Significant Accounting Policies [Text Block] | NOTE 2. Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and are expressed in U.S. dollars. Reclassifications Prior period amounts in the accompanying consolidated balance sheets have been reclassified to conform to current period presentation. Prior period amounts in the accompanying consolidated statements of operations and comprehensive loss have also been reclassified to conform to current period presentation. The reclassifications did not Additionally, prior period amounts in the accompanying consolidated statements of cash flow have also been reclassified to conform to current period presentation. The reclassifications did not Use of Estimates The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. These estimates include useful lives for property and equipment and related depreciation calculations, estimated amortization periods for payments received from product development and license agreements as they relate to revenue recognition, assumptions for valuing options and warrants, and income taxes. Actual results could differ from those estimates. Unaudited Interim Financial Information The accompanying interim condensed consolidated financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the results of operations for the periods presented. The year-end condensed consolidated balance sheet data was derived from audited financial statements but does not not Cash, Cash Equivalents, and Restricted Cash The Company considers all highly-liquid instruments with a stated maturity of three June 30, 2018, December 31, 2017, two Beginning fiscal 2018, No. 2016 18, Statement of Cash Flows (Topic 230 $474 December 31, 2017, $475 June 30, 2018. six June 30, 2018 2017, not The following table provides a reconciliation of the cash, cash equivalents, and restricted cash reported in the consolidated balance sheet that sum to the total of the same reported in the consolidated statement of cash flows: June 30, 2018 December 31, 2017 Cash and cash equivalents $ 6,833 $ 3,199 Restricted cash included in Other assets 475 474 Total cash, cash equivalents, and restricted cash in the statement of cash flows $ 7,308 $ 3,673 The restricted cash amount included in Other assets on the consolidated balance sheet represents amounts held as certificate of deposit for long-term financing and lease arrangements as contractually required by our financial institution and landlord. Concentrations of Credit Risk and Major Partners Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits of cash and cash equivalents with two Deposits in these banks may not During the six June 30, 2018 2017, three During the six June 30, 2018 2017, 10% Three Months Ended Six Months Ended June 30, June 30, Major distribution or collaboration partner 201 8 201 7 201 8 201 7 Distributor A 21 % 23 % 21 % 23 % Distributor B 23 % 25 % 24 % 25 % Distributor C 24 % 18 % 25 % 20 % Collaborator D 10 % * 10 % * *Not 10% As of June 30, 2018 December 31, 2017, 10% Major distribution or collaboration partner June 30, 2018 December 31, 2017 Distributor A 26 % 25 % Distributor B 33 % 23 % Distributor C 24 % 22 % Collaborator D * 20 % *Not 10% The Company relies on two not third may not Fair Value of Financial Assets and Liabilities Financial instruments, including cash, cash equivalents and restricted cash, accounts receivable, accounts payable and accrued liabilities are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments. Our warrant liability is carried at fair value. The Company measures the fair value of financial assets and liabilities based on U.S. GAAP guidance, which defines fair value, establishes a framework for measuring fair value, and requires disclosures about fair value measurements. Under U.S. GAAP, fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. A fair value hierarchy is also established, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. There are three may Level 1 Level 2 Level 3 Allowance for Doubtful Accounts The Company charges bad debt expense and records an allowance for doubtful accounts when management believes it to be unlikely that specific invoices will be collected. Management identifies amounts due that are in dispute and it believes are unlikely to be collected. As of June 30, 2018 December 31, 2017, $11 $13 120 Inventory Inventory is comprised of ( 1 2 3 June 30, 2018 December 31, 2017, $138 $140 Inventory is stated at the lower of cost or estimated net realizable value determined by the first first Property and Equipment Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets of five seven three seven seven The costs of normal maintenance, repairs, and minor replacements are charged to operations when incurred. Impairment of Long-Lived Assets The Company accounts for long-lived assets in accordance with U.S. GAAP, which requires that companies consider whether events or changes in facts and circumstances, both internally and externally, may no six June 30, 2018 June 30, 2017. not Comprehensive Income (Loss) Accounting Standards Codification (“ASC”) 220, Comprehensive Income Revenue Recognition Beginning January 1, 2018, 606, Revenue from Contracts with Customers The Company generates product revenue through product sales to its major distribution partners, a limited number of other distributors and via its webstore. Product supply is the only performance obligation contained in these arrangements, and the Company recognizes product revenue upon transfer of control to its major distribution partners at the amount of consideration that the Company expects to be entitled to, generally upon shipment to the distributor on a “sell-in” basis. Other revenue is primarily generated through commercial partner agreements with strategic partners for the development and commercialization of the Company’s product candidates. The terms of the agreements typically include more than one In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC Topic 606. ● Product supply ● Exclusive distribution rights in the product territory ● Regulatory submission and approval services ● Development services ● Sample supply ● Incremental discounts and product supply prepayments considered material rights to the customer The Company has optional additional items in contracts, which are considered marketing offers and are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s or the Company’s discretion are generally considered options. The Company assesses if these options provide a material right to the licensee and if so, such material rights are accounted for as separate performance obligations. Transaction Price The Company has both fixed and variable consideration. Under the Company’s license arrangements, non-refundable upfront fees are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Product supply selling prices are identified as variable consideration subject to the constraint on variable consideration for estimated discounts, rebates, chargebacks and product returns. Funding of research and development activities are considered variable payments until such costs are reimbursed, at which point they are considered fixed. The Company allocates the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation. For product supply under the Company’s distribution arrangements, contract liabilities are recorded for invoiced amounts that are subject to significant reversal, including product revenue allowances for cash consideration paid to customers for services, discounts, rebate programs, chargebacks, and product returns. Because the Company doesn’t have sufficient historical data to compute its own return rate, the return rate used to estimate the constraint on variable consideration for product returns is based on an average of peer and competitor company historical return rates. The Company updates the return rate assumption quarterly and applies it to the inventory balance that is held at the distributor and has not 30 one one At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not not not For arrangements that include sales-based royalties and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Allocation of Consideration As part of the accounting for arrangements that contain multiple performance obligations, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. When a contract contains more than one Timing of Recognition Significant management judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Revenue is recognized for products at a point in time and for licenses of functional intellectual property at the point in time the customer can use and benefit from the license. For performance obligations that are services, revenue is recognized over time proportionate to the costs that the Company has incurred to perform the services using the cost-to-cost input method. The Company’s intellectual property in the form of distribution rights are determined to be distinct from the other performance obligations identified in the arrangements and considered “right to use” licenses which the customer can benefit from at a point in time. The Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license. Cost of Goods Sold Cost of goods sold includes third Research and Development Costs The Company charges research and development costs to expense as incurred. These costs include salaries and benefits for research and development personnel, costs associated with clinical trials managed by contract research organizations, and other costs associated with research, development and regulatory activities. Research and development costs may no may Patent Costs Patent costs, including legal expenses, are expensed in the period in which they are incurred. Patent expenses are included in general and administrative expenses in the consolidated statements of operations and comprehensive loss. Stock-Based Compensation The Company accounts for stock-based compensation under the provisions of ASU No. 2014 12, Compensation-Stock Compensation (Topic 718 12 Income Taxes The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recognized if it is more likely than not not Common Stock Warrant Liability For warrants that are newly issued or modified and there is a deemed possibility that the Company may Net (Loss) per Share The Company computes net (loss) per share by presenting both basic and diluted (loss) per share (“EPS”). Basic EPS is computed by dividing net (loss) available to common shareholders by the weighted average number of common shares outstanding during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period, including stock options and warrants, using the treasury stock method, using the if-converted method. In computing diluted EPS, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options or warrants. Potentially dilutive common share equivalents are excluded from the diluted EPS computation in net loss periods since their effect would be anti-dilutive. During the three six June 30, 2018, $0.09 $0.22, $0.12 $0.26, three six June 30, 2017, no The following table sets forth the calculation of basic EPS and diluted EPS: Three Months Ended Six Months Ended June 30, June 30, 2018 2017 2018 2017 Numerator Net loss $ (1,589 ) $ (1,738 ) $ (3,739 ) $ (5,749 ) Less gain on changes in fair value of warrant liability (490 ) - (704 ) - Net loss, diluted $ (2,079 ) $ (1,738 ) $ (4,443 ) $ (5,749 ) Denominator Weighted average shares outstanding, basic 17,089 15,308 16,750 15,296 Net loss per share, basic $ (0.09 ) $ (0.11 ) $ (0.22 ) $ (0.38 ) Weighted average shares outstanding, basic 17,089 15,308 16,750 15,296 Effect of dilutive warrants 203 - 235 - Weighted average shares outstanding, diluted 17,292 15,308 16,985 15,296 Net loss per share, diluted $ (0.12 ) $ (0.11 ) $ (0.26 ) $ (0.38 ) The following outstanding stock options and stock warrants were excluded from the diluted net loss per share computation, as their effect would have been anti-dilutive: As of June 30, (in thousands) 2018 2017 Period end stock options to purchase common stock 3,189 2,828 Period end common stock warrants - 544 3,189 3,372 Recent Accounting Pronouncements In 2014, No. 2014 09, Revenue from Contracts with Customers (Topic 606 2015 2016, 606, 606, 606, December 15, 2017, one On January 1, 2018, 606 not January 1, 2018. not one January 1, 2018 606, not 605. 8 In November 2016, 2016 18, Statement of Cash Flows (Topic 230 one no one January 1, 2018 not In February 2016, 2016 02, Leases (Topic 842 ) Leases (Topic 840 ) 2016 02 first 2019. July 2017, 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 and 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. 480 not December 15, 2018, 2017 11 In June 2018, 2018 07, Improvements to Nonemployee Share-Based Payment Accounting (Topic 718 718 718 December 15, 2018, no 606. 2018 07 |