Summary of Significant Accounting Policies | (2) Summary of Significant Accounting Policies Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires that management makes estimates and assumptions that are included in the consolidated financial statements and accompanying notes. The actual results may differ from those estimates. Segment Information In accordance with Accounting Standard Codification (“ASC”) 280-10-50, Segment Reporting Foreign Currency The functional currency of subsidiaries outside the United States of America is the U.S. Dollar. Transactions in foreign currencies during the year are re-measured at rates of exchange on the dates of the transactions. Gains and losses related to re-measurement of items arising through operating activities are accounted for in the statement of operations and comprehensive loss and included in general and administrative expense. Aggregate foreign exchange loss was $12,000 and $59,000 for the years ended December 31, 2018 and 2017, respectively. Reclassifications Certain prior year balances within the consolidated financial statements have been classified to conform to current year presentation. Concentrations of Credit Risk Cash is generally deposited in demand deposit accounts that, from time to time, may exceed insurable limits. The Company has not experienced any losses from its deposits of cash. Fair Value of Financial Instruments The carrying values of certain of the Company’s financial instruments, such as prepaid expenses, accounts payable and accrued expenses, approximate fair value due to their short maturities. The Company’s debt obligation approximates fair value as a result of imputed interest which approximates prevailing market rates. Amounts payable to related parties, including the payable due to the Parent, which has no fixed maturity or expiration date, do not have readily determinable fair values. Cash The Company considers highly liquid investments with original maturities less than 90 days to be cash equivalents. As of December 31, 2018 and 2017, the Company had no such short-term investment instruments and maintained its cash in bank demand deposit accounts. Inventory The Company accounts for inventory at the lower of cost and net realizable value. Inventory is stated at weighted average cost, which is determined by applying the current average cost to the ending inventory. Inventory consists of lenses and lens inserters and other accessories used by physicians in the surgical process associated with the lenses. The Company maintains serialized records of all lenses, including the five-year expiration date of each lens, after which the lens cannot be sold. The Company considers the expiration dates of lenses, in addition to comparing the carrying amount of inventory to expected demand, and will write-down inventory for amounts determined to be excess or obsolete. Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation of property and equipment is computed using the straight-line method over their estimated useful lives of three to ten years. Leasehold improvements are amortized over the lesser of the useful life of the asset or the remaining term of the lease. Repairs and maintenance of property and equipment are expensed as incurred. Upon retirement or sale, the original cost and accumulated depreciation are removed and any gain or loss is recognized in the consolidated statements of operations and comprehensive loss. Impairment of Long-Lived Assets The Company reviews the recoverability of long-lived and finite-lived intangible assets when circumstances indicate that the carrying amount of assets might not be recoverable. This evaluation is based on various analyses, including undiscounted cash flow projections. In the event undiscounted cash flow projections indicate impairment, the Company would record an impairment based on the fair value of the assets at the date of the impairment. Intangible Assets On August 2, 2016, Presbia Ireland, Limited, a wholly-owned subsidiary of the Company, entered into an asset purchase agreement (the “Agreement”) with Neoptics AG (“Neoptics”) pursuant to which the Company acquired certain assets from Neoptics for an aggregate purchase price of 1.5 million Swiss Francs (approximately $1.5 million based on the exchange rate between the Swiss Franc and the U.S. Dollar on August 2, 2016) payable in three equal installments on each of August 2, 2016, December 31, 2017 and December 31, 2018. The assets acquired include patents, pending patents, and other immaterial assets. Effective August 2, 2016, the Company became responsible for all expenses associated with such assets. Pursuant to the terms of the Agreement, the acquisition closed on August 2, 2016. Substantially all of the fair value of the gross assets acquired is concentrated in the acquired intellectual property rights or patents and not in the trademarks, documents or electronic data obtained from the Seller. The Company determined the intellectual property right or patents were akin to inputs within the scope of ASC 805 “Business Combinations” and that no substantive processes were acquired in the assets acquisition. Therefore, the Company applied the asset acquisition accounting guidance in ASC 805-50-30 “ Initial Measurement of Acquisition of Assets Rather than a Business The Company made a final payment of $0.5 million in cash in exchange for these patents and patent applications in the year ended December 31, 2018. The useful life of the patents was determined to be 12 years and 4 months and will be amortized through November 25, 2028. The Company recorded amortization expense of approximately $136,000 with net carrying amount of approximately $1,344,000 as of December 31, 2018. For fiscal years 2019 to 2022, approximately $135,000 will be recorded annually as amortization expense for the Neoptics assets. The Company reviews its long-lived intangible assets for impairment at least annually or more frequently if impairment indicators arise. In evaluating the potential for impairment of the Neoptics assets, we make assumption regarding future operating performance, business trends and future useful life of these assets. As a result of these evaluations, the Company did not recognize impairment charges for the years ended December 31, 2018 and 2017, as it believes that the carrying value of these assets do not exceed their fair value. Costs incurred to develop software for the Company’s website are capitalized and amortized over the estimated useful life of the software and are included in intangible assets. Costs related to design or maintenance of website development is expensed as incurred. For the years ended December 31, 2018 and 2017, there were no capitalized costs associated with website development. Amortization expense of $1,000 and $15,000 was recorded the years ended December 31, 2018 and 2017, respectively. Net Loss per Common Share Basic net loss per ordinary share is calculated by dividing net loss, as adjusted for dividends on the USA New Preferred Shares in the period, by the weighted average number of ordinary shares outstanding during the reporting period, less unvested restricted stock awards. Diluted net loss allocated to ordinary shareholders per share is calculated based on the weighted average number of ordinary shares and dilutive potential ordinary shares outstanding during the period. Dilutive potential ordinary shares consist of the shares issuable upon the exercise of stock options and warrants, and upon the vesting of restricted shares under the treasury stock method. In net loss periods, basic and diluted net loss per share are identical since the effect of potential ordinary shares is anti-dilutive and therefore excluded. Basic and diluted net loss per share were calculated as follows (in thousands, except share and per share data): December 31, 2018 2017 Net Loss $ (8,415 ) $ (16,998 ) USA new preferred shares dividends $ 45 $ - Net loss attributable to common shareholders $ (8,460 ) $ (16,998 ) Weighted average shares outstanding – basic and diluted 17,077,817 16,298,505 Basic and diluted net loss per share $ (0.50 ) $ (1.04 ) The following potentially dilutive securities were excluded from the computation of diluted weighted average shares outstanding because their inclusion would have been antidilutive: December 31, 2018 2017 Options to purchase common stock 1,129,324 1,037,964 Restricted shares 49,189 — Warrant to purchase common stock (1)(2) 16,684,792 — Series 2 Redeemable Preferred Shares and USA New Preferred Shares outstanding 5,339 — Total potentially dilutive securities excluded from denominator of the diluted earnings per share Computation 17,868,719 1,037,964 (1) Includes 1,953,125 warrants to purchase ordinary shares of Presbia PLC at a price of US$2.56 per ordinary share, granted April 12, 2018 (see Note 8). (2) Includes 14,731,667 warrants to purchase ordinary shares of Presbia PLC at a price of US$0.60 per ordinary share, granted December 10, 2018 (see Note 8). Revenue Recognition Prior to 2018, we recognized revenue when there was persuasive evidence that an arrangement existed with our customers, selling prices were fixed or determinable, title or risk of loss had passed, and collection was reasonably assured. Revenue was recognized upon shipment and payments were either received in advance, or net 30 days for lenses or net 14 days for accessories. Distributor arrangements included certain perfunctory acceptance provisions and a one-year warranty, from the date of shipment, that products are free from defects in material workmanship. Under such provisions customers may reject shipments via written notifications ranging from 14-45 days or exchange defective product under warranty for the same non-defective product. We have not had any significant rejected shipments or warranty claims. We did not grant price concessions to our distributors. Effective January 1, 2018, the Company adopted the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), using the modified retrospective transition method. Under this method, the Company recognizes revenue based on an analysis of the goods and services provided to our customers in the ordinary course. We analyze all commercial agreements to identify (i) contracts and arrangements with customers that meet the criteria for revenue recognition under the new standard (ii) identify all performance obligations under the contractual arrangement, such as the delivery of our Microlens to our customers and any other deliverable(s) as defined in a commercial arrangement (iii) the determination of the transaction price, (iv) the allocation of such pricing over the defined contractual obligations in the contract with the customer and (v) the recognition of revenue once the customer has assumed control over the contractual obligations. Control refers to the ability on the part of the customer to obtain substantially all the benefits of possession of the delivered product or service. The Company is required by ASC 606 to disaggregate revenue into categories that depict the nature, amount, timing, and uncertainty of revenue and cash flows as affected by economic factors. Currently, the Company believes these economic factors are primarily attributable to different geographic regions, under one operating segment. Refer to Note 11, Operating Segments and Geographic Information, to the Company’s consolidated financial statements for additional details of revenues by geographic region. In the future, the Company will reassess whether geographic region revenue disaggregation continues to depict the nature, amount, timing, and uncertainty of revenue and cash flows as affected by economic factors. Future assessment may be affected by, but not limited to: (i) an increase in revenue; (ii) concentration of customers; and (iii) other economic factors, in accordance with ASC 606. In the years ended December 31, 2018 and 2017 there were five and four customers, respectively, that represented 100% of total sales recognized for each year. As of December 31, 2018, the Company was not authorized to manufacture or sell any of its products or services within the United States and, as a result, all of the Company’s revenues are derived from foreign customers. The Company recognized revenues of $21,000 and $14,000 from foreign ophthalmic clinics during the years ended December 31, 2018 and 2017, respectively. Clinical Trials In February 2015, the Company received approval from the FDA to commence enrollment of the second stage of its U.S. staged pivotal clinical trial of its Microlens involving the implantation of presbyopic patients. Enrollment for the second stage was completed in September 2015. The first staged-enrollment commenced during the first quarter of 2014, and during these trials, the Company incurred costs for patient recruiting, acquisition of clinical test equipment to be used in the trials, outside experts to read and interpret the results of the studies, third party costs to monitor the investigational sites and perform data collection activities and surgeon and patient fees in connection with the surgical procedures and follow-up visits. The Company’s policy with respect to the recognition of these costs is to record such costs as research and development expense in the consolidated statements of operations and comprehensive loss in the period in which the services are provided. The Company will evaluate the purchases of clinical test equipment, on a case by case basis, to determine if there exists an alternative use for the equipment following the clinical trials. In the event that the Company determines that there is no alternative use for the test equipment, that cost will be expensed as part of research and development expense. Stock-Based Compensation The compensation cost of stock-based awards granted to employees is measured at grant date, based on the estimated fair value of the award. The Company estimates the fair value of stock options using a Black-Scholes option pricing model. Restricted stock units awarded to employees in 2018 include a performance provision as well as a provision that the recipient must be employed as conditions of vesting. The fair value of restricted stock units issued prior to 2018 was determined using a Monte Carlo Simulation, or “MCS”, methodology, which considers the separate probabilities that of the price thresholds or market conditions will be achieved under the Restricted Stock Units Plan guidelines. Compensation expense for options granted to non-employees is determined as the fair value of consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. Stock-based compensation costs are expensed on a straight-line basis over the service period. The fair value of awards granted to non-employees is remeasured each period until the related service is complete or there exists a significant disincentive not to perform the required services. Stock-based compensation costs are reflected in the accompanying statements of operations and comprehensive loss based upon the underlying employees’ roles within the Company. Deferred Offering Costs Generally, costs incurred such as legal, accounting and other professional fees including printing costs in the course of preparing for a capital raise are deferred on the balance sheet as deferred offering costs, which are eventually reclassified when the capital raise is concluded as a reduction of the proceeds of the capital raise as part of additional paid in capital. On December 5, 2016, the Company filed with the SEC a Form S-1 Registration Statement under the Securities Act of 1933 for the purpose of distributing to holders of the Company’s ordinary shares, non-transferable and non-tradeable subscription rights to purchase ordinary shares (“rights offering”). During the years ended December 31, 2018 and 2017, the Company incurred approximately $0 million and $0.3 million related to its rights offering, respectively, which was completed on March 8, 2017. Upon completion of the rights offering, the Company netted approximately $0.3 million in offering costs against the gross proceeds in shareholders’ equity as of December 31, 2017. Income Taxes As described in Note 1, the Parent completed a restructuring on October 21, 2013. As a result, some of the entities are no longer pass-through entities or were restructured as taxable entities. Provisions for federal, foreign, state, and local income taxes are calculated on pre-tax income based on current tax law and include the cumulative effect of any changes in tax rates from those used previously in determining deferred tax assets and liabilities. Deferred income tax assets and liabilities are recorded for the expected future tax consequences of temporary differences between the financial statement carrying amounts and the income tax basis of assets and liabilities. A valuation allowance is recorded to reduce net deferred income tax assets to amounts that are more likely than not to be realized. Advertising Costs The Company incurs direct response advertising expense outside the United States in order to create awareness of the Company’s Microlens solution to presbyopia. The Company’s policy with respect to direct response advertising is to defer costs related to media and setup costs and amortize those costs to the consolidated statements of operations and comprehensive loss in the period in which the related revenue is recognized. Due to the early stages of market development and the uncertainty around the impact of advertising campaigns to-date, the Company expensed approximately $104,000, and $395,000 as part of sales and marketing expense in the consolidated statements of operations and comprehensive loss for the years ended December 31, 2018 and 2017, respectively. Risks and Uncertainties The Company’s product requires the approval of the FDA and regulatory agencies in the countries where the Company operates or expects to establish operations in the future. There is no assurance that the Company’s Future Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update (“ASU”) Leases (Topic 842) In February 2018, the FASB issued ASU Income Statement—Reporting Comprehensive Income (Topic 220)—Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. In June 2018, the FASB issued ASU No. 2018-07, Compensation — Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting Recent Accounting Standards In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). The new standard is based on the principle that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Topic 606 became effective for the Company in the first quarter of 2018 and allowed for full retrospective or a modified retrospective adoption approach. The Company adopted this new standard using the modified retrospective transition method In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows, which clarifies the classification of certain cash receipts and payments. The specific cash flow issues addressed by ASU 2016-15, with the objective of reducing the existing diversity in practice, are as follows: (1) Debt prepayment or debt extinguishment costs; (2) Settlement of zero-coupon debt instruments or other debt instruments with insignificant coupon interest rates; (3) Contingent consideration payments made after a business combination; (4) Proceeds from the settlement of insurance claims; (5) Proceeds from the settlement of corporate-owned life insurance policies; (6) Distributions received from equity method investees; (7) Beneficial interest in securitization transactions; and (8) Separately identifiable cash flows and application of the predominance in principle. ASU 2016-15 became effective for fiscal years beginning after December 15, 2017. The Company adopted this new standard in January 2018 and it did not have a material impact on its consolidated financial statements. In October 2016, the FASB issued ASU. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other than Inventory. This update requires entities to recognize the income tax consequences of an intra-entity transfer of an asset other than inventory when the transfer occurs. This update is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted as of the beginning of a fiscal year. The new standard must be adopted using a modified retrospective transition method, which is a cumulative-effective adjustment to retained earnings as of the beginning of the first effective reporting period. The Company adopted this new standard in January 2018 and it did not have a material impact on its consolidated financial statements. In May 2017, the FASB issued ASU 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting, which provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. This update is effective for annual reporting periods beginning after December 15, 2017. Early adoption is permitted. The Company adopted this ASU in January 2018 and it did not have a material impact on its consolidated financial statements. |