Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 26, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | OPGEN INC | ||
Entity Central Index Key | 0001293818 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Public Float | $ 35,998,374 | ||
Entity Common Stock, Shares Outstanding | 38,266,482 | ||
Entity Interactive Data Current | Yes | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 06-1614015 | ||
Entity File Number | 001-37367 | ||
Entity Address, Address Line One | 708 Quince Orchard Road | ||
Entity Address, City or Town | Gaithersburg | ||
Entity Address, State or Province | MD | ||
Entity Address, Postal Zip Code | 20878 | ||
City Area Code | 240 | ||
Local Phone Number | 813-1260 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | Portions of the registrant's definitive Proxy Statement to be filed with respect to its 2021 Annual Meeting of Stockholders are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein. The proxy statement will be filed with the Securities and Exchange Commission within 120 days after the registrant's fiscal year ended December 31, 2020. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 13,360,463 | $ 2,708,223 |
Accounts receivable, net | 653,104 | 567,811 |
Inventory, net | 1,485,986 | 473,030 |
Note receivable | 2,521,479 | |
Prepaid expenses and other current assets | 1,388,090 | 396,760 |
Total current assets | 16,887,643 | 6,667,303 |
Property and equipment, net | 3,259,487 | 130,759 |
Finance lease right-of-use assets, net | 449,628 | 958,590 |
Operating lease right-of-use assets | 2,082,300 | 1,043,537 |
Goodwill | 8,024,729 | 600,814 |
Intangible assets, net | 16,580,963 | 817,550 |
Strategic inventory | 1,686,342 | |
Other noncurrent assets | 779,953 | 203,271 |
Total assets | 49,751,045 | 10,421,824 |
Current liabilities | ||
Accounts payable | 1,868,666 | 1,056,035 |
Accrued compensation and benefits | 2,126,511 | 855,994 |
Accrued liabilities | 1,437,141 | 1,046,661 |
Deferred revenue | 9,808 | 9,808 |
Short-term notes payable | 699,000 | 373,599 |
Short-term finance lease liabilities | 266,470 | 579,030 |
Short-term operating lease liabilities | 964,434 | 1,017,414 |
Total current liabilities | 7,372,030 | 4,938,541 |
Note payable | 19,378,935 | 329,456 |
Derivative liabilities | 112,852 | |
Long-term finance lease liabilities | 46,794 | 313,263 |
Long-term operating lease liabilities | 1,492,544 | 547,225 |
Other long-term liabilities | 156,635 | |
Total liabilities | 28,559,790 | 6,128,485 |
Commitments and Contingencies (Note 10) | ||
Stockholders' equity | ||
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at December 31, 2020 and 2019, respectively | ||
Common stock, $0.01 par value; 50,000,000 shares authorized; 25,085,534 and 5,582,280 shares issued and outstanding at December 31, 2020 and 2019, respectively | 250,855 | 55,823 |
Additional paid-in capital | 219,129,045 | 178,779,814 |
Accumulated deficit | (200,735,827) | (174,524,983) |
Accumulated other comprehensive income (loss) | 2,547,182 | (17,315) |
Total stockholders' equity | 21,191,255 | 4,293,339 |
Total liabilities and stockholders' equity | $ 49,751,045 | $ 10,421,824 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 25,085,534 | 5,582,280 |
Common stock, shares outstanding | 25,085,534 | 5,582,280 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue | ||
Total revenue | $ 4,214,441 | $ 3,498,614 |
Operating expenses | ||
Research and development, net | 9,964,720 | 5,121,168 |
General and administrative | 8,801,661 | 6,252,442 |
Sales and marketing | 3,094,092 | 1,464,721 |
Transaction costs | 471,522 | 779,048 |
Impairment of right-of-use asset | 101,838 | 520,759 |
Impairment of intangible assets | 750,596 | |
Gain on sale of equipment | (100,000) | |
Total operating expenses | 26,932,920 | 15,769,859 |
Operating loss | (22,718,479) | (12,271,245) |
Other (expense) income | ||
Gain on extinguishment of debt | 884,970 | |
Interest and other income, net | 105,627 | 9,859 |
Interest expense | (3,399,384) | (187,549) |
Foreign currency transaction (losses)/gains | (1,468,855) | 2,410 |
Change in fair value of derivative financial instruments | 517,680 | 67 |
Total other expense | (3,359,962) | (175,213) |
Loss before income taxes | (26,078,441) | (12,446,458) |
Provision for income taxes | 132,403 | |
Net loss | $ (26,210,844) | $ (12,446,458) |
Net loss per common share - basic and diluted | $ (1.66) | $ (7.70) |
Weighted average shares outstanding - basic and diluted | 15,800,781 | 1,616,939 |
Net loss | $ (26,210,844) | $ (12,446,458) |
Other comprehensive income (loss) - foreign currency translation | 2,564,497 | (4,222) |
Comprehensive loss | (23,646,347) | (12,450,680) |
Product sales [Member] | ||
Revenue | ||
Total revenue | 2,704,364 | 2,168,179 |
Operating expenses | ||
Cost of products and services | 3,360,280 | 911,565 |
Laboratory services [Member] | ||
Revenue | ||
Total revenue | 167,736 | 5,435 |
Operating expenses | ||
Cost of products and services | 488,211 | 720,156 |
Collaborations Revenue [Member] | ||
Revenue | ||
Total revenue | $ 1,342,341 | $ 1,325,000 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Common Stock [Member] | Preferred Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2018 | $ 4,323 | $ 165,396,036 | $ (13,093) | $ (162,078,525) | $ 3,308,741 | |
Balance (in shares) at Dec. 31, 2018 | 432,286 | |||||
Offering of common stock and warrants, net of issuance costs | $ 51,500 | 13,010,908 | 13,062,408 | |||
Offering of common stock and warrants, net of issuance costs (in shares) | 5,150,000 | |||||
Issuance of RSUs | ||||||
Issuance of RSUs (in shares) | 12 | |||||
Stock compensation expense | 372,870 | 372,870 | ||||
Shares issued in business combination | ||||||
Stock cancellation | ||||||
Stock cancellation (in shares) | (18) | |||||
Foreign currency translation | (4,222) | (4,222) | ||||
Net loss | (12,446,458) | (12,446,458) | ||||
Balance at Dec. 31, 2019 | $ 55,823 | 178,779,814 | (17,315) | (174,524,983) | 4,293,339 | |
Balance (in shares) at Dec. 31, 2019 | 5,582,280 | |||||
Offering of common stock and warrants, net of issuance costs | $ 48,426 | 9,240,703 | 9,289,129 | |||
Offering of common stock and warrants, net of issuance costs (in shares) | 4,842,615 | |||||
At the market offering, net of offering costs | $ 75,216 | 15,746,706 | 15,821,922 | |||
At the market offering, net of offering costs (in shares) | 7,521,610 | |||||
Warrant exercises | $ 43,410 | 8,638,590 | 8,682,000 | |||
Warrant exercises (in shares) | 4,341,000 | |||||
Issuance of RSUs | $ 59 | (59) | ||||
Issuance of RSUs (in shares) | 5,916 | |||||
Stock compensation expense | 316,086 | 316,086 | ||||
Shares issued to settle convertible notes | $ 7,639 | 1,443,158 | 1,450,797 | |||
Shares issued to settle convertible notes (in shares) | 763,905 | |||||
Shares issued in business combination | $ 20,282 | 4,827,135 | 4,847,417 | |||
Shares issued in business combination (in shares) | 2,028,208 | |||||
Value of equity awards assumed in business combination | 136,912 | 136,912 | ||||
Foreign currency translation | 2,564,497 | 2,564,497 | ||||
Net loss | (26,210,844) | (26,210,844) | ||||
Balance at Dec. 31, 2020 | $ 250,855 | $ 219,129,045 | $ 2,547,182 | $ (200,735,827) | $ 21,191,255 | |
Balance (in shares) at Dec. 31, 2020 | 25,085,534 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (26,210,844) | $ (12,446,458) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 2,334,739 | 921,379 |
Noncash interest expense | 2,632,241 | 13,158 |
Noncash interest income | (87,233) | (21,479) |
Stock compensation expense | 316,086 | 372,870 |
(Gain) loss on sale of equipment | (100,000) | 9,904 |
Gain on extinguishment of debt | (884,970) | |
Change in fair value of warrant liability | (517,680) | (67) |
Impairment of right-of-use asset | 101,838 | 520,759 |
Impairment of intangible assets | 750,596 | |
Changes in operating assets and liabilities, net of acquisition | ||
Accounts receivable | 438,284 | (195,019) |
Inventory | (410,341) | 70,286 |
Other assets | 1,152,200 | 577,193 |
Accounts payable | (481,453) | (503,516) |
Accrued compensation and other liabilities | (1,559,881) | (818,433) |
Deferred revenue | (870,114) | (6,016) |
Net cash used in operating activities | (23,396,532) | (11,505,439) |
Cash flows from investing activities | ||
Acquisition of business net of cash acquired | 1,266,849 | |
Note receivable | (2,200,000) | (2,500,000) |
Purchases of property and equipment | (130,354) | (31,826) |
Proceeds from sale of equipment | 29,250 | |
Net cash used in investing activities | (1,063,505) | (2,502,576) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 15,821,922 | 4,782,509 |
Proceeds from issuance of units and exercises of pre-funded warrants, net of selling costs | 8,279,899 | |
Proceeds from issuance of common stock and pre-funded warrants in private placement, net of selling costs | 9,289,129 | |
Proceeds from the exercise of common warrants | 8,682,000 | |
Proceeds from debt, net of issuance costs | 1,871,308 | 470,519 |
Payments on debt | (998,182) | (828,850) |
Payments on finance lease obligations | (579,029) | (535,931) |
Net cash provided by financing activities | 34,087,148 | 12,168,146 |
Effects of exchange rates on cash | 1,586,541 | (3,735) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 11,213,652 | (1,843,604) |
Cash, cash equivalents and restricted cash at beginning of year | 2,893,603 | 4,737,207 |
Cash, cash equivalents and restricted cash at end of year | 14,107,255 | 2,893,603 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 952,050 | 187,359 |
Supplemental disclosures of noncash investing and financing activities | ||
Right-of-use assets acquired through operating leases | 1,008,039 | |
Right-of-use assets acquired through finance leases | 528,413 | |
Conversion of accounts payable to finance lease | 63,600 | |
Shares issued in business combination | 4,847,417 | |
Shares issued to settle convertible notes | 1,450,797 | |
Note receivable from sale of equipment included in other assets | $ 100,000 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Note 1 - Organization OpGen, Inc. (“OpGen” or the “Company”) was incorporated in Delaware in 2001. On April 1, 2020, OpGen completed its business combination transaction (the “Transaction”) with Curetis N.V., a public company with limited liability under the laws of the Netherlands (the “Seller” or “Curetis N.V.”), as contemplated by the Implementation Agreement, dated as of September 4, 2019 (the “Implementation Agreement”), by and among the Company, the Seller, and Crystal GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany and wholly-owned subsidiary of the Company (“Purchaser”). Pursuant to the Implementation Agreement, the Purchaser acquired all of the shares of Curetis GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany (“Curetis GmbH”), and certain other assets and liabilities of the Seller (together, “Curetis”) (see Note 4). References in this report to the “Company” include OpGen and its wholly-owned subsidiaries. The Company’s headquarters are in Gaithersburg, Maryland, and its principal operations are in Gaithersburg, Maryland; Holzgerlingen and Bodelshausen, Germany; and Vienna, Austria. The Company operates in one business segment. OpGen Overview OpGen is a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. The Company is developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s current product portfolio includes Unyvero, QuickFISH, PNA FISH, Acuitas AMR Gene Panel and Acuitas Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction as well as the Curetis CE-IVD-marked SARS CoV-2 test kit. On October 13, 2020, the Company announced its decision to discontinue the QuickFISH and PNA FISH product portfolio in its entirety by June 30, 2021 and certain licensing agreements with Life Technologies, a subsidiary of ThermoFisher, have therefore been terminated accordingly as of such date (see note 10). The Company's FISH customers and distribution partners have been informed accordingly and last orders have been received and processed during the last few months. The discontinuance of these product lines did not qualify for discontinued operations reporting. The focus of OpGen is on its combined broad portfolio of products, which include high impact rapid diagnostics and bioinformatics to interpret AMR genetic data. OpGen will continue to develop and seek FDA and other regulatory clearances or approvals, as applicable, for the Acuitas AMR Gene Panel (Isolates) diagnostic test, Unyvero UTI and IJI products. OpGen will continue to offer the FDA-cleared Unyvero LRT and LRT BAL Panels, as well as Unyvero UTI Panel and Acuitas AMR Gene Panel (Isolates) and Acuitas Lighthouse Software as RUO products to hospitals, public health departments, clinical laboratories, pharmaceutical companies and contract research organizations, or CROs. |
Going Concern and Management's
Going Concern and Management's Plans | 12 Months Ended |
Dec. 31, 2020 | |
Liquidation Basis Of Accounting Abstract [Abstract] | |
Going Concern and Management's Plans | Note 2 - Going Concern and Management’s Plans The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since inception, the Company has incurred, and continues to incur, significant losses from operations. The Company has funded its operations primarily through external investor financing arrangements and significant actions taken by the Company, including the following: · On November 23, 2020, the Company entered into a Purchase Agreement with an institutional investor (the “Holder”), pursuant to which the Company issued to the Investor, securities of the Company, including warrants (the “Existing Warrants”) to purchase up to 4,842,615 shares of Common Stock, of the Company (the “Warrant Shares”). The Existing Warrants were exercisable six months after their issuance at an exercise price of $1.94 per share and expire on the fifth and a half year anniversary of the date of issuance. On March 9, 2021, the Company entered into a Warrant Exercise Agreement (the “Exercise Agreement”) with the Holder. Pursuant to the Exercise Agreement, in order to induce the Holder to exercise all of the remaining 4,842,615 outstanding Existing Warrants for cash, pursuant to the terms of and subject to beneficial ownership limitations contained in the Existing Warrants, the Company agreed to issue to the Holder, new warrants (the “New Warrants”) to purchase 0.65 shares of Common Stock for each share of Common Stock issued upon such exercise of the remaining 4,842,615 outstanding Existing Warrants pursuant to the Exercise Agreement or an aggregate of 3,147,700 New Warrants. The terms of the New Warrants will be substantially similar to those of the Existing Warrants, except that the New Warrants will have an exercise price of $3.56. The New Warrants will be immediately exercisable and will expire five years from the date of the Exercise Agreement. The Holder will pay an aggregate of $255,751 to the Company for the purchase of the New Warrants. The Company received aggregate gross proceeds before expenses of approximately $9.65 million from the exercise of all of the remaining 4,842,615 outstanding Existing Warrants held by the Holder and the payment of the purchase price for the New Warrants (together, the “2021 Warrant Exercise”). · On February 11, 2021, the Company closed a private placement (the "February 2021 Offering”) with a single U.S.-based, healthcare-focused institutional investor for the purchase of (i) 2,784,184 shares of common stock and (ii) 5,549,149 pre-funded warrants, with each pre-funded warrant exercisable for one share of common stock. The Company also issued to the investor, in a concurrent private placement, unregistered common share purchase warrants to purchase 4,166,666 shares of the Company’s common stock. Each share of common stock and accompanying common warrant were sold together at a combined offering price of $3.00, and each pre-funded warrant and accompanying common warrant were sold together at a combined offering price of $2.99. The pre-funded warrants are immediately exercisable, at an exercise price of $0.01, and may be exercised at any time until all of the pre-funded warrants are exercised in full. The common warrants will have an exercise price of $3.55 per share, will be exercisable commencing on the six-month anniversary of the date of issuance, and will expire five and one half (5.5) years from the date of issuance. The February 2021 Offering raised aggregate net proceeds of $23.4 million, and gross proceeds of $25.0 million. · On November 25, 2020, the Company closed a private placement (the “2020 PIPE”) with one healthcare-focused U.S. institutional investor for the purchase of (i) 2,245,400 shares of common stock (ii) 4,842,615 warrants to purchase shares of common stock and (iii) 2,597,215 pre-funded warrants, with each pre-funded warrant exercisable for one share of common stock. Each share of common stock and accompanying common warrant were sold together at a combined offering price of $2.065, and each pre-funded warrant and accompanying common warrant were sold together at a combined offering price of $2.055. The common warrants have an exercise price of $1.94 per share, and are exercisable commencing on the six month anniversary of the date of issuance, and will expire five and one half (5.5) years from the date of issuance. The 2020 PIPE raised aggregate net proceeds of $9.3 million, and gross proceeds of $10.0 million. As of December 31, 2020, all 2,597,215 pre-funded warrants issued in the 2020 PIPE have been exercised. · On February 11, 2020, the Company entered into an At the Market Common Offering (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), which we amended and restated on November 13, 2020 to add BTIG, LLC (“BTIG”), pursuant to which the Company may offer and sell from time to time in an “at the market offering”, at its option, up to an aggregate of $22.1 million of shares of the Company's common stock through the sales agents, (the “2020 ATM Offering”). During the year ended December 31, 2020, the Company sold 7,521,610 shares of its common stock under the 2020 ATM Offering resulting in aggregate net proceeds to the Company of approximately $15.8 million, and gross proceeds of $16.7 million. · On October 28, 2019, the Company closed a public offering (the “October 2019 Public Offering”) of 2,590,170 units at $2.00 per unit and 2,109,830 pre-funded units at $1.99 per pre-funded unit, raising gross proceeds of approximately $9.4 million and net proceeds of approximately $8.3 million. Each unit included one share of common stock and one common warrant to purchase one share of common stock at an exercise price of $2.00 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase one share of common stock at an exercise price of $2.00 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. As of December 31, 2019, all 2,109,830 pre-funded warrants issued in the October 2019 Public Offering had been exercised. During the year ended December 31, 2020, 4,341,000 common warrants issued in the October 2019 Public Offering were exercised for net proceeds of approximately $8.7 million. As of December 31, 2020, 359,000 common warrants issued in the October 2019 Public Offering remain outstanding. · On March 29, 2019, the Company closed a public offering (the “March 2019 Public Offering”) of 450,000 shares of its common stock at a public offering price of $12.00 per share. The offering raised gross proceeds of $5.4 million and net proceeds of approximately $4.8 million. To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, strategic financings or other transactions, additional equity financings, debt financings and other funding transactions, licensing and/or partnering arrangements. There can be no assurance that the Company will be able to complete any such transaction on acceptable terms or otherwise. The Company believes that current cash including the net proceeds from the February 2021 Offering and 2021 Warrant Exercise will be sufficient to fund operations into the second quarter of 2022. This has led management to conclude that substantial doubt about the Company’s ability to continue as a going concern exists. In the event the Company is unable to successfully raise additional capital during or before the end of the second quarter of 2022, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated. Accordingly, in such circumstances, the Company would be compelled to immediately reduce general and administrative expenses and delay research and development projects, pause or abort clinical trials including the purchase of scientific equipment and supplies, until it is able to obtain sufficient financing. If such sufficient financing is not received on a timely basis, the Company would then need to pursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3 - Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The consolidated financial statements consolidate the operations of all controlled subsidiaries; all intercompany activity is eliminated. Foreign Currency The Company has subsidiaries located in Holzgerlingen, Germany; Vienna, Austria; and Copenhagen, Denmark, each of which use currencies other than the U.S. dollar as their functional currency. As a result, all assets and liabilities are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive income loss), a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive income (loss) at December 31, 2020 and 2019. Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts in the foreseeable future, are included in the determination of net loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar. Use of Estimates In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the 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. In the accompanying consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, stock-based compensation, allowances for doubtful accounts and inventory obsolescence, discount rates used to discount unpaid lease payments to present values, valuation of derivative financial instruments measured at fair value on a recurring basis, deferred tax assets and liabilities and related valuation allowance, determining the fair value of assets acquired and liabilities assumed in business combinations, the estimated useful lives of long-lived assets, and the recoverability of long-lived assets. Actual results could differ from those estimates. Fair value of financial instruments Financial instruments classified as current assets and liabilities (including cash and cash equivalent, receivables, accounts payable, deferred revenue and short-term notes) are carried at cost, which approximates fair value, because of the short-term maturities of those instruments. For additional fair value disclosures, see Note 6. Cash and cash equivalents and restricted cash The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limit of $250,000. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. At December 31, 2020 and 2019, the Company had funds totaling $746,792 and $185,380, respectively, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying consolidated balance sheets. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows: December 31, 2020 December 31, 2019 Cash and cash equivalents $ 13,360,463 $ 2,708,223 Restricted cash 746,792 185,380 Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows $ 14,107,255 $ 2,893,603 Accounts receivable The Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $20,753 as of December 31, 2020 and 2019, respectively. At December 31, 2020, the Company had accounts receivable from one customer which individually represented 20% of total accounts receivable. At December 31, 2019, the Company had accounts receivable from one customer which individually represented 44% of total accounts receivable. For the year ended December 31, 2020, revenue earned from one customer represented 21% of total revenues. For the year ended December 31, 2019, revenue earned from one customer represented 38% of total revenues. Inventory Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: December 31, 2020 2019 Raw materials and supplies $ 773,021 $ 315,542 Work-in-process 87,159 35,080 Finished goods 2,312,148 122,408 Total $ 3,172,328 $ 473,030 Inventory includes Unyvero instrument systems, Unyvero cartridges, reagents and components for Unyvero, Acuitas, QuickFISH and PNA FISH products, Curetis SARS CoV-2 test kits, and reagents and supplies used for the Company’s laboratory services. Inventory reserves for obsolescence and expirations were $288,378 and $92,454 at December 31, 2020 and 2019, respectively. The Company reviews inventory quantities on hand and analyzes the provision for excess and obsolete inventory based primarily on product expiration dating and its estimated sales forecast, which is based on sales history and anticipated future demand. The Company’s estimates of future product demand may not be accurate, and it may understate or overstate the provision required for excess and obsolete inventory. Accordingly, any significant unanticipated changes in demand could have a significant impact on the value of the Company’s inventory and results of operations. The Company classifies finished good inventory it does not expect to sell or use in clinical studies within 12 months of the consolidated balance sheets date as strategic inventory, a non-current asset. Long-lived assets Property and equipment Property and equipment is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets. The estimated service lives range from three to ten years. Depreciation expense was $1,152,954 and $186,244 for the years ended December 31, 2020 and 2019, respectively. Property and equipment consisted of the following at December 31, 2020 and 2019: December 31, 2020 2019 Laboratory and manufacturing equipment $ 6,317,340 $ 3,310,290 Office furniture and equipment 1,259,838 631,774 Computers and network equipment 1,692,154 1,469,534 Leasehold improvements 752,493 745,800 10,021,825 6,157,398 Less accumulated depreciation (6,762,338 ) (6,026,639 ) Property and equipment, net $ 3,259,487 $ 130,759 Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the years ended December 31, 2020 and 2019, the Company determined that its property and equipment was not impaired. Leases The Company determines if an arrangement is a lease at inception. For leases where the Company is the lessee, right-of-use (“ROU”) assets represent the Company’s right to use the underlying asset for the term of the lease and the lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the future lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date of the underlying lease arrangement to determine the present value of lease payments. The ROU asset also includes any prepaid lease payments and any lease incentives received. The lease term to calculate the ROU asset and related lease liability includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. The Company’s lease agreements generally do not contain any material variable lease payments, residual value guarantees or restrictive covenants. Lease expense for operating leases is recognized on a straight-line basis over the lease term as an operating expense while expense for financing leases is recognized as depreciation expense and interest expense using the effective interest method of recognition. The Company has made certain accounting policy elections whereby the Company (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12 months or less) and (ii) combines lease and non-lease elements of our operating leases. ROU Assets ROU assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which the Company can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. In conjunction with adoption of Accounting Standards Update (“ASU”) 2016-02, Leases Intangible assets and goodwill Intangible assets and goodwill as of December 31, 2020 consist of finite-lived and indefinite-lived intangible assets and goodwill. Finite-lived and indefinite-lived intangible assets Intangible assets include trademarks, developed technology, in-process research & development, software and customer relationships and consisted of the following as of December 31, 2020 and 2019: December 31, 2020 December 31, 2019 Subsidiary Cost Accumulated Amortization Impairment Effect of foreign exchange rates Net Balance Accumulated Amortization Net Balance Trademarks and tradenames AdvanDx $ 461,000 $ (217,413 ) $ (243,587 ) $ — $ — $ (205,887 ) $ 255,113 Developed technology AdvanDx 458,000 (308,526 ) (149,474 ) — — (292,170 ) 165,830 Customer relationships AdvanDx 1,094,000 (736,465 ) (357,535 ) — — (697,393 ) 396,607 Trademarks and tradenames Curetis 1,768,000 (147,161 ) — 194,119 1,814,958 — — Distributor relationships Curetis 2,362,000 (131,070 ) — 259,336 2,490,266 — — A50 - Developed technology Curetis 349,000 (41,504 ) — 38,319 345,815 — — Ares - Developed technology Curetis 5,333,000 (317,060 ) — 585,536 5,601,476 — — A30 - In-Process Research & Development Curetis 5,706,000 — — 622,448 6,328,448 — — $ 17,531,000 $ (1,899,199 ) $ (750,596 ) $ 1,699,758 $ 16,580,963 $ (1,195,450 ) $ 817,550 Identifiable intangible assets will be amortized on a straight-line basis over their estimated useful lives. The estimated useful lives of the intangibles are: Estimated Useful Life Trademarks and tradenames 10 years Customer/distributor relationships 15 years A50 – Developed technology 7 years Ares – Developed technology 14 years A30 – Acquired in-process research & development Indefinite Acquired IPR&D represents the fair value assigned to those research and development projects that were acquired in a business combination for which the related products have not received regulatory approval and have no alternative future use. IPR&D is capitalized at its fair value as an indefinite-lived intangible asset, and any development costs incurred after the acquisition are expensed as incurred. Upon achieving regulatory approval or commercial viability for the related product, the indefinite-lived intangible asset is accounted for as a finite-lived asset and is amortized on a straight-line basis over the estimated useful life. If the project is not completed or is terminated or abandoned, the Company may have an impairment related to the IPR&D which is charged to expense. Indefinite-lived intangible assets are tested for impairment annually and whenever events or changes in circumstances indicate that the carrying amount may be impaired. Impairment is calculated as the excess of the asset’s carrying value over its fair value. The Company reviews the useful lives of intangible assets when events or changes in circumstances occur which may potentially impact the estimated useful life of the intangible assets. Total amortization expense of intangible assets was $672,823 and $267,816 for the years ended December 31, 2020 and 2019, respectively. Expected future amortization of intangible assets is as follows: Year Ending December 31, 2021 $ 849,055 2022 849,055 2023 849,055 2024 849,055 2025 849,055 Thereafter 6,007,240 Total $ 10,252,515 Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. In accordance with ASC 360-10, Property, Plant and Equipment Goodwill Goodwill represents the excess of the purchase price paid when the Company acquired AdvanDx, Inc. in July 2015 and Curetis in April 2020, over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. The Company’s goodwill balance as of December 31, 2020 and 2019 was $ 8,024,729 The the carrying amount of as of December 31, 2020, and since December 31, 2019, were as follows: Balance as of December 31, 2019 $ 600,814 Acquisition of Curetis 6,688,652 Effect of foreign exchange rates 735,263 Balance as of December 31, 2020 $ 8,024,729 The Company conducts an impairment test of goodwill on an annual basis, and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. During the years ended December 31, 2020 and 2019, the Company determined that its goodwill was not impaired. Revenue recognition The Company derives revenues from (i) the sale of QuickFISH and PNA FISH diagnostic test products, Unyvero Application cartridges, Unyvero Systems, SARS CoV-2 tests, Acuitas AMR Gene Panel RUO test products, (ii) providing laboratory services, and (iii) providing collaboration services including funded software arrangements, and license arrangements. The Company analyzes contracts to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers, (ii) identification of distinct performance obligations in the contract, (iii) determination of contract transaction price, (iv) allocation of contract transaction price to the performance obligations and (v) determination of revenue recognition based on timing of satisfaction of the performance obligation. The Company recognizes revenues upon the satisfaction of its performance obligation (upon transfer of control of promised goods or services to our customers) in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services. The Company defers incremental costs of obtaining a customer contract and amortizes the deferred costs over the period that the goods and services are transferred to the customer. The Company had no material incremental costs to obtain customer contracts in any period presented. Deferred revenue results from amounts billed in advance to customers or cash received from customers in advance of services being provided. Government grant agreements and incentives From time to time, the Company may enter into arrangements with governmental entities for the purposes of obtaining funding for research and development activities. The Company recognizes funding from grants and research incentives received from Austrian government agencies in the consolidated statements of operations and comprehensive loss in the period during which the related qualifying expenses are incurred, provided that the conditions under which the grants or incentives were provided have been met. For grants under funding agreements and for proceeds under research incentive programs, the Company recognizes grant and incentive income in an amount equal to the estimated qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage. The Company classifies government grants received under these arrangements as a reduction to the related research and development expense incurred. The Company analyzes each arrangement on a case-by-case basis. For the year ended December 31, 2020, the Company recognized $495,153 as a reduction of research and development expense related to government grant arrangements. There were no grant proceeds recognized for the year ended December 31, 2019. As of December 31, 2020, the Company had earned but not yet received $413,530 related to these agreements and incentives included in prepaid expenses and other current assets. Research and development costs, net Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, fees paid to consultants and outside service partners. Stock-based compensation Stock-based compensation expense is recognized at fair value. The fair value of stock-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. A discussion of management’s methodology for developing each of the assumptions used in the Black-Scholes model is as follows: Fair value of common stock For periods prior to the Company’s IPO in May 2015, given the lack of an active public market for the common stock, the Company’s board of directors determined the fair value of the common stock. In the absence of a public market, and as an emerging company with no significant revenues, the Company believed that it was appropriate to consider a range of factors to determine the fair market value of the common stock at each grant date. The factors included: (1) the achievement of clinical and operational milestones by the Company; (2) the status of strategic relationships with collaborators; (3) the significant risks associated with the Company’s stage of development; (4) capital market conditions for life science and medical diagnostic companies, particularly similarly situated, privately held, early stage companies; (5) the Company’s available cash, financial condition and results of operations; (6) the most recent sales of the Company’s preferred stock; and (7) the preferential rights of the outstanding preferred stock. Since the IPO, the Company uses the quoted market price of its common stock as its fair value. Expected volatility Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Until a significant trading history for its common stock develops, the Company has identified several public entities of similar size, complexity and stage of development; accordingly, historical volatility has been calculated using the volatility of this peer group. Expected dividend yield The Company has never declared or paid dividends on its common stock and has no plans to do so in the foreseeable future. Risk-free interest rate This is the U.S. Treasury rate for the day of each option grant during the year, having a term that most closely resembles the expected term of the option. Expected term This is the period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of 10 years. The Company estimates the expected term of the option to be 6.25 years for options with a standard four-year vesting period, using the simplified method. Over time, management will track actual terms of the options and adjust their estimate accordingly so that estimates will approximate actual behavior for similar options. Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts. The Company had federal net operating loss (“NOL”) carryforwards of $ 196,511,928 188,282,298 The Company also has foreign NOL carryforwards of $160,540,528 at December 31, 2020 from their foreign subsidiaries. $138,576,755 of those foreign NOL carryforwards are from the Company’s operations in Germany. Despite the NOL carryforwards, the Company may have a current and future tax liability due to the nuances of German tax law around the use of NOL’s within a consolidated group. There is no assurance that the NOL carryforwards will ever be fully utilized. Loss per share Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 7.5 million shares and 5.1 million shares as of December 31, 2020 and 2019, respectively Adopted accounting pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) The Company adopted this guidance effective January 1, 2019 using the modified retrospective transition method and the following practical expedients: · The Company did not reassess if any expired or existing contracts are or contain leases. · The Company did not reassess the classification of any expired or existing leases. Additionally, the Company made ongoing accounting policy elections whereby the Company (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12 months or less) and (ii) combines lease and non-lease elements of our operating leases. Upon adoption of the new guidance on January 1, 2019, the Company recorded an operating lease ROU asset of approximately $2.2 million (net of existing deferred rent) and recognized a lease liability of approximately $2.5 million. Prior to the adoption of ASC 842, deferred rent was recorded and amortized to the extent the total minimum rental payments allocated to the period on a straight-line basis exceeded or were less than the cash payments required. The Company adopted Accounting Standards Update 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments Recently issued accounting standards In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes, In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Reform on Financial Reporting The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
Business Combination
Business Combination | 12 Months Ended |
Dec. 31, 2020 | |
Business Combinations [Abstract] | |
Business Combination | Note 4 – Business Combination On April 1, 2020, the Company completed its business combination transaction with Curetis N.V., a public company with limited liability under the laws of the Netherlands, as contemplated by the Implementation Agreement, dated as of September 4, 2019, by and among the Company, the Seller, and Crystal GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany and wholly-owned subsidiary of the Company. Pursuant to the Implementation Agreement, the Purchaser acquired all of the shares of Curetis GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany, and certain other assets and liabilities of the Seller, as further described below, and paid, as the sole consideration, 2,028,208 shares of the Company’s common stock, to the Seller, and reserved for future issuance (a) 134,356 shares of common stock, in connection with its assumption of the Seller’s 2016 Stock Option Plan, as amended (the “Seller Stock Option Plan”), and the outstanding awards thereunder, and (b) 500,000 shares of common stock to be issued upon the conversion, if any, of certain convertible notes issued by the Seller. At the closing, the Company assumed all of the liabilities of the Seller solely and exclusively related to the acquired business, which is providing innovative solutions, through development of proprietary platforms, diagnostic content, applied bioinformatics, lab services, research services and commercial collaborations and agreements, for molecular microbiology, diagnostics designed to address the global challenge of detecting severe infectious diseases and identifying antibiotic resistances in hospitalized patients. Pursuant to the Implementation Agreement, the Company also assumed and adopted the Seller Stock Option Plan as an Amended and Restated Stock Option Plan of the Company. In connection with the foregoing, the Company assumed all awards thereunder that were outstanding as of the closing date and converted such awards into options to purchase shares of the Company’s common stock pursuant to the terms of the applicable award. In addition, the Company assumed, at the closing, all of the outstanding convertible notes issued by the Seller in favor of YA II PN, LTD, pursuant to the Assignment of the Agreement for the Issuance of and Subscription to Notes Convertible into Shares, dated February 24, 2020, and entered into pursuant to the Implementation Agreement. Curetis’ assets and liabilities were measured and recognized at their fair values as of the transaction date and combined with the assets, liabilities and results of operations of OpGen after the consummation of the business combination. The allocation of the purchase price to acquired assets and assumed liabilities based on their underlying fair values requires the extensive use of significant estimates and management’s judgment. The allocation of the purchase price is preliminary at this time, and will remain as such until management completes valuations and other studies in order to finalize the valuation of the net assets acquired. These provisional estimates will be adjusted upon the availability of further information regarding events or circumstances which exist at the acquisition date and such adjustments may be significant. The components of the purchase price and net assets acquired are as follows: Purchase Price Number of shares issued to Curetis N.V 2,028,208 Multiplied by the market value per share of OpGen's common stock (i) $ 2.39 Total fair value of common stock issued to Curetis N.V shareholders 4,847,417 Fair value of replacement stock awards related to precombination service (ii) 136,912 Fair value of convertible notes assumed (iii) 1,323,750 Fair value of EIB debt assumed (iv) 15,784,892 Funds advanced to Curetis GmbH under Interim Facility 4,808,712 Cash, cash equivalents, and restricted cash acquired (1,266,849) $ 25,634,834 (i) The price per share of OpGen’s common stock was based on the closing price as reported on the Nasdaq Capital Market on April 1, 2020. (ii) The fair value of the stock options assumed was determined using the Black-Scholes option pricing model. (iii) To derive the fair value of the convertible notes, the Company estimated the fair value of the convertible notes with and without the derivative liability using a scenario analysis and Monte Carlo simulation. (iv) The fair value of the EIB debt is determined using a discounted cash flow analysis with current applicable rates for similar instruments. Net Assets Acquired Assets acquired Receivables $ 482,876 Inventory 2,022,577 Property and equipment 3,802,431 Right of use assets 1,090,812 Other current assets 925,364 Finite-lived intangible assets Trade names/trademarks 1,768,000 Customer/distributor relationships 2,362,000 A50 - Developed technology 349,000 Ares - Developed technology 5,333,000 Indefinite-lived intangible assets A30 - In-process research & development 5,706,000 Goodwill 6,688,652 Liabilities assumed Accounts payable (1,168,839 ) Accrued expenses and other current liabilities (1,953,927 ) Derivative liabilities (615,831 ) Lease liabilities (1,108,193 ) Other long-term liabilities (49,088 ) Net assets acquired $ 25,634,834 The fair value of identifiable intangible assets has been determined using the income approach, which involves significant unobservable inputs (Level 3 inputs). These inputs include projected sales, margin, required rate of return and tax rate, as well as an estimated royalty rate in the case of the trade names/trademarks intangibles. The trade names/trademarks intangibles are valued using a relief-from-royalty method. The customer/distributor relationships are valued using the with and without method. The developed technology intangibles are valued using a multi-period earnings method. The Company determined the fair value of an IPR&D asset resulting from the acquisition of Curetis using the multi-period earnings method under the income approach. This method reflects the present value of the projected cash flows that are expected to be generated by the IPR&D, less charges representing the required return on other assets to sustain those cash flows. The weighted-average amortization periods for finite-lived intangible assets acquired are 15 years for customer/distributor relationships, 10 years for developed technology and 10 years for trade names/trademarks. The total consideration paid in the acquisition exceeded the estimated fair value of the tangible and identifiable intangible assets acquired and liabilities assumed, resulting in approximately $6.7 million of goodwill. Goodwill, primarily related to expected synergies gained from combining operations, sales growth from future product offerings and customers, together with certain intangible assets that do not qualify for separate recognition, including assembled workforce, is not tax deductible in all relevant taxing jurisdictions. The following unaudited pro forma financial information summarizes the results of operations for the periods indicated as if the Transaction had been completed as of January 1, 2019. Pro forma information primarily reflects adjustments relating to the amortization of intangibles acquired and elimination of interest expense due under the interim facility. The pro forma amounts do not purport to be indicative of the results that would have actually been obtained if the acquisition occurred as of January 1, 2019 or that may be obtained in the future. Unaudited pro forma results Years ended December 31, 2020 2019 Revenues $ 5,239,192 $ 6,053,766 Net loss (29,319,303 ) (38,435,605 ) Net loss per share (1.86 ) (23.77 ) |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 12 Months Ended |
Dec. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Revenue from Contracts with Customers | Note 5 - Revenue from Contracts with Customers Disaggregated Revenue The Company provides diagnostic test products, laboratory services to hospitals, clinical laboratories and other healthcare provider customers, and enters into collaboration agreements with government agencies and healthcare providers. The revenues by type of service consist of the following: Years Ended December, 2020 2019 Product sales $ 2,704,364 $ 2,168,179 Laboratory services 167,736 5,435 Collaboration revenue 1,342,341 1,325,000 Total revenue $ 4,214,441 $ 3,498,614 Revenues by geography are as follows: Years Ended December, 2020 2019 Domestic $ 1,917,367 $ 3,322,615 International 2,297,074 175,999 Total revenue $ 4,214,441 $ 3,498,614 Deferred revenue Changes in deferred revenue for the period were as follows: Balance at December 31, 2019 $ 9,808 Acquired deferrals from Curetis 829,275 Revenue recognized in the current period from the amounts in the beginning balance — Revenue recognized in the current period from the amounts acquired from Curetis (870,114 ) Effect of foreign exchange rates 40,839 Balance at December 31, 2020 $ 9,808 Contract assets The Company had approximately $18,000 of contract assets as of December 31, 2020, which are generated when contractual billing schedules differ from revenue recognition timing. The Company had no contract assets as of December 31, 2019. Contract assets represent a conditional right to consideration for satisfied performance obligations that becomes a billed receivable when the conditions are satisfied. Unsatisfied performance obligations The Company had no unsatisfied performance obligations related to its contracts with customers at December 31, 2020 and 2019. |
Fair value measurements
Fair value measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Note 6 – Fair value measurements The Company classifies its financial instruments using a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: · Level 1 - defined as observable inputs such as quoted prices in active markets; · Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and · Level 3 - defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions such as expected revenue growth and discount factors applied to cash flow projections. For the year ended December 31, 2020, the Company has not transferred any assets between fair value measurement levels. Financial assets and liabilities measured at fair value on a recurring basis The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the hierarchy. In June 2019, Curetis drew down a third tranche of EUR 5.0 million from the European Investment Bank (“EIB”). In return for EIB waiving the condition precedent of a minimum cumulative equity capital raised of EUR 15 million to disburse this EUR 5.0 million tranche, the parties agreed on a 2.1% participation percentage interest (“PPI”). Upon maturity of the tranche, EIB would be entitled to an additional payment that is equity-linked and equivalent to 2.1% of the then total valuation of Curetis N.V. On July 9, 2020, the Company negotiated an amendment to the EIB debt financing facility. As part of the amendment, the parties adjusted the PPI percentage applicable to the previous EIB tranche of EUR 5.0 million which was funded in June 2019 from its original 2.1% PPI in Curetis N.V.’s equity value upon maturity to a new 0.3% PPI in OpGen’s equity value upon maturity between mid-2024 and mid-2025. This right constitutes an embedded derivative, which is separated and measured at fair value with changes being accounted for through profit or loss. The Company determines the fair value of the derivative using a Monte Carlo simulation model. Using this model, level 3 unobservable inputs include estimated discount rates and estimated risk-free interest rates. The Company’s convertible debt with YA II PN, LTD (see Note 7) included a conversion feature which constitutes an embedded derivative, which is separated and measured at fair value with subsequent changes being accounted for through profit or loss. The Company determines the fair value of the derivative using a Monte Carlo simulation model. Using this model, level 3 unobservable inputs include estimated volatility rates and estimated risk-free interest rates. The fair value of level 3 liabilities measured at fair value on a recurring basis for the year ended December 31, 2020 was as follows: Description Balance at December 2019 Acquired from Curetis Change in Fair Value Effect of Foreign Exchange Rates Balance at December 31, 2020 Participation percentage interest liability $ — $ 173,373 $ (75,222 ) $ 14,701 $ 112,852 Embedded conversion option liability — 442,458 (442,458 ) — — Total revenue $ — $ 615,831 $ (517,680 ) $ 14,701 $ 112,852 Financial assets and liabilities carried at fair value on a non-recurring basis The Company does not have any financial assets and liabilities measured at fair value on a non-recurring basis. Non-financial assets and liabilities carried at fair value on a recurring basis The Company does not have any non-financial assets and liabilities measured at fair value on a recurring basis. Non-financial assets and liabilities carried at fair value on a non-recurring basis The Company measures its long-lived assets, including property and equipment and intangible assets (including goodwill), at fair value on a non-recurring basis when a triggering event requires such evaluation. During the year ended December 31, 2020, the Company recorded impairment expense of $750,596 related to its intangible assets and $101,838 related to its ROU assets (see Note 3). |
Debt
Debt | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Debt | Note 7 – Debt The following table summarizes the Company’s long-term debt and short-term borrowings as December 31, 2020 and 2019: December 31, 2020 2019 EIB $ 25,936,928 $ — PPP 259,353 — MGHIF 331,904 662,789 Insurance financings 107,742 40,266 Total debt obligations 26,635,927 703,055 Unamortized debt discount (6,557,992 ) — Carrying value of debt 20,077,935 703,055 Less current portion (699,000 ) (373,599 ) Long-term debt $ 19,378,935 $ 329,456 MGHIF financing In July 2015, the Company entered into a Purchase Agreement with MGHIF, pursuant to which MGHIF purchased 2,273 shares of common stock of the Company at $2,200 per share for gross proceeds of $5.0 million. Pursuant to the Purchase Agreement, the Company also issued to MGHIF an 8% Senior Secured Promissory Note (the “MGHIF Note”) in the principal amount of $1.0 million with a two-year maturity date from the date of issuance. The Company’s obligations under the MGHIF Note are secured by a lien on all of OpGen’s assets excluding the assets of Curetis GmbH, Curetis USA, and Ares Genetics. On June 28, 2017, the MGHIF Note was amended and restated, and the maturity date of the MGHIF Note was extended by one year to July 14, 2018. As consideration for the agreement to extend the maturity date, the Company issued an amended and restated secured promissory note to MGHIF that (1) increased the interest rate to ten percent (10%) per annum and (2) provided for the issuance of common stock warrants to purchase 656 shares of its common stock to MGHIF. On June 11, 2018, the Company executed an Allonge to the MGHIF Note. The Allonge provided that accrued and unpaid interest of $285,512 due as of July 14, 2018, the original maturity date, be paid through the issuance of shares of OpGen’s common stock in a private placement transaction. In addition, the Allonge revised and extended the maturity date for payment of the MGHIF Note to six semi-annual payments of $166,667 plus accrued and unpaid interest beginning on January 2, 2019 and ending on July 1, 2021. The Allonge to the MGHIF Note was treated as a debt modification and, as such, the unamortized issuance costs of approximately $7,000 as of June 11, 2018 is deferred and amortized as incremental expense over the term of the MGHIF Note. Subsequent to December 31, 2020 the Company paid the final principal and accrued interest payment to MGHIF and the lien on the Company’s IP was released. On July 30, 2018, the Company issued 7,212 shares of common stock to MGHIF in a private placement transaction in payment of the $285,512 of accrued and unpaid interest due as of July 14, 2018 under the MGHIF Note. Yorkville Convertible Notes The Company agreed to assume, as a condition to closing the business combination with Curetis all of the outstanding convertible notes (the “Convertible Notes”) issued by Curetis N.V. in favor of YA II PN, LTD (“Yorkville”), pursuant to that certain Agreement for the Issuance of and Subscription to Notes Convertible into Shares and Share Subscription Warrants, dated October 2, 2018, by and between Curetis N.V. and Yorkville. On February 24, 2020, the Company entered into an Assignment of the Agreement for the Issuance of and Subscription to Notes Convertible into Shares (the “Assignment Agreement”) with Curetis N.V. and Yorkville. Pursuant to the Assignment Agreement, upon assumption of the Convertible Notes by the Company, the Convertible Notes ceased to be convertible into shares of Curetis N.V. and are instead convertible into shares of the Company’s common stock, par value $0.01. The Assignment Agreement provided that an amount of 500,000 shares of the Company’s common stock that comprise a portion of the consideration payable by the Company under the Implementation Agreement be reserved for issuance under the Convertible Notes. On June 17, 2020, the Company registered for resale an additional 450,000 shares of Company common stock issuable upon conversion of the Convertible Notes. At closing of the Transaction, an aggregate amount of €1.3 million of unconverted Convertible Notes was assumed by the Company. The Convertible Notes were measured and recognized at fair value at the acquisition date. The fair value of the Convertible Notes as of the closing of the Transaction was approximately $1.3 million. The resulting debt discount was amortized over the life of the Convertible Notes as an increase in interest expense. During year ended December 31, 2020, the Company issued 763,905 shares of common stock in satisfaction of approximately $1,451,000 of Convertible Notes. As of December 31, 2020, all notes have been converted. EIB Loan Facility In 2016, Curetis entered into a contract for an up to €25 million senior, unsecured loan financing facility from the European Investment Bank (“EIB”). The financing is in the first growth capital loan under the European Growth Finance Facility (“EGFF”), launched in November 2016. It is backed by a guarantee from the European Fund for Strategic Investment (“EFSI”), EFSI is an essential pillar of the Investment Plan for Europe (“IPE”), under which the EIB and the European Commission are working as strategic partners to support investments and bring back jobs and growth to Europe. The funding can be drawn in up to five tranches within 36 months, under the EIB amendment, and each tranche is to be repaid upon maturity five years after draw-down. In April 2017, Curetis drew down a first tranche of €10 million from this facility. This tranche has a floating interest rate of EURIBOR plus 4% payable after each 12-month-period from the draw-down-date and another additional 6% interest per annum that is deferred and payable at maturity together with the principal. In June 2018, another tranche of €3 million was drawn down. The terms and conditions are analogous to the first one. In June 2019, Curetis drew down a third tranche of €5 million from the EIB. In line with all prior tranches, the majority of interest is also deferred into the bullet repayment structure upon maturity. In return for EIB waiving the condition precedent of a minimum cumulative equity capital raised of €15 million to disburse this €5 million tranche, the parties agreed on a 2.1% PPI. Upon maturity of the tranche, not before approximately mid-2024 (and no later than mid-2025) EIB would be entitled to an additional payment that is equity-linked and equivalent to 2.1% of the then total valuation of Curetis N.V. As part of the amendment between the Company and EIB on July 9, 2020, the parties adjusted the PPI percentage applicable to the previous EIB tranche of €5 million which was funded in June 2019 from its original 2.1% PPI in Curetis N.V.’s equity value upon maturity to a new 0.3% PPI in OpGen’s equity value upon maturity. This right constitutes an embedded derivative, which is separated and measured at fair value with changes being accounted for through income or loss. On July 9, 2020, the Company negotiated an amendment to the EIB debt financing facility for an additional €5 million tranche. This additional tranche is earmarked to co-fund R&D programs across several of the platforms and the entire product portfolio of OpGen subsidiaries Curetis and Ares Genetics as it relates to COVID-19. This additional tranche, which can be drawn down, subject to certain conditions, at Curetis’ option within nine months from the Effective Date of the amendment, will also have a five-year term to maturity from such draw-down date and will accrue interest at a rate of 10% per annum. All interest payments during that five-year term are compounded and become payable only upon maturity of the principal amount of this tranche. The EIB tranche disbursement will become available subject to typical conditions precedent including a pledge of certain Curetis IP rights as security to EIB. All other terms and conditions of the EIB financing contract with Curetis remain unchanged. Additionally, on July 10, 2020, EIB agreed to defer total interest payments of €720k due in April and June 2020 under the first three tranches of the debt financing facility until December 31, 2020. The Company made these interest payments in December 2020. The EIB debt was measured and recognized at fair value as of the acquisition date. The fair value of the EIB debt was approximately $15.8 million as of the acquisition date. The resulting debt discount will be amortized over the life of the EIB debt as an increase to interest expense. As of December 31, 2020, the outstanding borrowings under all tranches were €21,136,768 (approximately USD $25,936 PPP On April 22, 2020, the Company entered into a Term Note (the “Company Note”) with Silicon Valley Bank (the “Bank”) pursuant to the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) administered by the U.S. Small Business Administration. The Company’s wholly-owned subsidiary, Curetis USA Inc. (“Curetis USA” and collectively with the Company, the “Borrowers”), also entered into a Term Note with the Bank (the “Subsidiary Note,” and collectively with the Company Note, the “Notes”). The Notes are dated April 22, 2020. The principal amount of the Company Note is $879,630, and the principal amount of the Subsidiary Note is $259,353. In accordance with the requirements of the CARES Act, the Borrowers will use the proceeds from the Notes in accordance with the requirements of the PPP to cover certain qualified expenses, including payroll costs, rent and utility costs. Interest accrues on the Notes at the rate of 1.00% per annum. The Borrowers may apply for forgiveness of amounts due under the Notes, in an amount equal to the sum of qualified expenses under the PPP, which include payroll costs, rent obligations, and covered utility payments incurred during the twenty-four weeks following disbursement under the Notes. The entire proceeds were used under the Notes for such qualifying expenses. OpGen filed for forgiveness of the Subsidiary note during November 2020. The Company Note was forgiven in November of 2020. Subject to any forgiveness under the PPP, the Subsidiary Note matures two years following the date of issuance and includes a period for the first ten months during which time required payments of interest and principal are deferred. Beginning on the eleventh month following the date of issuance, the Company is required to make 14 monthly payments of principal and interest. The Subsidiary Note may be prepaid at any time prior to maturity with no prepayment penalties. The Subsidiary Note provides for customary events of default, including, among others, those relating to breaches of their obligations under the Subsidiary Note, including a failure to make payments, any bankruptcy or similar proceedings involving the Borrower, and certain material effects on the Borrowers’ ability to repay the Subsidiary Note. The Borrower did not provide any collateral or guarantees for the Subsidiary Note. Total interest expense (including accretion of fair value to face value and amortization of debt discounts and financing fees) on all debt instruments was $3,399,984 and $187,549 for the years ended December 31, 2020 and 2019, respectively. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Note 8 - Stockholders’ Equity As of December 31, 2020, the Company has 50,000,000 shares of authorized common shares and 25,085,534 shares issued and outstanding, and 10,000,000 of authorized preferred shares, of which none were issued or outstanding. Following receipt of approval from stockholders at a special meeting of stockholders held on January 17, 2018, the Company filed an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty-five shares, and to reduce the authorized shares of common stock from 200,000,000 to 50,000,000 shares. Additionally, following receipt of approval from stockholders at a special meeting of stockholders held on August 22, 2019, the Company filed an additional amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty shares. All share amounts and per share prices in this Quarterly Report have been adjusted to reflect the reverse stock splits. On March 29, 2019, the Company closed the March 2019 Public Offering of 450,000 shares of its common stock at a public offering price of $12.00 per share. The offering raised gross proceeds of $5.4 million and net proceeds of approximately $4.8 million. On October 28, 2019, the Company closed the October 2019 Public Offering of 2,590,170 units at $2.00 per unit and 2,109,830 pre-funded units at $1.99 per pre-funded unit. The offering raised gross proceeds of approximately $9.4 million and net proceeds of approximately $8.3 million. As of December 31, 2020, the 2,109,830 pre-funded warrants issued in the October 2019 Public Offering have been exercised. Additionally, during the year ended December 31, 2020, 4,341,000 common warrants were exercised raising net proceeds of approximately $8.7 million. In connection with the October 2019 Public Offering, the Company issued to its placement agent warrants to purchase 235,000 shares of common stock. The warrants issued to the placement agent have an exercise price of $2.60 per share and are exercisable for five years. On February 11, 2020, the Company entered into an ATM Agreement with Wainwright, which we amended and restated on November 13, 2020 to add BTIG, LLC pursuant to which the Company may offer and sell from time to time in an “at the market offering,” at its option, up to an aggregate of $22.1 million of shares of the Company's common stock through the sales agents. During the year ended December 31, 2020, the Company sold 7,521,610 shares of its common stock under the 2020 ATM Offering resulting in aggregate net proceeds to the Company of approximately $15.8 million, and gross proceeds of $16.7 million. As of December 31, 2020, remaining availability under the ATM Agreement is $5.4 million. On April 1, 2020, the Company acquired all of the shares of Curetis GmbH, and certain other assets and liabilities of Curetis N.V., as further described in Notes 1 and 4, and paid, as the sole consideration, 2,028,208 shares of the Company’s common stock to the Seller. On November 25, 2020, the Company closed a private placement with one healthcare-focused U.S. institutional investor of (i) 2,245,400 shares of common stock together with 2,245,400 common warrants to purchase up to 2,245,400 shares of common stock and (ii) 2,597,215 pre-funded warrants, with each pre-funded warrant exercisable for one share of common stock, together with 2,597,215 common warrants to purchase up to 2,597,215 shares of common stock (the “2020 PIPE”). Each share of common stock and accompanying common warrant were sold together at a combined offering price of $2.065, and each pre-funded warrant and accompanying common warrant were sold together at a combined offering price of $2.055. The common warrants have an exercise price of $1.94 per share, and are exercisable commencing on the six month anniversary of the date of issuance, and will expire five and one half (5.5) years from the date of issuance. The 2020 PIPE raised aggregate net proceeds of $9.3 million, and gross proceeds of $10.0 million. As of December 31, 2020, all 2,597,215 pre-funded warrants issued in the 2020 PIPE have been exercised. Stock options In 2008, the Board adopted, and the stockholders approved, the 2008 Stock Option and Restricted Stock Plan (the “2008 Plan”), pursuant to which the Company’s Board of Directors may grant either incentive or non-qualified stock options or shares of restricted stock to directors, key employees, consultants and advisors. In April 2015, the Board adopted, and the Company’s stockholders approved, the 2015 Equity Incentive Plan (the “2015 Plan”); the 2015 Plan became effective upon the execution and delivery of the underwriting agreement for the Company’s IPO. Following the effectiveness of the 2015 Plan, no further grants have been made under the 2008 Plan. The 2015 Plan provides for the granting of incentive stock options within the meaning of Section 422 of the Code to employees and the granting of non-qualified stock options to employees, non-employee directors and consultants. The 2015 Plan also provides for the grants of restricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directors and consultants. Under the 2015 Plan, the aggregate number of shares of the common stock authorized for issuance may not exceed (1) 2,710 plus (2) the sum of the number of shares subject to outstanding awards under the 2008 Plan as of the 2015 Plan’s effective date, that are subsequently forfeited or terminated for any reason before being exercised or settled, plus (3) the number of shares subject to vesting restrictions under the 2008 Plan as of the 2015 Plan’s effective date that are subsequently forfeited. In addition, the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. Shares subject to awards granted under the 2015 Plan that are forfeited or terminated before being exercised or settled, or are not delivered to the participant because such award is settled in cash, will again become available for issuance under the 2015 Plan. However, shares that have actually been issued shall not again become available unless forfeited. As of December 31, 2020, 6,025 shares remain available for issuance under the 2015 Plan. On September 30, 2020, the Company held its 2020 Annual Meeting of Stockholders (the “2020 Annual Meeting”). At the 2020 Annual Meeting, stockholders of the Company voted to approve, among other things, a plan under which stock options to purchase an aggregate of 1.3 million shares of the Company’s common stock would be made by the Board of Directors of the Company outside of the stockholder-approved equity incentive plan to its executive officers and non-employee directors (the “2020 Stock Options Plan”). The 2020 Stock Options Plan and the grant made thereunder were approved by the Board of Directors on August 6, 2020, subject to receipt of stockholder approval at the 2020 Annual Meeting. The aggregate number of shares of the Company’s common stock authorized for issuance is 1,300,000 shares of common stock and all 1,300,000 stock options were issued on September 30, 2020. Shares subject to awards granted under the 2020 Stock Options Plan that are forfeited or terminated before being exercised will not be available for re-issuance under the 2020 Stock Options Plan. Replacement awards In connection with the business combination with Curetis, the Company issued equity awards to Curetis employees (“2016 Plan”), consisting of stock options (“replacement awards”) in exchange for their Curetis equity awards. The replacement awards consisted of 134,371 stock options with a weighted average grant date fair value of $1.68. The terms of these replacement awards are substantially similar to the original Curetis equity awards. The fair value of the replacement awards for services rendered through April 1, 2020, the acquisition date, was recognized as a component of the purchase consideration, with the remaining fair value of the replacement awards related to the post-combination services recorded as stock-based compensation over the remaining vesting period. For the years ended December 31, 2020 and 2019, the Company recognized stock compensation expense as follows: Years Ended December 31, 2020 2019 Cost of services $ 2,927 $ 2,781 Research and development 62,783 74,841 General and administrative 231,010 269,292 Sales and marketing 19,366 25,956 $ 316,086 $ 372,870 No income tax benefit for stock-based compensation arrangements was recognized in the consolidated statements of operations due to the Company’s net loss position. As of December 31, 2020, the Company had unrecognized expense related to its stock options of $1.3 million, which will be recognized over a weighted average period of 3.1 years. A summary of the status of options granted is presented below as of and for the years ended December 31, 2020 and 2019: Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at January 1, 2019 10,578 $ 411.60 7.6 $ 522 Granted — $ — Exercised — $ — Forfeited (302 ) $ 222.17 Expired (622 ) $ 269.87 Outstanding at December 31, 2019 9,654 $ 418.10 8.0 $ — Granted 1,525,000 $ 2.13 Exercised — $ — Assumed in business combination 134,371 $ 48.40 Forfeited (3,631 ) $ 21.11 Expired (872 ) $ 473.92 Outstanding at December 31, 2020 1,664,522 $ 7.99 9.4 $ — Vested and expected to vest 1,664,522 $ 7.99 9.4 $ — Exercisable at December 31, 2020 — $ — — $ — The total fair value of options vested in the years ended December 31, 2020 and 2019 was $549,341 and $375,789, respectively. The fair value of each option grant was estimated at the date of grant using the Black-Scholes option pricing model based on the assumptions below: Years Ended December 31, 2020 2019 Annual dividend — — Expected life (in years) 5.25 - 6.25 — Risk free interest rate 0.3%-0.5% — Expected volatility 40.9% - 46.6% — Restricted stock units A summary of the status of restricted stock units granted is presented below as of and for the years ended December 31, 2020 and 2019: Number of Units Weighted- Average Grant Date Fair Value Unvested at January 1, 2019 12 $ 623.20 Granted 17,150 $ 8.77 Vested (12 ) $ 623.20 Forfeited (2,175 ) $ 8.80 Unvested at December 31, 2019 14,975 $ 8.76 Granted — $ — Vested (5,924 ) $ 8.51 Forfeited (933 ) $ 8.84 Unvested at December 31, 2020 8,118 $ 8.93 As of December 31, 2020, there was approximately $49,000 of unrecognized compensation cost related to restricted stock units, which is expected to be recognized over a weighted average period of 1.3 years. Stock purchase warrants At December 31, 2020 and 2019, the following warrants to purchase shares of common stock were outstanding: Outstanding at December 31, Issuance Exercise Price Expiration 2020 (1) 2019 (1) January 2010 $ 3,955.00 January 2020 — 17 March 2010 $ 3,955.00 March 2020 — 7 November 2011 $ 3,955.00 November 2021 15 15 December 2011 $ 3,955.00 December 2021 2 2 February 2015 $ 3,300.00 February 2025 451 451 May 2015 $ 3,300.00 May 2020 — 6,697 May 2016 $ 656.20 May 2021 9,483 9,483 June 2016 $ 656.20 May 2021 4,102 4,102 June 2017 $ 390.00 June 2022 938 938 July 2017 $ 345.00 July 2022 318 318 July 2017 $ 250.00 July 2022 2,501 2,501 July 2017 $ 212.60 July 2022 50,006 50,006 February 2018 $ 81.25 February 2023 9,232 9,232 February 2018 $ 65.00 February 2023 92,338 92,338 October 2019 $ 2.00 October 2024 359,000 4,700,000 October 2019 $ 2.60 October 2024 235,000 235,000 November 2020 $ 1.94 May 2026 4,842,615 — November 2020 $ 2.68 May 2026 242,130 — 5,848,131 5,111,107 The warrants listed above were issued in connection with various equity, debt, preferred stock or development contract agreements. (1) Warrants to purchase fractional shares of common stock resulting from the reverse stock split on August 22, 2019 were rounded up to the next whole share of common stock on a holder by holder basis. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 9 - Income Taxes The Company’s loss before income taxes was $26.1 million and $12.5 million for the years ended December 31, 2020 and 2019, respectively. The Company’s provision for income taxes consists of the following for the years ended December 31, 2020 and 2019: December 31, 2020 2019 Current income tax provision Federal $ — $ — State — — Foreign 132,403 — Total 132,403 $ — Deferred income tax provision Federal — — State — — Foreign — — Total — — Total provision for income taxes $ 132,403 — At December 31, 2020 and 2019, the Company had net deferred tax assets of $103,185,302 and $54,359,488, respectively, primarily consisting of NOL carryforwards, research and development (“R&D”) credits, and differences between depreciation and amortization recorded for financial statement and tax purposes. The Company’s net deferred tax assets at December 31, 2020 and 2019 have been offset by a valuation allowance of $98,874,420 and $54,359,488, respectively. The valuation allowance has been recorded due to the uncertainty of realization of the deferred tax assets. The Company’s deferred tax assets and liabilities as of December 31, 2020 and 2019 are as follows: December 31, 2020 2019 Deferred tax assets: NOL carryforward $ 98,165,790 $ 51,247,762 R&E credit carryforward 2,559,479 2,559,479 Share-based compensation 319,397 325,571 Inventory reserve — 23,213 Depreciation 100,157 1,754 Interest expense 1,233,203 95,077 ROU liabilities 475,645 — Accruals and other 331,631 286,692 Total deferred tax assets 103,185,302 54,539,548 Valuation allowance (98,874,420 ) (54,359,488 ) Deferred tax liabilities: Intangible assets (3,885,485 ) (180,060 ) ROU assets (425,397 ) — Net $ — $ — The difference between the Company’s expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax loss and actual income tax provision (benefit) relates to the effect of the following: 2020 2019 Federal income tax benefit at statutory rates 21.0 % 21.0 % Permanent adjustment 0.6 % (1.9 )% Provision to return adjustment — 0.4 % State income tax benefit, net of federal benefit 3.5 % 4.4 % Foreign rate differential 2.8 % — Change in valuation allowance (28.4 )% (23.9 )% (0.5 )% 0.0 % As of December 31, 2020 and 2019, management assessed the realizability of net deferred tax assets and evaluated the need for a valuation allowance against the net deferred tax assets. This evaluation utilizes the framework contained in ASC 740, Income Taxes Management followed the guidance in ASC 740, which states that “a cumulative loss in recent years is a significant piece of negative evidence that is difficult to overcome” and concluded that the Company’s net deferred tax assets were not realizable as of December 31, 2020 and 2019. Accordingly, a valuation allowance of $98.9 million and $54.4 million has been recorded to offset the net deferred tax assets. The Company has federal NOL carryforwards of $ 196,511,928 188,282,298 The Tax Act made broad and complex changes to the U.S. tax code, including, but not limited to: (i) reducing the U.S. federal corporate tax rate from 35 percent to 21 percent; (ii) eliminating the corporate alternative minimum tax (AMT) and changing how existing AMT credits can be realized; (iii) creating a new limitation on deductible interest expense; and (iv) changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017; and (v) changing the U.S. federal taxation of earnings of foreign subsidiaries. The U.S. change in federal taxation for foreign subsidiary earnings included a one-time toll charge on deemed repatriated earnings of foreign subsidiaries as of December 31, 2017. As a result of the accumulated losses in the Company’s foreign subsidiary, the Company had no toll tax liability for the tax year ended December 31, 2017. For 2018, the Company considered in its estimated annual effective tax rate additional provisions of Tax Reform including changes to the deduction for interest expense pursuant to IRC Section 163(j) interest limitation. On March 27, 2020, the Unites States enacted the Coronavirus Aid, Relief and Economic Security Act (CARES Act). The CARES Act is an emergency economic stimulus package that includes spending and tax breaks to strengthen the United States economy and fund a nationwide effort to curtail the effect of COVID-19. While the CARES Act provides sweeping tax changes in response to the COVID-19 pandemic, some of the more significant provisions which are expected to impact the Company's financial statements include removal of certain limitations on utilization of net operating losses, increasing the loss carryback period for certain losses to five years, and increasing the ability to deduct interest expense, as well as amending certain provisions of the previously enacted Tax Cuts and Jobs Act. The Company doesn't believe that the CARES Act will have a material impact on its financial position, results of operations, or cash flows. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 10 - Commitments and Contingencies Registration and other stockholder rights In connection with the various investment transactions, the Company entered into registration rights agreements with stockholders, pursuant to which the investors were granted certain demand registration rights and/or piggyback and/or resale registration rights in connection with subsequent registered offerings of the Company’s common stock. Supply agreements In June 2017, the Company entered into an agreement with Life Technologies Corporation, a subsidiary of Thermo Fisher Scientific (“LTC”), to supply the Company with Thermo Fisher Scientific’s QuantStudio 5 Real-Time PCR Systems (“QuantStudio 5”) to be used to run OpGen’s Acuitas AMR Gene Panel tests. Under the terms of the agreement, the Company must notify LTC of the number of QuantStudio 5s that it commits to purchase in the following quarter. As of December 31, 2020, the Company had acquired twenty-four QuantStudio 5s including none during the year ended December 31, 2020. As of December 31, 2020, the Company has not committed to acquiring additional QuantStudio 5s in the next three months. Curetis places frame-work orders for Unyvero-Systems and for raw materials for its cartridge manufacturing to ensure availability during commercial ramp-up-phase and also to gain volume-scale-effects with regards to purchase prices. Some of the electronic parts used for the production of Unyvero-Systems have lead times of many months, hence it is necessary to order such systems with long-term framework-orders to ensure the demands from the market are covered. The aggregate purchase commitments over the next twelve months are approximately $3.1 million. Contingencies On March 11, 2020, the World Health Organization declared the outbreak of a novel coronavirus (“COVID-19”) as a global pandemic, which continues to spread throughout the United States and around the world. As a result, the Company has experienced a material impact on its business, financial condition and results of operations for the year ended December 31, 2020 and significant business disruptions as a result of the outbreak. For example, most of the Company’s employees in the U.S. are currently working remotely from home, the Company has suspended virtually all business travel, and the Company is generally unable to physically meet with future and current customers to sell and market its products. In addition, the COVID-19 pandemic has interrupted many of the Company’s clinical activities, which might delay its ability to complete clinical trials and obtain regulatory approval for new products including FDA clearance of its Acuitas AMR Gene Panel (Isolate) product. The Company is monitoring the impacts of COVID-19 on the global economy and on its business operations. However, at this time, it is difficult to predict how long the potential operational impacts of COVID-19 will remain in effect or to what degree they will impact the Company’s operations and financial results. An extended period of global supply chain and economic disruption could materially affect the Company’s business, results of operations, access to sources of liquidity and financial condition, as well as its ability to execute its business strategies and initiatives in their respective expected time frames. As a result, the Company is unable to estimate the potential impact on its business as of the date of this filing. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Leases | Note 11 – Leases The following table presents the Company’s ROU assets and lease liabilities as of December 31, 2020 and 2019: Lease Classification December 31, 2020 December 31, 2019 ROU Assets: Operating $ 2,082,300 $ 1,043,537 Financing 449,628 958,590 Total ROU assets $ 2,531,928 $ 2,002,127 Liabilities Current: Operating $ 964,434 $ 1,017,414 Finance 266,470 579,030 Noncurrent: Operating 1,492,544 547,225 Finance 46,794 313,263 Total lease liabilities $ 2,770,242 $ 2,456,932 Maturities of lease liabilities as of December 31, 2020 by year are as follows: Maturity of Lease Liabilities Operating Finance Total 2021 $ 1,005,811 $ 281,914 $ 1,287,725 2022 570,656 45,374 616,030 2023 424,495 3,364 427,859 2024 433,872 280 434,152 2025 409,055 — 409,055 Thereafter 2,782,432 — 2,782,432 Total lease payments 5,626,321 330,932 5,957,253 Less: Interest (1,957,343 ) (17,668 ) (1,975,011 ) Less: Tenant improvement allowance (1) (1,212,000 ) — (1,212,000 ) Present value of lease liabilities $ 2,456,978 $ 313,264 $ 2,770,242 (1) In accordance with ASC 842, a tenant allowance should be included in the measurement of the consideration in the lease agreement at inception and reflected as a reduction to the right-of-use asset and a corresponding reduction to the right-use-liability if the lessee both controls the construction of the tenant improvements and the expects to fully earn all of the tenant allowance. OpGen has met both conditions at the inception of its Rockville, Maryland lease and has recorded the Tenant Improvement Allowance accordingly. As the cash for the Tenant Improvement Allowance is received from the lessor under the terms of the Rockville, Maryland lease, the corresponding right-of-use liability will increase and will be amortized as part of the right-of use asset and liability amortization over the term of the Rockville, Maryland Lease in accordance with ASC 842. Consolidated statements of operations classification of lease costs as of the years ended December 31, 2020 and 2019 are as follows: Years ended December 31, Lease Cost Classification 2020 2019 Operating Operating expenses $ 1,205,551 $ 869,968 Finance: Amortization Operating expenses 508,962 467,319 Interest expense Other expenses 57,247 75,018 Total lease costs $ 1,771,760 $ 1,412,305 Other lease information as of December 31, 2020 is as follows: Other Information Total Weighted average remaining lease term (in years) Operating leases 8.7 Finance leases 1.1 Weighted average discount rate: Operating leases 7.0 % Finance leases 9.7 % Supplemental cash flow information for the years ended December 31, 2020, and 2019 is as follows: Supplemental Cash Flow Information 2020 2019 Cash paid for amounts included in the measurement of lease liabilities Cash used in operating activities Operating leases $ 1,205,551 $ 869,968 Finance leases $ 57,247 $ 75,018 Cash used in financing activities Finance leases $ 579,029 $ 535,931 ROU assets obtained in exchange for lease obligations: Operating leases $ 1,008,039 $ — Finance leases $ — $ 592,013 |
License Agreements, Research Co
License Agreements, Research Collaborations and Development Agreements | 12 Months Ended |
Dec. 31, 2020 | |
License Agreements Research Collaborations And Development Agreements [Abstract] | |
License Agreements, Research Collaborations and Development Agreements | Note 12 - License Agreements, Research Collaborations and Development Agreements NYSDOH In 2018, the Company announced a collaboration with the New York State Department of Health (“DOH”) and ILÚM Health Solutions, LLC (“ILÚM”), a wholly-owned subsidiary of Merck’s Healthcare Services and Solutions division, to develop a state-of-the-art research program to detect, track, and manage antimicrobial-resistant infections at healthcare institutions statewide. The Company is working together with DOH’s Wadsworth Center and ILÚM to develop an infectious disease digital health and precision medicine platform that connects healthcare institutions to DOH and uses genomic microbiology for statewide surveillance and control of antimicrobial resistance. As part of the collaboration, the Company received approximately $1.6 million over the 15-month demonstration portion of the project. The demonstration project began in early 2019 and was completed in the first quarter of 2020. In April 2021, the Company began a second-year expansion phase to build on the successes and experience of the first year pilot phase while focusing on accomplishing the goal of the effort to improve patient outcomes and save healthcare dollars by integrating real-time epidemiologic surveillance with rapid delivery of antibiotic resistance results to care-givers via web-based and mobile platforms. The second year contract includes a quarterly retainer-based project fee as well as volume-dependent per test fees for a total contract value of up to $450,000 to OpGen. During the years ended December 31, 2020 and 2019, the Company recognized $388,000 and $1,325,000, respectively, of revenue related to the contract. Sandoz In December 2018, Ares Genetics entered into a service frame agreement with Sandoz International GmbH (“Sandoz”), to leverage Ares Genetics’ database on the genetics of antibiotic resistance, ARESdb, and the ARES Technology Platform for Sandoz’ anti-infective portfolio. Under the terms of the frame agreement, which has an initial term of 36 months and is currently scheduled to terminate December 13, 2021, Ares Genetics and Sandoz intend to develop a digital anti-infectives platform, combining established microbiology laboratory methods with advanced bioinformatics and artificial intelligence methods to support drug development and life-cycle management. The collaboration, in the short- to mid-term, aims to both rapidly and cost-effectively re-purpose existing antibiotics and design value-added medicines with the objective of expanding indication areas and to overcome antibiotic resistance, in particular with regards to infections with bacteria that has already developed resistance against multiple treatment options. In the longer-term, the platform is expected to inform the development of novel anti-infectives that are less prone to encounter resistance and thereby preserve antibiotics as an effective treatment option. The agreement covers the first phases of the collaboration with Sandoz and provides certain moderate six-figure R&D funding to Ares Genetics . Qiagen On February 18, 2019, Ares Genetics and Qiagen GmbH, or Qiagen, entered into a strategic licensing agreement for ARESdb and AREStools, in the area of antimicrobial resistance (“AMR”) research. The agreement has a term of 20 years and may be terminated by Qiagen for convenience with 180 days written notice. Ares Genetics has retained the rights to use ARESdb and AREStools for AMR research, customized bioinformatics services, and for the development of specific AMR assays and applications for the Curetis Group (including Ares Genetics), as well as third parties (e.g. other diagnostics companies or partners in the pharmaceutical industry). As the Qiagen research offering is expected to also enable advanced molecular diagnostic services and products, Qiagen’s customers may obtain a diagnostic use license from Ares Genetics. Under the terms of the agreement, Qiagen, in exchange for a moderate six figure up-front licensing payment, has received an exclusive RUO license to develop and commercialize general bioinformatics offerings and services for AMR research use only, based on Ares Genetics’ database on the genetics of antimicrobial resistance, ARESdb, as well as on the ARES bioinformatics AMR toolbox, AREStools. Under the agreement, the parties agreed to a mid-single digit percentage royalty rate on Qiagen net sales, which is subject to a minimum royalty rate that steps up upon certain achieved milestones, which is payable to Ares Genetics. The parties also agreed to further modest six figure milestone payments upon certain product launches. Global leading IVD corporation On September 16, 2019, Ares Genetics entered into a multi-phase partnership with an undisclosed leading global in vitro diagnostics corporation, or the Partner, to jointly develop diagnostic solutions for infectious disease testing, based on next-generation sequencing, or NGS, technology. Ares Genetics and the Partner also entered into an R&D option agreement for the first phase of the partnership. Ares Genetics received an option fee of approximately $550,000. The initial 10-month term of the R&D collaboration, ended July 13, 2020, with payments excluding the option fee of approximately $1.2 million. In the first phase of the collaboration, which lasted 10 months, the parties have further enriched ARESdb with a focus on certain pathogens relevant in a first, undisclosed infectious disease indication. Additional clinical isolates of such pathogens have been sequenced by Ares Genetics at its recently established NGS laboratory in Vienna, Austria. Based on this enlarged and enriched dataset, Ares Genetics has further developed the algorithms for predictive antibiotic resistance testing for drug/pathogen combinations particularly relevant in the targeted indication to enable NGS-based infectious disease diagnostics. Under the initial agreement, the Partner funded Ares Genetics’ R&D activities for the genotypic and phenotypic characterization of additional bacterial strains to augment ARESdb and the development of optimized algorithms for predicting antibiotic resistance. Furthermore, in return for the up-front option fee, the Partner obtained a three-month right for first negotiation for an exclusive human clinical diagnostic use license to ARESdb and the ARES Technology Platform. The Company recognized approximately $870,000 of revenue related to the contract during the year ended December 31, 2020. FISH License The Company was party to one license agreement with Life Technologies to acquire certain patent rights and technologies related to its FISH product line. Royalties were incurred upon the sale of a product or service which utilizes the licensed technology. The Company terminated this license agreement in October 2020 effective as of June 30, 2020 in conjunction with its announced exit of the FISH business in June 2021. The Company paid a one-time settlement fee of $350,000 and will pay a 10% royalty on the sale of eligible products through June 2021 but is no longer subject to any minimum royalty obligations. The Company recognized net royalty expense of $(68,854) and $250,000 for the years ended December 31, 2020 and 2019, respectively. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 13 - Related Party Transactions On April 1, 2020, as part of the Transaction, Oliver Schacht, Ph.D., the former CEO of Curetis N.V., was appointed as the CEO of the Company, and Johannes Bacher the former COO of Curetis N.V. was appointed as the COO of the Company. Effective April 1, 2020, Mr. Schacht and Mr. Bacher were appointed as liquidators of Curetis N.V. in liquidation and Curetis GmbH was designated as Custodian of the Books for Curetis N.V. During a portion of the year ended December 31, 2020, Curetis N.V. in liquidation processed payroll for Mr. Schacht and Mr. Bacher and invoiced OpGen and Curetis GmbH, respectively, in line with their signed management agreements. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 14 – Subsequent Events Subsequent to December 31, 2020, the Company paid the final principal and accrued interest payment to MGHIF and the lien on the Company’s IP was released. On February 11, 2021, the Company closed the February 2021 Offering with a single U.S.-based, healthcare-focused institutional investor for the purchase of (i) 2,784,184 shares of common stock and (ii) 5,549,149 pre-funded warrants, with each pre-funded warrant exercisable for one share of common stock. The Company also issued to the investor, in a concurrent private placement, unregistered common warrants to purchase 4,166,666 shares of the Company’s common stock. Each share of common stock and accompanying common warrant were sold together at a combined offering price of $3.00, and each pre-funded warrant and accompanying common warrant were sold together at a combined offering price of $2.99. The pre-funded warrants are immediately exercisable, at an exercise price of $0.01, and may be exercised at any time until all of the pre-funded warrants are exercised in full. The common warrants will have an exercise price of $3.55 per share, will be exercisable commencing on the six-month anniversary of the date of issuance, and will expire five and one half (5.5) years from the date of issuance. The February 2021 Offering raised aggregate net proceeds of $23.4 million, and gross proceeds of $25.0 million. As of March 19, 2021, all pre-funded warrants issued in the February 2021 Offering have been exercised. As previously reported, on November 23, 2020, the Company entered into a Purchase Agreement with the Holder pursuant to which the Company issued to the Investor, securities of the Company, including Existing Warrants to purchase up to 4,842,615 shares of common stock. The Existing Warrants were exercisable six months after their issuance at an exercise price of $1.94 per share and expire on the fifth and a half year anniversary of the date of issuance. On March 9, 2021, the Company entered into the Exercise Agreement with the Holder. Pursuant to the Exercise Agreement, in order to induce the Holder to exercise all of the remaining 4,842,615 outstanding Existing Warrants for cash, pursuant to the terms of and subject to beneficial ownership limitations contained in the Existing Warrants, the Company agreed to issue to the Holder, New Warrants to purchase 0.65 shares of common Stock for each share of common stock issued upon such exercise of the remaining 4,842,615 outstanding Existing Warrants pursuant to the Exercise Agreement or an aggregate of 3,147,700 New Warrants. The terms of the New Warrants will be substantially similar to those of the Existing Warrants, except that the New Warrants will have an exercise price of $3.56. The New Warrants will be immediately exercisable and will expire five years from the date of the Exercise Agreement. On March 12, 2021, the Company and the Holder amended the Exercise Agreement to provide that the Holder would pay the Company $0.08125 for each New Warrant issued to the Holder. The Holder will pay an aggregate of $255,751 to the Company for the purchase of the New Warrants. The Company received aggregate gross proceeds before expenses of approximately $9.65 million from the exercise of all of the remaining 4,842,615 outstanding Existing Warrants held by the Holder and the payment of the purchase price for the New Warrants. In March 2021, the Company entered into a lease extension for its office and laboratory space in Holzgerlingen, Germany. The extension is for four years beginning in September of 2021 with an optional four year extension through September 2029. The total minimum payments due over the four year extension is approximately $810,000. The lease is subject to additional charges such as utilities and other costs. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The consolidated financial statements consolidate the operations of all controlled subsidiaries; all intercompany activity is eliminated. |
Foreign Currency | Foreign Currency The Company has subsidiaries located in Holzgerlingen, Germany; Vienna, Austria; and Copenhagen, Denmark, each of which use currencies other than the U.S. dollar as their functional currency. As a result, all assets and liabilities are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive income loss), a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive income (loss) at December 31, 2020 and 2019. Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts in the foreseeable future, are included in the determination of net loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar. |
Use of Estimates | Use of Estimates In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the 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. In the accompanying consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, stock-based compensation, allowances for doubtful accounts and inventory obsolescence, discount rates used to discount unpaid lease payments to present values, valuation of derivative financial instruments measured at fair value on a recurring basis, deferred tax assets and liabilities and related valuation allowance, determining the fair value of assets acquired and liabilities assumed in business combinations, the estimated useful lives of long-lived assets, and the recoverability of long-lived assets. Actual results could differ from those estimates. |
Fair value of financial instruments | Fair value of financial instruments Financial instruments classified as current assets and liabilities (including cash and cash equivalent, receivables, accounts payable, deferred revenue and short-term notes) are carried at cost, which approximates fair value, because of the short-term maturities of those instruments. For additional fair value disclosures, see Note 6. |
Cash, cash equivalents and restricted cash | Cash and cash equivalents and restricted cash The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limit of $250,000. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. At December 31, 2020 and 2019, the Company had funds totaling $746,792 and $185,380, respectively, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying consolidated balance sheets. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows: December 31, 2020 December 31, 2019 Cash and cash equivalents $ 13,360,463 $ 2,708,223 Restricted cash 746,792 185,380 Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows $ 14,107,255 $ 2,893,603 |
Accounts receivable | Accounts receivable The Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $20,753 as of December 31, 2020 and 2019, respectively. At December 31, 2020, the Company had accounts receivable from one customer which individually represented 20% of total accounts receivable. At December 31, 2019, the Company had accounts receivable from one customer which individually represented 44% of total accounts receivable. For the year ended December 31, 2020, revenue earned from one customer represented 21% of total revenues. For the year ended December 31, 2019, revenue earned from one customer represented 38% of total revenues. |
Inventory | Inventory Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: December 31, 2020 2019 Raw materials and supplies $ 773,021 $ 315,542 Work-in-process 87,159 35,080 Finished goods 2,312,148 122,408 Total $ 3,172,328 $ 473,030 Inventory includes Unyvero instrument systems, Unyvero cartridges, reagents and components for Unyvero, Acuitas, QuickFISH and PNA FISH products, Curetis SARS CoV-2 test kits, and reagents and supplies used for the Company’s laboratory services. Inventory reserves for obsolescence and expirations were $288,378 and $92,454 at December 31, 2020 and 2019, respectively. The Company reviews inventory quantities on hand and analyzes the provision for excess and obsolete inventory based primarily on product expiration dating and its estimated sales forecast, which is based on sales history and anticipated future demand. The Company’s estimates of future product demand may not be accurate, and it may understate or overstate the provision required for excess and obsolete inventory. Accordingly, any significant unanticipated changes in demand could have a significant impact on the value of the Company’s inventory and results of operations. The Company classifies finished good inventory it does not expect to sell or use in clinical studies within 12 months of the consolidated balance sheets date as strategic inventory, a non-current asset. |
Long-lived assets | Long-lived assets Property and equipment Property and equipment is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets. The estimated service lives range from three to ten years. Depreciation expense was $1,152,954 and $186,244 for the years ended December 31, 2020 and 2019, respectively. Property and equipment consisted of the following at December 31, 2020 and 2019: December 31, 2020 2019 Laboratory and manufacturing equipment $ 6,317,340 $ 3,310,290 Office furniture and equipment 1,259,838 631,774 Computers and network equipment 1,692,154 1,469,534 Leasehold improvements 752,493 745,800 10,021,825 6,157,398 Less accumulated depreciation (6,762,338 ) (6,026,639 ) Property and equipment, net $ 3,259,487 $ 130,759 Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the years ended December 31, 2020 and 2019, the Company determined that its property and equipment was not impaired. |
Leases | Leases The Company determines if an arrangement is a lease at inception. For leases where the Company is the lessee, right-of-use (“ROU”) assets represent the Company’s right to use the underlying asset for the term of the lease and the lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the future lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date of the underlying lease arrangement to determine the present value of lease payments. The ROU asset also includes any prepaid lease payments and any lease incentives received. The lease term to calculate the ROU asset and related lease liability includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. The Company’s lease agreements generally do not contain any material variable lease payments, residual value guarantees or restrictive covenants. Lease expense for operating leases is recognized on a straight-line basis over the lease term as an operating expense while expense for financing leases is recognized as depreciation expense and interest expense using the effective interest method of recognition. The Company has made certain accounting policy elections whereby the Company (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12 months or less) and (ii) combines lease and non-lease elements of our operating leases. ROU Assets ROU assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which the Company can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. In conjunction with adoption of Accounting Standards Update (“ASU”) 2016-02, Leases |
Intangible assets and goodwill | Intangible assets and goodwill Intangible assets and goodwill as of December 31, 2020 consist of finite-lived and indefinite-lived intangible assets and goodwill. Finite-lived and indefinite-lived intangible assets Intangible assets include trademarks, developed technology, in-process research & development, software and customer relationships and consisted of the following as of December 31, 2020 and 2019: December 31, 2020 December 31, 2019 Subsidiary Cost Accumulated Amortization Impairment Effect of foreign exchange rates Net Balance Accumulated Amortization Net Balance Trademarks and tradenames AdvanDx $ 461,000 $ (217,413 ) $ (243,587 ) $ — $ — $ (205,887 ) $ 255,113 Developed technology AdvanDx 458,000 (308,526 ) (149,474 ) — — (292,170 ) 165,830 Customer relationships AdvanDx 1,094,000 (736,465 ) (357,535 ) — — (697,393 ) 396,607 Trademarks and tradenames Curetis 1,768,000 (147,161 ) — 194,119 1,814,958 — — Distributor relationships Curetis 2,362,000 (131,070 ) — 259,336 2,490,266 — — A50 - Developed technology Curetis 349,000 (41,504 ) — 38,319 345,815 — — Ares - Developed technology Curetis 5,333,000 (317,060 ) — 585,536 5,601,476 — — A30 - In-Process Research & Development Curetis 5,706,000 — — 622,448 6,328,448 — — $ 17,531,000 $ (1,899,199 ) $ (750,596 ) $ 1,699,758 $ 16,580,963 $ (1,195,450 ) $ 817,550 Identifiable intangible assets will be amortized on a straight-line basis over their estimated useful lives. The estimated useful lives of the intangibles are: Estimated Useful Life Trademarks and tradenames 10 years Customer/distributor relationships 15 years A50 – Developed technology 7 years Ares – Developed technology 14 years A30 – Acquired in-process research & development Indefinite Acquired IPR&D represents the fair value assigned to those research and development projects that were acquired in a business combination for which the related products have not received regulatory approval and have no alternative future use. IPR&D is capitalized at its fair value as an indefinite-lived intangible asset, and any development costs incurred after the acquisition are expensed as incurred. Upon achieving regulatory approval or commercial viability for the related product, the indefinite-lived intangible asset is accounted for as a finite-lived asset and is amortized on a straight-line basis over the estimated useful life. If the project is not completed or is terminated or abandoned, the Company may have an impairment related to the IPR&D which is charged to expense. Indefinite-lived intangible assets are tested for impairment annually and whenever events or changes in circumstances indicate that the carrying amount may be impaired. Impairment is calculated as the excess of the asset’s carrying value over its fair value. The Company reviews the useful lives of intangible assets when events or changes in circumstances occur which may potentially impact the estimated useful life of the intangible assets. Total amortization expense of intangible assets was $672,823 and $267,816 for the years ended December 31, 2020 and 2019, respectively. Expected future amortization of intangible assets is as follows: Year Ending December 31, 2021 $ 849,055 2022 849,055 2023 849,055 2024 849,055 2025 849,055 Thereafter 6,007,240 Total $ 10,252,515 Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. In accordance with ASC 360-10, Property, Plant and Equipment Goodwill Goodwill represents the excess of the purchase price paid when the Company acquired AdvanDx, Inc. in July 2015 and Curetis in April 2020, over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. The Company’s goodwill balance as of December 31, 2020 and 2019 was $ 8,024,729 The the carrying amount of as of December 31, 2020, and since December 31, 2019, were as follows: Balance as of December 31, 2019 $ 600,814 Acquisition of Curetis 6,688,652 Effect of foreign exchange rates 735,263 Balance as of December 31, 2020 $ 8,024,729 The Company conducts an impairment test of goodwill on an annual basis, and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. During the years ended December 31, 2020 and 2019, the Company determined that its goodwill was not impaired. |
Revenue recognition | Revenue recognition The Company derives revenues from (i) the sale of QuickFISH and PNA FISH diagnostic test products, Unyvero Application cartridges, Unyvero Systems, SARS CoV-2 tests, Acuitas AMR Gene Panel RUO test products, (ii) providing laboratory services, and (iii) providing collaboration services including funded software arrangements, and license arrangements. The Company analyzes contracts to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers, (ii) identification of distinct performance obligations in the contract, (iii) determination of contract transaction price, (iv) allocation of contract transaction price to the performance obligations and (v) determination of revenue recognition based on timing of satisfaction of the performance obligation. The Company recognizes revenues upon the satisfaction of its performance obligation (upon transfer of control of promised goods or services to our customers) in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services. The Company defers incremental costs of obtaining a customer contract and amortizes the deferred costs over the period that the goods and services are transferred to the customer. The Company had no material incremental costs to obtain customer contracts in any period presented. Deferred revenue results from amounts billed in advance to customers or cash received from customers in advance of services being provided. |
Government grant agreements and research incentives | Government grant agreements and incentives From time to time, the Company may enter into arrangements with governmental entities for the purposes of obtaining funding for research and development activities. The Company recognizes funding from grants and research incentives received from Austrian government agencies in the consolidated statements of operations and comprehensive loss in the period during which the related qualifying expenses are incurred, provided that the conditions under which the grants or incentives were provided have been met. For grants under funding agreements and for proceeds under research incentive programs, the Company recognizes grant and incentive income in an amount equal to the estimated qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage. The Company classifies government grants received under these arrangements as a reduction to the related research and development expense incurred. The Company analyzes each arrangement on a case-by-case basis. For the year ended December 31, 2020, the Company recognized $495,153 as a reduction of research and development expense related to government grant arrangements. There were no grant proceeds recognized for the year ended December 31, 2019. As of December 31, 2020, the Company had earned but not yet received $413,530 related to these agreements and incentives included in prepaid expenses and other current assets. |
Research and development costs, net | Research and development costs, net Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, fees paid to consultants and outside service partners. |
Stock-based compensation | Stock-based compensation Stock-based compensation expense is recognized at fair value. The fair value of stock-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. A discussion of management’s methodology for developing each of the assumptions used in the Black-Scholes model is as follows: Fair value of common stock For periods prior to the Company’s IPO in May 2015, given the lack of an active public market for the common stock, the Company’s board of directors determined the fair value of the common stock. In the absence of a public market, and as an emerging company with no significant revenues, the Company believed that it was appropriate to consider a range of factors to determine the fair market value of the common stock at each grant date. The factors included: (1) the achievement of clinical and operational milestones by the Company; (2) the status of strategic relationships with collaborators; (3) the significant risks associated with the Company’s stage of development; (4) capital market conditions for life science and medical diagnostic companies, particularly similarly situated, privately held, early stage companies; (5) the Company’s available cash, financial condition and results of operations; (6) the most recent sales of the Company’s preferred stock; and (7) the preferential rights of the outstanding preferred stock. Since the IPO, the Company uses the quoted market price of its common stock as its fair value. Expected volatility Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Until a significant trading history for its common stock develops, the Company has identified several public entities of similar size, complexity and stage of development; accordingly, historical volatility has been calculated using the volatility of this peer group. Expected dividend yield The Company has never declared or paid dividends on its common stock and has no plans to do so in the foreseeable future. Risk-free interest rate This is the U.S. Treasury rate for the day of each option grant during the year, having a term that most closely resembles the expected term of the option. Expected term This is the period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of 10 years. The Company estimates the expected term of the option to be 6.25 years for options with a standard four-year vesting period, using the simplified method. Over time, management will track actual terms of the options and adjust their estimate accordingly so that estimates will approximate actual behavior for similar options. |
Income taxes | Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts. The Company had federal net operating loss (“NOL”) carryforwards of $ 196,511,928 188,282,298 The Company also has foreign NOL carryforwards of $160,540,528 at December 31, 2020 from their foreign subsidiaries. $138,576,755 of those foreign NOL carryforwards are from the Company’s operations in Germany. Despite the NOL carryforwards, the Company may have a current and future tax liability due to the nuances of German tax law around the use of NOL’s within a consolidated group. There is no assurance that the NOL carryforwards will ever be fully utilized. |
Loss per share | Loss per share Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 7.5 million shares and 5.1 million shares as of December 31, 2020 and 2019, respectively |
Adopted accounting pronouncements | Adopted accounting pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) The Company adopted this guidance effective January 1, 2019 using the modified retrospective transition method and the following practical expedients: · The Company did not reassess if any expired or existing contracts are or contain leases. · The Company did not reassess the classification of any expired or existing leases. Additionally, the Company made ongoing accounting policy elections whereby the Company (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12 months or less) and (ii) combines lease and non-lease elements of our operating leases. Upon adoption of the new guidance on January 1, 2019, the Company recorded an operating lease ROU asset of approximately $2.2 million (net of existing deferred rent) and recognized a lease liability of approximately $2.5 million. Prior to the adoption of ASC 842, deferred rent was recorded and amortized to the extent the total minimum rental payments allocated to the period on a straight-line basis exceeded or were less than the cash payments required. The Company adopted Accounting Standards Update 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments Recently issued accounting standards In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes, In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Reform on Financial Reporting The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows: December 31, 2020 December 31, 2019 Cash and cash equivalents $ 13,360,463 $ 2,708,223 Restricted cash 746,792 185,380 Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows $ 14,107,255 $ 2,893,603 |
Schedule of Inventories | Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: December 31, 2020 2019 Raw materials and supplies $ 773,021 $ 315,542 Work-in-process 87,159 35,080 Finished goods 2,312,148 122,408 Total $ 3,172,328 $ 473,030 |
Schedule of Property and equipment | Property and equipment consisted of the following at December 31, 2020 and 2019: December 31, 2020 2019 Laboratory and manufacturing equipment $ 6,317,340 $ 3,310,290 Office furniture and equipment 1,259,838 631,774 Computers and network equipment 1,692,154 1,469,534 Leasehold improvements 752,493 745,800 10,021,825 6,157,398 Less accumulated depreciation (6,762,338 ) (6,026,639 ) Property and equipment, net $ 3,259,487 $ 130,759 |
Schedule of Finite-Lived Intangible Assets | Intangible assets include trademarks, developed technology, In-Process Research & Development, software and customer relationships and consisted of the following as of December 31, 2020 and 2019: December 31, 2020 December 31, 2019 Subsidiary Cost Accumulated Amortization Impairment Effect of foreign exchange rates Net Balance Accumulated Amortization Net Balance Trademarks and tradenames AdvanDx $ 461,000 $ (217,413 ) $ (243,587 ) $ — $ — $ (205,887 ) $ 255,113 Developed technology AdvanDx 458,000 (308,526 ) (149,474 ) — — (292,170 ) 165,830 Customer relationships AdvanDx 1,094,000 (736,465 ) (357,535 ) — — (697,393 ) 396,607 Trademarks and tradenames Curetis 1,768,000 (147,161 ) — 194,119 1,814,958 — — Distributor relationships Curetis 2,362,000 (131,070 ) — 259,336 2,490,266 — — A50 - Developed technology Curetis 349,000 (41,504 ) — 38,319 345,815 — — Ares - Developed technology Curetis 5,333,000 (317,060 ) — 585,536 5,601,476 — — A30 - In-Process Research & Development Curetis 5,706,000 — — 622,448 6,328,448 — — $ 17,531,000 $ (1,899,199 ) $ (750,596 ) $ 1,699,758 $ 16,580,963 $ (1,195,450 ) $ 817,550 |
Schedule of Estimated Useful Lives of Identifiable Intangible Assets | The estimated useful lives of the intangibles are: Estimated Useful Life Trademarks and tradenames 10 years Customer/distributor relationships 15 years A50 – Developed technology 7 years Ares – Developed technology 14 years A30 – Acquired in-process research & development Indefinite |
Schedule of Expected Amortization of Intangible Assets | Total amortization expense of intangible assets was $672,823 and $267,816 for the years ended December 31, 2020 and 2019, respectively. Expected future amortization of intangible assets is as follows: Year Ending December 31, 2021 $ 849,055 2022 849,055 2023 849,055 2024 849,055 2025 849,055 Thereafter 6,007,240 Total $ 10,252,515 |
Schedule of Changes in Carrying Amount of Goodwill | The the carrying amount of as of December 31, 2020, and since December 31, 2019, were as follows: Balance as of December 31, 2019 $ 600,814 Acquisition of Curetis 6,688,652 Effect of foreign exchange rates 735,263 Balance as of December 31, 2020 $ 8,024,729 |
Business Combination (Tables)
Business Combination (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Business Combinations [Abstract] | |
Schedule of Components of Purchase Price and Net Assets Acquired | The components of the purchase price and net assets acquired are as follows: Purchase Price Number of shares issued to Curetis N.V 2,028,208 Multiplied by the market value per share of OpGen's common stock (i) $ 2.39 Total fair value of common stock issued to Curetis N.V shareholders 4,847,417 Fair value of replacement stock awards related to precombination service (ii) 136,912 Fair value of convertible notes assumed (iii) 1,323,750 Fair value of EIB debt assumed (iv) 15,784,892 Funds advanced to Curetis GmbH under Interim Facility 4,808,712 Cash, cash equivalents, and restricted cash acquired (1,266,849) $ 25,634,834 (i) The price per share of OpGen’s common stock was based on the closing price as reported on the Nasdaq Capital Market on April 1, 2020. (ii) The fair value of the stock options assumed was determined using the Black-Scholes option pricing model. (iii) To derive the fair value of the convertible notes, the Company estimated the fair value of the convertible notes with and without the derivative liability using a scenario analysis and Monte Carlo simulation. (iv) The fair value of the EIB debt is determined using a discounted cash flow analysis with current applicable rates for similar instruments. |
Schedule of Net Assets Acquired | Net Assets Acquired Assets acquired Receivables $ 482,876 Inventory 2,022,577 Property and equipment 3,802,431 Right of use assets 1,090,812 Other current assets 925,364 Finite-lived intangible assets Trade names/trademarks 1,768,000 Customer/distributor relationships 2,362,000 A50 - Developed technology 349,000 Ares - Developed technology 5,333,000 Indefinite-lived intangible assets A30 - In-process research & development 5,706,000 Goodwill 6,688,652 Liabilities assumed Accounts payable (1,168,839 ) Accrued expenses and other current liabilities (1,953,927 ) Derivative liabilities (615,831 ) Lease liabilities (1,108,193 ) Other long-term liabilities (49,088 ) Net assets acquired $ 25,634,834 |
Schedule of Unaudited Pro Forma Results | The following unaudited pro forma financial information summarizes the results of operations for the periods indicated as if the Transaction had been completed as of January 1, 2019. Pro forma information primarily reflects adjustments relating to the amortization of intangibles acquired and elimination of interest expense due under the interim facility. The pro forma amounts do not purport to be indicative of the results that would have actually been obtained if the acquisition occurred as of January 1, 2019 or that may be obtained in the future. Unaudited pro forma results Years ended December 31, 2020 2019 Revenues $ 5,239,192 $ 6,053,766 Net loss (29,319,303 ) (38,435,605 ) Net loss per share (1.86 ) (23.77 ) |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Revenues by Type of Service | The Company provides diagnostic test products, laboratory services to hospitals, clinical laboratories and other healthcare provider customers, and enters into collaboration agreements with government agencies and healthcare providers. The revenues by type of service consist of the following: Years Ended December, 2020 2019 Product sales $ 2,704,364 $ 2,168,179 Laboratory services 167,736 5,435 Collaboration revenue 1,342,341 1,325,000 Total revenue $ 4,214,441 $ 3,498,614 Revenues by geography are as follows: Years Ended December, 2020 2019 Domestic $ 1,917,367 $ 3,322,615 International 2,297,074 175,999 Total revenue $ 4,214,441 $ 3,498,614 |
Summary of Changes in Deferred Revenue | Deferred revenue Changes in deferred revenue for the period were as follows: Balance at December 31, 2019 $ 9,808 Acquired deferrals from Curetis 829,275 Revenue recognized in the current period from the amounts in the beginning balance — Revenue recognized in the current period from the amounts acquired from Curetis (870,114 ) Effect of foreign exchange rates 40,839 Balance at December 31, 2020 $ 9,808 |
Fair value measurements (Tables
Fair value measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | The fair value of level 3 liabilities measured at fair value on a recurring basis for the year ended December 31, 2020 was as follows: Description Balance at December 2019 Acquired from Curetis Change in Fair Value Effect of Foreign Exchange Rates Balance at December 31, 2020 Participation percentage interest liability $ — $ 173,373 $ (75,222 ) $ 14,701 $ 112,852 Embedded conversion option liability — 442,458 (442,458 ) — — Total revenue $ — $ 615,831 $ (517,680 ) $ 14,701 $ 112,852 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt and Short-term Borrowings | The following table summarizes the Company’s long-term debt and short-term borrowings as December 31, 2020 and 2019: December 31, 2020 2019 EIB $ 25,936,928 $ — PPP 259,353 — MGHIF 331,904 662,789 Insurance financings 107,742 40,266 Total debt obligations 26,635,927 703,055 Unamortized debt discount (6,557,992 ) — Carrying value of debt 20,077,935 703,055 Less current portion (699,000 ) (373,599 ) Long-term debt $ 19,378,935 $ 329,456 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Company Recognized Stock-Based Compensation Expense | For the years ended December 31, 2020 and 2019, the Company recognized stock compensation expense as follows: Years Ended December 31, 2020 2019 Cost of services $ 2,927 $ 2,781 Research and development 62,783 74,841 General and administrative 231,010 269,292 Sales and marketing 19,366 25,956 $ 316,086 $ 372,870 |
Schedule of Status of Options Granted | A summary of the status of options granted is presented below as of and for the years ended December 31, 2020 and 2019: Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at January 1, 2019 10,578 $ 411.60 7.6 $ 522 Granted — $ — Exercised — $ — Forfeited (302 ) $ 222.17 Expired (622 ) $ 269.87 Outstanding at December 31, 2019 9,654 $ 418.10 8.0 $ — Granted 1,525,000 $ 2.13 Exercised — $ — Assumed in business combination 134,371 $ 48.40 Forfeited (3,631 ) $ 21.11 Expired (872 ) $ 473.92 Outstanding at December 31, 2020 1,664,522 $ 7.99 9.4 $ — Vested and expected to vest 1,664,522 $ 7.99 9.4 $ — Exercisable at December 31, 2020 — $ — — $ — |
Schedule of Fair Value of Option Grant Estimated Using Black-Scholes Option Pricing Model | The fair value of each option grant was estimated at the date of grant using the Black-Scholes option pricing model based on the assumptions below: Years Ended December 31, 2020 2019 Annual dividend — — Expected life (in years) 5.25 - 6.25 — Risk free interest rate 0.3%-0.5% — Expected volatility 40.9% - 46.6% — |
Schedule of Status of Restricted Stock Unit Granted | A summary of the status of restricted stock units granted is presented below as of and for the years ended December 31, 2020 and 2019: Number of Units Weighted- Average Grant Date Fair Value Unvested at January 1, 2019 12 $ 623.20 Granted 17,150 $ 8.77 Vested (12 ) $ 623.20 Forfeited (2,175 ) $ 8.80 Unvested at December 31, 2019 14,975 $ 8.76 Granted — $ — Vested (5,924 ) $ 8.51 Forfeited (933 ) $ 8.84 Unvested at December 31, 2020 8,118 $ 8.93 |
Schedule of Warrants to Purchase Shares of Common Stock | At December 31, 2020 and 2019, the following warrants to purchase shares of common stock were outstanding: Outstanding at December 31, Issuance Exercise Price Expiration 2020 (1) 2019 (1) January 2010 $ 3,955.00 January 2020 — 17 March 2010 $ 3,955.00 March 2020 — 7 November 2011 $ 3,955.00 November 2021 15 15 December 2011 $ 3,955.00 December 2021 2 2 February 2015 $ 3,300.00 February 2025 451 451 May 2015 $ 3,300.00 May 2020 — 6,697 May 2016 $ 656.20 May 2021 9,483 9,483 June 2016 $ 656.20 May 2021 4,102 4,102 June 2017 $ 390.00 June 2022 938 938 July 2017 $ 345.00 July 2022 318 318 July 2017 $ 250.00 July 2022 2,501 2,501 July 2017 $ 212.60 July 2022 50,006 50,006 February 2018 $ 81.25 February 2023 9,232 9,232 February 2018 $ 65.00 February 2023 92,338 92,338 October 2019 $ 2.00 October 2024 359,000 4,700,000 October 2019 $ 2.60 October 2024 235,000 235,000 November 2020 $ 1.94 May 2026 4,842,615 — November 2020 $ 2.68 May 2026 242,130 — 5,848,131 5,111,107 The warrants listed above were issued in connection with various equity, debt, preferred stock or development contract agreements. (1) Warrants to purchase fractional shares of common stock resulting from the reverse stock split on August 22, 2019 were rounded up to the next whole share of common stock on a holder by holder basis. |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision Income Taxes Expense | The Company’s provision for income taxes consists of the following for the years ended December 31, 2020 and 2019: December 31, 2020 2019 Current income tax provision Federal $ — $ — State — — Foreign 132,403 — Total 132,403 $ — Deferred income tax provision Federal — — State — — Foreign — — Total — — Total provision for income taxes $ 132,403 — |
Schedule of Deferred Tax Assets and Liabilities | The Company’s deferred tax assets and liabilities as of December 31, 2020 and 2019 are as follows: December 31, 2020 2019 Deferred tax assets: NOL carryforward $ 98,165,790 $ 51,247,762 R&E credit carryforward 2,559,479 2,559,479 Share-based compensation 319,397 325,571 Inventory reserve — 23,213 Depreciation 100,157 1,754 Interest expense 1,233,203 95,077 ROU liabilities 475,645 — Accruals and other 331,631 286,692 Total deferred tax assets 103,185,302 54,539,548 Valuation allowance (98,874,420 ) (54,359,488 ) Deferred tax liabilities: Intangible assets (3,885,485 ) (180,060 ) ROU assets (425,397 ) — Net $ — $ — |
Schedule of Expected Income Tax Provision (Benefit) from Applying Federal Statutory Tax Rates to the Pre-Tax Loss and Actual Income Tax Provision (Benefit) | The difference between the Company’s expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax loss and actual income tax provision (benefit) relates to the effect of the following: 2020 2019 Federal income tax benefit at statutory rates 21.0 % 21.0 % Permanent adjustment 0.6 % (1.9 )% Provision to return adjustment — 0.4 % State income tax benefit, net of federal benefit 3.5 % 4.4 % Foreign rate differential 2.8 % — Change in valuation allowance (28.4 )% (23.9 )% (0.5 )% 0.0 % |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Schedule of ROU Assets and Lease Liabilities | The following table presents the Company’s ROU assets and lease liabilities as of December 31, 2020 and 2019: Lease Classification December 31, 2020 December 31, 2019 ROU Assets: Operating $ 2,082,300 $ 1,043,537 Financing 449,628 958,590 Total ROU assets $ 2,531,928 $ 2,002,127 Liabilities Current: Operating $ 964,434 $ 1,017,414 Finance 266,470 579,030 Noncurrent: Operating 1,492,544 547,225 Finance 46,794 313,263 Total lease liabilities $ 2,770,242 $ 2,456,932 |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities as of December 31, 2020 by year are as follows: Maturity of Lease Liabilities Operating Finance Total 2021 $ 1,005,811 $ 281,914 $ 1,287,725 2022 570,656 45,374 616,030 2023 424,495 3,364 427,859 2024 433,872 280 434,152 2025 409,055 — 409,055 Thereafter 2,782,432 — 2,782,432 Total lease payments 5,626,321 330,932 5,957,253 Less: Interest (1,957,343 ) (17,668 ) (1,975,011 ) Less: Tenant improvement allowance (1) (1,212,000 ) — (1,212,000 ) Present value of lease liabilities $ 2,456,978 $ 313,264 $ 2,770,242 (1) In accordance with ASC 842, a tenant allowance should be included in the measurement of the consideration in the lease agreement at inception and reflected as a reduction to the right-of-use asset and a corresponding reduction to the right-use-liability if the lessee both controls the construction of the tenant improvements and the expects to fully earn all of the tenant allowance. OpGen has met both conditions at the inception of its Rockville, Maryland lease and has recorded the Tenant Improvement Allowance accordingly. As the cash for the Tenant Improvement Allowance is received from the lessor under the terms of the Rockville, Maryland lease, the corresponding right-of-use liability will increase and will be amortized as part of the right-of use asset and liability amortization over the term of the Rockville, Maryland Lease in accordance with ASC 842. |
Schedule of Statement of Operations Classification of Lease Costs and Other Information | Consolidated statements of operations classification of lease costs as of the years ended December 31, 2020 and 2019 are as follows: Years ended December 31, Lease Cost Classification 2020 2019 Operating Operating expenses $ 1,205,551 $ 869,968 Finance: Amortization Operating expenses 508,962 467,319 Interest expense Other expenses 57,247 75,018 Total lease costs $ 1,771,760 $ 1,412,305 Other lease information as of December 31, 2020 is as follows: Other Information Total Weighted average remaining lease term (in years) Operating leases 8.7 Finance leases 1.1 Weighted average discount rate: Operating leases 7.0 % Finance leases 9.7 % |
Schedule of Supplemental Cash Flow Information | Supplemental cash flow information for the years ended December 31, 2020, and 2019 is as follows: Supplemental Cash Flow Information 2020 2019 Cash paid for amounts included in the measurement of lease liabilities Cash used in operating activities Operating leases $ 1,205,551 $ 869,968 Finance leases $ 57,247 $ 75,018 Cash used in financing activities Finance leases $ 579,029 $ 535,931 ROU assets obtained in exchange for lease obligations: Operating leases $ 1,008,039 $ — Finance leases $ — $ 592,013 |
Going Concern and Management'_2
Going Concern and Management's Plans (Details) - USD ($) | Mar. 09, 2021 | Feb. 11, 2021 | Mar. 29, 2019 | Dec. 31, 2020 | Nov. 25, 2020 | Nov. 23, 2020 | Oct. 28, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Mar. 12, 2021 | Feb. 11, 2020 |
Conversion of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 15,821,922 | $ 4,782,509 | |||||||||
Common Stock [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Offering of common stock and warrants | 4,842,615 | 5,150,000 | |||||||||
Stock issued during period, shares, new issues | 7,521,610 | ||||||||||
October 2019 Public Offering [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,590,170 | ||||||||||
Shares issued, price per share | $ 2 | ||||||||||
Each unit includes number of common shares apart from warrants | 1 | ||||||||||
Each unit includes number of common stock warrants apart from common stock | 1 | ||||||||||
Each prefunded unit included number prefunded warrants apart from common stock warrants | 1 | ||||||||||
Each prefunded unit included number common stock warrants apart from prefunded warrants | 1 | ||||||||||
Sale of stock, description of transaction | Each unit included one share of common stock and one common warrant to purchase one share of common stock at an exercise price of $2.00 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase one share of common stock at an exercise price of $2.00 per share. | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 2 | ||||||||||
Warrants exercisable period | 5 years | ||||||||||
October 2019 Public Offering [Member] | Pre Funded Warrant [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Warrants exercised | 2,109,830 | ||||||||||
October 2019 Public Offering [Member] | Pre-funded Units [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,109,830 | ||||||||||
Shares issued, price per share | $ 1.99 | ||||||||||
Gross proceeds from sale of common stock and warrants | $ 9,400,000 | ||||||||||
Net proceeds from sale of common stock and warrants | $ 8,300,000 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | ||||||||||
Warrants exercised | 2,109,830 | ||||||||||
October 2019 Public Offering [Member] | Common Stock [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 8,700,000 | ||||||||||
March 2019 Public Offering [Member] | Common Stock [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 450,000 | ||||||||||
Shares issued, price per share | $ 12 | ||||||||||
Gross proceeds from sale of common stock | $ 5,400,000 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 4,800,000 | ||||||||||
Healthcare-focused Institutional Investor [Member] | February 2021 Offering [Member] | Subsequent Event [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,784,184 | ||||||||||
Gross proceeds from sale of common stock | $ 25,000,000 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 23,400,000 | ||||||||||
Healthcare-focused Institutional Investor [Member] | February 2021 Offering [Member] | Subsequent Event [Member] | Pre Funded Warrant [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 5,549,149 | ||||||||||
Sale of stock, description of transaction | Each pre-funded warrant exercisable for one share of common stock. | ||||||||||
Investor [Member] | February 2021 Offering [Member] | Subsequent Event [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Offering of common stock and warrants | 4,166,666 | ||||||||||
Shares issued, price per share | $ 3 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.55 | ||||||||||
Warrants exercisable period | 6 months | ||||||||||
Warrants expiry period | 5 years 6 months | ||||||||||
Investor [Member] | February 2021 Offering [Member] | Subsequent Event [Member] | Pre Funded Warrant [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Shares issued, price per share | $ 2.99 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | ||||||||||
Healthcare-focused U.S. Institutional Investor [Member] | 2020 PIPE [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,245,400 | ||||||||||
Shares issued, price per share | $ 2.065 | ||||||||||
Gross proceeds from sale of common stock | $ 10,000,000 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 9,300,000 | ||||||||||
Sale of stock, description of transaction | Eeach pre-funded warrant exercisable for one share of common stock. | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.94 | ||||||||||
Warrants exercisable period | 6 months | ||||||||||
Warrants exercised | 4,842,615 | ||||||||||
Warrants expiry period | 5 years 6 months | ||||||||||
New warrants issue against outstanding warrants | 2,245,400 | ||||||||||
Healthcare-focused U.S. Institutional Investor [Member] | 2020 PIPE [Member] | Pre Funded Warrant [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,597,215 | ||||||||||
Shares issued, price per share | $ 2.055 | ||||||||||
Warrants exercised | 2,597,215 | ||||||||||
New warrants issue against outstanding warrants | 2,597,215 | ||||||||||
Warrant [Member] | Holder [Member] | Purchase Agreement [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Offering of common stock and warrants | 4,842,615 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.94 | ||||||||||
Warrants expiry period | 5 years 6 months | ||||||||||
Warrant [Member] | Holder [Member] | Exercise Agreement [Member] | Subsequent Event [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.56 | $ 0.08125 | |||||||||
Warrants expiry period | 5 years | ||||||||||
Number of warrants outstanding | 4,842,615 | ||||||||||
Number of each warrant issue to purchase common stock | 0.65 | ||||||||||
New warrants issue against outstanding warrants | 3,147,700 | ||||||||||
Payment to purchase new warrants | $ 255,751 | ||||||||||
Description of expenses related to purchase warrants | The Company received aggregate gross proceeds before expenses of approximately $9.65 million from the exercise of all of the remaining 4,842,615 outstanding Existing Warrants held by the Holder | ||||||||||
Common Stock [Member] | H.C. Wainwright & Co., LLC [Member] | 2020 ATM Offering [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 7,521,610 | ||||||||||
Gross proceeds from sale of common stock | $ 16,700,000 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | 15,800,000 | ||||||||||
Common Stock [Member] | H.C. Wainwright & Co., LLC [Member] | 2020 ATM Offering [Member] | Maximum [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Common shares available for future issuance amount | $ 22,100,000 | ||||||||||
Common Warrants [Member] | October 2019 Public Offering [Member] | |||||||||||
Conversion of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 8,700,000 | ||||||||||
Warrants exercised | 359,000 | 4,341,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Jan. 02, 2019 | |
Significant Accounting Policies [Line Items] | |||
FDIC limit of insurable cash | $ 250,000 | ||
Letters of credit outstanding, amount | 746,792 | $ 185,380 | |
Allowance for doubtful accounts receivable | 20,753 | 20,753 | |
Inventory valuation reserves | 288,378 | 92,454 | |
Amortization of intangible assets | 672,823 | 267,816 | |
Impairment of finite-lived intangible assets | $ 750,596 | ||
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | ||
Goodwill | $ 8,024,729 | $ 600,814 | |
Finite-lived intangible assets, fair value | $ 0 | ||
Antidilutive securities excluded from computation of earnings per share, amount | 7,500,000 | 5,100,000 | |
Operating lease right of use asset | $ 2,082,300 | $ 1,043,537 | $ 2,200,000 |
Operating lease liability | 2,456,978 | $ 2,500,000 | |
Depreciation expense | 1,152,954 | 186,244 | |
Research and development expense to government grant | 495,153 | ||
Earned but not yet received | 413,530 | ||
Domestic Country [Member] | |||
Significant Accounting Policies [Line Items] | |||
Operating loss carryforwards | $ 196,511,928 | 188,282,298 | |
Operating loss carryforwards, expiration terms | begin to expire in 2022 | ||
Foreign [Member] | |||
Significant Accounting Policies [Line Items] | |||
Operating loss carryforwards | $ 160,540,528 | ||
Operating loss carryforwards, foreign subsidiaries | $ 138,576,755 | ||
Minimum [Member] | |||
Significant Accounting Policies [Line Items] | |||
Accounts receivable period due | 30 days | ||
Fair value assumptions, expected term | 5 years 2 months 30 days | ||
Maximum [Member] | |||
Significant Accounting Policies [Line Items] | |||
Accounts receivable period due | 60 days | ||
Fair value assumptions, expected term | 6 years 2 months 30 days | ||
Employee Stock Option [Member] | Minimum [Member] | |||
Significant Accounting Policies [Line Items] | |||
Fair value assumptions, expected term | 6 years 2 months 30 days | ||
Employee Stock Option [Member] | Maximum [Member] | |||
Significant Accounting Policies [Line Items] | |||
Fair value assumptions, expected term | 10 years | ||
ASU 2016-02 [Member] | |||
Significant Accounting Policies [Line Items] | |||
Impairment charge | $ 101,838 | $ 520,759 | |
Customer One [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | |||
Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 20.00% | 44.00% | |
Customer One [Member] | Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | |||
Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 21.00% | 38.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash) (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||
Cash and cash equivalents | $ 13,360,463 | $ 2,708,223 |
Restricted cash | 746,792 | 185,380 |
Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows | $ 14,107,255 | $ 2,893,603 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Schedule of Inventories) (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Inventories | ||
Raw materials and supplies | $ 773,021 | $ 315,542 |
Work-in-process | 87,159 | 35,080 |
Finished goods | 2,312,148 | 122,408 |
Total | $ 1,485,986 | $ 473,030 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies (Schedule of Property and equipment) (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Property and equipment, Gross | $ 10,021,825 | $ 6,157,398 |
Less accumulated depreciation | (6,762,338) | (6,026,639) |
Property and equipment, net | 3,259,487 | 130,759 |
Laboratory and manufacturing equipment [Member] | ||
Property and equipment, Gross | 6,317,340 | 3,310,290 |
Office furniture and equipment [Member] | ||
Property and equipment, Gross | 1,259,838 | 631,774 |
Computers and network equipment [Member] | ||
Property and equipment, Gross | 1,692,154 | 1,469,534 |
Leasehold improvements [Member] | ||
Property and equipment, Gross | $ 752,493 | $ 745,800 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies (Schedule of Finite-Lived Intangible Assets) (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 17,531,000 | $ 17,531,000 |
Accumulated Amortization | (1,899,199) | (1,195,450) |
Impairment | (750,596) | |
Effect of foreign exchange rates | 1,699,758 | |
Net Balance | 16,580,963 | 817,550 |
Trademarks and tradenames [Member] | AdvanDx [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 461,000 | 461,000 |
Accumulated Amortization | (217,413) | (205,887) |
Impairment | (243,587) | |
Effect of foreign exchange rates | ||
Net Balance | 255,113 | |
Trademarks and tradenames [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 1,768,000 | 1,768,000 |
Accumulated Amortization | (147,161) | |
Impairment | ||
Effect of foreign exchange rates | 194,119 | |
Net Balance | 1,814,958 | |
Developed Technology [Member] | AdvanDx [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 458,000 | 458,000 |
Accumulated Amortization | (308,526) | (292,170) |
Impairment | (149,474) | |
Effect of foreign exchange rates | ||
Net Balance | 165,830 | |
Customer/distributor relationships [Member] | AdvanDx [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 1,094,000 | 1,094,000 |
Accumulated Amortization | (736,465) | (697,393) |
Impairment | (357,535) | |
Effect of foreign exchange rates | ||
Net Balance | 396,607 | |
Distributor Relationships [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 2,362,000 | 2,362,000 |
Accumulated Amortization | (131,070) | |
Impairment | ||
Effect of foreign exchange rates | 259,336 | |
Net Balance | 2,490,266 | |
A50 - Developed technology [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 349,000 | 349,000 |
Accumulated Amortization | (41,504) | |
Impairment | ||
Effect of foreign exchange rates | 38,319 | |
Net Balance | 345,815 | |
Ares - Developed technology [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 5,333,000 | 5,333,000 |
Accumulated Amortization | (317,060) | |
Impairment | ||
Effect of foreign exchange rates | 585,536 | |
Net Balance | 5,601,476 | |
A30 - Acquired in-process research & development [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 5,706,000 | 5,706,000 |
Accumulated Amortization | ||
Impairment | ||
Effect of foreign exchange rates | 622,448 | |
Net Balance | $ 6,328,448 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies (Schedule of Estimated Useful Lives of Identifiable Intangible Assets) (Details) | 12 Months Ended |
Dec. 31, 2020 | |
A50 - Developed technology [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 7 years |
Ares - Developed technology [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 14 years |
A30 - Acquired in-process research & development [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | Indefinite |
Trademarks and tradenames [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 10 years |
Customer/distributor relationships [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 15 years |
Summary of Significant Accou_10
Summary of Significant Accounting Policies (Schedule of Expected Amortization of Intangible Assets) (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||
2021 | $ 849,055 | |
2022 | 849,055 | |
2023 | 849,055 | |
2024 | 849,055 | |
2025 | 849,055 | |
Thereafter | 6,007,240 | |
Net Balance | $ 16,580,963 | $ 817,550 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies (Schedule of Changes in Carrying Amount of Goodwill) (Details) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Accounting Policies [Abstract] | |
Balance as of December 31, 2019 | $ 600,814 |
Acquisition of Curetis | 6,688,652 |
Effect of foreign exchange rates | 735,263 |
Balance as of December 31, 2020 | $ 8,024,729 |
Business Combination (Narrative
Business Combination (Narrative) (Details) | 12 Months Ended |
Dec. 31, 2020USD ($)shares | |
Customer/distributor relationships [Member] | |
Business Acquisition [Line Items] | |
Weighted-average amortization periods for finite-lived intangible assets acquired | 15 years |
Trademarks and tradenames [Member] | |
Business Acquisition [Line Items] | |
Weighted-average amortization periods for finite-lived intangible assets acquired | 10 years |
Curetis N.V [Member] | Customer/distributor relationships [Member] | |
Business Acquisition [Line Items] | |
Weighted-average amortization periods for finite-lived intangible assets acquired | 15 years |
Curetis N.V [Member] | Developed Technology [Member] | |
Business Acquisition [Line Items] | |
Weighted-average amortization periods for finite-lived intangible assets acquired | 10 years |
Curetis N.V [Member] | Trademarks and tradenames [Member] | |
Business Acquisition [Line Items] | |
Weighted-average amortization periods for finite-lived intangible assets acquired | 10 years |
Curetis N.V [Member] | 2016 Stock Option Plan [Member] | |
Business Acquisition [Line Items] | |
Common stock reserved for future issuance | shares | 134,356 |
Common stock to be issued upon conversion | $ | $ 500,000 |
Business Combination (Schedule
Business Combination (Schedule of Components of Purchase Price and Net Assets Acquired) (Details) - Curetis N.V [Member] | 12 Months Ended | |
Dec. 31, 2020USD ($)$ / sharesshares | ||
Purchase Price | ||
Number of shares issued to Curetis N.V | shares | 2,028,208 | |
Multiplied by the market value per share of OpGen's common stock | $ / shares | $ 2.39 | [1] |
Total fair value of common stock issued to Curetis N.V shareholders | $ 4,847,417 | |
Fair value of replacement stock awards related to precombination service | 136,912 | [2] |
Fair value of convertible notes assumed | 1,323,750 | [3] |
Fair value of EIB debt assumed | 15,784,892 | [4] |
Funds advanced to Curetis GmbH under Interim Facility | 4,808,712 | |
Cash, cash equivalents, and restricted cash acquired | (1,266,849) | |
Purchase Price | $ 25,634,834 | |
[1] | The price per share of OpGen's common stock was based on the closing price as reported on the Nasdaq Capital Market on April 1, 2020. | |
[2] | The fair value of the stock options assumed was determined using the Black-Scholes option pricing model. | |
[3] | To derive the fair value of the convertible notes, the Company estimated the fair value of the convertible notes with and without the derivative liability using a scenario analysis and Monte Carlo simulation. | |
[4] | The fair value of the EIB debt is determined using a discounted cash flow analysis with current applicable rates for similar instruments. |
Business Combination (Schedul_2
Business Combination (Schedule of Net Assets Acquired) (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Assets acquired | ||
Goodwill | $ 8,024,729 | $ 600,814 |
Curetis N.V [Member] | ||
Assets acquired | ||
Receivables | 482,876 | |
Inventory | 2,022,577 | |
Property and equipment | 3,802,431 | |
Right of use assets | 1,090,812 | |
Other current assets | 925,364 | |
Goodwill | 6,688,652 | |
Liabilities assumed | ||
Accounts payable | (1,168,839) | |
Accrued expenses and other current liabilities | (1,953,927) | |
Derivative liabilities | (615,831) | |
Lease liabilities | (1,108,193) | |
Other long-term liabilities | (49,088) | |
Net assets acquired | 25,634,834 | |
Curetis N.V [Member] | Trademarks and tradenames [Member] | ||
Assets acquired | ||
Finite-lived intangible assets | 1,768,000 | |
Curetis N.V [Member] | Customer/distributor relationships [Member] | ||
Assets acquired | ||
Finite-lived intangible assets | 2,362,000 | |
Curetis N.V [Member] | A50 - Developed technology [Member] | ||
Assets acquired | ||
Finite-lived intangible assets | 349,000 | |
Curetis N.V [Member] | Ares - Developed technology [Member] | ||
Assets acquired | ||
Finite-lived intangible assets | 5,333,000 | |
Curetis N.V [Member] | A30 - Acquired in-process research & development [Member] | ||
Assets acquired | ||
Indefinite-lived intangible assets | $ 5,706,000 |
Business Combination (Schedul_3
Business Combination (Schedule of Unaudited Pro Forma Results) (Details) - Curetis N.V [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Business Acquisition [Line Items] | ||
Revenues | $ 5,239,192 | $ 6,053,766 |
Net loss | $ (29,319,303) | $ (38,435,605) |
Net loss per share | $ (1.86) | $ (23.77) |
Revenue from contracts with c_3
Revenue from contracts with customers (Narrative) (Details) | Dec. 31, 2020USD ($) |
Revenue from Contract with Customer [Abstract] | |
Contract assets | $ 18,000 |
Revenue from contracts with c_4
Revenue from contracts with customers (Schedule of Revenues by Type of Service) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 4,214,441 | $ 3,498,614 |
Product sales [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 2,704,364 | 2,168,179 |
Laboratory services [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 167,736 | 5,435 |
Collaborations Revenue [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 1,342,341 | $ 1,325,000 |
Revenue from contracts with c_5
Revenue from contracts with customers (Schedule of Revenues by Geography) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 4,214,441 | $ 3,498,614 |
Domestic [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 1,917,367 | 3,322,615 |
International [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 2,297,074 | $ 175,999 |
Revenue from contracts with c_6
Revenue from contracts with customers (Summary of Changes in Deferred Revenue) (Details) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Revenue Recognition and Deferred Revenue [Abstract] | |
Balance at December 31, 2019 | $ 9,808 |
Acquired deferrals from Curetis | 829,275 |
Revenue recognized in the current period from the amounts in the beginning balance | |
Revenue recognized in the current period from the amounts acquired from Curetis | (870,114) |
Effect of foreign exchange rates | 40,839 |
Balance at December 31, 2020 | $ 9,808 |
Fair value measurements (Narrat
Fair value measurements (Narrative) (Details) | 1 Months Ended | 12 Months Ended | |
Jun. 30, 2019EUR (€) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Impairment of right-of-use asset | $ 101,838 | $ 520,759 | |
Fair Value on Non-Recurring Basis [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Impairment of non-financial assets and liabilities at fair value | 750,596 | ||
Impairment of right-of-use asset | $ 101,838 | ||
Fair Value on Recurring Basis [Member] | Curetis GmbH [Member] | European Investment Bank [Member] | Share-based Payment Arrangement, Tranche One [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Drew down amount | € | € 5,000,000 | ||
Participation percentage interest | 2.10% | ||
Additional payment percentage | 2.10% | ||
Fair Value on Recurring Basis [Member] | Curetis GmbH [Member] | European Investment Bank [Member] | Share-based Payment Arrangement, Tranche One [Member] | Minimum [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Cumulative equity capital raised | € | € 15,000,000 | ||
Fair Value on Recurring Basis [Member] | OpGen's Equity [Member] | European Investment Bank [Member] | Share-based Payment Arrangement, Tranche One [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Participation percentage interest | 0.30% | ||
Maturity period | mid-2024 and mid-2025 |
Fair value measurements (Schedu
Fair value measurements (Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis) (Details) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis | |
Balance at the beginning of the period | |
Acquired from Curetis | 615,831 |
Change in Fair Value | (517,680) |
Effect of Foreign Exchange Rates | 14,701 |
Balance at the end of the period | 112,852 |
Participation percentage interest liability [Member] | |
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis | |
Balance at the beginning of the period | |
Acquired from Curetis | 173,373 |
Change in Fair Value | (75,222) |
Effect of Foreign Exchange Rates | 14,701 |
Balance at the end of the period | 112,852 |
Embedded conversion option liability [Member] | |
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis | |
Balance at the beginning of the period | |
Acquired from Curetis | 442,458 |
Change in Fair Value | (442,458) |
Effect of Foreign Exchange Rates | |
Balance at the end of the period |
Debt (Narrative) (Details)
Debt (Narrative) (Details) | Jul. 10, 2020EUR (€) | Jul. 09, 2020EUR (€) | Jul. 14, 2018USD ($) | Jun. 11, 2018USD ($) | Jun. 17, 2020shares | Feb. 24, 2020$ / sharesshares | Jun. 30, 2019EUR (€) | Jul. 30, 2018USD ($)shares | Jun. 28, 2017shares | Apr. 30, 2017EUR (€) | Jul. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2020EUR (€)shares | Dec. 31, 2019USD ($)$ / shares | Dec. 31, 2016EUR (€) | Dec. 31, 2020EUR (€) | Jul. 10, 2020USD ($) | Apr. 22, 2020USD ($) | Jun. 30, 2018EUR (€) |
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 15,821,922 | $ 4,782,509 | |||||||||||||||||
Common stock, par value | $ / shares | $ 0.01 | $ 0.01 | |||||||||||||||||
Common Stock [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Stock issued during period, shares, new issues | shares | 7,521,610 | 7,521,610 | |||||||||||||||||
EIB [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Fund drawn period | 36 months | ||||||||||||||||||
Percentage of participation percentage interest | 2.10% | ||||||||||||||||||
Fair value of debt | $ 15,800,000 | ||||||||||||||||||
Amount of outstanding borrowings | $ 25,936,000 | ||||||||||||||||||
Deferred interest payable | $ 3,849,000 | ||||||||||||||||||
EIB [Member] | Euro [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Senior unsecured Loan | € | € 25,000,000 | ||||||||||||||||||
Amount of cumulative equity capital raised | € | € 15,000,000 | ||||||||||||||||||
Amount of outstanding borrowings | € | € 21,136,768 | ||||||||||||||||||
Deferred interest payable | € | € 3,136,768 | ||||||||||||||||||
EIB debt financing facility [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Debt instrument, interest rate, stated percentage | 10.00% | ||||||||||||||||||
Debt term | 5 years | ||||||||||||||||||
Defer total interest payments | € | € 720,000 | ||||||||||||||||||
PPP [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Debt instrument, face amount | $ 879,630 | ||||||||||||||||||
Percentage of interest accrues | 1.00% | 1.00% | |||||||||||||||||
Interest expense | $ 3,399,984 | $ 187,549 | |||||||||||||||||
PPP [Member] | Subsidiary Note [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Debt instrument, face amount | $ 259,353 | ||||||||||||||||||
MGHIF Financing Agreement [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Stock issued during period, shares, new issues | shares | 2,273 | ||||||||||||||||||
Shares issued, price per share | $ / shares | $ 2,200 | ||||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 5,000,000 | ||||||||||||||||||
Debt instrument, interest rate, stated percentage | 8.00% | ||||||||||||||||||
Debt instrument, face amount | $ 1,000,000 | ||||||||||||||||||
MGHIF Financing Agreement [Member] | Second Amended and Restated Senior Secured Promissory Note [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Accrued and unpaid interest | $ 285,512 | ||||||||||||||||||
Revised and extended the maturity date, payment terms | Six semi-annual payments | ||||||||||||||||||
Annual payments plus accrued and unpaid interest | $ 166,667 | ||||||||||||||||||
Beginning date of debt maturity | Jan. 2, 2019 | ||||||||||||||||||
Ending date of debt maturity | Jul. 1, 2021 | ||||||||||||||||||
Unamortized debt issuance costs | $ 7,000 | ||||||||||||||||||
MGHIF Financing Agreement [Member] | Second Amended and Restated Senior Secured Promissory Note [Member] | Private Placement [Member] | Common Stock [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Stock issued during period, shares, new issues | shares | 7,212 | ||||||||||||||||||
Accrued and unpaid interest | $ 285,512 | ||||||||||||||||||
Accrued and unpaid interest due date | Jul. 14, 2018 | ||||||||||||||||||
Amended and Restated MGHIF Financing Agreement [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Debt instrument, interest rate, stated percentage | 10.00% | ||||||||||||||||||
Debt instrument, extended maturity date | Jul. 14, 2018 | ||||||||||||||||||
Issuance of common stock warrants to purchase | shares | 656 | ||||||||||||||||||
Assignment Agreement [Member] | Convertible Note [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Stock issued during period, shares, new issues | shares | 763,905 | 763,905 | |||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 1,451,000 | ||||||||||||||||||
Common stock, par value | $ / shares | $ 0.01 | ||||||||||||||||||
Issuance of convertible notes | shares | 450,000 | 500,000 | |||||||||||||||||
Fair value of Convertible notes | $ 1,300,000 | ||||||||||||||||||
Assignment Agreement [Member] | Convertible Note [Member] | Euro [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Unconverted Convertible Notes | € | € 1,300,000 | ||||||||||||||||||
First Tranche [Member] | EIB [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Debt instrument, interest rate, stated percentage | 6.00% | ||||||||||||||||||
Interst rate | EURIBOR plus 4% payable | ||||||||||||||||||
First Tranche [Member] | EIB [Member] | Euro [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Senior unsecured Loan | € | € 10,000,000 | ||||||||||||||||||
Second Tranche [Member] | EIB [Member] | Euro [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Senior unsecured Loan | € | € 3,000,000 | ||||||||||||||||||
Third Tranche [Member] | EIB [Member] | Euro [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Senior unsecured Loan | € | 5,000,000 | ||||||||||||||||||
Four Tranche [Member] | EIB [Member] | Euro [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Senior unsecured Loan | € | € 5,000,000 | ||||||||||||||||||
OpGen's equity value [Member] | EIB [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Percentage of participation percentage interest | 0.30% | ||||||||||||||||||
Five Tranche [Member] | EIB [Member] | Euro [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Senior unsecured Loan | € | € 5,000,000 |
Debt (Schedule of Long-term Deb
Debt (Schedule of Long-term Debt and Short-term Borrowings) (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Instrument [Line Items] | ||
Total debt obligations | $ 26,635,927 | $ 703,055 |
Unamortized debt discount | (6,557,992) | |
Carrying value of debt | 20,077,935 | 703,055 |
Less current portion | (699,000) | (373,599) |
Long-term debt | 19,378,935 | 329,456 |
EIB [Member] | ||
Debt Instrument [Line Items] | ||
Total debt obligations | 25,936,928 | |
PPP [Member] | ||
Debt Instrument [Line Items] | ||
Total debt obligations | 259,353 | |
MGHIF [Member] | ||
Debt Instrument [Line Items] | ||
Total debt obligations | 331,904 | 662,789 |
Insurance financings [Member] | ||
Debt Instrument [Line Items] | ||
Total debt obligations | $ 107,742 | $ 40,266 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) - USD ($) | Apr. 02, 2020 | Dec. 31, 2020 | Nov. 25, 2020 | Mar. 29, 2020 | Oct. 28, 2019 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Feb. 11, 2020 | Jan. 17, 2018 | Jan. 16, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 | 50,000,000 | 200,000,000 | ||||||
Common stock, shares issued | 25,085,534 | 25,085,534 | 5,582,280 | ||||||||
Common stock, shares outstanding | 25,085,534 | 25,085,534 | 5,582,280 | ||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | ||||||||
Preferred stock, shares issued | 0 | 0 | 0 | ||||||||
Preferred stock, shares outstanding | 0 | 0 | 0 | ||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 15,821,922 | $ 4,782,509 | |||||||||
Stock options, granted | 1,525,000 | ||||||||||
Share-based compensation, tax benefit from compensation expense | $ 1,300,000 | ||||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, period for recognition | 3 years 1 month 6 days | ||||||||||
Share-based compensation arrangement by share-based payment award, options, vested in period, fair value | $ 549,341 | $ 375,789 | |||||||||
Restricted Stock Units [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, period for recognition | 1 year 3 months 19 days | ||||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, total | $ 49,000 | $ 49,000 | |||||||||
2015 Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 2,710 | 2,710 | |||||||||
Share-based compensation arrangement by share-based payment award, description | the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. | ||||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 6,025 | 6,025 | |||||||||
Share-based compensation arrangement by share-based payment award, common stock percentage | 4.00% | ||||||||||
2016 Stock Option Plan [Member] | Replacement Awards [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Weighted average grant date fair value of options awarded | $ 1.68 | ||||||||||
Number of share options granted | 134,371 | ||||||||||
Curetis GmbH [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Acquisition of shares | 2,028,208 | ||||||||||
ExecutiveOfficers And Non-Employee Directors [Member] | 2020 Stock Options Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Common shares available for future issuance amount | $ 1,300,000 | ||||||||||
Stock options, granted | 1,300,000 | ||||||||||
Common Stock [Member] | H.C. Wainwright & Co., LLC [Member] | 2020 ATM Offering [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 7,521,610 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 15,800,000 | ||||||||||
Gross proceeds from sale of common stock | 16,700,000 | ||||||||||
Remaining availability under market offering | 5,400,000 | ||||||||||
Common Stock [Member] | H.C. Wainwright & Co., LLC [Member] | 2020 ATM Offering [Member] | Maximum [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Common shares available for future issuance amount | $ 22,100,000 | ||||||||||
March 2019 Public Offering [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 450,000 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 4,800,000 | ||||||||||
Gross proceeds from sale of common stock | $ 5,400,000 | ||||||||||
Shares issued, price per share | $ 12 | ||||||||||
October 2019 Public Offering [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,590,170 | ||||||||||
Shares issued, price per share | $ 2 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 2 | ||||||||||
Warrants exercisable period | 5 years | ||||||||||
October 2019 Public Offering [Member] | Common Warrants [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 8,700,000 | ||||||||||
Warrants exercised | 359,000 | 4,341,000 | |||||||||
October 2019 Public Offering [Member] | Common Stock [Member] | Placement Agent [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 2.60 | ||||||||||
Warrants exercisable period | 5 years | ||||||||||
Issuance of common stock warrants to purchase | 235,000 | ||||||||||
October 2019 Public Offering [Member] | Pre-funded Units [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,109,830 | ||||||||||
Shares issued, price per share | $ 1.99 | ||||||||||
Gross proceeds from sale of common stock and warrants | $ 9,400,000 | ||||||||||
Net proceeds from sale of common stock and warrants | $ 8,300,000 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | ||||||||||
Warrants exercised | 2,109,830 | ||||||||||
October 2019 Public Offering [Member] | Pre Funded Warrant [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Warrants exercised | 2,109,830 | ||||||||||
2020 PIPE [Member] | Healthcare-focused U.S. Institutional Investor [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,245,400 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 9,300,000 | ||||||||||
Gross proceeds from sale of common stock | $ 10,000,000 | ||||||||||
Shares issued, price per share | $ 2.065 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.94 | ||||||||||
Warrants exercisable period | 6 months | ||||||||||
Warrants exercised | 4,842,615 | ||||||||||
Issuance of common stock warrants to purchase | 2,245,400 | ||||||||||
Warrants expiry period | 5 years 6 months | ||||||||||
2020 PIPE [Member] | Pre Funded Warrant [Member] | Healthcare-focused U.S. Institutional Investor [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,597,215 | ||||||||||
Shares issued, price per share | $ 2.055 | ||||||||||
Warrants exercised | 2,597,215 | ||||||||||
Issuance of common stock warrants to purchase | 2,597,215 |
Stockholders' Equity (Schedule
Stockholders' Equity (Schedule of Company Recognized Stock-Based Compensation Expense) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 316,086 | $ 372,870 |
Cost of Services [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 2,927 | 2,781 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 62,783 | 74,841 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 231,010 | 269,292 |
Sales and Marketing [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 19,366 | $ 25,956 |
Stockholders' Equity (Schedul_2
Stockholders' Equity (Schedule of Status of Options Granted) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | |||
Number of Options, Outstanding Balance | 9,654 | 10,578 | |
Number of Options, Granted | 1,525,000 | ||
Number of Options, Exercised | |||
Number of Options, Assumed in business combination | 134,371 | ||
Number of Options, Forfeited | (3,631) | (302) | |
Number of Options, Expired | (872) | (622) | |
Number of Options, Outstanding Balance | 1,664,522 | 9,654 | 10,578 |
Number of Options, Vested and expected to vest | 1,664,522 | ||
Number of Options, Exercisable | |||
Weighted Average Exercise Price, Outstanding Balance | $ 418.10 | $ 411.60 | |
Weighted Average Exercise Price, Granted | 2.13 | ||
Weighted Average Exercise Price, Exercised | |||
Weighted Average Exercise Price, Assumed in business combination | 48.40 | ||
Weighted Average Exercise Price, Forfeited | 21.11 | 222.17 | |
Weighted Average Exercise Price, Expired | 473.92 | 269.87 | |
Weighted Average Exercise Price, Outstanding Balance | 7.99 | $ 418.10 | $ 411.60 |
Weighted Average Exercise Price, Vested and expected to vest | 7.99 | ||
Weighted Average Exercise Price, Exercisable | |||
Weighted-Average Remaining Contractual Life, Outstanding (in years) | 9 years 4 months 24 days | 8 years | 7 years 7 months 6 days |
Weighted-Average Remaining Contractual Life, Vested and expected to vest (in years) | 9 years 4 months 24 days | ||
Weighted-Average Remaining Contractual Life, Exercisable (in years) | 0 years | ||
Aggregate Intrinsic Value, Outstanding | $ 522 | ||
Aggregate Intrinsic Value, Outstanding | $ 522 | ||
Aggregate Intrinsic Value, Vested and expected to vest | |||
Aggregate Intrinsic Value, Exercisable |
Stockholders' Equity (Schedul_3
Stockholders' Equity (Schedule of Fair Value of Option Grant Estimated Using Black-Scholes Option Pricing Model) (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Annual dividend | ||
Risk free interest rate, minimum | 0.30% | |
Risk free interest rate, maximum | 0.50% | |
Expected volatility, minimum | 40.90% | |
Expected volatility, maximum | 46.60% | |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 5 years 2 months 30 days | |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 6 years 2 months 30 days |
Stockholders' Equity (Schedul_4
Stockholders' Equity (Schedule of Status of Restricted Stock Unit Granted) (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Stockholders' Equity Note [Abstract] | ||
Number of Options, Outstanding Balance | 14,975 | 12 |
Number of Options, Granted | 17,150 | |
Number of Options, Vested | (5,924) | (12) |
Number of Options, Forfeited | (933) | (2,175) |
Number of Options, Outstanding Balance | 8,118 | 14,975 |
Weighted Average Grant Date Fair Value, Outstanding Balance | $ 8.76 | $ 623.20 |
Weighted Average Grant Date Fair Value, Granted | 8.77 | |
Weighted Average Grant Date Fair Value, Vested | 8.51 | 623.20 |
Weighted Average Grant Date Fair Value, Forfeited | 8.84 | 8.80 |
Weighted Average Grant Date Fair Value, Outstanding Balance | $ 8.93 | $ 8.76 |
Stockholders' Equity (Warrants
Stockholders' Equity (Warrants to Purchase Shares of Common Stock) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares of Common Stock Subject to Warrants | [1] | 5,848,131 | 5,111,107 |
January 2010 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 3,955 | ||
Expiration | 2020-01 | ||
Shares of Common Stock Subject to Warrants | [1] | 17 | |
March 2010 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 3,955 | ||
Expiration | 2020-03 | ||
Shares of Common Stock Subject to Warrants | [1] | 7 | |
November 2011 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 3,955 | ||
Expiration | 2021-11 | ||
Shares of Common Stock Subject to Warrants | [1] | 15 | 15 |
December 2011 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 3,955 | ||
Expiration | 2021-12 | ||
Shares of Common Stock Subject to Warrants | [1] | 2 | 2 |
February 2015 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 3,300 | ||
Expiration | 2025-02 | ||
Shares of Common Stock Subject to Warrants | [1] | 451 | 451 |
May 2015 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 3,300 | ||
Expiration | 2020-05 | ||
Shares of Common Stock Subject to Warrants | [1] | 6,697 | |
May 2016 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 656.20 | ||
Expiration | 2021-05 | ||
Shares of Common Stock Subject to Warrants | [1] | 9,483 | 9,483 |
June 2016 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 656.20 | ||
Expiration | 2021-05 | ||
Shares of Common Stock Subject to Warrants | [1] | 4,102 | 4,102 |
June 2017 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 390 | ||
Expiration | 2022-06 | ||
Shares of Common Stock Subject to Warrants | [1] | 938 | 938 |
July 2017 [Member] | Warrants Exercise Price One [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 345 | ||
Expiration | 2022-07 | ||
Shares of Common Stock Subject to Warrants | [1] | 318 | 318 |
July 2017 [Member] | Warrants Exercise Price Two [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 250 | ||
Expiration | 2022-07 | ||
Shares of Common Stock Subject to Warrants | [1] | 2,501 | 2,501 |
July 2017 [Member] | Warrants Exercise Price Three [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 212.60 | ||
Expiration | 2022-07 | ||
Shares of Common Stock Subject to Warrants | [1] | 50,006 | 50,006 |
February 2018 [Member] | Warrants Exercise Price Four [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 81.25 | ||
Expiration | 2023-02 | ||
Shares of Common Stock Subject to Warrants | [1] | 9,232 | 9,232 |
February 2018 [Member] | Warrants Exercise Price Five [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 65 | ||
Expiration | 2023-02 | ||
Shares of Common Stock Subject to Warrants | [1] | 92,338 | 92,338 |
October 2019 [Member] | Warrants Exercise Price Six [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 2 | ||
Expiration | 2024-10 | ||
Shares of Common Stock Subject to Warrants | [1] | 359,000 | 4,700,000 |
October 2019 [Member] | Warrants Exercise Price Seven [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 2.60 | ||
Expiration | 2024-10 | ||
Shares of Common Stock Subject to Warrants | [1] | 235,000 | 235,000 |
November 2020 [Member] | Warrants Exercise Price Eight [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 1.94 | ||
Expiration | 2026-05 | ||
Shares of Common Stock Subject to Warrants | [1] | 4,842,615 | |
November 2020 [Member] | Warrants Exercise Price Nine [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price | $ 2.68 | ||
Expiration | 2026-05 | ||
Shares of Common Stock Subject to Warrants | [1] | 242,130 | |
[1] | Warrants to purchase fractional shares of common stock resulting from the reverse stock split on August 22, 2019 were rounded up to the next whole share of common stock on a holder by holder basis. |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2017 | |
Income Tax [Line Items] | |||
Loss before income taxes | $ 26,100,000 | $ 12,500,000 | |
Net deferred tax assets | 103,185,302 | 54,359,488 | |
Deferred tax assets, valuation allowance | $ 98,874,420 | $ 54,359,488 | |
Maximum percentage of taxable income in which NOLs permitted to deduct | 80.00% | ||
U.S. federal corporate tax rate | 21.00% | 21.00% | |
Maximum [Member] | |||
Income Tax [Line Items] | |||
U.S. federal corporate tax rate | 35.00% | ||
Minimum [Member] | |||
Income Tax [Line Items] | |||
U.S. federal corporate tax rate | 21.00% | ||
Domestic Country [Member] | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | $ 196,511,928 | $ 188,282,298 | |
Operating loss carryforwards incurred prior to 2018, expiration terms | begin to expire in 2022 | ||
Foreign [Member] | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | $ 160,540,528 |
Income Taxes (Schedule of Provi
Income Taxes (Schedule of Provision for Income Taxes) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Current income tax provision | $ 132,403 | |
Deferred income tax provision | ||
Total provision for income taxes | 132,403 | |
Domestic Country [Member] | ||
Current income tax provision | ||
Deferred income tax provision | ||
State [Member] | ||
Current income tax provision | ||
Deferred income tax provision | ||
Foreign [Member] | ||
Current income tax provision | 132,403 | |
Deferred income tax provision |
Income Taxes (Schedule of Defer
Income Taxes (Schedule of Deferred Tax Assets and Liabilities) (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
NOL carryforward | $ 98,165,790 | $ 51,247,762 |
R&E credit carryforward | 2,559,479 | 2,559,479 |
Share-based compensation | 319,397 | 325,571 |
Inventory reserve | 23,213 | |
Depreciation | 100,157 | 1,754 |
Interest expense | 1,233,203 | 95,077 |
ROU liabilities | 475,645 | |
Accruals and other | 331,631 | 286,692 |
Total deferred tax assets | 103,185,302 | 54,539,548 |
Valuation allowance | (98,874,420) | (54,359,488) |
Deferred tax liabilities: | ||
Intangible assets | (3,885,485) | (180,060) |
ROU assets | (425,397) | |
Net |
Income Taxes (Schedule of Feder
Income Taxes (Schedule of Federal Statutory Tax Rates to the Pre-Tax Loss and Actual Income Tax Provision (Benefit)) (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax benefit at statutory rates | 21.00% | 21.00% |
Permanent adjustment | 0.60% | (1.90%) |
Provision to return adjustment | 0.40% | |
State income tax benefit, net of federal benefit | 3.50% | 4.40% |
Foreign rate differential | 2.80% | |
Change in valuation allowance | (28.40%) | (23.90%) |
Total | (0.50%) | 0.00% |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Life Technologies Corporation Supply Agreement [Member] | Quant Studio Five Real Time PCR Systems [Member] | |
Other Commitments [Line Items] | |
Agregate purchase commitment | $ 3.1 |
Leases (Schedule of ROU Assets
Leases (Schedule of ROU Assets and Lease Liabilities) (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 02, 2019 |
ROU Assets: | |||
Operating | $ 2,082,300 | $ 1,043,537 | $ 2,200,000 |
Financing | 449,628 | 958,590 | |
Total ROU assets | 2,531,928 | 2,002,127 | |
Current: | |||
Operating | 964,434 | 1,017,414 | |
Finance | 266,470 | 579,030 | |
Noncurrent: | |||
Operating | 1,492,544 | 547,225 | |
Finance | 46,794 | 313,263 | |
Total lease liabilities | $ 2,770,242 | $ 2,456,932 |
Leases (Schedule of Maturities
Leases (Schedule of Maturities of Lease Liabilities) (Details) - USD ($) | Dec. 31, 2020 | Jan. 02, 2019 | |
Operating | |||
2021 | $ 1,005,811 | ||
2022 | 570,656 | ||
2023 | 424,495 | ||
2024 | 433,872 | ||
2025 | 409,055 | ||
Thereafter | 2,782,432 | ||
Total lease payments | 5,626,321 | ||
Less: Interest | (1,957,343) | ||
Less: Tenant improvement allowance | [1] | (1,212,000) | |
Present value of lease liabilities | 2,456,978 | $ 2,500,000 | |
Finance | |||
2021 | 281,914 | ||
2022 | 45,374 | ||
2023 | 3,364 | ||
2024 | 280 | ||
2025 | |||
Thereafter | |||
Total lease payments | 330,932 | ||
Less: Interest | (17,668) | ||
Less: Tenant improvement allowance | [1] | ||
Present value of lease liabilities | 313,264 | ||
Total | |||
2021 | 1,287,725 | ||
2022 | 616,030 | ||
2023 | 427,859 | ||
2024 | 434,152 | ||
2025 | 409,055 | ||
Thereafter | 2,782,432 | ||
Total lease payments | 5,957,253 | ||
Less: Interest | (1,975,011) | ||
Less: Tenant improvement allowance | [1] | (1,212,000) | |
Present value of lease liabilities | $ 2,770,242 | ||
[1] | In accordance with ASC 842, a tenant allowance should be included in the measurement of the consideration in the lease agreement at inception and reflected as a reduction to the right-of-use asset and a corresponding reduction to the right-use-liability if the lessee both controls the construction of the tenant improvements and the expects to fully earn all of the tenant allowance. OpGen has met both conditions at the inception of its Rockville, Maryland lease and has recorded the Tenant Improvement Allowance accordingly. As the cash for the Tenant Improvement Allowance is received from the lessor under the terms of the Rockville, Maryland lease, the corresponding right-of-use liability will increase and will be amortized as part of the right-of use asset and liability amortization over the term of the Rockville, Maryland Lease in accordance with ASC 842. |
Leases (Schedule of Statement o
Leases (Schedule of Statement of Operations Classification of Lease Costs) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Lease Cost | ||
Total lease costs | $ 1,771,760 | $ 1,412,305 |
Operating Expense [Member] | ||
Lease Cost | ||
Operating | 1,205,551 | 869,968 |
Amortization | 508,962 | 467,319 |
Other Expense [Member] | ||
Lease Cost | ||
Interest expense | $ 57,247 | $ 75,018 |
Leases (Schedule of Other Infor
Leases (Schedule of Other Information) (Details) | Dec. 31, 2020 |
Weighted average remaining lease term (in years) | |
Operating leases | 8 years 8 months 12 days |
Finance leases | 1 year 1 month 6 days |
Weighted average discount rate: | |
Operating leases | 7.00% |
Finance leases | 9.70% |
Leases (Schedule of Supplementa
Leases (Schedule of Supplemental Cash Flow Information) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash used in operating activities | ||
Operating leases | $ 1,205,551 | $ 869,968 |
Finance leases | 57,247 | 75,018 |
Cash used in financing activities | ||
Finance leases | 579,029 | 535,931 |
ROU assets obtained in exchange for lease obligations | ||
Operating leases | 1,008,039 | |
Finance leases | $ 592,013 |
License agreements, research _2
License agreements, research collaborations and development agreements (Details) - USD ($) | Jul. 13, 2020 | Dec. 31, 2020 | Dec. 31, 2019 |
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Revenue from contract | $ 4,214,441 | $ 3,498,614 | |
Royalty expense | (68,854) | 250,000 | |
Annual future minimum royalty payments due | |||
Settlement fee | $ 350,000 | ||
Royalty percentage on sale of products | 10.00% | ||
Collaborations Revenue [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Revenue from contract | $ 1,342,341 | 1,325,000 | |
New York State Department of Health and ILUM Health Solutions, LLC [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Collaboration revenue receivable over 12 months of the project | $ 1,600,000 | ||
Contractual agreement period | 15 months | ||
New York State Department of Health and ILUM Health Solutions, LLC [Member] | Collaborations Revenue [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Revenue from contract | $ 388,000 | $ 1,325,000 | |
OpGen [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Contract value | $ 450,000 | ||
Qiagen [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Contractual agreement period | 20 years | ||
Global leading IVD corporation [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Contractual agreement period | 10 months | ||
Revenue from contract | $ 870,000 | ||
Option fees received | $ 1,200,000 | $ 550,000 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | Mar. 09, 2021 | Feb. 11, 2021 | Mar. 31, 2021 | Nov. 23, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Mar. 12, 2021 |
Subsequent Event [Line Items] | |||||||
Proceeds from issuance of common stock, net of issuance costs | $ 15,821,922 | $ 4,782,509 | |||||
Subsequent Event [Member] | Office and Laboratory Space [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Operating lease option to extend | The extension is for four years beginning in September of 2021 with an optional four year extension through September 2029. | ||||||
Minimum operating lease payments | $ 810,000 | ||||||
Healthcare-focused Institutional Investor [Member] | February 2021 Offering [Member] | Subsequent Event [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Stock issued during period, shares, new issues | 2,784,184 | ||||||
Gross proceeds from sale of common stock | $ 25,000,000 | ||||||
Proceeds from issuance of common stock, net of issuance costs | $ 23,400,000 | ||||||
Healthcare-focused Institutional Investor [Member] | February 2021 Offering [Member] | Subsequent Event [Member] | Pre Funded Warrant [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Stock issued during period, shares, new issues | 5,549,149 | ||||||
Sale of stock, description of transaction | Each pre-funded warrant exercisable for one share of common stock. | ||||||
Investor [Member] | February 2021 Offering [Member] | Subsequent Event [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Offering of common stock and warrants | 4,166,666 | ||||||
Shares issued, price per share | $ 3 | ||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.55 | ||||||
Warrants exercisable period | 6 months | ||||||
Warrants expiry period | 5 years 6 months | ||||||
Investor [Member] | February 2021 Offering [Member] | Subsequent Event [Member] | Pre Funded Warrant [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Shares issued, price per share | $ 2.99 | ||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | ||||||
Holder [Member] | Purchase Agreement [Member] | Warrant [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Offering of common stock and warrants | 4,842,615 | ||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.94 | ||||||
Warrants expiry period | 5 years 6 months | ||||||
Holder [Member] | Exercise Agreement [Member] | Subsequent Event [Member] | Warrant [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.56 | $ 0.08125 | |||||
Warrants expiry period | 5 years | ||||||
Number of warrants outstanding | 4,842,615 | ||||||
Number of each warrant issue to purchase common stock | 0.65 | ||||||
New warrants issue against outstanding warrants | 3,147,700 | ||||||
Payment to purchase new warrants | $ 255,751 | ||||||
Description of expenses related to purchase warrants | The Company received aggregate gross proceeds before expenses of approximately $9.65 million from the exercise of all of the remaining 4,842,615 outstanding Existing Warrants held by the Holder |