Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 06, 2021 | |
Entity Listings [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
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 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 | 132,769,471 | |
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 | |
No Trading Symbol Flag | true | |
Security Exchange Name | NASDAQ |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 42,408,958 | $ 55,921,152 |
Accounts receivable, net | 23,544,594 | 13,237,290 |
Inventories | 99,699,743 | 81,535,599 |
Prepaid expenses and other current assets | 5,701,863 | 3,046,466 |
Total current assets | 171,355,158 | 153,740,507 |
Property and equipment, net | 46,486,980 | 41,593,090 |
Intangible assets, net | 2,086,445 | 2,444,121 |
Goodwill | 3,529,509 | 3,529,509 |
Right to use assets | 6,829,040 | 4,259,191 |
Deposits and other assets | 2,526,660 | 2,106,976 |
TOTAL ASSETS | 232,813,792 | 207,673,394 |
Current liabilities: | ||
Accounts payable | 6,167,465 | 11,073,708 |
Accrued expenses and other current liabilities | 11,490,239 | 8,365,143 |
Current portion of deferred revenue | 142,834 | 142,834 |
Current portion of lease obligations | 385,858 | 365,682 |
Total current liabilities | 18,186,396 | 19,947,367 |
Senior notes payable, net of discount | 93,877,017 | 92,968,866 |
Deferred revenue, net of current portion | 2,047,281 | 2,118,698 |
Lease obligations, net of current portion | 7,073,415 | 4,334,151 |
Other non-current liabilities | 36,151 | 54,886 |
TOTAL LIABILITIES | 121,220,260 | 119,423,968 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS' EQUITY | ||
Preferred Stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding | 0 | 0 |
Common Stock - voting, $0.0001 par value, 300,000,000 and 150,000,000 shares authorized, 131,872,026 and 104,902,888 shares issued and outstanding | 13,187 | 10,490 |
Additional paid-in capital | 489,330,692 | 428,704,039 |
Accumulated deficit | (377,750,347) | (340,465,103) |
TOTAL STOCKHOLDERS' EQUITY | 111,593,532 | 88,249,426 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 232,813,792 | $ 207,673,394 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
STOCKHOLDERS' EQUITY | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 300,000,000 | 150,000,000 |
Common stock, shares issued (in shares) | 131,872,026 | 104,902,888 |
Common stock, shares outstanding (in shares) | 131,872,026 | 104,902,888 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
REVENUES: | ||||
Total revenues | $ 17,830,590 | $ 7,787,594 | $ 33,879,208 | $ 17,987,338 |
OPERATING EXPENSES: | ||||
Cost of product revenue (exclusive of amortization expense shown below) | 18,832,624 | 13,495,629 | 36,602,746 | 30,324,855 |
Research and development | 1,158,866 | 1,656,420 | 2,146,515 | 3,185,158 |
Plasma center operating expenses | 2,803,326 | 877,902 | 5,045,669 | 1,378,546 |
Amortization of intangible assets | 178,838 | 178,838 | 357,676 | 357,676 |
Selling, general and administrative | 10,438,168 | 8,702,630 | 20,472,083 | 16,634,714 |
Total operating expenses | 33,411,822 | 24,911,419 | 64,624,689 | 51,880,949 |
LOSS FROM OPERATIONS | (15,581,232) | (17,123,825) | (30,745,481) | (33,893,611) |
OTHER INCOME (EXPENSE): | ||||
Interest income | 5,926 | 19,411 | 27,985 | 267,479 |
Interest expense | (3,246,680) | (3,067,306) | (6,442,430) | (5,784,397) |
Other expense | (83,317) | (6,371) | (125,318) | (12,792) |
Other expense, net | (3,324,071) | (3,054,266) | (6,539,763) | (5,529,710) |
NET LOSS | $ (18,905,303) | $ (20,178,091) | $ (37,285,244) | $ (39,423,321) |
BASIC LOSS PER COMMON SHARE (in dollars per share) | $ (0.15) | $ (0.23) | $ (0.31) | $ (0.49) |
DILUTED LOSS PER COMMON SHARE (in dollars per share) | $ (0.15) | $ (0.23) | $ (0.31) | $ (0.49) |
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | ||||
Basic (in shares) | 127,416,126 | 86,347,467 | 121,571,501 | 80,064,641 |
Diluted (in shares) | 127,416,126 | 86,347,467 | 121,571,501 | 80,064,641 |
Product Revenue [Member] | ||||
REVENUES: | ||||
Total revenues | $ 17,794,881 | $ 7,751,885 | $ 33,807,791 | $ 17,915,921 |
License Revenue [Member] | ||||
REVENUES: | ||||
Total revenues | $ 35,709 | $ 35,709 | $ 71,417 | $ 71,417 |
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, 2019 | $ 5,932 | $ 290,903,772 | $ (264,716,555) | $ 26,193,149 |
Balance (in shares) at Dec. 31, 2019 | 59,318,355 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation | $ 0 | 676,548 | 0 | 676,548 |
Issuance of common stock, net of offering expenses | $ 2,703 | 88,701,336 | 0 | 88,704,039 |
Issuance of common stock, net of offering expenses (in shares) | 27,025,000 | |||
Exercise of stock options | $ 0 | 7,177 | 0 | 7,177 |
Exercise of stock options (in shares) | 1,958 | |||
Net loss | $ 0 | 0 | (19,245,230) | (19,245,230) |
Balance at Mar. 31, 2020 | $ 8,635 | 380,288,833 | (283,961,785) | 96,335,683 |
Balance (in shares) at Mar. 31, 2020 | 86,345,313 | |||
Balance at Dec. 31, 2019 | $ 5,932 | 290,903,772 | (264,716,555) | 26,193,149 |
Balance (in shares) at Dec. 31, 2019 | 59,318,355 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Net loss | (39,423,321) | |||
Balance at Jun. 30, 2020 | $ 8,635 | 381,010,696 | (304,139,876) | 76,879,455 |
Balance (in shares) at Jun. 30, 2020 | 86,349,981 | |||
Balance at Mar. 31, 2020 | $ 8,635 | 380,288,833 | (283,961,785) | 96,335,683 |
Balance (in shares) at Mar. 31, 2020 | 86,345,313 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation | $ 0 | 715,608 | 0 | 715,608 |
Exercise of stock options | $ 0 | 6,255 | 0 | 6,255 |
Exercise of stock options (in shares) | 4,668 | |||
Net loss | $ 0 | 0 | (20,178,091) | (20,178,091) |
Balance at Jun. 30, 2020 | $ 8,635 | 381,010,696 | (304,139,876) | 76,879,455 |
Balance (in shares) at Jun. 30, 2020 | 86,349,981 | |||
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, 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] | ||||
Net loss | (37,285,244) | |||
Balance at Jun. 30, 2021 | $ 13,187 | 489,330,692 | (377,750,347) | 111,593,532 |
Balance (in shares) at Jun. 30, 2021 | 131,872,026 | |||
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 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation | $ 0 | 805,189 | 0 | 805,189 |
Issuance of common stock, net of offering expenses | $ 883 | 17,188,677 | 0 | 17,189,560 |
Issuance of common stock, net of offering expenses (in shares) | 8,827,045 | |||
Net loss | $ 0 | 0 | (18,905,303) | (18,905,303) |
Balance at Jun. 30, 2021 | $ 13,187 | $ 489,330,692 | $ (377,750,347) | $ 111,593,532 |
Balance (in shares) at Jun. 30, 2021 | 131,872,026 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (37,285,244) | $ (39,423,321) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,555,622 | 1,674,490 |
Loss on disposal of fixed assets | 78,135 | 3,518 |
Stock-based compensation | 1,586,586 | 1,392,156 |
Amortization of debt discount | 908,151 | 874,732 |
Amortization of license revenue | (71,417) | (71,417) |
Changes in operating assets and liabilities: | ||
Accounts receivable | (10,307,304) | (3,044,246) |
Inventories | (18,164,144) | (2,936,614) |
Prepaid expenses and other current assets | (2,655,397) | (2,159,834) |
Deposits and other assets | (144,657) | (283,195) |
Accounts payable | (4,906,244) | (2,264,932) |
Accrued expenses | 2,980,534 | 399,295 |
Other current and non-current liabilities | (65,984) | (92,067) |
Net cash used in operating activities | (65,491,363) | (45,931,435) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (7,046,735) | (6,243,284) |
Proceeds from the sale of property and equipment | 0 | 2,000 |
Net cash used in investing activities | (7,046,735) | (6,241,284) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock, net of offering expenses | 59,102,075 | 88,704,039 |
Proceeds from the exercise of stock options | 0 | 13,432 |
Taxes paid on vested Restricted Stock Units | (59,311) | 0 |
Proceeds from issuance of note payable | 0 | 12,500,000 |
Payments on finance lease obligations | (16,860) | (15,765) |
Net cash provided by financing activities | 59,025,904 | 101,201,706 |
Net (decrease) increase in cash and cash equivalents | (13,512,194) | 49,028,987 |
Cash and cash equivalents - beginning of period | 55,921,152 | 26,752,135 |
Cash and cash equivalents - end of period | $ 42,408,958 | $ 75,781,122 |
ORGANIZATION AND BUSINESS
ORGANIZATION AND BUSINESS | 6 Months Ended |
Jun. 30, 2021 | |
ORGANIZATION AND BUSINESS [Abstract] | |
ORGANIZATION AND BUSINESS | 1. ORGANIZATION AND BUSINESS ADMA Biologics, Inc. (“ADMA” or the “Company”) is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. The Company’s targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons. ADMA operates through its wholly-owned subsidiaries ADMA BioManufacturing, LLC (“ADMA BioManufacturing”) and ADMA BioCenters Georgia Inc. (“ADMA BioCenters”). ADMA BioManufacturing was formed in January 2017 to facilitate the acquisition of the Biotest Therapy Business Unit (“BTBU”) from BPC Plasma, Inc. (formerly Biotest Pharmaceuticals Corporation) (“BPC” and, together with Biotest AG, “Biotest”) on June 6, 2017. The acquisition included certain assets (the “Biotest Assets”) of BTBU, which included the FDA-licensed BIVIGAM and Nabi-HB immunoglobulin products, and an FDA-licensed plasma fractionation manufacturing facility located in Boca Raton, FL (the “Boca Facility”) (the “Biotest Transaction”). BTBU had previously been the Company’s third-party contract manufacturer. ADMA BioCenters is the Company’s source plasma collection business with eight plasma collection facilities in various stages of approval and development located throughout the U.S., two of which hold an approved license with the U.S. Food and Drug Administration (the “FDA”) while a third facility has a Biologics License Application (“BLA”) pending FDA approval. 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 June 30, 2021, the Company had working capital of $153.2 million, including $42.4 million of cash and cash equivalents. Based upon the Company’s current projected revenue and expenditures, including capital expenditures and continued implementation of the Company’s commercialization and expansion activities, the Company’s management currently believes that its cash, cash equivalents, projected revenue and accounts receivable will be sufficient to fund ADMA’s operations, as currently conducted, into the fourth quarter of 2021. In order to have sufficient cash to fund its operations thereafter, the Company anticipates it will need to raise additional capital before the end of the fourth quarter of 2021. These estimates may change based upon several factors, including the success of the Company’s commercial sales of its products, manufacturing ramp-up activities, the acceptability of ADMA’s immune globulin products by physicians, patients or payers and the various financing options that may be available to the Company. In addition, the Company’s end-to-end production cycle from procurement of raw materials to commercial release of finished product can take between seven Due to numerous risks and uncertainties associated with FDA review, inspections and approvals related to the Company’s products or the labeled indications of such products, ongoing compliance requirements and capacity expansion efforts at the Company’s Boca Facility and future commercialization of the Company’s products, including the Company’s ability to obtain adequate quantities of FDA-approved plasma with proper specifications on acceptable terms for use in the Company’s manufacturing process, as well as the additional uncertainties surrounding the COVID-19 pandemic (see Note 10), the Company is unable to estimate with certainty the amounts of increased capital outlays and operating expenditures required to fund its commercial and development activities. The Company’s current estimates may be subject to change as circumstances regarding its business requirements evolve. Failure to secure any necessary financing in a timely manner and on commercially reasonable terms could have a material adverse effect on the Company’s business plan and financial performance and it could be forced to delay or discontinue its commercialization, product development or clinical activities or delay or discontinue the approval efforts for any of the Company’s products or product candidates. The Company has reported cumulative losses since inception in June 2004 through June 30, 2021 of $377.8 million. As such, these factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying consolidated financial statements do not include any adjustments related to the recoverability and classification of asset carrying amounts and the classification of liabilities that might be necessary from the outcome of this uncertainty. The Company may decide to raise capital through public or private equity offerings or debt financings, or obtain a bank credit facility or enter into corporate collaboration and licensing arrangements. The sale of additional equity or debt securities, if convertible, could result in dilution to the Company’s existing stockholders and, in such event, the market value of its common stock may decline. The incurrence of additional indebtedness would result in increased fixed obligations and could also result in covenants that would restrict the Company’s operations or other financing alternatives. In addition, the Company is exploring additional contract manufacturing arrangements and other business development opportunities, which may provide additional liquidity to the Company. During the six months ended June 30, 2021, the Company raised $59.1 million from the open market sale agreement dated August 5, 2020, as amended, (the “2020 Sale Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which the Company could offer and sell, from time to time, at its option, through or to Jefferies, shares of the Company’s common stock (see Note 8). In July of 2021, the Company raised an additional $1.5 million under the 2020 Sale Agreement, and the Company has reached the maximum amount of funds that can be raised under the 2020 Sale Agreement. On May 28, 2021, the Company entered into a new Open Market Sale AgreementSM (the “2021 Sale Agreement”) with Jefferies, pursuant to which the Company may offer and sell, from time to time, at its option, through or to Jefferies, up to an aggregate of $50,000,000 of shares of the Company’s common stock. As of August 11, 2021, there have been no sales of common stock under the 2021 Sale Agreement. There can be no assurance that the Company’s approved products will be commercially viable, or that research and development, plant capacity expansion, plasma center build-outs 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, protection of proprietary technology, and compliance with FDA and other governmental regulations and approval requirements. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
SUMMARY OF 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, 2020 included in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 25, 2021. The accompanying consolidated balance sheet as of December 31, 2020 was derived from the audited financial statements as of and for the year ended December 31, 2020. 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 June 30, 2021 and its results of operations, changes in equity and cash flows for the three and six months ended June 30, 2021. During the three and six months ended June 30, 2021 and 2020, 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 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 $0.2 million and $0.1 million at June 30, 2021 and December 31, 2020, respectively, which are recognized in the period the related revenue is recorded. The Company extends credit to its customers based upon an evaluation of each customer’s financial condition and credit history. Evaluations of the financial condition and associated credit risk of customers are performed on an ongoing basis. Inventories Raw materials inventory consists of various materials purchased from suppliers, including normal source plasma, used in the production of the Company’s products. Work-in-process and finished goods inventories (see Note 3) reflect the cost of raw materials as well as costs for direct and indirect labor, primarily salaries, wages and benefits for applicable employees, as well as an allocation of overhead costs related to the Boca Facility including utilities, property taxes, general repairs and maintenance, consumable supplies and depreciation. The allocation of Boca Facility overhead to inventory is generally based upon the estimated square footage of the Boca Facility that is used in the production of the Company’s products relative to the total square footage of the facility. Inventories, including plasma intended for resale and plasma intended for internal use in the Company’s manufacturing, commercialization or research and development activities, are carried at the lower of cost or net realizable value determined by the first-in, first-out method. Net realizable value is generally determined based upon the consideration the Company expects to receive when the inventory is sold, less costs to deliver the inventory to the recipient. The estimates for net realizable value of inventory are based on contractual terms or upon historical experience and certain other assumptions, and the Company believes that such assumptions are reasonable. Inventory is periodically reviewed to ensure that its carrying value does not exceed its net realizable value, and adjustments are recorded to write down such inventory, with a corresponding charge to cost of product revenue, when the carrying value or historical cost exceeds its estimated net realizable value. In addition, costs associated with the production of conformance or engineering lots that would not qualify as immediately available for commercial sale are charged to cost of product revenue and not capitalized into inventory. Goodwill Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill at June 30, 2021 and December 31, 2020 was $3.5 million. All of the Company’s goodwill is attributable to its ADMA BioManufacturing business segment and is related to the 2017 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, 2020 did not result in a goodwill impairment charge, and the Company did not record any impairment charges related to goodwill for the three and six months ended June 30, 2021 and 2020. Impairment of long-lived assets The Company assesses the recoverability of its long-lived assets, which include property and equipment and finite-lived intangible assets, whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s carrying value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the three and six months ended June 30, 2021 and 2020, the Company determined that there was no impairment of its long-lived assets. Revenue recognition Revenues for the three and six months ended June 30, 2021 and 2020 are comprised of (i) revenues from the sale of the Company’s immunoglobulin products, BIVIGAM, ASCENIV and Nabi-HB, (ii) product revenues from the sale of human plasma collected through the Company’s Plasma Collection Centers business segment, (iii) contract manufacturing and laboratory services revenue, (iv) revenues from the sale of intermediate by-products; and (v) license and other revenues primarily attributable to the out-licensing of ASCENIV to Biotest in 2012 to market and sell this product in Europe and selected countries in North Africa and the Middle East. Biotest has provided the Company with certain services and financial payments in accordance with the related Biotest license agreement and is obligated to pay the Company certain amounts in the future if certain milestones are achieved. Deferred revenue is amortized into income over the term of the Biotest license, representing a period of approximately 22 years. Product revenue is recognized when the customer is deemed to have control over the product. Control is determined based on when the product is shipped or delivered and title passes to the customer. Revenue is recorded in an amount that reflects the consideration the Company expects to receive in exchange. Revenue from the sale of the Company’s immunoglobulin products is recognized when the product reaches the customer’s destination, and is recorded net of estimated rebates, price protection arrangements and customer incentives, including prompt pay discounts, wholesaler chargebacks and other wholesaler fees. These estimates are based on historical experience and certain other assumptions, and the Company believes that such estimates are reasonable. For revenues associated with contract manufacturing and the sale of intermediates, control transfers to the customer and the performance obligation is satisfied when the customer takes possession of the product from the Boca Facility or from a third-party warehouse that is utilized by the Company. Product revenues from the sale of human plasma collected at the Company’s plasma collection centers are recognized at the time control of the product has been transferred to the customer, which generally occurs at the time of shipment. Product revenues are recognized at the time of delivery if the Company retains control of the product during shipment. For the six months ended June 30, 2021, five customers represented an aggregate of 85% of the Company’s consolidated revenues. For the six months ended June 30, 2020, three customers represented an aggregate of 81% of the Company’s consolidated revenues. 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 six months ended June 30, 2021 and 2020, the following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive effects: For the Six Months Ended June 30, 2021 2020 Stock options 7,783,029 6,801,779 Restricted stock units 686,133 326,000 Warrants 4,528,160 2,138,160 12,997,322 9,265,939 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 2016 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 June 30, 2021 and December 31, 2020, and during the three and six months ended June 30, 2021 and 2020, the Company recognized no adjustments for uncertain tax positions. Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326) |
INVENTORIES
INVENTORIES | 6 Months Ended |
Jun. 30, 2021 | |
INVENTORIES [Abstract] | |
INVENTORIES | 3. INVENTORIES The following table provides the components of inventories: June 30, 2021 December 31, 2020 Raw materials $ 33,058,221 $ 32,044,393 Work-in-process 49,163,125 30,293,288 Finished goods 17,478,397 19,197,918 Total inventories $ 99,699,743 $ 81,535,599 Raw materials includes plasma and other materials expected to be used in the production of BIVIGAM, ASCENIV and Nabi-HB, as there are alternative uses for these materials that provide a probable future benefit or will be consumed in the production of goods expected to be available for sale. 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 | 6 Months Ended |
Jun. 30, 2021 | |
INTANGIBLE ASSETS [Abstract] | |
INTANGIBLE ASSETS | 4. INTANGIBLE ASSETS Intangible assets at June 30, 2021 and December 31, 2020 consist of the following: June 30, 2021 December 31, 2020 Cost Accumulated Amortization Net Cost Accumulated Amortization Net Trademark and other intangible rights related to Nabi-HB $ 4,100,046 $ 2,391,693 $ 1,708,353 $ 4,100,046 $ 2,098,833 $ 2,001,213 Rights to intermediates 907,421 529,329 378,092 907,421 464,513 442,908 Customer contract 1,076,557 1,076,557 - 1,076,557 1,076,557 - $ 6,084,024 $ 3,997,579 $ 2,086,445 $ 6,084,024 $ 3,639,903 $ 2,444,121 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 June 30, 2021 and 2020, and $0.4 million for the six months ended June 30, 2021 and 2020. Estimated aggregate future aggregate amortization expense is expected to be as follows: 2021 $ 357,676 2022 715,352 2023 715,352 2024 298,065 |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 6 Months Ended |
Jun. 30, 2021 | |
PROPERTY AND EQUIPMENT [Abstract] | |
PROPERTY AND EQUIPMENT | 5. PROPERTY AND EQUIPMENT Property and equipment and related accumulated depreciation are summarized as follows: June 30, 2021 December 31, 2020 Manufacturing and laboratory equipment $ 15,082,205 $ 14,468,874 Office equipment and computer software 3,649,504 3,253,528 Furniture and fixtures 2,516,729 2,039,398 Construction in process 5,966,844 3,336,557 Leasehold improvements 7,192,820 5,272,490 Land 4,339,441 4,339,441 Buildings and building improvements 18,694,960 17,746,744 57,442,503 50,457,032 Less: Accumulated depreciation (10,955,523 ) (8,863,942 ) Total property and equipment, net $ 46,486,980 $ 41,593,090 Fixed assets 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 and six months ended June 30, 2021 of $1.1 million and $2.2 million, respectively. Depreciation expense for the three and six months ended June 30, 2020 was $ 0.7 million and $ million, respectively. |
ACCRUED EXPENSES AND OTHER CURR
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 6 Months Ended |
Jun. 30, 2021 | |
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 June 30, 2021 and December 31, 2020 are as follows: June 30, 2021 December 31, 2020 Accrued rebates $ 3,721,888 $ 2,604,245 Accrued distribution fees 1,928,901 828,120 Accrued payroll 691,483 734,972 Accrued testing 1,673,120 779,660 Accrued incentives 1,539,491 3,210,884 Accrued severance 789,534 - Other 1,145,822 207,262 Total accrued expenses and other current liabilities $ 11,490,239 $ 8,365,143 |
DEBT
DEBT | 6 Months Ended |
Jun. 30, 2021 | |
DEBT [Abstract] | |
DEBT | 7. DEBT A summary of outstanding senior notes payable is as follows: June 30, 2021 December 31, 2020 Notes payable $ 100,000,000 $ 100,000,000 Less: Debt discount (6,122,983 ) (7,031,134 ) Senior notes payable $ 93,877,017 $ 92,968,866 Under the Credit Agreement and Guaranty, as amended from time to time, (the “Perceptive Credit Agreement”) with Perceptive Credit Holdings II, LP, as the lender and administrative agent (“Perceptive”), the Company has a principal balance outstanding to Perceptive in the form of senior secured notes payable to Perceptive aggregating to $100.0 million with a maturity date of March 1, 2024 (the “Maturity Date”), subject to acceleration pursuant to the Perceptive Credit Agreement, including upon an Event of Default (as defined in the Perceptive Credit Agreement). On the Maturity Date, the Company will pay Perceptive the entire outstanding principal amount and any accrued and unpaid interest thereon. Prior to the Maturity Date, there are no scheduled principal payments due under the Perceptive Credit Agreement. Borrowings under the Perceptive Credit Agreement bear interest at a rate per annum equal to 7.5% plus the greater of (i) one-month LIBOR and (ii) 3.5%; provided, however, that upon, and during the continuance of, an Event of Default, the interest rate will automatically increase by an additional 400 basis points. Accrued interest is payable to Perceptive on the last day of each month during the term of the Perceptive Credit Facility. The rate of interest in effect as of June 30, 2021 was 11.0%, and the Company paid interest to Perceptive during the six months ended June 30, 2021 and 2020 in the amount of $5.5 million and $4.4 million, respectively. All of the Company’s obligations under the Perceptive 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 Perceptive 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 Perceptive Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s or its subsidiaries’ business activities; make certain Investments or Restricted Payments (each as defined in the Perceptive Credit Agreement); change its fiscal year; pay dividends; repay other certain indebtedness; engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that have the impact of restricting the Company’s ability to make loan repayments under the Perceptive Credit Agreement. In addition, the Company must (i) at all times prior to the Maturity Date maintain a minimum cash balance of $3.0 million; and (ii) as of the last day of each fiscal quarter commencing with the fiscal quarter ended June 30, 2019, report revenues for the trailing 12-month period that exceed the amounts set forth in the Perceptive Credit Agreement, which range from $7.0 million for the fiscal quarter ended June 30, 2019 to $55.0 million for the fiscal quarter ending December 31, 2021. At June 30, 2021, the Company was in compliance with all of the covenants contained in the Perceptive Credit Agreement. As a result of the fees paid to Perceptive and the value of the warrants issued to Perceptive under the terms of the Perceptive Credit Agreement, the Company recognized an aggregate discount on the senior secured notes in the amount of $7.1 million. The Company records debt discount as a reduction to the face amount of the debt, and the debt discount is amortized as interest expense over the life of the debt using the interest method. Based on the fair value of the Perceptive Warrants and the aggregate amount of fees and expenses associated with obtaining the Perceptive Credit Facility, the effective interest rate on senior secured notes payable to Perceptive as of June 30, 2021 was approximately 13.7%. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 6 Months Ended |
Jun. 30, 2021 | |
STOCKHOLDERS' EQUITY [Abstract] | |
STOCKHOLDERS' EQUITY | 8. STOCKHOLDERS’ EQUITY Preferred Stock The Company is currently authorized to issue up to 10 million shares of preferred stock, $0.0001, par value per share. There were no shares of preferred stock outstanding at June 30, 2021 and December 31, 2020. Common Stock As of June 30, 2021 and December 31, 2020, the Company was authorized to issue 300,000,000 and 150,000,000 shares, respectively, of its common stock, $0.0001 par value per share, and 131,872,026 and 104,902,888 shares of common stock were outstanding as of June 30, 2021 and December 31, 2020, respectively. On May 27, 2021, the Company’s stockholders approved an amendment to the Company’s certificate of incorporation which increased the number of shares of common stock that the Company is authorized to issue from 150,000,000 to 300,000,000. After giving effect to the 17,073,357 shares reserved for outstanding warrants and awards issued or reserved for future issuance under the Company’s equity incentive plans, as of June 30, 2021 there were 151,054,617 shares of common stock available for issuance. On August 5, 2020, the Company entered into the 2020 Sale Agreement with Jefferies (see Note 1), pursuant to which the Company could offer and sell, from time to time, at its option, through or to Jefferies, up to an aggregate of $50 million of shares of the Company’s common stock. On November 5, 2020 and February 3, 2021, the Company and Jefferies amended the 2020 Sale Agreement to provide for increases in the aggregate offering amount under the Sale Agreement such that the Company could sell shares having an aggregate offering price of up to $105.4 million under the 2020 Sale Agreement, as amended. During the six months ended June 30, 2021, the Company issued and sold 26,907,753 shares of common stock under the 2020 Sale Agreement and received net proceeds of $59.1 million (see Note 14). On May 28, 2021, the Company entered into the 2021 Sale Agreement with Jefferies, pursuant to which the Company may offer and sell, from time to time, at its option, through or to Jefferies, up to an aggregate of $50,000,000 of shares of the Company’s common stock. As of the date of this report, there have been no sales of common stock under this agreement. On February 11, 2020, the Company completed an underwritten public offering of 23,500,000 shares of its common stock for gross proceeds of $82.3 million. On February 21, 2020, the Company sold an additional 3,525,000 shares pursuant to the underwriters’ exercise of their option to purchase additional shares of the Company’s common stock for additional gross proceeds of $12.3 million. The Company received net proceeds, after underwriting discounts and other expenses associated with the offering, of approximately $88.7 million. Warrants At June 30, 2021 and December 31, 2020, the Company had outstanding warrants to purchase an aggregate of 4,528,160 shares of common stock, with a weighted average exercise price of $2.82 per share and expiration dates ranging between June 2022 and December 2030. Equity Incentive Plans 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 six months ended June 30, 2021 and 2020: Six Months Ended June 30, 2021 2020 Expected term 5.5 - 6.3 years 5.5 - 6.3 years Volatility 69% 62-67% Dividend yield 0.0 0.0 Risk-free interest rate 0.80-1.14% 0.38-1.68% During the six months ended June 30, 2021 and 2020, the Company granted options to purchase an aggregate of 1,658,050 and 1,232,500 shares of common stock, respectively, to its directors, employees and certain third-party service providers. The weighted average remaining contractual life of stock options outstanding and expected to vest at June 30, 2021 is 6.5 years. The weighted average remaining contractual life of stock options exercisable at June 30, 2021 is 5.2 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, 2020 6,922,931 $ 4.40 Forfeited (404,782 ) $ 2.96 Expired (393,170 ) $ 5.03 Granted 1,658,050 $ 2.26 Exercised - $ - Options outstanding, vested and expected to vest at June 30, 2021 7,783,029 $ 3.98 Options exercisable 5,011,506 $ 4.70 As of June 30, 2021, the Company had $4.2 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 six months ended June 30, 2021 and 2020, the Company granted Restricted Stock Units (“RSUs”) representing an aggregate of 542,244 and 341,000 shares, respectively, to certain management employees of the Company and to members of its Board of Directors. The RSUs vest annually over a period of four years for employees and semi-annually over a period of one year for directors. During the six months ended June 30, 2021, 87,750 shares vested in connection with grants of RSUs. With respect to these vested RSUs, 26,365 shares valued at approximately $59,000 were withheld by the Company to cover employees’ tax liabilities. On March 25, 2021, these shares were retired by the Company and were no longer outstanding as of June 30, 2021. A summary of the Company’s unvested RSU activity and related information is as follows: Shares Weighted Average Grant Date Fair Value Balance at December 31, 2020 326,000 $ 2.81 Granted 542,244 $ 2.29 Vested (87,750 ) $ 2.81 Forfeited (94,361 ) $ 2.53 Balance at June 30, 2021 686,133 $ 2.44 As of June 30, 2021, the Company had $1.5 million of unrecognized compensation expense related to unvested RSUs granted under the Company’s equity incentive plans, which is expected to be recognized over a weighted-average period of 3.3 years. Total stock-based compensation expense for all awards granted under the Company’s equity incentive plans for the three months and six months June 30, 2021 and 2020 is as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Research and development $ 42,479 $ 105,029 $ 147,706 $ 198,603 Plasma center operating expenses 13,637 8,510 24,455 15,754 Selling, general and administrative 665,836 539,256 1,254,327 1,063,145 Cost of product revenue 83,237 62,813 160,098 114,654 Total stock-based compensation expense $ 805,189 $ 715,608 $ 1,586,586 $ 1,392,156 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 6 Months Ended |
Jun. 30, 2021 | |
RELATED PARTY TRANSACTIONS [Abstract] | |
RELATED PARTY TRANSACTIONS | 9. RELATED PARTY TRANSACTIONS The Company leases an office building and equipment from Areth, LLC (“Areth”) pursuant to an agreement for services effective as of January 1, 2016, as amended from time to time. Rent expense for the six months ended June 30, 2021 and 2020 amounted to $60,000. 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 consolidated financial statements for the six months ended June 30, 2021 and 2020. In addition, during the six months ended June 30, 2021, the Company purchased certain specialized medical equipment and services related to the Company’s plasma collection centers, as well as personal protective equipment, from GenesisBPS and its affiliates (“Genesis”), in the amount of $0.1 million. This amount was immaterial to the consolidated financial statements for the three and six months ended June 30, 2020. Dr. Grossman and Adam Grossman each own shares of Genesis. See Note 7 for a discussion of the Company’s credit facility and related transactions with Perceptive, a holder of more than 10% of the Company’s common stock. During the three and six months ended June 30, 2021, in connection with the resignation of Dr. James Mond, the Company’s former Chief Scientific and Medical Officer, the Company recognized an expense and corresponding liability in the amount of $0.8 million for estimated payments to be made under a separation and transition agreement with Dr. Mond. Such payments are to be made in scheduled installments over a period of 10 months. In connection with the February 2020 public offering of the Company’s common stock (see Note 8) on February 11, 2020: (i) Perceptive Advisors, a principal stockholder of ADMA, purchased 4,563,700 shares of common stock through one of its affiliates, (ii) Dr. Grossman purchased 22,857 shares of common stock directly and 22,857 shares indirectly through an entity he controls, (iii) Lawrence P. Guiheen, a director of the Company, purchased 20,000 shares of common stock, (iv) Mr. Grossman purchased 28,571 shares of common stock directly and 57,143 shares indirectly through an entity he controls, (v) Brian Lenz, the Company’s Executive Vice President and Chief Financial Officer, purchased 7,142 shares of common stock, and (vi) Dr. Mond purchased 4,285 shares of common stock, all at the public offering price of $3.50 per share. |
COMMITMENT AND CONTINGENCIES
COMMITMENT AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2021 | |
COMMITMENT 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 variant 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. The Company had experienced some delays with final drug product release testing by third-party vendors. In response to these delays, the Company added additional release testing laboratories to its FDA-approved consortium listed in its drug approval documents which the Company believes has adequately addressed this issue. In addition, 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. The Company is also 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 may elect 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. During the second quarter of 2021, the Company was notified by the FDA that its submission for the approval of its in-house fill-finish process utilizing a recently installed aseptic filling machine will require a site inspection, either in person or virtually, of the Boca Facility. Although the inspection was completed in July of 2021, the FDA’s review of the Company’s regulatory filing with respect to its in-house fill-finish process and new aseptic filling machine remains ongoing. Although the Company anticipates receiving regulatory approval of this submission in the second half of 2021, no assurances can be provided as to the timing for completion of this FDA review or any other regulatory submissions or applications that may be impacted by restrictions related to COVID-19. 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. 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. 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. 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 may purchase RSV plasma from Grifols from the two plasma collection centers that were transferred to BPC on January 1, 2019 at a price equal to cost plus five percent 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 is in late-stage discussion with multiple third-party suppliers of NSP to supplement the 2017 Plasma Purchase Agreement, and the Company has also increased the number of planned plasma collection center buildouts and is 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 six months ended June 30, 2021, plasma purchases from Grifols totaled $17.5 million, or approximately 67% of the Company’s total inventory purchases. For the six months ended June 30, 2020, plasma purchases from Grifols totaled approximately $3.7 million, representing approximately 42% 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 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. This study is required to be completed by June of 2023. Employment contracts The Company has entered into employment agreements with its executive management team consisting of its President and Chief Executive Officer, its Executive Vice President and Chief Financial Officer and its former Executive Vice President, Chief Medical Officer and Chief Scientific Officer (see Note 9). Other commitments 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 June 30, 2021. The Company does not anticipate recognizing any significant losses relating to these arrangements. |
SEGMENTS
SEGMENTS | 6 Months Ended |
Jun. 30, 2021 | |
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 June 30, 2021 consists of eight plasma collection facilities in various stages of approval and development located throughout the U.S., two of which hold an approved license with the FDA while a third facility has a BLA pending FDA approval Summarized financial information concerning reportable segments is shown in the following tables: Three Months Ended June 30, 2021 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 16,347,880 $ 1,447,001 $ 35,709 $ 17,830,590 Cost of product revenue 17,382,292 1,450,332 - 18,832,624 Loss from operations (8,337,405 ) (2,794,219 ) (4,449,608 ) (15,581,232 ) Interest and other expense, net (78,793 ) (366 ) (3,244,912 ) (3,324,071 ) Net loss (8,416,198 ) (2,794,585 ) (7,694,520 ) (18,905,303 ) Depreciation and amortization expense 1,055,537 268,927 1,530 1,325,994 Total assets 169,799,509 20,593,411 42,420,872 232,813,792 Three Months Ended June 30, 2020 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 6,502,865 $ 1,249,020 $ 35,709 $ 7,787,594 Cost of product revenue 12,237,141 1,258,488 - 13,495,629 Loss from operations (12,852,835 ) (919,309 ) (3,351,681 ) (17,123,825 ) Interest and other expense, net (235,442 ) (33 ) (2,818,791 ) (3,054,266 ) Net loss (13,088,277 ) (919,342 ) (6,170,472 ) (20,178,091 ) Depreciation and amortization expense 772,241 111,106 2,305 885,652 Total assets 109,105,418 7,542,486 74,893,664 191,541,568 Six Months Ended June 30, 2021 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 29,768,923 $ 4,038,868 $ 71,417 $ 33,879,208 Cost of product revenue 32,832,049 3,770,697 - 36,602,746 Loss from operations (17,843,093 ) (4,765,060 ) (8,137,328 ) (30,745,481 ) Interest and other expense, net (100,307 ) (750 ) (6,438,706 ) (6,539,763 ) Net loss (17,943,400 ) (4,765,810 ) (14,576,034 ) (37,285,244 ) Capital expenditures 2,725,432 4,321,303 - 7,046,735 Depreciation and amortization expense 2,065,307 486,918 3,397 2,555,622 Six Months Ended June 30, 2020 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 14,246,139 $ 3,669,782 $ 71,417 $ 17,987,338 Cost of product revenue 26,689,094 3,635,761 - 30,324,855 Loss from operations (25,328,980 ) (1,376,464 ) (7,188,167 ) (33,893,611 ) Interest and other expense, net (474,314 ) (33 ) (5,055,363 ) (5,529,710 ) Net loss (25,803,294 ) (1,376,497 ) (12,243,530 ) (39,423,321 ) Capital expenditures 5,064,494 1,178,790 - 6,243,284 Depreciation and amortization expense 1,447,214 222,395 4,881 1,674,490 Net revenues according to geographic area, based on the location of where the product is shipped, is as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 United States $ 15,424,839 $ 6,797,170 $ 29,102,848 $ 15,453,443 International 2,405,751 990,424 4,776,360 2,533,895 Total revenues $ 17,830,590 $ 7,787,594 $ 33,879,208 $ 17,987,338 |
LEASE OBLIGATIONS
LEASE OBLIGATIONS | 6 Months Ended |
Jun. 30, 2021 | |
LEASE OBLIGATIONS [Abstract] | |
LEASE OBLIGATIONS | 12. LEASE OBLIGATIONS The Company leases certain properties and equipment for its ADMA BioCenters subsidiary and certain equipment for its ADMA BioManufacturing subsidiary, which leases provide the right to use the underlying assets and require lease payments through the respective lease terms which expire at various dates through 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 June 30, 2021 and 2020 was approximately $0.4 million and $0.1 million, respectively. Aggregate lease expense for the six months ended June 30, 2021 and 2020 was approximately $0.7 million and $0.2 million, respectively. Cash paid for the Company’s leases for the three months ended June 30, 2021 and 2020 was approximately $0.3 million and $0.1 million, respectively. Cash paid for the Company’s leases for the six months ended June 30, 2021 and 2020 was approximately $0.5 million and $0.2 million, respectively. During the six months ended June 30, 2021, the Company recognized additional right to use assets and corresponding lease liabilities of $2.8 million in connection with three new property leases where the Company intends to open additional plasma collection facilities. Including a finance lease the Company entered into in June 2018, the Company has aggregate lease liabilities of $7.5 million and $4.7 million as of June 30, 2021 and December 31, 2020, 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 9.3 years. Scheduled payments under the Company’s lease obligations are as follows: Remainder of 2021 $ 595,836 Year ended December 31, 2022 1,512,443 2023 1,526,406 2024 1,399,474 2025 1,405,411 2026 1,137,321 Thereafter 5,486,813 Total payments 13,063,704 Less: imputed interest (5,604,431 ) Current portion (385,858 ) Balance at June 30, 2021 $ 7,073,415 On June 11, 2021, t he Company entered into an additional property lease that the Company intends to use to store certain inventory for its ADMA BioManufacturing business segment. The Company has not taken possession of this leased property and its lease commencement date has not been determined. |
SUPPLEMENTAL DISCLOSURE OF CASH
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | 6 Months Ended |
Jun. 30, 2021 | |
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 six months ended June 30, 2021 and 2020 is as follows: 2021 2020 SUPPLEMENTAL CASH FLOW INFORMATION: Cash paid for interest $ 5,534,279 $ 4,192,165 Non-cash Financing and Investing Activities: Equipment acquired reflected in accounts payable and accrued liabilities $ 1,005,546 $ 1,228,000 Right-to-use assets in exchange for lease obligations $ 2,844,875 $ 1,723,594 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2021 | |
SUBSEQUENT EVENTS [Abstract] | |
SUBSEQUENT EVENTS | 14. SUBSEQUENT EVENTS On July 26, 2021, the Company sold an additional 897,445 shares of its common stock under the 2020 Sale Agreement and received net proceeds of approximately $1.5 million, which represents the remaining amount that could be raised under the 2020 Sale Agreement as of June 30, 2021. In accordance with terms of the 2020 Sale Agreement, the 2020 Sale Agreement automatically terminated upon the foregoing sale of common stock. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
SUMMARY OF 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, 2020 included in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 25, 2021. The accompanying consolidated balance sheet as of December 31, 2020 was derived from the audited financial statements as of and for the year ended December 31, 2020. 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 June 30, 2021 and its results of operations, changes in equity and cash flows for the three and six months ended June 30, 2021. During the three and six months ended June 30, 2021 and 2020, 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 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 $0.2 million and $0.1 million at June 30, 2021 and December 31, 2020, respectively, which are recognized in the period the related revenue is recorded. The Company extends credit to its customers based upon an evaluation of each customer’s financial condition and credit history. Evaluations of the financial condition and associated credit risk of customers are performed on an ongoing basis. |
Inventories | Inventories Raw materials inventory consists of various materials purchased from suppliers, including normal source plasma, used in the production of the Company’s products. Work-in-process and finished goods inventories (see Note 3) reflect the cost of raw materials as well as costs for direct and indirect labor, primarily salaries, wages and benefits for applicable employees, as well as an allocation of overhead costs related to the Boca Facility including utilities, property taxes, general repairs and maintenance, consumable supplies and depreciation. The allocation of Boca Facility overhead to inventory is generally based upon the estimated square footage of the Boca Facility that is used in the production of the Company’s products relative to the total square footage of the facility. Inventories, including plasma intended for resale and plasma intended for internal use in the Company’s manufacturing, commercialization or research and development activities, are carried at the lower of cost or net realizable value determined by the first-in, first-out method. Net realizable value is generally determined based upon the consideration the Company expects to receive when the inventory is sold, less costs to deliver the inventory to the recipient. The estimates for net realizable value of inventory are based on contractual terms or upon historical experience and certain other assumptions, and the Company believes that such assumptions are reasonable. Inventory is periodically reviewed to ensure that its carrying value does not exceed its net realizable value, and adjustments are recorded to write down such inventory, with a corresponding charge to cost of product revenue, when the carrying value or historical cost exceeds its estimated net realizable value. In addition, costs associated with the production of conformance or engineering lots that would not qualify as immediately available for commercial sale are charged to cost of product revenue and not capitalized into inventory. |
Goodwill | Goodwill Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill at June 30, 2021 and December 31, 2020 was $3.5 million. All of the Company’s goodwill is attributable to its ADMA BioManufacturing business segment and is related to the 2017 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, 2020 did not result in a goodwill impairment charge, and the Company did not record any impairment charges related to goodwill for the three and six months ended June 30, 2021 and 2020. |
Impairment of long-lived assets | Impairment of long-lived assets The Company assesses the recoverability of its long-lived assets, which include property and equipment and finite-lived intangible assets, whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s carrying value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the three and six months ended June 30, 2021 and 2020, the Company determined that there was no impairment of its long-lived assets. |
Revenue recognition | Revenue recognition Revenues for the three and six months ended June 30, 2021 and 2020 are comprised of (i) revenues from the sale of the Company’s immunoglobulin products, BIVIGAM, ASCENIV and Nabi-HB, (ii) product revenues from the sale of human plasma collected through the Company’s Plasma Collection Centers business segment, (iii) contract manufacturing and laboratory services revenue, (iv) revenues from the sale of intermediate by-products; and (v) license and other revenues primarily attributable to the out-licensing of ASCENIV to Biotest in 2012 to market and sell this product in Europe and selected countries in North Africa and the Middle East. Biotest has provided the Company with certain services and financial payments in accordance with the related Biotest license agreement and is obligated to pay the Company certain amounts in the future if certain milestones are achieved. Deferred revenue is amortized into income over the term of the Biotest license, representing a period of approximately 22 years. Product revenue is recognized when the customer is deemed to have control over the product. Control is determined based on when the product is shipped or delivered and title passes to the customer. Revenue is recorded in an amount that reflects the consideration the Company expects to receive in exchange. Revenue from the sale of the Company’s immunoglobulin products is recognized when the product reaches the customer’s destination, and is recorded net of estimated rebates, price protection arrangements and customer incentives, including prompt pay discounts, wholesaler chargebacks and other wholesaler fees. These estimates are based on historical experience and certain other assumptions, and the Company believes that such estimates are reasonable. For revenues associated with contract manufacturing and the sale of intermediates, control transfers to the customer and the performance obligation is satisfied when the customer takes possession of the product from the Boca Facility or from a third-party warehouse that is utilized by the Company. Product revenues from the sale of human plasma collected at the Company’s plasma collection centers are recognized at the time control of the product has been transferred to the customer, which generally occurs at the time of shipment. Product revenues are recognized at the time of delivery if the Company retains control of the product during shipment. For the six months ended June 30, 2021, five customers represented an aggregate of 85% of the Company’s consolidated revenues. For the six months ended June 30, 2020, three customers represented an aggregate of 81% of the Company’s consolidated revenues. |
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 common 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 six months ended June 30, 2021 and 2020, the following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive effects: For the Six Months Ended June 30, 2021 2020 Stock options 7,783,029 6,801,779 Restricted stock units 686,133 326,000 Warrants 4,528,160 2,138,160 12,997,322 9,265,939 |
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 2016 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 June 30, 2021 and December 31, 2020, and during the three and six months ended June 30, 2021 and 2020, the Company recognized no adjustments for uncertain tax positions. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326) |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Calculation of Diluted Loss Per Common Share | For the six months ended June 30, 2021 and 2020, the following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive effects: For the Six Months Ended June 30, 2021 2020 Stock options 7,783,029 6,801,779 Restricted stock units 686,133 326,000 Warrants 4,528,160 2,138,160 12,997,322 9,265,939 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
INVENTORIES [Abstract] | |
Components of Inventory | The following table provides the components of inventories: June 30, 2021 December 31, 2020 Raw materials $ 33,058,221 $ 32,044,393 Work-in-process 49,163,125 30,293,288 Finished goods 17,478,397 19,197,918 Total inventories $ 99,699,743 $ 81,535,599 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
INTANGIBLE ASSETS [Abstract] | |
Schedule of Intangible Assets | Intangible assets at June 30, 2021 and December 31, 2020 consist of the following: June 30, 2021 December 31, 2020 Cost Accumulated Amortization Net Cost Accumulated Amortization Net Trademark and other intangible rights related to Nabi-HB $ 4,100,046 $ 2,391,693 $ 1,708,353 $ 4,100,046 $ 2,098,833 $ 2,001,213 Rights to intermediates 907,421 529,329 378,092 907,421 464,513 442,908 Customer contract 1,076,557 1,076,557 - 1,076,557 1,076,557 - $ 6,084,024 $ 3,997,579 $ 2,086,445 $ 6,084,024 $ 3,639,903 $ 2,444,121 |
Intangible Asset Future Aggregate Amortization Expense | Estimated aggregate future aggregate amortization expense is expected to be as follows: 2021 $ 357,676 2022 715,352 2023 715,352 2024 298,065 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
PROPERTY AND EQUIPMENT [Abstract] | |
Property and Equipment | Property and equipment and related accumulated depreciation are summarized as follows: June 30, 2021 December 31, 2020 Manufacturing and laboratory equipment $ 15,082,205 $ 14,468,874 Office equipment and computer software 3,649,504 3,253,528 Furniture and fixtures 2,516,729 2,039,398 Construction in process 5,966,844 3,336,557 Leasehold improvements 7,192,820 5,272,490 Land 4,339,441 4,339,441 Buildings and building improvements 18,694,960 17,746,744 57,442,503 50,457,032 Less: Accumulated depreciation (10,955,523 ) (8,863,942 ) Total property and equipment, net $ 46,486,980 $ 41,593,090 |
ACCRUED EXPENSES AND OTHER CU_2
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities at June 30, 2021 and December 31, 2020 are as follows: June 30, 2021 December 31, 2020 Accrued rebates $ 3,721,888 $ 2,604,245 Accrued distribution fees 1,928,901 828,120 Accrued payroll 691,483 734,972 Accrued testing 1,673,120 779,660 Accrued incentives 1,539,491 3,210,884 Accrued severance 789,534 - Other 1,145,822 207,262 Total accrued expenses and other current liabilities $ 11,490,239 $ 8,365,143 |
DEBT (Tables)
DEBT (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
DEBT [Abstract] | |
Summary of Outstanding Senior Notes Payable | A summary of outstanding senior notes payable is as follows: June 30, 2021 December 31, 2020 Notes payable $ 100,000,000 $ 100,000,000 Less: Debt discount (6,122,983 ) (7,031,134 ) Senior notes payable $ 93,877,017 $ 92,968,866 |
STOCKHOLDERS EQUITY (Tables)
STOCKHOLDERS EQUITY (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
STOCKHOLDERS' EQUITY [Abstract] | |
Schedule of Assumptions | The following assumptions were used to determine the fair value of options granted during the six months ended June 30, 2021 and 2020: Six Months Ended June 30, 2021 2020 Expected term 5.5 - 6.3 years 5.5 - 6.3 years Volatility 69% 62-67% Dividend yield 0.0 0.0 Risk-free interest rate 0.80-1.14% 0.38-1.68% |
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, 2020 6,922,931 $ 4.40 Forfeited (404,782 ) $ 2.96 Expired (393,170 ) $ 5.03 Granted 1,658,050 $ 2.26 Exercised - $ - Options outstanding, vested and expected to vest at June 30, 2021 7,783,029 $ 3.98 Options exercisable 5,011,506 $ 4.70 |
Schedule of Unvested RSU Activity | A summary of the Company’s unvested RSU activity and related information is as follows: Shares Weighted Average Grant Date Fair Value Balance at December 31, 2020 326,000 $ 2.81 Granted 542,244 $ 2.29 Vested (87,750 ) $ 2.81 Forfeited (94,361 ) $ 2.53 Balance at June 30, 2021 686,133 $ 2.44 |
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 and six months June 30, 2021 and 2020 is as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Research and development $ 42,479 $ 105,029 $ 147,706 $ 198,603 Plasma center operating expenses 13,637 8,510 24,455 15,754 Selling, general and administrative 665,836 539,256 1,254,327 1,063,145 Cost of product revenue 83,237 62,813 160,098 114,654 Total stock-based compensation expense $ 805,189 $ 715,608 $ 1,586,586 $ 1,392,156 |
SEGMENTS (Tables)
SEGMENTS (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
SEGMENTS [Abstract] | |
Summarized Financial Information Concerning Reportable Segments | Summarized financial information concerning reportable segments is shown in the following tables: Three Months Ended June 30, 2021 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 16,347,880 $ 1,447,001 $ 35,709 $ 17,830,590 Cost of product revenue 17,382,292 1,450,332 - 18,832,624 Loss from operations (8,337,405 ) (2,794,219 ) (4,449,608 ) (15,581,232 ) Interest and other expense, net (78,793 ) (366 ) (3,244,912 ) (3,324,071 ) Net loss (8,416,198 ) (2,794,585 ) (7,694,520 ) (18,905,303 ) Depreciation and amortization expense 1,055,537 268,927 1,530 1,325,994 Total assets 169,799,509 20,593,411 42,420,872 232,813,792 Three Months Ended June 30, 2020 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 6,502,865 $ 1,249,020 $ 35,709 $ 7,787,594 Cost of product revenue 12,237,141 1,258,488 - 13,495,629 Loss from operations (12,852,835 ) (919,309 ) (3,351,681 ) (17,123,825 ) Interest and other expense, net (235,442 ) (33 ) (2,818,791 ) (3,054,266 ) Net loss (13,088,277 ) (919,342 ) (6,170,472 ) (20,178,091 ) Depreciation and amortization expense 772,241 111,106 2,305 885,652 Total assets 109,105,418 7,542,486 74,893,664 191,541,568 Six Months Ended June 30, 2021 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 29,768,923 $ 4,038,868 $ 71,417 $ 33,879,208 Cost of product revenue 32,832,049 3,770,697 - 36,602,746 Loss from operations (17,843,093 ) (4,765,060 ) (8,137,328 ) (30,745,481 ) Interest and other expense, net (100,307 ) (750 ) (6,438,706 ) (6,539,763 ) Net loss (17,943,400 ) (4,765,810 ) (14,576,034 ) (37,285,244 ) Capital expenditures 2,725,432 4,321,303 - 7,046,735 Depreciation and amortization expense 2,065,307 486,918 3,397 2,555,622 Six Months Ended June 30, 2020 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 14,246,139 $ 3,669,782 $ 71,417 $ 17,987,338 Cost of product revenue 26,689,094 3,635,761 - 30,324,855 Loss from operations (25,328,980 ) (1,376,464 ) (7,188,167 ) (33,893,611 ) Interest and other expense, net (474,314 ) (33 ) (5,055,363 ) (5,529,710 ) Net loss (25,803,294 ) (1,376,497 ) (12,243,530 ) (39,423,321 ) Capital expenditures 5,064,494 1,178,790 - 6,243,284 Depreciation and amortization expense 1,447,214 222,395 4,881 1,674,490 |
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 June 30, Six Months Ended June 30, 2021 2020 2021 2020 United States $ 15,424,839 $ 6,797,170 $ 29,102,848 $ 15,453,443 International 2,405,751 990,424 4,776,360 2,533,895 Total revenues $ 17,830,590 $ 7,787,594 $ 33,879,208 $ 17,987,338 |
LEASE OBLIGATIONS (Tables)
LEASE OBLIGATIONS (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
LEASE OBLIGATIONS [Abstract] | |
Payments Under Lease Obligations | Scheduled payments under the Company’s lease obligations are as follows: Remainder of 2021 $ 595,836 Year ended December 31, 2022 1,512,443 2023 1,526,406 2024 1,399,474 2025 1,405,411 2026 1,137,321 Thereafter 5,486,813 Total payments 13,063,704 Less: imputed interest (5,604,431 ) Current portion (385,858 ) Balance at June 30, 2021 $ 7,073,415 |
SUPPLEMENTAL DISCLOSURE OF CA_2
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION [Abstract] | |
Supplemental Cash Flow Information | Supplemental cash flow information for the six months ended June 30, 2021 and 2020 is as follows: 2021 2020 SUPPLEMENTAL CASH FLOW INFORMATION: Cash paid for interest $ 5,534,279 $ 4,192,165 Non-cash Financing and Investing Activities: Equipment acquired reflected in accounts payable and accrued liabilities $ 1,005,546 $ 1,228,000 Right-to-use assets in exchange for lease obligations $ 2,844,875 $ 1,723,594 |
ORGANIZATION AND BUSINESS (Deta
ORGANIZATION AND BUSINESS (Details) | Jul. 31, 2021USD ($) | May 28, 2021USD ($) | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Jun. 30, 2020Facility | Mar. 31, 2020USD ($) | Jun. 30, 2021USD ($)FacilityProduct | Aug. 11, 2021USD ($) | Dec. 31, 2020USD ($) |
Organization and Business [Abstract] | |||||||||
Number of Plasma Collection Facilities Under Development | Facility | 8 | 8 | |||||||
Number of FDA-Licensed Plasma Collection Facilities | Facility | 2 | 2 | |||||||
Number of FDA approved product | Product | 3 | ||||||||
Working capital | $ 153,200,000 | $ 153,200,000 | |||||||
Cash and cash equivalents | 42,400,000 | 42,400,000 | |||||||
Cumulative losses | (377,750,347) | $ (377,750,347) | $ (340,465,103) | ||||||
Common stock issuable under agreement | $ 17,189,560 | $ 41,912,515 | $ 88,704,039 | ||||||
Minimum [Member] | |||||||||
Organization and Business [Abstract] | |||||||||
Production cycle from procurement of raw materials to release of finished product | 7 months | ||||||||
Maximum [Member] | |||||||||
Organization and Business [Abstract] | |||||||||
Production cycle from procurement of raw materials to release of finished product | 12 months | ||||||||
Jefferies [Member] | 2020 Sale Agreement [Member] | |||||||||
Organization and Business [Abstract] | |||||||||
Proceeds from sales of common stock | $ 59,100,000 | ||||||||
Jefferies [Member] | 2020 Sale Agreement [Member] | Subsequent Event [Member] | |||||||||
Organization and Business [Abstract] | |||||||||
Proceeds from sales of common stock | $ 1,500,000 | ||||||||
Jefferies [Member] | 2021 Sale Agreement [Member] | Subsequent Event [Member] | |||||||||
Organization and Business [Abstract] | |||||||||
Sales of common stock | $ 0 | ||||||||
Jefferies [Member] | 2021 Sale Agreement [Member] | Maximum [Member] | |||||||||
Organization and Business [Abstract] | |||||||||
Common stock issuable under agreement | $ 50,000,000 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Accounts Receivable (Details) $ in Millions | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021USD ($)Customer | Dec. 31, 2020USD ($)Customer | |
Accounts Receivable [Abstract] | ||
Accounts receivable, allowances for contractual credits and doubtful accounts | $ | $ 0.2 | $ 0.1 |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Six Customers [Member] | ||
Accounts Receivable [Abstract] | ||
Number of customers | 6 | |
Percentage of account receivables | 94.00% | |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Three Customers [Member] | ||
Accounts Receivable [Abstract] | ||
Number of customers | 3 | |
Percentage of account receivables | 92.00% |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Goodwill (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Goodwill [Abstract] | |||||
Goodwill | $ 3,529,509 | $ 3,529,509 | $ 3,529,509 | ||
Impairment charges related to goodwill | $ 0 | $ 0 | $ 0 | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Impairment of Long-lived Assets (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Impairment of Long-lived Assets [Abstract] | ||||
Impairment of long-lived assets | $ 0 | $ 0 | $ 0 | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Revenue Recognition (Details) - Customer | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Five Customers [Member] | Revenues [Member] | Customer Concentration Risk [Member] | ||
Revenue Recognition [Abstract] | ||
Number of customers | 5 | |
Percentage of consolidated revenues | 85.00% | |
Three Customers [Member] | Revenues [Member] | Customer Concentration Risk [Member] | ||
Revenue Recognition [Abstract] | ||
Number of customers | 3 | |
Percentage of consolidated revenues | 81.00% | |
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 | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Loss Per Common Share [Abstract] | ||
Potentially dilutive securities (in shares) | 12,997,322 | 9,265,939 |
Stock Options [Member] | ||
Loss Per Common Share [Abstract] | ||
Potentially dilutive securities (in shares) | 7,783,029 | 6,801,779 |
Restricted Stock Units [Member] | ||
Loss Per Common Share [Abstract] | ||
Potentially dilutive securities (in shares) | 686,133 | 326,000 |
Warrants [Member] | ||
Loss Per Common Share [Abstract] | ||
Potentially dilutive securities (in shares) | 4,528,160 | 2,138,160 |
SUMMARY OF SIGNIFICANT ACCOUN_9
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Stock-based Compensation (Details) | 6 Months Ended |
Jun. 30, 2021 | |
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 ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Income Taxes [Abstract] | ||
Unrecognized tax benefits | $ 0 | $ 0 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
INVENTORIES [Abstract] | ||
Raw materials | $ 33,058,221 | $ 32,044,393 |
Work-in-process | 49,163,125 | 30,293,288 |
Finished goods | 17,478,397 | 19,197,918 |
Total inventories | $ 99,699,743 | $ 81,535,599 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Finite-Lived Intangible Assets, Net [Abstract] | |||||
Cost | $ 6,084,024 | $ 6,084,024 | $ 6,084,024 | ||
Accumulated amortization | 3,997,579 | 3,997,579 | 3,639,903 | ||
Net | 2,086,445 | 2,086,445 | 2,444,121 | ||
Amortization of intangible assets | 178,838 | $ 178,838 | 357,676 | $ 357,676 | |
Trademark and Other Intangible Rights Related to Nabi-HB [Member] | |||||
Finite-Lived Intangible Assets, Net [Abstract] | |||||
Cost | 4,100,046 | 4,100,046 | 4,100,046 | ||
Accumulated amortization | 2,391,693 | 2,391,693 | 2,098,833 | ||
Net | 1,708,353 | 1,708,353 | 2,001,213 | ||
Right to Intermediates [Member] | |||||
Finite-Lived Intangible Assets, Net [Abstract] | |||||
Cost | 907,421 | 907,421 | 907,421 | ||
Accumulated amortization | 529,329 | 529,329 | 464,513 | ||
Net | 378,092 | 378,092 | 442,908 | ||
Customer Contract [Member] | |||||
Finite-Lived Intangible Assets, Net [Abstract] | |||||
Cost | 1,076,557 | 1,076,557 | 1,076,557 | ||
Accumulated amortization | 1,076,557 | 1,076,557 | 1,076,557 | ||
Net | $ 0 | $ 0 | $ 0 |
INTANGIBLE ASSETS, Future Aggre
INTANGIBLE ASSETS, Future Aggregate Amortization Expense (Details) | Jun. 30, 2021USD ($) |
Estimated Aggregate Amortization Expense [Abstract] | |
Remaining of 2021 | $ 357,676 |
2022 | 715,352 |
2023 | 715,352 |
2024 | $ 298,065 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |||||
Property, plant and equipments, gross | $ 57,442,503 | $ 57,442,503 | $ 50,457,032 | ||
Less: accumulated depreciation | (10,955,523) | (10,955,523) | (8,863,942) | ||
Total property and equipment, net | 46,486,980 | 46,486,980 | 41,593,090 | ||
Depreciation expense | 1,100,000 | $ 700,000 | $ 2,200,000 | $ 1,300,000 | |
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 equipments, gross | 15,082,205 | $ 15,082,205 | 14,468,874 | ||
Office Equipment and Computer Software [Member] | |||||
Property, Plant and Equipment [Abstract] | |||||
Property, plant and equipments, gross | 3,649,504 | 3,649,504 | 3,253,528 | ||
Furniture and Fixtures [Member] | |||||
Property, Plant and Equipment [Abstract] | |||||
Property, plant and equipments, gross | 2,516,729 | 2,516,729 | 2,039,398 | ||
Construction in Process [Member] | |||||
Property, Plant and Equipment [Abstract] | |||||
Property, plant and equipments, gross | 5,966,844 | 5,966,844 | 3,336,557 | ||
Leasehold Improvements [Member] | |||||
Property, Plant and Equipment [Abstract] | |||||
Property, plant and equipments, gross | 7,192,820 | 7,192,820 | 5,272,490 | ||
Land [Member] | |||||
Property, Plant and Equipment [Abstract] | |||||
Property, plant and equipments, gross | 4,339,441 | 4,339,441 | 4,339,441 | ||
Buildings and Building Improvements [Member] | |||||
Property, Plant and Equipment [Abstract] | |||||
Property, plant and equipments, gross | $ 18,694,960 | $ 18,694,960 | $ 17,746,744 | ||
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 ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Accrued Expenses and Other Liabilities [Abstract] | ||
Accrued rebates | $ 3,721,888 | $ 2,604,245 |
Accrued distribution fees | 1,928,901 | 828,120 |
Accrued payroll | 691,483 | 734,972 |
Accrued testing | 1,673,120 | 779,660 |
Accrued incentives | 1,539,491 | 3,210,884 |
Accrued severance | 789,534 | 0 |
Other | 1,145,822 | 207,262 |
Total accrued expenses and other current liabilities | $ 11,490,239 | $ 8,365,143 |
DEBT (Details)
DEBT (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||||
Dec. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Senior Notes Payable [Abstract] | |||||||
Notes payable | $ 100,000,000 | $ 100,000,000 | $ 100,000,000 | ||||
Less: Debt discount | (6,122,983) | (6,122,983) | (7,031,134) | ||||
Senior notes payable | 93,877,017 | 93,877,017 | $ 92,968,866 | ||||
Payments of debt interest | 5,500,000 | $ 4,400,000 | |||||
Revenues | $ 17,830,590 | $ 7,787,594 | $ 33,879,208 | $ 17,987,338 | |||
Perceptive Credit Agreement [Member] | |||||||
Senior Notes Payable [Abstract] | |||||||
Maturity date | Mar. 1, 2024 | ||||||
Credit agreement, Interest rate | 7.50% | 7.50% | |||||
Credit agreement, Interest rate provided | 3.50% | ||||||
Increase basis points | 4.00% | ||||||
Effective interest rate | 11.00% | 11.00% | |||||
Revenues | $ 7,000,000 | ||||||
Perceptive Credit Agreement [Member] | Forecast [Member] | |||||||
Senior Notes Payable [Abstract] | |||||||
Revenues | $ 55,000,000 | ||||||
Perceptive Credit Agreement [Member] | Minimum [Member] | |||||||
Senior Notes Payable [Abstract] | |||||||
Cash balance | $ 3,000,000 | $ 3,000,000 | |||||
Perceptive Credit Agreement [Member] | LIBOR [Member] | |||||||
Senior Notes Payable [Abstract] | |||||||
Term of variable rate | 1 month | ||||||
Perceptive Credit Facility [Member] | |||||||
Senior Notes Payable [Abstract] | |||||||
Effective interest rate | 13.70% | 13.70% | |||||
Senior Notes [Member] | Perceptive Credit Agreement [Member] | |||||||
Senior Notes Payable [Abstract] | |||||||
Less: Debt discount | $ (7,100,000) | $ (7,100,000) |
STOCKHOLDERS' EQUITY, Preferred
STOCKHOLDERS' EQUITY, Preferred Stock (Details) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
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 ($) | May 28, 2021 | Feb. 03, 2021 | Aug. 05, 2020 | Feb. 21, 2020 | Feb. 11, 2020 | Jun. 30, 2021 | Mar. 31, 2021 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 |
Common Stock [Abstract] | |||||||||||
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 | 150,000,000 | ||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||
Common stock, shares outstanding (in shares) | 131,872,026 | 131,872,026 | 104,902,888 | ||||||||
Warrants outstanding (in shares) | 17,073,357 | 17,073,357 | |||||||||
Common stock, available for issuance (in shares) | 151,054,617 | 151,054,617 | |||||||||
Common stock issuable under agreement | $ 17,189,560 | $ 41,912,515 | $ 88,704,039 | ||||||||
Proceeds from issuance of common stock | $ 59,102,075 | $ 88,704,039 | |||||||||
Underwritten Public Offering [Member] | |||||||||||
Common Stock [Abstract] | |||||||||||
Proceeds from issuance of common stock | $ 88,700,000 | ||||||||||
Gross proceeds from issuance of common stock | $ 12,300,000 | $ 82,300,000 | |||||||||
2020 Sale Agreement [Member] | Jefferies LLC [Member] | |||||||||||
Common Stock [Abstract] | |||||||||||
Proceeds from issuance of common stock | $ 59,100,000 | ||||||||||
2020 Sale Agreement [Member] | Jefferies LLC [Member] | Maximum [Member] | |||||||||||
Common Stock [Abstract] | |||||||||||
Common stock issuable under agreement | $ 50,000,000 | ||||||||||
2020 Sale Agreement, As Amended [Member] | Jefferies LLC [Member] | Maximum [Member] | |||||||||||
Common Stock [Abstract] | |||||||||||
Common stock issuable under agreement | $ 105,400,000 | ||||||||||
2021 Sale Agreement [Member] | Jefferies LLC [Member] | Maximum [Member] | |||||||||||
Common Stock [Abstract] | |||||||||||
Common stock issuable under agreement | $ 50,000,000 | ||||||||||
Common Stock [Member] | |||||||||||
Common Stock [Abstract] | |||||||||||
Warrants outstanding (in shares) | 4,528,160 | 4,528,160 | 4,528,160 | ||||||||
Common stock issuable under agreement | $ 883 | $ 1,808 | $ 2,703 | ||||||||
Common stock shares sold during the period (in shares) | 8,827,045 | 18,080,708 | 27,025,000 | ||||||||
Common Stock [Member] | Underwritten Public Offering [Member] | |||||||||||
Common Stock [Abstract] | |||||||||||
Common stock shares sold during the period (in shares) | 3,525,000 | 23,500,000 | |||||||||
Common Stock [Member] | 2020 Sale Agreement [Member] | Jefferies LLC [Member] | |||||||||||
Common Stock [Abstract] | |||||||||||
Common stock shares sold during the period (in shares) | 26,907,753 | ||||||||||
Common Stock [Member] | 2021 Sale Agreement [Member] | Jefferies LLC [Member] | |||||||||||
Common Stock [Abstract] | |||||||||||
Common stock shares sold during the period (in shares) | 0 |
STOCKHOLDERS' EQUITY, Warrants
STOCKHOLDERS' EQUITY, Warrants (Details) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Warrants [Abstract] | ||
Warrants outstanding (in shares) | 17,073,357 | |
Weighted average exercise price of warrants (in dollars per share) | $ 2.82 | $ 2.82 |
Common Stock [Member] | ||
Warrants [Abstract] | ||
Warrants outstanding (in shares) | 4,528,160 | 4,528,160 |
STOCKHOLDERS' EQUITY, Equity In
STOCKHOLDERS' EQUITY, Equity Incentive Plans (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
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 | $ 805,189 | $ 715,608 | $ 1,586,586 | $ 1,392,156 |
Research and Development [Member] | ||||
Total stock-based compensation expense, Amount [Abstract] | ||||
Total stock-based compensation expense | 42,479 | 105,029 | 147,706 | 198,603 |
Plasma Center Operating Expenses [Member] | ||||
Total stock-based compensation expense, Amount [Abstract] | ||||
Total stock-based compensation expense | 13,637 | 8,510 | 24,455 | 15,754 |
Selling, General and Administrative [Member] | ||||
Total stock-based compensation expense, Amount [Abstract] | ||||
Total stock-based compensation expense | 665,836 | 539,256 | 1,254,327 | 1,063,145 |
Cost of Product Revenue [Member] | ||||
Total stock-based compensation expense, Amount [Abstract] | ||||
Total stock-based compensation expense | 83,237 | $ 62,813 | 160,098 | $ 114,654 |
Equity Incentive Plans [Member] | ||||
Stock Options, Weighted Average Exercise Price [Abstract] | ||||
Unrecognized compensation expense, stock options | $ 4,200,000 | $ 4,200,000 | ||
Unrecognized compensation expense recognition period | 2 years 7 months 6 days | |||
Stock Options [Member] | ||||
Fair Value Assumptions and Methodology [Abstract] | ||||
Volatility | 69.00% | |||
Dividend yield | 0.00% | 0.00% | ||
Stock Options [Abstract] | ||||
Number of stock options granted (in shares) | 1,658,050 | 1,232,500 | ||
Weighted average remaining contractual life of stock options, outstanding | 6 years 6 months | |||
Weighted average remaining contractual life of stock options, expected to vest | 6 years 6 months | |||
Weighted average remaining contractual life of stock options, exercisable | 5 years 2 months 12 days | |||
Stock Option, Shares [Abstract] | ||||
Options outstanding, vested and expected to vest, beginning balance (in shares) | 6,922,931 | |||
Forfeited (in shares) | (404,782) | |||
Expired (in shares) | (393,170) | |||
Granted (in shares) | 1,658,050 | |||
Exercised (in shares) | 0 | |||
Options outstanding, vested and expected to vest, ending balance (in shares) | 7,783,029 | 7,783,029 | ||
Options exercisable (in shares) | 5,011,506 | 5,011,506 | ||
Stock Options, Weighted Average Exercise Price [Abstract] | ||||
Options outstanding, vested and expected to vest, weighted average exercise price, beginning balance (in dollars per share) | $ 4.40 | |||
Forfeited, weighted average exercise price (in dollars per share) | 2.96 | |||
Expired, weighted average exercise price (in dollars per share) | 5.03 | |||
Granted, weighted average exercise price (in dollars per share) | 2.26 | |||
Exercised, weighted average exercise price (in dollars per share) | 0 | |||
Options outstanding, vested and expected to vest, weighted average exercise price, ending balance (in dollars per share) | $ 3.98 | 3.98 | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 4.70 | $ 4.70 | ||
Stock Options [Member] | Minimum [Member] | ||||
Fair Value Assumptions and Methodology [Abstract] | ||||
Expected term | 5 years 6 months | 5 years 6 months | ||
Volatility | 62.00% | |||
Risk-free interest rate | 0.80% | 0.38% | ||
Stock Options [Member] | Maximum [Member] | ||||
Fair Value Assumptions and Methodology [Abstract] | ||||
Expected term | 6 years 3 months 18 days | 6 years 3 months 18 days | ||
Volatility | 67.00% | |||
Risk-free interest rate | 1.14% | 1.68% | ||
Restricted Stock Units (RSUs) [Member] | ||||
Restricted Stock Units [Abstract] | ||||
Number of restricted stock units granted (in shares) | 542,244 | 341,000 | ||
Shares withheld for tax withholding obligation (in shares) | 26,365 | 26,365 | ||
Amount of shares withheld for tax withholding obligation | $ 59,000 | $ 59,000 | ||
Unvested RSU, Shares [Abstract] | ||||
Beginning balance (in shares) | 326,000 | |||
Granted (in shares) | 542,244 | |||
Vested (in shares) | (87,750) | |||
Forfeited (in shares) | (94,361) | |||
Ending balance (in shares) | 686,133 | 686,133 | ||
Unvested RSU, Weighted Average Grant Date Fair Value | ||||
Unvested, Weighted average grant date fair value, beginning balance (in dollars per share) | $ 2.81 | |||
Granted, Weighted average grant date fair value (in dollars per share) | 2.29 | |||
Vested, Weighted average grant date fair value (in dollars per share) | 2.81 | |||
Forfeited, Weighted average grant date fair value (in dollars per share) | 2.53 | |||
Unvested, Weighted average grant date fair value, ending balance (in dollars per share) | $ 2.44 | $ 2.44 | ||
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 | 3 years 3 months 18 days | |||
Unvested RSU, Weighted Average Grant Date Fair Value | ||||
Unrecognized compensation expense, non option | $ 1,500,000 | $ 1,500,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) | Feb. 11, 2020 | Jun. 30, 2020 | Jun. 30, 2021 |
Related Party Transactions [Abstract] | |||
Public offering price (in dollars per share) | $ 3.50 | ||
Dr. Grossman [Member] | Direct [Member] | |||
Related Party Transactions [Abstract] | |||
Common stock shares sold during the period (in shares) | 22,857 | ||
Dr. Grossman [Member] | Indirect [Member] | |||
Related Party Transactions [Abstract] | |||
Common stock shares sold during the period (in shares) | 22,857 | ||
Lawrence P. Guiheen [Member] | |||
Related Party Transactions [Abstract] | |||
Common stock shares sold during the period (in shares) | 20,000 | ||
Mr. Grossman [Member] | Direct [Member] | |||
Related Party Transactions [Abstract] | |||
Common stock shares sold during the period (in shares) | 28,571 | ||
Mr. Grossman [Member] | Indirect [Member] | |||
Related Party Transactions [Abstract] | |||
Common stock shares sold during the period (in shares) | 57,143 | ||
Brian Lenz [Member] | |||
Related Party Transactions [Abstract] | |||
Common stock shares sold during the period (in shares) | 7,142 | ||
Dr. James Mond [Member] | |||
Related Party Transactions [Abstract] | |||
Estimated payment for separation and transition agreement | $ 800,000 | ||
Period of scheduled installments for separation and transition agreement | 10 months | ||
Common stock shares sold during the period (in shares) | 4,285 | ||
Perceptive [Member] | |||
Related Party Transactions [Abstract] | |||
Minimum percentage of common stock held by lender | 10.00% | ||
Common stock shares sold during the period (in shares) | 4,563,700 | ||
Areth, LLC [Member] | |||
Related Party Transactions [Abstract] | |||
Rent expense | $ 60,000 | $ 60,000 | |
Genesis [Member] | |||
Related Party Transactions [Abstract] | |||
Purchased materials amount | $ 100,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) $ in Millions | 6 Months Ended | |
Jun. 30, 2021USD ($)FacilityTermCenter | Jun. 30, 2020USD ($) | |
Vendor Commitments [Abstract] | ||
Plasma supply agreement term | 10 years | |
Plasma purchased from Grifols | $ | $ 17.5 | $ 3.7 |
Percentage of inventory purchases | 67.00% | 42.00% |
2011 Plasma Purchase Agreement [Member] | ||
Vendor Commitments [Abstract] | ||
Number of renewal terms | 2 | |
Plasma purchase agreement renewal period | 5 years | |
Plasma purchase agreement term | 10 years | |
Number of plasma collection centers transferred to BPC | Center | 2 | |
Percentage of plasma purchase price equal to cost | 5.00% | |
2011 Plasma Purchase Agreement [Member] | Maximum [Member] | ||
Vendor Commitments [Abstract] | ||
Number of plasma collection facilities | Facility | 5 | |
2017 Plasma Purchase Agreement [Member] | ||
Vendor Commitments [Abstract] | ||
Number of renewal terms | 2 | |
Plasma purchase agreement renewal period | 2 years | |
Plasma purchase agreement term | 5 years |
SEGMENTS (Details)
SEGMENTS (Details) | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Jun. 30, 2020USD ($)Facility | Mar. 31, 2020USD ($) | Jun. 30, 2021USD ($)Facility | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | |
Segment Reporting Information [Abstract] | |||||||
Number of FDA-licensed plasma collection facilities | Facility | 2 | 2 | |||||
Number of plasma collection facilities under development | Facility | 8 | 8 | |||||
Revenues | $ 17,830,590 | $ 7,787,594 | $ 33,879,208 | $ 17,987,338 | |||
Cost of product revenue | 18,832,624 | 13,495,629 | 36,602,746 | 30,324,855 | |||
Loss from operations | (15,581,232) | (17,123,825) | (30,745,481) | (33,893,611) | |||
Interest and other expense, net | (3,324,071) | (3,054,266) | (6,539,763) | (5,529,710) | |||
Net loss | (18,905,303) | $ (18,379,941) | (20,178,091) | $ (19,245,230) | (37,285,244) | (39,423,321) | |
Capital expenditures | 7,046,735 | 6,243,284 | |||||
Depreciation and amortization expense | 1,325,994 | 885,652 | 2,555,622 | 1,674,490 | |||
Total assets | 232,813,792 | 191,541,568 | 232,813,792 | 191,541,568 | $ 207,673,394 | ||
United States [Member] | |||||||
Segment Reporting Information [Abstract] | |||||||
Revenues | 15,424,839 | 6,797,170 | 29,102,848 | 15,453,443 | |||
International [Member] | |||||||
Segment Reporting Information [Abstract] | |||||||
Revenues | 2,405,751 | 990,424 | 4,776,360 | 2,533,895 | |||
Corporate [Member] | |||||||
Segment Reporting Information [Abstract] | |||||||
Revenues | 35,709 | 35,709 | 71,417 | 71,417 | |||
Cost of product revenue | 0 | 0 | 0 | 0 | |||
Loss from operations | (4,449,608) | (3,351,681) | (8,137,328) | (7,188,167) | |||
Interest and other expense, net | (3,244,912) | (2,818,791) | (6,438,706) | (5,055,363) | |||
Net loss | (7,694,520) | (6,170,472) | (14,576,034) | (12,243,530) | |||
Capital expenditures | 0 | 0 | |||||
Depreciation and amortization expense | 1,530 | 2,305 | 3,397 | 4,881 | |||
Total assets | 42,420,872 | 74,893,664 | 42,420,872 | 74,893,664 | |||
Operating Segments [Member] | ADMA BioManufacturing [Member] | |||||||
Segment Reporting Information [Abstract] | |||||||
Revenues | 16,347,880 | 6,502,865 | 29,768,923 | 14,246,139 | |||
Cost of product revenue | 17,382,292 | 12,237,141 | 32,832,049 | 26,689,094 | |||
Loss from operations | (8,337,405) | (12,852,835) | (17,843,093) | (25,328,980) | |||
Interest and other expense, net | (78,793) | (235,442) | (100,307) | (474,314) | |||
Net loss | (8,416,198) | (13,088,277) | (17,943,400) | (25,803,294) | |||
Capital expenditures | 2,725,432 | 5,064,494 | |||||
Depreciation and amortization expense | 1,055,537 | 772,241 | 2,065,307 | 1,447,214 | |||
Total assets | 169,799,509 | 109,105,418 | 169,799,509 | 109,105,418 | |||
Operating Segments [Member] | Plasma Collection Centers [Member] | |||||||
Segment Reporting Information [Abstract] | |||||||
Revenues | 1,447,001 | 1,249,020 | 4,038,868 | 3,669,782 | |||
Cost of product revenue | 1,450,332 | 1,258,488 | 3,770,697 | 3,635,761 | |||
Loss from operations | (2,794,219) | (919,309) | (4,765,060) | (1,376,464) | |||
Interest and other expense, net | (366) | (33) | (750) | (33) | |||
Net loss | (2,794,585) | (919,342) | (4,765,810) | (1,376,497) | |||
Capital expenditures | 4,321,303 | 1,178,790 | |||||
Depreciation and amortization expense | 268,927 | 111,106 | 486,918 | 222,395 | |||
Total assets | $ 20,593,411 | $ 7,542,486 | $ 20,593,411 | $ 7,542,486 |
LEASE OBLIGATIONS (Details)
LEASE OBLIGATIONS (Details) | Jun. 11, 2021USD ($) | Jun. 30, 2021USD ($)Lease | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) |
LEASE OBLIGATIONS [Abstract] | ||||||
Incremental borrowing rate | 13.00% | |||||
Aggregate lease expense | $ 400,000 | $ 100,000 | $ 700,000 | $ 200,000 | ||
Cash payments for lease | 300,000 | $ 100,000 | 500,000 | $ 200,000 | ||
Right to use assets | 2,800,000 | 2,800,000 | ||||
Lease liabilities | $ 2,800,000 | 2,800,000 | ||||
Number of new property leases | Lease | 3 | |||||
Operating lease liabilities | $ 7,500,000 | $ 7,500,000 | $ 4,700,000 | |||
Weighted average remaining term | 9 years 3 months 18 days | 9 years 3 months 18 days | ||||
Payments Under Lease Obligations [Abstract] | ||||||
Remainder of 2021 | $ 595,836 | $ 595,836 | ||||
Year ended December 31, 2022 | 1,512,443 | 1,512,443 | ||||
2023 | 1,526,406 | 1,526,406 | ||||
2024 | 1,399,474 | 1,399,474 | ||||
2025 | 1,405,411 | 1,405,411 | ||||
2026 | 1,137,321 | 1,137,321 | ||||
Thereafter | 5,486,813 | 5,486,813 | ||||
Total payments | 13,063,704 | 13,063,704 | ||||
Less: imputed interest | (5,604,431) | (5,604,431) | ||||
Current portion | (385,858) | (385,858) | (365,682) | |||
Balance at June 30, 2021 | $ 7,073,415 | $ 7,073,415 | $ 4,334,151 | |||
Lease [Abstract] | ||||||
Initial term of lease | 90 months | |||||
Security deposit and initial payment | $ 300,000 | |||||
Rental payment | 0 | |||||
Minimum [Member] | ||||||
Lease [Abstract] | ||||||
Rental expense | 14,000 | |||||
Maximum [Member] | ||||||
Lease [Abstract] | ||||||
Rental expense | $ 24,000 |
SUPPLEMENTAL DISCLOSURE OF CA_3
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
SUPPLEMENTAL CASH FLOW INFORMATION [Abstract] | ||
Cash paid for interest | $ 5,534,279 | $ 4,192,165 |
Non-cash Financing and Investing Activities [Abstract] | ||
Equipment acquired reflected in accounts payable and accrued liabilities | 1,005,546 | 1,228,000 |
Right-to-use assets in exchange for lease obligations | $ 2,844,875 | $ 1,723,594 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) | Jul. 26, 2021 | Jun. 30, 2021 | Jun. 30, 2020 |
Subsequent Events [Abstract] | |||
Proceeds from issuance of common stock | $ 59,102,075 | $ 88,704,039 | |
Subsequent Event [Member] | 2020 Sale Agreement [Member] | |||
Subsequent Events [Abstract] | |||
Common stock shares sold under sale agreement (in shares) | 897,445 | ||
Proceeds from issuance of common stock | $ 1,500,000 |