its customers, as available. Further, the Company considers macroeconomic factors and the status of the pharmaceuticals industry to estimate if there are current expected credit losses within its trade receivables based on the trends of the Company’s expectation of the future status of such economic and industry-specific factors. Also, specific allowance amounts are established based on review of outstanding invoices to record the appropriate provision for customers that have a higher probability of default. The accounts receivable balance on the Company’s condensed consolidated balance sheet as of September 30, 2023 was $ 18,468,000 108,000 SCHEDULE OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS Balance at January 1, 2023 $ 73,000 Change in expected credit losses 68,000 Write-offs, net of recoveries (33,000 ) Balance at September 30, 2023 $ 108,000 |
Business Combinations and Asset Acquisitions | Business Combinations and Asset Acquisitions The Company evaluates acquisitions of assets and other similar transactions to assess whether the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether the Company has acquired inputs, process, and output, which would meet the requirements of a business. If determined to be a business combination, the Company accounts for the transaction under the acquisition method of accounting as indicated in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”). ASC 805, Business Combinations The consideration for the Company’s business acquisitions may include future payments that are contingent upon the occurrence of a particular event or events. The obligation for such contingent consideration payments are recorded at fair value on the acquisition date. The contingent consideration obligations are then evaluated each reporting period. Changes in the fair value of contingent consideration, other than changes due to payments, would be recognized as a gain or loss and recorded in the condensed consolidated statement of operations. If determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, Business Combinations – Related Issues |
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 for substantially the full term of the assets or liabilities. ● 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 September 30, 2023 and December 31, 2022, the Company measured its investment in Eton Pharmaceuticals, Inc. (“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 September 30, 2023 and December 31, 2022, the fair market value of the Company’s investment in Eton was $ 8,265,000 5,589,000 The Company’s 2026 Notes (as defined in Note 13) are carried at face value, including the unamortized premium, less unamortized debt issuance costs, the 2027 Notes (as described in Note 13) are carried at face value less unamortized debt issuance costs, and the Oaktree Loan (as defined in Note 13) is carried at face value less the original issue discount and unamortized debt issuance costs on the condensed consolidated balance sheets and the Company 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 Oaktree Loan is classified as a Level 2 instrument and its fair value is determined through an income approach that considers collateral coverage, yield calibration, yield analysis and any adjustments to implied yield associated with the Company’s fundamental measures. The following table presents the estimated fair values and the carrying values: SCHEDULE OF ESTIMATED FAIR VALUE September 30, 2023 December 31, 2022 Carrying Value Fair Value Carrying Value Fair Value 2026 Notes $ 73,020,000 $ 71,760,000 $ 72,436,000 $ 71,550,000 2027 Notes $ 37,234,000 $ 41,297,000 $ 31,738,000 $ 35,112,000 Oaktree Loan $ 71,932,000 $ 75,973,000 $ - $ - 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 lease liabilities. The carrying amount of these financial instruments, except for operating 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 value of the operating lease liabilities approximate their respective fair values. |
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 net loss per share is computed by dividing the net loss attributable to common stockholders for the period by the weighted average number of common and common equivalent shares, such as stock options, restricted stock units (“RSUs”), performance stock units (“PSUs”), and warrants, outstanding during the period. Common equivalent shares (using the treasury stock method) from stock options, unvested RSUs, unvested PSUs and warrants were 4,588,982 5,622,997 244,352 303,454 The following table shows the computation of basic net loss per share of common stock for the three and nine months ended September 30, 2023 and 2022: SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE 2023 2022 2023 2022 For the Three Months Ended September 30, For the Nine Months Ended September 30, 2023 2022 2023 2022 Numerator – net loss $ (4,391,000 ) $ (6,464,000 ) $ (15,263,000 ) $ (15,141,000 ) Denominator – weighted average number of shares outstanding, basic and diluted 34,255,197 27,349,642 31,689,947 27,293,756 Net loss per share, basic and diluted $ (0.13 ) $ (0.24 ) $ (0.48 ) $ (0.55 ) |
Income Taxes | Income Taxes The Company’s effective tax rate was (8.81) (0.50) 21 The Company’s effective tax rate was (53.96) (0.54) 21 As of September 30, 2023 and December 31, 2022, there were no |
Investment in Eton Pharmaceuticals, Inc | Investment in Eton Pharmaceuticals, Inc As of September 30, 2023, the Company owned 1,982,000 10 4.17 Investments — Equity Securities 1,348,000 2,676,000 (1,031,000) (4,341,000) 8,265,000 |
Investment in Melt Pharmaceuticals, Inc. – Related Party | Investment in Melt Pharmaceuticals, Inc. – Related Party As of September 30, 2023, the Company owns 3,500,000 36 0 100 0 100 The following table summarizes the Company’s investments in Melt as of September 30, 2023: SCHEDULE OF INVESTMENT Cost Share of Equity Method Paid-in-Kind In-substance Capital Net Carrying Basis Losses Interest Contributions Value Common stock $ 5,810,000 $ (5,810,000 ) $ - $ $ - Note receivable 13,500,000 (13,500,000 ) 4,265,000 (4,265,000 ) - $ 19,310,000 $ (19,310,000 ) $ 4,265,000 $ (4,265,000 ) $ - 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 As of September 30, 2023, the Company owned 3,500,000 20 0 The following table summarizes the Company’s investment in Surface as of September 30, 2023: SCHEDULE OF INVESTMENT Cost Share of Equity Net Carrying Basis Method Losses Value Common stock $ 5,320,000 $ (5,320,000 ) $ - See Note 6 for more information and related party disclosure regarding Surface. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In September 2016, FASB issued Accounting Standards Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments Accounting Guidance Issued but Not Adopted at September 30, 2023 In August 2023, FASB issued ASU 2023-05, Business Combinations—Joint Venture Formations (Subtopic 805-60): Recognition and Initial Measurement |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
SCHEDULE OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS | SCHEDULE OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS Balance at January 1, 2023 $ 73,000 Change in expected credit losses 68,000 Write-offs, net of recoveries (33,000 ) Balance at September 30, 2023 $ 108,000 |
SCHEDULE OF ESTIMATED FAIR VALUE | The following table presents the estimated fair values and the carrying values: SCHEDULE OF ESTIMATED FAIR VALUE September 30, 2023 December 31, 2022 Carrying Value Fair Value Carrying Value Fair Value 2026 Notes $ 73,020,000 $ 71,760,000 $ 72,436,000 $ 71,550,000 2027 Notes $ 37,234,000 $ 41,297,000 $ 31,738,000 $ 35,112,000 Oaktree Loan $ 71,932,000 $ 75,973,000 $ - $ - |
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 three and nine months ended September 30, 2023 and 2022: SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE 2023 2022 2023 2022 For the Three Months Ended September 30, For the Nine Months Ended September 30, 2023 2022 2023 2022 Numerator – net loss $ (4,391,000 ) $ (6,464,000 ) $ (15,263,000 ) $ (15,141,000 ) Denominator – weighted average number of shares outstanding, basic and diluted 34,255,197 27,349,642 31,689,947 27,293,756 Net loss per share, basic and diluted $ (0.13 ) $ (0.24 ) $ (0.48 ) $ (0.55 ) |
Melt Pharmaceuticals, Inc. [Member] | |
SCHEDULE OF INVESTMENT | The following table summarizes the Company’s investments in Melt as of September 30, 2023: SCHEDULE OF INVESTMENT Cost Share of Equity Method Paid-in-Kind In-substance Capital Net Carrying Basis Losses Interest Contributions Value Common stock $ 5,810,000 $ (5,810,000 ) $ - $ $ - Note receivable 13,500,000 (13,500,000 ) 4,265,000 (4,265,000 ) - $ 19,310,000 $ (19,310,000 ) $ 4,265,000 $ (4,265,000 ) $ - |
Surface Ophthalmics Inc [Member] | |
SCHEDULE OF INVESTMENT | The following table summarizes the Company’s investment in Surface as of September 30, 2023: SCHEDULE OF INVESTMENT Cost Share of Equity Net Carrying Basis Method Losses Value Common stock $ 5,320,000 $ (5,320,000 ) $ - |
REVENUES (Tables)
REVENUES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
SCHEDULE OF DISAGGREGATED REVENUE | Revenue disaggregated by revenue source for the three and nine months ended September 30, 2023 and 2022 consisted of the following: SCHEDULE OF DISAGGREGATED REVENUE 2023 2022 2023 2022 For the Three Months Ended For the Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Product sales, net $ 31,809,000 $ 21,575,000 $ 81,804,000 $ 63,433,000 Commission revenues - 1,044,000 - 3,576,000 Transfer of acquired product sales/profit 2,456,000 204,000 12,034,000 1,257,000 Total revenues $ 34,265,000 $ 22,823,000 $ 93,838,000 $ 68,266,000 |
INVESTMENT IN AND NOTE RECEIV_2
INVESTMENT IN AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC. - RELATED PARTY TRANSACTIONS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 2023 2022 For the Nine Months Ended September 30, 2023 2022 Revenues, net $ - $ - Loss from operations $ (3,663,000 ) $ (9,064,000 ) Net loss $ (5,407,000 ) $ (10,562,000 ) |
SCHEDULE OF CONDENSED BALANCE SHEET | The unaudited condensed balance sheet information of Melt is summarized below: SCHEDULE OF CONDENSED BALANCE SHEET 2023 2022 At September 30, At December 31, 2023 2022 Current assets $ 13,011,000 $ 655,000 Non-current assets 31,000 107,000 Total assets $ 13,042,000 $ 762,000 Total liabilities $ 20,733,000 $ 19,056,000 Total preferred stock and stockholders’ deficit (7,691,000 ) (18,294,000 ) Total liabilities and stockholders’ deficit $ 13,042,000 $ 762,000 |
INVESTMENT IN SURFACE OPHTHAL_2
INVESTMENT IN SURFACE OPHTHALMICS, INC. - RELATED PARTY TRANSACTIONS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investment In Surface Ophthalmics Inc. - 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 2023 2022 For the Nine Months Ended 2023 2022 Revenues, net $ - $ - Loss from operations $ (4,723,000 ) $ (5,338,000 ) Net loss $ (4,463,000 ) $ (5,338,000 ) |
SUMMARY OF CONDENSED BALANCE SHEET | The unaudited condensed balance sheet information of Surface is summarized below: SUMMARY OF CONDENSED BALANCE SHEET At September 30, At December 31, 2023 2022 Current assets $ 11,140,000 $ 15,350,000 Non-current assets 780,000 652,000 Total assets $ 11,920,000 $ 16,002,000 Total liabilities $ 1,392,000 $ 1,586,000 Total preferred stock and stockholders’ equity 10,528,000 14,416,000 Total liabilities and stockholders’ equity $ 11,920,000 $ 16,002,000 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORIES | SCHEDULE OF INVENTORIES September 30, 2023 December 31, 2022 Raw materials $ 5,289,000 $ 3,707,000 Work in progress 113,000 38,000 Finished goods 3,522,000 2,796,000 Total inventories $ 8,924,000 $ 6,541,000 |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS | Prepaid expenses and other current assets at September 30, 2023 and December 31, 2022 consisted of the following: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS September 30, 2023 December 31, 2022 Prepaid insurance $ 1,817,000 $ 858,000 Prepaid computer software licenses and related expenses 768,000 1,165,000 Due from Melt Pharmaceuticals 228,000 139,000 Other prepaid expenses 1,766,000 937,000 Prepaid Prescription Drug User fees 4,314,000 394,000 Deposits and other current assets 118,000 118,000 Total prepaid expenses and other current assets $ 9,011,000 $ 3,611,000 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT | Property, plant and equipment at September 30, 2023 and December 31, 2022 consisted of the following: SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT September 30, 2023 December 31, 2022 Property, plant and equipment, net: Computer hardware $ 1,228,000 $ 979,000 Furniture and equipment 915,000 860,000 Lab and pharmacy equipment 4,636,000 4,259,000 Leasehold improvements 6,654,000 6,449,000 Property, plant and equipment, gross 13,433,000 12,547,000 Accumulated depreciation (9,804,000 ) (9,061,000 ) Property, plant and equipment, net $ 3,629,000 $ 3,486,000 |
CAPITALIZED SOFTWARE COSTS (Tab
CAPITALIZED SOFTWARE COSTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Capitalized Software Costs | |
SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS | Capitalized software costs at September 30, 2023 and December 31, 2022 consisted of the following: SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS September 30, 2023 December 31, 2022 Capitalized software costs Capitalized internal-use software development costs $ 2,746,000 $ 1,413,000 Acquired third-party software license for internal-use 159,000 159,000 Total gross capitalized software for internal-use 2,905,000 1,572,000 Accumulated amortization (1,145,000 ) (793,000 ) Capitalized internal-use software in process 391,000 1,333,000 Total finite lived intangible assets net $ 2,151,000 $ 2,112,000 |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
SCHEDULE OF INTANGIBLE ASSETS | The Company’s intangible assets at September 30, 2023 consisted of the following: SCHEDULE OF INTANGIBLE ASSETS Amortization Periods (in years) Cost Accumulated Amortization Disposal Net Carrying Value Patents 17 19 $ 980,000 $ (226,000 ) $ - $ 754,000 Licenses 20 100,000 (30,000 ) (22,000 ) 48,000 Trademarks Indefinite 268,000 - - 268,000 Acquired NDAs 4 15 170,353,000 (8,889,000 ) - 161,464,000 Customer relationships 3 15 596,000 (498,000 ) - 98,000 Trade name 5 75,000 (5,000 ) - 70,000 Non-competition clause 3 4 50,000 (50,000 ) - - State pharmacy licenses 25 8,000 (7,000 ) - 1,000 $ 172,430,000 $ (9,705,000 ) $ (22,000 ) $ 162,703,000 |
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS | Amortization expense for intangible assets for the three and nine months ended September 30, 2023 and 2022 was as follows: SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS 2023 2022 2023 2022 For the Three Months Ended For the Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Patents $ 22,000 $ 22,000 $ 65,000 $ 65,000 Licenses 2,000 2,000 7,000 13,000 Acquired NDAs 2,551,000 341,000 7,526,000 1,023,000 Customer relationships 9,000 33,000 36,000 99,000 Amortization of intangible assets $ 2,584,000 $ 398,000 $ 7,634,000 $ 1,200,000 |
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE | Estimated future amortization expense for the Company’s intangible assets at September 30, 2023 was as follows: SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE Remainder of 2023 $ 2,458,000 2024 13,792,000 2025 13,792,000 2026 13,792,000 2027 13,501,000 Thereafter 105,100,000 Intangible assets $ 162,435,000 |
ACCOUNTS PAYABLE AND ACCRUED _2
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES | Accounts payable and accrued expenses at September 30, 2023 and December 31, 2022 consisted of the following: SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES September 30, December 31, 2023 2022 Accounts payable $ 6,025,000 $ 6,440,000 Income tax payable 1,221,000 - Accrued insurance premium 1,321,000 575,000 Accrued IHEEZO milestone payments - 5,000,000 Accrued litigation settlements 49,000 49,000 Accrued RPC transition payments (see Note 4) 59,000 453,000 Accrued managed care commercial rebates 2,118,000 - Accrued interest (see Note 13) 1,979,000 1,254,000 Accrued exit fee for note payable (see Note 13) 2,713,000 - Total accounts payable and accrued expenses $ 15,485,000 $ 13,771,000 Less: current portion (12,772,000 ) (13,771,000 ) Non-current total accrued expenses $ 2,713,000 $ - |
DEBT (Tables)
DEBT (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF LONG TERM DEBT | A summary of the Company’s debt at September 30, 2023 and December 31, 2022 is described as follows: SCHEDULE OF LONG TERM DEBT September 30, December 31, 2023 2022 8.625% Senior Notes, due April 2026 $ 75,000,000 $ 75,000,000 11.875% Senior Notes, due December 2027 40,250,000 35,000,000 Oaktree Loan, due January 2026 77,500,000 - Notes payable gross 192,750,000 110,000,000 Less: Unamortized debt issuance costs (10,564,000 ) (5,826,000 ) Notes payable net $ 182,186,000 $ 104,174,000 |
SCHEDULE OF FUTURE MINIMUM PAYMENT UNDER NOTES PAYABLES | At September 30, 2023, future minimum payments under the Company’s debt were as follows: SCHEDULE OF FUTURE MINIMUM PAYMENT UNDER NOTES PAYABLES Amount Remainder of 2023 $ 5,347,000 2024 21,159,000 2025 20,550,000 2026 159,894,000 2027 45,030,000 Total minimum payments 251,980,000 Less: amount representing interest payments (59,230,000 ) Notes payable, gross principal amount due 192,750,000 Less: unamortized debt issuance costs, net of premium (10,564,000 ) Notes payable, net of unamortized debt issuance costs $ 182,186,000 |
LEASES (Tables)
LEASES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
SCHEDULE OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES | Future lease payments under operating leases as of September 30, 2023 were as follows : SCHEDULE OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES Operating Leases Remainder of 2023 $ 310,000 2024 1,262,000 2025 1,093,000 2026 1,114,000 2027 972,000 Thereafter 5,829,000 Total minimum lease payments 10,580,000 Less: amount representing interest payments (3,060,000 ) Total operating lease obligations 7,520,000 Less: current portion, operating lease obligations (785,000 ) Operating lease obligations, net of current portion $ 6,735,000 |
STOCKHOLDERS_ EQUITY AND STOC_2
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
SCHEDULE OF STOCK OPTION PLAN ACTIVITY | A summary of stock option activity under the Plans for the nine months ended September 30, 2023 is as follows: SCHEDULE OF STOCK OPTION PLAN ACTIVITY Number of Shares Weighted Average Price Weighted Average Remaining Contractual Life Aggregate Intrinsic Value Options outstanding – January 1, 2023 3,027,701 $ 5.90 Options granted 95,500 $ 19.54 Options exercised (331,934 ) $ 7.55 Options cancelled/forfeited (76,175 ) $ 6.85 Options outstanding – September 30, 2023 2,715,092 $ 6.15 4.18 $ 32,347,000 Options exercisable 2,436,946 $ 5.51 3.65 $ 30,441,000 Options vested and expected to vest 2,676,550 $ 6.06 4.11 $ 32,114,000 |
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 2023 2022 Weighted-average fair value of options granted $ 11.89 $ 4.49 Expected terms (in years) 5.50 6.11 6.11 Expected volatility 68 70 % 68 70 % Risk-free interest rate 3.59 4.14 % 1.54 3.19 % Dividend yield - - |
SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE | The following table summarizes information about stock options outstanding and exercisable at September 30, 2023: SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE Options Outstanding Options Exercisable Range of Exercise Prices Number Outstanding Weighted Average Remaining Contractual Life in Years Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $ 1.47 1.73 295,852 4.20 $ 1.72 295,852 $ 1.72 $ 2.23 285,000 3.34 $ 2.23 285,000 $ 2.23 $ 2.40 2.60 24,068 3.27 $ 2.58 24,068 $ 2.58 $ 3.95 310,000 2.50 $ 3.95 310,000 $ 3.95 $ 4.08 5.72 123,225 4.67 $ 5.28 115,475 $ 5.25 $ 6.30 285,000 5.39 $ 6.30 285,000 $ 6.30 $ 6.75 7.26 105,062 8.32 $ 6.96 33,720 $ 6.96 $ 7.30 274,500 6.26 $ 7.30 274,500 $ 7.30 $ 7.37 7.79 238,712 4.43 $ 7.53 170,155 $ 7.50 $ 7.87 25.86 773,673 3.28 $ 9.43 643,176 $ 7.89 $ 1.47 25.86 2,715,092 4.18 $ 6.15 2,436,946 $ 5.51 |
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY | A summary of the Company’s RSU activity and related information for the nine months ended September 30, 2023 is as follows: SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY Number of Shares Weighted Average Grant Date Fair Value RSUs unvested - January 1, 2023 493,806 $ 7.99 RSUs granted 54,424 $ 16.54 RSUs vested (167,253 ) $ 8.13 RSUs cancelled/forfeited (75,000 ) $ 5.83 RSUs unvested - September 30, 2023 305,977 $ 9.96 |
SCHEDULE OF PERFORMANCE STOCK UNITS | SCHEDULE OF PERFORMANCE STOCK UNITS Tranche Number of Shares Target Share Price* Tranche 1 223,988 $ 25.00 Tranche 2 335,981 $ 35.00 Tranche 3 447,975 $ 45.00 Tranche 4 559,969 $ 50.00 * Target Share Price assumes that no dividends or like distributions are made to stockholders 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 the Target Share Price. |
SCHEDULE OF PERFORMANCE STOCK UNITS ACTIVITY | A summary of the Company’s PSU activity and related information for the nine months ended September 30, 2023 is as follows: SCHEDULE OF PERFORMANCE STOCK UNITS ACTIVITY Number of Shares Weighted Average Grant Date Fair Value PSUs unvested – January 1, 2023 1,567,913 $ 6.45 PSUs granted 1,567,913 $ 18.56 PSUs vested (1,567,913 ) $ 6.45 PSUs cancelled/forfeited - $ - PSUs unvested – September 30, 2023 1,567,913 $ 18.56 |
SCHEDULE OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES DIRECTORS CONSULTANTS | The Company recorded 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 2023 2022 2023 2022 For the Three Months Ended September 30, For the Nine Months Ended September 30, 2023 2022 2023 2022 Employees – selling, general and administrative $ 3,784,000 $ 1,611,000 $ 9,719,000 $ 4,942,000 Employees – research and development 475,000 163,000 1,224,000 525,000 Directors – selling, general and administrative 200,000 125,000 528,000 337,000 Consultants – selling, general and administrative 17,000 33,000 50,000 137,000 Total $ 4,476,000 $ 1,932,000 $ 11,521,000 $ 5,941,000 |
DESCRIPTION OF BUSINESS AND B_2
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION (Details Narrative) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Consolidation basis description | (i) entities in which it holds and/or controls, directly or indirectly, more than 50% of the voting rights |
SCHEDULE OF ACCOUNTS RECEIVABLE
SCHEDULE OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS (Details) | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Accounting Policies [Abstract] | |
Beginning balance | $ 73,000 |
Change in expected credit losses | 68,000 |
Write-offs, net of recoveries | (33,000) |
Ending balance | $ 108,000 |
SCHEDULE OF ESTIMATED FAIR VALU
SCHEDULE OF ESTIMATED FAIR VALUE (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Platform Operator, Crypto-Asset [Line Items] | ||
Carrying value | $ 192,750,000 | $ 110,000,000 |
Oaktree Loan [Member] | ||
Platform Operator, Crypto-Asset [Line Items] | ||
Carrying value | 77,500,000 | |
Fair Value, Inputs, Level 1 [Member] | 2026 Notes [Member] | ||
Platform Operator, Crypto-Asset [Line Items] | ||
Carrying value | 73,020,000 | 72,436,000 |
Fair value | 71,760,000 | 71,550,000 |
Fair Value, Inputs, Level 1 [Member] | 2027 Notes [Member] | ||
Platform Operator, Crypto-Asset [Line Items] | ||
Carrying value | 37,234,000 | 31,738,000 |
Fair value | 41,297,000 | 35,112,000 |
Fair Value, Inputs, Level 1 [Member] | Oaktree Loan [Member] | ||
Platform Operator, Crypto-Asset [Line Items] | ||
Carrying value | 71,932,000 | |
Fair value | $ 75,973,000 |
SCHEDULE OF BASIC AND DILUTED E
SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Accounting Policies [Abstract] | ||||
Numerator – net loss | $ (4,391,000) | $ (6,464,000) | $ (15,263,000) | $ (15,141,000) |
Denominator - weighted average number of shares outstanding, basic | 34,255,197 | 27,349,642 | 31,689,947 | 27,293,756 |
Denominator - weighted average number of shares outstanding, diluted | 34,255,197 | 27,349,642 | 31,689,947 | 27,293,756 |
Net loss per share, basic | $ (0.13) | $ (0.24) | $ (0.48) | $ (0.55) |
Net loss per share, diluted | $ (0.13) | $ (0.24) | $ (0.48) | $ (0.55) |
SCHEDULE OF INVESTMENT (Details
SCHEDULE OF INVESTMENT (Details) | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Melt Pharmaceuticals, Inc. [Member] | |
Schedule of Investments [Line Items] | |
Cost Basis | $ 19,310,000 |
Share of Equity Method Losses | (19,310,000) |
Paid in Kind Interest | 4,265,000 |
In Substance Capital Contributions | (4,265,000) |
Net carrying value | |
Common Stock [Member] | Melt Pharmaceuticals, Inc. [Member] | |
Schedule of Investments [Line Items] | |
Cost Basis | 5,810,000 |
Share of Equity Method Losses | (5,810,000) |
Paid in Kind Interest | |
Common Stock [Member] | Surface Ophthalmics Inc [Member] | |
Schedule of Investments [Line Items] | |
Cost Basis | 5,320,000 |
Share of Equity Method Losses | (5,320,000) |
Net carrying value | |
Note Receivable [Member] | Melt Pharmaceuticals, Inc. [Member] | |
Schedule of Investments [Line Items] | |
Cost Basis | 13,500,000 |
Share of Equity Method Losses | (13,500,000) |
Paid in Kind Interest | 4,265,000 |
In Substance Capital Contributions | (4,265,000) |
Net carrying value |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | |
Accounts receivable | $ 18,468,000 | $ 18,468,000 | ||||
Accounts receivable, allowance | $ 108,000 | $ 108,000 | $ 73,000 | |||
Effective income tax rate | (53.96%) | (0.54%) | (8.81%) | (0.50%) | ||
Federal income tax rate | 21% | 21% | 21% | 21% | ||
Unrecognized tax benefits | $ 0 | $ 0 | 0 | |||
Eton Pharmaceuticals, Inc. [Member] | ||||||
Investment owned, at fair value | $ 8,265,000 | $ 8,265,000 | ||||
Investment owned balance shares | 1,982,000 | 1,982,000 | ||||
Ownership percentage | 10% | 10% | ||||
Shares price | $ 4.17 | $ 4.17 | ||||
Unrealized gain loss on investments | $ 1,348,000 | $ (1,031,000) | $ 2,676,000 | $ (4,341,000) | ||
Melt Pharmaceuticals, Inc. [Member] | ||||||
Investment owned balance shares | 3,500,000 | 3,500,000 | ||||
Ownership percentage | 36% | 36% | ||||
Reduction in common stock investment | $ 0 | $ 0 | ||||
Investment interest rate | 100% | 100% | ||||
Surface Ophthalmics Inc [Member] | ||||||
Investment owned balance shares | 3,500,000 | 3,500,000 | ||||
Ownership percentage | 20% | 20% | ||||
Reduction in common stock investment | $ 0 | |||||
Restricted Stock Units (RSUs) [Member] | ||||||
Number of shares vested, RSUs | 244,352 | 303,454 | ||||
Stock Options, Unvested RSUs, Unvested PSUs and Warrants [Member] | ||||||
Antidilutive securities | 4,588,982 | 5,622,997 | ||||
Eton Pharmaceuticals, Inc. [Member] | ||||||
Investment owned, at fair value | $ 8,265,000 | $ 8,265,000 | $ 5,589,000 |
SCHEDULE OF DISAGGREGATED REVEN
SCHEDULE OF DISAGGREGATED REVENUE (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 34,265,000 | $ 22,823,000 | $ 93,838,000 | $ 68,266,000 |
Product Sales Net [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 31,809,000 | 21,575,000 | 81,804,000 | 63,433,000 |
Commissions [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 1,044,000 | 3,576,000 | ||
Transfer Of Acquired Product Profit [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 2,456,000 | $ 204,000 | $ 12,034,000 | $ 1,257,000 |
REVENUES (Details Narrative)
REVENUES (Details Narrative) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Revenue from Contract with Customer [Abstract] | ||
Contract with customer liability current | $ 153,000 | $ 113,000 |
RECENT PRODUCT ACQUISITIONS, _2
RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Jul. 31, 2023 | Jan. 31, 2023 | Oct. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2023 | |
Accrued Liabilities, Current | $ 59,000 | $ 59,000 | |||
Gain (Loss) on Disposition of Assets | 159,000 | ||||
Inventory, Gross | 330,000 | 330,000 | |||
One Time Payment [Member] | |||||
Costs incurred | $ 558,000 | ||||
Milestone payment | 130,000,000 | ||||
Purchase price acquisition | 130,558,000 | ||||
One Time Payment [Member] | Maximum [Member] | |||||
Milestone payment | $ 45,000,000 | ||||
Santen Products Acquisition [Member] | |||||
Royalty payments | $ 8,000,000 | ||||
Asset Purchase Agreement [Member] | |||||
Proceeds from related party | $ 6,000,000 | ||||
Milestones receivable based on agreed revenues | $ 4,500,000 | ||||
RPC Agreement [Member] | |||||
Cash | 59,000 | 59,000 | |||
VEVYE [Member] | |||||
Business acquired percentage | 0.10% | ||||
Royalty payments | $ 8,000,000 | ||||
Business Combination, Separately Recognized Transactions, Assets Recognized | 8,000,000 | 8,000,000 | |||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Assets | 70,000 | 70,000 | |||
Santen Products Acquisition [Member] | |||||
Costs incurred | $ 139,000 | 139,000 | |||
Milestone payment | 8,000,000 | ||||
Term milestone payment | 500,000 | ||||
Purchase price acquisition | $ 8,639,000 |
SCHEDULE OF CONDENSED INCOME ST
SCHEDULE OF CONDENSED INCOME STATEMENT (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues, net | $ 34,265,000 | $ 22,823,000 | $ 93,838,000 | $ 68,266,000 |
Loss from operations | 1,744,000 | (94,000) | 5,306,000 | 3,697,000 |
Net loss | $ (4,391,000) | $ (6,464,000) | (15,263,000) | (15,141,000) |
Melt Pharmaceuticals, Inc. [Member] | ||||
Revenues, net | ||||
Loss from operations | (3,663,000) | (9,064,000) | ||
Net loss | $ (5,407,000) | $ (10,562,000) |
SCHEDULE OF CONDENSED BALANCE S
SCHEDULE OF CONDENSED BALANCE SHEET (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets | $ 110,278,000 | $ 118,260,000 |
Total assets | 286,065,000 | 157,378,000 |
Total liabilities | 210,663,000 | 130,138,000 |
Total preferred stock and stockholders’ deficit | 75,757,000 | 27,595,000 |
Total liabilities and stockholders’ deficit | 286,065,000 | 157,378,000 |
Melt Pharmaceuticals, Inc. [Member] | ||
Current assets | 13,011,000 | 655,000 |
Non-current assets | 31,000 | 107,000 |
Total assets | 13,042,000 | 762,000 |
Total liabilities | 20,733,000 | 19,056,000 |
Total preferred stock and stockholders’ deficit | (7,691,000) | (18,294,000) |
Total liabilities and stockholders’ deficit | $ 13,042,000 | $ 762,000 |
INVESTMENT IN AND NOTE RECEIV_3
INVESTMENT IN AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC. - RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 01, 2021 | Feb. 28, 2019 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Apr. 30, 2022 | |
Reimbursable 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 | $ 0 | $ 89,000 | 30,000 | $ 100,000 | ||||
Repaid of related parties | 228,000 | $ 139,000 | ||||||
Melt Pharmaceuticals, Inc. [Member] | Series B Preferred Stock [Member] | ||||||||
Cash advance to related party debt | $ 17,000,000 | |||||||
Stock Repurchased During Period, Shares | 2,000,000 | |||||||
Melt Pharmaceuticals, Inc. [Member] | Management Services Agreement [Member] | ||||||||
Administrative fees expense | $ 10,000 | |||||||
Repaid of related parties | $ 500,000 | |||||||
Cash advance to related party debt | 500,000 | |||||||
Melt Pharmaceuticals, Inc. [Member] | Melt Loan Agreement [Member] | ||||||||
Notes receivable related parties | $ 17,765,000 | $ 17,765,000 | $ 15,984,000 |
SUMMARY OF CONDENSED INCOME STA
SUMMARY OF CONDENSED INCOME STATEMENT (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues, net | $ 34,265,000 | $ 22,823,000 | $ 93,838,000 | $ 68,266,000 |
Loss from operations | 1,744,000 | (94,000) | 5,306,000 | 3,697,000 |
Net loss | $ (4,391,000) | $ (6,464,000) | (15,263,000) | (15,141,000) |
Surface Pharmaceuticals Inc [Member] | ||||
Revenues, net | ||||
Loss from operations | (4,723,000) | (5,338,000) | ||
Net loss | $ (4,463,000) | $ (5,338,000) |
SUMMARY OF CONDENSED BALANCE SH
SUMMARY OF CONDENSED BALANCE SHEET (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets | $ 110,278,000 | $ 118,260,000 |
Total assets | 286,065,000 | 157,378,000 |
Total liabilities | 210,663,000 | 130,138,000 |
Total preferred stock and stockholders’ equity | 75,757,000 | 27,595,000 |
Total liabilities and stockholders’ equity | 286,065,000 | 157,378,000 |
Surface Pharmaceuticals Inc [Member] | ||
Current assets | 11,140,000 | 15,350,000 |
Non-current assets | 780,000 | 652,000 |
Total assets | 11,920,000 | 16,002,000 |
Total liabilities | 1,392,000 | 1,586,000 |
Total preferred stock and stockholders’ equity | 10,528,000 | 14,416,000 |
Total liabilities and stockholders’ equity | $ 11,920,000 | $ 16,002,000 |
INVESTMENT IN SURFACE OPHTHAL_3
INVESTMENT IN SURFACE OPHTHALMICS, INC. - RELATED PARTY TRANSACTIONS (Details Narrative) | Sep. 30, 2023 shares |
Surface Pharmaceuticals Inc [Member] | |
Investment owned shares | 3,500,000 |
SCHEDULE OF INVENTORIES (Detail
SCHEDULE OF INVENTORIES (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 5,289,000 | $ 3,707,000 |
Work in progress | 113,000 | 38,000 |
Finished goods | 3,522,000 | 2,796,000 |
Total inventories | $ 8,924,000 | $ 6,541,000 |
SCHEDULE OF PREPAID EXPENSES AN
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid insurance | $ 1,817,000 | $ 858,000 |
Prepaid computer software licenses and related expenses | 768,000 | 1,165,000 |
Due from Melt Pharmaceuticals | 228,000 | 139,000 |
Other prepaid expenses | 1,766,000 | 937,000 |
Prepaid Prescription Drug User fees | 4,314,000 | 394,000 |
Deposits and other current assets | 118,000 | 118,000 |
Total prepaid expenses and other current assets | $ 9,011,000 | $ 3,611,000 |
SCHEDULE OF PROPERTY, PLANT AND
SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Abstract] | ||
Computer hardware | $ 1,228,000 | $ 979,000 |
Furniture and equipment | 915,000 | 860,000 |
Lab and pharmacy equipment | 4,636,000 | 4,259,000 |
Leasehold improvements | 6,654,000 | 6,449,000 |
Property, plant and equipment, gross | 13,433,000 | 12,547,000 |
Accumulated depreciation | (9,804,000) | (9,061,000) |
Property, plant and equipment, net | $ 3,629,000 | $ 3,486,000 |
PROPERTY, PLANT AND EQUIPMENT_2
PROPERTY, PLANT AND EQUIPMENT (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation | $ 290,000 | $ 171,000 | $ 743,000 | $ 928,000 |
SCHEDULE OF FINITE LIVED INTANG
SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Total gross capitalized software for internal-use | $ 2,905,000 | $ 1,572,000 |
Accumulated amortization | (1,145,000) | (793,000) |
Capitalized internal-use software in process | 391,000 | 1,333,000 |
Total finite lived intangible assets net | 2,151,000 | 2,112,000 |
Capitalized Internal Use Software [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Total gross capitalized software for internal-use | 2,746,000 | 1,413,000 |
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 ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Capitalized Software Development Costs [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Amortization expenses | $ 115,000 | $ 76,000 | $ 352,000 | $ 162,000 |
SCHEDULE OF INTANGIBLE ASSETS (
SCHEDULE OF INTANGIBLE ASSETS (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 172,430,000 | |
Accumulated amortization | (9,705,000) | |
Disposal | (22,000) | |
Net Carrying value | 162,703,000 | $ 23,725,000 |
Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 980,000 | |
Accumulated amortization | (226,000) | |
Disposal | ||
Net Carrying value | $ 754,000 | |
Licenses [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 20 years | |
Cost | $ 100,000 | |
Accumulated amortization | (30,000) | |
Disposal | (22,000) | |
Net Carrying value | 48,000 | |
Trademarks [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 268,000 | |
Accumulated amortization | ||
Disposal | ||
Net Carrying value | $ 268,000 | |
Useful life, description | Indefinite | |
New Drug Applications [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 170,353,000 | |
Accumulated amortization | (8,889,000) | |
Disposal | ||
Net Carrying value | 161,464,000 | |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 596,000 | |
Accumulated amortization | (498,000) | |
Disposal | ||
Net Carrying value | $ 98,000 | |
Trade Names [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 5 years | |
Cost | $ 75,000 | |
Accumulated amortization | (5,000) | |
Disposal | ||
Net Carrying value | 70,000 | |
Non-Competition Clause [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 50,000 | |
Accumulated amortization | (50,000) | |
Disposal | ||
Net Carrying value | ||
State Pharmacy Licenses [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 25 years | |
Cost | $ 8,000 | |
Accumulated amortization | (7,000) | |
Disposal | ||
Net Carrying value | $ 1,000 | |
Minimum [Member] | Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 17 years | |
Minimum [Member] | New Drug Applications [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 4 years | |
Minimum [Member] | Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 3 years | |
Minimum [Member] | Non-Competition Clause [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 3 years | |
Maximum [Member] | Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 19 years | |
Maximum [Member] | New Drug Applications [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 15 years | |
Maximum [Member] | Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 15 years | |
Maximum [Member] | Non-Competition Clause [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 4 years |
SCHEDULE OF AMORTIZATION EXPENS
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Finite-Lived Intangible Assets [Line Items] | ||||
Amortization of intangible assets | $ 2,584,000 | $ 398,000 | $ 7,634,000 | $ 1,200,000 |
Patents [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Amortization of intangible assets | 22,000 | 22,000 | 65,000 | 65,000 |
Licenses [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Amortization of intangible assets | 2,000 | 2,000 | 7,000 | 13,000 |
Acquired New Drug Applications [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Amortization of intangible assets | 2,551,000 | 341,000 | 7,526,000 | 1,023,000 |
Customer Relationships [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Amortization of intangible assets | $ 9,000 | $ 33,000 | $ 36,000 | $ 99,000 |
SCHEDULE OF ESTIMATED FUTURE AM
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE (Details) | Sep. 30, 2023 USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Remainder of 2023 | $ 2,458,000 |
2024 | 13,792,000 |
2025 | 13,792,000 |
2026 | 13,792,000 |
2027 | 13,501,000 |
Thereafter | 105,100,000 |
Intangible assets | $ 162,435,000 |
SCHEDULE OF ACCOUNTS PAYABLE AN
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 6,025,000 | $ 6,440,000 |
Income tax payable | 1,221,000 | |
Accrued insurance premium | 1,321,000 | 575,000 |
Accrued IHEEZO milestone payments | 5,000,000 | |
Accrued litigation settlements | 49,000 | 49,000 |
Accrued RPC transition payments (see Note 4) | 59,000 | 453,000 |
Accrued managed care commercial rebates | 2,118,000 | |
Accrued interest (see Note 13) | 1,979,000 | 1,254,000 |
Accrued exit fee for note payable (see Note 13) | 2,713,000 | |
Total accounts payable and accrued expenses | 15,485,000 | 13,771,000 |
Less: current portion | (12,772,000) | (13,771,000) |
Non-current total accrued expenses | $ 2,713,000 |
ACCOUNTS PAYABLE AND ACCRUED _3
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Aug. 16, 2024 | Aug. 16, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Debt instrument interest rate, during period | 10.78% | 8.88% | 10.91% | 8.96% | ||
Financing Agreement [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Debt instrument interest rate, during period | 4.13% | |||||
Accrued monthly payments | $ 114,000 | |||||
Financing Agreement [Member] | Forecast [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Debt instrument interest rate, during period | 7.48% | |||||
Accrued monthly payments | $ 169,000 |
SCHEDULE OF LONG TERM DEBT (Det
SCHEDULE OF LONG TERM DEBT (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Short-Term Debt [Line Items] | ||
Notes payable gross | $ 192,750,000 | $ 110,000,000 |
Less: Unamortized debt issuance costs | (10,564,000) | (5,826,000) |
Notes payable net | 182,186,000 | 104,174,000 |
8.625% Senior Notes Due 2026 [Member] | ||
Short-Term Debt [Line Items] | ||
Notes payable gross | 75,000,000 | 75,000,000 |
11.875% Senior Notes Due 2027 [Member] | ||
Short-Term Debt [Line Items] | ||
Notes payable gross | 40,250,000 | 35,000,000 |
Oaktree Loan [Member] | ||
Short-Term Debt [Line Items] | ||
Notes payable gross | $ 77,500,000 |
SCHEDULE OF FUTURE MINIMUM PAYM
SCHEDULE OF FUTURE MINIMUM PAYMENT UNDER NOTES PAYABLES (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Remainder of 2023 | $ 5,347,000 | |
2024 | 21,159,000 | |
2025 | 20,550,000 | |
2026 | 159,894,000 | |
2027 | 45,030,000 | |
Total minimum payments | 251,980,000 | |
Less: amount representing interest payments | (59,230,000) | |
Notes payable, gross principal amount due | 192,750,000 | $ 110,000,000 |
Less: unamortized debt issuance costs, net of premium | (10,564,000) | (5,826,000) |
Notes payable, net of unamortized debt issuance costs | $ 182,186,000 | $ 104,174,000 |
DEBT (Details Narrative)
DEBT (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
Dec. 14, 2022 | Jul. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2021 | May 31, 2021 | Apr. 30, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Jan. 31, 2023 | |
Debt Instrument [Line Items] | ||||||||||||
Effective interest rate | 10.78% | 8.88% | 10.91% | 8.96% | ||||||||
Amortization of debt issuance costs and debt discount | $ 2,568,000 | $ 585,000 | ||||||||||
Oaktree Loan [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest expense | $ 2,995,000 | 5,660,000 | ||||||||||
Amortization of debt issuance costs and debt discount | 567,000 | 1,093,000 | ||||||||||
11.875% Senior Notes Due 2027 [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt principal amount | $ 35,000,000 | 950,000 | 950,000 | $ 5,250,000 | ||||||||
Proceeds from issuance of debt | $ 36,699,000 | $ 36,699,000 | ||||||||||
Debt instrument maturity date | Dec. 31, 2027 | |||||||||||
Effective interest rate | 11.875% | |||||||||||
Interest rate | 11.875% | 11.875% | ||||||||||
Interest expense | 1,375,000 | $ 4,141,000 | ||||||||||
Amortization of debt issuance costs and debt discount | 180,000 | $ 556,000 | ||||||||||
Shares issued price per share | $ 25 | $ 25 | ||||||||||
Deducting underwriting discounts and commissions and expenses | $ 3,551,000 | $ 3,551,000 | ||||||||||
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 | |||||||||||
Debt instrument increase (decrease) for period net | $ 5,000,000 | |||||||||||
Debt instrument maturity date | Apr. 30, 2026 | |||||||||||
Effective interest rate | 8.625% | |||||||||||
Interest rate | 8.625% | |||||||||||
Interest expense | 1,814,000 | $ 1,814,000 | $ 5,436,000 | 5,436,000 | ||||||||
Amortization of debt issuance costs and debt discount | $ 197,000 | $ 197,000 | $ 585,000 | $ 585,000 | ||||||||
Deducting underwriting discounts and commissions and expenses | $ 1,158,000 | |||||||||||
Redemption description | redemption price equal to 100% of the principal amount of the 2026 Notes to be redeemed | |||||||||||
Debt instrument unamortized premium | 322,000 | |||||||||||
8.625% Senior Notes Due 2026 [Member] | Investor [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument increase (decrease) for period net | 20,000,000 | |||||||||||
Proceeds from issuance of debt | $ 19,164,000 | $ 51,909,000 | ||||||||||
Shares issued price per share | $ 25.75 | $ 25 | ||||||||||
Deducting underwriting discounts and commissions and expenses | $ 3,091,000 | |||||||||||
Interest expense debt | $ 278,000 | |||||||||||
Oaktree Loan [Member] | Oaktree Fund Administration LLC [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt principal amount | $ 65,000,000 | |||||||||||
Proceeds from issuance of debt | 30,000,000 | |||||||||||
Debt instrument maturity date | Jan. 19, 2026 | |||||||||||
Effective interest rate | 11.90% | |||||||||||
Original debt discount | $ 3,415,000 | |||||||||||
Interest rate | 3.50% | 3.50% | ||||||||||
Stock issued | $ 2,275,000 | |||||||||||
Warrants to purchase shares | 750,000 | 750,000 | ||||||||||
Oaktree Loan [Member] | Oaktree Fund Administration LLC [Member] | Common Stock [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Warrants to purchase shares | 375,000 | 375,000 | ||||||||||
Oaktree Loan [Member] | Oaktree Fund Administration LLC [Member] | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Effective interest rate | 6.50% | |||||||||||
Oaktree Loan [Member] | Oaktree Fund Administration LLC [Member] | Maximum [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument increase (decrease) for period net | 35,000,000 | |||||||||||
Oaktree Loan [Member] | Oaktree Fund Administration LLC [Member] | Senior Secured Term Loan [Member] | Maximum [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt principal amount | $ 100,000,000 | |||||||||||
Oaktree Credit Agreement Amendment [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt principal amount | $ 12,500,000 | |||||||||||
Interest rate | 3.50% | 3.50% | ||||||||||
Oaktree Credit Agreement Amendment [Member] | Santen Products Acquisition [Member] | Oaktree Loan [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt principal amount | 77,500,000 | |||||||||||
Oaktree Credit Agreement Amendment [Member] | Maximum [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt principal amount | 2,713,000 | |||||||||||
Debt instrument increase (decrease) for period net | 112,500,000 | |||||||||||
Additional related exit fees | $ 438,000 | |||||||||||
Oaktree Credit Agreement Amendment [Member] | Maximum [Member] | Santen Products Acquisition [Member] | Oaktree Loan [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Additional principal loan amount remains available | 35,000,000 | |||||||||||
Oaktree Credit Agreement Amendment [Member] | Minimum [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt principal amount | 2,275,000 | |||||||||||
Debt instrument increase (decrease) for period net | $ 100,000,000 | |||||||||||
Loan and Security Agreement [Member] | BR Loan [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt principal amount | $ 100,000,000 | $ 59,750,000 | ||||||||||
Debt instrument maturity date | Dec. 14, 2025 | |||||||||||
Interest rate | 3% | |||||||||||
Interest rate | 10.875% | |||||||||||
Interest expense | $ 1,565,000 | |||||||||||
Amortization of debt issuance costs and debt discount | 356,000 | |||||||||||
Loss on extinguishment of debt | $ 5,465,000 |
SCHEDULE OF FUTURE LEASE PAYMEN
SCHEDULE OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Leases | ||
Remainder of 2023 | $ 310,000 | |
2024 | 1,262,000 | |
2025 | 1,093,000 | |
2026 | 1,114,000 | |
2027 | 972,000 | |
Thereafter | 5,829,000 | |
Total minimum lease payments | 10,580,000 | |
Less: amount representing interest payments | (3,060,000) | |
Total operating lease obligations | 7,520,000 | |
Less: current portion, operating lease obligations | (785,000) | $ (723,000) |
Operating lease obligations, net of current portion | $ 6,735,000 | $ 7,332,000 |
LEASES (Details Narrative)
LEASES (Details Narrative) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 USD ($) ft² | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) ft² | Sep. 30, 2022 USD ($) | |
Weighted average discount rate percent | 6.60% | 6.60% | ||
Lease term | 10 years 6 months 14 days | 10 years 6 months 14 days | ||
Operating lease payments | $ | $ 310,000 | $ 249,000 | $ 921,000 | $ 622,000 |
Operating lease expense | $ | $ 309,000 | $ 309,000 | $ 926,000 | $ 809,000 |
Carlsbad [Member] | ||||
Area of land | 5,789 | 5,789 | ||
Lease expiration date, description | March 2025 | |||
Ledgewood [Member] | ||||
Area of land | 35,326 | 35,326 | ||
Lease expiration date, description | July 2027 | |||
Area of land | 1,400 | |||
Ledgewood [Member] | Lease Amendment [Member] | ||||
Area of land | 8,900 | |||
Nashville [Member] | ||||
Area of land | 5,500 | 5,500 | ||
Lease expiration date, description | December 2024 | |||
Nashville 1 [Member] | ||||
Area of land | 11,552 | 11,552 | ||
Lease expiration date, description | September 2027 | |||
Minimum [Member] | Office and Laboratory Space [Member] | ||||
Lease term | 1 year | 1 year | ||
Maximum [Member] | Office and Laboratory Space [Member] | ||||
Lease term | 5 years | 5 years |
SCHEDULE OF STOCK OPTION PLAN A
SCHEDULE OF STOCK OPTION PLAN ACTIVITY (Details) - Stock Option Plan [Member] - USD ($) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of shares, outstanding, beginning balance | 3,027,701 |
Weighted average exercise price, outstanding, beginning balance | $ 5.90 |
Number of shares, options granted | 95,500 |
Weighted average exercise price, outstanding, beginning balance | $ 19.54 |
Number of shares, options exercised | (331,934) |
Weighted average exercise price, options exercised | $ 7.55 |
Number of shares, options cancelled/forfeited | (76,175) |
Weighted average exercise price, options cancelled/forfeited | $ 6.85 |
Number of shares, outstanding, ending balance | 2,715,092 |
Weighted average exercise price, outstanding, ending balance | $ 6.15 |
Weighted average. remaining contractual life, options outstanding | 4 years 2 months 4 days |
Aggregate intrinsic value, options outstanding | $ 32,347,000 |
Number of shares, options exercisable | 2,436,946 |
Weighted average exercise price, options exercisable | $ 5.51 |
Weighted average. remaining contractual life, options exercisable | 3 years 7 months 24 days |
Aggregate intrinsic value, options exercisable | $ 30,441,000 |
Number of shares, options vested and expected to vest | 2,676,550 |
Weighted average exercise price, options vested and expected to vest | $ 6.06 |
Weighted average. remaining contractual life, options vested and expected to vest | 4 years 1 month 9 days |
Aggregate intrinsic value, options exercisable | $ 32,114,000 |
SCHEDULE OF FAIR VALUE ASSUMPTI
SCHEDULE OF FAIR VALUE ASSUMPTIONS (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Weighted-average fair value of options granted | $ 16.54 | |
Share-Based Payment Arrangement, Option [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Weighted-average fair value of options granted | $ 11.89 | $ 4.49 |
Expected terms (in years) | 6 years 1 month 9 days | |
Expected volatility, minimum | 68% | 68% |
Expected volatility, maximum | 70% | 70% |
Risk-free interest rate, minimum | 3.59% | 1.54% |
Risk-free interest rate, maximum | 4.14% | 3.19% |
Dividend yield | ||
Share-Based Payment Arrangement, Option [Member] | Minimum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected terms (in years) | 5 years 6 months | |
Share-Based Payment Arrangement, Option [Member] | Maximum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected terms (in years) | 6 years 1 month 9 days |
SCHEDULE OF STOCK OPTION OUTSTA
SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE (Details) | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, minimum | $ 1.47 |
Range of Exercise Prices, maximum | $ 25.86 |
Number of Options Outstanding | shares | 2,715,092 |
Weighted Average Remaining Contractual Life in Years | 4 years 2 months 4 days |
Weighted Average Exercise Price | $ 6.15 |
Number Options Exercisable | shares | 2,436,946 |
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 | $ 1.73 |
Number of Options Outstanding | shares | 295,852 |
Weighted Average Remaining Contractual Life in Years | 4 years 2 months 12 days |
Weighted Average Exercise Price | $ 1.72 |
Number Options Exercisable | shares | 295,852 |
Weighted Average Exercisable Exercise Price | $ 1.72 |
Range Two [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, maximum | $ 2.23 |
Number of Options Outstanding | shares | 285,000 |
Weighted Average Remaining Contractual Life in Years | 3 years 4 months 2 days |
Weighted Average Exercise Price | $ 2.23 |
Number Options Exercisable | shares | 285,000 |
Weighted Average Exercisable Exercise Price | $ 2.23 |
Range Three [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, minimum | 2.40 |
Range of Exercise Prices, maximum | $ 2.60 |
Number of Options Outstanding | shares | 24,068 |
Weighted Average Remaining Contractual Life in Years | 3 years 3 months 7 days |
Weighted Average Exercise Price | $ 2.58 |
Number Options Exercisable | shares | 24,068 |
Weighted Average Exercisable Exercise Price | $ 2.58 |
Range Four [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 | 2 years 6 months |
Weighted Average Exercise Price | $ 3.95 |
Number Options Exercisable | shares | 310,000 |
Weighted Average Exercisable Exercise Price | $ 3.95 |
Range Five [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, minimum | 4.08 |
Range of Exercise Prices, maximum | $ 5.72 |
Number of Options Outstanding | shares | 123,225 |
Weighted Average Remaining Contractual Life in Years | 4 years 8 months 1 day |
Weighted Average Exercise Price | $ 5.28 |
Number Options Exercisable | shares | 115,475 |
Weighted Average Exercisable Exercise Price | $ 5.25 |
Range Six [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, maximum | $ 6.30 |
Number of Options Outstanding | shares | 285,000 |
Weighted Average Remaining Contractual Life in Years | 5 years 4 months 20 days |
Weighted Average Exercise Price | $ 6.30 |
Number Options Exercisable | shares | 285,000 |
Weighted Average Exercisable Exercise Price | $ 6.30 |
Range Seven [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, minimum | 6.75 |
Range of Exercise Prices, maximum | $ 7.26 |
Number of Options Outstanding | shares | 105,062 |
Weighted Average Remaining Contractual Life in Years | 8 years 3 months 25 days |
Weighted Average Exercise Price | $ 6.96 |
Number Options Exercisable | shares | 33,720 |
Weighted Average Exercisable Exercise Price | $ 6.96 |
Range Eight [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, maximum | $ 7.30 |
Number of Options Outstanding | shares | 274,500 |
Weighted Average Remaining Contractual Life in Years | 6 years 3 months 3 days |
Weighted Average Exercise Price | $ 7.30 |
Number Options Exercisable | shares | 274,500 |
Weighted Average Exercisable Exercise Price | $ 7.30 |
Range Nine [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 | 238,712 |
Weighted Average Remaining Contractual Life in Years | 4 years 5 months 4 days |
Weighted Average Exercise Price | $ 7.53 |
Number Options Exercisable | shares | 170,155 |
Weighted Average Exercisable Exercise Price | $ 7.50 |
Range Ten [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, minimum | 7.87 |
Range of Exercise Prices, maximum | $ 25.86 |
Number of Options Outstanding | shares | 773,673 |
Weighted Average Remaining Contractual Life in Years | 3 years 3 months 10 days |
Weighted Average Exercise Price | $ 9.43 |
Number Options Exercisable | shares | 643,176 |
Weighted Average Exercisable Exercise Price | $ 7.89 |
SCHEDULE OF RESTRICTED STOCK UN
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY (Details) | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Equity [Abstract] | |
Number of Shares, RSUs unvested, outstanding, beginning balance | shares | 493,806 |
Weighted average grant date fair value, beginning balance | $ / shares | $ 7.99 |
Number of Shares, RSUs granted | shares | 54,424 |
Weighted average grant date fair value, RSUs granted | $ / shares | $ 16.54 |
Number of Shares, RSUs vested | shares | (167,253) |
Weighted average grant date fair value, RSUs vested | $ / shares | $ 8.13 |
Number of Shares, RSUs cancelled/forfeited | shares | (75,000) |
Weighted average grant date fair value, RSUs cancelled/forfeited | $ / shares | $ 5.83 |
Number of Shares, RSUs unvested, outstanding, ending balance | shares | 305,977 |
Weighted average grant date fair value, ending balance | $ / shares | $ 9.96 |
SCHEDULE OF PERFORMANCE STOCK U
SCHEDULE OF PERFORMANCE STOCK UNITS (Details) | 9 Months Ended | |
Sep. 30, 2023 $ / 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 | $ 25 | [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 | $ 35 | [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 | $ 45 | [1] |
Share Based Compensation Award Tranche Four [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Shares | shares | 559,969 | |
Target Share Price | $ / shares | $ 50 | [1] |
[1]Target Share Price assumes that no dividends or like distributions are made to stockholders 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 the Target Share Price. |
SCHEDULE OF PERFORMANCE STOCK_2
SCHEDULE OF PERFORMANCE STOCK UNITS ACTIVITY (Details) - $ / shares | 1 Months Ended | 9 Months Ended |
Apr. 30, 2023 | Sep. 30, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Shares, RSUs unvested, outstanding, beginning balance | 493,806 | |
Weighted average grant date fair value, beginning balance | $ 7.99 | |
Number of Shares, PSUs granted | 54,424 | |
Weighted average grant date fair value, PSUs granted | $ 16.54 | |
Number of Shares, PSUs vested | (167,253) | |
Weighted average grant date fair value, PSUs vested | $ 8.13 | |
Number of Shares, PSUs cancelled/forfeited | (75,000) | |
Weighted average grant date fair value, PSUs cancelled/forfeited | $ 5.83 | |
Number of Shares, RSUs unvested, outstanding, ending balance | 305,977 | |
Weighted average grant date fair value, ending balance | $ 9.96 | |
Performance Stock Units PSU [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Shares, RSUs unvested, outstanding, beginning balance | 1,567,913 | |
Weighted average grant date fair value, beginning balance | $ 6.45 | |
Number of Shares, PSUs granted | 1,567,913 | 1,567,913 |
Weighted average grant date fair value, PSUs granted | $ 18.56 | |
Number of Shares, PSUs vested | (1,567,913) | |
Weighted average grant date fair value, PSUs vested | $ 6.45 | |
Number of Shares, PSUs cancelled/forfeited | ||
Weighted average grant date fair value, PSUs cancelled/forfeited | ||
Number of Shares, RSUs unvested, outstanding, ending balance | 1,567,913 | |
Weighted average grant date fair value, ending balance | $ 18.56 |
SCHEDULE OF STOCK BASED COMPENS
SCHEDULE OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES DIRECTORS CONSULTANTS (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||||
Total | $ 4,476,000 | $ 1,932,000 | $ 11,521,000 | $ 5,941,000 |
Employees [Member] | Selling, General and Administrative Expenses [Member] | ||||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||||
Total | 3,784,000 | 1,611,000 | 9,719,000 | 4,942,000 |
Employees [Member] | Research and Development Expense [Member] | ||||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||||
Total | 475,000 | 163,000 | 1,224,000 | 525,000 |
Director [Member] | Selling, General and Administrative Expenses [Member] | ||||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||||
Total | 200,000 | 125,000 | 528,000 | 337,000 |
Consultant [Member] | Selling, General and Administrative Expenses [Member] | ||||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||||
Total | $ 17,000 | $ 33,000 | $ 50,000 | $ 137,000 |
STOCKHOLDERS_ EQUITY AND STOC_3
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Jul. 31, 2023 | Apr. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Number of shares outstanding | 305,977 | 305,977 | 493,806 | ||||
Proceeds from stock option exercise | $ 355,000 | $ 7,000 | |||||
Exercise price, minimum | $ 1.47 | ||||||
Exercise price, maximum | $ 25.86 | ||||||
Number of shares granted | 54,424 | ||||||
Stock-based compensation | $ 11,521,000 | $ 5,941,000 | |||||
2017 Incentive Stock and Awards Plan [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Common shares available for future issuances | 490,493 | 490,493 | |||||
Employees and Directors [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Forfeiture factor rate | 10% | ||||||
Maximum [Member] | 2017 Incentive Stock and Awards Plan [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Number of shares authorized | 6,000,000 | 6,000,000 | |||||
Performance Stock Units [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Number of shares outstanding | 1,567,913 | ||||||
Shares withheld for tax withholding obligation, shares | 616,984 | ||||||
Payroll tax obligations, value | $ 11,273,000 | ||||||
Performance Stock Units [Member] | Minimum [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
TSR percentage | 50% | ||||||
Performance Stock Units [Member] | Maximum [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
TSR percentage | 175% | ||||||
Restricted Stock Units (RSUs) [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Number of common stock vested | 244,352 | 303,454 | |||||
Restricted Stock Units (RSUs) [Member] | Director [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Number of shares granted | 41,301 | ||||||
Share-based compensation shares fair value | $ 800,000 | ||||||
Share-Based Payment Arrangement, Option [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Closing price of common stock price per share | $ 14.37 | $ 14.37 | |||||
Unrecognized compensation expense | $ 1,781,000 | $ 1,781,000 | |||||
Weighted-average period years | 2 years 9 months 25 days | ||||||
Stock-based compensation | 154,000 | $ 241,000 | $ 617,000 | $ 771,000 | |||
Intrinsic value of options exercised | $ 4,399,000 | ||||||
Share-Based Payment Arrangement, Option [Member] | Employees and Consultant [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Vesting term description | Vesting terms for options granted to employees during the nine months ended September 30, 2023 included the following vesting schedule: 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 RSU [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Unrecognized compensation expense | 1,041,000 | $ 1,041,000 | |||||
Stock-based compensation | $ 374,000 | 427,000 | $ 789,000 | 1,378,000 | |||
Unvested RSUs And PSU [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Weighted-average period years | 4 months 24 days | ||||||
Performance Stock Units PSU [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Number of shares outstanding | 1,567,913 | 1,567,913 | 1,567,913 | ||||
Number of shares granted | 1,567,913 | 1,567,913 | |||||
Share-based compensation shares fair value | $ 29,106,000 | ||||||
Volatality rate | 65% | ||||||
Risk free intrest rate | 10.34% | ||||||
Unvested PSU [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Unrecognized compensation expense | $ 21,829,000 | $ 21,829,000 | |||||
Weighted-average period years | 1 year 6 months 3 days | ||||||
Stock-based compensation | $ 3,948,000 | $ 1,264,000 | $ 10,115,000 | $ 3,792,000 | |||
Common Stock Offering [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Offering price per share | $ 17.75 | ||||||
Number of shares sold | 3,887,324 | ||||||
Proceeds from issuance of common stock | $ 64,520,000 | ||||||
Other expenses | $ 4,480,000 | ||||||
Common Stock [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Number of shares issued | 3,887,324 | ||||||
Proceeds from stock option exercise | $ 355,000 | ||||||
Exercise of option, shares | 2,430 | 275 | 219,246 | 92,261 | |||
Exercise price, minimum | $ 1.70 | ||||||
Exercise price, maximum | $ 8.50 | ||||||
Common Stock [Member] | Mark LBaum [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Shares withheld for tax withholding obligation, shares | 77,167 | ||||||
Payroll tax obligations, value | $ 849,000 | ||||||
Number of shares issued | 62,367 | ||||||
Cashless exercise of options, shares | 180,000 | ||||||
Exercise price per share | $ 8.99 | $ 8.99 | |||||
Additional shares withheld for tax withholding obligation | 40,466 | ||||||
Common Stock [Member] | Andrew R Boll [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Shares withheld for tax withholding obligation, shares | 25,521 | ||||||
Payroll tax obligations, value | $ 189,000 | ||||||
Number of shares issued | 55,558 | ||||||
Cashless exercise of options, shares | 90,000 | ||||||
Exercise price per share | $ 6 | $ 6 | |||||
Additional shares withheld for tax withholding obligation | 8,921 | ||||||
Common Stock [Member] | Restricted Stock Units (RSUs) [Member] | Director [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Number of shares granted | 43,130 | ||||||
Common Stock [Member] | Restricted Stock Units (RSUs) [Member] | Director [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Number of shares issued | 131,760 | ||||||
Number of common stock vested | 13,123 | ||||||
Common Stock [Member] | Restricted Stock Units (RSUs) [Member] | Mark LBaum [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Shares withheld for tax withholding obligation, shares | 35,179 | ||||||
Payroll tax obligations, value | $ 519,000 | ||||||
Number of shares issued | 52,821 | ||||||
Number of shares granted | 88,000 | ||||||
Common Stock [Member] | Restricted Stock Units (RSUs) [Member] | Andrew R Boll [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Shares withheld for tax withholding obligation, shares | 9,602 | ||||||
Payroll tax obligations, value | $ 142,000 | ||||||
Number of shares issued | 13,398 | ||||||
Number of shares granted | 23,000 | ||||||
Common Stock [Member] | Share-Based Payment Arrangement, Option [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Number of shares issued | 61,934 | ||||||
Exercise of option, shares | 61,934 | ||||||
Common Stock [Member] | Performance Stock Units PSU [Member] | Minimum [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Share price | $ 25 | ||||||
Common Stock [Member] | Performance Stock Units PSU [Member] | Maximum [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Share price | $ 50 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Aug. 31, 2023 | Aug. 31, 2021 | Jul. 31, 2021 | Dec. 31, 2019 | Apr. 30, 2017 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Reduction in milestone amounts | $ 550,000 | ||||||||
Payment for milestone | $ 4,450,000 | $ 4,450,000 | |||||||
Klarity License Agreement [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty expense | 71,000 | $ 67,000 | 220,000 | $ 244,000 | |||||
Milestone payment in cash | 0 | 77,000 | 146,000 | 199,000 | |||||
Klarity License Agreement [Member] | Richard L. Lindstrom, M.D [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [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] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty expense | $ 50,000 | ||||||||
Klarity License Agreement [Member] | Richard L. Lindstrom, M.D [Member] | Second Payment [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty expense | 50,000 | ||||||||
Net sales | 50,000 | ||||||||
Klarity License Agreement [Member] | Richard L. Lindstrom, M.D [Member] | Final Payment [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty expense | 50,000 | ||||||||
Net sales | $ 100,000 | ||||||||
Injectable Asset Purchase Agreement [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty expense | 9,000 | 9,000 | 26,000 | 24,000 | |||||
Milestone payment in cash | 0 | 8,000 | 17,000 | 23,000 | |||||
Injectable Asset Purchase Agreement [Member] | Richard L. Lindstrom, M.D [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [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 | ||||||||
Asset Purchase, License and Related Agreements [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty expense | 220,000 | 185,000 | $ 705,000 | 695,000 | |||||
Sintetica Agreement [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Payment for royalties | $ 18,000,000 | ||||||||
Sintetica Agreement [Member] | Due Within Thirty Days [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Payment for royalties | $ 5,000,000 | ||||||||
Wakamoto Agreement [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Payment for royalties | $ 2,000,000 | ||||||||
Commercial payments for royalties | $ 6,200,000 | ||||||||
Dexycu Agreement [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Commission revenues | 1,044,000 | 3,576,000 | |||||||
Sales and Marketing Agreements [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Description for commission payments | Under the terms of the sales and marketing agreements, the Company was generally required to make commission payments equal to 10% to 14% of net sales for products above and beyond the initial existing sales amounts. | ||||||||
Commission expenses | $ 0 | $ 1,041,000 | $ 130,000 | $ 3,188,000 |
SEGMENTS AND CONCENTRATIONS (De
SEGMENTS AND CONCENTRATIONS (Details Narrative) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Single Customer [Member] | |||||
Revenue, Major Customer [Line Items] | |||||
Concentration risk percentage | 35% | 23% | |||
Revenue Benchmark [Member] | Supplier Concentration Risk [Member] | Three Suppliers [Member] | |||||
Revenue, Major Customer [Line Items] | |||||
Concentration risk percentage | 96% | 52% | 79% | 66% | |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Single Customer [Member] | |||||
Revenue, Major Customer [Line Items] | |||||
Concentration risk percentage | 48% | 0% | |||
Two Product Concentration Risk [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | |||||
Revenue, Major Customer [Line Items] | |||||
Concentration risk percentage | 32% | 34% | 35% | 33% |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - Common Stock [Member] - USD ($) | 1 Months Ended | 9 Months Ended |
Nov. 30, 2023 | Sep. 30, 2023 | |
Subsequent Event [Line Items] | ||
Number of shares issued | 3,887,324 | |
Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Number of shares issued | 125 | |
Proceeds from issuance of common stock | $ 1,000 | |
Options to purchase common shares | 125 | |
Exercise price per share | $ 6.75 |