RedHill Biopharma (RDHL) 6-K 23 Jul 19 2019 H1 Current report (foreign) Financial data

Document and Entity Information

Document and Entity Information	6 Months Ended
	Jun. 30, 2019
Document and Entity Information [Abstract]
Entity Registrant Name	Redhill Biopharma Ltd.
Entity Central Index Key	0001553846
Document Type	6-K
Document Period End Date	Jun. 30, 2019
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	H1

CONSOLIDATED STATEMENTS OF COMP

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
NET REVENUES	$ 1,563	$ 2,350	$ 3,300	$ 4,795
COST OF REVENUES	425	725	842	1,655
GROSS PROFIT	1,138	1,625	2,458	3,140
RESEARCH AND DEVELOPMENT EXPENSES, net	6,972	6,044	12,344	12,460
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES	4,147	3,123	7,283	6,293
GENERAL AND ADMINISTRATIVE EXPENSES	2,399	2,015	4,424	3,939
OPERATING LOSS	12,380	9,557	21,593	19,552
FINANCIAL INCOME	1,546	156	948	239
FINANCIAL EXPENSES	74	1,717	133	1,740
FINANCIAL EXPENSES (INCOME), net	(1,472)	1,561	(815)	1,501
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD	$ 10,908	$ 11,118	$ 20,778	$ 21,053
LOSS PER ORDINARY SHARE (U.S. dollars):
LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars):	$ 0.04	$ 0.05	$ 0.07	$ 0.10
WEIGHTED AVERAGE OF ORDINARY SHARES (in thousands)	283,687	213,439	283,687	213,316

CONSOLIDATED STATEMENTS OF FINA

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION - USD ($) $ in Thousands	Jun. 30, 2019	Dec. 31, 2018
CURRENT ASSETS:
Cash and cash equivalents	$ 8,995	$ 29,005
Bank deposits	9,403	8,271
Financial assets at fair value through profit or loss	16,471	15,909
Trade receivables	963	958
Prepaid expenses and other receivables	2,315	1,876
Inventory	1,826	769
Total current assets	39,973	56,788
NON-CURRENT ASSETS:
Bank deposits	147	140
Fixed assets	250	163
Right-of-use assets	4,005
Intangible assets	5,320	5,320
Total non-current assets	9,722	5,623
TOTAL ASSETS	49,695	62,411
CURRENT LIABILITIES:
Accounts payable	4,743	3,324
Lease liabilities	845
Accrued expenses and other current liabilities	8,465	7,057
Total current liabilities	14,053	10,381
NON-CURRENT LIABILITIES:
Derivative financial instruments	13	344
Lease liabilities	3,225
Royalty obligation	500	500
Total non-current liabilities	3,738	844
TOTAL LIABILITIES	17,791	11,225
EQUITY:
Ordinary shares	767	767
Additional paid-in capital	219,505	219,505
Accumulated deficit	(188,368)	(169,086)
TOTAL EQUITY	31,904	51,186
TOTAL LIABILITIES AND EQUITY	$ 49,695	$ 62,411

CONSOLIDATED STATEMENTS OF CHAN

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY - USD ($) $ in Thousands	Ordinary shares	Additional paid-in capital	Accumulated deficit	Total
Balance at beginning of period at Dec. 31, 2017	$ 575	$ 177,434	$ (132,944)	$ 45,065
Share-based compensation to employees and service providers			1,539	1,539
Exercise of warrants and options into ordinary shares	2	353		355
Comprehensive loss			(21,053)	(21,053)
Balance at end of period at Jun. 30, 2018	577	177,787	(152,458)	25,906
Balance at beginning of period at Mar. 31, 2018	577	177,787	(142,073)	36,291
Share-based compensation to employees and service providers			733	733
Comprehensive loss			(11,118)	(11,118)
Balance at end of period at Jun. 30, 2018	577	177,787	(152,458)	25,906
Balance at beginning of period at Dec. 31, 2018	767	219,505	(169,086)	51,186
Share-based compensation to employees and service providers			1,496	1,496
Comprehensive loss			(20,778)	(20,778)
Balance at end of period at Jun. 30, 2019	767	219,505	(188,368)	31,904
Balance at beginning of period at Mar. 31, 2019	767	219,505	(178,397)	41,875
Share-based compensation to employees and service providers			937	937
Comprehensive loss			(10,908)	(10,908)
Balance at end of period at Jun. 30, 2019	$ 767	$ 219,505	$ (188,368)	$ 31,904

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
OPERATING ACTIVITIES:
Comprehensive loss	$ (10,908)	$ (11,118)	$ (20,778)	$ (21,053)
Adjustments in respect of income and expenses not involving cash flow:
Share-based compensation to employees and service providers	937	733	1,496	1,539
Depreciation	226	23	456	45
Fair value adjustment on derivative financial instruments	(1,304)	1,667	(331)	1,617
Fair value losses (gains) on financial assets at fair value through profit or loss	(35)	13	(87)	112
Revaluation of bank deposits	(60)	(13)	(70)	77
Exchange differences in respect of lease liabilities	35		41
Exchange differences in respect of cash and cash equivalents	(23)	53	(39)	67
Total adjustments in respect of income and expenses not involving cash flow	(224)	2,476	1,466	3,457
Changes in assets and liability items:
Decrease (increase) in trade receivables	457	13	(5)	(268)
Decrease (increase) in prepaid expenses and other receivables	(1,072)	188	(439)	1,459
Increase in inventory	(538)	(130)	(1,057)	(37)
Increase (decrease) in accounts payable	330	1,299	1,419	(782)
Increase (decrease) in accrued expenses and other current liabilities	1,502	(1,127)	1,408	(671)
Total changes in assets and liability items	679	243	1,326	(299)
Net cash used in operating activities	(10,453)	(8,399)	(17,986)	(17,895)
INVESTING ACTIVITIES:
Purchase of fixed assets	(128)	(2)	(134)	(15)
Change in investment in current bank deposits	(3,200)	5,000	(1,069)	4,869
Purchase of financial assets at fair value through profit or loss	(1,942)	(42)	(2,575)	(1,088)
Proceeds from sale of financial assets at fair value through profit or loss	1,880	1,500	2,100	3,450
Net cash provided by investing activities	(3,390)	6,456	(1,678)	7,216
FINANCING ACTIVITIES:
Exercise of options into ordinary shares				355
Principal elements of lease payments	(199)		(385)
Repayment of payable in respect of intangible asset purchase				(500)
Net cash used in financing activities	(199)		(385)	(145)
DECREASE IN CASH AND CASH EQUIVALENTS	(14,042)	(1,943)	(20,049)	(10,824)
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS	23	(53)	39	(67)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD	23,014	7,560	29,005	16,455
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD	8,995	5,564	8,995	5,564
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH	162	$ 148	325	$ 415
Acquisition of right-of-use assets by means of lease liabilities	$ 1,101		$ 2,681

GENERAL

GENERAL	6 Months Ended
	Jun. 30, 2019
GENERAL
GENERAL	NOTE 1 - GENERAL: a. General 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. 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 when and if the Company’s business will generate sufficient revenues to sustain our business operations in accordance with our plan or profits from our therapeutic candidates and commercial products. Through June 30, 2019, 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 fund 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 the condensed consolidated interim financial statements These condensed consolidated interim financial statements were approved by the Board of Directors (the "BoD") on July 22, 2019.

BASIS OF PREPARATION OF THE CON

BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS	6 Months Ended
	Jun. 30, 2019
BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS	NOTE 2 - BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS: a. The Company’s condensed consolidated interim financial statements for the three and six months ended June 30, 2019 (the "Condensed Consolidated Interim Financial Statements") have been prepared in accordance with International Accounting Standard IAS 34, “Interim Financial Reporting”. These Condensed Consolidated Interim Financial Statements, which are unaudited, do not include all the information and disclosures that would otherwise be required in a complete set of annual financial statements and should be read in conjunction with the annual financial statements as of December 31, 2018 and their accompanying notes, which have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as published by the International Accounting Standards Board (“IASB”). The results of operations for the three and six months ended June 30, 2019 are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period. The accounting policies applied in the preparation of the Condensed Consolidated Interim Financial Statements are consistent with those applied in the preparation of the annual financial statements as of December 31, 2018, except for the adoption of International Financing Reporting Standard No. 16 “Leases” (“IFRS 16”), effective from January 1, 2019, as set out below. b. The impact of the adoption of IFRS 16 and the new accounting policies that have been applied from January 1, 2019 are disclosed in note 3 below.

CHANGES IN ACCOUNTING POLICIES

CHANGES IN ACCOUNTING POLICIES	6 Months Ended
	Jun. 30, 2019
CHANGES IN ACCOUNTING POLICIES
CHANGES IN ACCOUNTING POLICIES	NOTE 3 – CHANGES IN ACCOUNTING POLICIES: a. The Company has adopted IFRS 16 retrospectively from January 1, 2019, but has not restated comparatives for the 2018 reporting period, as permitted under the specific transitional provisions in the standard. The reclassifications and the adjustments arising from the new leasing rules are therefore recognized in the statement of financial position at the date of initial application. b. On adoption of IFRS 16, the Company recognized lease liabilities in relation to leases which had previously been classified as ‘operating leases’ under the principles of IAS 17 “Leases”. These liabilities were measured at the present value of the remaining lease payments, discounted using the lessee’s incremental borrowing rate as of January 1, 2019. The weighted average lessee’s incremental annual borrowing rate applied to the lease liabilities on January 1, 2019 was 6.9%. The lease liabilities recognized in the statement of financial position at the date of intial application were approximately $1.7 million, of which approximately $0.9 miillion were current lease liabilities and $0.8 miillion non-current lease liabilities. The associated right-of-use assets were measured at the amount equal to the lease liability and as a result there was no impact on retained earnings on January 1, 2019. On January 27, 2019, the Company signed an amendment to one of its leases, to extend the lease period for 7 years. As a result, the Company remeasured the lease liability by discouting the revised lease payments using a revised discount rate, which was the lessee’s incremental borrowing rate at the effective date of the modification. The Company accounted for the remeasurement of the lease liability as an additional amount of approximately $1.6 million by making a corresponding adjustment to the right-of-use asset. On May 8, 2019, the Company signed an amendment to one of its leases, to increase the scope of the lease, as well as extending the lease period by an additional year. The Company accounted for the remeasurement of the lease liability as an additional amount of approximately $1.0 million by making a corresponding adjustment to the right-of-use asset.The recognized right-of-use assets as of January 1, 2019 and June 30, 2019 relate to the following types of assets: Properties approximately $1 million and approximately $3.5 million, respectivelty, and Vehicles $0.7 million and $0.5 million, respectively. In applying IFRS 16 for the first time, the Company has used the following practical expedient permitted by the standard - the accounting for operating leases with a remaining lease term of less than 12 months as of January 1, 2019 as short-term leases. The company has also elected not to reassess whether a contract is, or contains a lease at the date of initial application. Instead, for contracts entered into before the transition date the Company relied on its assessment made applying IAS 17 and IFRIC 4 Determining whether an arrangement contains a Lease. c. Until the 2018 financial year, the leases of offices and cars by the Company and its subsidiary were classified as operating leases and payments made were charged to profit or loss on a straight-line basis over the period of the lease. From January 1, 2019, the leases are recognized as a right-of-use asset and a corresponding liability at the date at which the leased asset is available for use by the Company. Each lease payment is allocated between the liability and finance cost. The finance cost is charged to profit or loss over the lease period so as to produce a constant periodic rate of interest on the remaining balance of the liability for each period. The right-of-use asset is depreciated over the shorter of the asset's useful life and the lease term on a straight-line basis. Assets and liabilities arising from a lease are initially measured on a present value basis. Lease liabilities include the net present value of the following lease payments: fixed payments (including in-substance fixed payments) and variable lease payments that are based on an index or a rate. The lease payments are discounted using the lessee’s incremental borrowing rate, being the rate that the lessee would have to pay to borrow the funds necessary to obtain an asset of similar value in a similar economic environment with similar terms and conditions. Right-of-use assets are measured at cost being the amount of the initial measurement of lease liability. Payments associated with short-term leases and leases of low-value assets are recognized on a straight-line basis as an expense in profit or loss. Short-term leases are leases with a lease term of 12 months or less. Low-value assets comprise IT-equipment and small items of office furniture.

SHARE-BASED PAYMENTS

SHARE-BASED PAYMENTS	6 Months Ended
	Jun. 30, 2019
SHARE-BASED PAYMENTS
SHARE-BASED PAYMENTS	NOTE 4 - SHARE-BASED PAYMENTS: a. The following is information on options granted during the six months ended June 30, 2019: 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) February 2019 1,580,000 — 1,580,000 0.89 628 May 2019 5,640,000 — 5,640,000 0.92 2,433 June 2019 — 1,875,000 1,875,000 0.92 641 7,220,000 1,875,000 9,095,000 3,702 1) The options will vest as follows: for directors and employees of the Company and the Company's subsidiary who had provided services exceeding one year as of the grant date, options will vest in 16 equal quarterly installments over a four-year period. For directors and employees of the Company and the Company's subsidiary who had not provided services 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 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 10 years from the date of grant. 2) The options include both options exercisable into the Company's ordinary shares and options exercisable into the Company's ADSs. 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: $0.68-$0.81, expected volatility: 57.53%-58.27%, risk-free interest rate: 2.02-2.67% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates. b. On December 27, 2018, the BoD approved a 3-years extension of the exercise period of fully-vested options exercisable into the Company's ordinary shares granted to the Chief Executive Officer (followed by approval in general meeting of the Company’s shareholders held on June 24, 2019) and to a consultant that were originally scheduled to expire in February 2019. Accordingly, 1,000,000 options were extended with the new terms: the exercise price will increase by 50% to $1.08 per ordinary share, respectively, and will not be exercisable within one year of the extension. The total incremental fair value of the options as of the date of the extension was approximately $0.2 million and was recorded to the Statements of Comprehensive Loss immediately

NET REVENUES

NET REVENUES	6 Months Ended
	Jun. 30, 2019
NET REVENUES
NET REVENUES	NOTE 5 - NET REVENUES: Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 U.S dollars in thousands U.S dollars in thousands Commercialization of product 525 1,174 1,119 2,792 Promotional services 1,038 1,176 2,181 2,003 Total Net Revenues 1,563 2,350 3,300 4,795

FINANCIAL INSTRUMENTS

FINANCIAL INSTRUMENTS	6 Months Ended
	Jun. 30, 2019
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT	NOTE 6 - FINANCIAL INSTRUMENTS: a. Fair value hierarchy The following table presents Company assets and liabilities measured at fair value: Level 1 Level 3 Total U.S. dollars in thousands June 30, 2019: Assets - Financial assets at fair value through profit or loss 16,471 — 16,471 Liabilities - Derivative financial instruments — 13 13 December 31, 2018: Assets - Financial assets at fair value through profit or loss 15,909 — 15,909 Liabilities - Derivative financial instruments — 344 344 During the six months ended June 30, 2019, there were no transfers of financial assets and liabilities between Levels 1, 2 or 3 fair value measurements. There have been no changes in the methodologies used since December 31, 2018. b. Fair value measurements using significant unobservable input (Level 3) The following table presents the change in derivative financial liabilities measured at Level 3 for the three and six months ended June 30, 2019 and 2018: Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 U.S. dollars in thousands Balance at beginning of the period 1,317 398 344 448 Fair value adjustments recognized in profit or loss (1,304) 1,667 (331) 1,617 Balance at end of the period 13 2,065 13 2,065 The fair value of the above-mentioned derivative financial liabilities that are not traded in an active market is determined by using valuation techniques. The Company uses its judgment to select a variety of methods and make assumptions that are mainly based on market conditions at the end of each reporting period. The fair value of the above-mentioned derivative financial liabilities is computed using the Black-Scholes option pricing model. The fair value of the derivative financial liabilities as of June 30, 2019 is based on the price of an ADS on June 30, 2019 and on the following key parameters: risk-free interest rate of 2.09% and an average standard deviation of 42.33%. The fair value of the derivative financial liabilities as of December 31, 2018, was based on the price of an ADS on December 31, 2018 and on the following key parameters: risk-free interest rate of 2.63% and an average standard deviation of 60.55%. c. The carrying amount of cash equivalents, current and non-current bank deposits, receivables, account payables and accrued expenses approximate their fair value due to their short-term characteristics.

SEGMENT INFORMATION

SEGMENT INFORMATION	6 Months Ended
	Jun. 30, 2019
SEGMENT INFORMATION
SEGMENT INFORMATION	NOTE 7– SEGMENT INFORMATION The Company has two segments, Commercial Operations and Research and Development. The following tables present net revenues and operating loss for the Company's segments for the three and six months ended June 30, 2019 and 2018: Three Months Ended June 30, Six Months Ended June 30, 2019 2019 June 30, 2019: Commercial Operations Research and Development Consolidated Commercial Operations Research and Development Consolidated U.S. dollars in thousands U.S. dollars in thousands Net revenues 1,563 — 1,563 3,300 — 3,300 Operating loss 3,604 8,776 12,380 5,871 15,722 21,593 Three Months Ended June 30, Six Months Ended June 30, 2018 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 2,350 — 2,350 4,795 — 4,795 Operating loss 2,000 7,557 9,557 4,095 15,457 19,552

SHARE-BASED PAYMENTS (Tables)

SHARE-BASED PAYMENTS (Tables)	6 Months Ended
	Jun. 30, 2019
SHARE-BASED PAYMENTS
Schedule of information on options granted	a. The following is information on options granted during the six months ended June 30, 2019: 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) February 2019 1,580,000 — 1,580,000 0.89 628 May 2019 5,640,000 — 5,640,000 0.92 2,433 June 2019 — 1,875,000 1,875,000 0.92 641 7,220,000 1,875,000 9,095,000 3,702 1) The options will vest as follows: for directors and employees of the Company and the Company's subsidiary who had provided services exceeding one year as of the grant date, options will vest in 16 equal quarterly installments over a four-year period. For directors and employees of the Company and the Company's subsidiary who had not provided services 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 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 10 years from the date of grant. 2) The options include both options exercisable into the Company's ordinary shares and options exercisable into the Company's ADSs.

NET REVENUES (Tables)

NET REVENUES (Tables)	6 Months Ended
	Jun. 30, 2019
NET REVENUES
Schedule of net revenues	Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 U.S dollars in thousands U.S dollars in thousands Commercialization of product 525 1,174 1,119 2,792 Promotional services 1,038 1,176 2,181 2,003 Total Net Revenues 1,563 2,350 3,300 4,795

FINANCIAL INSTRUMENTS (Tables)

FINANCIAL INSTRUMENTS (Tables)	6 Months Ended
	Jun. 30, 2019
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 June 30, 2019: Assets - Financial assets at fair value through profit or loss 16,471 — 16,471 Liabilities - Derivative financial instruments — 13 13 December 31, 2018: Assets - Financial assets at fair value through profit or loss 15,909 — 15,909 Liabilities - Derivative financial instruments — 344 344
Schedule of change in derivative liabilities measured at Level 3	Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 U.S. dollars in thousands Balance at beginning of the period 1,317 398 344 448 Fair value adjustments recognized in profit or loss (1,304) 1,667 (331) 1,617 Balance at end of the period 13 2,065 13 2,065

SEGMENT INFORMATION (Tables)

SEGMENT INFORMATION (Tables)	6 Months Ended
	Jun. 30, 2019
SEGMENT INFORMATION
Schedule of segment information	Three Months Ended June 30, Six Months Ended June 30, 2019 2019 June 30, 2019: Commercial Operations Research and Development Consolidated Commercial Operations Research and Development Consolidated U.S. dollars in thousands U.S. dollars in thousands Net revenues 1,563 — 1,563 3,300 — 3,300 Operating loss 3,604 8,776 12,380 5,871 15,722 21,593 Three Months Ended June 30, Six Months Ended June 30, 2018 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 2,350 — 2,350 4,795 — 4,795 Operating loss 2,000 7,557 9,557 4,095 15,457 19,552

GENERAL (Details)

GENERAL (Details)	Jun. 30, 2019item
GENERAL
Number of therapeutic candidates out-licensed on an exclusive world-wide basis	1

CHANGES IN ACCOUNTING POLICIES

CHANGES IN ACCOUNTING POLICIES (Details) - USD ($) $ in Thousands	Jan. 27, 2019	Jun. 30, 2019	May 08, 2019	Jan. 01, 2019
Disclosure of initial application of standards or interpretations [line items]
Current lease liabilities		$ 845
Non-current lease liabilities		3,225
Right-of-use assets		4,005
IFRS 16
Disclosure of initial application of standards or interpretations [line items]
Weighted average lessee's incremental annual borrowing rate applied to the lease liabilities				6.90%
Lease liabilities	$ 1,600	1,700
Current lease liabilities		900
Non-current lease liabilities		$ 800
Lease term	7 years
Right-of-use assets			$ 1,000

CHANGES IN ACCOUNTING POLICIE_2

CHANGES IN ACCOUNTING POLICIES - Assets (Details) - USD ($) $ in Thousands	Jun. 30, 2019	Jan. 01, 2019
Disclosure of quantitative information about right-of-use assets [line items]
Right-of-use assets	$ 4,005
Properties
Disclosure of quantitative information about right-of-use assets [line items]
Right-of-use assets	3,500	$ 1,000
Vehicles
Disclosure of quantitative information about right-of-use assets [line items]
Right-of-use assets	$ 500	$ 700

SHARE-BASED PAYMENTS (Details)

SHARE-BASED PAYMENTS (Details)	Dec. 27, 2018shares	Jun. 30, 2019USD ($)installmentshares
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares		9,095,000
Fair value of options on date of grant in U.S. $ thousands		$ 3,702,000
February 2019
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares		1,580,000
Exercise price for 1 ordinary share ($)		$ 0.89
Fair value of options on date of grant in U.S. $ thousands		$ 628,000
May 2019
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares		5,640,000
Exercise price for 1 ordinary share ($)		$ 0.92
Fair value of options on date of grant in U.S. $ thousands		$ 2,433,000
June 2019
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares		1,875,000
Exercise price for 1 ordinary share ($)		$ 0.92
Fair value of options on date of grant in U.S. $ thousands		641,000
Stock Options | 2019 | Minimum
Disclosure of terms and conditions of share-based payment arrangement [line items]
Price of the Company's ordinary share		$ 0.68
Expected volatility		57.53%
Risk free interest rate		2.02%
Stock Options | 2019 | Maximum
Disclosure of terms and conditions of share-based payment arrangement [line items]
Price of the Company's ordinary share		$ 0.81
Expected volatility		58.27%
Risk free interest rate		2.67%
Stock Options | 2019 | 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 | 2019 | Vesting, services exceeding one year | Minimum
Disclosure of terms and conditions of share-based payment arrangement [line items]
Service period		1 year
Stock Options | 2019 | Vesting, 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
Percentage of options vesting		0.25%
Option term		10 years
Stock Options | 2019 | Vesting, services not exceeding one year | Maximum
Disclosure of terms and conditions of share-based payment arrangement [line items]
Service period		1 year
Other than directors
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares		7,220,000
Exercise price increase (as a percent)		50.00%
Other than directors | 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
Other than directors | Minimum
Disclosure of terms and conditions of share-based payment arrangement [line items]
Vesting period	1 year
Other than directors | February 2019
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares		1,580,000
Other than directors | May 2019
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares		5,640,000
To directors
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares		1,875,000
Extension of the exercise period	3 years
Incremental fair value		$ 200,000
To directors | February 2019 | Extension of options originally scheduled to expire in February 2019
Disclosure of terms and conditions of share-based payment arrangement [line items]
Number of fully-vested options | shares	1,000,000
To directors | June 2019
Disclosure of terms and conditions of share-based payment arrangement [line items]
Shares approved for issuance | shares		1,875,000

NET REVENUES (Details)

NET REVENUES (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Revenues
Commercialization of product	$ 525	$ 1,174	$ 1,119	$ 2,792
Promotional services	1,038	1,176	2,181	2,003
Total Net Revenues	$ 1,563	$ 2,350	$ 3,300	$ 4,795

FINANCIAL INSTRUMENTS - Assets

FINANCIAL INSTRUMENTS - Assets and Liabilities (Details) - USD ($) $ in Thousands	Jun. 30, 2019	Dec. 31, 2018	Jun. 30, 2018	Mar. 31, 2018	Dec. 31, 2017	Mar. 31, 2017
Assets
Financial assets at fair value through profits or losses	$ 16,471	$ 15,909
Derivative financial instruments.
Liabilities
Derivative financial instruments		344
Level 3 | Derivative financial instruments.
Liabilities
Derivative financial instruments	$ 13	$ 344	$ 2,065	$ 1,317	$ 448	$ 398

FINANCIAL INSTRUMENTS (Details)

FINANCIAL INSTRUMENTS (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended		12 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018	Dec. 31, 2018
Financial instruments
Financial assets at fair value through profit or loss	$ 16,471		$ 16,471		$ 15,909
Transfers between levels 1, 2 or 3 fair value measurements		$ 0		$ 0
Risk-free interest rate			2.09%		2.63%
Average standard deviation			42.33%		60.55%
Derivative financial instruments.
Financial instruments
Derivative liabilities- balance at beginning of the period			$ 344
Derivative liabilities- balance at end of the period					$ 344
At fair value
Financial instruments
Financial assets at fair value through profit or loss	16,471		16,471		15,909
At fair value | Derivative financial instruments.
Financial instruments
Derivative liabilities- balance at end of the period	13		13
Level 1 | At fair value
Financial instruments
Financial assets at fair value through profit or loss	16,471		16,471		15,909
Level 3 | Derivative financial instruments.
Financial instruments
Derivative liabilities- balance at beginning of the period		1,317	344	448	448
Fair value adjustments recognized in profit or loss	(1,304)	1,667	(331)	1,617
Derivative liabilities- balance at end of the period	13	$ 2,065	13	$ 2,065	$ 344
Level 3 | At fair value | Derivative financial instruments.
Financial instruments
Derivative liabilities- balance at end of the period	$ 13		$ 13

SEGMENT INFORMATION (Details)

SEGMENT INFORMATION (Details) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019USD ($)	Jun. 30, 2018USD ($)	Jun. 30, 2019USD ($)	Jun. 30, 2018USD ($)segment
Disclosure of operating segments [line items]
Number of segments | segment				2
Net revenues	$ 1,563	$ 2,350	$ 3,300	$ 4,795
Operating loss	12,380	9,557	21,593	19,552
Commercial Operation
Disclosure of operating segments [line items]
Net revenues	1,563	2,350	3,300	4,795
Operating loss	3,604	2,000	5,871	4,095
Research and Development
Disclosure of operating segments [line items]
Operating loss	$ 8,776	$ 7,557	$ 15,722	$ 15,457