Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 18, 2022 | Jun. 30, 2021 | |
Entity Listings [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
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 | ||
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 | $ 173,220,302 | ||
Entity Common Stock, Shares Outstanding | 195,920,353 | ||
Auditor Name | CohnReznick LLP | ||
Auditor Location | Holmdel, New Jersey | ||
Auditor Firm ID | 596 | ||
Common Stock [Member] | |||
Entity Listings [Line Items] | |||
Title of 12(b) Security | Common stock, par value $0.0001 per share | ||
Trading Symbol | ADMA | ||
Security Exchange Name | NASDAQ | ||
Preferred Share Purchase Right [Member] | |||
Entity Listings [Line Items] | |||
Title of 12(b) Security | Preferred Share Purchase Right | ||
Security Exchange Name | NASDAQ |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 51,089,118 | $ 55,921,152 |
Accounts receivable, net | 28,576,857 | 13,237,290 |
Inventories | 124,724,091 | 81,535,599 |
Prepaid expenses and other current assets | 4,339,245 | 3,046,466 |
Total current assets | 208,729,311 | 153,740,507 |
Property and equipment, net | 50,935,074 | 41,593,090 |
Intangible assets, net | 1,728,768 | 2,444,121 |
Goodwill | 3,529,509 | 3,529,509 |
Right-to-use assets | 7,262,658 | 4,259,191 |
Deposits and other assets | 4,067,404 | 2,106,976 |
TOTAL ASSETS | 276,252,724 | 207,673,394 |
Current liabilities: | ||
Accounts payable | 12,429,409 | 11,073,708 |
Accrued expenses and other current liabilities | 17,214,988 | 8,365,143 |
Current portion of deferred revenue | 142,834 | 142,834 |
Current portion of lease obligations | 591,084 | 365,682 |
Total current liabilities | 30,378,315 | 19,947,367 |
Senior notes payable, net of discount | 94,866,239 | 92,968,866 |
Deferred revenue, net of current portion | 1,975,865 | 2,118,698 |
Lease obligations, net of current portion | 7,462,388 | 4,334,151 |
Other non-current liabilities | 397,351 | 54,886 |
TOTAL LIABILITIES | 135,080,158 | 119,423,968 |
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 and 150,000,000 shares authorized, 195,813,817 and 104,902,888 shares issued and outstanding | 19,581 | 10,490 |
Additional paid-in capital | 553,265,706 | 428,704,039 |
Accumulated deficit | (412,112,721) | (340,465,103) |
TOTAL STOCKHOLDERS' EQUITY | 141,172,566 | 88,249,426 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 276,252,724 | $ 207,673,394 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
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 | 150,000,000 |
Common stock, shares issued (in shares) | 195,813,817 | 104,902,888 |
Common stock, shares outstanding (in shares) | 195,813,817 | 104,902,888 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
REVENUES: | ||
Total revenues | $ 80,942,625 | $ 42,219,783 |
Cost of product revenue | 79,769,341 | 61,291,426 |
Gross profit (loss) | 1,173,284 | (19,071,643) |
OPERATING EXPENSES: | ||
Research and development | 3,646,060 | 5,907,013 |
Plasma center operating expenses | 12,288,723 | 4,170,051 |
Amortization of intangible assets | 715,353 | 715,353 |
Selling, general and administrative | 42,896,889 | 35,050,817 |
Total operating expenses | 59,547,025 | 45,843,234 |
LOSS FROM OPERATIONS | (58,373,741) | (64,914,877) |
OTHER INCOME (EXPENSE): | ||
Interest income | 34,532 | 288,126 |
Interest expense | (13,056,834) | (11,985,066) |
Gain on extinguishment of debt | 0 | 991,797 |
Other expense | (251,575) | (128,528) |
Other expense, net | (13,273,877) | (10,833,671) |
NET LOSS | $ (71,647,618) | $ (75,748,548) |
BASIC LOSS PER COMMON SHARE (in dollars per share) | $ (0.51) | $ (0.88) |
DILUTED LOSS PER COMMON SHARE (in dollars per share) | $ (0.51) | $ (0.88) |
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | ||
Basic (in shares) | 139,578,538 | 86,145,052 |
Diluted (in shares) | 139,578,538 | 86,145,052 |
Product Revenue [Member] | ||
REVENUES: | ||
Total revenues | $ 80,799,791 | $ 42,076,949 |
License Revenue [Member] | ||
REVENUES: | ||
Total 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, 2019 | $ 5,932 | $ 290,903,772 | $ (264,716,555) | $ 26,193,149 |
Balance (in shares) at Dec. 31, 2019 | 59,318,355 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation | $ 0 | 2,855,122 | 0 | 2,855,122 |
Warrants issued in connection with note payable | 0 | 3,740,980 | 0 | 3,740,980 |
Vesting of restricted stock units | $ 2 | (2) | 0 | 0 |
Vesting of restricted stock units (in shares) | 15,000 | |||
Issuance of common stock, net of offering expenses | $ 4,555 | 131,190,736 | 0 | 131,195,291 |
Issuance of common stock, net of offering expenses (in shares) | 45,562,907 | |||
Stock options exercised | $ 1 | 13,431 | 0 | 13,432 |
Stock options exercised (in shares) | 6,626 | |||
Net loss | $ 0 | 0 | (75,748,548) | (75,748,548) |
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 |
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 | |||
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 | |||
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 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (71,647,618) | $ (75,748,548) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 5,495,502 | 3,942,292 |
Loss on disposal of fixed assets | 220,761 | 81,697 |
Stock-based compensation | 3,488,253 | 2,855,122 |
Amortization of debt discount | 1,897,373 | 1,782,428 |
Gain on extinguishment of debt | 0 | (991,797) |
Amortization of license revenue | (142,834) | (142,834) |
Changes in operating assets and liabilities: | ||
Accounts receivable | (15,339,567) | (9,767,371) |
Inventories | (43,188,489) | (28,470,864) |
Prepaid expenses and other current assets | (1,292,779) | (512,873) |
Deposits and other assets | (1,775,205) | (196,749) |
Accounts payable | 1,355,700 | 1,899,115 |
Accrued expenses | 8,341,341 | 3,401,815 |
Other current and non-current liabilities | 218,580 | (134,391) |
Net cash used in operating activities | (112,368,982) | (102,002,958) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (13,511,258) | (12,726,680) |
Proceeds from the sale of property and equipment | 0 | 2,000 |
Net cash used in investing activities | (13,511,258) | (12,724,680) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Principal payments on notes payable | 0 | (13,950,000) |
Proceeds from issuance of common stock, net of offering expenses | 121,144,103 | 131,195,291 |
Proceeds from the exercise of stock options | 0 | 13,432 |
Payment of debt refinancing fees | 0 | (830,000) |
Proceeds from issuance of note payable | 0 | 27,500,000 |
Taxes paid on vested restricted stock units | (61,598) | 0 |
Payments on finance lease obligations | (34,299) | (32,068) |
Net cash provided by financing activities | 121,048,206 | 143,896,655 |
Net (decrease) increase in cash and cash equivalents | (4,832,034) | 29,169,017 |
Cash and cash equivalents - beginning of year | 55,921,152 | 26,752,135 |
Cash and cash equivalents - end of year | $ 51,089,118 | $ 55,921,152 |
ORGANIZATION AND BUSINESS
ORGANIZATION AND BUSINESS | 12 Months Ended |
Dec. 31, 2021 | |
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 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 in various stages of approval and development located throughout the U.S., five of which hold an approved license with the U.S. Food and Drug Administration (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”), 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, 2021, the Company had working capital of $178.4 million, including $51.1 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, together with the remaining available funds under the distribution agreement discussed in Note 8 and the net proceeds received and expected to be received from the refinancing of the Company’s senior debt on March 23, 2022 (see Note 17), will be sufficient to fund ADMA’s operations, as currently conducted, into 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 is also continuing to evaluate a variety of strategic and financing alternatives through its ongoing engagement with Morgan Stanley as a financial advisor. During the year ended December 31, 2021, the Company issued 90,846,029 shares of its common stock through an underwritten public offering and various open market sale agreements for its common stock and received net proceeds of $121.1 million. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 and 2020, 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 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 $0.2 million and $0.1 million at December 31, 2021 and December 31, 2020, 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. 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, 2021 and 2020 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, 2021 and 2020. 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, 2021 and 2020 did not result in any impairment charges related to goodwill for the years ended December 31, 2021 and 2020. 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, 2021 and 2020, the Company determined that there was no impairment of its long-lived assets. Revenue recognition Revenues for the years ended December 31, 2021 and 2020 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 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, intermediates and the sale 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. 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 $1.4 million and $1.1 million for the years ended December 31, 2021 and 2020, 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 2017 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, 2021 and 2020, 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, 2021 2020 Stock options 7,862,722 6,922,931 Restricted stock units 4,485,133 326,000 Warrants 4,528,160 4,528,160 16,876,015 11,777,091 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 In June 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (Topic 326) |
INVENTORIES
INVENTORIES | 12 Months Ended |
Dec. 31, 2021 | |
INVENTORIES [Abstract] | |
INVENTORIES | 3. INVENTORIES The following table provides the components of inventories: December 31, December 31, Raw materials $ 36,755,720 $ 32,044,393 Work-in-process 58,968,535 30,293,288 Finished goods 28,999,836 19,197,918 Total inventories $ 124,724,091 $ 81,535,599 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 center which is expected to be sold to third-party customers. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2021 | |
PROPERTY AND EQUIPMENT [Abstract] | |
PROPERTY AND EQUIPMENT | 4. PROPERTY AND EQUIPMENT Property and equipment at December 31, 2021 and 2020 is summarized as follows: December 31, 2021 December 31, 2020 Manufacturing and laboratory equipment $ 16,702,991 $ 14,468,874 Office equipment and computer software 4,082,462 3,253,528 Furniture and fixtures 3,389,140 2,389,585 Construction in process 5,496,222 3,336,557 Leasehold improvements 11,129,639 5,272,490 Land 4,339,441 4,339,441 Buildings and building improvements 19,067,032 17,396,557 64,206,927 50,457,032 Less: Accumulated depreciation (13,271,853 ) (8,863,942 ) Total property, plant and equipment, net $ 50,935,074 $ 41,593,090 The Company recorded depreciation expense on property and equipment of $4.8 million and $3.2 million for the years ended December 31, 2021 and 2020, respectively. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2021 | |
INTANGIBLE ASSETS [Abstract] | |
INTANGIBLE ASSETS | 5. INTANGIBLE ASSETS Intangible assets at December 31, 2021 and 2020 consist of the following: December 31, 2021 December 31, 2020 Cost Accumulated Amortization Net Cost Accumulated Amortization Net Trademark and other intangible rights related to Nabi-HB $ 4,100,046 $ 2,684,554 $ 1,415,492 $ 4,100,046 $ 2,098,833 $ 2,001,213 Rights to intermediates 907,421 594,145 313,276 907,421 464,513 442,908 $ 5,007,467 $ 3,278,699 $ 1,728,768 $ 5,007,467 $ 2,563,346 $ 2,444,121 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, 2021 and 2020 was $0.7 million. Estimated aggregate future aggregate amortization expense is expected to be as follows: 2022 $ 715,352 2023 715,352 2024 298,064 |
ACCRUED EXPENSES AND OTHER LIAB
ACCRUED EXPENSES AND OTHER LIABILITIES | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 and 2020 are as follows: December 31, 2021 December 31, 2020 Accrued rebates $ 5,040,200 $ 2,604,245 Accrued distribution fees 4,739,651 828,120 Accrued incentives 4,066,109 3,210,884 Accrued testing 1,189,970 779,660 Accrued payroll 1,167,072 734,972 Other 1,011,986 207,262 Total accrued expenses and other current liabilities $ 17,214,988 $ 8,365,143 |
NOTES PAYABLE
NOTES PAYABLE | 12 Months Ended |
Dec. 31, 2021 | |
NOTES PAYABLE [Abstract] | |
NOTES PAYABLE | 7. NOTES PAYABLE Senior Notes Payable A summary of outstanding senior notes payable is as follows: December 31, 2021 December 31, 2020 Notes payable $ 100,000,000 $ 100,000,000 Less: Debt discount (5,133,761 ) (7,031,134 ) Senior notes payable $ 94,866,239 $ 92,968,866 On February 11, 2019 (the “Perceptive Closing Date”), the Company and all of its subsidiaries entered into a Credit Agreement and Guaranty (the “Perceptive Credit Agreement”) with Perceptive Credit Holdings II, LP, as the lender and administrative agent (“Perceptive”). The Perceptive Credit Agreement, as amended, provides for a senior secured term loan facility in a principal amount of $100.0 million (the “Perceptive Credit Facility”), comprised of (i) a term loan made on the Perceptive Closing Date in the principal amount of $45.0 million, as evidenced by the Company’s issuance of a promissory note (the “Perceptive Tranche I Note”) in favor of Perceptive on the Perceptive Closing Date (the “Perceptive Tranche I Loan”), (ii) a term loan in the principal amount of $27.5 million (the “Perceptive Tranche II Loan”) evidenced by the Company’s issuance of a promissory note (the “Perceptive Tranche II Note”) in favor of Perceptive on May 3, 2019, (iii) a term loan in the principal amount of $12.5 million evidenced by the Company’s issuance of a promissory note (the “Perceptive Tranche III Note”) in favor of Perceptive on March 20, 2020 (the “Perceptive Tranche III Loan”); and (iv) a term loan in the principal amount of $15 million evidenced by our issuance of a promissory note in favor of Perceptive on December 8, 2020 (the “Perceptive Tranche IV Loan”, and together with the Perceptive Tranche I Loan, the Perceptive Tranche II Loan and the Perceptive Tranche III Loan, the “Perceptive Loans”). The Perceptive Tranche III Loan is the result of an amendment to the Perceptive Credit Agreement that the Company and Perceptive entered into on May 3, 2019 (the “First Perceptive Amendment”), and the Perceptive Tranche III Loan became available to the Company upon the approval of BIVIGAM on May 9, 2019. The Perceptive Tranche IV Loan is the result of an amendment to the Perceptive Credit Facility entered into on December 8, 2020 (the “Second Perceptive Amendment”), which also extended the maturity date of the Perceptive Credit Facility to March 1, 2024 (the “Maturity Date”), subject to acceleration pursuant to the Perceptive Credit Agreement, including upon an Event of Default (as defined in the Perceptive Credit Agreement). Also on December 8, 2020, the Company retired a subordinated note payable to Biotest in the principal amount of $15.0 million with the proceeds from the Perceptive Tranche IV Loan. As part of this transaction, Biotest agreed to a 7% discount from the principal, and the obligation under the note was satisfied by a payment by the Company of approximately $14.0 million. As a result, the Company recorded a gain on the extinguishment of the note of approximately $1.0 million. Borrowings under the Perceptive Credit Agreement bear interest at a rate per annum equal to 7.5% plus the greater of (i) one-month LIBOR and (ii) 3.5%; provided, however, that upon, and during the continuance of, an Event of Default, the interest rate will automatically increase by an additional 400 basis points. Accrued interest was payable to Perceptive on the last day of each month during the term of the Perceptive Credit Facility. The rate of interest in effect as of the Perceptive Closing Date and at December 31, 2021 was 11.0%. On the Maturity Date, the Company was to have paid Perceptive the entire outstanding principal amount underlying the Perceptive Loans and any accrued and unpaid interest thereon. There were no scheduled principal payments on the Perceptive Loans prior to the Maturity Date. On March 23, 2022, the Company retired in full all of its outstanding obligations under the Perceptive Credit Agreement, including a redemption premium of $2.0 million per the amended terms of the Perceptive Credit Agreement, using the proceeds received from a new senior credit facility the Company entered into on that date (see Note 17). All of the Company’s obligations under the Perceptive Credit Agreement were secured by a first-priority lien and security interest in substantially all of the Company’s tangible and intangible assets, including intellectual property and all of the equity interests in the Company’s subsidiaries. The Perceptive Credit Agreement contained certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar financings. The negative covenants restricted or limited the ability of the Company and its subsidiaries to, among other things and subject to certain exceptions contained in the Perceptive Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s or its subsidiaries’ business activities; make certain Investments or Restricted Payments (each as defined in the Perceptive Credit Agreement); change its fiscal year; pay dividends; repay other certain indebtedness; engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that had the impact of restricting the Company’s ability to make loan repayments under the Perceptive Credit Agreement. In addition, the Company was required (i) at all times prior to the Maturity Date to maintain a minimum cash balance of $3.0 million; and (ii) as of the last day of each fiscal quarter commencing with the fiscal quarter ended June 30, 2019, report revenues for the trailing 12-month period that exceed the amounts set forth in the Perceptive Credit Agreement, which ranged from $7.0 million for the fiscal quarter ended June 30, 2019 to $55.0 million for the fiscal quarter ending December 31, 2021. At December 31, 2021, the Company was in compliance with all of the covenants contained in the Perceptive Credit Agreement. As consideration for the Perceptive Credit Agreement, the Company issued to Perceptive a warrant to purchase 1,360,000 shares of the Company’s common stock (the “Perceptive Warrant”) on the Perceptive Closing Date. The Perceptive Warrant has an exercise price equal to $3.28 per share, which is equal to the trailing 10-day volume weighted average price (“VWAP”) of the Company’s common stock on the business day immediately prior to the Perceptive Closing Date multiplied by 1.15. The Company valued the Perceptive Warrant at $2.7 million as of the Perceptive Closing Date and it has an expiration date of February 11, 2029. In connection with the First Perceptive Amendment, the Company issued an additional warrant (the “Perceptive Tranche III Warrant”) to purchase 250,000 shares of the Company’s common stock to Perceptive with an exercise price equal to $4.64 per share, which represents the trailing 10-day VWAP of the Company’s common stock as of May 2, 2019. The Perceptive Tranche III Warrant was valued by the Company at $0.9 million and has an expiration date of May 3, 2029. As consideration for the Second Perceptive Amendment, the Company issued an additional warrant (the “Perceptive Tranche IV Warrant” and, together with the Perceptive Warrant and the Perceptive Tranche III Warrant, the “Perceptive Warrants”) to purchase 2,390,000 shares of the Company’s common stock to Perceptive with an exercise price of $1.94 per share, which is equal to the trailing 10-day VWAP of the Company’s common stock on the business day immediately prior to the date of the Perceptive Second Amendment. The Perceptive Tranche IV Warrant was valued by the Company at $3.7 million and has an expiration date of December 8, 2030. Perceptive had represented to the Company, among other things, that it was an “accredited investor” (as such term is defined in Rule 501(a) of Regulation D under the Securities Act) and the Company issued the Perceptive Warrants in reliance upon an exemption from registration contained in Section 4(2) under the Securities Act. The Perceptive Warrants and the shares of common stock issuable thereunder may not be offered, sold, pledged or otherwise transferred in the U.S. absent registration or an applicable exemption from the registration requirements under the Securities Act. As a result of the fees paid to Perceptive and the value of the Perceptive Warrants, the Company recognized an aggregate discount on the Perceptive Loans in the amount of $7.1 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 Perceptive Warrants and the aggregate amount of fees and expenses associated with obtaining the Perceptive Credit Facility, the effective interest rate on the Perceptive Loans since December 8, 2020 was approximately 13.7%. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 and 2020. Common Stock As of December 31, 2021 and 2020, the Company was authorized to issue 300,000,000 and 150,000,000 shares, respectively, of its common stock, $0.0001 par value per share, and 195,813,817 and 104,902,888 shares of common stock were outstanding as of December 31, 2021 and 2020, 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, 87,241,078 shares of common stock were available for issuance as of December 31, 2021. 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 are being used (i) 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; (ii) to expand the Company’s plasma collection facility network; (iii) to scale up the manufacturing capacity of the Boca Facility and make continuous improvements in order to adhere to cGMP compliance; (iv) to explore business development opportunities; and (v) 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. During the year ended December 31, 2021, the Company issued 5,540,831 shares of its common stock under the Distribution Agreement and received net proceeds of $6.9 million. 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. For the year ended December 31, 2021, the Company issued and sold 27,805,198 shares of common stock under the 2020 Sale Agreement and received net proceeds of $60.4 million. For the year ended December 31, 2020, the Company sold 18,537,907 shares of common under the Sale Agreement and received net proceeds of $42.5 million. On February 11, 2020, the Company completed an underwritten public offering of 23,500,000 shares of its common stock for gross proceeds of $82.3 million. On February 21, 2020, the Company sold an additional 3,525,000 shares pursuant to the underwriters’ exercise of their option to purchase additional shares of the Company’s common stock for additional gross proceeds of $12.3 million. The Company received net proceeds, after underwriting discounts and other expenses associated with the offering, of approximately $88.7 million. During the year ended December 31, 2020, the Company issued 6,626 shares of common stock in connection with the exercise of stock options that had been granted to employees. Warrants On December 8, 2020, the Company issued the Perceptive Tranche IV Warrant, whereby Perceptive may purchase an aggregate of 2,390,000 shares of common stock at an exercise price $1.94 per share (see Note 7). The warrant was valued at $3.7 million, using the Black-Scholes option-pricing model assuming an expected term of 10 years, a volatility of 69.3%, a dividend yield of 0% and a risk-free interest rate of 0.92%. At December 31, 2021 and 2020, the Company had outstanding warrants to purchase an aggregate of 4,528,160 shares of common stock, with a weighted average exercise price of $2.82 per share and expiration dates ranging between June 2022 and December 2030. Equity Incentive Plans From time to time the Company grants 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 Board on March 15, 2017 and by the Company’s stockholders on May 25, 2017. Currently, the maximum number of shares reserved for grant under the 2014 Plan is: (a) 2,334,940 shares; plus (b) an annual increase as of the first day of the Company’s fiscal year, beginning in 2018 and occurring each year thereafter through 2022, equal to 4% of the outstanding shares of common stock as of the end of the Company’s immediately preceding fiscal year, or any lesser number of shares determined by the Board; provided, however, that no more than an aggregate of 10 million shares of common stock may be issued pursuant to incentive stock options intended to qualify under Section 422 of the Internal Revenue Code. As of December 31, 2021, an aggregate of 69,090 shares were available for issuance under the 2014 Plan. In accordance with the foregoing, on January 1, 2022 the aggregate number of shares available for issuance increased to 7,901,643. During the years ended December 31, 2021 and 2020, the Company granted options to purchase an aggregate of 1,895,550 and 1,468,412 shares of common stock, respectively, to its directors, employees and certain third-party service providers. The fair value of stock options granted was determined on the date of grant using the Black-Scholes model. The Black-Scholes option valuation 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, 2021 and 2020, 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, 2021 and 2020 were determined using the Black-Scholes option-pricing model with the following assumptions: Years Ended December 31, 2021 December 31, 2020 Expected term 5.5-6.3 years 5.5-6.3 years Volatility 68-70 % 62-70 % Dividend yield 0.0 0.0 Risk-free interest rate 0.80-1.27 % 0.33-1.68 % The 2014 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. All options granted under the 2014 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, 2021 and 2020: Shares Weighted Average Exercise Price Options outstanding, vested and expected to vest at December 31, 2019 5,630,351 $ 4.76 Forfeited (141,724 ) $ 3.81 Expired (27,482 ) $ 4.26 Granted 1,468,412 $ 2.93 Exercised (6,626 ) $ 2.03 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 Options exercisable 5,521,312 $ 4.54 As of December 31, 2021, the Company had $3.1 million of unrecognized compensation expense related to stock options granted under the Company’s equity incentive plan, which is expected to be recognized over a weighted-average period of 2.4 years. The weighted average remaining contractual term of stock options outstanding and expected to vest at December 31, 2021 is 6.1 years. The weighted average remaining contractual term of stock options exercisable at December 31, 2021 is 4.9 years. The following table summarizes additional information regarding outstanding and exercisable options under the stock option plans at December 31, 2021: 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 - $1.67 352,500 9.6 $ 1.10 $ 35,935 15,583 9.8 $ 1.10 $ 4,831 $1.73 - $2.60 1,673,518 8.9 $ 2.42 - 374,318 8.5 $ 2.42 - $2.62 - $3.93 4,209,177 5.9 $ 3.51 - 3,554,848 5.6 $ 3.51 - $3.98 - $5.97 487,040 5.6 $ 5.07 - 442,202 5.4 $ 5.07 $6.02 - $9.03 892,987 1.1 $ 7.74 - 886,861 1.0 $ 7.74 $9.37 - $10.80 247,500 2.9 $ 10.28 - 247,500 2.9 $ 10.28 - 7,862,722 6.1 $ 3.93 $ 35,935 5,521,312 4.9 $ 4.54 $ 4,831 During the years ended December 31, 2021 and 2020, the Company granted Restricted Stock Units (“RSUs”) representing an aggregate of 4,384,744 and 361,000 shares, respectively, to certain management employees of the Company and, during 2020, to members of its Board of Directors (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 vest on December 31, 2022, with the remainder vesting in quarterly installments through December 31, 2024. The milestone-based RSUs will vest upon achievement of the applicable milestone, with each milestone required to be achieved on or prior to December 31, 2022. The milestones required to be achieved in order for the milestone-based RSUs to vest were determined by the Board and are consistent with the 2022 operating plan approved by the Board. The Company will periodically assess the probability of vesting for each milestone-based RSU and will adjust compensation expense based on its probability assessment. In connection with the completion of the refinancing of the Company’s senior credit facility on March 23, 2022 (see Note 17), 254,745 milestone-based RSUs vested. During the year ended December 31, 2021, 92,750 shares vested in connection with grants of RSUs. With respect to these vested RSUs, 27,850 shares valued at approximately $62,000 were withheld by the Company to cover employees’ tax liabilities. These shares have been retired by the Company and were no longer outstanding as of December 31, 2021. 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, 2019 - $ - Granted 361,000 $ 2.82 Vested (15,000 ) $ 2.92 Forfeited (20,000 ) $ 2.83 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 As of December 31, 2021, the Company had $5.1 million of unrecognized compensation expense related to unvested RSUs granted under the Company’s equity incentive plan, which is expected to be recognized over a weighted-average period of 2.6 years. Total stock-based compensation expense for all awards granted under the Company’s equity incentive plan for the years ended December 31, 2021 and 2020 was as follows: 2021 2020 Research and development $ 153,924 $ 471,146 Plasma center operating expenses 60,257 33,464 Selling, general and administrative 2,958,008 2,107,577 Cost of product revenue 316,064 242,935 Total stock-based compensation expense $ 3,488,253 $ 2,855,122 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2021 | |
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. Effective October 1, 2017, monthly rent on this facility was reduced to $10,000. On September 27, 2018, the agreement was amended to extend the term of the agreement through September 30, 2019. On November 7, 2019, an additional amendment was entered into between Areth and the Company to extend the term of this agreement through September 30, 2020, and to provide for automatic one-year renewals unless ADMA gives written notice of termination to Areth 60 days prior to the end of the term. The Company did not provide such written notice to Areth as of July 31, 2021. Rent expense for the years ended December 31, 2021 and 2020 amounted to $0.1 million. Areth is a company controlled by Dr. Jerrold B. Grossman, the Vice Chairman of the Company’s Board of Directors, and Adam S. Grossman, the Company’s President and Chief Executive Officer. The Company also reimburses Areth for office, warehousing and building related (common area) expenses, equipment and certain other operational expenses, which were not material to the consolidated financial statements for the years ended December 31, 2021 and 2020. During the years ended December 31, 2021 and 2020, 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 and $0.1 million, respectively. Genesis is owned by Dr. Grossman and Adam Grossman. See Notes 7 and 17 for a discussion of the Company’s 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. Such payments are to be made in scheduled installments over a period of 10 months. 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 indirectly through an entity he controls, (ii) Dr. Grossman purchased 100,000 shares of common stock, (iii) Dr. Young Kwon, a member of the Company’s Board of Directors, purchased 100,000 shares of common stock, and (iv) Brian Lenz, the Company’s Executive Vice President and Chief Financial Officer, purchased 30,000 shares of common stock, all at the public offering price of $1.00 per share. In connection with the 2020 public offering of the Company’s common stock (see Note 8) on February 11, 2020: (i) Perceptive Advisors, a principal stockholder of ADMA, purchased 4,563,700 shares of common stock through one of its affiliates, (ii) Dr. Grossman purchased 22,857 shares of common stock directly and 22,857 shares indirectly through an entity he controls, (iii) Lawrence P. Guiheen, a director of the Company, purchased 20,000 shares of common stock, (iv) Mr. Grossman purchased 28,571 shares of common stock directly and 57,143 shares indirectly through an entity he controls, (v) Mr. Lenz purchased 7,142 shares of common stock, and (vi) Dr. Mond purchased 4,285 shares of common stock, all at the public offering price of $3.50 per share. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2021 | |
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 and Omicron 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 previous 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 has experienced lower than normal donor collections at its FDA approved plasma collection centers. 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 has also impacted, to a certain degree, the Company’s customer engagement initiatives, whereby ADMA’s sales and medical affairs field personnel have 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 Company has implemented a comprehensive suite of virtual engagement initiatives; however, clinician engagement has been reduced due to rapidly evolving COVID-19 priorities at U.S. medical centers. 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 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 other regulatory submissions or applications that may be impacted by restrictions related to COVID-19. During the years ended December 31, 2021 and 2020, revenue attributable to international customers was approximately 13% 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 pandemic or its 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 will have a material adverse impact on the Company’s business, financial condition, liquidity and results of operations. Vendor and Licensor 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 (see Note 16). Pursuant to this amendment, until January 1, 2022, the Company may 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 will be 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. 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 to supplement the 2017 Plasma Purchase Agreement. The Company has also increased its number of planned plasma collection center buildouts such that the Company expects to have 10 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 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. These studies are 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. The Company currently expects to incur expenses of approximately $3.0 million to $4.0 million to complete these studies, with both studies to be completed by June of 2023. In connection with the FDA’s 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. The Company expects to incur expenses of approximately $2 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 Company’s Board of Directors upon recommendation of the Compensation Committee of the Board of Directors, 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 is 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 consists 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 will be paid on June 15, 2022. Based on the terms of the retention agreements the Company entered into with each applicable executive and employee, $0.8 million of the first tranche is being recognized over the retention service period, which ends on December 31, 2022, with the remainder having been recognized as expense on September 30, 2021. The second tranche will be recognized as compensation expense over a 15-month period from October 1, 2021 through December 31, 2022. 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, 2021. The Company does not anticipate recognizing any significant losses relating to these arrangements. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 2020 Benefit at U.S. federal statutory rate $ (15,045,999 ) $ (15,907,195 ) State taxes - deferred (251,839 ) (3,797,393 ) Increase in valuation allowance 14,618,762 19,535,265 Research and development credits (239,585 ) (246,989 ) Decrease in federal net operating loss 623,679 - Other 294,982 416,312 Benefit for income taxes $ - $ - A summary of the Company’s deferred tax assets is as follows: Year Ended December 31, 2021 2020 Federal and state net operating loss carryforwards $ 73,036,983 $ 59,114,928 Federal and state research credits 31,333 921,577 Interest expense limitation carryforwards 6,013,040 2,911,508 Transaction costs 977,046 1,080,041 Deferred revenue 519,819 563,956 Accrued expenses and other 1,030,064 2,397,513 Total gross deferred tax assets 81,608,285 66,989,523 Less: valuation allowance for deferred tax assets (81,608,285 ) (66,989,523 ) Net deferred tax assets $ - $ - As of December 31, 2021, the Company had federal and state (post-apportioned basis) net operating losses (“NOLs”) of $299.9 million and $185.0 million, respectively. Approximately $55.2 million and $77.8 million of the foregoing federal and state NOLs, respectively, will expire at various dates from 2027 2041 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, 2021 and 2020, 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, 2021 | |
LEASE OBLIGATIONS [Abstract] | |
LEASE OBLIGATIONS | 12. LEASE OBLIGATIONS The Company leases certain properties and equipment for its ADMA BioCenters subsidiary and certain equipment for its ADMA BioManufacturing subsidiary, 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, 2021 and 2020, the Company used a discount rate of 13% 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. Aggregate lease expense for the Company’s operating leases for the years ended December 31, 2021 and 2020 was $1.4 million and $0.7 million, respectively. Aggregate cash paid on these leases for the years ended December 31, 2021 and 2020 was $1.1 million and $0.5 million, respectively. 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 or intends to open additional plasma collection facilities. Including a finance lease the Company entered into in June 2018, the Company has aggregate lease liabilities of $8.1 million and $4.7 million as of December 31, 2021 and 2020, 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 9.1 years. Scheduled payments under the Company’s lease obligations are as follows: Year ended December 31, 2022 $ 1,596,006 2023 1,641,603 2024 1,517,229 2025 1,525,793 2026 1,260,391 Thereafter 6,345,559 Total payments 13,886,581 Less: imputed interest (5,833,109 ) Current portion (591,084 ) Balance at December 31, 2021 $ 7,462,388 On June 11, 2021, t he Company entered into an additional property lease that the Company intends to use to store certain inventory for its ADMA BioManufacturing business segment. The Company has not taken possession of this leased property and its lease commencement date has not been determined. With the exception of a security deposit and six months’ rent totaling $0.3 million, no payments have been made under this lease. The initial term of the lease is for 90 months with monthly rental payments varying between approximately $14,000 and $24,000, including common area maintenance charges. On January 22, 2022, the Company entered into an additional property lease for its ninth has not taken possession of this leased property and its lease commencement date has not been determined. With the exception of a security deposit and an initial month’s rent totaling approximately $44,000, no payments have been made under this lease. The initial term of the lease is for 126 months with monthly rental payments varying between approximately $18,000 and $25,000, including common area maintenance charges. |
SEGMENTS
SEGMENTS | 12 Months Ended |
Dec. 31, 2021 | |
SEGMENTS [Abstract] | |
SEGMENTS | 13. SEGMENTS The Company is engaged in the manufacture, marketing and development of 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 in various stages of development as of December 31, 2021, six of which are operational and collecting plasma, and five of which hold an approved license with the FDA (and of which one facility has 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, 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 Year Ended December 31, 2020 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 36,673,287 $ 5,403,662 $ 142,834 $ 42,219,783 Cost of product revenue 55,908,696 5,382,730 - 61,291,426 Loss from operations (46,904,634 ) (4,410,890 ) (13,599,353 ) (64,914,877 ) Interest and other expense, net (984,017 ) (7,388 ) (10,834,063 ) (11,825,468 ) Gain on extinguishment of debt - - 991,797 991,797 Net loss (47,888,651 ) (4,418,278 ) (23,441,619 ) (75,748,548 ) Capital expenditures 7,579,437 5,147,243 - 12,726,680 Depreciation and amortization expense 3,341,506 591,593 9,193 3,942,292 Total assets 140,908,957 13,102,008 53,662,429 207,673,394 |
OTHER EMPLOYEE BENEFITS
OTHER EMPLOYEE BENEFITS | 12 Months Ended |
Dec. 31, 2021 | |
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 $1.1 million and $0.9 million of related compensation expense for the years ended December 31, 2021 and 2020, respectively. |
SUPPLEMENTAL DISCLOSURE OF CASH
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 and 2020 is as follows: 2021 2020 SUPPLEMENTAL CASH FLOW INFORMATION: Cash paid for interest $ 11,159,461 $ 10,267,632 Noncash Financing and Investing Activities: Equipment acquired reflected in accounts payable and accrued liabilities $ 1,352,627 $ 973,958 Right-to-use assets in exchange for lease obligations $ 3,554,473 $ 3,329,374 Warrants issued in connection with notes payable $ - $ 3,740,980 |
CONCENTRATIONS
CONCENTRATIONS | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021, three customers accounted for approximately 94% of the Company’s consolidated accounts receivable. At December 31, 2020, three customers accounted for approximately 92% of the Company’s consolidated accounts receivable. For the year ended December 31, 2021, four customers accounted for approximately 81% of the Company’s consolidated revenues. For the year ended December 31, 2020, three customers represented an aggregate of 82% of the Company’s consolidated revenues. The Company purchases substantially all of its raw material plasma from Grifols. For the year ended December 31, 2021, plasma purchases from Grifols were approximately $42.0 million, or 69% of the Company’s total inventory purchases. For the year ended December 31, 2020, plasma purchases from Grifols were approximately $25.0 million, or 68% of the Company’s total inventory purchases. Net revenues according to geographic area, based on the location of where the product is shipped, is as follows: Year Ended December 31, 2021 2020 United States $ 70,625,848 $ 36,552,244 International 10,316,777 5,667,539 Total revenues $ 80,942,625 $ 42,219,783 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2021 | |
SUBSEQUENT EVENTS [Abstract] | |
SUBSEQUENT EVENTS | 17. SUBSEQUENT EVENTS Refinancing of Senior Credit Facility 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”). T he Hayfin Credit Agreement provides for a senior secured term loan facility in a principal amount of up to $175.0 million (the “Hayfin Credit Facility”), composed of (i) a term loan made on the Hayfin Closing Date in the principal amount of $150.0 million(the “Hayfin Closing Date Loan”), and (ii) a delayed draw term loan in the principal amount of $25.0 million (the “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 expires on March 22, 2023 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. 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 Perceptive Credit Facility (see Note 7). The Company also used $2.0 million of the Hayfin Closing Date Loan proceeds to pay a redemption premium to Perceptive and used approximately $0.3 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 Borrowings under the Hayfin Credit Agreement will 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 tenor, as elected by the Company, and subject to a floor of 1.25%, plus an applicable margin of 9.5% (the “Applicable Margin”); provided, however, that upon, and during the continuance of, an Event of Default, the Applicable Margin shall increase by an additional 3% per annum. On the last day of each calendar month or quarter during the term of the Hayfin Credit Facility, the Company will pay accrued interest to Hayfin. The rate of interest in effect as of the Hayfin Closing Date was 10.75%. The Company will also pay “in kind” a portion of the interest on the Hayfin Loans for each monthly or quarterly interest period in an amount equal to 2.5% per annum, which will be added to the principal amount of the outstanding debt under the Hayfin Credit Facility. 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. Prior to the Hayfin Maturity Date, there will be 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 required to pay an exit fee of 1.0% of the amount of principal being paid. All of the Company’s obligations under the Hayfin Credit Agreement are secured by a first-priority lien and security interest in substantially all of the Company’s tangible and intangible assets, including intellectual property and all of the equity interests in the Company’s subsidiaries. The Hayfin Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar financings. The negative covenants restrict or limit the ability of the Company and its subsidiaries to, among other things and subject to certain exceptions contained in the Hayfin Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s or its subsidiaries’ business activities; make certain Investments or Restricted Payments (each as defined in the Hayfin Credit Agreement); change its fiscal year; pay dividends; repay other certain indebtedness; engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that have the impact of restricting the Company’s ability to make loan repayments under the Hayfin Credit Agreement. In addition, the Company is required (i) at all times prior to the Maturity Date to maintain a minimum cash balance of $6.0 million; and (ii) as of the last day of each fiscal quarter commencing with the fiscal quarter ending June 30, 2022, report IVIG product and related revenues for the trailing 12-month period that exceed the amounts set forth in the Hayfin Credit Agreement, which range from $75.0 million for the fiscal quarter ending June 30, 2022 to $250.0 million for the fiscal quarter ending December 31, 2026. As consideration for the Hayfin Credit Agreement, the Company issued to various entities affiliated with Hayfin, on the Hayfin Closing Date, warrants to purchase 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 “Closing Date Exercise Price”). 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 fees paid to Hayfin and the value of the Hayfin Warrants, the Company recognized an aggregate discount on the Hayfin Loans in the amount of $13.2 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 March 23, 2022 was approximately 12.9% |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 and 2020, 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 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 $0.2 million and $0.1 million at December 31, 2021 and December 31, 2020, 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. 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, 2021 and 2020 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, 2021 and 2020. 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, 2021 and 2020 did not result in any impairment charges related to goodwill for the years ended December 31, 2021 and 2020. |
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, 2021 and 2020, the Company determined that there was no impairment of its long-lived assets. |
Revenue Recognition | Revenue recognition Revenues for the years ended December 31, 2021 and 2020 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 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, intermediates and the sale 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. |
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 $1.4 million and $1.1 million for the years ended December 31, 2021 and 2020, 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 2017 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, 2021 and 2020, 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, 2021 2020 Stock options 7,862,722 6,922,931 Restricted stock units 4,485,133 326,000 Warrants 4,528,160 4,528,160 16,876,015 11,777,091 |
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 In June 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (Topic 326) |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Calculation of Diluted Loss Per Common Share | For the years ended December 31, 2021 and 2020, 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, 2021 2020 Stock options 7,862,722 6,922,931 Restricted stock units 4,485,133 326,000 Warrants 4,528,160 4,528,160 16,876,015 11,777,091 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
INVENTORIES [Abstract] | |
Components of Inventory | The following table provides the components of inventories: December 31, December 31, Raw materials $ 36,755,720 $ 32,044,393 Work-in-process 58,968,535 30,293,288 Finished goods 28,999,836 19,197,918 Total inventories $ 124,724,091 $ 81,535,599 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
PROPERTY AND EQUIPMENT [Abstract] | |
Property and Equipment | Property and equipment at December 31, 2021 and 2020 is summarized as follows: December 31, 2021 December 31, 2020 Manufacturing and laboratory equipment $ 16,702,991 $ 14,468,874 Office equipment and computer software 4,082,462 3,253,528 Furniture and fixtures 3,389,140 2,389,585 Construction in process 5,496,222 3,336,557 Leasehold improvements 11,129,639 5,272,490 Land 4,339,441 4,339,441 Buildings and building improvements 19,067,032 17,396,557 64,206,927 50,457,032 Less: Accumulated depreciation (13,271,853 ) (8,863,942 ) Total property, plant and equipment, net $ 50,935,074 $ 41,593,090 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
INTANGIBLE ASSETS [Abstract] | |
Schedule of Intangible Assets | Intangible assets at December 31, 2021 and 2020 consist of the following: December 31, 2021 December 31, 2020 Cost Accumulated Amortization Net Cost Accumulated Amortization Net Trademark and other intangible rights related to Nabi-HB $ 4,100,046 $ 2,684,554 $ 1,415,492 $ 4,100,046 $ 2,098,833 $ 2,001,213 Rights to intermediates 907,421 594,145 313,276 907,421 464,513 442,908 $ 5,007,467 $ 3,278,699 $ 1,728,768 $ 5,007,467 $ 2,563,346 $ 2,444,121 |
Intangible Asset Future Aggregate Amortization Expense | Amortization expense related to the Company’s intangible assets for the years ended December 31, 2021 and 2020 was $0.7 million. Estimated aggregate future aggregate amortization expense is expected to be as follows: 2022 $ 715,352 2023 715,352 2024 298,064 |
ACCRUED EXPENSES AND OTHER LI_2
ACCRUED EXPENSES AND OTHER LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
ACCRUED EXPENSES AND OTHER LIABILITIES [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities at December 31, 2021 and 2020 are as follows: December 31, 2021 December 31, 2020 Accrued rebates $ 5,040,200 $ 2,604,245 Accrued distribution fees 4,739,651 828,120 Accrued incentives 4,066,109 3,210,884 Accrued testing 1,189,970 779,660 Accrued payroll 1,167,072 734,972 Other 1,011,986 207,262 Total accrued expenses and other current liabilities $ 17,214,988 $ 8,365,143 |
NOTES PAYABLE (Tables)
NOTES PAYABLE (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
NOTES PAYABLE [Abstract] | |
Summary of Outstanding Senior Notes Payable | A summary of outstanding senior notes payable is as follows: December 31, 2021 December 31, 2020 Notes payable $ 100,000,000 $ 100,000,000 Less: Debt discount (5,133,761 ) (7,031,134 ) Senior notes payable $ 94,866,239 $ 92,968,866 |
STOCKHOLDERS EQUITY (Tables)
STOCKHOLDERS EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
STOCKHOLDERS' EQUITY [Abstract] | |
Schedule of Assumptions | The grant date fair values of stock options awarded during the years ended December 31, 2021 and 2020 were determined using the Black-Scholes option-pricing model with the following assumptions: Years Ended December 31, 2021 December 31, 2020 Expected term 5.5-6.3 years 5.5-6.3 years Volatility 68-70 % 62-70 % Dividend yield 0.0 0.0 Risk-free interest rate 0.80-1.27 % 0.33-1.68 % |
Schedule of Option Activity | The following table summarizes information about stock options outstanding as of December 31, 2021 and 2020: Shares Weighted Average Exercise Price Options outstanding, vested and expected to vest at December 31, 2019 5,630,351 $ 4.76 Forfeited (141,724 ) $ 3.81 Expired (27,482 ) $ 4.26 Granted 1,468,412 $ 2.93 Exercised (6,626 ) $ 2.03 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 Options exercisable 5,521,312 $ 4.54 |
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, 2021: 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 - $1.67 352,500 9.6 $ 1.10 $ 35,935 15,583 9.8 $ 1.10 $ 4,831 $1.73 - $2.60 1,673,518 8.9 $ 2.42 - 374,318 8.5 $ 2.42 - $2.62 - $3.93 4,209,177 5.9 $ 3.51 - 3,554,848 5.6 $ 3.51 - $3.98 - $5.97 487,040 5.6 $ 5.07 - 442,202 5.4 $ 5.07 $6.02 - $9.03 892,987 1.1 $ 7.74 - 886,861 1.0 $ 7.74 $9.37 - $10.80 247,500 2.9 $ 10.28 - 247,500 2.9 $ 10.28 - 7,862,722 6.1 $ 3.93 $ 35,935 5,521,312 4.9 $ 4.54 $ 4,831 |
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, 2019 - $ - Granted 361,000 $ 2.82 Vested (15,000 ) $ 2.92 Forfeited (20,000 ) $ 2.83 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 |
Schedule of Stock-Based Compensation Expense | Total stock-based compensation expense for all awards granted under the Company’s equity incentive plan for the years ended December 31, 2021 and 2020 was as follows: 2021 2020 Research and development $ 153,924 $ 471,146 Plasma center operating expenses 60,257 33,464 Selling, general and administrative 2,958,008 2,107,577 Cost of product revenue 316,064 242,935 Total stock-based compensation expense $ 3,488,253 $ 2,855,122 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 2020 Benefit at U.S. federal statutory rate $ (15,045,999 ) $ (15,907,195 ) State taxes - deferred (251,839 ) (3,797,393 ) Increase in valuation allowance 14,618,762 19,535,265 Research and development credits (239,585 ) (246,989 ) Decrease in federal net operating loss 623,679 - Other 294,982 416,312 Benefit for income taxes $ - $ - |
Deferred Tax Assets | A summary of the Company’s deferred tax assets is as follows: Year Ended December 31, 2021 2020 Federal and state net operating loss carryforwards $ 73,036,983 $ 59,114,928 Federal and state research credits 31,333 921,577 Interest expense limitation carryforwards 6,013,040 2,911,508 Transaction costs 977,046 1,080,041 Deferred revenue 519,819 563,956 Accrued expenses and other 1,030,064 2,397,513 Total gross deferred tax assets 81,608,285 66,989,523 Less: valuation allowance for deferred tax assets (81,608,285 ) (66,989,523 ) Net deferred tax assets $ - $ - |
LEASE OBLIGATIONS (Tables)
LEASE OBLIGATIONS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
LEASE OBLIGATIONS [Abstract] | |
Payments Under Lease Obligations | The Company’s operating leases have a weighted average remaining term of 9.1 years. Scheduled payments under the Company’s lease obligations are as follows: Year ended December 31, 2022 $ 1,596,006 2023 1,641,603 2024 1,517,229 2025 1,525,793 2026 1,260,391 Thereafter 6,345,559 Total payments 13,886,581 Less: imputed interest (5,833,109 ) Current portion (591,084 ) Balance at December 31, 2021 $ 7,462,388 |
SEGMENTS (Tables)
SEGMENTS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
SEGMENTS [Abstract] | |
Summarized Financial Information Concerning Reportable Segments | Summarized financial information concerning reportable segments is shown in the following tables: 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 Year Ended December 31, 2020 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 36,673,287 $ 5,403,662 $ 142,834 $ 42,219,783 Cost of product revenue 55,908,696 5,382,730 - 61,291,426 Loss from operations (46,904,634 ) (4,410,890 ) (13,599,353 ) (64,914,877 ) Interest and other expense, net (984,017 ) (7,388 ) (10,834,063 ) (11,825,468 ) Gain on extinguishment of debt - - 991,797 991,797 Net loss (47,888,651 ) (4,418,278 ) (23,441,619 ) (75,748,548 ) Capital expenditures 7,579,437 5,147,243 - 12,726,680 Depreciation and amortization expense 3,341,506 591,593 9,193 3,942,292 Total assets 140,908,957 13,102,008 53,662,429 207,673,394 |
SUPPLEMENTAL DISCLOSURE OF CA_2
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION [Abstract] | |
Supplemental Cash Flow Information | Supplemental cash flow information for the years ended December 31, 2021 and 2020 is as follows: 2021 2020 SUPPLEMENTAL CASH FLOW INFORMATION: Cash paid for interest $ 11,159,461 $ 10,267,632 Noncash Financing and Investing Activities: Equipment acquired reflected in accounts payable and accrued liabilities $ 1,352,627 $ 973,958 Right-to-use assets in exchange for lease obligations $ 3,554,473 $ 3,329,374 Warrants issued in connection with notes payable $ - $ 3,740,980 |
CONCENTRATIONS (Tables)
CONCENTRATIONS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 2020 United States $ 70,625,848 $ 36,552,244 International 10,316,777 5,667,539 Total revenues $ 80,942,625 $ 42,219,783 |
ORGANIZATION AND BUSINESS (Deta
ORGANIZATION AND BUSINESS (Details) | Oct. 25, 2021USD ($)shares | Feb. 21, 2020shares | Feb. 11, 2020shares | Dec. 31, 2021USD ($)FacilityProductshares | Dec. 31, 2020USD ($)shares |
Organization and Business [Abstract] | |||||
Number of plasma collection facilities under approval and development | Facility | 10 | ||||
Number of FDA-licensed plasma collection facilities | Facility | 5 | ||||
Number of FDA approved product | Product | 3 | ||||
Working capital | $ 178,400,000 | ||||
Cash and cash equivalents | 51,100,000 | ||||
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 | 121,144,103 | $ 131,195,291 | ||
Underwritten Public Offering [Member] | |||||
Organization and Business [Abstract] | |||||
Proceeds from issuance of common stock, net of offering expenses | 88,700,000 | ||||
Sale Agreement [Member] | Underwritten Public Offering [Member] | |||||
Organization and Business [Abstract] | |||||
Proceeds from issuance of common stock, net of offering expenses | $ 121,100,000 | ||||
Common Stock [Member] | |||||
Organization and Business [Abstract] | |||||
Common stock shares sold during the period (in shares) | shares | 90,846,029 | 45,562,907 | |||
Common Stock [Member] | Underwritten Public Offering [Member] | |||||
Organization and Business [Abstract] | |||||
Common stock shares sold during the period (in shares) | shares | 3,525,000 | 23,500,000 | 90,846,029 |
SUMMARY OF ACCOUNTING POLICIES,
SUMMARY OF ACCOUNTING POLICIES, Accounts Receivable (Details) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Accounts Receivable [Abstract] | ||
Accounts receivable, allowances for contractual credits and doubtful accounts | $ 0.2 | $ 0.1 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES, Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Buildings [Member] | |
Property and Equipment [Abstract] | |
Useful life | 30 years |
Land and Buildings [Member] | Minimum [Member] | |
Property and Equipment [Abstract] | |
Useful life | 3 years |
Land and Buildings [Member] | Maximum [Member] | |
Property and Equipment [Abstract] | |
Useful life | 15 years |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES, Goodwill (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Goodwill [Abstract] | ||
Goodwill | $ 3,529,509 | $ 3,529,509 |
Impairment charges related to goodwill | $ 0 | $ 0 |
SIGNIFICANT ACCOUNTING POLICI_6
SIGNIFICANT ACCOUNTING POLICIES, Impairment of Long-lived Assets (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Impairment of Long-lived Assets [Abstract] | ||
Impairment of long-lived assets | $ 0 | $ 0 |
SIGNIFICANT ACCOUNTING POLICI_7
SIGNIFICANT ACCOUNTING POLICIES, Revenue Recognition (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Biotest License Agreement [Member] | |
Revenue Recognition [Abstract] | |
Amortization period | 22 years |
SIGNIFICANT ACCOUNTING POLICI_8
SIGNIFICANT ACCOUNTING POLICIES, Advertising and Marketing Expenses (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Advertising and Marketing Expenses [Abstract] | ||
Advertising and marketing expenses | $ 1.4 | $ 1.1 |
SIGNIFICANT ACCOUNTING POLICI_9
SIGNIFICANT ACCOUNTING POLICIES, Stock-based Compensation (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Stock-based Compensation [Abstract] | |
Equity incentive plans, vesting period | 4 years |
Equity incentive plans, term | 10 years |
SIGNIFICANT ACCOUNTING POLIC_10
SIGNIFICANT ACCOUNTING POLICIES, Loss per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Loss Per Share [Abstract] | ||
Potentially dilutive securities (in shares) | 16,876,015 | 11,777,091 |
Stock Options [Member] | ||
Loss Per Share [Abstract] | ||
Potentially dilutive securities (in shares) | 7,862,722 | 6,922,931 |
Restricted Stock Units [Member] | ||
Loss Per Share [Abstract] | ||
Potentially dilutive securities (in shares) | 4,485,133 | 326,000 |
Warrants [Member] | ||
Loss Per Share [Abstract] | ||
Potentially dilutive securities (in shares) | 4,528,160 | 4,528,160 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
INVENTORIES [Abstract] | ||
Raw materials | $ 36,755,720 | $ 32,044,393 |
Work-in-process | 58,968,535 | 30,293,288 |
Finished goods | 28,999,836 | 19,197,918 |
Total inventories | $ 124,724,091 | $ 81,535,599 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | $ 64,206,927 | $ 50,457,032 |
Less: accumulated depreciation | (13,271,853) | (8,863,942) |
Total property and equipment, net | 50,935,074 | 41,593,090 |
Depreciation expense | 4,800,000 | 3,200,000 |
Manufacturing and Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | 16,702,991 | 14,468,874 |
Office Equipment and Computer Software [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | 4,082,462 | 3,253,528 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | 3,389,140 | 2,389,585 |
Construction in Process [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | 5,496,222 | 3,336,557 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Property, plant and equipment, gross | 11,129,639 | 5,272,490 |
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 | $ 19,067,032 | $ 17,396,557 |
INTANGIBLE ASSETS, Summary (Det
INTANGIBLE ASSETS, Summary (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Finite-Lived Intangible Assets, Net [Abstract] | ||
Cost | $ 5,007,467 | $ 5,007,467 |
Accumulated amortization | 3,278,699 | 2,563,346 |
Net | 1,728,768 | 2,444,121 |
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 | 2,684,554 | 2,098,833 |
Net | $ 1,415,492 | 2,001,213 |
Amortization period | 7 years | |
Rights to Intermediates [Member] | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Cost | $ 907,421 | 907,421 |
Accumulated amortization | 594,145 | 464,513 |
Net | $ 313,276 | $ 442,908 |
Amortization period | 7 years |
INTANGIBLE ASSETS, Future Aggre
INTANGIBLE ASSETS, Future Aggregate Amortization Expense (Details) | Dec. 31, 2021USD ($) |
Estimated Aggregate Amortization Expense [Abstract] | |
2022 | $ 715,352 |
2023 | 715,352 |
2024 | $ 298,064 |
ACCRUED EXPENSES AND OTHER LI_3
ACCRUED EXPENSES AND OTHER LIABILITIES (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Expenses and Other Current Liabilities [Abstract] | ||
Accrued rebates | $ 5,040,200 | $ 2,604,245 |
Accrued distribution fees | 4,739,651 | 828,120 |
Accrued incentives | 4,066,109 | 3,210,884 |
Accrued testing | 1,189,970 | 779,660 |
Accrued payroll | 1,167,072 | 734,972 |
Other | 1,011,986 | 207,262 |
Total accrued expenses and other current liabilities | $ 17,214,988 | $ 8,365,143 |
NOTES PAYABLE, Senior Notes Pay
NOTES PAYABLE, Senior Notes Payable (Details) - USD ($) | Dec. 08, 2020 | May 02, 2019 | Dec. 31, 2021 | Jun. 30, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 23, 2022 | Feb. 11, 2019 |
Senior Notes Payable [Abstract] | ||||||||
Notes payable | $ 100,000,000 | $ 100,000,000 | $ 100,000,000 | |||||
Less: Debt discount | (5,133,761) | (5,133,761) | (7,031,134) | |||||
Senior notes payable | $ 94,866,239 | 94,866,239 | 92,968,866 | |||||
Subordinated note payable to Biotest | $ 15,000,000 | |||||||
Debt discount percentage | 7.00% | |||||||
Repayment of subordinated debt | $ 14,000,000 | |||||||
Gain on extinguishment of debt | 0 | 991,797 | ||||||
Revenues | $ 80,942,625 | $ 42,219,783 | ||||||
Warrant exercise price per share (in dollars per share) | $ 2.82 | $ 2.82 | $ 2.82 | |||||
Subordinated Notes [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Gain on extinguishment of debt | $ 1,000,000 | |||||||
Second Perceptive Amendment [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Shares issued upon exercise of warrants (in shares) | 2,390,000 | |||||||
Warrant exercise price per share (in dollars per share) | $ 1.94 | $ 1.94 | ||||||
Trailing period for VWAP | 10 days | |||||||
Perceptive Credit Agreement [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Notes payable | $ 100,000,000 | |||||||
Maturity date | Feb. 11, 2029 | |||||||
Credit agreement, interest rate | 7.50% | 7.50% | ||||||
Credit agreement, interest rate provided | 3.50% | |||||||
Increase basis points | 4.00% | |||||||
Effective interest rate | 11.00% | 11.00% | ||||||
Shares issued upon exercise of warrants (in shares) | 1,360,000 | |||||||
Warrant exercise price per share (in dollars per share) | $ 3.28 | $ 3.28 | ||||||
Trailing period for VWAP | 10 days | |||||||
Multiplier for VWAP | 1.15 | |||||||
Fair value of warrants | $ 2,700,000 | |||||||
Perceptive Credit Agreement [Member] | Subsequent Event [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Redemption premium | $ 2,000,000 | |||||||
Perceptive Credit Agreement [Member] | Senior Notes [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Less: Debt discount | $ (7,100,000) | (7,100,000) | ||||||
Perceptive Credit Agreement [Member] | Minimum [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Cash balance | 3,000,000 | $ 3,000,000 | ||||||
Revenues | $ 7,000,000 | |||||||
Perceptive Credit Agreement [Member] | Maximum [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Revenues | $ 55,000,000 | |||||||
Perceptive Credit Agreement [Member] | LIBOR [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Term of variable rate | 1 month | |||||||
Perceptive Credit Agreement [Member] | Marathon Credit Facility [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Maturity date | Mar. 1, 2024 | |||||||
Perceptive Tranche I Loan [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Notes payable | 45,000,000 | |||||||
Perceptive Tranche II Loan [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Notes payable | 27,500,000 | |||||||
Perceptive Tranche III Loan [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Notes payable | 12,500,000 | |||||||
Perceptive Tranche IV Loan [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Notes payable | $ 15,000,000 | |||||||
Perceptive Credit Facility [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Effective interest rate | 13.70% | 13.70% | ||||||
Perceptive Tranche III Warrant [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Maturity date | May 3, 2029 | |||||||
Shares issued upon exercise of warrants (in shares) | 250,000 | |||||||
Warrant exercise price per share (in dollars per share) | $ 4.64 | |||||||
Trailing period for VWAP | 10 days | |||||||
Fair value of warrants | $ 900,000 | |||||||
Perceptive Tranche IV Warrant [Member] | ||||||||
Senior Notes Payable [Abstract] | ||||||||
Maturity date | Dec. 8, 2030 | |||||||
Fair value of warrants | $ 3,700,000 |
STOCKHOLDERS' EQUITY, Preferred
STOCKHOLDERS' EQUITY, Preferred Stock (Details) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
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 | $ 0.0001 |
Preferred stock, outstanding (in shares) | 0 | 0 | 0 |
STOCKHOLDERS' EQUITY, Common St
STOCKHOLDERS' EQUITY, Common Stock (Details) - USD ($) | Oct. 25, 2021 | Sep. 03, 2021 | Feb. 03, 2021 | Aug. 05, 2020 | Feb. 21, 2020 | Feb. 11, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | May 27, 2021 |
Common Stock [Abstract] | |||||||||
Common stock, shares authorized (in shares) | 300,000,000 | 150,000,000 | 150,000,000 | ||||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |||||||
Common stock, shares outstanding (in shares) | 195,813,817 | 104,902,888 | |||||||
Common stock, available for issuance (in shares) | 87,241,078 | ||||||||
Common stock shares sold during the period (in shares) | 57,500,000 | ||||||||
Common stock issuable under agreement | $ 57,500,000 | $ 121,144,103 | $ 131,195,291 | ||||||
Proceeds from issuance of common stock | $ 53,800,000 | 121,144,103 | 131,195,291 | ||||||
Underwritten Public Offering [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Proceeds from issuance of common stock | 88,700,000 | ||||||||
Gross proceeds from issuance of common stock | $ 12,300,000 | $ 82,300,000 | |||||||
Sale Agreement [Member] | Underwritten Public Offering [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Proceeds from issuance of common stock | 121,100,000 | ||||||||
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] | |||||||||
Common Stock [Abstract] | |||||||||
Proceeds from issuance of common stock | $ 42,500,000 | ||||||||
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] | |||||||||
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) | 90,846,029 | 45,562,907 | |||||||
Common stock issuable under agreement | $ 9,085 | $ 4,555 | |||||||
Stock options exercised (in shares) | 6,626 | ||||||||
Common Stock [Member] | Underwritten Public Offering [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Common stock shares sold during the period (in shares) | 3,525,000 | 23,500,000 | 90,846,029 | ||||||
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] | Sale Agreement, Amended [Member] | Jefferies LLC [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Common stock shares sold during the period (in shares) | 18,537,907 | ||||||||
Common Stock [Member] | Distribution Agreement [Member] | Raymond James & Associates Inc. [Member] | |||||||||
Common Stock [Abstract] | |||||||||
Common stock shares sold during the period (in shares) | 5,540,831 |
STOCKHOLDERS' EQUITY, Warrants
STOCKHOLDERS' EQUITY, Warrants (Details) - USD ($) $ / shares in Units, $ in Millions | Dec. 08, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Warrants [Abstract] | |||
Warrant exercise price (in dollars per share) | $ 2.82 | $ 2.82 | |
Common Stock [Member] | |||
Warrants [Abstract] | |||
Warrants outstanding (in shares) | 4,528,160 | 4,528,160 | |
Perceptive Tranche IV Warrant [Member] | |||
Warrants [Abstract] | |||
Warrant to purchase shares of common stock (in shares) | 2,390,000 | ||
Warrant exercise price (in dollars per share) | $ 1.94 | ||
Fair value of warrants | $ 3.7 | ||
Expected term | 10 years | ||
Volatility | 69.30% | ||
Dividend yield | 0.00% | ||
Risk-free interest rate | 0.92% |
STOCKHOLDERS' EQUITY, Equity In
STOCKHOLDERS' EQUITY, Equity Incentive Plans (Details) - USD ($) | Mar. 23, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 01, 2022 |
Stock Options [Abstract] | ||||
Shares reserved for grant (in shares) | 87,241,078 | |||
Number of stock options granted (in shares) | 1,895,550 | 1,468,412 | ||
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 | 4 years 10 months 24 days | |||
Stock Option Outstanding and Exercisable [Abstract] | ||||
Outstanding at beginning of period (in shares) | 7,862,722 | |||
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) | $ 3.93 | |||
Options outstanding, aggregate intrinsic value | $ 35,935 | |||
Options exercisable (in shares) | 5,521,312 | |||
Weighted average remaining contractual life of stock options, exercisable | 4 years 10 months 24 days | |||
Options exercisable, weighted average exercise price (in dollars per share) | $ 4.54 | |||
Options exercisable, aggregate intrinsic value | $ 4,831 | |||
Restricted Stock Units [Abstract] | ||||
Restricted stock units vested over a period | 4 years | |||
Total stock-based compensation expense, Amount [Abstract] | ||||
Stock-based compensation | $ 3,488,253 | $ 2,855,122 | ||
Research and Development [Member] | ||||
Total stock-based compensation expense, Amount [Abstract] | ||||
Stock-based compensation | 153,924 | 471,146 | ||
Plasma Center Operating Expenses [Member] | ||||
Total stock-based compensation expense, Amount [Abstract] | ||||
Stock-based compensation | 60,257 | 33,464 | ||
Selling, General and Administrative [Member] | ||||
Total stock-based compensation expense, Amount [Abstract] | ||||
Stock-based compensation | 2,958,008 | 2,107,577 | ||
Cost of Product Revenue [Member] | ||||
Total stock-based compensation expense, Amount [Abstract] | ||||
Stock-based compensation | $ 316,064 | $ 242,935 | ||
$1.10 - $1.67 [Member] | ||||
Stock Options [Abstract] | ||||
Weighted average remaining contractual life of stock options, outstanding | 9 years 7 months 6 days | |||
Stock Option Outstanding and Exercisable [Abstract] | ||||
Exercise price range, lower limit (in dollars per share) | $ 1.10 | |||
Exercise price range, upper limit (in dollars per share) | $ 1.67 | |||
Outstanding at beginning of period (in shares) | 352,500 | |||
Weighted average remaining contractual life of stock options, outstanding | 9 years 7 months 6 days | |||
Options outstanding, weighted average exercise price (in dollars per share) | $ 1.10 | |||
Options outstanding, aggregate intrinsic value | $ 35,935 | |||
Options exercisable (in shares) | 15,583 | |||
Weighted average remaining contractual life of stock options, exercisable | 9 years 9 months 18 days | |||
Options exercisable, weighted average exercise price (in dollars per share) | $ 1.10 | |||
Options exercisable, aggregate intrinsic value | $ 4,831 | |||
$1.73 - $2.60 [Member] | ||||
Stock Options [Abstract] | ||||
Weighted average remaining contractual life of stock options, outstanding | 8 years 10 months 24 days | |||
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) | $ 2.60 | |||
Outstanding at beginning of period (in shares) | 1,673,518 | |||
Weighted average remaining contractual life of stock options, outstanding | 8 years 10 months 24 days | |||
Options outstanding, weighted average exercise price (in dollars per share) | $ 2.42 | |||
Options outstanding, aggregate intrinsic value | $ 0 | |||
Options exercisable (in shares) | 374,318 | |||
Weighted average remaining contractual life of stock options, exercisable | 8 years 6 months | |||
Options exercisable, weighted average exercise price (in dollars per share) | $ 2.42 | |||
Options exercisable, aggregate intrinsic value | $ 0 | |||
$2.62 - $3.93 [Member] | ||||
Stock Options [Abstract] | ||||
Weighted average remaining contractual life of stock options, outstanding | 5 years 10 months 24 days | |||
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) | 4,209,177 | |||
Weighted average remaining contractual life of stock options, outstanding | 5 years 10 months 24 days | |||
Options outstanding, weighted average exercise price (in dollars per share) | $ 3.51 | |||
Options outstanding, aggregate intrinsic value | $ 0 | |||
Options exercisable (in shares) | 3,554,848 | |||
Weighted average remaining contractual life of stock options, exercisable | 5 years 7 months 6 days | |||
Options exercisable, weighted average exercise price (in dollars per share) | $ 3.51 | |||
Options exercisable, aggregate intrinsic value | $ 0 | |||
$3.98 - $5.97 [Member] | ||||
Stock Options [Abstract] | ||||
Weighted average remaining contractual life of stock options, outstanding | 5 years 7 months 6 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) | 487,040 | |||
Weighted average remaining contractual life of stock options, outstanding | 5 years 7 months 6 days | |||
Options outstanding, weighted average exercise price (in dollars per share) | $ 5.07 | |||
Options outstanding, aggregate intrinsic value | $ 0 | |||
Options exercisable (in shares) | 442,202 | |||
Weighted average remaining contractual life of stock options, exercisable | 5 years 4 months 24 days | |||
Options exercisable, weighted average exercise price (in dollars per share) | $ 5.07 | |||
$6.02 - $9.03 [Member] | ||||
Stock Options [Abstract] | ||||
Weighted average remaining contractual life of stock options, outstanding | 1 year 1 month 6 days | |||
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) | 892,987 | |||
Weighted average remaining contractual life of stock options, outstanding | 1 year 1 month 6 days | |||
Options outstanding, weighted average exercise price (in dollars per share) | $ 7.74 | |||
Options outstanding, aggregate intrinsic value | $ 0 | |||
Options exercisable (in shares) | 886,861 | |||
Weighted average remaining contractual life of stock options, exercisable | 1 year | |||
Options exercisable, weighted average exercise price (in dollars per share) | $ 7.74 | |||
$9.37 - $10.80 [Member] | ||||
Stock Options [Abstract] | ||||
Weighted average remaining contractual life of stock options, outstanding | 2 years 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) | $ 10.80 | |||
Outstanding at beginning of period (in shares) | 247,500 | |||
Weighted average remaining contractual life of stock options, outstanding | 2 years 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 | 2 years 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 | 4.00% | |||
Shares available for issuance (in shares) | 10,000,000 | |||
Stock Option Outstanding and Exercisable [Abstract] | ||||
Unrecognized compensation expense, stock options | $ 3,100,000 | |||
Unrecognized compensation expense recognition period | 2 years 4 months 24 days | |||
Equity Incentive Plans [Member] | Subsequent Event [Member] | ||||
Stock Options [Abstract] | ||||
Shares available for issuance (in shares) | 7,901,643 | |||
Stock Options [Member] | ||||
Fair Value Assumptions and Methodology [Abstract] | ||||
Dividend yield | 0.00% | 0.00% | ||
Stock Option, Shares [Abstract] | ||||
Options outstanding, vested and expected to vest, beginning balance (in shares) | 6,922,931 | 5,630,351 | ||
Forfeited (in shares) | (529,202) | (141,724) | ||
Expired (in shares) | (426,557) | (27,482) | ||
Granted (in shares) | 1,895,550 | 1,468,412 | ||
Exercised (in shares) | 0 | (6,626) | ||
Options outstanding, vested and expected to vest, ending balance (in shares) | 7,862,722 | 6,922,931 | ||
Options exercisable (in shares) | 5,521,312 | |||
Stock Options, Weighted Average Exercise Price [Abstract] | ||||
Options outstanding, vested and expected to vest, weighted average exercise price, beginning balance (in dollars per share) | $ 4.40 | $ 4.76 | ||
Forfeited, weighted average exercise price (in dollars per share) | 2.89 | 3.81 | ||
Expired, weighted average exercise price (in dollars per share) | 4.91 | 4.26 | ||
Granted, weighted average exercise price (in dollars per share) | 2.14 | 2.93 | ||
Exercised, weighted average exercise price (in dollars per share) | 0 | 2.03 | ||
Options outstanding, vested and expected to vest, weighted average exercise price, ending balance (in dollars per share) | 3.93 | $ 4.40 | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 4.54 | |||
Stock Options [Member] | Minimum [Member] | ||||
Fair Value Assumptions and Methodology [Abstract] | ||||
Expected term | 5 years 6 months | 5 years 6 months | ||
Volatility | 68.00% | 62.00% | ||
Risk-free interest rate | 0.80% | 0.33% | ||
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 | 70.00% | 70.00% | ||
Risk-free interest rate | 1.27% | 1.68% | ||
Restricted Stock Units (RSUs) [Member] | ||||
Stock Option Outstanding and Exercisable [Abstract] | ||||
Unrecognized compensation expense, non option | $ 5,100,000 | |||
Unrecognized compensation expense recognition period | 2 years 7 months 6 days | |||
Restricted Stock Units [Abstract] | ||||
Shares withheld for tax withholding obligation (in shares) | 27,850 | |||
Amount of shares withheld for tax withholding obligation | $ 62,000 | |||
Unvested RSU, Shares [Abstract] | ||||
Beginning balance (in shares) | 326,000 | 0 | ||
Granted (in shares) | 4,384,744 | 361,000 | ||
Vested (in shares) | (92,750) | (15,000) | ||
Forfeited (in shares) | (132,861) | (20,000) | ||
Ending balance (in shares) | 4,485,133 | 326,000 | ||
Unvested RSU, Weighted Average Grant Date Fair Value | ||||
Unvested, Weighted average grant date fair value, beginning balance (in dollars per share) | $ 2.81 | $ 0 | ||
Granted, Weighted average grant date fair value (in dollars per share) | 1.30 | 2.82 | ||
Vested, Weighted average grant date fair value (in dollars per share) | 2.82 | 2.92 | ||
Forfeited, Weighted average grant date fair value (in dollars per share) | 2.51 | 2.83 | ||
Unvested, Weighted average grant date fair value, ending balance (in dollars per share) | $ 1.34 | $ 2.81 | ||
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 | 50.00% | |||
Milestone Based Restricted Stock (RSUs) [Member] | Subsequent Event [Member] | ||||
Unvested RSU, Shares [Abstract] | ||||
Vested (in shares) | (254,745) | |||
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 ($) | Oct. 25, 2021 | Feb. 11, 2020 | Oct. 31, 2017 | Dec. 31, 2021 | Dec. 31, 2020 |
Related Party Transactions [Abstract] | |||||
Common stock shares sold during the period (in shares) | 57,500,000 | ||||
Public offering price (in dollars per share) | $ 1 | $ 3.50 | |||
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 | ||||
Common stock shares sold during the period (in shares) | 4,285 | ||||
Mr. Grossman [Member] | Direct [Member] | |||||
Related Party Transactions [Abstract] | |||||
Common stock shares sold during the period (in shares) | 100,000 | 28,571 | |||
Mr. Grossman [Member] | Indirect [Member] | |||||
Related Party Transactions [Abstract] | |||||
Common stock shares sold during the period (in shares) | 250,000 | 57,143 | |||
Dr. Grossman [Member] | |||||
Related Party Transactions [Abstract] | |||||
Common stock shares sold during the period (in shares) | 100,000 | ||||
Dr. Grossman [Member] | Direct [Member] | |||||
Related Party Transactions [Abstract] | |||||
Common stock shares sold during the period (in shares) | 22,857 | ||||
Dr. Grossman [Member] | Indirect [Member] | |||||
Related Party Transactions [Abstract] | |||||
Common stock shares sold during the period (in shares) | 22,857 | ||||
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) | 30,000 | 7,142 | |||
Lawrence P. Guiheen [Member] | |||||
Related Party Transactions [Abstract] | |||||
Common stock shares sold during the period (in shares) | 20,000 | ||||
Perceptive [Member] | |||||
Related Party Transactions [Abstract] | |||||
Minimum percentage of common stock held by lender | 5.00% | ||||
Common stock shares sold during the period (in shares) | 4,563,700 | ||||
Areth, LLC [Member] | |||||
Related Party Transactions [Abstract] | |||||
Rent expense | $ 10,000 | $ 100,000 | $ 100,000 | ||
Lease automatic renewal period | 1 year | ||||
Notice period for termination | 60 days | ||||
Genesis [Member] | |||||
Related Party Transactions [Abstract] | |||||
Purchased materials amount | $ 200,000 | $ 100,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) | Apr. 01, 2019USD ($) | Dec. 19, 2012USD ($) | Dec. 31, 2021USD ($)TermFacilityTrancheCenter | Dec. 31, 2020USD ($) | Jun. 15, 2022USD ($) | Sep. 30, 2021USD ($) |
Vendor and Licensor Commitments [Abstract] | ||||||
Number of FDA inspections completed | Facility | 2 | |||||
Plasma supply agreement term | 10 years | |||||
Post-Marketing Commitments [Abstract] | ||||||
Amount of expenses to complete studies | $ 2,000,000 | $ 3,646,060 | $ 5,907,013 | |||
Other Commitments [Abstract] | ||||||
Number of tranches | Tranche | 2 | |||||
Compensation expense period | 15 years | |||||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | International Customers [Member] | ||||||
Vendor and Licensor Commitments [Abstract] | ||||||
Concentration risk, percentage | 13.00% | 13.00% | ||||
Maximum [Member] | ||||||
Post-Marketing Commitments [Abstract] | ||||||
Amount of expenses to complete studies | $ 4,000,000 | |||||
Minimum [Member] | ||||||
Post-Marketing Commitments [Abstract] | ||||||
Amount of expenses to complete studies | $ 3,000,000 | |||||
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 | 5.00% | |||||
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, 2021 | Dec. 31, 2020 | |
INCOME TAXES [Abstract] | ||
Benefit at U.S. Federal statutory rate | $ (15,045,999) | $ (15,907,195) |
State taxes - deferred | (251,839) | (3,797,393) |
Increase in valuation allowance | 14,618,762 | 19,535,265 |
Research and development credits | (239,585) | (246,989) |
Decrease in federal net operating loss | 623,679 | 0 |
Other | 294,982 | 416,312 |
Benefit for income taxes | $ 0 | $ 0 |
INCOME TAXES, Deferred Tax Asse
INCOME TAXES, Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
INCOME TAXES [Abstract] | ||
Federal and state net operating loss carryforwards | $ 73,036,983 | $ 59,114,928 |
Federal and state research credits | 31,333 | 921,577 |
Interest expense limitations carryforwards | 6,013,040 | 2,911,508 |
Transaction costs | 977,046 | 1,080,041 |
Deferred revenue | 519,819 | 563,956 |
Accrued expenses and other | 1,030,064 | 2,397,513 |
Total gross deferred tax assets | 81,608,285 | 66,989,523 |
Less: valuation allowance for deferred tax assets | (81,608,285) | (66,989,523) |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAXES, Net Operating Los
INCOME TAXES, Net Operating Loss Carryforwards (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
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, 2041 | |
Federal [Member] | ||
Net Operating Loss Carryforwards [Abstract] | ||
Net operating loss carryforwards | $ 299,900,000 | |
Write-off of federal NOLs | 3,000,000 | |
Write-off of federal research and development tax credits | 1,000,000 | |
Federal [Member] | 2027 through 2040 [Member] | ||
Net Operating Loss Carryforwards [Abstract] | ||
Net operating loss carryforwards | 55,200,000 | |
State [Member] | ||
Net Operating Loss Carryforwards [Abstract] | ||
Net operating loss carryforwards | 185,000,000 | |
Write-off of state NOLs | 28,100,000 | |
State [Member] | 2027 through 2040 [Member] | ||
Net Operating Loss Carryforwards [Abstract] | ||
Net operating loss carryforwards | $ 77,800,000 |
LEASE OBLIGATIONS (Details)
LEASE OBLIGATIONS (Details) | Jan. 22, 2022USD ($)Facility | Dec. 31, 2021USD ($)Lease | Dec. 31, 2020USD ($) | Jun. 11, 2021USD ($) |
LEASE OBLIGATIONS [Abstract] | ||||
Incremental borrowing rate | 13.00% | |||
Aggregate lease expense | $ 1,400,000 | $ 700,000 | ||
Cash payments for lease | 1,100,000 | 500,000 | ||
Right to use assets | 3,600,000 | |||
Lease liabilities | $ 3,600,000 | |||
Number of new property leases | Lease | 4 | |||
Operating and financing lease liabilities | $ 8,100,000 | 4,700,000 | ||
Weighted average remaining term | 9 years 1 month 6 days | |||
Payments Under Lease Obligations [Abstract] | ||||
Year ended December 31, 2022 | $ 1,596,006 | |||
2023 | 1,641,603 | |||
2024 | 1,517,229 | |||
2025 | 1,525,793 | |||
2026 | 1,260,391 | |||
Thereafter | 6,345,559 | |||
Total payments | 13,886,581 | |||
Less: imputed interest | (5,833,109) | |||
Current portion | (591,084) | (365,682) | ||
Balance at December 31, 2021 | 7,462,388 | $ 4,334,151 | ||
Lease [Abstract] | ||||
Security deposit and initial payment | $ 300,000 | |||
Rental payment | $ 0 | |||
Initial term of lease | 90 months | |||
Subsequent Event [Member] | ||||
Lease [Abstract] | ||||
Security deposit and initial payment | $ 44,000 | |||
Rental payment | $ 0 | |||
Initial term of lease | 126 months | |||
Number of additional plasma collection facilities | Facility | 9 | |||
Minimum [Member] | ||||
Lease [Abstract] | ||||
Rental expense | $ 14,000 | |||
Minimum [Member] | Subsequent Event [Member] | ||||
Lease [Abstract] | ||||
Rental expense | $ 18,000 | |||
Maximum [Member] | ||||
Lease [Abstract] | ||||
Rental expense | $ 24,000 | |||
Maximum [Member] | Subsequent Event [Member] | ||||
Lease [Abstract] | ||||
Rental expense | $ 25,000 |
SEGMENTS (Details)
SEGMENTS (Details) | 12 Months Ended | |
Dec. 31, 2021USD ($)Facility | Dec. 31, 2020USD ($) | |
Segment Reporting Information [Abstract] | ||
Number of plasma collection facilities under development | Facility | 10 | |
Number of operational collection plasma facilities | Facility | 6 | |
Number of FDA-licensed plasma collection facilities | Facility | 5 | |
Number of FDA-licensed plasma collection facilities received approval from Korean Ministry of Food and Drug Safety | Facility | 1 | |
Revenues | $ 80,942,625 | $ 42,219,783 |
Cost of product revenue | 79,769,341 | 61,291,426 |
Loss from operations | (58,373,741) | (64,914,877) |
Interest and other expense, net | (13,273,877) | (11,825,468) |
Gain (loss) on extinguishment of debt | 0 | 991,797 |
Net loss | (71,647,618) | (75,748,548) |
Capital expenditures | 13,511,258 | 12,726,680 |
Depreciation and amortization expense | 5,495,502 | 3,942,292 |
Total assets | 276,252,724 | 207,673,394 |
Corporate [Member] | ||
Segment Reporting Information [Abstract] | ||
Revenues | 142,834 | 142,834 |
Cost of product revenue | 0 | 0 |
Loss from operations | (17,024,068) | (13,599,353) |
Interest and other expense, net | (13,050,164) | (10,834,063) |
Gain (loss) on extinguishment of debt | 991,797 | |
Net loss | (30,074,232) | (23,441,619) |
Capital expenditures | 0 | 0 |
Depreciation and amortization expense | 5,334 | 9,193 |
Total assets | 43,180,014 | 53,662,429 |
Operating Segments [Member] | ADMA BioManufacturing [Member] | ||
Segment Reporting Information [Abstract] | ||
Revenues | 74,935,528 | 36,673,287 |
Cost of product revenue | 74,124,999 | 55,908,696 |
Loss from operations | (29,293,309) | (46,904,634) |
Interest and other expense, net | (218,053) | (984,017) |
Gain (loss) on extinguishment of debt | 0 | |
Net loss | (29,511,362) | (47,888,651) |
Capital expenditures | 4,876,983 | 7,579,437 |
Depreciation and amortization expense | 4,217,771 | 3,341,506 |
Total assets | 208,391,019 | 140,908,957 |
Operating Segments [Member] | Plasma Collection Centers [Member] | ||
Segment Reporting Information [Abstract] | ||
Revenues | 5,864,263 | 5,403,662 |
Cost of product revenue | 5,644,342 | 5,382,730 |
Loss from operations | (12,056,364) | (4,410,890) |
Interest and other expense, net | (5,660) | (7,388) |
Gain (loss) on extinguishment of debt | 0 | |
Net loss | (12,062,024) | (4,418,278) |
Capital expenditures | 8,634,275 | 5,147,243 |
Depreciation and amortization expense | 1,272,397 | 591,593 |
Total assets | $ 24,681,691 | $ 13,102,008 |
OTHER EMPLOYEE BENEFITS (Detail
OTHER EMPLOYEE BENEFITS (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
OTHER EMPLOYEE BENEFITS [Abstract] | ||
Compensation expense | $ 1.1 | $ 0.9 |
SUPPLEMENTAL DISCLOSURE OF CA_3
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
SUPPLEMENTAL CASH FLOW INFORMATION [Abstract] | ||
Cash paid for interest | $ 11,159,461 | $ 10,267,632 |
Noncash Financing and Investing Activities [Abstract] | ||
Equipment acquired reflected in accounts payable and accrued liabilities | 1,352,627 | 973,958 |
Right-to-use assets in exchange for lease obligations | 3,554,473 | 3,329,374 |
Warrants issued in connection with notes payable | $ 0 | $ 3,740,980 |
CONCENTRATIONS (Details)
CONCENTRATIONS (Details) | 12 Months Ended | |
Dec. 31, 2021USD ($)Customer | Dec. 31, 2020USD ($)Customer | |
Risks and Uncertainties [Abstract] | ||
Plasma purchased from Grifols | $ 42,000,000 | $ 25,000,000 |
Percentage of inventory purchases | 69.00% | 68.00% |
Segment Reporting Information [Abstract] | ||
Revenues | $ 80,942,625 | $ 42,219,783 |
United States [Member] | ||
Segment Reporting Information [Abstract] | ||
Revenues | 70,625,848 | 36,552,244 |
International [Member] | ||
Segment Reporting Information [Abstract] | ||
Revenues | $ 10,316,777 | $ 5,667,539 |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Three Customers [Member] | ||
Risks and Uncertainties [Abstract] | ||
Number of customers | Customer | 3 | 3 |
Concentration risk, percentage | 94.00% | 92.00% |
Revenue [Member] | Customer Concentration Risk [Member] | Three Customers [Member] | ||
Risks and Uncertainties [Abstract] | ||
Number of customers | Customer | 3 | |
Concentration risk, percentage | 82.00% | |
Revenue [Member] | Customer Concentration Risk [Member] | Four Customers [Member] | ||
Risks and Uncertainties [Abstract] | ||
Number of customers | Customer | 4 | |
Concentration risk, percentage | 81.00% |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) | Mar. 23, 2022USD ($)d$ / sharesshares | Dec. 31, 2026USD ($) | Jun. 30, 2022USD ($) | Dec. 31, 2021USD ($)$ / shares | Dec. 31, 2020USD ($)$ / shares |
Refinancing of Senior Credit Facility [Abstract] | |||||
Notes payable | $ 100,000,000 | $ 100,000,000 | |||
Payment for outstanding obligations | 0 | 13,950,000 | |||
Loss on extinguishment of debt | 0 | 991,797 | |||
Revenues | $ 80,942,625 | $ 42,219,783 | |||
Warrant exercise price per share (in dollars per share) | $ / shares | $ 2.82 | $ 2.82 | |||
Debt discount | $ 5,133,761 | $ 7,031,134 | |||
Hayfin Credit Agreement [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Maturity date | Mar. 23, 2029 | ||||
Trailing period for VWAP | 30 days | ||||
Hayfin Credit Agreement [Member] | Subsequent Event [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Upfront fee paid in kind | $ 1,800,000 | ||||
Loss on extinguishment of debt | $ (6,700,000) | ||||
Applicable margin | 9.50% | ||||
Effective interest rate | 12.90% | ||||
Percentage of interest amount to pay in kind | 2.50% | ||||
Percentage of exit fee on outstanding principal amount being paid | 1.00% | ||||
Scheduled principal payments | $ 0 | ||||
Increase applicable margin | 3.00% | ||||
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 | ||||
Fair value of warrants | $ 9,600,000 | ||||
Debt discount | $ 13,200,000 | ||||
Hayfin Credit Agreement [Member] | Minimum [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Cash balance | $ 6,000,000 | ||||
Hayfin Credit Agreement [Member] | Minimum [Member] | Forecast [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Revenues | $ 75,000,000 | ||||
Hayfin Credit Agreement [Member] | Maximum [Member] | Forecast [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Revenues | $ 250,000,000 | ||||
Hayfin Credit Agreement [Member] | Prepaid on or Prior to First Anniversary [Member] | Subsequent Event [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Percentage of prepaid principal amount | 7.00% | ||||
Hayfin Credit Agreement [Member] | Prepaid after the First Anniversary [Member] | Subsequent Event [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Percentage of prepaid principal amount | 3.00% | ||||
Hayfin Credit Agreement [Member] | Prepaid after the Second Anniversary [Member] | Subsequent Event [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Percentage of prepaid principal amount | 1.00% | ||||
Hayfin Credit Agreement [Member] | Federal Funds Rate [Member] | Subsequent Event [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Credit agreement, interest rate provided | 0.50% | ||||
Hayfin Credit Agreement [Member] | Secured Overnight Financing Rate [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Term of variable rate | 1 month | ||||
Hayfin Credit Agreement [Member] | Secured Overnight Financing Rate [Member] | Subsequent Event [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Credit agreement, interest rate provided | 1.00% | ||||
Applicable margin | 8.50% | ||||
Hayfin Credit Agreement [Member] | Secured Overnight Financing Rate [Member] | Minimum [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Term of variable rate | 1 month | ||||
Hayfin Credit Agreement [Member] | Secured Overnight Financing Rate [Member] | Maximum [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Term of variable rate | 3 months | ||||
Hayfin Credit Agreement [Member] | Base Rate [Member] | Subsequent Event [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Percentage of floor interest rate | 1.25% | ||||
Hayfin Credit Facility [Member] | Hayfin Credit Agreement [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Maturity date | Mar. 23, 2027 | ||||
Hayfin Credit Facility [Member] | Hayfin Credit Agreement [Member] | Maximum [Member] | Subsequent Event [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Notes payable | $ 175,000,000 | ||||
Hayfin Closing Date Loan [Member] | Subsequent Event [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Payment for outstanding obligations | 100,000,000 | ||||
Hayfin Closing Date Loan [Member] | Hayfin Credit Agreement [Member] | Subsequent Event [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Notes payable | 150,000,000 | ||||
Redemption premium | 2,000,000 | ||||
Payment for certain fees and expenses | $ 300,000 | ||||
Effective interest rate | 10.75% | ||||
Hayfin Delayed Draw Loan [Member] | Hayfin Credit Agreement [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Maturity date | Mar. 22, 2023 | ||||
Hayfin Delayed Draw Loan [Member] | Hayfin Credit Agreement [Member] | Subsequent Event [Member] | |||||
Refinancing of Senior Credit Facility [Abstract] | |||||
Notes payable | $ 25,000,000 |