Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 07, 2019 | |
Document And Entity Information | ||
Entity Registrant Name | ADMA BIOLOGICS, INC. | |
Entity Central Index Key | 0001368514 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Is Entity's Reporting Status Current? | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Common Stock, Shares Outstanding | 46,380,306 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2019 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets | ||
Cash and cash equivalents | $ 16,534,278 | $ 22,754,852 |
Accounts receivable, net | 1,310,404 | 1,392,441 |
Inventories | 18,439,912 | 18,616,169 |
Prepaid expenses and other current assets | 2,049,552 | 1,766,163 |
Total current assets | 38,334,146 | 44,529,625 |
Property and equipment, net | 29,694,764 | 30,115,730 |
Intangible assets, net | 3,793,177 | 4,004,412 |
Goodwill | 3,529,509 | 3,529,509 |
Assets to be transferred under purchase agreement | 0 | 1,153,508 |
Restricted cash | 0 | 4,000,000 |
Deposits and other assets | 2,768,374 | 1,543,737 |
TOTAL ASSETS | 78,119,970 | 88,876,521 |
Current liabilities | ||
Accounts payable | 5,479,791 | 5,900,394 |
Accrued expenses and other current liabilities | 2,505,996 | 3,551,835 |
Current portion of deferred revenue | 142,834 | 142,834 |
Current portion of lease obligations | 209,506 | 29,983 |
Total current liabilities | 8,338,127 | 9,625,046 |
Notes payable, net of discount | 40,885,103 | 26,440,830 |
End of term liability, notes payable | 0 | 2,760,000 |
Deferred revenue, net of current portion | 2,368,657 | 2,404,365 |
Note payable - related party, net of discount | 14,882,337 | 14,874,184 |
Obligation to transfer assets under purchase agreement | 0 | 12,621,844 |
Lease obligations, net of current portion | 1,461,452 | 119,080 |
Other non-current liabilities | 145,340 | 260,734 |
TOTAL LIABILITIES | 68,081,016 | 69,106,083 |
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, 75,000,000 shares authorized, 46,353,068 shares issued and outstanding | 4,635 | 4,635 |
Additional Paid-In Capital | 239,539,512 | 236,203,041 |
Accumulated Deficit | (229,505,193) | (216,437,238) |
TOTAL STOCKHOLDERS' EQUITY | 10,038,954 | 19,770,438 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 78,119,970 | $ 88,876,521 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Stockholders Equity | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 75,000,000 | 75,000,000 |
Common stock, issued | 46,353,068 | 46,353,068 |
Common stock, outstanding | 46,353,068 | 46,353,068 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
REVENUES: | ||
Product revenue | $ 3,492,881 | $ 4,006,298 |
License and other revenue | 35,708 | 35,708 |
Total Revenues | 3,528,589 | 4,042,006 |
OPERATING EXPENSES | ||
Cost of product revenue (exclusive of amortization expense shown below) | 9,405,179 | 12,242,748 |
Research and development | 870,635 | 965,571 |
Plasma center operating expenses | 654,486 | 1,833,774 |
Amortization of intangibles | 211,235 | 211,235 |
Selling, general and administrative | 5,595,470 | 5,321,181 |
TOTAL OPERATING EXPENSES | 16,737,005 | 20,574,509 |
LOSS FROM OPERATIONS | (13,208,416) | (16,532,503) |
OTHER INCOME (EXPENSE): | ||
Interest and other income | 127,399 | 26,546 |
Interest expense | (1,540,507) | (1,323,152) |
Loss on extinguishment of debt | (9,962,495) | 0 |
Gain on transfer of plasma center assets | 11,527,421 | 0 |
Other (expense) income | (11,357) | 6,967 |
Other income (expense), net | 140,461 | (1,289,639) |
NET LOSS | $ (13,067,955) | $ (17,822,142) |
BASIC AND DILUTED LOSS PER COMMON SHARE | $ (0.28) | $ (0.39) |
WEIGHTED AVERAGE SHARES OUTSTANDING, Basic and Diluted | 46,353,068 | 45,317,042 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) - USD ($) | Common Stock | Non-Voting Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Beginning balance, shares at Dec. 31, 2017 | 36,725,499 | 8,591,160 | |||
Beginning balance, amount at Dec. 31, 2017 | $ 3,673 | $ 859 | $ 191,022,018 | $ (150,693,793) | $ 40,332,757 |
Stock-based compensation | 514,784 | 514,784 | |||
Stock options exercised | 585 | ||||
Warrants issued in connection with note payable | 0 | ||||
Net loss | (17,822,142) | (17,822,142) | |||
Ending balance, shares at Mar. 31, 2018 | 36,726,084 | 8,591,160 | |||
Ending balance, amount at Mar. 31, 2018 | $ 3,673 | $ 859 | 191,536,802 | (168,515,935) | 23,025,399 |
Beginning balance, shares at Dec. 31, 2018 | 46,353,068 | ||||
Beginning balance, amount at Dec. 31, 2018 | $ 4,635 | 236,203,041 | (216,437,238) | 19,770,438 | |
Stock-based compensation | 637,263 | 637,263 | |||
Warrants issued in connection with note payable | 2,699,208 | 2,699,208 | |||
Net loss | (13,067,955) | (13,067,955) | |||
Ending balance, shares at Mar. 31, 2019 | 46,353,068 | ||||
Ending balance, amount at Mar. 31, 2019 | $ 4,635 | $ 239,539,512 | $ (229,505,193) | $ 10,038,954 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (13,067,955) | $ (17,822,142) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 805,330 | 829,541 |
Loss on disposal of fixed assets | 391 | 0 |
Stock-based compensation | 637,263 | 514,784 |
Gain on transfer of plasma assets | (11,527,421) | 0 |
Amortization of debt discount | 244,767 | 255,847 |
Loss on extinguishment of debt | 9,962,495 | 0 |
Amortization of license revenue | (35,708) | (35,708) |
Changes in operating assets and liabilities, net of acquisition: | ||
Accounts receivable | 82,037 | 222,552 |
Inventories | (25,310) | 189,379 |
Prepaid expenses and other current assets | (289,134) | (652,474) |
Deposits and other assets | 179,644 | (29,515) |
Accounts payable | (420,601) | (202,754) |
Accrued expenses | (762,541) | 88,640 |
Other current and non-current liabilities | (70,442) | 207,736 |
Net cash used in operating activities | (14,287,184) | (16,434,114) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (110,453) | (549,246) |
Net cash provided by (used in) investing activities | (110,453) | (549,246) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Principal payments on note payable | (30,000,000) | 0 |
Payment of end of term fee | (2,760,000) | 0 |
Payment of debt refinancing fees | (6,499,867) | 0 |
Proceeds from issuance of note payable | 45,000,000 | 0 |
Payment of debt issuance costs | (1,555,762) | 0 |
Payments on capital lease obligations | (7,308) | 0 |
Payments of leasehold improvement loan | 0 | (4,377) |
Net cash provided by (used in) financing activities | 4,177,063 | (4,377) |
Net (decrease) increase in cash and cash equivalents | (10,220,574) | (16,987,737) |
Cash and cash equivalents, including restricted cash - beginning of period | 26,754,852 | 48,607,574 |
Cash and cash equivalents, including restricted cash - end of period | $ 16,534,278 | $ 31,619,837 |
1. ORGANIZATION AND BUSINESS
1. ORGANIZATION AND BUSINESS | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
1. ORGANIZATION AND BUSINESS | ADMA Biologics, Inc. (“ADMA” or the “Company”) is a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment of immune deficiencies and the prevention and treatment of 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 Bio Centers Georgia Inc. (“ADMA Bio Centers”). ADMA BioManufacturing was formed in January 2017 to facilitate the acquisition of the Biotest Therapy Business Unit (“BTBU”) from Biotest Pharmaceuticals Corporation (“BPC” and, together with Biotest AG, “Biotest”) as more fully described below. BTBU had been the Company’s third-party manufacturer for its then-lead pipeline product candidate, previously referred to as “RI-002.” ADMA Bio Centers is the Company’s source plasma collection business with a plasma collection facility located in Kennesaw, GA which holds an approved license with the U.S. Food and Drug Administration (the “FDA”). Effective January 1, 2019, in connection with the Biotest Transaction defined below, the Company transferred its FDA-approved Norcross, GA and Marietta, GA plasma collection facilities to BPC (see Note 11). On June 6, 2017, ADMA completed the acquisition of certain assets (the “Biotest Assets”) of BTBU, which included two FDA-licensed products, Nabi-HB (Hepatitis B Immune Globulin, Human) and BIVIGAM (Immune Globulin Intravenous, Human), and a plasma fractionation manufacturing facility located in Boca Raton, FL (the “Boca Facility”) (the “Biotest Transaction”). In addition to Nabi-HB and BIVIGAM, the Company provides contract manufacturing services for certain clients and expects to generate revenues from the sale of intermediate by-products which result from the immunoglobulin production process. The Boca Facility is FDA-licensed and certified by the German Health Authority. Immediately following the closing of the Biotest Transaction, the Biotest Assets were contributed into ADMA BioManufacturing. On April 1, 2019, the FDA approved ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), formerly referred to as RI-002. ASCENIV is an Intravenous Immune Globulin (“IVIG”) drug product for the treatment of Primary Humoral Immunodeficiency Disease (“PIDD” or “PI”) in adults and adolescents (12 to 17 years of age). The Company anticipates having the product available for commercial launch during the second half of 2019. Prior to the acquisition of BTBU and the FDA approval for ASCENIV, in July 2016 the FDA issued a Complete Response Letter (“CRL”) to the Company for the Company’s Biologics License Application (“BLA”) for RI-002. The RI-002 CRL reaffirmed the issues set forth in the November 2014 warning letter (the “Warning Letter”) that had been issued by the FDA to Biotest related to certain compliance issues identified at the Boca Facility, but did not cite any concerns with the clinical safety or efficacy data for RI-002, nor did the FDA request any additional clinical studies be completed prior to FDA approval of RI-002. The FDA identified in the RI-002 CRL, among other things, certain outstanding inspection issues and deficiencies related to chemistry, manufacturing and controls and Good Manufacturing Practices at the Boca Facility and certain of the Company’s third-party vendors, and requested documentation of corrections for a number of these issues. The FDA had indicated in the RI-002 CRL that it could not grant final approval of the RI-002 BLA until, among other things, these deficiencies were resolved. Upon the completion of the Biotest Transaction, ADMA gained control over the regulatory, quality, general operations and drug substance manufacturing process at the Boca Facility. In April 2018, the FDA inspected the Boca Facility and in July 2018 the Company’s FDA status with respect to the Boca Facility improved from Official Action Indicated to Voluntary Action Indicated, and the Company determined that this inspection of the Boca Facility was successfully closed out. Nabi-HB is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus. Nabi-HB is indicated for the treatment of acute exposure to blood containing hepatitis B surface antigen (“HBsAg”), prenatal exposure to infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection. FDA approval for Nabi-HB was received on March 24, 1999. Under ADMA’s ownership, production of Nabi-HB resumed during the third quarter of 2017, resulting in ongoing commercial revenues. BIVIGAM is an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency. BIVIGAM is currently under FDA review for the Prior Approval Supplement (the “PAS”) that the Company submitted to the FDA in June 2018 to amend BIVIGAM’s FDA-approved BLA which, once approved, would enable the Company to relaunch and commercialize this product in the U.S. In December 2018, the Company received a CRL from the FDA in response to the PAS (the “BIVIGAM CRL”), and the Company has since received several information requests from the FDA, each containing a limited number of questions. The Company believes that all requests contained in the various information requests were addressable, and has responded to all of them. The Company to date has not received a formal BIVIGAM CRL resubmission acknowledgement and has not received clarity on the FDA’s intended classification or review timing. Although the Company believes that the FDA is actively reviewing the PAS submission and subsequent information request responses, the Company cannot provide any assurance or predict with certainty the schedule for when the Company will, if at all, receive authorization from the FDA with respect to the PAS. In addition, the anticipated relaunch of BIVIGAM is dependent upon the timing of certain FDA decisions, production slots available with the Company’s contract fill/finish provider, approvals that may need to be obtained for product labeling as well as other commercial requirements and regulatory factors. Biotest had originally received FDA approval for BIVIGAM on December 19, 2012, prior to the acquisition of BTBU, and product sales commenced in the first quarter of 2013. In December 2016, Biotest temporarily suspended the commercial production of BIVIGAM in order to focus on the completion of planned improvements to the manufacturing process. ADMA resumed production of BIVIGAM during the fourth quarter of 2017. As of March 31, 2019, the Company had working capital of $30.0 million, including $16.5 million of cash and cash equivalents. Based upon the Company’s current projected revenue and expenditures, including capital expenditures and continued implementation of the Company’s commercialization and expansion activities, as well as certain other assumptions, the Company’s management currently believes that its cash, cash equivalents, projected revenue and accounts receivable, along with the additional $40.0 million it is able to access under its senior credit facility, $12.5 million of which is contingent upon FDA approval of the PAS, will be sufficient to fund ADMA’s operations, as currently conducted, into the fourth quarter of 2019. In order to have sufficient cash to fund its operations thereafter and to continue as a going concern, the Company will need to raise capital by the fourth quarter of 2019. These estimates may change based upon how quickly the Company is able to obtain FDA approval for BIVIGAM, commercial manufacturing ramp-up activities and the various financing options being explored. The Company currently has no firm commitments for additional financing, and there can be no assurances that the Company will be able to secure additional financing on terms that are acceptable to the Company, or at all. Furthermore, if the Company’s assumptions underlying its estimated expenses and revenues are incorrect, it may have to raise additional capital sooner than currently anticipated. Due to numerous risks and uncertainties associated with FDA approval of the Company’s products, ongoing remediation and capacity expansion efforts at the Company’s Boca Facility and potential future commercialization of the Company’s products and product candidates, the Company is unable to estimate with certainty the amounts of increased capital outlays and operating expenditures required to fund its development activities. The Company’s current estimates may be subject to change as circumstances regarding its business requirements evolve. The Company may decide to raise capital through public or private equity offerings or debt financings, or obtain a bank credit facility or corporate collaboration and licensing arrangements. The sale of additional equity or debt securities, if convertible, could result in dilution to the Company’s stockholders and, in such event, the value and potential future market price 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. 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 product development, clinical trial or commercialization activities, delay or discontinue the approval efforts for any of the Company’s potential products or potentially cease operations. The Company has reported cumulative losses since inception in June 2004 through March 31, 2019 of $229.5 million. Management believes that the Company will continue to incur net losses and negative net cash flows from operating activities to fund its operations and meet its obligations on a timely basis through the foreseeable future. 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. In February 2019, the Company refinanced its senior debt (see Note 6) whereby the Company received net proceeds of approximately $4.2 million, and an additional $4.0 million, which was reflected as restricted cash in the accompanying consolidated balance sheet at December 31, 2018, was released by the Company’s then-senior creditor to the Company. On May x, 2019, the Company received the additional $27.5 million that was available to the Company under its senior credit facility and amended the facility to increase the total amount available under the facility by an additional $12.5 million (see Note 14). There can be no assurance that the Company’s research and development will be successfully completed or that any product will be approved or commercially viable. The Company is subject to risks common to companies in the biotechnology industry 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. |
2. SUMMARY OF SIGNIFICANT ACCOU
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
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, 2018 included in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 13, 2019. The accompanying consolidated balance sheet as of December 31, 2018 was derived from the audited financial statements for the year ended December 31, 2018. 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 consolidated interim financial statements prepared in accordance with U.S. GAAP. All intercompany balances and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of March 31, 2019 and its results of operations for the three months ended March 31, 2019 and 2018 and cash flows for the three months ended March 31, 2019 and 2018. During the three months ended March 31, 2019 and 2018, comprehensive loss was equal to the net loss amounts presented for the respective periods in the accompanying condensed consolidated statements of operations. In addition, certain prior year balances have been reclassified to conform to the current presentation. Specifically, for the three months ended March 31, 2018, approximately $0.3 million was reclassified from research and development expenses to selling, general and administrative expenses in the accompanying 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 fair value of assets acquired and liabilities assumed in a business combination, realizable value of accounts receivable, valuation of inventory, assumptions used in the fair value of awa Fair value of financial instruments The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents 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 6) approximates fair value due to the variable interest rate on this debt. With respect to the related party note payable in the amount of $15.0 million as of March 31, 2019 and December 31, 2018, which is held by a principal stockholder of the Company and was issued concurrent with an acquisition transaction with an affiliate of such stockholder (see Note 6), the Company has concluded that an estimation of fair value for this note is not practicable. Accounts receivable Accounts receivable are reported at realizable value, net of allowances for contractual credits and doubtful accounts, which are recognized in the period the related revenue is recorded. At March 31, 2019, four customers accounted for an aggregate of 96% of the Company’s total accounts receivable, and at December 31, 2018, three customers accounted for approximately 95% of the Company’s total accounts receivable. Inventories Inventories, including plasma intended for resale and plasma intended for internal use in the Company’s research and development and future anticipated commercialization activities, are carried at the lower of cost or net realizable value determined by the first-in, first-out method. Although the Company expects that BIVIGAM and ASCENIV inventory manufactured prior to March 31, 2019 will ultimately be available for commercial sale, due to uncertainties surrounding the Warning Letter, the PAS and, as of March 31, 2019, the RI-002 BLA, resolution of which are dependent upon action by the FDA prior to this inventory being available for commercial sale, all costs related to the production of BIVIGAM and ASCENIV during the three months ended March 31, 2019 and 2018 in the amount of $0.6 million and $3.7 million, respectively, have been charged to cost of product revenue in the accompanying consolidated statements of operations. Goodwill Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill at March 31, 2019 and December 31, 2018 was $3.5 million. All of the Company’s goodwill is attributable to its ADMA BioManufacturing business segment. 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, and the Company did not record any impairment charges related to goodwill for the three months ended March 31, 2019 and 2018. Impairment of long-lived assets The Company assesses the recoverability of its long-lived assets, which include property and equipment and definite-lived intangible assets, whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s carrying value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the three months ended March 31, 2019 and 2018, the Company determined that there was no impairment of its long-lived assets. Revenue recognition Revenues for the three months ended March 31, 2019 and 2018 are comprised of (i) revenues from the sale of Nabi-HB, (ii) product revenues from the sale of human plasma collected from the Company’s Plasma Collection Centers business segment; and (iii) license and other revenues primarily attributable to the out-licensing of ASCENIV to Biotest 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 recognized over the term of the Biotest license. Deferred revenue is amortized into income for a period of approximately 22 years, the term of the Biotest license agreement. 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 Nabi-HB 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 the Company believes that such estimates are reasonable. For revenues associated with contract manufacturing, control transfers to the customer and the performance obligation is satisfied when the customer takes possession of the product from the Boca Facility. Product revenues from the sale of human plasma collected at the Company’s plasma collection centers are recognized at the time control of the product has been transferred to the customer, which generally occurs at the time of shipment. Product revenues are recognized at the time of delivery if the Company retains control of the product during shipment. For the three months ended March 31, 2019, two customers represented an aggregate of 81% of the Company’s consolidated revenues. For the three months ended March 31, 2018, sales to BPC represented 58% of the Company’s consolidated revenues, and two other customers represented 32% of the Company’s consolidated revenues. Cost of product revenue Cost of product revenue includes expenses related to process development as well as 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. Expenses associated with remediating the issues identified in the Warning Letter for the three months ended March 31, 2019 and 2018 were approximately $0.1 million and $0.7 million, respectively, and are reflected in cost of product revenue in the accompanying consolidated statements of operations. I 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 as the Company reported a net loss for all periods presented. For the three months ended March 31, 2019 and 2018, the following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive effects: For the Three Months Ended March 31, 2019 2018 Stock options 5,599,435 4,127,950 Warrants 1,888,160 528,160 7,487,595 4,656,110 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 statements of operations as compensation expense based on their fair values at the date of grant. The Company uses the Black-Scholes option pricing model to determine the fair value of options granted. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated vesting period of the award, which is generally four years (see Note 7). Stock options granted under the Company’s equity incentive plans generally have a term of 10 years. 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 2015 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 fifty percent likely of being realized upon ultimate settlement. Derecognition of a tax benefit previously recognized could result in the Company recording a tax liability that would reduce net assets. Based on its analysis, the Company has determined that it has not incurred any liability for unrecognized tax benefits as of March 31, 2019 and December 31, 2018, and during the three months ended March 31, 2019 and 2018, the Company recognized no adjustments for uncertain tax positions. Recent Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) |
3. INVENTORIES
3. INVENTORIES | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
3. INVENTORIES | The following table provides the components of inventories: March 31, December 31, Raw materials $ 13,799,170 $ 14,019,668 Work-in-progress 870,264 — Finished goods 3,770,478 4,596,501 Total inventories $ 18,439,912 $ 18,616,169 Inventories are stated at the lower of cost or net realizable value with cost being determined on the first-in, first-out method. Raw materials includes plasma and other materials expected to be used in the production of ASCENIV and BIVIGAM, as there are alternative uses for these materials which 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. Finished goods inventory at March 31, 2019 is comprised of $2.1 million of Nabi-HB, $1.5 million of product manufactured under a contract manufacturing agreement and $0.2 million of plasma collected at the Company’s plasma collection center. Finished goods inventory at December 31, 2018 is comprised of $2.3 million of Nabi-HB, $1.2 million of product manufactured under a contract manufacturing agreement and $1.1 million of plasma collected at the Company’s plasma collection centers. |
4. INTANGIBLE ASSETS
4. INTANGIBLE ASSETS | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
4. INTANGIBLE ASSETS | Intangible assets at March 31, 2019 and December 31, 2018 consist of the following: March 31, 2019 December 31, 2018 Accumulated Accumulated Cost Amortization Net Cost Amortization Net Trademark and other intangible rights related to Nabi-HB $ 4,100,046 $ 1,073,821 $ 3,026,225 $ 4,100,046 $ 927,391 $ 3,172,655 Rights to intermediates 907,421 237,659 669,762 907,421 205,250 702,171 Customer contract 1,076,557 979,367 97,190 1,076,557 946,971 129,586 $ 6,084,024 $ 2,290,847 $ 3,793,177 $ 6,084,024 $ 2,079,612 $ 4,004,412 All of the Company’s intangible assets were acquired in the Biotest Transaction. Amortization expense related to these intangible assets for the three months ended March 31, 2019 and 2018 was $0.2 million. Estimated aggregate future aggregate amortization expense for the next five years is expected to be as follows: Remainder of 2019 $ 633,704 2020 715,352 2021 715,352 2022 715,352 2023 715,352 |
5. PROPERTY AND EQUIPMENT
5. PROPERTY AND EQUIPMENT | 3 Months Ended |
Mar. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
5. PROPERTY AND EQUIPMENT | Property and equipment and related accumulated depreciation are summarized as follows: March 31, 2019 December 31, 2018 Manufacturing and laboratory equipment $ 8,366,402 $ 8,233,203 Office equipment and computer software 1,571,178 1,608,994 Furniture and fixtures 1,212,045 1,163,552 Construction in process 911,744 845,538 Leasehold improvements 1,673,084 1,660,709 Land 4,339,441 4,339,441 Buildings and building improvements 15,700,092 15,685,325 33,773,986 33,536,762 Less: Accumulated depreciation (4,079,222 ) (3,421,032 ) Total property and equipment, net $ 29,694,764 $ 30,115,730 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 3 to 10 years. Leasehold improvements are amortized over the lesser of the lease term or their estimated useful lives. The Company recorded depreciation expense on property and equipment for the three months ended March 31, 2019 and 2018 of $0.6 million. Depreciation expense for the three months ended March 31, 2018 includes $0.1 million on the plasma assets that were transferred to Biotest on January 1, 2019 (see Notes 1 and 11). |
6. DEBT
6. DEBT | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
6. DEBT | Senior Notes Payable A summary of outstanding senior notes payable is as follows: March 31, 2019 December 31, 2018 Notes payable: $ 45,000,000 $ 30,000,000 Less: Debt discount (4,114,897 ) (3,559,170 ) Senior notes payable $ 40,885,103 $ 26,440,830 On February 11, 2019, (the “Perceptive Closing Date”), the Company and all of its subsidiaries entered into a Credit Agreement and Guaranty (the “Perceptive Credit Agreement”) with Perceptive Credit Holdings II, LP, as the lender and administrative agent (“Perceptive”). The Perceptive Credit Agreement provides for a senior secured term loan facility in a principal amount of up to $72.5 million (the “Perceptive Credit Facility”), comprised of (i) a term loan made on the Perceptive Closing Date in the principal amount of $45.0 million, as evidenced by the Company’s issuance of a promissory note (the “Perceptive Tranche I Note”) in favor of Perceptive on the Perceptive Closing Date (the “Perceptive Tranche I Loan”), and (ii) an additional term loan in the principal amount of up to $27.5 million, but no less than $10.0 million (the “Perceptive Tranche II Loan” and, together with the Perceptive Tranche I Loan, the “Initial Perceptive Loans”), which Perceptive Tranche II Loan was made on in full on May 3, 2019 (see Note 14). The Perceptive Credit Facility has a maturity date of March 1, 2022 (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 Perceptive Closing Date, the Company used $30.0 million of the Perceptive Tranche I Loan to terminate and pay in full all of the outstanding obligations under its previously existing credit agreement with Marathon Healthcare Finance Fund, L.P. (“Marathon”) (the “Marathon Credit Facility”). The Company also (i) used $2.8 million of the Perceptive Tranche I Loan to pay a deferred facility fee to Marathon, (ii) used $6.5 million of the Perceptive Tranche I Loan to pay a prepayment penalty to Marathon, (iii) used $0.7 million of the Perceptive Tranche I Loan to pay outstanding accrued interest to Marathon, and (iv) used proceeds of the Perceptive Tranche I Loan to pay certain fees and expenses incurred in connection with the Perceptive Credit Facility of approximately $1.5 million. In addition, Marathon released $4.0 million of cash that was held in a debt service reserve account per the terms of the Marathon Credit Facility, which was reflected as restricted cash in the accompanying consolidated balance sheet as of December 31, 2018, to the Company. As a result of the Company’s entering into the Perceptive Credit Agreement and terminating the Marathon Credit Facility, the Company recognized a loss on the extinguishment of debt in the amount of approximately $10.0 million, comprised of the $6.5 million prepayment penalty and the write-off of unamortized debt discount related to the Marathon Credit Facility in the amount of $3.5 million. Borrowings under the Perceptive Credit Agreement bear interest at a rate per annum equal to 7.5% plus the greater of (i) one-month LIBOR and (ii) 3.5%; provided, however, that upon, and during the continuance of, an Event of Default, the interest rate will automatically increase by an additional 400 basis points. On the last day of each month during the term of the Perceptive Credit Facility, the Company will pay accrued interest to Perceptive. The rate of interest in effect as of the Perceptive Closing Date and at March 31, 2019 was 11.0%. On the Maturity Date, the Company will pay Perceptive the entire outstanding principal amount underlying the Perceptive Loans and any accrued and unpaid interest thereon. Prior to the Maturity Date, there will be no scheduled principal payments on the Perceptive Loans. The Company may prepay outstanding principal on the Perceptive Loans at any time and from time to time upon three business days’ prior written notice, subject to the payment to Perceptive of, (A) any accrued but unpaid interest on the prepaid principal amount plus (B) a redemption premium amount equal to (i) 5.0% of the prepaid principal amount, if prepaid on or prior to the first anniversary of the Perceptive Closing Date, (ii) 4.0% of the prepaid principal amount, if prepaid after the first anniversary of the Perceptive Closing Date and on or prior to the second anniversary of the Perceptive Closing Date, or (iii) 3.0% of the prepaid principal amount, if prepaid after the second anniversary of the Perceptive Closing Date and on or prior to the third anniversary of the Perceptive Closing Date. 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 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 has 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 ending June 30, 2019, receive revenue for the trailing 12-month period in amounts set forth in the Perceptive Credit Agreement, which range from $7.0 million for the fiscal quarter ending June 30, 2019 to $55.0 million for the fiscal quarter ending December 31, 2021. As consideration for the Perceptive Credit Agreement, the Company issued to Perceptive, on the Perceptive Closing Date, a warrant to purchase 1,360,000 shares of the Company’s common stock (the “Perceptive Warrant”). The Perceptive Warrant has an exercise price equal to $3.28 per share, which is equal to the trailing 10-day VWAP of the Company’s common stock on the business day immediately prior to the Perceptive Closing Date multiplied by 1.15. The Perceptive Warrant was valued by the Company at $2.7 million as of the Perceptive Closing Date and has an expiration date of February 11, 2029. Perceptive represented to the Company, among other things, that it was an “accredited investor” (as such term is defined in Rule 501(a) of Regulation D under the Securities Act) and the Company issued the Perceptive Warrant in reliance upon an exemption from registration contained in Section 4(2) under the Securities Act. The Perceptive Warrant and the shares of common stock issuable thereunder may not be offered, sold, pledged or otherwise transferred in the U.S. absent registration or an applicable exemption from the registration requirements under the Securities Act. As a result of the fees paid to Perceptive and the value of the Perceptive Warrant, the Company recognized a discount on the Perceptive Initial Note in the amount of $4.3 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 Warrant and the aggregate amount of fees and expenses associated with obtaining the Perceptive Credit Facility, the effective interest rate on the Perceptive Initial Note as of the Perceptive Closing Date was approximately 14.7%. Related Party Note Payable A summary of the outstanding related party note payable is as follows: March 31, 2019 December 31, 2018 Related party note payable to Biotest $ 15,000,000 $ 15,000,000 Less: Debt discount (117,663 ) (125,816 ) Note payable - related party $ 14,882,337 $ 14,874,184 In connection with the acquisition of the Biotest Assets (see Note 1), ADMA BioManufacturing issued a subordinated note payable to BPC and in connection therewith received cash proceeds of $15.0 million. This note has since been assigned from BPC to Biotest AG. The note bears interest at a rate of 6.0% per annum and matures on June 6, 2022. The Company is obligated to make semi-annual interest payments, with all principal and unpaid interest due at maturity. The note is subordinate to all amounts outstanding under the Perceptive Credit Agreement. In the event of default, all principal and unpaid interest is due on demand. The subordinated note also contains several non-financial covenants with which the Company was in compliance as of March 31, 2019. |
7. STOCKHOLDERS' EQUITY
7. STOCKHOLDERS' EQUITY | 3 Months Ended |
Mar. 31, 2019 | |
STOCKHOLDERS' EQUITY | |
7. STOCKHOLDERS' EQUITY | Preferred Stock The Company is currently authorized to issue up to 10 million shares of preferred stock, $0.0001, par value per share. There were no shares of preferred stock outstanding at March 31, 2019 and December 31, 2018. Common Stock As of March 31, 2019 and December 31, 2018, the Company was authorized to issue 75,000,000 shares of its common stock, $0.0001 par value per share, and 46,353,068 shares of common stock were outstanding. After giving effect to shares reserved for the issuance of warrants and stock options, as of March 31, 2019, 21,159,337 shares of common stock were available for issuance. Warrants On the Perceptive Closing Date, the Company issued the Perceptive Warrant, whereby Perceptive may purchase an aggregate of 1,360,000 shares of common stock at an exercise price of $3.28 per share. The Perceptive Warrant became exercisable on the Perceptive Closing Date, and were valued at $2.7 million. The Perceptive Warrant was valued using the Black-Scholes option-pricing model assuming an expected term of 10 years, a volatility of 61.2%, a dividend yield of 0% and a risk-free interest rate of 2.65%. At March 31, 2019, the Company had outstanding warrants to purchase an aggregate of 1,888,160 shares of common stock, with a weighted average exercise price of $3.69 per share and expiration dates ranging between June 2022 and February 2029. Equity Incentive Plans The fair value of stock options granted under the Company’s 2007 Employee Stock Option Plan (the “2007 Plan”) and the ADMA Biologics, Inc. 2014 Omnibus Incentive Compensation Plan, as amended and restated (the “2014 Plan”), was determined on the date of grant using the Black-Scholes option valuation model. The Black-Scholes model was developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of certain subjective assumptions including the expected stock price volatility. The stock options granted to employees and directors have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair value estimate. The following assumptions were used to determine the fair value of options granted during the three months ended March 31, 2019 and 2018: Three Months Ended March 31, 2019 2018 Expected term 5.8 - 6.3 years 6.3 years Volatility 61 % 57 % Dividend yield 0.0 0.0 Risk-free interest rate 2.25-2.63% 2.59 % During the three months ended March 31, 2019 and 2018, the Company granted options to purchase an aggregate of 1,330,850 and 848,700 shares of common stock, respectively, to its directors and employees. Also during the three months ended March 31, 2019 and 2018, the Company granted options to purchase 5,000 and 20,000 shares of common stock, respectively, to third party service providers. The weighted average remaining contractual life of stock options outstanding and expected to vest at March 31, 2019 is 7.8 years. The weighted average remaining contractual life of stock options exercisable at March 31, 2019 is 6.3 years. A summary of the Company’s option activity under the 2007 Plan and 2014 Plan and related information is as follows: Shares Weighted Average Exercise Price Balance at December 31, 2018 4,342,231 $ 5.16 Forfeited (74,906 ) $ 4.61 Expired (3,740 ) $ 4.75 Granted 1,335,850 $ 3.42 Exercised — $ — Balance at March 31, 2019 5,599,435 $ 4.75 Options exercisable 2,588,091 $ 5.93 Stock-based compensation expense for the three ended March 31, 2019 and 2018 is as follows: 2019 2018 Research and development $ 86,523 $ 78,305 Plasma centers 11,540 7,086 Selling, general and administrative 498,471 394,858 Cost of product revenue 40,729 34,535 Total stock-based compensation expense $ 637,263 $ 514,784 As of March 31, 2019, the Company had $6.2 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 2.8 years. |
8. RELATED PARTY TRANSACTIONS
8. RELATED PARTY TRANSACTIONS | 3 Months Ended |
Mar. 31, 2019 | |
Related Party Transactions [Abstract] | |
8. RELATED PARTY TRANSACTIONS | The Company leases an office building and equipment from Areth, LLC (“Areth”) pursuant to an agreement for services effective as of January 1, 2016, as amended from time to time. Effective October 1, 2017, monthly rent on this facility was reduced to $10,000. On September 27, 2018, the agreement was amended to extend the term of the agreement through September 30, 2019. Rent expense amounted to $30,000 for the three months ended March 31, 2019 and 2018, and includes fees for the use of such office space and for other information technology, general warehousing and administrative services. Areth is a company controlled by Dr. Jerrold B. Grossman, the Company’s Vice Chairman, 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 three months ended March 31, 2019 and 2018. As part of the Biotest Transaction, the Company issued a $15.0 million subordinated note payable to Biotest (see Note 6), and recognized interest expense on this note for the three months ended March 31, 2019 and 2018 in the amount of $0.2. For the three months ended March 31, 2019 and 2018, the Company recognized revenues under its out-licensing agreements with Biotest of approximately $36,000. Deferred revenue of $2.5 million as of March 31, 2019 and 2018 is related to these agreements. Biotest was historically the Company’s largest customer for the sale of normal source plasma. Plasma sales to Biotest for the three months ended March 31, 2018 were $2.3 million. The agreement under which the Company supplied normal source plasma to Biotest expired by its terms on December 31, 2018 and was not renewed. Accounts receivable includes $0 and $1.0 million due from Biotest as of March 31, 2019 and December 31, 2018, respectively. Additionally, Biotest is a supplier of plasma to ADMA. For the three months ended March 31, 2019 and 2018, the Company purchased $0.2 million of plasma from Biotest. Included in accounts payable is $0.3 million and $2.0 million due to Biotest as of March 31, 2019 and December 31, 2018, respectively. The following table summarizes the related party balances with Biotest: Three Months Ended March 31, 2019 2018 Sale and purchase of plasma Product revenue $ — $ 2,328,291 Purchases 160,489 195,018 License revenue 35,708 35,708 Interest expense 225,000 225,000 March 31, December 31, 2019 2018 Accounts receivable $ — $ 961,145 Accounts payable 296,362 2,010,774 Accrued expenses 24,049 10,659 Note payable, net of discount 14,882,337 14,874,184 Accrued interest 290,000 65,000 Deferred revenue 2,511,491 2,547,199 In connection with the acquisition of the Biotest Assets, the Company entered into a Transition Services Agreement with BPC pursuant to which each of the Company and BPC agreed to provide transition services to the other party, including services related to finance, human resources, information technologies, leasing of equipment and clinical and regulatory services for a period of up to 24 months after the June 6, 2017 closing date, as well as agreements to lease certain laboratory space within the Boca Facility to BPC for a period of up to 24 months after the closing date of the acquisition transaction. As of March 31, 2019 and December 31, 2018, approximately $24,000 and $11,000, respectively, was payable by the Company to BPC for services rendered and expenses incurred on behalf of the Company related to these agreements. This amount is reflected in accrued expenses in the accompanying consolidated balance sheets. Under the terms of the acquisition of the Biotest Assets, the Company transferred ownership of two plasma collection centers to BPC on January 1, 2019 (see Note 11). The Company and BPC entered into an additional transition services agreement effective as of January 1, 2019 under which the Company agreed to provide certain transition services to BPC related to the plasma collection centers that were transferred. Amounts billed to BPC by the Company under this agreement for the three months ended March 31, 2019 were not material to the consolidated financial statements. See Notes 6 and 14 for a discussion of the Company’s credit facility and related transactions with Perceptive, a holder of greater than 10% of the Company’s common stock. |
9. COMMITMENT AND CONTINGENCIES
9. COMMITMENT AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
9. COMMITMENT 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. Contract manufacturing agreement In connection with the acquisition of the Biotest Assets, the Company acquired all of the rights and assumed all of the obligations under an existing agreement with a third party related to the fractionation of plasma provided by the third party. This contract, as amended from time to time, maintains minimum production requirements as well as a payment due to the counterparty to the contract of $1.5 million per year if the minimum volume is not manufactured in that year and no other breach or default under the contract has occurred. 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 the end of 2021. However, the timing of the completion of these studies is dependent upon the availability of BIVIGAM and the completion of the planned manufacturing process improvements. 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 March 31, 2019. The Company does not anticipate recognizing any significant losses relating to these arrangements. |
10. SEGMENTS
10. SEGMENTS | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
10. SEGMENTS | The Company is engaged in the manufacture, marketing and development of specialty plasma-derived biologics. The Company’s ADMA BioManufacturing segment reflects the Company’s immune globulin manufacturing and development operations in Boca Raton, FL, acquired on June 6, 2017 (see Note 1). The Plasma Collection Centers segment consists of one and three FDA-licensed source plasma collection facility located in Georgia for the three months ended March 31, 2019 and 2018, respectively. The Corporate segment includes general and administrative overhead expenses. The Company defines its segments as those business units whose operating results are regularly reviewed by the chief operating decision maker (“CODM”) to analyze performance and allocate resources. The Company’s CODM is its President and Chief Executive Officer. Three Months Ended March 31, 2019 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 1,343,983 $ 2,148,898 $ 35,708 $ 3,528,589 Cost of product revenue 7,940,346 1,464,833 — 9,405,179 (Loss) income from operations (10,620,807 ) 29,579 (2,617,188 ) (13,208,416 ) Interest and other (expense) income, net (169,613 ) 13,620 (1,268,472 ) (1,424,465 ) Gain on transfer of plasma center assets — 11,527,421 — 11,527,421 Loss on extinguishment of debt — — (9,962,495 ) (9,962,495 ) Net (loss) income (10,790,420 ) 11,570,620 (13,848,155 ) (13,067,955 ) Capital expenditures 110,453 — — 110,453 Depreciation and amortization expense 687,393 114,241 3,696 805,330 Total assets 57,529,070 4,038,367 16,552,533 78,119,970 Three Months Ended March 31, 2018 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 1,666,243 $ 2,340,055 $ 35,708 $ 4,042,006 Cost of product revenue 10,697,642 1,545,106 — 12,242,748 Loss from operations (12,724,718 ) (1,038,824 ) (2,768,961 ) (16,532,503 ) Interest and other expense, net (240,054 ) (435 ) (1,049,150 ) (1,289,639 ) Net loss (12,964,772 ) (1,039,259 ) (3,818,111 ) (17,822,142 ) Total assets 47,481,781 27,532,613 16,123,231 91,137,625 Depreciation and amortization expense 631,832 188,914 8,795 829,541 Capital expenditures 105,199 444,047 — 549,246 |
11. TRANSFER OF PLASMA CENTER A
11. TRANSFER OF PLASMA CENTER ASSETS | 3 Months Ended |
Mar. 31, 2019 | |
Transfer Of Plasma Center Assets | |
11. TRANSFER OF PLASMA CENTER ASSETS | As part of the purchase price for the Biotest Transaction (see Note 1), the Company transferred its Marietta, GA and Norcross, GA plasma collection centers to BPC effective January 1, 2019. The |
12. LEASE OBLIGATIONS
12. LEASE OBLIGATIONS | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
12. LEASE OBLIGATIONS | The Company leases certain properties and equipment for its ADMA Bio Centers 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 2026. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. The Company determines if an arrangement is an operating lease at inception. Leases with an initial term of 12 months or less are not recorded on the balance sheet. All other leases are recorded on the balance sheet with assets representing the right to use the underlying asset for the lease term and lease liabilities representing the obligation to make lease payments arising from the lease. Right-to-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term and include options to extend or terminate the lease when they are reasonably certain to be exercised. The present value of the lease payments is determined using the Company’s incremental borrowing rate as of the date of application of ASU 2016-02, or the lease commencement date. For the lease liabilities recognized upon the application of ASU 2016-02, the Company used a discount rate of 13% to determine the present value of its lease obligations. The Company’s operating lease expense is recognized on a straight-line basis over the lease term and is reflected in Plasma center operating expenses and Selling, general and administrative expenses. Aggregate rent expense and cash paid for the Company’s operating leases was $0.1 million for the three months ended March 31, 2019. In connection with the adoption of ASU 2016-02 on January 1, 2019 (see Note 2), the Company recognized right to use assets and lease liabilities of approximately $1.4 million. Including a finance lease the Company entered into in June 2018, the Company has aggregate lease liabilities of $1.7 million as of March 31, 2019, which are comprised primarily of the lease for the Company’s plasma collection center in Kennesaw, GA and an administrative office lease in Roswell, GA related to the Company’s ADMA Bio Centers subsidiary. The Company’s operating leases have a weighted average remaining term of 6.6 years. Scheduled payments under the Company’s lease obligations are as follows: Remainder of 2019 $ 303,686 Year ended December 31, 2020 400,837 2021 378,932 2022 379,969 2023 360,197 Thereafter 606,913 Total payments 2,430,534 Less: imputed interest (759,576 ) Balance at March 31, 2019 $ 1,670,958 |
13. SUPPLEMENTAL DISCLOSURE OF
13. SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | 3 Months Ended |
Mar. 31, 2019 | |
Supplemental Cash Flow Information [Abstract] | |
13. SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | Supplemental cash flow information for the three months ended March 31, 2019 and 2018 is as follows: 2019 2018 SUPPLEMENTAL CASH FLOW INFORMATION: Cash paid for interest $ 1,369,939 $ 825,513 Noncash Financing and Investing Activities: Equipment acquired reflected in accounts payable and accrued liabilities $ 35,823 $ 116,766 Warrants issued in connection with notes payable $ 2,699,208 $ — |
14. SUBSEQUENT EVENTS
14. SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2019 | |
Subsequent Events [Abstract] | |
14. SUBSEQUENT EVENTS | BLA Approval On April 1, 2019, the FDA approved ASCENIV, Immune Globulin Intravenous, Human – slra 10% Liquid, formerly referred to as RI-002. ASCENIV is an IVIG drug product for the treatment of PI in adults and adolescents (12 to 17 years of age). The Company anticipates having the product available for commercial launch during the second half of 2019. Credit Facility On May 3, 2019, in connection with the FDA’s approval of ASCENIV, the Company accessed the additional $27.5 million available under the Perceptive Credit Facility through the issuance of a promissory note evidencing the Perceptive Tranche II Loan (see Note 6). The Company intends to use the proceeds from the Perceptive Tranche II Loan (i) to support the commercial launch of ASCENIV anticipated during the second half of 2019, (ii) to expand the Company’s plasma collection facility network; and (iii) for working capital and general corporate purposes, including the procurement of raw material inventory. Also on May 3, 2019, the Company and Perceptive entered into an amendment to the Perceptive Credit Agreement (the “Perceptive Amendment”) whereby Perceptive agreed to an additional commitment under the Perceptive Credit Facility in the principal amount of up to $12.5 million (the “Perceptive Tranche III Loan”) to be drawn-down at the Company’s sole option. The Perceptive Tranche III Loan is subject to the satisfaction of certain conditions, including, but not limited to, FDA approval of the BIVIGAM PAS and no Material Adverse Changes (as defined in the Perceptive Credit Agreement) having occurred since December 31, 2018; provided that the Perceptive Tranche III Loan would not be made later than March 31, 2020. The Perceptive Tranche III Loan will have terms that are substantially identical to those of the Initial Perceptive Loans. The Perceptive Tranche III Loan required the Company to pay a facility fee to Perceptive in the amount equal to 1% of the maximum amount of the Perceptive Tranche III Loan on May 3, 2019. In addition, the Company issued a warrant (the “Perceptive Tranche III Warrant”) to purchase 250,000 shares of the Company’s common stock to Perceptive with an exercise price equal to $4.64 per share, which represents the trailing 10-day volume weighted average price of the Company’s common stock as of May 2, 2019. |
2. SUMMARY OF SIGNIFICANT ACC_2
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
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, 2018 included in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 13, 2019. The accompanying consolidated balance sheet as of December 31, 2018 was derived from the audited financial statements for the year ended December 31, 2018. 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 consolidated interim financial statements prepared in accordance with U.S. GAAP. All intercompany balances and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of March 31, 2019 and its results of operations for the three months ended March 31, 2019 and 2018 and cash flows for the three months ended March 31, 2019 and 2018. During the three months ended March 31, 2019 and 2018, comprehensive loss was equal to the net loss amounts presented for the respective periods in the accompanying condensed consolidated statements of operations. In addition, certain prior year balances have been reclassified to conform to the current presentation. Specifically, for the three months ended March 31, 2018, approximately $0.3 million was reclassified from research and development expenses to selling, general and administrative expenses in the accompanying 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 fair value of assets acquired and liabilities assumed in a business combination, realizable value of accounts receivable, valuation of inventory, 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 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 6) approximates fair value due to the variable interest rate on this debt. With respect to the related party note payable in the amount of $15.0 million as of March 31, 2019 and December 31, 2018, which is held by a principal stockholder of the Company and was issued concurrent with an acquisition transaction with an affiliate of such stockholder (see Note 6), the Company has concluded that an estimation of fair value for this note is not practicable. |
Accounts receivable | Accounts receivable are reported at realizable value, net of allowances for contractual credits and doubtful accounts, which are recognized in the period the related revenue is recorded. At March 31, 2019, four customers accounted for an aggregate of 96% of the Company’s total accounts receivable, and at December 31, 2018, three customers accounted for approximately 95% of the Company’s total accounts receivable. |
Inventories | Inventories, including plasma intended for resale and plasma intended for internal use in the Company’s research and development and future anticipated commercialization activities, are carried at the lower of cost or net realizable value determined by the first-in, first-out method. Although the Company expects that BIVIGAM and ASCENIV inventory manufactured prior to March 31, 2019 will ultimately be available for commercial sale, due to uncertainties surrounding the Warning Letter, the PAS and, as of March 31, 2019, the RI-002 BLA, resolution of which are dependent upon action by the FDA prior to this inventory being available for commercial sale, all costs related to the production of BIVIGAM and ASCENIV during the three months ended March 31, 2019 and 2018 in the amount of $0.6 million and $3.7 million, respectively, have been charged to cost of product revenue in the accompanying consolidated statements of operations. |
Goodwill | Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill at March 31, 2019 and December 31, 2018 was $3.5 million. All of the Company’s goodwill is attributable to its ADMA BioManufacturing business segment. 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, and the Company did not record any impairment charges related to goodwill for the three months ended March 31, 2019 and 2018. |
Impairment of long-lived assets | The Company assesses the recoverability of its long-lived assets, which include property and equipment and definite-lived intangible assets, whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s carrying value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the three months ended March 31, 2019 and 2018, the Company determined that there was no impairment of its long-lived assets. |
Revenue recognition | Revenues for the three months ended March 31, 2019 and 2018 are comprised of (i) revenues from the sale of Nabi-HB, (ii) product revenues from the sale of human plasma collected from the Company’s Plasma Collection Centers business segment; and (iii) license and other revenues primarily attributable to the out-licensing of ASCENIV to Biotest 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 recognized over the term of the Biotest license. Deferred revenue is amortized into income for a period of approximately 22 years, the term of the Biotest license agreement. 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 Nabi-HB 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 the Company believes that such estimates are reasonable. For revenues associated with contract manufacturing, control transfers to the customer and the performance obligation is satisfied when the customer takes possession of the product from the Boca Facility. Product revenues from the sale of human plasma collected at the Company’s plasma collection centers are recognized at the time control of the product has been transferred to the customer, which generally occurs at the time of shipment. Product revenues are recognized at the time of delivery if the Company retains control of the product during shipment. For the three months ended March 31, 2019, two customers represented an aggregate of 81% of the Company’s consolidated revenues. For the three months ended March 31, 2018, sales to BPC represented 58% of the Company’s consolidated revenues, and two other customers represented 32% of the Company’s consolidated revenues. |
Cost of product revenue | Cost of product revenue includes expenses related to process development as well as 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. Expenses associated with remediating the issues identified in the Warning Letter for the three months ended March 31, 2019 and 2018 were approximately $0.1 million and $0.7 million, respectively, and are reflected in cost of product revenue in the accompanying consolidated statements of operations. I |
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 as the Company reported a net loss for all periods presented. For the three months ended March 31, 2019 and 2018, the following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive effects: For the Three Months Ended March 31, 2019 2018 Stock options 5,599,435 4,127,950 Warrants 1,888,160 528,160 7,487,595 4,656,110 |
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 statements of operations as compensation expense based on their fair values at the date of grant. The Company uses the Black-Scholes option pricing model to determine the fair value of options granted. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated vesting period of the award, which is generally four years (see Note 7). Stock options granted under the Company’s equity incentive plans generally have a term of 10 years. |
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 2015 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 fifty percent likely of being realized upon ultimate settlement. Derecognition of a tax benefit previously recognized could result in the Company recording a tax liability that would reduce net assets. Based on its analysis, the Company has determined that it has not incurred any liability for unrecognized tax benefits as of March 31, 2019 and December 31, 2018, and during the three months ended March 31, 2019 and 2018, the Company recognized no adjustments for uncertain tax positions. |
Recent Accounting Pronouncements | In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) |
2. SUMMARY OF SIGNIFICANT ACC_3
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of dilutive securities | For the Three Months Ended March 31, 2019 2018 Stock options 5,599,435 4,127,950 Warrants 1,888,160 528,160 7,487,595 4,656,110 |
3. INVENTORIES (Tables)
3. INVENTORIES (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | March 31, December 31, Raw materials $ 13,799,170 $ 14,019,668 Work-in-progress 870,264 — Finished goods 3,770,478 4,596,501 Total inventories $ 18,439,912 $ 18,616,169 |
4. INTANGIBLE ASSETS (Tables)
4. INTANGIBLE ASSETS (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of intangible assets | March 31, 2019 December 31, 2018 Accumulated Accumulated Cost Amortization Net Cost Amortization Net Trademark and other intangible rights related to Nabi-HB $ 4,100,046 $ 1,073,821 $ 3,026,225 $ 4,100,046 $ 927,391 $ 3,172,655 Rights to intermediates 907,421 237,659 669,762 907,421 205,250 702,171 Customer contract 1,076,557 979,367 97,190 1,076,557 946,971 129,586 $ 6,084,024 $ 2,290,847 $ 3,793,177 $ 6,084,024 $ 2,079,612 $ 4,004,412 |
Intangible asset future aggregate amortization expense | Remainder of 2019 $ 633,704 2020 715,352 2021 715,352 2022 715,352 2023 715,352 |
5. PROPERTY AND EQUIPMENT (Tabl
5. PROPERTY AND EQUIPMENT (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | March 31, 2019 December 31, 2018 Manufacturing and laboratory equipment $ 8,366,402 $ 8,233,203 Office equipment and computer software 1,571,178 1,608,994 Furniture and fixtures 1,212,045 1,163,552 Construction in process 911,744 845,538 Leasehold improvements 1,673,084 1,660,709 Land 4,339,441 4,339,441 Buildings and building improvements 15,700,092 15,685,325 33,773,986 33,536,762 Less: Accumulated depreciation (4,079,222 ) (3,421,032 ) Total property and equipment, net $ 29,694,764 $ 30,115,730 |
6. DEBT (Tables)
6. DEBT (Tables) - Oxford Loan | 3 Months Ended |
Mar. 31, 2019 | |
Summary of notes payable | March 31, 2019 December 31, 2018 Notes payable: $ 45,000,000 $ 30,000,000 Less: Debt discount (4,114,897 ) (3,559,170 ) Senior notes payable $ 40,885,103 $ 26,440,830 |
Summary of related party notes payable | March 31, 2019 December 31, 2018 Related party note payable to Biotest $ 15,000,000 $ 15,000,000 Less: Debt discount (117,663 ) (125,816 ) Note payable - related party $ 14,882,337 $ 14,874,184 |
7. STOCKHOLDERS' EQUITY (Tables
7. STOCKHOLDERS' EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
STOCKHOLDERS' EQUITY | |
Schedule of assumptions | Three Months Ended March 31, 2019 2018 Expected term 5.8 - 6.3 years 6.3 years Volatility 61 % 57 % Dividend yield 0.0 0.0 Risk-free interest rate 2.25-2.63% 2.59 % |
Schedule of stock option activity | Shares Weighted Average Exercise Price Balance at December 31, 2018 4,342,231 $ 5.16 Forfeited (74,906 ) $ 4.61 Expired (3,740 ) $ 4.75 Granted 1,335,850 $ 3.42 Exercised — $ — Balance at March 31, 2019 5,599,435 $ 4.75 Options exercisable 2,588,091 $ 5.93 |
Stock-based compensation expense | 2019 2018 Research and development $ 86,523 $ 78,305 Plasma centers 11,540 7,086 Selling, general and administrative 498,471 394,858 Cost of product revenue 40,729 34,535 Total stock-based compensation expense $ 637,263 $ 514,784 |
8. RELATED PARTY TRANSACTIONS (
8. RELATED PARTY TRANSACTIONS (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Related Party Transactions [Abstract] | |
Schedule of related party transactions | Three Months Ended March 31, 2019 2018 Sale and purchase of plasma Product revenue $ — $ 2,328,291 Purchases 160,489 195,018 License revenue 35,708 35,708 Interest expense 225,000 225,000 March 31, December 31, 2019 2018 Accounts receivable $ — $ 961,145 Accounts payable 296,362 2,010,774 Accrued expenses 24,049 10,659 Note payable, net of discount 14,882,337 14,874,184 Accrued interest 290,000 65,000 Deferred revenue 2,511,491 2,547,199 |
10. SEGMENTS (Tables)
10. SEGMENTS (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Summarized segment financial information | Three Months Ended March 31, 2019 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 1,343,983 $ 2,148,898 $ 35,708 $ 3,528,589 Cost of product revenue 7,940,346 1,464,833 — 9,405,179 (Loss) income from operations (10,620,807 ) 29,579 (2,617,188 ) (13,208,416 ) Interest and other (expense) income, net (169,613 ) 13,620 (1,268,472 ) (1,424,465 ) Gain on transfer of plasma center assets — 11,527,421 — 11,527,421 Loss on extinguishment of debt — — (9,962,495 ) (9,962,495 ) Net (loss) income (10,790,420 ) 11,570,620 (13,848,155 ) (13,067,955 ) Capital expenditures 110,453 — — 110,453 Depreciation and amortization expense 687,393 114,241 3,696 805,330 Total assets 57,529,070 4,038,367 16,552,533 78,119,970 Three Months Ended March 31, 2018 ADMA BioManufacturing Plasma Collection Centers Corporate Consolidated Revenues $ 1,666,243 $ 2,340,055 $ 35,708 $ 4,042,006 Cost of product revenue 10,697,642 1,545,106 — 12,242,748 Loss from operations (12,724,718 ) (1,038,824 ) (2,768,961 ) (16,532,503 ) Interest and other expense, net (240,054 ) (435 ) (1,049,150 ) (1,289,639 ) Net loss (12,964,772 ) (1,039,259 ) (3,818,111 ) (17,822,142 ) Total assets 47,481,781 27,532,613 16,123,231 91,137,625 Depreciation and amortization expense 631,832 188,914 8,795 829,541 Capital expenditures 105,199 444,047 — 549,246 |
12. LEASE OBLIGATIONS (Tables)
12. LEASE OBLIGATIONS (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Schedule of future minimum lease payments | Remainder of 2019 $ 303,686 Year ended December 31, 2020 400,837 2021 378,932 2022 379,969 2023 360,197 Thereafter 606,913 Total payments 2,430,534 Less: imputed interest (759,576 ) Balance at March 31, 2019 $ 1,670,958 |
13. SUPPLEMENTAL DISCLOSURE O_2
13. SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Supplemental Cash Flow Information [Abstract] | |
Schedule of supplemental cash flow information | 2019 2018 SUPPLEMENTAL CASH FLOW INFORMATION: Cash paid for interest $ 1,369,939 $ 825,513 Noncash Financing and Investing Activities: Equipment acquired reflected in accounts payable and accrued liabilities $ 35,823 $ 116,766 Warrants issued in connection with notes payable $ 2,699,208 $ — |
1. ORGANIZATION AND BUSINESS (D
1. ORGANIZATION AND BUSINESS (Details Narrative) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents | $ 16,534,278 | $ 22,754,852 |
Accumulated deficit | $ (229,505,193) | $ (216,437,238) |
2. SUMMARY OF SIGNIFICANT ACC_4
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Potentially dilutive securities | 7,487,595 | 4,656,110 |
Stock Options | ||
Potentially dilutive securities | 559,435 | 4,127,950 |
Warrants | ||
Potentially dilutive securities | 1,888,160 | 528,160 |
2. SUMMARY OF SIGNIFICANT ACC_5
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||
Goodwill | $ 3,529,509 | $ 3,529,509 |
3. INVENTORIES (Details)
3. INVENTORIES (Details) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 13,799,170 | $ 14,019,668 |
Work-in-progress | 870,264 | 0 |
Finished goods | 3,770,478 | 4,596,501 |
Total inventories | $ 18,439,912 | $ 18,616,169 |
4. INTANGIBLE ASSETS (Details)
4. INTANGIBLE ASSETS (Details) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Cost | $ 6,084,024 | $ 6,084,024 |
Accumulated Amortization | 2,290,847 | 2,079,612 |
Net | 3,793,177 | 4,004,412 |
Trademark and other intangible rights related to Nabi-HB | ||
Cost | 4,100,046 | 4,100,046 |
Accumulated Amortization | 1,073,821 | 927,391 |
Net | 3,026,225 | 3,172,655 |
Right to intermediates | ||
Cost | 907,421 | 907,421 |
Accumulated Amortization | 237,659 | 205,250 |
Net | 669,762 | 702,171 |
Customer contract | ||
Cost | 1,076,557 | 1,076,557 |
Accumulated Amortization | 979,367 | 946,971 |
Net | $ 97,190 | $ 129,586 |
4. INTANGIBLE ASSETS (Details 1
4. INTANGIBLE ASSETS (Details 1) | Mar. 31, 2019USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Remainder of 2019 | $ 633,704 |
2020 | 715,352 |
2021 | 715,352 |
2022 | 715,352 |
2023 | $ 715,352 |
5. PROPERTY AND EQUIPMENT (Deta
5. PROPERTY AND EQUIPMENT (Details) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Property, plant and equipment, gross | $ 33,773,986 | $ 33,536,762 |
Less: accumulated depreciation and amortization | (4,079,222) | (3,421,032) |
Property, plant and equipment, net | 29,694,764 | 30,115,730 |
Manufacturing and laboratory equipment | ||
Property, plant and equipment, gross | 8,366,402 | 8,233,203 |
Office equipment and computer software | ||
Property, plant and equipment, gross | 1,571,178 | 1,608,994 |
Furniture and fixtures | ||
Property, plant and equipment, gross | 1,212,045 | 1,163,552 |
Construction in process | ||
Property, plant and equipment, gross | 911,744 | 845,538 |
Leasehold improvements | ||
Property, plant and equipment, gross | 1,673,084 | 1,660,709 |
Land | ||
Property, plant and equipment, gross | 4,339,441 | 4,339,441 |
Buildings | ||
Property, plant and equipment, gross | $ 15,700,092 | $ 15,685,325 |
5. PROPERTY AND EQUIPMENT (De_2
5. PROPERTY AND EQUIPMENT (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 600,000 | $ 600,000 |
6. DEBT (Details)
6. DEBT (Details) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Debt Disclosure [Abstract] | ||
Notes payable | $ 45,000,000 | $ 30,000,000 |
Less: | ||
Debt discount | (4,114,897) | (3,559,170) |
Senior notes payable | $ 40,885,103 | $ 26,440,830 |
6. DEBT (Details 1)
6. DEBT (Details 1) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Debt Disclosure [Abstract] | ||
Related party note payable to Biotest | $ 15,000,000 | $ 15,000,000 |
Less: | ||
Debt discount | (117,663) | (125,816) |
Note payable - related party | $ 14,882,337 | $ 14,874,184 |
7. STOCKHOLDERS' EQUITY (Detail
7. STOCKHOLDERS' EQUITY (Details) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
STOCKHOLDERS' EQUITY | ||
Expected term | 6 years 3 months 18 days | |
Expected term, minimum | 5 years 9 months 18 days | |
Expected term, maximum | 6 years 3 months 18 days | |
Volatility | 61.00% | 61.00% |
Dividend yield | 0.00% | 0.00% |
Risk-free interest rate | 2.59% | |
Risk-free interest rate, minimum | 2.25% | |
Risk-free interest rate, maximum | 2.63% |
7. STOCKHOLDERS' EQUITY (Deta_2
7. STOCKHOLDERS' EQUITY (Details 1) | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Shares | |
Outstanding at beginning of period | shares | 4,342,231 |
Forfeited | shares | (4,906) |
Expired | shares | (3,740) |
Granted | shares | 1,335,850 |
Exercised | shares | 0 |
Outstanding at end of period | shares | 5,599,435 |
Options exercisable | shares | 2,588,091 |
Weighted Average Exercise Price | |
Outstanding at beginning of period | $ / shares | $ 5.16 |
Forfeited | $ / shares | 4.61 |
Expired | $ / shares | 4.75 |
Granted | $ / shares | 3.42 |
Exercised | $ / shares | .00 |
Outstanding at end of period | $ / shares | 4.75 |
Options exercisable | $ / shares | $ 5.93 |
7. STOCKHOLDERS' EQUITY (Deta_3
7. STOCKHOLDERS' EQUITY (Details 2) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Total stock-based compensation expense | $ 637,263 | $ 514,784 |
Research and development | ||
Total stock-based compensation expense | 86,523 | 78,305 |
Plasma centers | ||
Total stock-based compensation expense | 11,540 | 7,086 |
Selling, general and administrative | ||
Total stock-based compensation expense | 498,471 | 394,858 |
Cost of goods sold | ||
Total stock-based compensation expense | $ 40,729 | $ 34,535 |
7. STOCKHOLDERS' EQUITY (Deta_4
7. STOCKHOLDERS' EQUITY (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | |
STOCKHOLDERS' EQUITY | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 75,000,000 | 75,000,000 |
Common stock, issued | 46,353,068 | 46,353,068 |
Common stock, outstanding | 46,353,068 | 46,353,068 |
Unrecognized compensation expense | $ 6,200,000 | |
Unrecognized compensation expense recognition period | 2 years 9 months 18 days |
8. RELATED PARTY TRANSACTIONS_2
8. RELATED PARTY TRANSACTIONS (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Sale and purchase of plasma | |||
Product revenue | $ 0 | $ 2,328,291 | |
Purchases | 160,489 | 195,018 | |
License revenue | 35,708 | 35,708 | |
Interest expense | 225,000 | $ 225,000 | |
Accounts receivable | 0 | $ 961,145 | |
Prepaid expenses and other current assets | 0 | 0 | |
Accounts payable | 296,362 | 2,010,774 | |
Accrued expenses | 24,049 | 10,659 | |
Note payable, net of discount | 14,882,337 | 14,874,184 | |
Accrued interest | 290,000 | 65,000 | |
Deferred revenue | $ 2,511,491 | $ 2,547,199 |
10. SEGMENTS (Details)
10. SEGMENTS (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Revenues | $ 3,528,589 | $ 4,042,006 | |
Cost of product revenue | 9,405,179 | 12,242,748 | |
(Loss) income from operations | (13,208,416) | (16,532,503) | |
Interest and other (expense) income, net | (1,424,465) | (1,289,639) | |
Gain on transfer of plasma center assets | 11,527,421 | 0 | |
Loss on extinguishment of debt | (9,962,495) | 0 | |
Net (loss) income | (13,067,955) | (17,822,142) | |
Purchase of property and equipment | 110,453 | 549,246 | |
Depreciation and amortization expense | 805,330 | 829,541 | |
Total assets | 78,119,970 | 91,137,625 | $ 88,876,521 |
ADMA BioManufacturing | |||
Revenues | 1,343,983 | 1,666,243 | |
Cost of product revenue | 7,940,346 | 10,697,642 | |
(Loss) income from operations | (10,620,807) | (12,724,718) | |
Interest and other (expense) income, net | (169,613) | (240,054) | |
Gain on transfer of plasma center assets | 0 | ||
Loss on extinguishment of debt | 0 | ||
Net (loss) income | (10,790,420) | (12,964,772) | |
Purchase of property and equipment | 110,453 | 105,199 | |
Depreciation and amortization expense | 687,393 | 631,832 | |
Total assets | 57,529,070 | 47,481,781 | |
Plasma Collection Centers | |||
Revenues | 2,148,898 | 2,340,055 | |
Cost of product revenue | 1,464,833 | 1,545,106 | |
(Loss) income from operations | 29,579 | (1,038,824) | |
Interest and other (expense) income, net | 13,620 | (435) | |
Gain on transfer of plasma center assets | 11,527,421 | ||
Loss on extinguishment of debt | 0 | ||
Net (loss) income | 11,570,620 | (1,039,259) | |
Purchase of property and equipment | 0 | 444,047 | |
Depreciation and amortization expense | 114,241 | 188,914 | |
Total assets | 4,038,367 | 27,532,613 | |
Corporate | |||
Revenues | 35,708 | 35,708 | |
Cost of product revenue | 0 | 0 | |
(Loss) income from operations | (2,617,188) | (2,768,961) | |
Interest and other (expense) income, net | (1,268,472) | (1,049,150) | |
Gain on transfer of plasma center assets | 0 | ||
Loss on extinguishment of debt | (9,962,495) | ||
Net (loss) income | (13,848,155) | (3,818,111) | |
Purchase of property and equipment | 0 | 0 | |
Depreciation and amortization expense | 3,696 | 8,795 | |
Total assets | $ 16,552,533 | $ 16,123,231 |
12. LEASE OBLIGATIONS (Details)
12. LEASE OBLIGATIONS (Details) | Mar. 31, 2019USD ($) |
Leases [Abstract] | |
Remainder of 2019 | $ 303,686 |
2020 | 400,837 |
2021 | 378,932 |
2022 | 379,969 |
2023 | 360,197 |
Thereafter | 606,913 |
Total payments | 2,430,534 |
Less: imputed interest | (759,576) |
Total | $ 1,670,958 |
13. SUPPLEMENTAL DISCLOSURE O_3
13. SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
SUPPLEMENTAL INFORMATION: | ||
Cash paid for interest | $ 1,369,939 | $ 825,513 |
Noncash Financing and Inesting Activities: | ||
Equipment acquired reflected in accounts payable and accrued liabilities | 35,823 | 116,766 |
Warrants issued in connection with note payable | $ 2,699,208 | $ 0 |