Document and Entity Information
Document and Entity Information | 12 Months Ended |
Dec. 31, 2017shares | |
Document and Entity Information [Abstract] | |
Entity Registrant Name | RedHill Biopharma Ltd. |
Entity Central Index Key | 1,553,846 |
Document Type | 20-F |
Document Period End Date | Dec. 31, 2017 |
Amendment Flag | false |
Current Fiscal Year End Date | --12-31 |
Entity Well-known Seasoned Issuer | No |
Entity Current Reporting Status | Yes |
Entity Filer Category | Accelerated Filer |
Entity Common Stock, Shares Outstanding | 212,729,434 |
Document Fiscal Year Focus | 2,017 |
Document Fiscal Period Focus | FY |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |||
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | |||||
NET REVENUES | $ 4,007 | $ 101 | $ 3 | ||
COST OF REVENUES | 2,126 | ||||
GROSS PROFIT | 1,881 | 101 | 3 | ||
RESEARCH AND DEVELOPMENT EXPENSES, net | 32,969 | 25,241 | 17,771 | ||
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES | 12,014 | 1,555 | [1] | 1,386 | [1] |
GENERAL AND ADMINISTRATIVE EXPENSES | 8,025 | 3,848 | [1] | 2,748 | [1] |
OTHER EXPENSES | 845 | 100 | |||
OPERATING LOSS | 51,972 | 30,543 | 22,002 | ||
FINANCIAL INCOME | 6,505 | 1,548 | 1,124 | ||
FINANCIAL EXPENSES | 77 | 375 | 212 | ||
FINANCIAL INCOME, net | (6,428) | (1,173) | (912) | ||
LOSS AND COMPREHENSIVE LOSS FOR THE YEAR | $ 45,544 | $ 29,370 | $ 21,090 | ||
LOSS PER ORDINARY SHARE (U.S. dollars): | |||||
Basic (in dollars per share) | $ 0.26 | $ 0.23 | $ 0.19 | ||
Diluted (U.S. dollars) | $ 0.26 | $ 0.24 | $ 0.19 | ||
[1] | *Reclassified to conform to the current year presentation. |
CONSOLIDATED STATEMENTS OF FINA
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 16,455 | $ 53,786 | |
Bank deposits | 13,163 | 55 | |
Financial assets at fair value through profit or loss | 16,587 | 12,313 | |
Trade receivables | 1,528 | 99 | [1] |
Prepaid expenses and other receivables | 3,290 | 1,562 | [1] |
Inventory | 653 | ||
Total current assets | 51,676 | 67,815 | |
NON-CURRENT ASSETS: | |||
Bank deposits | 152 | 137 | |
Fixed assets | 230 | 165 | |
Intangible assets | 5,285 | 6,095 | |
Total non-current assets | 5,667 | 6,397 | |
TOTAL ASSETS | 57,343 | 74,212 | |
CURRENT LIABILITIES: | |||
Accounts payable | 4,805 | 60 | [1] |
Accrued expenses and other current liabilities | 6,025 | 3,296 | [1] |
Payable in respect of intangible asset purchase | 1,000 | 2,000 | |
Total current liabilities | 11,830 | 5,356 | |
NON-CURRENT LIABILITIES: | |||
Derivative financial instruments | 448 | 6,155 | |
TOTAL LIABILITIES | 12,278 | 11,511 | |
COMMITMENTS | |||
EQUITY: | |||
Ordinary shares | 575 | 441 | |
Additional paid-in capital | 177,434 | 150,838 | |
Warrants | 1,057 | ||
Accumulated deficit | (132,944) | (89,635) | |
TOTAL EQUITY | 45,065 | 62,701 | |
TOTAL LIABILITIES AND EQUITY | $ 57,343 | $ 74,212 | |
[1] | *Reclassified to conform to the current year presentation. |
CONSOLIDATED STATEMENT OF CHANG
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY - USD ($) $ in Thousands | Ordinary shares | Additional paid-in capital | Warrants | Accumulated deficit | Total | |
Balance at beginning of period at Dec. 31, 2014 | $ 240 | $ 65,461 | $ 1,528 | $ (42,218) | $ 25,011 | |
Share-based compensation to employees and service providers | 1,364 | 1,364 | ||||
Issuance of ordinary shares, net of expenses | 103 | 54,581 | 54,684 | |||
Exercise of warrants and options into ordinary shares | [1] | 108 | 108 | |||
Warrants expiration | 471 | (471) | ||||
Comprehensive loss | (21,090) | (21,090) | ||||
Balance at end of period at Dec. 31, 2015 | 343 | 120,621 | 1,057 | (61,944) | 60,077 | |
Share-based compensation to employees and service providers | 1,679 | 1,679 | ||||
Issuance of ordinary shares, net of expenses | 96 | 29,956 | 30,052 | |||
Warrants expiration | 2 | 261 | 263 | |||
Comprehensive loss | (29,370) | (29,370) | ||||
Balance at end of period at Dec. 31, 2016 | 441 | 150,838 | 1,057 | (89,635) | 62,701 | |
Share-based compensation to employees and service providers | 2,235 | 2,235 | ||||
Issuance of ordinary shares, net of expenses | 119 | 22,097 | 22,216 | |||
Exercise of warrants and options into ordinary shares | 15 | 3,442 | 3,457 | |||
Warrants expiration | 1,057 | $ (1,057) | ||||
Comprehensive loss | (45,544) | (45,544) | ||||
Balance at end of period at Dec. 31, 2017 | $ 575 | $ 177,434 | $ (132,944) | $ 45,065 | ||
[1] | Represents amounts of less than $1 thousand. |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
OPERATING ACTIVITIES: | |||
Comprehensive loss | $ (45,544) | $ (29,370) | $ (21,090) |
Adjustments in respect of income and expenses not involving cash flow: | |||
Share-based compensation to employees and service providers | 2,235 | 1,679 | 1,364 |
Depreciation | 81 | 44 | 36 |
Write-off of intangible assets | 845 | 100 | |
Fair value adjustment on derivative financial instruments | (5,687) | (1,152) | (888) |
Fair value losses (gains) on financial assets at fair value through profit or loss | 127 | (67) | |
Revaluation of bank deposits | (123) | (274) | (69) |
Issuance cost in respect of warrants | 368 | ||
Exchange differences in respect of cash and cash equivalents | (367) | (39) | 150 |
Total adjustments in respect of income and expenses not involving cash flow | (2,889) | 559 | 693 |
Changes in assets and liability items: | |||
Decrease (increase) in trade receivables | (1,429) | 99 | |
Decrease (increase) in prepaid expenses and other receivables | (1,728) | 612 | 702 |
Increase in inventory | (653) | ||
Increase (decrease) in accounts payable | 4,745 | (60) | 153 |
Increase (decrease) in accrued expenses | 2,729 | (98) | 1,716 |
Total changes in assets and liability items | 3,664 | 553 | 2,571 |
Net cash used in operating activities | (44,769) | (28,258) | (17,826) |
INVESTING ACTIVITIES: | |||
Purchase of fixed assets | (146) | (85) | (14) |
Purchase of intangible assets | (1,035) | (35) | (1,620) |
Change in investment in current bank deposits | (13,000) | 36,838 | (29,500) |
Purchase of non-current bank deposits | (58) | ||
Purchase of financial assets at fair value through profit or loss | (21,923) | (12,246) | |
Proceeds from sale of financial assets at fair value through profit or loss | 17,522 | ||
Maturity of non-current bank deposits | 10,000 | ||
Net cash provided by (used in) investing activities | (18,582) | 24,472 | (21,192) |
FINANCING ACTIVITIES: | |||
Proceeds from issuance of ordinary shares and warrants, net of expenses | 22,216 | 35,754 | 54,684 |
Exercise of warrants and options into ordinary shares, net of expenses | 3,437 | 263 | 108 |
Net cash provided by financing activities | 25,653 | 36,017 | 54,792 |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (37,698) | 32,231 | 15,774 |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | 367 | 39 | (150) |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 53,786 | 21,516 | 5,892 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD | 16,455 | 53,786 | 21,516 |
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH | $ 469 | $ 408 | 236 |
Supplementary information on investing activities not involving cash flows - Purchase of intangible assets. | $ 1,925 |
GENERAL
GENERAL | 12 Months Ended |
Dec. 31, 2017 | |
GENERAL | |
GENERAL | NOTE 1 - GENERAL: a. General RedHill Biopharma Ltd. (the “Company”), incorporated in Israel on August 3, 2009, together with its recently established wholly-owned subsidiary RedHill Biopharma Inc. incorporated in Delaware on January 19, 2017, is a specialty biopharmaceutical company, primarily focused on late clinical-stage development and commercialization of proprietary and in-licensed or acquired drugs for gastrointestinal (“GI”) diseases and cancer. In February 2011, the Company listed its securities on the Tel-Aviv Stock Exchange (“TASE”) and since December 2012, the Company’s American Depositary Shares (“ADSs”) have been listed on the NASDAQ Capital Market (“NASDAQ”). The Company’s registered address is 21 Ha’arba’a St, Tel-Aviv, Israel. The Company is primarily engaged in the research and development of its therapeutic candidates and, since January 2017, has pursued its commercial activities in the U.S. through RedHill Biopharma Inc. To date the Company has out-licensed on an exclusive worldwide basis only one of its therapeutic candidates and has generated only approximately $4 million revenues from its commercial operations. Accordingly, there is no assurance that the Company’s business will generate sustainable positive cash flows. Through December 31, 2017, the Company has an accumulated deficit and its activities have been funded primarily through public and private offerings of the Company’s securities. The Company plans to further fund its future operations through commercialization and out-licensing or selling and marketing of its therapeutic candidates, commercialization of in-licensed or acquired products and raising additional capital through the sale of equity, debt or through other financing that does not cause dilution to our shareholders. The Company’s current cash resources are not sufficient to complete the research and development of all of the Company’s therapeutic candidates and to fully support its commercial operations until generation of sustainable positive cash flows. Management expects that the Company will incur additional losses as it continues to focus its resources on advancing the development of its therapeutic candidates, as well as advancing its commercial operations, based on a prioritized plan that will result in negative cash flows from operating activities. The Company believes its existing capital resources should be sufficient to fund its current and planned operations for at least the next 12 months. If the Company is unable to out-license, sell or commercialize its therapeutic candidates, generate sufficient and sustainable revenues from its commercial operations, or obtain future financing, the Company may be forced to delay, reduce the scope of, or eliminate one or more of its research and development or commercialization programs, any of which may have a material adverse effect on the Company’s business, financial condition and results of operations. b. Approval of financial statements These financial statements were approved by the Board of Directors on February 21, 2018. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2017 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES : a. Basis for presentation of the financial statements The consolidated financial statements of the Company as of December 31, 2017 and 2016 and for each of the three years for the period ended on December 31, 2017 have been prepared in accordance with International Financial Reporting Standards (“IFRS”), as issued by the International Accounting Standards Board (“IASB”). The significant accounting policies described below have been applied consistently in relation to all the periods presented, unless otherwise stated. The consolidated financial statements have been prepared under the historical cost convention, subject to adjustments in respect of revaluation of financial assets and financial liabilities at fair value through profit or loss. The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in applying the Company’s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the financial statements, are disclosed in Note 3. Actual results could differ significantly from those estimates and assumptions. b. Translation of foreign currency balances and transactions 1) Functional and presentation currency Items included in the consolidated financial statements are measured using the currency of the primary economic environment in which the Company operates (the “Functional Currency”). The consolidated financial statements are presented in U.S. dollars (“$”), which is the Company’s functional and presentation currency. 2) Transactions and balances Foreign currency transactions in currencies different from the Functional Currency (hereafter foreign currency, mostly New Israeli Shekels (“NIS”)) are translated into the Functional Currency using the exchange rates at the dates of the transactions. Foreign exchange differences resulting from the settlement of such transactions and from the translation of period-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recorded in the Statements of Comprehensive Loss under Financing Income or Financial Expenses. c. Principles of consolidation Commencing 2017, the Company’s consolidated financial statements include the accounts of the Company and its subsidiary. All material intercompany balances and transactions have been eliminated upon consolidation. d. Cash and cash equivalents Cash and cash equivalents include cash on hand and unrestricted short-term bank deposits with maturities of three months or less. e. Trade receivables Trade receivables are recognized initially at fair value. Subsequent to the initial recognition, they are measured at amortized cost using the effective interest rate method, less any impairment loss. f. Inventory The Company’s inventory represents items that are available for commercial sale. The inventory is stated at the lower of cost or net realizable value with cost determined using the first-in, first-out method. The Company recognized an amount of $0.8 million in inventory cost as part of cost of revenues during the year ended December 31, 2017. The Company continually evaluates inventory for potential loss due to excess quantity or obsolete or slow-moving inventory by comparing sales history and sales projections to the inventory on hand. When evidence indicates that the carrying value of a product may not be recoverable, a charge is recorded to reduce the inventory to its current net realizable value. g. Fixed assets Fixed assets items are initially recognized at acquisition cost. Fixed assets items are stated at cost less accumulated depreciation. Depreciation is computed by the straight-line method, to reduce the cost of fixed assets to their residual value over their estimated useful lives as follows: % Computers equipment 33 Office furniture and equipment 8-15 Leasehold improvements are depreciated by the straight-line method over the shorter of the term of the lease or the estimated useful life of the improvements. h. Research and development 1) Research and development assets acquired by the Company, the development of which has not yet been completed, are stated at cost and are not amortized. These assets are tested for impairment once a year. At the time these assets will be available for use, they will be amortized by the straight-line method over their useful lives. 2) Research and development expenses are charged to profit or loss as incurred. An intangible asset arising from the development of the Company’s therapeutic candidates is recognized if all of the following conditions are met: · it is technically feasible to complete the intangible asset so that it will be available for use; · management intends to complete the intangible asset and use it or sell it; · there is an ability to use or sell the intangible asset; · it can be demonstrated how the intangible asset will generate probable future economic benefits; and · adequate technical, financial and other resources to complete the development and to use or sell the intangible asset are available and costs associated with the intangible asset during development can be measured reliably. Other development costs that do not meet the above criteria are recognized as expenses as incurred. Development costs previously recognized as an expense are not recognized as an asset in a subsequent period. As of December 31, 2017, the Company had not yet capitalized any development costs. 3) Amounts paid to purchase intellectual property of therapeutic candidates are capitalized and recorded as intangible assets. Amounts due for future payment based on contractual agreements are accrued upon reaching the relevant milestones. 4) Research and development costs for the performance of pre-clinical trials, clinical trials and manufacturing by subcontractors are recognized as expenses when incurred. i. Impairment of non-financial assets Depreciable assets are tested for impairment if any events have occurred or changes in circumstances have taken place which might indicate that their carrying amounts may not be recoverable. Research and development assets, the development of which has not yet been completed, are not amortized and are tested for impairment on an annual basis. An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use. For purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units). Nonfinancial assets that were subject to impairment are reviewed for possible reversal of the impairment recognized in respect thereof at each date of the Statements of Financial Position. j. Financial assets 1) Classification The financial assets of the Company are classified into the following categories: financial assets at fair value through profit or loss, and loans and receivables. The classification depends on the purpose for which the financial assets were acquired. The Company’s management determines the classification of its financial assets at initial recognition. a) Financial assets at fair value through profit or loss Financial assets at fair value through profit or loss includes financial assets that are managed and their performance is evaluated on a fair value basis; thus, upon their initial recognition, these assets are designated by management at fair value through profit or loss. Assets in this category are classified as current assets if they are expected to be settled within 12 months; otherwise, they are classified as noncurrent. b) Loans and receivables Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They are included in current assets, except for those with maturities greater than 12 months after the statements of financial position date (for which they are classified as noncurrent assets). The loans and receivables of the Company are included in trade receivables, prepaid expenses and other receivables, cash and cash equivalents and bank deposits in the Statements of Financial Position. 2) Recognition and measurement Regular purchases and sales of financial assets are recognized on the settlement date, which is the date on which the asset is delivered to the Company or delivered by the Company. Investments are initially recognized at fair value plus transaction costs for all financial assets not recorded at fair value through profit or loss. Financial assets measured at fair value through profit or loss are initially recognized at fair value, and transaction costs are expensed to profit or loss. Financial assets are derecognized when the rights to receive cash flow from the investments have expired or have been transferred and the Company has transferred substantially all risks and rewards of ownership. Financial assets at fair value through profit or loss are subsequently recorded at fair value. Loans and receivables are measured in subsequent periods at amortized cost using the effective interest method. Gains or losses arising from changes in the fair value of financial assets at fair value through profit or loss are presented in the Statement of Comprehensive Loss under “Financial Expenses (Income), net”. k. Accounts payable Accounts payable are obligations to pay for goods or services that have been acquired from suppliers in the ordinary course of business. Accounts payable are classified as current liabilities if payment is due within one year or less; otherwise they are presented as noncurrent liabilities. Accounts payable are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method. l. Warrants Receipts in respect of warrants are classified as equity to the extent that they confer the right to purchase a fixed number of shares for a fixed exercise price. Warrants that confer the right to net share settlement do not qualify for equity classification and are classified as derivative liabilities. See m below. m. Derivative financial instruments The derivative financial instruments of the Company represent warrants. n. Share capital The Company’s ordinary shares are classified as the Company’s share capital. Incremental costs directly attributed to the issuance of new shares or warrants are presented under equity as a deduction from the proceeds of issuance. o. Employee benefits 1) Pension and retirement benefit obligations In any matter related to payment of pension and severance pay to employees in Israel to be dismissed or to retire from the Company, the Company operates in accordance with labor laws. Labor laws and agreements in Israel and the Company’s practice require the Company to pay severance pay and/or pensions to employees dismissed or retiring, in certain circumstances. The Company has a severance pay plan in accordance with Section 14 of the Israeli Severance Pay Law with the plan treated as a defined contribution plan. According to the plan, the Company regularly makes payments to severance pay or pension funds without having a legal or constructive obligation to pay further contributions if the fund does not hold sufficient assets to pay all employees in the plan the benefits relating to employee service in the current and prior periods. Contributions for severance pay or pension are recognized as employee benefit expenses when they are due commensurate with receipt of work services from the employee and no further provision is required in the financial statements. The Company’s subsidiary provides, at will, benefit contributions for its employees. 2) Vacation and recreation pay Under Israeli law, each employee in Israel is entitled to vacation days and recreation pay, both computed on an annual basis. This entitlement is based on the period of employment. The Company records a liability and expenses vacation and recreation pay based on the benefit accumulated by each employee. p. Share-based payments The Company operates a number of equity-settled, share-based compensation plans to employees (as defined in IFRS 2 “Share-Based Payments”) and service providers. As part of the plans, the Company grants employees and service providers, from time to time and at its discretion, options to purchase Company shares. The fair value of the employee and service provider services received in exchange for the grant of the options is recognized as an expense in profit or loss and is recorded as accumulated deficit within equity. The total amount recognized as an expense over the vesting period of the options (the period during which all vesting conditions are expected to be met) is determined by reference to the fair value of the options granted at the date of grant. Vesting conditions are included in the assumptions about the number of options that are expected to vest. The total expense is recognized over the vesting period, which is the period over which all of the specified vesting conditions are to be satisfied. At the end of each reporting period, the Company revises its estimates of the number of options that are expected to vest based on nonmarket vesting conditions. The Company recognizes the impact of the revision to original estimates, if any, in profit or loss, with a corresponding adjustment to accumulated deficit. When exercising options, the Company issues new shares. The proceeds, less direct attributable transaction costs, are recognized as share capital (par value) and share premium. q. Revenue from contracts with customers As of January 1, 2017, the Company early adopted IFRS 15, with full retrospective application. The adoption of IFRS 15 did not have an effect on either revenue recognized in prior periods, nor to accumulated deficits as of January 1, 2015. IFRS 15 introduces a five-step model for recognizing revenue from contracts with customers, as follows: · identify the contract with a customer; · identify the performance obligations in the contract; · determine the transaction price; · allocate the transaction price to the performance obligations in the contract; and · recognize revenue when (or as) the entity satisfies a performance obligation. 1) Revenues from promotional services The Company recognizes revenue from promotional services related to Donnatal ® and Esomeprazole Strontium Delayed-Release Capsules 49.3 mg as it satisfies its performance obligation over time, in an amount equal to the consideration it expects to be entitled to, taking into consideration the constraint on variable considerations stipulated in IFRS 15. 2) Revenues from the sale of products Principal versus agent considerations When another party is involved in providing goods or services to a customer, the Company analyzes whether the Company acts as a principal or an agent in the transaction, based on whether the Company obtains control of the product before it is transferred to the customer, using the indicators provided in IFRS 15. In the commercialization of EnteraGam ® , the Company is determined to be the principal in the arrangement (rather than an agent of Entera Health), and therefore, revenue in the amount the Company is entitled to from its customers is recognized on a gross basis, from which royalties to Entera Health Inc. (“Entera Health”) are being accounted for in cost of revenues. The Company recognizes revenues from the sale of EnteraGam ® at a point in time when control over the product is transferred to customers. The transaction price in these arrangements is the consideration the Company expects to be entitled to from the customer, reduced by estimates of rebates, discounts, allowances and provision for product returns, given or expected to be given, which vary by product arrangement and buying groups. These estimates have been based on actual in-market data received pre- and post- end of the accounting period and have been applied to inventory held at wholesalers and pharmacies. The Company will continue to refine these estimates and methodologies over time as the breadth of in-market data increases. 3) Revenues from out-licensing of the Company's therapeutic candidates Revenue incurred in connection with the out-licensing of a right to use the Company’s intellectual property is recognized at a point in time when control over the license is transferred to the licensee. The transaction price contains variable considerations contingent upon the licensee achieving certain milestones, as well as sales-based royalties, in accordance with the relevant agreement. Revenue from achieving additional milestones is recognized only when it is highly probable that a significant reversal of cumulative revenues will not occur, usually upon achievement of the specific milestone, in accordance with the relevant agreement. Sales-based royalties are not included in the transaction price; rather they are recognized as incurred, due to the specific exception for sales-based royalties in licensing of intellectual property. 4) Practical expedients and exemptions The Company expenses sales commissions when incurred. These costs are recorded as selling and marketing expenses. r. Advertising and promotional expenses Advertising and promotional costs include distribution of free products’ samples. These costs are recognized as an expense when incurred. s. Leases Leases in which a significant portion of the risks and rewards of ownership are retained by the lessor are classified as operating leases. Payments made under operating leases are charged to the Statements of Comprehensive Loss on a straight-line basis over the period of the lease. t. Loss per ordinary share The computation of basic loss per share is based on the Company’s loss divided by the weighted average number of ordinary shares outstanding during the period. In calculating the diluted loss per share, the Company adds the weighted average of the number of shares to be issued to the average number of shares outstanding used to calculate the basic loss per share, assuming all shares that have a potentially dilutive effect have been exercised into shares. u. Deferred taxes Deferred income tax is recognized using the liability method for temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the financial statements. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantially enacted by the Statements of Financial Position date and are expected to apply when the related deferred income tax asset will be realized or the deferred income tax liability will be settled. Deferred income tax assets are recognized only to the extent that it is probable that future taxable profit will be available against which the temporary differences can be utilized. Since the Company is unable to assess whether it will have taxable income in the foreseeable future, no deferred tax assets were recorded in these financial statements. v. Standards and interpretations to existing standards that are not yet in effect and have not been early adopted by the Company International Financial Reporting Standard No. 9 “Financial Instruments” (hereafter - IFRS 9) IFRS 9 “Financial instruments” addresses the classification, measurement and recognition of financial assets and financial liabilities. The complete version of IFRS 9 was issued in July 2014. It replaces the guidance in IAS 39 that relates to the classification and measurement of financial instruments. IFRS 9 retains but simplifies the mixed measurement model and establishes three primary measurement categories for financial assets: amortized cost, fair value through other comprehensive income, and fair value through profit or loss. The basis of classification depends on the entity’s business model and the contractual cash flow characteristics of the financial asset. Investments in equity instruments are required to be measured at fair value through profit or loss with the irrevocable option at inception to present changes in fair value in other comprehensive income. Furthermore, the expected credit losses model replaces the incurred loss impairment model used in IAS 39. For financial liabilities, there were no changes to classification and measurement except for the recognition of changes in the Company’s own credit risk in other comprehensive income for liabilities designated at fair value through profit or loss. The standard is effective for accounting periods beginning on or after January 1, 2018. The Company assessed the impact of IFRS 9 to be immaterial. International Financial Reporting Standard No. 16 “Leases” (hereafter - IFRS 16) IFRS 16 defines a lease as a contract, or part of a contract, that conveys the right to use an asset (the underlying asset) for a period of time in exchange for consideration. Under IFRS 16 lessees have to recognize a lease liability reflecting future lease payments and a ‘right-of-use asset’ for almost all lease contracts. The standard replaces the current guidance in IAS 17. The standard is effective for annual periods beginning on or after January 1, 2019. The Company is currently assessing the impact of adopting IFRS 16. The Company expects to adopt the standard using the cumulative effect approach and applying for additional reliefs as allowed by the standard’s transition provisions. See operating lease agreements on note 12b. |
CRITICAL ACCOUNTING ESTIMATES A
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS | 12 Months Ended |
Dec. 31, 2017 | |
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS | |
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS | NOTE 3 - CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS: Estimates and judgments are continually evaluated and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. The Company makes judgments and estimates and assumptions concerning the future. The resulting accounting estimates will, by definition, seldom equal the related actual results. The material judgments, estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the following financial year are in respect of impairment of intangible assets. The Company reviews once a year or when indications of impairment are present, whether research and development assets are to be impaired. See note 2i. The Company makes judgments to determine whether indications are present that require reviewing impairment of these intangible assets. An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amounts of each asset are based on the Company’s estimates as to the development of the therapeutic candidates, changes in market scope, market competition and timetables for regulatory approvals. |
FINANCIAL INSTRUMENTS AND FINAN
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | 12 Months Ended |
Dec. 31, 2017 | |
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | |
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | NOTE 4 - FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT: a. Financial risk management: 1) Financial risk factors The Company’s activities expose it to a variety of financial risks: market risk (including foreign exchange risk and price risks), credit and interest risks, and liquidity risk. The Company’s overall risk management program focuses on the unpredictability of financial markets and seeks to minimize potential adverse effects on the Company’s results of operations and financial position. Risk management is performed by the Chief Financial Officer of the Company who identifies and evaluates financial risks in close cooperation with the Company’s Chief Executive Officer. The Company’s finance department is responsible for carrying out financial risk management activities in accordance with policies approved by its board of directors. The board of directors provides general guidelines for overall financial risk management as well as policies dealing with specific areas, such as exchange rate risk, interest rate risk, credit risk, use of financial instruments and investment of excess cash. In order to minimize market risk and credit risk, the Company has invested the majority of its cash balances in low-risk investments, such as (i) highly-rated bank deposits with terms of up to one-year term with exit points and (ii) a managed portfolio of selected corporate bonds, comprised of a diversified mix of highly-rated bonds. No more than 10% of the total value of the Company’s portfolio is invested in a single bond issuer. (a) Market risks The Company might be exposed to foreign exchange risk as a result of making payments to employees or service providers and investment of some liquidity in currencies other than the U.S. dollar (i.e., the Functional Currency). The Company manages the foreign exchange risk by aligning the currencies for holding liquidity with the currencies of expected expenses, based on the expected cash flows of the Company. Had the Functional Currency of the Company been stronger by 5% against the NIS, assuming all other variables remained constant, the Company would have recognized an additional expense of $56,,000 $78,000 and $12,000 in profit or loss for the years ended, December 31, 2017, 2016 and 2015, respectively. The foreign exchange risks associated with these balances are immaterial. (b) Credit and interest risks Credit and interest risks arise from cash and cash equivalents, deposits with banks, financial assets at fair value through profit or loss, as well as receivables. A substantial portion of liquid instruments of the Company is invested in short-term deposits or corporate bonds in highly-rated banks. The Company estimates that since the liquid instruments are mainly invested for the short term and with highly-rated institutions, the credit and interest risks associated with these balances are low. Credit risk is the risk that customers may fail to pay their debts. The Company manages credit risk by setting credit limits, performing controls and monitoring qualitative and quantitative indicators of trade receivable balances such as the period of credit taken and overdue payments. Customer credit risk also arises as a result of the concentration of the Company’s revenues with its largest customers. See also note 22b. (c) Liquidity risk Prudent liquidity risk management requires maintaining sufficient cash and the availability of funding through an adequate amount of committed credit facilities. Management monitors rolling forecasts of the Company’s liquidity reserve (comprising of cash and cash equivalents, deposits and financial assets through profit or loss). This is generally carried out based on the expected cash flow in accordance with practice and limits set by the management of the Company. As of December 31, 2017, the Company has generated revenues from commercialization and promotional activities; however, and as no sufficient revenue from the commercial operations was generated to compensate for operating expenses and as sales, royalties or commercialization revenues from the therapeutic candidates have not been generated, it is exposed to liquidity risk. As of December 31, 2017 and 2016, the Company’s non-derivative financial liabilities include accounts payable, accrued expenses and payable in respect of intangible asset purchase for a period of less than 1 year. 2) Capital risk management The Company’s objectives when managing capital are to safeguard the Company’s ability to continue as a going concern in order to provide returns for shareholders, maintain optimal capital structure and to reduce the cost of capital. 3) Fair value estimation The following is an analysis of financial instruments measured at fair value using valuation methods. The different levels have been defined as follows: · quoted prices (unadjusted) in active markets for identical assets or liabilities (level 1) · inputs other than quoted prices included within level 1 that are observable for the asset or liability, either directly (that is, as prices) or indirectly (that is, derived from prices) (level 2) · inputs for the asset or liability that are not based on observable market data (that is, unobservable inputs) (level 3) The fair value of financial instruments traded in active markets is based on quoted market prices at dates of Statements of Financial Position. A market is regarded as active if quoted prices are readily and regularly available from an exchange, dealer, broker, industry group, pricing service, or regulatory agency, and those prices represent actual and regularly occurring market transactions on an arm’s length basis. These instruments are included in level 1. The fair value of financial instruments that are not traded in an active market is determined by using valuation techniques. These valuation techniques maximize the use of observable market data where it is available and rely as little as possible on entity-specific estimates. If all significant inputs required to determine the fair value an instrument are observable, the instrument is included in level 2. If one or more of the significant inputs is not based on observable market data, the instrument is included in level 3. The following table presents Company assets and liabilities measured at fair value: Level 1 Level 3 Total U.S. dollars in thousands December 31, 2017: Assets - Financial assets at fair value through profit or loss 16,587 — 16,587 Liabilities - Derivative financial instruments — 448 448 December 31, 2016: Assets - Financial assets at fair value through profit or loss 12,313 — 12,313 Liabilities - Derivative financial instruments — 6,155 6,155 The following table presents the change in derivative liabilities measured at level 3 for the years ended December 31, 2017 and 2016: Derivative financial instruments Year ended December 31 2017 2016 U.S. dollars in thousands Balance at beginning of the year 6,155 1,237 Proceeds received during the reported year — 6,070 Exercise of derivative into shares (20) — Fair value adjustments recognized in profit or loss (5,687) (1,152) Balance at the end of the year 448 6,155 The fair value of the above-mentioned derivative financial liabilities that are not traded in an active market is determined by using valuation techniques. The Company uses its judgment to select a variety of methods and make assumptions that are mainly based on market conditions existing at the end of each reporting period. For more information regarding the derivatives, see note 15. b. Classification of financial instruments by groups: Assets at Loans and Total U.S. dollars in thousands As of December 31, 2017: Cash and cash equivalents — 16,455 16,455 Bank deposits — 13,315 13,315 Trade receivables — 1,528 1,528 Other receivables (except prepaid expenses) — 3,160 3,160 Financial assets at fair value through profit or loss 16,587 — 16,587 16,587 34,458 51,045 As of December 31, 2016: Cash and cash equivalents — 53,786 53,786 Bank deposits — 192 192 Trade receivables — *99 99 Other receivables (except prepaid expenses) — *1,442 1,442 Financial assets at fair value through profit or loss 12,313 — 12,313 12,313 55,519 67,832 Financial liabilities at fair value Financial through liabilities at profit or amortized loss cost Total U.S. dollars in thousands As of December 31, 2017: Accounts payable — 4,805 4,805 Accrued expenses and other current liabilities — 6,025 6,025 Derivative financial instruments 448 — 448 Payable in respect of intangible asset purchase — 1,000 1,000 448 11,830 12,278 As of December 31, 2016: Accounts payable — *60 60 Accrued expenses and other current liabilities — *3,296 3,296 Derivative financial instruments 6,155 — 6,155 Payable in respect of intangible asset purchase — 2,000 2,000 6,155 5,356 11,511 * c. Composition of financial instruments by currency: Other U.S. dollar currencies Total U.S. dollars in thousands As of December 31, 2017: Assets: Cash and cash equivalents 15,319 1,136 16,455 Bank deposits 13,101 214 13,315 Financial assets at fair value through profit or loss 16,587 — 16,587 Trade receivable 1,528 — 1,528 Other receivables (except prepaid expenses) 2,426 734 3,160 48,961 2,084 51,045 Liabilities: Accounts payable 4,333 472 4,805 Accrued expenses and other currents liabilities 6,005 20 6,025 Payable in respect of intangible asset purchase 1,000 — 1,000 Derivative financial instruments 448 — 448 11,786 492 12,278 37,175 1,592 38,767 As of December 31, 2016: Assets: Cash and cash equivalents 51,936 1,850 53,786 Bank deposits — 192 192 Financial assets at fair value through profit or loss 12,313 — 12,313 Receivables (except prepaid expenses) 1,078 463 1,541 65,327 2,505 67,832 Liabilities: Accounts payable and accrued expenses 3,227 129 3,356 Payable in respect of intangible asset purchase 2,000 — 2,000 Derivative financial instruments 6,155 — 6,155 11,382 129 11,511 53,945 2,376 56,321 |
CASH, CASH EQUIVALENTS AND BANK
CASH, CASH EQUIVALENTS AND BANK DEPOSITS | 12 Months Ended |
Dec. 31, 2017 | |
CASH, CASH EQUIVALENTS AND BANK DEPOSITS | |
CASH, CASH EQUIVALENTS AND BANK DEPOSITS | NOTE 5 – CASH, CASH EQUIVALENTS AND BANK DEPOSITS: a. Cash and cash equivalents December 31 2017 2016 U.S. dollars in thousands Cash in bank 8,305 53,772 Short-term bank deposits 8,150 14 16,455 53,786 The carrying amounts of the cash and cash equivalents approximate their fair values. b. Bank deposits The bank deposits include deposits invested for terms of three months to one year and bear interest at an average annual rate of 1.1%. |
FINANCIAL ASSETS AT FAIR VALUE
FINANCIAL ASSETS AT FAIR VALUE THROUGH PROFIT OR LOSS | 12 Months Ended |
Dec. 31, 2017 | |
FINANCIAL ASSETS AT FAIR VALUE THROUGH PROFIT OR LOSS. | |
FINANCIAL ASSETS AT FAIR VALUE THROUGH PROFIT OR LOSS | NOTE 6 - FINANCIAL ASSETS AT FAIR VALUE THROUGH PROFIT OR LOSS: These financial assets as of December 31, 2017 represent a portfolio of U.S. dollar-denominated marketable securities managed and valued by the Company based on the fair value of all portfolio securities. Taking into consideration the manner of management of the portfolio and the evaluation of its performances, the Company classified the entire investment in marketable securities as financial assets at fair value through profit or loss. The fair value of the securities is based on their exchange market price at the end of each trading day and reporting period. |
PREPAID EXPENSES AND OTHER RECE
PREPAID EXPENSES AND OTHER RECEIVABLES | 12 Months Ended |
Dec. 31, 2017 | |
PREPAID EXPENSES AND OTHER RECEIVABLES | |
PREPAID EXPENSES AND OTHER RECEIVABLES | NOTE 7 - PREPAID EXPENSES AND OTHER RECEIVABLES: December 31 2017 2016 U.S. dollars in thousands Advance to suppliers 2,426 1,049 Discount from service provider 537 230 Prepaid expenses 130 120 Government institutions 197 163 3,290 1,562 The fair value of other receivables, which constitute of financial assets, approximates their carrying amount. |
FIXED ASSETS
FIXED ASSETS | 12 Months Ended |
Dec. 31, 2017 | |
FIXED ASSETS | |
FIXED ASSETS | NOTE 8 - FIXED ASSETS: The composition of assets and accumulated depreciation, grouped by major classifications: Cost Accumulated depreciation Depreciated balance December 31 December 31 December 31 2017 2016 2017 2016 2017 2016 U.S. dollars in thousands Office furniture and equipment (including computers) 349 203 163 101 186 102 Leasehold improvements 132 132 88 69 44 63 481 335 251 170 230 165 |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2017 | |
INTANGIBLE ASSETS | |
INTANGIBLE ASSETS | NOTE 9 - INTANGIBLE ASSETS: The intangible assets represent R&D assets with respect to intellectual property rights of the therapeutic candidates purchased by the Company under licensing agreements or under asset acquisition agreements. The changes in those assets are as follows: Year Ended December 31 2017 2016 U.S. dollars in thousands Cost: Balance at beginning of year 6,195 6,160 Additions during the year 35 35 Deductions during the year (945) — Balance at end of year 5,285 6,195 Write-off charge — (100) 5,285 6,095 In February 2017, the Company deducted from the intangible assets cost an amount of $100,000, written off in prior years, due to final termination notice provided to a Danish company for the exclusive rights to a Drug Candidate intended to treat congestive heart failure, left atrium dysfunction and high blood pressure. In February 2017, the Company recognized loss in an amount of $45,000, paid to a private German company for the exclusive option for acquiring rights to an oncology therapeutic candidate. As the Company did not exercise or extend its option, the entire amount was deducted from the intangible assets cost and recorded as a loss in the Consolidated Statement of Comprehensive Loss under Other Expenses. In December 2017, the Company recognized loss in an amount of $800,000, paid to a Canadian company for the exclusive rights to a non-core migraine therapeutic candidate. Given the Company’s increasing focus on GI diseases, in particular its two key Phase III GI programs, a termination notice was issued to the Canadian company and the entire amount was deducted from the intangible assets cost and recorded as a loss in the Consolidated Statement of Comprehensive Loss under Other Expenses. For further details regarding the intangible assets, see note 12. |
LIABILITY FOR EMPLOYEE RIGHTS U
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | 12 Months Ended |
Dec. 31, 2017 | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | NOTE 10 - LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT: a. Labor laws and agreements in Israel require the Company to pay severance pay and/or pensions to an employee dismissed or retiring from their employment, in certain circumstances. b. The Company’s pension liability and the Company’s liability for payment of severance pay for employees in Israel for whom the liability is within the scope of Section 14 of the Severance Pay Law is covered by ongoing deposits with defined contribution plans. The amounts deposited are not included in the Statements of Financial Position. The amounts charged as an expense with respect to defined contribution plans in 2017, 2016 and 2015 were $155,000, $121,000 and $95,000, respectively. |
ACCRUED EXPENSES AND OTHER CURR
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 12 Months Ended |
Dec. 31, 2017 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | NOTE 11 - ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: December 31 2017 2016 U.S. dollars in thousands Accrued expenses 4,969 2,903 Employees and related liabilities 1,045 295 Government institutions 11 98 6,025 3,296 The fair value of the accounts payable and accrued expense balances approximates their carrying amounts. |
COMMITMENTS
COMMITMENTS | 12 Months Ended |
Dec. 31, 2017 | |
COMMITMENTS | |
COMMITMENTS | NOTE 12 - COMMITMENTS: a. Agreements to purchase intellectual property and U.S. rights to promote: 1) On May 2, 2010, the Company entered into an agreement with SCOLR Pharma Inc. (“SCOLR”), a U.S. company that granted the Company an exclusive license to use its rights relating to a therapeutic candidate. According to the agreement, the Company paid the U.S. company an initial amount of $100,000, and undertook to pay the U.S. company potential royalties on future sales of this therapeutic candidate and milestone payments. Through December 31, 2017, the Company paid the U.S. company only the above-mentioned initial amount. In 2013, SCOLR announced that it had ceased business operations. Under the terms of the license agreement, the Company had protection granted to the licensee under the United States Bankruptcy Code. On March 7, 2014, the Company entered into a licensing agreement with a U.S. university to secure certain patent rights related to the above-mentioned therapeutic candidate. The Company, therefore, terminated the agreement with the U.S. company and licensed the patents directly from the U.S. university, the original owner of the patents. Under the agreement, the Company agreed to pay the U.S. university certain future royalties. 2) On August 26, 2010, the Company entered into an agreement with IntelGenx Corp, a Canadian-based company (“IntelGenx”) which is traded in the U.S. and Canada, to co-develop RIZAPORT ® , a therapeutic candidate for the treatment of acute migraines. Pursuant to the agreement, the Company paid IntelGenx milestone payments in the aggregate amount of $800,000. In addition, in accordance with the agreement, through December 31, 2017, the Company participated in the research and development costs in the amount of approximately $1.3 million that was recorded in the Statements of Comprehensive Loss under Research and Development Expenses. Given the Company’s increasing focus on GI diseases, in particular the Company’s two key Phase III GI programs, the Company provided IntelGenx on December 5, 2017 a notice of termination for the agreement with IntelGenx. See also note 9. 3) On August 11, 2010, the Company entered into an agreement with an Australian company in an asset purchase agreement to acquire intellectual property relating to three therapeutic candidates for the treatment of gastrointestinal conditions. Pursuant to the asset purchase agreement, the Company paid the Australian company an initial amount of $500,000 and undertook to pay future payments in the range of 7% - 20% from the Company’s revenues may be generated from the sale and license of the therapeutic candidates, less certain deductible amounts, as detailed in the agreement. Through December 31, 2017, the Company paid the Australian company the above-mentioned initial amount. In 2014, the Company entered into a licensing agreement with Salix Pharmaceuticals, Ltd. (“Salix”), which was later acquired by Valeant Pharmaceuticals International, Inc. , pursuant to which Salix licensed the exclusive worldwide rights to one of the above-mentioned therapeutic candidates. Under the license agreement, Salix paid an upfront payment of $7 million with subsequent potential milestone payments up to a total of $5 million. Salix also agreed to pay the Company tiered royalties on net sales, ranging from low single-digits up to low double-digits. Following the execution of the licensing agreement, the Company paid the Australian company an additional amount of $1 million. In 2014, the upfront payment of $7 million was recognized as revenue in the Statement of Comprehensive Loss and the additional amount paid was recognized as cost of revenues in the Statements of Comprehensive Loss. 4) On June 30, 2014, the Company entered into an agreement with a German publicly-traded company that granted the Company the exclusive worldwide (excluding China, Hong Kong, Taiwan and Macao) development and commercialization rights to all indications to an oncology therapeutic candidate. Under the terms of the agreement, the Company paid the German company an initial amount of $1 million and agreed to pay the German company potential tiered royalties, less certain deductible amounts as detailed in the agreement, ranging from mid-teens up to 30%. Such potential royalties are due until the later of (i) the expiration of the last to expire licensed patent that covers the product in the relevant country; and (ii) the expiration of regulatory exclusivity in the relevant country. Through December 31, 2017, the Company has paid the German company only the initial amount mentioned above. 5) 6) On December 30, 2016, the Company entered into an exclusive co-promotion agreement with a subsidiary of Concordia, an international specialty pharmaceutical company, focused on generic and legacy pharmaceutical products and orphan drugs. Under the exclusive co-promotion agreement, the Company is responsible for certain promotional activities related to Donnatal ® (Phenobarbital, Hycosamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) in certain U.S. territories. The companies share the revenues generated from the promotion of Donnatal ® based on agreed upon split. There are no upfront or milestone payments required under the agreement. The initial term of the agreement is three years. The parties may terminate the agreement upon prior written notice for reasons set forth in the agreement. 7) On April 4, 2017, the Company signed an exclusive license agreement with Entera Health, a privately held U.S. company focused on the research, manufacturing, and commercialization of value-added proteins and protein co-products, granting the Company the exclusive U.S. rights to EnteraGam ® , a commercially-available medical food intended for the dietary management of chronic diarrhea and loose stools which must be administered under medical supervision. Under the license agreement, the Company is required to pay Entera Health royalties based on net sales, as detailed in the agreement. The initial term of the agreement is four years. The parties may terminate the agreement upon prior written notice for the reasons set forth in the agreement. 8) On August 16, 2017, the Company signed an agreement with ParaPRO LLC. (“ParaPro”), an Indiana-based specialty pharmacy company focused on on acquiring, developing and commercializing proprietary products, granting the Company the exclusive right to co-promote Esomeprazole Strontium Delayed-Release Capsules 49.3 mg to gastroenterologists in certain U.S territories according to an agreed co-promotion plan. Esomeprazole Strontium Delayed-Release Capsules The initial term of the agreement is four years. Each party may terminate the agreement upon prior written notice to the other party for reasons set forth in the agreement. b. Operating lease agreements The Company entered into an operating lease agreement for the Israeli offices it uses. The agreement will expire on January 31, 2020. The projected yearly rental expenses are approximately $410,000 per year. During 2017 the Company subleases a portion of the office space to a tenant for approximately $96,000. The Company also entered into an operating lease agreement for the U.S. offices it uses. The agreement will expire on March 31, 2023. The projected yearly rental expenses are approximately $168,000 per year. As of December 31, 2017, an amount of $152,000 was deposited with a bank to secure the lease obligations. |
INCOME TAX
INCOME TAX | 12 Months Ended |
Dec. 31, 2017 | |
INCOME TAX | |
INCOME TAX | NOTE 13 - INCOME TAX: a. Taxation of the Company in Israel 1) Measurement of results for tax purposes The Company elected to compute its taxable income in accordance with Income Tax Regulations (Rules for Accounting for Foreign Investors Companies and Certain Partnerships and Setting their Taxable Income), 1986. Accordingly, the Company’s taxable income or loss is calculated in U.S. dollars. The results of the Company are measured for tax purposes in accordance with Accounting Principles Generally Accepted in Israel (Israeli GAAP). These financial statements are prepared in accordance with IFRS. The differences between IFRS and Israeli GAAP, both on an annual and a cumulative basis cause differences between taxable results and the results reflected in these financial statements. 2) Tax rates The net income of the Company is subject to the Israeli corporate tax rate. Israeli corporate tax rates for 2016 and 2015 were 25% and 26.5%, respectively. On December 22, 2016, the Israeli Budgetary Law for 2017 and 2018 was approved to, among other changes, reduce the corporate tax rate to 24% for 2017 and 23% for 2018 and thereafter. b. U.S. subsidiary The subsidiary incorporated in the U.S is taxed under U.S. tax laws. Accordingly, the applicable corporate tax rate in 2017 is 34%. On December 22, 2017, the Tax Cuts and Jobs Act (the “2017 Act”) was enacted and the applicable tax rate was reduced to 21% from 2018 and thereafter. As a general rule, inter-company transactions between the Israel-resident Company and its U.S-resident subsidiary are subject to the reporting provisions of the Income Tax Regulations, section 85-A, 2006. c . Carry forward losses As of December 31, 2017, the Company had net operating losses carried forward (“NOLs”) of approximately $76 million. Under Israeli tax laws, carry forward tax losses have no expiration date. As of December 31, 2017, the U.S. subsidiary had net operating losses carried forward of approximately $10 million. Under U.S. tax laws, for NOLs arising after December 31, 2017, the 2017 Act limits a taxpayer’s ability to utilize NOL carryforwards to 80% of taxable income. In addition, NOLs arising after 2017 can be carried forward indefinitely, but carryback is generally prohibited. NOLs generated in tax years beginning before January 1, 2018 will not be subject to the foregoing taxable income limitation and will continue to have a two-year carryback and twenty-year carryforward period. Deferred tax assets on losses for tax purposes carried forward to subsequent years are recognized if utilization of the related tax benefit against a future taxable income is expected. The Company has not created deferred taxes on its carryforward losses since their utilization is not expected in the foreseeable future. d . Deductible temporary differences The amount of cumulative deductible temporary differences, other than carryforward losses (as mentioned in c. above), for which deferred tax assets have not been recognized in the Statements of Financial Position as of December 31, 2017 and 2016, were $28 million and $29 million, respectively. These temporary differences have no expiration dates. e . Tax assessments The Company has not been assessed for tax purposes since its incorporation. The Company’s tax assessments for 2012 are therefore considered final. |
EQUITY
EQUITY | 12 Months Ended |
Dec. 31, 2017 | |
EQUITY | |
EQUITY | NOTE 14 - EQUITY: a. Share capital 1) Composition Company share capital is composed of ordinary shares of NIS 0.01 par value, as follows: Number of shares December 31 2017 2016 In thousands Authorized 300,000 300,000 Issued and paid 212,729 164,974 The Company’s ordinary shares are traded on the TASE and the Company’s ADSs are traded on the NASDAQ under the symbol “RDHL”. Each ADS represents 10 ordinary shares. The last reported market price for the Company’s securities on December 31, 2017 was $5.14 per ADS on the NASDAQ and $0.50 per share on the TASE (based on the exchange rate reported by the Bank of Israel for that date). On February 16, 2016, a special general meeting of shareholders approved the increase of the authorized share capital of the Company to 300,000,000 ordinary shares. 2) Exercise of warrants and options During 2016, the Company received notifications of exercise with respect to options that had been issued to employees and consultants of the Company. Accordingly, the Company issued 725,790 ordinary shares for $263,000. During 2017 the Company received notifications of exercise with respect to options that had been issued to employees and a consultant of the Company. Accordingly, the Company issued 2,988,750 ordinary shares for $809,000. In January 2017, the Company received notification of exercise with respect to non-tradable warrants that had been issued in 2014 to investors in the form of private placements. Accordingly, the Company issued 2,526,320 ordinary shares for approximately $2.63 million. 3) In December 2016, the Company completed an underwritten public offering and a registered direct offering in the U.S. of an aggregate of 3,713,415 ADSs and warrants to purchase 1,856,708 ADSs for gross proceeds to the Company of $38.1 million. Net proceeds to the Company from the offering, following discounts, commissions and expenses amounting to $2.3 million, were approximately $35.8 million. As part of the offering, one of the Company's directors, purchased 95,000 ADSs and warrants to purchase 47,500 ADSs for a total consideration of $1 million. In addition, as part of the public offering, the underwriters received an option to purchase 337,500 ADSs and warrants to purchase 168,750 ADSs. On December 27, 2016, the underwriters partially exercised their option and purchased warrants to purchase 168,750 ADSs. On January 3, 2017, the underwriters partially exercised their option and purchased 133,104 ADSs for approximately $1.28 million. Following the partial exercise of the underwriters’ option, the underwritten public offering and the concurrent registered direct offering (total of 3,846,519 ADSs and warrants to purchase 2,025,458 ADSs, representing aggregate gross proceeds from both offerings of approximately $39.4 million before deducting underwriting discounts and commissions, placement agent fees and other offering expenses) were closed. The warrants were classified as a financial liability due to a net settlement provision. These derivatives were recognized and subsequently measured at fair value through profit or loss. The consideration, net of issuance expenses, was allocated to the various issued instruments. Out of the gross consideration, an amount of $6.1 million was allocated to the warrants. The remainder of approximately $32 million was allocated to ADSs. Issuance expenses were allocated both to the liability instruments and to the equity component. Expenses allocated to the liability instruments, an amount of $0.4 million, were recorded directly to the Statements of Comprehensive Loss, and expenses in the amount of $1.9 million allocated to the equity component were recorded against share premium. 4) In November 2017, the Company completed an underwritten public offering in the U.S. of an aggregate of 4,090,909 ADSs for gross proceeds to the Company of approximately $22.5 million. Net proceeds to the Company from the offering, following underwriting discounts and other offering expenses of approximately $1.5 million, were approximately $21 million. b. Warrants The warrants issued under investment agreements from January 2014 were exercisable into 4,183,496 ordinary shares. The warrants had a three-year term and were exercisable at an exercise price of $1.40 per ordinary share. In January 2017, the warrants expired along with any right or claim of the holders. |
DERIVATIVE FINANCIAL INSTRUMENT
DERIVATIVE FINANCIAL INSTRUMENTS | 12 Months Ended |
Dec. 31, 2017 | |
DERIVATIVE FINANCIAL INSTRUMENTS | |
DERIVATIVE FINANCIAL INSTRUMENTS | NOTE 15 - DERIVATIVE FINANCIAL INSTRUMENTS: a. Warrants issued in 2014 The warrants issued under an investment agreement from January 2014 were classified as a financial liability due to a net settlement provision. These warrants were exercisable into 357,896 ADSs and had a three-year term. In January 2017, the Company received notification of exercise with respect to these non-tradable warrants that had been issued in 2014 to investors in the form of private placements. Accordingly, the Company issued 2,526,320 ordinary shares for approximately $2.63 million. The remaining unexercised warrants to purchase 1,052,640 ordinary shares expired along with any right or claim whatsoever of the holders. b. Warrants issued in 2016 The warrants issued under the offering, as described in note 14a(3) above, were classified as a financial liability due to a net settlement provision. These warrants are exercisable into 2,025,458 ADSs. The warrants have a three-year term and may be exercised either for cash or on a cashless basis at an exercise price of $13.33 per ADS. The fair value of the warrants is computed using the Black and Scholes option pricing model. The fair value of the warrants upon issuance was computed based on the price of an ADS and based on the following parameters: risk-free interest rate of 1.56% and an average standard deviation of 53.13%. The fair value of the warrants as of December 31, 2017, is based on the price of an ADS as of December 31, 2017 and its based on the following parameters: risk-free interest rate of 1.89% and an average standard deviation of 48.59%. |
SHARE-BASED PAYMENTS
SHARE-BASED PAYMENTS | 12 Months Ended |
Dec. 31, 2017 | |
SHARE-BASED PAYMENTS | |
SHARE-BASED PAYMENTS | NOTE 16 - SHARE-BASED PAYMENTS: On May 30, 2010, a general meeting of shareholders approved the option plan of the Company (the “Option Plan”), after being approved by the Board of Directors. In 2017 the Option Plan was amended and restated as the 2010 Award Plan (the “Award Plan”). As of December 31, 2017, the Award Plan allow the Company to allocate up to 33,646,039 options to employees, consultants and directors reserved by the Board of Directors for issuance under the Award Plan. The terms and conditions of the grants were determined by the board of directors and are according to the Award Plan. a. The following is information on options granted in 2017: Number of options granted According to the award plan Exercise Fair value of of the Company price for 1 options on date of Other than ordinary grant in U.S.$ Date of grant directors (1) To directors Total share ($) thousands (2) March 2017 3,650,000 — 3,650,000 1.08 1,777 May 2017 — 640,000 640,000 1.08 290 May 2017 — 500,000 500,000 1.09 227 July 2017 2,445,000 — 2,445,000 0.98 1,205 6,095,000 1,140,000 7,235,000 3,499 1) The options will vest as follows: for employees and consultants of the Company who had provided services exceeding one year to the Company as of the grant date, the options will vest in 16 equal quarterly installments over a four-year period. For employees and consultants of the Company who had not provided services to the Company exceeding one year as of the grant date, the options will vest as follows: 1/4 of the options will vest one year following the grant date and the rest over the following three years in 12 equal quarterly installments. During the contractual term the options will be exercisable, either in full or in part, from the vesting date until the end of 7 years from the date of grant. 2017 grants include both options exercisable into the Company’s ordinary shares and options exercisable to the Company’s ADSs. 2) The fair value of the options was computed using the binomial model and the underlying data used was mainly the following: price of the Company’s ordinary share: $0.98 - $1.09, expected volatility: 49.48% - 58.09%, risk-free interest rate: 2.05% - 2.23% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates. The expected volatility assumption used is based on the historical volatility of the Company’s share. b. The following is information on options granted in 2016: Number of options granted According to the award plan Exercise Fair value of of the Company price for 1 options on date of Other than ordinary grant in U.S.$ Date of grant directors (1) To directors (1) Total share ($) thousands (2) April 2016 590,000 — 590,000 1.41 400 June 2016 — 1,500,000 1,500,000 1.28 725 June 20 16 (3) — 150,000 150,000 1.48 105 590,000 1,650,000 2,240,000 1,230 1) The options will vest as follows: for employees and consultants of the Company who had provided services exceeding one year to the Company as of the grant date, the options will vest in 16 equal quarterly installments over a four-year period. For employees and consultants of the Company who had not provided services to the Company exceeding one year as of the grant date, the options will vest as follows: 1/4 of the options will vest one year following the grant date and the rest over the following three years in 12 equal quarterly installments. During the contractual term the options will be exercisable, either in full or in part, from the vesting date until the end of 7 years from the date of grant. 2) The fair value of the options was computed using the binomial model and the underlying data used was mainly the following: price of the Company’s ordinary share: $1.28 - $1.41, expected volatility: 52.52% - 53.09%, risk-free interest rate: 1.51% - 1.57% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates. The expected volatility assumption used is based on the historical volatility of the Company’s share. 3) In June 2016, the Company’s annual general meeting of shareholders approved the acceleration of 150,000 unvested options of Alicia Rotbard, of blessed memory, a former external director of the Company. Each option was exercisable into one ordinary share at an exercise price of $1.48 per share. These options expired in November 2017. The allocated expenses, in the amount of $105 thousand were recorded directly to the Statements of Comprehensive Loss under General and Administrative Expenses. c. Changes in the number of options and weighted averages of exercise prices are as follows: Year Ended December 31 2017 2016 Weighted Weighted average of average of Number of exercise Number of exercise options price ($) options price ($) Outstanding at beginning of year 22,025,548 0.95 20,511,338 0.88 Exercised (2,988,750) 0.27 (725,790) 0.36 Expired and forfeited (490,000) 1.37 — — Granted 7,235,000 1.05 2,240,000 1.33 Outstanding at end of year 25,781,798 1.05 22,025,548 0.95 Exercisable at end of year 16,842,697 0.99 15,168,938 0.85 d. The following is information about exercise price and remaining useful life of outstanding options at year-end: December 31, 2017 December 31, 2016 Number of Number of options Weighted options Weighted outstanding average of outstanding average of at end of Exercise price remaining at end of Exercise price remaining year range useful life year range useful life 25,781,798 $0.5-$1.61 3.5 22,025,548 $0.17-$1.61 3.8 e. Expenses recognized in profit or loss for the options are as follows: Year Ended December 31 2017 2016 2015 U.S. dollars in thousands 1,679 1,364 The remaining compensation expenses as of December 31, 2017 are $2.7 million and will be expensed in full by July 2021. The options granted to Company employees in Israel are governed by relevant rules in Section 102 to the Israel Income Tax Ordinance (hereinafter the “Ordinance”). According to the treatment elected by the Company and these rules, the Company is not entitled to claim as tax deductions the amounts charged to employees as a benefit, including amounts recognized as payroll benefits in Company accounts for the options the employees received within the Award Plan. Options granted to option holders who are related parties of the Company are governed by Section 3(i) to the Ordinance. |
NET REVENUES
NET REVENUES | 12 Months Ended |
Dec. 31, 2017 | |
NET REVENUES | |
NET REVENUES | NOTE 17 – NET REVENUES: Year Ended December 31 2017 2016 2015 U.S dollars in thousands Licensing — 100 — Commercialization of product 3,240 — — Promotional services 767 — — Other Revenues — 1 3 4,007 101 3 a) In 2016 the Company recorded revenues with respect to RIZAPORT ® . b) In 2017 the Company recorded revenues with respect to the commercialization of EnteraGam® initiated in June 2017 and promotional activities of Donnatal ® initiated in June 2017 and Esomeprazole Strontium Delayed-Release Capsules 49.3 mg initiated in September 2017. |
RESEARCH AND DEVELOPMENT EXPENS
RESEARCH AND DEVELOPMENT EXPENSES, net | 12 Months Ended |
Dec. 31, 2017 | |
RESEARCH AND DEVELOPMENT EXPENSES, net. | |
RESEARCH AND DEVELOPMENT EXPENSES, net | NOTE 18 - RESEARCH AND DEVELOPMENT EXPENSES, net : Year Ended December 31 2017 2016 2015 U.S. dollars in thousands Payroll and related expenses 653 652 621 Professional services 2,218 1,816 1,953 Share-based payments 793 841 842 Clinical and pre-clinical trials 28,221 21,013 13,611 Intellectual property development 401 428 216 Other 964 772 713 Discount from service provider* (281) (281) (185) 32,969 25,241 17,771 * |
SELLING, MARKETING AND BUSINESS
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES | 12 Months Ended |
Dec. 31, 2017 | |
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES | |
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES | NOTE 19 – SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES: Year Ended December 31 2017 *2016 *2015 U.S. dollars in thousands Payroll and related expenses 5,012 301 334 Share-based payments 387 65 20 Professional services 1,778 947 883 Samples 1,569 — — Travel and related expenses 2,236 81 23 Office-related expenses 395 86 53 Other 637 75 73 12,014 1,555 1,386 * |
GENERAL AND ADMINISTRATIVE EXPE
GENERAL AND ADMINISTRATIVE EXPENSES | 12 Months Ended |
Dec. 31, 2017 | |
GENERAL AND ADMINISTRATIVE EXPENSES | |
GENERAL AND ADMINISTRATIVE EXPENSES | NOTE 20 – GENERAL AND ADMINISTRATIVE EXPENSES: Year Ended December 31 2017 *2016 *2015 U.S. dollars in thousands Payroll and related expenses 3,311 1,082 652 Share-based payments 1,054 773 502 Professional services 2,246 1,391 1,167 Office-related expenses 567 300 120 Other 847 302 307 8,025 3,848 2,748 * |
FINANCIAL INCOME, net
FINANCIAL INCOME, net | 12 Months Ended |
Dec. 31, 2017 | |
FINANCIAL INCOME, net | |
FINANCIAL INCOME, net | NOTE 21 - FINANCIAL INCOME, net: Year Ended December 31 2017 2016 2015 U.S dollars in thousands Financial income: Fair value gains on derivative financial instruments 5,687 1,152 888 Gains on financial assets at fair value through profit or loss 189 80 — Gains from changes in exchange rates 332 34 — Interest from bank deposits 297 282 236 6,505 1,548 1,124 Financial expenses: Loss from changes in exchange rates — — 200 Issuance cost with respect of warrants — 368 — Other 77 7 12 77 375 212 Financial income, net (6,428) (1,173) (912) |
SEGMENT INFORMATION
SEGMENT INFORMATION | 12 Months Ended |
Dec. 31, 2017 | |
SEGMENT INFORMATION | |
SEGMENT INFORMATION | NOTE 22 – SEGMENT INFORMATION All of the activity of the Company in 2015 and 2016 related to the Research & Development segment. Commencing 2017, the Company has two segments, Commercial Operations and Research & Development. In line with the reporting to the Chief Executive Officer, the performance of these segments is reviewed at sales, revenues and operating loss levels. The Commercial Operations segment covers all areas relating to the commercial sales and operating expenses directly related to that activity and is being performed by the Company’s U.S. subsidiary. The Research and Development segment includes all activities related to the research and development of therapeutic candidates and is being performed by the Company. There is no segmentation of the Statements of Financial Position. Charges such as depreciation, impairment and other non-cash expenses are charged to the relevant segment. a. Segment information Year Ended December 31 2017 Commercial Operation Research And Development Consolidated U.S. dollars in thousands Net revenues 4,007 — 4,007 Cost of revenues 2,126 — 2,126 Gross profit 1,881 — 1,881 Research and development expenses, net — 32,969 32,969 Selling, marketing, and business development expenses 10,520 1,494 12,014 General and administrative expenses 2,680 5,345 8,025 Other expenses — 845 845 Operating loss 11,319 40,653 51,972 b. Major customers The percentages of total net revenues for the year ended December 31, 2017 from one customer were 59% and from another customer were 19%. The Company’s revenues were entirely in the U.S. and the payment terms for all customers are 30 to 60 days. |
LOSS PER ORDINARY SHARE
LOSS PER ORDINARY SHARE | 12 Months Ended |
Dec. 31, 2017 | |
LOSS PER ORDINARY SHARE | |
LOSS PER ORDINARY SHARE | NOTE 23 - LOSS PER ORDINARY SHARE: a. Basic The basic loss per share is calculated by dividing the loss by the weighted average number of ordinary shares in issue during the period. The following is data taken into account in the computation of loss per share: Year Ended December 31 2017 2016 2015 Loss (U.S. dollars in thousands) 45,544 29,370 21,090 Weighted average number of ordinary shares outstanding during the period (in thousands) 176,579 128,514 110,814 Basic loss per share (U.S. dollars) 0.26 0.23 0.19 b. Diluted Diluted loss per share is calculated by adjusting the weighted average number of ordinary shares outstanding, assuming conversion of all potential dilutive ordinary shares, using the treasury stock method. The Company has two categories of dilutive potential ordinary shares: warrants issued to investors and options issued to employees and service providers. The effect of options issued to employees and service providers, for all reporting years, is anti-dilutive. In 2017, the effect of warrants is anti-dilutive. Year Ended December 31 2017 2016 2015 Loss (U.S. dollars in thousands) 45,544 29,370 21,090 Adjustment for financial income of warrants — 1,208 346 Loss used to determine diluted loss per share 45,544 30,578 21,436 Weighted average number of ordinary shares outstanding during the period (in thousands) 176,579 128,514 110,814 Adjustment for warrants — 295 901 Weighted average number of ordinary shares for diluted loss per share (in thousands) 176,579 128,809 111,715 Diluted loss per share (U.S. dollars) 0.26 0.24 0.19 |
RELATED PARTIES
RELATED PARTIES | 12 Months Ended |
Dec. 31, 2017 | |
RELATED PARTIES | |
RELATED PARTIES | NOTE 24 - RELATED PARTIES: a. Key management in 2017 includes members of the Board of Directors and the Chief Executive Officer Year Ended December 31 2017 2016 2015 U.S. dollars in thousands Key management compensation: Salaries and other short-term employee benefits 677 576 776 Post-employment benefits 35 32 58 Share-based payments 557 504 382 Other long-term benefits 7 11 27 b. Balances with related parties: December 31 2017 2016 U.S. dollars in thousand Current liabilities - Credit balance in “accrued expenses and other current liabilities” 199 174 Non-current liabilities - Derivative financial instruments 11 144 |
EVENTS SUBSEQUENT TO DECEMBER 3
EVENTS SUBSEQUENT TO DECEMBER 31, 2017 | 12 Months Ended |
Dec. 31, 2017 | |
EVENTS SUBSEQUENT TO DECEMBER 31, 2017 | |
EVENTS SUBSEQUENT TO DECEMBER 31, 2017 | NOTE 25 - EVENTS SUBSEQUENT TO DECEMBER 31, 2017: a. In January 2018, the Company received notifications of exercise with respect to share options that had been issued to directors of the Company. Accordingly, the Company issued 710,000 ordinary shares for $0.4 million. b. On January 24, 2018, the Board of Directors of the Company approved an extension of the exercise period of options granted to employees and consultants who are not directors in February 2011 with original maturity on February 2018, to February 3, 2021. Accordingly, 2,844,210 options were extended with the new terms, the exercise price will be increased from $0.50 to $0.75 per ordinary share and the 3 years extension period will contain prohibition on exercising the options in the first year until February 3, 2019. The estimated fair value of the options on the extension date was $0.2 million. The Board of Directors of the Company also approved the extension of the exercise period of 1,540,000 options to the Company's Chief Executive Officer granted in February 2011, under the same terms detailed above, subject to the approval of the Company’s shareholders. c. On January 24, 2018, the Board of Directors of the Company granted 165,000 options to purchase ADSs to employees of the Company’s subsidiary, under the Company’s stock options plan. The estimated fair value of the options on the grant date was $0.5 million. d. On February 2018, the Company has signed an amendment to the agreement signed on March 30, 2015 with a U.S.-based private company. See note 12a(5). |
SUMMARY OF SIGNIFICANT ACCOUN31
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis for presentation of the financial statements | a. Basis for presentation of the financial statements The consolidated financial statements of the Company as of December 31, 2017 and 2016 and for each of the three years for the period ended on December 31, 2017 have been prepared in accordance with International Financial Reporting Standards (“IFRS”), as issued by the International Accounting Standards Board (“IASB”). The significant accounting policies described below have been applied consistently in relation to all the periods presented, unless otherwise stated. The consolidated financial statements have been prepared under the historical cost convention, subject to adjustments in respect of revaluation of financial assets and financial liabilities at fair value through profit or loss. The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in applying the Company’s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the financial statements, are disclosed in Note 3. Actual results could differ significantly from those estimates and assumptions. |
Translation of foreign currency balances and transactions | b. Translation of foreign currency balances and transactions 1) Functional and presentation currency Items included in the consolidated financial statements are measured using the currency of the primary economic environment in which the Company operates (the “Functional Currency”). The consolidated financial statements are presented in U.S. dollars (“$”), which is the Company’s functional and presentation currency. 2) Transactions and balances Foreign currency transactions in currencies different from the Functional Currency (hereafter foreign currency, mostly New Israeli Shekels (“NIS”)) are translated into the Functional Currency using the exchange rates at the dates of the transactions. Foreign exchange differences resulting from the settlement of such transactions and from the translation of period-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recorded in the Statements of Comprehensive Loss under Financing Income or Financial Expenses. |
Principles of consolidation | c. Principles of consolidation Commencing 2017, the Company’s consolidated financial statements include the accounts of the Company and its subsidiary. All material intercompany balances and transactions have been eliminated upon consolidation. |
Cash and cash equivalents | d. Cash and cash equivalents Cash and cash equivalents include cash on hand and unrestricted short-term bank deposits with maturities of three months or less. |
Trade receivables | e. Trade receivables Trade receivables are recognized initially at fair value. Subsequent to the initial recognition, they are measured at amortized cost using the effective interest rate method, less any impairment loss. |
Inventory | f. Inventory The Company’s inventory represents items that are available for commercial sale. The inventory is stated at the lower of cost or net realizable value with cost determined using the first-in, first-out method. The Company recognized an amount of $0.8 million in inventory cost as part of cost of revenues during the year ended December 31, 2017. The Company continually evaluates inventory for potential loss due to excess quantity or obsolete or slow-moving inventory by comparing sales history and sales projections to the inventory on hand. When evidence indicates that the carrying value of a product may not be recoverable, a charge is recorded to reduce the inventory to its current net realizable value. |
Fixed assets | g. Fixed assets Fixed assets items are initially recognized at acquisition cost. Fixed assets items are stated at cost less accumulated depreciation. Depreciation is computed by the straight-line method, to reduce the cost of fixed assets to their residual value over their estimated useful lives as follows: % Computers equipment 33 Office furniture and equipment 8-15 Leasehold improvements are depreciated by the straight-line method over the shorter of the term of the lease or the estimated useful life of the improvements. |
Research and development | h. Research and development 1) Research and development assets acquired by the Company, the development of which has not yet been completed, are stated at cost and are not amortized. These assets are tested for impairment once a year. At the time these assets will be available for use, they will be amortized by the straight-line method over their useful lives. 2) Research and development expenses are charged to profit or loss as incurred. An intangible asset arising from the development of the Company’s therapeutic candidates is recognized if all of the following conditions are met: · it is technically feasible to complete the intangible asset so that it will be available for use; · management intends to complete the intangible asset and use it or sell it; · there is an ability to use or sell the intangible asset; · it can be demonstrated how the intangible asset will generate probable future economic benefits; and · adequate technical, financial and other resources to complete the development and to use or sell the intangible asset are available and costs associated with the intangible asset during development can be measured reliably. Other development costs that do not meet the above criteria are recognized as expenses as incurred. Development costs previously recognized as an expense are not recognized as an asset in a subsequent period. As of December 31, 2017, the Company had not yet capitalized any development costs. 3) Amounts paid to purchase intellectual property of therapeutic candidates are capitalized and recorded as intangible assets. Amounts due for future payment based on contractual agreements are accrued upon reaching the relevant milestones. 4) Research and development costs for the performance of pre-clinical trials, clinical trials and manufacturing by subcontractors are recognized as expenses when incurred. |
Impairment of non-financial assets | i. Impairment of non-financial assets Depreciable assets are tested for impairment if any events have occurred or changes in circumstances have taken place which might indicate that their carrying amounts may not be recoverable. Research and development assets, the development of which has not yet been completed, are not amortized and are tested for impairment on an annual basis. An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use. For purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units). Nonfinancial assets that were subject to impairment are reviewed for possible reversal of the impairment recognized in respect thereof at each date of the Statements of Financial Position. |
Financial assets | j. Financial assets 1) Classification The financial assets of the Company are classified into the following categories: financial assets at fair value through profit or loss, and loans and receivables. The classification depends on the purpose for which the financial assets were acquired. The Company’s management determines the classification of its financial assets at initial recognition. a) Financial assets at fair value through profit or loss Financial assets at fair value through profit or loss includes financial assets that are managed and their performance is evaluated on a fair value basis; thus, upon their initial recognition, these assets are designated by management at fair value through profit or loss. Assets in this category are classified as current assets if they are expected to be settled within 12 months; otherwise, they are classified as noncurrent. b) Loans and receivables Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They are included in current assets, except for those with maturities greater than 12 months after the statements of financial position date (for which they are classified as noncurrent assets). The loans and receivables of the Company are included in trade receivables, prepaid expenses and other receivables, cash and cash equivalents and bank deposits in the Statements of Financial Position. 2) Recognition and measurement Regular purchases and sales of financial assets are recognized on the settlement date, which is the date on which the asset is delivered to the Company or delivered by the Company. Investments are initially recognized at fair value plus transaction costs for all financial assets not recorded at fair value through profit or loss. Financial assets measured at fair value through profit or loss are initially recognized at fair value, and transaction costs are expensed to profit or loss. Financial assets are derecognized when the rights to receive cash flow from the investments have expired or have been transferred and the Company has transferred substantially all risks and rewards of ownership. Financial assets at fair value through profit or loss are subsequently recorded at fair value. Loans and receivables are measured in subsequent periods at amortized cost using the effective interest method. Gains or losses arising from changes in the fair value of financial assets at fair value through profit or loss are presented in the Statement of Comprehensive Loss under “Financial Expenses (Income), net”. |
Accounts payable | k. Accounts payable Accounts payable are obligations to pay for goods or services that have been acquired from suppliers in the ordinary course of business. Accounts payable are classified as current liabilities if payment is due within one year or less; otherwise they are presented as noncurrent liabilities. Accounts payable are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method. |
Warrants | l. Warrants Receipts in respect of warrants are classified as equity to the extent that they confer the right to purchase a fixed number of shares for a fixed exercise price. Warrants that confer the right to net share settlement do not qualify for equity classification and are classified as derivative liabilities. See m below. |
Derivative financial instruments | m. Derivative financial instruments The derivative financial instruments of the Company represent warrants. |
Share capital | n. Share capital The Company’s ordinary shares are classified as the Company’s share capital. Incremental costs directly attributed to the issuance of new shares or warrants are presented under equity as a deduction from the proceeds of issuance. |
Employee benefits | o. Employee benefits 1) Pension and retirement benefit obligations In any matter related to payment of pension and severance pay to employees in Israel to be dismissed or to retire from the Company, the Company operates in accordance with labor laws. Labor laws and agreements in Israel and the Company’s practice require the Company to pay severance pay and/or pensions to employees dismissed or retiring, in certain circumstances. The Company has a severance pay plan in accordance with Section 14 of the Israeli Severance Pay Law with the plan treated as a defined contribution plan. According to the plan, the Company regularly makes payments to severance pay or pension funds without having a legal or constructive obligation to pay further contributions if the fund does not hold sufficient assets to pay all employees in the plan the benefits relating to employee service in the current and prior periods. Contributions for severance pay or pension are recognized as employee benefit expenses when they are due commensurate with receipt of work services from the employee and no further provision is required in the financial statements. The Company’s subsidiary provides, at will, benefit contributions for its employees. 2) Vacation and recreation pay Under Israeli law, each employee in Israel is entitled to vacation days and recreation pay, both computed on an annual basis. This entitlement is based on the period of employment. The Company records a liability and expenses vacation and recreation pay based on the benefit accumulated by each employee. |
Share-based payments | p. Share-based payments The Company operates a number of equity-settled, share-based compensation plans to employees (as defined in IFRS 2 “Share-Based Payments”) and service providers. As part of the plans, the Company grants employees and service providers, from time to time and at its discretion, options to purchase Company shares. The fair value of the employee and service provider services received in exchange for the grant of the options is recognized as an expense in profit or loss and is recorded as accumulated deficit within equity. The total amount recognized as an expense over the vesting period of the options (the period during which all vesting conditions are expected to be met) is determined by reference to the fair value of the options granted at the date of grant. Vesting conditions are included in the assumptions about the number of options that are expected to vest. The total expense is recognized over the vesting period, which is the period over which all of the specified vesting conditions are to be satisfied. At the end of each reporting period, the Company revises its estimates of the number of options that are expected to vest based on nonmarket vesting conditions. The Company recognizes the impact of the revision to original estimates, if any, in profit or loss, with a corresponding adjustment to accumulated deficit. When exercising options, the Company issues new shares. The proceeds, less direct attributable transaction costs, are recognized as share capital (par value) and share premium. |
Revenue from contracts with customers | q. Revenue from contracts with customers As of January 1, 2017, the Company early adopted IFRS 15, with full retrospective application. The adoption of IFRS 15 did not have an effect on either revenue recognized in prior periods, nor to accumulated deficits as of January 1, 2015. IFRS 15 introduces a five-step model for recognizing revenue from contracts with customers, as follows: · identify the contract with a customer; · identify the performance obligations in the contract; · determine the transaction price; · allocate the transaction price to the performance obligations in the contract; and · recognize revenue when (or as) the entity satisfies a performance obligation. 1) Revenues from promotional services The Company recognizes revenue from promotional services related to Donnatal ® and Esomeprazole Strontium Delayed-Release Capsules 49.3 mg as it satisfies its performance obligation over time, in an amount equal to the consideration it expects to be entitled to, taking into consideration the constraint on variable considerations stipulated in IFRS 15. 2) Revenues from the sale of products Principal versus agent considerations When another party is involved in providing goods or services to a customer, the Company analyzes whether the Company acts as a principal or an agent in the transaction, based on whether the Company obtains control of the product before it is transferred to the customer, using the indicators provided in IFRS 15. In the commercialization of EnteraGam ® , the Company is determined to be the principal in the arrangement (rather than an agent of Entera Health), and therefore, revenue in the amount the Company is entitled to from its customers is recognized on a gross basis, from which royalties to Entera Health Inc. (“Entera Health”) are being accounted for in cost of revenues. The Company recognizes revenues from the sale of EnteraGam ® at a point in time when control over the product is transferred to customers. The transaction price in these arrangements is the consideration the Company expects to be entitled to from the customer, reduced by estimates of rebates, discounts, allowances and provision for product returns, given or expected to be given, which vary by product arrangement and buying groups. These estimates have been based on actual in-market data received pre- and post- end of the accounting period and have been applied to inventory held at wholesalers and pharmacies. The Company will continue to refine these estimates and methodologies over time as the breadth of in-market data increases. 3) Revenues from out-licensing of the Company's therapeutic candidates Revenue incurred in connection with the out-licensing of a right to use the Company’s intellectual property is recognized at a point in time when control over the license is transferred to the licensee. The transaction price contains variable considerations contingent upon the licensee achieving certain milestones, as well as sales-based royalties, in accordance with the relevant agreement. Revenue from achieving additional milestones is recognized only when it is highly probable that a significant reversal of cumulative revenues will not occur, usually upon achievement of the specific milestone, in accordance with the relevant agreement. Sales-based royalties are not included in the transaction price; rather they are recognized as incurred, due to the specific exception for sales-based royalties in licensing of intellectual property. 4) Practical expedients and exemptions The Company expenses sales commissions when incurred. These costs are recorded as selling and marketing expenses. |
Advertising and promotional expenses | r. Advertising and promotional expenses Advertising and promotional costs include distribution of free products’ samples. These costs are recognized as an expense when incurred. |
Leases | s. Leases Leases in which a significant portion of the risks and rewards of ownership are retained by the lessor are classified as operating leases. Payments made under operating leases are charged to the Statements of Comprehensive Loss on a straight-line basis over the period of the lease. |
Loss per ordinary share | t. Loss per ordinary share The computation of basic loss per share is based on the Company’s loss divided by the weighted average number of ordinary shares outstanding during the period. In calculating the diluted loss per share, the Company adds the weighted average of the number of shares to be issued to the average number of shares outstanding used to calculate the basic loss per share, assuming all shares that have a potentially dilutive effect have been exercised into shares. |
Deferred taxes | u. Deferred taxes Deferred income tax is recognized using the liability method for temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the financial statements. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantially enacted by the Statements of Financial Position date and are expected to apply when the related deferred income tax asset will be realized or the deferred income tax liability will be settled. Deferred income tax assets are recognized only to the extent that it is probable that future taxable profit will be available against which the temporary differences can be utilized. Since the Company is unable to assess whether it will have taxable income in the foreseeable future, no deferred tax assets were recorded in these financial statements. |
Standards and interpretations to existing standards that are not yet in effect and have not been early adopted by the Company | v. Standards and interpretations to existing standards that are not yet in effect and have not been early adopted by the Company International Financial Reporting Standard No. 9 “Financial Instruments” (hereafter - IFRS 9) IFRS 9 “Financial instruments” addresses the classification, measurement and recognition of financial assets and financial liabilities. The complete version of IFRS 9 was issued in July 2014. It replaces the guidance in IAS 39 that relates to the classification and measurement of financial instruments. IFRS 9 retains but simplifies the mixed measurement model and establishes three primary measurement categories for financial assets: amortized cost, fair value through other comprehensive income, and fair value through profit or loss. The basis of classification depends on the entity’s business model and the contractual cash flow characteristics of the financial asset. Investments in equity instruments are required to be measured at fair value through profit or loss with the irrevocable option at inception to present changes in fair value in other comprehensive income. Furthermore, the expected credit losses model replaces the incurred loss impairment model used in IAS 39. For financial liabilities, there were no changes to classification and measurement except for the recognition of changes in the Company’s own credit risk in other comprehensive income for liabilities designated at fair value through profit or loss. The standard is effective for accounting periods beginning on or after January 1, 2018. The Company assessed the impact of IFRS 9 to be immaterial. International Financial Reporting Standard No. 16 “Leases” (hereafter - IFRS 16) IFRS 16 defines a lease as a contract, or part of a contract, that conveys the right to use an asset (the underlying asset) for a period of time in exchange for consideration. Under IFRS 16 lessees have to recognize a lease liability reflecting future lease payments and a ‘right-of-use asset’ for almost all lease contracts. The standard replaces the current guidance in IAS 17. The standard is effective for annual periods beginning on or after January 1, 2019. The Company is currently assessing the impact of adopting IFRS 16. The Company expects to adopt the standard using the cumulative effect approach and applying for additional reliefs as allowed by the standard’s transition provisions. See operating lease agreements on note 12b. |
SUMMARY OF SIGNIFICANT ACCOUN32
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of estimated useful lives of fixed assets | % Computers equipment 33 Office furniture and equipment 8-15 |
FINANCIAL INSTRUMENTS AND FIN33
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | |
Schedule of assets and liabilities measured at fair value | Level 1 Level 3 Total U.S. dollars in thousands December 31, 2017: Assets - Financial assets at fair value through profit or loss 16,587 — 16,587 Liabilities - Derivative financial instruments — 448 448 December 31, 2016: Assets - Financial assets at fair value through profit or loss 12,313 — 12,313 Liabilities - Derivative financial instruments — 6,155 6,155 |
Schedule of change in derivative liabilities measured at Level 3 | Derivative financial instruments Year ended December 31 2017 2016 U.S. dollars in thousands Balance at beginning of the year 6,155 1,237 Proceeds received during the reported year — 6,070 Exercise of derivative into shares (20) — Fair value adjustments recognized in profit or loss (5,687) (1,152) Balance at the end of the year 448 6,155 |
Schedule of classification of financial instruments by group | Assets at Loans and Total U.S. dollars in thousands As of December 31, 2017: Cash and cash equivalents — 16,455 16,455 Bank deposits — 13,315 13,315 Trade receivables — 1,528 1,528 Other receivables (except prepaid expenses) — 3,160 3,160 Financial assets at fair value through profit or loss 16,587 — 16,587 16,587 34,458 51,045 As of December 31, 2016: Cash and cash equivalents — 53,786 53,786 Bank deposits — 192 192 Trade receivables — *99 99 Other receivables (except prepaid expenses) — *1,442 1,442 Financial assets at fair value through profit or loss 12,313 — 12,313 12,313 55,519 67,832 Financial liabilities at fair value Financial through liabilities at profit or amortized loss cost Total U.S. dollars in thousands As of December 31, 2017: Accounts payable — 4,805 4,805 Accrued expenses and other current liabilities — 6,025 6,025 Derivative financial instruments 448 — 448 Payable in respect of intangible asset purchase — 1,000 1,000 448 11,830 12,278 As of December 31, 2016: Accounts payable — *60 60 Accrued expenses and other current liabilities — *3,296 3,296 Derivative financial instruments 6,155 — 6,155 Payable in respect of intangible asset purchase — 2,000 2,000 6,155 5,356 11,511 * |
Schedule of composition of financial instruments by currency | Other U.S. dollar currencies Total U.S. dollars in thousands As of December 31, 2017: Assets: Cash and cash equivalents 15,319 1,136 16,455 Bank deposits 13,101 214 13,315 Financial assets at fair value through profit or loss 16,587 — 16,587 Trade receivable 1,528 — 1,528 Other receivables (except prepaid expenses) 2,426 734 3,160 48,961 2,084 51,045 Liabilities: Accounts payable 4,333 472 4,805 Accrued expenses and other currents liabilities 6,005 20 6,025 Payable in respect of intangible asset purchase 1,000 — 1,000 Derivative financial instruments 448 — 448 11,786 492 12,278 37,175 1,592 38,767 As of December 31, 2016: Assets: Cash and cash equivalents 51,936 1,850 53,786 Bank deposits — 192 192 Financial assets at fair value through profit or loss 12,313 — 12,313 Receivables (except prepaid expenses) 1,078 463 1,541 65,327 2,505 67,832 Liabilities: Accounts payable and accrued expenses 3,227 129 3,356 Payable in respect of intangible asset purchase 2,000 — 2,000 Derivative financial instruments 6,155 — 6,155 11,382 129 11,511 53,945 2,376 56,321 |
CASH, CASH EQUIVALENTS AND BA34
CASH, CASH EQUIVALENTS AND BANK DEPOSITS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
CASH, CASH EQUIVALENTS AND BANK DEPOSITS | |
Schedule of cash and cash equivalents | December 31 2017 2016 U.S. dollars in thousands Cash in bank 8,305 53,772 Short-term bank deposits 8,150 14 16,455 53,786 |
PREPAID EXPENSES AND OTHER RE35
PREPAID EXPENSES AND OTHER RECEIVABLES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
PREPAID EXPENSES AND OTHER RECEIVABLES | |
Schedule of prepaid expenses and other receivables | December 31 2017 2016 U.S. dollars in thousands Advance to suppliers 2,426 1,049 Discount from service provider 537 230 Prepaid expenses 130 120 Government institutions 197 163 3,290 1,562 |
FIXED ASSETS (Tables)
FIXED ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
FIXED ASSETS | |
Schedule of composition of assets and accumulated depreciation, grouped by major classifications | Cost Accumulated depreciation Depreciated balance December 31 December 31 December 31 2017 2016 2017 2016 2017 2016 U.S. dollars in thousands Office furniture and equipment (including computers) 349 203 163 101 186 102 Leasehold improvements 132 132 88 69 44 63 481 335 251 170 230 165 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
INTANGIBLE ASSETS | |
Schedule of intangible assets changes | Year Ended December 31 2017 2016 U.S. dollars in thousands Cost: Balance at beginning of year 6,195 6,160 Additions during the year 35 35 Deductions during the year (945) — Balance at end of year 5,285 6,195 Write-off charge — (100) 5,285 6,095 |
ACCRUED EXPENSES AND OTHER CU38
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | |
Schedule of accrued expenses and other current liabilities | December 31 2017 2016 U.S. dollars in thousands Accrued expenses 4,969 2,903 Employees and related liabilities 1,045 295 Government institutions 11 98 6,025 3,296 |
EQUITY (Tables)
EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
EQUITY | |
Schedule of composition of share capital | Number of shares December 31 2017 2016 In thousands Authorized 300,000 300,000 Issued and paid 212,729 164,974 |
SHARE-BASED PAYMENTS (Tables)
SHARE-BASED PAYMENTS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
SHARE-BASED PAYMENTS | |
Schedule of information on options granted | a. The following is information on options granted in 2017: Number of options granted According to the award plan Exercise Fair value of of the Company price for 1 options on date of Other than ordinary grant in U.S.$ Date of grant directors (1) To directors Total share ($) thousands (2) March 2017 3,650,000 — 3,650,000 1.08 1,777 May 2017 — 640,000 640,000 1.08 290 May 2017 — 500,000 500,000 1.09 227 July 2017 2,445,000 — 2,445,000 0.98 1,205 6,095,000 1,140,000 7,235,000 3,499 1) The options will vest as follows: for employees and consultants of the Company who had provided services exceeding one year to the Company as of the grant date, the options will vest in 16 equal quarterly installments over a four-year period. For employees and consultants of the Company who had not provided services to the Company exceeding one year as of the grant date, the options will vest as follows: 1/4 of the options will vest one year following the grant date and the rest over the following three years in 12 equal quarterly installments. During the contractual term the options will be exercisable, either in full or in part, from the vesting date until the end of 7 years from the date of grant. 2017 grants include both options exercisable into the Company’s ordinary shares and options exercisable to the Company’s ADSs. 2) The fair value of the options was computed using the binomial model and the underlying data used was mainly the following: price of the Company’s ordinary share: $0.98 - $1.09, expected volatility: 49.48% - 58.09%, risk-free interest rate: 2.05% - 2.23% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates. The expected volatility assumption used is based on the historical volatility of the Company’s share. b. The following is information on options granted in 2016: Number of options granted According to the award plan Exercise Fair value of of the Company price for 1 options on date of Other than ordinary grant in U.S.$ Date of grant directors (1) To directors (1) Total share ($) thousands (2) April 2016 590,000 — 590,000 1.41 400 June 2016 — 1,500,000 1,500,000 1.28 725 June 20 16 (3) — 150,000 150,000 1.48 105 590,000 1,650,000 2,240,000 1,230 1) The options will vest as follows: for employees and consultants of the Company who had provided services exceeding one year to the Company as of the grant date, the options will vest in 16 equal quarterly installments over a four-year period. For employees and consultants of the Company who had not provided services to the Company exceeding one year as of the grant date, the options will vest as follows: 1/4 of the options will vest one year following the grant date and the rest over the following three years in 12 equal quarterly installments. During the contractual term the options will be exercisable, either in full or in part, from the vesting date until the end of 7 years from the date of grant. 2) The fair value of the options was computed using the binomial model and the underlying data used was mainly the following: price of the Company’s ordinary share: $1.28 - $1.41, expected volatility: 52.52% - 53.09%, risk-free interest rate: 1.51% - 1.57% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates. The expected volatility assumption used is based on the historical volatility of the Company’s share. In June 2016, the Company’s annual general meeting of shareholders approved the acceleration of 150,000 unvested options of Alicia Rotbard, of blessed memory, a former external director of the Company. Each option was exercisable into one ordinary share at an exercise price of $1.48 per share. These options expired in November 2017. The allocated expenses, in the amount of $105 thousand were recorded directly to the Statements of Comprehensive Loss under General and Administrative Expenses. |
Schedule of number of shares and weighted averages of exercise prices | Year Ended December 31 2017 2016 Weighted Weighted average of average of Number of exercise Number of exercise options price ($) options price ($) Outstanding at beginning of year 22,025,548 0.95 20,511,338 0.88 Exercised (2,988,750) 0.27 (725,790) 0.36 Expired and forfeited (490,000) 1.37 — — Granted 7,235,000 1.05 2,240,000 1.33 Outstanding at end of year 25,781,798 1.05 22,025,548 0.95 Exercisable at end of year 16,842,697 0.99 15,168,938 0.85 |
Schedule of information about exercise price and remaining useful life of outstanding options | December 31, 2017 December 31, 2016 Number of Number of options Weighted options Weighted outstanding average of outstanding average of at end of Exercise price remaining at end of Exercise price remaining year range useful life year range useful life 25,781,798 $0.5-$1.61 3.5 22,025,548 $0.17-$1.61 3.8 |
Schedule of expenses recognized in profit or loss | Year Ended December 31 2017 2016 2015 U.S. dollars in thousands 1,679 1,364 |
NET REVENUES (Tables)
NET REVENUES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
NET REVENUES | |
Schedule of net revenues | Year Ended December 31 2017 2016 2015 U.S dollars in thousands Licensing — 100 — Commercialization of product 3,240 — — Promotional services 767 — — Other Revenues — 1 3 4,007 101 3 a) In 2016 the Company recorded revenues with respect to RIZAPORT ® . In 2017 the Company recorded revenues with respect to the commercialization of EnteraGam® initiated in June 2017 and promotional activities of Donnatal ® initiated in June 2017 and Esomeprazole Strontium Delayed-Release Capsules 49.3 mg initiated in September 2017. |
RESEARCH AND DEVELOPMENT EXPE42
RESEARCH AND DEVELOPMENT EXPENSES, net (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
RESEARCH AND DEVELOPMENT EXPENSES, net. | |
Schedule of research and development expenses, net | Year Ended December 31 2017 2016 2015 U.S. dollars in thousands Payroll and related expenses 653 652 621 Professional services 2,218 1,816 1,953 Share-based payments 793 841 842 Clinical and pre-clinical trials 28,221 21,013 13,611 Intellectual property development 401 428 216 Other 964 772 713 Discount from service provider* (281) (281) (185) 32,969 25,241 17,771 * |
GENERAL AND ADMINISTRATIVE EX43
GENERAL AND ADMINISTRATIVE EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
GENERAL AND ADMINISTRATIVE EXPENSES | |
Schedule of general and administrative expenses | Year Ended December 31 2017 *2016 *2015 U.S. dollars in thousands Payroll and related expenses 3,311 1,082 652 Share-based payments 1,054 773 502 Professional services 2,246 1,391 1,167 Office-related expenses 567 300 120 Other 847 302 307 8,025 3,848 2,748 * |
FINANCIAL INCOME, net (Tables)
FINANCIAL INCOME, net (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
FINANCIAL INCOME, net | |
Schedule of financial income, net | Year Ended December 31 2017 2016 2015 U.S dollars in thousands Financial income: Fair value gains on derivative financial instruments 5,687 1,152 888 Gains on financial assets at fair value through profit or loss 189 80 — Gains from changes in exchange rates 332 34 — Interest from bank deposits 297 282 236 6,505 1,548 1,124 Financial expenses: Loss from changes in exchange rates — — 200 Issuance cost with respect of warrants — 368 — Other 77 7 12 77 375 212 Financial income, net (6,428) (1,173) (912) |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
SEGMENT INFORMATION | |
Schedule of segment information | Year Ended December 31 2017 Commercial Operation Research And Development Consolidated U.S. dollars in thousands Net revenues 4,007 — 4,007 Cost of revenues 2,126 — 2,126 Gross profit 1,881 — 1,881 Research and development expenses, net — 32,969 32,969 Selling, marketing, and business development expenses 10,520 1,494 12,014 General and administrative expenses 2,680 5,345 8,025 Other expenses — 845 845 Operating loss 11,319 40,653 51,972 |
LOSS PER ORDINARY SHARE (Tables
LOSS PER ORDINARY SHARE (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
LOSS PER ORDINARY SHARE | |
Schedule of loss per ordinary share | a. Basic The basic loss per share is calculated by dividing the loss by the weighted average number of ordinary shares in issue during the period. The following is data taken into account in the computation of loss per share: Year Ended December 31 2017 2016 2015 Loss (U.S. dollars in thousands) 45,544 29,370 21,090 Weighted average number of ordinary shares outstanding during the period (in thousands) 176,579 128,514 110,814 Basic loss per share (U.S. dollars) 0.26 0.23 0.19 b. Diluted Diluted loss per share is calculated by adjusting the weighted average number of ordinary shares outstanding, assuming conversion of all potential dilutive ordinary shares, using the treasury stock method. The Company has two categories of dilutive potential ordinary shares: warrants issued to investors and options issued to employees and service providers. The effect of options issued to employees and service providers, for all reporting years, is anti-dilutive. In 2017, the effect of warrants is anti-dilutive. Year Ended December 31 2017 2016 2015 Loss (U.S. dollars in thousands) 45,544 29,370 21,090 Adjustment for financial income of warrants — 1,208 346 Loss used to determine diluted loss per share 45,544 30,578 21,436 Weighted average number of ordinary shares outstanding during the period (in thousands) 176,579 128,514 110,814 Adjustment for warrants — 295 901 Weighted average number of ordinary shares for diluted loss per share (in thousands) 176,579 128,809 111,715 Diluted loss per share (U.S. dollars) 0.26 0.24 0.19 |
RELATED PARTIES (Tables)
RELATED PARTIES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
RELATED PARTIES | |
Schedule of key management compensation: | Year Ended December 31 2017 2016 2015 U.S. dollars in thousands Key management compensation: Salaries and other short-term employee benefits 677 576 776 Post-employment benefits 35 32 58 Share-based payments 557 504 382 Other long-term benefits 7 11 27 |
Schedule of balances with related parties | December 31 2017 2016 U.S. dollars in thousand Current liabilities - Credit balance in “accrued expenses and other current liabilities” 199 174 Non-current liabilities - Derivative financial instruments 11 144 |
GENERAL (Details)
GENERAL (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017USD ($)item | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
GENERAL | |||
Number of therapeutic candidates out-licensed on an exclusive world-wide basis | item | 1 | ||
Revenue | $ | $ 4,007 | $ 101 | $ 3 |
SUMMARY OF SIGNIFICANT ACCOUN49
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2017USD ($)g | |
Accounting Policies [Line Items] | |
Inventory recognized as part of cost of revenues | $ | $ 0.8 |
Computer equipment | |
Accounting Policies [Line Items] | |
Depreciation rate (as a percent) | 33.00% |
Office furniture and equipment | Minimum | |
Accounting Policies [Line Items] | |
Depreciation rate (as a percent) | 8.00% |
Office furniture and equipment | Maximum | |
Accounting Policies [Line Items] | |
Depreciation rate (as a percent) | 15.00% |
Esomeprazole | |
Accounting Policies [Line Items] | |
Metric units of product | g | 0.0493 |
FINANCIAL INSTRUMENTS AND FIN50
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (Details) | 12 Months Ended | ||
Dec. 31, 2017USD ($)item | Dec. 31, 2016USD ($)item | Dec. 31, 2015USD ($) | |
Financial instruments | |||
Percentage of currency stronger against the NIS | 5.00% | 5.00% | 5.00% |
Additional expense that would have been recognized | $ 56,000 | $ 78,000 | $ 12,000 |
Financial assets at fair value through profit or loss | 16,587,000 | 12,313,000 | |
Fair value adjustments recognized in profit or loss | $ 5,687,000 | $ 1,152,000 | 888,000 |
Maximum | |||
Financial instruments | |||
Maturity periods for cash balances in highly-rated bank deposits | 1 year | ||
Portfolio invested in a single bond issuer (as a percent) | 10.00% | ||
Period for non-derivative financial liabilities | item | 1 | 1 | |
Derivative financial instruments. | |||
Financial instruments | |||
Derivative liabilities- balance at beginning of the year | $ 6,155,000 | ||
Derivative liabilities- balance at the end of the year | 448,000 | $ 6,155,000 | |
At fair value | |||
Financial instruments | |||
Financial assets at fair value through profit or loss | 16,587,000 | 12,313,000 | |
Level 1 | At fair value | |||
Financial instruments | |||
Financial assets at fair value through profit or loss | 16,587,000 | 12,313,000 | |
Level 3 | Derivative financial instruments. | |||
Financial instruments | |||
Derivative liabilities- balance at beginning of the year | 6,155,000 | 1,237,000 | |
Proceeds received during the reported year | 6,070,000 | ||
Exercise of derivative into shares | (20,000) | ||
Fair value adjustments recognized in profit or loss | (5,687,000) | (1,152,000) | |
Derivative liabilities- balance at the end of the year | $ 448,000 | $ 6,155,000 | $ 1,237,000 |
FINANCIAL INSTRUMENTS AND FIN51
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT – By group and by currency (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Financial instruments | ||
Financial assets | $ 51,045 | $ 67,832 |
Financial liabilities | 12,278 | 11,511 |
Financial instruments, net | 38,767 | 56,321 |
U.S. dollar | ||
Financial instruments | ||
Financial assets | 48,961 | 65,327 |
Financial liabilities | 11,786 | 11,382 |
Financial instruments, net | 37,175 | 53,945 |
Other Currencies | ||
Financial instruments | ||
Financial assets | 2,084 | 2,505 |
Financial liabilities | 492 | 129 |
Financial instruments, net | 1,592 | 2,376 |
Accounts payable | ||
Financial instruments | ||
Financial liabilities | 4,805 | 60 |
Accounts payable | U.S. dollar | ||
Financial instruments | ||
Financial liabilities | 4,333 | |
Accounts payable | Other Currencies | ||
Financial instruments | ||
Financial liabilities | 472 | |
Accounts payable and accrued expenses | ||
Financial instruments | ||
Financial liabilities | 6,025 | 3,356 |
Accounts payable and accrued expenses | U.S. dollar | ||
Financial instruments | ||
Financial liabilities | 6,005 | 3,227 |
Accounts payable and accrued expenses | Other Currencies | ||
Financial instruments | ||
Financial liabilities | 20 | 129 |
Accrued expenses and other current liabilities | ||
Financial instruments | ||
Financial liabilities | 6,025 | 3,296 |
Derivative financial instruments. | ||
Financial instruments | ||
Financial liabilities | 448 | 6,155 |
Derivative financial instruments. | U.S. dollar | ||
Financial instruments | ||
Financial liabilities | 448 | 6,155 |
Payable in respect of intangible asset purchase | ||
Financial instruments | ||
Financial liabilities | 1,000 | 2,000 |
Payable in respect of intangible asset purchase | U.S. dollar | ||
Financial instruments | ||
Financial liabilities | 1,000 | 2,000 |
Financial liabilities at fair value through profit or loss | ||
Financial instruments | ||
Financial liabilities | 448 | 6,155 |
Financial liabilities at fair value through profit or loss | Derivative financial instruments. | ||
Financial instruments | ||
Financial liabilities | 448 | 6,155 |
Financial liabilities at amortised cost | ||
Financial instruments | ||
Financial liabilities | 11,830 | 5,356 |
Financial liabilities at amortised cost | Accounts payable | ||
Financial instruments | ||
Financial liabilities | 4,805 | 60 |
Financial liabilities at amortised cost | Accrued expenses and other current liabilities | ||
Financial instruments | ||
Financial liabilities | 6,025 | 3,296 |
Financial liabilities at amortised cost | Payable in respect of intangible asset purchase | ||
Financial instruments | ||
Financial liabilities | 1,000 | 2,000 |
Financial assets at fair value through profit or loss | ||
Financial instruments | ||
Financial assets | 16,587 | 12,313 |
Loans and receivables | ||
Financial instruments | ||
Financial assets | 34,458 | 55,519 |
Cash and cash equivalents | ||
Financial instruments | ||
Financial assets | 16,455 | 53,786 |
Cash and cash equivalents | U.S. dollar | ||
Financial instruments | ||
Financial assets | 15,319 | 51,936 |
Cash and cash equivalents | Other Currencies | ||
Financial instruments | ||
Financial assets | 1,136 | 1,850 |
Cash and cash equivalents | Loans and receivables | ||
Financial instruments | ||
Financial assets | 16,455 | 53,786 |
Bank deposits | ||
Financial instruments | ||
Financial assets | 13,315 | 192 |
Bank deposits | U.S. dollar | ||
Financial instruments | ||
Financial assets | 13,101 | |
Bank deposits | Other Currencies | ||
Financial instruments | ||
Financial assets | 214 | 192 |
Bank deposits | Loans and receivables | ||
Financial instruments | ||
Financial assets | 13,315 | 192 |
Trade receivables | ||
Financial instruments | ||
Financial assets | 1,528 | 99 |
Trade receivables | U.S. dollar | ||
Financial instruments | ||
Financial assets | 1,528 | |
Trade receivables | Loans and receivables | ||
Financial instruments | ||
Financial assets | 1,528 | 99 |
Other receivables (except prepaid expenses) | ||
Financial instruments | ||
Financial assets | 3,160 | 1,442 |
Other receivables (except prepaid expenses) | U.S. dollar | ||
Financial instruments | ||
Financial assets | 2,426 | |
Other receivables (except prepaid expenses) | Other Currencies | ||
Financial instruments | ||
Financial assets | 734 | |
Other receivables (except prepaid expenses) | Loans and receivables | ||
Financial instruments | ||
Financial assets | 3,160 | 1,442 |
Financial assets at fair value through profit or loss | ||
Financial instruments | ||
Financial assets | 16,587 | 12,313 |
Financial assets at fair value through profit or loss | U.S. dollar | ||
Financial instruments | ||
Financial assets | 16,587 | 12,313 |
Financial assets at fair value through profit or loss | Financial assets at fair value through profit or loss | ||
Financial instruments | ||
Financial assets | $ 16,587 | 12,313 |
Receivables (except prepaid expenses) | ||
Financial instruments | ||
Financial assets | 1,541 | |
Receivables (except prepaid expenses) | U.S. dollar | ||
Financial instruments | ||
Financial assets | 1,078 | |
Receivables (except prepaid expenses) | Other Currencies | ||
Financial instruments | ||
Financial assets | $ 463 |
CASH, CASH EQUIVALENTS AND BA52
CASH, CASH EQUIVALENTS AND BANK DEPOSITS (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cash and Cash Equivalents [Line Items] | ||||
Cash in bank | $ 8,305 | $ 53,772 | ||
Short-term bank deposits | 8,150 | 14 | ||
Cash and cash equivalents | $ 16,455 | $ 53,786 | $ 21,516 | $ 5,892 |
Minimum | ||||
Cash and Cash Equivalents [Line Items] | ||||
Bank deposits, term | 3 months | |||
Bank deposits, annual interest rate | 1.10% | |||
Maximum | ||||
Cash and Cash Equivalents [Line Items] | ||||
Bank deposits, term | 1 year |
PREPAID EXPENSES AND OTHER RE53
PREPAID EXPENSES AND OTHER RECEIVABLES (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 | |
PREPAID EXPENSES AND OTHER RECEIVABLES | |||
Advances to suppliers | $ 2,426 | $ 1,049 | |
Discount from service provider | 537 | 230 | |
Prepaid expenses | 130 | 120 | |
Government institutions | 197 | 163 | |
Total prepaid expenses and other receivables | $ 3,290 | $ 1,562 | [1] |
[1] | *Reclassified to conform to the current year presentation. |
FIXED ASSETS (Details)
FIXED ASSETS (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Fixed assets | ||
Fixed assets | $ 230 | $ 165 |
Cost | ||
Fixed assets | ||
Fixed assets | 481 | 335 |
Accumulated depreciation | ||
Fixed assets | ||
Fixed assets | 251 | 170 |
Office furniture and equipment (including computers) | ||
Fixed assets | ||
Fixed assets | 186 | 102 |
Office furniture and equipment (including computers) | Cost | ||
Fixed assets | ||
Fixed assets | 349 | 203 |
Office furniture and equipment (including computers) | Accumulated depreciation | ||
Fixed assets | ||
Fixed assets | 163 | 101 |
Leasehold improvements | ||
Fixed assets | ||
Fixed assets | 44 | 63 |
Leasehold improvements | Cost | ||
Fixed assets | ||
Fixed assets | 132 | 132 |
Leasehold improvements | Accumulated depreciation | ||
Fixed assets | ||
Fixed assets | $ 88 | $ 69 |
INTANGIBLE ASSETS - Changes in
INTANGIBLE ASSETS - Changes in Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Reconciliation of changes in intangible assets | ||
Balance at beginning of year | $ 6,095 | |
Write-off charge | $ (100) | |
Balance at end of year | 5,285 | 6,095 |
Cost | ||
Reconciliation of changes in intangible assets | ||
Balance at beginning of year | 6,195 | 6,160 |
Additions during the year | 35 | 35 |
Deductions during the year | (945) | |
Balance at end of year | $ 5,285 | $ 6,195 |
INTANGIBLE ASSETS - Narrative (
INTANGIBLE ASSETS - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Reconciliation of changes in intangible assets | ||
Recognized loss | $ 100,000 | |
Drug candidate, congestive heart failure | ||
Reconciliation of changes in intangible assets | ||
Recognized loss | $ 100,000 | |
Therapeutic candidate, acute migraine | ||
Reconciliation of changes in intangible assets | ||
Recognized loss | 800,000 | |
Therapeutic candidate, pancreatic cancer | ||
Reconciliation of changes in intangible assets | ||
Recognized loss | $ 45,000 |
LIABILITY FOR EMPLOYEE RIGHTS57
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | |||
Defined contribution plans expense | $ 155,000 | $ 121,000 | $ 95,000 |
ACCRUED EXPENSES AND OTHER CU58
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | |||
Accrued expenses | $ 4,969 | $ 2,903 | |
Employees and related liabilities | 1,045 | 295 | |
Government Institutions | 11 | 98 | |
Accrued expenses and other current liabilities | $ 6,025 | $ 3,296 | [1] |
[1] | *Reclassified to conform to the current year presentation. |
COMMITMENTS (Details)
COMMITMENTS (Details) | Aug. 16, 2017 | Mar. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Aug. 11, 2010USD ($)item | May 02, 2010USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2017USD ($)itemg | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Feb. 28, 2018USD ($) |
Commitments | ||||||||||||
Revenue | $ 4,007,000 | $ 101,000 | $ 3,000 | |||||||||
Number of key programs | item | 2 | |||||||||||
Esomeprazole | ||||||||||||
Commitments | ||||||||||||
Metric units of product | g | 0.0493 | |||||||||||
U.S. Publicly Traded Company Arrangement | ||||||||||||
Commitments | ||||||||||||
Upfront initial payment per agreement | $ 100,000 | |||||||||||
IntelGenx Corp Arrangement | ||||||||||||
Commitments | ||||||||||||
Upfront initial payment per agreement | $ 800,000 | |||||||||||
Research and development costs to date | $ 1,300,000 | |||||||||||
Salix Pharmaceuticals, Ltd. Agreement [Member] | ||||||||||||
Commitments | ||||||||||||
Upfront initial payment per agreement | $ 7,000,000 | |||||||||||
Milestones to be paid | 5,000,000 | |||||||||||
Revenue | 7,000,000 | |||||||||||
Australian Asset Purchase Agreement | ||||||||||||
Commitments | ||||||||||||
Upfront initial payment per agreement | $ 500,000 | $ 1,000,000 | ||||||||||
Australian Asset Purchase Agreement | Minimum | ||||||||||||
Commitments | ||||||||||||
Percentage of revenues to be paid in the future | 7.00% | |||||||||||
Australian Asset Purchase Agreement | Maximum | ||||||||||||
Commitments | ||||||||||||
Percentage of revenues to be paid in the future | 20.00% | |||||||||||
Giaconda Asset Purchase Agreement [Member] | ||||||||||||
Commitments | ||||||||||||
Number of therapeutic candidates | item | 3 | |||||||||||
German Publicly Traded Company Arrangement | ||||||||||||
Commitments | ||||||||||||
Upfront initial payment per agreement | $ 1,000,000 | |||||||||||
German Publicly Traded Company Arrangement | Maximum | ||||||||||||
Commitments | ||||||||||||
Royalties percentage | 30.00% | |||||||||||
U.S. Private Company Arrangement | ||||||||||||
Commitments | ||||||||||||
Upfront initial payment per agreement | $ 1,500,000 | |||||||||||
Aggregate payments made as of reporting period | 2,500,000 | $ 500,000 | ||||||||||
Milestone current liability | $ 1,000,000 | $ 500,000 | ||||||||||
Concordia Subsidiary Copromotion Arrangement | ||||||||||||
Commitments | ||||||||||||
Upfront initial payment per agreement | $ 0 | |||||||||||
Agreement term | 3 years | |||||||||||
Para Pro LLC | ||||||||||||
Commitments | ||||||||||||
Agreement term | 4 years | |||||||||||
Para Pro LLC | Esomeprazole | ||||||||||||
Commitments | ||||||||||||
Metric units of product | g | 0.0493 | |||||||||||
Revenue Milestone | U.S. Private Company Arrangement | Maximum | ||||||||||||
Commitments | ||||||||||||
Milestones to be paid | $ 2,000,000 |
COMMITMENTS Operating Lease (De
COMMITMENTS Operating Lease (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Operating lease | ||
Bank deposits for operating lease | $ 152,000 | $ 137,000 |
Israel | ||
Operating lease | ||
Projected yearly rental expenses | 410,000 | |
Projected yearly sublease payments receivable from third party | 96,000 | |
U.S. | ||
Operating lease | ||
Projected yearly rental expenses | $ 168,000 |
INCOME TAX (Details)
INCOME TAX (Details) - USD ($) $ in Millions | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax [Line Items] | ||||
Deductible temporary differences | $ 28 | $ 29 | ||
Israel | ||||
Income Tax [Line Items] | ||||
Corporate tax rate | 24.00% | 25.00% | 26.50% | |
Israel | Forecast | ||||
Income Tax [Line Items] | ||||
Corporate tax rate | 23.00% | |||
Israel | Net operating losses carried forward | ||||
Income Tax [Line Items] | ||||
Deferred tax assets | $ 76 | |||
U.S. | ||||
Income Tax [Line Items] | ||||
Corporate tax rate | 34.00% | |||
U.S. | Forecast | ||||
Income Tax [Line Items] | ||||
Corporate tax rate | 21.00% | |||
U.S. | Net operating losses carried forward | ||||
Income Tax [Line Items] | ||||
Deferred tax assets | $ 10 |
EQUITY (Details)
EQUITY (Details) | Jan. 04, 2017USD ($)shares | Jan. 03, 2017USD ($)shares | Dec. 27, 2016shares | Nov. 30, 2017USD ($)shares | Jan. 31, 2017USD ($)shares | Dec. 31, 2016USD ($)itemshares | Jan. 31, 2014$ / sharesshares | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($)shares | Dec. 31, 2015USD ($) | Dec. 31, 2017₪ / sharesshares | Dec. 31, 2017$ / sharesshares | Feb. 16, 2016shares |
Disclosure of classes of share capital [line items] | |||||||||||||
Number of shares issued | 4,090,909 | ||||||||||||
Proceeds from issuance of shares, gross | $ | $ 22,500,000 | ||||||||||||
Share issue related costs | $ | 1,500,000 | ||||||||||||
Proceeds from issuance of shares | $ | $ 21,000,000 | $ 22,216,000 | $ 35,754,000 | $ 54,684,000 | |||||||||
American Depository Shares | Underwriters | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
Procceds from issuance of ordinary shares and warrants | $ | $ 39,400,000 | ||||||||||||
Stock Options | American Depository Shares | Underwriters | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
Number of shares issued | 3,846,519 | 133,104 | |||||||||||
Proceeds from exercise of options | $ | $ 1,280,000 | ||||||||||||
Ordinary shares and warrants | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
Number of shares issued | 2,526,320 | ||||||||||||
Procceds from issuance of ordinary shares and warrants | $ | $ 2,630,000 | ||||||||||||
Ordinary shares and warrants | American Depository Shares | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
Share issue related costs | $ | $ 2,300,000 | ||||||||||||
Procceds from issuance of ordinary shares and warrants | $ | 38,100,000 | ||||||||||||
Proceeds from issuance of ordinary shares, net of expenses | $ | 35,800,000 | ||||||||||||
Ordinary shares and warrants | American Depository Shares | To directors | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
Proceeds from issuance of ordinary shares, net of expenses | $ | $ 1,000,000 | ||||||||||||
Number of directors that purchased shares and warrants | item | 1 | ||||||||||||
Ordinary shares | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
Par value per share | ₪ / shares | ₪ 0.01 | ||||||||||||
Authorized | 300,000,000 | 300,000,000 | 300,000,000 | 300,000,000 | 300,000,000 | ||||||||
Issued and paid | 164,974,000 | 164,974,000 | 212,729,000 | 212,729,000 | |||||||||
Market price per ordinary share | $ / shares | $ 5.14 | ||||||||||||
Ordinary shares | American Depository Shares | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
American depository share equivalent | 10 | 10 | |||||||||||
Market price per American Depository share | $ / shares | $ 0.50 | ||||||||||||
Number of shares issued | 3,713,415 | 3,713,415 | |||||||||||
Share issue related costs | $ | $ 1,900,000 | ||||||||||||
Proceeds from issuance of ordinary shares, net of expenses | $ | $ 32,000,000 | ||||||||||||
Ordinary shares | American Depository Shares | To directors | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
Number of shares issued | 95,000 | 95,000 | |||||||||||
Ordinary shares | American Depository Shares | Underwriters | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
Options issued to purchase shares | 337,500 | ||||||||||||
Ordinary shares | Stock Options | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
Number of shares issued | 725,790 | 725,790 | 2,988,750 | 2,988,750 | |||||||||
Proceeds from exercise of options | $ | $ 809,000 | $ 263,000 | |||||||||||
Warrants | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
Warrants issued | 4,183,496 | ||||||||||||
Exercise price of warrants | $ / shares | $ 1.40 | ||||||||||||
Warrants | American Depository Shares | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
Warrants issued | 1,856,708 | ||||||||||||
Share issue related costs | $ | $ 400,000 | ||||||||||||
Proceeds from issuance of ordinary shares, net of expenses | $ | $ 6,100,000 | ||||||||||||
Warrants | American Depository Shares | To directors | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
Warrants issued | 47,500 | ||||||||||||
Warrants | American Depository Shares | Underwriters | |||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||
Options issued to purchase warrants | 168,750 | ||||||||||||
Warrants issued | 2,025,458 | ||||||||||||
Exercise of warrants (in shares) | 168,750 |
DERIVATIVE FINANCIAL INSTRUME63
DERIVATIVE FINANCIAL INSTRUMENTS (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Jan. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2014 | Nov. 30, 2017 | |
Disclosure of detailed information about hedges [line items] | ||||||
Number of shares issued | 4,090,909 | |||||
Warrants issued in 2014 | ||||||
Disclosure of detailed information about hedges [line items] | ||||||
Number of shares issued | 2,526,320 | |||||
Proceeds from warrant exercises | $ 2,630 | |||||
Number of warrants expired | 1,052,640 | |||||
Warrants exercisable into number of ADSs | 357,896 | |||||
Derivative term | 3 years | |||||
Warrants issued in 2016 | ||||||
Disclosure of detailed information about hedges [line items] | ||||||
Warrants exercisable into number of ADSs | 2,025,458 | 48.59 | 2,025,458 | |||
Derivative term | 3 years | |||||
Risk-free interest rate | 1.56% | 1.89% | ||||
Average standard deviation | 53.13% | |||||
Warrants exercise price | $ 13.33 | $ 13.33 |
SHARE-BASED PAYMENTS - Informat
SHARE-BASED PAYMENTS - Information on Options Granted (Details) | 12 Months Ended | |||
Dec. 31, 2017USD ($)Optioninstallmentshares | Dec. 31, 2016USD ($)Optioninstallmentshares | Dec. 31, 2015shares | Jun. 30, 2016item$ / shares | |
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 7,235,000 | 2,240,000 | ||
Number of options granted | Option | 7,235,000 | 2,240,000 | ||
Exercise price for 1 ordinary share ($) | $ 1.05 | $ 1.33 | ||
Fair value of options on date of grant in U.S. $ thousands | $ 3,499,000 | $ 1,230,000 | ||
Each option exercisable into number of ordinary shares, ratio | Option | 16,842,697 | 15,168,938 | ||
March 2,017 | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 3,650,000 | |||
Exercise price for 1 ordinary share ($) | $ 1.08 | |||
Fair value of options on date of grant in U.S. $ thousands | $ 1,777,000 | |||
May 2017, first tranche | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 640,000 | |||
Exercise price for 1 ordinary share ($) | $ 1.08 | |||
Fair value of options on date of grant in U.S. $ thousands | $ 290,000 | |||
May 2017, second tranche | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 500,000 | |||
Exercise price for 1 ordinary share ($) | $ 1.09 | |||
Fair value of options on date of grant in U.S. $ thousands | $ 227,000 | |||
July 2,017 | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 2,445,000 | |||
Exercise price for 1 ordinary share ($) | $ 0.98 | |||
Fair value of options on date of grant in U.S. $ thousands | 1,205,000 | |||
April 2,016 | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 590,000 | |||
Exercise price for 1 ordinary share ($) | $ 1.41 | |||
Fair value of options on date of grant in U.S. $ thousands | $ 400,000 | |||
June 2016, first tranche | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 1,500,000 | |||
Exercise price for 1 ordinary share ($) | $ 1.28 | |||
Fair value of options on date of grant in U.S. $ thousands | $ 725,000 | |||
June 2016, second tranche | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 150,000 | |||
Exercise price for 1 ordinary share ($) | $ 1.48 | |||
Fair value of options on date of grant in U.S. $ thousands | $ 105,000 | |||
Stock Options | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 33,646,039 | |||
Stock Options | 2016 | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Option term | 7 years | |||
Stock Options | 2016 | Minimum | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Price of the Company’s ordinary share | $ 0.98 | |||
Expected volatility | 49.48% | |||
Risk free interest rate | 2.05% | |||
Stock Options | 2016 | Maximum | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Price of the Company’s ordinary share | $ 1.09 | |||
Expected volatility | 58.09% | |||
Risk free interest rate | 2.23% | |||
Stock Options | 2016 | Vesting, services exceeding one year | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Number of equal quarterly vesting installments | installment | 16 | |||
Vesting period | 4 years | |||
Stock Options | 2016 | Vesting, services exceeding one year | Minimum | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Service period | 1 year | |||
Stock Options | 2016 | Vesting, services not exceeding one year | Maximum | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Service period | 1 year | |||
Stock Options | 2016 | Vesting, one year following the date of grant (services not exceeding one year) | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Vesting period | 1 year | |||
Percentage of options vesting | 0.25% | |||
Stock Options | 2016 | Vesting, three years following one year after the date of grant (services not exceeding one year) | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Number of equal quarterly vesting installments | installment | 12 | |||
Vesting period | 3 years | |||
Stock Options | June 2016, second tranche | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Acceleration of unvested options (shares) | shares | 150,000 | |||
Each option exercisable into number of ordinary shares, ratio | item | 1 | |||
Options exercisable, exercise price | $ / shares | $ 1.48 | |||
Allocated share-based compensation expense | $ 105,000 | |||
Stock Options | 2015 | Minimum | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Price of the Company’s ordinary share | $ 1.28 | |||
Expected volatility | 52.52% | |||
Risk free interest rate | 1.51% | |||
Stock Options | 2015 | Maximum | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Price of the Company’s ordinary share | $ 1.41 | |||
Expected volatility | 53.09% | |||
Risk free interest rate | 1.57% | |||
Other than directors | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 6,095,000 | 590,000 | ||
Other than directors | March 2017 | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 3,650,000 | |||
Other than directors | July 2017 | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 2,445,000 | |||
Other than directors | April 2016 | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 590,000 | |||
Other than directors | Stock Options | 2015 | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Vesting period | 4 years | |||
Option term | 7 years | |||
Other than directors | Stock Options | 2015 | Minimum | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Service period | 1 year | |||
Other than directors | Stock Options | 2015 | Vesting, services exceeding one year | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Number of equal quarterly vesting installments | installment | 16 | |||
Other than directors | Stock Options | 2015 | Vesting, services not exceeding one year | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Service period | 1 year | |||
Other than directors | Stock Options | 2015 | Vesting, one year following the date of grant (services not exceeding one year) | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Vesting period | 1 year | |||
Percentage of options vesting | 0.25% | |||
Other than directors | Stock Options | 2015 | Vesting, three years following one year after the date of grant (services not exceeding one year) | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Number of equal quarterly vesting installments | installment | 12 | |||
Vesting period | 3 years | |||
To directors | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 1,140,000 | 1,650,000 | ||
To directors | May 2017, first tranche | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 640,000 | |||
To directors | May 2017, second tranche | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 500,000 | |||
To directors | June 2016, first tranche | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 1,500,000 | |||
To directors | June 2016, second tranche | ||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||
Shares approved for issuance | shares | 150,000 |
SHARE-BASED PAYMENTS - Number o
SHARE-BASED PAYMENTS - Number of Shares and Weighted Averages of Exercise Prices (Details) | 12 Months Ended | |
Dec. 31, 2017USD ($)Option | Dec. 31, 2016USD ($)Option | |
SHARE-BASED PAYMENTS | ||
Number of options, outstanding at beginning of year | Option | 22,025,548 | 20,511,338 |
Number of options, exercised | Option | (2,988,750) | (725,790) |
Number of options, expired and forfeited | Option | (490,000) | |
Number of options, granted | Option | 7,235,000 | 2,240,000 |
Number of options, outstanding at end of year | Option | 25,781,798 | 22,025,548 |
Number of options, exercisable at end of year | Option | 16,842,697 | 15,168,938 |
Weighted average of exercise price, outstanding at beginning of year | $ | $ 0.95 | $ 0.88 |
Weighted average of exercise price, exercised | $ | 0.27 | 0.36 |
Weighted average of exercise price, expired and forfeited | $ | 1.37 | |
Weighted average of exercise price, granted | $ | 1.05 | 1.33 |
Weighted average of exercise price, outstanding at end of year | $ | 1.05 | 0.95 |
Weighted average of exercise price, exercisable at end of year | $ | $ 0.99 | $ 0.85 |
SHARE-BASED PAYMENTS - Inform66
SHARE-BASED PAYMENTS - Information About Exercise Price and Remaining Useful Life of Outstanding Options (Details) | Dec. 31, 2017USD ($)OptionY | Dec. 31, 2016USD ($)OptionY | Dec. 31, 2015Option |
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||
Number of options outstanding at end of Year | Option | 25,781,798 | 22,025,548 | 20,511,338 |
Weighted average of remaining useful life | Y | 3.5 | 3.8 | |
Minimum | |||
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||
Exercise price range | $ 0.50 | $ 0.17 | |
Maximum | |||
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||
Exercise price range | $ 1.61 | $ 1.61 |
SHARE-BASED PAYMENTS - Expenses
SHARE-BASED PAYMENTS - Expenses Recognized in Profit or Loss (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
SHARE-BASED PAYMENTS | |||
Expenses recognized in profit or loss | $ 2,235 | $ 1,679 | $ 1,364 |
Unrecognized compensation expenses | $ 2,700 |
NET REVENUES (Details)
NET REVENUES (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017USD ($)g | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Revenues | |||
Licensing | $ 100 | ||
Commercialization of product | $ 3,240 | ||
Promotional services | 767 | ||
Other Revenues | 1 | $ 3 | |
Total Net Revenues | $ 4,007 | $ 101 | $ 3 |
Esomeprazole | |||
Revenues | |||
Metric units of product | g | 0.0493 |
RESEARCH AND DEVELOPMENT EXPE69
RESEARCH AND DEVELOPMENT EXPENSES, net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Research And Development Expenses Net [Line Items] | |||
Discount from service provider | $ (281) | $ (281) | $ (185) |
Research and development expenses, net | 32,969 | 25,241 | 17,771 |
Payroll and related expenses | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 653 | 652 | 621 |
Professional services | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 2,218 | 1,816 | 1,953 |
Share-based payments | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 793 | 841 | 842 |
Clinical and pre-clinical trials | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 28,221 | 21,013 | 13,611 |
Intellectual property development | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 401 | 428 | 216 |
Other | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | $ 964 | $ 772 | $ 713 |
SELLING, MARKETING AND BUSINE70
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |||
Selling Marketing And Business Development Expenses [Line Items] | |||||
Selling, marketing and business development expenses | $ 12,014 | $ 1,555 | [1] | $ 1,386 | [1] |
Payroll and related expenses | |||||
Selling Marketing And Business Development Expenses [Line Items] | |||||
Selling, marketing and business development expenses | 5,012 | 301 | 334 | ||
Share-based payments | |||||
Selling Marketing And Business Development Expenses [Line Items] | |||||
Selling, marketing and business development expenses | 387 | 65 | 20 | ||
Professional services | |||||
Selling Marketing And Business Development Expenses [Line Items] | |||||
Selling, marketing and business development expenses | 1,778 | 947 | 883 | ||
Samples | |||||
Selling Marketing And Business Development Expenses [Line Items] | |||||
Selling, marketing and business development expenses | 1,569 | ||||
Travel and related expenses | |||||
Selling Marketing And Business Development Expenses [Line Items] | |||||
Selling, marketing and business development expenses | 2,236 | 81 | 23 | ||
Office related expenses, net | |||||
Selling Marketing And Business Development Expenses [Line Items] | |||||
Selling, marketing and business development expenses | 395 | 86 | 53 | ||
Other | |||||
Selling Marketing And Business Development Expenses [Line Items] | |||||
Selling, marketing and business development expenses | $ 637 | $ 75 | $ 73 | ||
[1] | *Reclassified to conform to the current year presentation. |
GENERAL AND ADMINISTRATIVE EX71
GENERAL AND ADMINISTRATIVE EXPENSES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |||
General And Administrative Expense [Line Items] | |||||
General and administrative expenses | $ 8,025 | $ 3,848 | [1] | $ 2,748 | [1] |
Payroll and related expenses | |||||
General And Administrative Expense [Line Items] | |||||
General and administrative expenses | 3,311 | 1,082 | 652 | ||
Share-based payments | |||||
General And Administrative Expense [Line Items] | |||||
General and administrative expenses | 1,054 | 773 | 502 | ||
Professional services | |||||
General And Administrative Expense [Line Items] | |||||
General and administrative expenses | 2,246 | 1,391 | 1,167 | ||
Office related expenses, net | |||||
General And Administrative Expense [Line Items] | |||||
General and administrative expenses | 567 | 300 | 120 | ||
Other | |||||
General And Administrative Expense [Line Items] | |||||
General and administrative expenses | $ 847 | $ 302 | $ 307 | ||
[1] | *Reclassified to conform to the current year presentation. |
FINANCIAL INCOME, net (Details)
FINANCIAL INCOME, net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
FINANCIAL INCOME, net | |||
Fair value gain on derivative financial instruments | $ 5,687 | $ 1,152 | $ 888 |
Gains on financial assets at fair value through profit or loss | 189 | 80 | |
Gain from changes in exchange rates | 332 | 34 | |
Interest from bank deposits | 297 | 282 | 236 |
Financial income | 6,505 | 1,548 | 1,124 |
Loss from changes in exchange rates | 200 | ||
Issuance cost with respect of warrants | 368 | ||
Other | 77 | 7 | 12 |
Financial expenses | 77 | 375 | 212 |
Financial income net | $ (6,428) | $ (1,173) | $ (912) |
SEGMENT INFORMATION (Details)
SEGMENT INFORMATION (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |||
Disclosure of operating segments [line items] | |||||
Net revenues | $ 4,007 | $ 101 | $ 3 | ||
Cost of revenues | 2,126 | ||||
Gross profit | 1,881 | 101 | 3 | ||
Research and development expenses, net | 32,969 | 25,241 | 17,771 | ||
Selling, marketing and business development expenses | 12,014 | 1,555 | [1] | 1,386 | [1] |
General and administrative expenses | 8,025 | 3,848 | [1] | 2,748 | [1] |
Other expenses | 845 | 100 | |||
Operating loss | 51,972 | $ 30,543 | $ 22,002 | ||
Commercial Operation | |||||
Disclosure of operating segments [line items] | |||||
Net revenues | 4,007 | ||||
Cost of revenues | 2,126 | ||||
Gross profit | 1,881 | ||||
Selling, marketing and business development expenses | 10,520 | ||||
General and administrative expenses | 2,680 | ||||
Operating loss | 11,319 | ||||
Research and development | |||||
Disclosure of operating segments [line items] | |||||
Research and development expenses, net | 32,969 | ||||
Selling, marketing and business development expenses | 1,494 | ||||
General and administrative expenses | 5,345 | ||||
Other expenses | 845 | ||||
Operating loss | $ 40,653 | ||||
[1] | *Reclassified to conform to the current year presentation. |
SEGMENT INFORMATION - Major Cus
SEGMENT INFORMATION - Major Customers (Details) | 12 Months Ended |
Dec. 31, 2017 | |
Minimum | |
Disclosure of major customers [line items] | |
Payment terms for customers | 30 years |
Maximum | |
Disclosure of major customers [line items] | |
Payment terms for customers | 60 years |
Customer One | |
Disclosure of major customers [line items] | |
Percentage of revenue | 59.00% |
Customer Two | |
Disclosure of major customers [line items] | |
Percentage of revenue | 19.00% |
LOSS PER ORDINARY SHARE - Basic
LOSS PER ORDINARY SHARE - Basic (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Basic | |||
Loss (U.S. dollars in thousands) | $ 45,544 | $ 29,370 | $ 21,090 |
Weighted average number of ordinary shares outstanding during the period (in thousands) | 176,579 | 128,514 | 110,814 |
Basic loss per share (U.S. dollars) | $ 0.26 | $ 0.23 | $ 0.19 |
LOSS PER ORDINARY SHARE - Dilut
LOSS PER ORDINARY SHARE - Diluted (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Diluted | |||
Loss (U.S. dollars in thousands) | $ 45,544 | $ 29,370 | $ 21,090 |
Adjustment for financial income of warrants | 1,208 | 346 | |
Loss used to determine diluted loss per share | $ 45,544 | $ 30,578 | $ 21,436 |
Weighted average number of ordinary shares outstanding during the period (in thousands) | 176,579 | 128,514 | 110,814 |
Adjustment for warrants | 295 | 901 | |
Weighted average number of ordinary shares for diluted loss per share (in thousands) | 176,579 | 128,809 | 111,715 |
Diluted loss per share (U.S. dollars) | $ 0.26 | $ 0.24 | $ 0.19 |
RELATED PARTIES - Key Managemen
RELATED PARTIES - Key Management Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
RELATED PARTIES | |||
Salaries and other short-term employee benefits | $ 677 | $ 576 | $ 776 |
Post-employment benefits | 35 | 32 | 58 |
Share-based payments | 557 | 504 | 382 |
Other long-term benefits | $ 7 | $ 11 | $ 27 |
RELATED PARTIES - Balances with
RELATED PARTIES - Balances with Related Parties (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Current liabilities | ||
Credit balance in “accrued expenses and other current liabilities” | $ 199 | $ 174 |
Non-current liabilities | ||
Derivative financial instruments | $ 11 | $ 144 |
EVENTS SUBSEQUENT TO DECEMBER79
EVENTS SUBSEQUENT TO DECEMBER 31, 2017 (Details) | Jan. 24, 2018USD ($)OptionsYshares | Jan. 23, 2018USD ($) | Jan. 31, 2018USD ($)shares | Dec. 31, 2017USD ($)Option | Dec. 31, 2016USD ($)Option | Nov. 30, 2017shares |
Disclosure of non-adjusting events after reporting period [line items] | ||||||
Number of shares issued | shares | 4,090,909 | |||||
Number of options, granted | Option | 7,235,000 | 2,240,000 | ||||
Weighted average of exercise price, granted | $ 1.05 | $ 1.33 | ||||
Fair value of options on date of grant in U.S. $ thousands | $ 3,499,000 | $ 1,230,000 | ||||
Ordinary share options | Major ordinary share transactions | ||||||
Disclosure of non-adjusting events after reporting period [line items] | ||||||
Number of shares issued | shares | 710,000 | |||||
Proceeds from exercise of options | $ 400,000 | |||||
Stock Options | Major ordinary share transactions | ||||||
Disclosure of non-adjusting events after reporting period [line items] | ||||||
Options granted | shares | 2,844,210 | |||||
Weighted average of exercise price, granted | $ 0.75 | $ 0.5 | ||||
Expected useful life to exercise | Y | 3 | |||||
Fair value of options on date of grant in U.S. $ thousands | $ 200,000 | |||||
Stock Options | Chief Executive Officer | Major ordinary share transactions | ||||||
Disclosure of non-adjusting events after reporting period [line items] | ||||||
Number of options, granted | Options | 1,540,000 | |||||
American Depository Shares | Stock Options | Employees | Major ordinary share transactions | ||||||
Disclosure of non-adjusting events after reporting period [line items] | ||||||
Number of options, granted | Options | 165,000 | |||||
Fair value of options on date of grant in U.S. $ thousands | $ 500,000 |