Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 06, 2022 | |
Entity Listings [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
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 Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 196,351,925 | |
Common Stock [Member] | ||
Entity Listings [Line Items] | ||
Title of 12(b) Security | Common Stock | |
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 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 69,504,946 | $ 51,089,118 |
Accounts receivable, net | 25,629,625 | 28,576,857 |
Inventories | 139,146,311 | 124,724,091 |
Prepaid expenses and other current assets | 5,519,301 | 4,339,245 |
Total current assets | 239,800,183 | 208,729,311 |
Property and equipment, net | 53,220,480 | 50,935,074 |
Intangible assets, net | 1,549,930 | 1,728,768 |
Goodwill | 3,529,509 | 3,529,509 |
Right-to-use assets | 7,106,642 | 7,262,658 |
Deposits and other assets | 2,825,748 | 4,067,404 |
TOTAL ASSETS | 308,032,492 | 276,252,724 |
Current liabilities: | ||
Accounts payable | 14,115,135 | 12,429,409 |
Accrued expenses and other current liabilities | 16,654,540 | 17,214,988 |
Current portion of deferred revenue | 142,834 | 142,834 |
Current portion of lease obligations | 654,003 | 591,084 |
Total current liabilities | 31,566,512 | 30,378,315 |
Senior notes payable, net of discount | 138,423,052 | 94,866,239 |
Deferred revenue, net of current portion | 1,940,156 | 1,975,865 |
End of term fee | 1,500,000 | 0 |
Lease obligations, net of current portion | 7,284,079 | 7,462,388 |
Other non-current liabilities | 385,628 | 397,351 |
TOTAL LIABILITIES | 181,099,427 | 135,080,158 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS' EQUITY | ||
Preferred Stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding | 0 | 0 |
Common Stock - voting, $0.0001 par value, 300,000,000 shares authorized, 196,347,529 and 195,813,817 shares issued and outstanding | 19,635 | 19,581 |
Additional paid-in capital | 564,034,008 | 553,265,706 |
Accumulated deficit | (437,120,578) | (412,112,721) |
TOTAL STOCKHOLDERS' EQUITY | 126,933,065 | 141,172,566 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 308,032,492 | $ 276,252,724 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
STOCKHOLDERS' EQUITY | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 196,347,529 | 195,813,817 |
Common stock, shares outstanding (in shares) | 196,347,529 | 195,813,817 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
REVENUES: | ||
Revenues | $ 29,103,093 | $ 16,048,618 |
Cost of product revenue | 25,441,046 | 17,770,122 |
Gross profit (loss) | 3,662,047 | (1,721,504) |
OPERATING EXPENSES: | ||
Research and development | 624,111 | 987,649 |
Plasma center operating expenses | 3,974,589 | 2,242,343 |
Amortization of intangible assets | 178,838 | 178,838 |
Selling, general and administrative | 13,699,575 | 10,033,915 |
Total operating expenses | 18,477,113 | 13,442,745 |
LOSS FROM OPERATIONS | (14,815,066) | (15,164,249) |
OTHER INCOME (EXPENSE): | ||
Interest income | 33,068 | 22,059 |
Interest expense | (3,389,038) | (3,195,750) |
Loss on extinguishment of debt | (6,669,941) | 0 |
Other expense | (166,880) | (42,001) |
Other expense, net | (10,192,791) | (3,215,692) |
NET LOSS | $ (25,007,857) | $ (18,379,941) |
BASIC LOSS PER COMMON SHARE (in dollars per share) | $ (0.13) | $ (0.16) |
DILUTED LOSS PER COMMON SHARE (in dollars per share) | $ (0.13) | $ (0.16) |
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | ||
Basic (in shares) | 195,871,932 | 115,661,937 |
Diluted (in shares) | 195,871,932 | 115,661,937 |
Product Revenue [Member] | ||
REVENUES: | ||
Revenues | $ 29,067,385 | $ 16,012,910 |
License Revenue [Member] | ||
REVENUES: | ||
Revenues | $ 35,708 | $ 35,708 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2020 | $ 10,490 | $ 428,704,039 | $ (340,465,103) | $ 88,249,426 |
Balance (in shares) at Dec. 31, 2020 | 104,902,888 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation | $ 0 | 781,397 | 0 | 781,397 |
Vesting of Restricted Stock Units, net of shares withheld for taxes and retired | $ 6 | (59,317) | 0 | (59,311) |
Vesting of Restricted Stock Units, net of shares withheld for taxes and retired (in shares) | 61,385 | |||
Issuance of common stock, net of offering expenses | $ 1,808 | 41,910,707 | 0 | 41,912,515 |
Issuance of common stock, net of offering expenses (in shares) | 18,080,708 | |||
Net loss | $ 0 | 0 | (18,379,941) | (18,379,941) |
Balance at Mar. 31, 2021 | $ 12,304 | 471,336,826 | (358,845,044) | 112,504,086 |
Balance (in shares) at Mar. 31, 2021 | 123,044,981 | |||
Balance at Dec. 31, 2021 | $ 19,581 | 553,265,706 | (412,112,721) | 141,172,566 |
Balance (in shares) at Dec. 31, 2021 | 195,813,817 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation | $ 0 | 1,641,388 | 0 | 1,641,388 |
Warrants issued in connection with note payable | 0 | 9,569,604 | 0 | 9,569,604 |
Vesting of Restricted Stock Units, net of shares withheld for taxes and retired | $ 54 | (442,690) | 0 | (442,636) |
Vesting of Restricted Stock Units, net of shares withheld for taxes and retired (in shares) | 533,712 | |||
Net loss | $ 0 | 0 | (25,007,857) | (25,007,857) |
Balance at Mar. 31, 2022 | $ 19,635 | $ 564,034,008 | $ (437,120,578) | $ 126,933,065 |
Balance (in shares) at Mar. 31, 2022 | 196,347,529 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (25,007,857) | $ (18,379,941) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,590,217 | 1,229,628 |
Loss on disposal of fixed assets | 2,000 | 781 |
Stock-based compensation | 1,641,388 | 781,397 |
Amortization of debt discount | 584,842 | 443,794 |
Loss on extinguishment of debt | 6,669,941 | 0 |
Amortization of license revenue | (35,708) | (35,708) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 2,947,233 | (2,124,740) |
Inventories | (14,422,219) | (12,610,601) |
Prepaid expenses and other current assets | (1,180,056) | (2,756,142) |
Deposits and other assets | 1,397,672 | 19,718 |
Accounts payable | 1,685,724 | 1,079,144 |
Accrued expenses | (1,775,526) | (843,043) |
Other current and non-current liabilities | (111,064) | (33,413) |
Net cash used in operating activities | (26,013,413) | (33,229,126) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (2,842,085) | (2,571,161) |
Net cash used in investing activities | (2,842,085) | (2,571,161) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Principal payments on notes payable | (100,000,000) | 0 |
Proceeds from issuance of common stock, net of offering expenses | 0 | 41,912,515 |
Payment of debt refinancing fees | (2,000,000) | 0 |
Proceeds from issuance of note payable | 151,750,000 | 0 |
Taxes paid on vested Restricted Stock Units | (91,367) | (59,311) |
Payments on finance lease obligations | (8,941) | (8,360) |
Payment of deferred financing fees | (2,378,366) | 0 |
Net cash provided by financing activities | 47,271,326 | 41,844,844 |
Net increase in cash and cash equivalents | 18,415,828 | 6,044,557 |
Cash and cash equivalents - beginning of year | 51,089,118 | 55,921,152 |
Cash and cash equivalents - end of period | $ 69,504,946 | $ 61,965,709 |
ORGANIZATION AND BUSINESS
ORGANIZATION AND BUSINESS | 3 Months Ended |
Mar. 31, 2022 | |
ORGANIZATION AND BUSINESS [Abstract] | |
ORGANIZATION AND BUSINESS | 1. ORGANIZATION AND BUSINESS ADMA Biologics, Inc. (“ADMA” or the “Company”) is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. The Company’s targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons. ADMA operates through its wholly-owned subsidiaries ADMA BioManufacturing, LLC (“ADMA BioManufacturing”) and ADMA BioCenters Georgia Inc. (“ADMA BioCenters”). ADMA BioManufacturing was formed in January 2017 to facilitate the acquisition of the Biotest Therapy Business Unit (“BTBU”) from BPC Plasma, Inc. (formerly Biotest Pharmaceuticals Corporation) (“BPC” and, together with Biotest AG, “Biotest”) on June 6, 2017. The acquisition included certain assets of BTBU, including the U.S. Food and Drug Administration (“FDA”)-licensed BIVIGAM and Nabi-HB immunoglobulin products, and an FDA-licensed plasma fractionation manufacturing facility located in Boca Raton, FL (the “Boca Facility”) (the “Biotest Transaction”). BTBU had previously been the Company’s third-party contract manufacturer. ADMA BioCenters is the Company’s source plasma collection business with of which hold an approved license with the FDA. The Company has three FDA-approved products, all of which are currently marketed and commercially available: (i) BIVIGAM (Immune Globulin Intravenous, Human), an Intravenous Immune Globulin (“IVIG”) product indicated for the treatment of Primary Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”), 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 March 31, 2022, the Company had working capital of $208.2 million, including $69.5 million of cash and cash equivalents. Based upon the Company’s current projected revenue and expenditures, including capital expenditures and continued implementation of the Company’s commercialization and expansion activities, the Company’s management currently believes that its cash, cash equivalents, projected revenue and accounts receivable, together with the remaining available funds under the distribution agreement entered into in September of 2021 (see 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 7), 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 efforts with respect to the sale 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. 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 alternatives through its ongoing engagement with Morgan Stanley as a financial advisor. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2022 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information. 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”). The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 24, 2022. The accompanying consolidated balance sheet as of December 31, 2021 was derived from the audited financial statements as of and for the year ended December 31, 2021. These condensed consolidated interim financial statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X, and therefore omit or condense certain footnotes and other information normally included in complete consolidated financial statements prepared in accordance with U.S. GAAP. All intercompany balances and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of March 31, 2022 and its results of operations, changes in stockholders’ equity and cash flows for the three months ended March 31, 2022 and 2021. During the three months ended March 31, 2022 and 2021, comprehensive loss was equal to the net loss amounts presented for the respective periods in the accompanying condensed consolidated statements of operations. Operating results for interim periods are not necessarily indicative of the results that may be expected for the full fiscal year. Use of Estimates The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include rebates and chargebacks deducted from gross revenues, the realizable value of accounts receivable, valuation of inventory, assumptions used in projecting future liquidity and capital requirements, assumptions used in the fair value of awards granted under the Company’s equity incentive plans and warrants issued in connection with the issuance of notes payable and the valuation allowance for the Company’s deferred tax assets. 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 secured term loan (see Note 7) approximates fair value due to the variable interest rate on this debt. Accounts Receivable Accounts receivable is reported at realizable value, net of allowances for contractual credits and doubtful accounts in the amount of $0.1 million and $0.2 million at March 31, 2022 and December 31, 2021, respectively, which are recognized in the period the related revenue is recorded. The Company extends credit to its customers based upon an evaluation of each customer’s financial condition and credit history. Evaluations of the financial condition and associated credit risk of customers are performed on an ongoing basis. Inventories Raw materials inventory consists of various materials purchased from suppliers, including normal source plasma, used in the production of the Company’s products. Work-in-process and finished goods inventories (see Note 3) reflect the cost of raw materials as well as costs for direct and indirect labor, primarily salaries, wages and benefits for applicable employees, as well as an allocation of overhead costs related to the Boca Facility including utilities, property taxes, general repairs and maintenance, consumable supplies and depreciation. The allocation of Boca Facility overhead to inventory is generally based upon the estimated square footage of the Boca Facility that is used in the production of the Company’s products relative to the total square footage of the facility. Inventories, including plasma intended for resale and plasma intended for internal use in the Company’s manufacturing, commercialization or research and development activities, are carried at the lower of cost or net realizable value determined by the first-in, first-out method. 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. Goodwill Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill at March 31, 2022 and December 31, 2021 was $3.5 million. All of the Company’s goodwill is attributable to its ADMA BioManufacturing business segment and is related to the Biotest Transaction. 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 test as of October 1, 2021 did not result in a goodwill impairment charge, and the Company did not record any impairment charges related to goodwill for the three months ended March 31, 2022 and 2021. Impairment of Long-Lived Assets The Company assesses the recoverability of its long-lived assets, which include property and equipment and finite-lived intangible assets, whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s carrying value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the three months ended March 31, 2022 and 2021, the Company determined that there was no impairment of its long-lived assets. Revenue Recognition Revenues for the three months ended March 31, 2022 and 2021 are comprised of (i) revenues from the sale of the Company’s immunoglobulin products, BIVIGAM, ASCENIV and Nabi-HB, 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. For the three months ended March 31, 2022, 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. Loss Per Common Share Basic loss per common 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 common 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 is excluded from the diluted loss per common share computation to the extent that it would be anti-dilutive. As a result, no potentially dilutive securities are included in the computation of any of the accompanying diluted loss per share amounts in the accompanying condensed consolidated financial statements as the Company reported a net loss for all periods presented. For the three months ended March 31, 2022 and 2021, the following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive effects: For the Three Months Ended March 31, 2022 2021 Stock options 8,686,068 8,103,165 Restricted stock units 4,729,758 730,994 Warrants 13,631,207 4,528,160 27,047,033 13,362,319 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. 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. 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. 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 50% 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. Based on its analysis, the Company has determined that it has not incurred any liability for unrecognized tax benefits as of March 31, 2022 and December 31, 2021, and during the three months ended March 31, 2022 and 2021, the Company recognized |
INVENTORIES
INVENTORIES | 3 Months Ended |
Mar. 31, 2022 | |
INVENTORIES [Abstract] | |
INVENTORIES | 3. INVENTORIES The following table provides the components of inventories: March 31, 2022 December 31, 2021 Raw materials $ 46,034,969 $ 36,755,720 Work-in-process 45,139,511 58,968,535 Finished goods 47,971,831 28,999,836 Total inventories $ 139,146,311 $ 124,724,091 Raw materials includes plasma and other materials expected to be used in the production of BIVIGAM, ASCENIV and Nabi-HB. These materials will be consumed in the production of goods expected to be available for sale or otherwise have alternative uses that provide a probable future benefit. All other activities and materials associated with the production of inventories used in research and development activities are expensed as incurred. Work-in-process inventory primarily consists of bulk drug substance and unlabeled filled vials of the Company’s immunoglobulin products. Finished goods inventory is comprised of immunoglobulin product inventory and related intermediates that are available for commercial sale, as well as plasma collected at the Company’s plasma collection centers which is expected to be sold to third-party customers. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 3 Months Ended |
Mar. 31, 2022 | |
INTANGIBLE ASSETS [Abstract] | |
INTANGIBLE ASSETS | 4. INTANGIBLE ASSETS Intangible assets at March 31, 2022 and December 31, 2021 consist of the following: March 31, 2022 December 31, 2021 Cost Accumulated Amortization Net Cost Accumulated Amortization Net Trademark and other intangible rights related to Nabi-HB $ 4,100,046 $ 2,830,985 $ 1,269,061 $ 4,100,046 $ 2,684,554 $ 1,415,492 Rights to intermediates 907,421 626,552 280,869 907,421 594,145 313,276 $ 5,007,467 $ 3,457,537 $ 1,549,930 $ 5,007,467 $ 3,278,699 $ 1,728,768 All of the Company’s intangible assets were acquired in the Biotest Transaction. Amortization expense related to these intangible assets was $0.2 million for the three months ended March 31, 2022 and 2021. Estimated aggregate future aggregate amortization expense is expected to be as follows: Remainder of 2022 $ 536,514 2023 715,352 2024 298,064 |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 3 Months Ended |
Mar. 31, 2022 | |
PROPERTY AND EQUIPMENT [Abstract] | |
PROPERTY AND EQUIPMENT | 5. PROPERTY AND EQUIPMENT Property and equipment and related accumulated depreciation are summarized as follows: March 31, 2022 December 31, 2021 Manufacturing and laboratory equipment $ 17,100,261 $ 16,702,991 Office equipment and computer software 4,323,549 4,082,462 Furniture and fixtures 3,693,317 3,389,140 Construction in process 6,384,242 5,496,222 Leasehold improvements 12,966,337 11,129,639 Land 4,339,441 4,339,441 Buildings and building improvements 19,093,765 19,067,032 67,900,912 64,206,927 Less: Accumulated depreciation (14,680,432 ) (13,271,853 ) Total property, plant and equipment, net $ 53,220,480 $ 50,935,074 Property and equipment 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 were assigned a useful life of 30 years. Property and equipment other than land and buildings have useful lives ranging from three The Company recorded depreciation expense on property and equipment for the three months ended March 31, 2022 and 2021 of $1.4 million and $ 1.1 million, respectively. |
ACCRUED EXPENSES AND OTHER CURR
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 3 Months Ended |
Mar. 31, 2022 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES [Abstract] | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 6. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES Accrued expenses and other current liabilities at March 31, 2022 and December 31, 2021 are as follows: March 31, 2022 December 31, 2021 Accrued rebates $ 6,324,746 $ 5,040,200 Accrued distribution fees 2,794,447 4,739,651 Accrued incentives 1,565,993 4,066,109 Accrued testing 674,191 1,189,970 Accrued payroll 2,206,409 1,167,072 Other 3,088,754 1,011,986 Total accrued expenses and other current liabilities $ 16,654,540 $ 17,214,988 |
DEBT
DEBT | 3 Months Ended |
Mar. 31, 2022 | |
DEBT [Abstract] | |
DEBT | 7. DEBT A summary of outstanding senior notes payable is as follows: March 31, 2022 December 31, 2021 Notes payable $ 151,750,000 $ 100,000,000 Less: Debt discount (13,326,948 ) (5,133,761 ) Senior notes payable $ 138,423,052 $ 94,866,239 On March 23, 2022, (the “Hayfin Closing Date”) the Company and all of its subsidiaries entered into a Credit and Guaranty Agreement (the “Hayfin Credit Agreement”) with Hayfin Services LLP (“Hayfin”). The Hayfin Credit Agreement provides for a senior secured term loan facility in a principal amount of up to $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 Company’s previously existing credit facility (the “Perceptive Credit Facility”) with Perceptive Credit Holdings II, LP (“Perceptive”). The Company also used $2.0 million of the Hayfin Closing Date Loan proceeds to pay a redemption premium to Perceptive and used approximately $0.6 million of the Hayfin Closing Date Loan proceeds to pay certain fees and expenses incurred in connection with this transaction. In addition, a $1.8 million upfront fee payable to Hayfin was paid “in kind” and was added to the outstanding principal balance in accordance with the terms of the Hayfin Credit Agreement. In connection with the retirement of the Perceptive Credit Facility and all of the obligations thereunder, the Company recorded a loss on extinguishment of debt in the amount of $6.7 million, consisting of the write-off of unamortized discount related to the Perceptive indebtedness and the redemption premium paid to Perceptive. Borrowings under the Hayfin Credit Agreement 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 and at March 31, 2022 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. This exit fee is recorded separately as a non-current liability on the accompanying consolidated balance sheet as of March 31, 2022. Prior to the Hayfin Maturity Date, there are no scheduled principal payments on the Hayfin Loans. The Company may prepay outstanding principal on the Hayfin Loans at any time and from time to time upon five 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 of March 31, 2022, the Company was in compliance with all of the covenants contained in the Hayfin Credit Agreement. As consideration for the Hayfin Credit Agreement, the Company issued to various entities affiliated with Hayfin, on the Hayfin Closing Date, warrants to purchase an aggregate of 9,103,047 shares of the Company’s common stock (the “Hayfin Warrants”). The Hayfin Warrants have an exercise price equal to $1.6478 per share, which is equal to the trailing 30-day Volume Weighted-average Price of the Company’s common stock on the business day immediately prior to the Hayfin Closing Date. The Hayfin Warrants were valued by the Company at approximately $9.6 million as of the Hayfin Closing Date and have an expiration date of March 23, 2029. As a result of the upfront fee and exit fee paid or payable to Hayfin, the expenses incurred by the Company in connection with this transaction and the value of the Hayfin Warrants, the Company recognized an aggregate discount on the Hayfin Loans in the amount of $13.4 million. The Company records debt discount as a reduction to the face amount of the debt, and the debt discount is amortized as interest expense over the life of the debt using the interest method. Based on the fair value of the Hayfin Warrants and the aggregate amount of fees and expenses associated with obtaining the Hayfin Credit Facility, the effective interest rate on the Hayfin Loans as of the Hayfin Closing Date and as of March 31, 2022 was approximately 13.0%. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended |
Mar. 31, 2022 | |
STOCKHOLDERS' EQUITY [Abstract] | |
STOCKHOLDERS' EQUITY | 8. STOCKHOLDERS’ EQUITY Preferred Stock The Company is currently authorized to issue up to 10 million shares of preferred stock, $0.0001, par value per share. There were no shares of preferred stock outstanding at March 31, 2022 and December 31, 2021. Common Stock As of March 31, 2022 and December 31, 2021, the Company was authorized to issue 300,000,000 shares of its common stock, $0.0001 par value per share, and 196,347,529 and 195,813,817 shares of common stock were outstanding as of March 31, 2022 and December 31, 2021, respectively. After giving effect to the 32,811,653 shares reserved for outstanding warrants and awards issued or reserved for future issuance under the Company’s equity incentive plans, as of March 31, 2022 there were 70,840,818 shares of common stock available for issuance. On September 3, 2021, & 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 million of shares of the Company’s common stock (the “Distribution Agreement”). The Company intends to use any net proceeds from the sale of 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 collection centers, working capital, capital expenditures, expansion and resources for commercialization activities, and other potential research and development and business opportunities. The Company currently has approximately $42.8 million of shares available to sell under the Distribution Agreement. 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 Warrants In connection with the Hayfin Credit Agreement that the Company entered into on March 23, 2022 (see Note 7), the Company issued the Hayfin Warrants to purchase 9,103,047 shares of the Company’s common stock. The Hayfin Warrants were valued at $9.6 million using the Black-Scholes option-pricing model assuming an expected term of seven years, a volatility of 68.1%, a dividend yield of 0% and a risk-free rate of interest of 2.36%. At March 31, 2022, the Company had outstanding warrants to purchase an aggregate of 13,631,207 shares of common stock, with a weighted-average exercise price of $2.04 per share. At December 31, 2021, 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 The fair value of stock options granted under the Company’s 2007 Employee Stock Option Plan (the “2007 Plan”) and the ADMA Biologics, Inc. 2014 Omnibus Incentive Compensation Plan, as amended and restated (the “2014 Plan”), was determined on the date of grant using the Black-Scholes option valuation model. The Black-Scholes model was developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of certain subjective assumptions including the expected stock price volatility. The stock options granted to employees and directors have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair value estimate. The following assumptions were used to determine the fair value of options granted during the three months ended March 31, 2022 and 2021: Three Months Ended March 31, 2022 2021 Expected term 5.5 - 6.3 years 5.5 - 6.3 years Volatility 68 % 69 % Dividend yield 0.0 0.0 Risk-free interest rate 1.72-1.73 % 0.80-1.04 % During the three months ended March 31, 2022 and 2021, the Company granted options to purchase an aggregate of 1,194,032 and 1,441,050 shares of common stock, respectively, to its directors and employees. The weighted average remaining contractual life of stock options outstanding and expected to vest at March 31, 2022 is 6.6 years. The weighted average remaining contractual life of stock options exercisable at March 31, 2022 is 5.3 years. A summary of the Company’s option activity under the 2007 Plan and 2014 Plan and related information is as follows: Shares Weighted Average Exercise Price Options outstanding, vested and expected to vest at December 31, 2021 7,862,722 $ 3.93 Forfeited (9,186 ) $ 2.13 Expired (361,500 ) $ 6.48 Granted 1,194,032 $ 1.67 Options outstanding, vested and expected to vest at March 31, 2022 8,686,068 $ 3.51 Options exercisable 5,646,819 $ 4.25 As of March 31, 2022, the Company had $3.8 million of unrecognized compensation expense related to options granted under the Company’s equity incentive plans, which is expected to be recognized over a weighted-average period of 2.6 years. During the three months ended March 31, 2022 and 2021, the Company granted Restricted Stock Units (“RSUs”) representing an aggregate of 1,059,266 and 492,744 shares, respectively, to certain management employees of the Company and to members of its Board of Directors . These RSUs generally vest annually over a period of four years for employees and semi-annually over a period of one year for directors . During the three months ended March 31, 2022 March 31, 2022 A summary of the Company’s unvested RSU activity and related information is as follows: Shares Weighted Average Grant Date Fair Value Balance at December 31, 2021 4,485,133 $ 1.34 Granted 1,059,266 $ 1.67 Vested (799,641 ) $ 1.41 Forfeited (15,000 ) $ 1.22 Balance at March 31, 2022 4,729,758 $ 1.41 As of March 31, 2022 Total stock-based compensation expense for all awards granted under the Company’s equity incentive plans for the three months ended March 31, 2022 and 2021 is as follows: Three Months Ended March 31, 2022 2021 Research and development $ 4,671 $ 105,227 Plasma center operating expenses 21,052 10,818 Selling, general and administrative 1,517,602 588,491 Cost of product revenue 98,063 76,861 Total stock-based compensation expense $ 1,641,388 $ 781,397 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 3 Months Ended |
Mar. 31, 2022 | |
RELATED PARTY TRANSACTIONS [Abstract] | |
RELATED PARTY TRANSACTIONS | 9. RELATED PARTY TRANSACTIONS The Company leases an office building and equipment from Areth, LLC (“Areth”) pursuant to an agreement for services effective as of January 1, 2016, as amended from time to time. Rent expense for the three months ended March 31, 2022 and 2021 amounted to $30,000. 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 and building-related (common area) expenses, equipment and certain other operational expenses, which were not material to the condensed consolidated financial statements for the three months ended March 31, 2022 and 2021. During the three months ended March 31, 2022 and 2021, the Company purchased certain specialized medical equipment and services related to the Company’s plasma collection centers, as well as personal protective equipment, from GenesisBPS and its affiliates (“Genesis”), which were not material to the consolidated financial statements. Genesis is owned by Dr. Grossman and Adam Grossman. See Note 7 for a discussion of the Company’s former credit facility and related transactions with Perceptive, a holder of more than 5% of the Company’s common stock as of March 31, 2022. |
COMMITMENT AND CONTINGENCIES
COMMITMENT AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2022 | |
COMMITMENTS AND CONTINGENCIES [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 10. COMMITMENTS AND CONTINGENCIES General Legal Matters From time to time, the Company is or may become subject to certain legal proceedings and claims arising in connection with the normal course of its business. Management does not expect that the outcome of any such claims or actions will have a material effect on the Company’s liquidity, results of operations or financial condition. COVID-19 Pandemic The Company continues to monitor the ongoing developments related to the COVID-19 pandemic, including the emergence of the Delta 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 three months ended March 31, 2022 and 2021, revenue attributable to international customers was approximately 6% and 15%, respectively, of the Company’s total revenues. As the Company seeks to grow this aspect of its business, it may also be subject to the impacts of the COVID-19 pandemic in locations outside the United States. Notwithstanding the foregoing, the COVID-19 pandemic to date has not had a material impact on the Company’s financial condition or results of operations, and the Company does not believe that its production operations at the Boca Facility, the Company’s contract fill/finishers or its plasma collection facilities have been significantly impacted by the COVID-19 pandemic. As a result, the Company does not anticipate and has not experienced any material impairments with respect to any of its long-lived assets, including the Company’s property and equipment, goodwill or intangible assets. Although the COVID-19 pandemic has not, to date, materially adversely impacted the Company’s capital and financial resources, because the Company is unable to determine the ultimate severity or duration of the 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 Commitments Pursuant to the terms of a plasma purchase agreement with BPC dated as of November 17, 2011 (the “2011 Plasma Purchase Agreement”), the Company agreed to purchase from BPC an annual minimum volume of source plasma containing antibodies to RSV to be used in the manufacture of ASCENIV. The Company must purchase a to-be-determined and agreed upon annual minimum volume from BPC, but may also collect high-titer RSV plasma from up to five wholly-owned ADMA plasma collection facilities. During 2015, the Company and BPC amended the 2011 Plasma Purchase Agreement to allow the Company the ability to collect its raw material RSV high-titer plasma from other third-party collection organizations, thus allowing the Company to expand its reach for raw material supply as it executes its commercialization plans for ASCENIV. As part of the closing of the Biotest Transaction, the parties amended the 2011 Plasma Purchase Agreement to extend the initial term through the ten-year anniversary of the closing date of the Biotest Transaction. Unless terminated earlier, the 2011 Plasma Purchase Agreement expires in June 2027, after which it may be renewed for two additional five-year periods if agreed to by the parties. On December 10, 2018, BPC assigned its rights and obligations under the 2011 Plasma Purchase Agreement to Grifols Worldwide Operations Limited (“Grifols”) as its successor-in-interest, effective January 1, 2019. On January 1, 2019, Grifols and the Company entered into an additional amendment to the 2011 Plasma Purchase Agreement for the purchase of source plasma containing antibodies to RSV from Grifols. Pursuant to this amendment, until January 1, 2022, the Company could purchase RSV plasma from Grifols from the two plasma collection centers that were transferred to BPC on January 1, 2019 at a price equal to cost plus five percent (5%) (without any additional increase due to inflation). Effective January 1, 2022, RSV plasma purchased from these two plasma collection centers are subject to the pricing terms in effect for RSV plasma purchased from other plasma collection centers owned by Grifols. On June 6, 2017, the Company and BPC entered into a Plasma Supply Agreement pursuant to which BPC supplies, on an exclusive basis subject to certain exceptions, to ADMA BioManufacturing an annual minimum volume of hyperimmune plasma that contain antibodies to the Hepatitis B virus for the manufacture of Nabi-HB. The Plasma Supply Agreement has a 10-year term. On July 19, 2018, the Company and BPC entered into an amendment to the Plasma Supply Agreement to provide, among other things, that in the event BPC elects not to supply in excess of ADMA BioManufacturing’s specified amount of Hepatitis B plasma and ADMA BioManufacturing is unable to secure Hepatitis B plasma from a third party at a price that is within a low double- digit percentage of the price that ADMA BioManufacturing pays to BPC, then BPC shall reimburse ADMA BioManufacturing for the difference in price ADMA BioManufacturing incurs. On December 10, 2018, BPC assigned its rights and obligations under the Plasma Supply Agreement to Grifols, effective January 1, 2019. On June 6, 2017, the Company and BPC entered into a Plasma Purchase Agreement (the “2017 Plasma Purchase Agreement”), pursuant to which ADMA BioManufacturing purchases normal source plasma (“NSP”) from BPC at agreed upon annual quantities and prices. The 2017 Plasma Purchase Agreement has an initial term of five years after which the 2017 Plasma Purchase Agreement may be renewed for additional two terms of two years each upon the mutual written consent of the parties. On July 19, 2018, the Company and BPC entered into an amendment to the 2017 Plasma Purchase Agreement to, among other things, provide agreed upon amounts of normal source plasma to be supplied by BPC to ADMA BioManufacturing in calendar year 2019 at a specified price per liter, provided that ADMA BioManufacturing delivers a valid purchase order to BPC. Additionally, pursuant to the amendment to the 2017 Plasma Purchase Agreement, BPC agreed that, for calendar years 2020 and 2021, it shall supply no less than a high double-digit percentage of ADMA BioManufacturing’s requested NSP amounts, provided that such requested NSP amounts are within an agreed range, at a price per liter to be mutually determined. Furthermore, pursuant to the amendment to the 2017 Plasma Purchase Agreement, in the event BPC fails to supply ADMA BioManufacturing with at least a high double-digit percentage of ADMA BioManufacturing’s requested NSP amounts, BPC shall promptly reimburse ADMA BioManufacturing the difference in price ADMA BioManufacturing incurs due to BPC’s election not to supply NSP to ADMA BioManufacturing in such amounts as requested. On December 10, 2018, BPC assigned its rights and obligations under the Plasma Purchase Agreement to Grifols, effective January 1, 2019. Effective as of May 12, 2021, the Company and Grifols amended the foregoing 2017 Plasma Purchase Agreement whereby, among other things, the term of the agreement was extended through December 31, 2022, while certain historical provisions were deleted. 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. The Company purchases substantially all of its raw material plasma from Grifols. For the three months ended March 31, 2022, plasma purchases from Grifols totaled $15.5 million, or approximately 75% of the Company’s total inventory purchases. For the three months ended March 31, 2021, plasma purchases from Grifols totaled approximately $12.7 million, representing approximately 72% of the Company’s total inventory purchases. 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 with Brian Lenz, its Executive Vice President, Chief Financial Officer and General Manager, ADMA BioCenters. 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 March 31, 2022. The Company does not anticipate recognizing any significant losses relating to these arrangements. |
SEGMENTS
SEGMENTS | 3 Months Ended |
Mar. 31, 2022 | |
SEGMENTS [Abstract] | |
SEGMENTS | 11. 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 immunoglobulin manufacturing, commercial and development operations in Boca Raton, FL, acquired on June 6, 2017 (see Note 1). The Plasma Collection Centers segment as of March 31, 2022 consists of 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 FDA Summarized financial information concerning reportable segments is shown in the following tables: Three Months Ended March 31, 2022 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 25,728,625 $ 3,338,760 $ 35,708 $ 29,103,093 Cost of product revenue 22,213,781 3,227,265 - 25,441,046 Loss from operations (4,442,684 ) (3,863,094 ) (6,509,288 ) (14,815,066 ) Interest and other expense, net (49,267 ) (729 ) (3,472,854 ) (3,522,850 ) Loss on extinguishment of debt - - (6,669,941 ) (6,669,941 ) Net loss (4,491,951 ) (3,863,823 ) (16,652,083 ) (25,007,857 ) Capital expenditures 1,310,379 1,531,706 - 2,842,085 Depreciation and amortization expense 1,111,951 477,503 763 1,590,217 Total assets 214,150,322 32,568,911 61,313,259 308,032,492 Three Months Ended March 31, 2021 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 13,421,043 $ 2,591,867 $ 35,708 $ 16,048,618 Cost of product revenue 15,449,757 2,320,365 - 17,770,122 Loss from operations (9,505,689 ) (1,970,841 ) (3,687,719 ) (15,164,249 ) Interest and other expense, net (21,513 ) (384 ) (3,193,795 ) (3,215,692 ) Net loss (9,527,202 ) (1,971,225 ) (6,881,514 ) (18,379,941 ) Capital expenditures 1,012,980 1,558,181 - 2,571,161 Depreciation and amortization expense 1,009,770 217,991 1,867 1,229,628 Total assets 156,535,177 17,397,612 61,734,239 235,667,028 Net revenues according to geographic area, based on the location of where the product is shipped, is as follows: Three Months Ended March 31, 2022 2021 United States $ 27,316,151 $ 13,678,008 International 1,786,942 2,370,610 Total revenues $ 29,103,093 $ 16,048,618 |
LEASE OBLIGATIONS
LEASE OBLIGATIONS | 3 Months Ended |
Mar. 31, 2022 | |
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 2032. 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 of 13%. The Company’s 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 leases for the three months ended March 31, 2022 and 2021 was approximately $0.4 million and $0.3 million, respectively. Cash paid for the Company’s leases for the three months ended March 31, 2022 and 2021 was approximately $0.4 million and $0.2 million, respectively. Including a finance lease the Company entered into in June 2018, the Company has aggregate lease liabilities of $7.9 million and $8.1 million as of March 31, 2022 and December 31, 2021, respectively, which are comprised primarily of the leases for the Company’s plasma collection centers and an administrative office lease related to the Company’s ADMA BioCenters subsidiary. The Company’s operating leases have a weighted average remaining term of 8.9 years. Scheduled payments under the Company’s lease obligations are as follows: Remainder of 2022 $ 1,228,526 Year ended December 31, 2023 1,641,603 2024 1,517,229 2025 1,525,793 2026 1,260,391 2027 1,289,679 Thereafter 5,055,880 Total payments 13,519,101 Less: imputed interest (5,581,019 ) Current portion (654,003 ) Balance at March 31, 2022 $ 7,284,079 During the three months ended March 31, 2022, t he Company entered into an additional property lease for its ninth . |
SUPPLEMENTAL DISCLOSURE OF CASH
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | 3 Months Ended |
Mar. 31, 2022 | |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION [Abstract] | |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | 13. SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION Supplemental cash flow information for the three months ended March 31, 2022 and 2021 is as follows: 2022 2021 SUPPLEMENTAL CASH FLOW INFORMATION: Cash paid for interest $ 2,525,987 $ 2,751,956 Noncash Financing and Investing Activities: Equipment acquired reflected in accounts payable and accrued liabilities $ 1,940,425 $ 1,797,249 Right-to-use assets in exchange for lease obligations $ - $ 2,073,627 Warrants issued in connection with notes payable $ 9,569,604 $ - |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information. 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”). The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 24, 2022. The accompanying consolidated balance sheet as of December 31, 2021 was derived from the audited financial statements as of and for the year ended December 31, 2021. These condensed consolidated interim financial statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X, and therefore omit or condense certain footnotes and other information normally included in complete consolidated financial statements prepared in accordance with U.S. GAAP. All intercompany balances and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of March 31, 2022 and its results of operations, changes in stockholders’ equity and cash flows for the three months ended March 31, 2022 and 2021. During the three months ended March 31, 2022 and 2021, comprehensive loss was equal to the net loss amounts presented for the respective periods in the accompanying condensed consolidated statements of operations. Operating results for interim periods are not necessarily indicative of the results that may be expected for the full fiscal year. |
Use of Estimates | Use of Estimates The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include rebates and chargebacks deducted from gross revenues, the realizable value of accounts receivable, valuation of inventory, assumptions used in projecting future liquidity and capital requirements, assumptions used in the fair value of awards granted under the Company’s equity incentive plans and warrants issued in connection with the issuance of notes payable and the valuation allowance for the Company’s deferred tax assets. |
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 secured term loan (see Note 7) approximates fair value due to the variable interest rate on this debt. |
Accounts Receivable | Accounts Receivable Accounts receivable is reported at realizable value, net of allowances for contractual credits and doubtful accounts in the amount of $0.1 million and $0.2 million at March 31, 2022 and December 31, 2021, respectively, which are recognized in the period the related revenue is recorded. The Company extends credit to its customers based upon an evaluation of each customer’s financial condition and credit history. Evaluations of the financial condition and associated credit risk of customers are performed on an ongoing basis. |
Inventories | Inventories Raw materials inventory consists of various materials purchased from suppliers, including normal source plasma, used in the production of the Company’s products. Work-in-process and finished goods inventories (see Note 3) reflect the cost of raw materials as well as costs for direct and indirect labor, primarily salaries, wages and benefits for applicable employees, as well as an allocation of overhead costs related to the Boca Facility including utilities, property taxes, general repairs and maintenance, consumable supplies and depreciation. The allocation of Boca Facility overhead to inventory is generally based upon the estimated square footage of the Boca Facility that is used in the production of the Company’s products relative to the total square footage of the facility. Inventories, including plasma intended for resale and plasma intended for internal use in the Company’s manufacturing, commercialization or research and development activities, are carried at the lower of cost or net realizable value determined by the first-in, first-out method. 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. |
Goodwill | Goodwill Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill at March 31, 2022 and December 31, 2021 was $3.5 million. All of the Company’s goodwill is attributable to its ADMA BioManufacturing business segment and is related to the Biotest Transaction. 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 test as of October 1, 2021 did not result in a goodwill impairment charge, and the Company did not record any impairment charges related to goodwill for the three months ended March 31, 2022 and 2021. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company assesses the recoverability of its long-lived assets, which include property and equipment and finite-lived intangible assets, whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s carrying value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the three months ended March 31, 2022 and 2021, the Company determined that there was no impairment of its long-lived assets. |
Revenue Recognition | Revenue Recognition Revenues for the three months ended March 31, 2022 and 2021 are comprised of (i) revenues from the sale of the Company’s immunoglobulin products, BIVIGAM, ASCENIV and Nabi-HB, 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. For the three months ended March 31, 2022, |
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. |
Loss Per Share | Loss Per Common Share Basic loss per common 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 common 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 is excluded from the diluted loss per common share computation to the extent that it would be anti-dilutive. As a result, no potentially dilutive securities are included in the computation of any of the accompanying diluted loss per share amounts in the accompanying condensed consolidated financial statements as the Company reported a net loss for all periods presented. For the three months ended March 31, 2022 and 2021, the following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive effects: For the Three Months Ended March 31, 2022 2021 Stock options 8,686,068 8,103,165 Restricted stock units 4,729,758 730,994 Warrants 13,631,207 4,528,160 27,047,033 13,362,319 |
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. 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. 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. 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 50% 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. Based on its analysis, the Company has determined that it has not incurred any liability for unrecognized tax benefits as of March 31, 2022 and December 31, 2021, and during the three months ended March 31, 2022 and 2021, the Company recognized |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Calculation of Diluted Loss Per Common Share | For the three months ended March 31, 2022 and 2021, the following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive effects: For the Three Months Ended March 31, 2022 2021 Stock options 8,686,068 8,103,165 Restricted stock units 4,729,758 730,994 Warrants 13,631,207 4,528,160 27,047,033 13,362,319 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
INVENTORIES [Abstract] | |
Components of Inventory | The following table provides the components of inventories: March 31, 2022 December 31, 2021 Raw materials $ 46,034,969 $ 36,755,720 Work-in-process 45,139,511 58,968,535 Finished goods 47,971,831 28,999,836 Total inventories $ 139,146,311 $ 124,724,091 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
INTANGIBLE ASSETS [Abstract] | |
Schedule of Intangible Assets | Intangible assets at March 31, 2022 and December 31, 2021 consist of the following: March 31, 2022 December 31, 2021 Cost Accumulated Amortization Net Cost Accumulated Amortization Net Trademark and other intangible rights related to Nabi-HB $ 4,100,046 $ 2,830,985 $ 1,269,061 $ 4,100,046 $ 2,684,554 $ 1,415,492 Rights to intermediates 907,421 626,552 280,869 907,421 594,145 313,276 $ 5,007,467 $ 3,457,537 $ 1,549,930 $ 5,007,467 $ 3,278,699 $ 1,728,768 |
Intangible Asset Future Aggregate Amortization Expense | All of the Company’s intangible assets were acquired in the Biotest Transaction. Amortization expense related to these intangible assets was $0.2 million for the three months ended March 31, 2022 and 2021. Estimated aggregate future aggregate amortization expense is expected to be as follows: Remainder of 2022 $ 536,514 2023 715,352 2024 298,064 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
PROPERTY AND EQUIPMENT [Abstract] | |
Property and Equipment | Property and equipment and related accumulated depreciation are summarized as follows: March 31, 2022 December 31, 2021 Manufacturing and laboratory equipment $ 17,100,261 $ 16,702,991 Office equipment and computer software 4,323,549 4,082,462 Furniture and fixtures 3,693,317 3,389,140 Construction in process 6,384,242 5,496,222 Leasehold improvements 12,966,337 11,129,639 Land 4,339,441 4,339,441 Buildings and building improvements 19,093,765 19,067,032 67,900,912 64,206,927 Less: Accumulated depreciation (14,680,432 ) (13,271,853 ) Total property, plant and equipment, net $ 53,220,480 $ 50,935,074 |
ACCRUED EXPENSES AND OTHER CU_2
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities at March 31, 2022 and December 31, 2021 are as follows: March 31, 2022 December 31, 2021 Accrued rebates $ 6,324,746 $ 5,040,200 Accrued distribution fees 2,794,447 4,739,651 Accrued incentives 1,565,993 4,066,109 Accrued testing 674,191 1,189,970 Accrued payroll 2,206,409 1,167,072 Other 3,088,754 1,011,986 Total accrued expenses and other current liabilities $ 16,654,540 $ 17,214,988 |
DEBT (Tables)
DEBT (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
DEBT [Abstract] | |
Summary of Outstanding Senior Notes Payable | A summary of outstanding senior notes payable is as follows: March 31, 2022 December 31, 2021 Notes payable $ 151,750,000 $ 100,000,000 Less: Debt discount (13,326,948 ) (5,133,761 ) Senior notes payable $ 138,423,052 $ 94,866,239 |
STOCKHOLDERS EQUITY (Tables)
STOCKHOLDERS EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
STOCKHOLDERS' EQUITY [Abstract] | |
Schedule of Assumptions | The following assumptions were used to determine the fair value of options granted during the three months ended March 31, 2022 and 2021: Three Months Ended March 31, 2022 2021 Expected term 5.5 - 6.3 years 5.5 - 6.3 years Volatility 68 % 69 % Dividend yield 0.0 0.0 Risk-free interest rate 1.72-1.73 % 0.80-1.04 % |
Schedule of Option Activity | A summary of the Company’s option activity under the 2007 Plan and 2014 Plan and related information is as follows: Shares Weighted Average Exercise Price Options outstanding, vested and expected to vest at December 31, 2021 7,862,722 $ 3.93 Forfeited (9,186 ) $ 2.13 Expired (361,500 ) $ 6.48 Granted 1,194,032 $ 1.67 Options outstanding, vested and expected to vest at March 31, 2022 8,686,068 $ 3.51 Options exercisable 5,646,819 $ 4.25 |
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, 2021 4,485,133 $ 1.34 Granted 1,059,266 $ 1.67 Vested (799,641 ) $ 1.41 Forfeited (15,000 ) $ 1.22 Balance at March 31, 2022 4,729,758 $ 1.41 |
Schedule of Stock-Based Compensation Expense | Total stock-based compensation expense for all awards granted under the Company’s equity incentive plans for the three months ended March 31, 2022 and 2021 is as follows: Three Months Ended March 31, 2022 2021 Research and development $ 4,671 $ 105,227 Plasma center operating expenses 21,052 10,818 Selling, general and administrative 1,517,602 588,491 Cost of product revenue 98,063 76,861 Total stock-based compensation expense $ 1,641,388 $ 781,397 |
SEGMENTS (Tables)
SEGMENTS (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
SEGMENTS [Abstract] | |
Summarized Financial Information Concerning Reportable Segments | Summarized financial information concerning reportable segments is shown in the following tables: Three Months Ended March 31, 2022 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 25,728,625 $ 3,338,760 $ 35,708 $ 29,103,093 Cost of product revenue 22,213,781 3,227,265 - 25,441,046 Loss from operations (4,442,684 ) (3,863,094 ) (6,509,288 ) (14,815,066 ) Interest and other expense, net (49,267 ) (729 ) (3,472,854 ) (3,522,850 ) Loss on extinguishment of debt - - (6,669,941 ) (6,669,941 ) Net loss (4,491,951 ) (3,863,823 ) (16,652,083 ) (25,007,857 ) Capital expenditures 1,310,379 1,531,706 - 2,842,085 Depreciation and amortization expense 1,111,951 477,503 763 1,590,217 Total assets 214,150,322 32,568,911 61,313,259 308,032,492 Three Months Ended March 31, 2021 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 13,421,043 $ 2,591,867 $ 35,708 $ 16,048,618 Cost of product revenue 15,449,757 2,320,365 - 17,770,122 Loss from operations (9,505,689 ) (1,970,841 ) (3,687,719 ) (15,164,249 ) Interest and other expense, net (21,513 ) (384 ) (3,193,795 ) (3,215,692 ) Net loss (9,527,202 ) (1,971,225 ) (6,881,514 ) (18,379,941 ) Capital expenditures 1,012,980 1,558,181 - 2,571,161 Depreciation and amortization expense 1,009,770 217,991 1,867 1,229,628 Total assets 156,535,177 17,397,612 61,734,239 235,667,028 |
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: Three Months Ended March 31, 2022 2021 United States $ 27,316,151 $ 13,678,008 International 1,786,942 2,370,610 Total revenues $ 29,103,093 $ 16,048,618 |
LEASE OBLIGATIONS (Tables)
LEASE OBLIGATIONS (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
LEASE OBLIGATIONS [Abstract] | |
Payments Under Lease Obligations | Scheduled payments under the Company’s lease obligations are as follows: Remainder of 2022 $ 1,228,526 Year ended December 31, 2023 1,641,603 2024 1,517,229 2025 1,525,793 2026 1,260,391 2027 1,289,679 Thereafter 5,055,880 Total payments 13,519,101 Less: imputed interest (5,581,019 ) Current portion (654,003 ) Balance at March 31, 2022 $ 7,284,079 |
SUPPLEMENTAL DISCLOSURE OF CA_2
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION [Abstract] | |
Supplemental Cash Flow Information | Supplemental cash flow information for the three months ended March 31, 2022 and 2021 is as follows: 2022 2021 SUPPLEMENTAL CASH FLOW INFORMATION: Cash paid for interest $ 2,525,987 $ 2,751,956 Noncash Financing and Investing Activities: Equipment acquired reflected in accounts payable and accrued liabilities $ 1,940,425 $ 1,797,249 Right-to-use assets in exchange for lease obligations $ - $ 2,073,627 Warrants issued in connection with notes payable $ 9,569,604 $ - |
ORGANIZATION AND BUSINESS (Deta
ORGANIZATION AND BUSINESS (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2022USD ($)ProductFacility | |
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 | $ | $ 208.2 |
Cash and cash equivalents | $ | $ 69.5 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Accounts Receivable (Details) $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022USD ($)Customer | Dec. 31, 2021USD ($)Customer | |
Accounts Receivable [Abstract] | ||
Accounts receivable, allowances for contractual credits and doubtful accounts | $ | $ 0.1 | $ 0.2 |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Six Customers [Member] | ||
Accounts Receivable [Abstract] | ||
Number of customers | 4 | |
Percentage of account receivables | 92.00% | |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Three Customers [Member] | ||
Accounts Receivable [Abstract] | ||
Number of customers | 3 | |
Percentage of account receivables | 94.00% |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Goodwill (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Goodwill [Abstract] | |||
Goodwill | $ 3,529,509 | $ 3,529,509 | |
Impairment charges related to goodwill | $ 0 | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Impairment of Long-lived Assets (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Impairment of Long-lived Assets [Abstract] | ||
Impairment of long-lived assets | $ 0 | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Revenue Recognition (Details) - Customer | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Four Customers [Member] | Revenues [Member] | Customer Concentration Risk [Member] | ||
Revenue Recognition [Abstract] | ||
Number of customers | 3 | |
Percentage of consolidated revenues | 83.00% | |
Three Customers [Member] | Revenues [Member] | Customer Concentration Risk [Member] | ||
Revenue Recognition [Abstract] | ||
Number of customers | 5 | |
Percentage of consolidated revenues | 86.00% | |
Biotest License Agreement [Member] | ||
Revenue Recognition [Abstract] | ||
Amortization period | 22 years |
SUMMARY OF SIGNIFICANT ACCOUN_8
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Loss per Common Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Loss Per Common Share [Abstract] | ||
Potentially dilutive securities (in shares) | 27,047,033 | 13,362,319 |
Stock Options [Member] | ||
Loss Per Common Share [Abstract] | ||
Potentially dilutive securities (in shares) | 8,686,068 | 8,103,165 |
Restricted Stock Units [Member] | ||
Loss Per Common Share [Abstract] | ||
Potentially dilutive securities (in shares) | 4,729,758 | 730,994 |
Warrants [Member] | ||
Loss Per Common Share [Abstract] | ||
Potentially dilutive securities (in shares) | 13,631,207 | 4,528,160 |
SUMMARY OF SIGNIFICANT ACCOUN_9
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Stock-based Compensation (Details) | 3 Months Ended |
Mar. 31, 2022 | |
Stock-based Compensation [Abstract] | |
Equity incentive plans, vesting period | 4 years |
Equity incentive plans, term | 10 years |
SUMMARY OF SIGNIFICANT ACCOU_10
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Income Taxes (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Income Taxes [Abstract] | ||
Unrecognized tax benefits | $ 0 | $ 0 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
INVENTORIES [Abstract] | ||
Raw materials | $ 46,034,969 | $ 36,755,720 |
Work-in-process | 45,139,511 | 58,968,535 |
Finished goods | 47,971,831 | 28,999,836 |
Total inventories | $ 139,146,311 | $ 124,724,091 |
INTANGIBLE ASSETS, Summary (Det
INTANGIBLE ASSETS, Summary (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets, Net [Abstract] | |||
Cost | $ 5,007,467 | $ 5,007,467 | |
Accumulated amortization | 3,457,537 | 3,278,699 | |
Net | 1,549,930 | 1,728,768 | |
Amortization of intangible assets | 178,838 | $ 178,838 | |
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 | 2,830,985 | 2,684,554 | |
Net | 1,269,061 | 1,415,492 | |
Rights to Intermediates [Member] | |||
Finite-Lived Intangible Assets, Net [Abstract] | |||
Cost | 907,421 | 907,421 | |
Accumulated amortization | 626,552 | 594,145 | |
Net | $ 280,869 | $ 313,276 |
INTANGIBLE ASSETS, Future Aggre
INTANGIBLE ASSETS, Future Aggregate Amortization Expense (Details) | Mar. 31, 2022USD ($) |
Estimated Aggregate Amortization Expense [Abstract] | |
Remainder of 2022 | $ 536,514 |
2023 | 715,352 |
2024 | $ 298,064 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |||
Property, plant and equipment, gross | $ 67,900,912 | $ 64,206,927 | |
Less: accumulated depreciation | (14,680,432) | (13,271,853) | |
Total property, plant and equipment, net | 53,220,480 | 50,935,074 | |
Depreciation expense | $ 1,400,000 | $ 1,100,000 | |
Minimum [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Estimated useful life | 3 years | ||
Maximum [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Estimated useful life | 10 years | ||
Manufacturing and Laboratory Equipment [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Property, plant and equipment, gross | $ 17,100,261 | 16,702,991 | |
Office Equipment and Computer Software [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Property, plant and equipment, gross | 4,323,549 | 4,082,462 | |
Furniture and Fixtures [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Property, plant and equipment, gross | 3,693,317 | 3,389,140 | |
Construction in Process [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Property, plant and equipment, gross | 6,384,242 | 5,496,222 | |
Leasehold Improvements [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Property, plant and equipment, gross | 12,966,337 | 11,129,639 | |
Land [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Property, plant and equipment, gross | 4,339,441 | 4,339,441 | |
Buildings and Building Improvements [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Property, plant and equipment, gross | $ 19,093,765 | $ 19,067,032 | |
Building [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Estimated useful life | 30 years |
ACCRUED EXPENSES AND OTHER CU_3
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses and Other Current Liabilities [Abstract] | ||
Accrued rebates | $ 6,324,746 | $ 5,040,200 |
Accrued distribution fees | 2,794,447 | 4,739,651 |
Accrued incentives | 1,565,993 | 4,066,109 |
Accrued testing | 674,191 | 1,189,970 |
Accrued payroll | 2,206,409 | 1,167,072 |
Other | 3,088,754 | 1,011,986 |
Total accrued expenses and other current liabilities | $ 16,654,540 | $ 17,214,988 |
DEBT (Details)
DEBT (Details) | Mar. 23, 2022USD ($)d$ / sharesshares | Dec. 31, 2026USD ($) | Jun. 30, 2022USD ($) | Mar. 31, 2022USD ($)$ / shares | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($)$ / shares |
Senior Notes Payable [Abstract] | ||||||
Notes payable | $ 151,750,000 | $ 100,000,000 | ||||
Less: Debt discount | (13,326,948) | (5,133,761) | ||||
Senior notes payable | 138,423,052 | $ 94,866,239 | ||||
Payment for outstanding obligations | 100,000,000 | $ 0 | ||||
Loss on extinguishment of debt | (6,669,941) | 0 | ||||
Revenues | $ 29,103,093 | $ 16,048,618 | ||||
Warrant exercise price per share (in dollars per share) | $ / shares | $ 2.04 | $ 2.82 | ||||
Hayfin Credit Agreement [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Less: Debt discount | $ (13,400,000) | |||||
Maturity date | Mar. 23, 2029 | |||||
Upfront fee paid in kind | 1,800,000 | |||||
Loss on extinguishment of debt | $ (6,700,000) | |||||
Applicable margin | 9.50% | |||||
Effective interest rate | 13.00% | |||||
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 | |||||
Trailing period for VWAP | 30 days | |||||
Fair value of warrants | $ 9,600,000 | |||||
Hayfin Credit Agreement [Member] | Minimum [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Cash balance | $ 6,000,000 | |||||
Hayfin Credit Agreement [Member] | Minimum [Member] | Forecast [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Revenues | $ 75,000,000 | |||||
Hayfin Credit Agreement [Member] | Maximum [Member] | Forecast [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Revenues | $ 250,000,000 | |||||
Hayfin Credit Agreement [Member] | Prepaid on or Prior to First Anniversary [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Percentage of prepaid principal amount | 7.00% | |||||
Hayfin Credit Agreement [Member] | Prepaid after the First Anniversary [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Percentage of prepaid principal amount | 3.00% | |||||
Hayfin Credit Agreement [Member] | Prepaid after the Second Anniversary [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Percentage of prepaid principal amount | 1.00% | |||||
Hayfin Credit Agreement [Member] | Federal Funds Rate [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Credit agreement, interest rate provided | 0.50% | |||||
Hayfin Credit Agreement [Member] | Secured Overnight Financing Rate [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Credit agreement, interest rate provided | 1.00% | |||||
Term of variable rate | 1 month | |||||
Applicable margin | 8.50% | |||||
Hayfin Credit Agreement [Member] | Secured Overnight Financing Rate [Member] | Minimum [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Term of variable rate | 1 month | |||||
Hayfin Credit Agreement [Member] | Secured Overnight Financing Rate [Member] | Maximum [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Term of variable rate | 3 months | |||||
Hayfin Credit Agreement [Member] | Base Rate [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Percentage of floor interest rate | 1.25% | |||||
Hayfin Credit Facility [Member] | Hayfin Credit Agreement [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Maturity date | Mar. 23, 2027 | |||||
Hayfin Credit Facility [Member] | Hayfin Credit Agreement [Member] | Maximum [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Notes payable | $ 175,000,000 | |||||
Hayfin Closing Date Loan [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Payment for outstanding obligations | 100,000,000 | |||||
Hayfin Closing Date Loan [Member] | Hayfin Credit Agreement [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Notes payable | 150,000,000 | |||||
Redemption premium | 2,000,000 | |||||
Payment for certain fees and expenses | 600,000 | |||||
Effective interest rate | 10.75% | |||||
Hayfin Delayed Draw Loan [Member] | Hayfin Credit Agreement [Member] | ||||||
Senior Notes Payable [Abstract] | ||||||
Notes payable | $ 25,000,000 | |||||
Maturity date | Mar. 22, 2023 |
STOCKHOLDERS' EQUITY, Preferred
STOCKHOLDERS' EQUITY, Preferred Stock (Details) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Preferred Stock [Abstract] | ||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, outstanding (in shares) | 0 | 0 |
STOCKHOLDERS' EQUITY, Common St
STOCKHOLDERS' EQUITY, Common Stock (Details) - USD ($) | Sep. 03, 2021 | Feb. 03, 2021 | Aug. 05, 2020 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 |
Common Stock [Abstract] | ||||||
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 | ||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||
Common stock, shares outstanding (in shares) | 196,347,529 | 195,813,817 | ||||
Warrants outstanding (in shares) | 32,811,653 | |||||
Common stock, available for issuance (in shares) | 70,840,818 | |||||
Common stock issuable under agreement | $ 41,912,515 | |||||
Net proceeds from issuance of common stock | $ 0 | 41,912,515 | ||||
Sale Agreement [Member] | Jefferies LLC [Member] | ||||||
Common Stock [Abstract] | ||||||
Net proceeds from issuance of common stock | 41,900,000 | |||||
Sale Agreement [Member] | Jefferies LLC [Member] | Maximum [Member] | ||||||
Common Stock [Abstract] | ||||||
Common stock issuable under agreement | $ 50,000,000 | |||||
Sale Agreement, Amended [Member] | Jefferies LLC [Member] | Maximum [Member] | ||||||
Common Stock [Abstract] | ||||||
Common stock issuable under agreement | $ 105,400,000 | |||||
Distribution Agreement [Member] | Raymond James & Associates Inc. [Member] | ||||||
Common Stock [Abstract] | ||||||
Common stock issuable under agreement | $ 42,800,000 | |||||
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] | ||||||
Warrants outstanding (in shares) | 13,631,207 | 4,528,160 | ||||
Common stock issuable under agreement | $ 1,808 | |||||
Common stock shares sold during the period (in shares) | 18,080,708 | |||||
Common Stock [Member] | Sale Agreement [Member] | Jefferies LLC [Member] | ||||||
Common Stock [Abstract] | ||||||
Common stock shares sold during the period (in shares) | 18,080,708 |
STOCKHOLDERS' EQUITY, Warrants
STOCKHOLDERS' EQUITY, Warrants (Details) - USD ($) $ / shares in Units, $ in Millions | Mar. 23, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Warrants [Abstract] | |||
Warrants outstanding (in shares) | 32,811,653 | ||
Weighted average exercise price of warrants (in dollars per share) | $ 2.04 | $ 2.82 | |
Hayfin Credit Agreement [Member] | |||
Warrants [Abstract] | |||
Warrant to purchase shares of common stock (in shares) | 9,103,047 | ||
Fair value of warrants | $ 9.6 | ||
Expected term | 7 years | ||
Volatility | 68.10% | ||
Dividend yield | 0.00% | ||
Risk-free interest rate | 2.36% | ||
Weighted average exercise price of warrants (in dollars per share) | $ 1.6478 | ||
Common Stock [Member] | |||
Warrants [Abstract] | |||
Warrants outstanding (in shares) | 13,631,207 | 4,528,160 |
STOCKHOLDERS' EQUITY, Equity In
STOCKHOLDERS' EQUITY, Equity Incentive Plans (Details) - USD ($) | Mar. 23, 2022 | Mar. 31, 2022 | Mar. 31, 2021 |
Restricted Stock Units [Abstract] | |||
Restricted stock units vested over a period | 4 years | ||
Total stock-based compensation expense, Amount [Abstract] | |||
Total stock-based compensation expense | $ 1,641,388 | $ 781,397 | |
Hayfin Credit Agreement [Member] | |||
Fair Value Assumptions and Methodology [Abstract] | |||
Expected term | 7 years | ||
Volatility | 68.10% | ||
Dividend yield | 0.00% | ||
Risk-free interest rate | 2.36% | ||
Research and Development [Member] | |||
Total stock-based compensation expense, Amount [Abstract] | |||
Total stock-based compensation expense | $ 4,671 | 105,227 | |
Plasma Center Operating Expenses [Member] | |||
Total stock-based compensation expense, Amount [Abstract] | |||
Total stock-based compensation expense | 21,052 | 10,818 | |
Selling, General and Administrative [Member] | |||
Total stock-based compensation expense, Amount [Abstract] | |||
Total stock-based compensation expense | 1,517,602 | 588,491 | |
Cost of Product Revenue [Member] | |||
Total stock-based compensation expense, Amount [Abstract] | |||
Total stock-based compensation expense | 98,063 | $ 76,861 | |
Equity Incentive Plans [Member] | |||
Stock Options, Weighted Average Exercise Price [Abstract] | |||
Unrecognized compensation expense, stock options | $ 3,800,000 | ||
Unrecognized compensation expense recognition period | 2 years 7 months 6 days | ||
Stock Options [Member] | |||
Fair Value Assumptions and Methodology [Abstract] | |||
Volatility | 68.00% | 69.00% | |
Dividend yield | 0.00% | 0.00% | |
Stock Options [Abstract] | |||
Number of stock options granted (in shares) | 1,194,032 | 1,441,050 | |
Weighted average remaining contractual life of stock options, outstanding | 6 years 7 months 6 days | ||
Weighted average remaining contractual life of stock options, expected to vest | 6 years 7 months 6 days | ||
Weighted average remaining contractual life of stock options, exercisable | 5 years 3 months 18 days | ||
Stock Option, Shares [Abstract] | |||
Options outstanding, vested and expected to vest, beginning balance (in shares) | 7,862,722 | ||
Forfeited (in shares) | (9,186) | ||
Expired (in shares) | (361,500) | ||
Granted (in shares) | 1,194,032 | ||
Options outstanding, vested and expected to vest, ending balance (in shares) | 8,686,068 | ||
Options exercisable (in shares) | 5,646,819 | ||
Stock Options, Weighted Average Exercise Price [Abstract] | |||
Options outstanding, vested and expected to vest, weighted average exercise price, beginning balance (in dollars per share) | $ 3.93 | ||
Forfeited, weighted average exercise price (in dollars per share) | 2.13 | ||
Expired, weighted average exercise price (in dollars per share) | 6.48 | ||
Granted, weighted average exercise price (in dollars per share) | 1.67 | ||
Options outstanding, vested and expected to vest, weighted average exercise price, ending balance (in dollars per share) | 3.51 | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 4.25 | ||
Stock Options [Member] | Minimum [Member] | |||
Fair Value Assumptions and Methodology [Abstract] | |||
Expected term | 5 years 6 months | 5 years 6 months | |
Risk-free interest rate | 1.72% | 0.80% | |
Stock Options [Member] | Maximum [Member] | |||
Fair Value Assumptions and Methodology [Abstract] | |||
Expected term | 6 years 3 months 18 days | 6 years 3 months 18 days | |
Risk-free interest rate | 1.73% | 1.04% | |
Restricted Stock Units (RSUs) [Member] | |||
Restricted Stock Units [Abstract] | |||
Number of restricted stock units granted (in shares) | 1,059,266 | 492,744 | |
Shares withheld for tax withholding obligation (in shares) | 265,929 | ||
Amount of shares withheld for tax withholding obligation | $ 400,000 | ||
Unvested RSU, Shares [Abstract] | |||
Beginning balance (in shares) | 4,485,133 | ||
Granted (in shares) | 1,059,266 | ||
Vested (in shares) | (799,641) | ||
Forfeited (in shares) | (15,000) | ||
Ending balance (in shares) | 4,729,758 | ||
Unvested RSU, Weighted Average Grant Date Fair Value | |||
Unvested, Weighted average grant date fair value, beginning balance (in dollars per share) | $ 1.34 | ||
Granted, Weighted average grant date fair value (in dollars per share) | 1.67 | ||
Vested, Weighted average grant date fair value (in dollars per share) | 1.41 | ||
Forfeited, Weighted average grant date fair value (in dollars per share) | 1.22 | ||
Unvested, Weighted average grant date fair value, ending balance (in dollars per share) | $ 1.41 | ||
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] | Employees [Member] | |||
Restricted Stock Units [Abstract] | |||
Restricted stock units vested over a period | 4 years | ||
Restricted Stock Units (RSUs) [Member] | Equity Incentive Plans [Member] | |||
Stock Options, Weighted Average Exercise Price [Abstract] | |||
Unrecognized compensation expense recognition period | 2 years 8 months 12 days | ||
Unvested RSU, Weighted Average Grant Date Fair Value | |||
Unrecognized compensation expense, non option | $ 5,700,000 | ||
Milestone Based Restricted Stock (RSUs) [Member] | BIVIGAM [Member] | |||
Unvested RSU, Shares [Abstract] | |||
Vested (in shares) | (382,117) | ||
Milestone Based Restricted Stock (RSUs) [Member] | Hayfin Credit Agreement [Member] | |||
Unvested RSU, Shares [Abstract] | |||
Vested (in shares) | (254,745) |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Perceptive [Member] | ||
Related Party Transactions [Abstract] | ||
Minimum percentage of common stock held by lender | 5.00% | |
Areth, LLC [Member] | ||
Related Party Transactions [Abstract] | ||
Rent expense | $ 30,000 | $ 30,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) | Apr. 01, 2019USD ($) | Dec. 19, 2012USD ($) | Mar. 31, 2022USD ($)FacilityTermCenterTranche | Mar. 31, 2021USD ($) | Dec. 31, 2021 | Jun. 15, 2022USD ($) | Sep. 30, 2021USD ($) |
Vendor Commitments [Abstract] | |||||||
Number of plasma collection facilities | Facility | 9 | ||||||
Plasma supply agreement term | 10 years | ||||||
Plasma purchased from Grifols | $ 15,500,000 | $ 12,700,000 | |||||
Percentage of inventory purchases | 75.00% | 72.00% | |||||
Post-Marketing Commitments [Abstract] | |||||||
Research and Development Expense | $ 2,000,000 | $ 624,111 | $ 987,649 | ||||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | International Customers [Member] | |||||||
COVID-19 Pandemic [Abstract] | |||||||
Concentration risk, percentage | 6.00% | 15.00% | |||||
Minimum [Member] | |||||||
Post-Marketing Commitments [Abstract] | |||||||
Research and Development Expense | $ 3,000,000 | ||||||
Maximum [Member] | |||||||
Post-Marketing Commitments [Abstract] | |||||||
Research and Development Expense | $ 4,000,000 | ||||||
Employee Retention Program [Member] | |||||||
Other Commitments [Abstract] | |||||||
Number of tranches | Tranche | 2 | ||||||
Retention amount paid to employees, tranche one | $ 1,300,000 | ||||||
Amount of first tranche recognized over the retention service period | $ 800,000 | ||||||
Compensation expense period | 15 months | ||||||
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 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 that collects RSV Plasma which were transferred to BPC | Center | 2 | ||||||
Percentage of plasma purchase price equal to cost | 5.00% | ||||||
2011 Plasma Purchase Agreement [Member] | Maximum [Member] | |||||||
Vendor Commitments [Abstract] | |||||||
Number of plasma collection facilities | Facility | 5 | ||||||
2017 Plasma Purchase Agreement [Member] | |||||||
Vendor 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 |
SEGMENTS (Details)
SEGMENTS (Details) | 3 Months Ended | ||
Mar. 31, 2022USD ($)Facility | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($) | |
Segment Reporting Information [Abstract] | |||
Number of plasma collection facilities under development | Facility | 10 | ||
Number of FDA-licensed plasma collection facilities | Facility | 5 | ||
Revenues | $ 29,103,093 | $ 16,048,618 | |
Cost of product revenue | 25,441,046 | 17,770,122 | |
Loss from operations | (14,815,066) | (15,164,249) | |
Interest and other expense, net | (3,522,850) | (3,215,692) | |
Loss on extinguishment of debt | (6,669,941) | 0 | |
Net loss | (25,007,857) | (18,379,941) | |
Capital expenditures | 2,842,085 | 2,571,161 | |
Depreciation and amortization expense | 1,590,217 | 1,229,628 | |
Total assets | 308,032,492 | 235,667,028 | $ 276,252,724 |
United States [Member] | |||
Segment Reporting Information [Abstract] | |||
Revenues | 27,316,151 | 13,678,008 | |
International [Member] | |||
Segment Reporting Information [Abstract] | |||
Revenues | 1,786,942 | 2,370,610 | |
Corporate [Member] | |||
Segment Reporting Information [Abstract] | |||
Revenues | 35,708 | 35,708 | |
Cost of product revenue | 0 | 0 | |
Loss from operations | (6,509,288) | (3,687,719) | |
Interest and other expense, net | (3,472,854) | (3,193,795) | |
Loss on extinguishment of debt | (6,669,941) | ||
Net loss | (16,652,083) | (6,881,514) | |
Capital expenditures | 0 | 0 | |
Depreciation and amortization expense | 763 | 1,867 | |
Total assets | 61,313,259 | 61,734,239 | |
Operating Segments [Member] | ADMA BioManufacturing [Member] | |||
Segment Reporting Information [Abstract] | |||
Revenues | 25,728,625 | 13,421,043 | |
Cost of product revenue | 22,213,781 | 15,449,757 | |
Loss from operations | (4,442,684) | (9,505,689) | |
Interest and other expense, net | (49,267) | (21,513) | |
Loss on extinguishment of debt | 0 | ||
Net loss | (4,491,951) | (9,527,202) | |
Capital expenditures | 1,310,379 | 1,012,980 | |
Depreciation and amortization expense | 1,111,951 | 1,009,770 | |
Total assets | 214,150,322 | 156,535,177 | |
Operating Segments [Member] | Plasma Collection Centers [Member] | |||
Segment Reporting Information [Abstract] | |||
Revenues | 3,338,760 | 2,591,867 | |
Cost of product revenue | 3,227,265 | 2,320,365 | |
Loss from operations | (3,863,094) | (1,970,841) | |
Interest and other expense, net | (729) | (384) | |
Loss on extinguishment of debt | 0 | ||
Net loss | (3,863,823) | (1,971,225) | |
Capital expenditures | 1,531,706 | 1,558,181 | |
Depreciation and amortization expense | 477,503 | 217,991 | |
Total assets | $ 32,568,911 | $ 17,397,612 |
LEASE OBLIGATIONS (Details)
LEASE OBLIGATIONS (Details) | 3 Months Ended | ||
Mar. 31, 2022USD ($)Facility | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($) | |
LEASE OBLIGATIONS [Abstract] | |||
Incremental borrowing rate | 13.00% | ||
Aggregate lease expense | $ 400,000 | $ 300,000 | |
Cash payments for lease | 400,000 | $ 200,000 | |
Operating and financing lease liabilities | $ 7,900,000 | $ 8,100,000 | |
Weighted average remaining term | 8 years 10 months 24 days | ||
Payments Under Lease Obligations [Abstract] | |||
Remainder of 2022 | $ 1,228,526 | ||
Year ended December 31, 2023 | 1,641,603 | ||
2024 | 1,517,229 | ||
2025 | 1,525,793 | ||
2026 | 1,260,391 | ||
2027 | 1,289,679 | ||
Thereafter | 5,055,880 | ||
Total payments | 13,519,101 | ||
Less: imputed interest | (5,581,019) | ||
Current portion | (654,003) | (591,084) | |
Balance at March 31, 2022 | $ 7,284,079 | $ 7,462,388 | |
Lease [Abstract] | |||
Number of plasma collection facilities | Facility | 9 | ||
Security deposit and initial payment | $ 44,000 | ||
Rental payment | $ 0 | ||
Initial term of lease | 126 months | ||
Minimum [Member] | |||
Lease [Abstract] | |||
Rental expense | $ 18,000 | ||
Maximum [Member] | |||
Lease [Abstract] | |||
Rental expense | $ 24,000 |
SUPPLEMENTAL DISCLOSURE OF CA_3
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
SUPPLEMENTAL CASH FLOW INFORMATION [Abstract] | ||
Cash paid for interest | $ 2,525,987 | $ 2,751,956 |
Noncash Financing and Investing Activities [Abstract] | ||
Equipment acquired reflected in accounts payable and accrued liabilities | 1,940,425 | 1,797,249 |
Right-to-use assets in exchange for lease obligations | 0 | 2,073,627 |
Warrants issued in connection with notes payable | $ 9,569,604 | $ 0 |