Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 15, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Entity Registrant Name | EMMAUS LIFE SCIENCES, INC. | ||
Entity Central Index Key | 0001420031 | ||
Document Type | 10-K | ||
Trading Symbol | EMMA | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity a Well-known Seasoned Issuer | No | ||
Entity a Voluntary Filer | No | ||
Entity's Reporting Status Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 390,094,571 | ||
Entity Common Stock, Shares Outstanding | 35,867,637 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2018 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
CURRENT ASSETS | ||
Cash and cash equivalents ($13,175,071 and $0 attributable to the VIE) | $ 17,079,734 | $ 15,836,063 |
Restricted cash | 6,720,000 | |
Accounts receivable | 1,351,395 | 26,814 |
Inventories, net | 4,704,571 | 625,299 |
Investment in marketable securities | 49,342,776 | 99,836,397 |
Marketable securities, pledged to creditor | 238,304 | 160,925 |
Income tax receivable | 9,648 | |
Prepaid expenses and other current assets ($272,670 and $0 attributable to the VIE) | 733,008 | 290,371 |
Total current assets | 73,459,436 | 123,495,869 |
PROPERTY AND EQUIPMENT, NET | 151,686 | 105,302 |
OTHER ASSETS | ||
Long-term investment at cost | 538,202 | 65,520 |
Intangibles, net | 53,760 | 67,200 |
Deposits and other assets | 352,103 | 111,581 |
Total other assets | 944,065 | 244,301 |
Total assets | 74,555,187 | 123,845,472 |
CURRENT LIABILITIES | ||
Accounts payable and accrued expenses | 9,123,475 | 5,695,310 |
Deferred rent | 18,725 | 30,078 |
Other current liabilities | 5,180,733 | 10,109 |
Warrant derivative liabilities | 26,377,000 | |
Notes payable, net | 6,394,161 | 7,871,143 |
Notes payable to related parties, net | 467,806 | 2,036,261 |
Convertible notes payable, net | 11,253,348 | 7,025,002 |
Convertible notes payable to related parties, net | 5,088,542 | 400,000 |
Total current liabilities | 37,526,790 | 49,444,903 |
LONG-TERM LIABILITIES | ||
Deferred rent | 267,694 | 10,821 |
Other long-term liabilities | 36,221,500 | 36,852,290 |
Warrant derivative liabilities | 1,399,000 | 1,882,000 |
Notes payable, net | 1,021,395 | |
Conversion option liabilities | 1,289,000 | |
Convertible notes payable, net | 5,484,551 | 20,075,780 |
Convertible notes payable to related parties, net | 8,528,540 | |
Total long-term liabilities | 52,922,680 | 60,109,891 |
Total liabilities | 90,449,470 | 109,554,794 |
STOCKHOLDERS’ EQUITY (DEFICIT) | ||
Preferred stock — par value $0.001 per share, 20,000,000 shares authorized, none issued and outstanding | ||
Common stock — par value $0.001 per share, 100,000,000 shares authorized, 35,558,305 shares and 34,885,506 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 35,559 | 34,886 |
Additional paid-in capital | 140,903,946 | 113,111,745 |
Accumulated other comprehensive income (loss) | (69,127) | 41,275,785 |
Accumulated deficit | (156,667,567) | (140,131,738) |
Total stockholders’ equity (deficit) | (15,797,189) | 14,290,678 |
Noncontrolling interests | (97,094) | |
Total liabilities & stockholders’ equity (deficit) | $ 74,555,187 | $ 123,845,472 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, authorized | 20,000,000 | 20,000,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized | 100,000,000 | 100,000,000 |
Common stock, issued | 35,558,305 | 34,885,506 |
Common stock, outstanding | 35,558,305 | 34,885,506 |
Cash and cash equivalents | $ 17,079,734 | $ 15,836,063 |
Prepaid expenses and other current assets | 733,008 | 290,371 |
Variable Interest Entity [Member] | ||
Cash and cash equivalents | 13,175,071 | 0 |
Prepaid expenses and other current assets | $ 272,670 | $ 0 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||
REVENUES, NET | $ 15,076,822 | $ 513,447 |
COST OF GOODS SOLD | 763,520 | 283,833 |
GROSS PROFIT | 14,313,302 | 229,614 |
OPERATING EXPENSES | ||
Research and development | 1,722,897 | 2,815,106 |
Selling | 4,813,529 | 1,233,013 |
General and administrative | 17,876,527 | 15,071,360 |
Total operating expenses | 24,412,953 | 19,119,479 |
LOSS FROM OPERATIONS | (10,099,651) | (18,889,865) |
OTHER INCOME (EXPENSE) | ||
Other income | 737,971 | |
Loss on debt extinguishment | (3,244,769) | |
Change in fair value of warrant derivative liabilities | 20,674,000 | (15,777,000) |
Change in fair value of embedded conversion option | 466,000 | |
Net losses on equity investment in marketable securities | (43,977,002) | |
Interest and other income (loss) | 231,604 | (6,768) |
Interest expense | (22,825,190) | (11,000,559) |
Total other income (expenses) | (47,937,386) | (26,784,327) |
LOSS BEFORE INCOME TAXES | (58,037,037) | (45,674,192) |
INCOME TAXES (BENEFIT) | 6,222 | (12,303,110) |
NET LOSS INCLUDING NONCONTROLLING INTERESTS | (58,043,259) | (33,371,082) |
Net loss attributable to noncontrolling interests | 145,699 | |
NET LOSS ATTRIBUTABLE TO THE COMPANY | (57,897,560) | (33,371,082) |
COMPONENTS OF OTHER COMPREHENSIVE INCOME (LOSS) | ||
Unrealized holding gain (loss) on marketable securities | 44,752,413 | |
Foreign currency translation adjustments | 17,129 | (25,882) |
Other comprehensive income (loss) | 17,129 | 44,726,531 |
COMPREHENSIVE INCOME (LOSS) | (58,026,130) | 11,355,449 |
Amounts attributable to noncontrolling interests: | ||
Net loss attributable to noncontrolling interests | 145,699 | |
Foreign currency translation adjustments | 310 | |
Comprehensive loss attributable to noncontrolling interest | 146,009 | |
COMPREHENSIVE INCOME (LOSS) ATTRIBUTABLE TO THE COMPANY | $ (57,880,121) | $ 11,355,449 |
NET LOSS PER COMMON SHARE | $ (1.65) | $ (0.96) |
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING | 35,097,990 | 34,790,498 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - 12 months ended Dec. 31, 2018 - USD ($) | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] | Total Emmaus Stockholders' Equity / Deficit [Member] | Non Controlling Interests [Member] |
Balance, beginning at Dec. 31, 2017 | $ 14,290,678 | $ 34,886 | $ 113,111,745 | $ 41,275,785 | $ (140,131,738) | $ 14,290,678 | |
Balance, beginning (in shares) at Dec. 31, 2017 | 34,885,506 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Cumulative effect adjustment on adoption of ASU 2016-01 | (41,361,731) | 41,361,731 | |||||
Beneficial conversion feature relating to convertible and promissory notes payable | 17,199,036 | 17,199,036 | 17,199,036 | ||||
Warrant issued in conjunction with debt | 9,687,000 | 9,687,000 | 9,687,000 | ||||
Exercise of warrants | 110,650 | $ 31 | 110,619 | 110,650 | |||
Exercise of warrants (in Shares) | 30,500 | ||||||
Stock issued for cash | 1,323,295 | $ 125 | 1,274,875 | 1,275,000 | $ 48,295 | ||
Stock issued for cash (in shares) | 125,000 | ||||||
Repurchase and cancellation of common stock | (5,076,000) | $ (1,195) | (5,074,805) | (5,076,000) | |||
Repurchase of common stock and cancelled (in shares) | (1,195,000) | ||||||
Share-based compensation | 4,597,188 | 4,597,188 | 4,597,188 | ||||
Exercise of common stock options (cashless) | $ 84 | (84) | |||||
Exercise of common stock options (cashless) (in shares) | 84,248 | ||||||
Exercise of warrants (cashless) | $ 1,628 | (1,628) | |||||
Exercise of warrants (cashless) (in shares) | 1,628,051 | ||||||
Foreign currency translation effect | 17,129 | 16,819 | 16,819 | 310 | |||
Net loss | (58,043,259) | (57,897,560) | (57,897,560) | (145,699) | |||
Balance, ending at Dec. 31, 2018 | $ (15,894,283) | $ 35,559 | $ 140,903,946 | $ (69,127) | $ (156,667,567) | $ (15,797,189) | $ (97,094) |
Balance, ending (in shares) at Dec. 31, 2018 | 35,558,305 |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 29, 2017 |
Statement Of Stockholders Equity [Abstract] | |||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Common stock, authorized | 100,000,000 | 100,000,000 | 100,000,000 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (58,043,259) | $ (33,371,082) |
Adjustments to reconcile net loss to net cash flows from operating activities | ||
Depreciation and amortization | 60,682 | 32,379 |
Cost of scrapped inventory written off | 7,896 | 62,738 |
Amortization of discount of convertible notes | 18,263,040 | 8,859,370 |
Foreign exchange adjustments on convertible notes and notes payable | 54,442 | 78,969 |
Net losses on equity investment in marketable securities | 43,977,002 | |
Tax benefit recognized on unrealized gain on securities | (12,306,343) | |
Loss on debt settlement | 3,244,769 | |
Loss on disposal of property and equipment | 6,358 | |
Share-based compensation | 4,597,188 | 5,051,838 |
Change in fair value of warrant derivative liabilities | (20,674,000) | 15,777,000 |
Change in fair value of embedded conversion option | (466,000) | |
Net changes in operating assets and liabilities | ||
Accounts receivable | (1,324,222) | (12,322) |
Inventories | (4,086,987) | (517,073) |
Prepaid expenses and other current assets | (429,058) | (141,746) |
Deposits and other assets | (240,851) | 104,971 |
Income tax | (9,648) | |
Accounts payable and accrued expenses | 4,631,655 | 3,724,412 |
Deferred rent | 245,521 | (16,197) |
Other current liabilities | 5,170,314 | 10,159 |
Other long-term liabilities | (630,485) | 36,852,290 |
Net cash flows provided by (used in) operating activities | (5,652,001) | 24,195,721 |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Payments towards intangible asset | (67,200) | |
Sale of marketable securities | 6,439,240 | 0 |
Purchases of property and equipment | (93,545) | (90,059) |
Purchase of marketable securities and investment at cost | (469,052) | (31,903,450) |
Net cash flows provided by (used in) investing activities | 5,876,643 | (32,060,709) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Repurchase of common stock and warrants | (11,262,000) | |
Proceeds from notes payable issued, net of issuance cost and discount | 11,560,000 | 4,503,751 |
Proceeds from convertible notes payable issued, net of issuance cost and discount | 17,644,700 | 25,069,654 |
Payments of notes payable | (5,077,167) | (794,339) |
Payments of convertible notes | (20,000,000) | (804,105) |
Proceeds from exercise of warrants | 110,650 | |
Proceeds from issuance of common stock | 1,275,000 | 1,141,600 |
Proceeds from noncontrolling interest | 48,295 | |
Net cash flows provided by (used in) financing activities | (5,700,522) | 29,116,561 |
Effect of exchange rate changes on cash | (449) | (12,850) |
Net increase (decrease) in cash, cash equivalents and restricted cash | (5,476,329) | 21,238,723 |
Cash, cash equivalents and restricted cash, beginning of period | 22,556,063 | 1,317,340 |
Cash, cash equivalents and restricted cash, end of period | 17,079,734 | 22,556,063 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW ACTIVITIES | ||
Interest paid | 2,177,612 | 825,241 |
Income taxes paid | 3,036 | 3,233 |
Exercised of warrants and options on cashless basis | $ 1,712 | |
Conversion of notes payable to common stock | 200,000 | |
Conversion of accrued interest payable to common stock | $ 10,079 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
DESCRIPTION OF BUSINESS | NOTE 1—DESCRIPTION OF BUSINESS Organization —Emmaus Life Sciences, Inc. (the “Company” or “Emmaus”), which is a commercial-stage biopharmaceutical company engaged in the discovery, development, marketing and sales of innovative treatments and therapies primarily for rare and orphan diseases, was incorporated in the state of Delaware on September 24, 2007. Pursuant to an Agreement and Plan of Merger, dated April 21, 2011 (the “Merger Agreement”), by and among the Company, AFH Merger Sub, Inc., a wholly‑owned subsidiary of the Company (“AFH Merger Sub”), AFH Holding and Advisory, LLC (“AFH Advisory”), and Emmaus Medical, Inc. (“Emmaus Medical”), Emmaus Medical merged with and into AFH Merger Sub with Emmaus Medical continuing as the surviving entity (the “Merger”). Upon the closing of the Merger, the Company changed its name from “AFH Acquisition IV, Inc.” to “Emmaus Holdings, Inc.” and became the parent company of Emmaus Medical. The Company changed its name from “Emmaus Holdings, Inc.” to “Emmaus Life Sciences, Inc.” on September 14, 2011. Emmaus Medical is a Delaware corporation originally incorporated on September 12, 2003. Emmaus Medical, LLC was organized on December 20, 2000. In October 2003, Emmaus Medical, LLC conducted a reorganization and merged with Emmaus Medical. As a result of the merger, Emmaus Medical acquired the exclusive patent rights for a treatment for sickle cell disease (“SCD”). In October 2010, the Company established Emmaus Medical Japan, Inc., a Japanese corporation (“EM Japan”) by funding 97% of the initial capital. EM Japan is engaged in the business of trading in nutritional supplements and other medical products and drugs. The results of EM Japan have been included in the consolidated financial statements of the Company since the date of formation. The aggregate formation cost was $52,500. Emmaus Medical acquired the additional 3% of the outstanding shares of EM Japan during the three months ended March 31, 2011 and is now the 100% owner of the outstanding share capital. In November 2011, the Company formed Emmaus Medical Europe, Ltd. (“EM Europe”), a wholly owned subsidiary of Emmaus Medical. EM Europe’s primary focus is expanding the business of Emmaus Medical in Europe. In December 2016, the Company formed Emmaus Life Sciences Korea Co. Ltd. (“ELSK”), a wholly owned subsidiary of Emmaus Medical. ELSK’s primary focus is expanding the business of Emmaus Medical in Korea. Emmaus Life Sciences, Inc., and its direct and direct wholly-owned subsidiaries are collectively referred to herein as the “Company.” Nature of Business —The Company is a biopharmaceutical company engaged in the discovery, development, marketing and sales of innovative treatments and therapies primarily for rare and orphan diseases and a leader in the treatment of sickle cell disease, or SCD. On July 7, 2017, the U.S. Food and Drug Administration, or FDA, approved our lead product Endari™ (L-glutamine oral powder), to reduce the acute complications of SCD in adult and pediatric patients five years of age and older. We began marketing and selling Endari in the United States in January 2018. Endari is reimbursable by the Center of Medicare and Medicaid Services, and every state provides coverage for Endari for outpatient prescription to all eligible Medicaid enrollees within their state Medicaid programs. Additionally, Emmaus has distribution agreements in place with the nation’s leading distributors and pharmacy benefit managers, making Endari available at selected pharmacies nationwide. We expect net revenues to continue to increase as we expand our marketing and commercialization efforts in the United States. In January 2018, we filed the European Medicines Agency, or EMA, an application for marketing authorization on our L-glutamine oral powder in the European Union, or EU, for treating SCD. WE expect the EMA’s decision regarding our application in the third quarter of 2019. If approved, we intend to seek to begin marketing and sale of our product in the EU by the end of 2019. Endari has received Orphan Drug designation from the FDA and Orphan Medicinal designation from the European Commission, or EC, which designations generally afford marketing exclusivity for Endari for a seven-year period in the United States and for a ten-year period in the EU, respectively, following marketing approval. Endari also will be entitled to an additional two years of marketing exclusivity in the EU based on Emmaus’ accepted pediatric investigation plan. SCD is a rare, debilitating and lifelong hereditary blood disorder that affects approximately 100,000 patients in the U.S. and up to 25 million patients worldwide, the majority of which are of African descent. Approximately one in every 365 African-American children are born with SCD. FDA approval of Endari was based upon the results of a 48-week randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical trial evaluating the effects of Endari, as compared to placebo in 230 adults and children with SCD. The results demonstrated that Endari reduced the frequency of sickle cell crises by 25% and hospitalizations by 33%. Additional findings included a 41% decrease in cumulative hospital days and greater than 60% fewer incidents of acute chest syndrome in patients treated with Endari. The safety of Endari was based upon data from 298 patients, 187 treated with Endari and 111 patients treated with placebo in Phase 2 and Phase 3 studies. Endari’s safety profile was similar to placebo, and Endari was well-tolerated in pediatric and adult patients alike. The most common adverse reactions, occurring in more than 10% of patients treated with Endari, were constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain (non-cardiac). On July 4, 2018, the FDA acknowledged receipt of our investigational new drug application, or IND, for the treatment of diverticulosis using the same pharmaceutical-grade L-glutamine oral powder used in Endari. We subsequently received a “Study May Proceed” letter from the FDA, and in April 2019 we intend to commence a Pilot/Phase 1 study of the safety and efficacy of pharmaceutical-grade L-glutamine oral powder in 10 patients at multiple study sites. The study will evaluate the change in the number and size of colonic diverticula and assess safety. An Emmaus-led team at Los Angeles Biomedical Research Institute, or LA BioMed, an independent non-profit biomedical research organization academically affiliated with the David Geffen School of Medicine at University of California, at Los Angeles that works in partnership with Harbor-UCLA Medical Center, is conducting pre-clinical studies of Cultured Autologous Oral Mucosal Epithelial Cell Sheet, or CAOMECS, technology licensed by us from our strategic partner, CellSeed Inc., a Japanese company, which we refer to as CellSeed. Our lead CAOMECS program is for the treatment of corneal diseases. The development of CAOMECS for treating corneal and other diseases is in the early stages. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of presentation —The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) codified in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain prior period amounts have been reclassified to conform to the current period presentation. Going concern —The accompanying consolidated financial statements have been prepared on the basis that the Company will continue as a going concern. The Company had net losses attribute to the Company of $57.9 million and $33.4 million for the years ended December 31, 2018 and 2017, respectively. In addition, the Company has a significant amount of notes payable and other obligations due within the next twelve months and is projecting that its operating losses and expected capital needs, including the expected costs relating to the commercialization of Endari, will exceed its existing cash balances and cash expected to be generated from operations for the foreseeable future. In order to meet the Company’s expected obligations, management intends to raise additional funds through equity and debt financings and partnership agreements. However, there can be no assurance that the Company will be able to complete any additional equity or debt financings or enter into partnership agreements. Therefore, due to the uncertainty of the Company’s ability to meet its current operating and capital expenses, there is substantial doubt about the Company’s ability to continue as a going concern, as the continuation and expansion of its business is dependent upon obtaining further financing, successful and sufficient market acceptance of its products, and achieving a profitable level of operations. The consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties. Principles of consolidation —The consolidated financial statements include the accounts of the Company (and its wholly‑owned subsidiary, Emmaus Medical, and Emmaus Medical’s wholly‑owned subsidiaries, Newfield Nutrition, EM Japan, ELSK and EM Europe). All significant intercompany transactions have been eliminated. The Company also consolidates a variable interest entity (VIE) when the Company has one or more variable interest and is the primary beneficiary of the VIE in question. The Company is deemed to be the primary beneficiary of the VIE if it has both (a) the power to direct the activities of the VIE that most significantly affect the VIE’s economic performance and (b) During 2018, the Company and Japan Industrial Partners formed EJ Holdings, Inc. to acquire and operate manufacturing facility in Ube, Japan. As part of the formation, the Company invested JPY3,600,000 (approximately US$ 32,000) in exchange for 40% of voting shares in EJ Holdings, Inc. The Company anticipates that the manufacturing facility to be acquired will be Company’s supplier of pharmaceutical grade L-glutamine. Emmaus has determined that EJ Holdings, Inc. is a VIE as substantially all of its activities involve Emmaus, the investor with disproportionally few voting rights. Emmaus also determined that it is the primary beneficiary of EJ Holdings, Inc. and therefore, consolidates EJ Holdings, Inc. into its financial statements. Emmaus determinations above and related accounting treatment depend on judgements and assumptions, most significant of which relate to the nature and economics of future business activities of EJ Holdings, Inc. as well as the role and participation of Japan Industrial Partners. As part of consolidation of EJ Holdings, Inc. all significant intercompany transactions have been eliminated. The Company reports 60% equity interest held by Japan Industrial Partners in EJ Holdings, Inc. as a noncontrolling interest, a separate part of consolidated equity. Estimates —Financial statements prepared in accordance with GAAP require management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Among other things, management has estimated the useful lives of equipment and other assets, valuation of intangible assets, along with the variables used to calculate the valuation of stock options and warrants using the Black‑Scholes‑Merton option valuation model. The various warrants issued by the Company in (i) a private placement in September 2013, (ii) in connection with GPB debt transactions in December 2017 and (iii) replacement warrants issued in June 2014 contain non‑standard anti‑dilution protection and, consequently, are being accounted for as liabilities that are remeasured to fair market value at each reporting period (Note 7). In addition, the remaining initial private placement warrants may now utilize a cashless exercise feature since the shares associated with them were not registered by the one‑year anniversary of their issue. These warrants are classified as warrant derivative liabilities and continue to be remeasured at fair value each reporting period. The initial value as well as the fair value of all such warrants were determined using a Binomial Monte‑Carlo Cliquet (aka Ratchet) Option Pricing Model. The model is similar to traditional Black‑Scholes‑type option pricing models except that the exercise price resets at certain dates in the future. Actual results could differ from those estimates. Cash and cash equivalents —Cash and cash equivalents include short‑term securities with original maturities of less than ninety days. The Company maintains its cash and cash equivalents at insured financial institutions, the balances of which may, at times, exceed federally insured limits. Management believes that the risk of loss due to the concentrations is minimal. Restricted Cash — Restricted cash includes funds that are held in escrow by the lender and restricted as to withdrawal until certain conditions are met. In February 2018, the Company made a full prepayment of the Initial Note. All the restricted cash held in escrow was returned to GPB. See Note 7 under “Purchase Agreement with GPB.” The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported on our consolidated statements of cash flows as of December 31, 2018 and 2017: As of December 31, 2018 2017 Cash and cash equivalents $ 17,079,734 $ 15,836,063 Restricted cash — 6,720,000 Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows $ 17,079,734 $ 22,556,063 Inventories —Inventories are valued based on first‑in, first‑out and at the lesser of cost or net realizable value. Work‑in‑process inventories consist of L‑glutamine for the Company’s Endari and AminoPure products that has not yet been packaged and labeled for sale. Substantially all of the raw material purchases during the years ended December 31, 2018 and 2017 were from one vendor. The below table presents inventory by category: As of December 31, Inventories by category 2018 2017 Raw materials and components $ 170,997 $ — Work-in-process 2,471,147 124,801 Finished goods 2,062,427 500,498 Total $ 4,704,571 $ 625,299 Prepaid expenses and other current assets — Prepaid expenses and other current assets consisted of the following at December 31, 2018 and 2017: As of December 31, 2018 2017 Prepaid insurance $ 81,797 $ 132,387 Other prepaid expenses and current assets 651,211 157,984 $ 733,008 $ 290,371 Deposits —Carrying value of amounts transferred to third parties for security purposes that are expected to be returned or applied towards payment after one year or beyond the operating cycle, if longer, are recorded as deposits. Deposit amounts further consist of retainer payments for professional services and security deposits for its offices. Revenue recognition — Effective January 1, 2018, the Company adopted ASC 606, Revenue from Contracts with Customers using the modified retrospective transition methods. The adoption of ASC 606 did not have a material impact on the measurement or on the recognition of revenue of contracts for which all revenue had not been recognized as of January 1, 2018, therefore no cumulative adjustment has been made to the opening balance of accumulated deficit at the beginning of 2018. The comparative information has not been restated and continues to be reported under the accounting standards in effect for the periods presented. Since January 2018, the Company has generated revenues through the sale of Endari as a treatment for SCD. The Company also generates revenues to a much lesser extent from NutreStore L-glutamine powder, as well as AminoPure, a nutritional supplement. Revenues from Endari product sales are recognized upon transfer to our distributors, which are customers of the Company, when they obtain control of our products. These distributors subsequently resell our products to specialty pharmacy providers, health care providers, hospitals, patients and clinics. In addition to distribution agreements with these distributors, the Company enters into arrangements with specialty pharmacy providers, in-office dispensing providers, group purchasing organizations, and government entities that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of our products. These various discounts, rebates, and charge-backs are referred to as “variable consideration.” Revenues from product sales are recorded net of these variable considerations. Prior to recognizing revenues, the Company’s management forecasts and estimates variable consideration. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenues recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Provisions for returns and other adjustments are provided for in the period in which the related revenues are recorded. Actual amounts of consideration ultimately received may differ from the management estimates. If actual results in the future vary from the estimates, the management will adjust these estimates, which would affect net product revenues in the period such variances become known. The following are our significant categories of sales discounts and allowances: Sales Discounts: The Company provides its customers prompt payment discounts that are explicitly stated in its contracts and are recorded as a reduction of revenues in the period the revenues are recognized. Product Returns: The Company offers its distributors a right to return product purchased directly from the Company, which is principally based upon (i) overstocks, (ii) inactive product or non-moving product due to market conditions, and (iii) expired products. Product return allowances are estimated and recorded at the time of sale. Government Rebates: The Company is subject to discount obligations under state Medicaid programs and the Medicare prescription drug coverage gap program. The Company’s management estimates Medicaid and Medicare prescription drug coverage gap rebates based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the related revenues are recognized, resulting in a reduction of product revenues and the establishment of a current liability that is included as an accrued liability in our balance sheet. The liability for these rebates consists primarily of estimates of claims expected to be received in future periods related to recognized revenues. Chargebacks and Discounts: Chargebacks for fees and discounts represent the estimated obligations resulting from contractual commitments to sell products to certain specialty pharmacy providers, in-office dispensing providers, group purchasing organizations, and government entities at prices lower than the list prices charged to distributors. The distributors charge the Company for the difference between what they pay for the products and the Company’s contracted selling price to these specialty pharmacy providers, in-office dispensing providers, group purchasing organizations, and government entities. These reserves are established in the same period that the related revenues are recognized, resulting in a reduction of revenues. Chargeback amounts are generally determined at the time of resale of products by the distributors. The following table summarizes revenues from each of our customers who individually accounted for 10% or more of the Company’s total revenues (as a percentage to total revenue). As of December 31, 2018 2017 AmerisourceBergen Specialty Group 77 % — McKesson Plasma and Biologics LLC 13 % — Johnson Chemical Pharm Works Co. Ltd — 29.0 % Advertising cost —Advertising costs are expensed as incurred. Advertising costs for the years ended December 31, 2018 and 2017 were $ 97,514 and $ 59,045, respectively. Property and equipment —Equipment, Furniture and fixtures are recorded at historical cost and amortized on a straight‑line basis over their estimated useful lives of 5 to 7 years. Leasehold improvements are recorded at historical cost and amortized on a straight‑line basis over the shorter of their estimated useful lives or the lease terms. Maintenance and repairs are expensed as incurred, while major additions and improvements are capitalized. Gains and losses on disposition are included in other income (expenses), if any. Intangibles —The Company’s intangible assets include website development costs. These intangible assets are amortized over a period of 5 years, the estimated economic life of intangible assets. The intangible assets are assessed by management for potential impairment on an annual basis. No impairment existed as of December 31, 2018 and 2017. Impairment of long‑lived assets —The Company evaluates the carrying value of its long‑lived assets for impairment whenever events or changes in circumstances indicate that such carrying values may not be recoverable. The Company uses its best judgment based on the current facts and circumstances relating to its business when determining whether any significant impairment factors exist. If the Company determines that the carrying values of long‑lived assets may not be recoverable based upon the existence of one or more indicators of impairment, the Company performs an undiscounted cash flow analysis to determine if impairment exists. If impairment exists, the Company measures the impairment based on the difference between the asset’s carrying amount and its fair value, and the impairment is charged to the consolidated statement of comprehensive loss in the period in which the long‑lived asset impairment is determined to have occurred. No impairment existed as of December 31, 2018 and 2017. Research and development —Research and development consists of expenditures for the research and development of new products and technologies, which primarily involve contract research, payroll‑related expenses, and other related supplies. Research and development costs are expensed as incurred. Intangible assets acquired for research and development purposes are capitalized if they have alternative future use. Share‑based compensation —The Company recognizes compensation cost for share‑based compensation awards over the service term of the recipients of the share‑based awards. The fair value of share‑based compensation is calculated using the Black‑Scholes‑Merton pricing model. The Black‑Scholes‑Merton model requires subjective assumptions regarding future stock price volatility and expected time to exercise, which greatly affect the calculated values. The expected term of awards granted is calculated using the simplified method allowed under the Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin Nos. 107 and 110. The risk‑free rate selected to value any particular grant is based on the U.S. Treasury rate on the grant date that corresponds to the expected term of the award. The expected volatility is based on the historical volatility of the common stock of comparable publicly traded companies. These factors could change, affecting the determination of stock‑based compensation expense in future periods. Income taxes —The Company accounts for income taxes under the asset and liability method, wherein deferred tax assets and liabilities are recognized for the future tax consequences attributable to the differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. 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 the enactment occurs. A valuation allowance is provided for certain deferred tax assets if it is more likely than not that the Company will not realize tax assets through the generation of future taxable income for the related jurisdictions. For balance sheet presentation, current deferred tax assets and liabilities within each tax jurisdiction have been offset and presented as a single amount and non‑current deferred tax assets and liabilities within each tax jurisdiction have been offset and presented as a single amount. When tax returns are filed, it is highly probable that some positions taken would be sustained upon examination by the taxing authorities, while others are subject to uncertainty about the merits of the position taken or the amount of the position that would be ultimately sustained. The benefit of a tax position is recognized in the financial statements in the period during which, based on all available evidence, management believes it is more likely than not that the position will be sustained upon examination, including the resolution of appeals or litigation processes, if any. Tax positions taken are not offset or aggregated with other positions. Tax positions that meet the more‑ likely‑than‑not recognition threshold are measured as the largest amount of tax benefit that is more than 50 percent likely of being realized upon settlement with the applicable taxing authority. The portion of the benefits associated with tax positions taken that exceeds the amount measured as described above is reflected as a liability for unrecognized tax benefits along with any associated interest and penalties that would be payable to the taxing authorities upon examination. As of December 31, 2017 and 2018, the Company had no unrecognized tax benefits, and the Company had no positions which, in the opinion of management, would be reversed if challenged by a taxing authority. In the event the Company is assessed interest and/or penalties, such amounts will be classified as income tax expense in the financial statements. Comprehensive income (loss) —Comprehensive income (loss) includes net loss and other comprehensive income (loss). The items of other comprehensive income (loss) for the Company are unrealized gains and losses on marketable securities and foreign translation adjustments relating to its subsidiaries. When the Company realizes a gain or loss on marketable securities for which an unrealized gain or loss was previously recognized, a corresponding reclassification adjustment is made to remove the unrealized gain or loss from accumulated other comprehensive income and reflect the realized gain or loss in current operations upon adoption of 2016-01. Marketable securities — The Company’s marketable securities consist of the following securities; (a) 39,250 shares of capital stock of CellSeed, Inc. (“CellSeed”) those that remain of 147,100 shares acquired in January 2009 for ¥100,028,000 Japanese Yen (JPY) (equivalent to $1.1 million USD), at ¥680 JPY per share; (b) 849,744 shares of capital stock of KPM Tech Co., Ltd. (“KPM”) which were acquired in October 2016 for ₩14,318,186,400 South Korean Won (KRW) (equivalent to $13.0 million USD) at ₩16,850 KRW per share; (c) 271,950 shares of capital stock of Hanil Vacuum Co., Ltd. (“Hanil”) which were acquired in October 2016 for ₩1,101,397,500 KRW (equivalent to $1.0 million USD) at ₩4,050 KRW per share; and (d) 6,643,559 shares of capital stock of Telcon, Inc. (“Telcon”) which were acquired in July 2017 for ₩36,001,446,221 KRW (equivalent to $31.8 million USD) at ₩5,419 KRW per share. As of December 31, 2018 and December 31, 2017, the closing price per CellSeed share on the Tokyo Stock Exchange was ¥668 JPY ($6.07 USD) and ¥462 JPY ($4.10 USD), respectively, the closing price per Telcon share on the Korean Securities Dealers Automated Quotations (“KOSDAQ”) was ₩8,280 KRW ($7.43 USD) and ₩14,900 KRW ($13.95 USD), respectively. As of December 31, 2017, the closing price per KPM share on KOSDAQ the was ₩1,625 KRW ($1.52 USD) after 1-for-5 reverse stock split effective June 28, 2017 and the closing price per Hanil share on KOSDAQ was ₩2,830 KRW ($2.65 USD). The Company sold all of its KPM and Hanil shares during the year ended December 31, 2018. As of December 31, 2018, 39,250 shares of CellSeed stock are pledged to secure a $300,000 convertible note issued to Mitsubishi UFJ Capital III Limited Partnership that is due on demand and are classified as current assets, as marketable securities, pledged to creditor. Loss on debt settlement —The Company records loss on debt settlement when the Company’s common stocks are issued in settlement for non-convertible debt and its accrued interest. During the years ended December 31, 2018 and 2017, the Company recorded a loss on debt settlement of $3,244,769 and $0, respectively. Foreign Currency Translation —The Company’s reporting currency is the U.S. dollar. The Yen, Korean Won, and the Euro are the functional currencies of its subsidiaries, EM Japan, ELSK and EM Europe, respectively, as they are the primary currencies within the economic environments in which EM Japan, ELSK and EM Europe operate. Assets and liabilities of their operations are translated into U.S. dollars at period‑end exchange rates, and revenues and expenses are translated into U.S. dollars at average exchange rates in effect during each reporting period. Adjustments resulting from the translation are reported in other comprehensive income or loss. Financial Instruments —Financial instruments included in the financial statements are comprised of cash and cash equivalents, restricted cash, investment in marketable securities, marketable securities pledged to creditor, long-term investment at cost, accounts receivable, note receivable, warrant derivative liabilities, accounts payable, certain accrued liabilities, convertible notes payable, notes payable and other contingent liabilities. The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate their fair values due to the short‑term nature of those instruments. Other long-term liabilities —Other long-term liabilities consist of the following at December 31, 2018 and 2017: As of December 31, 2018 2017 Trade discount $ 26,221,500 $ 31,841,500 Unearned revenue 10,000,000 5,000,000 Other long-term liabilities — 10,790 Total other long-term liabilities $ 36,221,500 $ 36,852,290 The Company entered into an API Supply Agreement (the “API Agreement”) with Telcon pursuant to which Telcon advanced to the Company approximately ₩36.0 billion KRW (approximately $31.8 million USD) in consideration as an advance trade discount to supply 25% of the Company’s requirements for bulk containers of pharmaceutical grade L-glutamine (“PGLG”) for a term of five years with 10 one-year renewal periods for a maximum of 15 years. The agreement will automatically renew unless terminated by either party in writing. The agreement does not include yearly purchase commitments or margin guarantees. The advance trade discount shall be applied against purchases made by the Company from Telcon over the life of the agreement. Fair value measurements —The Company defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company measures fair value under a framework that provides a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described as follows: Level 1: Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access. Level 2: Inputs to the valuation methodology include: • Quoted prices for similar assets or liabilities in active markets; • Quoted prices for identical or similar assets or liabilities in inactive markets; • Inputs other than quoted prices that are observable for the asset or liability; • Inputs that are derived principally from or corroborated by observable market data by correlation or other means. If the asset or liability has a specified (contractual) term, the Level 2 inputs must be observable for substantially the full term of the asset or liability. Level 3: Inputs to the valuation methodology are unobservable and significant to the fair value measurement. The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value assigned to marketable securities is determined by obtaining quoted prices on nationally recognized securities exchanges, and are classified as Level 1 investments at December 31, 2018 and 2017. The fair value of the Company’s debt instruments is not materially different from their carrying values as presented. The fair value of the Company’s convertible debt instruments was determined based on Level 2 inputs. The carrying value of the debt was discounted based on allocating proceeds to other financial instruments within the arrangement as discussed in Note 6. Certain of our outstanding warrants contain nonstandard anti-dilution protections or a cashless exercise feature and, consequently, are accounted for as liabilities that are remeasured at fair value on a recurring basis, whose fair value is determined using Level 3 inputs. The Level 3 inputs in the valuation of warrants include expected term and expected volatility. These warrants are classified as warrant derivative liabilities in the consolidated balance sheet and continue to be remeasured at fair value each reporting period. The Level 3 inputs in the valuation of warrants include expected term and expected volatility. The following tables present the activity for those items measured at fair value on a recurring basis using Level 3 inputs during 2018 and 2017: Year ended December 31, Warrant Derivative Liabilities—Stock Purchase Warrants 2018 2017 Balance, beginning of period $ 26,377,000 $ 10,600,000 Repurchased (6,186,000 ) — Change in fair value included in the statement of comprehensive income (loss) (20,191,000 ) 15,777,000 Balance, end of period $ — $ 26,377,000 As of September 11, 2018, all of the Private Placement warrants, replacement warrants and Broker Warrants had been exercised primarily on a cashless basis, or had expired. The following table presents warrants issued in conjunction with Purchase Agreement with GPB (see Note 7) measured at fair value as of December 31, 2018 and 2017: Year ended December 31, 2018 Year ended December 31, 2017 Liability Instrument—GPB Warrants Embedded Conversion Option Warrants Embedded Conversion Option Balance, beginning of period $ 1,882,000 $ 1,289,000 $ — $ — Fair value at issuance date — — 1,882,000 1,289,000 Change in fair value included in the statement of comprehensive income (loss) (483,000 ) (466,000 ) — — Extinguished upon debt repayment — (823,000 ) — — Balance, end of period $ 1,399,000 $ — $ 1,882,000 $ 1,289,000 The Company evaluated the warrant and embedded conversion option as well as the embedded put options in the debt agreement and warrant under ASC 815-40 and ASC 815-15-25-1, respectively, and concluded that the warrant and embedded conversion and contingently exercisable put options are required to be separately recognized at fair value as a liability and derivative liability, respectively as of December 31, 2018 and 2017. Moreover, any changes in the fair value of the warrant liability and the derivative bifurcated option liability shall be recognized in earnings. During 2018, the Company has paid all GPB debt early, resulting the Company to release embedded conversion option liabilities. The value of warrant derivative liabilities and the change in fair value of the warrant derivative are determined using a Binominal Monte-Carlo Cliquet (aka “ Ratchet”) Option Pricing Model. The model is similar to traditional Black-Scholes-type option pricing models, except that the exercise price resets at certain dates in the future. The value as of the dates set for the in the table below, was based on upon following assumptions: GPB Stock Purchase Warrants December 31, 2018 December 31, 2017 December 31, 2017 Stock price $ 9.10 $ 11.40 $ 11.40 Risk‑free interest rate 2.48 % 2.20 % 1.62 % Expected volatility (peer group) 70.00 % 70.00 % 55.80 % Expected life (in years) 4.00 5.00 0.70 Expected dividend yield — — — Number outstanding 240,764 240,764 3,320,501 Balance, end of period: Warrant derivative liabilities (long-term) $ 1,399,000 $ 1,882,000 $ 26,377,000 Debt and Related Party Debt —The Company accounts for the proceeds from the issuance of convertible notes payable with detachable stock purchase warrants and embedded conversion features in accordance with ASC 470‑ 20, Debt with Conversion and Other Options . Under ASC 470‑20, the proceeds from the issuance of a debt instrument with detachable stock purchase warrants shall be allocated to the two elements based on the relative fair values of the debt instrument without the warrants and of the warrants themselves at the time of issuance. The portion of the proceeds allocated to the warrants is accounted for as additional paid‑in capital and the remaining proceeds are allocated to the debt instrument, which results in a discount to debt that is amortized and charged as interest expense over the term of the note agreement. Additionally, pursuant to ASC 470‑20, the intrinsic value of the embedded conversion feature of the convertible notes payable is included in the discount to debt and amortized and charged to interest expense over the term of the note agreement. The following table presents the effective interest rates on the original loan principal amount for loans originated in the respective periods that either had a beneficial conversion interest or an attached warrant: Type of Loan Term of Loan Stated Annual Interest Original Loan Principal Amount Conversion Rate Beneficial Conversion Discount Amount Warrants Issued with Notes Exercise Price Warrant FMV Discount Amount Effective Interest Rate Including Discounts 2016 convertible notes payable Due 10% 61,535 $ 4.50 6,837 - $ - - 21.10% 2017 convertible notes payable Due on demand - 2 years 10% 7,819,835 $3.50 - $10.00 3,346,449 - $ - - 25% - 110% 2018 convertible notes payable Due on demand - 2 years 6% - 10% 28,955,566 $3.50 - $10.00 12,476,566 - $ - - 10% - 110% $ 36,836,936 $ 15,829,852 $ - $ - Related party notes are disclosed as separate line items in the Company’s balance sheet presentation. Net loss per share —In accordance with ASC 260, “Earnings per Share, ” the basic loss per common share is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding. Dilutive loss per share is computed in a manner similar to the basic loss per common share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | NOTE 3—PROPERTY AND EQUIPMENT Property and equipment consisted of the following As of December 31, 2018 2017 Equipment $ 305,250 $ 225,615 Leasehold improvements 70,249 61,054 Furniture and fixtures 79,001 74,090 Total property and equipment 454,500 360,759 Less: accumulated depreciation (302,814 ) (255,457 ) Property and Equipment, net $ 151,686 $ 105,302 During the years ended December 31, 2018 and 2017, depreciation expense was $47,242 and $32,379 , respectively. |
INVESTMENTS
INVESTMENTS | 12 Months Ended |
Dec. 31, 2018 | |
Investments [Abstract] | |
INVESTMENTS | NOTE 4 — INVESTMENTS Equity Securities— Effective January 1, 2018, the Company adopted ASU 2016-01 which requires the Company to measure all equity investments that do not result in consolidation and are not accounted for under the equity method at fair value and recognize any changes in earnings. The Company uses quoted market prices to determine the fair value of equity securities with readily determinable fair values. For equity securities without readily determinable fair values, the Company has elected the measurement alternative under which the Company measures these investments at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer. Management assesses each of these investments on an individual basis. Additionally, on a quarterly basis, management is required to make a qualitative assessment of whether the investment is impaired; however, the Company is not required to determine the fair value of these investments unless impairment indicators existed. When impairment indicators exist, the Company generally uses discounted cash flow analyses to determine the fair value. For the year ended December 31, 2018, the Company did not recognize any fair value adjustments for equity securities without readily determinable fair values. The Company recognized a cumulative effect adjustment of $41.4 million, net of $12.3 million income tax benefit, to increase the opening balance of accumulated deficit with an offset to accumulated other comprehensive income as of January 1, 2018, in connection with the adoption of ASU 2016-01. For fiscal periods beginning prior to January 1, 2018, marketable equity securities not accounted for under the equity method were classified as available-for-sale. There were no marketable equity securities classified as trading. For equity securities classified as available-for-sale, realized gains and losses were included in net loss. Unrealized gains and losses on equity securities classified as available-for-sale were recognized in accumulated other comprehensive income (loss), net of deferred taxes. In addition, the Company had equity securities without readily determinable fair values that were recorded at cost. For these cost method investments, the Company recorded dividend income, if any, when applicable dividends were declared. Cost method investments were reported as investment in marketable securities, marketable securities, pledged to creditor and long-term investment at cost in our consolidated balance sheets. Dividend income from cost method investments was reported in other income (expenses) in our consolidated statements of comprehensive loss. The Company estimated that the fair values of its cost method investments approximated their carrying values as of December 31, 2018 and 2017. The fair values of our equity securities were included in the following line items in our consolidated balance sheets: As of December 31, 2018 As of December 31, 2017 Fair Value with Changes Recognized in Income Measurement Alternative - No Readily Determinable Fair Value Fair Value with Changes Recognized in Income Measurement Alternative - No Readily Determinable Fair Value Marketable securities $ 49,581,080 $ — $ 99,997,322 $ — Long-term investment at cost — 538,202 65,520 Total equity securities $ 49,581,080 $ 538,202 $ 99,997,322 $ 65,520 Proceeds from the sales of marketable securities classified as available-for-sales and sold were $6.4 million and none in the year ended December 31, 2018 and 2017, respectively. Net unrealized losses on available-for-sales on marketable securities still held at the year ended December 31, 2018 was $43.2 million. As of December 31, 2017, equity securities consisted of the following: Gross Unrealized Estimated Cost Gains Losses Fair Value Trading securities $ — $ — $ — $ — Available-for-sale securities 46,209,017 60,812,231 (6,958,406 ) 100,062,842 Total equity securities $ 46,209,017 $ 60,812,231 $ (6,958,406 ) $ 100,062,842 As of December 31, 2017, the Company had investments classified as available-for-sale in which our cost basis exceeded the fair value of our investment. Management assessed each of the investment in marketable securities that were in a gross unrealized loss position to determine if the decline in fair value was other than temporary. Management's assessment as to the nature of a decline in fair value is based on, among other things, the length of time and the extent to which the market value has been less than our cost basis; the financial condition and near-term prospects of the issuer, and the Company’s intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in market value. As a result of these assessments, management determined that the decline in fair value of these investments and did not record any impairment charges. |
ACCOUNTS PAYABLE AND ACCRUED EX
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | NOTE 5—ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses consisted of the following at: December 31, 2018 December 31, 2017 Accounts payable: Regulatory fees $ — $ 715,999 Clinical and regulatory expenses 83,025 116,736 Commercialization consulting fees 3,938 40,000 Legal expenses 43,858 87,701 Consulting fees 2,036,380 143,038 Accounting fees 73,290 67,293 Selling expenses 381,572 35,383 Investor relations and public relations expenses 44,484 55,526 Other vendors 937,190 337,960 Total amounts payable 3,603,737 1,599,636 Accrued interest payable, related parties 842,389 318,120 Accrued interest payable 2,138,133 1,449,154 Accrued expenses: Wages and payroll taxes payable 156,612 1,711,541 Deferred salary 291,667 291,667 Paid vacation payable 263,975 186,978 Accrued rebates 1,743,847 — Other accrued expenses 83,115 138,214 Total accrued expenses 2,539,216 2,328,400 Total accounts payable and accrued expenses $ 9,123,475 $ 5,695,310 |
NOTES PAYABLE
NOTES PAYABLE | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
NOTES PAYABLE | NOTE 6—NOTES PAYABLE Notes payable consisted of the following at December 31, 2018 and 2017: Year Issued Interest Rate Range Term of Notes Conversion Price Principal Outstanding December 31, 2018 Discount Amount December 31, 2018 Carrying Amount December 31, 2018 Shares Underlying Notes December 31, 2018 Principal Outstanding December 31, 2017 Discount Amount December 31, 2017 Carrying Amount December 31, 2017 Shares Underlying Notes December 31, 2017 Notes payable 2013 10% Due on demand — $ 908,900 $ — $ 908,900 — $ 887,600 $ — $ 887,600 — 2015 10% Due on demand — $ 10,000 — 10,000 — — — — — 2016 10% - 11% Due on demand — 843,335 — 843,335 — 833,335 — 833,335 — 2017 5% - 11% Due on demand — 2,575,410 — 2,575,410 — 6,150,208 — 6,150,208 — 2018 10% - 11% Due on demand- 18 months — 12,311,000 9,233,089 3,077,911 — — — — — $ 16,648,645 $ 9,233,089 $ 7,415,556 — $ 7,871,143 $ — $ 7,871,143 — Current $ 12,448,645 $ 6,054,484 6,394,161 — $ 7,871,143 $ — $ 7,871,143 — Non-current $ 4,200,000 $ 3,178,605 1,021,395 — $ — $ — $ — — Notes payable - related party 2015 11% Due on demand — $ — — $ — — $ 310,000 — $ 310,000 — 2016 10% - 11% Due on demand — 270,000 — 270,000 — 810,510 — 810,510 — 2017 10% Due on demand — 38,583 — 38,583 — 915,751 — 915,751 — 2018 11% Due on demand 159,223 — 159,223 — — — — — $ 467,806 $ — $ 467,806 — $ 2,036,261 $ — $ 2,036,261 — Current $ 467,806 $ — $ 467,806 — $ 2,036,261 $ — $ 2,036,261 — Non-current $ — $ — $ — — $ — $ — $ — — Convertible notes payable 2011 10% 5 years $ 3.05 $ 300,000 $ — $ 300,000 98,285 $ 300,000 $ — $ 300,000 98,285 2014 10% Due on demand - 2 years $3.05 - $3.60 518,846 — 518,846 183,648 486,878 — 486,878 168,766 2016 10% Due on demand - 2 years $3.60 - $4.50 61,535 — 61,535 16,753 1,516,329 83,298 1,433,031 441,048 2017 10% - 13.5% Due on demand - 3 years $3.50 - $10.31 2,819,835 348,944 2,470,891 899,613 36,113,296 11,232,423 24,880,873 5,357,488 2018 6% - 10% Due on demand - 2 years $3.50 - $10.00 19,555,566 6,168,939 13,386,627 3,664,143 — — — — $ 23,255,782 $ 6,517,883 $ 16,737,899 4,862,442 $ 38,416,503 $ 11,315,721 $ 27,100,782 6,065,587 Current $ 16,604,029 $ 5,350,681 $ 11,253,348 3,981,232 $ 12,860,912 $ 5,835,910 $ 7,025,002 3,449,984 Non-current $ 6,651,753 $ 1,167,202 $ 5,484,551 881,210 $ 25,555,591 $ 5,479,811 $ 20,075,780 2,615,603 Convertible notes payable - related party 2012 10% Due on demand $ 3.30 $ 200,000 $ — $ 200,000 74,182 $ 200,000 $ — $ 200,000 68,122 2015 10% 2 years $ 4.50 200,000 — 200,000 58,350 200,000 — 200,000 53,905 2017 10% 2 years $ 10.00 5,000,000 311,458 4,688,542 532,671 — — — — 2018 10% 2 years $ 10.00 9,400,000 871,460 8,528,540 971,963 — — — — $ 14,800,000 $ 1,182,918 13,617,082 1,637,166 $ 400,000 $ — $ 400,000 122,027 Current $ 5,400,000 $ 311,458 $ 5,088,542 665,203 $ 400,000 $ — $ 400,000 122,027 Non-current $ 9,400,000 $ 871,460 $ 8,528,540 971,963 $ — $ — $ — — Grand Total $ 55,172,233 $ 16,933,890 $ 38,238,343 6,499,608 $ 48,723,907 $ 11,315,721 37,408,186 6,187,614 Note: Notes payables and convertible note payables for certain individuals have been reclassified from unrelated party to related party and vice versa from fiscal year ended December 31, 2017 and 2018 as the relationships with these individuals have changed. The average stated interest rate of notes payable was 10% and 11% for years ended December 31, 2018 and 2017, respectively. The average effective interest rate of notes payable for the years ended December 31, 2018 and 2017 was 35% and 24% respectively, after giving effect to discounts relating to beneficial conversion features and the fair value of warrants issued in connection with these notes. The notes payable and convertible notes payable do not have restrictive financial covenants or acceleration clauses associated with a material adverse change event. The holders of the convertible notes have the option to convert their notes into the Company’s common stock at the stated conversion price during the term of their convertible notes. Conversion prices on these convertible notes payable range from $3.05 to $10.31 per share. Certain notes with a $4.50 and a $10.00 stated conversion price in the second year of their two‑year term are subject to automatic conversion into shares of the Company’s common stock at a conversion price equal to 80% of the initial public offering price at the time of a qualified public offering. All due on demand notes are treated as current liabilities. Contractual principal payments due on notes payable are as follows: Year Ending December 31, 2018 2019 $ 34,920,480 2020 20,251,753 Total $ 55,172,233 The Company estimated the total fair value of any beneficial conversion feature and accompanying warrants in allocating the debt proceeds. The proceeds allocated to the beneficial conversion feature were determined by taking the estimated fair value of shares issuable under the convertible notes less the fair value of the number of shares that would be issued if the conversion rate equaled the fair value of the Company’s common stock as of the date of issuance (see Note 2). The fair value of the warrants issued in conjunction with notes was determined using the Binominal Monte-Carlo Cliquet option pricing model with the following inputs for the years ended: 2018 2017 Stock price $ 11.10 $ 11.40 Exercise price $ 11.30 $ 10.80 Term 5 years 5 years Risk‑free interest rate 3.05% 2.20% Expected dividend yield — — Expected volatility 70.0% 70.00% In situations where the debt included both a beneficial conversion feature and a warrant, the proceeds were allocated to the warrants and beneficial conversion feature based on the pro‑rata fair value. |
STOCKHOLDERS' DEFICIT
STOCKHOLDERS' DEFICIT | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders Equity Note [Abstract] | |
STOCKHOLDERS' DEFICIT | NOTE 7—STOCKHOLDERS’ DEFICIT Private Placement —On September 11, 2013, the Company issued an aggregate of 3,020,501 units at a price of $2.50 per unit (the “Private Placement”). Each unit consisted of one share of common stock and one common stock warrant for the purchase of an additional share of common stock. The aggregate purchase price for the units was $7,551,253. In addition, 300,000 warrants for the purchase of a share of common stock were issued to a broker under the same terms as the Private Placement transaction (the “Broker Warrants”). The warrants issued in the Private Placement and the Broker Warrants entitle the holders thereof to purchase, at any time on or prior to September 11, 2018, shares of common stock of the Company at an exercise price of $3.50 per share. The warrants contain non‑standard anti‑dilution protection and, consequently, are being accounted for as liabilities, were originally recorded at fair value, and are adjusted to fair market value each reporting period. Because the shares of common stock underlying the Private Placement warrants and Broker Warrants were not effectively registered for resale by September 11, 2014, the warrant holders have an option to exercise the warrants using a cashless exercise feature. The shares have not been registered for resale as of December 31, 2017. The availability to warrant holders of the cashless exercise feature as of September 11, 2014 caused the then‑outstanding 2,225,036 Private Placement warrants and Broker Warrants with fair value of $7,068,000 to be reclassified from liability classified warrants to warrant derivative liabilities and to continue to be remeasured at fair value each reporting period. On June 10, 2014, certain warrant holders exercised 1,095,465 warrants issued in the Private Placement for the exercise price of $3.50 per share, resulting in the Company receiving aggregate exercise proceeds of $3.8 million and issuing 1,095,465 shares of common stock. Prior to exercise, these Private Placement warrants were accounted for at fair value as liability classified warrants. As of June 10, 2014, immediately prior to exercise, the carrying value of these Private Placement warrants was reduced to their fair value immediately prior to exercise of $1.8 million, representing their intrinsic value, with this adjusted carrying value of $1.8 million being transferred to additional paid‑in capital. Also on June 10, 2014, based on an offer made to holders of Private Placement warrants in connection with such exercises, the Company issued an aggregate of 1,095,465 replacement warrants to holders exercising Private Placement warrants, which replacement warrants have terms that are generally the same as the exercised warrants, including an expiration date of September 11, 2018 and an exercise price of $3.50 per share. The replacement warrants are treated for accounting purposes as liability classified warrants, and their issuance gave rise to a $3.5 million warrant exercise inducement expense based on their fair value as of issuance as determined using a Binomial Monte‑Carlo Cliquet (aka Ratchet) Option Pricing Model. Because the shares of common stock underlying the replacement warrants were not effectively registered for resale by June 10, 2015, the warrant holders have an option to exercise the warrants using a cashless exercise feature. The shares have not been registered for resale as of December 31, 2016. The availability to warrant holders of the cashless exercise feature as of June 10, 2015 caused the then‑outstanding 1,095,465 replacement warrants with fair value of $2,545,000 to be reclassified from liability classified warrants to warrant derivative liabilities and to continue to be remeasured at fair value each reporting period. As of December 31, 2017, the aggregate fair value of the Private Placement warrants, replacement warrants, and the Broker Warrants was $26,377,000 (see Note 2). For further details regarding registration rights associated with the Private Placement warrants, replacement warrants, and Broker Warrants, see the Registration Rights section below in this footnote. In September 2018, all of the Private Placement warrants, replacement warrants and Broker Warrants had been exercised primarily on a cashless basis, or had expired. Purchase Agreement with GPB —On December 29, 2017, the Company entered into the Purchase Agreement with GPB, pursuant to which the Company issued to GPB a $13,000,000 principal amount senior secured convertible promissory note (the “Initial Note”) for an aggregate purchase price of $12,480,000. The Initial Note was issued with a 4.0% original issue discount. Capitalized terms not defined herein have the definitions given to them in the Purchase Agreement. The Initial Note, which matures on December 29, 2020 (the “Maturity Date”), initially provides for monthly payments of interest, which accrues at the rate of 12.5% per annum. In addition, the Initial Note also provides for an annual payment of paid in kind interest at the rate of 1.0% per annum. Beginning on the 30th month after the issuance of the Initial Note, the Company is required to make monthly principal payments in an amount equal to 5% of the original principal amount. The Initial Note (including accrued and unpaid interest) may be prepaid, in whole or in part, at any time prior to the Maturity Date, upon twenty (20) days’ prior written notice; provided, however, that during such notice period, GPB may exercise its conversion rights described below in whole or in part. Upon a prepayment, in whole or in part, the Company shall pay GPB an additional success fee equal to (a) 2% of any such payment if such payment is paid prior to the 24th-month anniversary of the Original Issue Date or (b) 3% of any such payment if such amount is paid on or after the 24th-month anniversary of the Original Issue Date, inclusive of the Maturity Date. The Initial Note is convertible at any time, in whole or in part, at GPB’s option, into shares of the Company’s Common Stock (“Company Shares”) at a conversion price of $10.31 per Company Share, with customary adjustments for stock splits, stock dividends and other recapitalization events and anti-dilution provisions set forth in the Initial Note. If the Company effects a public listing of Common Stock for trading on any market, whether through a direct listing application or merger transaction, at price per share of Common Stock which is below the conversion price, the conversion price shall be subject to a one-time adjustment to a 10% premium to such public listing price. The Initial Note (a) provides for customary affirmative and negative covenants, including restrictions on the Company incurring subsequent debt, and (b) contains customary event of default provisions with a default interest rate of the lesser of 17.5% for the cash interest or the maximum rate permitted by law. Upon the occurrence of an event of default, GPB may require the Company to redeem the Initial Note at 120% of the then outstanding principal balance plus any accrued and unpaid interest thereon. Subject to certain limited exceptions, the Initial Note is secured by a lien on all of the assets of the Company and its subsidiaries, including the intellectual property of the Company and its subsidiaries, pursuant to a security agreement entered into among the Company and its subsidiaries and GPB (the “Security Agreement”) and an intellectual property security agreement entered into among the Company and its subsidiaries and GPB (“IP Security Agreement”). Subsidiaries of the Company also entered into a guaranty agreement (the “Guaranty Agreement”) pursuant to which the subsidiaries have guaranteed all obligations of the Company to GPB. Pursuant to the Purchase Agreement, in connection with the Initial Note, the Company issued to GPB a warrant (the “Initial Warrant”) that allows GPB to purchase Company Shares with a value of approximately 20% of the face amount of the Initial Note at an exercise price of $10.80 per Company Share, with customary adjustments for stock splits, stock dividends and other recapitalization events and anti-dilution provisions set forth in the Initial Warrant. If the Company effects a public listing of Common Stock for trading on any securities market or exchange, whether through a direct listing application or merger transaction, at a price per share less than the exercise price, the exercise price will be adjusted on a one-time basis to a 10% premium to the dilutive issuance price and the number of shares issuable under the Initial Warrant will be increased on a full ratchet basis. The Initial Warrant is exercisable six months after issuance and has a term of five years after the initial exercise date. The Purchase Agreement provides for the issuance of up to three additional notes by the Company: (i) the Escrow Note, with a principal amount of $7,000,000 with a purchase price of $6,720,000 (4% original issue discount), (ii) the Second Note, with a principal amount of $5,000,000 with a purchase price of $4,800,000 (4% original issue discount) and the Third Note, with a principal amount of $5,000,000 with a purchase price of $4,800,000 (4% original issue discount) (collectively with the Initial Note, the “Notes”). These additional Notes are issuable upon the satisfaction of certain conditions by the Company related to perfection of GPB’s security interest in foreign subsidiary assets and meeting revenue goals. The interest rate, payment terms, conversion rights, events of default and other terms and conditions of the Escrow Note, Second Note and Third Note will be substantially the same as those of the Initial Note. Pursuant to the Purchase Agreement, upon issuance of each additional Note after the Initial Note, the Company is required to issue additional warrants with terms substantially similar to the terms of the Initial Warrant (collectively with the Initial Warrant, the “Warrants”). GPB also has a right of participation for any Company offering, financing or debt issuance for 36 months after December 29, 2017. The Company is required to maintain a 6-month interest reserve. In addition, subject to limited exceptions, GPB will not have the right to convert any portion of the Notes or exercise the Warrants if GPB, together with its affiliates, would beneficially own in excess of 4.99% of the number of shares of the Company’s Common Stock outstanding immediately after giving effect to its conversion (the “Beneficial Ownership Limitation”). The Beneficial Ownership Limitation may be adjusted upon not less than 61 days’ prior notice to the Company, provided that such Beneficial Ownership Limitation in no event shall exceed 9.99%. In connection with the Purchase Agreement, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”) pursuant to which the Company has agreed to file a registration statement with SEC relating to the offer and sale by GPB of the Company Shares underlying the Notes and Warrants. The Company is required to file a registration statement within one hundred eighty (180) days of closing of a public listing of the Company’s Common Stock for trading on any national securities exchange (excluding any over-the-counter market), whether through a direct listing application or merger transaction. The Company is required to have the registration statement become effective on the earlier of (A) the date that is two-hundred and forty (240) days following the later to occur of (i) the date of closing of the public listing or (ii) or in the event the registration statement receives a “full review” by the Commission, the date that is 300 days following the date of closing of the public listing, or (B) the date which is within three (3) business days after the date on which the Commission informs the Company (i) that the Commission will not review the registration statement or (ii) that the Company may request the acceleration of the effectiveness of the registration statement. If the Company does not effect such registration within that period of time, it will be required to pay GPB certain late payments specified in the Registration Rights Agreement. In February 2018, the Company made a full prepayment of the Initial Note. Upon such prepayment, the Purchase Agreement and the Company’s obligations under the Transaction Documents entered into pursuant to the Purchase Agreement were terminated except for a warrant for 240,764 shares of common stock of the Company at an exercise price of $10.80 per share (the “Initial Warrant”) and a Registration Rights Agreement. In October 2018, the Company sold and issued $12.2 million principal amount of debentures and warrants to purchase an aggregate of up to 1,220,000 share of the Company common stock. The net proceeds of the sale of the debentures and warrants were used to fund the loan to EJ Holdings, Inc. The debentures bear interest at the rate of 10% per annum, payable monthly commencing November 1, 2018, and will mature on April 21, 2020. The Company will be obliged to redeem $1,000,000 principal amount debentures monthly, commencing in May 2019, and to redeem the debentures in full upon a “subsequent financing” of at least $20 million, subject to certain exceptions, or in the “event of default” (as defined). The Company’s obligations under the debentures are secured by a security interest in substantially all of our assets, except for certain pledged marketable securities and are guaranteed by the U.S. subsidiaries, Emmaus Medical, Inc. and Newfield Nutrition Corporation. The common stock purchase warrants are exercisable for five years beginning April 22, 2019 at an initial exercise price of $11.30 per share, which will be subject to reduction if we become a listed company or our common stock becomes quoted on a trading market based upon the public offering price or “VWAP” of the Company common stock. The exercise price also will be subject to adjustment in certain other customary circumstances. T.R. Winston & Company, LLC acted as placement agent in connection with the sales of the debentures and warrants pursuant to an amended and restated fee agreement with us dated October 1, 2018. In accordance with the fee agreement, the Company paid T.R. Winston a cash fee equal to 5% of the gross proceeds received from the purchasers granted T.R. Winston warrants to purchase up to 120,000 shares of the Company common stock on the same terms as the common stock purchase warrants sold to the purchasers and reimbursed T.R. Winston for certain legal fees and expenses. A summary of outstanding warrants as of December 31, 2018 and 2017 is presented below. Year ended Year ended December 31, 2018 December 31, 2017 Warrants outstanding, beginning of period 5,265,432 5,024,668 Granted 1,542,000 240,764 Exercised (2,385,317 ) — Cancelled, forfeited and expired (985,684 ) — Warrants outstanding, end of period 3,436,431 5,265,432 A summary of outstanding warrants by year issued and exercise price as of December 31, 2018 is presented below. Outstanding Exercisable Year issued and Exercise Price Number of Warrants Issued Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Total Weighted Average Exercise Price At December 31, 2014 $ 3.50 50,000 0.33 $ 3.50 50,000 $ 3.50 2014 Total 50,000 50,000 At December 31, 2015 $ 4.90 110,417 1.18 $ 4.90 110,417 $ 4.90 2015 Total 110,417 110,417 At December 31, 2016 $ 4.50 118,750 2.50 $ 4.50 118,750 $ 4.50 $ 4.70 75,000 2.33 $ 4.70 75,000 $ 4.70 $ 5.00 1,300,000 2.36 $ 5.00 1,300,000 $ 5.00 2016 Total 1,493,750 1,493,750 At December 31, 2017 $ 10.80 240,764 4.50 $ 10.80 240,764 $ 10.80 2017 Total 240,764 240,764 At December 31, 2018 $ 11.30 1,541,500 4.78 $ 11.30 1,541,500 $ 11.30 Grand Total 3,436,431 3,436,431 Stock options —The 2011 Stock Incentive Plan, which is shareholder‑approved, permits grants of incentive stock options to employees, including executive officers, and other share‑based awards such as stock appreciation rights, restricted stock, stock units, stock bonus and unrestricted stock awards to employees, directors, and consultants for up to 9,000,000 shares of common stock. On February 28, 2013, the number of shares of common stock authorized for issuance under the 2011 Stock Incentive Plan was increased from 3,000,000 shares to 6,000,000 shares. On July 14, 2014, the number of shares of common stock authorized for issuance under the 2011 Stock Incentive Plan was increased from 6,000,000 shares to 9,000,000 shares. Options granted under the 2011 Stock Incentive Plan expire 10 years after grant. Options granted to directors vest in quarterly installments, and all other option grants vest over a minimum period of three years, all based on continuous service with the Company. Management has valued stock options at their date of grant utilizing the Black‑Scholes‑Merton Option pricing model. The fair value of the underlying shares was determined by the market value of stock of similar companies and recent arm’s length transactions involving the sale of the Company’s common stock. The expected volatility was calculated using the historical volatility of a similar public entity in the industry through August 2013 and a group of similar public entities thereafter. The following table presents the assumptions used on recent dates on which options were granted by the Board of Directors. 9/27/2018 8/8/2018 2/27/2018 12/31/2017 Stock Price $ 11.10 $ 11.30 $ 11.40 $ 11.40 Exercise Price $ 11.10 $ 11.30 $ 11.40 $ 11.40 Term 10 years 10 years 10 years 10 years Risk-Free Rate 2.99 % 2.88 % 2.75 % 2.27 % Dividend Yield — — — — Volatility 69.14 % 66.09 % 68.18 % 68.18 % In making the determination of fair value and finding similar companies, the Company considered the industry, stage of life cycle, size and financial leverage of such other entities. While the Company was initially able to identify only one similar public company using these criteria, based on the more advanced stage of development of the Company additional similar companies with enough historical data that met the industry criterion have now been identified. Accordingly, the Company has based its expected volatility on the historical stock prices of a group peer of companies since September 2013. The risk‑free interest rate is based on the implied yield available on U.S. Treasury issues with an equivalent term approximating the expected life of the options depending on the date of the grant and expected life of the options. During the year ended December 31, 2018, the Company’s Board of Directors granted 357,000 options to its officers, directors and employees. The option will vest as follows: one‑third (1/3) will vest on the first anniversary of the grant date, and the remaining two‑thirds (2/3) will vest in twenty‑four approximately equal monthly installments over a period of two years thereafter. During the year ended December 31, 2017, 50,000 options were granted by the Company’s Board of Directors to a consultant. These options vested immediately, have an exercise price of $11.40 per share and are exercisable through 2027. As of December 31, 2018 and 2017, there were 6,642,200 and 6,775,200 options outstanding, respectively, under the 2011 Stock Incentive Plan. A summary of the Company’s stock option activity for the years ended December 31, 2018 and 2017 is presented below : December 31, 2018 December 31, 2017 Number of Options Weighted‑ Average Exercise Price Number of Options Weighted‑ Average Exercise Price Options outstanding, beginning of period 6,775,200 $ 4.12 6,955,200 $ 4.10 Granted or deemed issued 357,000 $ 11.28 50,000 $ 11.40 Exercised (170,000 ) $ 4.59 (11,895 ) $ 4.19 Cancelled, forfeited and expired (320,000 ) $ 6.06 (218,105 ) $ 4.98 Options outstanding, end of period 6,642,200 $ 4.40 6,775,200 $ 4.12 Options exercisable at end of year 5,958,783 $ 3.87 5,604,439 $ 3.95 Options available for future grant 2,357,800 2,224,800 During the years ended December 31, 2018 and 2017, the Company recognized $4.6 million and $5.1 million, respectively, of share‑based compensation cost arising from stock option grants. As of December 31, 2018, there was $3.3 million of total unrecognized compensation cost related to unvested share‑based compensation arrangements granted under the 2011 Stock Incentive Plan. That cost is expected to be recognized over the weighted average remaining period of 1.9 years. Registration rights — Pursuant to the Purchase Warrant relating to the GPB Debt Holdings II, LLC issued by the Company on December 29, 2017, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”) pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the “Commission”) relating to the offer and sale by GPB of the Company Shares underlying the Warrants. The Company is required to file a registration statement within one hundred eighty (180) days of closing of a public listing of the Company’s Common Stock for trading on any national securities exchange (excluding any over-the-counter market), whether through a direct listing application or merger transaction. The Company is required to have the registration statement become effective on the earlier of (A) the date that is two-hundred and forty (240) days following the later to occur of (i) the date of closing of the public listing or (ii) or in the event the registration statement receives a “full review” by the Commission, the date that is 300 days following the date of closing of the public listing, or (B) the date which is within three (3) business days after the date on which the Commission informs the Company (i) that the Commission will not review the registration statement or (ii) that the Company may request the acceleration of the effectiveness of the registration statement. If the Company does not effect such registration within that period of time, it will be required to pay GPB for liquidated damages an amount of cash equal to 2% of the product of (i) the number of Registrable Securities and (ii) the Closing Sale Price or Closing Bid Price as of the trading day immediately prior to the Event Date, such payments to be made on the Event Date and every thirty (30) day anniversary thereafter with a maximum penalty of 12% until the applicable Event is cured; provided, however, that in the event the Commission does not permit all of the Registrable Securities to be included in the Registration Statement because of its application of Rule 415, liquidated damages shall only be payable by the Company based on the portion of the Holder’s initial investment in the Securities that corresponds to the number of such Holder’s Registrable Securities permitted to be registered by the Commission in such Registration Statement pursuant to Rule 415. Pursuant to the Subscription Agreements relating to the Private Placement and certain warrants, as well as pursuant to the replacement of certain warrants by the Company on June 10, 2014, the Company agreed to use its commercially reasonable best efforts to have on file with the SEC, by September 11, 2014 and at the Company’s sole expense, a registration statement to permit the public resale of 4,115,966 shares of Company common stock and 3,320,501 shares of common stock underlying warrants (collectively, the “Registrable Securities”). In the event such registration statement includes securities to be offered and sold by the Company in a fully underwritten primary public offering pursuant to an effective registration under the Securities Act of 1933, as amended (the “Securities Act”), and the Company is advised in good faith by any managing underwriter of securities being offered pursuant to such registration statement that the number of Registrable Securities proposed to be sold in such offering is greater than the number of such securities which can be included in such offering without materially adversely affecting such offering, the Company will include in such registration the following securities in the following order of priority: (i) any securities the Company proposes to sell, and (ii) the Registrable Securities, with any reductions in the number of Registrable Securities actually included in such registration to be allocated on a pro rata basis among the holders thereof. The registration rights described above apply until all Registrable Securities have been sold pursuant to Rule 144 under the Securities Act or may be sold without registration in reliance on Rule 144 under the Securities Act without limitation as to volume and without the requirement of any notice filing. If the shares of common stock underlying these warrants to purchase 3,320,501 shares are not registered for resale at the time of exercise, and the registration rights described above then apply with respect to the holder of such warrants, such holder may exercise such warrants on a cashless basis. In such a cashless exercise of all the shares covered by the warrant, the warrant holder would receive a number of shares equal to the quotient of (i) the difference between the fair market value of the common stock, as defined, and the $3.50 exercise price, as adjusted, multiplied by the number of shares exercisable under the warrant, divided by (ii) the fair market value of the common stock, as defined. The Company has not yet filed a registration statement with respect to the resale of the Registrable Securities. The Company believes that it has used commercially reasonable efforts to file a registration statement with respect to the resale of Registrable Securities. Korean Private Placement —On September 12, 2016, the Company entered into Letter of Agreement with KPM and Hanil, both Korean‑based public companies whose shares are listed on KOSDAQ, a trading board of Korea Exchange in South Korea. In the Letter of Agreement, the parties agreed that KPM and Hanil would purchase by September 30, 2016 $17 million and $3 million, respectively, of shares of our common stock at a price of $4.50 per share. In exchange, the Company agreed to invest $13 million and $1 million in future capital increases by KPM and Hanil, respectively, at prices based upon the trading prices of KPM and Hanil shares on KOSDAQ. The Letter of Agreement contemplates that KPM and Hanil may purchase additional shares of our common stock in a second transaction to be mutually agreed upon by the parties. In connection with the Letter of Agreement, KPM and Hanil entered into our standard form subscription agreement with respect to their purchase of shares which contains customary representations and warranties of the parties. On September 29, 2016, KPM and Hanil purchased and acquired from the Company 3,777,778 shares and 666,667 shares, respectively, of common stock at a price of $4.50 a share for $17 million and $3 million, respectively, for a gross total of $20 million. The Company recognized $720,000 as a reduction to its additional paid‑in‑capital for fees and commissions payable by the Company in connection with the transaction. Pursuant to the terms of the Letter of Agreement dated September 12, 2016, the Company invested $13 million and $1 million in capital increases by KPM and Hanil, respectively, at $15.32 and $3.68, respectively, per capita share. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 8—INCOME TAXES The provision (benefit) for income taxes consists of the following for the years ended December 31, 2018 and 2017: 2018 2017 Current U.S. $ 5,586 $ 2,400 International 636 833 Deferred U.S. — (12,306,343 ) International — — $ 6,222 $ (12,303,110 ) A valuation allowance for the net deferred tax assets has been recorded as it is more likely than not that these benefits will not be realized through future operations. Deferred tax assets consist of the following as of December 31, 2018 and 2017: 2018 2017 Net operating loss carryforward $ 19,900,927 $ 15,086,163 General business tax credit 9,342,425 8,911,700 Stock options 6,011,522 3,583,299 Charitable contribution 139,124 38,128 Accrued expenses 364,306 229,105 Unearned revenue 1,395,870 — Allowance for bad AR 172,939 — Other 317,845 29,855 Total gross deferred tax assets 37,644,958 27,878,250 Less valuation allowance (34,599,232 ) (13,381,045 ) Net deferred tax assets $ 3,045,726 $ 14,497,205 Deferred tax liabilities consist of the following as of December 31, 2018 and 2017: 2018 2017 Unrealized gain on LT investment $ 2,964,943 $ — Unrealized gain on foreign exchange translation and others (78,281 ) (32,752 ) Unrealized gain on marketable securities — (14,464,453 ) Other (2,502 ) — Total deferred tax liability $ 2,884,160 $ (14,497,205 ) During 2018, the valuation allowance increased by $21.2 million and during 2017, the valuation allowance decreased by $23.4 million, respectively. As of December 31, 2018 and 2017, the Company had net operating loss carryforwards for federal reporting purposes of approximately $64.8 million and $64.6 million, which are available to offset future federal taxable income, if any. Net operation loss generated in 2017 and prior expire in various years through 2037. In addition, the Company had net operating loss carryforwards for state income tax purposes of approximately $55.7 million and $57.9 million respectively, which expire in various years through 2038. The utilization of our net operating losses could be subject to an annual limitation as a result of certain past and future events, such as acquisition or other significant equity events, which may be deemed as a “change in ownership” under the provisions of the Internal Revenue Code of 1986, as amended, and similar state provisions. The annual limitations could result in the expiration of net operating losses and tax credits before utilization. As of December 31, 2018 and 2017, the Company has general business tax credits of $9.3million and $8.9 million, respectively, for federal tax purposes. The tax credits are available to offset future tax liabilities, if any, through 2038. The income tax provision differs from that computed using the statutory federal tax rate of 21%, due to the following: 2018 2017 Tax benefit at statutory federal rate $ (12,169,762 ) $ (15,496,876 ) State taxes, net of federal tax benefit (3,786,890 ) (398,315 ) Increase in valuation allowance 6,753,526 (8,943,404 ) Permanent items 750,485 9,521,184 General business tax credit (430,724 ) (1,407,553 ) Impact from tax rate change (34% to 21%) — 10,210,183 OCI, tax benefit — (12,306,343 ) Other 8,889,587 6,518,014 $ 6,222 $ (12,303,110 ) As of December 31, 2018 and 2017, the Company had no unrecognized tax benefits, and the Company had no position which, in the opinion of management, would be reversed if challenged by a taxing authority. In the event the Company is assessed interest and/or penalties, such amounts will be classified as income tax expense in the financial statements. As of December 31, 2018, all federal tax returns since 2015 and state tax returns since 2014 are still subject to adjustment upon audit. No tax returns are currently being examined by taxing authorities. Tax Reform — On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the “Act”) was signed into law making significant changes to the Internal Revenue Code. Changes include, but are not limited to, a corporate tax rate decrease from 34% to 21% effective for tax years beginning after December 31, 2017, the transition of U.S international taxation from a worldwide tax system to a territorial system, and a one-time transition tax on the mandatory deemed repatriation of cumulative foreign earnings as of December 31, 2017 to be accounted for in this period of enactment in accordance with its understanding of the Act and guidance available as of the date of this filing |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 9—COMMITMENTS AND CONTINGENCIES Operating leases —The Company leases its office space under operating leases with unrelated entities. The rent expense during the years ended December 31, 2018 and 2017 amounted to $668,620 and $563,382, respectively. Future minimum lease payments under the agreements are as follows: Year Amount 2019 $ 729,825 2020 974,008 2021 973,428 2022 1,003,437 Thereafter 3,665,179 Total $ 7,345,877 Management Control Acquisition Agreement — On June 12, 2017, the Company entered into a Management Control Acquisition Agreement (the “MCAA”) with Telcon Holdings, Inc. (“Telcon Holdings”), a Korean corporation, and Telcon Inc. (“Telcon”), a Korean-based public company whose shares are listed on KOSDAQ, a trading board of Korea Exchange in South Korea. In accordance with the MCAA, the Company invested ₩36.0 billion KRW (approximately $31.8 million USD) to purchase 6,643,559 shares of Telcon’s common stock shares at a purchase price of ₩5,419 KRW (approximately $4.79 USD) per share. Upon consummation of the MCAA, the Company became Telcon’s largest shareholder owning approximately 10.3% of Telcon’s outstanding common stock shares and received representation on its board of directors. The MCAA was amended in certain respect and supplemented by an Agreement, dated as of September 29, 2017, among the parties. Pursuant to the September 2017 Agreement, among other things, Telcon purchased 4,444,445 Emmaus shares from KPM and Hanil at a price of $6.60 per share. On July 2, 2018, we entered into an Additional Agreement with Evercore Investment Holdings Co., Ltd. (formerly Telcon Holdings Co., Ltd.), (“Evercore”), and Telcon RF Pharmaceutical Inc. (formerly Telcon Inc.), (“Telcon”). In the Additional Agreement, we agreed to use the proceeds from the sales of our KPM shares to repurchase Emmaus shares from Telcon at a price of $7.60 a share, subject to certain exceptions, and Telcon granted us the right to purchase from Telcon all or a portion of its Emmaus shares at a price of $7.60 a share until October 31, 2018 and at a price to be agreed upon after October 31, 2018. We repurchased 495,000 shares from Telcon at a price of $7.60 a share in 2018. Then, the date was extended to May 31, 2019. Telcon also granted us under the Additional Agreement a right of first refusal until June 30, 2019 to purchase any Emmaus shares that Telcon may wish to sell. In connection with the MCAA, on June 15, 2017, Emmaus and Telcon entered into exclusive distribution agreements for the distribution of L-glutamine powder for diverticulosis treatment for the South Korea, Japan and China Territories, with the intention to add the Australia territory. In the Additional Agreement, the parties agreed to dispense with a distribution agreement for Australia, and that the parties have no liabilities or obligations with respect to the intended Australia distribution, including any related liabilities and obligations under the September 2017 Agreement. The Additional Agreement provides for specified damages in the event of a breach of the Additional Agreement by any party. API Supply Agreement — On June 12, 2017, the Company entered into an API Supply Agreement (the “API Agreement”) with Telcon pursuant to which Telcon paid the Company approximately ₩36.0 billion KRW (approximately $31.8 million USD) in consideration of the right to supply 25% of the Company’s requirements for bulk containers of PGLG for a fifteen-year term. Due to unforeseen circumstances, the Company and Telcon held new discussions to re-negotiate certain terms of the API Agreement. The Company and Telcon made significant changes to critical terms of the API Agreement, which resulted in the Company and Telcon signing a Raw Material Supply Agreement (“Revised API Agreement”) on July 12, 2017. The Revised API Agreement is effective for a term of five years with 10 one-year renewal periods for a maximum of 15 years and the agreement will automatically renew unless terminated by either party in writing. The Revised API Agreement does not include yearly purchase commitments or margin guarantees, but revises the API Agreement such that a unit price is established for 940,000 kilograms of PGLG at $50 USD per kilogram for a total of $47.0 million over the 15 years. The Revised API Supply Agreement is silent on yearly purchase commitments and margin guarantees on purchases of $5.0 million and $2.5 million, respectively. The raw materials purchased from Telcon are measured at net realizable value while the excess is recorded against the deferred Trade Discount. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 10—RELATED PARTY TRANSACTIONS The following table sets forth information relating to our loans from related persons outstanding as of the date hereof or at any time during the year ended December 31, 2018. Class Lender Interest Rate Date of Loan Term of Loan Principal Amount Outstanding at December 31, 2018 Highest Principal Outstanding Amount of Principal Repaid or Converted into Stock Amount of Interest Paid Conversion Rate Shares Underlying Notes December 31, 2018 Current, Promissory note payable to related parties: Masaharu & Emiko Osato (3) 11% 12/29/2015 Due on Demand $ — $ 300,000 $ 300,000 $ 76,036 $ — $ — Lan T. Tran (2) 11% 2/10/2016 Due on Demand — 130,510 130,510 28,712 — — Masaharu & Emiko Osato (3) 11% 2/25/2016 Due on Demand — 400,000 400,000 94,389 — — Lan T. Tran (2) 10% 4/29/2016 Due on Demand 20,000 20,000 — — — — Hope Hospice (1) 10% 6/3/2016 Due on Demand 250,000 250,000 — — — — Lan T. Tran (2) 10% 2/9/2017 Due on Demand 12,000 12,000 — — — — Yutaka Niihara (2)(3) 10% 9/14/2017 Due on Demand 26,583 903,751 877,167 94,584 — — Lan T. Tran (2) 11% 2/10/2018 Due on Demand 159,223 159,223 — — — Subtotal $ 467,806 $ 2,175,484 $ 1,707,678 $ 293,721 $ — Current, Convertible notes payable to related parties: Yasushi Nagasaki (2) 10% 6/29/2012 Due on Demand $ 200,000 $ 200,000 $ — $ — $ 3.30 $ 74,182 Yutaka & Soomi Niihara (2)(3) 10% 11/16/2015 2 years 200,000 200,000 — — $ 4.50 $ 58,350 Wei Peu Zen (3) 10% 11/6/2017 2 years 5,000,000 5,000,000 — 250,000 $ 10.00 $ 532,671 Subtotal $ 5,400,000 $ 5,400,000 $ — $ 250,000 $ 665,203 Non Current, Convertible notes payable to related parties: Profit Preview International Group, Ltd. (4) 10% 2/1/2018 2 years 4,037,000 4,037,000 — 201,850 $ 10.00 $ 420,456 Profit Preview International Group, Ltd. (4) 10% 3/21/2018 2 years 5,363,000 5,363,000 — 268,150 $ 10.00 $ 551,507 Subtotal $ 9,400,000 $ 9,400,000 $ — $ 470,000 $ 971,963 Total $ 15,267,806 $ 16,975,484 $ 1,707,678 $ 1,013,721 $ 1,637,166 The following table sets forth information relating to our loans from related persons outstanding as of the date hereof or at any time during the year ended December 31, 2017. Class Lender Interest rate Date of loan Term of Loan Principal Amount Outstanding at December 31, 2017 Highest Principal Outstanding Amount of Principal Repaid Amount of Interest Paid Conversion Rate Shares Underlying Notes at December 31, 2017 Current, Promissory note payable to related parties: Hope Hospice (1) 8% 1/17/2012 Due on Demand $ — $ 200,000 $ 200,000 $ 7,331 — — Hope Hospice (1) 8% 6/14/2012 Due on Demand — 200,000 200,000 14,762 — — Hope Hospice (1) 8% 6/21/2012 Due on Demand — 100,000 100,000 7,249 — — Hope Hospice (1) 8% 2/11/2013 Due on Demand — 50,000 50,000 1,559 — — Hope Hospice (1) 10% 1/7/2015 Due on Demand — 100,000 100,000 28,630 — — IRA Service Trust Co. FBO Peter B. Ludlum (2) 10% 2/20/2015 Due on Demand 10,000 10,000 — — — — Masaharu & Emiko Osato (3) 11% 12/29/2015 Due on Demand 300,000 300,000 — — — — Yutaka Niihara (2)(3) 10% 5/21/2015 Due on Demand 0 826,105 94,339 61,829 — — Lan T. Tran (2) 11% 2/10/2016 Due on Demand 130,510 130,510 — — — — Masaharu & Emiko Osato (3) 11% 2/25/2016 Due on Demand 400,000 400,000 — — — — Hope Hospice (1) 10% 4/4/2016 Due on Demand — 50,000 50,000 8,110 — — Lan T. Tran (2) 10% 4/29/2016 Due on Demand 20,000 20,000 — — — — IRA Service Trust Co. FBO Peter B. Ludlum (2) 10% 5/5/2016 Due on Demand 10,000 10,000 — — — — Hope Hospice (1) 10% 6/3/2016 Due on Demand 250,000 250,000 — — — — Lan T. Tran (2) 10% 2/9/2017 Due on Demand 12,000 12,000 — — — — Yutaka Niihara (2)(3) 10% 9/14/2017 Due on Demand 903,751 903,751 — — — — Subtotal $ 2,036,261 $ 3,562,366 $ 794,339 $ 129,470 — Current, Convertible notes payable to related parties: Yasushi Nagasaki (2) 10% 6/29/2012 Due on Demand $ 200,000 $ 388,800 $ 188,800 $ 57,886 $ 3.30 68,122 Charles & Kimxa Stark (2) 10% 10/1/2015 2 years — 20,000 20,000 4,405 $ 4.50 — Yutaka & Soomi Niihara (2)(3) 10% 11/16/2015 2 years 200,000 200,000 — — $ 4.50 53,905 Subtotal $ 400,000 $ 608,800 $ 208,800 $ 62,291 122,027 Total $ 2,436,261 $ 4,171,166 $ 1,003,139 $ 191,761 122,027 (1) Dr. Niihara, our director and Chief Executive Officer, is also the Chief Executive Officer of Hope Hospice (2) Officer (3) Director (4) Mr. Zen, a Director, is the sole owner of Profit Preview International Group, Ltd. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 11—SUBSEQUENT EVENTS Subsequent to the year ended December 31, 2018, the Company issued the following: Common Shares Issued after December 31, 2018 Amounts Number of Shares Issued Common shares $ 1,885,000 227,500 On January 7, 2019, we announced our entry into an Agreement and Plan of Merger and Reorganization, dated as of January 4, 2019 (as it may be amended, the “Merger Agreement”), among Emmaus, MYnd Analytics, Inc. (“Parent”) and Athena Merger Subsidiary, Inc. (“Merger Sub”), pursuant to which Merger Sub will merger with and into Emmaus, with Emmaus surviving as a subsidiary of Parent. On March 5, 2019, we entered into a securities amendment agreement with the holders of our 10% senior secured debentures and related common stock purchase warrants issued in October 2018. The amendment provides that the securities purchase agreement among the company and the holders of the debentures entered into on September 8, 2018, as previously amended, is to be further amended in certain respects, and the debentures and warrants are to be amended in certain respects and restated in their entirety, concurrent with and subject to the completion of our proposed merger transaction with MYnd Analytics, Inc. described in our Current Report on Form 8-K filed with the Securities and Exchange Commission (the “ SEC”) on January 7, 2019. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation —The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) codified in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain prior period amounts have been reclassified to conform to the current period presentation. |
Going concern | Going concern —The accompanying consolidated financial statements have been prepared on the basis that the Company will continue as a going concern. The Company had net losses attribute to the Company of $57.9 million and $33.4 million for the years ended December 31, 2018 and 2017, respectively. In addition, the Company has a significant amount of notes payable and other obligations due within the next twelve months and is projecting that its operating losses and expected capital needs, including the expected costs relating to the commercialization of Endari, will exceed its existing cash balances and cash expected to be generated from operations for the foreseeable future. In order to meet the Company’s expected obligations, management intends to raise additional funds through equity and debt financings and partnership agreements. However, there can be no assurance that the Company will be able to complete any additional equity or debt financings or enter into partnership agreements. Therefore, due to the uncertainty of the Company’s ability to meet its current operating and capital expenses, there is substantial doubt about the Company’s ability to continue as a going concern, as the continuation and expansion of its business is dependent upon obtaining further financing, successful and sufficient market acceptance of its products, and achieving a profitable level of operations. The consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties. |
Principles of consolidation | Principles of consolidation —The consolidated financial statements include the accounts of the Company (and its wholly‑owned subsidiary, Emmaus Medical, and Emmaus Medical’s wholly‑owned subsidiaries, Newfield Nutrition, EM Japan, ELSK and EM Europe). All significant intercompany transactions have been eliminated. The Company also consolidates a variable interest entity (VIE) when the Company has one or more variable interest and is the primary beneficiary of the VIE in question. The Company is deemed to be the primary beneficiary of the VIE if it has both (a) the power to direct the activities of the VIE that most significantly affect the VIE’s economic performance and (b) During 2018, the Company and Japan Industrial Partners formed EJ Holdings, Inc. to acquire and operate manufacturing facility in Ube, Japan. As part of the formation, the Company invested JPY3,600,000 (approximately US$ 32,000) in exchange for 40% of voting shares in EJ Holdings, Inc. The Company anticipates that the manufacturing facility to be acquired will be Company’s supplier of pharmaceutical grade L-glutamine. Emmaus has determined that EJ Holdings, Inc. is a VIE as substantially all of its activities involve Emmaus, the investor with disproportionally few voting rights. Emmaus also determined that it is the primary beneficiary of EJ Holdings, Inc. and therefore, consolidates EJ Holdings, Inc. into its financial statements. Emmaus determinations above and related accounting treatment depend on judgements and assumptions, most significant of which relate to the nature and economics of future business activities of EJ Holdings, Inc. as well as the role and participation of Japan Industrial Partners. As part of consolidation of EJ Holdings, Inc. all significant intercompany transactions have been eliminated. The Company reports 60% equity interest held by Japan Industrial Partners in EJ Holdings, Inc. as a noncontrolling interest, a separate part of consolidated equity. |
Estimates | Estimates —Financial statements prepared in accordance with GAAP require management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Among other things, management has estimated the useful lives of equipment and other assets, valuation of intangible assets, along with the variables used to calculate the valuation of stock options and warrants using the Black‑Scholes‑Merton option valuation model. The various warrants issued by the Company in (i) a private placement in September 2013, (ii) in connection with GPB debt transactions in December 2017 and (iii) replacement warrants issued in June 2014 contain non‑standard anti‑dilution protection and, consequently, are being accounted for as liabilities that are remeasured to fair market value at each reporting period (Note 7). In addition, the remaining initial private placement warrants may now utilize a cashless exercise feature since the shares associated with them were not registered by the one‑year anniversary of their issue. These warrants are classified as warrant derivative liabilities and continue to be remeasured at fair value each reporting period. The initial value as well as the fair value of all such warrants were determined using a Binomial Monte‑Carlo Cliquet (aka Ratchet) Option Pricing Model. The model is similar to traditional Black‑Scholes‑type option pricing models except that the exercise price resets at certain dates in the future. Actual results could differ from those estimates. |
Cash and cash equivalents | Cash and cash equivalents —Cash and cash equivalents include short‑term securities with original maturities of less than ninety days. The Company maintains its cash and cash equivalents at insured financial institutions, the balances of which may, at times, exceed federally insured limits. Management believes that the risk of loss due to the concentrations is minimal. |
Restricted Cash | Restricted Cash — Restricted cash includes funds that are held in escrow by the lender and restricted as to withdrawal until certain conditions are met. In February 2018, the Company made a full prepayment of the Initial Note. All the restricted cash held in escrow was returned to GPB. See Note 7 under “Purchase Agreement with GPB.” The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported on our consolidated statements of cash flows as of December 31, 2018 and 2017: As of December 31, 2018 2017 Cash and cash equivalents $ 17,079,734 $ 15,836,063 Restricted cash — 6,720,000 Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows $ 17,079,734 $ 22,556,063 |
Inventories | Inventories —Inventories are valued based on first‑in, first‑out and at the lesser of cost or net realizable value. Work‑in‑process inventories consist of L‑glutamine for the Company’s Endari and AminoPure products that has not yet been packaged and labeled for sale. Substantially all of the raw material purchases during the years ended December 31, 2018 and 2017 were from one vendor. The below table presents inventory by category: As of December 31, Inventories by category 2018 2017 Raw materials and components $ 170,997 $ — Work-in-process 2,471,147 124,801 Finished goods 2,062,427 500,498 Total $ 4,704,571 $ 625,299 |
Prepaid expenses and other current assets | Prepaid expenses and other current assets — Prepaid expenses and other current assets consisted of the following at December 31, 2018 and 2017: As of December 31, 2018 2017 Prepaid insurance $ 81,797 $ 132,387 Other prepaid expenses and current assets 651,211 157,984 $ 733,008 $ 290,371 |
Deposits | Deposits —Carrying value of amounts transferred to third parties for security purposes that are expected to be returned or applied towards payment after one year or beyond the operating cycle, if longer, are recorded as deposits. Deposit amounts further consist of retainer payments for professional services and security deposits for its offices. |
Revenue recognition | Revenue recognition — Effective January 1, 2018, the Company adopted ASC 606, Revenue from Contracts with Customers using the modified retrospective transition methods. The adoption of ASC 606 did not have a material impact on the measurement or on the recognition of revenue of contracts for which all revenue had not been recognized as of January 1, 2018, therefore no cumulative adjustment has been made to the opening balance of accumulated deficit at the beginning of 2018. The comparative information has not been restated and continues to be reported under the accounting standards in effect for the periods presented. Since January 2018, the Company has generated revenues through the sale of Endari as a treatment for SCD. The Company also generates revenues to a much lesser extent from NutreStore L-glutamine powder, as well as AminoPure, a nutritional supplement. Revenues from Endari product sales are recognized upon transfer to our distributors, which are customers of the Company, when they obtain control of our products. These distributors subsequently resell our products to specialty pharmacy providers, health care providers, hospitals, patients and clinics. In addition to distribution agreements with these distributors, the Company enters into arrangements with specialty pharmacy providers, in-office dispensing providers, group purchasing organizations, and government entities that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of our products. These various discounts, rebates, and charge-backs are referred to as “variable consideration.” Revenues from product sales are recorded net of these variable considerations. Prior to recognizing revenues, the Company’s management forecasts and estimates variable consideration. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenues recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Provisions for returns and other adjustments are provided for in the period in which the related revenues are recorded. Actual amounts of consideration ultimately received may differ from the management estimates. If actual results in the future vary from the estimates, the management will adjust these estimates, which would affect net product revenues in the period such variances become known. The following are our significant categories of sales discounts and allowances: Sales Discounts: The Company provides its customers prompt payment discounts that are explicitly stated in its contracts and are recorded as a reduction of revenues in the period the revenues are recognized. Product Returns: The Company offers its distributors a right to return product purchased directly from the Company, which is principally based upon (i) overstocks, (ii) inactive product or non-moving product due to market conditions, and (iii) expired products. Product return allowances are estimated and recorded at the time of sale. Government Rebates: The Company is subject to discount obligations under state Medicaid programs and the Medicare prescription drug coverage gap program. The Company’s management estimates Medicaid and Medicare prescription drug coverage gap rebates based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the related revenues are recognized, resulting in a reduction of product revenues and the establishment of a current liability that is included as an accrued liability in our balance sheet. The liability for these rebates consists primarily of estimates of claims expected to be received in future periods related to recognized revenues. Chargebacks and Discounts: Chargebacks for fees and discounts represent the estimated obligations resulting from contractual commitments to sell products to certain specialty pharmacy providers, in-office dispensing providers, group purchasing organizations, and government entities at prices lower than the list prices charged to distributors. The distributors charge the Company for the difference between what they pay for the products and the Company’s contracted selling price to these specialty pharmacy providers, in-office dispensing providers, group purchasing organizations, and government entities. These reserves are established in the same period that the related revenues are recognized, resulting in a reduction of revenues. Chargeback amounts are generally determined at the time of resale of products by the distributors. The following table summarizes revenues from each of our customers who individually accounted for 10% or more of the Company’s total revenues (as a percentage to total revenue). As of December 31, 2018 2017 AmerisourceBergen Specialty Group 77 % — McKesson Plasma and Biologics LLC 13 % — Johnson Chemical Pharm Works Co. Ltd — 29.0 % |
Advertising cost | Advertising cost —Advertising costs are expensed as incurred. Advertising costs for the years ended December 31, 2018 and 2017 were $ 97,514 and $ 59,045, respectively. |
Property and equipment | Property and equipment —Equipment, Furniture and fixtures are recorded at historical cost and amortized on a straight‑line basis over their estimated useful lives of 5 to 7 years. Leasehold improvements are recorded at historical cost and amortized on a straight‑line basis over the shorter of their estimated useful lives or the lease terms. Maintenance and repairs are expensed as incurred, while major additions and improvements are capitalized. Gains and losses on disposition are included in other income (expenses), if any. |
Intangibles | Intangibles —The Company’s intangible assets include website development costs. These intangible assets are amortized over a period of 5 years, the estimated economic life of intangible assets. The intangible assets are assessed by management for potential impairment on an annual basis. No impairment existed as of December 31, 2018 and 2017. |
Impairment of long-lived assets | Impairment of long‑lived assets —The Company evaluates the carrying value of its long‑lived assets for impairment whenever events or changes in circumstances indicate that such carrying values may not be recoverable. The Company uses its best judgment based on the current facts and circumstances relating to its business when determining whether any significant impairment factors exist. If the Company determines that the carrying values of long‑lived assets may not be recoverable based upon the existence of one or more indicators of impairment, the Company performs an undiscounted cash flow analysis to determine if impairment exists. If impairment exists, the Company measures the impairment based on the difference between the asset’s carrying amount and its fair value, and the impairment is charged to the consolidated statement of comprehensive loss in the period in which the long‑lived asset impairment is determined to have occurred. No impairment existed as of December 31, 2018 and 2017. |
Research and development | Research and development —Research and development consists of expenditures for the research and development of new products and technologies, which primarily involve contract research, payroll‑related expenses, and other related supplies. Research and development costs are expensed as incurred. Intangible assets acquired for research and development purposes are capitalized if they have alternative future use. |
Share-based compensation | Share‑based compensation —The Company recognizes compensation cost for share‑based compensation awards over the service term of the recipients of the share‑based awards. The fair value of share‑based compensation is calculated using the Black‑Scholes‑Merton pricing model. The Black‑Scholes‑Merton model requires subjective assumptions regarding future stock price volatility and expected time to exercise, which greatly affect the calculated values. The expected term of awards granted is calculated using the simplified method allowed under the Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin Nos. 107 and 110. The risk‑free rate selected to value any particular grant is based on the U.S. Treasury rate on the grant date that corresponds to the expected term of the award. The expected volatility is based on the historical volatility of the common stock of comparable publicly traded companies. These factors could change, affecting the determination of stock‑based compensation expense in future periods. |
Income taxes | Income taxes —The Company accounts for income taxes under the asset and liability method, wherein deferred tax assets and liabilities are recognized for the future tax consequences attributable to the differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. 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 the enactment occurs. A valuation allowance is provided for certain deferred tax assets if it is more likely than not that the Company will not realize tax assets through the generation of future taxable income for the related jurisdictions. For balance sheet presentation, current deferred tax assets and liabilities within each tax jurisdiction have been offset and presented as a single amount and non‑current deferred tax assets and liabilities within each tax jurisdiction have been offset and presented as a single amount. When tax returns are filed, it is highly probable that some positions taken would be sustained upon examination by the taxing authorities, while others are subject to uncertainty about the merits of the position taken or the amount of the position that would be ultimately sustained. The benefit of a tax position is recognized in the financial statements in the period during which, based on all available evidence, management believes it is more likely than not that the position will be sustained upon examination, including the resolution of appeals or litigation processes, if any. Tax positions taken are not offset or aggregated with other positions. Tax positions that meet the more‑ likely‑than‑not recognition threshold are measured as the largest amount of tax benefit that is more than 50 percent likely of being realized upon settlement with the applicable taxing authority. The portion of the benefits associated with tax positions taken that exceeds the amount measured as described above is reflected as a liability for unrecognized tax benefits along with any associated interest and penalties that would be payable to the taxing authorities upon examination. As of December 31, 2017 and 2018, the Company had no unrecognized tax benefits, and the Company had no positions which, in the opinion of management, would be reversed if challenged by a taxing authority. In the event the Company is assessed interest and/or penalties, such amounts will be classified as income tax expense in the financial statements. |
Comprehensive income (loss) | Comprehensive income (loss) —Comprehensive income (loss) includes net loss and other comprehensive income (loss). The items of other comprehensive income (loss) for the Company are unrealized gains and losses on marketable securities and foreign translation adjustments relating to its subsidiaries. When the Company realizes a gain or loss on marketable securities for which an unrealized gain or loss was previously recognized, a corresponding reclassification adjustment is made to remove the unrealized gain or loss from accumulated other comprehensive income and reflect the realized gain or loss in current operations upon adoption of 2016-01. |
Marketable securities | Marketable securities — The Company’s marketable securities consist of the following securities; (a) 39,250 shares of capital stock of CellSeed, Inc. (“CellSeed”) those that remain of 147,100 shares acquired in January 2009 for ¥100,028,000 Japanese Yen (JPY) (equivalent to $1.1 million USD), at ¥680 JPY per share; (b) 849,744 shares of capital stock of KPM Tech Co., Ltd. (“KPM”) which were acquired in October 2016 for ₩14,318,186,400 South Korean Won (KRW) (equivalent to $13.0 million USD) at ₩16,850 KRW per share; (c) 271,950 shares of capital stock of Hanil Vacuum Co., Ltd. (“Hanil”) which were acquired in October 2016 for ₩1,101,397,500 KRW (equivalent to $1.0 million USD) at ₩4,050 KRW per share; and (d) 6,643,559 shares of capital stock of Telcon, Inc. (“Telcon”) which were acquired in July 2017 for ₩36,001,446,221 KRW (equivalent to $31.8 million USD) at ₩5,419 KRW per share. As of December 31, 2018 and December 31, 2017, the closing price per CellSeed share on the Tokyo Stock Exchange was ¥668 JPY ($6.07 USD) and ¥462 JPY ($4.10 USD), respectively, the closing price per Telcon share on the Korean Securities Dealers Automated Quotations (“KOSDAQ”) was ₩8,280 KRW ($7.43 USD) and ₩14,900 KRW ($13.95 USD), respectively. As of December 31, 2017, the closing price per KPM share on KOSDAQ the was ₩1,625 KRW ($1.52 USD) after 1-for-5 reverse stock split effective June 28, 2017 and the closing price per Hanil share on KOSDAQ was ₩2,830 KRW ($2.65 USD). The Company sold all of its KPM and Hanil shares during the year ended December 31, 2018. As of December 31, 2018, 39,250 shares of CellSeed stock are pledged to secure a $300,000 convertible note issued to Mitsubishi UFJ Capital III Limited Partnership that is due on demand and are classified as current assets, as marketable securities, pledged to creditor. |
Loss on debt settlement | Loss on debt settlement —The Company records loss on debt settlement when the Company’s common stocks are issued in settlement for non-convertible debt and its accrued interest. During the years ended December 31, 2018 and 2017, the Company recorded a loss on debt settlement of $3,244,769 and $0, respectively. |
Foreign Currency Translation | Foreign Currency Translation —The Company’s reporting currency is the U.S. dollar. The Yen, Korean Won, and the Euro are the functional currencies of its subsidiaries, EM Japan, ELSK and EM Europe, respectively, as they are the primary currencies within the economic environments in which EM Japan, ELSK and EM Europe operate. Assets and liabilities of their operations are translated into U.S. dollars at period‑end exchange rates, and revenues and expenses are translated into U.S. dollars at average exchange rates in effect during each reporting period. Adjustments resulting from the translation are reported in other comprehensive income or loss. |
Financial Instruments | Financial Instruments —Financial instruments included in the financial statements are comprised of cash and cash equivalents, restricted cash, investment in marketable securities, marketable securities pledged to creditor, long-term investment at cost, accounts receivable, note receivable, warrant derivative liabilities, accounts payable, certain accrued liabilities, convertible notes payable, notes payable and other contingent liabilities. The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate their fair values due to the short‑term nature of those instruments. |
Other long-term liabilities | Other long-term liabilities —Other long-term liabilities consist of the following at December 31, 2018 and 2017: As of December 31, 2018 2017 Trade discount $ 26,221,500 $ 31,841,500 Unearned revenue 10,000,000 5,000,000 Other long-term liabilities — 10,790 Total other long-term liabilities $ 36,221,500 $ 36,852,290 The Company entered into an API Supply Agreement (the “API Agreement”) with Telcon pursuant to which Telcon advanced to the Company approximately ₩36.0 billion KRW (approximately $31.8 million USD) in consideration as an advance trade discount to supply 25% of the Company’s requirements for bulk containers of pharmaceutical grade L-glutamine (“PGLG”) for a term of five years with 10 one-year renewal periods for a maximum of 15 years. The agreement will automatically renew unless terminated by either party in writing. The agreement does not include yearly purchase commitments or margin guarantees. The advance trade discount shall be applied against purchases made by the Company from Telcon over the life of the agreement. |
Fair value measurements | Fair value measurements —The Company defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company measures fair value under a framework that provides a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described as follows: Level 1: Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access. Level 2: Inputs to the valuation methodology include: • Quoted prices for similar assets or liabilities in active markets; • Quoted prices for identical or similar assets or liabilities in inactive markets; • Inputs other than quoted prices that are observable for the asset or liability; • Inputs that are derived principally from or corroborated by observable market data by correlation or other means. If the asset or liability has a specified (contractual) term, the Level 2 inputs must be observable for substantially the full term of the asset or liability. Level 3: Inputs to the valuation methodology are unobservable and significant to the fair value measurement. The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value assigned to marketable securities is determined by obtaining quoted prices on nationally recognized securities exchanges, and are classified as Level 1 investments at December 31, 2018 and 2017. The fair value of the Company’s debt instruments is not materially different from their carrying values as presented. The fair value of the Company’s convertible debt instruments was determined based on Level 2 inputs. The carrying value of the debt was discounted based on allocating proceeds to other financial instruments within the arrangement as discussed in Note 6. Certain of our outstanding warrants contain nonstandard anti-dilution protections or a cashless exercise feature and, consequently, are accounted for as liabilities that are remeasured at fair value on a recurring basis, whose fair value is determined using Level 3 inputs. The Level 3 inputs in the valuation of warrants include expected term and expected volatility. These warrants are classified as warrant derivative liabilities in the consolidated balance sheet and continue to be remeasured at fair value each reporting period. The Level 3 inputs in the valuation of warrants include expected term and expected volatility. The following tables present the activity for those items measured at fair value on a recurring basis using Level 3 inputs during 2018 and 2017: Year ended December 31, Warrant Derivative Liabilities—Stock Purchase Warrants 2018 2017 Balance, beginning of period $ 26,377,000 $ 10,600,000 Repurchased (6,186,000 ) — Change in fair value included in the statement of comprehensive income (loss) (20,191,000 ) 15,777,000 Balance, end of period $ — $ 26,377,000 As of September 11, 2018, all of the Private Placement warrants, replacement warrants and Broker Warrants had been exercised primarily on a cashless basis, or had expired. The following table presents warrants issued in conjunction with Purchase Agreement with GPB (see Note 7) measured at fair value as of December 31, 2018 and 2017: Year ended December 31, 2018 Year ended December 31, 2017 Liability Instrument—GPB Warrants Embedded Conversion Option Warrants Embedded Conversion Option Balance, beginning of period $ 1,882,000 $ 1,289,000 $ — $ — Fair value at issuance date — — 1,882,000 1,289,000 Change in fair value included in the statement of comprehensive income (loss) (483,000 ) (466,000 ) — — Extinguished upon debt repayment — (823,000 ) — — Balance, end of period $ 1,399,000 $ — $ 1,882,000 $ 1,289,000 The Company evaluated the warrant and embedded conversion option as well as the embedded put options in the debt agreement and warrant under ASC 815-40 and ASC 815-15-25-1, respectively, and concluded that the warrant and embedded conversion and contingently exercisable put options are required to be separately recognized at fair value as a liability and derivative liability, respectively as of December 31, 2018 and 2017. Moreover, any changes in the fair value of the warrant liability and the derivative bifurcated option liability shall be recognized in earnings. During 2018, the Company has paid all GPB debt early, resulting the Company to release embedded conversion option liabilities. The value of warrant derivative liabilities and the change in fair value of the warrant derivative are determined using a Binominal Monte-Carlo Cliquet (aka “ Ratchet”) Option Pricing Model. The model is similar to traditional Black-Scholes-type option pricing models, except that the exercise price resets at certain dates in the future. The value as of the dates set for the in the table below, was based on upon following assumptions: GPB Stock Purchase Warrants December 31, 2018 December 31, 2017 December 31, 2017 Stock price $ 9.10 $ 11.40 $ 11.40 Risk‑free interest rate 2.48 % 2.20 % 1.62 % Expected volatility (peer group) 70.00 % 70.00 % 55.80 % Expected life (in years) 4.00 5.00 0.70 Expected dividend yield — — — Number outstanding 240,764 240,764 3,320,501 Balance, end of period: Warrant derivative liabilities (long-term) $ 1,399,000 $ 1,882,000 $ 26,377,000 |
Debt and Related Party Debt | Debt and Related Party Debt —The Company accounts for the proceeds from the issuance of convertible notes payable with detachable stock purchase warrants and embedded conversion features in accordance with ASC 470‑ 20, Debt with Conversion and Other Options . Under ASC 470‑20, the proceeds from the issuance of a debt instrument with detachable stock purchase warrants shall be allocated to the two elements based on the relative fair values of the debt instrument without the warrants and of the warrants themselves at the time of issuance. The portion of the proceeds allocated to the warrants is accounted for as additional paid‑in capital and the remaining proceeds are allocated to the debt instrument, which results in a discount to debt that is amortized and charged as interest expense over the term of the note agreement. Additionally, pursuant to ASC 470‑20, the intrinsic value of the embedded conversion feature of the convertible notes payable is included in the discount to debt and amortized and charged to interest expense over the term of the note agreement. The following table presents the effective interest rates on the original loan principal amount for loans originated in the respective periods that either had a beneficial conversion interest or an attached warrant: Type of Loan Term of Loan Stated Annual Interest Original Loan Principal Amount Conversion Rate Beneficial Conversion Discount Amount Warrants Issued with Notes Exercise Price Warrant FMV Discount Amount Effective Interest Rate Including Discounts 2016 convertible notes payable Due 10% 61,535 $ 4.50 6,837 - $ - - 21.10% 2017 convertible notes payable Due on demand - 2 years 10% 7,819,835 $3.50 - $10.00 3,346,449 - $ - - 25% - 110% 2018 convertible notes payable Due on demand - 2 years 6% - 10% 28,955,566 $3.50 - $10.00 12,476,566 - $ - - 10% - 110% $ 36,836,936 $ 15,829,852 $ - $ - Related party notes are disclosed as separate line items in the Company’s balance sheet presentation. |
Net loss per share | Net loss per share —In accordance with ASC 260, “Earnings per Share, ” the basic loss per common share is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding. Dilutive loss per share is computed in a manner similar to the basic loss per common share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. As of December 31, 2018 and 2017, there were 16,578,239 and 18,228,246 shares of potentially dilutive securities outstanding, respectively. As the Company reported a net loss, none of the potentially dilutive securities were included in the calculation of diluted loss per share since their effect would be anti‑dilutive for all periods presented. |
Segment Reporting | Segment Reporting —The Company operates one reportable segment and one additional segment which is immaterial to its financial statements. Accordingly, no segment disclosures have been presented. |
Recent accounting pronouncements | Recent accounting pronouncements — In January 2016, the FASB issued ASU No. 2016‑01, Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-01”). The amendments applicable to the Company in this Update (1) supersede the guidance to classify equity securities, except equity method securities, with readily determinable fair values into trading or available‑for‑sale categories and require equity securities to be measured at fair value with changes in the fair value recognized through net income, (2) allow equity investments that do not have readily determinable fair values to be remeasured at fair value either upon the occurrence of an observable price change or upon identification of an impairment, (3) require assessment for impairment of equity investments without readily determinable fair values qualitatively at each reporting period, (4) eliminate the requirement to disclose the methods and significant assumptions used in calculating the fair value of financial instruments required to be disclosed for financial instruments measured at amortized cost on the balance sheet, (5) require public business entities to use the exit price notion when measuring the fair value of financial instruments for disclosure purposes, (6) require separate presentation of financial assets and financial liabilities by measurement category and form of financial asset (that is, securities or loans and receivables) on the balance sheet or the accompanying notes to the financial statements, (7) clarify that an entity should evaluate the need for a valuation allowance on a deferred tax asset related to marketable securities in combination with the entity’s other deferred tax assets. This Update was effective beginning January 1, 2018 and the Company is now recognizing any changes in the fair value of certain equity investments in net income as prescribed by the new standard rather than in other comprehensive income. The Company recognized a cumulative effect adjustment to increase the opening balance of retained earnings as of January 1, 2018 by $41.4 million, net of 12.3 million income tax benefit. Refer to Note 4 for additional disclosures required by this ASU. In February 2016, the FASB issued ASU No. 2016‑02, Leases In April 2016, the FASB issued ASU 2016‑10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing In January 2017, the FASB issued ASU No. 2017‑01, Business Combinations (Topic 805): Clarifying the Definition of a Business In May 2017, the FASB issued ASU No. 2017-09, Compensation — Stock Compensation (Topic 718): Scope of Modification Accounting In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260) Distinguishing Liabilities from Equity (Topic 480) Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features, II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. In February 2018, the FASB issued ASU No. 2018-02, Income Statement – Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income In February 2018, the FASB issued ASU No. 2018-03, Technical Corrections and Improvements to Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities Fair Value Measurement Derivatives and Hedging— Embedded Derivatives Financial Instruments— Overall In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement accompanying footnote disclosures In August 2018, the FASB issued ASU 2018-15, Intangibles – Goodwill and Other – Internal-Use Software (Subtopic 350-40) Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract In October 2018, the FASB issued ASU 2018-17, Consolidation (Topic 810) Targeted Improvements to Related Party guidance for Variable Interest Entities Interest Held Through Related Parties That Are Under Common Control. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of reconciliation of cash, cash equivalents, and restricted cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported on our consolidated statements of cash flows as of December 31, 2018 and 2017: As of December 31, 2018 2017 Cash and cash equivalents $ 17,079,734 $ 15,836,063 Restricted cash — 6,720,000 Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows $ 17,079,734 $ 22,556,063 |
Schedule of inventory | The below table presents inventory by category: As of December 31, Inventories by category 2018 2017 Raw materials and components $ 170,997 $ — Work-in-process 2,471,147 124,801 Finished goods 2,062,427 500,498 Total $ 4,704,571 $ 625,299 |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets consisted of the following at December 31, 2018 and 2017: As of December 31, 2018 2017 Prepaid insurance $ 81,797 $ 132,387 Other prepaid expenses and current assets 651,211 157,984 $ 733,008 $ 290,371 |
Summarizes revenues from each of our customers who individually accounted for 10% or more of total revenues | The following table summarizes revenues from each of our customers who individually accounted for 10% or more of the Company’s total revenues (as a percentage to total revenue). As of December 31, 2018 2017 AmerisourceBergen Specialty Group 77 % — McKesson Plasma and Biologics LLC 13 % — Johnson Chemical Pharm Works Co. Ltd — 29.0 % |
Schedule of other long-term liabilities | Other long-term liabilities consist of the following at December 31, 2018 and 2017: As of December 31, 2018 2017 Trade discount $ 26,221,500 $ 31,841,500 Unearned revenue 10,000,000 5,000,000 Other long-term liabilities — 10,790 Total other long-term liabilities $ 36,221,500 $ 36,852,290 |
Schedule of changes in fair value of liabilities | The following tables present the activity for those items measured at fair value on a recurring basis using Level 3 inputs during 2018 and 2017: Year ended December 31, Warrant Derivative Liabilities—Stock Purchase Warrants 2018 2017 Balance, beginning of period $ 26,377,000 $ 10,600,000 Repurchased (6,186,000 ) — Change in fair value included in the statement of comprehensive income (loss) (20,191,000 ) 15,777,000 Balance, end of period $ — $ 26,377,000 As of September 11, 2018, all of the Private Placement warrants, replacement warrants and Broker Warrants had been exercised primarily on a cashless basis, or had expired. |
Schedule of warrants issued in conjunction with Purchase Agreement with GPB | The following table presents warrants issued in conjunction with Purchase Agreement with GPB (see Note 7) measured at fair value as of December 31, 2018 and 2017: Year ended December 31, 2018 Year ended December 31, 2017 Liability Instrument—GPB Warrants Embedded Conversion Option Warrants Embedded Conversion Option Balance, beginning of period $ 1,882,000 $ 1,289,000 $ — $ — Fair value at issuance date — — 1,882,000 1,289,000 Change in fair value included in the statement of comprehensive income (loss) (483,000 ) (466,000 ) — — Extinguished upon debt repayment — (823,000 ) — — Balance, end of period $ 1,399,000 $ — $ 1,882,000 $ 1,289,000 |
Schedule of assumptions used in the valuation of warrants | The value as of the dates set for the in the table below, was based on upon following assumptions: GPB Stock Purchase Warrants December 31, 2018 December 31, 2017 December 31, 2017 Stock price $ 9.10 $ 11.40 $ 11.40 Risk‑free interest rate 2.48 % 2.20 % 1.62 % Expected volatility (peer group) 70.00 % 70.00 % 55.80 % Expected life (in years) 4.00 5.00 0.70 Expected dividend yield — — — Number outstanding 240,764 240,764 3,320,501 Balance, end of period: Warrant derivative liabilities (long-term) $ 1,399,000 $ 1,882,000 $ 26,377,000 |
Schedule of notes payable with beneficial conversion feature or warrants | The following table presents the effective interest rates on the original loan principal amount for loans originated in the respective periods that either had a beneficial conversion interest or an attached warrant: Type of Loan Term of Loan Stated Annual Interest Original Loan Principal Amount Conversion Rate Beneficial Conversion Discount Amount Warrants Issued with Notes Exercise Price Warrant FMV Discount Amount Effective Interest Rate Including Discounts 2016 convertible notes payable Due 10% 61,535 $ 4.50 6,837 - $ - - 21.10% 2017 convertible notes payable Due on demand - 2 years 10% 7,819,835 $3.50 - $10.00 3,346,449 - $ - - 25% - 110% 2018 convertible notes payable Due on demand - 2 years 6% - 10% 28,955,566 $3.50 - $10.00 12,476,566 - $ - - 10% - 110% $ 36,836,936 $ 15,829,852 $ - $ - |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Schedule of property and equipment | Property and equipment consisted of the following As of December 31, 2018 2017 Equipment $ 305,250 $ 225,615 Leasehold improvements 70,249 61,054 Furniture and fixtures 79,001 74,090 Total property and equipment 454,500 360,759 Less: accumulated depreciation (302,814 ) (255,457 ) Property and Equipment, net $ 151,686 $ 105,302 |
INVESTMENTS (Tables)
INVESTMENTS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Investments [Abstract] | |
Schedule of fair values of equity securities | The fair values of our equity securities were included in the following line items in our consolidated balance sheets: As of December 31, 2018 As of December 31, 2017 Fair Value with Changes Recognized in Income Measurement Alternative - No Readily Determinable Fair Value Fair Value with Changes Recognized in Income Measurement Alternative - No Readily Determinable Fair Value Marketable securities $ 49,581,080 $ — $ 99,997,322 $ — Long-term investment at cost — 538,202 65,520 Total equity securities $ 49,581,080 $ 538,202 $ 99,997,322 $ 65,520 |
Schedule of equity securities | As of December 31, 2017, equity securities consisted of the following: Gross Unrealized Estimated Cost Gains Losses Fair Value Trading securities $ — $ — $ — $ — Available-for-sale securities 46,209,017 60,812,231 (6,958,406 ) 100,062,842 Total equity securities $ 46,209,017 $ 60,812,231 $ (6,958,406 ) $ 100,062,842 |
ACCOUNTS PAYABLE AND ACCRUED _2
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Schedule of accounts payable and accrued expenses | Accounts payable and accrued expenses consisted of the following at: December 31, 2018 December 31, 2017 Accounts payable: Regulatory fees $ — $ 715,999 Clinical and regulatory expenses 83,025 116,736 Commercialization consulting fees 3,938 40,000 Legal expenses 43,858 87,701 Consulting fees 2,036,380 143,038 Accounting fees 73,290 67,293 Selling expenses 381,572 35,383 Investor relations and public relations expenses 44,484 55,526 Other vendors 937,190 337,960 Total amounts payable 3,603,737 1,599,636 Accrued interest payable, related parties 842,389 318,120 Accrued interest payable 2,138,133 1,449,154 Accrued expenses: Wages and payroll taxes payable 156,612 1,711,541 Deferred salary 291,667 291,667 Paid vacation payable 263,975 186,978 Accrued rebates 1,743,847 — Other accrued expenses 83,115 138,214 Total accrued expenses 2,539,216 2,328,400 Total accounts payable and accrued expenses $ 9,123,475 $ 5,695,310 |
NOTES PAYABLE (Tables)
NOTES PAYABLE (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of notes payable | Notes payable consisted of the following at December 31, 2018 and 2017: Year Issued Interest Rate Range Term of Notes Conversion Price Principal Outstanding December 31, 2018 Discount Amount December 31, 2018 Carrying Amount December 31, 2018 Shares Underlying Notes December 31, 2018 Principal Outstanding December 31, 2017 Discount Amount December 31, 2017 Carrying Amount December 31, 2017 Shares Underlying Notes December 31, 2017 Notes payable 2013 10% Due on demand — $ 908,900 $ — $ 908,900 — $ 887,600 $ — $ 887,600 — 2015 10% Due on demand — $ 10,000 — 10,000 — — — — — 2016 10% - 11% Due on demand — 843,335 — 843,335 — 833,335 — 833,335 — 2017 5% - 11% Due on demand — 2,575,410 — 2,575,410 — 6,150,208 — 6,150,208 — 2018 10% - 11% Due on demand- 18 months — 12,311,000 9,233,089 3,077,911 — — — — — $ 16,648,645 $ 9,233,089 $ 7,415,556 — $ 7,871,143 $ — $ 7,871,143 — Current $ 12,448,645 $ 6,054,484 6,394,161 — $ 7,871,143 $ — $ 7,871,143 — Non-current $ 4,200,000 $ 3,178,605 1,021,395 — $ — $ — $ — — Notes payable - related party 2015 11% Due on demand — $ — — $ — — $ 310,000 — $ 310,000 — 2016 10% - 11% Due on demand — 270,000 — 270,000 — 810,510 — 810,510 — 2017 10% Due on demand — 38,583 — 38,583 — 915,751 — 915,751 — 2018 11% Due on demand 159,223 — 159,223 — — — — — $ 467,806 $ — $ 467,806 — $ 2,036,261 $ — $ 2,036,261 — Current $ 467,806 $ — $ 467,806 — $ 2,036,261 $ — $ 2,036,261 — Non-current $ — $ — $ — — $ — $ — $ — — Convertible notes payable 2011 10% 5 years $ 3.05 $ 300,000 $ — $ 300,000 98,285 $ 300,000 $ — $ 300,000 98,285 2014 10% Due on demand - 2 years $3.05 - $3.60 518,846 — 518,846 183,648 486,878 — 486,878 168,766 2016 10% Due on demand - 2 years $3.60 - $4.50 61,535 — 61,535 16,753 1,516,329 83,298 1,433,031 441,048 2017 10% - 13.5% Due on demand - 3 years $3.50 - $10.31 2,819,835 348,944 2,470,891 899,613 36,113,296 11,232,423 24,880,873 5,357,488 2018 6% - 10% Due on demand - 2 years $3.50 - $10.00 19,555,566 6,168,939 13,386,627 3,664,143 — — — — $ 23,255,782 $ 6,517,883 $ 16,737,899 4,862,442 $ 38,416,503 $ 11,315,721 $ 27,100,782 6,065,587 Current $ 16,604,029 $ 5,350,681 $ 11,253,348 3,981,232 $ 12,860,912 $ 5,835,910 $ 7,025,002 3,449,984 Non-current $ 6,651,753 $ 1,167,202 $ 5,484,551 881,210 $ 25,555,591 $ 5,479,811 $ 20,075,780 2,615,603 Convertible notes payable - related party 2012 10% Due on demand $ 3.30 $ 200,000 $ — $ 200,000 74,182 $ 200,000 $ — $ 200,000 68,122 2015 10% 2 years $ 4.50 200,000 — 200,000 58,350 200,000 — 200,000 53,905 2017 10% 2 years $ 10.00 5,000,000 311,458 4,688,542 532,671 — — — — 2018 10% 2 years $ 10.00 9,400,000 871,460 8,528,540 971,963 — — — — $ 14,800,000 $ 1,182,918 13,617,082 1,637,166 $ 400,000 $ — $ 400,000 122,027 Current $ 5,400,000 $ 311,458 $ 5,088,542 665,203 $ 400,000 $ — $ 400,000 122,027 Non-current $ 9,400,000 $ 871,460 $ 8,528,540 971,963 $ — $ — $ — — Grand Total $ 55,172,233 $ 16,933,890 $ 38,238,343 6,499,608 $ 48,723,907 $ 11,315,721 37,408,186 6,187,614 Note: Notes payables and convertible note payables for certain individuals have been reclassified from unrelated party to related party and vice versa from fiscal year ended December 31, 2017 and 2018 as the relationships with these individuals have changed. |
Schedule of contractual principal payments of notes payable | Contractual principal payments due on notes payable are as follows: Year Ending December 31, 2018 2019 $ 34,920,480 2020 20,251,753 Total $ 55,172,233 |
Schedule of fair value assumptions for warrants issued in conjunction with notes | The fair value of the warrants issued in conjunction with notes was determined using the Binominal Monte-Carlo Cliquet option pricing model with the following inputs for the years ended: 2018 2017 Stock price $ 11.10 $ 11.40 Exercise price $ 11.30 $ 10.80 Term 5 years 5 years Risk‑free interest rate 3.05% 2.20% Expected dividend yield — — Expected volatility 70.0% 70.00% |
STOCKHOLDERS' DEFICIT (Tables)
STOCKHOLDERS' DEFICIT (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders Equity Note [Abstract] | |
Schedule of outstanding warrants | A summary of outstanding warrants as of December 31, 2018 and 2017 is presented below. Year ended Year ended December 31, 2018 December 31, 2017 Warrants outstanding, beginning of period 5,265,432 5,024,668 Granted 1,542,000 240,764 Exercised (2,385,317 ) — Cancelled, forfeited and expired (985,684 ) — Warrants outstanding, end of period 3,436,431 5,265,432 A summary of outstanding warrants by year issued and exercise price as of December 31, 2018 is presented below. Outstanding Exercisable Year issued and Exercise Price Number of Warrants Issued Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Total Weighted Average Exercise Price At December 31, 2014 $ 3.50 50,000 0.33 $ 3.50 50,000 $ 3.50 2014 Total 50,000 50,000 At December 31, 2015 $ 4.90 110,417 1.18 $ 4.90 110,417 $ 4.90 2015 Total 110,417 110,417 At December 31, 2016 $ 4.50 118,750 2.50 $ 4.50 118,750 $ 4.50 $ 4.70 75,000 2.33 $ 4.70 75,000 $ 4.70 $ 5.00 1,300,000 2.36 $ 5.00 1,300,000 $ 5.00 2016 Total 1,493,750 1,493,750 At December 31, 2017 $ 10.80 240,764 4.50 $ 10.80 240,764 $ 10.80 2017 Total 240,764 240,764 At December 31, 2018 $ 11.30 1,541,500 4.78 $ 11.30 1,541,500 $ 11.30 Grand Total 3,436,431 3,436,431 |
Schedule of valuation assumptions | Management has valued stock options at their date of grant utilizing the Black‑Scholes‑Merton Option pricing model. The fair value of the underlying shares was determined by the market value of stock of similar companies and recent arm’s length transactions involving the sale of the Company’s common stock. The expected volatility was calculated using the historical volatility of a similar public entity in the industry through August 2013 and a group of similar public entities thereafter. The following table presents the assumptions used on recent dates on which options were granted by the Board of Directors. 9/27/2018 8/8/2018 2/27/2018 12/31/2017 Stock Price $ 11.10 $ 11.30 $ 11.40 $ 11.40 Exercise Price $ 11.10 $ 11.30 $ 11.40 $ 11.40 Term 10 years 10 years 10 years 10 years Risk-Free Rate 2.99 % 2.88 % 2.75 % 2.27 % Dividend Yield — — — — Volatility 69.14 % 66.09 % 68.18 % 68.18 % |
Schedule of option activity | A summary of the Company’s stock option activity for the years ended December 31, 2018 and 2017 is presented below : December 31, 2018 December 31, 2017 Number of Options Weighted‑ Average Exercise Price Number of Options Weighted‑ Average Exercise Price Options outstanding, beginning of period 6,775,200 $ 4.12 6,955,200 $ 4.10 Granted or deemed issued 357,000 $ 11.28 50,000 $ 11.40 Exercised (170,000 ) $ 4.59 (11,895 ) $ 4.19 Cancelled, forfeited and expired (320,000 ) $ 6.06 (218,105 ) $ 4.98 Options outstanding, end of period 6,642,200 $ 4.40 6,775,200 $ 4.12 Options exercisable at end of year 5,958,783 $ 3.87 5,604,439 $ 3.95 Options available for future grant 2,357,800 2,224,800 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of provision (benefit) for income taxes | The provision (benefit) for income taxes consists of the following for the years ended December 31, 2018 and 2017: 2018 2017 Current U.S. $ 5,586 $ 2,400 International 636 833 Deferred U.S. — (12,306,343 ) International — — $ 6,222 $ (12,303,110 ) |
Schedule of deferred tax assets and liabilities | Deferred tax assets consist of the following as of December 31, 2018 and 2017: 2018 2017 Net operating loss carryforward $ 19,900,927 $ 15,086,163 General business tax credit 9,342,425 8,911,700 Stock options 6,011,522 3,583,299 Charitable contribution 139,124 38,128 Accrued expenses 364,306 229,105 Unearned revenue 1,395,870 — Allowance for bad AR 172,939 — Other 317,845 29,855 Total gross deferred tax assets 37,644,958 27,878,250 Less valuation allowance (34,599,232 ) (13,381,045 ) Net deferred tax assets $ 3,045,726 $ 14,497,205 Deferred tax liabilities consist of the following as of December 31, 2018 and 2017: 2018 2017 Unrealized gain on LT investment $ 2,964,943 $ — Unrealized gain on foreign exchange translation and others (78,281 ) (32,752 ) Unrealized gain on marketable securities — (14,464,453 ) Other (2,502 ) — Total deferred tax liability $ 2,884,160 $ (14,497,205 ) |
Schedule of income tax provision computed using the statutory federal tax rate | The income tax provision differs from that computed using the statutory federal tax rate of 21%, due to the following: 2018 2017 Tax benefit at statutory federal rate $ (12,169,762 ) $ (15,496,876 ) State taxes, net of federal tax benefit (3,786,890 ) (398,315 ) Increase in valuation allowance 6,753,526 (8,943,404 ) Permanent items 750,485 9,521,184 General business tax credit (430,724 ) (1,407,553 ) Impact from tax rate change (34% to 21%) — 10,210,183 OCI, tax benefit — (12,306,343 ) Other 8,889,587 6,518,014 $ 6,222 $ (12,303,110 ) |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of future minimum lease payments | Future minimum lease payments under the agreements are as follows: Year Amount 2019 $ 729,825 2020 974,008 2021 973,428 2022 1,003,437 Thereafter 3,665,179 Total $ 7,345,877 |
RELATED PARTY TRANSACTIONS (Tab
RELATED PARTY TRANSACTIONS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Schedule of outstanding loans from related parties | The following table sets forth information relating to our loans from related persons outstanding as of the date hereof or at any time during the year ended December 31, 2018. Class Lender Interest Rate Date of Loan Term of Loan Principal Amount Outstanding at December 31, 2018 Highest Principal Outstanding Amount of Principal Repaid or Converted into Stock Amount of Interest Paid Conversion Rate Shares Underlying Notes December 31, 2018 Current, Promissory note payable to related parties: Masaharu & Emiko Osato (3) 11% 12/29/2015 Due on Demand $ — $ 300,000 $ 300,000 $ 76,036 $ — $ — Lan T. Tran (2) 11% 2/10/2016 Due on Demand — 130,510 130,510 28,712 — — Masaharu & Emiko Osato (3) 11% 2/25/2016 Due on Demand — 400,000 400,000 94,389 — — Lan T. Tran (2) 10% 4/29/2016 Due on Demand 20,000 20,000 — — — — Hope Hospice (1) 10% 6/3/2016 Due on Demand 250,000 250,000 — — — — Lan T. Tran (2) 10% 2/9/2017 Due on Demand 12,000 12,000 — — — — Yutaka Niihara (2)(3) 10% 9/14/2017 Due on Demand 26,583 903,751 877,167 94,584 — — Lan T. Tran (2) 11% 2/10/2018 Due on Demand 159,223 159,223 — — — Subtotal $ 467,806 $ 2,175,484 $ 1,707,678 $ 293,721 $ — Current, Convertible notes payable to related parties: Yasushi Nagasaki (2) 10% 6/29/2012 Due on Demand $ 200,000 $ 200,000 $ — $ — $ 3.30 $ 74,182 Yutaka & Soomi Niihara (2)(3) 10% 11/16/2015 2 years 200,000 200,000 — — $ 4.50 $ 58,350 Wei Peu Zen (3) 10% 11/6/2017 2 years 5,000,000 5,000,000 — 250,000 $ 10.00 $ 532,671 Subtotal $ 5,400,000 $ 5,400,000 $ — $ 250,000 $ 665,203 Non Current, Convertible notes payable to related parties: Profit Preview International Group, Ltd. (4) 10% 2/1/2018 2 years 4,037,000 4,037,000 — 201,850 $ 10.00 $ 420,456 Profit Preview International Group, Ltd. (4) 10% 3/21/2018 2 years 5,363,000 5,363,000 — 268,150 $ 10.00 $ 551,507 Subtotal $ 9,400,000 $ 9,400,000 $ — $ 470,000 $ 971,963 Total $ 15,267,806 $ 16,975,484 $ 1,707,678 $ 1,013,721 $ 1,637,166 The following table sets forth information relating to our loans from related persons outstanding as of the date hereof or at any time during the year ended December 31, 2017. Class Lender Interest rate Date of loan Term of Loan Principal Amount Outstanding at December 31, 2017 Highest Principal Outstanding Amount of Principal Repaid Amount of Interest Paid Conversion Rate Shares Underlying Notes at December 31, 2017 Current, Promissory note payable to related parties: Hope Hospice (1) 8% 1/17/2012 Due on Demand $ — $ 200,000 $ 200,000 $ 7,331 — — Hope Hospice (1) 8% 6/14/2012 Due on Demand — 200,000 200,000 14,762 — — Hope Hospice (1) 8% 6/21/2012 Due on Demand — 100,000 100,000 7,249 — — Hope Hospice (1) 8% 2/11/2013 Due on Demand — 50,000 50,000 1,559 — — Hope Hospice (1) 10% 1/7/2015 Due on Demand — 100,000 100,000 28,630 — — IRA Service Trust Co. FBO Peter B. Ludlum (2) 10% 2/20/2015 Due on Demand 10,000 10,000 — — — — Masaharu & Emiko Osato (3) 11% 12/29/2015 Due on Demand 300,000 300,000 — — — — Yutaka Niihara (2)(3) 10% 5/21/2015 Due on Demand 0 826,105 94,339 61,829 — — Lan T. Tran (2) 11% 2/10/2016 Due on Demand 130,510 130,510 — — — — Masaharu & Emiko Osato (3) 11% 2/25/2016 Due on Demand 400,000 400,000 — — — — Hope Hospice (1) 10% 4/4/2016 Due on Demand — 50,000 50,000 8,110 — — Lan T. Tran (2) 10% 4/29/2016 Due on Demand 20,000 20,000 — — — — IRA Service Trust Co. FBO Peter B. Ludlum (2) 10% 5/5/2016 Due on Demand 10,000 10,000 — — — — Hope Hospice (1) 10% 6/3/2016 Due on Demand 250,000 250,000 — — — — Lan T. Tran (2) 10% 2/9/2017 Due on Demand 12,000 12,000 — — — — Yutaka Niihara (2)(3) 10% 9/14/2017 Due on Demand 903,751 903,751 — — — — Subtotal $ 2,036,261 $ 3,562,366 $ 794,339 $ 129,470 — Current, Convertible notes payable to related parties: Yasushi Nagasaki (2) 10% 6/29/2012 Due on Demand $ 200,000 $ 388,800 $ 188,800 $ 57,886 $ 3.30 68,122 Charles & Kimxa Stark (2) 10% 10/1/2015 2 years — 20,000 20,000 4,405 $ 4.50 — Yutaka & Soomi Niihara (2)(3) 10% 11/16/2015 2 years 200,000 200,000 — — $ 4.50 53,905 Subtotal $ 400,000 $ 608,800 $ 208,800 $ 62,291 122,027 Total $ 2,436,261 $ 4,171,166 $ 1,003,139 $ 191,761 122,027 (1) Dr. Niihara, our director and Chief Executive Officer, is also the Chief Executive Officer of Hope Hospice (2) Officer (3) Director (4) Mr. Zen, a Director, is the sole owner of Profit Preview International Group, Ltd. |
SUBSEQUENT EVENTS (Tables)
SUBSEQUENT EVENTS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Schedule of subsequent events | Subsequent to the year ended December 31, 2018, the Company issued the following: Common Shares Issued after December 31, 2018 Amounts Number of Shares Issued Common shares $ 1,885,000 227,500 |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 31, 2011 | Oct. 31, 2010 | |
US [Member] | |||
Business Acquisition [Line Items] | |||
Orphan Drug designation provides market exclusivity period after marketing approval | 7 years | ||
EU [Member] | |||
Business Acquisition [Line Items] | |||
Orphan Drug designation provides market exclusivity period after marketing approval | 10 years | ||
Orphan Drug designation provides additional marketing exclusivity period | 2 years | ||
Emmaus Medical Japan, Inc [Member] | |||
Business Acquisition [Line Items] | |||
Percentage of acquired interest | 3.00% | 97.00% | |
Aggregate formation cost | $ 52,500 | ||
Business acquisition, current ownership percentage | 100.00% |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) | Jan. 01, 2018USD ($) | Jun. 28, 2017$ / shares | Jun. 12, 2017USD ($)Number | Jun. 12, 2017KRW (₩)Number | Oct. 31, 2018USD ($) | Jul. 31, 2017USD ($)shares | Jul. 31, 2017KRW (₩)₩ / sharesshares | Oct. 31, 2016USD ($)shares | Oct. 31, 2016KRW (₩)₩ / sharesshares | Jan. 31, 2009USD ($)shares | Jan. 31, 2009JPY (¥)¥ / sharesshares | Dec. 31, 2018USD ($)VendorSegment$ / sharesshares | Dec. 31, 2017USD ($)Vendor$ / sharesshares | Dec. 31, 2018JPY (¥)¥ / sharesshares | Dec. 31, 2018₩ / shares | Oct. 31, 2018JPY (¥) | Dec. 31, 2017¥ / shares | Dec. 31, 2017₩ / shares | Jun. 28, 2017₩ / shares |
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Net loss | $ (57,897,560) | $ (33,371,082) | |||||||||||||||||
Number of vendors | Vendor | 1 | 1 | |||||||||||||||||
Advertising costs | $ 97,514 | $ 59,045 | |||||||||||||||||
Intangible assets, useful life | 5 years | ||||||||||||||||||
Impairment of intangible assets | $ 0 | 0 | |||||||||||||||||
Impairment of long lived assets | 0 | 0 | |||||||||||||||||
Unrecognized tax benefits | 0 | 0 | |||||||||||||||||
Loss on debt settlement | $ (3,244,769) | $ 0 | |||||||||||||||||
Potentially dilutive securities outstanding | shares | 16,578,239 | 18,228,246 | |||||||||||||||||
Number of reportable segments | Segment | 1 | ||||||||||||||||||
ASU 2016-01 [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Cumulative effect adjustment on adoption of ASU 2016-01 | $ 41,400,000 | $ 41,400,000 | |||||||||||||||||
Cumulative effect on retained earnings, tax | $ 12,300,000 | $ 12,300,000 | |||||||||||||||||
API Supply Agreement [Member] | Telcon, Inc. ("Telcon") [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Proceeds from supply agreement | $ 31,800,000 | ||||||||||||||||||
API Supply Agreement [Member] | Telcon, Inc. ("Telcon") [Member] | Korea (South), Won | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Proceeds from supply agreement | ₩ | ₩ 36,000,000,000 | ||||||||||||||||||
Pharmaceutical Grade L-glutamine [Member] | API Supply Agreement [Member] | Telcon, Inc. ("Telcon") [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Percentage of right to supply | 25.00% | 25.00% | |||||||||||||||||
Agreement term | 5 years | 5 years | |||||||||||||||||
Number of renewals | Number | 10 | 10 | |||||||||||||||||
2011 Convertible notes payable [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Debt instrument annual interest | 10.00% | 10.00% | |||||||||||||||||
Convertible notes payable, carrying amount | $ 300,000 | ||||||||||||||||||
Minimum [Member] | Furniture and Fixtures [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Useful life | 5 years | ||||||||||||||||||
Maximum [Member] | Pharmaceutical Grade L-glutamine [Member] | API Supply Agreement [Member] | Telcon, Inc. ("Telcon") [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Agreement term | 15 years | 15 years | |||||||||||||||||
Maximum [Member] | Furniture and Fixtures [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Useful life | 7 years | ||||||||||||||||||
CellSeed, Inc. [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Shares held as marketable securities | shares | 39,250 | 39,250 | |||||||||||||||||
Shares originally purchased (in shares) | shares | 147,100 | 147,100 | |||||||||||||||||
Investment | $ 1,100,000 | ¥ 100,028,000 | |||||||||||||||||
Investment, in per share | ¥ / shares | ¥ 680 | ||||||||||||||||||
Investment, closing price | (per share) | $ 6.07 | $ 4.10 | ¥ 668 | ¥ 462 | |||||||||||||||
Stock pledged against note | shares | 39,250 | 39,250 | |||||||||||||||||
KPM Tech [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Shares held as marketable securities | shares | 849,744 | 849,744 | |||||||||||||||||
Investment | $ 13,000,000 | ₩ 14,318,186,400 | |||||||||||||||||
Investment, in per share | ₩ / shares | ₩ 16,850 | ||||||||||||||||||
Investment, closing price | (per share) | 1.52 | ₩ 1,625 | |||||||||||||||||
Reverse stock split description | 1-for-5 reverse stock split | ||||||||||||||||||
Reverse stock split ratio | 0.20 | ||||||||||||||||||
Hanil Vacuum [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Shares held as marketable securities | shares | 271,950 | 271,950 | |||||||||||||||||
Investment | $ 1,000,000 | ₩ 1,101,397,500 | |||||||||||||||||
Investment, in per share | ₩ / shares | ₩ 4,050 | ||||||||||||||||||
Investment, closing price | (per share) | $ 2.65 | ₩ 2,830 | |||||||||||||||||
Telcon, Inc. ("Telcon") [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Shares held as marketable securities | shares | 6,643,559 | 6,643,559 | |||||||||||||||||
Investment | $ 31,800,000 | ₩ 36,001,446,221 | |||||||||||||||||
Investment, in per share | ₩ / shares | ₩ 5,419 | ||||||||||||||||||
Investment, closing price | (per share) | $ 7.43 | $ 13.95 | ₩ 8,280 | ₩ 14,900 | |||||||||||||||
Telcon, Inc. ("Telcon") [Member] | API Supply Agreement [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Proceeds from supply agreement | $ 31,800,000 | ||||||||||||||||||
Telcon, Inc. ("Telcon") [Member] | API Supply Agreement [Member] | Korea (South), Won | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Proceeds from supply agreement | ₩ | ₩ 36,000,000,000 | ||||||||||||||||||
Telcon, Inc. ("Telcon") [Member] | Pharmaceutical Grade L-glutamine [Member] | API Supply Agreement [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Percentage of right to supply | 25.00% | 25.00% | |||||||||||||||||
Agreement term | 15 years | 15 years | |||||||||||||||||
EJ Holding, Inc. [Member] | Japan Industrial Partners [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Equity interest | 60.00% | 60.00% | |||||||||||||||||
EJ Holding, Inc. [Member] | |||||||||||||||||||
Summary of Significant Accounting Policy [Line Items] | |||||||||||||||||||
Investment amount | $ 32,000 | ¥ 3,600,000 | |||||||||||||||||
Percentage of voting interest | 40.00% | 40.00% | |||||||||||||||||
Unsecured long-term debt | $ 13,200,000 | ¥ 1,500,000,000 | |||||||||||||||||
Debt instrument, maturity date | Sep. 30, 2028 | ||||||||||||||||||
Debt instrument annual interest | 1.00% | 1.00% |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 17,079,734 | $ 15,836,063 | |
Restricted cash | 6,720,000 | ||
Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows | $ 17,079,734 | $ 22,556,063 | $ 1,317,340 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 1) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Inventories by category | ||
Raw materials and components | $ 170,997 | |
Work-in-process | 2,471,147 | $ 124,801 |
Finished goods | 2,062,427 | 500,498 |
Total | $ 4,704,571 | $ 625,299 |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 2) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Accounting Policies [Abstract] | ||
Prepaid insurance | $ 81,797 | $ 132,387 |
Other prepaid expenses and current assets | 651,211 | 157,984 |
Prepaid expenses and other current assets | $ 733,008 | $ 290,371 |
SUMMARY OF SIGNIFICANT ACCOUN_8
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 3) - Sales Revenue, Net [Member] - Customer Concentration Risk [Member] | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
AmerisourceBergen Specialty Group [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Concentration risk, percentage | 77.00% | |
McKesson Plasma and Biologics LLC [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Concentration risk, percentage | 13.00% | |
Johnson Chemical Pharm Works Co. Ltd [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Concentration risk, percentage | 29.00% |
SUMMARY OF SIGNIFICANT ACCOUN_9
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 4) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Summary of Significant Accounting Policy [Line Items] | ||
Other long-term liabilities | $ 36,221,500 | $ 36,852,290 |
Other Long-Term Liabilities [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Other long-term liabilities | 10,790 | |
Unearned Revenue [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Other long-term liabilities | 10,000,000 | 5,000,000 |
Trade Discount [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Other long-term liabilities | $ 26,221,500 | $ 31,841,500 |
SUMMARY OF SIGNIFICANT ACCOU_10
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 5) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Warrant Derivative Liabilities - Stock Purchase Warrants [Member] | Level 3 [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance, beginning of period | $ 26,377,000 | $ 10,600,000 |
Repurchased | (6,186,000) | |
Change in fair value included in the statement of comprehensive income (loss) | (20,191,000) | 15,777,000 |
Balance, end of period | 26,377,000 | |
Liability Instrument - Warrants [Member] | GPB Debt Holdings II, LLC [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance, beginning of period | 1,882,000 | |
Fair value at issuance date | 1,882,000 | |
Change in fair value included in the statement of comprehensive income (loss) | (483,000) | |
Balance, end of period | 1,399,000 | 1,882,000 |
Liability Instrument - Embedded Conversion Option [Member] | GPB Debt Holdings II, LLC [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance, beginning of period | 1,289,000 | |
Fair value at issuance date | 1,289,000 | |
Change in fair value included in the statement of comprehensive income (loss) | (466,000) | |
Extinguished upon debt repayment | $ (823,000) | |
Balance, end of period | $ 1,289,000 |
SUMMARY OF SIGNIFICANT ACCOU_11
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 6) | Dec. 31, 2018USD ($)$ / sharesshares | Sep. 27, 2018$ / shares | Aug. 08, 2018$ / shares | Feb. 27, 2018$ / shares | Dec. 31, 2017USD ($)$ / sharesshares |
Summary of Significant Accounting Policy [Line Items] | |||||
Stock price | $ 11.10 | $ 11.30 | $ 11.40 | $ 11.40 | |
Stock Purchase Warrants [Member] | |||||
Summary of Significant Accounting Policy [Line Items] | |||||
Stock price | $ 11.40 | ||||
Number outstanding | shares | 3,320,501 | ||||
Warrant derivative liabilities (long-term) | $ | $ 26,377,000 | ||||
GPB Debt Holdings II, LLC [Member] | |||||
Summary of Significant Accounting Policy [Line Items] | |||||
Stock price | $ 9.10 | $ 11.40 | |||
Number outstanding | shares | 240,764 | 240,764 | |||
Warrant derivative liabilities (long-term) | $ | $ 1,399,000 | $ 1,882,000 | |||
Measurement Input, Risk Free Interest Rate | Stock Purchase Warrants [Member] | |||||
Summary of Significant Accounting Policy [Line Items] | |||||
Warrants and rights outstanding, measurement input | 1.62 | ||||
Measurement Input, Risk Free Interest Rate | GPB Debt Holdings II, LLC [Member] | |||||
Summary of Significant Accounting Policy [Line Items] | |||||
Warrants and rights outstanding, measurement input | 2.48 | 2.20 | |||
Measurement Input, Price Volatility | Stock Purchase Warrants [Member] | |||||
Summary of Significant Accounting Policy [Line Items] | |||||
Warrants and rights outstanding, measurement input | 55.80 | ||||
Measurement Input, Price Volatility | GPB Debt Holdings II, LLC [Member] | |||||
Summary of Significant Accounting Policy [Line Items] | |||||
Warrants and rights outstanding, measurement input | 70 | 70 | |||
Measurement Input, Expected Term | Stock Purchase Warrants [Member] | |||||
Summary of Significant Accounting Policy [Line Items] | |||||
Expected life (in years) | 8 months 12 days | ||||
Measurement Input, Expected Term | GPB Debt Holdings II, LLC [Member] | |||||
Summary of Significant Accounting Policy [Line Items] | |||||
Expected life (in years) | 4 years | 5 years |
SUMMARY OF SIGNIFICANT ACCOU_12
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 7) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Summary of Significant Accounting Policy [Line Items] | ||
Original Loan Principal Amount | $ 36,836,936 | |
Beneficial Conversion Discount Amount | $ 15,829,852 | |
Minimum [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Conversion Rate (in dollars per share) | $ 3.05 | |
Maximum [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Conversion Rate (in dollars per share) | $ 10.31 | |
2016 Convertible Notes Payable [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Stated Annual Interest | 10.00% | |
Original Loan Principal Amount | $ 61,535 | |
Conversion Rate (in dollars per share) | $ 4.50 | |
Beneficial Conversion Discount Amount | $ 6,837 | |
Effective Interest Rate Including Discounts | 21.10% | |
2016 Convertible Notes Payable [Member] | Minimum [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Term of Loan | Due on demand | |
Conversion Rate (in dollars per share) | $ 3.60 | |
2016 Convertible Notes Payable [Member] | Maximum [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Term of Loans | 2 years | |
Conversion Rate (in dollars per share) | $ 4.50 | |
2017 Convertible Notes Payable [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Stated Annual Interest | 10.00% | |
Original Loan Principal Amount | $ 7,819,835 | |
Beneficial Conversion Discount Amount | $ 3,346,449 | |
2017 Convertible Notes Payable [Member] | Minimum [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Term of Loan | Due on demand | |
Conversion Rate (in dollars per share) | $ 3.50 | |
Effective Interest Rate Including Discounts | 25.00% | |
2017 Convertible Notes Payable [Member] | Maximum [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Term of Loans | 2 years | |
Conversion Rate (in dollars per share) | $ 10 | |
Effective Interest Rate Including Discounts | 110.00% | |
2018 Convertible Notes Payable [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Original Loan Principal Amount | $ 28,955,566 | |
Beneficial Conversion Discount Amount | $ 12,476,566 | |
2018 Convertible Notes Payable [Member] | Minimum [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Term of Loan | Due on demand | |
Stated Annual Interest | 6.00% | |
Conversion Rate (in dollars per share) | $ 3.50 | |
Effective Interest Rate Including Discounts | 10.00% | |
2018 Convertible Notes Payable [Member] | Maximum [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Term of Loans | 2 years | |
Stated Annual Interest | 10.00% | |
Conversion Rate (in dollars per share) | $ 10 | |
Effective Interest Rate Including Discounts | 110.00% |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Property and equipment | ||
Property and equipment, gross | $ 454,500 | $ 360,759 |
Less: accumulated depreciation | (302,814) | (255,457) |
Property and Equipment, net | 151,686 | 105,302 |
Equipment [Member] | ||
Property and equipment | ||
Property and equipment, gross | 305,250 | 225,615 |
Leasehold Improvements [Member] | ||
Property and equipment | ||
Property and equipment, gross | 70,249 | 61,054 |
Furniture and Fixtures [Member] | ||
Property and equipment | ||
Property and equipment, gross | $ 79,001 | $ 74,090 |
PROPERTY AND EQUIPMENT (Detai_2
PROPERTY AND EQUIPMENT (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property Plant And Equipment [Abstract] | ||
Depreciation expense | $ 47,242 | $ 32,379 |
INVESTMENTS (Details Narrative)
INVESTMENTS (Details Narrative) - USD ($) | Jan. 01, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Schedule Of Investments [Line Items] | |||
Marketable equity securities classified as trading, value | $ 0 | ||
Proceeds from sales of marketable securities | 6,439,240 | $ 0 | |
Net unrealized losses on available for sales on marketable securities | 43,200,000 | ||
ASU 2016-01 [Member] | |||
Schedule Of Investments [Line Items] | |||
Cumulative effect adjustment on adoption of ASU 2016-01 | $ 41,400,000 | 41,400,000 | |
Cumulative effect on accumulated deficit, tax | $ 12,300,000 | $ 12,300,000 |
INVESTMENTS (Details 1)
INVESTMENTS (Details 1) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Schedule Of Investments [Line Items] | ||
Fair Value with Changes Recognized in Income | $ 49,581,080 | $ 99,997,322 |
Measurement Alternative - No Readily Determinable Fair Value | 538,202 | 65,520 |
Marketable Equity Securities [Member] | ||
Schedule Of Investments [Line Items] | ||
Fair Value with Changes Recognized in Income | 49,581,080 | 99,997,322 |
Long-Term Investment At Cost [Member] | ||
Schedule Of Investments [Line Items] | ||
Measurement Alternative - No Readily Determinable Fair Value | $ 538,202 | $ 65,520 |
INVESTMENTS (Details 2)
INVESTMENTS (Details 2) | Dec. 31, 2017USD ($) |
Schedule Of Investments [Line Items] | |
Cost | $ 46,209,017 |
Gross Unrealized Gains | 60,812,231 |
Gross Unrealized Losses | (6,958,406) |
Estimated Fair Fair Value | 100,062,842 |
Available-for-sale securities [Member] | |
Schedule Of Investments [Line Items] | |
Cost | 46,209,017 |
Gross Unrealized Gains | 60,812,231 |
Gross Unrealized Losses | (6,958,406) |
Estimated Fair Fair Value | $ 100,062,842 |
ACCOUNTS PAYABLE AND ACCRUED _3
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Accounts payable: | ||
Regulatory fees | $ 715,999 | |
Clinical and regulatory expenses | $ 83,025 | 116,736 |
Commercialization consulting fees | 3,938 | 40,000 |
Legal expenses | 43,858 | 87,701 |
Consulting fees | 2,036,380 | 143,038 |
Accounting fees | 73,290 | 67,293 |
Selling expenses | 381,572 | 35,383 |
Investor relations and public relations expenses | 44,484 | 55,526 |
Other vendors | 937,190 | 337,960 |
Total amounts payable | 3,603,737 | 1,599,636 |
Accrued interest payable, related parties | 842,389 | 318,120 |
Accrued interest payable | 2,138,133 | 1,449,154 |
Accrued expenses: | ||
Wages and payroll taxes payable | 156,612 | 1,711,541 |
Deferred salary | 291,667 | 291,667 |
Paid vacation payable | 263,975 | 186,978 |
Accrued rebates | 1,743,847 | |
Other accrued expenses | 83,115 | 138,214 |
Total accrued expenses | 2,539,216 | 2,328,400 |
Total accounts payable and accrued expenses | $ 9,123,475 | $ 5,695,310 |
NOTES PAYABLE (Details)
NOTES PAYABLE (Details) | 12 Months Ended | |
Dec. 31, 2018USD ($)Number$ / shares | Dec. 31, 2017USD ($)Number$ / shares | |
Principal Outstanding | $ 55,172,233 | $ 48,723,907 |
Discount Amount | 16,933,890 | 11,315,721 |
Carrying Amount | $ 38,238,343 | $ 37,408,186 |
Shares Underlying Principal | Number | 6,499,608 | 6,187,614 |
Notes payable, current | $ 6,394,161 | $ 7,871,143 |
Notes payable, non-current | $ 1,021,395 | |
Minimum [Member] | ||
Conversion Price | $ / shares | $ 3.05 | |
Maximum [Member] | ||
Conversion Price | $ / shares | $ 10.31 | |
2013 Notes payable [Member] | ||
Interest rate | 10.00% | |
Term of Notes | Due on demand | |
Principal Outstanding | $ 908,900 | $ 887,600 |
Carrying Amount | $ 908,900 | 887,600 |
2015 Notes payable [Member] | ||
Interest rate | 10.00% | |
Term of Notes | Due on demand | |
Principal Outstanding | $ 10,000 | |
Carrying Amount | $ 10,000 | |
2016 Notes payable [Member] | ||
Term of Notes | Due on demand | |
Principal Outstanding | $ 843,335 | 833,335 |
Carrying Amount | $ 843,335 | 833,335 |
2016 Notes payable [Member] | Minimum [Member] | ||
Interest rate | 10.00% | |
2016 Notes payable [Member] | Maximum [Member] | ||
Interest rate | 11.00% | |
2017 Notes payable [Member] | ||
Term of Notes | Due on demand | |
Principal Outstanding | $ 2,575,410 | 6,150,208 |
Carrying Amount | $ 2,575,410 | 6,150,208 |
2017 Notes payable [Member] | Minimum [Member] | ||
Interest rate | 5.00% | |
2017 Notes payable [Member] | Maximum [Member] | ||
Interest rate | 11.00% | |
2018 Notes payable [Member] | ||
Principal Outstanding | $ 12,311,000 | |
Discount Amount | 9,233,089 | |
Carrying Amount | $ 3,077,911 | |
2018 Notes payable [Member] | Minimum [Member] | ||
Interest rate | 10.00% | |
Term of Notes | Due on demand | |
2018 Notes payable [Member] | Maximum [Member] | ||
Interest rate | 11.00% | |
Term of Notes | 18 months | |
Notes Payable [Member] | ||
Principal Outstanding | $ 16,648,645 | 7,871,143 |
Discount Amount | 9,233,089 | |
Carrying Amount | 7,415,556 | 7,871,143 |
Principal Outstanding, Current | 12,448,645 | 7,871,143 |
Discount Amount Current | 6,054,484 | |
Notes payable, current | 6,394,161 | 7,871,143 |
Principal Outstanding, Non Current | 4,200,000 | |
Discount Amount Non Current | 3,178,605 | |
Notes payable, non-current | $ 1,021,395 | |
2015 Notes payable - related party [Member] | ||
Interest rate | 11.00% | |
Term of Notes | Due on demand | |
Principal Outstanding | 310,000 | |
Carrying Amount | 310,000 | |
2016 Notes payable - related party [Member] | ||
Term of Notes | Due on demand | |
Principal Outstanding | $ 270,000 | 810,510 |
Carrying Amount | $ 270,000 | 810,510 |
2016 Notes payable - related party [Member] | Minimum [Member] | ||
Interest rate | 10.00% | |
2016 Notes payable - related party [Member] | Maximum [Member] | ||
Interest rate | 11.00% | |
2017 Notes payable - related party [Member] | ||
Interest rate | 10.00% | |
Term of Notes | Due on demand | |
Principal Outstanding | $ 38,583 | 915,751 |
Carrying Amount | $ 38,583 | 915,751 |
2018 Notes payable - related party [Member] | ||
Interest rate | 11.00% | |
Term of Notes | Due on demand | |
Principal Outstanding | $ 159,223 | |
Carrying Amount | 159,223 | |
Notes payable - related party [Member] | ||
Principal Outstanding | 467,806 | 2,036,261 |
Carrying Amount | 467,806 | 2,036,261 |
Principal Outstanding, Current | 467,806 | 2,036,261 |
Notes payable, current | $ 467,806 | $ 2,036,261 |
NOTES PAYABLE (Details 1)
NOTES PAYABLE (Details 1) | 12 Months Ended | |
Dec. 31, 2018USD ($)Number$ / shares | Dec. 31, 2017USD ($)Number$ / shares | |
Principal Outstanding | $ 55,172,233 | $ 48,723,907 |
Discount Amount | 16,933,890 | 11,315,721 |
Carrying Amount | $ 38,238,343 | $ 37,408,186 |
Shares Underlying Principal | Number | 6,499,608 | 6,187,614 |
Convertible notes payable, Current | $ 11,253,348 | $ 7,025,002 |
Convertible notes payable, Non Current | $ 5,484,551 | $ 20,075,780 |
Minimum [Member] | ||
Conversion Price | $ / shares | $ 3.05 | |
Maximum [Member] | ||
Conversion Price | $ / shares | $ 10.31 | |
2011 Convertible notes payable [Member] | ||
Interest rate | 10.00% | |
Term of Notes | 5 years | |
Conversion Price | $ / shares | $ 3.05 | |
Principal Outstanding | $ 300,000 | $ 300,000 |
Carrying Amount | $ 300,000 | $ 300,000 |
Shares Underlying Principal | Number | 98,285 | 98,285 |
2014 Convertible notes payable [Member] | ||
Interest rate | 10.00% | |
Principal Outstanding | $ 518,846 | $ 486,878 |
Carrying Amount | $ 518,846 | $ 486,878 |
Shares Underlying Principal | Number | 183,648 | 168,766 |
2014 Convertible notes payable [Member] | Minimum [Member] | ||
Term of Notes | Due on demand | |
Conversion Price | $ / shares | $ 3.05 | |
2014 Convertible notes payable [Member] | Maximum [Member] | ||
Term of Notes | 2 years | |
Conversion Price | $ / shares | $ 3.60 | |
2016 Convertible Notes Payable [Member] | ||
Interest rate | 10.00% | |
Conversion Price | $ / shares | $ 4.50 | |
Principal Outstanding | $ 61,535 | $ 1,516,329 |
Discount Amount | 83,298 | |
Carrying Amount | $ 61,535 | $ 1,433,031 |
Shares Underlying Principal | Number | 16,753 | 441,048 |
2016 Convertible Notes Payable [Member] | Minimum [Member] | ||
Term of Notes | Due on demand | |
Conversion Price | $ / shares | $ 3.60 | |
2016 Convertible Notes Payable [Member] | Maximum [Member] | ||
Term of Notes | 2 years | |
Conversion Price | $ / shares | $ 4.50 | |
2017 Convertible notes payable [Member] | ||
Principal Outstanding | $ 2,819,835 | $ 36,113,296 |
Discount Amount | 348,944 | 11,232,423 |
Carrying Amount | $ 2,470,891 | $ 24,880,873 |
Shares Underlying Principal | Number | 899,613 | 5,357,488 |
2017 Convertible notes payable [Member] | Minimum [Member] | ||
Interest rate | 10.00% | |
Term of Notes | Due on demand | |
Conversion Price | $ / shares | $ 3.50 | |
2017 Convertible notes payable [Member] | Maximum [Member] | ||
Interest rate | 13.50% | |
Term of Notes | 3 years | |
Conversion Price | $ / shares | $ 10.31 | |
2018 Convertible Notes Payable [Member] | ||
Principal Outstanding | $ 19,555,566 | |
Discount Amount | 6,168,939 | |
Carrying Amount | $ 13,386,627 | |
Shares Underlying Principal | Number | 3,664,143 | |
2018 Convertible Notes Payable [Member] | Minimum [Member] | ||
Interest rate | 6.00% | |
Term of Notes | Due on demand | |
Conversion Price | $ / shares | $ 3.50 | |
2018 Convertible Notes Payable [Member] | Maximum [Member] | ||
Interest rate | 10.00% | |
Term of Notes | 2 years | |
Conversion Price | $ / shares | $ 10 | |
Convertible Notes Payable [Member] | ||
Principal Outstanding | $ 23,255,782 | $ 38,416,503 |
Discount Amount | 6,517,883 | 11,315,721 |
Carrying Amount | $ 16,737,899 | $ 27,100,782 |
Shares Underlying Principal | Number | 4,862,442 | 6,065,587 |
Principal Outstanding, Current | $ 16,604,029 | $ 12,860,912 |
Principal Outstanding, Non Current | 6,651,753 | 25,555,591 |
Discount Amount Current | 5,350,681 | 5,835,910 |
Discount Amount Non Current | 1,167,202 | 5,479,811 |
Convertible notes payable, Current | 11,253,348 | 7,025,002 |
Convertible notes payable, Non Current | $ 5,484,551 | $ 20,075,780 |
Shares Underlying Principal Current | Number | 3,981,232 | 3,449,984 |
Shares Underlying Principal Non Current | Number | 881,210 | 2,615,603 |
2012 Convertible notes payable - related party [Member] | ||
Interest rate | 10.00% | |
Term of Notes | Due on demand | |
Conversion Price | $ / shares | $ 3.30 | |
Principal Outstanding | $ 200,000 | $ 200,000 |
Carrying Amount | $ 200,000 | $ 200,000 |
Shares Underlying Principal | Number | 74,182 | 68,122 |
2015 Convertible notes payable - related party [Member] | ||
Interest rate | 10.00% | |
Term of Notes | 2 years | |
Conversion Price | $ / shares | $ 4.50 | |
Principal Outstanding | $ 200,000 | $ 200,000 |
Carrying Amount | $ 200,000 | $ 200,000 |
Shares Underlying Principal | Number | 58,350 | 53,905 |
2017 Convertible notes payable - related party [Member] | ||
Interest rate | 10.00% | |
Term of Notes | 2 years | |
Conversion Price | $ / shares | $ 10 | |
Principal Outstanding | $ 5,000,000 | |
Discount Amount | 311,458 | |
Carrying Amount | $ 4,688,542 | |
Shares Underlying Principal | Number | 532,671 | |
2018 Convertible notes payable - related party [Member] | ||
Interest rate | 10.00% | |
Term of Notes | 2 years | |
Conversion Price | $ / shares | $ 10 | |
Principal Outstanding | $ 9,400,000 | |
Discount Amount | 871,460 | |
Carrying Amount | $ 8,528,540 | |
Shares Underlying Principal | Number | 971,963 | |
Convertible notes payable - related party [Member] | ||
Principal Outstanding | $ 14,800,000 | $ 400,000 |
Discount Amount | 1,182,918 | |
Carrying Amount | $ 13,617,082 | $ 400,000 |
Shares Underlying Principal | Number | 1,637,166 | 122,027 |
Principal Outstanding, Current | $ 5,400,000 | $ 400,000 |
Principal Outstanding, Non Current | 9,400,000 | |
Discount Amount Current | 311,458 | |
Discount Amount Non Current | 871,460 | |
Convertible notes payable, Current | 5,088,542 | $ 400,000 |
Convertible notes payable, Non Current | $ 8,528,540 | |
Shares Underlying Principal Current | Number | 665,203 | 122,027 |
Shares Underlying Principal Non Current | Number | 971,963 |
NOTES PAYABLE (Details Narrativ
NOTES PAYABLE (Details Narrative) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Average stated interest rate | 10.00% | 11.00% |
Average effective interest rate | 35.00% | 24.00% |
Description of debt conversion | Certain notes with a $4.50 and a $10.00 stated conversion price in the second year of their twoyear term are subject to automatic conversion into shares of the Company’s common stock at a conversion price equal to 80% of the initial public offering price at the time of a qualified public offering. | |
Percentage of initial public offering price | 80.00% | |
Warrants [Member] | ||
Method of calculation of fair value of warrants | Binominal Monte-Carlo Cliquet option pricing model | |
Minimum [Member] | ||
Conversion Price | $ 3.05 | |
Maximum [Member] | ||
Conversion Price | $ 10.31 |
NOTES PAYABLE (Details 2)
NOTES PAYABLE (Details 2) | Dec. 31, 2018USD ($) |
Long Term Debt By Maturity [Abstract] | |
2019 | $ 34,920,480 |
2020 | 20,251,753 |
Total | $ 55,172,233 |
NOTES PAYABLE (Details 3)
NOTES PAYABLE (Details 3) | Dec. 31, 2018$ / shares | Sep. 27, 2018$ / shares | Aug. 08, 2018$ / shares | Feb. 27, 2018$ / shares | Dec. 31, 2017$ / shares |
Stock price | $ 11.10 | $ 11.30 | $ 11.40 | $ 11.40 | |
Warrants [Member] | Convertible Notes Payable [Member] | |||||
Stock price | $ 11.10 | $ 11.40 | |||
Warrants [Member] | Convertible Notes Payable [Member] | Exercise Price [Member] | |||||
Warrants and rights outstanding, measurement input | 11.30 | 10.80 | |||
Warrants [Member] | Convertible Notes Payable [Member] | Term [Member] | |||||
Term | 5 years | 5 years | |||
Warrants [Member] | Convertible Notes Payable [Member] | Risk-free Interest Rate [Member] | |||||
Warrants and rights outstanding, measurement input | 3.05 | 2.20 | |||
Warrants [Member] | Convertible Notes Payable [Member] | Expected Volatility [Member] | |||||
Warrants and rights outstanding, measurement input | 70 | 70 |
STOCKHOLDERS' DEFICIT (Details
STOCKHOLDERS' DEFICIT (Details Narrative) | Dec. 29, 2017USD ($)Note$ / shares | Sep. 29, 2016USD ($)shares | Sep. 12, 2016USD ($)$ / shares | Jun. 10, 2015USD ($)shares | Jun. 10, 2014USD ($)$ / sharesshares | Sep. 11, 2013USD ($)$ / sharesshares | Oct. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Feb. 28, 2018$ / sharesshares | Dec. 31, 2016shares | Sep. 11, 2014USD ($)shares | Jul. 14, 2014shares | Feb. 28, 2013shares | Feb. 27, 2013shares |
Warrants outstanding | shares | 3,436,431 | ||||||||||||||
Fair value of outstanding warrants | $ 26,377,000 | ||||||||||||||
Adjustment to additional paid-in capital - warrants | $ 9,687,000 | ||||||||||||||
Convertible notes prinicipal amount | 38,238,343 | 37,408,186 | |||||||||||||
Original Loan Principal Amount | 36,836,936 | ||||||||||||||
Share-based compensation | $ 4,597,188 | $ 5,051,838 | |||||||||||||
Period remaining for recognition of unrecognized compensation cost | 1 year 10 months 24 days | ||||||||||||||
2011 Stock Incentive Option Plan [Member] | |||||||||||||||
Options granted | shares | 357,000 | 50,000 | |||||||||||||
Exercise price - options vested | $ / shares | $ 11.28 | $ 11.40 | |||||||||||||
Options outstanding | shares | 6,642,200 | 6,775,200 | 6,955,200 | ||||||||||||
Total unrecognized compensation cost | $ 3,300,000 | ||||||||||||||
2011 Stock Incentive Option Plan [Member] | Share Based Compensation Award, Tranche One [Member] | |||||||||||||||
Vesting period | 1 year | ||||||||||||||
Vesting percentage | 33.33% | ||||||||||||||
2011 Stock Incentive Option Plan [Member] | Share Based Compensation Award, Tranche Two [Member] | |||||||||||||||
Vesting period | 2 years | ||||||||||||||
Vesting percentage | 66.67% | ||||||||||||||
2011 Stock Incentive Option Plan [Member] | Stock Options [Member] | |||||||||||||||
Number of shares authorized under the plan | shares | 9,000,000 | 9,000,000 | 6,000,000 | 3,000,000 | |||||||||||
Expiration period | 10 years | ||||||||||||||
Vesting period | 3 years | ||||||||||||||
Share-based compensation | $ 4,600,000 | $ 5,100,000 | |||||||||||||
GPB Debt Holdings II, LLC [Member] | Purchase Warrant [Member] | |||||||||||||||
Percent of product of registrable securities and closing sale price liable upon non registration as liquidation damages | 2.00% | ||||||||||||||
Maximum [Member] | |||||||||||||||
Conversion Price | $ / shares | $ 10.31 | ||||||||||||||
Maximum [Member] | GPB Debt Holdings II, LLC [Member] | Purchase Warrant [Member] | |||||||||||||||
Penalty percent of product of registrable securities and closing sale price liable upon non registration as liquidation damages | 12.00% | ||||||||||||||
Minimum [Member] | |||||||||||||||
Conversion Price | $ / shares | $ 3.05 | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | |||||||||||||||
Minimum interest reserve period to be maintained | 6 months | ||||||||||||||
Percentage of beneficially own in excess of common shares outstanding | 4.99% | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | Maximum [Member] | |||||||||||||||
Percentage of beneficially own in excess of common shares outstanding | 9.99% | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | |||||||||||||||
Exercise price | $ / shares | $ 11.30 | $ 10.80 | |||||||||||||
Warrants outstanding | shares | 240,764 | ||||||||||||||
Warrants exercisable term | 5 years | ||||||||||||||
Date from which warrants are exercisable | Apr. 22, 2019 | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | T.R. Winston & Company, LLC [Member] | |||||||||||||||
Cash fee paid as percentage of gross proceeds from purchasers | 5.00% | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | Securities Purchase Agreement [Member] | |||||||||||||||
Principal amount of debentures and warrants issued | $ 12,200,000 | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | Maximum [Member] | T.R. Winston & Company, LLC [Member] | |||||||||||||||
Number of common stock to be purchased | shares | 120,000 | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | Maximum [Member] | Securities Purchase Agreement [Member] | |||||||||||||||
Number of common stock to be purchased | shares | 1,220,000 | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | Senior Secured Convertible Promissory Note [Member] | |||||||||||||||
Maturity date | Dec. 29, 2020 | ||||||||||||||
Percentage of monthly payments interest rate | 12.50% | ||||||||||||||
Percentage of annual paymnets paid in kind interest rate | 1.00% | ||||||||||||||
Percentage portion of principal amount for which monthly payment is required | 5.00% | ||||||||||||||
Percentage of additional success fee paid prior to 24th-month anniversary | 2.00% | ||||||||||||||
Percentage of additional success fee on or after 24th-month anniversary | 3.00% | ||||||||||||||
Conversion Price | $ / shares | $ 10.31 | ||||||||||||||
Percentage of conversion price premium to public listing price | 10.00% | ||||||||||||||
Interest rate in event of default in maximum rate permitted by law | 17.50% | ||||||||||||||
Percentage of outstanding principal balance | 120.00% | ||||||||||||||
Debt face amount percentage | 20.00% | ||||||||||||||
Debt instrument exercise price | $ / shares | $ 10.80 | ||||||||||||||
Percentage of premium dilutive issuance price and number of shares issuable | 10.00% | ||||||||||||||
Initial warrants exercisable period after issuance | 5 years | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | 10% Redeemable Debenture [Member] | |||||||||||||||
Maturity date | Apr. 21, 2020 | ||||||||||||||
Percentage of monthly payments interest rate | 10.00% | ||||||||||||||
Monthly redemption payment on principal amount | $ 1,000,000 | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | 10% Redeemable Debenture [Member] | Minimum [Member] | |||||||||||||||
Debt instrument redemption amount | $ 20,000,000 | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | Convertible Debt | |||||||||||||||
Number of issaunce of maximum additional promissory notes | Note | 3 | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | Convertible Debt | Senior Secured Convertible Promissory Note [Member] | |||||||||||||||
Convertible notes prinicipal amount | $ 13,000,000 | ||||||||||||||
Original Loan Principal Amount | $ 12,480,000 | ||||||||||||||
Original issue discount percentage | 4.00% | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | Convertible Debt | Escrow Note [Member] | |||||||||||||||
Convertible notes prinicipal amount | $ 7,000,000 | ||||||||||||||
Original Loan Principal Amount | $ 6,720,000 | ||||||||||||||
Original issue discount percentage | 4.00% | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | Convertible Debt | Second Note [Member] | |||||||||||||||
Convertible notes prinicipal amount | $ 5,000,000 | ||||||||||||||
Original Loan Principal Amount | $ 4,800,000 | ||||||||||||||
Original issue discount percentage | 4.00% | ||||||||||||||
GPB Debt Holdings II, LLC [Member] | Convertible Debt | Third Note [Member] | |||||||||||||||
Convertible notes prinicipal amount | $ 5,000,000 | ||||||||||||||
Original Loan Principal Amount | $ 4,800,000 | ||||||||||||||
Original issue discount percentage | 4.00% | ||||||||||||||
KPM Tech Co., Ltd [Member] | Letter of Agreement [Member] | |||||||||||||||
Common stock price | $ / shares | $ 15.32 | ||||||||||||||
Future capital increases | $ 13,000,000 | ||||||||||||||
Hanil Vacuum Co Ltd [Member] | Letter of Agreement [Member] | |||||||||||||||
Common stock price | $ / shares | $ 3.68 | ||||||||||||||
Future capital increases | $ 1,000,000 | ||||||||||||||
Private Placement [Member] | |||||||||||||||
Units issued in offering | shares | 3,020,501 | ||||||||||||||
Unit price of offering | $ / shares | $ 2.50 | ||||||||||||||
Units issued in offering | $ 7,551,253 | ||||||||||||||
Warrants issued to broker of the offering | shares | 300,000 | ||||||||||||||
Exercise price | $ / shares | $ 3.50 | $ 3.50 | |||||||||||||
Warrants outstanding | shares | 2,225,036 | ||||||||||||||
Fair value of outstanding warrants | $ 1,800,000 | $ 7,068,000 | |||||||||||||
Number of warrants exercised | shares | 1,095,465 | ||||||||||||||
Proceeds from exercise of warrants | $ 3,800,000 | ||||||||||||||
Issuance of common stock for exercise of warrants | shares | 1,095,465 | ||||||||||||||
Adjustment to additional paid-in capital - warrants | $ 1,800,000 | ||||||||||||||
Private Placement [Member] | Common Stock | |||||||||||||||
Common stock subscription | shares | 4,115,966 | ||||||||||||||
Private Placement [Member] | Warrant [Member] | |||||||||||||||
Common stock subscription | shares | 3,320,501 | ||||||||||||||
Private Placement [Member] | Replacement Warrants [Member] | |||||||||||||||
Exercise price | $ / shares | $ 3.50 | ||||||||||||||
Private Placement [Member] | Letter of Agreement [Member] | |||||||||||||||
Reduction in additional paid in capital | $ 720,000 | ||||||||||||||
Private Placement [Member] | KPM Tech Co., Ltd [Member] | Letter of Agreement [Member] | |||||||||||||||
Purchase of common stock | $ 17,000,000 | ||||||||||||||
Common stock price | $ / shares | $ 4.50 | ||||||||||||||
Future capital investment | $ 13,000,000 | ||||||||||||||
Number of shares issued | shares | 3,777,778 | ||||||||||||||
Private Placement [Member] | Hanil Vacuum Co Ltd [Member] | Letter of Agreement [Member] | |||||||||||||||
Purchase of common stock | 3,000,000 | ||||||||||||||
Future capital investment | $ 1,000,000 | ||||||||||||||
Number of shares issued | shares | 666,667 | ||||||||||||||
Private Placement [Member] | KPM Tech Co., Ltd and Hanil Vacuum Co Ltd [Member] | Letter of Agreement [Member] | |||||||||||||||
Purchase of common stock | $ 20,000,000 | ||||||||||||||
Private Placement [Member] | Replacement Warrants [Member] | |||||||||||||||
Exercise price | $ / shares | $ 3.50 | ||||||||||||||
Warrants outstanding | shares | 1,095,465 | ||||||||||||||
Fair value of outstanding warrants | $ 2,545,000 | ||||||||||||||
Warrants Issued with Notes (in shares) | shares | 1,095,465 | ||||||||||||||
Warrant exercise inducement expense | $ 3,500,000 |
STOCKHOLDERS' DEFICIT (Details)
STOCKHOLDERS' DEFICIT (Details) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Warrants outstanding, ending | 3,436,431 | |
Warrant [Member] | ||
Warrants outstanding, beginning | 5,265,432 | 5,024,668 |
Granted | 1,542,000 | 240,764 |
Exercised | (2,385,317) | |
Cancelled, forfeited and expired | (985,684) | |
Warrants outstanding, ending | 3,436,431 | 5,265,432 |
STOCKHOLDERS' DEFICIT (Detail_2
STOCKHOLDERS' DEFICIT (Details 1) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Number of Warrants Issued, Outstanding | 3,436,431 |
Total, Execisable | 3,436,431 |
Warrants Issued in 2014 - Exercise Price $3.50 [Member] | |
Number of Warrants Issued, Outstanding | 50,000 |
Weighted Average Remaining Contractual Life (Years), Outsanding | 3 months 29 days |
Weighted Average Exercise Price, Outsanding | $ / shares | $ 3.50 |
Total, Execisable | 50,000 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 3.50 |
Warrants Issued in 2014 [Member] | |
Number of Warrants Issued, Outstanding | 50,000 |
Total, Execisable | 50,000 |
Warrants Issued in 2015 - Exercise Price $4.90 [Member] | |
Number of Warrants Issued, Outstanding | 110,417 |
Weighted Average Remaining Contractual Life (Years), Outsanding | 1 year 2 months 4 days |
Weighted Average Exercise Price, Outsanding | $ / shares | $ 4.90 |
Total, Execisable | 110,417 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 4.90 |
Warrants Issued in 2015 [Member] | |
Number of Warrants Issued, Outstanding | 110,417 |
Total, Execisable | 110,417 |
Warrants Issued in 2016 - Exercise Price $4.50 [Member] | |
Number of Warrants Issued, Outstanding | 118,750 |
Weighted Average Remaining Contractual Life (Years), Outsanding | 2 years 6 months |
Weighted Average Exercise Price, Outsanding | $ / shares | $ 4.50 |
Total, Execisable | 118,750 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 4.50 |
Warrants Issued in 2016 [Member] | |
Number of Warrants Issued, Outstanding | 1,493,750 |
Total, Execisable | 1,493,750 |
Warrants Issued in 2016 - Exercise Price $4.70 [Member] | |
Number of Warrants Issued, Outstanding | 75,000 |
Weighted Average Remaining Contractual Life (Years), Outsanding | 2 years 3 months 29 days |
Weighted Average Exercise Price, Outsanding | $ / shares | $ 4.70 |
Total, Execisable | 75,000 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 4.70 |
Warrants Issued in 2016 - Exercise Price $5.00 [Member] | |
Number of Warrants Issued, Outstanding | 1,300,000 |
Weighted Average Remaining Contractual Life (Years), Outsanding | 2 years 4 months 9 days |
Weighted Average Exercise Price, Outsanding | $ / shares | $ 5 |
Total, Execisable | 1,300,000 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 5 |
Warrants Issued in 2017 - Exercise Price $ 10.80 [Member] | |
Number of Warrants Issued, Outstanding | 240,764 |
Weighted Average Remaining Contractual Life (Years), Outsanding | 4 years 6 months |
Weighted Average Exercise Price, Outsanding | $ / shares | $ 10.80 |
Total, Execisable | 240,764 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 10.80 |
Warrants Issued in 2018 - Exercise Price $ 11.30 [Member] | |
Number of Warrants Issued, Outstanding | 1,541,500 |
Weighted Average Remaining Contractual Life (Years), Outsanding | 4 years 9 months 10 days |
Weighted Average Exercise Price, Outsanding | $ / shares | $ 11.30 |
Total, Execisable | 1,541,500 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 11.30 |
Warrants Issued in 2017 [Member] | |
Number of Warrants Issued, Outstanding | 240,764 |
Total, Execisable | 240,764 |
STOCKHOLDERS' DEFICIT (Detail_3
STOCKHOLDERS' DEFICIT (Details 2) - $ / shares | Sep. 27, 2018 | Aug. 08, 2018 | Feb. 27, 2018 | Dec. 31, 2017 |
Stockholders Equity Note [Abstract] | ||||
Stock price | $ 11.10 | $ 11.30 | $ 11.40 | $ 11.40 |
Exercise Price | $ 11.10 | $ 11.30 | $ 11.40 | $ 11.40 |
Term | 10 years | 10 years | 10 years | 10 years |
Risk-Free Rate | 2.99% | 2.88% | 2.75% | 2.27% |
Volatility | 69.14% | 66.09% | 68.18% | 68.18% |
STOCKHOLDERS' DEFICIT (Detail_4
STOCKHOLDERS' DEFICIT (Details 3) - 2011 Stock Incentive Option Plan [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Options outstanding, beginning | 6,775,200 | 6,955,200 |
Granted or deemed issued | 357,000 | 50,000 |
Exercised | (170,000) | (11,895) |
Cancelled, forfeited and expired | (320,000) | (218,105) |
Options outstanding, end | 6,642,200 | 6,775,200 |
Options exercisable | 5,958,783 | 5,604,439 |
Options available for future grant | 2,357,800 | 2,224,800 |
Options outstanding, beginning | $ 4.12 | $ 4.10 |
Granted or deemed issued | 11.28 | 11.40 |
Exercised | 4.59 | 4.19 |
Cancelled, forfeited and expired | 6.06 | 4.98 |
Options outstanding, end | 4.40 | 4.12 |
Options exercisable | $ 3.87 | $ 3.95 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Current | ||
Current U.S. | $ 5,586 | $ 2,400 |
International | 636 | 833 |
Deferred | ||
Deferred U.S. | (12,306,343) | |
INCOME TAXES (BENEFIT) | $ 6,222 | $ (12,303,110) |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Components of net deferred tax assets | ||
Net operating loss carryforward | $ 19,900,927 | $ 15,086,163 |
General business tax credit | 9,342,425 | 8,911,700 |
Stock options | 6,011,522 | 3,583,299 |
Charitable contribution | 139,124 | 38,128 |
Accrued expenses | 364,306 | 229,105 |
Unearned revenue | 1,395,870 | |
Allowance for bad AR | 172,939 | |
Other | 317,845 | 29,855 |
Total gross deferred tax assets | 37,644,958 | 27,878,250 |
Less valuation allowance | (34,599,232) | (13,381,045) |
Net deferred tax assets | $ 3,045,726 | $ 14,497,205 |
INCOME TAXES (Details 2)
INCOME TAXES (Details 2) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | ||
Unrealized gain on LT investment | $ 2,964,943 | |
Unrealized gain on foreign exchange translation and others | (78,281) | $ (32,752) |
Unrealized gain on marketable securities | (14,464,453) | |
Other | (2,502) | |
Total deferred tax liability | $ 2,884,160 | |
Total deferred tax liability | $ (14,497,205) |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Operating Loss Carryforwards [Line Items] | ||
Valuation allowance increase (decrease) | $ 21.2 | $ (23.4) |
General business tax credits | $ 9.3 | $ 8.9 |
Statutory federal tax rate (in percent) | 21.00% | 34.00% |
Change in corporate tax rate (in percent) | 21.00% | 34.00% |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards expiration | Dec. 31, 2037 | |
Business credits expiration | Dec. 31, 2038 | |
Net operating loss carryforwards | $ 64.8 | $ 64.6 |
State and Local | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards expiration | Dec. 31, 2038 | |
Net operating loss carryforwards | $ 55.7 | $ 57.9 |
INCOME TAXES (Details 3)
INCOME TAXES (Details 3) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Reconciliation of effective income tax | ||
Tax benefit at statutory federal rate | $ (12,169,762) | $ (15,496,876) |
State taxes, net of federal tax benefit | (3,786,890) | (398,315) |
Increase in valuation allowance | 6,753,526 | (8,943,404) |
Permanent items | 750,485 | 9,521,184 |
General business tax credit | (430,724) | (1,407,553) |
Impact from tax rate change (34% to 21%) | 10,210,183 | |
OCI, tax benefit | (12,306,343) | |
Other | 8,889,587 | 6,518,014 |
INCOME TAXES (BENEFIT) | $ 6,222 | $ (12,303,110) |
INCOME TAXES (Details 3) (Paren
INCOME TAXES (Details 3) (Parenthetical) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Statutory federal tax rate (in percent) | 21.00% | 34.00% |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) | Oct. 31, 2018$ / shares | Sep. 29, 2017$ / sharesshares | Jul. 12, 2017USD ($)Numberkg$ / kg | Jun. 12, 2017USD ($)$ / sharesshares | Jun. 12, 2017KRW (₩)₩ / shares | Jul. 31, 2017USD ($) | Jul. 31, 2017KRW (₩)₩ / shares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / shares | Dec. 31, 2018₩ / shares | Dec. 31, 2017₩ / shares |
Rent expense | $ 668,620 | $ 563,382 | |||||||||
Telcon, Inc. ("Telcon") [Member] | |||||||||||
Investment | $ 31,800,000 | ₩ 36,001,446,221 | |||||||||
Investment, in per share | ₩ / shares | ₩ 5,419 | ||||||||||
Investment, closing price | (per share) | $ 7.43 | $ 13.95 | ₩ 8,280 | ₩ 14,900 | |||||||
Share repurchases, initial price per share | $ / shares | $ 7.60 | ||||||||||
Share repurchased during period | shares | 495,000 | ||||||||||
Share repurchases, price per share | $ / shares | $ 7.60 | ||||||||||
Telcon, Inc. ("Telcon") [Member] | Management Control Acquistion Agreement [Member] | |||||||||||
Investment | $ 31,800,000 | ||||||||||
Investment, closing price | $ / shares | $ 4.79 | ||||||||||
Ownership interest | 10.30% | ||||||||||
Telcon, Inc. ("Telcon") [Member] | Management Control Acquistion Agreement [Member] | Korea (South), Won | |||||||||||
Investment | ₩ | ₩ 36,000,000,000 | ||||||||||
Shares originally purchased (in shares) | shares | 6,643,559 | ||||||||||
Investment, in per share | ₩ / shares | ₩ 5,419 | ||||||||||
Telcon, Inc. ("Telcon") [Member] | API Supply Agreement [Member] | |||||||||||
Proceeds from supply agreement | $ 31,800,000 | ||||||||||
Telcon, Inc. ("Telcon") [Member] | API Supply Agreement [Member] | Pharmaceutical Grade L-glutamine [Member] | |||||||||||
Percentage of right to supply | 25.00% | 25.00% | |||||||||
Agreement term | 15 years | 15 years | |||||||||
Telcon, Inc. ("Telcon") [Member] | API Supply Agreement [Member] | Korea (South), Won | |||||||||||
Proceeds from supply agreement | ₩ | ₩ 36,000,000,000 | ||||||||||
Telcon, Inc. ("Telcon") [Member] | Revised API Agreement [Member] | |||||||||||
Agreement term | 5 years | ||||||||||
Number of renewals | Number | 10 | ||||||||||
Weight of drug per supply agreement | kg | 940,000 | ||||||||||
Unit price of grade L-glutamine | $ / kg | 50 | ||||||||||
Purchase amount | $ 47,000,000 | ||||||||||
Telcon, Inc. ("Telcon") [Member] | Revised API Agreement [Member] | Maximum [Member] | |||||||||||
Agreement term | 15 years | ||||||||||
Yearly purchase commitments | $ 2,500,000 | ||||||||||
Telcon, Inc. ("Telcon") [Member] | Revised API Agreement [Member] | Minimum [Member] | |||||||||||
Yearly purchase commitments | $ 5,000,000 | ||||||||||
KPM Tech Co And Hanil Vacuum Co [Member] | Telcon, Inc. ("Telcon") [Member] | |||||||||||
Number of shares issued | shares | 4,444,445 | ||||||||||
Common stock price | $ / shares | $ 6.60 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES (Details) | Dec. 31, 2018USD ($) |
Future minimum lease payments | |
2019 | $ 729,825 |
2020 | 974,008 |
2021 | 973,428 |
2022 | 1,003,437 |
Thereafter | 3,665,179 |
Total | $ 7,345,877 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) | 12 Months Ended | ||
Dec. 31, 2018USD ($)Number$ / shares | Dec. 31, 2017USD ($)Number$ / shares | ||
Short-term Debt [Line Items] | |||
Principal Amount Outstanding | $ 38,238,343 | $ 37,408,186 | |
Shares Underlying Notes | Number | 6,499,608 | 6,187,614 | |
Masaharu & Emiko Osato [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [1] | 11.00% | 11.00% |
Date of Loan | [1] | Dec. 29, 2015 | Dec. 29, 2015 |
Term of Loan | [1] | Due on Demand | Due on Demand |
Principal Amount Outstanding | [1] | $ 300,000 | |
Highest Principal Outstanding | [1] | $ 300,000 | $ 300,000 |
Amount of Principal Repaid | [1] | 300,000 | |
Amount of Interest Paid | [1] | $ 76,036 | |
Lan T. Tran [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [2] | 11.00% | |
Date of Loan | [2] | Feb. 10, 2016 | |
Term of Loan | [2] | Due on Demand | |
Highest Principal Outstanding | [2] | $ 130,510 | |
Amount of Principal Repaid | [2] | 130,510 | |
Amount of Interest Paid | [2] | $ 28,712 | |
Masaharu & Emiko Osato [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [1] | 11.00% | 11.00% |
Date of Loan | [1] | Feb. 25, 2016 | Feb. 25, 2016 |
Term of Loan | [1] | Due on Demand | Due on Demand |
Principal Amount Outstanding | [1] | $ 400,000 | |
Highest Principal Outstanding | [1] | $ 400,000 | $ 400,000 |
Amount of Principal Repaid | [1] | 400,000 | |
Amount of Interest Paid | [1] | $ 94,389 | |
Lan T. Tran [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [2] | 10.00% | 11.00% |
Date of Loan | [2] | Apr. 29, 2016 | Feb. 10, 2016 |
Term of Loan | [2] | Due on Demand | Due on Demand |
Principal Amount Outstanding | [2] | $ 20,000 | $ 130,510 |
Highest Principal Outstanding | [2] | $ 20,000 | $ 130,510 |
Hope Hospice [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [3] | 10.00% | 10.00% |
Date of Loan | [3] | Jun. 3, 2016 | Apr. 4, 2016 |
Term of Loan | [3] | Due on Demand | Due on Demand |
Principal Amount Outstanding | [3] | $ 250,000 | |
Highest Principal Outstanding | [3] | $ 250,000 | $ 50,000 |
Amount of Principal Repaid | [3] | 50,000 | |
Amount of Interest Paid | [3] | $ 8,110 | |
Lan T. Tran [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [2] | 10.00% | 10.00% |
Date of Loan | [2] | Feb. 9, 2017 | Apr. 29, 2016 |
Term of Loan | [2] | Due on Demand | Due on Demand |
Principal Amount Outstanding | [2] | $ 12,000 | $ 20,000 |
Highest Principal Outstanding | [2] | $ 12,000 | $ 20,000 |
Yutaka Niihara [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [1],[2] | 10.00% | 10.00% |
Date of Loan | [1],[2] | Sep. 14, 2017 | Sep. 14, 2017 |
Term of Loan | [1],[2] | Due on Demand | Due on Demand |
Principal Amount Outstanding | [1],[2] | $ 26,583 | $ 903,751 |
Highest Principal Outstanding | [1],[2] | 903,751 | 903,751 |
Amount of Principal Repaid | [1],[2] | 877,167 | |
Amount of Interest Paid | [1],[2] | $ 94,584 | |
Lan T. Tran [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [2] | 11.00% | |
Date of Loan | [2] | Feb. 10, 2018 | |
Term of Loan | [2] | Due on Demand | |
Principal Amount Outstanding | [2] | $ 159,223 | |
Highest Principal Outstanding | [2] | 159,223 | |
Promissory Note Payable To Related Parties [Member] | |||
Short-term Debt [Line Items] | |||
Principal Amount Outstanding | 467,806 | 2,036,261 | |
Highest Principal Outstanding | 2,175,484 | 3,562,366 | |
Amount of Principal Repaid | 1,707,678 | 794,339 | |
Amount of Interest Paid | $ 293,721 | $ 129,470 | |
Yasushi Nagasaki [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [2] | 10.00% | 10.00% |
Date of Loan | [2] | Jun. 29, 2012 | Jun. 29, 2012 |
Term of Loan | [2] | Due on Demand | Due on Demand |
Principal Amount Outstanding | [2] | $ 200,000 | $ 200,000 |
Highest Principal Outstanding | [2] | $ 200,000 | 388,800 |
Amount of Principal Repaid | [2] | 188,800 | |
Amount of Interest Paid | [2] | $ 57,886 | |
Conversion Rate (in dollars per share) | $ / shares | [2] | $ 3.30 | $ 3.30 |
Shares Underlying Notes | Number | [2] | 74,182 | 68,122 |
Yutaka & Soomi Niihara [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [1],[2] | 10.00% | 10.00% |
Date of Loan | [1],[2] | Nov. 16, 2015 | Nov. 16, 2015 |
Term of Loan | [1],[2] | 2 years | 2 years |
Principal Amount Outstanding | [1],[2] | $ 200,000 | $ 200,000 |
Highest Principal Outstanding | [1],[2] | $ 200,000 | $ 200,000 |
Conversion Rate (in dollars per share) | $ / shares | [1],[2] | $ 4.50 | $ 4.50 |
Shares Underlying Notes | Number | [1],[2] | 58,350 | 53,905 |
Wei Peu Zen [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [1] | 10.00% | |
Date of Loan | [1] | Nov. 6, 2017 | |
Term of Loan | [1] | 2 years | |
Principal Amount Outstanding | [1] | $ 5,000,000 | |
Highest Principal Outstanding | [1] | 5,000,000 | |
Amount of Interest Paid | [1] | $ 250,000 | |
Conversion Rate (in dollars per share) | $ / shares | [1] | $ 10 | |
Shares Underlying Notes | Number | [1] | 532,671 | |
Convertible notes payable - related party current [Member] | |||
Short-term Debt [Line Items] | |||
Principal Amount Outstanding | $ 5,400,000 | ||
Highest Principal Outstanding | 5,400,000 | ||
Amount of Interest Paid | $ 250,000 | ||
Shares Underlying Notes | Number | 665,203 | ||
Profit Preview International Group, Ltd. [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [4] | 10.00% | |
Date of Loan | [4] | Feb. 1, 2018 | |
Term of Loan | [4] | 2 years | |
Principal Amount Outstanding | [4] | $ 4,037,000 | |
Highest Principal Outstanding | [4] | 4,037,000 | |
Amount of Interest Paid | [4] | $ 201,850 | |
Conversion Rate (in dollars per share) | $ / shares | [4] | $ 10 | |
Shares Underlying Notes | Number | [4] | 420,456 | |
Profit Preview International Group, Ltd. [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [4] | 10.00% | |
Date of Loan | [4] | Mar. 21, 2018 | |
Term of Loan | [4] | 2 years | |
Principal Amount Outstanding | [4] | $ 5,363,000 | |
Highest Principal Outstanding | [4] | 5,363,000 | |
Amount of Interest Paid | [4] | $ 268,150 | |
Conversion Rate (in dollars per share) | $ / shares | [4] | $ 10 | |
Shares Underlying Notes | Number | [4] | 551,507 | |
Convertible notes payable - related party non-current [Member] | |||
Short-term Debt [Line Items] | |||
Principal Amount Outstanding | $ 9,400,000 | ||
Highest Principal Outstanding | 9,400,000 | ||
Amount of Interest Paid | $ 470,000 | ||
Shares Underlying Notes | Number | 971,963 | ||
Promissory note payable and convertible notes payable - related party [Member] | |||
Short-term Debt [Line Items] | |||
Principal Amount Outstanding | $ 15,267,806 | $ 2,436,261 | |
Highest Principal Outstanding | 16,975,484 | 4,171,166 | |
Amount of Principal Repaid | 1,707,678 | 1,003,139 | |
Amount of Interest Paid | $ 1,013,721 | $ 191,761 | |
Shares Underlying Notes | Number | 1,637,166 | 122,027 | |
Hope Hospice [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [3] | 8.00% | |
Date of Loan | [3] | Jan. 17, 2012 | |
Term of Loan | [3] | Due on Demand | |
Highest Principal Outstanding | [3] | $ 200,000 | |
Amount of Principal Repaid | [3] | 200,000 | |
Amount of Interest Paid | [3] | $ 7,331 | |
Hope Hospice [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [3] | 8.00% | |
Date of Loan | [3] | Jun. 14, 2012 | |
Term of Loan | [3] | Due on Demand | |
Highest Principal Outstanding | [3] | $ 200,000 | |
Amount of Principal Repaid | [3] | 200,000 | |
Amount of Interest Paid | [3] | $ 14,762 | |
Hope Hospice [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [3] | 8.00% | |
Date of Loan | [3] | Jun. 21, 2012 | |
Term of Loan | [3] | Due on Demand | |
Highest Principal Outstanding | [3] | $ 100,000 | |
Amount of Principal Repaid | [3] | 100,000 | |
Amount of Interest Paid | [3] | $ 7,249 | |
Hope Hospice [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [3] | 8.00% | |
Date of Loan | [3] | Feb. 11, 2013 | |
Term of Loan | [3] | Due on Demand | |
Highest Principal Outstanding | [3] | $ 50,000 | |
Amount of Principal Repaid | [3] | 50,000 | |
Amount of Interest Paid | [3] | $ 1,559 | |
Hope Hospice [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [3] | 10.00% | |
Date of Loan | [3] | Jan. 7, 2015 | |
Term of Loan | [3] | Due on Demand | |
Highest Principal Outstanding | [3] | $ 100,000 | |
Amount of Principal Repaid | [3] | 100,000 | |
Amount of Interest Paid | [3] | $ 28,630 | |
IRA Service Trust Co. FBO Peter B. Ludlum [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [2] | 10.00% | |
Date of Loan | [2] | Feb. 20, 2015 | |
Term of Loan | [2] | Due on Demand | |
Principal Amount Outstanding | [2] | $ 10,000 | |
Highest Principal Outstanding | [2] | $ 10,000 | |
Yutaka Niihara [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [1],[2] | 10.00% | |
Date of Loan | [1],[2] | May 21, 2015 | |
Term of Loan | [1],[2] | Due on Demand | |
Principal Amount Outstanding | [1],[2] | $ 0 | |
Highest Principal Outstanding | [1],[2] | 826,105 | |
Amount of Principal Repaid | [1],[2] | 94,339 | |
Amount of Interest Paid | [1],[2] | $ 61,829 | |
IRA Service Trust Co. FBO Peter B. Ludlum Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [2] | 10.00% | |
Date of Loan | [2] | May 5, 2016 | |
Term of Loan | [2] | Due on Demand | |
Principal Amount Outstanding | [2] | $ 10,000 | |
Highest Principal Outstanding | [2] | $ 10,000 | |
Hope Hospice [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [3] | 10.00% | |
Date of Loan | [3] | Jun. 3, 2016 | |
Term of Loan | [3] | Due on Demand | |
Principal Amount Outstanding | [3] | $ 250,000 | |
Highest Principal Outstanding | [3] | $ 250,000 | |
Lan T. Tran [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [2] | 10.00% | |
Date of Loan | [2] | Feb. 9, 2017 | |
Term of Loan | [2] | Due on Demand | |
Principal Amount Outstanding | [2] | $ 12,000 | |
Highest Principal Outstanding | [2] | $ 12,000 | |
Charles & Kimxa Stark [Member] | |||
Short-term Debt [Line Items] | |||
Interest Rate | [2] | 10.00% | |
Date of Loan | [2] | Oct. 1, 2015 | |
Term of Loan | [2] | 2 years | |
Highest Principal Outstanding | [2] | $ 20,000 | |
Amount of Principal Repaid | [2] | 20,000 | |
Amount of Interest Paid | [2] | $ 4,405 | |
Conversion Rate (in dollars per share) | $ / shares | [2] | $ 4.50 | |
Convertible notes payable - related party [Member] | |||
Short-term Debt [Line Items] | |||
Principal Amount Outstanding | $ 13,617,082 | $ 400,000 | |
Highest Principal Outstanding | 608,800 | ||
Amount of Principal Repaid | 208,800 | ||
Amount of Interest Paid | $ 62,291 | ||
Shares Underlying Notes | Number | 1,637,166 | 122,027 | |
[1] | Director | ||
[2] | Officer | ||
[3] | Dr. Niihara, our director and Chief Executive Officer, is also the Chief Executive Officer of Hope Hospice. | ||
[4] | Mr. Zen, a Director, is the sole owner of Profit Preview International Group, Ltd. |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) | Jan. 01, 2019 | Dec. 31, 2018 |
Common shares | $ 1,323,295 | |
Common Stock [Member] | ||
Common shares | $ 125 | |
Number of Shares Issued | 125,000 | |
Common Stock [Member] | Subsequent Event [Member] | ||
Common shares | $ 1,885,000 | |
Number of Shares Issued | 227,500 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) | Mar. 05, 2019 |
Senior Secured Debentures [Member] | Subsequent Event [Member] | |
Subsequent Event [Line Items] | |
Debt instrument annual interest | 10.00% |