Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 17, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Document Transition Report | false | ||
Entity File Number | 001-36728 | ||
Entity Registrant Name | ADMA BIOLOGICS, INC. | ||
Entity Central Index Key | 0001368514 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 56-2590442 | ||
Entity Address, Address Line One | 465 State Route 17 | ||
Entity Address, City or Town | Ramsey | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 07446 | ||
City Area Code | 201 | ||
Local Phone Number | 478-5552 | ||
Title of 12(b) Security | Common stock, par value $0.0001 per share | ||
Trading Symbol | ADMA | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 372,622,681 | ||
Entity Common Stock, Shares Outstanding | 222,155,625 | ||
Auditor Firm ID | 596 | ||
Auditor Name | CohnReznick LLP | ||
Auditor Location | Parsippany, New Jersey |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 86,521,542 | $ 51,089,118 |
Accounts receivable, net | 15,505,048 | 28,576,857 |
Inventories | 163,280,047 | 124,724,091 |
Prepaid expenses and other current assets | 5,095,146 | 4,339,245 |
Total current assets | 270,401,783 | 208,729,311 |
Property and equipment, net | 58,261,481 | 50,935,074 |
Intangible assets, net | 1,013,415 | 1,728,768 |
Goodwill | 3,529,509 | 3,529,509 |
Right-to-use assets | 10,485,447 | 7,262,658 |
Deposits and other assets | 4,770,246 | 4,067,404 |
TOTAL ASSETS | 348,461,881 | 276,252,724 |
Current liabilities: | ||
Accounts payable | 13,229,390 | 12,429,409 |
Accrued expenses and other current liabilities | 24,989,349 | 17,214,988 |
Current portion of deferred revenue | 142,834 | 142,834 |
Current portion of lease obligations | 905,369 | 591,084 |
Total current liabilities | 39,266,942 | 30,378,315 |
Senior notes payable, net of discount | 142,833,063 | 94,866,239 |
Deferred revenue, net of current portion | 1,833,031 | 1,975,865 |
End of term fee | 1,500,000 | 0 |
Lease obligations, net of current portion | 10,704,176 | 7,462,388 |
Other non-current liabilities | 350,454 | 397,351 |
TOTAL LIABILITIES | 196,487,666 | 135,080,158 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS' EQUITY | ||
Preferred Stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding | 0 | 0 |
Common Stock - voting, $0.0001 par value, 300,000,000 shares authorized, 221,816,930 and 195,813,817 shares issued and outstanding | 22,182 | 19,581 |
Additional paid-in capital | 629,968,704 | 553,265,706 |
Accumulated deficit | (478,016,671) | (412,112,721) |
TOTAL STOCKHOLDERS' EQUITY | 151,974,215 | 141,172,566 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 348,461,881 | $ 276,252,724 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
STOCKHOLDERS' EQUITY | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 221,816,930 | 195,813,817 |
Common stock, shares outstanding (in shares) | 221,816,930 | 195,813,817 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
REVENUES: | ||
Revenues | $ 154,079,692 | $ 80,942,625 |
Cost of product revenue | 118,814,535 | 79,769,341 |
Gross profit | 35,265,157 | 1,173,284 |
OPERATING EXPENSES: | ||
Research and development | 3,613,764 | 3,646,060 |
Plasma center operating expenses | 17,843,096 | 12,288,723 |
Amortization of intangible assets | 715,353 | 715,353 |
Selling, general and administrative | 52,458,024 | 42,896,889 |
Total operating expenses | 74,630,237 | 59,547,025 |
LOSS FROM OPERATIONS | (39,365,080) | (58,373,741) |
OTHER INCOME (EXPENSE): | ||
Interest income | 44,833 | 34,532 |
Interest expense | (19,279,373) | (13,056,834) |
Loss on extinguishment of debt | (6,669,941) | 0 |
Other expense | (634,389) | (251,575) |
Other expense, net | (26,538,870) | (13,273,877) |
NET LOSS | $ (65,903,950) | $ (71,647,618) |
BASIC LOSS PER COMMON SHARE (in dollars per share) | $ (0.33) | $ (0.51) |
DILUTED LOSS PER COMMON SHARE (in dollars per share) | $ (0.33) | $ (0.51) |
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | ||
Basic (in shares) | 197,874,895 | 139,578,538 |
Diluted (in shares) | 197,874,895 | 139,578,538 |
Product Revenue [Member] | ||
REVENUES: | ||
Revenues | $ 153,936,858 | $ 80,799,791 |
License Revenue [Member] | ||
REVENUES: | ||
Revenues | $ 142,834 | $ 142,834 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2020 | $ 10,490 | $ 428,704,039 | $ (340,465,103) | $ 88,249,426 |
Balance (in shares) at Dec. 31, 2020 | 104,902,888 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation | $ 0 | 3,488,253 | 0 | 3,488,253 |
Issuance of common stock, net of offering expenses | $ 9,085 | 121,135,018 | 0 | 121,144,103 |
Issuance of common stock, net of offering expenses (in shares) | 90,846,029 | |||
Vesting of Restricted Stock Units, net of shares withheld for taxes and retired | $ 6 | (61,604) | 0 | (61,598) |
Vesting of Restricted Stock Units, net of shares withheld for taxes and retired (in shares) | 64,900 | |||
Net loss | $ 0 | 0 | (71,647,618) | (71,647,618) |
Balance at Dec. 31, 2021 | $ 19,581 | 553,265,706 | (412,112,721) | 141,172,566 |
Balance (in shares) at Dec. 31, 2021 | 195,813,817 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation | $ 0 | 5,214,531 | 0 | 5,214,531 |
Warrants issued in connection with note payable | 0 | 9,569,604 | 0 | 9,569,604 |
Issuance of common stock, net of offering expenses | $ 2,413 | 64,642,876 | 0 | 64,645,289 |
Issuance of common stock, net of offering expenses (in shares) | 24,125,873 | |||
Vesting of Restricted Stock Units, net of shares withheld for taxes and retired | $ 181 | (2,899,021) | 0 | (2,898,840) |
Vesting of Restricted Stock Units, net of shares withheld for taxes and retired (in shares) | 1,808,561 | |||
Stock options exercised | $ 7 | 175,008 | 0 | 175,015 |
Stock options exercised (in shares) | 68,679 | |||
Net loss | $ 0 | 0 | (65,903,950) | (65,903,950) |
Balance at Dec. 31, 2022 | $ 22,182 | $ 629,968,704 | $ (478,016,671) | $ 151,974,215 |
Balance (in shares) at Dec. 31, 2022 | 221,816,930 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (65,903,950) | $ (71,647,618) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 7,113,369 | 5,495,502 |
Loss on disposal of fixed assets | 426,536 | 220,761 |
Interest paid in kind | 2,997,746 | 0 |
Stock-based compensation | 5,214,531 | 3,488,253 |
Amortization of debt discount | 2,401,669 | 1,897,373 |
Loss on extinguishment of debt | 6,669,941 | 0 |
Amortization of license revenue | (142,834) | (142,834) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 13,071,809 | (15,339,567) |
Inventories | (38,555,957) | (43,188,489) |
Prepaid expenses and other current assets | (755,900) | (1,292,779) |
Deposits and other assets | 122,468 | (1,775,205) |
Accounts payable | 799,981 | 1,355,700 |
Accrued expenses | 7,534,572 | 8,341,341 |
Other current and non-current liabilities | (502,238) | 218,580 |
Net cash used in operating activities | (59,508,257) | (112,368,982) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (13,911,171) | (13,511,258) |
Net cash used in investing activities | (13,911,171) | (13,511,258) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Principal payments on notes payable | (100,000,000) | 0 |
Proceeds from issuance of common stock, net of offering expenses | 64,645,289 | 121,144,103 |
Payment of debt refinancing fees | (2,000,000) | 0 |
Proceeds from issuance of note payable | 151,750,000 | 0 |
Taxes paid on vested Restricted Stock Units | (2,898,840) | (61,598) |
Payments on finance lease obligations | (36,684) | (34,299) |
Proceeds from the exercise of stock options | 175,015 | 0 |
Payment of deferred financing fees | (2,782,928) | 0 |
Net cash provided by financing activities | 108,851,852 | 121,048,206 |
Net increase (decrease) in cash and cash equivalents | 35,432,424 | (4,832,034) |
Cash and cash equivalents - beginning of year | 51,089,118 | 55,921,152 |
Cash and cash equivalents - end of year | $ 86,521,542 | $ 51,089,118 |
ORGANIZATION AND BUSINESS
ORGANIZATION AND BUSINESS | 12 Months Ended |
Dec. 31, 2022 | |
ORGANIZATION AND BUSINESS [Abstract] | |
ORGANIZATION AND BUSINESS | 1. ORGANIZATION AND BUSINESS ADMA Biologics, Inc. (“ADMA” or the “Company”) is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. The Company’s targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons. ADMA operates through its wholly-owned subsidiaries ADMA BioManufacturing, LLC (“ADMA BioManufacturing”) and ADMA BioCenters Georgia Inc. (“ADMA BioCenters”). ADMA BioManufacturing was formed in January 2017 to facilitate the acquisition of the Biotest Therapy Business Unit (“BTBU”) from BPC Plasma, Inc. (formerly Biotest Pharmaceuticals Corporation) (“BPC” and, together with Biotest AG, “Biotest”) on June 6, 2017. The acquisition included certain assets (the “Biotest Assets”) of BTBU, which included the U.S. Food and Drug Administration (“FDA”)-licensed BIVIGAM and Nabi-HB immunoglobulin products, and an FDA-licensed plasma fractionation manufacturing facility located in Boca Raton, FL (the “Boca Facility”) (the “Biotest Transaction”). BTBU had previously been the Company’s third-party contract manufacturer. ADMA BioCenters is the Company’s source plasma collection business with ten plasma collection facilities located throughout the U.S., eight of which hold an approved license with the FDA. The Company has three FDA-approved products, all of which are currently marketed and commercially available: (i) BIVIGAM (Immune Globulin Intravenous, Human), an Intravenous Immune Globulin (“IVIG”) product indicated for the treatment of Primary Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”) or Inborn Errors of Immunity, and for which the Company received FDA approval on May 9, 2019 and commenced commercial sales in August 2019; (ii) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an IVIG product indicated for the treatment of PI, for which the Company received FDA approval on April 1, 2019 and commenced first commercial sales in October 2019; and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is indicated for the treatment of acute exposure to blood containing Hepatitis B surface antigen (“HBsAg”) and other listed exposures to Hepatitis B. In addition to its commercially available immunoglobulin products, the Company provides contract manufacturing and laboratory services for certain clients and generates revenues from the sale of intermediate by-products that result from the immunoglobulin production process. The Company seeks to develop a pipeline of plasma-derived therapeutics, and its products and product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients with or at risk for certain infectious diseases. As of December 31, 2022, the Company had working capital of $231.1 million, including $86.5 million of cash and cash equivalents. Based upon the Company’s current projected revenue and expenditures, including capital expenditures and continued implementation of the Company’s commercialization and expansion activities, the Company’s management currently believes that its cash, cash equivalents, projected revenue and accounts receivable will be sufficient to fund ADMA’s operations, as currently conducted, through the end of the first quarter of 2024, at which time the Company believes it will begin to generate positive cash flow from operations. These estimates may change based upon several factors, including the success of the Company’s commercial sales of its products, whether or not the assumptions underlying the Company’s projected revenues and expenses are correct and the acceptability of ADMA’s immune globulin products by physicians, patients or payers. There can be no assurance that the Company’s approved products will be commercially viable, or that plant capacity expansion, plasma center buildouts or other capital improvements will be successfully completed or that any product developed in the future will be approved. The Company is subject to risks common to companies in the biotechnology and pharmaceutical manufacturing industries including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors of new technological innovations, dependence on key personnel, inflationary pressures, supply chain constraints, protection of proprietary technology, and compliance with FDA and other governmental regulations and approval requirements. The Company continues to evaluate a variety of strategic alternatives through its ongoing engagement with Morgan Stanley. The exploration of value-creating opportunities remains a top corporate priority for ADMA. On December 9, 2022, the Company issued 24,125,873 shares of its common stock through an underwritten public offering and received net proceeds of $64.6 million, and on March 23, 2022 the Company received approximately $47.0 million in net proceeds from the refinancing of its senior credit facility (see Note 7). |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2022 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | 2. SIGNIFICANT ACCOUNTING POLICIES Principles of consolidation and basis of presentation The accompanying consolidated financial statements include the accounts of ADMA and its wholly-owned subsidiaries, and have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and in accordance with Article 8 of Regulation S-X of the Securities and Exchange Commission (the “SEC”). All intercompany balances have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (the “FASB”). During the years ended December 31, 2022 and 2021, comprehensive loss was equal to the net loss amounts presented for the respective periods in the accompanying consolidated statements of operations. Use of estimates The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include rebates and chargebacks deducted from gross revenues, the realizable value of accounts receivable, valuation of inventory, assumptions used in projecting future liquidity and capital requirements, assumptions used in the fair value of awards granted under the Company’s equity incentive plans and warrants issued in connection with the issuance of notes payable and the valuation allowance for the Company’s deferred tax assets. Cash and cash equivalents The Company considers all highly liquid instruments purchased with a maturity of three months or less to be cash equivalents. The Company regularly maintains cash and cash equivalents at third-party financial institutions in excess of the Federal Deposit Insurance Corporation insurance limit. Although the Company monitors the daily cash balances in its operating accounts and adjusts the balances as appropriate, these balances could be impacted, and there could be a material adverse effect on the Company’s business, if one or more of the financial institutions with which the Company has deposits fails or is subject to other adverse conditions in the financial or credit markets. To date, the Company has not experienced a loss or lack of access to its deposited cash or cash equivalents; however, the Company cannot provide assurance that access to its cash and cash equivalents will not be impacted by adverse conditions in the financial and credit markets in the future. Accounts receivable Accounts receivable is reported at realizable value, net of allowances for contractual credits and doubtful accounts in the amount of $0.1 million and $0.2 million at December 31, 2022 and 2021, respectively, which are recognized in the period the related revenue is recorded. The Company extends credit to its customers based upon an evaluation of each customer’s financial condition and credit history. Evaluations of the financial condition and associated credit risk of customers are performed on an ongoing basis. Inventories Raw materials inventory consists of various materials purchased from suppliers, including normal source plasma, used in the production of the Company’s products. Work-in-process and finished goods inventories (see Note 3) reflect the cost of raw materials as well as costs for direct and indirect labor, primarily salaries, wages and benefits for applicable employees, as well as an allocation of overhead costs related to the Boca Facility including utilities, property taxes, general repairs and maintenance, consumable supplies and depreciation. The allocation of Boca Facility overhead to inventory is generally based upon the estimated square footage of the Boca Facility that is used in the production of the Company’s products relative to the total square footage of the facility. Inventories, including plasma intended for resale and plasma intended for internal use in the Company’s manufacturing, commercialization or research and development activities, are carried at the lower of cost or net realizable value determined by the first-in, first-out method. For both the Company’s immune globulin products and plasma intended for resale and internal use, net realizable value is generally determined based upon the consideration the Company expects to receive when the inventory is sold, less costs to deliver the inventory to the recipient. The estimates for net realizable value of inventory are based on contractual terms or upon historical experience and certain other assumptions, and the Company believes that such assumptions are reasonable. Inventory is periodically reviewed to ensure that its carrying value does not exceed its net realizable value, and adjustments are recorded to write down such inventory, with a corresponding charge to cost of product revenue, when the carrying value or historical cost exceeds its estimated net realizable value. In addition, costs associated with the production of conformance or engineering lots that would not qualify as immediately available for commercial sale are charged to cost of product revenue and not capitalized into inventory. Property and equipment Assets comprising property and equipment (see Note 4) are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the asset’s estimated useful life. Land is not depreciated. The buildings have been assigned a useful life of 30 years. Property and equipment other than land and buildings have useful lives ranging from 3 to 15 years. Leasehold improvements are amortized over the lesser of the lease term or their estimated useful lives. Goodwill Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill at December 31, 2022 and 2021 was $3.5 million, all of which is attributable to the Company’s ADMA BioManufacturing business segment. There were no changes to the carrying amount of goodwill during the years ended December 31, 2022 and 2021. Goodwill is not amortized but is assessed for impairment on an annual basis or more frequently if impairment indicators exist. The Company has the option to perform a qualitative assessment of goodwill to determine whether it is more likely than not that the fair value of its reporting unit is less than its carrying amount, including goodwill and other intangible assets. If the Company concludes that this is the case, then it must perform a goodwill impairment test by comparing the fair value of the reporting unit to its carrying value. An impairment charge is recorded to the extent the reporting unit’s carrying value exceeds its fair value, not to exceed the total amount of goodwill allocated to that reporting unit. The Company performs its annual goodwill impairment test as of October 1 of each year. The Company’s annual goodwill impairment tests as of October 1, 2022 and 2021 did not result in any impairment charges related to goodwill for the years ended December 31, 2022 and 2021. Impairment of long-lived assets The Company assesses the recoverability of its long-lived assets, which include property and equipment and finite-lived intangible assets, whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s carrying value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the years ended December 31, 2022 and 2021, the Company determined that there was no impairment of its long-lived assets. Revenue recognition Revenues for the years ended December 31, 2022 and 2021 are comprised of (i) revenues from the sale of the Company’s immunoglobulin products, BIVIGAM, ASCENIV and Nabi-HB, (ii) product revenues from the sale of human plasma collected by the Company’s Plasma Collection Centers business segment, (iii) contract manufacturing and laboratory services revenue, (iv) revenues from the sale of intermediate by-products; and (v) license and other revenues primarily attributable to the out-licensing of ASCENIV to Biotest in 2012 to market and sell this product in Europe and selected countries in North Africa and the Middle East. Biotest has provided the Company with certain services and financial payments in accordance with the related Biotest license agreement and is obligated to pay the Company certain amounts in the future if certain milestones are achieved. Deferred revenue is amortized into income over the term of the Biotest license, representing a period of approximately 22 years. Product revenue is recognized when the customer is deemed to have control over the product. Control is determined based on when the product is shipped or delivered and title passes to the customer. Revenue is recorded in an amount that reflects the consideration the Company expects to receive in exchange. Revenue from the sale of the Company’s immunoglobulin products is recognized when the product reaches the customer’s destination, and is recorded net of estimated rebates, price protection arrangements and customer incentives, including prompt pay discounts, wholesaler chargebacks and other wholesaler fees. These estimates are based on contractual arrangements, historical experience and certain other assumptions, and the Company believes that such estimates are reasonable. For revenues associated with contract manufacturing and the sale of intermediates, control transfers to the customer and the performance obligation is satisfied when the customer takes possession of the product from the Boca Facility or from a third-party warehouse that is utilized by the Company. Product revenues from the sale of human plasma collected at the Company’s plasma collection centers are recognized at the time control of the product has been transferred to the customer, which generally occurs at the time of shipment. Product revenues are recognized at the time of delivery if the Company retains control of the product during shipment. Cost of product revenue Cost of product revenue includes costs associated with the manufacture of the Company’s FDA approved products and intermediates and for the collection of human source plasma, as well as expenses related to conformance batch production, process development and scientific and technical operations when these operations are attributable to marketed products. When the activities of these operations are attributable to new products in development, the expenses are classified as research and development expenses. Research and development expenses Research and development expenses consist of clinical research organization costs, costs related to clinical trials, post-marketing commitment studies for BIVIGAM and ASCENIV, wages, benefits and stock-based compensation for employees directly related to research and development activities. All research and development costs are expensed as incurred. Plasma center operating expenses Plasma center operating expenses consist of certain general and administrative plasma center costs, initial opening, marketing and start-up costs, rent expense, maintenance, utilities, compensation and benefits for center and administrative staff, advertising and promotion expenses and computer software fees related to donor collections. Advertising and marketing expenses Advertising and marketing expense includes cost for promotional materials and trade show expenses for the marketing of the Company’s products and services and expenses incurred for attracting donors to the Company’s plasma collection centers. All advertising and marketing expenses are expensed as incurred. Advertising and marketing expenses were $2.2 million and $1.4 million for the years ended December 31, 2022 and 2021, respectively. Stock-based compensation The Company follows recognized accounting guidance which requires all equity-based payments, including grants of stock options, to be recognized in the statement of operations as compensation expense based on their fair values at the date of grant. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a straight-line basis over the associated vesting period of the award based on the grant date fair value of the award. Stock options granted under the Company’s equity incentive plans generally have a four-year vesting period and a term of 10 years. For milestone-based equity awards (see Note 8) the Company periodically assesses the probability of vesting for each milestone-based award and adjusts compensation expense based on its probability assessment. Pursuant to ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting (Topic 718) Income taxes The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or its tax returns. Under this method, deferred tax assets and liabilities are recognized for the temporary differences between the tax bases of assets and liabilities and their respective financial reporting amounts at enacted tax rates in effect for the years in which the temporary differences are expected to reverse. The Company records a valuation allowance on its deferred tax assets if it is more likely than not that the Company will not generate sufficient taxable income to utilize its deferred tax assets (see Note 11). The Company is subject to income tax examinations by major taxing authorities for all tax years since 2018 and for previous periods as it relates to the Company’s net operating loss carryforwards. Loss Per Share Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share is calculated by dividing net loss attributable to common stockholders as adjusted for the effect of dilutive securities, if any, by the weighted average number of shares of common stock and dilutive common stock outstanding during the period. Potentially dilutive common stock includes the shares of common stock issuable upon the exercise of outstanding stock options and warrants (using the treasury stock method). Potentially dilutive common stock in the diluted net loss per share computation is excluded to the extent that it would be anti-dilutive. No potentially dilutive securities are included in the computation of any diluted per share amounts as the Company reported a net loss for all periods presented. For the years ended December 31, 2022 and 2021, the following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive effects: For the Years Ended December 31, 2022 2021 Stock options 8,256,211 7,862,722 Restricted Stock Units 2,866,987 4,485,133 Warrants 13,525,148 4,528,160 24,648,346 16,876,015 Fair value of financial instruments The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable and accounts payable are shown at cost, which approximates fair value due to the short-term nature of these instruments. The debt outstanding under the Company’s senior notes payable (see Note 7) approximates fair value due to the variable interest rate on this debt. Recent Accounting Pronouncements There were no new accounting pronouncements adopted during the years ended December 31, 2022 and 2021 that had a significant impact on the Company’s consolidated financial statements. |
INVENTORIES
INVENTORIES | 12 Months Ended |
Dec. 31, 2022 | |
INVENTORIES [Abstract] | |
INVENTORIES | 3. INVENTORIES The following table provides the components of inventories: December 31, December 31, Raw materials $ 48,644,527 $ 36,755,720 Work-in-process 56,170,853 58,968,535 Finished goods 58,464,667 28,999,836 Total inventories $ 163,280,047 $ 124,724,091 Raw materials includes plasma and other materials expected to be used in the production of BIVIGAM, ASCENIV and Nabi-HB. These materials will be consumed in the production of goods expected to be available for sale or otherwise have alternative uses that provide a probable future benefit. All other activities and materials associated with the production of inventories used in research and development activities are expensed as incurred. Work-in-process inventory primarily consists of bulk drug substance and unlabeled filled vials of the Company’s immunoglobulin products. Finished goods inventory is comprised of immunoglobulin product inventory and related intermediates that are available for commercial sale, as well as plasma collected at the Company’s plasma collection centers which is expected to be sold to third-party customers. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2022 | |
PROPERTY AND EQUIPMENT [Abstract] | |
PROPERTY AND EQUIPMENT | 4. PROPERTY AND EQUIPMENT Property and equipment at December 31, 2022 and 2021 is summarized as follows: December 31, 2022 December 31, 2021 Manufacturing and laboratory equipment $ 18,767,807 $ 16,702,991 Office equipment and computer software 5,318,669 4,082,462 Furniture and fixtures 5,109,898 3,389,140 Construction in process 6,726,995 5,496,222 Leasehold improvements 17,930,905 11,129,639 Land 4,339,441 4,339,441 Buildings and building improvements 19,544,307 19,067,032 77,738,022 64,206,927 Less: Accumulated depreciation (19,476,541 ) (13,271,853 ) Total property, plant and equipment, net $ 58,261,481 $ 50,935,074 The Company recorded depreciation expense on property and equipment of $6.4 million and $4.8 million for the years ended December 31, 2022 and 2021, respectively. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2022 | |
INTANGIBLE ASSETS [Abstract] | |
INTANGIBLE ASSETS | 5. INTANGIBLE ASSETS Intangible assets at December 31, 2022 and 2021 consist of the following: December 31, 2022 December 31, 2021 Cost Accumulated Amortization Net Cost Accumulated Amortization Net Trademark and other intangible rights related to Nabi-HB $ 4,100,046 $ 3,270,276 $ 829,770 $ 4,100,046 $ 2,684,554 $ 1,415,492 Rights to intermediates 907,421 723,776 183,645 907,421 594,145 313,276 $ 5,007,467 $ 3,994,052 $ 1,013,415 $ 5,007,467 $ 3,278,699 $ 1,728,768 Under the previous contract manufacturing agreement between ADMA and BPC, intermediate by-products derived from the manufacture of ASCENIV were property of Biotest. As a result of the Biotest Transaction, ADMA obtained the right to these intermediate products, which are being amortized over a period of seven years. The intangible rights to Nabi-HB are also being amortized over a period of seven years. Amortization expense related to the Company’s intangible assets for the years ended December 31, 2022 and 2021 was $0.7 million. Estimated aggregate future aggregate amortization expense is expected to be as follows: 2023 715,352 2024 298,063 |
ACCRUED EXPENSES AND OTHER LIAB
ACCRUED EXPENSES AND OTHER LIABILITIES | 12 Months Ended |
Dec. 31, 2022 | |
ACCRUED EXPENSES AND OTHER LIABILITIES [Abstract] | |
ACCRUED EXPENSES AND OTHER LIABILITIES | 6. ACCRUED EXPENSES AND OTHER LIABILITIES Accrued expenses and other current liabilities at December 31, 2022 and 2021 are as follows: December 31, 2022 December 31, 2021 Accrued rebates $ 11,436,484 $ 5,040,200 Accrued distribution fees 3,166,896 4,739,651 Accrued incentives 4,193,919 4,066,109 Accrued testing 309,867 1,189,970 Accrued payroll and other compensation 4,086,379 1,197,337 Other 1,795,804 981,721 Total accrued expenses and other current liabilities $ 24,989,349 $ 17,214,988 |
NOTES PAYABLE
NOTES PAYABLE | 12 Months Ended |
Dec. 31, 2022 | |
NOTES PAYABLE [Abstract] | |
NOTES PAYABLE | 7. NOTES PAYABLE Senior Notes Payable A summary of outstanding senior notes payable is as follows: December 31, 2022 December 31, 2021 Notes payable $ 154,747,746 $ 100,000,000 Less: Debt discount (11,914,683 ) (5,133,761 ) Senior notes payable $ 142,833,063 $ 94,866,239 On March 23, 2022 (the “Hayfin Closing Date”), the Company and all of its subsidiaries entered into a Credit and Guaranty Agreement (the “Hayfin Credit Agreement”) with Hayfin Services LLP (“Hayfin”). The Hayfin Credit Agreement provides for a senior secured term loan facility in a principal amount of up to Hayfin Credit Facility composed of (i) a term loan made on the Hayfin Closing Date in the principal amount of ( the “Hayfin Closing Date Loan”), and (ii) a delayed draw term loan in the principal amount of Hayfin Delayed Draw Loan and, together with the Hayfin Closing Date Loan, the “Hayfin Loans The obligation of the lenders to make the Hayfin Delayed Draw Loan was to expire on March 22, 2023 (see Note 17) and is subject to the satisfaction of certain conditions, including, but not limited to, the Company’s meeting certain 12-month revenue targets as set forth in the Hayfin Credit Agreement, which the Company has met. The Hayfin Credit Facility has a maturity date of March 23, 2027 (the “Hayfin Maturity Date”), subject to acceleration pursuant to the Hayfin Credit Agreement, including upon an Event of Default (as defined in the Hayfin Credit Agreement). On the Hayfin Closing Date, the Company used $100.0 million of the Hayfin Closing Date Loan to terminate and pay in full all of the outstanding obligations under the Company’s previously existing credit facility (the “Perceptive Credit Facility”) with Perceptive Credit Holdings II, LP (“Perceptive”). The Company also used $2.0 million of the Hayfin Closing Date Loan proceeds to pay a redemption premium to Perceptive and used approximately $1.0 million of the Hayfin Closing Date Loan proceeds to pay certain fees and expenses incurred in connection with this transaction. In addition, a $1.8 million upfront fee payable to Hayfin was paid “in kind” and was added to the outstanding principal balance in accordance with the terms of the Hayfin Credit Agreement. In connection with the retirement of the Perceptive Credit Facility and all of the obligations thereunder, the Company recorded a loss on extinguishment of debt in the amount of $6.7 million, consisting of the write-off of unamortized discount related to the Perceptive indebtedness and the redemption premium paid to Perceptive. Borrowings under the Hayfin Credit Agreement bear interest, at the Company’s election, at either (a) a base rate (equal to the highest of (i) the rate of interest per annum last quoted by The Wall Street Journal as the “Prime Rate” in the United States, (ii) the federal funds rate in effect on such day plus 0.50% and (iii) adjusted Term Secured Overnight Financing Rate (“SOFR”) for a one-month tenor in effect on such day plus 1.00%), plus an applicable margin of 8.5%, or (b) adjusted Term SOFR for either a one-month or three-month On the Hayfin Maturity Date, the Company will pay Hayfin the entire outstanding principal amount underlying the Hayfin Loans and any accrued and unpaid interest thereon, as well as an exit fee of 1.0% of the outstanding principal amount being paid. This exit fee is recorded separately as a non-current liability on the accompanying consolidated balance sheet as of December 31, 2022. Prior to the Hayfin Maturity Date, there are no scheduled principal payments on the Hayfin Loans. The Company may prepay outstanding principal on the Hayfin Loans at any time and from time to time upon five business days’ prior written notice, subject to the payment to Hayfin of, (A) any accrued but unpaid interest on the prepaid principal amount plus (B) an early prepayment fee in the amount equal to (i) 7.0% of the prepaid principal amount, if prepaid on or prior to the first anniversary of the Hayfin Closing Date, (ii) 3.0% of the prepaid principal amount, if prepaid after the first anniversary of the Hayfin Closing Date and on or prior to the second anniversary of the Hayfin Closing Date, or (iii) 1.0% of the prepaid principal amount, if prepaid after the second anniversary of the Hayfin Closing Date and on or prior to the third anniversary of the Hayfin Closing Date. In addition, for any prepayments of principal or payment of principal on the Hayfin Maturity Date, the Company is also required to pay the exit fee. All of the Company’s obligations under the Hayfin Hayfin Hayfin Hayfin Hayfin Hayfin Hayfin As consideration for the Hayfin Credit Agreement, the Company issued to various entities affiliated with Hayfin, on the Hayfin Closing Date, warrants to purchase an aggregate of 9,103,047 shares of the Company’s common stock (the “Hayfin Warrants”). The Hayfin Warrants have an exercise price equal to $1.6478 per share, which is equal to the trailing 30-day Volume Weighted-average Price of the Company’s common stock on the business day immediately prior to the Hayfin Closing Date. The Hayfin Warrants were valued by the Company at approximately $9.6 million as of the Hayfin Closing Date and have an expiration date of March 23, 2029. As a result of the upfront fee and exit fee paid or payable to Hayfin, the expenses incurred by the Company in connection with this transaction and the value of the Hayfin Warrants, the Company recognized an aggregate discount on the Hayfin Loans in the amount of $13.9 million. The Company records debt discount as a reduction to the face amount of the debt, and the debt discount is amortized as interest expense over the life of the debt using the interest method. Based on the fair value of the Hayfin Warrants and the aggregate amount of fees and expenses associated with obtaining the Hayfin Credit Facility, the effective interest rate on the Hayfin Loans as of the Hayfin Closing Date and as of December 31, 2022 was approximately 13.0% and 16.1%, respectively. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2022 | |
STOCKHOLDERS' EQUITY [Abstract] | |
STOCKHOLDERS' EQUITY | 8. STOCKHOLDERS ’ EQUITY Preferred Stock The Company is currently authorized to issue up to 10 million shares of preferred stock, $0.0001 par value per share. There were no shares of preferred stock outstanding at December 31, 2022 and 2021. Common Stock As of December 31, 2022 and 2021, the Company was authorized to issue 300,000,000 shares of its common stock, $0.0001 par value per share, and 221,816,930 and 195,813,817 shares of common stock were outstanding as of December 31, 2022 and 2021, respectively. On May 27, 2021, the Company amended its Second Amended and Restated Certificate of Incorporation to increase the number of shares of common stock that the Company is authorized to issue from 150,000,000 to 300,000,000. After giving effect to shares reserved for the issuance of warrants and for awards issued under the Company’s equity incentive plans, 29,177,763 shares of common stock were available for issuance as of December 31, 2022. On December 9, 2022, the Company completed an underwritten public offering whereby the Company issued 24,125,873 shares of its common stock. Net proceeds after underwriting discounts and expenses associated with the offering were approximately $64.6 million and are being used to accelerate commercialization and production activities, complete plasma center buildouts and obtain FDA approvals, to conclude post‑FDA marketing approval research and development projects, and for working capital, capital expenditures and general corporate purposes. During the year ended December 31, 2022, outstanding stock options aggregating to 68,679 shares of common stock were exercised, and the Company received net proceeds from the exercises of approximately $0.2 million. On October 25, 2021, the Company completed an underwritten public offering whereby the Company issued 57.5 million shares of common stock and received gross proceeds of $57.5 million. Net proceeds after underwriting discounts and expenses associated with the offering were approximately $53.8 million, and were used to advance the commercial sales of the Company’s FDA approved products through the procurement of raw materials for the manufacturing of BIVIGAM and ASCENIV, to expand the Company’s plasma collection facility network, to scale up the manufacturing capacity of the Boca Facility and make continuous improvements in order to adhere to cGMP compliance, to explore business development opportunities and for general corporate purposes and other capital expenditures. On September 3, 2021, the Company entered into a distribution agreement with Raymond James & Associates, Inc., as agent (“Agent”), pursuant to which the Company may offer and sell, from time to time, at its option, through or to the Agent, up to an aggregate of $50 million of shares of the Company’s common stock (the “Distribution Agreement”). The Company currently intends to use any net proceeds from the sale of its common stock under the Distribution Agreement for general corporate purposes, including procurement of source plasma and other raw materials, supply chain initiatives and production expenditures, funding expansion of plasma centers, working capital, capital expenditures, expansion and resources for commercialization activities, and other potential research and development and business opportunities. T he Company currently has approximately $42.8 million of shares available to sell under the Distribution Agreement. There were no sales under the Distribution Agreement during the year ended December 31, 2022 On August 5, 2020, the Company entered into an open market sale agreement (as amended from time to time, the “Sale Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which the Company could offer and sell, from time to time, at its option, through or to Jefferies, up to an aggregate of $50 million of shares of the Company’s common stock. On November 5, 2020 and February 3, 2021, the Company and Jefferies amended the Sale Agreement to provide for increases in the aggregate offering amount under the Sale Agreement such that the Company could sell shares having an aggregate offering price of up to $105.4 million under the Sale Agreement, as amended. The Sale Agreement was terminated on August 31, 2021. Warrants On March 23, 2022, the Company issued the Hayfin Warrants, whereby affiliates of Hayfin may purchase an aggregate of 9,103,047 shares of common stock at an exercise price $1.6478 per share (see Note 7). The Hayfin Warrants was valued at $9.6 million, using the Black-Scholes option pricing model assuming an expected term of 7 years, a volatility of 68.1%, a dividend yield of 0% and a risk-free interest rate of 2.36%. During the year ended December 31, 2022, warrants to purchase 31,750 shares of common stock that had been issued to a former noteholder of the Company expired. At December 31, 2022 and 2021, the Company had outstanding warrants to purchase an aggregate of 13,525,148 and 4,528,160 shares, respectively, of common stock, with a weighted average exercise price of $1.99 and $2.82 per share, respectively, and expiration dates ranging between May 2023 and December 2030. Equity Incentive Plans From time to time the Company granted stock options or other equity-based awards under the Company’s Amended and Restated 2014 Omnibus Incentive Compensation Plan (the “2014 Plan”). The 2014 Plan, as amended, was approved by the Company’s Board of Directors (the “Board”) During the years ended December 31, 2022 and 2021, the Company granted options to purchase an aggregate of 1,194,032 and 1,895,550 shares of common stock, respectively, to its directors and employees under the 2014 Plan. The fair value of stock options granted was determined on the date of grant using the Black-Scholes model. The Black-Scholes option pricing model was developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable. The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the underlying Black-Scholes assumptions can materially affect the fair value estimate. To determine the risk-free interest rate, the Company utilized the U.S. Treasury yield curve in effect at the time of the grant with a term consistent with the term of the awards granted by the Company. The expected term of the options granted is in accordance with Staff Accounting Bulletins 107 and 110, which is based on the average between vesting terms and contractual terms. The expected dividend yield reflects the Company’s current and expected future policy for dividends on the Company’s common stock. For the years ended December 31, 2022 and 2021, the expected stock price volatility for the Company’s stock options was calculated by examining the historical volatility of the Company’s common stock since the stock became publicly traded in the fourth quarter of 2013. The grant date fair values of stock options awarded during the years ended December 31, 2022 and 2021 were determined using the Black-Scholes option pricing model with the following assumptions: Years Ended December 31, 2022 December 31, 2021 Expected term 5.5-6.3 years 5.5-6.3 years Volatility 68 % 68-70 % Dividend yield 0.0 0.0 Risk-free interest rate 1.72-1.73 % 0.80-1.27 % On June 21, 2022, the Company’s stockholders approved the ADMA Biologics, Inc. 2022 Compensation Plan (the “2022 Equity Plan”). Approval of the 2022 Equity Plan resulted in approximately 18 million additional shares of the Company’s common stock being reserved for future awards. The 2022 Equity Plan provides for the Board or a Committee of the Board (the “Committee”) to grant awards to optionees and to determine the exercise price, vesting term, expiration date and all other terms and conditions of the awards, including acceleration of the vesting of an award at any time. Any options granted under the 2022 Equity Plan are intended to be Incentive Stock Options (“ISOs”), unless specified by the Committee to be Non-Qualified Options (“NQOs”) as defined by the Internal Revenue Code. ISOs and NQOs may be granted to employees, consultants or Board members at an option price not less than the fair market value of the common stock subject to the stock option agreement. The following table summarizes information about stock options outstanding as of December 31, 2022 and 2021: Shares Weighted Average Exercise Price Options outstanding, vested and expected to vest at December 31, 2020 6,922,931 $ 4.40 Forfeited (529,202 ) $ 2.89 Expired (426,557 ) $ 4.91 Granted 1,895,550 $ 2.14 Exercised - $ - Options outstanding, vested and expected to vest at December 31, 2021 7,862,722 $ 3.93 Forfeited (31,540 ) $ 2.37 Expired (700,324 ) $ 6.86 Granted 1,194,032 $ 1.67 Exercised (68,679 ) $ 2.55 Options outstanding, vested and expected to vest at December 31, 2022 8,256,211 $ 3.37 Options exercisable 6,213,959 $ 3.80 As of December 31, 2022, the Company had $2.3 million of unrecognized compensation expense related to stock options granted under the Company’s equity incentive plans, which is expected to be recognized over a weighted-average period of 2.2 years. The weighted average remaining contractual term of stock options outstanding and expected to vest at December 31, 2022 is 6.1 years. The weighted average remaining contractual term of stock options exercisable at December 31, 2022 is 5.3 years. The following table summarizes additional information regarding outstanding and exercisable options under the stock option plans at December 31, 2022: Stock Options Outstanding Stock Options Exercisable Range of Exercise Prices Options Outstanding Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Aggregate Intrinsic Value Options Outstanding Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Aggregate Intrinsic Value $1.10 - $1.67 1,523,824 9.1 $ 1.61 $ 3,452,237 406,160 9.0 $ 1.52 $ 959,663 $1.73 - $2.60 1,623,353 8.0 $ 2.35 2,491,181 943,200 8.0 $ 2.36 1,430,931 $2.62 - $3.93 4,083,311 5.0 $ 3.46 1,696,824 3,852,447 4.8 $ 3.49 1,495,461 $3.98 - $5.97 470,428 4.7 $ 5.03 - 456,857 4.6 $ 5.06 - $6.02 - $9.03 307,795 1.5 $ 8.05 - 307,795 1.5 $ 8.05 - $9.37 - $10.80 247,500 1.9 $ 10.28 - 247,500 1.9 $ 10.28 - 8,256,211 6.1 $ 3.37 $ 7,640,242 6,213,959 5.3 $ 3.80 $ 3,886,055 During the years ended December 31, 2022 and 2021, the Company granted Restricted Stock Units (“RSUs”) representing an aggregate of 1,174,266 and 4,384,744 shares, respectively, to certain management employees of the Company and during 2022, to members of the Board. Except for the RSUs granted under the Company’s retention incentive program discussed below, the RSUs generally vest annually over a period of four years for employees and semi-annually over a period of one year for directors. The RSUs granted during the year ended December 31, 2021 include 3,832,500 shares granted under a retention incentive program implemented by the Company for its executive management and certain employees (see Note 10), whereby the Company issued an aggregate of 2,685,000 time-based RSUs and 1,147,500 milestone-based RSUs. Fifty percent of the time-based RSUs granted under the retention incentive program vested on December 31, 2022, with the remainder vesting in quarterly installments through December 31, 2024. The milestone-based RSUs vested upon achievement of the applicable milestone, and all of the milestone-based RSUs vested during the year ended December 31, 2022. The milestones required to be achieved in order for the milestone-based RSUs to vest were determined by the Board and were consistent with the 2022 operating plan approved by the Board During the years ended December 31, 2022 and 2021, 2,727,412 and 92,750 shares, respectively, vested in connection with grants of RSUs. With respect to the RSUs vested during the year ended December 31, 2022,918,851 shares valued at approximately $2.9 million were withheld by the Company to cover employees’ tax liabilities . For the RSUs vested during the year ended December 31, 2021 These shares have been retired by the Company or were otherwise no longer outstanding as of December 31, 2022 A summary of the Company’s unvested RSU activity and related information is as follows: Shares Weighted Average Grant Date Fair Value Balance at December 31, 2020 326,000 $ 2.81 Granted 4,384,744 $ 1.30 Vested (92,750 ) $ 2.82 Forfeited (132,861 ) $ 2.51 Balance at December 31, 2021 4,485,133 $ 1.34 Granted 1,174,266 $ 1.74 Vested (2,727,412 ) $ 1.25 Forfeited (65,000 ) $ 1.40 Balance at December 31, 2022 2,866,987 $ 1.59 As of December 31, 2022, the Company had $3.8 million of unrecognized compensation expense related to unvested RSUs granted under the Company’s equity incentive plans, which is expected to be recognized over a weighted-average period of 2.4 years. Total stock-based compensation expense for all awards granted under the Company’s equity incentive plans for the years ended December 31, 2022 and 2021 was as follows: 2022 2021 Research and development $ 19,476 $ 153,924 Plasma center operating expenses 81,668 60,257 Selling, general and administrative 4,716,219 2,958,008 Cost of product revenue 397,168 316,064 Total stock-based compensation expense $ 5,214,531 $ 3,488,253 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2022 | |
RELATED PARTY TRANSACTIONS [Abstract] | |
RELATED PARTY TRANSACTIONS | 9. RELATED PARTY TRANSACTIONS The Company leases an office building and equipment from Areth, LLC (“Areth”) pursuant to an agreement for services effective as of January 1, 2016, as amended from time to time , and pays October 18, 2022 Company amended the agreement to extend its term to December 31, 2026, with automatic successive one-year renewals thereafter. Either party may terminate the agreement by providing the other party with ’s prior written notice During the years ended December 31, 2022 and 2021, the Company purchased certain specialized medical equipment and services related to the Company’s plasma collection centers, as well as personal protective equipment, from GenesisBPS and its affiliates (“Genesis”) in the amount of $0.2 million. Genesis is owned by Dr. Grossman and Adam Grossman. See Note 7 for a discussion of the Company’s prior credit facility and related transactions with Perceptive, a holder of more than 5% of the Company’s common stock. During the year ended December 31, 2021, in connection with the resignation of Dr. James Mond, the Company’s former Chief Scientific and Medical Officer, the Company recognized an expense and corresponding liability in the amount of $0.8 million for payments to be made under a separation and transition agreement with Dr. Mond. These payments were made in scheduled installments over a period of 10 months. In connection with the 2022 public offering of the Company’s common stock (see Note 8) on December 9, 2022: (i) Mr. Grossman purchased 14,983 shares of common stock directly and 14,982 shares of common stock indirectly through an entity he controls, and (ii) Brian Lenz, the Company’s Executive Vice President and Chief Financial Officer, purchased 6,993 shares of common stock, all at the public offering price of $2.86 per share. In connection with the 2021 public offering of the Company’s common stock (see Note 8) on October 25, 2021: (i) Mr. Grossman purchased 100,000 shares of common stock directly and 250,000 shares of common stock Dr. Young Kwon, a member of the Board, Brian Lenz, the Company’s Executive Vice President and Chief Financial Officer, |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2022 | |
COMMITMENTS AND CONTINGENCIES [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 10. COMMITMENTS AND CONTINGENCIES General Legal Matters From time to time the Company is or may become subject to certain legal proceedings and claims arising in connection with the normal course of its business. Management does not expect that the outcome of any such claims or actions will have a material effect on the Company’s liquidity, results of operations or financial condition. COVID-19 Pandemic The Company continues to monitor the ongoing developments related to the COVID-19 pandemic, including the emergence of the Delta, Omicron and BA.2 variants and other resistant strains of the coronavirus, and its impacts to the Company’s commercial and manufacturing operations and plasma collection facilities, including collections of source plasma, procurement of raw materials and packaging materials, a portion of which are sourced internationally, and the testing of finished drug product that is required prior to its availability for commercial sale. A substantial portion of such testing has historically been performed by contract laboratories outside the United States. Due to a combination of previously mandated state and local “shelter-in-place” orders, as well as government stimulus packages, persisting social distancing measures and varying roll-outs of vaccinations by state, the Company experienced lower than normal donor collections at its FDA approved plasma collection centers during 2021. The Company was also subject to delays in shipments of source plasma from its contracted third-party suppliers, as well as delays in deliveries for personal protective equipment, reagents and other non-plasma raw materials and supplies used in the manufacture and distribution of its products. In addition, the Company is subject to supply chain delays as a result of certain of its suppliers diverting significant resources towards the rapid development and distribution of COVID-19 vaccines and, as a result, the Company has elected to carry more raw materials inventory than it has in the past. The COVID-19 pandemic previously impacted, to a certain degree, the Company’s customer engagement initiatives, whereby ADMA’s sales and medical affairs field personnel faced difficulties communicating directly with physicians and other healthcare professionals, as well as the cancellation or postponement of a number of key scientific and medical meetings, further limiting the Company’s ability to communicate with potential customers. The pandemic could also impact the Company’s ability to interact with the FDA or other regulatory authorities and may result in delays in the conduct of inspections or review of pending applications or submissions. Although the Company received FDA approvals for four of its plasma collection centers during the year ended December 31, 2022 and received several FDA approvals and two FDA inspections of the Boca Facility were completed during the year ended December 31, 2021, no assurances can be provided as to the timing for completion of any future regulatory submissions or applications that may be impacted by restrictions related to COVID-19. During the years ended December 31, 2022 and 2021, revenue attributable to international customers was approximately 5% and 13%, respectively, of the Company’s total revenues. As the Company seeks to grow this aspect of its business, it may also be subject to the impacts of the COVID-19 pandemic in locations outside the United States. Notwithstanding the foregoing, the COVID-19 pandemic to date has not had a material impact on the Company’s financial condition or results of operations, and the Company does not believe that its production operations at the Boca Facility, the Company’s contract fill/finishers or its plasma collection facilities have been significantly impacted by the COVID-19 pandemic. As a result, the Company does not anticipate and has not experienced any material impairments with respect to any of its long-lived assets, including the Company’s property and equipment, goodwill or intangible assets. Although the COVID-19 pandemic has not, to date, materially adversely impacted the Company’s capital and financial resources, because the Company is unable to determine the ultimate severity or duration of the COVID-19 pandemic or other pandemics or their long-term effects on, among other things, the global, national or local economies, the capital and credit markets or the Company’s workforce, customers or our suppliers, at this time the Company is unable to predict whether COVID-19 or other pandemics will have a material adverse impact on the Company’s business, financial condition, liquidity or results of operations. Vendor Commitments Pursuant to the terms of a plasma purchase agreement with BPC dated as of November 17, 2011 (the “2011 Plasma Purchase Agreement”), the Company agreed to purchase from BPC an annual minimum volume of source plasma containing antibodies to RSV to be used in the manufacture of ASCENIV. The Company must purchase a to-be-determined and agreed upon annual minimum volume from BPC, but may also collect high-titer RSV plasma from up to five wholly-owned ADMA plasma collection facilities. During 2015, the Company and BPC amended the 2011 Plasma Purchase Agreement to allow the Company the ability to collect its raw material RSV high-titer plasma from other third-party collection organizations, thus allowing the Company to expand its reach for raw material supply as it executes its commercialization plans for ASCENIV. As part of the closing of the Biotest Transaction, the parties amended the 2011 Plasma Purchase Agreement to extend the initial term through the ten-year anniversary of the closing date of the Biotest Transaction. Unless terminated earlier, the 2011 Plasma Purchase Agreement expires in June 2027, after which it may be renewed for two additional five-year periods if agreed to by the parties. On December 10, 2018, BPC assigned its rights and obligations under the 2011 Plasma Purchase Agreement to Grifols Worldwide Operations Limited (“Grifols”) as its successor-in-interest, effective January 1, 2019. On January 1, 2019, Grifols and the Company entered into an additional amendment to the 2011 Plasma Purchase Agreement for the purchase of source plasma containing antibodies to RSV from Grifols. Pursuant to this amendment, until January 1, 2022, the Company could purchase RSV plasma from Grifols from the two plasma collection centers that were transferred to BPC on January 1, 2019 at a price equal to cost plus five percent (5%) (without any additional increase due to inflation). Effective January 1, 2022, RSV plasma purchased from these two plasma collection centers are subject to the pricing terms in effect for RSV plasma purchased from other plasma collection centers owned by Grifols. On June 6, 2017, the Company and BPC entered into a Plasma Supply Agreement pursuant to which BPC supplies, on an exclusive basis subject to certain exceptions, to ADMA BioManufacturing an annual minimum volume of hyperimmune plasma that contain antibodies to the Hepatitis B virus for the manufacture of Nabi-HB. The Plasma Supply Agreement has a 10-year term. On July 19, 2018, the Company and BPC entered into an amendment to the Plasma Supply Agreement to provide, among other things, that in the event BPC elects not to supply in excess of ADMA BioManufacturing’s specified amount of Hepatitis B plasma and ADMA BioManufacturing is unable to secure Hepatitis B plasma from a third party at a price that is within a low double- digit percentage of the price that ADMA BioManufacturing pays to BPC, then BPC shall reimburse ADMA BioManufacturing for the difference in price ADMA BioManufacturing incurs. On December 10, 2018, BPC assigned its rights and obligations under the Plasma Supply Agreement to Grifols, effective January 1, 2019. On June 6, 2017, the Company and BPC entered into a Plasma Purchase Agreement (the “2017 Plasma Purchase Agreement”), pursuant to which ADMA BioManufacturing purchases normal source plasma (“NSP”) from BPC at agreed upon annual quantities and prices. The 2017 Plasma Purchase Agreement has an initial term of five years after which the 2017 Plasma Purchase Agreement may be renewed for additional two terms of two years each upon the mutual written consent of the parties. On July 19, 2018, the Company and BPC entered into an amendment to the 2017 Plasma Purchase Agreement to, among other things, provide agreed upon amounts of normal source plasma to be supplied by BPC to ADMA BioManufacturing in calendar year 2019 at a specified price per liter, provided that ADMA BioManufacturing delivers a valid purchase order to BPC. Additionally, pursuant to the amendment to the 2017 Plasma Purchase Agreement, BPC agreed that, for calendar years 2020 and 2021, it shall supply no less than a high double-digit percentage of ADMA BioManufacturing’s requested NSP amounts, provided that such requested NSP amounts are within an agreed range, at a price per liter to be mutually determined. Furthermore, pursuant to the amendment to the 2017 Plasma Purchase Agreement, in the event BPC fails to supply ADMA BioManufacturing with at least a high double-digit percentage of ADMA BioManufacturing’s requested NSP amounts, BPC shall promptly reimburse ADMA BioManufacturing the difference in price ADMA BioManufacturing incurs due to BPC’s election not to supply NSP to ADMA BioManufacturing in such amounts as requested. On December 10, 2018, BPC assigned its rights and obligations under the Plasma Purchase Agreement to Grifols, effective January 1, 2019. Effective as of May 12, 2021, the Company and Grifols amended the foregoing 2017 Plasma Purchase Agreement whereby, among other things, the term of the agreement was extended through December 31, 2022, while certain historical provisions were deleted. The 2017 Plasma Purchase Agreement expired on December 31, 2022 and was not renewed. In order to maintain a reliable supply of raw material plasma thereafter, the Company has executed additional agreements with multiple third-party suppliers of NSP. The Company has also increased its number of planned plasma collection center buildouts such that the Company expects to have ten FDA-approved plasma collection centers in operation by the end of 2023, while also continuing to increase its plasma collection capabilities at its ADMA BioCenters plasma collection centers business segment. Post-Marketing Commitments In connection with the FDA approval of the BLA for BIVIGAM on December 19, 2012, Biotest committed to perform two additional post-marketing studies, a pediatric study to evaluate the efficacy and safety of BIVIGAM in children and adolescents, and a post-authorization safety study to further assess the potential risk of hypotension and hepatic and renal impairment in BIVIGAM-treated patients with primary humoral immunodeficiency. The Pediatric study for BIVIGAM has been completed, and the safety study is still pending completion. ADMA has assumed the remaining obligations, and the costs of the studies will be expensed as incurred as research and development expenses. For the years ended December 31, 2022 and 2021, the Company incurred expenses related to these studies of $2.2 million and $1.7 million, respectively. The Company currently expects to incur expenses of approximately $2.0 million to complete these studies, with both studies anticipated to be completed by June of 2023. In connection with the FDA approval of ASCENIV on April 1, 2019, the Company is required to perform a pediatric study to evaluate the safety and efficacy of ASCENIV in children and adolescents. For the years ended December 31, 2022 and 2021, the Company incurred expenses related to this study in the amount of $0.5 million and $0.6 million, respectively. The Company expects to incur expenses of approximately $1.5 million to complete this study, which is required to be completed by June of 2023. Employment Contracts The Company has entered into employment agreements with Mr. Grossman and Mr. Lenz. Other Commitments On September 28, 2021, following the approval of the Board upon recommendation of the Compensation Committee of the Board, and in consultation with an independent compensation consultant, the Company implemented a retention incentive program, consisting of cash payments and awards of RSUs (see Note 8), to the Company’s management, including Mr. Grossman and Mr. Lenz, and to certain other employees. The purpose of the retention program was to promote and ensure business continuity and provide an incentive to the Company’s executive management and certain other employees considering the operational challenges presented by the ongoing COVID -19 pandemic and the competitive work environment in which the Company operates as an FDA regulated manufacturer of specialized biologic therapies. The retention awards were granted considering the nationwide labor shortages and the increased employee turnover rates that the Company, its pharmaceutical peers and other companies outside of the Company’s industry have reported experiencing. The cash portion of the retention program consisted of two tranches. The first tranche was paid to employees on September 30, 2021 in the amount of $1.3 million, and the second tranche aggregating to approximately $1.3 million was paid on June 15, 2022. Based on the terms of the retention agreements the Company entered into with each applicable executive and employee, approximately $0.8 million of each tranche was recognized over the retention service period, which began on October 1, 2021 and ended on December 31, 2022, with the remainder having been recognized as expense when paid. In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service providers. Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities. The Company’s maximum exposure under these arrangements is unknown as of December 31, 2022. The Company does not anticipate recognizing any significant losses relating to these arrangements. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2022 | |
INCOME TAXES [Abstract] | |
INCOME TAXES | 11. INCOME TAXES A reconciliation of income taxes at the U.S. federal statutory rate to the benefit for income taxes is as follows: Year Ended December 31, 2022 2021 Benefit at U.S. federal statutory rate $ (13,839,830 ) $ (15,045,999 ) State taxes - deferred (1,773,349 ) (251,839 ) Increase in valuation allowance 15,117,100 14,618,762 Research and development credits (211,343 ) (239,585 ) Decrease in federal net operating loss - 623,679 162(m) disallowance 862,027 63,515 Other (154,605 ) 231,467 Benefit for income taxes $ - $ - A summary of the Company’s deferred tax assets is as follows: Year Ended December 31, 2022 2021 Federal and state net operating loss carryforwards $ 81,526,316 $ 73,036,983 Federal and state research credits 407,280 31,333 Interest expense limitation carryforwards 12,194,369 6,013,040 Transaction costs 881,782 977,046 Deferred revenue 479,510 519,819 Accrued expenses and other 1,236,128 1,030,064 Total gross deferred tax assets 96,725,385 81,608,285 Less: valuation allowance for deferred tax assets (96,725,385 ) (81,608,285 ) Net deferred tax assets $ - $ - As of December 31, 2022, the Company had federal and state (post-apportioned basis) net operating losses (“NOLs”) of $334.5 million and $211.7 million, respectively, as well as federal research and development tax credit carryforwards of approximately $0.4 million. Approximately $55.2 million and $91.8 million of the foregoing federal and state NOLs, respectively, will expire at various dates from 2027 2042 As of December 31, 2021, the Company performed an analysis of limitations imposed by Section 382 and as a result the Company wrote off the deferred tax assets related to $3.0 million of federal NOLs, $1.0 million of federal research and development tax credits and $28.1 million of state NOLs which were limited by historical ownership changes. As a result, there was a $3.9 million reduction to the Company’s net deferred tax assets, which was offset by a corresponding $3.9 million reduction in the Company’s valuation allowance, resulting in no net impact to the Company’s provision for income taxes for the year ended December 31, 2021. A valuation allowance, if needed, reduces deferred tax assets to the amount expected to be realized. When determining the amount of net deferred tax assets that are more likely than not to be realized, the Company assesses all available positive and negative evidence. This evidence includes, but is not limited to, prior earnings history, expected future earnings, carry-back and carry-forward periods and the feasibility of ongoing tax strategies that could potentially enhance the likelihood of the realization of a deferred tax asset. The weight given to the positive and negative evidence is commensurate with the extent the evidence may be objectively verified. As such, it is generally difficult for positive evidence regarding projected future taxable income, exclusive of reversing taxable temporary differences, to outweigh objective negative evidence of recent financial reporting losses. Based on these criteria and the relative weighting of both the positive and negative evidence available, management continues to maintain a full valuation allowance against its net deferred tax assets. In accordance with U.S. GAAP, the Company is required to determine whether a tax position of the Company is more likely than not to be sustained upon examination by the applicable taxing authority, including resolution of any related appeals or litigation processes, based on the technical merits of the position. The tax benefit to be recognized is measured as the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. Derecognition of a tax benefit previously recognized could result in the Company recording a tax liability that would reduce net assets. The amount of the liability for which an exposure exists is measured as the largest amount of benefit determined on a cumulative probability basis that the Company believes is more likely than not to be realized upon ultimate settlement of the position. Components of the liability are classified as either a current or a long-term liability in the accompanying consolidated balance sheets based on when the Company expects each of the items to be settled. The Company does not have any unrecognized tax benefits as of December 31, 2022 and 2021 and does not anticipate a significant change in unrecognized tax benefits during the next 12 months. |
LEASE OBLIGATIONS
LEASE OBLIGATIONS | 12 Months Ended |
Dec. 31, 2022 | |
LEASE OBLIGATIONS [Abstract] | |
LEASE OBLIGATIONS | 12. LEASE OBLIGATIONS The Company leases certain properties and equipment for its ADMA BioCenters and ADMA BioManufacturing subsidiaries, which leases provide the right to use the underlying assets and require lease payments through the respective lease terms which expire at various dates through 2033. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. The Company determines if an arrangement is an operating lease at inception. Leases with an initial term of 12 months or less are not recorded on the balance sheet. All other leases are recorded on the balance sheet with assets representing the right to use the underlying asset for the lease term and lease liabilities representing the obligation to make lease payments arising from the lease. Right-to-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term and include options to extend or terminate the lease when they are reasonably certain to be exercised. The present value of the lease payments is determined using the Company’s incremental borrowing rate as of the lease commencement date. For the lease liabilities recognized during the years ended December 31, 2022 and 2021, the Company used discount rates of 13% to 14% to determine the present value of its lease obligations. The Company’s operating lease expense is recognized on a straight-line basis over the lease term and is reflected in Plasma center operating expenses and Selling, general and administrative expenses in the accompanying consolidated statements of operations. Aggregate lease expense for the Company’s operating leases for the years ended December 31, 2022 and 2021 was $2.1 million and $1.4 million, respectively. Aggregate cash paid on these leases for the years ended December 31, 2022 and 2021 was $1.8 million and $1.4 million, respectively. During the year ended December 31, 2022, the Company recognized additional right-to-use assets and corresponding lease liabilities aggregating to approximately $4.0 million in connection with two new property leases where the Company has opened additional plasma collection facilities, a property lease for the storage of raw materials inventory and a property lease for the building that the Company utilizes as its corporate headquarters (see Note 9). During the year ended December 31, 2021, the Company recognized additional right-to-use assets and corresponding lease liabilities of $3.6 million in connection with four new property leases where the Company has opened additional plasma collection facilities. Including a finance lease the Company entered into in June 2018, the Company has aggregate lease liabilities of $11.6 million and $8.1 million as of December 31, 2022 and 2021, respectively, which are comprised primarily of the leases for the Company’s plasma collection centers. The Company’s operating leases have a weighted average remaining term of 8.4 years. Scheduled payments under the Company’s lease obligations are as follows: Year ended December 31, 2023 $ 2,367,057 2024 2,343,314 2025 2,366,432 2026 2,116,036 2027 2,040,690 Thereafter 8,238,571 Total payments 19,472,100 Less: imputed interest (7,862,555 ) Current portion (905,369 ) Balance at December 31, 2022 $ 10,704,176 One of the Company’s operating leases, pertaining to the administrative offices for its Plasma Collection Centers business segment, is scheduled to expire in November of 2023. The current monthly payment for this lease is approximately $10,000. The Company intends to renew the lease for an additional five years in accordance with the terms of the lease, however no renewal agreement has been finalized. |
SEGMENTS
SEGMENTS | 12 Months Ended |
Dec. 31, 2022 | |
SEGMENTS [Abstract] | |
SEGMENTS | 13. SEGMENTS The Company is engaged in manufacturing, marketing and developing specialty plasma-derived biologics. The Company’s ADMA BioManufacturing segment reflects the Company’s immune globulin manufacturing and development operations in Florida, acquired on June 6, 2017. The Plasma Collection Centers segment consists of ten plasma collection facilities as of December 31, 2022, nine of which were operational and collecting plasma, and seven of which hold an approved license with the FDA (and of which three facilities have received approvals from the Korean Ministry of Food and Drug Safety as well as FDA approval to implement a Hepatitis B immunization program). The Corporate segment includes general and administrative overhead expenses. The Company defines its segments as those business units whose operating results are regularly reviewed by the chief operating decision maker (“CODM”) to analyze performance and allocate resources. The Company’s CODM is its President and Chief Executive Officer. Summarized financial information concerning reportable segments is shown in the following tables: Year Ended December 31, 2022 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 144,069,543 $ 9,867,315 $ 142,834 $ 154,079,692 Cost of product revenue 108,881,938 9,932,597 - 118,814,535 Income (loss) from operations 879,387 (17,908,378 ) (22,336,089 ) (39,365,080 ) Interest and other expense, net (504,787 ) (3,266 ) (19,360,876 ) (19,868,929 ) Loss on extinguishment of debt - - (6,669,941 ) (6,669,941 ) Net income (loss) 374,600 (17,911,644 ) (48,366,906 ) (65,903,950 ) Capital expenditures 5,246,860 8,664,311 - 13,911,171 Depreciation and amortization expense 4,708,879 2,403,572 918 7,113,369 Total assets 238,159,534 37,070,535 73,231,812 348,461,881 Year Ended December 31, 2021 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 74,935,528 $ 5,864,263 $ 142,834 $ 80,942,625 Cost of product revenue 74,124,999 5,644,342 - 79,769,341 Loss from operations (29,293,309 ) (12,056,364 ) (17,024,068 ) (58,373,741 ) Interest and other expense, net (218,053 ) (5,660 ) (13,050,164 ) (13,273,877 ) Net loss (29,511,362 ) (12,062,024 ) (30,074,232 ) (71,647,618 ) Capital expenditures 4,876,983 8,634,275 - 13,511,258 Depreciation and amortization expense 4,217,771 1,272,397 5,334 5,495,502 Total assets 208,391,019 24,681,691 43,180,014 276,252,724 |
OTHER EMPLOYEE BENEFITS
OTHER EMPLOYEE BENEFITS | 12 Months Ended |
Dec. 31, 2022 | |
OTHER EMPLOYEE BENEFITS [Abstract] | |
OTHER EMPLOYEE BENEFITS | 14. OTHER EMPLOYEE BENEFITS The Company sponsors a 401(k) savings plan. Under the plan, employees may make contributions which are eligible for a Company discretionary percentage contribution as defined in the plan and determined by the Board of Directors. The Company recognized $1.3 million and $1.1 million of related compensation expense for the years ended December 31, 2022 and 2021, respectively. |
SUPPLEMENTAL DISCLOSURE OF CASH
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | 12 Months Ended |
Dec. 31, 2022 | |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION [Abstract] | |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | 15. SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION Supplemental cash flow information for the years ended December 31, 2022 and 2021 is as follows: 2022 2021 SUPPLEMENTAL CASH FLOW INFORMATION: Cash paid for interest $ 13,879,958 $ 11,159,461 Noncash Financing and Investing Activities: Equipment acquired reflected in accounts payable and accrued liabilities $ 1,494,916 $ 1,352,627 Right-to-use assets in exchange for lease obligations $ 4,048,099 $ 3,554,473 Warrants issued in connection with notes payable $ 9,569,604 $ - |
CONCENTRATIONS
CONCENTRATIONS | 12 Months Ended |
Dec. 31, 2022 | |
CONCENTRATIONS [Abstract] | |
CONCENTRATIONS | 16. CONCENTRATIONS Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash and cash equivalents and accounts receivable. At December 31, 2022, two customers accounted for approximately 92% of the Company’s consolidated accounts receivable. At December 31, 2021, three customers accounted for approximately 94% of the Company’s consolidated accounts receivable. For the year ended December 31, 2022, two customers accounted for approximately 74% of the Company’s consolidated revenues. For the year ended December 31, 2021, four customers accounted for approximately During the years ended December 31, 2022 and 2021, plasma purchases from Grifols totaled approximately $47.7 million and $42.0 million, respectively, or approximately Net revenues according to geographic area, based on the location of where the product is shipped, is as follows: Year Ended December 31, 2022 2021 United States $ 146,426,617 $ 70,625,848 International 7,653,075 10,316,777 Total revenues $ 154,079,692 $ 80,942,625 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2022 | |
SUBSEQUENT EVENTS [Abstract] | |
SUBSEQUENT EVENTS | 17. SUBSEQUENT EVENTS On March 22, 2023, the Company and Hayfin entered into an amendment to the Hayfin Credit Agreement whereby the lenders’ obligation to make the Hayfin Delayed Draw Loan (see Note 7) was extended to June 30, 2023. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Principles of Consolidation and Basis of Presentation | Principles of consolidation and basis of presentation The accompanying consolidated financial statements include the accounts of ADMA and its wholly-owned subsidiaries, and have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and in accordance with Article 8 of Regulation S-X of the Securities and Exchange Commission (the “SEC”). All intercompany balances have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (the “FASB”). During the years ended December 31, 2022 and 2021, comprehensive loss was equal to the net loss amounts presented for the respective periods in the accompanying consolidated statements of operations. |
Use of Estimates | Use of estimates The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include rebates and chargebacks deducted from gross revenues, the realizable value of accounts receivable, valuation of inventory, assumptions used in projecting future liquidity and capital requirements, assumptions used in the fair value of awards granted under the Company’s equity incentive plans and warrants issued in connection with the issuance of notes payable and the valuation allowance for the Company’s deferred tax assets. |
Cash and Cash Equivalents | Cash and cash equivalents The Company considers all highly liquid instruments purchased with a maturity of three months or less to be cash equivalents. The Company regularly maintains cash and cash equivalents at third-party financial institutions in excess of the Federal Deposit Insurance Corporation insurance limit. Although the Company monitors the daily cash balances in its operating accounts and adjusts the balances as appropriate, these balances could be impacted, and there could be a material adverse effect on the Company’s business, if one or more of the financial institutions with which the Company has deposits fails or is subject to other adverse conditions in the financial or credit markets. To date, the Company has not experienced a loss or lack of access to its deposited cash or cash equivalents; however, the Company cannot provide assurance that access to its cash and cash equivalents will not be impacted by adverse conditions in the financial and credit markets in the future. |
Accounts Receivable | Accounts receivable Accounts receivable is reported at realizable value, net of allowances for contractual credits and doubtful accounts in the amount of $0.1 million and $0.2 million at December 31, 2022 and 2021, respectively, which are recognized in the period the related revenue is recorded. The Company extends credit to its customers based upon an evaluation of each customer’s financial condition and credit history. Evaluations of the financial condition and associated credit risk of customers are performed on an ongoing basis. |
Inventories | Inventories Raw materials inventory consists of various materials purchased from suppliers, including normal source plasma, used in the production of the Company’s products. Work-in-process and finished goods inventories (see Note 3) reflect the cost of raw materials as well as costs for direct and indirect labor, primarily salaries, wages and benefits for applicable employees, as well as an allocation of overhead costs related to the Boca Facility including utilities, property taxes, general repairs and maintenance, consumable supplies and depreciation. The allocation of Boca Facility overhead to inventory is generally based upon the estimated square footage of the Boca Facility that is used in the production of the Company’s products relative to the total square footage of the facility. Inventories, including plasma intended for resale and plasma intended for internal use in the Company’s manufacturing, commercialization or research and development activities, are carried at the lower of cost or net realizable value determined by the first-in, first-out method. For both the Company’s immune globulin products and plasma intended for resale and internal use, net realizable value is generally determined based upon the consideration the Company expects to receive when the inventory is sold, less costs to deliver the inventory to the recipient. The estimates for net realizable value of inventory are based on contractual terms or upon historical experience and certain other assumptions, and the Company believes that such assumptions are reasonable. Inventory is periodically reviewed to ensure that its carrying value does not exceed its net realizable value, and adjustments are recorded to write down such inventory, with a corresponding charge to cost of product revenue, when the carrying value or historical cost exceeds its estimated net realizable value. In addition, costs associated with the production of conformance or engineering lots that would not qualify as immediately available for commercial sale are charged to cost of product revenue and not capitalized into inventory. |
Property and Equipment | Property and equipment Assets comprising property and equipment (see Note 4) are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the asset’s estimated useful life. Land is not depreciated. The buildings have been assigned a useful life of 30 years. Property and equipment other than land and buildings have useful lives ranging from 3 to 15 years. Leasehold improvements are amortized over the lesser of the lease term or their estimated useful lives. |
Goodwill | Goodwill Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill at December 31, 2022 and 2021 was $3.5 million, all of which is attributable to the Company’s ADMA BioManufacturing business segment. There were no changes to the carrying amount of goodwill during the years ended December 31, 2022 and 2021. Goodwill is not amortized but is assessed for impairment on an annual basis or more frequently if impairment indicators exist. The Company has the option to perform a qualitative assessment of goodwill to determine whether it is more likely than not that the fair value of its reporting unit is less than its carrying amount, including goodwill and other intangible assets. If the Company concludes that this is the case, then it must perform a goodwill impairment test by comparing the fair value of the reporting unit to its carrying value. An impairment charge is recorded to the extent the reporting unit’s carrying value exceeds its fair value, not to exceed the total amount of goodwill allocated to that reporting unit. The Company performs its annual goodwill impairment test as of October 1 of each year. The Company’s annual goodwill impairment tests as of October 1, 2022 and 2021 did not result in any impairment charges related to goodwill for the years ended December 31, 2022 and 2021. |
Impairment of Long-Lived Assets | Impairment of long-lived assets The Company assesses the recoverability of its long-lived assets, which include property and equipment and finite-lived intangible assets, whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s carrying value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the years ended December 31, 2022 and 2021, the Company determined that there was no impairment of its long-lived assets. |
Revenue Recognition | Revenue recognition Revenues for the years ended December 31, 2022 and 2021 are comprised of (i) revenues from the sale of the Company’s immunoglobulin products, BIVIGAM, ASCENIV and Nabi-HB, (ii) product revenues from the sale of human plasma collected by the Company’s Plasma Collection Centers business segment, (iii) contract manufacturing and laboratory services revenue, (iv) revenues from the sale of intermediate by-products; and (v) license and other revenues primarily attributable to the out-licensing of ASCENIV to Biotest in 2012 to market and sell this product in Europe and selected countries in North Africa and the Middle East. Biotest has provided the Company with certain services and financial payments in accordance with the related Biotest license agreement and is obligated to pay the Company certain amounts in the future if certain milestones are achieved. Deferred revenue is amortized into income over the term of the Biotest license, representing a period of approximately 22 years. Product revenue is recognized when the customer is deemed to have control over the product. Control is determined based on when the product is shipped or delivered and title passes to the customer. Revenue is recorded in an amount that reflects the consideration the Company expects to receive in exchange. Revenue from the sale of the Company’s immunoglobulin products is recognized when the product reaches the customer’s destination, and is recorded net of estimated rebates, price protection arrangements and customer incentives, including prompt pay discounts, wholesaler chargebacks and other wholesaler fees. These estimates are based on contractual arrangements, historical experience and certain other assumptions, and the Company believes that such estimates are reasonable. For revenues associated with contract manufacturing and the sale of intermediates, control transfers to the customer and the performance obligation is satisfied when the customer takes possession of the product from the Boca Facility or from a third-party warehouse that is utilized by the Company. Product revenues from the sale of human plasma collected at the Company’s plasma collection centers are recognized at the time control of the product has been transferred to the customer, which generally occurs at the time of shipment. Product revenues are recognized at the time of delivery if the Company retains control of the product during shipment. |
Cost of Product Revenue | Cost of product revenue Cost of product revenue includes costs associated with the manufacture of the Company’s FDA approved products and intermediates and for the collection of human source plasma, as well as expenses related to conformance batch production, process development and scientific and technical operations when these operations are attributable to marketed products. When the activities of these operations are attributable to new products in development, the expenses are classified as research and development expenses. |
Research and Development Expenses | Research and development expenses Research and development expenses consist of clinical research organization costs, costs related to clinical trials, post-marketing commitment studies for BIVIGAM and ASCENIV, wages, benefits and stock-based compensation for employees directly related to research and development activities. All research and development costs are expensed as incurred. |
Plasma Center Operating Expenses | Plasma center operating expenses Plasma center operating expenses consist of certain general and administrative plasma center costs, initial opening, marketing and start-up costs, rent expense, maintenance, utilities, compensation and benefits for center and administrative staff, advertising and promotion expenses and computer software fees related to donor collections. |
Advertising and Marketing Expenses | Advertising and marketing expenses Advertising and marketing expense includes cost for promotional materials and trade show expenses for the marketing of the Company’s products and services and expenses incurred for attracting donors to the Company’s plasma collection centers. All advertising and marketing expenses are expensed as incurred. Advertising and marketing expenses were $2.2 million and $1.4 million for the years ended December 31, 2022 and 2021, respectively. |
Stock-Based Compensation | Stock-based compensation The Company follows recognized accounting guidance which requires all equity-based payments, including grants of stock options, to be recognized in the statement of operations as compensation expense based on their fair values at the date of grant. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a straight-line basis over the associated vesting period of the award based on the grant date fair value of the award. Stock options granted under the Company’s equity incentive plans generally have a four-year vesting period and a term of 10 years. For milestone-based equity awards (see Note 8) the Company periodically assesses the probability of vesting for each milestone-based award and adjusts compensation expense based on its probability assessment. Pursuant to ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting (Topic 718) |
Income Taxes | Income taxes The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or its tax returns. Under this method, deferred tax assets and liabilities are recognized for the temporary differences between the tax bases of assets and liabilities and their respective financial reporting amounts at enacted tax rates in effect for the years in which the temporary differences are expected to reverse. The Company records a valuation allowance on its deferred tax assets if it is more likely than not that the Company will not generate sufficient taxable income to utilize its deferred tax assets (see Note 11). The Company is subject to income tax examinations by major taxing authorities for all tax years since 2018 and for previous periods as it relates to the Company’s net operating loss carryforwards. |
Loss Per Share | Loss Per Share Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share is calculated by dividing net loss attributable to common stockholders as adjusted for the effect of dilutive securities, if any, by the weighted average number of shares of common stock and dilutive common stock outstanding during the period. Potentially dilutive common stock includes the shares of common stock issuable upon the exercise of outstanding stock options and warrants (using the treasury stock method). Potentially dilutive common stock in the diluted net loss per share computation is excluded to the extent that it would be anti-dilutive. No potentially dilutive securities are included in the computation of any diluted per share amounts as the Company reported a net loss for all periods presented. For the years ended December 31, 2022 and 2021, the following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive effects: For the Years Ended December 31, 2022 2021 Stock options 8,256,211 7,862,722 Restricted Stock Units 2,866,987 4,485,133 Warrants 13,525,148 4,528,160 24,648,346 16,876,015 |
Fair Value of Financial Instruments | Fair value of financial instruments The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable and accounts payable are shown at cost, which approximates fair value due to the short-term nature of these instruments. The debt outstanding under the Company’s senior notes payable (see Note 7) approximates fair value due to the variable interest rate on this debt. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements There were no new accounting pronouncements adopted during the years ended December 31, 2022 and 2021 that had a significant impact on the Company’s consolidated financial statements. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Calculation of Diluted Loss Per Common Share | For the years ended December 31, 2022 and 2021, the following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive effects: For the Years Ended December 31, 2022 2021 Stock options 8,256,211 7,862,722 Restricted Stock Units 2,866,987 4,485,133 Warrants 13,525,148 4,528,160 24,648,346 16,876,015 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
INVENTORIES [Abstract] | |
Components of Inventory | The following table provides the components of inventories: December 31, December 31, Raw materials $ 48,644,527 $ 36,755,720 Work-in-process 56,170,853 58,968,535 Finished goods 58,464,667 28,999,836 Total inventories $ 163,280,047 $ 124,724,091 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
PROPERTY AND EQUIPMENT [Abstract] | |
Property and Equipment | Property and equipment at December 31, 2022 and 2021 is summarized as follows: December 31, 2022 December 31, 2021 Manufacturing and laboratory equipment $ 18,767,807 $ 16,702,991 Office equipment and computer software 5,318,669 4,082,462 Furniture and fixtures 5,109,898 3,389,140 Construction in process 6,726,995 5,496,222 Leasehold improvements 17,930,905 11,129,639 Land 4,339,441 4,339,441 Buildings and building improvements 19,544,307 19,067,032 77,738,022 64,206,927 Less: Accumulated depreciation (19,476,541 ) (13,271,853 ) Total property, plant and equipment, net $ 58,261,481 $ 50,935,074 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
INTANGIBLE ASSETS [Abstract] | |
Schedule of Intangible Assets | Intangible assets at December 31, 2022 and 2021 consist of the following: December 31, 2022 December 31, 2021 Cost Accumulated Amortization Net Cost Accumulated Amortization Net Trademark and other intangible rights related to Nabi-HB $ 4,100,046 $ 3,270,276 $ 829,770 $ 4,100,046 $ 2,684,554 $ 1,415,492 Rights to intermediates 907,421 723,776 183,645 907,421 594,145 313,276 $ 5,007,467 $ 3,994,052 $ 1,013,415 $ 5,007,467 $ 3,278,699 $ 1,728,768 |
Intangible Asset Future Aggregate Amortization Expense | Amortization expense related to the Company’s intangible assets for the years ended December 31, 2022 and 2021 was $0.7 million. Estimated aggregate future aggregate amortization expense is expected to be as follows: 2023 715,352 2024 298,063 |
ACCRUED EXPENSES AND OTHER LI_2
ACCRUED EXPENSES AND OTHER LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
ACCRUED EXPENSES AND OTHER LIABILITIES [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities at December 31, 2022 and 2021 are as follows: December 31, 2022 December 31, 2021 Accrued rebates $ 11,436,484 $ 5,040,200 Accrued distribution fees 3,166,896 4,739,651 Accrued incentives 4,193,919 4,066,109 Accrued testing 309,867 1,189,970 Accrued payroll and other compensation 4,086,379 1,197,337 Other 1,795,804 981,721 Total accrued expenses and other current liabilities $ 24,989,349 $ 17,214,988 |
NOTES PAYABLE (Tables)
NOTES PAYABLE (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
NOTES PAYABLE [Abstract] | |
Summary of Outstanding Senior Notes Payable | A summary of outstanding senior notes payable is as follows: December 31, 2022 December 31, 2021 Notes payable $ 154,747,746 $ 100,000,000 Less: Debt discount (11,914,683 ) (5,133,761 ) Senior notes payable $ 142,833,063 $ 94,866,239 |
STOCKHOLDERS EQUITY (Tables)
STOCKHOLDERS EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
STOCKHOLDERS' EQUITY [Abstract] | |
Schedule of Assumptions | The grant date fair values of stock options awarded during the years ended December 31, 2022 and 2021 were determined using the Black-Scholes option pricing model with the following assumptions: Years Ended December 31, 2022 December 31, 2021 Expected term 5.5-6.3 years 5.5-6.3 years Volatility 68 % 68-70 % Dividend yield 0.0 0.0 Risk-free interest rate 1.72-1.73 % 0.80-1.27 % |
Schedule of Option Activity | The following table summarizes information about stock options outstanding as of December 31, 2022 and 2021: Shares Weighted Average Exercise Price Options outstanding, vested and expected to vest at December 31, 2020 6,922,931 $ 4.40 Forfeited (529,202 ) $ 2.89 Expired (426,557 ) $ 4.91 Granted 1,895,550 $ 2.14 Exercised - $ - Options outstanding, vested and expected to vest at December 31, 2021 7,862,722 $ 3.93 Forfeited (31,540 ) $ 2.37 Expired (700,324 ) $ 6.86 Granted 1,194,032 $ 1.67 Exercised (68,679 ) $ 2.55 Options outstanding, vested and expected to vest at December 31, 2022 8,256,211 $ 3.37 Options exercisable 6,213,959 $ 3.80 |
Summary of Outstanding and Exercisable Options by Price Range | The following table summarizes additional information regarding outstanding and exercisable options under the stock option plans at December 31, 2022: Stock Options Outstanding Stock Options Exercisable Range of Exercise Prices Options Outstanding Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Aggregate Intrinsic Value Options Outstanding Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Aggregate Intrinsic Value $1.10 - $1.67 1,523,824 9.1 $ 1.61 $ 3,452,237 406,160 9.0 $ 1.52 $ 959,663 $1.73 - $2.60 1,623,353 8.0 $ 2.35 2,491,181 943,200 8.0 $ 2.36 1,430,931 $2.62 - $3.93 4,083,311 5.0 $ 3.46 1,696,824 3,852,447 4.8 $ 3.49 1,495,461 $3.98 - $5.97 470,428 4.7 $ 5.03 - 456,857 4.6 $ 5.06 - $6.02 - $9.03 307,795 1.5 $ 8.05 - 307,795 1.5 $ 8.05 - $9.37 - $10.80 247,500 1.9 $ 10.28 - 247,500 1.9 $ 10.28 - 8,256,211 6.1 $ 3.37 $ 7,640,242 6,213,959 5.3 $ 3.80 $ 3,886,055 |
Schedule of Unvested RSU Activity | A summary of the Company’s unvested RSU activity and related information is as follows: Shares Weighted Average Grant Date Fair Value Balance at December 31, 2020 326,000 $ 2.81 Granted 4,384,744 $ 1.30 Vested (92,750 ) $ 2.82 Forfeited (132,861 ) $ 2.51 Balance at December 31, 2021 4,485,133 $ 1.34 Granted 1,174,266 $ 1.74 Vested (2,727,412 ) $ 1.25 Forfeited (65,000 ) $ 1.40 Balance at December 31, 2022 2,866,987 $ 1.59 |
Schedule of Stock-Based Compensation Expense | Total stock-based compensation expense for all awards granted under the Company’s equity incentive plans for the years ended December 31, 2022 and 2021 was as follows: 2022 2021 Research and development $ 19,476 $ 153,924 Plasma center operating expenses 81,668 60,257 Selling, general and administrative 4,716,219 2,958,008 Cost of product revenue 397,168 316,064 Total stock-based compensation expense $ 5,214,531 $ 3,488,253 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
INCOME TAXES [Abstract] | |
Reconciliation of Income Taxes | A reconciliation of income taxes at the U.S. federal statutory rate to the benefit for income taxes is as follows: Year Ended December 31, 2022 2021 Benefit at U.S. federal statutory rate $ (13,839,830 ) $ (15,045,999 ) State taxes - deferred (1,773,349 ) (251,839 ) Increase in valuation allowance 15,117,100 14,618,762 Research and development credits (211,343 ) (239,585 ) Decrease in federal net operating loss - 623,679 162(m) disallowance 862,027 63,515 Other (154,605 ) 231,467 Benefit for income taxes $ - $ - |
Deferred Tax Assets | A summary of the Company’s deferred tax assets is as follows: Year Ended December 31, 2022 2021 Federal and state net operating loss carryforwards $ 81,526,316 $ 73,036,983 Federal and state research credits 407,280 31,333 Interest expense limitation carryforwards 12,194,369 6,013,040 Transaction costs 881,782 977,046 Deferred revenue 479,510 519,819 Accrued expenses and other 1,236,128 1,030,064 Total gross deferred tax assets 96,725,385 81,608,285 Less: valuation allowance for deferred tax assets (96,725,385 ) (81,608,285 ) Net deferred tax assets $ - $ - |
LEASE OBLIGATIONS (Tables)
LEASE OBLIGATIONS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
LEASE OBLIGATIONS [Abstract] | |
Payments Under Lease Obligations | The Company’s operating leases have a weighted average remaining term of 8.4 years. Scheduled payments under the Company’s lease obligations are as follows: Year ended December 31, 2023 $ 2,367,057 2024 2,343,314 2025 2,366,432 2026 2,116,036 2027 2,040,690 Thereafter 8,238,571 Total payments 19,472,100 Less: imputed interest (7,862,555 ) Current portion (905,369 ) Balance at December 31, 2022 $ 10,704,176 |
SEGMENTS (Tables)
SEGMENTS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
SEGMENTS [Abstract] | |
Summarized Financial Information Concerning Reportable Segments | Summarized financial information concerning reportable segments is shown in the following tables: Year Ended December 31, 2022 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 144,069,543 $ 9,867,315 $ 142,834 $ 154,079,692 Cost of product revenue 108,881,938 9,932,597 - 118,814,535 Income (loss) from operations 879,387 (17,908,378 ) (22,336,089 ) (39,365,080 ) Interest and other expense, net (504,787 ) (3,266 ) (19,360,876 ) (19,868,929 ) Loss on extinguishment of debt - - (6,669,941 ) (6,669,941 ) Net income (loss) 374,600 (17,911,644 ) (48,366,906 ) (65,903,950 ) Capital expenditures 5,246,860 8,664,311 - 13,911,171 Depreciation and amortization expense 4,708,879 2,403,572 918 7,113,369 Total assets 238,159,534 37,070,535 73,231,812 348,461,881 Year Ended December 31, 2021 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 74,935,528 $ 5,864,263 $ 142,834 $ 80,942,625 Cost of product revenue 74,124,999 5,644,342 - 79,769,341 Loss from operations (29,293,309 ) (12,056,364 ) (17,024,068 ) (58,373,741 ) Interest and other expense, net (218,053 ) (5,660 ) (13,050,164 ) (13,273,877 ) Net loss (29,511,362 ) (12,062,024 ) (30,074,232 ) (71,647,618 ) Capital expenditures 4,876,983 8,634,275 - 13,511,258 Depreciation and amortization expense 4,217,771 1,272,397 5,334 5,495,502 Total assets 208,391,019 24,681,691 43,180,014 276,252,724 |
SUPPLEMENTAL DISCLOSURE OF CA_2
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION [Abstract] | |
Supplemental Cash Flow Information | Supplemental cash flow information for the years ended December 31, 2022 and 2021 is as follows: 2022 2021 SUPPLEMENTAL CASH FLOW INFORMATION: Cash paid for interest $ 13,879,958 $ 11,159,461 Noncash Financing and Investing Activities: Equipment acquired reflected in accounts payable and accrued liabilities $ 1,494,916 $ 1,352,627 Right-to-use assets in exchange for lease obligations $ 4,048,099 $ 3,554,473 Warrants issued in connection with notes payable $ 9,569,604 $ - |
CONCENTRATIONS (Tables)
CONCENTRATIONS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
CONCENTRATIONS [Abstract] | |
Net Revenues According to Geographic Area | Net revenues according to geographic area, based on the location of where the product is shipped, is as follows: Year Ended December 31, 2022 2021 United States $ 146,426,617 $ 70,625,848 International 7,653,075 10,316,777 Total revenues $ 154,079,692 $ 80,942,625 |
ORGANIZATION AND BUSINESS (Deta
ORGANIZATION AND BUSINESS (Details) | 12 Months Ended | ||||
Dec. 09, 2022 USD ($) shares | Mar. 23, 2022 USD ($) | Oct. 25, 2021 USD ($) shares | Dec. 31, 2022 USD ($) Product Facility shares | Dec. 31, 2021 USD ($) shares | |
Organization and Business [Abstract] | |||||
Number of plasma collection facilities under approval and development | Facility | 10 | ||||
Number of current FDA-licensed plasma collection facilities | Facility | 8 | ||||
Number of FDA approved product | Product | 3 | ||||
Working capital | $ 231,100,000 | ||||
Cash and cash equivalents | 86,500,000 | ||||
Common stock shares sold during the period (in shares) | shares | 57,500,000 | ||||
Proceeds from issuance of common stock, net of offering expenses | $ 53,800,000 | $ 64,645,289 | $ 121,144,103 | ||
Proceeds from refinancing of senior credit facility | $ 47,000,000 | ||||
Underwritten Public Offering [Member] | |||||
Organization and Business [Abstract] | |||||
Proceeds from issuance of common stock, net of offering expenses | $ 64,600,000 | ||||
Common Stock [Member] | |||||
Organization and Business [Abstract] | |||||
Common stock shares sold during the period (in shares) | shares | 24,125,873 | 90,846,029 | |||
Common Stock [Member] | Underwritten Public Offering [Member] | |||||
Organization and Business [Abstract] | |||||
Common stock shares sold during the period (in shares) | shares | 24,125,873 | ||||
Proceeds from issuance of common stock, net of offering expenses | $ 64,600,000 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES, Accounts Receivable (Details) - USD ($) $ in Millions | Dec. 31, 2022 | Dec. 31, 2021 |
Accounts Receivable [Abstract] | ||
Accounts receivable, allowances for contractual credits and doubtful accounts | $ 0.1 | $ 0.2 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES, Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Minimum [Member] | |
Property and Equipment [Abstract] | |
Useful life | 3 years |
Maximum [Member] | |
Property and Equipment [Abstract] | |
Useful life | 15 years |
Buildings [Member] | |
Property and Equipment [Abstract] | |
Useful life | 30 years |
SIGNIFICANT ACCOUNTING POLICI_6
SIGNIFICANT ACCOUNTING POLICIES, Goodwill (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Goodwill [Abstract] | ||
Goodwill | $ 3,529,509 | $ 3,529,509 |
Impairment charges related to goodwill | $ 0 | $ 0 |
SIGNIFICANT ACCOUNTING POLICI_7
SIGNIFICANT ACCOUNTING POLICIES, Impairment of Long-lived Assets (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Impairment of Long-lived Assets [Abstract] | ||
Impairment of long-lived assets | $ 0 | $ 0 |
SIGNIFICANT ACCOUNTING POLICI_8
SIGNIFICANT ACCOUNTING POLICIES, Revenue Recognition (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Biotest License Agreement [Member] | |
Revenue Recognition [Abstract] | |
Amortization period | 22 years |
SIGNIFICANT ACCOUNTING POLICI_9
SIGNIFICANT ACCOUNTING POLICIES, Advertising and Marketing Expenses (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Advertising and Marketing Expenses [Abstract] | ||
Advertising and marketing expenses | $ 2.2 | $ 1.4 |
SIGNIFICANT ACCOUNTING POLIC_10
SIGNIFICANT ACCOUNTING POLICIES, Stock-based Compensation (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Stock-based Compensation [Abstract] | |
Equity incentive plans, vesting period | 4 years |
Equity incentive plans, term | 10 years |
SIGNIFICANT ACCOUNTING POLIC_11
SIGNIFICANT ACCOUNTING POLICIES, Loss per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Loss Per Share [Abstract] | ||
Potentially dilutive securities (in shares) | 24,648,346 | 16,876,015 |
Stock Options [Member] | ||
Loss Per Share [Abstract] | ||
Potentially dilutive securities (in shares) | 8,256,211 | 7,862,722 |
Restricted Stock Units [Member] | ||
Loss Per Share [Abstract] | ||
Potentially dilutive securities (in shares) | 2,866,987 | 4,485,133 |
Warrants [Member] | ||
Loss Per Share [Abstract] | ||
Potentially dilutive securities (in shares) | 13,525,148 | 4,528,160 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
INVENTORIES [Abstract] | ||
Raw materials | $ 48,644,527 | $ 36,755,720 |
Work-in-process | 56,170,853 | 58,968,535 |
Finished goods | 58,464,667 | 28,999,836 |
Total inventories | $ 163,280,047 | $ 124,724,091 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | $ 77,738,022 | $ 64,206,927 |
Less: accumulated depreciation | (19,476,541) | (13,271,853) |
Total property and equipment, net | 58,261,481 | 50,935,074 |
Depreciation expense | 6,400,000 | 4,800,000 |
Manufacturing and Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | 18,767,807 | 16,702,991 |
Office Equipment and Computer Software [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | 5,318,669 | 4,082,462 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | 5,109,898 | 3,389,140 |
Construction in Process [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | 6,726,995 | 5,496,222 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | 17,930,905 | 11,129,639 |
Land [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | 4,339,441 | 4,339,441 |
Buildings and Building Improvements [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | $ 19,544,307 | $ 19,067,032 |
INTANGIBLE ASSETS, Summary (Det
INTANGIBLE ASSETS, Summary (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets, Net [Abstract] | ||
Cost | $ 5,007,467 | $ 5,007,467 |
Accumulated amortization | 3,994,052 | 3,278,699 |
Net | 1,013,415 | 1,728,768 |
Amortization of intangible assets | 715,353 | 715,353 |
Trademark and Other Intangible Rights Related to Nabi-HB [Member] | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Cost | 4,100,046 | 4,100,046 |
Accumulated amortization | 3,270,276 | 2,684,554 |
Net | $ 829,770 | 1,415,492 |
Amortization period | 7 years | |
Rights to Intermediates [Member] | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Cost | $ 907,421 | 907,421 |
Accumulated amortization | 723,776 | 594,145 |
Net | $ 183,645 | $ 313,276 |
Amortization period | 7 years |
INTANGIBLE ASSETS, Future Aggre
INTANGIBLE ASSETS, Future Aggregate Amortization Expense (Details) | Dec. 31, 2022 USD ($) |
Estimated Aggregate Amortization Expense [Abstract] | |
2023 | $ 715,352 |
2024 | $ 298,063 |
ACCRUED EXPENSES AND OTHER LI_3
ACCRUED EXPENSES AND OTHER LIABILITIES (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses and Other Current Liabilities [Abstract] | ||
Accrued rebates | $ 11,436,484 | $ 5,040,200 |
Accrued distribution fees | 3,166,896 | 4,739,651 |
Accrued incentives | 4,193,919 | 4,066,109 |
Accrued testing | 309,867 | 1,189,970 |
Accrued payroll and other compensation | 4,086,379 | 1,197,337 |
Other | 1,795,804 | 981,721 |
Total accrued expenses and other current liabilities | $ 24,989,349 | $ 17,214,988 |
NOTES PAYABLE (Details)
NOTES PAYABLE (Details) | 3 Months Ended | 12 Months Ended | ||||
Mar. 23, 2022 USD ($) d $ / shares shares | Dec. 31, 2026 USD ($) | Jun. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) $ / shares | Dec. 31, 2021 USD ($) | Dec. 31, 2020 $ / shares | |
Senior Notes Payable [Abstract] | ||||||
Notes payable | $ 154,747,746 | $ 100,000,000 | ||||
Less: Debt discount | $ (13,900,000) | (11,914,683) | (5,133,761) | |||
Senior notes payable | 142,833,063 | 94,866,239 | ||||
Payment for outstanding obligations | 100,000,000 | 0 | ||||
Loss on extinguishment of debt | (6,669,941) | 0 | ||||
Interest paid-in-kind | 2,997,746 | 0 | ||||
Revenues | $ 154,079,692 | $ 80,942,625 | ||||
Warrant exercise price per share (in dollars per share) | $ / shares | $ 1.99 | $ 2.82 | ||||
Hayfin Credit Agreement [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Maturity date | Mar. 23, 2029 | |||||
Upfront fee paid in kind | 1,800,000 | |||||
Loss on extinguishment of debt | $ (6,700,000) | |||||
Applicable margin | 9.50% | |||||
Increase applicable margin | 3% | |||||
Effective interest rate | 13% | 16.10% | ||||
Percentage of interest amount to pay in kind | 2.50% | |||||
Interest paid-in-kind | $ 3,000,000 | |||||
Percentage of exit fee on outstanding principal amount being paid | 1% | |||||
Scheduled principal payments | $ 0 | |||||
Number of business days prior written notice for prepay outstanding principal | d | 5 | |||||
Shares issued upon exercise of warrants (in shares) | shares | 9,103,047 | |||||
Warrant exercise price per share (in dollars per share) | $ / shares | $ 1.6478 | |||||
Trailing period for VWAP | 30 days | |||||
Fair value of warrants | $ 9,600,000 | |||||
Hayfin Credit Agreement [Member] | Minimum [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Cash balance | $ 6,000,000 | |||||
Revenues | $ 75,000,000 | |||||
Hayfin Credit Agreement [Member] | Maximum [Member] | Forecast [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Revenues | $ 250,000,000 | |||||
Hayfin Credit Agreement [Member] | Prepaid on or Prior to First Anniversary [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Percentage of prepaid principal amount | 7% | |||||
Hayfin Credit Agreement [Member] | Prepaid after the First Anniversary [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Percentage of prepaid principal amount | 3% | |||||
Hayfin Credit Agreement [Member] | Prepaid after the Second Anniversary [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Percentage of prepaid principal amount | 1% | |||||
Hayfin Credit Agreement [Member] | Federal Funds Rate [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Credit agreement, interest rate provided | 0.50% | |||||
Hayfin Credit Agreement [Member] | Secured Overnight Financing Rate [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Credit agreement, interest rate provided | 1% | |||||
Term of variable rate | 1 month | |||||
Applicable margin | 8.50% | |||||
Hayfin Credit Agreement [Member] | Secured Overnight Financing Rate [Member] | Minimum [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Term of variable rate | 1 month | |||||
Hayfin Credit Agreement [Member] | Secured Overnight Financing Rate [Member] | Maximum [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Term of variable rate | 3 months | |||||
Hayfin Credit Agreement [Member] | Base Rate [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Percentage of floor interest rate | 1.25% | |||||
Hayfin Credit Facility [Member] | Hayfin Credit Agreement [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Maturity date | Mar. 23, 2027 | |||||
Hayfin Credit Facility [Member] | Hayfin Credit Agreement [Member] | Maximum [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Notes payable | $ 175,000,000 | |||||
Hayfin Closing Date Loan [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Payment for outstanding obligations | 100,000,000 | |||||
Hayfin Closing Date Loan [Member] | Hayfin Credit Agreement [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Notes payable | 150,000,000 | |||||
Redemption premium | 2,000,000 | |||||
Payment for certain fees and expenses | $ 1,000,000 | |||||
Effective interest rate | 10.75% | 13.90% | ||||
Hayfin Delayed Draw Loan [Member] | Hayfin Credit Agreement [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Notes payable | $ 25,000,000 | |||||
Maturity date | Mar. 22, 2023 |
STOCKHOLDERS' EQUITY, Preferred
STOCKHOLDERS' EQUITY, Preferred Stock (Details) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Preferred Stock [Abstract] | ||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, outstanding (in shares) | 0 | 0 |
STOCKHOLDERS' EQUITY, Common St
STOCKHOLDERS' EQUITY, Common Stock (Details) - USD ($) | 12 Months Ended | ||||||||
Dec. 09, 2022 | Oct. 25, 2021 | Sep. 03, 2021 | Feb. 03, 2021 | Aug. 05, 2020 | Feb. 21, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | May 27, 2021 | |
Common Stock [Abstract] | |||||||||
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 | |||||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |||||||
Common stock, shares outstanding (in shares) | 221,816,930 | 195,813,817 | |||||||
Common stock, available for issuance (in shares) | 29,177,763 | ||||||||
Common stock shares sold during the period (in shares) | 57,500,000 | ||||||||
Common stock issuable under agreement | $ 57,500,000 | $ 64,645,289 | $ 121,144,103 | ||||||
Proceeds from issuance of common stock | $ 53,800,000 | 64,645,289 | 121,144,103 | ||||||
Net proceeds from stock options exercised | 175,015 | 0 | |||||||
Maximum [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Common stock, shares authorized (in shares) | 300,000,000 | ||||||||
Minimum [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Common stock, shares authorized (in shares) | 150,000,000 | ||||||||
Underwritten Public Offering [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Proceeds from issuance of common stock | $ 64,600,000 | ||||||||
Sale Agreement [Member] | Jefferies LLC [Member] | Maximum [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Common stock issuable under agreement | $ 50,000,000 | ||||||||
2020 Sale Agreement [Member] | Jefferies LLC [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Proceeds from issuance of common stock | 60,400,000 | ||||||||
Sale Agreement, Amended [Member] | Jefferies LLC [Member] | Maximum [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Common stock issuable under agreement | $ 105,400,000 | ||||||||
Distribution Agreement [Member] | Raymond James & Associates Inc. [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Common stock issuable under agreement | $ 42,800,000 | ||||||||
Proceeds from issuance of common stock | $ 6,900,000 | ||||||||
Distribution Agreement [Member] | Raymond James & Associates Inc. [Member] | Maximum [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Common stock issuable under agreement | $ 50,000,000 | ||||||||
Common Stock [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Common stock shares sold during the period (in shares) | 24,125,873 | 90,846,029 | |||||||
Common stock issuable under agreement | $ 2,413 | $ 9,085 | |||||||
Net proceeds from stock options exercised | $ 200,000 | ||||||||
Stock options exercised (in shares) | 68,679 | ||||||||
Common Stock [Member] | Underwritten Public Offering [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Common stock shares sold during the period (in shares) | 24,125,873 | ||||||||
Proceeds from issuance of common stock | $ 64,600,000 | ||||||||
Common Stock [Member] | 2020 Sale Agreement [Member] | Jefferies LLC [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Common stock shares sold during the period (in shares) | 27,805,198 | ||||||||
Common Stock [Member] | Distribution Agreement [Member] | Raymond James & Associates Inc. [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Common stock shares sold during the period (in shares) | 0 | 5,540,831 |
STOCKHOLDERS' EQUITY, Warrants
STOCKHOLDERS' EQUITY, Warrants (Details) - USD ($) $ / shares in Units, $ in Millions | Mar. 23, 2022 | Dec. 31, 2022 | Dec. 31, 2020 |
Warrants [Abstract] | |||
Warrant exercise price (in dollars per share) | $ 1.99 | $ 2.82 | |
Hayfin Credit Agreement [Member] | |||
Warrants [Abstract] | |||
Warrant to purchase shares of common stock (in shares) | 9,103,047 | ||
Warrant exercise price (in dollars per share) | $ 1.6478 | ||
Fair value of warrants | $ 9.6 | ||
Expected term | 7 years | ||
Volatility | 68.10% | ||
Dividend yield | 0% | ||
Risk-free interest rate | 2.36% | ||
Common Stock [Member] | |||
Warrants [Abstract] | |||
Warrant to purchase shares of common stock (in shares) | 31,750 | ||
Warrants outstanding (in shares) | 13,525,148 | 4,528,160 |
STOCKHOLDERS' EQUITY, Equity In
STOCKHOLDERS' EQUITY, Equity Incentive Plans (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Jan. 03, 2022 | |
Stock Options [Abstract] | |||
Shares reserved for grant (in shares) | 29,177,763 | ||
Number of stock options granted (in shares) | 1,194,032 | 1,895,550 | |
Weighted average remaining contractual life of stock options, outstanding | 6 years 1 month 6 days | ||
Weighted average remaining contractual life of stock options, expected to vest | 6 years 1 month 6 days | ||
Weighted average remaining contractual life of stock options, exercisable | 5 years 3 months 18 days | ||
Stock Option Outstanding and Exercisable [Abstract] | |||
Outstanding at beginning of period (in shares) | 8,256,211 | ||
Weighted average remaining contractual life of stock options, outstanding | 6 years 1 month 6 days | ||
Options outstanding, weighted average exercise price (in dollars per share) | $ 3.37 | ||
Options outstanding, aggregate intrinsic value | $ 7,640,242 | ||
Options exercisable (in shares) | 6,213,959 | ||
Weighted average remaining contractual life of stock options, exercisable | 5 years 3 months 18 days | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 3.8 | ||
Options exercisable, aggregate intrinsic value | $ 3,886,055 | ||
Restricted Stock Units [Abstract] | |||
Restricted stock units vested over a period | 4 years | ||
Total stock-based compensation expense, Amount [Abstract] | |||
Stock-based compensation | $ 5,214,531 | $ 3,488,253 | |
Research and Development [Member] | |||
Total stock-based compensation expense, Amount [Abstract] | |||
Stock-based compensation | 19,476 | 153,924 | |
Plasma Center Operating Expenses [Member] | |||
Total stock-based compensation expense, Amount [Abstract] | |||
Stock-based compensation | 81,668 | 60,257 | |
Selling, General and Administrative [Member] | |||
Total stock-based compensation expense, Amount [Abstract] | |||
Stock-based compensation | 4,716,219 | 2,958,008 | |
Cost of Product Revenue [Member] | |||
Total stock-based compensation expense, Amount [Abstract] | |||
Stock-based compensation | $ 397,168 | $ 316,064 | |
$1.10 - $1.67 [Member] | |||
Stock Options [Abstract] | |||
Weighted average remaining contractual life of stock options, outstanding | 9 years 1 month 6 days | ||
Stock Option Outstanding and Exercisable [Abstract] | |||
Exercise price range, lower limit (in dollars per share) | $ 1.1 | ||
Exercise price range, upper limit (in dollars per share) | $ 1.67 | ||
Outstanding at beginning of period (in shares) | 1,523,824 | ||
Weighted average remaining contractual life of stock options, outstanding | 9 years 1 month 6 days | ||
Options outstanding, weighted average exercise price (in dollars per share) | $ 1.61 | ||
Options outstanding, aggregate intrinsic value | $ 3,452,237 | ||
Options exercisable (in shares) | 406,160 | ||
Weighted average remaining contractual life of stock options, exercisable | 9 years | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 1.52 | ||
Options exercisable, aggregate intrinsic value | $ 959,663 | ||
$1.73 - $2.60 [Member] | |||
Stock Options [Abstract] | |||
Weighted average remaining contractual life of stock options, outstanding | 8 years | ||
Stock Option Outstanding and Exercisable [Abstract] | |||
Exercise price range, lower limit (in dollars per share) | $ 1.73 | ||
Exercise price range, upper limit (in dollars per share) | $ 2.6 | ||
Outstanding at beginning of period (in shares) | 1,623,353 | ||
Weighted average remaining contractual life of stock options, outstanding | 8 years | ||
Options outstanding, weighted average exercise price (in dollars per share) | $ 2.35 | ||
Options outstanding, aggregate intrinsic value | $ 2,491,181 | ||
Options exercisable (in shares) | 943,200 | ||
Weighted average remaining contractual life of stock options, exercisable | 8 years | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 2.36 | ||
Options exercisable, aggregate intrinsic value | $ 1,430,931 | ||
$2.62 - $3.93 [Member] | |||
Stock Options [Abstract] | |||
Weighted average remaining contractual life of stock options, outstanding | 5 years | ||
Stock Option Outstanding and Exercisable [Abstract] | |||
Exercise price range, lower limit (in dollars per share) | $ 2.62 | ||
Exercise price range, upper limit (in dollars per share) | $ 3.93 | ||
Outstanding at beginning of period (in shares) | 4,083,311 | ||
Weighted average remaining contractual life of stock options, outstanding | 5 years | ||
Options outstanding, weighted average exercise price (in dollars per share) | $ 3.46 | ||
Options outstanding, aggregate intrinsic value | $ 1,696,824 | ||
Options exercisable (in shares) | 3,852,447 | ||
Weighted average remaining contractual life of stock options, exercisable | 4 years 9 months 18 days | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 3.49 | ||
Options exercisable, aggregate intrinsic value | $ 1,495,461 | ||
$3.98 - $5.97 [Member] | |||
Stock Options [Abstract] | |||
Weighted average remaining contractual life of stock options, outstanding | 4 years 8 months 12 days | ||
Stock Option Outstanding and Exercisable [Abstract] | |||
Exercise price range, lower limit (in dollars per share) | $ 3.98 | ||
Exercise price range, upper limit (in dollars per share) | $ 5.97 | ||
Outstanding at beginning of period (in shares) | 470,428 | ||
Weighted average remaining contractual life of stock options, outstanding | 4 years 8 months 12 days | ||
Options outstanding, weighted average exercise price (in dollars per share) | $ 5.03 | ||
Options outstanding, aggregate intrinsic value | $ 0 | ||
Options exercisable (in shares) | 456,857 | ||
Weighted average remaining contractual life of stock options, exercisable | 4 years 7 months 6 days | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 5.06 | ||
Options exercisable, aggregate intrinsic value | $ 0 | ||
$6.02 - $9.03 [Member] | |||
Stock Options [Abstract] | |||
Weighted average remaining contractual life of stock options, outstanding | 1 year 6 months | ||
Stock Option Outstanding and Exercisable [Abstract] | |||
Exercise price range, lower limit (in dollars per share) | $ 6.02 | ||
Exercise price range, upper limit (in dollars per share) | $ 9.03 | ||
Outstanding at beginning of period (in shares) | 307,795 | ||
Weighted average remaining contractual life of stock options, outstanding | 1 year 6 months | ||
Options outstanding, weighted average exercise price (in dollars per share) | $ 8.05 | ||
Options outstanding, aggregate intrinsic value | $ 0 | ||
Options exercisable (in shares) | 307,795 | ||
Weighted average remaining contractual life of stock options, exercisable | 1 year 6 months | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 8.05 | ||
Options exercisable, aggregate intrinsic value | $ 0 | ||
$9.37 - $10.80 [Member] | |||
Stock Options [Abstract] | |||
Weighted average remaining contractual life of stock options, outstanding | 1 year 10 months 24 days | ||
Stock Option Outstanding and Exercisable [Abstract] | |||
Exercise price range, lower limit (in dollars per share) | $ 9.37 | ||
Exercise price range, upper limit (in dollars per share) | $ 10.8 | ||
Outstanding at beginning of period (in shares) | 247,500 | ||
Weighted average remaining contractual life of stock options, outstanding | 1 year 10 months 24 days | ||
Options outstanding, weighted average exercise price (in dollars per share) | $ 10.28 | ||
Options outstanding, aggregate intrinsic value | $ 0 | ||
Options exercisable (in shares) | 247,500 | ||
Weighted average remaining contractual life of stock options, exercisable | 1 year 10 months 24 days | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 10.28 | ||
Options exercisable, aggregate intrinsic value | $ 0 | ||
2014 Omnibus Incentive Compensation Plan [Member] | |||
Stock Options [Abstract] | |||
Shares reserved for grant (in shares) | 2,334,940 | ||
Shares available for issuance (in shares) | 69,090 | ||
Equity Incentive Plans [Member] | |||
Stock Options [Abstract] | |||
Percentage of outstanding shares of common stock | 4% | ||
Shares available for issuance (in shares) | 10,000,000 | 7,901,643 | |
Stock Option Outstanding and Exercisable [Abstract] | |||
Unrecognized compensation expense, stock options | $ 2,300,000 | ||
Unrecognized compensation expense recognition period | 2 years 2 months 12 days | ||
Stock Options [Member] | |||
Fair Value Assumptions and Methodology [Abstract] | |||
Dividend yield | 0% | 0% | |
Stock Option, Shares [Abstract] | |||
Options outstanding, vested and expected to vest, beginning balance (in shares) | 7,862,722 | 6,922,931 | |
Forfeited (in shares) | (31,540) | (529,202) | |
Expired (in shares) | (700,324) | (426,557) | |
Granted (in shares) | 1,194,032 | 1,895,550 | |
Exercised (in shares) | (68,679) | 0 | |
Options outstanding, vested and expected to vest, ending balance (in shares) | 8,256,211 | 7,862,722 | |
Options exercisable (in shares) | 6,213,959 | ||
Stock Options, Weighted Average Exercise Price [Abstract] | |||
Options outstanding, vested and expected to vest, weighted average exercise price, beginning balance (in dollars per share) | $ 3.93 | $ 4.4 | |
Forfeited, weighted average exercise price (in dollars per share) | 2.37 | 2.89 | |
Expired, weighted average exercise price (in dollars per share) | 6.86 | 4.91 | |
Granted, weighted average exercise price (in dollars per share) | 1.67 | 2.14 | |
Exercised, weighted average exercise price (in dollars per share) | 2.55 | 0 | |
Options outstanding, vested and expected to vest, weighted average exercise price, ending balance (in dollars per share) | 3.37 | $ 3.93 | |
Options exercisable, weighted average exercise price (in dollars per share) | $ 3.8 | ||
Stock Options [Member] | Minimum [Member] | |||
Fair Value Assumptions and Methodology [Abstract] | |||
Expected term | 5 years 6 months | 5 years 6 months | |
Volatility | 68% | ||
Risk-free interest rate | 1.72% | 0.80% | |
Stock Options [Member] | Maximum [Member] | |||
Fair Value Assumptions and Methodology [Abstract] | |||
Expected term | 6 years 3 months 18 days | 6 years 3 months 18 days | |
Volatility | 68% | 70% | |
Risk-free interest rate | 1.73% | 1.27% | |
Restricted Stock Units (RSUs) [Member] | |||
Stock Option Outstanding and Exercisable [Abstract] | |||
Unrecognized compensation expense, non option | $ 3,800,000 | ||
Unrecognized compensation expense recognition period | 2 years 4 months 24 days | ||
Restricted Stock Units [Abstract] | |||
Number of restricted stock units granted (in shares) | 1,174,266 | 4,384,744 | |
Shares withheld for tax withholding obligation (in shares) | 918,851 | 27,850 | |
Amount of shares withheld for tax withholding obligation | $ 2,900,000 | $ 62,000,000 | |
Unvested RSU, Shares [Abstract] | |||
Beginning balance (in shares) | 4,485,133 | 326,000 | |
Granted (in shares) | 1,174,266 | 4,384,744 | |
Vested (in shares) | (2,727,412) | (92,750) | |
Forfeited (in shares) | (65,000) | (132,861) | |
Ending balance (in shares) | 2,866,987 | 4,485,133 | |
Unvested RSU, Weighted Average Grant Date Fair Value | |||
Unvested, Weighted average grant date fair value, beginning balance (in dollars per share) | $ 1.34 | $ 2.81 | |
Granted, Weighted average grant date fair value (in dollars per share) | 1.74 | 1.3 | |
Vested, Weighted average grant date fair value (in dollars per share) | 1.25 | 2.82 | |
Forfeited, Weighted average grant date fair value (in dollars per share) | 1.4 | 2.51 | |
Unvested, Weighted average grant date fair value, ending balance (in dollars per share) | $ 1.59 | $ 1.34 | |
Restricted Stock Units (RSUs) [Member] | Employees [Member] | |||
Restricted Stock Units [Abstract] | |||
Restricted stock units vested over a period | 4 years | ||
Restricted Stock Units (RSUs) [Member] | Directors [Member] | |||
Restricted Stock Units [Abstract] | |||
Restricted stock units vested over a period | 1 year | ||
Restricted Stock Units (RSUs) [Member] | Employee Retention Program [Member] | |||
Restricted Stock Units [Abstract] | |||
Number of restricted stock units granted (in shares) | 3,832,500 | ||
Time Based Restricted Stock (RSUs) [Member] | Employee Retention Program [Member] | |||
Restricted Stock Units [Abstract] | |||
Number of restricted stock units granted (in shares) | 2,685,000 | ||
Time Based Restricted Stock (RSUs) [Member] | Employee Retention Program [Member] | Tranche One [Member] | |||
Restricted Stock Units [Abstract] | |||
Vesting percentage of RSUs granted under retention bonus program | 50% | ||
Milestone Based Restricted Stock (RSUs) [Member] | Employee Retention Program [Member] | |||
Restricted Stock Units [Abstract] | |||
Number of restricted stock units granted (in shares) | 1,147,500 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Dec. 09, 2022 | Oct. 25, 2021 | Jan. 31, 2016 | Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |||||
Common stock shares sold during the period (in shares) | 57,500,000 | ||||
Dr. James Mond [Member] | |||||
Related Party Transactions [Abstract] | |||||
Estimated payment for separation and transition agreement | $ 800,000 | ||||
Period of scheduled installments for separation and transition agreement | 10 months | ||||
Mr. Grossman [Member] | Direct [Member] | |||||
Related Party Transactions [Abstract] | |||||
Common stock shares sold during the period (in shares) | 14,983 | 100,000 | |||
Mr. Grossman [Member] | Indirect [Member] | |||||
Related Party Transactions [Abstract] | |||||
Common stock shares sold during the period (in shares) | 14,982 | 250,000 | |||
Dr. Grossman [Member] | |||||
Related Party Transactions [Abstract] | |||||
Common stock shares sold during the period (in shares) | 100,000 | ||||
Dr. Young Kwon [Member] | |||||
Related Party Transactions [Abstract] | |||||
Common stock shares sold during the period (in shares) | 100,000 | ||||
Brian Lenz [Member] | |||||
Related Party Transactions [Abstract] | |||||
Common stock shares sold during the period (in shares) | 6,993 | 30,000 | |||
Public offering price (in dollars per share) | $ 2.86 | $ 1 | |||
Perceptive [Member] | |||||
Related Party Transactions [Abstract] | |||||
Minimum percentage of common stock held by lender | 5% | ||||
Areth, LLC [Member] | |||||
Related Party Transactions [Abstract] | |||||
Rent expense | $ 10,000 | $ 100,000 | $ 100,000 | ||
Lease extended maturity date | Dec. 31, 2026 | ||||
Lease automatic renewal period | 1 year | ||||
Notice period for termination | 1 year | ||||
Genesis [Member] | |||||
Related Party Transactions [Abstract] | |||||
Purchased materials amount | $ 200,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) | 12 Months Ended | |||||
Apr. 01, 2019 USD ($) | Dec. 19, 2012 USD ($) | Dec. 31, 2022 USD ($) Facility Center Term Tranche | Dec. 31, 2021 USD ($) Facility | Jun. 15, 2022 USD ($) | Sep. 30, 2021 USD ($) | |
Vendor and Licensor Commitments [Abstract] | ||||||
Number of FDA-licensed plasma collection facilities approved | Facility | 4 | |||||
Number of FDA inspections completed | Facility | 2 | |||||
Plasma supply agreement term | 10 years | |||||
Post-Marketing Commitments [Abstract] | ||||||
Amount of expenses to complete studies | $ 1,500,000 | $ 2,000,000 | $ 3,613,764 | $ 3,646,060 | ||
Other Commitments [Abstract] | ||||||
Number of tranches | Tranche | 2 | |||||
BIVIGAM [Member] | ||||||
Post-Marketing Commitments [Abstract] | ||||||
Amount of expenses to complete studies | $ 2,200,000 | 1,700,000 | ||||
ASCENIV [Member] | ||||||
Post-Marketing Commitments [Abstract] | ||||||
Amount of expenses to complete studies | $ 500,000 | $ 600,000 | ||||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | International Customers [Member] | ||||||
Vendor and Licensor Commitments [Abstract] | ||||||
Concentration risk, percentage | 5% | 13% | ||||
Employee Retention Program [Member] | ||||||
Other Commitments [Abstract] | ||||||
Retention amount paid to employees, tranche one | $ 1,300,000 | |||||
Amount of first tranche recognized over the retention service period | $ 800,000 | |||||
Employee Retention Program [Member] | Plan [Member] | ||||||
Other Commitments [Abstract] | ||||||
Retention amount payable to employees, second tranche | $ 1,300,000 | |||||
2011 Plasma Purchase Agreement [Member] | ||||||
Vendor and Licensor Commitments [Abstract] | ||||||
Plasma purchase agreement term | 10 years | |||||
Number of renewal terms | Term | 2 | |||||
Plasma purchase agreement renewal period | 5 years | |||||
Number of plasma collection centers transferred to BPC | Center | 2 | |||||
Percentage of plasma purchase price equal to cost | 5% | |||||
2011 Plasma Purchase Agreement [Member] | Maximum [Member] | ||||||
Vendor and Licensor Commitments [Abstract] | ||||||
Number of plasma collection facilities | Facility | 5 | |||||
2017 Plasma Purchase Agreement [Member] | ||||||
Vendor and Licensor Commitments [Abstract] | ||||||
Number of plasma collection facilities | Facility | 10 | |||||
Plasma purchase agreement term | 5 years | |||||
Number of renewal terms | Term | 2 | |||||
Plasma purchase agreement renewal period | 2 years |
INCOME TAXES, Reconciliation of
INCOME TAXES, Reconciliation of Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
INCOME TAXES [Abstract] | ||
Benefit at U.S. Federal statutory rate | $ (13,839,830) | $ (15,045,999) |
State taxes - deferred | (1,773,349) | (251,839) |
Increase in valuation allowance | 15,117,100 | 14,618,762 |
Research and development credits | (211,343) | (239,585) |
Decrease in federal net operating loss | 0 | 623,679 |
162(m) disallowance | 862,027 | 63,515 |
Other | (154,605) | 231,467 |
Benefit for income taxes | $ 0 | $ 0 |
INCOME TAXES, Deferred Tax Asse
INCOME TAXES, Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
INCOME TAXES [Abstract] | ||
Federal and state net operating loss carryforwards | $ 81,526,316 | $ 73,036,983 |
Federal and state research credits | 407,280 | 31,333 |
Interest expense limitations carryforwards | 12,194,369 | 6,013,040 |
Transaction costs | 881,782 | 977,046 |
Deferred revenue | 479,510 | 519,819 |
Accrued expenses and other | 1,236,128 | 1,030,064 |
Total gross deferred tax assets | 96,725,385 | 81,608,285 |
Less: valuation allowance for deferred tax assets | (96,725,385) | (81,608,285) |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAXES, Net Operating Los
INCOME TAXES, Net Operating Loss Carryforwards (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Net Operating Loss Carryforwards [Abstract] | ||
Reduction of net deferred tax assets | $ (3,900,000) | |
Reduction of valuation allowance | (3,900,000) | |
Unrecognized tax benefits | $ 0 | 0 |
Minimum [Member] | ||
Net Operating Loss Carryforwards [Abstract] | ||
Net operating loss carryforwards, expiration | Dec. 31, 2027 | |
Maximum [Member] | ||
Net Operating Loss Carryforwards [Abstract] | ||
Net operating loss carryforwards, expiration | Dec. 31, 2042 | |
Federal [Member] | ||
Net Operating Loss Carryforwards [Abstract] | ||
Net operating loss carryforwards | $ 334,500,000 | |
Write-off of federal NOLs | 3,000,000 | |
Write-off of federal research and development tax credits | 1,000,000 | |
Federal [Member] | 2027 through 2042 [Member] | ||
Net Operating Loss Carryforwards [Abstract] | ||
Net operating loss carryforwards | 55,200,000 | |
Federal [Member] | Research and Development [Member] | ||
Net Operating Loss Carryforwards [Abstract] | ||
Tax credit carryforwards | 400,000 | |
State [Member] | ||
Net Operating Loss Carryforwards [Abstract] | ||
Net operating loss carryforwards | 211,700,000 | |
Write-off of state NOLs | $ 28,100,000 | |
State [Member] | 2027 through 2042 [Member] | ||
Net Operating Loss Carryforwards [Abstract] | ||
Net operating loss carryforwards | $ 91,800,000 |
LEASE OBLIGATIONS (Details)
LEASE OBLIGATIONS (Details) | 12 Months Ended | |
Dec. 31, 2022 USD ($) Lease | Dec. 31, 2021 USD ($) Lease | |
LEASE OBLIGATIONS [Abstract] | ||
Incremental borrowing rate | 13% | 14% |
Aggregate lease expense | $ 2,100,000 | $ 1,400,000 |
Cash payments for lease | 1,800,000 | 1,400,000 |
Right to use assets | 4,000,000 | 3,600,000 |
Lease liabilities | $ 4,000,000 | $ 3,600,000 |
Number of new property leases | Lease | 2 | 4 |
Operating and financing lease liabilities | $ 11,600,000 | $ 8,100,000 |
Weighted average remaining term | 8 years 4 months 24 days | |
Payments Under Lease Obligations [Abstract] | ||
Year ended December 31, 2023 | $ 2,367,057 | |
2024 | 2,343,314 | |
2025 | 2,366,432 | |
2026 | 2,116,036 | |
2027 | 2,040,690 | |
Thereafter | 8,238,571 | |
Total payments | 19,472,100 | |
Less: imputed interest | (7,862,555) | |
Current portion | (905,369) | (591,084) |
Balance at December 31, 2022 | 10,704,176 | $ 7,462,388 |
Rental expense | $ 10,000 | |
Lease renewal term | 5 years |
SEGMENTS (Details)
SEGMENTS (Details) | 12 Months Ended | |
Dec. 31, 2022 USD ($) Facility | Dec. 31, 2021 USD ($) | |
Segment Reporting Information [Abstract] | ||
Number of plasma collection facilities under development | Facility | 10 | |
Number of operational collection plasma facilities | Facility | 9 | |
Number of FDA-licensed plasma collection facilities | Facility | 7 | |
Number of FDA-licensed plasma collection facilities received approval from Korean Ministry of Food and Drug Safety | Facility | 3 | |
Revenues | $ 154,079,692 | $ 80,942,625 |
Cost of product revenue | 118,814,535 | 79,769,341 |
Income (loss) from operations | (39,365,080) | (58,373,741) |
Interest and other expense, net | (19,868,929) | (13,273,877) |
Loss on extinguishment of debt | (6,669,941) | 0 |
Net income (loss) | (65,903,950) | (71,647,618) |
Capital expenditures | 13,911,171 | 13,511,258 |
Depreciation and amortization expense | 7,113,369 | 5,495,502 |
Total assets | 348,461,881 | 276,252,724 |
Corporate [Member] | ||
Segment Reporting Information [Abstract] | ||
Revenues | 142,834 | 142,834 |
Cost of product revenue | 0 | 0 |
Income (loss) from operations | (22,336,089) | (17,024,068) |
Interest and other expense, net | (19,360,876) | (13,050,164) |
Loss on extinguishment of debt | (6,669,941) | |
Net income (loss) | (48,366,906) | (30,074,232) |
Capital expenditures | 0 | 0 |
Depreciation and amortization expense | 918 | 5,334 |
Total assets | 73,231,812 | 43,180,014 |
Operating Segments [Member] | ADMA BioManufacturing [Member] | ||
Segment Reporting Information [Abstract] | ||
Revenues | 144,069,543 | 74,935,528 |
Cost of product revenue | 108,881,938 | 74,124,999 |
Income (loss) from operations | 879,387 | (29,293,309) |
Interest and other expense, net | (504,787) | (218,053) |
Loss on extinguishment of debt | 0 | |
Net income (loss) | 374,600 | (29,511,362) |
Capital expenditures | 5,246,860 | 4,876,983 |
Depreciation and amortization expense | 4,708,879 | 4,217,771 |
Total assets | 238,159,534 | 208,391,019 |
Operating Segments [Member] | Plasma Collection Centers [Member] | ||
Segment Reporting Information [Abstract] | ||
Revenues | 9,867,315 | 5,864,263 |
Cost of product revenue | 9,932,597 | 5,644,342 |
Income (loss) from operations | (17,908,378) | (12,056,364) |
Interest and other expense, net | (3,266) | (5,660) |
Loss on extinguishment of debt | 0 | |
Net income (loss) | (17,911,644) | (12,062,024) |
Capital expenditures | 8,664,311 | 8,634,275 |
Depreciation and amortization expense | 2,403,572 | 1,272,397 |
Total assets | $ 37,070,535 | $ 24,681,691 |
OTHER EMPLOYEE BENEFITS (Detail
OTHER EMPLOYEE BENEFITS (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
OTHER EMPLOYEE BENEFITS [Abstract] | ||
Compensation expense | $ 1.3 | $ 1.1 |
SUPPLEMENTAL DISCLOSURE OF CA_3
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
SUPPLEMENTAL CASH FLOW INFORMATION [Abstract] | ||
Cash paid for interest | $ 13,879,958 | $ 11,159,461 |
Noncash Financing and Investing Activities [Abstract] | ||
Equipment acquired reflected in accounts payable and accrued liabilities | 1,494,916 | 1,352,627 |
Right-to-use assets in exchange for lease obligations | 4,048,099 | 3,554,473 |
Warrants issued in connection with notes payable | $ 9,569,604 | $ 0 |
CONCENTRATIONS (Details)
CONCENTRATIONS (Details) | 12 Months Ended | |
Dec. 31, 2022 USD ($) Customer | Dec. 31, 2021 USD ($) Customer | |
Risks and Uncertainties [Abstract] | ||
Plasma purchased from Grifols | $ | $ 47,700,000 | $ 42,000,000 |
Percentage of inventory purchases | 65% | 69% |
Segment Reporting Information [Abstract] | ||
Revenues | $ | $ 154,079,692 | $ 80,942,625 |
United States [Member] | ||
Segment Reporting Information [Abstract] | ||
Revenues | $ | 146,426,617 | 70,625,848 |
International [Member] | ||
Segment Reporting Information [Abstract] | ||
Revenues | $ | $ 7,653,075 | $ 10,316,777 |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Two Customers [Member] | ||
Risks and Uncertainties [Abstract] | ||
Number of customers | Customer | 2 | |
Concentration risk, percentage | 92% | |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Three Customers [Member] | ||
Risks and Uncertainties [Abstract] | ||
Number of customers | Customer | 3 | |
Concentration risk, percentage | 94% | |
Revenue [Member] | Customer Concentration Risk [Member] | Two Customers [Member] | ||
Risks and Uncertainties [Abstract] | ||
Number of customers | Customer | 2 | |
Concentration risk, percentage | 74% | |
Revenue [Member] | Customer Concentration Risk [Member] | Four Customers [Member] | ||
Risks and Uncertainties [Abstract] | ||
Number of customers | Customer | 4 | |
Concentration risk, percentage | 81% |