Document and Entity Information - shares |
6 Months Ended | |
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Jun. 30, 2018 |
Jul. 19, 2018 |
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Document Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2018 | |
Document Fiscal Year Focus | 2018 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | NVCR | |
Entity Registrant Name | Novocure Ltd | |
Entity Central Index Key | 0001645113 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 92,902,560 |
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares |
6 Months Ended | 12 Months Ended |
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Jun. 30, 2018 |
Dec. 31, 2017 |
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Statement Of Financial Position [Abstract] | ||
Common stock, par value | ||
Common stock, shares authorized | Unlimited | Unlimited |
Common stock, shares issued | 92,503,273 | 89,478,032 |
Common stock, shares outstanding | 92,503,273 | 89,478,032 |
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | 12 Months Ended | ||
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Jun. 30, 2018 |
Jun. 30, 2017 |
Jun. 30, 2018 |
Jun. 30, 2017 |
Dec. 31, 2017 |
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Income Statement [Abstract] | |||||
Net revenues | $ 61,514 | $ 38,376 | $ 113,639 | $ 73,256 | $ 177,026 |
Cost of revenues | 19,833 | 13,152 | 38,071 | 24,816 | 55,609 |
Gross profit | 41,681 | 25,224 | 75,568 | 48,440 | 121,417 |
Operating costs and expenses: | |||||
Research, development and clinical trials | 11,362 | 9,371 | 22,466 | 18,782 | 38,103 |
Sales and marketing | 19,196 | 16,360 | 37,331 | 31,116 | 63,528 |
General and administrative | 18,208 | 15,023 | 35,533 | 27,445 | 59,114 |
Total operating costs and expenses | 48,766 | 40,754 | 95,330 | 77,343 | 160,745 |
Operating loss | (7,085) | (15,530) | (19,762) | (28,903) | (39,328) |
Financial expenses, net | 2,860 | 2,183 | 7,713 | 4,629 | 9,169 |
Loss before income taxes | (9,945) | (17,713) | (27,475) | (33,532) | (48,497) |
Income taxes | 5,565 | 3,461 | 8,759 | 5,687 | 13,165 |
Net loss | $ (15,510) | $ (21,174) | $ (36,234) | $ (39,219) | $ (61,662) |
Basic and diluted net loss per ordinary share | $ (0.17) | $ (0.24) | $ (0.40) | $ (0.45) | $ (0.70) |
Weighted average number of ordinary shares used in computing basic and diluted net loss per share | 91,331,862 | 88,218,868 | 90,658,735 | 87,835,926 | 88,546,719 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | 12 Months Ended | ||
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Jun. 30, 2018 |
Jun. 30, 2017 |
Jun. 30, 2018 |
Jun. 30, 2017 |
Dec. 31, 2017 |
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Statement Of Income And Comprehensive Income [Abstract] | |||||
Net loss | $ (15,510) | $ (21,174) | $ (36,234) | $ (39,219) | $ (61,662) |
Other comprehensive income (loss), net of tax: | |||||
Change in foreign currency translation adjustments | 11 | 1 | 21 | 10 | 8 |
Pension benefit plan | 44 | 183 | 49 | 134 | 532 |
Total comprehensive loss | $ (15,455) | $ (20,990) | $ (36,164) | $ (39,075) | $ (61,122) |
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - 6 months ended Jun. 30, 2018 - USD ($) $ in Thousands |
Total |
Ordinary Shares |
Additional Paid-in Capital |
Accumulated Other Comprehensive Loss |
Accumulated Deficit |
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Balance at Dec. 31, 2017 | $ 113,564 | $ 697,165 | $ (1,343) | $ (582,258) | |||
Balance (in shares) at Dec. 31, 2017 | 89,478,032 | ||||||
Proceeds from issuance of shares | 938 | 938 | |||||
Proceeds from issuance of shares (in shares) | 54,386 | ||||||
Share-based compensation to employees | 18,726 | 18,726 | |||||
Exercise of options and warrants and vested RSUs | 12,855 | 12,855 | |||||
Exercise of options and warrants and vested RSUs (in shares) | 2,970,855 | ||||||
Cumulative effect adjustment on retained earnings | [1] | 2,162 | 2,162 | ||||
Other comprehensive income, net of tax benefit of $8 | 70 | 70 | |||||
Net loss | (36,234) | (36,234) | |||||
Balance at Jun. 30, 2018 | $ 112,081 | $ 729,684 | $ (1,273) | $ (616,330) | |||
Balance (in shares) at Jun. 30, 2018 | 92,503,273 | ||||||
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CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (Parenthetical) $ in Thousands |
6 Months Ended |
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Jun. 30, 2018
USD ($)
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Statement Of Stockholders Equity [Abstract] | |
Other comprehensive income (loss), tax benefit | $ 8 |
Organization and Basis of Presentation |
6 Months Ended |
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Jun. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Basis of Presentation |
NOTE 1: ORGANIZATION AND BASIS OF PRESENTATION Organization. NovoCure Limited (including its consolidated subsidiaries, the “Company”) was incorporated in the Bailiwick of Jersey and is principally engaged in the development, manufacture and commercialization of Tumor Treating Fields for the treatment of solid tumors. The Company has regulatory approvals and clearances in certain countries for Optune, its first Tumor Treating Fields delivery system, to treat adult patients with glioblastoma (“GBM”). Financial statement preparation. The accompanying consolidated financial statements include the accounts of the Company and its consolidated subsidiaries, and intercompany accounts and transactions have been eliminated. In the opinion of the Company’s management, the consolidated financial statements reflect all adjustments, which are normal and recurring in nature, necessary for fair financial statement presentation. The preparation of these consolidated financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and assumptions that affect the amounts reported in these consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. These consolidated financial statements and accompanying notes should be read in conjunction with the Company’s annual consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 (the “2017 10-K”) filed with the Securities and Exchange Commission (the “SEC”) on February 22, 2018. The significant accounting policies applied in the audited annual consolidated financial statements of the Company as disclosed in the 2017 10-K are applied consistently in these unaudited interim consolidated financial statements, except as noted below: Recently Adopted Accounting Pronouncements. In May 2014, FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) (ASU 2014-09), an updated standard on revenue recognition and issued subsequent amendments to the initial guidance in March 2016, April 2016, May 2016 and December 2016 within ASU 2016-08, 2016-10, 2016-12 and 2016-20, respectively (collectively, “ASC 606”). The core principle of the new standard is for companies to recognize revenue to depict the transfer of goods and services to patients in amounts that reflect the consideration to which the company expects to be entitled in exchange for those goods and services. In addition, the new standard requires expanded disclosures. The Company has adopted the standard effective January 1, 2018 using the modified retrospective method for all contracts. The reported results for 2018 reflect the application of ASC 606 guidance while the reported results for 2017 were prepared under the guidance of ASC 605, Revenue Recognition (ASC 605). The amount of revenue recognized in 2018 reflects the consideration to which the Company expects to be entitled to receive in exchange for Optune. In preparation for adoption of the standard, the Company has implemented internal controls and key system functionality to enable the preparation of financial information, including the assessment of the impact of the standard. The Company uses the portfolio approach to apply the standard to portfolios of contracts with similar characteristics. Adoption of the standard resulted in an increase to trade receivables of $2,807, deferred revenues of $645 and a cumulative impact to the Company's accumulated deficit as of January 1, 2018 of $2,162. Optune is comprised of two main components: (1) an electric field generator and (2) transducer arrays and related accessories. We retain title to the electric field generator, and the patient is provided replacement transducer arrays and technical support for the device during the term of treatment. The electric field generator and transducer arrays are always supplied and function together and are not sold on a standalone basis. To recognize revenue under ASC 606, the Company applies the following five steps: 1. Identify the contract with a patient. A contract with a patient exists when (i) the Company enters into an enforceable contract with a patient that defines each party’s rights regarding delivery of and payment for Optune, (ii) the contract has commercial substance and (iii) the Company determines that collection of substantially all consideration for Optune is probable based on the payer’s intent and ability to pay the promised consideration. The evidence of a contract generally consists of a prescription, a patient service agreement and the verification of the assigned payer for the contract and intention to collect. 2. Identify the performance obligations in the contract. Optune contracts include the lease of the device, the supply obligation of disposable transducer arrays and technical support for the term of treatment. To the extent a contract includes multiple promised products and/or services, the Company must apply judgment to determine whether those products and/or services are capable of being distinct in the context of the contract. If these criteria are not met the promised products and/or services are accounted for as a combined performance obligation. In the Company’s case, Optune’s device, support, and disposables are provided as one inseparable package of monthly treatment for a single monthly fee. 3. Determine the transaction price. The transaction price is determined based on the consideration to which the Company will be entitled in exchange for providing Optune to the patient. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. The Company has agreements with many payers that define explicit discounts off the gross transaction price. In addition to the explicit discounts negotiated with each payer, the Company expects to receive, in aggregate for a given portfolio, less than the gross revenue net of explicit discounts. ASC 606 requires that the Company recognize this variable consideration as an implicit discount in the billing period. The implicit discount includes both an estimate of claims that will pay at an amount less than billed and an estimate of claims that will not pay within a given time horizon. The implicit discount adjustments to the transaction price are due to concessions, not collectability concerns driven by payer credit risk. 4. Allocate the transaction price to performance obligations in the contract. If a contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. As discussed above, there is one performance obligation under the Company’s contracts and, therefore, the monthly transaction price determined for the performance obligation will be recognized over time ratably over the monthly term of the treatment. 5. Recognize revenue when or as the Company satisfies a performance obligation. The Company satisfies performance obligations over time as discussed above. Revenue is recognized at the time the related performance obligation is satisfied by transferring a promised service to a patient. The patient consumes the benefits of Optune treatment on a daily basis over the monthly term. As this criterion is met, the revenues will be recognized over the monthly term. In accordance with ASC 606, the impact of our adoption of ASC 606 on our condensed consolidated statements of income for the six and three months ended June 30, 2018 were a decrease in net revenues of $5,531 and $1,993, respectively, an increase in net loss of $5,371 and $2,035, respectively, and a decrease in our basic and diluted net loss per ordinary share of $0.06 and $0.02, respectively. The impact of our adoption of Topic 606 on our balance sheet as of June 30, 2018 was a decrease in trade receivables of $2,760, an increase to other payables and accrued expenses (deferred revenues net of tax provision) of $521 and an accumulated deficit as of June 30, 2018 of $3,209. In August 2016, FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230) Classification of Certain Cash Receipts and Cash Payments. ASU 2016-15 eliminates the diversity in practice related to the classification of certain cash receipts and payments for debt prepayment or extinguishment costs, the maturing of a zero coupon bond, the settlement of contingent liabilities arising from a business combination, proceeds from insurance settlements, distributions from certain equity method investees and beneficial interests obtained in a financial asset securitization. ASU 2016-15 designates the appropriate cash flow classification, including requirements to allocate certain components of these cash receipts and payments among operating, investing and financing activities. The retrospective transition method, requiring adjustment to all comparative periods presented, is required unless it is impracticable for some of the amendments, in which case those amendments would be prospectively as of the earliest date practicable. The Company adopted the standard effective as of January 1, 2018, and the adoption of this standard did not have an impact on the Company's consolidated financial statements. In November 2016, FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. This standard requires the presentation of the statement of cash flows to show the changes in the total of cash, cash equivalents, restricted cash and restricted cash equivalents. The standard is effective for fiscal years and the interim periods within those fiscal years beginning after December 15, 2017. The Company adopted the standard retrospectively to all periods presented effective as of January 1, 2018. Recent Accounting Pronouncements. In February 2016, FASB issued ASU 2016-02-Leases (ASC 842), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e. lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of their classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. The new standard requires lessors to account for leases using an approach that is substantially equivalent to existing guidance for sales-type leases, direct financing leases and operating leases. ASC 842 supersedes the previous leases standard, ASC 840. The standard is effective on January 1, 2019, with early adoption permitted. The Company currently anticipates adopting the new standard effective January 1, 2019 and is evaluating the impact of the adoption of this standard on its consolidated financial statements. In June 2016, FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the more timely recognition of losses. ASU 2016-13 also applies to employee benefit plan accounting, with an effective date of the first quarter of fiscal 2020. The amendments in this update are effective for fiscal years beginning after December 31, 2019, including interim periods within those fiscal years. The Company is currently assessing the impact of the adoption of this standard on its consolidated financial statements, footnote disclosures and employee benefit plans’ accounting. In June 2018, FASB issued ASU 2018-07 to expand the scope of ASC Topic 718, Compensation - Stock Compensation, to include share-based payment transactions for acquiring goods and services from nonemployees. The pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2018, with early adoption permitted. The Company is evaluating the effects of this standard on its consolidated financial statements.
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Short-Term Investments |
6 Months Ended |
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Jun. 30, 2018 | |
Debt Securities Current [Abstract] | |
Short-Term Investments | NOTE 2: SHORT-TERM INVESTMENTS The Company invests in marketable U.S. Treasury Bills (“T-bills”) that are classified as held-to-maturity securities. The amortized cost and recorded basis of the T-bills are presented as short-term investments in the amount of $104,499 and $104,719 as of June 30, 2018 and December 31, 2017, respectively, and their estimated fair value as of June 30, 2018 and December 31, 2017 was $104,512 and $104,655, respectively. |
Inventories |
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Jun. 30, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories | NOTE 3: INVENTORIES Inventories are stated at the lower of cost or market. The weighted average methodology is applied to determine cost. As of June 30, 2018 and December 31, 2017, the Company’s inventories were composed of:
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Commitments and Contingent Liabilities |
6 Months Ended |
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Jun. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingent Liabilities | NOTE 4: COMMITMENTS AND CONTINGENT LIABILITIES The facilities of the Company are leased under various operating lease agreements for periods ending no later than 2024. The Company also leases motor vehicles under various operating leases, which expire on various dates, the latest of which is in 2021. As of June 30, 2018 and December 31, 2017, the Company pledged bank deposits of $1,145 and $1,038, respectively, to cover bank guarantees in respect of its leases of operating facilities and obtained bank guarantees for the fulfillment of the Company’s lease and other contractual commitments of $1,305 and $1,202, respectively. In the first quarter of 2018, the Company made a milestone payment of $5.5 million (the “Milestone Payment”) to the Technion Research and Development Foundation (“Technion”) pursuant to the settlement agreement dated February 10, 2015 (the “Settlement Agreement”). Pursuant to the Settlement Agreement, and in exchange for a release of potential disputes regarding intellectual property developed by our founder and previously assigned to us, the Company was obligated to pay the Milestone Payment to Technion in the quarter following the quarter in which the Company achieved $250.0 million of cumulative net sales (as defined in the Settlement Agreement) (the “Net Sales Milestone”). The Company achieved the Net Sales Milestone in the fourth quarter of 2017. |
Long Term Loan |
6 Months Ended |
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Jun. 30, 2018 | |
Debt Disclosure [Abstract] | |
Long Term Loan |
NOTE 5: LONG TERM LOAN
On February 7, 2018, the Company and certain of its subsidiaries entered into a Loan and Security Agreement (“2018 Loan Agreement”) with BioPharma Credit PLC pursuant to which such lender made a term loan to the Company in the principal amount of $150 million (the “2018 Credit Facility”). The term loan, which was drawn in full upon execution of the 2018 Loan Agreement, bears interest at 9.0% per annum, payable quarterly in arrears. The Company used a portion of the proceeds of the 2018 Credit Facility to repay in full the Company’s obligations under its existing term loan credit facility and will use the remaining proceeds to fund general corporate purposes.
The 2018 Credit Facility will mature on February 7, 2023, at which time any unpaid principal and accrued unpaid interest in respect of the term loan will be due and payable. The Company may prepay the term loan, in full, at any time. The Company must prepay the term loan (i) in full or in part upon the entry into certain licensing arrangements and (ii) in full in the event of a change of control. In each case, any prepayment (whether permitted or mandatory) is subject to a prepayment premium and/or make-whole payment. The pre-payment fee if the Company prepays outstanding loan amounts prior to February 7, 2021 is 2.0% and is 1.0% if made after the February 7, 2021 but prior to February 7, 2022. All obligations under the 2018 Credit Facility are guaranteed by the Company’s current and future direct and indirect subsidiaries. In addition, the obligations under the 2018 Credit Facility are secured by a first-priority security interest in substantially all of the property and assets of, as well as the equity interests owned by, the Company and certain of the other guarantors. The 2018 Credit Facility contains other customary covenants. Total net issuance costs of the 2018 Credit Facility, which were $805 as of June 30, 2018, are presented net of the 2018 Credit Facility proceeds and are amortized to interest expense over the five year term of the loan using the effective interest method. On February 7, 2018, the Company’s 2015 term loan credit facility was terminated upon the Company’s repayment in full of the term loan issued thereunder. The un-amortized discount in the amount of $1,160 and issuance costs in the amount of $1,399 were fully amortized and included in the Company’s first quarter finance expenses. |
Share Capital |
6 Months Ended |
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Jun. 30, 2018 | |
Share Based Compensation Allocation And Classification In Financial Statements [Abstract] | |
Share Capital | NOTE 6: SHARE CAPITAL For the six months ended June 30, 2018, warrants to purchase 201,692 ordinary shares with an exercise price of $3.59 per share were cashlessly exercised, resulting in the issuance of 167,212 ordinary shares. Also, warrants to purchase 1,549 ordinary shares with an exercise price of $3.59 per share were exercised for cash. For the six months ended June 30, 2018, options to purchase 2,253,654 ordinary shares were exercised, resulting in the issuance of 2,251,676 ordinary shares. |
Equity Incentive Plans |
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Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity Incentive Plans | NOTE 7: EQUITY INCENTIVE PLANS In September 2015, the Company adopted the 2015 Omnibus Incentive Plan (the “2015 Plan”). Under the 2015 Plan, the Company can issue various types of equity compensation awards such as share options, restricted shares, performance shares, restricted stock units (“RSUs”), performance units, long-term cash awards and other share-based awards. Options granted under the 2015 Plan generally have a four-year vesting period and expire ten years after the date of grant. Options granted under the 2015 Plan that are cancelled or forfeited before expiration become available for future grants. RSUs granted under the 2015 Plan vest in equal installments over a three-year period. As of June 30, 2018, 10,416,052 ordinary shares were available for grant under the 2015 Plan. A summary of the status of the Company’s option plans as of June 30, 2018 and changes during the period then ended is presented below:
A summary of the status of the Company’s RSUs as of June 30, 2018 and changes during the period then ended is presented below:
In September 2015, the Company adopted an employee share purchase plan (“ESPP”) to encourage and enable eligible employees to acquire ownership of the Company’s ordinary shares purchased through accumulated payroll deductions on an after-tax basis. In the United States, the ESPP is intended to be an “employee stock purchase plan” within the meaning of Section 423 of the Internal Revenue Code and the provisions of the ESPP will be construed in a manner consistent with the requirements of such section. The Company began its offerings under the ESPP on August 1, 2016. As of June 30, 2018, 2,223,319 ordinary shares were available to be purchased by eligible employees under the ESPP and 314,207 shares had been issued under the ESPP. The fair value of share-based awards was estimated using the Black-Scholes model for all equity grants. For market condition awards, the Company also applied the Monte-Carlo simulation model, with the following underlying assumptions:
The total non-cash share-based compensation expense related to all of the Company’s equity-based awards recognized for the three and six months ended June 30, 2018 and 2017 and the year ended December 31, 2017 was:
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Supplemental Information |
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Geographic Areas Long Lived Assets [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Supplemental Information | NOTE 8: SUPPLEMENTAL INFORMATION The Company operates in a single reportable segment. The following table presents long-lived assets by location:
The Company’s revenues by geographic region, based on the customer’s location, are summarized as follows:
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Organization and Basis of Presentation (Policies) |
6 Months Ended |
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Jun. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements. In May 2014, FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) (ASU 2014-09), an updated standard on revenue recognition and issued subsequent amendments to the initial guidance in March 2016, April 2016, May 2016 and December 2016 within ASU 2016-08, 2016-10, 2016-12 and 2016-20, respectively (collectively, “ASC 606”). The core principle of the new standard is for companies to recognize revenue to depict the transfer of goods and services to patients in amounts that reflect the consideration to which the company expects to be entitled in exchange for those goods and services. In addition, the new standard requires expanded disclosures. The Company has adopted the standard effective January 1, 2018 using the modified retrospective method for all contracts. The reported results for 2018 reflect the application of ASC 606 guidance while the reported results for 2017 were prepared under the guidance of ASC 605, Revenue Recognition (ASC 605). The amount of revenue recognized in 2018 reflects the consideration to which the Company expects to be entitled to receive in exchange for Optune. In preparation for adoption of the standard, the Company has implemented internal controls and key system functionality to enable the preparation of financial information, including the assessment of the impact of the standard. The Company uses the portfolio approach to apply the standard to portfolios of contracts with similar characteristics. Adoption of the standard resulted in an increase to trade receivables of $2,807, deferred revenues of $645 and a cumulative impact to the Company's accumulated deficit as of January 1, 2018 of $2,162. Optune is comprised of two main components: (1) an electric field generator and (2) transducer arrays and related accessories. We retain title to the electric field generator, and the patient is provided replacement transducer arrays and technical support for the device during the term of treatment. The electric field generator and transducer arrays are always supplied and function together and are not sold on a standalone basis. To recognize revenue under ASC 606, the Company applies the following five steps: 1. Identify the contract with a patient. A contract with a patient exists when (i) the Company enters into an enforceable contract with a patient that defines each party’s rights regarding delivery of and payment for Optune, (ii) the contract has commercial substance and (iii) the Company determines that collection of substantially all consideration for Optune is probable based on the payer’s intent and ability to pay the promised consideration. The evidence of a contract generally consists of a prescription, a patient service agreement and the verification of the assigned payer for the contract and intention to collect. 2. Identify the performance obligations in the contract. Optune contracts include the lease of the device, the supply obligation of disposable transducer arrays and technical support for the term of treatment. To the extent a contract includes multiple promised products and/or services, the Company must apply judgment to determine whether those products and/or services are capable of being distinct in the context of the contract. If these criteria are not met the promised products and/or services are accounted for as a combined performance obligation. In the Company’s case, Optune’s device, support, and disposables are provided as one inseparable package of monthly treatment for a single monthly fee. 3. Determine the transaction price. The transaction price is determined based on the consideration to which the Company will be entitled in exchange for providing Optune to the patient. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. The Company has agreements with many payers that define explicit discounts off the gross transaction price. In addition to the explicit discounts negotiated with each payer, the Company expects to receive, in aggregate for a given portfolio, less than the gross revenue net of explicit discounts. ASC 606 requires that the Company recognize this variable consideration as an implicit discount in the billing period. The implicit discount includes both an estimate of claims that will pay at an amount less than billed and an estimate of claims that will not pay within a given time horizon. The implicit discount adjustments to the transaction price are due to concessions, not collectability concerns driven by payer credit risk. 4. Allocate the transaction price to performance obligations in the contract. If a contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. As discussed above, there is one performance obligation under the Company’s contracts and, therefore, the monthly transaction price determined for the performance obligation will be recognized over time ratably over the monthly term of the treatment. 5. Recognize revenue when or as the Company satisfies a performance obligation. The Company satisfies performance obligations over time as discussed above. Revenue is recognized at the time the related performance obligation is satisfied by transferring a promised service to a patient. The patient consumes the benefits of Optune treatment on a daily basis over the monthly term. As this criterion is met, the revenues will be recognized over the monthly term. In accordance with ASC 606, the impact of our adoption of ASC 606 on our condensed consolidated statements of income for the six and three months ended June 30, 2018 were a decrease in net revenues of $5,531 and $1,993, respectively, an increase in net loss of $5,371 and $2,035, respectively, and a decrease in our basic and diluted net loss per ordinary share of $0.06 and $0.02, respectively. The impact of our adoption of Topic 606 on our balance sheet as of June 30, 2018 was a decrease in trade receivables of $2,760, an increase to other payables and accrued expenses (deferred revenues net of tax provision) of $521 and an accumulated deficit as of June 30, 2018 of $3,209. In August 2016, FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230) Classification of Certain Cash Receipts and Cash Payments. ASU 2016-15 eliminates the diversity in practice related to the classification of certain cash receipts and payments for debt prepayment or extinguishment costs, the maturing of a zero coupon bond, the settlement of contingent liabilities arising from a business combination, proceeds from insurance settlements, distributions from certain equity method investees and beneficial interests obtained in a financial asset securitization. ASU 2016-15 designates the appropriate cash flow classification, including requirements to allocate certain components of these cash receipts and payments among operating, investing and financing activities. The retrospective transition method, requiring adjustment to all comparative periods presented, is required unless it is impracticable for some of the amendments, in which case those amendments would be prospectively as of the earliest date practicable. The Company adopted the standard effective as of January 1, 2018, and the adoption of this standard did not have an impact on the Company's consolidated financial statements. In November 2016, FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. This standard requires the presentation of the statement of cash flows to show the changes in the total of cash, cash equivalents, restricted cash and restricted cash equivalents. The standard is effective for fiscal years and the interim periods within those fiscal years beginning after December 15, 2017. The Company adopted the standard retrospectively to all periods presented effective as of January 1, 2018. Recent Accounting Pronouncements. In February 2016, FASB issued ASU 2016-02-Leases (ASC 842), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e. lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of their classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. The new standard requires lessors to account for leases using an approach that is substantially equivalent to existing guidance for sales-type leases, direct financing leases and operating leases. ASC 842 supersedes the previous leases standard, ASC 840. The standard is effective on January 1, 2019, with early adoption permitted. The Company currently anticipates adopting the new standard effective January 1, 2019 and is evaluating the impact of the adoption of this standard on its consolidated financial statements. In June 2016, FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the more timely recognition of losses. ASU 2016-13 also applies to employee benefit plan accounting, with an effective date of the first quarter of fiscal 2020. The amendments in this update are effective for fiscal years beginning after December 31, 2019, including interim periods within those fiscal years. The Company is currently assessing the impact of the adoption of this standard on its consolidated financial statements, footnote disclosures and employee benefit plans’ accounting. In June 2018, FASB issued ASU 2018-07 to expand the scope of ASC Topic 718, Compensation - Stock Compensation, to include share-based payment transactions for acquiring goods and services from nonemployees. The pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2018, with early adoption permitted. The Company is evaluating the effects of this standard on its consolidated financial statements.
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Inventories (Tables) |
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Jun. 30, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Inventories | Inventories are stated at the lower of cost or market. The weighted average methodology is applied to determine cost. As of June 30, 2018 and December 31, 2017, the Company’s inventories were composed of:
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Equity Incentive Plans (Tables) |
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Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Stock Option Plans | A summary of the status of the Company’s option plans as of June 30, 2018 and changes during the period then ended is presented below:
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Schedule of RSU's | A summary of the status of the Company’s RSUs as of June 30, 2018 and changes during the period then ended is presented below:
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Schedule of Fair Value Assumptions Used for All Equity Based Awards Estimated Using Black-Scholes Option Pricing Model | The fair value of share-based awards was estimated using the Black-Scholes model for all equity grants. For market condition awards, the Company also applied the Monte-Carlo simulation model, with the following underlying assumptions:
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Schedule of Non-cash Share-based Compensation Expense Related to Company's Equity-Based Awards | The total non-cash share-based compensation expense related to all of the Company’s equity-based awards recognized for the three and six months ended June 30, 2018 and 2017 and the year ended December 31, 2017 was:
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Supplemental Information (Tables) |
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Geographic Areas Long Lived Assets [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Long-Lived Assets by Location | The following table presents long-lived assets by location:
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Schedule of Revenues by Geographic Region | The Company’s revenues by geographic region, based on the customer’s location, are summarized as follows:
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Organization and Basis of Presentation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 6 Months Ended | 12 Months Ended | ||
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Jun. 30, 2018 |
Jun. 30, 2017 |
Jun. 30, 2018 |
Jun. 30, 2017 |
Dec. 31, 2017 |
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Organization and Basis of Presentation [Line Items] | |||||
Increase (decrease) in trade receivables | $ 3,599 | $ 2,064 | $ 5,271 | $ 7,550 | $ 23,228 |
Decrease in net revenue | 61,514 | 38,376 | 113,639 | 73,256 | 177,026 |
Net loss | $ (15,510) | $ (21,174) | $ (36,234) | $ (39,219) | $ (61,662) |
Decrease in basic and diluted net loss per ordinary share | $ (0.17) | $ (0.24) | $ (0.40) | $ (0.45) | $ (0.70) |
Increase in other payables and accrued expenses | $ (528) | $ 4,888 | $ (8,828) | $ 3,478 | $ 14,460 |
Accounting Standards Update 2014-09 [Member] | |||||
Organization and Basis of Presentation [Line Items] | |||||
Increase (decrease) in trade receivables | (2,760) | 2,807 | |||
Increase in deferred revenue | 645 | ||||
Cumulative deficit effect adjustment resulting from ASU 2014-09 adoption | (3,209) | (3,209) | $ (2,162) | ||
Net loss | $ (2,035) | $ (5,371) | |||
Decrease in basic and diluted net loss per ordinary share | $ (0.02) | $ (0.06) | |||
Increase in other payables and accrued expenses | $ 521 | ||||
Accounting Standards Update 2014-09 [Member] | Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | |||||
Organization and Basis of Presentation [Line Items] | |||||
Decrease in net revenue | $ (1,993) | $ (5,531) | |||
Accounting Standards Update 2014-09 [Member] | First Generation Optune System Field Equipment [Member] | |||||
Organization and Basis of Presentation [Line Items] | |||||
Identify the contract with patient | Identify the contract with a patient. A contract with a patient exists when (i) the Company enters into an enforceable contract with a patient that defines each party’s rights regarding delivery of and payment for Optune, (ii) the contract has commercial substance and (iii) the Company determines that collection of substantially all consideration for Optune is probable based on the payer’s intent and ability to pay the promised consideration. The evidence of a contract generally consists of a prescription, a patient service agreement and the verification of the assigned payer for the contract and intention to collect. | ||||
Identify the performance obligations in the contract, description | Optune contracts include the lease of the device, the supply obligation of disposable transducer arrays and technical support for the term of treatment. To the extent a contract includes multiple promised products and/or services, the Company must apply judgment to determine whether those products and/or services are capable of being distinct in the context of the contract. If these criteria are not met the promised products and/or services are accounted for as a combined performance obligation. In the Company’s case, Optune’s device, support, and disposables are provided as one inseparable package of monthly treatment for a single monthly fee | ||||
Determine the transaction price, description | The transaction price is determined based on the consideration to which the Company will be entitled in exchange for providing Optune to the patient. | ||||
Allocate the transaction price to performance obligations in the contract, description | If a contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. As discussed above, there is one performance obligation under the Company’s contracts and, therefore, the monthly transaction price determined for the performance obligation will be recognized over time ratably over the monthly term of the treatment. | ||||
Recognize revenue when or as the company satisfies a performance obligation, description | The Company satisfies performance obligations over time as discussed above. Revenue is recognized at the time the related performance obligation is satisfied by transferring a promised service to a patient. The patient consumes the benefits of Optune treatment on a daily basis over the monthly term. As this criterion is met, the revenues will be recognized over the monthly term. |
Short-Term Investments - Additional Information (Details) - USD ($) $ in Thousands |
Jun. 30, 2018 |
Dec. 31, 2017 |
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Investments Debt And Equity Securities [Abstract] | ||
Short-term investments | $ 104,499 | $ 104,719 |
Estimated fair value of short-term investments | $ 104,512 | $ 104,655 |
Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands |
Jun. 30, 2018 |
Dec. 31, 2017 |
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Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,519 | $ 4,276 |
Work in progress | 5,267 | 8,435 |
Finished products | 12,120 | 9,314 |
Total | $ 19,906 | $ 22,025 |
Commitments and Contingent Liabilities - Additional Information (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | |
---|---|---|---|
Mar. 31, 2018 |
Jun. 30, 2018 |
Dec. 31, 2017 |
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Loss Contingencies [Line Items] | |||
Operating lease expiration description | The facilities of the Company are leased under various operating lease agreements for periods ending no later than 2024. | ||
Pledged bank deposits | $ 1,145 | $ 1,038 | |
Operating lease and other contractual commitments | 1,305 | $ 1,202 | |
Settlement agreement date | February 10, 2015 | ||
Settlement Agreement | |||
Loss Contingencies [Line Items] | |||
Settlement expense | $ 5,500 | ||
Net sales milestone | $ 250,000 | ||
Motor Vehicles | |||
Loss Contingencies [Line Items] | |||
Operating lease expiration description | The Company also leases motor vehicles under various operating leases, which expire on various dates, the latest of which is in 2021. | ||
Maximum | |||
Loss Contingencies [Line Items] | |||
Operating lease agreements, expiration year | 2024 | ||
Maximum | Motor Vehicles | |||
Loss Contingencies [Line Items] | |||
Operating lease agreements, expiration year | 2021 |
Long Term Loan - Additional Information (Details) - USD ($) $ in Thousands |
6 Months Ended | |
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Feb. 07, 2018 |
Jun. 30, 2018 |
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2018 Credit Facility | ||
Line Of Credit Facility [Line Items] | ||
Term loan, principal amount | $ 150,000 | |
Interest on term loan credit facility | 9.00% | |
Interest, frequency of payment | quarterly | |
Term loan credit facility, expiation date | Feb. 07, 2023 | |
Debt issuance costs, net | $ 805 | |
Term loan credit facility, maturity term | 5 years | |
2018 Credit Facility | Prior to February 7, 2021 | ||
Line Of Credit Facility [Line Items] | ||
Pre-payment fee, percentage | 2.00% | |
2018 Credit Facility | February 7, 2021 to February 7, 2022 | ||
Line Of Credit Facility [Line Items] | ||
Pre-payment fee, percentage | 1.00% | |
Term Loan | ||
Line Of Credit Facility [Line Items] | ||
Debt issuance costs, net | $ 1,399 | |
Debt instrument, un-amortized discount | $ 1,160 |
Share Capital - Additional Information (Details) |
6 Months Ended |
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Jun. 30, 2018
$ / shares
shares
| |
Share Capital [Line Items] | |
The Number of ordinary shares that originally could be purchased by exercise of warrants | 201,692 |
Warrants exercise price | $ / shares | $ 3.59 |
Options exercised | 2,253,654 |
Ordinary shares issued upon option exercise | 2,251,676 |
Warrant | |
Share Capital [Line Items] | |
The Number of ordinary shares that originally could be purchased by exercise of warrants in cash | 1,549 |
Warrant | Warrants Not Settleable in Cash | |
Share Capital [Line Items] | |
Number of shares issued upon the exercise of warrants | 167,212 |
Equity Incentive Plans - Additional Information (Details) |
6 Months Ended |
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Jun. 30, 2018
shares
| |
ESPP | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Ordinary shares available for grants | 2,223,319 |
Shares issued under plan | 314,207 |
2015 Plan | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Ordinary shares available for grants | 10,416,052 |
2015 Plan | Option | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Stock awards granted, vesting period | 4 years |
Stock awards granted, expiration period | 10 years |
2015 Plan | RSUs | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Stock awards granted, vesting period | 3 years |
Equity Incentive Plans - Schedule of Stock Option Plan (Details) |
6 Months Ended |
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Jun. 30, 2018
$ / shares
shares
| |
Number of options | |
Number of options, Outstanding at beginning of year | shares | 14,806,027 |
Number of options, Granted | shares | 2,199,389 |
Number of options, Exercised | shares | (2,253,654) |
Number of options, Forfeited and cancelled | shares | (127,262) |
Number of options, Outstanding at ending of year | shares | 14,624,500 |
Number of options, Exercisable options | shares | 5,955,869 |
Weighted average exercise price | |
Weighted average exercise price, Outstanding at beginning of year | $ / shares | $ 10.64 |
Weighted average exercise price, Granted | $ / shares | 22.31 |
Weighted average exercise price, Exercised | $ / shares | 6.54 |
Weighted average exercise price, Forfeited and cancelled | $ / shares | 14.59 |
Weighted average exercise price, Outstanding at end of year | $ / shares | 12.99 |
Weighted average exercise price, Exercisable options | $ / shares | $ 10.20 |
Equity Incentive Plans - Schedule of RSU's (Details) - RSUs |
6 Months Ended |
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Jun. 30, 2018
$ / shares
shares
| |
Number of RSUs | |
Number of RSUs, unvested at beginning of year | shares | 1,651,219 |
Number of RSUs, granted | shares | 482,232 |
Number of RSUs, vested | shares | (550,418) |
Number of RSUs, forfeited and cancelled | shares | (10,760) |
Number of RSUs, unvested at ending of year | shares | 1,572,273 |
Weighted average grant date fair value price | |
Weighted average grant date date fair value price, unvested at beginning of year | $ / shares | $ 9.66 |
Weighted average grant date date fair value price, granted | $ / shares | 22.20 |
Weighted average grant date date fair value price, vested | $ / shares | 9.66 |
Weighted average grant date date fair value price, forfeited and cancelled | $ / shares | 12.13 |
Weighted average grant date date fair value price, unvested at ending of year | $ / shares | $ 13.49 |
Supplemental Information - Schedule of Long-Lived Assets by Location (Details) - USD ($) $ in Thousands |
Jun. 30, 2018 |
Dec. 31, 2017 |
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Revenues From External Customers And Long Lived Assets [Line Items] | ||
Long-lived assets | $ 16,999 | $ 18,067 |
United States | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Long-lived assets | 9,731 | 10,372 |
Switzerland | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Long-lived assets | 4,211 | 5,114 |
Israel | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Long-lived assets | 2,238 | 2,081 |
Others | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Long-lived assets | $ 819 | $ 500 |
Supplemental Information - Schedule of Revenues by Geographic Region (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | 12 Months Ended | ||
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Jun. 30, 2018 |
Jun. 30, 2017 |
Jun. 30, 2018 |
Jun. 30, 2017 |
Dec. 31, 2017 |
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Revenues From External Customers And Long Lived Assets [Line Items] | |||||
Net revenues | $ 61,514 | $ 38,376 | $ 113,639 | $ 73,256 | $ 177,026 |
United States | |||||
Revenues From External Customers And Long Lived Assets [Line Items] | |||||
Net revenues | 41,935 | 31,367 | 79,738 | 60,526 | 134,688 |
EMEA | |||||
Revenues From External Customers And Long Lived Assets [Line Items] | |||||
Net revenues | 18,522 | 6,891 | 32,396 | 12,559 | 42,035 |
Japan | |||||
Revenues From External Customers And Long Lived Assets [Line Items] | |||||
Net revenues | $ 1,057 | $ 118 | $ 1,505 | $ 171 | $ 303 |
Supplemental Information - Schedule of Revenues by Geographic Region (Parenthetical) (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | 12 Months Ended | ||
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Jun. 30, 2018 |
Jun. 30, 2017 |
Jun. 30, 2018 |
Jun. 30, 2017 |
Dec. 31, 2017 |
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Revenues From External Customers And Long Lived Assets [Line Items] | |||||
Net revenues | $ 61,514 | $ 38,376 | $ 113,639 | $ 73,256 | $ 177,026 |
Germany | |||||
Revenues From External Customers And Long Lived Assets [Line Items] | |||||
Net revenues | $ 17,651 | $ 6,817 | $ 31,009 | $ 12,216 | $ 40,215 |