Document and Entity Information
Document and Entity Information | 12 Months Ended | |||
Dec. 31, 2017 | Mar. 15, 2018shares | Jun. 30, 2017USD ($) | Jun. 30, 2017AUD ($) | |
Document And Entity Information [Abstract] | ||||
Document Type | 10-K | |||
Amendment Flag | false | |||
Document Period End Date | Dec. 31, 2017 | |||
Document Fiscal Year Focus | 2,017 | |||
Document Fiscal Period Focus | FY | |||
Trading Symbol | GIDYL | |||
Entity Registrant Name | GI DYNAMICS, INC. | |||
Entity Central Index Key | 1,245,791 | |||
Current Fiscal Year End Date | --12-31 | |||
Entity Well-known Seasoned Issuer | No | |||
Entity Current Reporting Status | Yes | |||
Entity Voluntary Filers | No | |||
Entity Filer Category | Smaller Reporting Company | |||
Entity Common Stock, Shares Outstanding | 12,333,101 | |||
Entity Public Float | $ 13,965,318 | $ 18,155,640 |
Consolidated Balance Sheets
Consolidated Balance Sheets € in Millions, $ in Millions | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Current assets: | ||
Cash and cash equivalents | $ 3,034,000 | $ 8,293,000 |
Restricted cash | 30,000 | 30,000 |
Accounts receivable, net | 40,000 | 30,000 |
Inventory, net | 0 | 213,000 |
Prepaid expenses and other current assets | 265,000 | 483,000 |
Total current assets | 3,369,000 | 9,049,000 |
Property and equipment, net | 97,000 | 149,000 |
Total assets | 3,466,000 | 9,198,000 |
Current liabilities: | ||
Accounts payable | 1,191,000 | 1,006,000 |
Accrued expenses | 1,021,000 | 1,160,000 |
Deferred revenue | 11,000 | 11,000 |
Short term debt to related party, net of debt issuance costs | 4,929,000 | |
Short term note payable | 214,000 | |
Total current liabilities | 7,152,000 | 2,391,000 |
Warrants liability | 29,000 | 17,000 |
Total liabilities | 7,181,000 | 2,408,000 |
Commitments (Note 12) | ||
Stockholders’ equity (deficit): | ||
Preferred stock, $0.01 par value – 500,000 shares authorized; no shares issued and outstanding at December 31, 2017 and 2016 | ||
Common stock | 112,000 | 109,000 |
Additional paid-in capital | 255,294,000 | 254,884,000 |
Accumulated deficit | (259,121,000) | (248,203,000) |
Total stockholders’ equity (deficit) | (3,715,000) | 6,790,000 |
Total liabilities and stockholders’ equity (deficit) | $ 3,466,000 | $ 9,198,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 500,000 | 500,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 50,000,000 | 13,000,000 |
Common stock, shares issued | 11,157,489 | 10,907,857 |
Common stock, shares outstanding | 11,157,489 | 10,907,857 |
Class B common stock | ||
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 0 | 1,000,000 |
Common stock, shares issued | 0 | 0 |
Common stock, shares outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Income Statement [Abstract] | ||
Revenue | $ 53 | $ 545 |
Cost of revenue | 265 | 1,291 |
Gross loss | (212) | (746) |
Operating expenses: | ||
Research and development | 3,597 | 3,928 |
Sales and marketing | 1,821 | 2,194 |
General and administrative | 5,074 | 6,250 |
Total operating expenses | 10,492 | 12,372 |
Loss from operations | (10,704) | (13,118) |
Other income (expense): | ||
Interest income | 33 | 42 |
Interest expense | (183) | |
Foreign exchange loss | (10) | 10 |
Re-measurement of warrant liability | (12) | (17) |
Other income (expense), net | (172) | 35 |
Loss before income tax expense | (10,876) | (13,083) |
Income tax expense | 14 | 33 |
Net loss | $ (10,890) | $ (13,116) |
Basic and diluted net loss per common share | $ (0.98) | $ (1.37) |
Weighted-average number of common shares used in basic and diluted net loss per common share | 11,157,489 | 9,555,246 |
Comprehensive loss | $ (10,890) | $ (13,116) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning Balance at Dec. 31, 2015 | $ 18,258 | $ 95 | $ 253,250 | $ (235,087) |
Beginning Balance (in shares) at Dec. 31, 2015 | 9,505,389 | |||
Issuance of common stock upon exercise of stock options and vesting of restricted stock (in shares) | 5,000 | |||
Issuance of common stock upon vesting of shares subject to repurchase | 3 | 3 | ||
Issuance of common stock upon vesting of shares subject to repurchase (in share) | 168 | |||
Issuance of shares upon private placement, net of issuance costs | 978 | $ 14 | 964 | |
Issuance of shares upon private placement, net of issuance costs (in shares) | 1,397,300 | |||
Stock-based compensation expense | 667 | 667 | ||
Net loss | (13,116) | (13,116) | ||
Ending Balance at Dec. 31, 2016 | $ 6,790 | $ 109 | 254,884 | (248,203) |
Ending Balance (in shares) at Dec. 31, 2016 | 10,907,857 | |||
Issuance of common stock upon vesting of shares subject to repurchase (in share) | 0 | |||
Issuance of shares upon private placement, net of issuance costs | $ 198 | $ 3 | 195 | |
Issuance of shares upon private placement, net of issuance costs (in shares) | 249,632 | |||
Stock-based compensation expense related to accounting change with respect to forfeiture rate | 28 | (28) | ||
Stock-based compensation expense | 187 | 187 | ||
Net loss | (10,890) | (10,890) | ||
Ending Balance at Dec. 31, 2017 | $ (3,715) | $ 112 | $ 255,294 | $ (259,121) |
Ending Balance (in shares) at Dec. 31, 2017 | 11,157,489 |
Consolidated Statements of Sto6
Consolidated Statements of Stockholders' Equity (Deficit) (Parenthetical) $ in Millions | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Statement Of Stockholders Equity [Abstract] | |
Issuance of shares upon private placement and share purchase plan, issuance costs | $ 0.1 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows $ in Thousands, € in Millions, $ in Millions | 12 Months Ended | |
Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Operating activities: | ||
Net loss | $ (10,890) | $ (13,116) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 57 | 190 |
Stock-based compensation expense | 187 | 667 |
Amortization of debt issuance costs | 44 | |
Re-measurement of warrant liability | 12 | 17 |
Change in inventory reserve | (76) | (77) |
Impairment and abandonment of fixed assets | 145 | |
Loss on sale of property and equipment | 7 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (10) | 10 |
Prepaid expenses and other current assets | 218 | 243 |
Inventory | 289 | 889 |
Accounts payable | 185 | 571 |
Accrued expenses | (139) | (1,908) |
Net cash used in operating activities | (10,123) | (12,362) |
Investing activities | ||
Purchases of property and equipment | (5) | (94) |
Proceeds from sale of property and equipment | 3 | |
Change in restricted cash | (30) | |
Net cash used in investing activities | (5) | (121) |
Financing activities | ||
Proceeds from issuance of common stock | 198 | 978 |
Proceeds from short-term debt-related party | 5,000 | |
Proceeds from borrowings | 305 | |
Debt issuance costs | 115 | |
Payments on capital leases | (2) | |
Payments on borrowings | (214) | (95) |
Net cash provided by financing activities | 4,869 | 1,186 |
Net decrease in cash and cash equivalents | (5,259) | (11,297) |
Cash and cash equivalents at beginning of year | 8,293 | 19,590 |
Cash and cash equivalents at end of year | 3,034 | 8,293 |
Supplemental cash flow disclosures | ||
Income taxes paid | 31 | 73 |
Effect on retained earnings of adopting ASU No. 2016-09 in 2017 | $ 28 | |
Issuance of common stock upon vesting of shares subject to repurchase | $ 3 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Nature of Business | 1. Nature of Business GI Dynamics, Inc. (the “Company”) was incorporated on March 24, 2003, as a Delaware corporation, with operations based in Boston, Massachusetts. GI Dynamics is a clinical stage medical device company focused on the development and commercialization of EndoBarrier, a medical device indicated for treatment of patients with type 2 diabetes and obesity or obesity alone. Diabetes mellitus type 2 (also known as type 2 diabetes) is a long-term progressive metabolic disorder characterized by high blood sugar, insulin resistance, and reduced insulin production. People with type 2 diabetes represent 90% of the worldwide diabetes population, whereas 10% of this population is diagnosed with type 1 diabetes (a form of diabetes mellitus in which not enough insulin is produced). Being overweight is a condition where the patient’s body mass index (BMI) is greater than 25 (kg/m 2 When considering treatment for type 2 diabetes, it is optimal to address obesity concurrently with diabetes. EndoBarrier ® The current treatment paradigm for type 2 diabetes is pharmacological, whereby treating clinicians prescribe a treatment regimen of 1–4 concurrent medications that could include insulin for patients with higher levels of blood sugar. Insulin carries a significant risk of increased mortality and directly contributes to weight gain, which in turn leads to higher levels of insulin resistance and diabetes. In other words, the primary drug used to treat severe type 2 diabetes raises risk significantly and increases the downstream progression of the disease by increasing obesity. Fewer than 50% of patients treated pharmacologically for type 2 diabetes are adequately managed, meaning that medication does not halt the progressive nature of diabetes. The current pharmacological treatment algorithms for type 2 diabetes fall short of ideal, creating a large and unfilled treatment gap. Our vision is to make EndoBarrier Since incorporation, the Company has devoted substantially all of its efforts to product commercialization, research and development, business planning, recruiting management and technical staff, acquiring operating assets, and raising capital. The Company currently operates in one reportable business segment. In 2011, the Company began commercial sales of its product, the EndoBarrier, which was approved and commercially available in multiple countries outside the U.S. at the time. In the U.S., the Company received approval from the Food and Drug Administration (“FDA”), to commence its pivotal trial of EndoBarrier (the “ENDO Trial”), which the Company began in 2013. The multi- center, randomized, double-blinded study planned to enroll 500 patients with uncontrolled type 2 diabetes and obesity at 25 sites in the U.S. The primary endpoint was improvement in diabetes control as measured by HbA1c levels. In the second half of fiscal year 2015, the Company announced its decision to stop the ENDO Trial. On August 21, 2015, the Company announced that it was reducing headcount by approximately 46% as part of its efforts to restructure its business and expenses in response to stopping the ENDO Trial and to ensure sufficient cash remained available for it to establish new priorities, continue limited market development and research, and to evaluate strategic options. In the second and third quarters of fiscal 2016, the Company took additional actions that it thought necessary to allow the opportunity to evolve its strategic options. These actions resulted in non-recurring charges totaling approximately $1.1 million, including $0.4 million related to restructuring charges in our second quarter, $0.6 million related to employee departures in both our second and third quarters and $0.1 million related to abandonment of our former headquarters in Lexington, MA. In October 2016, the Company received final cancellation notification from the Therapeutic Goods Administration (“TGA”) for the listing of EndoBarrier on the Australian Register of Therapeutic Goods (“ARTG”). In May 2017, the Company received notification from its notified body, SGS United Kingdom Limited (“SGS”), that the CE Mark for EndoBarrier had been suspended pending closure of non-conformances related to its quality management system required under International Organization for Standardization (“ISO”) regulations. On November 10, 2017, the Company received notification from SGS that SGS was withdrawing the Certificate of Conformance for EndoBarrier, ending the CE Marking of EndoBarrier in Europe and select Middle East countries. In December 2017, the Company received notification from the Medicines and Healthcare Products Regulatory Agency (“MHRA”) that all EndoBarrier delivery systems (liners) in inventory need to be returned to the Company. From its inception in 2003 to its initial public offering (“IPO”) in 2011, the Company was financed by a series of preferred stock financings In September 2011, the Company completed its initial public offering (“IPO”) of common stock in the form of CHESS Depositary Interests (“CDIs”) in Australia. As a result of the IPO and simultaneous private placement in the U.S., the Company raised a total of approximately $72.5 million in proceeds, net of expenses and repayment of $6.0 million of the Company’s Convertible Term Promissory Notes. Additionally, in July and August 2013, the Company issued CDIs on the Australian Securities Exchange (“ASX”) through a private placement and Share Purchase Plan (“SPP”), which raised a total of approximately $52.5 million, net of expenses. In May 2014, the Company raised an additional approximately $30.8 million, net of expenses, when it sold CDIs on the ASX through a private placement. On December 20, 2016, the Company completed a private placement issue of 69,865,000 CDIs (1,397,300 shares) at an issue price of $0.22 per CDI raising approximately $1.0 million, net of issuance costs. In January 2017, the Company completed the issue of 12,481,600 CDI’s (249,632 shares) to eligible investors under a Security Purchase Plan for approximately $0.83 per share resulting in net proceeds after issuance costs of approximately $0.2 million. In June 2017, the Company completed a Convertible Term Promissory Note (the “Note”) financing with its largest shareholder Crystal Amber for a gross amount of $5.0 million that accrues interest at 5% per annum compounded annually. Crystal Amber is deemed a Related Party of the Company due to the size of its ownership position. The Note is due by December 31, 2018 and contains provisions for conversion during the term of the Note (See Note 11 of the Condensed Consolidated Financial Statements for a more complete description of the terms and conditions). Going Concern Evaluation As of December 31, 2017, the Company’s primary source of liquidity is its cash and cash equivalents balances. The Company continues to evaluate which markets are appropriate to continue pursuing reimbursement, market awareness and general market development and selling efforts, and continue to restructure its business and costs, establish new priorities, and evaluate strategic options. As a result, if the Company remains in business, it expects to incur significant operating losses for the next several years. The Company has incurred operating losses since inception and at December 31, 2017, had an accumulated deficit of approximately $259 million and a working capital deficit of $3.78 million. GI Dynamics expects to incur significant operating losses for the next several years. At December 31, 2017, the Company had approximately $3.03 million in cash and cash equivalents. The Company does not expect its current cash balances will be sufficient to enable it to conduct an additional clinical trial for the purpose of seeking regulatory approval from the FDA. The Company will need to raise additional funds through any combination of collaborative arrangements, strategic alliances, and additional equity and debt financings or from other sources. The Company does not expect its current cash balances will be sufficient to continue to fund its operations after April 2018. In addition, as previously disclosed in May 2017, the Company received notification from its notified body SGS that the CE Mark for EndoBarrier had been suspended pending closure of non-conformances related to its quality management system required under ISO 13485:2003 and 93/42/EEC. On November 10, 2017, the Company received notification from SGS that SGS was withdrawing the CE Certificate of Conformity for EndoBarrier effective November 12, 2017. Withdrawal of the CE Certificate of Conformity means that the Company cannot affix the CE Mark and sell EndoBarrier in European Union countries until another Certificate of Conformity is issued by another notified body. The Company will need to raise additional capital in the second quarter in order to continue to pursue its current business objectives as planned and to continue to fund its operations. The Company is looking to raise additional funds through any combination of additional equity and debt financings or from other sources. However, the Company has no guaranteed source of capital that will sustain operations through the second quarter, and there can be no assurance that any such potential financing opportunities will be available on acceptable terms, if at all. If the Company is unable to raise capital when needed, it could be forced to cease operations, including discontinuing research and development activities involving obtaining regulatory approval for the commercialization of EndoBarrier. As such, if access to capital is not achieved in the near term, it will materially harm the Company’s business, financial condition and results of operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and liabilities and commitments in the normal course of business. The consolidated financial statements for the year ended December 31, 2017 do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Basis of Presentation | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Basis of Presentation | 2. Summary of Significant Accounting Policies and Basis of Presentation Principles of Consolidation The accompanying consolidated financial statements include the accounts of GI Dynamics, Inc. and its wholly owned subsidiaries. All intercompany transactions and balances are eliminated in consolidation. The functional currency of GID Europe Holding B.V., GID Europe B.V., GID Germany GmbH and GI Dynamics Australia Pty Ltd is the U.S. dollar. Consolidated balance sheet accounts of the Company’s subsidiaries are remeasured into U.S. dollars using the exchange rate in effect at the consolidated balance sheet date while expenses are remeasured using the average exchange rate in effect during the period. Gains and losses arising from remeasurement of the wholly owned subsidiaries’ financial statements are included in the determination of net loss. Use of Estimates The preparation of consolidated financial statements in accordance with generally accepted accounting principles in the U.S. requires the Company’s management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent assets and liabilities. On an ongoing basis, the Company’s management evaluates its estimates, including those related to revenue recognition, allowance for doubtful accounts, inventory valuation including reserves for excess and obsolete inventory, impairment of long-lived assets, income taxes including the valuation allowance for deferred tax assets, research and development, contingencies, valuation of warrant liabilities, estimates used to assess its ability to continue as a going concern and stock-based compensation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known. Cash and Cash Equivalents The Company considers all highly liquid investment instruments with an original maturity when purchased of three months or less to be cash equivalents. Investments qualifying as cash equivalents primarily consist of money market funds and have a carrying amount that approximates fair value. The amount of cash equivalents included in cash and cash equivalents was approximately $2.6 million and $6.3 million at December 31, 2017 and 2016, respectively. At December 31, 2017 and 2016, the Company had approximately $0 and $0.1 million, respectively, of cash and cash equivalents denominated in Australian dollars that is subject to foreign currency gain and loss. At December 31, 2017 and 2016, the Company had approximately $0.3 million and $0.2 million of cash and cash equivalents denominated in euros that is subject to foreign currency gain and loss. Inventory The Company states inventory at the lower of first-in, first-out cost or net realizable value. The Company records a provision for excess, expired, and obsolete inventory based primarily on estimates of forecasted revenues. A significant change in the timing or level of demand for products as compared to forecasted amounts may result in recording additional provisions for excess, expired, and obsolete inventory in the future. When capitalizing inventory, the Company considers factors such as status of regulatory approval, alternative use of inventory, and anticipated commercial use of the product. At December 31, 2017 and 2016, the Company had an approximate net inventory balance of $0 and $213 thousand, respectively. Property and Equipment Property and equipment, including leasehold improvements, are recorded at cost and are depreciated when placed in service using the straight-line method based on their estimated useful lives as follows: Asset Description Estimated Useful Life (In Years) Laboratory and manufacturing equipment 5 Computer equipment and software 3 Office furniture and equipment 5 Included in property and equipment are certain costs of software obtained for internal use. Costs incurred during the preliminary project stage are expensed as incurred, while costs incurred during the application development stage are capitalized and amortized over the estimated useful life of the software. The Company also capitalizes costs related to specific upgrades and enhancements when it is probable the expenditures will result in additional functionality. Maintenance and training costs related to software obtained for internal use are expensed as incurred. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the remaining lease term. Costs for capital assets not yet placed into service have been capitalized as construction in progress and will be depreciated in accordance with the above guidelines once placed into service. Maintenance and repair costs are expensed as incurred. Revenue Recognition The Company has generated all of its revenue from sales of its EndoBarrier to health care providers and third- party distributors who resell the product to health care providers. The Company considers revenue to be realized or realizable and earned when all of the following criteria are met: persuasive evidence of a sales arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable, and collectability is reasonably assured. Revenue is recognized upon passage of title and risk of loss to customers, unless a consignment arrangement exists and provided an estimate can be made for sales returns. With respect to these criteria: • The evidence of an arrangement generally consists of a health care provider or distributor purchase order with the necessary approvals and acceptance by the Company. • Transfer of title and risk and rewards of ownership are passed to the health care provider or third-party distributor upon delivery of the products. • The selling prices for all sales are fixed and agreed with the health care provider or third-party distributor. Provisions for discounts and rebates to customers are established as a reduction to revenue in the same period the related sales are recorded. When doubt exists about collectability from specific customers, the Company defers revenue from sales of products to those customers until payment is received. In certain circumstances the Company allows customers to return defective or nonconforming products for credit or replacement products. Defective or nonconforming products typically include those products that resulted in an unsuccessful implant procedure. The Company considers these transactions to be product returns and bases its estimate for sales returns upon historical trends and records the amount as a reduction to revenue upon the initial sale of the product. Prospectively, the Company will evaluate whether it has sufficient data to determine return estimates as it enters new markets. The Company has certain relationships in which title to delivered product passes to a buyer, but the substance of the transaction is that of a consignment arrangement. In these cases, the Company recognizes revenue when the product is implanted or otherwise consumed and payment is received from the customer, which indicates that the Company has no further obligations to the customer and that the sale is complete. For these transactions, revenue recognition is deferred until the sale is complete. At December 31, 2017 and 2016, the Company had deferred revenue of approximately $11 thousand. At December 31, 2017, following the notification by MHRA, the Company calculated an estimate for returns, reversed its revenue and recorded an accrued expense estimate of $202 thousand of product return related costs. Shipping and Handling Costs Shipping and handling costs are included in costs of revenue. Research and Development Costs Research and development costs are expensed when incurred. Research and development costs include costs of all basic research activities as well as other research, engineering, and technical effort required to develop a new product or service or make significant improvement to an existing product or manufacturing process. Research and development costs also include pre-approval regulatory and clinical trial expenses. Patent Costs The Company expenses as incurred all costs, including legal expenses, associated with obtaining patents until the patented technology becomes feasible. All costs incurred after the patented technology is feasible will be capitalized as an intangible asset. As of December 31, 2017, no such costs had been capitalized since inception of the Company. The Company has expensed approximately $0.4 million of patent costs within general and administrative expenses in the consolidated statements of operations and comprehensive loss for each year ended December 31, 2017 and 2016. Stock-Based Compensation The Company accounts for stock-based compensation in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 718, Stock Compensation For awards that vest based on service conditions, the Company uses the straight-line method to allocate compensation expense to reporting periods. The grant date fair value of options granted is calculated using the Black-Scholes option pricing model, which requires the use of subjective assumptions including volatility, expected term and the fair value of the underlying common stock, among others. The Company periodically issues performance-based awards. For these awards, vesting will occur upon the achievement of certain milestones. When achievement of the milestone is deemed probable, the Company expenses the compensation of the respective awards over the implicit service period. Stock awards to non-employees are accounted for in accordance with ASC 505-50, Equity-Based Payments to Non-Employees Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting The stock-based compensation plans provide that grantees may have the right to exercise an option prior to vesting. Shares purchased upon the exercise of unvested options will be subject to the same vesting schedule as the underlying options and are subject to repurchase at the original exercise price by the Company should the grantee discontinue providing services to the Company for any reason, prior to becoming fully vested in such shares. Impairment of Long-Lived Assets The Company regularly reviews the carrying amount of its long-lived assets to determine whether indicators of impairment may exist that warrant adjustments to carrying values or estimated useful lives. If indications of impairment exist, projected future undiscounted cash flows associated with the asset are compared to the carrying amount to determine whether the asset’s value is recoverable. If the carrying value of the asset exceeds such projected undiscounted cash flows, the asset will be written down to its estimated fair value. Comprehensive Loss Comprehensive loss is the change in equity of a company during a period from transactions and other events and circumstances, excluding transactions resulting from investments by owners and distributions to owners. The Company currently does not have any changes in equity from non-owner sources. As a result, comprehensive loss was equal to the net loss for all periods reported. Loss Contingencies In accordance with ASC 450, Contingencies Income Taxes The Company provides for income taxes under the liability method. The Company records deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial reporting and the tax bases of assets and liabilities measured using the enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to reflect the uncertainty associated with their ultimate realization. The Company accounts for uncertain tax positions recognized in the consolidated financial statements by applying a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Guarantees The Company has identified the guarantees described below as disclosable, in accordance with ASC 460, Guarantees As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ insurance coverage that should limit its exposure and enable it to recover a portion of any future amounts paid. The Company is a party to a number of agreements entered into in the ordinary course of business that contain typical provisions that obligate the Company to indemnify the other parties to such agreements upon the occurrence of certain events. Such indemnification obligations are usually in effect from the date of execution of the applicable agreement for a period equal to the applicable statute of limitations. The aggregate maximum potential future liability of the Company under such indemnification provisions is uncertain. As of December 31, 2017, and 2016, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible. As a result, no related reserves have been established. Subsequent Events The Company evaluates events occurring after the date of its consolidated balance sheet for potential recognition or disclosure in its consolidated financial statements. There have been subsequent events that occurred through the date the Company issued its consolidated financial statements that require disclosure in or adjustment to its consolidated financial statements. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the effect of recently issued standards that are not yet effective will not have a material effect on its consolidated financial position or results of operations upon adoption. In May 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-09 (“ASU 2014-09”), Revenue from Contracts with Customers Revenue Recognition In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern . In July 2015, the FASB issued ASU No. 2015-11, Simplifying the Measurement of Inventory In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting In August 2016, the FASB issued ASU No. 2016-15, Classification of Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force) Statement of Cash Flows In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (a consensus of the FASB Emerging Issue Task Force) |
Net Loss per Common Share
Net Loss per Common Share | 12 Months Ended |
Dec. 31, 2017 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | 3. Net Loss per Common Share Basic net loss per common share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period. Potential common stock equivalents are determined using the treasury stock method. For diluted net loss per share purposes, the Company excludes stock options and other stock-based awards, including shares issued as a result of option exercises but which are subject to repurchase by the Company, whose effect would be anti-dilutive from the calculation. During each of the years ended December 31, 2017 and 2016, common stock equivalents were excluded from the calculation of diluted net loss per common share, as their effect was anti-dilutive due to the net loss incurred. Therefore, basic and diluted net loss per share was the same in all periods presented. The following potentially dilutive securities have been excluded from the computation of diluted weighted- average shares outstanding as of December 31, 2017 and 2016, as they would be anti-dilutive: Years Ended December 31, 2017 2016 Warrants to purchase common stock 28,532 28,532 Options to purchase common stock and other stock-based awards 1,384,880 1,152,072 Total 1,413,412 1,180,604 |
Common Stock Warrants
Common Stock Warrants | 12 Months Ended |
Dec. 31, 2017 | |
Derivative Instruments And Hedging Activities Disclosure [Abstract] | |
Common Stock Warrants | 4. Common Stock Warrants In connection with the Company’s IPO in September 2011, the Company issued warrants in an aggregate amount of 50,000 shares of common stock at an exercise price of A$55.00 per share to the lead manager of the IPO and certain other investors. The warrants expired on the fifth anniversary of their date of grant. On May 4, 2016, the Company entered into a consulting agreement pursuant to which the consulting firm will provide strategic advisory, finance, accounting, human resources and administrative functions, including chief financial officer services, to the Company. In connection with the consulting agreement, the Company granted the consulting firm a warrant (“Consultant Warrant,” together with the IPO Warrants, the “Warrants”) to purchase up to 28,532 shares of the Company’s common stock at an exercise price per share equal to $0.64. The Consultant Warrant vests on a monthly basis over two years and has a term of five years. The Company has reserved 28,532 shares of common stock related to the Consultant Warrant. As of December 31, 2017, no Consultant Warrants had been exercised. The Company accounts for the warrants under ASC 815, Derivatives and Hedging |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 5. Fair Value of Financial Instruments The tables below present information about the Company’s assets and liabilities that are measured at fair value on a recurring basis as of December 31, 2017 and 2016, and indicates the fair value hierarchy of the valuation techniques the Company used to determine such fair value. In general, fair values determined by Level 1 inputs utilize observable inputs such as quoted prices in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are either directly or indirectly observable, such as quoted prices, interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points in which there is little or no market data, requiring the Company to develop its own assumptions for the asset or liability. The following tables present the assets and liabilities the Company has measured at fair value on a recurring basis (in thousands): Fair Value Measurements at Reporting Date Using Quoted Prices Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Description December 31, 2017 (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 2,584 $ 2,584 $ — $ — Total assets $ 2,584 $ 2,584 $ — $ — Liabilities Warrant liability $ 29 $ — $ — $ 29 Total liabilities $ 29 $ — $ — $ 29 Fair Value Measurements at Reporting Date Using Quoted Prices in Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Description December 31, (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 6,344 $ 6,344 $ — $ — Total assets $ 6,344 $ 6,344 $ — $ — Liabilities Warrant liability $ 17 $ — $ — $ 17 Total liabilities $ 17 $ — $ — $ 17 The assumptions used in the Black-Scholes option pricing model to determine the fair value of the common stock warrants at December 31, 2017 and 2016 were as follows: December 31, 2017 2016 Exercise price (A$55.00 at the then current exchange rate) $ 0.64 $ 0.64 Fair value of common stock $ 0.60 $ 0.59 Expected volatility 142.6 % 90.5 % Expected term (in years) 3.34 4.34 Risk-free interest rate 2.02 % 1.78 % Expected dividend yield –% –% The following table rolls forward the fair value of the warrants, where fair value is determined by Level 3 inputs (in thousands): Balance at December 31, 2015 $ — Grant of Consulting warrants May 2016 $ 12 Increase in fair value of warrants upon re-measurement included in other expense 5 Balance at December 31, 2016 $ 17 Increase in fair value of warrants upon re-measurement included in other expense 12 Balance at December 31, 2017 $ 29 Cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities at December 31, 2017 and 2016 are carried at amounts that approximate fair value due to their short-term maturities and highly liquid nature of these instruments. |
Concentrations of Credit Risk,
Concentrations of Credit Risk, Accounts Receivable and Related Valuation Account | 12 Months Ended |
Dec. 31, 2017 | |
Receivables [Abstract] | |
Concentrations of Credit Risk, Accounts Receivable and Related Valuation Account | 6. Concentrations of Credit Risk, Accounts Receivable and Related Valuation Account Financial instruments that subject the Company to credit risk primarily consist of cash and cash equivalents, restricted cash and accounts receivable. The Company maintains its cash and cash equivalent balances with high quality financial institutions, and consequently, the Company believes that such funds are subject to minimal credit risk. The Company’s short-term investments potentially subject the Company to concentrations of credit risk. The Company has adopted an investment policy that limits the amounts the Company may invest in any one type of investment and requires all investments held by the Company to hold at least an A rating from a recognized credit rating agency, thereby reducing credit risk concentration. Accounts receivable primarily consist of amounts due from customers, including distributors and health care providers in different countries. In light of the current economic state of many foreign countries, the Company continues to monitor the creditworthiness of its customers. In May 2017, the Company entered into a sales arrangement with certain distributors totaling $517 thousand of EndoBarrier inventory. Due to certain extended right of return periods and payment terms, the Company determined that the revenue and related product costs associated with this transaction should be deferred for accounting purposes. As a result, the Company has recorded an adjustment to accounts receivable of $559 thousand for the unpaid portion of deferred revenue which includes an adjustment of approximately $40 thousand for revaluation of receivables denominated in foreign currency at December 31, 2017. The Company recognized revenue of $18 thousand and related costs of $27 thousand for this transaction. At December 31, 2017, four health care providers accounted for approximately 100% of the Company’s accounts receivable balance, of approximately equal sums. At December 31, 2016, one health care provider accounted for approximately 43% of the Company’s accounts receivable and another health care provider accounted for approximately 22% of the Company’s accounts receivable. The Company grants credit to customers in the normal course of business but generally does not require collateral or any other security to support its receivables. The Company makes judgments as to its ability to collect outstanding receivables and provides an allowance for receivables when collection becomes doubtful. Provisions are made based upon a specific review of all significant outstanding invoices and the overall quality and age of those invoices not individually reviewed. Amounts determined to be uncollectible are written off against this reserve. The Company recorded write-offs of uncollectible accounts receivable of approximately $22 thousand in the year ended December 31, 2017 and $48 thousand in the year ended December 31, 2016. As of December 31, 2017, the Company believes its allowance for doubtful accounts of approximately $42 thousand is adequate based on its review. The following table shows the components of the Company’s accounts receivable at December 31, 2017 and 2016 (in thousands): December 31, 2017 2016 Accounts receivable $ 85 $ 68 Less: allowance for doubtful accounts (42 ) (16 ) Less: allowance for sales returns (3 ) (22 ) Total $ 40 $ 30 The following is a roll forward of the Company’s allowance for doubtful accounts (in thousands): Year Ended December 31, 2017 2016 Beginning balance $ 16 $ 59 Net charges to expenses 48 5 Utilization of allowances (22 ) (48 ) Ending balance $ 42 $ 16 |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2017 | |
Inventory Disclosure [Abstract] | |
Inventory | 7. Inventory The Company states inventory at the lower of first-in, first-out cost or net realizable value. The Company records a provision for excess, expired, and obsolete inventory based primarily on estimates of forecasted revenues. A significant change in the timing or level of demand for products as compared to forecasted amounts may result in recording additional provisions for excess, expired, and obsolete inventory in the future. When capitalizing inventory, the Company considers factors such as status of regulatory approval, alternative use of inventory, and anticipated commercial use of the product. The determination of obsolete or excess inventory requires the Company to estimate the future demand for its products within appropriate time horizons. The estimated future demand is compared to inventory levels to determine the amount, if any, of obsolete and excess inventory. The demand forecast includes the Company’s estimates of market growth and various internal estimates, and is based on assumptions that are consistent with the plans and estimates the Company is using to manage its underlying business and short-term manufacturing plans. Forecasting demand for EndoBarrier in a market in which there are few, if any, comparable approved devices and for which reimbursement from third-party payers is limited has been difficult. As of December 31, 2017, we have fully reserved our inventory. In 2015, the Company performed an analysis of its inventory on hand and due to current evidence that the utility of certain amounts of its inventory as it was expected to be used will be less than its cost recorded an approximately $3.2 million charge for excess, expired and obsolete inventory. Factors contributing to the inventory write-down included: the effect that the ENDO Trial enrollment hold and subsequent termination had on commercial activity and the Company’s inventory levels, the expected timing of third-party payer reimbursement in its commercial markets, its conclusion that certain inventory will not be used for sales inside or outside the U.S. and the historical accuracy of its demand forecasts. As of December 31, 2017, and 2016, the Company has a reserve totaling approximately $5 million for each year. During 2017, the Company charged the remaining balance of its inventory in normal course of business to cost of sales. As of December 31, 2017, the Company has fully reserved for its inventory on hand and expects to utilize the reserved inventory to meet its future strategic goals I nventory, net of reserves, at December 31, 2017 and 2016 was as follows (in thousands): December 31, 2017 2016 Finished goods $ — $ 213 Work-in-process — — Raw materials — — Total $ — $ 213 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2017 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 8. Property and Equipment Property and equipment consisted of the following (in thousands): December 31, 2017 2016 Laboratory and manufacturing equipment $ 591 $ 591 Computer equipment and software 1,179 1,174 Office furniture and equipment 183 183 Leasehold improvements 21 21 1,974 1,969 Less accumulated depreciation and amortization (1,877 ) (1,820 ) Total $ 97 $ 149 As part of the Company’s restructuring in 2016 in connection with the abandonment of its Company headquarters in Lexington, Massachusetts, the Company recognized a charge for impaired fixed assets as follows (in thousands): December 31, 2016 Cost of revenue $ 24 Research and development 79 General and administrative 42 $ 145 At December 31, 2017 and 2016, the Company had no assets under capital lease. Depreciation and amortization expense of property and equipment totaled approximately $57 thousand and $0.2 million for the years ended December 31, 2017 and 2016. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2017 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | 9. Accrued Expenses Accrued expenses consisted of the following (in thousands): December 31, 2017 2016 Clinical trials $ — $ 16 Payroll and related liabilities 181 430 Professional fees 421 617 Credit refunds 279 — Interest payable 136 — Other 4 97 Total $ 1,021 $ 1,160 In 2017 and 2016, the Company recorded $0 and approximately $0.6 million of separation-related expenses of which $0 and $0.1 million is included in payroll and related liabilities at December 31, 2017 and 2016, respectively. In 2017, following the notification by MHRA, the Company notified its customers to return their inventory on hand. The Company calculated an estimate for returns, reversed its revenue and recorded an accrued expense estimate of $202 thousand of product return related costs in addition to $77 thousand of credit memos granted to customers. In 2017, the Company recorded $136 thousand of interest payable on its $5 million Short Term Debt to Related Party. |
Short-Term Notes Payable
Short-Term Notes Payable | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Short-Term Notes Payable | 10. Short-Term Note Payable During the year ended December 31, 2016, the Company entered into a short-term loan agreement with First Insurance Funding Corp to borrow $306,380 to purchase insurance. The agreement called for ten monthly payments of $30,638 which included principal and interest. The annual interest rate on the borrowing was 1.95%. The outstanding balance at December 31, 2017 and 2016 was $0 and $214 thousand and was included in other current liabilities on the accompanying balance sheet. |
Short-Term Debt to Related Part
Short-Term Debt to Related Party | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Short- Term Debt to Related Party | 11. Short-Term Debt to Related Party On June 15, 2017, the Company entered into a Note Purchase Agreement by and between the Company, as borrower, and Crystal Amber Fund Limited, as purchaser (the “Purchaser”). Pursuant to the Note Purchase Agreement, the Company issued and sold to the Purchaser a Senior Secured Convertible Promissory Note in an aggregate original principal amount of $5.0 million (the “Note”). The Purchaser is a related party and is the Company’s largest shareholder. The Note accrues interest at a rate equal to 5% per annum, compounded annually, other than during the continuance of an event of default, when the Note accrues interest at a rate of 8% per annum. The entire outstanding principal balance and all unpaid accrued interest thereon is due on the maturity date, December 31, 2018. The Note is secured by a first priority security interest in substantially all personal property assets of the Company, including intellectual property. Subject to the receipt of any required shareholder approval (as described in the Listing Rules of the Australian Securities Exchange (the “ASX”), the entire outstanding principal balance under the Note and all unpaid accrued interest thereon is convertible into CHESS Depositary Interests (“CDIs”), each representing 1/50th of a share of the Company’s common stock, (i) at the option of the Purchaser at a conversion price calculated based on the five-day volume weighted average closing price of the Company’s CDIs on the ASX, or (ii) automatically upon the occurrence of an equity financing in which the Company raises at least $10.0 million (a “Qualified Financing”) at the price per CDI of the CDIs issued and sold in such financing. If shareholder approval is required to approve the issuance of any CDIs upon such a conversion and such approval is not obtained, the Company is obligated to prepay all accrued and unpaid interest plus 110% of the remaining outstanding unconverted principal balance on the earlier of the maturity date or the date that is six months following the date of the stockholder meeting at which the requisite approval was not obtained. In the event that the Borrower issues additional CDIs in a subsequent equity financing at a price per CDI that is less than the then-effective optional conversion price (based on the five-day volume weighted average price on the ASX), the Purchaser has a 30-day option to convert (subject to any applicable shareholder approval) at an adjusted conversion price reflecting, on a weighted average basis, the lower price per CDI. The number of CDIs that the Purchaser may acquire upon conversion of the Note at this adjusted conversion price is limited to the number that maintains the Purchaser’s fully-diluted ownership percentage of the Company at the same level as existed immediately preceding the applicable subsequent equity financing. In addition, upon a change of control of the Company (other than a change of control resulting from a Qualified Financing) in which the Company’s stockholders receive cash consideration, the Company is obligated to prepay all accrued and unpaid interest plus 110% of the remaining outstanding unconverted principal balance. Other than as described above, the Company may not prepay the Note without the consent of the Purchaser. The Note Purchase Agreement contains customary events of default including a failure to perform obligations under the Note Purchase Agreement, bankruptcy, a decision by the board of directors of the Company to wind up the Company, or if the Company otherwise ceases to carry on its ongoing business operations. If a default occurs and is not cured within the applicable cure period or is not waived, any outstanding obligations under the Note may be accelerated. The Note Purchase Agreement and related Note documents also contain additional representations and warranties, covenants and conditions, in each case customary for transactions of this type. The company has recorded the $5.0 million note net of its debt issuance costs and will amortize this cost over life of the note. For the year ended December 31, 2017, the Company recognized interest expense of $136 thousand and amortization of the issuance costs of $44 thousand related to the Senior Secured Convertible Promissory Note. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies Lease Commitments In June 2016, the Company entered into a non-cancelable agreement to lease approximately 4,200 square feet of office space in Boston, Massachusetts. The lease commenced in June 2016 and expires in April 2018. Rent during the term is $11.9 thousand per month. Future minimum lease payments under all non-cancelable lease arrangements at December 31, 2017 are as follows (in thousands): Year Ending December 31, 2018 $ 42 2019 — 2020 — 2021 — 2022 — Total future minimum lease payments $ 42 Rent expense on non-cancelable operating leases was approximately $0.1 License Agreement In 2003, the Company entered into a license agreement (“License Agreement”) for certain intellectual property. The License Agreement required the Company to pay $75 thousand at execution, make payments of $12.5 thousand in 2004, and $25 thousand each year thereafter, until the date of first commercial sale of the product, as defined in the License Agreement. In 2011, the Company began commercial sales of the product as defined in the License Agreement and as a result ceased making the yearly payments. The royalty obligation begins with U.S. commercial sales of products as defined in the License Agreement, if any. The royalty percentage may vary on products covered by the License Agreement, but in any case, the royalties are not considered significant. The patent covered by the License Agreement expired in 2017. |
Stockholders_ Equity (Deficit)
Stockholders’ Equity (Deficit) | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Stockholders’ Equity (Deficit) | 13. Stockholders’ Equity (Deficit) On April 9, 2015, the Company amended its certificate of incorporation to reflect the one-for-ten reverse stock split approved by its shareholders. On May 22, 2017, the Stockholders of the Company approved an increase of its authorized shares of Common Stock from 13,000,000 to 50,000,000 and to eliminate Class B shares of Common Stock of the Company. As of December 31, 2017, the authorized capital stock of the Company consists of 50,500,000 shares, of which 50,000,000 shares are designated as Common Stock and 500,000 shares are designated as Preferred Stock. As of December 31, 2017, the Company has raised net proceeds of approximately $232.8 million through sales of its equity from inception. Common Stock The Company had authorized Class B common stock in order to meet the Listing Rules of the ASX so far as they apply to escrowed securities. In the event that holders of common stock, who were subject to ASX-imposed escrow, breached the terms of their escrow agreement or the Listing Rules as they apply to escrowed securities, their common stock would have been automatically converted into Class B common stock until the earlier to occur of the expiration of the escrow period or the breach being rectified. The Class B common stock was identical to and ranked equally with the common stock except that Class B common stock had no voting rights and was not entitled to any dividends. Class B Common Stock of the Company was eliminated on May 22, 2017. No shares of common stock were subject to such an escrow. In December 2016, GI Dynamics raised approximately $1.0 million, net of expenses, in an offering of 69,865,000 CDIs (1,397,300 shares) to sophisticated and professional investors in Australia and certain other jurisdictions. In January 2017, the Company completed the issue of 12,481,600 CDI’s (249,632 shares) to eligible investors under a Security Purchase Plan for approximately $0.83 per share resulting in net proceeds after issuance costs of approximately $0.2 million. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | 14. Share-Based Compensation The Company has two stock-based compensation plans. The Board of Directors adopted the 2003 Omnibus Stock Plan (the “2003 Plan”), which provides for the grant of qualified incentive stock options and nonqualified stock options or other awards to the Company’s employees, officers, directors, advisors, and outside consultants to purchase up to an aggregate of 922,086 shares of the Company’s common stock. In August 2011, the Board of Directors adopted the 2011 Employee, Director and Consultant Equity Incentive Plan (the “2011 Plan”, together with the 2003 Plan, the “Plans”) as the successor to the 2003 Plan. Under the 2011 Plan, the Company may grant incentive stock options, nonqualified stock options, restricted and unrestricted stock awards and other stock-based awards. The Company had initially reserved 450,000 shares of its common stock for issue under the 2011 Plan. Awards that are returned to the Company’s 2003 Plan as a result of their forfeiture, expiration or cancellation without delivery of common stock shares or that result in the forfeiture of shares back to the Company on or after August 1, 2011, the date the 2011 Plan became effective, are automatically made available for issuance under the 2011 Plan. At August 1, 2011, 80,235 shares available for grant under the 2003 Plan were transferred to the 2011 Plan. At December 31, 2017, 1,060,920 shares were available for grant under the 2011 Plan. In addition, the 2011 Plan allows for an annual increase in the number of shares available for issue under the 2011 Plan commencing on the first day of each fiscal year during the period beginning in fiscal year 2012 and ending in fiscal year 2020. The annual increase in the number of shares shall be equal to the lowest of: • 500,000 shares; • 4% of the number of common shares outstanding as of such date; and • an amount determined by the Board of Directors or the Company’s compensation committee. Accordingly, during year ended December 31, 2017 and December 31, 2016, 436,314 and 380,222 shares were added to the 2011 Plan, respectively. Stock-Based Compensation Stock-based compensation is reflected in the consolidated statements of operations and comprehensive loss as follows for the years ended December 31, 2017 and 2016 (in thousands): Years Ended December 31, 2017 2016 Operations $ — $ 34 Research and development 19 56 Sales and marketing 75 159 General and administrative 93 418 $ 187 $ 667 The stock options granted under the Plans generally vest over a four-year period and expire ten years from the date of grant. From time to time, the Company grants stock options to purchase common stock subject to performance-based milestones. The vesting of these stock options will occur upon the achievement of certain milestones. When achievement of the milestone is deemed probable, the Company expenses the compensation of the respective stock option over the implicit service period. In calculating stock-based compensation costs, the Company estimates the fair value of stock options using the Black-Scholes option-pricing model. The Black-Scholes option-pricing model was developed for use in estimating the fair value of short-lived, exchange-traded options that have no vesting restrictions and are fully transferable. The Company estimates the number of awards that will be forfeited in calculating compensation costs. Such costs are then recognized over the requisite service period of the awards on a straight-line basis. Determining the fair value of stock-based awards using the Black-Scholes option-pricing model requires the use of highly subjective assumptions, including the expected term of the award and expected stock price volatility. The weighted-average assumptions used to estimate the fair value of employee stock options using the Black-Scholes option-pricing model were as follows for the years ended December 31, 2017 and 2016: Years Ended December 31, 2017 2016 Expected volatility 93.3 % 75.8 % Expected term (in years) 6.05 6.05 Risk-free interest rate 2.3 % 2.1 % Expected dividend yield 0 % 0 % Expected Volatility Volatility measures the amount that a stock price has fluctuated or is expected to fluctuate during a period. As the Company was not publicly traded prior to September 2011 and therefore had no trading history, stock price volatility was estimated based on an analysis of historical and implied volatility of comparable public companies. Expected Term The Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock option grants. As a result, for stock option grants made during the years ended December 31, 2017 and 2016, the expected term was estimated using the “simplified method.” The simplified method is based on the average of the contractual term of the option and the weighted-average vesting period of the option. For options granted to non-employees, the Company used the remaining contractual life to estimate the expected term of non-employee awards for the years ended December 31, 2017 and 2016. Risk-Free Interest Rate The risk-free interest rate used for each grant is based on a zero-coupon U.S. Treasury instrument with a remaining term similar to the expected term of the stock-based award. Expected Dividend Yield The Company has not paid and does not anticipate paying cash dividends on its shares of common stock in the foreseeable future; therefore, the expected dividend yield is assumed to be zero. Stock Options The following table summarizes share-based activity under the Company’s stock option plans: Shares of Common Stock Attributable to Options Weighted- Average Exercise Price Weighted- Average Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Outstanding at December 31, 2016 748,571 $ 8.67 8.38 — Granted 408,635 $ 1.07 Exercised Cancelled (164,985 ) $ 11.81 Outstanding at December 31, 2017 992,221 $ 4.88 7.57 — Vested or expected to vest at December 31, 2017 992,221 $ 1.00 10.46 — Exercisable at December 31, 2017 388,007 $ 10.71 5.72 — As of December 31, 2017, there was approximately $0.4 million of unrecognized stock-based compensation, related to unvested stock option grants having service-based vesting under the Plans which is expected to be recognized over a weighted-average period of 2 years. The total unrecognized stock- based compensation cost will be adjusted for future changes in estimated forfeitures. The weighted-average grant date fair value of options granted during the years ended December 31, 2017 and 2016, was $1.07 and $1.00, respectively. The total intrinsic value of options exercised during the years ended December 31, 2017 and 2016 was $0 for both years. The intrinsic value represents the difference between the fair value of the Company’s common stock on the date of exercise and the exercise price of the stock option. There were no cash received from option exercises during the years ended December 31, 2017 and 2016. No tax benefits were realized from options and other stock-based payment arrangements during these periods. The stock-based compensation plans provide that grantees may have the right to exercise an option prior to vesting. Shares purchased upon the exercise of unvested options will be subject to the same vesting schedule as the underlying options, and are subject to repurchase at the original exercise price by the Company should the grantee discontinue providing services to the Company for any reason, prior to becoming fully vested in such shares. At December 31, 2017 and 2016, there were no common stock issued pursuant to the exercise of unvested options that remain unvested and subject to repurchase by the Company. The exercise of these shares is not substantive and as a result, the cash paid for the exercise price is considered a deposit or prepayment of the exercise price and is recorded as a liability. The liability related to these shares was approximately zero at December 31, 2017 and 2016. Additionally, while the shares of common stock subject to repurchase are included in the legally issued shares, they are excluded from the calculation of outstanding shares. Restricted Stock Units & Performance Stock Units Each restricted stock unit and performance stock unit (“RSU & PSU”) represents a contingent right to receive one share of the Company’s common stock. There is no consideration payable on the vesting of RSUs & PSUs issued under the Plans. Upon vesting, the RSUs & PSUs are exercised automatically and settled in shares of the Company’s common stock. During the years ended December 31, 2017 and 2016, the Company awarded a total of 0 and 392,659 RSUs & PSUs, respectively, to employees and directors of the Company, respectively. The following table summarizes information related to RSU & PSU activity during the year ended December 31, 2017: Number of Units Weighted- Average Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Outstanding at December 31, 2016 403,501 9.11 $ 365 Granted Exercised Cancelled (10,842 ) Outstanding at December 31, 2017 392,659 8.27 $ 429 The aggregate intrinsic value at December 31, 2017 and 2016 noted in the table above represents the closing price of the Company’s common stock multiplied by the number of RSUs & PSUs outstanding. The fair value of each RSU & PSU award equals the closing price of the Company’s common stock on the date of grant. The weighted average grant date fair value per share of RSUs & PSUs granted in the years ended December 31, 2017 and 2016 was $0 and $0.75, respectively. At December 31, 2017, 392,659 of the RSUs & PSUs outstanding are subject to performance-based vesting criteria. For these awards, the vesting will occur upon the achievement of certain product revenue, regulatory and reimbursement milestones. When achievement of the milestone is deemed probable, the Company expenses the compensation of the respective stock award over the implicit service period. At December 31, 2016, 403,501 of the RSUs & PSUs outstanding are subject to performance-based vesting criteria. For these awards, the vesting will occur upon the achievement of certain product revenue, regulatory and reimbursement milestones. When achievement of the milestone is deemed probable, the Company expenses the compensation of the respective stock award over the implicit service period. During the years ended December 31, 2017 and 2016, the Company recognized stock-based compensation related to RSUs & PSUs having service-based vesting of approximately $0 and $(0.1) million, respectively. As of December 31, 2017, there was approximately $243 thousand of unrecognized stock-based compensation expense related to non-vested RSU & PSU awards that have service-based vesting. Non-employee awards The Company accounts for non-employee awards in accordance with ASC 505-50. Stock-based compensation expense related to stock options granted to non-employees is recognized as services are rendered, generally on a straight-line basis. The Company believes that the fair value of the stock options is more reliably measurable than the fair value of the services rendered. The fair value of the stock options granted is remeasured at each reporting date using the Black-Scholes option pricing model as prescribed by ASC 718. During the year ended December 31, 2017, the Company granted options to purchase 115,500 shares of common stock to non-employees with an aggregate fair value of approximately $171 thousand of which 46,500 shares with an aggregate fair value of approximately $78 thousand were cancelled during year ending December 31, 2017. In 2016, the Company granted 50,000 stock options to purchase 50,000 shares of common stock to non-employees. The Company has recorded non-employee stock-based compensation expense in accordance with ASC 505-50 of approximately $34 thousand and $0.5 million during the years ended December 31, 2017 and 2016, respectively, which is included in the total stock-based compensation expense. |
Segment Reporting
Segment Reporting | 12 Months Ended |
Dec. 31, 2017 | |
Segment Reporting [Abstract] | |
Segment Reporting | 15. Segment Reporting Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision-maker in deciding how to allocate resources and in assessing performance. The Company has one reportable segment which designs, develops, manufactures and markets medical devices for non-surgical approaches to treating type 2 diabetes and obesity. Geographic Reporting All the Company’s revenue is attributable to customers outside the U.S. The Company is dependent on favorable economic and regulatory environments for its products. Products are sold to customers located in Europe, the Middle East, and the Asia Pacific region and sales are attributed to a country or region based on the location of the customer to whom the products are sold. At December 31, 2017, long-lived assets, comprised of property and equipment, of approximately $0.1 million are all held in the U.S. Product sales by geographic location for the years ended December 31, 2017 and 2016 are listed in the table below (in thousands). Years Ended December 31, 2017 2016 Europe $ 53 $ 309 Middle East — 154 Asia Pacific — 82 Total $ 53 $ 545 Major Customers For the year ended December 31, 2017, one distributor accounted for approximately 100% of the Company’s revenue. For the year ended December 31, 2016, a different |
Retirement Plans
Retirement Plans | 12 Months Ended |
Dec. 31, 2017 | |
Compensation And Retirement Disclosure [Abstract] | |
Retirement Plans | 16. Retirement Plans The Company has a 401(k) retirement and savings plan (“401(k) Plan”) covering all qualified U.S. employees. The 401(k) Plan is a defined contribution plan and allows each participant to contribute up to 100% of the participant’s base wages up to an amount not to exceed an annual statutory maximum. The Company has made discretionary contributions to the 401(k) Plan and recorded expenses of approximately $37 thousand and $0.1 million for the years ended December 31, 2017 and 2016, respectively. The Company maintains a defined contribution plan for certain international employees. The Company contributes 100% of the cost of the defined contribution. The Company recorded expenses of approximately $38 thousand and $26 thousand for the years ended December 31, 2017 and 2016, respectively, under this plan. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 17. Income Taxes On December 22, 2017, the United States enacted new tax reform (“Tax Act”). The Act contains provisions with separate effective dates but is generally effective for taxable years beginning after December 31, 2017. In December 2017, the SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act (SAB 118) which allows the Company to record provisional amounts during a measurement period not to extend beyond one year of the enactment date. Since the Tax Act was passed late in the fourth quarter of 2017, and ongoing guidance and accounting interpretation are expected over the next 12 months, the Company considers the accounting of the transition tax and deferred tax re-measurements to be incomplete due to the forthcoming guidance and ongoing analysis of final year-end data and tax positions. The Company expects to complete its analysis within the measurement period in accordance with SAB 118. Included in the Tax Act are provisions which repatriate the aggregate of post-1986 earnings and profits of foreign corporations. The Company has calculated the impact of repatriation on a provisional basis under SAB 118. Repatriation will reduce Federal U.S. tax attributes by $23 thousand for the year ended December 31, 2017. Beginning with the year ending December 31, 2018, the corporate statutory rates on U.S. earnings will be reduced from 34% to 21%. The impact of the future rate reduction resulted in a decrease to the deferred tax assets and an offset to the valuation allowance for the year ending December 31, 2017 by $28.9 million relating to the revaluation of the net deferred tax asset. The Company is currently evaluating the impact of the Tax Act as it relates to the foreign subsidiaries. The Company intends to record any impact currently when it occurs rather than deferring the impact. Other than the repatriation tax referenced above and reduction in statutory rate, the Company does not anticipate the Tax Act will have a material impact on income taxes in future years. Loss before provision for income taxes consisted of the following (in thousands): Years Ended December 31, 2017 2016 Domestic $ (10,923 ) $ (13,124 ) Foreign 47 41 Total $ (10,876 ) $ (13,083 ) The provision for income taxes in the accompanying consolidated statements of operations and comprehensive loss consisted of the following (in thousands): Years Ended December 31, 2017 2016 Current Provision: Federal $ — $ — State 1 17 Foreign 13 16 Total 14 33 Deferred (Benefit) Provision: Federal — — State — — Foreign — — Total — — Total provision $ 14 $ 33 A reconciliation of income taxes from operations computed using the U.S. federal statutory rate of 34% to that reflected in operations follows (in thousands): Years Ended December 31, 2017 2016 Income tax benefit using U.S. federal statutory rate $ (3,698 ) $ (4,449 ) Rate Changes 28,942 — Permanent differences 35 16 State income taxes, net of federal benefit (141 ) (661 ) Stock compensation 53 1,218 Tax credits (127 ) (42 ) Foreign tax rate differential (2 ) 1 Change in the valuation allowance (25,161 ) 1,303 Unrealized gain — 2,673 Other 113 (26 ) Total $ 14 $ 33 Components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2017 2016 Deferred tax assets: Net operating loss carryforwards $ 59,823 $ 79,648 Research and development credit carryforwards 4,005 3,713 Capitalized research and development costs 464 1,366 Capitalized start-up expenses 2,846 4,594 Depreciation and other 1,920 3,081 Total deferred tax assets 69,058 92,402 Valuation allowance (69,058 ) (92,402 ) Net deferred tax asset $ — $ — Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of the Company’s deferred tax assets and determined that it is more likely than not that the Company will not recognize the benefits of the deferred tax assets related to the U.S. and the Netherlands. As a result, a valuation allowance of approximately $69.1 million and $92.4 million was established at December 31, 2017 and 2016, respectively. The valuation allowance decreased by approximately $23.3 million during the year ended December 31, 2017, primarily due to the revaluation of the net deferred tax asset at the reduced 21% U.S. corporate income tax future rate. At December 31, 2017, the Company had U.S. federal and state net operating loss carryforwards of approximately $223.0 million and $205.6 million, respectively. These operating loss carryforwards will expire at various times beginning in 2024 through 2037 for federal purposes and begin to expire in 2030 and will continue to expire through 2037 for state purposes. In addition, at December 31, 2017, the Company also has U.S. federal and state research and development tax credit carryforwards (excluding ASC 740, Income Taxes Utilization of net operating loss carryforwards and research and development credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in the future in accordance with Section 382 of the Internal Revenue Code of 1986 (“IRC Section 382”) and with Section 383 of the Internal Revenue Code of 1986, as well as similar state provisions. These ownership changes may limit the amount of net operating loss carryforwards and research and development credit carryforwards that can be utilized annually to offset future taxable income and taxes, respectively. In general, an ownership change, as defined by IRC Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50 percentage points over a three-year period. The Company has completed several financings since its inception, which may have resulted in a change in control as defined by IRC Section 382 or could result in a change in control in the future. As of December 31, 2017, the Company has not, as yet, conducted an IRC Section 382 study, which could impact its ability to utilize net operating loss and tax credit carryforwards annually in the future to offset the Company’s taxable income, if any. The Company applies ASC 740-10, which provides guidance on the accounting for uncertainty in income taxes recognized in financial statements and requires the impact of a tax position to be recognized in the financial statements if that position is more likely than not of being sustained by the taxing authority. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. At December 31, 2017 and 2016, the Company had unrecognized tax liabilities of approximately $1.5 million and $1.4 million, respectively. The following is a roll forward of the Company’s unrecognized tax benefits (in thousands): December 31, 2017 2016 Unrecognized tax benefit – as of the beginning of the year $ 1,449 $ 1,426 Gross increases – tax positions of the prior periods — — Gross increases – current period tax positions 32 23 Unrecognized tax benefits – as of the end of the year $ 1,481 $ 1,449 The Company will recognize interest and penalties related to uncertain tax positions, should they be assessed, in income tax expense. As of December 31, 2017, and 2016, the Company had no accrued interest or penalties related to uncertain tax positions, and no amounts have been recognized in the Company’s consolidated statements of comprehensive loss. The statute of limitations for assessment by the Internal Revenue Service (“IRS”) and state tax authorities is open for tax years ended December 31, 2013 through December 31, 2017, although carryforward attributes that were generated prior to tax year 2013 may still be adjusted upon examination by the IRS or state tax authorities if they either have been or will be used in a future period. The statute of limitations for assessment by foreign tax authorities is open for tax years ended December 31, 2013 through December 31, 2017. There are currently no federal or state audits in progress. The Company has not yet completed a study of its research and development credit carryforwards. Once completed, this study may result in an adjustment to the Company’s research and development credit carryforwards. A full valuation allowance has been provided against the Company’s research and development credits, and if an adjustment is required at the time the study is completed, this adjustment would be offset by an adjustment to the deferred tax asset established for the research and development credit carryforward and the valuation allowance. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | 18. Subsequent Events On January 22, 2018, the Company announced that it had received commitments for a private placement of 58,780,619 fully paid CDIs of the Company (representing 1,175,612 shares of common stock) at an issue price of A$0.035 per CDI to sophisticated and professional investors in Australia, the United States and the United Kingdom, consisting of U.S. and non-U.S. persons (as defined in Regulation S (“Regulation S”) of the Securities Act of 1933 (the “Securities Act”)) to raise up to approximately $1.62 million (the “2018 Placement”). The issue of CDIs under the 2018 Placement occurred in two tranches. The first tranche closed on January 22, 2018 (US EST), pursuant to which the Company issued 28,467,063 CDIs (representing 569,341 shares of common stock) resulting in gross proceeds of approximately $781 thousand. The closing of the second tranche of the 2018 Placement, resulted in the raising of $830 thousand by the issue of 30,313,556 CDIs (606,271 shares), following stockholder approval at the adjourned Special Meeting of stockholders on February 27, 2018. Crystal Amber Fund, a related party and Board member, participated in the second tranche Placement, purchasing 27,391,756 CDIs and 2,921,800 CDIs, respectively. |
Summary of Significant Accoun26
Summary of Significant Accounting Policies and Basis of Presentation (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of GI Dynamics, Inc. and its wholly owned subsidiaries. All intercompany transactions and balances are eliminated in consolidation. The functional currency of GID Europe Holding B.V., GID Europe B.V., GID Germany GmbH and GI Dynamics Australia Pty Ltd is the U.S. dollar. Consolidated balance sheet accounts of the Company’s subsidiaries are remeasured into U.S. dollars using the exchange rate in effect at the consolidated balance sheet date while expenses are remeasured using the average exchange rate in effect during the period. Gains and losses arising from remeasurement of the wholly owned subsidiaries’ financial statements are included in the determination of net loss. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in accordance with generally accepted accounting principles in the U.S. requires the Company’s management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent assets and liabilities. On an ongoing basis, the Company’s management evaluates its estimates, including those related to revenue recognition, allowance for doubtful accounts, inventory valuation including reserves for excess and obsolete inventory, impairment of long-lived assets, income taxes including the valuation allowance for deferred tax assets, research and development, contingencies, valuation of warrant liabilities, estimates used to assess its ability to continue as a going concern and stock-based compensation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investment instruments with an original maturity when purchased of three months or less to be cash equivalents. Investments qualifying as cash equivalents primarily consist of money market funds and have a carrying amount that approximates fair value. The amount of cash equivalents included in cash and cash equivalents was approximately $2.6 million and $6.3 million at December 31, 2017 and 2016, respectively. At December 31, 2017 and 2016, the Company had approximately $0 and $0.1 million, respectively, of cash and cash equivalents denominated in Australian dollars that is subject to foreign currency gain and loss. At December 31, 2017 and 2016, the Company had approximately $0.3 million and $0.2 million of cash and cash equivalents denominated in euros that is subject to foreign currency gain and loss. |
Inventory | Inventory The Company states inventory at the lower of first-in, first-out cost or net realizable value. The Company records a provision for excess, expired, and obsolete inventory based primarily on estimates of forecasted revenues. A significant change in the timing or level of demand for products as compared to forecasted amounts may result in recording additional provisions for excess, expired, and obsolete inventory in the future. When capitalizing inventory, the Company considers factors such as status of regulatory approval, alternative use of inventory, and anticipated commercial use of the product. At December 31, 2017 and 2016, the Company had an approximate net inventory balance of $0 and $213 thousand, respectively. |
Property and Equipment | Property and Equipment Property and equipment, including leasehold improvements, are recorded at cost and are depreciated when placed in service using the straight-line method based on their estimated useful lives as follows: Asset Description Estimated Useful Life (In Years) Laboratory and manufacturing equipment 5 Computer equipment and software 3 Office furniture and equipment 5 Included in property and equipment are certain costs of software obtained for internal use. Costs incurred during the preliminary project stage are expensed as incurred, while costs incurred during the application development stage are capitalized and amortized over the estimated useful life of the software. The Company also capitalizes costs related to specific upgrades and enhancements when it is probable the expenditures will result in additional functionality. Maintenance and training costs related to software obtained for internal use are expensed as incurred. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the remaining lease term. Costs for capital assets not yet placed into service have been capitalized as construction in progress and will be depreciated in accordance with the above guidelines once placed into service. Maintenance and repair costs are expensed as incurred. |
Revenue Recognition | Revenue Recognition The Company has generated all of its revenue from sales of its EndoBarrier to health care providers and third- party distributors who resell the product to health care providers. The Company considers revenue to be realized or realizable and earned when all of the following criteria are met: persuasive evidence of a sales arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable, and collectability is reasonably assured. Revenue is recognized upon passage of title and risk of loss to customers, unless a consignment arrangement exists and provided an estimate can be made for sales returns. With respect to these criteria: • The evidence of an arrangement generally consists of a health care provider or distributor purchase order with the necessary approvals and acceptance by the Company. • Transfer of title and risk and rewards of ownership are passed to the health care provider or third-party distributor upon delivery of the products. • The selling prices for all sales are fixed and agreed with the health care provider or third-party distributor. Provisions for discounts and rebates to customers are established as a reduction to revenue in the same period the related sales are recorded. When doubt exists about collectability from specific customers, the Company defers revenue from sales of products to those customers until payment is received. In certain circumstances the Company allows customers to return defective or nonconforming products for credit or replacement products. Defective or nonconforming products typically include those products that resulted in an unsuccessful implant procedure. The Company considers these transactions to be product returns and bases its estimate for sales returns upon historical trends and records the amount as a reduction to revenue upon the initial sale of the product. Prospectively, the Company will evaluate whether it has sufficient data to determine return estimates as it enters new markets. The Company has certain relationships in which title to delivered product passes to a buyer, but the substance of the transaction is that of a consignment arrangement. In these cases, the Company recognizes revenue when the product is implanted or otherwise consumed and payment is received from the customer, which indicates that the Company has no further obligations to the customer and that the sale is complete. For these transactions, revenue recognition is deferred until the sale is complete. At December 31, 2017 and 2016, the Company had deferred revenue of approximately $11 thousand. At December 31, 2017, following the notification by MHRA, the Company calculated an estimate for returns, reversed its revenue and recorded an accrued expense estimate of $202 thousand of product return related costs. |
Shipping and Handling Costs | Shipping and Handling Costs Shipping and handling costs are included in costs of revenue. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed when incurred. Research and development costs include costs of all basic research activities as well as other research, engineering, and technical effort required to develop a new product or service or make significant improvement to an existing product or manufacturing process. Research and development costs also include pre-approval regulatory and clinical trial expenses. |
Patent Costs | Patent Costs The Company expenses as incurred all costs, including legal expenses, associated with obtaining patents until the patented technology becomes feasible. All costs incurred after the patented technology is feasible will be capitalized as an intangible asset. As of December 31, 2017, no such costs had been capitalized since inception of the Company. The Company has expensed approximately $0.4 million of patent costs within general and administrative expenses in the consolidated statements of operations and comprehensive loss for each year ended December 31, 2017 and 2016. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 718, Stock Compensation For awards that vest based on service conditions, the Company uses the straight-line method to allocate compensation expense to reporting periods. The grant date fair value of options granted is calculated using the Black-Scholes option pricing model, which requires the use of subjective assumptions including volatility, expected term and the fair value of the underlying common stock, among others. The Company periodically issues performance-based awards. For these awards, vesting will occur upon the achievement of certain milestones. When achievement of the milestone is deemed probable, the Company expenses the compensation of the respective awards over the implicit service period. Stock awards to non-employees are accounted for in accordance with ASC 505-50, Equity-Based Payments to Non-Employees Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting The stock-based compensation plans provide that grantees may have the right to exercise an option prior to vesting. Shares purchased upon the exercise of unvested options will be subject to the same vesting schedule as the underlying options and are subject to repurchase at the original exercise price by the Company should the grantee discontinue providing services to the Company for any reason, prior to becoming fully vested in such shares. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company regularly reviews the carrying amount of its long-lived assets to determine whether indicators of impairment may exist that warrant adjustments to carrying values or estimated useful lives. If indications of impairment exist, projected future undiscounted cash flows associated with the asset are compared to the carrying amount to determine whether the asset’s value is recoverable. If the carrying value of the asset exceeds such projected undiscounted cash flows, the asset will be written down to its estimated fair value. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is the change in equity of a company during a period from transactions and other events and circumstances, excluding transactions resulting from investments by owners and distributions to owners. The Company currently does not have any changes in equity from non-owner sources. As a result, comprehensive loss was equal to the net loss for all periods reported. |
Loss Contingencies | Loss Contingencies In accordance with ASC 450, Contingencies |
Income Taxes | Income Taxes The Company provides for income taxes under the liability method. The Company records deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial reporting and the tax bases of assets and liabilities measured using the enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to reflect the uncertainty associated with their ultimate realization. The Company accounts for uncertain tax positions recognized in the consolidated financial statements by applying a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. |
Guarantees | Guarantees The Company has identified the guarantees described below as disclosable, in accordance with ASC 460, Guarantees As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ insurance coverage that should limit its exposure and enable it to recover a portion of any future amounts paid. The Company is a party to a number of agreements entered into in the ordinary course of business that contain typical provisions that obligate the Company to indemnify the other parties to such agreements upon the occurrence of certain events. Such indemnification obligations are usually in effect from the date of execution of the applicable agreement for a period equal to the applicable statute of limitations. The aggregate maximum potential future liability of the Company under such indemnification provisions is uncertain. As of December 31, 2017, and 2016, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible. As a result, no related reserves have been established. |
Subsequent Events | Subsequent Events The Company evaluates events occurring after the date of its consolidated balance sheet for potential recognition or disclosure in its consolidated financial statements. There have been subsequent events that occurred through the date the Company issued its consolidated financial statements that require disclosure in or adjustment to its consolidated financial statements. |
New Accounting Pronouncements | New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the effect of recently issued standards that are not yet effective will not have a material effect on its consolidated financial position or results of operations upon adoption. In May 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-09 (“ASU 2014-09”), Revenue from Contracts with Customers Revenue Recognition In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern . In July 2015, the FASB issued ASU No. 2015-11, Simplifying the Measurement of Inventory In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting In August 2016, the FASB issued ASU No. 2016-15, Classification of Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force) Statement of Cash Flows In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (a consensus of the FASB Emerging Issue Task Force) |
Summary of Significant Accoun27
Summary of Significant Accounting Policies and Basis of Presentation (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Property and Equipment | Property and equipment, including leasehold improvements, are recorded at cost and are depreciated when placed in service using the straight-line method based on their estimated useful lives as follows: Asset Description Estimated Useful Life (In Years) Laboratory and manufacturing equipment 5 Computer equipment and software 3 Office furniture and equipment 5 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Earnings Per Share [Abstract] | |
Potentially Dilutive Securities Excluded from Computation of Diluted Weighted Average Shares | The following potentially dilutive securities have been excluded from the computation of diluted weighted- average shares outstanding as of December 31, 2017 and 2016, as they would be anti-dilutive: Years Ended December 31, 2017 2016 Warrants to purchase common stock 28,532 28,532 Options to purchase common stock and other stock-based awards 1,384,880 1,152,072 Total 1,413,412 1,180,604 |
Fair Value of Financial Instr29
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Assets and Liabilities Measured on Recurring Basis | The following tables present the assets and liabilities the Company has measured at fair value on a recurring basis (in thousands): Fair Value Measurements at Reporting Date Using Quoted Prices Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Description December 31, 2017 (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 2,584 $ 2,584 $ — $ — Total assets $ 2,584 $ 2,584 $ — $ — Liabilities Warrant liability $ 29 $ — $ — $ 29 Total liabilities $ 29 $ — $ — $ 29 Fair Value Measurements at Reporting Date Using Quoted Prices in Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Description December 31, (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 6,344 $ 6,344 $ — $ — Total assets $ 6,344 $ 6,344 $ — $ — Liabilities Warrant liability $ 17 $ — $ — $ 17 Total liabilities $ 17 $ — $ — $ 17 |
Assumptions Used in the Black-Scholes Option Pricing Model to Determine the Fair Value of the Common Stock Warrants | The assumptions used in the Black-Scholes option pricing model to determine the fair value of the common stock warrants at December 31, 2017 and 2016 were as follows: December 31, 2017 2016 Exercise price (A$55.00 at the then current exchange rate) $ 0.64 $ 0.64 Fair value of common stock $ 0.60 $ 0.59 Expected volatility 142.6 % 90.5 % Expected term (in years) 3.34 4.34 Risk-free interest rate 2.02 % 1.78 % Expected dividend yield –% –% |
Rollforward of Fair Value of Warrants | The following table rolls forward the fair value of the warrants, where fair value is determined by Level 3 inputs (in thousands): Balance at December 31, 2015 $ — Grant of Consulting warrants May 2016 $ 12 Increase in fair value of warrants upon re-measurement included in other expense 5 Balance at December 31, 2016 $ 17 Increase in fair value of warrants upon re-measurement included in other expense 12 Balance at December 31, 2017 $ 29 |
Concentrations of Credit Risk30
Concentrations of Credit Risk, Accounts Receivable and Related Valuation Account (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Receivables [Abstract] | |
Components of Company's Accounts Receivable | The following table shows the components of the Company’s accounts receivable at December 31, 2017 and 2016 (in thousands): December 31, 2017 2016 Accounts receivable $ 85 $ 68 Less: allowance for doubtful accounts (42 ) (16 ) Less: allowance for sales returns (3 ) (22 ) Total $ 40 $ 30 |
Roll Forward of Allowance for Doubtful Accounts | The following is a roll forward of the Company’s allowance for doubtful accounts (in thousands): Year Ended December 31, 2017 2016 Beginning balance $ 16 $ 59 Net charges to expenses 48 5 Utilization of allowances (22 ) (48 ) Ending balance $ 42 $ 16 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Inventory Disclosure [Abstract] | |
Inventory, Net of Reserves | I nventory, net of reserves, at December 31, 2017 and 2016 was as follows (in thousands): December 31, 2017 2016 Finished goods $ — $ 213 Work-in-process — — Raw materials — — Total $ — $ 213 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | Property and equipment consisted of the following (in thousands): December 31, 2017 2016 Laboratory and manufacturing equipment $ 591 $ 591 Computer equipment and software 1,179 1,174 Office furniture and equipment 183 183 Leasehold improvements 21 21 1,974 1,969 Less accumulated depreciation and amortization (1,877 ) (1,820 ) Total $ 97 $ 149 |
Recognized Charge for Impaired Fixed Assets | As part of the Company’s restructuring in 2016 in connection with the abandonment of its Company headquarters in Lexington, Massachusetts, the Company recognized a charge for impaired fixed assets as follows (in thousands): December 31, 2016 Cost of revenue $ 24 Research and development 79 General and administrative 42 $ 145 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | Accrued expenses consisted of the following (in thousands): December 31, 2017 2016 Clinical trials $ — $ 16 Payroll and related liabilities 181 430 Professional fees 421 617 Credit refunds 279 — Interest payable 136 — Other 4 97 Total $ 1,021 $ 1,160 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | |
Future Minimum Lease Payments Under All Non-cancelable Lease Arrangements | Future minimum lease payments under all non-cancelable lease arrangements at December 31, 2017 are as follows (in thousands): Year Ending December 31, 2018 $ 42 2019 — 2020 — 2021 — 2022 — Total future minimum lease payments $ 42 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | Stock-based compensation is reflected in the consolidated statements of operations and comprehensive loss as follows for the years ended December 31, 2017 and 2016 (in thousands): Years Ended December 31, 2017 2016 Operations $ — $ 34 Research and development 19 56 Sales and marketing 75 159 General and administrative 93 418 $ 187 $ 667 |
Weighted-average Assumptions used to Estimate Fair Value of Stock Options | The weighted-average assumptions used to estimate the fair value of employee stock options using the Black-Scholes option-pricing model were as follows for the years ended December 31, 2017 and 2016: Years Ended December 31, 2017 2016 Expected volatility 93.3 % 75.8 % Expected term (in years) 6.05 6.05 Risk-free interest rate 2.3 % 2.1 % Expected dividend yield 0 % 0 % |
Share-Based Activity | The following table summarizes share-based activity under the Company’s stock option plans: Shares of Common Stock Attributable to Options Weighted- Average Exercise Price Weighted- Average Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Outstanding at December 31, 2016 748,571 $ 8.67 8.38 — Granted 408,635 $ 1.07 Exercised Cancelled (164,985 ) $ 11.81 Outstanding at December 31, 2017 992,221 $ 4.88 7.57 — Vested or expected to vest at December 31, 2017 992,221 $ 1.00 10.46 — Exercisable at December 31, 2017 388,007 $ 10.71 5.72 — |
Restricted Stock Units and Performance Stock Units Activity | The following table summarizes information related to RSU & PSU activity during the year ended December 31, 2017: Number of Units Weighted- Average Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Outstanding at December 31, 2016 403,501 9.11 $ 365 Granted Exercised Cancelled (10,842 ) Outstanding at December 31, 2017 392,659 8.27 $ 429 |
Segment Reporting (Tables)
Segment Reporting (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Segment Reporting [Abstract] | |
Product Sales by Geographic Location | Product sales by geographic location for the years ended December 31, 2017 and 2016 are listed in the table below (in thousands). Years Ended December 31, 2017 2016 Europe $ 53 $ 309 Middle East — 154 Asia Pacific — 82 Total $ 53 $ 545 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Loss Before Provision for Income Taxes | Loss before provision for income taxes consisted of the following (in thousands): Years Ended December 31, 2017 2016 Domestic $ (10,923 ) $ (13,124 ) Foreign 47 41 Total $ (10,876 ) $ (13,083 ) |
Summary of Provision for Income Taxes in Accompanying Consolidated Statements of Operations and Comprehensive Loss | The provision for income taxes in the accompanying consolidated statements of operations and comprehensive loss consisted of the following (in thousands): Years Ended December 31, 2017 2016 Current Provision: Federal $ — $ — State 1 17 Foreign 13 16 Total 14 33 Deferred (Benefit) Provision: Federal — — State — — Foreign — — Total — — Total provision $ 14 $ 33 |
Reconciliation of Income Taxes from Operations Computed using U.S. Federal Statutory Rate | A reconciliation of income taxes from operations computed using the U.S. federal statutory rate of 34% to that reflected in operations follows (in thousands): Years Ended December 31, 2017 2016 Income tax benefit using U.S. federal statutory rate $ (3,698 ) $ (4,449 ) Rate Changes 28,942 — Permanent differences 35 16 State income taxes, net of federal benefit (141 ) (661 ) Stock compensation 53 1,218 Tax credits (127 ) (42 ) Foreign tax rate differential (2 ) 1 Change in the valuation allowance (25,161 ) 1,303 Unrealized gain — 2,673 Other 113 (26 ) Total $ 14 $ 33 |
Summary of Net Deferred Tax Assets and Liabilities | Components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2017 2016 Deferred tax assets: Net operating loss carryforwards $ 59,823 $ 79,648 Research and development credit carryforwards 4,005 3,713 Capitalized research and development costs 464 1,366 Capitalized start-up expenses 2,846 4,594 Depreciation and other 1,920 3,081 Total deferred tax assets 69,058 92,402 Valuation allowance (69,058 ) (92,402 ) Net deferred tax asset $ — $ — |
Rollforward of Unrecognized Tax Benefits | The following is a roll forward of the Company’s unrecognized tax benefits (in thousands): December 31, 2017 2016 Unrecognized tax benefit – as of the beginning of the year $ 1,449 $ 1,426 Gross increases – tax positions of the prior periods — — Gross increases – current period tax positions 32 23 Unrecognized tax benefits – as of the end of the year $ 1,481 $ 1,449 |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) $ / shares in Units, $ in Thousands, € in Millions, $ in Millions | Jan. 31, 2017USD ($)$ / sharesshares | Dec. 20, 2016USD ($)$ / sharesshares | Aug. 21, 2015 | Jun. 30, 2017USD ($) | Jan. 31, 2017USD ($)$ / sharesshares | May 31, 2014USD ($) | Sep. 30, 2011USD ($) | Aug. 31, 2013USD ($) | Jun. 30, 2016USD ($) | Sep. 30, 2016USD ($) | Dec. 31, 2017USD ($)SegmentPatientSiteshares | Dec. 31, 2016USD ($)shares | Dec. 31, 2017USD ($) | Dec. 31, 2017AUD ($) | Dec. 31, 2017EUR (€) | Dec. 31, 2016AUD ($) | Dec. 31, 2016EUR (€) | Dec. 31, 2015USD ($) |
Nature Of Operations [Line Items] | ||||||||||||||||||
Number of reportable segments | Segment | 1 | |||||||||||||||||
Number of patients to enroll under double-blinded study plan with uncontrolled type 2 diabetes and obesity | Patient | 500 | |||||||||||||||||
Number of sites consider for trial of EndoBarrier Therapy | Site | 25 | |||||||||||||||||
Percentage of reducing headcount | 46.00% | |||||||||||||||||
Non-recurring charges | $ 1,100 | |||||||||||||||||
Issuance of shares, value | $ 30,800 | $ 72,500 | $ 52,500 | $ 198 | $ 978 | |||||||||||||
Repayment of convertible term promissory notes | $ 6,000 | |||||||||||||||||
Stock issued, shares | shares | 249,632 | 1,397,300 | ||||||||||||||||
Common stock issued, price per share | $ / shares | $ 0.83 | $ 0.83 | ||||||||||||||||
Private placement amount received | $ 1,000 | |||||||||||||||||
Proceeds from issuance of common stock | $ 200 | $ 200 | 198 | 978 | $ 232,800 | |||||||||||||
Debt principal amount | 5,000 | 5,000 | ||||||||||||||||
Accumulated deficit | (259,121) | (248,203) | (259,121) | |||||||||||||||
Working capital deficit | (3,780) | (3,780) | ||||||||||||||||
Cash and cash equivalents | 3,034 | 8,293 | $ 3,034 | $ 0 | € 0.3 | $ 0.1 | € 0.2 | $ 19,590 | ||||||||||
Senior Secured Convertible Promissory Notes | ||||||||||||||||||
Nature Of Operations [Line Items] | ||||||||||||||||||
Debt principal amount | $ 5,000 | |||||||||||||||||
Interest rate during period | 5.00% | |||||||||||||||||
Maturity Date | Dec. 31, 2018 | |||||||||||||||||
Common stock | ||||||||||||||||||
Nature Of Operations [Line Items] | ||||||||||||||||||
Issuance of shares, value | $ 3 | $ 14 | ||||||||||||||||
Stock issued, shares | shares | 1,397,300 | 249,632 | 249,632 | 1,397,300 | ||||||||||||||
CHESS Depositary Interests | ||||||||||||||||||
Nature Of Operations [Line Items] | ||||||||||||||||||
Stock issued, shares | shares | 12,481,600 | 69,865,000 | 12,481,600 | |||||||||||||||
Common stock issued, price per share | $ / shares | $ 0.22 | |||||||||||||||||
Restructuring Charges | ||||||||||||||||||
Nature Of Operations [Line Items] | ||||||||||||||||||
Non-recurring charges | $ 400 | |||||||||||||||||
Employee Severance | ||||||||||||||||||
Nature Of Operations [Line Items] | ||||||||||||||||||
Non-recurring charges | 600 | |||||||||||||||||
Facility Closing | ||||||||||||||||||
Nature Of Operations [Line Items] | ||||||||||||||||||
Non-recurring charges | $ 100 |
Summary of Significant Accoun39
Summary of Significant Accounting Policies and Basis of Presentations - Additional Information (Detail) € in Millions, $ in Millions | 12 Months Ended | ||||||
Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2017AUD ($) | Dec. 31, 2017EUR (€) | Dec. 31, 2016AUD ($) | Dec. 31, 2016EUR (€) | Dec. 31, 2015USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||||||
Cash and cash equivalents | $ 3,034,000 | $ 8,293,000 | $ 0 | € 0.3 | $ 0.1 | € 0.2 | $ 19,590,000 |
Inventory, net | 0 | 213,000 | |||||
Deferred revenue | 11,000 | 11,000 | |||||
Estimated accrued expense for product return related costs | 202,000 | ||||||
General and administrative | 5,074,000 | 6,250,000 | |||||
Accounting Standards Update 2016-09 | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Decrease in accumulated deficit | 28,000 | ||||||
Patents | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
General and administrative | 400,000 | 400,000 | |||||
Cash and Cash Equivalents | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Cash equivalents | $ 2,600,000 | $ 6,300,000 |
Property and Equipment, Includi
Property and Equipment, Including Leasehold Improvements (Detail) | 12 Months Ended |
Dec. 31, 2017 | |
Laboratory and manufacturing equipment | |
Property Plant And Equipment [Line Items] | |
Estimated useful life | 5 years |
Computer equipment and software | |
Property Plant And Equipment [Line Items] | |
Estimated useful life | 3 years |
Office furniture and equipment | |
Property Plant And Equipment [Line Items] | |
Estimated useful life | 5 years |
Potentially Dilutive Securities
Potentially Dilutive Securities Excluded from Computation of Diluted Weighted Average Shares (Detail) - shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 1,413,412 | 1,180,604 |
Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 28,532 | 28,532 |
Options to purchase common stock and other stock-based awards | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 1,384,880 | 1,152,072 |
Common Stock Warrants - Additio
Common Stock Warrants - Additional Information (Detail) | May 04, 2016$ / sharesshares | Sep. 30, 2011$ / sharesshares | Dec. 31, 2017shares |
Class of Warrant or Right [Line Items] | |||
Common stock warrants, shares issued in connection with IPO | 50,000 | ||
Common stock warrant, exercise price | $ / shares | $ 55 | ||
Consulting Agreement | Consultant Warrant and IPO Warrants | |||
Class of Warrant or Right [Line Items] | |||
Common stock warrants, shares issued in connection with IPO | 28,532 | ||
Common stock warrant, exercise price | $ / shares | $ 0.64 | ||
Consulting Agreement | Consultant Warrant | |||
Class of Warrant or Right [Line Items] | |||
Vesting period of warrants | 2 years | ||
Contractual life of warrants | 5 years | ||
Common stock warrant, share reserved | 28,532 | ||
Common stock warrant, shares exercised | 0 | ||
IPO | |||
Class of Warrant or Right [Line Items] | |||
Class of warrants expired | Sep. 30, 2016 |
Fair Value of Assets and Liabil
Fair Value of Assets and Liabilities Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liability | $ 29 | $ 17 |
Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 2,584 | 6,344 |
Warrant liability | 29 | 17 |
Total liabilities | 29 | 17 |
Fair Value, Measurements, Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 2,584 | 6,344 |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 2,584 | 6,344 |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 2,584 | 6,344 |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liability | 29 | 17 |
Total liabilities | $ 29 | $ 17 |
Assumptions Used in the Black-S
Assumptions Used in the Black-Scholes Option Pricing Model to Determine the Fair Value of the Common Stock Warrants (Detail) - Warrant | 12 Months Ended | |||
Dec. 31, 2017$ / shares | Dec. 31, 2016$ / shares | Dec. 31, 2017$ / shares | Dec. 31, 2016$ / shares | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Exercise price | (per share) | $ 0.64 | $ 0.64 | $ 55 | $ 55 |
Fair value of common stock | $ 0.60 | $ 0.59 | ||
Expected volatility | 142.60% | 90.50% | ||
Expected term | 3 years 4 months 2 days | 4 years 4 months 2 days | ||
Risk-free interest rate | 2.02% | 1.78% | ||
Expected dividend yield | 0.00% | 0.00% |
Assumptions Used in the Black45
Assumptions Used in the Black-Scholes Option Pricing Model to Determine the Fair Value of the Common Stock Warrants (Parenthetical) (Detail) | Dec. 31, 2017$ / shares | Dec. 31, 2017$ / shares | Dec. 31, 2016$ / shares | Dec. 31, 2016$ / shares |
Warrant | ||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Exercise price | (per share) | $ 0.64 | $ 55 | $ 0.64 | $ 55 |
Rollforward of Fair Value of Wa
Rollforward of Fair Value of Warrants (Detail) - Warrant - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | $ 17 | |
Grant of Consulting warrants May 2016 | $ 12 | |
Increase in fair value of warrants upon re-measurement included in other expense | 12 | 5 |
Ending balance | $ 29 | $ 17 |
Concentrations of Credit Risk47
Concentrations of Credit Risk, Accounts Receivable and Related Valuation Account - Additional Information (Detail) | Dec. 31, 2017USD ($)Customer | Dec. 31, 2016USD ($)Customer | May 31, 2017USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Accounts Notes And Loans Receivable [Line Items] | |||||
Adjustment to account receivable | $ 10,000 | $ (10,000) | |||
Deferred revenue | $ 11,000 | $ 11,000 | 11,000 | 11,000 | |
Write-offs of uncollectible accounts receivable | 22,000 | 48,000 | |||
Allowance for doubtful accounts | $ 42,000 | $ 16,000 | 42,000 | $ 16,000 | |
Accounts Receivable | Credit Concentration Risk | Four Health Care Providers | |||||
Accounts Notes And Loans Receivable [Line Items] | |||||
Number of customers | Customer | 4 | 1 | |||
Concentration risk percentage | 100.00% | 22.00% | |||
Accounts Receivable | Credit Concentration Risk | Health Care Provider One | |||||
Accounts Notes And Loans Receivable [Line Items] | |||||
Number of customers | Customer | 1 | ||||
Concentration risk percentage | 43.00% | ||||
Sales Arrangement | |||||
Accounts Notes And Loans Receivable [Line Items] | |||||
Sales arrangement entered | $ 517,000 | ||||
Adjustment to account receivable | 559,000 | ||||
Deferred revenue | $ 18,000 | 18,000 | |||
Deferred product costs | $ 27,000 | 27,000 | |||
Sales Arrangement | Foreign Currency | |||||
Accounts Notes And Loans Receivable [Line Items] | |||||
Adjustment to account receivable | $ 40,000 |
Components of Company's Account
Components of Company's Accounts Receivable (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Accounts Notes Loans And Financing Receivable Gross Allowance And Net [Abstract] | ||
Accounts receivable | $ 85 | $ 68 |
Less: allowance for doubtful accounts | (42) | (16) |
Less: allowance for sales returns | (3) | (22) |
Total | $ 40 | $ 30 |
Roll Forward of Allowance for D
Roll Forward of Allowance for Doubtful Accounts (Detail) - Allowance for Doubtful Accounts - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | $ 16 | $ 59 |
Net charges to expenses | 48 | 5 |
Utilization of allowances | (22) | (48) |
Ending balance | $ 42 | $ 16 |
Inventory - Additional Informat
Inventory - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Inventory Disclosure [Abstract] | |||
Change in inventory reserves | $ (76) | $ (77) | $ 3,200 |
Raw material inventory reserve | $ 5,000 | $ 5,000 |
Inventory, Net of Reserves (Det
Inventory, Net of Reserves (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 213,000 | |
Total | $ 0 | $ 213,000 |
Property and Equipment (Detail)
Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Property Plant And Equipment [Line Items] | ||
Property Plant and equipment gross | $ 1,974 | $ 1,969 |
Less accumulated depreciation and amortization | (1,877) | (1,820) |
Total | 97 | 149 |
Laboratory and manufacturing equipment | ||
Property Plant And Equipment [Line Items] | ||
Property Plant and equipment gross | 591 | 591 |
Computer equipment and software | ||
Property Plant And Equipment [Line Items] | ||
Property Plant and equipment gross | 1,179 | 1,174 |
Office furniture and equipment | ||
Property Plant And Equipment [Line Items] | ||
Property Plant and equipment gross | 183 | 183 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property Plant and equipment gross | $ 21 | $ 21 |
Recognized Charge for Impaired
Recognized Charge for Impaired Fixed Assets (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Impaired Long-Lived Assets Held and Used [Line Items] | |
Impairment loss on fixed assets | $ 145 |
Cost of revenue | |
Impaired Long-Lived Assets Held and Used [Line Items] | |
Impairment loss on fixed assets | 24 |
Research and Development Expense | |
Impaired Long-Lived Assets Held and Used [Line Items] | |
Impairment loss on fixed assets | 79 |
General and Administrative Expense | |
Impaired Long-Lived Assets Held and Used [Line Items] | |
Impairment loss on fixed assets | $ 42 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Property Plant And Equipment [Abstract] | ||
Assets under capital leases | $ 0 | $ 0 |
Depreciation and amortization expense | $ 57,000 | $ 200,000 |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Payables And Accruals [Abstract] | ||
Clinical trials | $ 16 | |
Payroll and related liabilities | $ 181 | 430 |
Professional fees | 421 | 617 |
Credit refunds | 279 | |
Interest payable | 136 | |
Other | 4 | 97 |
Total | $ 1,021 | $ 1,160 |
Accrued Expenses - Additional I
Accrued Expenses - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Payables And Accruals [Abstract] | ||
Separation related expenses | $ 0 | $ 600,000 |
Payroll and related liabilities | 0 | $ 100,000 |
Estimated accrued expense for product return related costs | 202,000 | |
Credit memos granted to customers | 77,000 | |
Interest payable | 136,000 | |
Short-term debt to related party, principal amount | $ 5,000,000 |
Short Term Notes Payable - Addi
Short Term Notes Payable - Additional Information (Detail) | 12 Months Ended | |
Dec. 31, 2016USD ($)Installment | Dec. 31, 2017USD ($) | |
Short-term Debt [Line Items] | ||
Short term loan payable | $ 4,929,000 | |
First Insurance Funding Corp | Short Term Loan Agreement | ||
Short-term Debt [Line Items] | ||
Short term loan, maximum borrowing capacity | $ 306,380 | |
Number of monthly payments | Installment | 10 | |
Monthly payments, including principal and interest | $ 30,638 | |
Annual interest rate | 1.95% | |
Short term loan payable | $ 214,000 | $ 0 |
Short-Term Debt to Related Pa58
Short-Term Debt to Related Party - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Jun. 15, 2017 | |
Debt Instrument [Line Items] | ||
Debt principal amount | $ 5,000 | |
Amortization of the issuance costs | $ 44 | |
Senior Secured Convertible Promissory Notes | ||
Debt Instrument [Line Items] | ||
Debt principal amount | $ 5,000 | |
Interest rate during period | 5.00% | |
Interest rate during default | 8.00% | |
Maturity Date | Dec. 31, 2018 | |
Interest expense | $ 136 | |
Amortization of the issuance costs | 44 | |
Senior Secured Convertible Promissory Notes | Chess Deposit Interest | ||
Debt Instrument [Line Items] | ||
Qualified financing least amount raised | $ 10,000 | |
Percentage of remaining outstanding unconverted principal balance payment obligation | 110.00% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | |||||||||
Jun. 30, 2016USD ($)ft² | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2010USD ($) | Dec. 31, 2009USD ($) | Dec. 31, 2008USD ($) | Dec. 31, 2007USD ($) | Dec. 31, 2006USD ($) | Dec. 31, 2005USD ($) | Dec. 31, 2004USD ($) | Dec. 31, 2003USD ($) | |
Commitments And Contingencies Disclosure [Abstract] | |||||||||||
Rentable area of leased premises | ft² | 4,200 | ||||||||||
Lease commenced date | 2016-06 | ||||||||||
Lease expiration date | 2018-04 | ||||||||||
Rent expense | $ 11,900 | $ 100,000 | $ 500,000 | ||||||||
License agreement payment | $ 25,000 | $ 25,000 | $ 25,000 | $ 25,000 | $ 25,000 | $ 25,000 | $ 12,500 | $ 75,000 |
Future Minimum Lease Payments U
Future Minimum Lease Payments Under All Non-cancelable Lease Arrangements (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2,018 | $ 42 |
Total future minimum lease payments | $ 42 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) - Additional Information (Detail) $ / shares in Units, $ in Thousands | Jan. 31, 2017USD ($)$ / sharesshares | Dec. 20, 2016USD ($)$ / sharesshares | Apr. 09, 2015 | Jan. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2017USD ($)shares | Dec. 31, 2016USD ($)shares | Dec. 31, 2017USD ($)shares | May 22, 2017shares |
Class of Stock [Line Items] | ||||||||
Reverse stock split ratio, description | On April 9, 2015, the Company amended its certificate of incorporation to reflect the one-for-ten reverse stock split approved by its shareholders | |||||||
Reverse stock split ratio | 0.1 | |||||||
Common stock, shares authorized | 50,000,000 | 13,000,000 | 50,000,000 | 50,000,000 | ||||
Capital stock, shares authorized | 50,500,000 | 50,500,000 | ||||||
Preferred stock, shares authorized | 500,000 | 500,000 | 500,000 | |||||
Proceeds from issuance of shares | $ | $ 200 | $ 200 | $ 198 | $ 978 | $ 232,800 | |||
Private placement amount received | $ | $ 1,000 | |||||||
Stock issued, shares | 249,632 | 1,397,300 | ||||||
Common stock issued, price per share | $ / shares | $ 0.83 | $ 0.83 | ||||||
CHESS Depositary Interests | ||||||||
Class of Stock [Line Items] | ||||||||
Stock issued, shares | 12,481,600 | 69,865,000 | 12,481,600 | |||||
Common stock issued, price per share | $ / shares | $ 0.22 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) | 12 Months Ended | |||
Dec. 31, 2017USD ($)CompensationPlan$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Aug. 31, 2011shares | Aug. 01, 2011shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of stock-based compensation plans | CompensationPlan | 2 | |||
Annual increase in number of shares available for grant | shares | 500,000 | |||
Percentage of common shares outstanding | 4.00% | |||
Number of shares available for issue, additional shares | shares | 436,314 | 380,222 | ||
Stock options, vesting period | 4 years | |||
Stock options, expire period | 10 years | |||
Unrecognized stock-based compensation | $ | $ 400,000 | |||
Weighted-average grant date fair value of options granted | $ / shares | $ 1.07 | $ 1 | ||
Option exercised total intrinsic value | $ | $ 0 | $ 0 | ||
Proceeds from exercise of stock options | $ | 0 | 0 | ||
Tax benefits realized from options and other stock-based payment | $ | $ 0 | $ 0 | ||
Shares of common stock issued pursuant to exercise of unvested options | shares | 0 | 0 | ||
Cash paid for the exercise price | $ | $ 0 | $ 0 | ||
Stock-based compensation expense | $ | $ 187,000 | $ 667,000 | ||
Stock Option | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Recognized weighted-average period years | 2 years | |||
Restricted Stock Units (RSUs) and Performance Stock Units (PSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares of common stock to be received, per restricted stock unit and performance stock unit | 1 | |||
Shares granted to employees | shares | 0 | 392,659 | ||
Weighted average grant date fair value per share | $ / shares | $ 0 | $ 0.75 | ||
Restricted stock units outstanding | shares | 392,659 | 403,501 | ||
Performance Shares | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Restricted stock units outstanding | shares | 392,659 | 403,501 | ||
Unrecognized stock based compensation | $ | $ 243,000 | |||
Restricted Stock Units (RSUs) and Performance Stock Units (PSUs) Having Service-Based Vesting | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense (benefit) | $ | $ 0 | $ (100,000) | ||
Non Employees | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options granted, shares | shares | 115,500 | 50,000 | ||
Options granted, aggregate fair value | $ | $ 171,000 | |||
Options cancelled, shares | shares | 46,500 | |||
Options cancelled, aggregate fair value | $ | $ 78,000 | |||
Stock-based compensation expense | $ | $ 34,000 | $ 500,000 | ||
Stock Incentive Plan 2003 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares available for future grants | shares | 922,086 | |||
Stock Incentive Plan 2011 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares available for future grants | shares | 1,060,920 | 80,235 | ||
Share reserved for incentive plan | shares | 450,000 |
Stock-Based compensation Reflec
Stock-Based compensation Reflected in Consolidated Statements of Operations and Comprehensive Loss (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 187 | $ 667 |
Operations | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 34 | |
Research and Development Expense | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 19 | 56 |
Sales and marketing | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 75 | 159 |
General and Administrative Expense | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 93 | $ 418 |
Weighted-average Assumptions us
Weighted-average Assumptions used to Estimate Fair Value of Stock Options (Detail) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Expected volatility | 93.30% | 75.80% |
Expected term (in years) | 6 years 18 days | 6 years 18 days |
Risk-free interest rate | 2.30% | 2.10% |
Expected dividend yield | 0.00% | 0.00% |
Share-Based Activity (Detail)
Share-Based Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Options | ||
Outstanding, beginning balance | 748,571 | |
Granted | 408,635 | |
Exercised | 0 | |
Cancelled | (164,985) | |
Outstanding, ending balance | 992,221 | 748,571 |
Vested or expected to vest at December 31, 2017 | 992,221 | |
Exercisable at December 31, 2017 | 388,007 | |
Weighted Average Exercise Price | ||
Outstanding, beginning balance | $ 8.67 | |
Granted | 1.07 | |
Exercised | 0 | |
Cancelled | 11.81 | |
Outstanding, ending balance | 4.88 | $ 8.67 |
Vested or expected to vest at December 31, 2017 | 1 | |
Exercisable at December 31, 2017 | $ 10.71 | |
Weighted Average Contractual Life (in Years) | ||
Outstanding at end of period | 7 years 6 months 25 days | 8 years 4 months 17 days |
Vested or expected to vest at December 31, 2017 | 10 years 5 months 15 days | |
Exercisable at December 31, 2017 | 5 years 8 months 19 days | |
Aggregate Intrinsic Value | ||
Outstanding at end of period | $ 0 | $ 0 |
Vested or expected to vest at December 31, 2017 | 0 | |
Exercisable at December 31, 2017 | $ 0 |
Restricted Stock Units and Perf
Restricted Stock Units and Performance Stock Units Activity (Detail) - Restricted Stock Units (RSUs) and Performance Stock Units (PSUs) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Number of Units | ||
Outstanding, beginning balance | 403,501 | |
Granted | 0 | 392,659 |
Exercised | 0 | |
Cancelled | (10,842) | |
Outstanding, ending balance | 392,659 | 403,501 |
Weighted Average Contractual Life (in years) | ||
Outstanding at end of period | 8 years 3 months 7 days | 9 years 1 month 9 days |
Aggregate Intrinsic Value | ||
Outstanding Aggregate Intrinsic Value | $ 429 | $ 365 |
Segment Reporting - Additional
Segment Reporting - Additional Information (Detail) $ in Millions | 12 Months Ended | |
Dec. 31, 2017USD ($)SegmentCustomer | Dec. 31, 2016Customer | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Number of reportable segments | Segment | 1 | |
Long-lived assets | $ | $ 0.1 | |
Sales Revenue, Net | Customer Concentration Risk | Distributor One | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Number of customers | 1 | |
Concentration risk percentage | 100.00% | 24.00% |
Sales Revenue, Net | Customer Concentration Risk | Other Customer | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Number of customers | 0 |
Product Sales by Geographic Loc
Product Sales by Geographic Location (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | $ 53 | $ 545 |
Europe | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | $ 53 | 309 |
Middle East | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | 154 | |
Asia Pacific | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | $ 82 |
Retirement Plans - Additional I
Retirement Plans - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Defined Benefit Plan Disclosure [Line Items] | ||
Defined contribution plan company contribution percentage | 100.00% | |
Defined contribution plan cost recognized | $ 37 | $ 100 |
International employees | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Defined contribution plan company contribution percentage | 100.00% | |
Defined contribution plan cost recognized | $ 38 | $ 26 |
Income Tax - Additional Informa
Income Tax - Additional Information (Detail) - USD ($) | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Taxes [Line Items] | ||||
Tax cuts and jobs act of 2017, income tax benefit from repatriation of foreign earnings | $ 23,000 | |||
U.S. federal statutory rate | 34.00% | |||
Tax cuts and jobs act of 2017, decrease in deferred tax assets | $ 28,900,000 | |||
Tax cuts and jobs act of 2017, deferred tax asset valuation allowance | 28,900,000 | |||
Unrecognized tax liabilities | 1,481,000 | $ 1,449,000 | $ 1,426,000 | |
Uncertain tax positions, accrued interest or penalties | 0 | 0 | ||
UNITED STATES | ||||
Income Taxes [Line Items] | ||||
Deferred tax assets valuation allowance | 69,100,000 | $ 92,400,000 | ||
Decrease in deferred tax valuation allowance | (23,300,000) | |||
Federal | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | 223,000,000 | |||
Federal | Research and development | ||||
Income Taxes [Line Items] | ||||
Tax credit carryforwards | $ 2,800,000 | |||
Federal | Earliest Tax Year | ||||
Income Taxes [Line Items] | ||||
Operating loss carryforward expiration year | 2,024 | |||
Federal | Earliest Tax Year | Research and development | ||||
Income Taxes [Line Items] | ||||
Tax credit carryforwards expiration year | 2,023 | |||
Federal | Latest Tax Year | ||||
Income Taxes [Line Items] | ||||
Operating loss carryforward expiration year | 2,037 | |||
Federal | Latest Tax Year | Research and development | ||||
Income Taxes [Line Items] | ||||
Tax credit carryforwards expiration year | 2,037 | |||
State | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | $ 205,600,000 | |||
State | Research and development | ||||
Income Taxes [Line Items] | ||||
Tax credit carryforwards | $ 1,200,000 | |||
State | Earliest Tax Year | ||||
Income Taxes [Line Items] | ||||
Operating loss carryforward expiration year | 2,030 | |||
Open Tax Year | 2,013 | |||
State | Earliest Tax Year | Research and development | ||||
Income Taxes [Line Items] | ||||
Tax credit carryforwards expiration year | 2,018 | |||
State | Latest Tax Year | ||||
Income Taxes [Line Items] | ||||
Operating loss carryforward expiration year | 2,037 | |||
Open Tax Year | 2,017 | |||
State | Latest Tax Year | Research and development | ||||
Income Taxes [Line Items] | ||||
Tax credit carryforwards expiration year | 2,032 | |||
Foreign | Earliest Tax Year | ||||
Income Taxes [Line Items] | ||||
Open Tax Year | 2,013 | |||
Foreign | Latest Tax Year | ||||
Income Taxes [Line Items] | ||||
Open Tax Year | 2,017 | |||
Scenario, Plan | ||||
Income Taxes [Line Items] | ||||
U.S. federal statutory rate | 21.00% |
Loss before Provision for Incom
Loss before Provision for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | ||
Domestic | $ (10,923) | $ (13,124) |
Foreign | 47 | 41 |
Loss before income tax expense | $ (10,876) | $ (13,083) |
Summary Provision for Income Ta
Summary Provision for Income Taxes in Accompanying Consolidated Statements of Operations and Comprehensive Loss (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Current Provision: | ||
Federal | $ 0 | $ 0 |
State | 1 | 17 |
Foreign | 13 | 16 |
Total | 14 | 33 |
Deferred (Benefit) Provision: | ||
Federal | 0 | 0 |
State | 0 | 0 |
Foreign | 0 | 0 |
Total | 0 | 0 |
Total provision | $ 14 | $ 33 |
Reconciliation of Income Taxes
Reconciliation of Income Taxes from Operations (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | ||
Income tax benefit using U.S. federal statutory rate | $ (3,698) | $ (4,449) |
Rate Changes | 28,942 | |
Permanent differences | 35 | 16 |
State income taxes, net of federal benefit | (141) | (661) |
Stock compensation | 53 | 1,218 |
Tax credits | (127) | (42) |
Foreign tax rate differential | (2) | 1 |
Change in the valuation allowance | (25,161) | 1,303 |
Unrealized gain | 2,673 | |
Other | 113 | (26) |
Total provision | $ 14 | $ 33 |
Summary of Net Deferred Tax Ass
Summary of Net Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 59,823 | $ 79,648 |
Research and development credit carryforwards | 4,005 | 3,713 |
Capitalized research and development costs | 464 | 1,366 |
Capitalized start-up expenses | 2,846 | 4,594 |
Depreciation and other | 1,920 | 3,081 |
Total deferred tax assets | 69,058 | 92,402 |
Valuation allowance | (69,058) | (92,402) |
Net deferred tax asset | $ 0 | $ 0 |
Unrecognized Tax Benefits (Deta
Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | ||
Unrecognized tax benefit – as of the beginning of the year | $ 1,449 | $ 1,426 |
Gross increases – tax positions of the prior periods | 0 | 0 |
Gross increases – current period tax positions | 32 | 23 |
Unrecognized tax benefits – as of the end of the year | $ 1,481 | $ 1,449 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Feb. 27, 2018 | Jan. 22, 2018 | Jan. 31, 2017 | Dec. 20, 2016 | Jan. 31, 2017 | Dec. 31, 2017 | Dec. 31, 2016 |
Subsequent Event [Line Items] | |||||||
Stock issued, shares | 249,632 | 1,397,300 | |||||
Common stock issued, price per share | $ 0.83 | $ 0.83 | |||||
Private placement amount received | $ 1,000 | ||||||
Common stock | |||||||
Subsequent Event [Line Items] | |||||||
Stock issued, shares | 1,397,300 | 249,632 | 249,632 | 1,397,300 | |||
CHESS Depositary Interests | |||||||
Subsequent Event [Line Items] | |||||||
Stock issued, shares | 12,481,600 | 69,865,000 | 12,481,600 | ||||
Common stock issued, price per share | $ 0.22 | ||||||
Subsequent Event | Private Placement | |||||||
Subsequent Event [Line Items] | |||||||
Private placement amount received | $ 1,620 | ||||||
Subsequent Event | Private Placement | Common stock | |||||||
Subsequent Event [Line Items] | |||||||
Stock issued, shares | 1,175,612 | ||||||
Subsequent Event | Private Placement | CHESS Depositary Interests | |||||||
Subsequent Event [Line Items] | |||||||
Stock issued, shares | 58,780,619 | ||||||
Common stock issued, price per share | $ 0.035 | ||||||
Subsequent Event | Private Placement | Tranche One | |||||||
Subsequent Event [Line Items] | |||||||
Private placement amount received | $ 781 | ||||||
Subsequent Event | Private Placement | Tranche One | Common stock | |||||||
Subsequent Event [Line Items] | |||||||
Stock issued, shares | 569,341 | ||||||
Subsequent Event | Private Placement | Tranche One | CHESS Depositary Interests | |||||||
Subsequent Event [Line Items] | |||||||
Stock issued, shares | 28,467,063 | ||||||
Subsequent Event | Private Placement | Tranche Two | |||||||
Subsequent Event [Line Items] | |||||||
Private placement amount received | $ 830 | ||||||
Subsequent Event | Private Placement | Tranche Two | Common stock | |||||||
Subsequent Event [Line Items] | |||||||
Stock issued, shares | 606,271 | ||||||
Subsequent Event | Private Placement | Tranche Two | CHESS Depositary Interests | |||||||
Subsequent Event [Line Items] | |||||||
Stock issued, shares | 30,313,556 | ||||||
Subsequent Event | Private Placement | Tranche Two | CHESS Depositary Interests | Board Member | |||||||
Subsequent Event [Line Items] | |||||||
Stock issued, shares | 2,921,800 | ||||||
Subsequent Event | Private Placement | Tranche Two | CHESS Depositary Interests | Crystal Amber Fund | |||||||
Subsequent Event [Line Items] | |||||||
Stock issued, shares | 27,391,756 |