Document and Entity Information - USD ($) |
12 Months Ended | ||
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Dec. 31, 2017 |
Mar. 09, 2018 |
Jun. 30, 2017 |
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Document And Entity Information | |||
Entity Registrant Name | Corindus Vascular Robotics, Inc. | ||
Entity Central Index Key | 0001528557 | ||
Document Type | 10-K | ||
Trading Symbol | CVRS | ||
Document Period End Date | Dec. 31, 2017 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity a Well-known Seasoned Issuer | No | ||
Entity a Voluntary Filer | No | ||
Entity's Reporting Status Current | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 204,251,114 | ||
Entity Common Stock, Shares Outstanding | 188,772,869 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2017 |
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares |
Dec. 31, 2017 |
Dec. 31, 2016 |
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Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized shares | 10,000,000 | 10,000,000 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized shares | 250,000,000 | 250,000,000 |
Common stock, issued shares | 188,764,851 | 119,025,221 |
Common stock, outstanding shares | 188,764,851 | 119,025,221 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands |
12 Months Ended | ||
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Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
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Income Statement [Abstract] | |||
Revenue | $ 9,650 | $ 2,842 | $ 2,729 |
Cost of revenue | 9,265 | 5,042 | 3,724 |
Gross profit (loss) | 385 | (2,200) | (995) |
Operating expenses: | |||
Research and development | 9,517 | 10,313 | 10,033 |
Selling, general and administrative | 24,777 | 19,564 | 16,143 |
Total operating expense | 34,294 | 29,877 | 26,176 |
Operating loss | (33,909) | (32,077) | (27,171) |
Interest and other expense, net | (214) | (1,001) | (1,592) |
Net loss | $ (34,123) | $ (33,078) | $ (28,763) |
Net loss per share--basic and diluted (in dollars per share) | $ (0.20) | $ (0.28) | $ (0.25) |
Weighted-average common shares used in computing net loss per share--basic and diluted (in shares) | 173,925,450 | 119,019,700 | 113,254,925 |
Other comprehensive loss: | |||
Net loss | $ (34,123) | $ (33,078) | $ (28,763) |
Unrealized gain (loss) on marketable securities | 14 | (14) | |
Comprehensive loss | $ (34,123) | $ (33,064) | $ (28,777) |
CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands |
12 Months Ended | |
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Dec. 31, 2017 |
Dec. 31, 2015 |
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Statement of Stockholders' Equity [Abstract] | ||
Issuance costs | $ 415 | $ 794 |
Nature of Operations |
12 Months Ended | ||
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Dec. 31, 2017 | |||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Nature of Operations |
The Company
Corindus Vascular Robotics, Inc. (the “Company”), formerly named Your Internet Defender, Inc. (“YIDI”), acquired Corindus, Inc., a privately-held company, in a reverse acquisition on August 12, 2014 (the “Acquisition”). The Company was previously a Nevada corporation, but effective June 28, 2016, the Company changed its state of incorporation from the State of Nevada to the State of Delaware. The Company’s corporate headquarters and research and development facility are in Waltham, Massachusetts and the Company is engaged in the design, manufacture and sale of precision vascular robotic-assisted systems (“CorPath System”) for use in interventional vascular procedures.
Since its inception on March 21, 2002, the Company has devoted its efforts principally to research and development, business development activities and raising capital. In July 2012, the Company received 510(k) clearance from the United States Food and Drug Administration (“FDA”) for the CorPath 200 System and initiated a limited commercial launch in the U.S. In 2013, the Company moved into the growth stage, investing in sales and marketing in order to build the customer base. While the Company’s device is initially cleared for and targeting percutaneous coronary intervention (“PCI”) and peripheral vascular procedures, the Company believes its technology platform has the capability to be developed in the future for other segments of the vascular intervention market, including neurointerventional and other more complex cardiac interventions such as structural heart procedures.
In October 2015, the Company received 510(k) clearance from the FDA for its robotic-assisted CorPath 200 System to be used during PCI procedures performed via radial access. The 510(k) clearance was based on results of a clinical trial conducted at Spectrum Health, Grand Rapids, Michigan, and St. Joseph’s Hospital Health Center, Syracuse, New York.
In March 2016, the Company received 510(k) clearance from the FDA for its robotic-assisted CorPath 200 System for use in peripheral vascular interventions. The 510(k) clearance for peripheral intervention was based on results of a clinical trial conducted at Medical University of Graz in Graz, Austria.
In October 2016, the Company received 510(k) clearance from the FDA for its CorPath GRX, the second generation of its CorPath System and in February 2018, the Company received 510(k) clearance from the FDA for CorPath GRX to be used during peripheral vascular interventions. In March 2018, the Company received 510(k) clearance from the FDA for the first automated robotic movement designed for the CorPath GRX platform. The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures. The Company began commercial shipment of the CorPath GRX in late January 2017.
The Company’s future capital requirements will depend upon many factors, including progress with developing, manufacturing and marketing its technologies, the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights, its ability to establish collaborative arrangements, marketing activities and competing technological and market developments, including regulatory changes affecting medical procedure reimbursement, and overall economic conditions in the Company’s target markets.
Liquidity
On March 16, 2018, the Company closed on a private placement of convertible preferred stock for gross proceeds of $25,000. The preferred stock is convertible into an aggregate of 20,000,000 shares of common stock, and is entitled to receive non-compounding dividends in additional shares of preferred stock, at the rate of 12% per annum, subject to reduction in the event certain milestones are achieved. The preferred stock purchasers were also issued warrants to purchase an aggregate of 8,750,000 shares of common stock at an exercise price of $1.40 per share, exercisable either for cash or on a cashless basis.
On March 16, 2018, the Company completed a financing arrangement with two lenders which provides for borrowings of up to $26 million in the form of up to $23 million in term loans and up to a $3 million revolving line-of-credit through March 2022. As of March 16, 2018, the Company had $12 million in principal outstanding under the term loan facility and $0 in principal outstanding under the revolving loan facility. An additional $5.5 million in term loans may become available in the future provided the Company has achieved a specified gross profit milestone prior to January 1, 2019, and an additional $5.5 million may become available provided the Company receives net cash proceeds of $30 million from a future sale of the Company's equity securities prior to July 1, 2019 and achieves a specified gross profit milestone prior to September 1, 2019. Until such time that the Company achieves the specified criteria, the additional term loans are not available to the Company. The Company cannot assure you that the Company will achieve the gross profit or equity financing milestones that will trigger the Company's ability to further draw the term loan facility. The revolving line-of-credit also has various clauses which restrict its availability and for which the Company currently does not meet such restrictions. The outstanding term loans bear interest at a floating rate per annum equal to the greater of (i) 8.83% and (ii) the sum of (a) the one month ICE Benchmark LIBOR based on U.S. Dollar deposits, plus (b) 7.25%. The outstanding principal under the revolving line bears interest at a floating rate per annum equal to the greater of (i) 5.0% and (ii) the sum of (a) the “prime rate,” as reported in the Wall Street Journal, plus (b) 0.5%, which interest is payable monthly. Both loan facilities are secured by substantially all of the Company's personal property other than the Company's intellectual property. Both loan facilities include customary affirmative and negative covenants. Upon the earlier of the second advance under the term loan facility or the first advance under the revolving loan facility, the Company must also achieve minimum revenue on a monthly basis measured against a percentage of the Company's Board of Directors-approved projections for the applicable fiscal year. The Company's failure to satisfy the revenue, or any other, covenant could result in an event of default under the loan facilities. Both loan facilities also include other events of default, the occurrence and continuation of which could cause interest to be charged at the rate that is otherwise applicable plus 5.0% and would provide the collateral agent under the term loan facility or the lender under the revolving loan facility, as applicable, with the right to exercise remedies against the Company and the collateral securing the loan facilities. These events of default include, among other things, any failure by the Company to pay principal or interest due under the loan facilities, a breach of certain covenants under the loan facilities, the Company's insolvency, a material adverse change, the occurrence of any default under certain other indebtedness in an amount greater than $0.25 million, one or more judgments against the Company in an amount greater than $0.25 million individually or in the aggregate, and any default under the other loan facility.
The Company has incurred losses since inception and has funded its cash flow deficits primarily through the issuance of capital stock and debt. As of December 31, 2017, the Company had an accumulated deficit of $180,841. As of December 31, 2017, the Company had cash and cash equivalents of $17,458 and working capital of $16,429. The Company anticipates that these available resources and the additional financings discussed above will be sufficient to meet the Company’s cash requirements for at least the next 12 months from March 19, 2018. However, as the Company continues to incur losses and cash flow deficits, its transition to profitability is dependent upon achieving a level of revenues adequate to support its cost structure, but the Company will otherwise rely on additional capital funding until such time as that is achieved. As such, the Company has evaluated whether or not its cash and cash equivalents on hand and the cash proceeds from the financing activities described above would be sufficient to sustain projected operating activities through March 19, 2019 as required by Accounting Standards Codification (ASC) 205-40 Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern. Based on the Company’s current forecasts of annual cash flow deficits, which are estimated to be approximately $37,000 to $39,000 per year, the Company will have cash through approximately May 2019.
Due to the inherent uncertainty in predicting revenues and certain variable costs, management has considered its ability to reduce cash flow deficits and has determined that if it does not achieve its revenue forecast, it would undertake the following activities to reduce its cash flow deficits:
● Defer or limit some or all of its spending on capital equipment that management believes is necessary to reduce manufacturing costs of cassettes and CorPath systems to be used in marketing and training activities that were otherwise planned for 2018; ● Eliminate or defer the 2018 discretionary bonus payouts for all bonus eligible employees, including executive management; ● Reduce spending on travel, clinical programs and prototypes; ● Eliminate planned headcount additions in marketing, sales, and manufacturing; and ● Reduce external consulting resources who otherwise would be used to assist in installations of CorPath systems.
As a result, management believes its plans can be effectively implemented as all of the actions are within the Company’s control and will be finalized and will be able to be effectively implemented, if required.
The Company may never achieve profitability, and unless and until doing so, the Company intends to fund future operations through additional non-dilutive or dilutive financings. There can be no assurances, however, that additional funding will be available on terms acceptable to the Company, if at all. |
Significant Accounting Policies |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Significant Accounting Policies |
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Corindus, Inc. and Corindus Security Corporation. All intercompany transactions and balances have been eliminated in consolidation. The functional currency of both wholly-owned subsidiaries is the U.S. dollar and, therefore, the Company has not recorded any currency translation adjustments.
In the fourth quarter of 2014, the Company participated in the formation of a not-for-profit, which was established to generate awareness of the health risks linked to the use of fluoroscopy in hospital catheterization. As of December 31, 2017, the Company’s Chief Executive Officer and one of its senior executives represented two of the four voting members of the board of directors of the entity. As a result, under the voting model used for the consolidation of related parties which are controlled by a company, the Company has consolidated the financial statements of the entity, and recognized expenses of $36, $123, and $386 for the years ended December 31, 2017, 2016 and 2015, respectively. The entity had assets and liabilities of $15 and $7, respectively, on its balance sheet at December 31, 2017 and had both assets and liabilities of $23 on its balance sheet at December 31, 2016.
Segment Information
The Company operates in one business segment, which is the development, marketing and sale of robotic-assisted vascular intervention devices. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. To date, the chief operating decision maker has made such decisions and assessed performance at the company level, as one segment. The Company’s chief operating decision maker is the Chief Executive Officer.
Revenues from domestic customers were $6,694, $1,867 and $2,683 for the years ending December 31, 2017, 2016 and 2015, respectively. Revenues from international customers in Japan, Dubai, Israel, and Kuwait, were $2,956, $975 and $46 for the years ending December 31, 2017, 2016 and 2015, respectively.
Use of Estimates
The process of preparing financial statements in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements. Such management estimates include those relating to revenue recognition, inventory valuation, assumptions used in the valuation of stock-based awards, and valuation allowances against deferred income tax assets. Actual results could differ from those estimates.
Cash Equivalents
The Company considers highly liquid short-term investments, which consist of money market funds, with original maturity dates of three months or less at the date of purchase, to be cash equivalents. From time to time, the Company’s cash balances may exceed federal deposit insurance limits.
Marketable Securities
The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. The Company had classified all of its marketable securities during 2016 “available-for-sale” pursuant to ASC 320, Investments – Debt and Equity Securities. The Company records available-for-sale securities at fair value, with the unrealized gains and losses included in accumulated other comprehensive loss in stockholders’ equity.
The Company adjusts the cost of available-for-sale debt securities for amortization of premiums and accretion of discounts to maturity. The Company includes such amortization and accretion in interest and other expense. The cost of securities sold is based on the specific identification method. The Company includes interest income on securities classified as available-for-sale in interest and other expense.
The Company reviews marketable securities for other-than-temporary impairment whenever the fair value of a marketable security is less than the amortized cost and evidence indicates that a marketable security’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statements of operations if the Company has experienced a credit loss, has the intent to sell the marketable security, or if it is more likely than not that the Company will be required to sell the marketable security before recovery of the amortized cost basis.
During 2016, the activity in the Company’s accumulated other comprehensive loss was composed solely of activity related to the Company’s available-for-sale securities. There were no realized gains or losses recognized on the maturity of available-for-sale securities during the year ended December 31, 2016, and as a result, the Company did not reclassify any amount out of accumulated other comprehensive loss during the year.
Fair Value Measurements
In accordance with ASC 820, Fair Value Measurements and Disclosures, the Company generally defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company uses a three-tier fair value hierarchy, which classifies the inputs used in measuring fair values. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements), and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below:
At both December 31, 2017 and 2016, the Company had only one asset, cash equivalents, that was measured at fair value on a recurring basis. The Company had cash equivalents totaling approximately $0 and $164 at December 31, 2017 and 2016, respectively, which were valued based on Level l inputs.
The Company’s financial instruments of deposits and notes receivable are carried at cost and approximate their fair values given the liquid nature of such items. The fair value of the Company’s capital lease obligation approximates its carrying value at December 31, 2017 due to its recent negotiation with lessor. The fair value of the Company’s long-term debt amounted to $3,759 at December 31, 2016 based on discounted cash flow analysis, which includes Level 3 inputs and fair value approximates recorded amounts.
Concentrations of Credit Risk and Significant Customers
The Company had the following customers that accounted for greater than 10% of its revenues for the years ended December 31, 2017, 2016 and 2015, respectively:
The Company had five other customers that together accounted for 84% of the Company’s accounts receivable balance at December 31, 2017, but none of these customers exceeded 10% of its revenues in 2017. Given the current revenue levels, in a period in which the Company sells a system, that customer is likely to represent a significant customer.
The Company had four other customers that together accounted for 73% of the Company’s accounts receivable balance at December 31, 2016, but none of these customers exceeded 10% of its revenues in 2016.
Off-Balance Sheet Arrangements
The Company has no significant off-balance sheet risk such as foreign exchange contracts, option contracts, or other hedging arrangements.
Allowance for Doubtful Accounts
The Company evaluates the collectability of accounts receivable on a regular basis. The allowance for doubtful accounts, if any, is based upon various factors including the financial condition and payment history of customers, an overall review of collections experience on other accounts and economic factors or events expected to affect future collections experience. The Company’s accounts receivable consist primarily of amounts due from large, well-capitalized customers and while the Company reviews their creditworthiness, collectability is generally not an issue. The Company records an allowance for doubtful accounts, when necessary, based on the potential for collectability issues within the customer base. The Company’s allowance for doubtful accounts was $0 at December 31, 2017 and 2016.
Product Warranty
Customers are permitted to return defective products under the Company’s standard product warranty program. For CorPath Systems, the Company’s standard one-year warranty provides for the repair of any product that malfunctions. Return and replacement can only occur if a material breach of the warranty remains uncured for 30 days. A roll-forward of the Company’s warranty liability is as follows:
Inventories
Inventories are valued at the lower of cost or net realizable value using the first-in, first-out (FIFO) method. The Company routinely monitors the recoverability of its inventory and records the lower of cost or market reserves based on current selling prices and reserves for excess and obsolete inventory based on historical and forecasted usage, as required. Scrap and excess manufacturing costs are charged to cost of revenue as incurred and not capitalized as part of inventories. The Company only capitalizes pre-launch inventories when purchased for commercial use and it deems regulatory approval to be probable.
Property and Equipment
Property and equipment is carried at cost. Major items and betterments are capitalized; maintenance and repairs are charged to expense as incurred. The Company capitalizes certain costs incurred in connection with developing or obtaining internal-use software. Software costs that do not meet capitalization criteria are expensed as incurred. Demonstration equipment represents internally manufactured capital equipment that is used on-site at trade shows and at customer locations to demonstrate the CorPath System. Field equipment represents internally manufactured capital equipment placed at customer locations under programs that involve the customer’s agreement to provide their facility as a training/showsite for other potential customers while purchasing cassettes for their cases performed. As of December 31, 2017, the Company had placed three CorPath GRX field equipment units and one CorPath GRX for a customer’s evaluation purposes.
Depreciation on the demonstration equipment is charged to selling, general and administrative and the depreciation on the field equipment is charged to cost of revenue. Depreciation is computed under the straight-line method over the estimated useful lives of the respective assets.
Depreciation is provided over the following estimated asset lives:
Impairment of Long-Lived Assets
The Company’s long-lived assets principally consist of property and equipment. The Company continually monitors events and changes in circumstances that could indicate carrying amounts of long-lived assets may not be recoverable. An impairment loss is recognized when expected cash flows are less than an asset’s carrying value. Accordingly, when indicators of impairment are present, the Company evaluates the carrying value of such assets in relation to the operating performance and estimated future undiscounted cash flows of the underlying assets. The Company’s policy is to record an impairment loss when it is determined that the carrying amount of the asset may not be recoverable. During 2016, the undiscounted estimated cash flows from certain equipment placed at customer locations was less than the related equipment’s carrying value. As such, the Company recorded an impairment charge of $125 based on the difference between the estimated fair value of the equipment and its carrying value. The impairment charge of $88 and $37 is recorded within cost of revenues and selling, general and administrative, respectively, in the accompanying 2016 consolidated statement of operations. There were no other impairment charges or indicators of impairment for the years ended December 31, 2017, 2016 or 2015.
Comprehensive Loss
Comprehensive loss is comprised of net loss and changes in the unrealized gains and losses on marketable securities. Accumulated other comprehensive loss, a component of stockholders’ equity, is comprised of the cumulative unrealized gains and/or losses from the change in fair market value of the Company’s marketable securities. Accumulated other comprehensive loss was $0 as of both December 31, 2017 and 2016.
Revenue Recognition
The CorPath System is a capital medical device used by hospitals and surgical centers to perform heart catheterizations. Use of the CorPath System requires a sterile, single-use cassette (the “CorPath Cassette”), which is sold separately, for each procedure. Products are sold to customers with no rights of return. The Company recognizes revenue on the sale of products when the following criteria are met:
In each arrangement, the Company is responsible for installation of the CorPath System and initial user training, which services are deemed essential to the functionality of the system. Therefore, the Company recognizes system revenue when the CorPath System is delivered and installed, and accepted by the end user customer.
Each CorPath System is sold with a standard one year warranty, which provides that the CorPath System will function as intended and during that one year period, the Company will either replace the product or a portion thereof or provide the necessary repair service during the Company’s normal service hours. The Company accrues for the estimated costs of the warranty once the CorPath System is installed.
The Company generally enters into multiple element arrangements, which include the sale of a CorPath System with an initial order of CorPath Cassettes, and may include either a basic service plan or a premium service plan. The basic service plan provides for an extended warranty period and the premium service plan provides for the extended warranty as well as component upgrades, when and if they become available during the service period. Deliverables, which are accounted for as separate units of accounting under multiple-element arrangements include: (a) the CorPath System, including installation and initial training, which are subject to customer acceptance and (b) the initial shipment of CorPath Cassettes to the customer, and may include either (c) an extended warranty or (d) component upgrades.
The Company recognizes revenue on multiple-element arrangements in accordance with ASU 2009-13, Revenue Recognition (Topic 605): Multiple Deliverable Revenue Arrangements, based on the estimated selling price of each element. In accordance with ASU 2009-13, the Company uses vendor-specific objective evidence (“VSOE”), if available, to determine the selling price of each element. If VSOE is not available, the Company uses third-party evidence (“TPE”) to determine the selling price. If TPE is not available, the Company uses its best estimate to develop the estimated selling price (“BESP”). The Company uses BESP to determine the selling price of its systems as well as the basic and premium service plans. BESP is determined based on estimated costs plus a reasonable margin, and has generally been consistent with the price charged to the customer for such products and services. The determination of BESP also considers the price of the service plans charged to customers when such services are sold separately in subsequent transactions. The Company also uses BESP to determine the selling price of the initial order of cassettes, which considers the price at which it charges its customers when the cassettes are sold separately.
Revenue related to basic and premium service plans is recognized on a straight-line basis over the life of the service contract. Revenue from cassettes and accessories is recorded upon delivery and services provided by the Company outside of a basic or premium service contract are recognized as the services are provided. If a revenue arrangement contains an undelivered element, such as a specified upgrade, revenues are deferred until delivery is complete.
There are no performance, cancellation, termination, and refund-type provisions under the Company’s multiple element arrangements.
At times, the Company may provide products to customers in exchange for future purchases of products and provision of services. The costs of any such products are included in cost of revenue in the accompanying consolidated statements of operations.
The Company also uses a One-Stent Program to demonstrate its confidence in the CorPath System’s ability to help accurately measure anatomy and precisely place only one stent per lesion. The Company provides eligible customers registered under the program a $1 credit against future CorPath Cassette purchases for a qualifying CorPath PCI procedure which uses more than one stent per lesion. The estimated cost of honoring the potential obligation under the program is recorded as a reduction of revenue at the time of shipment. These costs have not been significant to date.
The Company records shipping and handling costs as a selling expense in the period incurred, and records payments from customers for shipping costs as a reduction of selling expenses. Such amounts have not been material in the periods presented.
Research and Development
Costs for research and development are expensed as incurred. Research and development expense consists primarily of salaries, salary-related expenses and costs of contractors and materials.
Income Taxes
The Company accounts for income taxes using the liability method, whereby deferred tax asset and liability account balances are determined based on differences between financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable.
The Company accounts for uncertain tax positions using a “more-likely-than-not” threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position. The Company evaluates these tax positions on an annual basis. The Company also accrues for potential interest and penalties related to unrecognized tax benefits in income tax expense.
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.
Stock-Based Compensation
The Company recognizes compensation costs resulting from the issuance of service stock-based awards to employees and directors as an expense in the consolidated statements of operations over the requisite service period based on a measurement of fair value for each stock award. The awards issued to date have primarily been stock options with service-based vesting periods over two or four years, restricted stock units with service-based vesting periods of one year, and shares of unrestricted common stock. During 2017, certain shares of unrestricted common stock were granted to a non-employee director of the Company which were fully vested upon grant. Accordingly, compensation expense related to unrestricted stock was recognized on the date of the grant. During 2016, the Company issued certain stock-based awards that contain both performance and service-based vesting conditions which vest over periods of up to 25 months. The Company records expense on these awards when it becomes probable that the performance condition and requisite service will be met. The Company recognizes compensation costs resulting from the issuance of stock-based awards to non-employees as an expense in the consolidated statements of operations over the service period based on a measurement of fair value for each stock award at each performance date and period end.
Prior to the Company’s initial public offering, the fair value of the Common Stock was obtained from quoted market prices on the OTCQB as provided by OTC Market Groups, Inc. In connection with the public offering in May 2015, the Company’s Common Stock was approved for listing on the NYSE American, where it commenced trading under the symbol “CVRS”. As such, subsequent to this, the Company utilizes quoted market prices to calculate fair value of stock-based awards.
The following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes-Merton option-pricing model (“Black-Scholes Model”).
The risk-free interest rate assumption is based upon observed U.S. government treasury interest rates with a term that is consistent with the expected term of the Company’s employee stock options. The expected term is based on the average of the vesting period and contractual term of the Company’s options given the lack of historical data available. The Company does not pay a dividend, and is not expected to pay a dividend in the foreseeable future.
Due to a lack of a public market for the Company’s Common Stock for an extended period of time, the Company utilized comparable public companies’ volatility rates as a proxy of its expected volatility for purposes of the Black-Scholes Model. Stock-based compensation expense is recorded net of estimated forfeitures and is adjusted periodically for actual forfeitures. The Company uses historical data to estimate forfeiture rates. For the years ended December 31, 2017, 2016 and 2015, forfeitures were estimated to be 5.0% each year.
Recent Accounting Pronouncements
In May 2014, August 2015, April 2016 and May 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers, ASU 2015-14, Revenue from Contracts with Customers, Deferral of the Effective Date, ASU 2016-10, Revenue from Contracts with Customers, Identifying Performance Obligations and Licensing, and ASU 2016-12, Revenue from Contracts with Customers, Narrow-Scope Improvements and Practical Expedients, respectively, (collectively referred to as “Topic 606”). Topic 606 outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers, and supersedes current revenue recognition guidance, including industry-specific guidance. It also requires entities to disclose both quantitative and qualitative information that enable financial statements users to understand the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. The amendments in these ASUs are effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. The two permitted transition methods under the new standard are the full retrospective method, in which case the standard would be applied to each prior reporting period presented and the cumulative effect of applying the standard would be recognized at the earliest period shown, or the modified retrospective method, in which case the cumulative effect of applying the standard would be recognized at the date of initial application. The Company will adopt the guidance on January 1, 2018 and will apply the modified retrospective transition approach only to contracts that have undelivered performance obligations as of this date. The Company performed a review of all revenue streams to identify any differences in the timing, measurement or presentation of revenue recognition. The Company has an installed base of 62 CorPath Systems as of December 31, 2017. The Company assessed all of these systems, and determined that a large number of those installations will not be impacted by the implementation of Topic 606 since there will be no future performance obligations under those arrangements upon adoption. As a result, the Company identified a limited number of contracts for which there will be future performance obligations as of the adoption date. Pertaining to these contracts, the adoption of Topic 606 will result in certain components of services being unbundled from previously bundled arrangements, and result in an acceleration of the timing of revenue recognition related to the Company’s services. The new standard requires revenues to be estimated and recognized upon transfer of the promised goods and services, and the Company determined that the accelerated recognition of service revenues will result in a cumulative adjustment to revenues as of the adoption date. Adoption of the new standard will result in the capitalization of certain costs to obtain service contracts and the capitalization of such costs will result in an adjustment to capitalized expenses as of the adoption date. The Company is in the process of finalizing the overall impact of the adoption of this standard on its fourth quarter sales and will finalize in the first quarter of 2018. The Company’s calculations indicate that such amounts may not be material to the Company’s results of operations.
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which amends leasing accounting requirements. The new standard requires lessee recognition on the balance sheet of a right-of-use asset and a lease liability, initially measured at the present value of the lease payments. It further requires recognition in the income statement of a single lease cost, calculated so that the cost of the lease is allocated over the lease term generally on a straight-line basis. Finally, it requires classification of all cash payments within operating activities in the statement of cash flows. It is effective for fiscal years commencing after December 15, 2018 and early adoption is permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements.
In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230), Classification of Certain Cash Receipts and Cash Payments, which reduces diversity in how certain cash receipts and cash payments are presented and classified in the Consolidated Statements of Cash Flows. It is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017 and will be required to be applied retrospectively, with early adoption permitted. The Company is currently evaluating the impact of this update on its consolidated financial statements and related disclosures.
In May 2017, the FASB issued ASU 2017-09, Compensation—Stock Compensation (Topic 718) - Scope of Modification Accounting, which clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. It is effective prospectively for annual periods beginning on or after December 15, 2017, with early adoption permitted. The Company is currently evaluating the impact of this update on its consolidated financial statements and related disclosures. |
Inventories |
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Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories |
The Company’s inventories are valued at the lower of cost or net realizable value using the FIFO method and consist of the following:
The Company wrote down inventories by $268 during the year ended December 31, 2017 to properly state amounts at the lower of cost or net realizable value. |
Property and Equipment |
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Property and Equipment |
Property and equipment are stated at cost and are being depreciated using the straight-line basis over the assets’ estimated useful lives. Depreciation and amortization expense was $723, $725 and $706 for the fiscal years 2017, 2016 and 2015, respectively. Property and equipment consist of the following:
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Accrued Expenses |
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Payables and Accruals [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses |
Accrued expenses consist of the following:
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Long-Term Debt |
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Dec. 31, 2017 | |||
Debt Disclosure [Abstract] | |||
Long-Term Debt |
On June 11, 2014, the Company entered into a Loan and Security Agreement pursuant to which the lender agreed to make available to the Company $10,000 in two separate $5,000 loans under secured promissory notes. The initial note was made on June 11, 2014 in an aggregate principal amount equal to $5,000 (the “Initial Promissory Note”) and was repayable in equal monthly installments of principal and interest over 27 months beginning on July 1, 2015. On December 31, 2014, the Company borrowed the additional $5,000 (the “Second Promissory Note”) under the Loan and Security Agreement. The Second Promissory note was also repayable in equal monthly installments of principal and interest over 27 months beginning on July 1, 2015.
In connection with the Initial Promissory Note, the Company issued the lender warrants to purchase 177,514 shares of the Company’s Common Stock at an exercise price of $1.41 per share. The fair value of the warrant issued to the lender was determined to be $230 at the date of issuance, and was recorded as a discount on the debt. Additionally, in connection with the Second Promissory Note, the Company issued the lender warrants to purchase 177,514 shares of the Company’s Common Stock at an exercise price of $1.41 per share. The fair value of the warrant issued to the lender was determined to be $619 at the date of issuance, and was recorded as a discount on the debt. The Company amortized the debt discount to interest expense over the term of the debt using the effective interest method.
All amounts due under the Loan and Security Agreements were fully repaid on October 2, 2017. |
Income Taxes |
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Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Taxes |
There was no federal or state provision for income taxes for the years ended December 31, 2017, 2016 or 2015 due to the Company’s operating losses and a full valuation allowance on deferred income tax assets for all periods since inception. All of the Company’s loss before provision for income taxes is attributable to its United States operations.
The Company’s effective income tax rate differs from the statutory federal income tax rate as follows:
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and the related valuation allowance were as follows:
On December 22, 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 recording of provisional amounts during a measurement period not to extend beyond one year of the enactment date. In accordance with SAB 118, the Company has determined that its deferred tax asset value and associated valuation allowance reduction of $20,104 is a provisional amount and a reasonable estimate at December 31, 2017. The final impact may differ from this provisional amount due to, among other things, changes in interpretations and assumptions the Company has made thus far and the issuance of additional regulatory or other guidance. The Company expects to complete the final impact within the measurement period. The Company has provided a full valuation allowance against the deferred income tax assets, since it has a history of losses, which are all attributable to the U.S. and currently does not have enough positive evidence required under U.S. GAAP to reverse its valuation allowance. Management does not believe it is more likely than not that its deferred tax assets relating to the loss carryforwards and other temporary differences will be realized in the future. For the year ended December 31, 2016, the valuation allowance increased by $12,121, resulting principally from increased operating loss carryforward. For the year ended December 31, 2017, the valuation allowance decreased by $6,338, resulting principally from the change in deferred federal tax rate from 34% to 21% due to US tax reform. At December 31, 2017, the Company had U.S. federal and state net operating loss carryforwards of approximately $147,795 and $91,631, respectively, that can be carried forward and offset against future taxable income. The Federal net operating loss carryforwards will begin to expire in 2028 and the state NOL carryforwards expire in various amounts, but none before 2022.
Effective as of January 1, 2017, the Company adopted a change in accounting policy in accordance with ASU 2016-09 to account for excess tax benefits and tax deficiencies as income tax expense or benefit, treated as discrete items in the reporting period in which they occur, and to recognize previously unrecognized deferred tax assets that arose directly from (or the use of which was postponed by) tax deductions related to equity compensation in excess of compensation recognized for financial reporting. The recognition of the federal and state excess tax benefit net operating losses increased the net operating loss deferred tax asset by $438. No prior periods were restated as a result of this change in accounting policy as the Company maintains a valuation allowance against its deferred tax assets, which also increased by $438 after adoption.
The Company also had federal and state tax credits of approximately $1,935 and $1,256 at December 31, 2017, respectively, which may be used to offset future tax liabilities. These tax credit carryforwards will expire at various times beginning in 2029 for federal purposes and 2018 for state purposes.
Utilization of net operating losses and tax credit carryforwards may be subject to a substantial annual limitation due to the “change in ownership” provisions of the Internal Revenue Code of 1986, and similar state provisions. The annual limitation may result in the expiration of net operating losses before utilization. Through December 31, 2017, the Company has completed several financings since its inception which it believes has not resulted in any changes in ownership as defined by Sections 382 and 383 of the Internal Revenue Code. If the financings caused an “ownership change”, generally defined as a greater than 50 percent change (by value) in its equity ownership over a three-year period, the Company’s attributes may be subject to an annual limitation. Subsequent ownership changes may further affect the limitation in future years.
Significant judgment is required in evaluating the Company’s tax positions and in determining the Company’s provision for income taxes. In the ordinary course of business, there are many transactions and calculations for which the ultimate tax determination is uncertain. As of December 31, 2017, the Company was not under audit in any tax jurisdiction. The U.S. statute of limitations will remain open to examination by the tax authorities until the utilization of net operating loss carryforwards. The Company accrues interest and penalties, if any, related to unrecognized tax benefits in income tax expense.
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Stockholders' Equity |
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Dec. 31, 2017 | |||
Equity [Abstract] | |||
Stockholders' Equity |
The Company is authorized to issue 250,000,000 shares of common stock. Holders of Common Stock are entitled to vote on all matters and are entitled to the number of votes equal to the number of common shares held. Holders of Common Stock shall be entitled to receive dividends when and if declared by the Board of Directors. No dividends have been declared to date. In certain events, including the liquidation, dissolution or winding up of the Company, the remaining assets of the Company shall be distributed ratably among the holders of Common Stock.
The Company is authorized to issue 10,000,000 shares of preferred stock. As of December 31, 2017 and 2016, the Company had no shares of preferred stock issued or outstanding.
At December 31, 2017, there were 18,613,366 shares of common stock reserved for the potential exercise of warrants (355,028), stock options (18,215,932), and restricted stock units (42,406) and 3,752,598 shares that are available for grant under the 2014 Stock Award Plan. |
Stock-Based Compensation |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation |
In connection with the Acquisition, Corindus exchanged options to purchase shares of its Common Stock for YIDI’s options to purchase shares of YIDI’s Common Stock (the “Replacement Plan Options”). The 2014 Stock Award Plan is the replacement plan for options previously awarded under the Corindus, Inc. 2006 Umbrella Option Plan and the Corindus, Inc. 2008 Stock Incentive Plan and is the plan under which all future Company options will be issued. The 2014 Stock Award Plan was limited to award issuances which in the aggregate could not exceed 9,035,016 shares, all of which shares will be used for the issuance of the Company stock-based awards, including options to purchase common stock, restricted stock and restricted stock units. Replacement Plan Options are exercisable for up to ten years from the date of original vesting commencement date of the options.
On April 30, 2015, the Company’s Board of Directors and shareholders owning a majority of the Company’s outstanding shares of common stock approved an increase in the authorized shares of common stock under the 2014 Stock Award Plan from 9,035,016 shares to 18,661,856 shares. On June 22, 2017, the stockholders of the Company approved an amendment to the Company’s Amended and Restated 2014 Stock Award Plan to increase the number of shares of common stock available for issuance under the plan by 4,038,144 shares, from 18,661,856 shares to 22,700,000 shares (the “Plan Amendment”). The Plan Amendment was previously adopted by the Company’s Board of Directors, subject to stockholder approval, and became effective upon the receipt of stockholder approval at the Company’s Annual Meeting.
Awards of 2,293 shares of unrestricted common stock granted to a non-employee director in 2017 were valued at the closing price of the Company’s common stock at the date of grant and were fully vested on the date of grant. Stock-based compensation awards of 68,768 shares of restricted stock units granted to non-employee directors in 2017. Upon vesting, the Company issues shares of common stock for its restricted stock units. The shares issues have a required holding period of 36 months from the date of grant of the restricted stock units. As a result, the Company has valued the restricted stock units based on the closing price of the Company’s common stock on the date of grant less a discount for lack of marketability during the holding period of 20%. The 20% discount was calculated based on various studies quantifying discounts for lack of marketability with similar metrics to the Company. The factors considered in the discount for lack of marketability analysis include market value of equity, holding period, total revenue, total assets, volatility, total shareholders’ equity, and net income. Restricted stock studies are a source of public information on the discount for lack of marketability as the focus of these studies is the purchase of restricted securities. Restricted securities are shares issued and sold by a publicly traded company without prior registration with the Securities and Exchange Commission. Because of the restriction on the marketability of the securities, companies purchase the securities at prices lower than the price of a registered security of the same company. The difference between the two prices represents the discount for the lack of marketability. The related compensation expense is being amortized over the twelve month vesting period. Compensation costs recognized related to these awards totaled $27 in 2017 and was included in selling, general and administrative in the accompanying consolidated statement of operations, with remaining unrecognized compensation expense of $33 to be recognized over the remaining vesting period of approximately 6.6 months. Restricted stock units of 26,362 vested and were issued during 2017 leaving 42,406 to be issued upon vesting in 2018.
A summary of the activity under the Company’s stock option plans is as follows:
The fair value of employee options is estimated on the date of each grant using the Black-Scholes Model. The weighted-average grant date fair value of options granted during the year ended December 31, 2017, 2016 and 2015 were $0.81, $0.65 and $1.80, respectively. As of December 31, 2017, there was approximately $5,659 of unrecognized compensation cost related to non-vested stock-based compensation arrangements under the 2014 Stock Award Plan. That cost was expected to be recognized over a weighted-average period of 2.51 years.
The total intrinsic value of options exercised in 2017 was $251.
Stock-based compensation expense was allocated based on the employees’ function as follows:
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Warrants to Purchase Common Stock |
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Warrants to Purchase Common Stock |
The Company issued warrants to purchase 355,028 shares of the Company’s common stock at $1.41 per share in connection with its outstanding borrowing arrangement as described in Note 6.
The table below is a roll-forward of the Company’s warrant activity for the year ended December 31, 2017:
On October 11, 2017, a warrant to purchase 4,728,191 shares of Common Stock held by Koninklijke Philips NV (“Philips”) was automatically exercised on a net exercise basis in connection with its expiration. Upon expiration of the warrant, Philips paid the exercise price of $1.06 per share through the Company’s withholding of 3,334,586 of the warrant shares to pay the exercise price and issuing 1,393,605 shares of Common Stock to Philips. The shares were issued in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended.
The Company has 355,028 warrants outstanding at December 31, 2017 with an exercise price of $1.41 and an expiration date of May 28, 2020. |
Related Party Transactions |
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Dec. 31, 2017 | |||
Related Party Transactions [Abstract] | |||
Related Party Transactions |
Philips Medical Systems, Nederland B.V.
On January 21, 2011, the Company entered into a distributor agreement with Philips appointing Philips to be the sole distributor for the promotion and sale of the Company’s CorPath System. The agreement was terminated on August 7, 2014. The Company may continue to sell CorPath Systems through Philips on a sale by sale basis under a non-exclusive arrangement under mutually agreeable terms, which may include a continued level of discounted pricing, until such time the Company either executes a new distribution arrangement with Philips or the Company no longer does business with Philips.
There were no revenues from or shipments to Philips during the year ended December 31, 2017. For the years ended December 31, 2016 and 2015, the Company recorded revenues of $375 and $125, respectively, from shipments to Philips under the distributor agreement. There were no amounts outstanding from Philips at December 31, 2017 resulting from selling activity under the agreement. At December 31, 2016, Philips owed the Company $250 resulting from selling activity under the agreement.
On October 11, 2017, a warrant to purchase 4,728,191 shares of Common Stock held by Philips was automatically exercised on a net exercise basis in connection with its expiration. Upon expiration of the warrant, Philips paid the exercise price of $1.06 per share through the Company’s withholding of 3,334,586 of the warrant shares to pay the exercise price and issuing 1,393,605 shares of Common Stock to Philips. The shares were issued in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended.
Shareholder Loans
On June 14, 2010, the Company loaned funds to certain stockholders of the Company for tax payments to be made to the Israel Tax Authority in connection with a tax ruling related to a reorganization that took place in 2008 and the Company received non-interest bearing notes receivable, which documented such loans. The total amount of notes receivable issued was $145. The notes receivable were repayable upon the disposition of the Company’s common stock by the existing shareholder. Notes receivable amounted to $71 at December 31, 2016 and was included in prepaid expenses and other current assets in the accompanying consolidated balance sheet. The notes receivable were collected during 2017.
Private Placement
On March 15, 2017, the Company closed on a private placement for the sale of an aggregate of 68,055,700 shares of its common stock at $0.6616 per share, for an aggregate purchase price of approximately $45,026 before deducting offering expenses of approximately $415. The financing round involved a syndicate of top-tier healthcare investors. Existing key investors who participated in this financing included HealthCor Partners Management, the Company’s largest shareholder, Royal Philips, an affiliate of Philips, and Energy Capital. New investors whose participation in this financing resulted in beneficial ownership of greater than 5% of the Company’s common stock included Consonance Capital and Hudson Executive Capital, L.P. |
Commitments and Contingencies |
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Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies |
The Company has an operating lease for approximately 26,402 square feet at its corporate headquarters and manufacturing plant in Waltham, Massachusetts, which expires in January 2021. The lease terms include escalating rent payments over the life of the lease and rent expense is recognized over the life of the lease on a straight-line basis. The difference between the amount expensed and actual rent payments is recorded as deferred rent included within other liabilities in the consolidated balance sheets. In connection with the lease, the Company is required to maintain a security deposit with its landlord. The security deposit is approximately $134 at December 31, 2017 and 2016, and is included in deposits and other assets in the accompanying consolidated balance sheets. The Company has a capital lease covering office furniture and carpeting, which expires in November 2020.
Total rent expense was $661, $597, and $574 for the years end December 31, 2017, 2016 and 2015, respectively. At December 31, 2017, the Company’s future minimum lease payments are indicated below:
Assets held under the capital lease arrangement and the related accumulated amortization totaled $164 and $6, respectively, at December 31, 2017. Amortization of property under the capital lease is included in depreciation and amortization in the accompanying financial statements.
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Net Loss per Share |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss per Share |
Basic net loss per share is computed by dividing net loss by the weighted average shares of common stock outstanding for each period. Diluted net loss per share is the same as basic net loss per share since the Company has net losses for each period presented. The following common stock equivalents were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
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401(k) Plan |
12 Months Ended | ||
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Dec. 31, 2017 | |||
Retirement Benefits [Abstract] | |||
401(k) Plan |
The Company has a tax-qualified employee savings and retirement 401(k) plan, covering all qualified employees. Participants may elect a salary deferral up to the statutorily prescribed annual limit for tax-deferred contributions. The Company matches 100% of the participant’s first 3% of eligible contributions plus 50% of the participant’s next 2% of contributions. Amounts expensed related to this plan totaled $392, $254 and $215 in 2017, 2016 and 2015, respectively. |
Selected Quarterly Financial Data (Unaudited) |
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Quarterly Financial Information Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Selected Quarterly Financial Data (Unaudited) |
The following table presents unaudited operating results for each of the Company’s quarters in the years ended December 31, 2017 and 2016:
Note: Quarterly net loss per share amounts may not sum to net loss per share for the year due to rounding. |
Subsequent Events |
12 Months Ended | |||
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Dec. 31, 2017 | ||||
Subsequent Events [Abstract] | ||||
Subsequent Events |
On March 16, 2018, the Company closed on a private placement of convertible preferred stock for gross proceeds of $25,000. The preferred stock is convertible into an aggregate of 20,000,000 shares of common stock, and is entitled to receive non-compounding dividends in additional shares of preferred stock, at the rate of 12% per annum, subject to reduction in the event certain milestones are achieved. The preferred stock purchasers were also issued warrants to purchase an aggregate of 8,750,000 shares of common stock at an exercise price of $1.40 per share, exercisable either for cash or on a cashless basis.
On March 16, 2018, the Company completed a financing arrangement with two lenders which provides for borrowings of up to $26 million in the form of up to $23 million in term loans and up to a $3 million revolving line-of-credit through March 2022. As of March 16, 2018, the Company had $12 million in principal outstanding under the term loan facility and $0 in principal outstanding under the revolving loan facility. An additional $5.5 million in term loans may become available in the future provided the Company has achieved a specified gross profit milestone prior to January 1, 2019, and an additional $5.5 million may become available provided the Company receives net cash proceeds of $30 million from a future sale of the Company's equity securities prior to July 1, 2019 and achieves a specified gross profit milestone prior to September 1, 2019. Until such time that the Company achieves the specified criteria, the additional term loans are not available to the Company. The Company cannot assure you that the Company will achieve the gross profit or equity financing milestones that will trigger the Company's ability to further draw the term loan facility. The revolving line-of-credit also has various clauses which restrict its availability and for which the Company currently does not meet such restrictions. The outstanding term loans bear interest at a floating rate per annum equal to the greater of (i) 8.83% and (ii) the sum of (a) the one month ICE Benchmark LIBOR based on U.S. Dollar deposits, plus (b) 7.25%. The outstanding principal under the revolving line bears interest at a floating rate per annum equal to the greater of (i) 5.0% and (ii) the sum of (a) the “prime rate,” as reported in the Wall Street Journal, plus (b) 0.5%, which interest is payable monthly. Both loan facilities are secured by substantially all of the Company's personal property other than the Company's intellectual property. Both loan facilities include customary affirmative and negative covenants. Upon the earlier of the second advance under the term loan facility or the first advance under the revolving loan facility, the Company must also achieve minimum revenue on a monthly basis measured against a percentage of the Company's Board of Directors-approved projections for the applicable fiscal year. The Company's failure to satisfy the revenue, or any other, covenant could result in an event of default under the loan facilities. Both loan facilities also include other events of default, the occurrence and continuation of which could cause interest to be charged at the rate that is otherwise applicable plus 5.0% and would provide the collateral agent under the term loan facility or the lender under the revolving loan facility, as applicable, with the right to exercise remedies against the Company and the collateral securing the loan facilities. These events of default include, among other things, any failure by the Company to pay principal or interest due under the loan facilities, a breach of certain covenants under the loan facilities, the Company's insolvency, a material adverse change, the occurrence of any default under certain other indebtedness in an amount greater than $0.25 million, one or more judgments against the Company in an amount greater than $0.25 million individually or in the aggregate, and any default under the other loan facility.
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Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Principles of Consolidation | Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Corindus, Inc. and Corindus Security Corporation. All intercompany transactions and balances have been eliminated in consolidation. The functional currency of both wholly-owned subsidiaries is the U.S. dollar and, therefore, the Company has not recorded any currency translation adjustments.
In the fourth quarter of 2014, the Company participated in the formation of a not-for-profit, which was established to generate awareness of the health risks linked to the use of fluoroscopy in hospital catheterization. As of December 31, 2017, the Company’s Chief Executive Officer and one of its senior executives represented two of the four voting members of the board of directors of the entity. As a result, under the voting model used for the consolidation of related parties which are controlled by a company, the Company has consolidated the financial statements of the entity, and recognized expenses of $36, $123, and $386 for the years ended December 31, 2017, 2016 and 2015, respectively. The entity had assets and liabilities of $15 and $7, respectively, on its balance sheet at December 31, 2017 and had both assets and liabilities of $23 on its balance sheet at December 31, 2016. |
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Segment Information | Segment Information
The Company operates in one business segment, which is the development, marketing and sale of robotic-assisted vascular intervention devices. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. To date, the chief operating decision maker has made such decisions and assessed performance at the company level, as one segment. The Company’s chief operating decision maker is the Chief Executive Officer.
Revenues from domestic customers were $6,694, $1,867 and $2,683 for the years ending December 31, 2017, 2016 and 2015, respectively. Revenues from international customers in Japan, Dubai, Israel, and Kuwait, were $2,956, $975 and $46 for the years ending December 31, 2017, 2016 and 2015, respectively. |
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Use of Estimates | Use of Estimates
The process of preparing financial statements in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements. Such management estimates include those relating to revenue recognition, inventory valuation, assumptions used in the valuation of stock-based awards, and valuation allowances against deferred income tax assets. Actual results could differ from those estimates. |
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Cash Equivalents | Cash Equivalents
The Company considers highly liquid short-term investments, which consist of money market funds, with original maturity dates of three months or less at the date of purchase, to be cash equivalents. From time to time, the Company’s cash balances may exceed federal deposit insurance limits. |
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Marketable Securities | Marketable Securities
The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. The Company had classified all of its marketable securities during 2016 “available-for-sale” pursuant to ASC 320, Investments – Debt and Equity Securities. The Company records available-for-sale securities at fair value, with the unrealized gains and losses included in accumulated other comprehensive loss in stockholders’ equity.
The Company adjusts the cost of available-for-sale debt securities for amortization of premiums and accretion of discounts to maturity. The Company includes such amortization and accretion in interest and other expense. The cost of securities sold is based on the specific identification method. The Company includes interest income on securities classified as available-for-sale in interest and other expense.
The Company reviews marketable securities for other-than-temporary impairment whenever the fair value of a marketable security is less than the amortized cost and evidence indicates that a marketable security’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statements of operations if the Company has experienced a credit loss, has the intent to sell the marketable security, or if it is more likely than not that the Company will be required to sell the marketable security before recovery of the amortized cost basis.
During 2016, the activity in the Company’s accumulated other comprehensive loss was composed solely of activity related to the Company’s available-for-sale securities. There were no realized gains or losses recognized on the maturity of available-for-sale securities during the year ended December 31, 2016, and as a result, the Company did not reclassify any amount out of accumulated other comprehensive loss during the year. |
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Fair Value Measurements | Fair Value Measurements
In accordance with ASC 820, Fair Value Measurements and Disclosures, the Company generally defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company uses a three-tier fair value hierarchy, which classifies the inputs used in measuring fair values. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements), and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below:
At both December 31, 2017 and 2016, the Company had only one asset, cash equivalents, that was measured at fair value on a recurring basis. The Company had cash equivalents totaling approximately $0 and $164 at December 31, 2017 and 2016, respectively, which were valued based on Level l inputs.
The Company’s financial instruments of deposits and notes receivable are carried at cost and approximate their fair values given the liquid nature of such items. The fair value of the Company’s capital lease obligation approximates its carrying value at December 31, 2017 due to its recent negotiation with lessor. The fair value of the Company’s long-term debt amounted to $3,759 at December 31, 2016 based on discounted cash flow analysis, which includes Level 3 inputs and fair value approximates recorded amounts.
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Concentrations of Credit Risk and Significant Customers | Concentrations of Credit Risk and Significant Customers
The Company had the following customers that accounted for greater than 10% of its revenues for the years ended December 31, 2017, 2016 and 2015, respectively:
The Company had five other customers that together accounted for 84% of the Company’s accounts receivable balance at December 31, 2017, but none of these customers exceeded 10% of its revenues in 2017. Given the current revenue levels, in a period in which the Company sells a system, that customer is likely to represent a significant customer.
The Company had four other customers that together accounted for 73% of the Company’s accounts receivable balance at December 31, 2016, but none of these customers exceeded 10% of its revenues in 2016. |
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Off-Balance Sheet Arrangements | Off-Balance Sheet Arrangements
The Company has no significant off-balance sheet risk such as foreign exchange contracts, option contracts, or other hedging arrangements. |
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Allowance for Doubtful Accounts | Allowance for Doubtful Accounts
The Company evaluates the collectability of accounts receivable on a regular basis. The allowance for doubtful accounts, if any, is based upon various factors including the financial condition and payment history of customers, an overall review of collections experience on other accounts and economic factors or events expected to affect future collections experience. The Company’s accounts receivable consist primarily of amounts due from large, well-capitalized customers and while the Company reviews their creditworthiness, collectability is generally not an issue. The Company records an allowance for doubtful accounts, when necessary, based on the potential for collectability issues within the customer base. The Company’s allowance for doubtful accounts was $0 at December 31, 2017 and 2016. |
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Product Warranty | Product Warranty
Customers are permitted to return defective products under the Company’s standard product warranty program. For CorPath Systems, the Company’s standard one-year warranty provides for the repair of any product that malfunctions. Return and replacement can only occur if a material breach of the warranty remains uncured for 30 days. A roll-forward of the Company’s warranty liability is as follows:
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Inventories | Inventories
Inventories are valued at the lower of cost or net realizable value using the first-in, first-out (FIFO) method. The Company routinely monitors the recoverability of its inventory and records the lower of cost or market reserves based on current selling prices and reserves for excess and obsolete inventory based on historical and forecasted usage, as required. Scrap and excess manufacturing costs are charged to cost of revenue as incurred and not capitalized as part of inventories. The Company only capitalizes pre-launch inventories when purchased for commercial use and it deems regulatory approval to be probable. |
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Property and Equipment | Property and Equipment
Property and equipment is carried at cost. Major items and betterments are capitalized; maintenance and repairs are charged to expense as incurred. The Company capitalizes certain costs incurred in connection with developing or obtaining internal-use software. Software costs that do not meet capitalization criteria are expensed as incurred. Demonstration equipment represents internally manufactured capital equipment that is used on-site at trade shows and at customer locations to demonstrate the CorPath System. Field equipment represents internally manufactured capital equipment placed at customer locations under programs that involve the customer’s agreement to provide their facility as a training/showsite for other potential customers while purchasing cassettes for their cases performed. As of December 31, 2017, the Company had placed three CorPath GRX field equipment units and one CorPath GRX for a customer’s evaluation purposes.
Depreciation on the demonstration equipment is charged to selling, general and administrative and the depreciation on the field equipment is charged to cost of revenue. Depreciation is computed under the straight-line method over the estimated useful lives of the respective assets.
Depreciation is provided over the following estimated asset lives:
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Impairment of Long-Lived Assets | Impairment of Long-Lived Assets
The Company’s long-lived assets principally consist of property and equipment. The Company continually monitors events and changes in circumstances that could indicate carrying amounts of long-lived assets may not be recoverable. An impairment loss is recognized when expected cash flows are less than an asset’s carrying value. Accordingly, when indicators of impairment are present, the Company evaluates the carrying value of such assets in relation to the operating performance and estimated future undiscounted cash flows of the underlying assets. The Company’s policy is to record an impairment loss when it is determined that the carrying amount of the asset may not be recoverable. During 2016, the undiscounted estimated cash flows from certain equipment placed at customer locations was less than the related equipment’s carrying value. As such, the Company recorded an impairment charge of $125 based on the difference between the estimated fair value of the equipment and its carrying value. The impairment charge of $88 and $37 is recorded within cost of revenues and selling, general and administrative, respectively, in the accompanying 2016 consolidated statement of operations. There were no other impairment charges or indicators of impairment for the years ended December 31, 2017, 2016 or 2015. |
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Comprehensive Loss | Comprehensive Loss
Comprehensive loss is comprised of net loss and changes in the unrealized gains and losses on marketable securities. Accumulated other comprehensive loss, a component of stockholders’ equity, is comprised of the cumulative unrealized gains and/or losses from the change in fair market value of the Company’s marketable securities. Accumulated other comprehensive loss was $0 as of both December 31, 2017 and 2016. |
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Revenue Recognition | Revenue Recognition
The CorPath System is a capital medical device used by hospitals and surgical centers to perform heart catheterizations. Use of the CorPath System requires a sterile, single-use cassette (the “CorPath Cassette”), which is sold separately, for each procedure. Products are sold to customers with no rights of return. The Company recognizes revenue on the sale of products when the following criteria are met:
In each arrangement, the Company is responsible for installation of the CorPath System and initial user training, which services are deemed essential to the functionality of the system. Therefore, the Company recognizes system revenue when the CorPath System is delivered and installed, and accepted by the end user customer.
Each CorPath System is sold with a standard one year warranty, which provides that the CorPath System will function as intended and during that one year period, the Company will either replace the product or a portion thereof or provide the necessary repair service during the Company’s normal service hours. The Company accrues for the estimated costs of the warranty once the CorPath System is installed.
The Company generally enters into multiple element arrangements, which include the sale of a CorPath System with an initial order of CorPath Cassettes, and may include either a basic service plan or a premium service plan. The basic service plan provides for an extended warranty period and the premium service plan provides for the extended warranty as well as component upgrades, when and if they become available during the service period. Deliverables, which are accounted for as separate units of accounting under multiple-element arrangements include: (a) the CorPath System, including installation and initial training, which are subject to customer acceptance and (b) the initial shipment of CorPath Cassettes to the customer, and may include either (c) an extended warranty or (d) component upgrades.
The Company recognizes revenue on multiple-element arrangements in accordance with ASU 2009-13, Revenue Recognition (Topic 605): Multiple Deliverable Revenue Arrangements, based on the estimated selling price of each element. In accordance with ASU 2009-13, the Company uses vendor-specific objective evidence (“VSOE”), if available, to determine the selling price of each element. If VSOE is not available, the Company uses third-party evidence (“TPE”) to determine the selling price. If TPE is not available, the Company uses its best estimate to develop the estimated selling price (“BESP”). The Company uses BESP to determine the selling price of its systems as well as the basic and premium service plans. BESP is determined based on estimated costs plus a reasonable margin, and has generally been consistent with the price charged to the customer for such products and services. The determination of BESP also considers the price of the service plans charged to customers when such services are sold separately in subsequent transactions. The Company also uses BESP to determine the selling price of the initial order of cassettes, which considers the price at which it charges its customers when the cassettes are sold separately.
Revenue related to basic and premium service plans is recognized on a straight-line basis over the life of the service contract. Revenue from cassettes and accessories is recorded upon delivery and services provided by the Company outside of a basic or premium service contract are recognized as the services are provided. If a revenue arrangement contains an undelivered element, such as a specified upgrade, revenues are deferred until delivery is complete.
There are no performance, cancellation, termination, and refund-type provisions under the Company’s multiple element arrangements.
At times, the Company may provide products to customers in exchange for future purchases of products and provision of services. The costs of any such products are included in cost of revenue in the accompanying consolidated statements of operations.
The Company also uses a One-Stent Program to demonstrate its confidence in the CorPath System’s ability to help accurately measure anatomy and precisely place only one stent per lesion. The Company provides eligible customers registered under the program a $1 credit against future CorPath Cassette purchases for a qualifying CorPath PCI procedure which uses more than one stent per lesion. The estimated cost of honoring the potential obligation under the program is recorded as a reduction of revenue at the time of shipment. These costs have not been significant to date.
The Company records shipping and handling costs as a selling expense in the period incurred, and records payments from customers for shipping costs as a reduction of selling expenses. Such amounts have not been material in the periods presented. |
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Research and Development | Research and Development
Costs for research and development are expensed as incurred. Research and development expense consists primarily of salaries, salary-related expenses and costs of contractors and materials. |
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Income Taxes | Income Taxes
The Company accounts for income taxes using the liability method, whereby deferred tax asset and liability account balances are determined based on differences between financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable.
The Company accounts for uncertain tax positions using a “more-likely-than-not” threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position. The Company evaluates these tax positions on an annual basis. The Company also accrues for potential interest and penalties related to unrecognized tax benefits in income tax expense.
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. |
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Stock-Based Compensation | Stock-Based Compensation
The Company recognizes compensation costs resulting from the issuance of service stock-based awards to employees and directors as an expense in the consolidated statements of operations over the requisite service period based on a measurement of fair value for each stock award. The awards issued to date have primarily been stock options with service-based vesting periods over two or four years, restricted stock units with service-based vesting periods of one year, and shares of unrestricted common stock. During 2017, certain shares of unrestricted common stock were granted to a non-employee director of the Company which were fully vested upon grant. Accordingly, compensation expense related to unrestricted stock was recognized on the date of the grant. During 2016, the Company issued certain stock-based awards that contain both performance and service-based vesting conditions which vest over periods of up to 25 months. The Company records expense on these awards when it becomes probable that the performance condition and requisite service will be met. The Company recognizes compensation costs resulting from the issuance of stock-based awards to non-employees as an expense in the consolidated statements of operations over the service period based on a measurement of fair value for each stock award at each performance date and period end.
Prior to the Company’s initial public offering, the fair value of the Common Stock was obtained from quoted market prices on the OTCQB as provided by OTC Market Groups, Inc. In connection with the public offering in May 2015, the Company’s Common Stock was approved for listing on the NYSE American, where it commenced trading under the symbol “CVRS”. As such, subsequent to this, the Company utilizes quoted market prices to calculate fair value of stock-based awards.
The following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes-Merton option-pricing model (“Black-Scholes Model”).
The risk-free interest rate assumption is based upon observed U.S. government treasury interest rates with a term that is consistent with the expected term of the Company’s employee stock options. The expected term is based on the average of the vesting period and contractual term of the Company’s options given the lack of historical data available. The Company does not pay a dividend, and is not expected to pay a dividend in the foreseeable future.
Due to a lack of a public market for the Company’s Common Stock for an extended period of time, the Company utilized comparable public companies’ volatility rates as a proxy of its expected volatility for purposes of the Black-Scholes Model. Stock-based compensation expense is recorded net of estimated forfeitures and is adjusted periodically for actual forfeitures. The Company uses historical data to estimate forfeiture rates. For the years ended December 31, 2017, 2016 and 2015, forfeitures were estimated to be 5.0% each year. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Recent Accounting Pronouncements | Recent Accounting Pronouncements
In May 2014, August 2015, April 2016 and May 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers, ASU 2015-14, Revenue from Contracts with Customers, Deferral of the Effective Date, ASU 2016-10, Revenue from Contracts with Customers, Identifying Performance Obligations and Licensing, and ASU 2016-12, Revenue from Contracts with Customers, Narrow-Scope Improvements and Practical Expedients, respectively, (collectively referred to as “Topic 606”). Topic 606 outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers, and supersedes current revenue recognition guidance, including industry-specific guidance. It also requires entities to disclose both quantitative and qualitative information that enable financial statements users to understand the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. The amendments in these ASUs are effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. The two permitted transition methods under the new standard are the full retrospective method, in which case the standard would be applied to each prior reporting period presented and the cumulative effect of applying the standard would be recognized at the earliest period shown, or the modified retrospective method, in which case the cumulative effect of applying the standard would be recognized at the date of initial application. The Company will adopt the guidance on January 1, 2018 and will apply the modified retrospective transition approach only to contracts that have undelivered performance obligations as of this date. The Company performed a review of all revenue streams to identify any differences in the timing, measurement or presentation of revenue recognition. The Company has an installed base of 62 CorPath Systems as of December 31, 2017. The Company assessed all of these systems, and determined that a large number of those installations will not be impacted by the implementation of Topic 606 since there will be no future performance obligations under those arrangements upon adoption. As a result, the Company identified a limited number of contracts for which there will be future performance obligations as of the adoption date. Pertaining to these contracts, the adoption of Topic 606 will result in certain components of services being unbundled from previously bundled arrangements, and result in an acceleration of the timing of revenue recognition related to the Company’s services. The new standard requires revenues to be estimated and recognized upon transfer of the promised goods and services, and the Company determined that the accelerated recognition of service revenues will result in a cumulative adjustment to revenues as of the adoption date. Adoption of the new standard will result in the capitalization of certain costs to obtain service contracts and the capitalization of such costs will result in an adjustment to capitalized expenses as of the adoption date. The Company is in the process of finalizing the overall impact of the adoption of this standard on its fourth quarter sales and will finalize in the first quarter of 2018. The Company’s calculations indicate that such amounts may not be material to the Company’s results of operations.
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which amends leasing accounting requirements. The new standard requires lessee recognition on the balance sheet of a right-of-use asset and a lease liability, initially measured at the present value of the lease payments. It further requires recognition in the income statement of a single lease cost, calculated so that the cost of the lease is allocated over the lease term generally on a straight-line basis. Finally, it requires classification of all cash payments within operating activities in the statement of cash flows. It is effective for fiscal years commencing after December 15, 2018 and early adoption is permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements.
In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230), Classification of Certain Cash Receipts and Cash Payments, which reduces diversity in how certain cash receipts and cash payments are presented and classified in the Consolidated Statements of Cash Flows. It is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017 and will be required to be applied retrospectively, with early adoption permitted. The Company is currently evaluating the impact of this update on its consolidated financial statements and related disclosures.
In May 2017, the FASB issued ASU 2017-09, Compensation—Stock Compensation (Topic 718) - Scope of Modification Accounting, which clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. It is effective prospectively for annual periods beginning on or after December 15, 2017, with early adoption permitted. The Company is currently evaluating the impact of this update on its consolidated financial statements and related disclosures. |
Significant Accounting Policies (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of customers that accounted for greater than 10% of revenues | The Company had the following customers that accounted for greater than 10% of its revenues for the years ended December 31, 2017, 2016 and 2015, respectively:
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Schedule of roll-forward of warranty liability | A roll-forward of the Company’s warranty liability is as follows:
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Schedule of assumptions used to estimate the fair value of stock options granted | The following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes-Merton option-pricing model (“Black-Scholes Model”).
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Inventories (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of inventories | The Company’s inventories are valued at the lower of cost or net realizable value using the FIFO method and consist of the following:
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Property and Equipment (Tables) |
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Dec. 31, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of property and equipment | Property and equipment consist of the following:
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Accrued Expenses (Tables) |
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Dec. 31, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of accrued expenses | Accrued expenses consist of the following:
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Income Taxes (Tables) |
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Dec. 31, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of reconciliation of effective income tax rate to the statutory federal income tax rate | The Company’s effective income tax rate differs from the statutory federal income tax rate as follows:
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Schedule of deferred income tax assets | Significant components of the Company’s deferred tax assets and the related valuation allowance were as follows:
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Stock-Based Compensation (Tables) |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of activity under stock option plans | A summary of the activity under the Company’s stock option plans is as follows:
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Schedule of stock-based compensation expense | Stock-based compensation expense was allocated based on the employees’ function as follows:
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Warrants to Purchase Common Stock (Tables) |
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Warrants To Purchase Common Stock | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of rollforward of warrant activity | The table below is a roll-forward of the Company’s warrant activity for the year ended December 31, 2017:
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Commitments and Contingencies (Tables) |
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Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of future minimum lease payments | At December 31, 2017, the Company’s future minimum lease payments are indicated below:
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Net Loss per Share (Tables) |
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Dec. 31, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of securities excluded from the calculation of diluted net loss per share | The following common stock equivalents were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
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Selected Quarterly Financial Data (Tables) |
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Quarterly Financial Information Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of quarterly financial results | The following table presents unaudited operating results for each of the Company’s quarters in the years ended December 31, 2017 and 2016:
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Significant Accounting Policies (Details) - Sales Revenue, Net [Member] |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
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Customer A [Member] | |||
Concentration percentage | 20.00% | ||
Customer B [Member] | |||
Concentration percentage | 1.00% | 28.00% | |
Customer C [Member] | |||
Concentration percentage | 13.00% | 5.00% | |
Customer D [Member] | |||
Concentration percentage | 12.00% | ||
Customer E [Member] | |||
Concentration percentage | 1.00% | 1.00% | 13.00% |
Customer F [Member] | |||
Concentration percentage | 11.00% | ||
Customer G [Member] | |||
Concentration percentage | 1.00% | 10.00% |
Significant Accounting Policies (Details 1) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Movement in Standard Product Warranty Accrual [Roll Forward] | ||
Beginning balance, Product warrant liability | $ 57 | $ 68 |
Provision for warranty obligation | 352 | 67 |
Settlements | (113) | (78) |
Ending balance, Product warrant liability | $ 296 | $ 57 |
Significant Accounting Policies (Details 2) - Stock Option Plans [Member] |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
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Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate - minimum | 1.87% | 1.27% | 1.54% |
Risk-free interest rate - maximum | 2.38% | 2.45% | 1.97% |
Expected term in years | 6 years 29 days | ||
Expected volatility | 50.00% | ||
Expected volatility - minimum | 55.00% | 48.00% | |
Expected volatility - maximum | 67.00% | 64.00% | |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term in years | 6 years | 6 years 29 days | |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term in years | 10 years | 10 years |
Significant Accounting Policies (Details Narrative 1) |
12 Months Ended |
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Dec. 31, 2017 | |
Machinery and Equipment [Member] | |
Estimated useful lives | 5 years |
Computer Equipment [Member] | |
Estimated useful lives | 3 years |
Office Furniture and Equipment [Member] | |
Estimated useful lives | 5 years |
Vendor Tooling [Member] | Minimum [Member] | |
Estimated useful lives | 1 year 6 months |
Vendor Tooling [Member] | Maximum [Member] | |
Estimated useful lives | 3 years |
Software [Member] | |
Estimated useful lives | 4 years |
Demonstration Equipment [Member] | |
Estimated useful lives | 3 years |
Field Equipment [Member] | |
Estimated useful lives | 3 years |
Inventories (Details) - USD ($) $ in Thousands |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Raw material | $ 945 | $ 578 |
Work in progress | 310 | 163 |
Finished goods | 848 | 804 |
Inventories, net | $ 2,103 | $ 1,545 |
Inventories (Details Narrative) $ in Thousands |
12 Months Ended |
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Dec. 31, 2017
USD ($)
| |
Inventory Disclosure [Abstract] | |
Inventory write-down | $ 268 |
Property and Equipment (Details Narrative) - USD ($) $ in Thousands |
12 Months Ended | ||
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Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
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Property, Plant and Equipment [Abstract] | |||
Depreciation and amortization expense | $ 723 | $ 725 | $ 706 |
Accrued Expenses (Details) - USD ($) $ in Thousands |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Payables and Accruals [Abstract] | ||
Payroll and benefits | $ 1,764 | $ 751 |
Professional and consultant fees | 579 | 368 |
Commissions | 542 | 433 |
Warranty | 296 | 57 |
Travel expense | 242 | 43 |
Sales tax payable | 83 | 41 |
Interest | 33 | |
Other | 131 | 68 |
Accrued expenses | $ 3,637 | $ 1,794 |
Long-Term Debt (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
12 Months Ended | |||
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Jun. 11, 2014 |
Dec. 31, 2014 |
Dec. 31, 2017 |
Dec. 31, 2016 |
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Exercise price of warrant | $ 1.41 | $ 1.08 | ||
Promissory Note 1 [Member] | ||||
Available borrowing under Loan and Security Agreement | $ 10,000 | |||
Amount of each separate note | $ 5,000 | |||
Note issuance date | Jun. 11, 2014 | |||
Frequency of debt payments | Monthly | |||
Term of debt payments | 27 months | |||
Date of first required payment | Jul. 01, 2015 | |||
Number of shares callable by warrants outstanding | 177,514 | |||
Exercise price of warrant | $ 1.41 | |||
Fair value of the warrant issued | $ 230 | |||
Promissory Note 2 [Member] | ||||
Amount of each separate note | $ 5,000 | |||
Frequency of debt payments | Monthly | |||
Term of debt payments | 27 months | |||
Date of first required payment | Jul. 01, 2015 | |||
Number of shares callable by warrants outstanding | 177,514 | |||
Exercise price of warrant | $ 1.41 | |||
Fair value of the warrant issued | $ 619 |
Income Taxes (Details) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Income Tax Disclosure [Abstract] | |||
Statutory U.S. federal rate | 34.00% | 34.00% | 34.00% |
State income tax | 2.60% | 1.70% | 3.70% |
Permanent items | 0.30% | (0.10%) | (0.40%) |
Other | 1.00% | (0.50%) | |
Change in state tax rate | 0.10% | (0.60%) | 0.70% |
Deferred federal rate reduction (Effect of US tax reform) | (58.90%) | ||
Federal R&D credit | 1.00% | 1.10% | 1.30% |
State R&D and other credits | 0.50% | 0.50% | 0.50% |
Change in valuation allowance | 19.40% | (36.60%) | (39.30%) |
Income Taxes (Details 1) - USD ($) $ in Thousands |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Deferred income tax assets: | ||
Operating loss carryforwards | $ 35,950 | $ 42,130 |
Start-up expenditures | 1,404 | 2,351 |
Property and equipment | 40 | 77 |
Stock-based compensation expense | 1,420 | 1,197 |
Research and development credit carryforwards | 2,928 | 2,258 |
Accrued expenses and other | 628 | 695 |
Total deferred income tax assets | 42,370 | 48,708 |
Valuation allowance | $ (42,370) | $ (48,708) |
Income Taxes (Details Narrative) - USD ($) $ in Thousands |
12 Months Ended | ||||
---|---|---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Statutory U.S. federal rate | 34.00% | 34.00% | 34.00% | ||
Change in valuation allowance | $ (20,104) | $ (6,307) | $ 12,121 | ||
Deferred Tax Assets [Member] | |||||
Change in valuation allowance | 438 | ||||
Increased in deferred tax asset - NOL | 438 | ||||
Subsequent Fiscal Years [Member] | |||||
Statutory U.S. federal rate | 21.00% | ||||
State [Member] | |||||
Net operating loss carryforwards | 91,631 | 91,631 | |||
Tax credit carryforwards | 1,256 | 1,256 | |||
Federal [Member] | |||||
Net operating loss carryforwards | 147,795 | 147,795 | |||
Tax credit carryforwards | $ 1,935 | $ 1,935 |
Stockholders' Equity (Details Narrative) - shares |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock, authorized shares | 250,000,000 | 250,000,000 |
Preferred stock, authorized shares | 10,000,000 | 10,000,000 |
2014 Stock Award Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for future issuance | 18,613,366 | |
Common stock reserved for exercise of warrants | 355,028 | |
Stock options available for grant | 3,752,598 | |
Stock options outstanding | 18,215,932 | |
Restricted stock units outstanding | 42,406 |
Stock-Based Compensation (Details 1) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Stock-based compensation expense | $ 2,892 | $ 2,366 | $ 505 |
Research and Development Expense [Member] | |||
Stock-based compensation expense | 258 | 170 | 74 |
Selling General And Administrative Expense [Member] | |||
Stock-based compensation expense | $ 2,634 | $ 2,196 | $ 431 |
Warrants to Purchase Common Stock (Details) |
12 Months Ended |
---|---|
Dec. 31, 2017
$ / shares
shares
| |
Warrants, Number of Shares [Rollforward] | |
Outstanding at beginning | shares | 5,083,219 |
Exercised | shares | (4,728,191) |
Outstanding at end | shares | 355,028 |
Warrants, Weighted-Average Exercise Price [Rollforward] | |
Outstanding at beginning | $ / shares | $ 1.08 |
Exercised | $ / shares | 1.06 |
Outstanding at end | $ / shares | $ 1.41 |
Warrants to Purchase Common Stock (Details Narrative) - $ / shares |
12 Months Ended | ||
---|---|---|---|
Oct. 11, 2017 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Number of warrants | 355,028 | 5,083,219 | |
Exercise price of warrant | $ 1.41 | $ 1.08 | |
Warrant exercised (shares) | 4,728,191 | ||
Philips [Member] | Warrant [Member] | |||
Exercise price of warrant | $ 1.06 | ||
Warrant exercised (shares) | 4,728,191 | ||
Issuance of common stock for warrant exercised (shares) | 1,393,605 | ||
Warrant shares withheld to pay exercise price (shares) | 3,334,586 | ||
Warrant [Member] | |||
Number of warrants | 355,028 | ||
Exercise price of warrant | $ 1.41 | ||
Date of Expiration | May 28, 2020 |
Commitments and Contingencies (Details) $ in Thousands |
Dec. 31, 2017
USD ($)
|
---|---|
Operating Lease | |
2018 | $ 577 |
2019 | 648 |
2020 | 665 |
2021 | 55 |
Total Lease Payments | 1,945 |
Capital Lease | |
2018 | 67 |
2019 | 67 |
2020 | 48 |
Total Lease Payments | 182 |
Less amount representing interest | 31 |
Minimum lease payments | 151 |
Less current portion of obligation under capital lease | 49 |
Long-term obligation under capital lease | $ 102 |
Commitments and Contingencies (Details Narrative) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017
USD ($)
ft²
|
Dec. 31, 2016
USD ($)
|
Dec. 31, 2015
USD ($)
|
|
Commitments and Contingencies Disclosure [Abstract] | |||
Office and manufacturing lease (square footage) | ft² | 26,402 | ||
Operating lease expiration date | Jan. 31, 2021 | ||
Security deposit | $ 134 | $ 134 | |
Rent expense | 661 | $ 597 | $ 574 |
Accumulated amortization capital lease | 6 | ||
Assets held under the capital lease | $ 164 |
Net Loss per Share (Details) - shares |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Number of anti-dilutive securities | 18,613,366 | 22,606,291 | 13,985,882 |
Stock Options [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Number of anti-dilutive securities | 18,215,932 | 17,523,072 | 8,778,503 |
Warrant [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Number of anti-dilutive securities | 355,028 | 5,083,219 | 5,207,379 |
Restricted Stock Units [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Number of anti-dilutive securities | 42,406 |
401(k) Plan (Details Narrative) - 401(k) Plan [Member] - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Defined Benefit Plan Disclosure [Line Items] | |||
Administration expenses | $ 392 | $ 254 | $ 215 |
Company match eligible contributions - first (percent) | 100.00% | ||
First eligible contribution | 3.00% | ||
Next eligible contribution | 2.00% | ||
Company match eligible contributions - second (percent) | 50.00% |
Selected Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 12 Months Ended | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2017 |
Sep. 30, 2017 |
Jun. 30, 2017 |
Mar. 31, 2017 |
Dec. 31, 2016 |
Sep. 30, 2016 |
Jun. 30, 2016 |
Mar. 31, 2016 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue | $ 4,190 | $ 2,425 | $ 2,258 | $ 777 | $ 538 | $ 688 | $ 508 | $ 1,108 | $ 9,650 | $ 2,842 | $ 2,729 |
Cost of revenue | 2,990 | 2,183 | 2,200 | 1,892 | 1,630 | 1,220 | 1,114 | 1,078 | 9,265 | 5,042 | 3,724 |
Gross profit (loss) | 1,200 | 242 | 58 | (1,115) | (1,092) | (532) | (606) | 30 | 385 | (2,200) | (995) |
Operating expenses | 9,182 | 8,081 | 8,395 | 8,636 | 8,517 | 7,313 | 6,772 | 7,275 | 34,294 | 29,877 | 26,176 |
Operating loss | (7,982) | (7,839) | (8,337) | (9,751) | (9,609) | (7,845) | (7,378) | (7,245) | (33,909) | (32,077) | (27,171) |
Total other expense, net | 11 | (14) | (77) | (134) | (182) | (221) | (216) | (382) | (214) | (1,001) | |
Net loss | $ (7,971) | $ (7,853) | $ (8,414) | $ (9,885) | $ (9,791) | $ (8,066) | $ (7,594) | $ (7,627) | $ (34,123) | $ (33,078) | $ (28,763) |
Net loss per share-basic and diluted (in dollars per share) | $ (0.04) | $ (0.04) | $ (0.04) | $ (0.07) | $ (0.08) | $ (0.07) | $ (0.06) | $ (0.06) | $ (0.20) | $ (0.28) | $ (0.25) |