RedHill Biopharma (RDHL) 20-F 26 Feb 19 2018 FY Annual report (foreign) Financial data

Document and Entity Information

Document and Entity Information	12 Months Ended
	Dec. 31, 2018shares
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, 2018
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Filer Category	Accelerated Filer
Entity Common Stock, Shares Outstanding	283,686,908
Entity Emerging Growth Company	false
Entity Shell Company	false
Document Fiscal Year Focus	2,018
Document Fiscal Period Focus	FY

CONSOLIDATED STATEMENTS OF COMP

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
NET REVENUES	$ 8,360	$ 4,007	$ 101
COST OF REVENUES	2,837	2,126
GROSS PROFIT	5,523	1,881	101
RESEARCH AND DEVELOPMENT EXPENSES, net	24,862	32,969	25,241
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES	12,486	12,014	1,555
GENERAL AND ADMINISTRATIVE EXPENSES	7,506	8,025	3,848
OTHER EXPENSES		845
OPERATING LOSS	39,331	51,972	30,543
FINANCIAL INCOME	678	6,505	1,548
FINANCIAL EXPENSES	167	77	375
FINANCIAL INCOME, net	511	6,428	1,173
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD	$ 38,820	$ 45,544	$ 29,370
LOSS PER ORDINARY SHARE (U.S. dollars):
Basic (in dollars per share)	$ 0.17	$ 0.26	$ 0.23
Diluted (U.S. dollars)	$ 0.17	$ 0.26	$ 0.24
WEIGHTED AVERAGE OF ORDINARY SHARES (in thousands)	231,204	176,579	128,514

CONSOLIDATED STATEMENTS OF FINA

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION - USD ($) $ in Thousands	Dec. 31, 2018	Dec. 31, 2017
CURRENT ASSETS:
Cash and cash equivalents	$ 29,005	$ 16,455
Bank deposits	8,271	13,163
Financial assets at fair value through profit or loss	15,909	16,587
Trade receivables	958	1,528
Prepaid expenses and other receivables	1,876	3,290
Inventory	769	653
Total current assets	56,788	51,676
NON-CURRENT ASSETS:
Bank deposits	140	152
Fixed assets	163	230
Intangible assets	5,320	5,285
Total non-current assets	5,623	5,667
TOTAL ASSETS	62,411	57,343
CURRENT LIABILITIES:
Accounts payable	3,324	4,805
Accrued expenses and other current liabilities	7,057	6,025
Payable in respect of intangible asset purchase		1,000
Total current liabilities	10,381	11,830
NON-CURRENT LIABILITIES:
Derivative financial instruments	344	448
Royalty obligation	500
Total non-current liabilities	844	448
TOTAL LIABILITIES	11,225	12,278
EQUITY:
Ordinary shares	767	575
Additional paid-in capital	219,505	177,434
Accumulated deficit	(169,086)	(132,944)
TOTAL EQUITY	51,186	45,065
TOTAL LIABILITIES AND EQUITY	$ 62,411	$ 57,343

CONSOLIDATED STATEMENTS OF CHAN

CONSOLIDATED STATEMENTS 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, 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
Exercise of warrants and options into ordinary shares	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
Share-based compensation to employees and service providers				2,678	2,678
Issuance of ordinary shares, net of expenses	190	41,712			41,902
Exercise of warrants and options into ordinary shares	2	359			361
Comprehensive loss				(38,820)	(38,820)
Balance at end of period at Dec. 31, 2018	$ 767	$ 219,505		$ (169,086)	$ 51,186

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
OPERATING ACTIVITIES:
Comprehensive loss	$ (38,820)	$ (45,544)	$ (29,370)
Adjustments in respect of income and expenses not involving cash flow:
Share-based compensation to employees and service providers	2,678	2,235	1,679
Depreciation	90	81	44
Write-off of intangible assets		845
Fair value adjustment on derivative financial instruments	(104)	(5,687)	(1,152)
Fair value losses (gains) on financial assets at fair value through profit or loss	137	127	(67)
Revaluation of bank deposits	35	(123)	(274)
Issuance cost in respect of warrants			368
Exchange differences in respect of cash and cash equivalents	103	(367)	(39)
Total adjustments in respect of income and expenses not involving cash flow	2,939	(2,889)	559
Changes in assets and liability items:
Decrease (increase) in trade receivables	570	(1,429)	99
Decrease (increase) in prepaid expenses and other receivables	1,414	(1,728)	612
Decrease (increase) in inventory	(116)	(653)
Increase (decrease) in accounts payable	(1,481)	4,745	(60)
Increase (decrease) in accrued expenses and other current liabilities	1,032	2,729	(98)
Total changes in assets and liability items	1,419	3,664	553
Net cash used in operating activities	(34,462)	(44,769)	(28,258)
INVESTING ACTIVITIES:
Purchase of fixed assets	(23)	(146)	(85)
Purchase of intangible assets	(35)	(1,035)	(35)
Change in investment in current bank deposits	4,869	(13,000)	36,838
Purchase of financial assets at fair value through profit or loss	(6,976)	(21,923)	(12,246)
Proceeds from sale of financial assets at fair value through profit or loss	7,517	17,522
Net cash provided by (used in) investing activities	5,352	(18,582)	24,472
FINANCING ACTIVITIES:
Proceeds from issuance of ordinary shares, net of expenses	41,902	22,216	35,754
Exercise of warrants and options into ordinary shares, net of expenses	361	3,437	263
Repayment of payable in respect of intangible asset purchase	(500)
Net cash provided by financing activities	41,763	25,653	36,017
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	12,653	(37,698)	32,231
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS	(103)	367	39
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD	16,455	53,786	21,516
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD	29,005	16,455	53,786
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH	$ 728	$ 469	$ 408

GENERAL

GENERAL	12 Months Ended
	Dec. 31, 2018
GENERAL
GENERAL	NOTE 1 - GENERAL: a. General 1) RedHill Biopharma Ltd. (the “Company”), incorporated in Israel on August 3, 2009, together with its wholly-owned subsidiary RedHill Biopharma Inc. (the “Company’s subsidiary”), incorporated in Delaware, U.S. on January 19, 2017, is a specialty biopharmaceutical company, primarily focused on late-stage clinical development and commercialization of proprietary drugs for gastrointestinal (“GI”) diseases. 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 the Company’s subsidiary. In February 2011, the Company listed its securities on the Tel-Aviv Stock Exchange (“TASE”) and from December 2012 through July 2018, the Company’s American Depositary Shares (“ADSs”) were listed on the NASDAQ Capital Market. Since July 2018, the Company’s ADSs have been listed on the NASDAQ Global Market (“NASDAQ”). The Company’s registered address is 21 Ha’arba’a St, Tel-Aviv, Israel. 2) U.S. rights to commercialize and co-promote In April 2017, the Company signed an exclusive license agreement with a privately held U.S. company, granting the Company certain commercialization rights to commercialize EnteraGam®. Under the license agreement, the Company is required to pay royalties based on net sales, as provided in the agreement. The initial term of the agreement is four years. See also note 2o(2). In December 2016, the Company entered into an agreement with an international specialty pharmaceutical company, granting the Company certain rights to promote Donnatal ® in certain U.S. territories. In addition, in August 2017 and June 2018, the Company entered into agreements with U.S. companies, granting the Company certain rights to promote Esomeprazole Strontium Delayed-Release Capsules 49.3 mg and Mytesi ® , respectively, in certain U.S. territories . According to these agreements, fees are paid to the Company based on units sold of the products during each period. The initial terms of the agreements are between a year and a half and four years. See also note 2o(1). 3) To date the Company has out-licensed on an exclusive worldwide basis only one of its therapeutic candidates and has generated limited revenues from its commercial activities. Accordingly, there is no assurance that the Company’s business will generate sustainable positive cash flows. Through December 31, 2018, 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 of its therapeutic candidates, commercialization of in-licensed or acquired products and raising additional capital through equity or debt financing or through non-dilutive financing. 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 or results of operations. b. Approval of financial statements These financial statements were approved by the Board of Directors on February 25, 2019.

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	12 Months Ended
	Dec. 31, 2018
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, 2018 and 2017 and for each of the three years for the period ended on December 31, 2018 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 transactions and balances 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 and its subsidiary operate (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 Shekel (“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 the amount of consideration that is unconditional, unless they contain significant financing components. 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 held for sale in the ordinary course of business, in the process of production for a sale in the ordinary course of business or materials or supplies to be used in the production process, to the extent they are recoverable. 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 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 asset 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: % Computer 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, 2018, 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 Statements of Financial Position. j. Financial assets As of January 1, 2018, the Company adopted IFRS 9 “Financial Instruments” . 1) Classification The financial assets of the Company are classified into the following categories: financial assets at fair value through profit or loss, and financial assets at amortized cost. The classification is done on the basis of the Company’s business model for managing the financial asset and the contractual cash flow characteristics of the financial asset. a) Financial assets at amortized cost Financial assets at amortized cost are assets held within a business model whose objective is to hold assets in order to collect contractual cash flows and the contractual terms of the financial asset give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding. Financial assets at amortized cost 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). Financial assets at amortized cost of the Company are included in trade receivables, other receivables and bank deposits in the Statements of Financial Position. b) Financial assets at fair value through profit or loss Financial assets at fair value through profit or loss of the Company are assets not measured at amortized cost in accordance with (1)(a) above. 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. 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, except for trade receivables, that are recognized initially at the amount of consideration that is unconditional unless they contain significant financing components. Financial assets measured at fair value through profit or loss are initially recognized at fair value, related 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. Financial assets at amortized cost 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”. 3) Impairment The Company recognizes a loss allowance for expected credit losses on financial assets at amortized cost. At each reporting date, the Company assesses whether the credit risk on a financial instrument has increased significantly since initial recognition. If the financial instrument is determined to have low credit risk at the reporting date, the Company assumes that the credit risk on a financial instrument has not increased significantly since initial recognition. The Company measures the loss allowance for expected credit losses on trade receivables that are within the scope of IFRS 15 and on financial instruments for which the credit risk has increased significantly since initial recognition based on lifetime expected credit losses. Otherwise, the Company measures the loss allowance at an amount equal to 12-month expected credit losses at the current reporting date. Prior to the effective date and adoption of IFRS 9, the financial assets of the Company were classified into the following categories: financial assets at fair value through profit or loss, and loans and receivables. The classification depended on the purpose for which the financial assets were acquired, also, prior to the adoption of IFRS 9, the Company assessed at December 31, 2017 whether there is any objective evidence that a financial asset or group of financial assets was impaired. k. Financial liabilities Financial liabilities are initially recognized at their fair value minus, in the case of a financial liability not at fair value through profit or loss, transaction costs that are directly attributable to the issue of the financial liability. Financial liabilities are subsequently measured at amortized cost, except for derivative financial instruments, which are subsequently measured at fair value through profit or loss. Financial liabilities are classified as current liabilities if payment is due within one year or less, otherwise they are classified as non-current liabilities. The Company’s financial liabilities at amortized cost are included in accounts payable, accrued expenses and other current liabilities and payable in respect of intangible asset. The derivative financial instruments represent warrants that confer the right to net share settlement. The Company removes a financial liability (or a part of a financial liability) from its Statement of Financial Position when, and only when, it is extinguished (when the obligation specified in the contract is discharged, canceled or expired). The Company accounts for a substantial modification of the terms of an existing financial liability or a part of it as an extinguishment of the original financial liability and the recognition of a new financial liability. The difference between the carrying amount of a financial liability (or part of a financial liability) extinguished and the consideration paid, including any non-cash assets transferred or liabilities assumed, is recognized in profit or loss. l. 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. m. 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 as well as the Company’s practice, require the Company to pay severance pay and/or pensions to employees dismissed or retired, in certain circumstances. The Company has a severance pay plan in accordance with Section 14 of the Israeli Severance Pay Law which is 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 the related payments to employees’ service in 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 expenses and liability for vacation and recreation pay based on the benefit accumulated by each employee. n. Share-based payments The Company operates several 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 non-market 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. o. 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 deficit 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 as it satisfies its performance obligation over time, in an amount equal to the consideration to which 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 a third 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 connection with the commercialization of EnteraGam ® , the Company is determined to be the principal in the arrangement, rather than an agent of Entera Health Inc. (“Entera Health”), since the Company controls the product before transferring it to a customer. Therefore, revenue in the amount the Company is entitled to receive from its customers is recognized on a gross basis, from which royalties payable to Entera Health are 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 (upon delivery). The transaction price in these arrangements is the consideration to which the Company expects to be entitled 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. The Company estimates its variable consideration using the most likely amount method using actual in-market data received pre- and post- end of the accounting period and are 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. Variable payments, contingent on achieving additional milestones, are included in the transaction price based on most likely amount method. Amounts included in the transaction price are recognized only when it is highly probable that a significant reversal of cumulative revenues will not occur, usually upon achievement of a specific milestone, in accordance with the relevant agreement. Sales-based royalties are not included in the transaction price; rather they are recognized as the related sale occurs, 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 since the amortization period of the asset that the Company otherwise would have recognized would have been for less than one year. These costs are recorded as selling and marketing expenses. p. Advertising and promotional expenses Advertising and promotional costs include, among others, distribution of free samples of the commercialized products. These costs are recognized as an expense when incurred. q. 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. r. 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. s. 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 these financial statements. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantially enacted by the date of the Statements of Financial Position 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. t. 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. 16 “Leases” (hereafter - IFRS 16) IFRS 16 was issued in January 2016. It will result in almost all leases being recognized on the balance sheet by lessees, as the distinction between operating and finance leases is removed. Under the new standard, an asset (the right to use the leased item) and a financial liability to pay rentals are recognized. The only exceptions are short-term and low-value leases. The Company has reviewed all of the Company’s and its subsidiary’s leasing arrangements over the last year in light of the new lease accounting rules in IFRS 16. The standard will affect primarily the accounting for the Company’s operating leases. As at the reporting date, the Company has non-cancellable operating lease commitments of $1.8 million, see note 13b. The Company expects to recognize right-of-use assets and lease liabilities of approximately $1.7 million on January 1, 2019. The Company will apply the standard from its mandatory adoption date of January 1, 2019. The Company intends to apply the simplified transition approach and will not restate comparative amounts for the year prior to first adoption. The Company expects that net loss will increase by an immaterial amount for 2019 as a result of adopting the new rules. Operating cash flows for 2019 will increase, and financing cash flows will decrease by approximately $0.9 million as repayment of the principal portion of the lease liabilities will be classified as cash flows from financing activities.

CRITICAL ACCOUNTING ESTIMATES A

CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS	12 Months Ended
	Dec. 31, 2018
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, 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 with respect to impairment of intangible assets. The Company reviews once a year or when indications of impairment are present, whether research and development related 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 the potential market, market competition and timetables for regulatory approvals.

FINANCIAL INSTRUMENTS AND FINAN

FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT	12 Months Ended
	Dec. 31, 2018
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT	NOTE 4 - FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT: 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”). 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 corporate bonds portfolio is invested in a single bond issuer. (a) Market risks The Company might be exposed to foreign exchange risk as a result of its payments to employees and 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 $58,,000 $56,000 and $78,000 in profit or loss for the years ended, December 31, 2018, 2017 and 2016, 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 23b. (c) Liquidity risk Prudent liquidity risk management requires maintaining sufficient cash or 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, 2018, 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 yet been generated, the Company is exposed to liquidity risk. As of December 31, 2018, the Company’s non-derivative financial liabilities, include accounts payable, accrued expenses, and other current liabilities 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); and · 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 the 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 of an instrument are observable, then 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, 2018: Assets - Financial assets at fair value through profit or loss 15,909 — 15,909 Liabilities - Derivative financial instruments — 344 344 December 31, 2017: Assets - Financial assets at fair value through profit or loss 16,587 — 16,587 Liabilities - Derivative financial instruments — 448 448 The following table presents the change in derivative liabilities measured at level 3 for the years ended December 31, 2018 and 2017: Derivative financial instruments Year Ended December 31, 2018 2017 U.S. dollars in thousands Balance at beginning of the year 448 6,155 Exercise of derivative into shares — (20) Fair value adjustments recognized in profit or loss (104) (5,687) Balance at end of the year 344 448 The fair value of the above-mentioned derivative financial instruments 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 derivative financial instruments, see note 16.

CASH, CASH EQUIVALENTS AND BANK

CASH, CASH EQUIVALENTS AND BANK DEPOSITS	12 Months Ended
	Dec. 31, 2018
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, 2018 2017 U.S. dollars in thousands Cash in bank 7,736 8,305 Short-term bank deposits 21,269 8,150 29,005 16,455 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 2.03%.

FINANCIAL ASSETS AT FAIR VALUE

FINANCIAL ASSETS AT FAIR VALUE THROUGH PROFIT OR LOSS	12 Months Ended
	Dec. 31, 2018
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, 2018 represent a portfolio of marketable debt securities. The Company’s business model regarding this portfolio is to realize cash flows through the sale of its assets, rather than hold these assets to collect their contractual cash flows or both to collect contractual cash flows and to sell these financial assets. The Company is primarily focused on fair value information and uses that information to assess the assets’ performance and to make decisions. Therefore, this portfolio is classified 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, 2018
PREPAID EXPENSES AND OTHER RECEIVABLES
PREPAID EXPENSES AND OTHER RECEIVABLES	NOTE 7 - PREPAID EXPENSES AND OTHER RECEIVABLES: December 31, 2018 2017 U.S. dollars in thousands Advance to suppliers 1,319 2,426 Discount from service provider 241 537 Prepaid expenses 120 130 Government institutions 196 197 1,876 3,290 The fair value of other receivables, which constitute of financial assets, approximates their carrying amount.

INVENTORY

INVENTORY	12 Months Ended
	Dec. 31, 2018
INVENTORY
INVENTORY	NOTE 8 - INVENTORY: December 31, 2018 2017 U.S. dollars in thousands Raw materials 507 — Finished goods 262 653 769 653 During the years ended December 31, 2018 and 2017, the Company recognized amounts of $1 million and $0.8 million, respectively, in inventory cost as part of cost of revenues.

FIXED ASSETS

FIXED ASSETS	12 Months Ended
	Dec. 31, 2018
FIXED ASSETS
FIXED ASSETS	NOTE 9- FIXED ASSETS: The composition of assets and accumulated depreciation grouped by major classifications: Cost Accumulated depreciation Depreciated balance December 31 December 31 December 31 2018 2017 2018 2017 2018 2017 U.S. dollars in thousands Office furniture and equipment (including computers) 372 349 235 163 137 186 Leasehold improvements 132 132 106 88 26 44 504 481 341 251 163 230

INTANGIBLE ASSETS

INTANGIBLE ASSETS	12 Months Ended
	Dec. 31, 2018
INTANGIBLE ASSETS
INTANGIBLE ASSETS	NOTE 10 - 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, 2018 2017 U.S. dollars in thousands Cost: Balance at beginning of year 5,285 6,195 Additions during the year 35 35 Deductions during the year — (945) Balance at end of year 5,320 5,285 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 non-core therapeutic candidate that was intended to treat congestive heart failure, left atrium dysfunction and high blood pressure. In February 2017, the Company recognized a loss in the amount of $45,000 paid to a private German company for the exclusive option to acquire rights to an oncology therapeutic candidate. As the Company did not exercise or extend its option to acquire these rights, 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 a loss in the 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 3 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 13.

LIABILITY FOR EMPLOYEE RIGHTS U

LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT	12 Months Ended
	Dec. 31, 2018
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT	NOTE 11 - 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 2018, 2017 and 2016 were $182,000, $155,000 and $121,000, respectively.

ACCRUED EXPENSES AND OTHER CURR

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES	12 Months Ended
	Dec. 31, 2018
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES	NOTE 12 - ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: December 31, 2018 2017 U.S. dollars in thousands Accrued expenses 5,599 4,969 Employees and related liabilities 1,380 1,045 Government institutions 78 11 7,057 6,025 The fair value of the accounts payable and accrued expense balances approximates their carrying amounts.

COMMITMENTS

COMMITMENTS	12 Months Ended
	Dec. 31, 2018
COMMITMENTS
COMMITMENTS	NOTE 13 - COMMITMENTS: a. Agreements to purchase intellectual property 1) On August 11, 2010, the Company entered into an agreement with private 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, as amended, 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 that may be generated from the sale and sublicense of the therapeutic candidates, less certain deductible amounts, as detailed in the agreement. Such potential payments are due until termination or expiration of the last of the patents transferred to the Company pursuant to the agreement (each on a product-by-product basis). In 2014, the Company entered into a licensing agreement with Salix Pharmaceuticals, Ltd., which was later acquired by Valeant Pharmaceuticals International, Inc. and subsequently renamed to Bausch Health Companies Inc. (“Bausch Health”) , pursuant to which Bausch Health licensed from the Company the exclusive worldwide rights to one of the above-mentioned therapeutic candidates. Under the license agreement, Bausch Health paid an upfront payment of $7 million with subsequent potential milestone payments up to a total of $5 million. In March 2018, the 2014 license agreement was amended, among other things, to increase the lower end of the range of potential royalty payments to be paid to the Company on net sales from low single digits to high single digits, such that the total potential royalties payments will range from high single digits up to low double digits. Following the execution of the 2014 license agreement, the Company recognized revenues in 2014 in the amount of the upfront payment and subsequently paid the Australian company an additional amount of $1 million. The additional amount paid was recognized as cost of revenues in the Statement of Comprehensive Loss. Through December 31, 2018, the Company has paid the Australian company in total $1.5 million, as mentioned above. 2) 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 a therapeutic candidate. Under the terms of the agreement, the Company paid the German company an upfront payment 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 and 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, 2018, the Company has paid the German company only the initial amount mentioned above. 3) Following an amendment to the agreement from February 2018, during December 2018 the Company elected to convert the current payment of the remaining $0.5 million into increased future potential royalty payments. As of December 31, 2018, the Company recognized an amount of $0.5 million as a non-current liability with respect to the increase in potential royalty payments. b. Operating lease agreements The Company and its subsidiary lease offices and vehicles under non-cancellable operating leases expiring within two to five years. The office and vehicle obligations are payable as follows: December 31, 2018 U.S. dollars in thousands Less than 1 year 994 2-5 years 853 1,847 As of December 31, 2018, an amount of $140,000 was deposited with a bank to secure the lease obligations. In January 2019, the Company signed an amendment to its Israeli office lease agreement. According to the amendment, the Company obliged to lease the offices through January 31, 2026 for an annual lease amount of approximately $0.4 million.

INCOME TAX

INCOME TAX	12 Months Ended
	Dec. 31, 2018
INCOME TAX
INCOME TAX	NOTE 14 - 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 2018, 2017 and 2016 were 23%, 24% and 25%, respectively. b. U.S. subsidiary The Company’s subsidiary is incorporated in the U.S and is taxed under U.S. tax laws. The applicable corporate tax rate in 2017 was 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, 2018, the Company had net operating losses carried forward (“NOLs”) of approximately $135 million. Under Israeli tax laws, carry forward tax losses have no expiration date. As of December 31, 2018, the U.S. subsidiary had net operating losses carried forward of approximately $18 million, of which approximately $10 million which expires in 2037, and approximately $8 million which does not expire, but is limited to offset 80% of the net income in the year it is utilized. 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, 2018 and 2017, were $27 million and $28 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 2013 are therefore considered final.

EQUITY

EQUITY	12 Months Ended
	Dec. 31, 2018
EQUITY
EQUITY	NOTE 15 - 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, 2018 2017 In thousands Authorized 600,000 300,000 Issued and paid 283,687 212,729 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, 2018 was $5.55 per ADS on the NASDAQ and $0.54 per share on the TASE (based on the exchange rate reported by the Bank of Israel for that date). On May 2, 2018, a general meeting of the Company’s shareholders approved the increase of the authorized share capital of the Company to 600,000,000 ordinary shares. 2) Exercise of warrants and options During 2018 and 2017, the Company issued 719,374 and 2,988,750 ordinary shares for $0.4 million and $0.8 million, respectively, resulting from exercises of options that had been issued to employees, consultants and directors of the Company. 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 January 2017, the underwriters for the Company’s December 2016 underwritten public offering partially exercised their option and purchased 133,103 ADSs for approximately $1.28 million. Following the partial exercise of the underwriters’ option, the underwritten public offering and the concurrent registered direct offering totaled 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. 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. 5) 6) In December 2018, the Company completed an underwritten offering in the U.S. of an aggregate 2,857,143 ADSs, each representing ten of its ordinary shares, for gross proceeds to the Company of approximately $20 million. Net proceeds to the Company from the offering, following underwriting commissions and other offering expenses, were approximately $18.4 million a. Warrants In January 2017, warrants issued under investment agreements from January 21, 2014, that were exercisable into 4,183,496 ordinary shares, expired along with any right or claim of the holders.

DERIVATIVE FINANCIAL INSTRUMENT

DERIVATIVE FINANCIAL INSTRUMENTS	12 Months Ended
	Dec. 31, 2018
DERIVATIVE FINANCIAL INSTRUMENTS
DERIVATIVE FINANCIAL INSTRUMENTS	NOTE 16 - DERIVATIVE FINANCIAL INSTRUMENTS: a. Warrants issued in 2014 The warrants were classified as a financial liability due to a net settlement provision. In January 2017, the Company issued 2,526,320 ordinary shares for approximately $2.63 million resulting from exercises of these warrants. 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 December 2016 offering, 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, 2018, was computed based on the price of an ADS as of December 31, 2018 and based on the following parameters: risk-free interest rate of 2.63% and an average standard deviation of 60.55%.

SHARE-BASED PAYMENTS

SHARE-BASED PAYMENTS	12 Months Ended
	Dec. 31, 2018
SHARE-BASED PAYMENTS
SHARE-BASED PAYMENTS	NOTE 17 - 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, 2018, the Award Plan allows the Company to allocate up to 38,518,375 options to employees, consultants and directors and are 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 2018: 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 to To directors ordinary grant in U.S. dollars Date of grant directors (1) (1)(2) Total share ($) in thousands (3) January 2018 1,455,000 — 1,455,000 0.56 433 March 2018 3,210,000 — 3,210,000 0.65 808 May 2018 — 500,000 500,000 0.65 111 August 2018 630,000 — 630,000 0.84 238 November 2018 210,000 — 210,000 0.90 102 5,505,000 500,000 6,005,000 1,692 1 The options include both options exercisable into the Company’s ordinary shares and options exercisable to the Company’s ADSs. 2) The general meeting of the Company’s shareholders held on May 2, 2018 (the “May 2018 AGM”), subsequent to approval of the Company’s Board of Directors, granted 500,000 options under the Company’s stock options plan to the Company's Chairman of the Board of Directors and Chief Executive Officer. 3) 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: $0.48 - $0.88, expected volatility: 50.99% - 58.4%, risk-free interest rate: 2.65% - 3.19% 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 in based on the historical volatility of the Company’s share. b. During 2018, the Board of Directors approved a three years extension of the exercise period of fully-vested options exercisable into the Company's ordinary shares granted to employees and consultants that were originally scheduled to expire in February 2018, March 2018, August 2018, January 2019 and February 2019. Accordingly, 2,844,210 options, 120,000 options, 260,000 options, 750,000 options and 400,000 options, respectively, were extended with new terms: the exercise price will increase by 50% to $0.75, $1.575, $1.035, $1.08 and $1.08 per ordinary share, respectively, and will not be exercisable within one year of the extension. These options originally had a term of seven years. The total incremental fair value of the options as of the date of the extension was approximately $0.4 million and was recorded to the Statement of Comprehensive Loss immediately. a. The May 2018 AGM, subsequent to approval of the Company’s Board of Directors, granted three year extensions of the exercise period of 1,540,000 fully-vested options exercisable into the Company's ordinary shares and 150,000 fully-vested options exercisable into the Company's ordinary shares granted to the Company's Chairman of the Board of Directors and Chief Executive Officer and to a non-executive director of the Company, respectively, that were originally scheduled to expire in February 2018 and May 2018, respectively. These options originally had a term of seven years, and the extensions are under the same terms as detailed in b above. The total incremental fair value of the options on the date of May 2018 AGM was $0.1 million and was recorded to the Statements of Comprehensive Loss immediately. In December 2018, the Board of Directors of the Company also approved the extension of the exercise period of 600,000 options to the Company's Chief Executive Officer that were originally scheduled to expire in February 2019, under the same terms detailed above, subject to the approval of the Company’s shareholders. These options also originally had a term of seven years. d. The following is information on options granted in 2017: Number of options granted According to the Award Plan Exercise Fair value of of the Company price for 1 options on date of Other than to ordinary grant in U.S. dollars Date of grant directors (1) To directors (1) Total share ($) in 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 directors, 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 directors, 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 - $1.09, expected volatility: 49.48% - 58.09%, risk-free interest rate: 2.05% - 2.23% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates. The expected volatility assumption used is based on the historical volatility of the Company’s share. e. Changes in the number of options and weighted averages of exercise prices are as follows: Year Ended December 31, 2018 2017 Weighted Weighted average of average of Number of exercise Number of exercise options price ($) options price ($) Outstanding at beginning of year 25,781,798 1.05 22,025,548 0.95 Exercised (719,374) 0.02 (2,988,750) 0.27 Expired and forfeited (1,707,189) 0.96 (490,000) 1.37 Granted 6,005,000 0.66 7,235,000 1.05 Outstanding at end of year 29,360,235 1.05 25,781,798 1.05 Exercisable at end of year 12,962,574 1.25 16,842,697 0.99 f. The following is information about the exercise price and remaining useful life of outstanding options at year-end: December 31, 2018 2017 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 29,360,235 $0.56-$1.61 4.3 25,781,798 $0.5-$1.61 3.5 g. Expenses recognized in profit or loss for the options are as follows: Year Ended December 31, 2018 2017 2016 U.S. dollars in thousands 2,235 1,679 The remaining compensation expenses as of December 31, 2018 are $1.8 million and will be expensed in full by December 2022. 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, 2018
NET REVENUES
NET REVENUES	NOTE 18 – NET REVENUES: Year Ended December 31, 2018 2017 2016 U.S dollars in thousands Licensing — — 100 Commercialization of product 4,671 3,240 — Promotional services 3,689 767 — Other revenues 1 8,360 4,007 101 In 2018 and 2017, revenues consist solely revenues with respect to commercialization and promotional activities of the company’s commercial products, as detailed in note 1a(2).

RESEARCH AND DEVELOPMENT EXPENS

RESEARCH AND DEVELOPMENT EXPENSES, net	12 Months Ended
	Dec. 31, 2018
RESEARCH AND DEVELOPMENT EXPENSES, net.
RESEARCH AND DEVELOPMENT EXPENSES, net	NOTE 19 - RESEARCH AND DEVELOPMENT EXPENSES, net: Year Ended December 31, 2018 2017 2016 U.S. dollars in thousands Payroll and related expenses 552 653 652 Professional services 2,297 2,218 1,816 Share-based payments 872 793 841 Clinical and pre-clinical trials 20,373 27,940 20,732 Intellectual property development 290 401 428 Other 478 964 772 24,862 32,969 25,241

SELLING, MARKETING AND BUSINESS

SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES	12 Months Ended
	Dec. 31, 2018
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES	NOTE 20 – SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES: Year Ended December 31, 2018 2017 2016 U.S. dollars in thousands Payroll and related expenses 7,540 5,012 301 Share-based payments 575 387 65 Professional services 1,626 1,778 947 Samples — 1,569 — Travel and related expenses 1,822 2,236 81 Office-related expenses 495 395 86 Other 428 637 75 12,486 12,014 1,555

GENERAL AND ADMINISTRATIVE EXPE

GENERAL AND ADMINISTRATIVE EXPENSES	12 Months Ended
	Dec. 31, 2018
GENERAL AND ADMINISTRATIVE EXPENSES
GENERAL AND ADMINISTRATIVE EXPENSES	NOTE 21 – GENERAL AND ADMINISTRATIVE EXPENSES: Year Ended December 31, 2018 2017 2016 U.S. dollars in thousands Payroll and related expenses 3,880 3,311 1,082 Share-based payments 1,231 1,054 773 Professional services 1,461 2,246 1,391 Office-related expenses 547 567 300 Other 387 847 302 7,506 8,025 3,848

FINANCIAL INCOME, net

FINANCIAL INCOME, net	12 Months Ended
	Dec. 31, 2018
FINANCIAL INCOME, net
FINANCIAL INCOME, net	NOTE 22- FINANCIAL INCOME, net: Year Ended December 31, 2018 2017 2016 U.S dollars in thousands Financial income: Fair value gains on derivative financial instruments 104 5,687 1,152 Gains on financial assets at fair value through profit or loss 295 189 80 Gains from changes in exchange rates — 332 34 Interest from bank deposits 279 297 282 678 6,505 1,548 Financial expenses: Loss from changes in exchange rates 125 — — Issuance cost with respect of warrants — — 368 Other 42 77 7 167 77 375 Financial income, net (511) (6,428) (1,173)

SEGMENT INFORMATION

SEGMENT INFORMATION	12 Months Ended
	Dec. 31, 2018
SEGMENT INFORMATION
SEGMENT INFORMATION	NOTE 23 – SEGMENT INFORMATION 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 revenues, gross profit and operating expenses 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, Year Ended December 31, 2018 2017 December 31, 2018: Commercial Operations Research and Development Consolidated Commercial Operations Research and Development Consolidated U.S. dollars in thousands U.S. dollars in thousands Net revenues 8,360 — 8,360 4,007 — 4,007 Cost of revenues 2,837 — 2,837 2,126 — 2,126 Gross profit 5,523 — 5,523 1,881 — 1,881 Research and development expenses, net — 24,862 24,862 — 32,969 32,969 Selling, marketing and business development expenses 11,329 1,157 12,486 10,520 1,494 12,014 General and administrative expenses 2,795 4,711 7,506 2,680 5,345 8,025 Other expenses — — — — 845 845 Operating loss 8,601 30,730 39,331 11,319 40,653 51,972 b. Major customers The percentages of total net revenues for the year ended December 31, 2018 and the year ended December 31, 2017 from one customer were 46% and 59%, respectively and from another customer were 42% and 19% respectively. 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, 2018
LOSS PER ORDINARY SHARE
LOSS PER ORDINARY SHARE	NOTE 24- 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 basic loss per share: Year Ended December 31, 2018 2017 2016 Loss (U.S. dollars in thousands) 38,820 45,544 29,370 Weighted average number of ordinary shares outstanding during the period (in thousands) 231,204 176,579 128,514 Basic loss per share (U.S. dollars) 0.17 0.26 0.23 b. Diluted Diluted loss per share is calculated by adjusting the weighted average number of ordinary shares outstanding, assuming conversion of all potentially dilutive ordinary shares, using the treasury stock method. The Company has two categories of potentially dilutive 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 and 2018, the effect of warrants is anti-dilutive. Year Ended December 31, 2018 2017 2016 Loss (U.S. dollars in thousands) 38,820 45,544 29,370 Adjustment for financial income of warrants — — 1,208 Loss used to determine diluted loss per share 38,820 45,544 30,578 Weighted average number of ordinary shares outstanding during the period (in thousands) 231,204 176,579 128,514 Adjustment for warrants — — 295 Weighted average number of ordinary shares for diluted loss per share (in thousands) 231,204 176,579 128,809 Diluted loss per share (U.S. dollars) 0.17 0.26 0.24

RELATED PARTIES

RELATED PARTIES	12 Months Ended
	Dec. 31, 2018
RELATED PARTIES
RELATED PARTIES	NOTE 25 - RELATED PARTIES: a. Key management in 2018 includes members of the Board of Directors and the Chief Executive Officer Year Ended December 31, 2018 2017 2016 U.S. dollars in thousands Key management compensation: Salaries and other short-term employee benefits 734 677 576 Post-employment benefits 36 35 32 Share-based payments 510 557 504 Other long-term benefits 26 7 11 b. Balances with related parties: December 31, 2018 2017 U.S. dollars in thousand Current liabilities - Credit balance in “accrued expenses and other current liabilities” 178 199 Non-current liabilities - Derivative financial instruments 8 11

EVENTS SUBSEQUENT TO DECEMBER 3

EVENTS SUBSEQUENT TO DECEMBER 31, 2018	12 Months Ended
	Dec. 31, 2018
EVENTS SUBSEQUENT TO DECEMBER 31, 2018
EVENTS SUBSEQUENT TO DECEMBER 31, 2018	NOTE 26 – EVENT SUBSEQUENT TO DECEMBER 31, 2018: On February 25, 2019, the Board of Directors of the Company approved a grant of 178,000 options to purchase ADSs to employees of the Company’s subsidiary and 100,000 options to purchase ordinary shares to advisory board members and an employee of the Company, under the Company’s stock options plan. The estimated fair value of the options on the grant date was $0.8 million.

SUMMARY OF SIGNIFICANT ACCOUN_2

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	12 Months Ended
	Dec. 31, 2018
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, 2018 and 2017 and for each of the three years for the period ended on December 31, 2018 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 transactions and balances 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 and its subsidiary operate (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 Shekel (“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 the amount of consideration that is unconditional, unless they contain significant financing components. 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 held for sale in the ordinary course of business, in the process of production for a sale in the ordinary course of business or materials or supplies to be used in the production process, to the extent they are recoverable. 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 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 asset 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: % Computer 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, 2018, 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 Statements of Financial Position.
Financial assets	j. Financial assets As of January 1, 2018, the Company adopted IFRS 9 “Financial Instruments” . 1) Classification The financial assets of the Company are classified into the following categories: financial assets at fair value through profit or loss, and financial assets at amortized cost. The classification is done on the basis of the Company’s business model for managing the financial asset and the contractual cash flow characteristics of the financial asset. a) Financial assets at amortized cost Financial assets at amortized cost are assets held within a business model whose objective is to hold assets in order to collect contractual cash flows and the contractual terms of the financial asset give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding. Financial assets at amortized cost 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). Financial assets at amortized cost of the Company are included in trade receivables, other receivables and bank deposits in the Statements of Financial Position. b) Financial assets at fair value through profit or loss Financial assets at fair value through profit or loss of the Company are assets not measured at amortized cost in accordance with (1)(a) above. 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. 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, except for trade receivables, that are recognized initially at the amount of consideration that is unconditional unless they contain significant financing components. Financial assets measured at fair value through profit or loss are initially recognized at fair value, related 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. Financial assets at amortized cost 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”. 3) Impairment The Company recognizes a loss allowance for expected credit losses on financial assets at amortized cost. At each reporting date, the Company assesses whether the credit risk on a financial instrument has increased significantly since initial recognition. If the financial instrument is determined to have low credit risk at the reporting date, the Company assumes that the credit risk on a financial instrument has not increased significantly since initial recognition. The Company measures the loss allowance for expected credit losses on trade receivables that are within the scope of IFRS 15 and on financial instruments for which the credit risk has increased significantly since initial recognition based on lifetime expected credit losses. Otherwise, the Company measures the loss allowance at an amount equal to 12-month expected credit losses at the current reporting date. Prior to the effective date and adoption of IFRS 9, the financial assets of the Company were classified into the following categories: financial assets at fair value through profit or loss, and loans and receivables. The classification depended on the purpose for which the financial assets were acquired, also, prior to the adoption of IFRS 9, the Company assessed at December 31, 2017 whether there is any objective evidence that a financial asset or group of financial assets was impaired.
Financial liabilities	k. Financial liabilities Financial liabilities are initially recognized at their fair value minus, in the case of a financial liability not at fair value through profit or loss, transaction costs that are directly attributable to the issue of the financial liability. Financial liabilities are subsequently measured at amortized cost, except for derivative financial instruments, which are subsequently measured at fair value through profit or loss. Financial liabilities are classified as current liabilities if payment is due within one year or less, otherwise they are classified as non-current liabilities. The Company’s financial liabilities at amortized cost are included in accounts payable, accrued expenses and other current liabilities and payable in respect of intangible asset. The derivative financial instruments represent warrants that confer the right to net share settlement. The Company removes a financial liability (or a part of a financial liability) from its Statement of Financial Position when, and only when, it is extinguished (when the obligation specified in the contract is discharged, canceled or expired). The Company accounts for a substantial modification of the terms of an existing financial liability or a part of it as an extinguishment of the original financial liability and the recognition of a new financial liability. The difference between the carrying amount of a financial liability (or part of a financial liability) extinguished and the consideration paid, including any non-cash assets transferred or liabilities assumed, is recognized in profit or loss.
Share capital	l. 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	m. 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 as well as the Company’s practice, require the Company to pay severance pay and/or pensions to employees dismissed or retired, in certain circumstances. The Company has a severance pay plan in accordance with Section 14 of the Israeli Severance Pay Law which is 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 the related payments to employees’ service in 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 expenses and liability for vacation and recreation pay based on the benefit accumulated by each employee.
Share-based payments	n. Share-based payments The Company operates several 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 non-market 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	o. 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 deficit 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 as it satisfies its performance obligation over time, in an amount equal to the consideration to which 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 a third 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 connection with the commercialization of EnteraGam ® , the Company is determined to be the principal in the arrangement, rather than an agent of Entera Health Inc. (“Entera Health”), since the Company controls the product before transferring it to a customer. Therefore, revenue in the amount the Company is entitled to receive from its customers is recognized on a gross basis, from which royalties payable to Entera Health are 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 (upon delivery). The transaction price in these arrangements is the consideration to which the Company expects to be entitled 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. The Company estimates its variable consideration using the most likely amount method using actual in-market data received pre- and post- end of the accounting period and are 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. Variable payments, contingent on achieving additional milestones, are included in the transaction price based on most likely amount method. Amounts included in the transaction price are recognized only when it is highly probable that a significant reversal of cumulative revenues will not occur, usually upon achievement of a specific milestone, in accordance with the relevant agreement. Sales-based royalties are not included in the transaction price; rather they are recognized as the related sale occurs, 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 since the amortization period of the asset that the Company otherwise would have recognized would have been for less than one year. These costs are recorded as selling and marketing expenses.
Advertising and promotional expenses	p. Advertising and promotional expenses Advertising and promotional costs include, among others, distribution of free samples of the commercialized products. These costs are recognized as an expense when incurred.
Leases	q. 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	r. 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	s. 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 these financial statements. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantially enacted by the date of the Statements of Financial Position 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	t. 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. 16 “Leases” (hereafter - IFRS 16) IFRS 16 was issued in January 2016. It will result in almost all leases being recognized on the balance sheet by lessees, as the distinction between operating and finance leases is removed. Under the new standard, an asset (the right to use the leased item) and a financial liability to pay rentals are recognized. The only exceptions are short-term and low-value leases. The Company has reviewed all of the Company’s and its subsidiary’s leasing arrangements over the last year in light of the new lease accounting rules in IFRS 16. The standard will affect primarily the accounting for the Company’s operating leases. As at the reporting date, the Company has non-cancellable operating lease commitments of $1.8 million, see note 13b. The Company expects to recognize right-of-use assets and lease liabilities of approximately $1.7 million on January 1, 2019. The Company will apply the standard from its mandatory adoption date of January 1, 2019. The Company intends to apply the simplified transition approach and will not restate comparative amounts for the year prior to first adoption. The Company expects that net loss will increase by an immaterial amount for 2019 as a result of adopting the new rules. Operating cash flows for 2019 will increase, and financing cash flows will decrease by approximately $0.9 million as repayment of the principal portion of the lease liabilities will be classified as cash flows from financing activities

SUMMARY OF SIGNIFICANT ACCOUN_3

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)	12 Months Ended
	Dec. 31, 2018
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Schedule of estimated useful lives of fixed assets	% Computer equipment 33 Office furniture and equipment 8-15

CASH, CASH EQUIVALENTS AND BA_2

CASH, CASH EQUIVALENTS AND BANK DEPOSITS (Tables)	12 Months Ended
	Dec. 31, 2018
CASH, CASH EQUIVALENTS AND BANK DEPOSITS
Schedule of cash and cash equivalents	December 31, 2018 2017 U.S. dollars in thousands Cash in bank 7,736 8,305 Short-term bank deposits 21,269 8,150 29,005 16,455

FINANCIAL INSTRUMENTS AND FIN_2

FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (Tables)	12 Months Ended
	Dec. 31, 2018
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, 2018: Assets - Financial assets at fair value through profit or loss 15,909 — 15,909 Liabilities - Derivative financial instruments — 344 344 December 31, 2017: Assets - Financial assets at fair value through profit or loss 16,587 — 16,587 Liabilities - Derivative financial instruments — 448 448
Schedule of change in derivative liabilities measured at Level 3	Derivative financial instruments Year Ended December 31, 2018 2017 U.S. dollars in thousands Balance at beginning of the year 448 6,155 Exercise of derivative into shares — (20) Fair value adjustments recognized in profit or loss (104) (5,687) Balance at end of the year 344 448

PREPAID EXPENSES AND OTHER RE_2

PREPAID EXPENSES AND OTHER RECEIVABLES (Tables)	12 Months Ended
	Dec. 31, 2018
PREPAID EXPENSES AND OTHER RECEIVABLES
Schedule of prepaid expenses and other receivables	December 31, 2018 2017 U.S. dollars in thousands Advance to suppliers 1,319 2,426 Discount from service provider 241 537 Prepaid expenses 120 130 Government institutions 196 197 1,876 3,290

INVENTORY (Tables)

INVENTORY (Tables)	12 Months Ended
	Dec. 31, 2018
INVENTORY
Schedule of Inventory	December 31, 2018 2017 U.S. dollars in thousands Raw materials 507 — Finished goods 262 653 769 653

FIXED ASSETS (Tables)

FIXED ASSETS (Tables)	12 Months Ended
	Dec. 31, 2018
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 2018 2017 2018 2017 2018 2017 U.S. dollars in thousands Office furniture and equipment (including computers) 372 349 235 163 137 186 Leasehold improvements 132 132 106 88 26 44 504 481 341 251 163 230

INTANGIBLE ASSETS (Tables)

INTANGIBLE ASSETS (Tables)	12 Months Ended
	Dec. 31, 2018
INTANGIBLE ASSETS
Schedule of intangible assets changes	Year Ended December 31, 2018 2017 U.S. dollars in thousands Cost: Balance at beginning of year 5,285 6,195 Additions during the year 35 35 Deductions during the year — (945) Balance at end of year 5,320 5,285

ACCRUED EXPENSES AND OTHER CU_2

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables)	12 Months Ended
	Dec. 31, 2018
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Schedule of accrued expenses and other current liabilities	December 31, 2018 2017 U.S. dollars in thousands Accrued expenses 5,599 4,969 Employees and related liabilities 1,380 1,045 Government institutions 78 11 7,057 6,025

COMMITMENTS (Tables)

COMMITMENTS (Tables)	12 Months Ended
	Dec. 31, 2018
COMMITMENTS
Schedule of operating lease agreements	December 31, 2018 U.S. dollars in thousands Less than 1 year 994 2-5 years 853 1,847

EQUITY (Tables)

EQUITY (Tables)	12 Months Ended
	Dec. 31, 2018
EQUITY
Schedule of composition of share capital	Number of shares December 31, 2018 2017 In thousands Authorized 600,000 300,000 Issued and paid 283,687 212,729

SHARE-BASED PAYMENTS (Tables)

SHARE-BASED PAYMENTS (Tables)	12 Months Ended
	Dec. 31, 2018
SHARE-BASED PAYMENTS
Schedule of information on options granted	a. The following is information on options granted in 2018: 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 to To directors ordinary grant in U.S. dollars Date of grant directors (1) (1)(2) Total share ($) in thousands (3) January 2018 1,455,000 — 1,455,000 0.56 433 March 2018 3,210,000 — 3,210,000 0.65 808 May 2018 — 500,000 500,000 0.65 111 August 2018 630,000 — 630,000 0.84 238 November 2018 210,000 — 210,000 0.90 102 5,505,000 500,000 6,005,000 1,692 1 The options include both options exercisable into the Company’s ordinary shares and options exercisable to the Company’s ADSs. 2) The general meeting of the Company’s shareholders held on May 2, 2018 (the “May 2018 AGM”), subsequent to approval of the Company’s Board of Directors, granted 500,000 options under the Company’s stock options plan to the Company's Chairman of the Board of Directors and Chief Executive Officer. 3) 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: $0.48 - $0.88, expected volatility: 50.99% - 58.4%, risk-free interest rate: 2.65% - 3.19% 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 in based on the historical volatility of the Company’s share. b. During 2018, the Board of Directors approved a three years extension of the exercise period of fully-vested options exercisable into the Company's ordinary shares granted to employees and consultants that were originally scheduled to expire in February 2018, March 2018, August 2018, January 2019 and February 2019. Accordingly, 2,844,210 options, 120,000 options, 260,000 options, 750,000 options and 400,000 options, respectively, were extended with new terms: the exercise price will increase by 50% to $0.75, $1.575, $1.035, $1.08 and $1.08 per ordinary share, respectively, and will not be exercisable within one year of the extension. These options originally had a term of seven years. The total incremental fair value of the options as of the date of the extension was approximately $0.4 million and was recorded to the Statement of Comprehensive Loss immediately. a. The May 2018 AGM, subsequent to approval of the Company’s Board of Directors, granted three year extensions of the exercise period of 1,540,000 fully-vested options exercisable into the Company's ordinary shares and 150,000 fully-vested options exercisable into the Company's ordinary shares granted to the Company's Chairman of the Board of Directors and Chief Executive Officer and to a non-executive director of the Company, respectively, that were originally scheduled to expire in February 2018 and May 2018, respectively. These options originally had a term of seven years, and the extensions are under the same terms as detailed in b above. The total incremental fair value of the options on the date of May 2018 AGM was $0.1 million and was recorded to the Statements of Comprehensive Loss immediately. In December 2018, the Board of Directors of the Company also approved the extension of the exercise period of 600,000 options to the Company's Chief Executive Officer that were originally scheduled to expire in February 2019, under the same terms detailed above, subject to the approval of the Company’s shareholders. These options also originally had a term of seven years. d. The following is information on options granted in 2017: Number of options granted According to the Award Plan Exercise Fair value of of the Company price for 1 options on date of Other than to ordinary grant in U.S. dollars Date of grant directors (1) To directors (1) Total share ($) in 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 directors, 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 directors, 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 - $1.09, expected volatility: 49.48% - 58.09%, risk-free interest rate: 2.05% - 2.23% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates. The expected volatility assumption used is based on the historical volatility of the Company’s share.
Schedule of number of shares and weighted averages of exercise prices	Year Ended December 31, 2018 2017 Weighted Weighted average of average of Number of exercise Number of exercise options price ($) options price ($) Outstanding at beginning of year 25,781,798 1.05 22,025,548 0.95 Exercised (719,374) 0.02 (2,988,750) 0.27 Expired and forfeited (1,707,189) 0.96 (490,000) 1.37 Granted 6,005,000 0.66 7,235,000 1.05 Outstanding at end of year 29,360,235 1.05 25,781,798 1.05 Exercisable at end of year 12,962,574 1.25 16,842,697 0.99
Schedule of information about exercise price and remaining useful life of outstanding options	December 31, 2018 2017 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 29,360,235 $0.56-$1.61 4.3 25,781,798 $0.5-$1.61 3.5
Schedule of expenses recognized in profit or loss	Year Ended December 31, 2018 2017 2016 U.S. dollars in thousands 2,235 1,679

NET REVENUES (Tables)

NET REVENUES (Tables)	12 Months Ended
	Dec. 31, 2018
NET REVENUES
Schedule of net revenues	Year Ended December 31, 2018 2017 2016 U.S dollars in thousands Licensing — — 100 Commercialization of product 4,671 3,240 — Promotional services 3,689 767 — Other revenues 1 8,360 4,007 101

RESEARCH AND DEVELOPMENT EXPE_2

RESEARCH AND DEVELOPMENT EXPENSES, net (Tables)	12 Months Ended
	Dec. 31, 2018
RESEARCH AND DEVELOPMENT EXPENSES, net.
Schedule of research and development expenses, net	Year Ended December 31, 2018 2017 2016 U.S. dollars in thousands Payroll and related expenses 552 653 652 Professional services 2,297 2,218 1,816 Share-based payments 872 793 841 Clinical and pre-clinical trials 20,373 27,940 20,732 Intellectual property development 290 401 428 Other 478 964 772 24,862 32,969 25,241

SELLING, MARKETING AND BUSINE_2

SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES (Tables)	12 Months Ended
	Dec. 31, 2018
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES
Schedule of selling, marketing and business development expenses	Year Ended December 31, 2018 2017 2016 U.S. dollars in thousands Payroll and related expenses 7,540 5,012 301 Share-based payments 575 387 65 Professional services 1,626 1,778 947 Samples — 1,569 — Travel and related expenses 1,822 2,236 81 Office-related expenses 495 395 86 Other 428 637 75 12,486 12,014 1,555

GENERAL AND ADMINISTRATIVE EX_2

GENERAL AND ADMINISTRATIVE EXPENSES (Tables)	12 Months Ended
	Dec. 31, 2018
GENERAL AND ADMINISTRATIVE EXPENSES
Schedule of general and administrative expenses	Year Ended December 31, 2018 2017 2016 U.S. dollars in thousands Payroll and related expenses 3,880 3,311 1,082 Share-based payments 1,231 1,054 773 Professional services 1,461 2,246 1,391 Office-related expenses 547 567 300 Other 387 847 302 7,506 8,025 3,848

FINANCIAL INCOME, net (Tables)

FINANCIAL INCOME, net (Tables)	12 Months Ended
	Dec. 31, 2018
FINANCIAL INCOME, net
Schedule of financial income, net	Year Ended December 31, 2018 2017 2016 U.S dollars in thousands Financial income: Fair value gains on derivative financial instruments 104 5,687 1,152 Gains on financial assets at fair value through profit or loss 295 189 80 Gains from changes in exchange rates — 332 34 Interest from bank deposits 279 297 282 678 6,505 1,548 Financial expenses: Loss from changes in exchange rates 125 — — Issuance cost with respect of warrants — — 368 Other 42 77 7 167 77 375 Financial income, net (511) (6,428) (1,173)

SEGMENT INFORMATION (Tables)

SEGMENT INFORMATION (Tables)	12 Months Ended
	Dec. 31, 2018
SEGMENT INFORMATION
Schedule of segment information	Year Ended December 31, Year Ended December 31, 2018 2017 December 31, 2018: Commercial Operations Research and Development Consolidated Commercial Operations Research and Development Consolidated U.S. dollars in thousands U.S. dollars in thousands Net revenues 8,360 — 8,360 4,007 — 4,007 Cost of revenues 2,837 — 2,837 2,126 — 2,126 Gross profit 5,523 — 5,523 1,881 — 1,881 Research and development expenses, net — 24,862 24,862 — 32,969 32,969 Selling, marketing and business development expenses 11,329 1,157 12,486 10,520 1,494 12,014 General and administrative expenses 2,795 4,711 7,506 2,680 5,345 8,025 Other expenses — — — — 845 845 Operating loss 8,601 30,730 39,331 11,319 40,653 51,972

LOSS PER ORDINARY SHARE (Tables

LOSS PER ORDINARY SHARE (Tables)	12 Months Ended
	Dec. 31, 2018
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 basic loss per share: Year Ended December 31, 2018 2017 2016 Loss (U.S. dollars in thousands) 38,820 45,544 29,370 Weighted average number of ordinary shares outstanding during the period (in thousands) 231,204 176,579 128,514 Basic loss per share (U.S. dollars) 0.17 0.26 0.23 b. Diluted Diluted loss per share is calculated by adjusting the weighted average number of ordinary shares outstanding, assuming conversion of all potentially dilutive ordinary shares, using the treasury stock method. The Company has two categories of potentially dilutive 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 and 2018, the effect of warrants is anti-dilutive. Year Ended December 31, 2018 2017 2016 Loss (U.S. dollars in thousands) 38,820 45,544 29,370 Adjustment for financial income of warrants — — 1,208 Loss used to determine diluted loss per share 38,820 45,544 30,578 Weighted average number of ordinary shares outstanding during the period (in thousands) 231,204 176,579 128,514 Adjustment for warrants — — 295 Weighted average number of ordinary shares for diluted loss per share (in thousands) 231,204 176,579 128,809 Diluted loss per share (U.S. dollars) 0.17 0.26 0.24

RELATED PARTIES (Tables)

RELATED PARTIES (Tables)	12 Months Ended
	Dec. 31, 2018
RELATED PARTIES
Schedule of key management compensation:	Year Ended December 31, 2018 2017 2016 U.S. dollars in thousands Key management compensation: Salaries and other short-term employee benefits 734 677 576 Post-employment benefits 36 35 32 Share-based payments 510 557 504 Other long-term benefits 26 7 11
Schedule of balances with related parties	December 31, 2018 2017 U.S. dollars in thousand Current liabilities - Credit balance in “accrued expenses and other current liabilities” 178 199 Non-current liabilities - Derivative financial instruments 8 11

GENERAL (Details)

GENERAL (Details)	12 Months Ended
	Dec. 31, 2018
EnteraGam [member]
General [Line Items]
Agreement Term	4 years
Donnatal and Mytesi [member] | Minimum
General [Line Items]
Agreement Term	1 year 6 months
Donnatal and Mytesi [member] | Maximum
General [Line Items]
Agreement Term	4 years

SUMMARY OF SIGNIFICANT ACCOUN_4

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) $ in Millions	Jan. 01, 2019	Dec. 31, 2018
IFRS 16
Decrease in cash flows from financing activities		$ 0.9
Forecast
IFRS 16
Recognition of right-of-use assets and lease liabilities	$ 1.7
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%

FINANCIAL INSTRUMENTS AND FIN_3

FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (Details)	12 Months Ended
	Dec. 31, 2018USD ($)item	Dec. 31, 2017USD ($)item	Dec. 31, 2016USD ($)
Financial instruments
Percentage of currency stronger against the NIS	5.00%	5.00%	5.00%
Additional expense that would have been recognized	$ 58,000	$ 56,000	$ 78,000
Financial assets at fair value through profit or loss	15,909,000	16,587,000
Fair value adjustments recognized in profit or loss	$ 104,000	$ 5,687,000	1,152,000
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 period	$ 448,000
Derivative liabilities- balance at end of the period	344,000	$ 448,000
At fair value
Financial instruments
Financial assets at fair value through profit or loss	15,909,000	16,587,000
Level 1 | At fair value
Financial instruments
Financial assets at fair value through profit or loss	15,909,000	16,587,000
Level 3 | Derivative financial instruments.
Financial instruments
Derivative liabilities- balance at beginning of the period	448,000	6,155,000
Exercise of derivative into shares		(20,000)
Fair value adjustments recognized in profit or loss	(104,000)	(5,687,000)
Derivative liabilities- balance at end of the period	$ 344,000	$ 448,000	$ 6,155,000

CASH, CASH EQUIVALENTS AND BA_3

CASH, CASH EQUIVALENTS AND BANK DEPOSITS (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Cash and Cash Equivalents [Line Items]
Cash in bank	$ 7,736	$ 8,305
Short-term bank deposits	21,269	8,150
Cash and cash equivalents	$ 29,005	$ 16,455	$ 53,786	$ 21,516
Minimum
Cash and Cash Equivalents [Line Items]
Bank deposits, term	3 months
Bank deposits, annual interest rate	2.03%
Maximum
Cash and Cash Equivalents [Line Items]
Bank deposits, term	1 year

PREPAID EXPENSES AND OTHER RE_3

PREPAID EXPENSES AND OTHER RECEIVABLES (Details) - USD ($) $ in Thousands	Dec. 31, 2018	Dec. 31, 2017
PREPAID EXPENSES AND OTHER RECEIVABLES
Advances to suppliers	$ 1,319	$ 2,426
Discount from service provider	241	537
Prepaid expenses	120	130
Government institutions	196	197
Total prepaid expenses and other receivables	$ 1,876	$ 3,290

INVENTORY (Details)

INVENTORY (Details) - USD ($) $ in Thousands	Dec. 31, 2018	Dec. 31, 2017
INVENTORY
Raw materials	$ 507
Finished goods	262	$ 653
Total current inventories	769	653
Inventories recognized as part of cost of revenues	$ 1,000	$ 800

FIXED ASSETS (Details)

FIXED ASSETS (Details) - USD ($) $ in Thousands	Dec. 31, 2018	Dec. 31, 2017
Fixed assets
Fixed assets	$ 163	$ 230
Cost
Fixed assets
Fixed assets	504	481
Accumulated depreciation
Fixed assets
Fixed assets	341	251
Office furniture and equipment (including computers)
Fixed assets
Fixed assets	137	186
Office furniture and equipment (including computers) | Cost
Fixed assets
Fixed assets	372	349
Office furniture and equipment (including computers) | Accumulated depreciation
Fixed assets
Fixed assets	235	163
Leasehold improvements
Fixed assets
Fixed assets	26	44
Leasehold improvements | Cost
Fixed assets
Fixed assets	132	132
Leasehold improvements | Accumulated depreciation
Fixed assets
Fixed assets	$ 106	$ 88

INTANGIBLE ASSETS - Changes in

INTANGIBLE ASSETS - Changes in Assets (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Reconciliation of changes in intangible assets
Balance at beginning of year	$ 5,285
Balance at end of year	5,320	$ 5,285
Cost
Reconciliation of changes in intangible assets
Balance at beginning of year	5,285	6,195
Additions during the year	35	35
Deductions during the year		(945)
Balance at end of year	$ 5,320	$ 5,285

INTANGIBLE ASSETS - Narrative (

INTANGIBLE ASSETS - Narrative (Details) - USD ($)	1 Months Ended
	Dec. 31, 2017	Feb. 28, 2017
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 RIGHTS_2

LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Details) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT
Defined contribution plans expense	$ 182,000	$ 155,000	$ 121,000

ACCRUED EXPENSES AND OTHER CU_3

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands	Dec. 31, 2018	Dec. 31, 2017
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued expenses	$ 5,599	$ 4,969
Employees and related liabilities	1,380	1,045
Government Institutions	78	11
Accrued expenses and other current liabilities	$ 7,057	$ 6,025

COMMITMENTS - Agreements to Pur

COMMITMENTS - Agreements to Purchase IP (Details)	Jun. 30, 2014USD ($)	Aug. 11, 2010USD ($)item	Dec. 31, 2014USD ($)	Dec. 31, 2018USD ($)	Mar. 30, 2015USD ($)
Australian Asset Purchase Agreement
Commitments
Number of therapeutic candidates | item		3
Upfront initial payment per agreement		$ 500,000	$ 1,000,000
Aggregate payments made				$ 1,500,000
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%
Salix Pharmaceuticals, Ltd. Agreement [Member]
Commitments
Upfront initial payment per agreement			7,000,000
Salix Pharmaceuticals, Ltd. Agreement [Member] | Maximum
Commitments
Milestones to be paid			$ 5,000,000
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
Milestones to be paid					$ 2,000,000
Aggregate payments made				$ 3,000,000	1,500,000
Revenue Milestone | U.S. Private Company Arrangement | Maximum
Commitments
Milestones to be paid					$ 2,000,000

COMMITMENTS - Operating Lease A

COMMITMENTS - Operating Lease Agreements (Details) - USD ($)	Jan. 31, 2019	Dec. 31, 2018
Operating lease
Obligations under non-cancellable operating lease		$ 1,847,000
Amount deposited with bank to secure lease obligation		$ 140,000
Minimum
Operating lease
Operating lease, term		2 years
Maximum
Operating lease
Operating lease, term		5 years
Israel | Amendment to lease agreement [member]
Operating lease
Obligations under non-cancellable operating lease	$ 400,000
Less than 1 year
Operating lease
Obligations under non-cancellable operating lease		$ 994,000
2-5 years
Operating lease
Obligations under non-cancellable operating lease		$ 853,000

INCOME TAX (Details)

INCOME TAX (Details) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Income Tax [Line Items]
Deductible temporary differences		$ 27	$ 28
Israel
Income Tax [Line Items]
Corporate tax rate		23.00%	24.00%	25.00%
Net operating losses		$ 135
U.S.
Income Tax [Line Items]
Net operating losses		18
U.S. | Forecast
Income Tax [Line Items]
Corporate tax rate	21.00%
U.S. | Net operating losses expiring in 2037 [Member]
Income Tax [Line Items]
Net operating losses		10
U.S. | Net operating losses with no expiriation [Member]
Income Tax [Line Items]
Net operating losses		$ 8

EQUITY (Details)

EQUITY (Details) $ / shares in Units, $ in Thousands	1 Months Ended					12 Months Ended
	Dec. 31, 2018USD ($)	Aug. 31, 2018USD ($)shares	Nov. 30, 2017USD ($)shares	Jan. 31, 2017USD ($)shares	Jan. 31, 2014shares	Dec. 31, 2018USD ($)	Dec. 31, 2017USD ($)shares	Dec. 31, 2016USD ($)	Dec. 31, 2018₪ / sharesshares	Dec. 31, 2018$ / sharesshares	May 02, 2018shares
Disclosure of classes of share capital [line items]
Proceeds from issuance of shares | $						$ 41,902	$ 22,216	$ 35,754
American Depository Shares
Disclosure of classes of share capital [line items]
Number of shares issued		4,166,667	4,090,909						2,857,143	2,857,143
Proceeds from issuance of shares, gross | $	$ 20,000	$ 25,000	$ 22,500
Share issue related costs | $			1,500
Proceeds from issuance of shares | $	$ 18,400	$ 23,500	$ 21,000
American Depository Shares | Underwriters
Disclosure of classes of share capital [line items]
Number of shares issued				3,846,519
Stock Options | American Depository Shares | Underwriters
Disclosure of classes of share capital [line items]
Number of shares issued				133,103
Proceeds from exercise of options | $				$ 1,280
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
Ordinary shares
Disclosure of classes of share capital [line items]
Par value per share | ₪ / shares									₪ 0.01
Authorized							300,000,000		600,000,000	600,000,000	600,000,000
Issued and paid							212,729,000		283,687,000	283,687,000
Market price per ordinary share | $ / shares										$ 5.55
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										$ 0.54
Ordinary shares | Stock Options
Disclosure of classes of share capital [line items]
Proceeds from exercise of options | $						$ 400	$ 800
Warrants
Disclosure of classes of share capital [line items]
Warrants issued					4,183,496
Warrants | Stock Options | American Depository Shares | Underwriters
Disclosure of classes of share capital [line items]
Warrants issued				2,025,458
Procceds from issuance of ordinary shares and warrants | $				$ 39,400

DERIVATIVE FINANCIAL INSTRUME_2

DERIVATIVE FINANCIAL INSTRUMENTS (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended		12 Months Ended
	Jan. 31, 2017	Dec. 31, 2016	Dec. 31, 2018	Dec. 31, 2016	Jan. 03, 2017
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 issued in 2016
Disclosure of detailed information about hedges [line items]
Warrants exercisable into number of ADSs			60.55		2,025,458
Derivative term				3 years
Risk-free interest rate		1.56%	2.63%
Average standard deviation		53.13%
Warrants exercise price		$ 13.33		$ 13.33

SHARE-BASED PAYMENTS (Details)

SHARE-BASED PAYMENTS (Details)	Dec. 31, 2018USD ($)Optionshares	May 02, 2018USD ($)	Dec. 31, 2018USD ($)Optionshares	May 31, 2018USD ($)shares	Dec. 31, 2018USD ($)Optioninstallmentshares	Dec. 31, 2017USD ($)Optioninstallmentshares
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares					6,005,000	7,235,000
Number of options granted | Option					6,005,000	7,235,000
Exercise price for 1 ordinary share ($)					$ 0.66	$ 1.05
Fair value of options on date of grant in U.S. $ thousands	$ 1,692,000		$ 1,692,000		$ 1,692,000	$ 3,499,000
Each option exercisable into number of ordinary shares, ratio | Option	12,962,574		12,962,574		12,962,574	16,842,697
January 2,018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares					1,455,000
Exercise price for 1 ordinary share ($)					$ 0.56
Fair value of options on date of grant in U.S. $ thousands	$ 433,000		$ 433,000		$ 433,000
March 2,018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares					3,210,000
Exercise price for 1 ordinary share ($)					$ 0.65
Fair value of options on date of grant in U.S. $ thousands	808,000		808,000		$ 808,000
May 2,018
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 ($)					$ 0.65
Fair value of options on date of grant in U.S. $ thousands	111,000		111,000		$ 111,000
August 2,018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares					630,000
Exercise price for 1 ordinary share ($)					$ 0.84
Fair value of options on date of grant in U.S. $ thousands	238,000		238,000		$ 238,000
November 2,018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares					210,000
Exercise price for 1 ordinary share ($)					$ 0.90
Fair value of options on date of grant in U.S. $ thousands	$ 102,000		$ 102,000		$ 102,000
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
Stock Options
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares	38,518,375
Extension of the exercise period					3 years
Stock Options | 2018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Option term						10 years
Stock Options | 2018 | Minimum
Disclosure of terms and conditions of share-based payment arrangement [line items]
Price of the Company’s ordinary share					$ 0.48
Expected volatility					50.99%
Risk free interest rate					2.65%
Stock Options | 2018 | Maximum
Disclosure of terms and conditions of share-based payment arrangement [line items]
Price of the Company’s ordinary share					$ 0.88
Expected volatility					58.40%
Risk free interest rate					3.19%
Stock Options | 2018 | 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 | 2018 | Vesting, services exceeding one year | Minimum
Disclosure of terms and conditions of share-based payment arrangement [line items]
Service period					1 year
Stock Options | 2018 | 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 | 2018 | 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 | 2018 | 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
Stock Options | 2017 | 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 | 2017 | 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%
Other than directors
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares					5,505,000	6,095,000
Other than directors | January 2018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares					1,455,000
Other than directors | March 2018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares					3,210,000
Other than directors | August 2018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares					630,000
Other than directors | November 2018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares					210,000
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 | Stock Options
Disclosure of terms and conditions of share-based payment arrangement [line items]
Exercise price increase (as a percent)					50.00%
Incremental fair value					$ 400,000
Other than directors | Stock Options | Extension of options originally scheduled to expire in February 2018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Exercise price for 1 ordinary share ($)					$ 0.75
Number of fully-vested options | shares					2,844,210
Other than directors | Stock Options | Extension of options originally scheduled to expire in March 2018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Exercise price for 1 ordinary share ($)					$ 1.575
Number of fully-vested options | shares					120,000
Other than directors | Stock Options | Extension of options originally scheduled to expire in August 2018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Exercise price for 1 ordinary share ($)					$ 1.035
Number of fully-vested options | shares					260,000
Other than directors | Stock Options | Extension of options originally scheduled to expire in January 2019
Disclosure of terms and conditions of share-based payment arrangement [line items]
Exercise price for 1 ordinary share ($)					$ 1.08
Number of fully-vested options | shares					750,000
Other than directors | Stock Options | Extension of options originally scheduled to expire in February 2019
Disclosure of terms and conditions of share-based payment arrangement [line items]
Exercise price for 1 ordinary share ($)					$ 1.08
Number of fully-vested options | shares					400,000
Other than directors | Stock Options | Minimum
Disclosure of terms and conditions of share-based payment arrangement [line items]
Vesting period					1 year
Other than directors | Stock Options | 2017
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 | 2017 | Minimum
Disclosure of terms and conditions of share-based payment arrangement [line items]
Service period						1 year
Other than directors | Stock Options | 2017 | 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 | 2017 | 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 | 2017 | 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 | 2017 | 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					500,000	1,140,000
To directors | May 2018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares					500,000
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 | Stock Options
Disclosure of terms and conditions of share-based payment arrangement [line items]
Number of options granted		500,000
Number of shares that were granted an extension | shares			600,000
Incremental fair value				$ 100,000
To directors | Stock Options | Extension of options originally scheduled to expire in February 2018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Number of fully-vested options | shares				1,540,000
To directors | Stock Options | Extension of options originally scheduled to expire in May 2018
Disclosure of terms and conditions of share-based payment arrangement [line items]
Number of fully-vested options | 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, 2018USD ($)Option	Dec. 31, 2017USD ($)Option
SHARE-BASED PAYMENTS
Number of options, outstanding at beginning of year | Option	25,781,798	22,025,548
Number of options, exercised | Option	(719,374)	(2,988,750)
Number of options, expired and forfeited | Option	(1,707,189)	(490,000)
Number of options, granted | Option	6,005,000	7,235,000
Number of options, outstanding at end of year | Option	29,360,235	25,781,798
Number of options, exercisable at end of year | Option	12,962,574	16,842,697
Weighted average of exercise price, outstanding at beginning of year | $	$ 1.05	$ 0.95
Weighted average of exercise price, exercised | $	0.02	0.27
Weighted average of exercise price, expired and forfeited | $	0.96	1.37
Weighted average of exercise price, granted | $	0.66	1.05
Weighted average of exercise price, outstanding at end of year | $	1.05	1.05
Weighted average of exercise price, exercisable at end of year | $	$ 1.25	$ 0.99

SHARE-BASED PAYMENTS - Informat

SHARE-BASED PAYMENTS - Information About Exercise Price and Remaining Useful Life of Outstanding Options (Details)	Dec. 31, 2018USD ($)YOption	Dec. 31, 2017USD ($)YOption	Dec. 31, 2016Option
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]
Number of options outstanding at end of Year | Option	29,360,235	25,781,798	22,025,548
Weighted average of remaining useful life | Y	4.3	3.5
Minimum
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]
Exercise price range	$ 0.56	$ 0.50
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, 2018	Dec. 31, 2017	Dec. 31, 2016
SHARE-BASED PAYMENTS
Expenses recognized in profit or loss	$ 2,678	$ 2,235	$ 1,679
Unrecognized compensation expenses	$ 1,800

NET REVENUES (Details)

NET REVENUES (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Revenues
Licensing			$ 100
Commercialization of product	$ 4,671	$ 3,240
Promotional services	3,689	767
Other Revenues			1
Total Net Revenues	$ 8,360	$ 4,007	$ 101

RESEARCH AND DEVELOPMENT EXPE_3

RESEARCH AND DEVELOPMENT EXPENSES, net (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Research And Development Expenses Net [Line Items]
Research and development expenses, net	$ 24,862	$ 32,969	$ 25,241
Payroll and related expenses
Research And Development Expenses Net [Line Items]
Research and development expenses, gross	552	653	652
Professional services
Research And Development Expenses Net [Line Items]
Research and development expenses, gross	2,297	2,218	1,816
Share-based payments
Research And Development Expenses Net [Line Items]
Research and development expenses, gross	872	793	841
Clinical and pre-clinical trials
Research And Development Expenses Net [Line Items]
Research and development expenses, gross	20,373	27,940	20,732
Intellectual property development
Research And Development Expenses Net [Line Items]
Research and development expenses, gross	290	401	428
Other
Research And Development Expenses Net [Line Items]
Research and development expenses, gross	$ 478	$ 964	$ 772

SELLING, MARKETING AND BUSINE_3

SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Selling Marketing And Business Development Expenses [Line Items]
Selling, marketing and business development expenses	$ 12,486	$ 12,014	$ 1,555
Payroll and related expenses
Selling Marketing And Business Development Expenses [Line Items]
Selling, marketing and business development expenses	7,540	5,012	301
Share-based payments
Selling Marketing And Business Development Expenses [Line Items]
Selling, marketing and business development expenses	575	387	65
Professional services
Selling Marketing And Business Development Expenses [Line Items]
Selling, marketing and business development expenses	1,626	1,778	947
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	1,822	2,236	81
Office related expenses, net
Selling Marketing And Business Development Expenses [Line Items]
Selling, marketing and business development expenses	495	395	86
Other
Selling Marketing And Business Development Expenses [Line Items]
Selling, marketing and business development expenses	$ 428	$ 637	$ 75

GENERAL AND ADMINISTRATIVE EX_3

GENERAL AND ADMINISTRATIVE EXPENSES (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
General And Administrative Expense [Line Items]
General and administrative expenses	$ 7,506	$ 8,025	$ 3,848
Payroll and related expenses
General And Administrative Expense [Line Items]
General and administrative expenses	3,880	3,311	1,082
Share-based payments
General And Administrative Expense [Line Items]
General and administrative expenses	1,231	1,054	773
Professional services
General And Administrative Expense [Line Items]
General and administrative expenses	1,461	2,246	1,391
Office related expenses, net
General And Administrative Expense [Line Items]
General and administrative expenses	547	567	300
Other
General And Administrative Expense [Line Items]
General and administrative expenses	$ 387	$ 847	$ 302

FINANCIAL INCOME, net (Details)

FINANCIAL INCOME, net (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
FINANCIAL INCOME, net
Fair value gain on derivative financial instruments	$ 104	$ 5,687	$ 1,152
Gains on financial assets at fair value through profit or loss	295	189	80
Gain from changes in exchange rates		332	34
Interest from bank deposits	279	297	282
Financial income	678	6,505	1,548
Loss from changes in exchange rates	125
Issuance cost with respect of warrants			368
Other	42	77	7
Financial expenses	167	77	375
Financial income net	$ (511)	$ (6,428)	$ (1,173)

SEGMENT INFORMATION (Details)

SEGMENT INFORMATION (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Disclosure of operating segments [line items]
Net revenues	$ 8,360	$ 4,007	$ 101
Cost of revenues	2,837	2,126
Gross profit	5,523	1,881	101
Research and development expenses, net	24,862	32,969	25,241
Selling, marketing and business development expenses	12,486	12,014	1,555
General and administrative expenses	7,506	8,025	3,848
Other expenses		845
Operating loss	39,331	51,972	$ 30,543
Commercial Operation
Disclosure of operating segments [line items]
Net revenues	8,360	4,007
Cost of revenues	2,837	2,126
Gross profit	5,523	1,881
Selling, marketing and business development expenses	11,329	10,520
General and administrative expenses	2,795	2,680
Operating loss	8,601	11,319
Research and Development
Disclosure of operating segments [line items]
Research and development expenses, net	24,862	32,969
Selling, marketing and business development expenses	1,157	1,494
General and administrative expenses	4,711	5,345
Other expenses		845
Operating loss	$ 30,730	$ 40,653

SEGMENT INFORMATION - Major Cus

SEGMENT INFORMATION - Major Customers (Details)	12 Months Ended
	Dec. 31, 2018	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	46.00%	59.00%
Customer Two
Disclosure of major customers [line items]
Percentage of revenue	42.00%	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, 2018	Dec. 31, 2017	Dec. 31, 2016
Basic
Loss (U.S. dollars in thousands)	$ 38,820	$ 45,544	$ 29,370
Weighted average number of ordinary shares outstanding during the period (in thousands)	231,204	176,579	128,514
Basic loss per share (U.S. dollars)	$ 0.17	$ 0.26	$ 0.23

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, 2018	Dec. 31, 2017	Dec. 31, 2016
Diluted
Loss (U.S. dollars in thousands)	$ 38,820	$ 45,544	$ 29,370
Adjustment for financial income of warrants			1,208
Loss used to determine diluted loss per share	$ 38,820	$ 45,544	$ 30,578
Weighted average number of ordinary shares outstanding during the period (in thousands)	231,204	176,579	128,514
Adjustment for warrants			295
Weighted average number of ordinary shares for diluted loss per share (in thousands)	231,204	176,579	128,809
Diluted loss per share (U.S. dollars)	$ 0.17	$ 0.26	$ 0.24

RELATED PARTIES - Key Managemen

RELATED PARTIES - Key Management Compensation (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
RELATED PARTIES
Salaries and other short-term employee benefits	$ 734	$ 677	$ 576
Post-employment benefits	36	35	32
Share-based payments	510	557	504
Other long-term benefits	$ 26	$ 7	$ 11

RELATED PARTIES - Balances with

RELATED PARTIES - Balances with Related Parties (Details) - USD ($) $ in Thousands	Dec. 31, 2018	Dec. 31, 2017
Current liabilities
Credit balance in “accrued expenses and other current liabilities”	$ 178	$ 199
Non-current liabilities
Derivative financial instruments	$ 8	$ 11

EVENTS SUBSEQUENT TO DECEMBER_2

EVENTS SUBSEQUENT TO DECEMBER 31, 2018 (Details) $ in Thousands	Feb. 25, 2019USD ($)Options	Dec. 31, 2018USD ($)Option	Dec. 31, 2017USD ($)Option
Disclosure of non-adjusting events after reporting period [line items]
Number of options, granted | Option		6,005,000	7,235,000
Estimated fair value of the options on the grant date | $		$ 1,692	$ 3,499
Stock Options | Major ordinary share transactions
Disclosure of non-adjusting events after reporting period [line items]
Number of options, granted | Options	100,000
Estimated fair value of the options on the grant date | $	$ 800
American Depository Shares | Major ordinary share transactions
Disclosure of non-adjusting events after reporting period [line items]
Number of ADSs, granted | Options	178,000