SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Refer to the Annual Report for a summary of significant accounting policies. There have been no material changes to the Company’s significant accounting policies during the nine months ended September 30, 2018 except for revenues, which are discussed below. Below are disclosures of certain interim balances, transactions, and significant assumptions used in computing fair value as of and for the three and nine months ended September 30, 2018 and comparative amounts from the prior fiscal periods: Revenues – Effective January 1, 2018, the Company adopted Accounting Standard codification (“ASC”) Topic 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 sickle cell disease (“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. Up until June 30, 2018, the Company recognized Endari sales revenues based upon the script data reports on shipments to patients as the Company did not have sufficient historical information to reliably forecast and estimate variable consideration and product returns. During the three months ended September 30, 2018, the Company obtained additional information based on new contracts signed with major distributors and pharmacies, knowledge of our reimbursement payor mix, as well as improved visibility as to the relatively fast turnover of Endari inventory at the distributor level. As such, the new information obtained in the three months ended September 30, 2018 provided the Company with the ability to better forecast and estimate the expected variable consideration related to sales to the distributors, which are customers of the Company, as well as establishing the expectation of a low level of product returns. The gross sales of Endari to these customers were $1.3 million, $3.8 million and $5.5 million for the three month periods ended March 31, June 30 and September 30 of 2018, respectively. The net revenues for Endari reported for these periods were $0.7 million, $2.3 million and $4.7 million for the three month periods ended March 31, June 30 and September 30 of 2018, respectively. The effect of being better able to forecast and estimate the expected variable consideration permitted the Company, in the three months ended September 30, 2018, to recognize $0.7 million in revenues that had been deferred in prior periods when the Company did not have sufficient historical information to reliably forecast and estimate variable consideration and product returns. 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. Inventories — All of the raw material purchased during the nine months ended September 30, 2018 were from two vendors and for the year ended December 31, 2017 were from one vendor. The below table presents inventory by category: Inventories by category September 30, 2018 December 31, 2017 Raw materials and components $ 184,126 $ — Work-in-process 924,275 124,801 Finished goods 2,238,828 500,498 Total $ 3,347,229 $ 625,299 Advertising cost — Advertising costs are expensed as incurred. Advertising costs for the three months ended September 30, 2018 and 2017 were $16,750 and $18,201, respectively. Advertising costs for the nine months ended September 30, 2018 and 2017 were $76,654 and $35,399, respectively. 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 the 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 September 30, 2018 and December 31, 2017, the closing prices per CellSeed share on the Tokyo Stock Exchange were ¥1,001 ($8.80 USD) and ¥462 JPY ($4.10 USD), respectively, and the closing prices per Telcon share on the Korean Securities Dealers Automated Quotations (“KOSDAQ”) were ₩10,300 ($9.27 USD) and ₩14,900 KRW ($13.95 USD), respectively. As of December 31, 2017, the closing price per KPM share on KOSDAQ was ₩1,625 KRW ($1.52 USD) and the closing price per Hanil share on KOSDAQ was ₩2,830 KRW ($2.65 USD). During the three months ended September 30, 2018, the Company sold all of its KPM and Hanil shares. As of September 30, 2018, and December 31, 2017, 39,250 shares of CellSeed common stock were pledged to secure a $300,000 convertible note of the Company issued to Mitsubishi UFJ Capital III Limited Partnership that is due on demand and were classified as current assets, as marketable securities, pledged to creditor. In addition, as of September 30, 2018 and December 31, 2017 6,643,559 shares of Telcon were pledged to secure the API Supply Agreement (see Note 8) in which Emmaus received $31,800,000 related to a trade advance discount. These shares were classified as current assets, as investment in marketable securities Prepaid expenses and other current assets — Prepaid expenses and other current assets consisted of the following at September 30, 2018 and December 31, 2017: September 30, 2018 December 31, 2017 Prepaid insurance $ 72,510 $ 132,387 Other prepaid expenses and current assets 246,633 157,984 Total prepaid expenses $ 319,143 $ 290,371 Other long-term liabilities —Other long-term liabilities consisted of the following at September 30, 2018 and December 31, 2017: September 30, 2018 December 31, 2017 Trade discount $ 29,531,500 $ 31,841,500 Unearned revenue 10,000,000 5,000,000 Other long-term liabilities — 10,790 Total other long-term liabilities $ 39,531,500 $ 36,852,290 The Company has 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) as a 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 terms. 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 will be applied against purchases made by the Company from Telcon over the life of the agreement. Fair value measurements — The following table presents the activity for those items measured at fair value on a recurring basis using Level 3 inputs during the nine months ended September 30, 2018 and the year ended December 31, 2017: Nine Months Ended Year Ended Warrant Derivative Liabilities—Stock Purchase Warrants September 30, 2018 December 31, 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 The following table presents warrants issued to GPB Debt Holdings II, LLC as described in Note 7 measured at fair value as of September 30, 2018: Nine Months Ended September 30, 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) (160,000 ) (466,000 ) — — Extinguished upon debt repayment — (823,000 ) — — Balance, end of period $ 1,722,000 $ — $ 1,882,000 $ 1,289,000 The value of warrant derivative liabilities and the change in fair value of the warrant derivative liabilities 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. The value as of the dates set forth in the table below, was based on upon following assumptions: September 30, 2018 December 31, 2017 Stock price $ 11.10 $ 11.40 Risk‑free interest rate 2.92 % 2.20 % Expected volatility (peer group) 70.00 % 70.00 % Expected life (in years) 4.25 5.00 Expected dividend yield — — Number outstanding 240,764 240,764 Balance, end of period: Warrant derivative liabilities (long-term) $ 1,722,000 $ 1,882,000 Debt and related party debt — The following table presents the effective interest rates on loans originated and refinanced in the respective periods that either had a beneficial conversion feature 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 2017 convertible notes payable Due on demand - 3 years 10% - 13.5% $ 36,113,296 $3.50 - $10.31 $ 11,678,725 240,764 $ 10.80 $ 1,882,000 10% - 110% 2018 convertible notes payable Due on demand - 2 years 6% - 10% 26,501,808 $3.50 - $10.00 10,218,609 — — — 19% - 110% $ 62,615,104 $ 21,897,334 240,764 $ 1,882,000 Related party notes are disclosed as separate line items in the Company’s consolidated balance sheets. Net loss per share — As of September 30, 2018 and 2017, respectively, potentially dilutive securities exercisable or convertible into 15,286,940 and 15,617,245 shares of Company common stock were outstanding. No potentially dilutive securities were included in the calculation of diluted net loss per share since their effect would be anti-dilutive for all periods presented. Recent accounting pronouncements —In January 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities . 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 available-for-sale 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 Targeted Improvements In April 2016, the FASB issued ASU 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing 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 |