Document and Entity Information
Document and Entity Information | 12 Months Ended |
Dec. 31, 2018shares | |
Document And Entity Information | |
Entity Registrant Name | KAMADA LTD |
Entity Central Index Key | 1,567,529 |
Document Type | 20-F |
Document Period End Date | Dec. 31, 2018 |
Amendment Flag | false |
Current Fiscal Year End Date | --12-31 |
Is Entity a Well-known Seasoned Issuer? | No |
Is Entity a Voluntary Filer? | No |
Is Entity's Reporting Status Current? | Yes |
Entity Filer Category | Accelerated Filer |
Entity Shell Company | false |
Entity Emerging Growth Company | false |
Entity Common Stock, Shares Outstanding | 40,295,078 |
Document Fiscal Period Focus | FY |
Document Fiscal Year Focus | 2,018 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current Assets | ||
Cash and cash equivalents | $ 18,093 | $ 12,681 |
Short-term investments | 32,499 | 30,338 |
Trade receivables, net | 27,674 | 30,662 |
Other accounts receivables | 3,308 | 2,132 |
Inventories | 29,316 | 21,070 |
Total Current Assets | 110,890 | 96,883 |
Non-Current Assets | ||
Property, plant and equipment, net | 25,004 | 25,178 |
Other long term assets | 174 | 49 |
Deferred taxes | 2,048 | |
Total Non-Current Assets | 27,226 | 25,227 |
Total Assets | 138,116 | 122,110 |
Current Liabilities | ||
Current maturities of loans and capital leases | 562 | 614 |
Trade payables | 17,285 | 18,036 |
Other accounts payables | 5,261 | 5,820 |
Deferred revenues | 461 | 4,927 |
Total Current Liabilities | 23,569 | 29,397 |
Non-Current Liabilities | ||
Loans and capital leases | 716 | 1,370 |
Deferred revenues | 668 | 707 |
Employee benefit liabilities, net | 787 | 1,144 |
Total Non-Current Liabilities | 2,171 | 3,221 |
Shareholder's Equity | ||
Ordinary shares | 10,409 | 10,400 |
Additional paid in capital net | 179,147 | 177,874 |
Capital reserve due to translation to presentation currency | (3,490) | (3,490) |
Capital reserve from hedges | (57) | 46 |
Capital reserve from securities measured at fair value through other comprehensive income | 34 | (4) |
Capital reserve from share-based payments | 9,353 | 9,566 |
Capital reserve from employee benefits | 4 | (337) |
Accumulated deficit | (83,024) | (104,563) |
Total Shareholder's Equity | 112,376 | 89,492 |
Total Liabilities and Shareholder's Equity | $ 138,116 | $ 122,110 |
Consolidated Statements of Prof
Consolidated Statements of Profit or Loss and Other Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Profit or loss [abstract] | |||
Revenues from proprietary products | $ 90,784 | $ 79,559 | $ 55,958 |
Revenues from distribution | 23,685 | 23,266 | 21,536 |
Total revenues | 114,469 | 102,825 | 77,494 |
Cost of revenues from proprietary products | 52,796 | 51,335 | 37,723 |
Cost of revenues from distribution | 20,201 | 19,402 | 18,411 |
Total cost of revenues | 72,997 | 70,737 | 56,134 |
Gross profit | 41,472 | 32,088 | 21,360 |
Research and development expenses | 9,747 | 11,973 | 16,245 |
Selling and marketing expenses | 3,630 | 4,398 | 3,243 |
General and administrative expenses | 8,525 | 8,273 | 7,353 |
Other expense | 311 | ||
Operating income (loss) | 19,259 | 7,444 | (5,481) |
Financial income | 820 | 500 | 469 |
Income (expense) in respect of currency exchange differences and derivatives instruments, net | 602 | (612) | 127 |
Financial expenses | (340) | (162) | (126) |
Income (loss) before tax on income | 20,341 | 7,170 | (5,011) |
Taxes on income | (1,955) | 269 | 1,722 |
Net Income (loss) | 22,296 | 6,901 | (6,733) |
Items that may be reclassified to profit or loss in subsequent periods: | |||
Gain (loss) from securities measured at fair value through other comprehensive income | 51 | (23) | (54) |
Gain (loss) on cash flow hedges | (176) | 329 | 47 |
Net amounts transferred to the statement of profit or loss for cash flow hedges | 70 | (256) | (73) |
Items that will not be reclassified to profit or loss in subsequent periods: | |||
Actuarial gain (loss) from defined benefit plans | 340 | (256) | (22) |
Deferred tax | (9) | ||
Total comprehensive income (loss) | $ 22,572 | $ 6,695 | $ (6,835) |
Income (loss) per share attributable to equity holders of the Company: | |||
Basic income (loss) per share | $ 0.55 | $ 0.18 | $ (0.18) |
Diluted income (loss) per share | $ 0.55 | $ 0.18 | $ (0.18) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Equity - USD ($) $ in Thousands | Share capital [Member] | Additional paid in capital [Member] | Capital reserve from Available for sale financial assets [Member] | Capital reserve due to translation to presentation currency [Member] | Capital reserve from hedges [Member] | Capital reserve from share-based payments [Member] | Capital reserve from employee benefits [Member] | Accumulated deficit [Member] | Total | ||
Balance at Dec. 31, 2015 | $ 9,320 | $ 162,238 | $ 73 | $ (3,490) | $ (1) | $ 9,157 | $ (59) | $ (104,731) | $ 72,507 | ||
Net income | (6,733) | (6,733) | |||||||||
Other comprehensive income (loss), net | (54) | (26) | (22) | (102) | |||||||
Total comprehensive income (loss) | (54) | (26) | (22) | (6,733) | (6,835) | ||||||
Exercise and forfeiture of share-based payment into shares | [1] | 433 | (433) | [1] | |||||||
Cost of share-based payment | 1,071 | 1,071 | |||||||||
Balance at Dec. 31, 2016 | 9,320 | 162,671 | 19 | (3,490) | (27) | 9,795 | (81) | (111,464) | 66,743 | ||
Net income | 6,901 | 6,901 | |||||||||
Other comprehensive income (loss), net | (23) | 73 | (256) | (206) | |||||||
Total comprehensive income (loss) | (23) | 73 | (256) | 6,901 | 6,695 | ||||||
Exercise and forfeiture of share-based payment into shares | 3 | 712 | (712) | 3 | |||||||
Issuance of ordinary shares, net of issuance costs | 1,077 | 14,491 | 15,568 | ||||||||
Cost of share-based payment | 483 | 483 | |||||||||
Balance at Dec. 31, 2017 | 10,400 | 177,874 | (4) | (3,490) | 46 | 9,566 | (337) | (104,563) | 89,492 | ||
Cumulative effect of initially applying IFRS 15 | (757) | (757) | |||||||||
Net income | 22,296 | 22,296 | |||||||||
Other comprehensive income (loss), net | 38 | (103) | 341 | 276 | |||||||
Total comprehensive income (loss) | 38 | (103) | 341 | 22,296 | 22,572 | ||||||
Exercise and forfeiture of share-based payment into shares | 9 | 1,161 | (1,161) | 9 | |||||||
Cost of share-based payment | 948 | 948 | |||||||||
Deferred taxes | 112 | 112 | |||||||||
Balance at Dec. 31, 2018 | $ 10,409 | $ 179,147 | $ 34 | $ (3,490) | $ (57) | $ 9,353 | $ 4 | $ (83,024) | $ 112,376 | ||
[1] | Represent an amount lower than $1 thousands. |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | ||
Cash Flows from Operating Activities | ||||
Net income (loss) | $ 22,296 | $ 6,901 | $ (6,733) | |
Adjustments to the profit or loss items: | ||||
Depreciation, amortization and impairment | 3,703 | 3,523 | 3,501 | |
Financial expenses (income), net | (1,082) | 274 | (470) | |
Cost of share-based payment | 948 | 483 | 1,071 | |
Taxes on income | (1,955) | 269 | 1,722 | |
Loss (gain) from sale of property and equipment | 55 | (52) | (18) | |
Change in employee benefit liabilities, net | (16) | 166 | (87) | |
Adjustments to the profit or loss items | 1,653 | 4,663 | 5,719 | |
Changes in asset and liability items: | ||||
Decrease (increase) in trade receivables, net | 2,311 | (9,967) | 3,489 | |
Decrease (increase) in other accounts receivables | (1,336) | 328 | 211 | |
Decrease (increase) in inventories | (8,246) | 4,524 | 742 | |
Decrease (increase) in deferred expenses | 235 | 594 | (433) | |
Decrease in trade payables | (1,116) | (838) | (2,650) | |
Increase (decrease) in other accounts payables | (658) | 71 | 1,520 | |
Decrease in deferred revenues | (5,256) | (2,930) | 1,035 | |
Total Changes in asset and liability | (14,066) | (8,218) | 3,914 | |
Cash received (paid) during the year for: | ||||
Interest paid | (54) | (21) | (60) | |
Interest received | 739 | 399 | 842 | |
Taxes paid | (22) | (116) | (1,785) | |
Cash received (paid) during the year | 663 | 262 | (1,003) | |
Net cash provided by operating activities | 10,546 | 3,608 | 1,897 | |
Cash Flows from Investing Activities | ||||
Investment in short term investments, net | (2,322) | (11,501) | 4,236 | |
Purchase of property and equipment and intangible assets | (2,884) | (4,167) | (2,641) | |
Proceeds from sale of property and equipment | 30 | 60 | 42 | |
Net cash used in investing activities | (5,176) | (15,608) | 1,637 | |
Cash Flows from Financing Activities | ||||
Proceeds from exercise of share base payments | 9 | 3 | [1] | |
Receipt of long-term loans | 279 | 1,701 | ||
Repayment of long-term loans | (596) | (530) | (211) | |
Proceeds from issuance of ordinary shares, net | 15,568 | |||
Net cash provided by (used in) financing activities | (587) | 15,320 | 1,490 | |
Exchange differences on balances of cash and cash equivalent | 629 | (607) | (103) | |
Increase in cash and cash equivalents | 5,412 | 2,713 | 4,921 | |
Cash and cash equivalents at the beginning of the year | 12,681 | 9,968 | 5,047 | |
Cash and cash equivalents at the end of the year | 18,093 | 12,681 | 9,968 | |
Significant non-cash transactions | ||||
Purchase of property and equipment through capital lease | 282 | 132 | ||
Purchase of property and equipment | $ 720 | $ 1,681 | $ 1,968 | |
[1] | Represent an amount lower than $1 thousands. |
GENERAL
GENERAL | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of general [Abstract] | |
GENERAL | Note 1: - General a. General description of the Company and its activity Kamada Ltd. ("the Company") a plasma-derived protein therapeutics company focused on orphan indications, has a commercial product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a high purity, liquid form, as well as other plasma-derived proteins. The Company's flagship product is "GLASSIA®" Kamada markets GLASSIA in the U.S. through a strategic partnership with Shire plc, now part of Takeda, and in other counties through local distributors. In addition, the Company’s rabies immune globulin (Human) product received FDA approval for Post-Exposure Prophylaxis against rabies infection in August 2017 and was launched in the US in April 2018 under the brand name KEDRAB® and through a collaboration agreement with Kedrion Biophamra. Kamada has a product line consisting of six other products which are marketed in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company's activity is divided into two operating segments: Proprietary Products Develop and manufacture plasma-derived therapeutics and market them in more than 15 countries. Distribution Distribute imported drugs in Israel, which are manufactured by third parties, majority of which are produced from plasma or its derivative products. The Company's securities are listed for trading on the Tel Aviv stock exchange and on the NASDAQ. b. The Company has two wholly-owned subsidiaries – Kamada Inc which is not active and Kamada Biopharma Limited. In addition the Company owns 74% of Kamada Assets Ltd ("Kamada Assets"). See note 26 with respect to a new wholly owned subsidiary establish post December 31, 2018. c. Definitions In these Financial Statements – The Company - Kamada Ltd. The Group - The Company and its subsidiaries. Subsidiary - A company which the Company has a control over (as defined in IFRS 10) and whose financial statements are consolidated with the Company's Financial Statements. Related parties - As defined in IAS 24. USD/$ - U.S. dollar. NIS - New Israeli Shekel |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of significant accounting policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | Note 2: - Significant Accounting Policies a. Basis of presentation of financial statements 1. These financial statements have been prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standard Board. 2. Measurement basis: The Company's consolidated Financial Statements are prepared on a cost basis, except for financial instruments (including derivatives) at fair value through profit or loss and other comprehensive income such as marketable securities financial assets, employee benefit assets and employee benefit liabilities. The Company has elected to present profit or loss items using the "function of expense" method. b . The Company's operating cycle is one year. c. The consolidated financial statements comprise the financial statements of companies that are controlled by the Company (subsidiaries). Control is achieved when the Company is exposed, or has rights, to variable returns from its involvement with the investee and has the ability to affect those returns through its power over the investee. The consolidation of the financial statements commences on the date on which control is obtained and ends when such control ceases. The financial statements of the Company and of the subsidiaries are prepared as of the same dates and periods. The consolidated financial statements are prepared using uniform accounting policies by all companies in the Group. Significant intercompany balances and transactions and gains or losses resulting from intercompany transactions are eliminated in full in the consolidated financial statements. d. Functional currency, presentation currency and foreign currency 1. Functional currency and presentation currency The consolidated financial statements are presented in U.S. dollars, which is the Company's functional and presentation currency. 2. Transactions, assets and liabilities in foreign currency Transactions denominated in foreign currency are recorded on initial recognition at the exchange rate at the date of the transaction. After initial recognition, monetary assets and liabilities denominated in foreign currency are translated at the end of each reporting period into the functional currency at the exchange rate at that date. Exchange differences are recognized in profit or loss. Non-monetary assets and liabilities measured at cost in a foreign currency are translated at the exchange rate at the date of the transaction. e. Cash and cash equivalents Cash comprise of cash at banks and on hand. Cash equivalents are considered as highly liquid investments, including unrestricted short-term bank deposits with an original maturity of three months or less from the date of purchase, which are subject to an insignificant risk of changes in value. f. Short-term investments: Short-term bank deposits with a maturity of more than three months from the deposit date but less than one year and securities measured at fair value through other comprehensive income. g. Allowance for doubtful accounts The allowance for doubtful accounts is determined in respect of specific debts whose collection, in the opinion of the Company's management, is doubtful. Impaired debts are derecognized when they are assessed as uncollectible. As of December 31, 2018 and December 31, 2017 there was no allowance for doubtful accounts. h. Inventories Inventories are measured at the lower of cost and net realizable value. The cost of inventories comprises costs of purchase of raw and other materials and costs incurred in bringing the inventories to their present location and condition. Net realizable value is the estimated selling price in the ordinary course of business. Cost of inventories is determined as follows: Raw materials - At cost using the first-in, first-out method. Fair value of raw material received at no charge is not included in the inventory value. Work in process - Direct and indirect costs including materials, labor and other direct and indirect manufacturing costs calculated at average costs for the quarter and allocated to the manufactured batches during that quarter based on predetermined allocation factors. Finished products - Direct and indirect costs including materials, labor and other direct and indirect manufacturing costs calculated at average costs and allocated to the manufactured finished products during that quarter based on predetermined allocation factors. Purchased products - At cost using the first-in, first-out method. The Company periodically evaluates the condition and age of inventories and accounts for impairment of inventories with a lower market value or which are slow moving. i . Research and development costs Research expenditures are recognized in profit or loss when incurred and include preclinical and clinical costs (as well as cost of materials associated with the development of new products or existing products for new therapeutic indications). In addition, these costs include additional product development activities with respect to approved and distributed products as well as Post Marketing Commitment research and development activities. An intangible asset arising from a development project or from the development phase of an internal project is recognized if the Company can demonstrate the technical feasibility of completing the intangible asset so that it will be available for use or sale; the Company's intention to complete the intangible asset and use or sell it; the Company's ability to use or sell the intangible asset; how the intangible asset will generate future economic benefits; the availability of adequate technical, financial and other resources to complete the intangible asset; and the Company's ability to measure reliably the expenditure attributable to the intangible asset during its development. Since the Company development projects are often subject to regulatory approval procedures and other uncertainties, the conditions for the capitalization of costs incurred before receipt of approvals are not normally satisfied and therefore, development expenditures are recognized in profit or loss when incurred . j. Revenue recognition Regarding the initial adoption of IFRS 15, "Revenue from Contracts with Customers" ("the Standard"), the Company elected to adopt the provisions of the Standard using the modified retrospective method with the application of certain practical expedients and without restatement of comparative data. Revenues are recognized in profit or loss when the revenues can be measured reliably, it is probable that the economic benefits associated with the transaction will flow to the Company and the costs incurred or to be incurred in respect of the transaction can be measured reliably. Revenues are recognized at an amount that reflects the consideration to which an entity expects to be entitled in exchange for transferring goods or services to a customer. Agreements with strategic partner that include upfront and milestone payments contain a performance obligation that is satisfied over time given that the customer simultaneously receives and consumes the benefits provided by the Company. The Company recognizes revenue for upfront payments over time rather than at a point of time. The Company identified the existence of a significant financing component resulting from an upfront payment and recorded revenue against finance expense in the financial statements of 2018. In the tables below is the impact of IFRS 15 on the financial statements: As of January 01, 2018 before implementation of IFRS 15 Difference As of January ,01 2018 according to IFRS 15 U.S. Dollars in thousands Accumulated deficit $ (104,563 ) $ (757 ) $ (105,320 ) According to the previous accounting policy Difference As presented in the financial statements U.S. Dollars in thousands As of December 31, 2018 Current Liabilities Deferred revenues $ 1,129 - $ 1,129 Accumulated deficit (83,024 ) - (83,024 ) According to the previous accounting policy Difference As presented in the financial statements U.S. Dollars in thousands For the Year ended on December 31, 2018 Total revenues $ 113,652 $ 817 $ 114,469 Financial expenses (280 ) (60 ) (340 ) Net income 21,539 757 22,296 In cases where the Company operates as a principal supplier and it exposed to the risks and rewards associated with the transaction, revenues are presented on a gross basis. In events when the Company receives at no charge raw material, that is required for manufacturing one of the Company's products, the Company recorded the fair value of the raw material used and sold as revenue and charged the same fair value to cost of revenue. Deferred revenues Deferred revenues include unearned amounts received from customers not yet recognized as revenues. k. Taxes on income Taxes on income in profit or loss comprise of current and deferred taxes. Current or deferred taxes are recognized in profit or loss, except to the extent that the tax arises from items which are recognized directly in other comprehensive income or in equity. 1. Current taxes: The current tax liability is measured using the tax rates and tax laws that have been enacted or substantively enacted by the end of reporting period as well as adjustments required in connection with the tax liability in respect of previous years. 2. Deferred taxes: Deferred taxes are computed in respect of temporary differences between the carrying amounts in the financial statements and the amounts attributed for tax purposes. Deferred taxes are measured at the tax rates that are expected to apply when the asset is realized or the liability is settled, based on tax laws that have been enacted or substantively enacted by the end of the reporting period. Deferred taxes are offset in the statement of financial position if there is a legally enforceable right to offset a current tax asset against a current tax liability and the deferred taxes relate to the same taxpayer and the same taxation authority. l. Leases The criteria for classifying leases as finance or operating leases depend on the substance of the agreements and are made at the inception of the lease in accordance with the following principles as set out in IAS 17. The Group as lessee: 1. Finance lease Finance leases transfer to the Company substantially all the risks and benefits incidental to ownership of the leased asset. At the commencement of the lease term, the leased assets are measured at the fair value of the leased asset or, if lower, at the present value of the minimum lease payments. The leased asset is depreciated over the shorter of the lease term and the expected life of the leased asset. 2. Operating lease Lease agreements are classified as an operating lease if they do not transfer substantially all the risks and benefits incidental to ownership of the leased asset. Lease payments are recognized as an expense in profit or loss on a straight-line basis over the lease term. m. Property, plant and equipment Property, plant and equipment are measured at cost, including directly attributable costs and financing costs, less accumulated depreciation, accumulated impairment losses and any related investment grants and excluding day-to-day servicing expenses. Cost includes spare parts and auxiliary equipment that can be used only in connection with the plant and equipment. The Company's assets include computer systems comprising hardware and software. Software forming an integral part of the hardware to the extent that the hardware cannot function without the software installed on it is classified as property, plant and equipment. In contrast, software that adds functionality to the hardware is classified as an intangible asset. The cost of assets includes the cost of materials, direct labor costs, as well as any costs directly attributable to bringing the asset to the location and condition necessary for it to operate in the manner intended by management. Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows: % Mainly Buildings 2.5-4 4 Machinery and equipment 10-20 15 Vehicles 15 15 Computers, software, equipment and office furniture 6-33 33 Leasehold improvements ( * ) 10 (*) Leasehold improvements are depreciated on a straight-line basis over the shorter of the lease term (including the extension option held by the Company and intended to be exercised) and the expected life of the improvement. The useful life, depreciation method and residual value of an asset are reviewed at the year-end and any changes are accounted for prospectively as a change in accounting estimate. Depreciation of an asset ceases at the earlier of the date that the asset is classified as held for sale and the date that the asset is derecognized. n. Impairment of non-financial assets The Company evaluates the need to record an impairment of the carrying amount of non-financial assets whenever events or changes in circumstances indicate that the carrying amount is not recoverable. If the carrying amount of non-financial assets exceeds their recoverable amount, the assets are reduced to their recoverable amount. The recoverable amount is the higher of fair value less costs of sale and value in use. In measuring value in use, the expected future cash flows are discounted using a pre-tax discount rate that reflects the risks specific to the asset. The recoverable amount of an asset that does not generate independent cash flows is determined for the cash-generating unit to which the asset belongs. An impairment loss of an asset, is reversed only if there have been changes in the estimates used to determine the asset's recoverable amount since the last impairment loss was recognized. Reversal of an impairment loss, as above, shall not be increased above the lower of the carrying amount that would have been determined (net of depreciation or amortization) had no impairment loss been recognized for the asset in prior years and its recoverable amount. o. Financial instruments Regarding the initial adoption of IFRS 9, "Financial Instruments" ("the Standard"), the Company elected to adopt the provisions of the Standard retrospectively without restatement of comparative data. 1. Financial assets Financial After initial recognition, the accounting treatment of financial assets is based on their classification as follows: Debt financial instruments are subsequently measured at fair value through profit or loss (FVPL), amortized cost, or fair value through other comprehensive income (FVOCI). The classification is based on two criteria: the Company’s business model for managing the assets; and whether the instruments’ contractual cash flows represent ‘solely payments of principal and interest’ on the principal amount outstanding (the ‘SPPI criterion’). The classification and measurement of the Company’s debt financial assets are as follows: • Debt instruments at amortized cost for financial assets that are held within a business model with the objective to hold the financial assets in order to collect contractual cash flows that meet the SPPI criterion. This category includes the Company’s Trade and other receivables. • Debt instruments at FVOCI, with gains or losses recycled to profit or loss on derecognition. Financial assets in this category are the Company’s quoted debt instruments that meet the SPPI criterion and are held within a business model both to collect cash flows and to sell. Interest earned whilst holding AFS financial investments is reported as interest income using the effective interest rate method. Financial assets at FVPL comprise derivative a. Impairment of financial assets The Company assesses at the end of each reporting period whether there is any objective evidence of impairment of a financial asset or group of financial assets. The Company records an allowance for expected credit loss ("ECL") for all debt financial assets not held at FVPL. ECLs are based on the difference between the contractual cash flows due in accordance with the contract and all the cash flows that the Company expects to receive. For other debt financial assets (i.e., debt securities at FVOCI), the ECL is based on the 12-month ECL. The 12-month ECL is the portion of lifetime ECLs that results from default events on a financial instrument that are possible within 12 months after the reporting date. As of December 31, 2018 there is no ECL allowance. 2. Financial liabilities Financial liabilities within the scope of IFRS 9 are initially measured at fair value. After initial recognition, the accounting treatment of financial liabilities is based on their classification as follows: a. Financial liabilities measured at amortized cost Loans, including capital leases, are measured based on their terms at amortized cost using the effective interest method taking into account directly attributable transaction costs. b. Financial liabilities measured at fair value Derivatives are classified as fair value through profit and loss unless they are designated as effective hedging instruments. Transaction costs are recognized in profit or loss. 3. Fair value measurement Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurement is based on the assumption that the transaction will take place in the asset's or the liability's principal market, or in the absence of a principal market, in the most advantageous market. The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest. A fair value measurement of a non-financial asset takes into account a market participant's ability to generate economic benefits by using the asset in its highest and best use or by selling it to another market participant that would use the asset in its highest and best use. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities for which fair value is measured or disclosed in the financial statements are categorized within the fair value hierarchy, described as follows, based on the lowest level input that is significant to the fair value measurement as a whole: - Level 1 - quoted prices (unadjusted) in active markets for identical assets or liabilities. - Level 2 - inputs other than quoted prices included within Level 1 that are observable either directly or indirectly. - Level 3 - inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data). 4. Offsetting financial instruments Financial assets and financial liabilities are offset and the net amount is presented in the statement of financial position if there is a legally enforceable right to set off the recognized amounts and there is an intention either to settle on a net basis or to realize the asset and settle the liability simultaneously. The right of set-off must be legally enforceable not only during the ordinary course of business of the parties to the contract but also in the event of bankruptcy or insolvency of one of the parties. In order for the right of set-off to be currently available, it must not be contingent on a future event, there may not be periods during which the right is not available, or there may not be any events that will cause the right to expire. 5. De-recognition of financial instruments a. Financial assets Financial assets are derecognized when the contractual rights to the cash flows from the financial asset expire or the Company has transferred its contractual rights to receive cash flows from the financial asset or assumes an obligation to pay the cash flows in full without material delay to a third party and has transferred substantially all the risks and rewards of the asset, or has neither transferred nor retained substantially all the risks and rewards of the asset, but has transferred control of the asset. b. Financial liabilities A financial liability is derecognized when it is extinguished, that is when the obligation is discharged or cancelled or expires. A financial liability is extinguished when the debtor (the Company) discharges the liability by paying in cash, other financial assets, goods or services or is legally released from the liability. p. Derivative financial instruments designated as hedges The Company enters into contracts for derivative financial instruments such as forward currency contracts and cylinder strategy in respect of foreign currency to hedge risks associated with foreign exchange rates fluctuations. Such derivative financial instruments are carried as financial assets when the fair value is positive and as financial liabilities when the fair value is negative. At the inception of a hedge relationship, the Company formally designates and documents the hedge relationship to which the Company wishes to apply hedge accounting and the risk management objective and strategy for undertaking the hedge. The hedge effectiveness is assessed at the end of each reporting period. Any gains or losses arising from changes in the fair value of derivatives that do not qualify for hedge accounting are recorded immediately in profit or loss. Cash flow hedges The effective portion of the gain or loss on the hedging instrument is recognized as other comprehensive income (loss), while any ineffective portion is recognized immediately in profit or loss. Amounts recognized as other comprehensive income (loss) are reclassified to profit or loss when the hedged transaction affects profit or loss, such as when the hedged income or expense is recognized or when a forecast payment occurs. If the forecast transaction or firm commitment is no longer expected to occur, amounts previously recognized in other comprehensive income are reclassified to profit or loss. If the hedging instrument expires or is sold, terminated or exercised, or if its designation as a hedge is revoked, amounts previously recognized in other comprehensive income remain in other comprehensive income until the forecast transaction or firm commitment occurs. q. Accrued expenses A provision in accordance with IAS 37 is recognized when the Group has a present (legal or constructive) obligation as a result of a past event, it is expected to require the use of economic resources to clear the obligation and a reliable estimate can be made of it. r. Employee benefit liabilities The Company has several employee benefit plans: 1. Short-term employee benefits Short-term employee benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions and are recognized as expenses as the services are rendered. A liability in respect of a cash bonus is recognized when the Company has a legal or constructive obligation to make such payment as a result of past service rendered by an employee and a reliable estimate of the amount can be made. 2. Post-employment benefits The post-employment benefits plans are normally financed by contributions to insurance companies and classified as defined contribution plans or as defined benefit plans. The Company has defined contribution plans pursuant to Section 14 to the Israeli Severance Pay Law under which the Company pays fixed contributions to certain employees under section 14 and will have no legal or constructive obligation to pay further contributions. Contributions to the defined contribution plan in respect of severance or retirement pay are recognized as an expense when contributed concurrently with performance of the employee's services. In addition the Company operates a defined benefit plan in respect of severance pay pursuant to the Israeli Severance Pay Law. According to the Law, employees are entitled to severance pay upon dismissal or retirement. The liability for termination of employment is measured using the projected unit credit method. The actuarial assumptions include expected salary increases and rates of employee's turnover based on the estimated timing of payment. The amounts are presented based on discounted expected future cash flows using a discount rate determined by reference to market yields at the reporting date on high quality corporate bonds that are linked to the Consumer Price Index with a term that is consistent with the estimated term of the severance pay obligation. In respect of its severance pay obligation to certain of its employees, the Company makes current deposits in pension funds and insurance companies ("the plan assets"). Plan assets comprise assets held by a long-term employee benefit fund or qualifying insurance policies. Plan assets are not available to the Company's own creditors and cannot be returned directly to the Company. The liability for employee benefits shown in the statement of financial position reflects the present value of the defined benefit obligation less the fair value of the plan assets. Re-measurements of the net liability are recognized in other comprehensive income in the period in which they occur. s. Share-based payment transactions The Company's employees and Board of Directors members are entitled to remuneration in the form of equity-settled share-based payment transactions. Equity-settled transactions The cost of equity-settled transactions (options and restricted shares) with employees and Board of Directors members is measured at the fair value of the equity instruments granted at grant date. The fair value of options is determined using a standard option pricing model. The fair value of restricted shares is determined using the share price at the grant date. The cost of equity-settled transactions is recognized in profit or loss together with a corresponding increase in shareholder's equity during the period which the performance and/or service conditions are to be satisfied ending on the date on which the relevant employees become entitled to the award ("the vesting period"). The cumulative expense recognized for equity-settled transactions at the end of each reporting period until the vesting date reflects the extent to which the vesting period has expired and the Company’s best estimate of the number of equity instruments that will ultimately vest. No expense is recognized for awards that do not ultimately vest. In the event that the Company modifies the conditions on which equity-instruments were granted, an additional expense is calculated and recognized t. Earnings (loss) per Share Earnings (loss) per share are calculated by dividing the net income (loss) attributable to Company shareholders by the weighted number of ordinary shares outstanding during the period. Ordinary shares underlying shares options or restricted shares are only included in the calculation of diluted income (loss) per share when their impact dilutes the income (loss) per share. Furthermore, potential ordinary shares converted during the period are included under diluted income (loss) per share only until the conversion date, and from that date on are included under basic income (loss) per share. |
SIGNIFICANT ACCOUNTING JUDGMENT
SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUMPTIONS USED IN THE PREPARATION OF THE FINANCIAL STATEMENTS | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of significant accounting judgments, estimates and assumptions used in the preparation of the financial statements [Abstract] | |
SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUMPTIONS USED IN THE PREPARATION OF THE FINANCIAL STATEMENTS | Note 3: - Significant accounting judgments, estimates and assumptions used in the preparation of the financial statements In the process of applying the significant accounting policies, the Group has made the following judgments which have the most significant effect on the amounts recognized in the financial statements: a. Judgments Revenue The Company assesses the criteria for recognition of revenue related to up-front payments and milestones as outlined by IFRS 15. Judgment is necessary to determine over which period the Company will satisfy its performance obligations related to up-front payments and milestones and whether financing component exists. For additional information, refer to Note 17a. b . Estimates and assumptions The preparation of the financial statements requires management to make estimates and assumptions that have an effect on the application of the accounting policies and on the reported amounts of assets, liabilities, revenues and expenses. Changes in accounting estimates are reported in the period of the change in estimate. The key assumptions made in the financial statements concerning uncertainties at the end of the reporting period and the critical estimates computed by the Company that may result in a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed below. - Legal claims In estimating the likelihood of outcome of legal claims filed against the Company, the Company relies on the opinion of its legal counsel. These estimates are based on the legal counsel's best professional judgment, taking into account the stage of proceedings and historical legal precedents in respect of the different issues. Since the outcome of the claims will be determined in courts, the results could differ from these estimates. - Pensions and other post-employment benefits The liability in respect of post-employment defined benefit plans is determined using actuarial valuations. The actuarial valuation involves making assumptions about, among others, discount rates, expected rates of return on assets, future salary increases and mortality rates. Due to the long-term nature of these plans, such estimates are subject to significant uncertainty. - Determining the fair value of share-based payment transactions Estimating fair value for share-based payment transactions requires determination of the most appropriate - Provisions for clinical trial and related expenses Accrued expenses costs for clinical trial activities performed by third parties, are based on estimates on the progress of completion of the clinical trials or services, as of the end of each reporting period, pursuant to the contract with the third parties, and the agreed upon fee to be paid for such services. - Capitalization of materials for clinical trials and inventory designated for R&D activities The Company recognizes inventory produced for commercial sale, including costs incurred prior to regulatory approval but subsequent to the filing of a regulatory request when the Company has determined that the inventory has probable future economic benefit. Inventory is not recognized prior to completion of a phase III clinical trial. For products with an approved indication, raw materials and purchased drug product associated with development programs are included in inventory and charged to research and development expense when consumed. For products without an approved indication, drug product is charged to research and development expense. - Recognition of deferred tax asset in respect of carry forward tax losses The Company recorded a deferred tax asset in respect of carry forward tax losses based on effective tax rate calculation considering the Law for the Encouragement of Capital Investments and future taxable income estimation and the probability that in the future there will be taxable income against which the carry forwards losses can be utilized. This estimation can affect the recognition or reversal of deferred tax asset in the profit or loss. For information regarding deferred taxes recognition, please refer to note 21. - Impairment test for the production facility The Company performed an impairment test due to indications that can, in the future, result in a possible impairment. The Company calculated the recoverable amount of the production facility to determine whether the book value exceeds its recoverable amount. The impairment test was based on a DCF model using the Company's long term forecast. As of December 31, 2018 no impairment was recorded as the recoverable amount exceeded the book value. |
DISCLUSURE OF NEW STANDARDS IN
DISCLUSURE OF NEW STANDARDS IN THE PERIOD PRIOR TO THEIR ADOPTION | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of new ifrs in the period [Abstract] | |
DISCLUSURE OF NEW STANDARDS IN THE PERIOD PRIOR TO THEIR ADOPTION | Note 4: - DISCLUSURE OF NEW STANDARDS IN THE PERIOD PRIOR TO THEIR ADOPTION a. IFRS 16 – Leases IFRS 16, replaces IAS 17 (Leases), and affects the accounting treatment for lessees with respect to leased assets. Pursuant to IFRS 16, all leases (except short term leases and small asset leases) will be recognized in the balance sheet. Initially, the lease liability and the right-of-use asset are measured at the present value of future lease payments (defined as economically unavoidable payments). The right-of-use asset is subsequently depreciated in a similar way to other assets such as tangible assets, i.e. typically in a straight-line over the lease term. Lessees will be required to separately recognize the interest expense on the lease liability and the depreciation expense on the right-of-use asset. Lessees will be also required to re-measure the lease liability upon the occurrence of certain events (e.g., a change in the lease term, a change in future lease payments resulting from a change in an index or rate used to determine those payments). The lessee will generally recognize the amount of the re-measurement of the lease liability as an adjustment to the right-of-use asset. The new Standard is effective for annual periods be ginning on or after January 1, 2019. Earlier is permitted provided that IFRS 15, "Revenue from Contracts with Customers", is applied concurrently. The Company plans to adopt IFRS 16 using the cumulative effect method without changing comparative information. The The Company elects to use the exemptions proposed by the standard with respect to lease contracts for which the underlying asset is of low value. The Company has leases of certain office equipment (i.e., printing and photocopying machines) that are considered of low value. During 2018, the Company has performed a detailed impact assessment of IFRS 16. Impact on the statement of financial position (increase/(decrease)) as at January 1, 2019: Assets U.S. Dollars in thousands Property, plant and equipment (right-of-use assets) 4,138 Lease liabilities 4,622 Net impact on equity (484 ) Pursuant to the adoption of IFRS 16, the Company’s operating expenses will be changed by the difference between the previously recognized lease costs and the depreciation costs on account of the Right-of-Use assets. In addition, the Company will begin to recognize interest expenses regarding the lease liability, which were not recognized in prior periods. Moreover, as of December 31, 2018 the effect of the initial adoption of the new Standard in 2019 is expected to result in a decrease in the Company's lease expenses of $967 thousands and an increase in the Company's depreciation and finance expenses of $804 thousands and $185 thousands, respectively. The total effect of the initial adoption of the new Standard in 2019 is expected to result in an increase of $163 thousands in operating income and a decrease of $22 thousands in income before taxes. b. IFRIC 23 - Uncertainty over Income Tax Treatment IFRIC 23 clarifies application of recognition and measurement requirements in IAS 12 (Income Taxes) when there is uncertainty over income tax treatment. In determining taxable profit (tax loss), tax bases, unused tax losses, unused tax credits and tax rates, an entity must consider the probability that a taxation authority will accept an uncertain tax treatment. An entity has to determine whether to consider each uncertain tax treatment separately or together with one or more other uncertain tax treatments. The approach that better predicts the resolution of the uncertainty should be followed. IFRIC 23 is effective for annual reporting periods beginning on or after 1 January 2019. The Company will apply the interpretation from its effective date. The Company evaluated the possible impact of IFRIC 23, reviewed its tax position taken, in the Company's tax returns for all tax years currently open to examination by a taxing authority. The Company believes the implementation of is not expected to have a material impact on its financial statements. |
CASH AND CASH EQUIVALENTS
CASH AND CASH EQUIVALENTS | 12 Months Ended |
Dec. 31, 2018 | |
Cash and cash equivalents [abstract] | |
CASH AND CASH EQUIVALENTS | NOTE 5: - CASH AND CASH EQUIVALENTS December 31, 2018 2017 U.S. Dollars in thousands Cash and deposits for immediate withdrawal $ 18,018 $ 8,539 Cash equivalents in USD deposits (1) - 4,001 Cash equivalents in NIS deposits (2) 75 141 $ 18,093 $ 12,681 (1) The deposits bear interest of 1.53% per year, as of December 31, 2017 . (2) The deposits bear interest of 0.16% per year, as of December 31, 2018 and 0.01% per year, as of December 31, 2017. |
SHORT-TERM INVESTMENTS
SHORT-TERM INVESTMENTS | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of short-term investments [Abstract] | |
SHORT-TERM INVESTMENTS | Note 6: - Short-Term Investments December 31, 2018 2017 U.S. Dollars in thousands Fair value through other comprehensive income $ 10,325 $ 8,597 Marketable securities (equity and debt) at fair value through profit or loss (2) - 1,663 Bank deposits in USD (1) 22,174 20,078 $ 32,499 $ 30,338 (1) The deposits bear interest of 2.6%-3.5% and 1.7%-2.3% per year, as of December 31, 2018 and 2017, respectively. (2) Following implementation of IFRS 9 all the investment portfolio is measured as fair value through other comprehensive income. As a result the Company reclassified from FVTPL to FVOCI as of January 1, 2018. |
TRADE RECEIVABLES, NET
TRADE RECEIVABLES, NET | 12 Months Ended |
Dec. 31, 2018 | |
Trade and other current receivables [abstract] | |
TRADE RECEIVABLES, NET | Note 7: - Trade Receivables, net December 31, 2018 2017 U.S. Dollars in thousands Open accounts: In NIS $ 6,780 $ 8,263 In USD 20,814 22,284 $ 27,594 $ 30,547 Checks receivable 80 115 $ 27,674 $ 30,662 Less allowance for doubtful accounts - - Trade receivables, net $ 27,674 $ 30,662 An analysis of past due but not impaired trade receivables with reference to reporting date: Past due trade receivables with aging of Neither past due Up to 30 Days 30-60 60-90 90-120 Over 120 days Total U.S. Dollars in thousands December 31, 2018 $ 27,215 $ 337 $ 15 $ 15 $ 6 $ 6 $ 27,594 December 31, 2017 $ 29,692 $ 680 $ 21 $ 152 $ 2 - $ 30,547 |
OTHER ACCOUNTS RECEIVABLES
OTHER ACCOUNTS RECEIVABLES | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of other accounts receivables [Abstract] | |
OTHER ACCOUNTS RECEIVABLES | Note 8: - Other accounts Receivables December 31, 2018 2017 U.S. Dollars in thousands Materials for clinical trials and inventory designated for R&D activities $ 399 $ 635 Prepaid expenses 1,086 822 Government authorities 1,552 563 Accrued interest 66 66 Accrued income 193 33 Other 12 13 $ 3,308 $ 2,132 |
INVENTORIES
INVENTORIES | 12 Months Ended |
Dec. 31, 2018 | |
Classes of current inventories [abstract] | |
INVENTORIES | Note 9: – Inventories December 31, 2018 2017 U.S. Dollars in thousands Finished products $ 7,023 $ 5,168 Purchased products 4,813 2,695 Work in progress 4,792 6,159 Raw materials 12,688 7,048 $ 29,316 $ 21,070 (1) During the years 2018, 2017 and 2016, the Company recorded, as cost of revenues, an impairment of inventories of $61 thousands, $460 thousands and $544 thousands, respectively. |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of detailed information about property, plant and equipment [abstract] | |
PROPERTY, PLANT AND EQUIPMENT | Note 10: – Property, Plant and equipment a. Composition and movement: 2018 Land and Buildings(1) Machinery and Equipment Vehicles Computers, Software, Equipment and Office Furniture Leasehold Improvements Total U.S. Dollars in thousands Cost ` Balance at January 1, 2018 $ 28,399 $ 29,602 $ 66 $ 6,522 $ 1,273 $ 65,862 Additions 806 2,331 19 590 (132 ) 3,614 Sale and write-off (38 ) (1,547 ) - (619 ) - (2,204 ) Balance as of December 31, 2018 29,167 30,386 85 6,493 1,141 67,272 Accumulated Depreciation Balance as of January 1, 2018 13,916 21,430 59 5,194 85 40,684 Depreciation and impairment 1,198 1,711 4 672 118 3,703 Sale and write-off (38 ) (1,462 ) - (619 ) - (2,119 ) Balance as of December 31, 2018 15,076 21,679 63 5,247 203 42,268 Depreciated cost as of December 31, 2018 $ 14,091 $ 8,707 $ 22 $ 1,246 $ 938 $ 25,004 2017 Land and Buildings(1) Machinery and Equipment (1) (2) Vehicles Computers, Software, Equipment and Office Furniture Leasehold Improvements Total U.S. Dollars in thousands Cost Balance at January 1, 2017 $ 27,618 $ 26,485 $ 94 $ 5,520 $ 1,052 $ 60,769 Additions 781 3,151 - 1,002 1,196 6,130 Sale and write-off - (34 ) (28 ) - (975 ) (1,037 ) Balance as of December 31, 2017 28,399 29,602 66 6,522 1,273 65,862 Accumulated Depreciation Balance as of January 1, 2017 12,606 19,972 86 4,559 967 38,190 Depreciation and impairment 1,310 1,492 1 635 85 3,523 Sale and write-off - (34 ) (28 ) - (967 ) (1,029 ) Balance as of December 31, 2017 13,916 21,430 59 5,194 85 40,684 Depreciated cost as of December 31, 2017 $ 14,483 $ 8,172 $ 7 1,328 $ 1,188 $ 25,178 (1) Including labor costs charged in 2018 and 2017 to the cost of facilities, machinery and equipment in the amount of $514 thousands and $431 thousands, respectively. (2) Including financing costs of $44 thousands capitalized in 2017 to the cost of machinery and equipment. During 2018 no financing costs were capitalized. b. As for liens, refer to Note 18. c. Capitalized leasing rights of land from the Israel land administration. December 31, 2018 2017 U.S. Dollars in thousands Under finance lease $ 1,004 $ 1,016 The Group has capitalized leasing rights from the Israel Land Administration for an area of 16,880 m² in Beit Kama, Israel, on which the Company’s manufacturing plant and other buildings are located. The sum attributed to capitalized rights is presented under property, plant and equipment and is depreciated over the leasing period, which includes the option period. During 2010, the Company signed an agreement with the Israel Land Administration to consolidate its leasing rights and extend the lease period to 2058, including an extension option for additional 49 years thereafter. |
OTHER LONG TERM ASSETS
OTHER LONG TERM ASSETS | 12 Months Ended |
Dec. 31, 2018 | |
Miscellaneous non-current assets [abstract] | |
OTHER LONG TERM ASSETS | Note 11: - other Long Term Assets December 31, 2018 2017 U.S. Dollars in thousands Distribution right (1) 123 - Long term pre-paid expenses 51 49 $ 174 $ 49 (1) During 2018 the Company entered into agreement to obtain the distribution right of a certain therapeutic product to be distributed in Israel, subject to Israeli Ministry of Health (“IL MOH") marketing approval. Pursuant to the agreement, the Company was required to make certain upfront and milestone payments. These payments are accounted for as long term assets through obtaining IL MOH marketing authorization, and it will be amortized during the product's economic useful life. |
TRADE PAYABLES
TRADE PAYABLES | 12 Months Ended |
Dec. 31, 2018 | |
Trade and other current payables [abstract] | |
TRADE PAYABLES | Note 12: - Trade Payables December 31, 2018 2017 U.S. Dollars in thousands Open debts mainly in USD $ 11,408 $ 11,246 Open debts in NIS 5,876 6,789 Sub-Total 17,284 18,035 Notes payable 1 1 $ 17,285 $ 18,036 |
OTHER ACCOUNTS PAYABLES
OTHER ACCOUNTS PAYABLES | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of other accounts payable [Abstract] | |
OTHER ACCOUNTS PAYABLES | Note 13: – Other accounts Payables December 31, 2018 2017 U.S. Dollars in thousands Employees and payroll accruals $ 4,708 $ 4,735 Derivatives financial instruments 64 8 Accrued Expenses and Others 489 1,077 $ 5,261 $ 5,820 |
LOANS AND CAPITAL LEASES
LOANS AND CAPITAL LEASES | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of loans and capital leases [abstract] | |
LOANS AND CAPITAL LEASES | Note 14: - Loans and capital leases December 31, 2018 2017 U.S. Dollars in thousands Total loans and capital leases (1) 1,278 1,984 Less current maturities 562 614 Long term loans and capital leases $ 716 $ 1,370 (1) Capital leases balance was $138 thousands and $274 thousands, as of December 31, 2018 and 2017, respectively. Bank loans The loans are |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of detailed information about financial instruments [abstract] | |
FINANCIAL INSTRUMENTS | Note 15: - Financial Instruments a. Classification of financial assets and liabilities The financial assets and financial liabilities in the balance sheet are classified by groups of financial instruments pursuant to IFRS 9: December 31, 2018 2017 U.S. Dollars in thousands Financial assets Financial assets at fair value: Marketable securities (equity and debt) – through profit or loss - $ 1,663 Financial assets at fair value through other comprehensive income: Financial assets at fair value through other comprehensive income 10,324 8,597 Financial assets at cost: Cash and cash equivalent 18,093 * 12,681 Short term bank deposits 22,175 *20,078 $ 50,592 $ 43,019 Financial liabilities Derivatives instruments mainly measured at fair value through other comprehensive income $ 64 $ 8 Financial liabilities measured at amortized cost: Bank loans and capital leases 1,278 1,984 $ 1,342 $ 1,992 *Reclassified b. Financial risk factors The Company's activities expose it to various financial risks, such as market risk ( foreign Risk management is the responsibility of the Company CEO and CFO, in accordance with the approved by the Board of Directors. The Board of Directors provides principles for the overall risk management. 1. Market risks a) Foreign exchange risk The Company operates in an international environment and is exposed to foreign exchange risk resulting from the exposure to different currencies, mainly the NIS and EUR. Foreign exchange risks arise from recognized assets and liabilities denominated in a foreign currency other than the functional currency, such as trade and other accounts receivables, trade and other accounts payables, loans and capital leases. As of December 31, 2018, the Company has a position in financial derivatives intended to hedge changes in the exchange rate of the USD vs. the NIS (see also f. below). b) Price risk As of December 31, 2018, the Company has financial instruments, classified as assets measured at fair value through other comprehensive income for which the Company is exposed to risk of fluctuations in the security price that is determined by reference to the quoted market price. 2. Credit risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents, short-term bank deposits, marketable securities, trade receivables and foreign currency derivative contracts. a) Trade receivables: The Company regularly monitors the credit extended to its customers and their general financial condition, and, when necessary, requires collateral as security for these debts such as letters of creditor and down payments. In addition, the Company partially insures its overseas sales with foreign trade risk insurance. The Company keeps constant track of customer debt and the Financial Statements include an allowance for doubtful accounts that adequately reflects, in the Company's assessment, the loss embodied in the debts the collection of which is in doubt. The Company’s maximum exposure to credit risk for the components of the statement of financial position as of December 31, 2018 and 2017 is the carrying amount of trade receivables. b) Cash and cash equivalent and short term investments: The Company holds cash, cash equivalents, short term deposits and other financial instruments at a major financial institutions in Israel. In accordance with Company policy, evaluations of Short-term include short-term deposits with low risk for a period less than one year. The Company’s marketable securities consist of investment-grade corporate bonds, government bonds (Including U.S., Israeli and other government bonds). The Company’s investment policy, limits the amount the Company may invest in any one type of investment or issuer and the average maturities of the bond portfolio, thereby reducing credit risk concentrations. The Company has not experienced any significant losses on its short term investments. c) Foreign currency derivative contracts: The Company is exposed to foreign currency exchange movements, primarily in Israel. Consequently, it enters into various foreign currency exchange contracts with major financial institutions (see also f. below). 3. Liquidity risk The table below summarizes the maturity profile of the Company's financial liabilities based on contractual undiscounted payments: December 31, 2018 Less than one year 1 to 2 2 to 3 3 to 5 Total U.S. Dollars in thousands Trade payables $ 17,285 - - - $ 17,285 Other accounts payables 5,261 - - - 5,261 Long term loans and capital leases (including interest) $ 595 $ 495 $ 209 $ 32 $ 1,331 $ 23,141 $ 495 $ 209 $ 32 $ 23,877 December 31, 2017 Less than one year 1 to 2 2 to 3 3 to 5 Total U.S. Dollars in thousands Trade payables $ 18,036 - - - $ 18,036 Other accounts payables 5,820 - - - 5,820 Long term loans and capital leases (including interest) 669 634 532 260 2,095 $ 24,525 $ 634 $ 532 $ 260 $ 25,951 Changes in liabilities arising from financing activities January 1, 2018 Payments Foreign exchange movement Cash from new loans New leases December 31, 2018 U.S. Dollars in thousands Bank loans $ 1,710 (460 ) (110 ) - - 1,140 Capital leases 274 (136 ) - - - 138 Total $ 1,984 $ (596 ) $ (110 ) - - $ 1,278 c. Fair value The following table demonstrates the carrying amount and fair value of the financial instruments presented in the financial statements not at fair value: Carrying Amount Fair Value December 31, December 31, 2018 2017 2018 2017 U.S. Dollars in thousands Financial liabilities Bank loans and capital Leases $ 1,278 $ 1,984 $ 1,275 $ 1,984 The fair value of the bank loans and capital leases was based on standard pricing valuation model such as DCF which considers the present value of future cash flows discounted at the interest rate that reflects market conditions (Level 3). The carrying amount of cash and cash equivalents, short term bank deposits, trade and other receivables, trade and other payables approximates their fair value, due to the short term maturities of the financial instruments. d. Classification of financial instruments by fair value hierarchy Financial assets (liabilities) measured at fair value: Financial assets (liabilities) measured at fair value: Level 1 Level 2 U.S. Dollars in thousands December 31, 2018 Debt securities (corporate and government) measured fair value through other comprehensive income $ 1,588 8,736 Derivatives instruments - (64 ) $ 1,588 $ 8,672 Level 1 Level 2 U.S. Dollars in thousands December 31, 2017 Marketable securities at fair value through profit or loss: Equity shares $ 77 Mutual funds 456 Debt securities (corporate and government) 1,130 Derivatives instruments (8 ) Available for sale debt securities (corporate and government) $ 8,597 $ 1,663 $ 8,589 During 2018 there was no transfer due to the fair value measurement of any financial instrument from Level 1 to Level 2, and furthermore, there were no transfers to or from Level 3 due to the fair value measurement of any financial instrument. Sensitivity tests and principal work assumptions The selected changes in the relevant risk variables were determined based on management's estimate as to reasonable possible changes in these risk variables. The Company has performed sensitivity tests of principal market risk factors that are liable to affect its reported operating results or financial position. The sensitivity tests present the profit or loss in respect of each financial instrument for the relevant risk variable chosen for that instrument as of each reporting date. The test of risk factors was determined based on the materiality of the exposure of the operating results or financial condition of each risk with reference to the functional currency and assuming that all the other variables are constant December 31, 2018 2017 U.S. Dollars in thousands Sensitivity test to changes in market price of listed Securities Gain (loss) from change: 5% increase in market price $ 519 $ 513 5% decrease in market price $ (519 ) $ (513 ) Sensitivity test to changes in foreign currency: Gain (loss) from change: 5% increase in NIS $ (21 ) $ (143 ) 5% decrease in NIS $ 21 $ 143 5% increase in Euro $ (197 ) $ (135 ) 5% decrease in Euro $ 197 $ 135 e. Linkage terms of financial liabilities by groups of financial instruments pursuant to IFRS 9: December 31, 2018 2017 U.S. Dollars in thousands In NIS: Bank loans measured at amortized cost $ 1,140 $ 1,710 In USD: Capital leases measured at amortized cost $ 138 $ 274 f. Derivatives and hedging: Derivatives instruments not designated as hedging The Company has foreign currency forward contracts designed to protect it from exposure to fluctuations in exchange rates, mainly of NIS and EUR, in respect of its trade receivables, trade payables and inventory. Foreign currency forward contracts are not designated as cash flow hedges, fair value or net investment in a foreign operation. These derivatives are not considered as hedge accounting. As of December 31, 2018 the fair value of the derivative instruments not designated as hedging was a liability of $6 thousands. The open transactions for those derivatives were in an amount of $5,009 thousands. Cash flow hedges As of December 31, 2018, the Company held NIS/USD hedging contracts (cylinder contracts) designated as hedges of expected future salaries expenses and for expected future purchases from Israeli suppliers. The main terms of these positions were set to match the terms of the hedged items. As of December 31, 2018 the fair value of the derivative instruments designated as hedge accounting was a liability of $58 thousands. The open transactions for those derivatives were in an amount of $1,169 thousands. Cash flow hedges of the expected salaries expenses in December 31, 2018 was estimated as highly effective and accordingly a net unrecognized loss was recorded in other comprehensive income in the amount of $99 thousands. |
EMPLOYEE BENEFIT LIABILITIES, N
EMPLOYEE BENEFIT LIABILITIES, NET | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of defined benefit plans [abstract] | |
EMPLOYEE BENEFIT LIABILITIES, NET | Note 16: - Employee Benefit Liabilities, NET Employee benefits consist of short-term benefits and post-employment benefits. a. Post-employment benefits: According to the labor laws and Severance Pay Law in Israel, the Company is required to pay compensation to an employee upon dismissal or retirement or to make current contributions in defined contribution plans pursuant to Section 14 of the Severance Pay Law, as specified below. The Company's liability is accounted for as a post-employment benefit only for employees not under Section 14. The computation of the Company's employee benefit liability is made in accordance with a valid employment contract or a collective employees agreement based on the employee's salary and employment terms which establish the entitlement to receive the compensation. The post-employment employee benefits are normally financed by contributions classified as defined benefit plans, as detailed below: 1. Defined contribution deposit The Company’s agreements with part of its employees are in accordance with section 14 of the Israeli Severance Pay Law. Contributions made by the Company in accordance with Section 14 release the Company from any future severance liabilities in respect of those employees. The expenses for the defined benefit deposit in 2018, 2017 and 2016 were $ 992 thousands, $ 884 thousands and $669 thousands, respectively. 2. Defined benefit plans The Company accounts for the payment of compensation as a defined benefit plan for which an employee benefit liability is recognized and for which the Company deposits amounts in a long-term employee benefit fund and in qualifying insurance policies. 3. Expenses recognized in comprehensive income (loss): Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Current service cost $ 292 $ 356 $ 359 Interest expenses, net 25 23 20 Current service cost (income) due to the transfer of real yield from the compensation component to the royalties' component in executive insurance policies before 2004 3 (7 ) 5 Total employee benefit expenses 320 372 384 Actual return on plan assets $ 171 $ 119 $ 22 The expenses are presented in the Statement of Comprehensive income (loss) as follows Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Cost of revenues $ 175 $ 211 $ 228 Research and development 50 57 62 Selling and marketing 75 *73 *67 General and administrative 20 *31 *27 $ 320 $ 372 $ 384 * Reclassified 4. The plan liabilities, net: December 31, 2018 2017 U.S. Dollars in thousands Defined benefit obligation $ 4,987 $ 5,907 Fair value of plan assets (4,200 ) (4,763 ) Total liabilities, net $ 787 $ 1,144 5 . Changes in the present value of defined benefit obligation 2018 2017 U.S. Dollars in thousands Balance at January 1, $ 5,907 $ 5,235 Interest costs 110 151 Current service cost 292 356 Benefits paid (645 ) (641 ) Demographic assumptions (29 ) (28 ) Financial assumptions (223 ) 254 Past Experience (2 ) 6 Currency Exchange (423 ) 574 Balance at December 31, $ 4,987 $ 5,907 6. Plan assets a) Plan assets Plan assets comprise assets held by long-term employee benefit funds and qualifying insurance policies. b) Changes in the fair value of plan assets 2018 2017 U.S. Dollars in thousands Balance at January 1, $ 4,763 $ 4,513 Expected return 85 127 Contributions by employer 182 227 Benefits paid (564 ) (586 ) Demographic assumptions 5 1 Financial assumptions (2 ) 1 Past Experience 83 (11 ) Current service cost due to the transfer of real yield from the compensation component to the royalties component in executive insurance policies before 2004 (3 ) 7 Currency exchange (349 ) 484 Balance at December 31, $ 4,200 $ 4,763 7. The principal assumptions underlying the defined benefit plan 2018 2017 2016 % Discount rate of the plan liability 2.02 2.27 3.72 Future salary increases 3.6 4 4 The sensitivity analyses below have been determined based on reasonably possible changes of the principal assumptions underlying the defined benefit plan as mentioned above, occurring at the end of the reporting period. In the event that the discount rate would be one percent higher or lower, and all other assumptions were held constant, the defined benefit obligation would decrease by $189 thousands or increase by $241 thousands, respectively. In the event that the expected salary growth would increase or decrease by one percent, and all other assumptions were held constant, the defined benefit obligation would increase by $229 thousands or decrease by $182 thousands, respectively. |
CONTINGENT LIABILITIES AND COMM
CONTINGENT LIABILITIES AND COMMITMENTS | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of contingent liabilities and commitments [Abstract] | |
CONTINGENT LIABILITIES AND COMMITMENTS | Note 17: - Contingent Liabilities and commitments a. On August 23, 2010, the Company entered into a 30 years collaboration agreement with Baxter Healthcare Corporation ("Baxter") with respect to obtaining the distribution rights the Company's AAT IV drug ("GLASSIA. During 2015, Baxter assigned all its rights under the collaboration agreement to Baxalta US Inc. ("Baxalta") which was acquired during 2016 by Shire plc, which is now part of Takeda (“Takeda” and in these consolidated financial statements Baxter, Baxalta and Shire will be referred to as "Takeda"). The collaboration agreement consists of three main agreements (1) An Exclusive Manufacturing, Supply and Distribution agreement for GLASSIA in the United States, Canada, Australia and New Zealand ("the Territory" and "the Distribution Agreement", respectively); (2) Technology License Agreement for the use of the Company's knowhow and patents for the production, continued development and sale of GLASSIA by Takeda ("the License Agreement") in the Territory; and (3) A Paste Supply Agreement for the supply by Takeda of raw materials to be used by the Company for the production of GLASSIA ("the Raw Materials Supply Agreement"). Pursuant to the agreements, the Company was entitled to certain upfront and milestone payments at a total amount of $45 million, and for a minimum commitment of Takeda to acquire GLASSIA produced by the Company at a total amount of $ 60 million over the first five years of the Distribution Agreement. In addition, the Company is entitled to royalty payments, of no less than $5 million per year, on account of sales of GLASSIA that would be produced by Takeda in accordance with the License Agreement. Between 2013 and 2016, the parties amended the License Agreement and the Distribution Agreement to extend the supply of GLASSIA by the Company to Takeda and increase Takeda’s minimum purchase commitment. As of December 31, 2018, the Company received a total of $39.5 million on account of the agreed upfront and milestone payments from Takeda pursuant to the Distribution and License Agreements as amended. Prior to the last amendment of the Distribution Agreement in October 2016, the net sums received were recorded as deferred revenues and were recognized as revenues based on the actual sales of GLASSIA and on a pro-rata basis. Starting October 2016, the balance of the deferred revenues is recognized on a straight line basis according to Takeda’s updated minimum purchase commitment through December 31, 2018, which was the term of the supply commitment period prior to the October 2016 amendment. Non-refundable revenues due to the achievement of milestones are recognized upon reaching the milestone. Pursuant to the October 2016 amendment of the Distribution Agreement, the distribution period is currently extended through the end of 2020, with the start of GLASSIA production by Takeda in 2021. Pursuant to the Distribution Agreement Takeda is responsible to conduct any required additional clinical studies required to obtain or maintain GLASSIA’S marketing authorization in the Territory. Under certain condition, the Company will be required to participate in the funding of these clinical studies in a total amount not to exceed $10 million. Pursuant to the Raw Material Supply Agreement Takeda undertook to provide the Company, free of charge, all quantities of raw materials required by the Company for manufacturing GLASSIA to be sold to Takeda for distribution in the Territory. The Company accounts for the fair value of the raw material used and sold as revenues and charges the same fair value to cost of revenue. In addition, the Company has the right to acquire from Takeda raw materials for its continued development, production, sale and distribution of GLASSIA by the Company outside the Territory. b. The Company has engaged in operating lease agreements for office and storage spaces. These agreements will expire in 2026. Minimum future lease fees for the office and storage spaces as of December 31, 2018 are as follows: U.S. Dollars in thousands Year 1 $ 577 Year 2 to 5 2,365 Year 6 and thereafter 1,848 $ 4,790 c. The Company has engaged in operating lease agreements for the vehicles in its possession. These agreements will expire between 2019 and 2021. Minimum U.S Dollars in thousands Year 1 $ 406 Year 2 209 Year 3 29 $ 644 d. In November 2006, the Company entered into an agreement with a third party in connection with a supply by the third party of a certain medical devise required for the development of a Company’s product. Pursuant to the agreement, the Company was licensed to use developments made by the third party. Furthermore, the third party will provide the Company with devices for carrying out the clinical trials, free of charge. In the event that the development is successful and the underlining product obtains required marketing authorization, the Company will pay the third party royalties based on sales of the devices through the later of the medical device patents expiration period or 15 years from the first commercial sale of the Company’s product. On expiration of the royalty period, the license will become non-exclusive and the Company shall be entitled to use the rights granted to it pursuant to the agreement without paying royalties or any other compensation. In addition, and according to a mechanism set in the agreement, the third party would be required to pay royalties to the Company of the total net sales of the medical device exceeding a certain sum, through the later of the medical device patents expiration period or 15 years from the first commercial sale of the Company’s product. In February 2008, the parties executed an amendment to the agreement according to which the exclusive global license granted to the Company was expanded to two additional indications. The royalties are applicable to all indications mentioned above. In addition, the parties entered into a commercialization and supply agreement, which ensures long-term regular supply of the device, including spare parts. e. In August 2007, the Company entered into a long-term agreement with a third party for the purchase of a raw material used for the development, manufacture, sale and distribution of a Company’s product at graded amounts and prices. In addition to the price paid by the Company for the raw material, the Company will pay the supplier an additional sum upon the sale of the product manufactured using the third party’s raw material in specific territories as set in the agreement. As of December 31, 201 8 , there were no sales of the Company’s product in these specific territories since marketing authorization from the relevant regulatory agencies was not yet obtained. f. In July 2011, the Company entered into a strategic collaboration agreement with for clinical development, marketing, distribution and sales in the United States of , the Company’s The product, KEDRAB, is developed, manufactured and marketed by the Company in other countries. The Company obtained U.S marketing approval from the FDA for in August 2017. Launch of the product in the US was initiated in the beginning of 2018. In October the parties entered into an amendment to the agreement pursuant to which the parties agreed to conduct a required post-marketing-commitment clinical study which was initiated in March 2017 and is still ongoing. The cost of the study is equally shared between the parties. |
GUARANTEES AND CHARGES
GUARANTEES AND CHARGES | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of guarantees and charges [Abstract] | |
GUARANTEES AND CHARGES | Note 18: - Guarantees and charges The Company provided a bank guarantees in the amount of $ 208 thousands in favor of the Lessor of its leased office facility in Rehovot, Israel, and for other obligation, as guarantee for meeting its obligations under the lease agreement. The Company pledged specific purchased assets as collateral against loans, in the original amount of NIS 8,355 thousands, received to fund the purchase of such assets. |
EQUITY
EQUITY | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of classes of share capital [abstract] | |
EQUITY | Note 19: - Equity a. share capital December 31, 2018 December 31, 2017 Authorized Outstanding Authorized Outstanding ordinary shares of NIS 1 par value 70,000,000 40,295,078 70,000,000 40,262,819 b. Rights attached to Shares Voting rights at the shareholders general meeting, rights to dividend, rights in case of liquidation . c. Share options and restricted shares During 2018 and 2017, 53,584 and 10,659 share options, respectively, were exercised, on a cash-less basis, into 8,686 and 1,988 ordinary shares of NIS 1 par value each and 23,572 and 7,656 restricted shares were vested for total consideration of $9 thousand and $3 thousands, respectively. For additional d. Capital management in the Company The Company's goals in its capital management are to preserve capital ratios that will ensure stability and liquidity to support business activity and create maximum value for shareholders. |
SHARE-BASED PAYMENT
SHARE-BASED PAYMENT | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of terms and conditions of share-based payment arrangement [abstract] | |
SHARE-BASED PAYMENT | Note 20: - Share-Based Payment On July 24, 2011, the Company's Board of Directors approved a new unregistered share options plan. In September 2016 the Company's Board of Directors approved an amendment to the plan, to cover issuance of restricted shares (“RS”) under the plan and named it the Israeli Share Award Plan ("2011 Plan"). Pursuant to the 2011 Plan, granted share options and RS generally vest over a four-year period following the date of the grant in 13 installments: 25% of the options vest on the first anniversary of the grant date and 6.25% options vest at the end of each quarter thereafter. a. Expense recognized in the financial statements The share based compensation expense that was recognized for services received from employees and Board of Directors members is presented in the following table: For the Year Ended December 31 2018 2017 2016 U.S. Dollar in thousands Cost of revenues $ 401 $ 179 $ 332 Research and development 224 138 134 Selling and marketing 51 48 71 General and administrative 272 118 534 Total share-based compensation $ 948 $ 483 $ 1,071 b. Share options granted to the Company's Chief Executive Officer ("CEO") On December 20, 2018, the Company’s general shareholders meeting approved the grant of 90,000 options exercisable into ordinary shares at an exercise price of NIS 18.93 per option and 30,000 RSs at no exercise price to Mr. Amir London, the Company’s CEO. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $156 thousands. The fair value of the RSs was estimated based on the market price of the shares on the grant date at $148 thousands. c. Share options granted to Employees 1. During 2018the Company's Board of Directors approved the grant of 417,825options, respectively to employees and members of the Company’s management. The fair value of the options calculated on the date of grant using the was estimated at $795 thousands. 2. During 2018, the Company's Board of Directors approved the grant of 66,308 RSs to the Company’s employees and management. The RSs do not have exercise price. The fair value of the RSs was estimated based on the market price of the share on the grant date at $344 thousands. d. Share options granted to board of directors members 1. On December 20, 2018, the Company’s general shareholders meeting approved the grant of a total of 110,000 options to the Company’s board of director members. The options are exercisable into ordinary shares at a range of an exercise price of NIS 18.93 - 22.54 per option. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $170 thousands. Change of Awards during the Year The following table lists the number of share options, the weighted average exercise prices of share options and changes in share options grants during the year: 2018 2017 2016 Number of Options Weighted Average Exercise Price Number of Options Weighted Average Exercise Price Number of Options Weighted Average Exercise Price In NIS In NIS In NIS Outstanding at beginning of year 2,572,372 32.47 2,487,236 35.20 2,281,493 38.96 Granted 617,825 19.02 458,950 21.10 401,275 15.17 Exercised (53,584 ) 15.77 (10,659 ) 18.19 (8,398 ) 18.47 Forfeited (691,016 ) 30.51 (363,155 ) 35.70 (187,134 ) 39.22 Outstanding at end of year 2,445,597 29.99 2,572,372 32.47 2,487,236 35.20 Exercisable at end of year 1,406,048 38.02 1,755,253 38.69 1,543,358 40.44 The weighted average remaining contractual life for the share options 3.63 3.22 3.62 The range of exercise prices for share options outstanding as of December 31, 2017 and 2018 were NIS 15- NIS 57. Exercise is by cashless method. The following table lists the number of RSs and changes in RSs grants during the year: Number of RSs 2018 2017 2016 U.S. Dollars in thousands Outstanding at beginning of year 76,512 27,333 - Granted 96,308 58,835 29,333 End of restriction period (23,572 ) (7,656 ) - Forfeited (9,542 ) (2,000 ) (2,000 ) Outstanding at end of year 139,706 76,512 27,333 The weighted average remaining contractual life for the restricted share 5.79 5.92 6.20 Measurement of the fair value of share options The Company uses the binomial model when estimating the grant date fair value of equity-settled share options. The measurement was made at the grant date of equity-settled share options since the options were granted to employees and Board of Directors members. The following table lists the inputs to the binomial model used for the fair value measurement of equity-settled share options for the above plan: 2018 2017 2016 Dividend yield (%) - - - Expected volatility of the share prices (%) 25-39 37-45 32-51 Risk-free interest rate (%) 0.2 – 2.0 0.1 – 1.83 0.13 – 1.83 Contractual term of up to (years) 6.5 6.5 6.5 Exercise multiple 2 2 2 Weighted average share prices (NIS) 18.49-21.17 16.05-16.44 15.17 Expected average forfeiture rate (%) 1-5 1-5 0-5 |
TAXES ON INCOME
TAXES ON INCOME | 12 Months Ended |
Dec. 31, 2018 | |
Taxes On Income Schedule Of Theoretical Tax | |
TAXES ON INCOME | NOTE 21: TAXES ON INCOME a. Tax laws applicable to the Company Law for the Encouragement of Industry (Taxes), 1969 The Law for the Encouragement of Industry (Taxes), 1969 (the “Encouragement of Industry An Industrial Company is entitled to certain tax benefits, including: (i) a deduction of the cost of purchases of patents, know-how and certain other intangible property rights (other than goodwill) used for the development or promotion of the Industrial Enterprise in equal amounts over a period of eight years, beginning from the year in which such rights were first used, (ii) the right to elect to file consolidated tax returns, under certain conditions, with additional Israeli Industrial Companies under its control, and (iii) the right to deduct expenses related to public offerings in equal amounts over a period of three years beginning from the year of the offering. Eligibility for benefits under the Encouragement of Industry Law is not contingent upon the approval of any governmental authority . Law for the Encouragement of Capital Investments, 1959 Tax benefits prior to Amendment 60 The Company's facilities in Israel have been granted Approved Enterprise status under the Law for the Encouragement of Capital Investments, 1959, commonly referred to as the “Investment Law”. The Investment Law provides that capital investments in a production facility (or other eligible assets) may be designated as an Approved Enterprise. Until 2005, the designation required advance approval from the Investment Center of the Israel Ministry of Industry, Trade and Labor. Each certificate of approval for an Approved Enterprise ("Certificate of Approval") relates to a specific investment program, delineated both by the financial scope of the investment and by the physical characteristics of the facility or the asset. Under the Approved Enterprise programs, a company is eligible for governmental grants (“Grants Track”). Under the Grants Track the Company is eligible for investments grants awarded at various rates according to the development area in which the plant is located: in Development Zone A the rate is 24% and in Development Zone B the rate is 10%. In addition to the above grants, the Company is eligible to tax exemption at the first two years of the benefit period (as define below) and is subject to reduced corporate tax of 10% to 25% during the remaining five to eight years (depending on the extent of foreign investment in the Company) of the benefit period. The benefits period is limited to the earlier of 12 years from completion of the investment or commencement of production ("Year of Operation"), or 14 years from the year in which the certificate of approval was obtained. The benefit period for part of the Company plants has ended by 2017. Under the Investment Law a company may elect to receive an alternative package comprised of tax benefits (“Alternative Track”) instead of the above mentioned grants Track. Under the Alternative Track, a company’s undistributed income derived from an Approved Enterprise is exempt from corporate tax for an initial period of two to ten years (depending on the geographic location of the Approved Enterprise within Israel which begins in the first year that the Company realizes taxable income from the Approved Enterprise following the year of operation (as define below). After expiration of the initial tax exemption period, the Company is eligible for a reduced corporate tax rate of 10% to 25% for the following five to eight years, depending on the extent of foreign investment in the Company (as shown in the table below). The benefits period is limited to 12 years from the Year of Operation, or 14 years from the year in which the certificate of approval was obtained, whichever is earlier. Tax benefits under Amendment 60 On April 1, 2005, an amendment to the Investment Law was effected (“Amendment 60”). The amendment revised the criteria for investments qualified to receive tax benefits. An eligible investment program under the amendment will qualify for benefits as a Privileged Enterprise (rather than the previous terminology of Approved Enterprise). Pursuant to the Amendment, to be entitled to receive the tax benefits, a company must make an investment in the Privileged Enterprise exceeding a certain percentage or a minimum amount specified in the Investments Law. Such investment may be made over a period of no more than three years ending at the end of the year in which the company requested to have the tax benefits apply to the Privileged Enterprise (the “Year of Election”). The Company received a Tax Ruling from the Israeli Tax Authority that its activity is an industrial activity and the Company will be eligible for the status of a Privileged Enterprise, provided that it meets the requirements under the ruling. The Year of Election is 2009.The Company also obtained 2012 as a Year of Election. The duration of tax benefits is subject to a limitation of the earlier of 7 to 10 years (depending on the extent of foreign investment in the company) from the first year in which the company generated taxable income (at, or after, the year of election) , or 12 years from the first day of the Year of Election. The amendment does not apply to investment programs approved prior to December 31, 2004. The new tax regime applies to new investment programs only. The tax benefits available under Approved Enterprise or Privileged Enterprise relate only to taxable income attributable to the specific Approved Enterprise or Privileged Enterprise, and the Company's effective tax rate will be the result of a weighted combination of the applicable rates. Percent of Reduced Tax Period Tax Exemption Period Foreign Ownership Rate of Reduced Tax 0-25% 25% 5/0 years 2/10 years 25-49% 25% 8/0 years 2/10 years 49-74% 20% 8/0 years 2/10 years 74-90% 15% 8/0 years 2/10 years 90-100% 10% 8/0 years 2/10 years The benefits available to an Approved Enterprise and a Privileged Enterprise are conditioned upon terms stipulated in the Investment Law and the related regulations and the criteria (for an Approved Enterprise) set forth in the applicable certificate of approval. If the Company does not fulfill these conditions, in whole or in part, the benefits can be cancelled and may be required to refund the amount of the benefits, linked to the Israeli consumer price index plus interest. The Company believes that its Privileged Enterprise programs currently operate in compliance with all applicable conditions and criteria. In the event that a company declares and pays dividends from tax-exempt income, the company will be taxed on the otherwise exempt income at the same reduced corporate tax rate that would have applied to that income. Payment of dividends derived from income that was taxed at reduced rates, but not tax-exempt, does not result in additional tax consequences to the company. Shareholders who receive dividends derived from Approved Enterprise or Privileged Enterprise income are generally taxed at a rate of 15%, which is withheld and paid by the company paying the dividend, if the dividend is distributed during the benefits period or within the following 12 years (the limitation does not apply to a Foreign Investors Company, which is a company that more than 25% of its shares owned by non-Israeli residents). Preferred Enterprise Tax Benefits under the 2011 Amendment As of January 1, 2011 new legislation amending to the Investment Law was effected (the “2011 Amendment”). Pursuant to the amendment a new status of “Preferred Company” and “Preferred Enterprise”, replacing the existed status of “Privileged Company” and “Privileged Enterprise”. Similarly to “Beneficiary Company”, a Preferred Company is an industrial company owning a Preferred Enterprise which meets certain conditions (including a minimum threshold of 25% export). However, under this new legislation the requirement for a minimum investment in productive assets was cancelled. Under the 2011 Amendment, a uniform corporate tax rate will apply to all qualifying income of the Preferred Company, as opposed to the former law, which was limited to income from the Approved Enterprises and Beneficiary Enterprise during the benefits period. The uniform corporate tax rate will be 7% in Development Area A, and 12.5% elsewhere in Israel. On August 5, 2013, the "Knesset" issued the Law for Changing National Priorities (Legislative Amendments for Achieving Budget Targets for 2013 and 2014), which consists of Amendment 71 to the Encouragement Law ("the Amendment"). According to the Amendment, the tax rate on preferred income from a Preferred Enterprise in 2014 and onwards will be 9% in Development Area A, and 16% elsewhere in Israel. The Amendment also prescribes that any dividends distributed to individuals or foreign residents from the preferred enterprise's earnings as above will be subject to tax at a rate of 20% from 2014 and onwards (or a reduced rate under an applicable double tax treaty). Upon a distribution of a dividend to an Israeli company, no withholding tax is remitted. In December 2016, the Israeli "Knesset" amended the Investment Law. According to the amendment, effective from January 1, 2017 the tax rate on: 1. Preferred income from a preferred enterprise will be 16% (in development area A – 7.5% instead of 9%). 2. Preferred income resulting from IP in a preferred technology enterprise will be 12% (in development area A – 7.5%). 3. Preferred income resulting from IP in a special preferred technology enterprise will be 6%. 4. Any dividends distributed from technology enterprise earnings to a foreign company that qualifies the provisions that are detailed in the law, will be subject to tax at a rate of 4%. The Company has evaluated the effect of the adoption of the Amendment on its tax position, and as of the date of the approval of the financial statements, the Company believes that it will not apply the Amendment. The Company may elect to adopt the amendment in the future. b. Tax rates applicable to the Company (other than the applicable preferred tax) In December 2016, the Israeli "Knesset" approved, as part of the economic efficiency law (Legislative Amendments for Achieving Budget Targets for 2017 and 2018), a reduction of the corporate tax rate in 2017 from 25% to 24%, and in 2018 from 24% to 23%. c. Tax assessments 1. Finalized tax assessments The Company has finalized tax assessments through the end of tax year 2013. 2. Settlement of tax assessments On July 10, 2016, the Company and the Israel Tax Authority (ITA) entered into a settlement agreement for the tax years 2004-2006. As part of the agreement, the Company paid NIS 5,000 million ($ 1.3 million) (including interest and CPI adjustment). d. Carry forward losses for tax purposes and other temporary differences As of December 31, 2018, the Company has carry forward losses and other temporary differences in the amount of $ 65,177 thousands. Final tax assessments for the years 2014 onwards could have an impact on the balance of carry forward tax losses for which deferred tax asset was not recognized. During 2018, the Company initially recorded deferred tax asset at an amount of $ 2, 048 thousands representing utilization of $ 37,224 thousands of its carry forward losses in the foreseeable future. The Company did not record deferred tax asset for the remaining portion of its carry forward losses due to estimation that their utilization in the foreseeable future is not probable. e. Deferred taxes: The Company initially recorded deferred tax assets for carry forward losses and other temporary differences, as their utilization in the foreseeable future is estimated to be probable. Below is the roll forward for deferred taxes: Total U.S Dollars in thousands Balance at January 1, 2018 $ - Amount carried to profit and loss 1,944 Amount carried to other comprehensive income (8 ) Amount carried to other capital reserve 112 Balance as of December 31, 2018 $ 2,048 f. Taxes on income Year ended December 31, 2018 2017 2016 U.S. Dollars in thousands Current taxes $ - $ 129 $ 362 Deferred tax income (1,944 ) - - Taxes in respect of prior years (11 ) 140 1,360 Taxes on income $ (1,955 ) $ 269 $ 1,722 g. Theoretical tax: The table below represent the reconciliation between the statutory tax rate and the effective tax rate as recorded in profit or loss Year ended December 31, 2018 U.S. Dollars in thousands Gain before taxes on income $ 20,341 Statutory tax rate 23 % Tax calculated using the statutory tax rate 4,678 Carry-forward tax losses utilization for which no deferred taxes were provided, net (4,678 ) Temporary differences for which deferred taxes are initially recognized (1,944 ) Prior year taxes (11 ) Tax on income $ (1,955 ) Effective tax rate 9.6 % |
SUPPLEMENTARY INFORMATION TO TH
SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF PROFIT AND LOSS | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of supplementary information to the statements of comprehensive loss [Abstract] | |
SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF PROFIT AND LOSS | Note 22: - Supplementary Information to the Statements of profit and loss a. Additional information about revenues Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Revenues from major customers each of whom amount to 10% or more, of total revenues Customer A $ 63,788 $ 60,383 $ 40,451 Customer B - - 10,225 Customer C 11,779 - - $ 75,567 $ 60,383 $ 50,676 b. Revenues based on the location of the customers, are as follows: Year Ended December 31, 2018 2017 2016 U.S. Dollars in U.S.A $ 75,331 $ 60,405 $ 40,585 Israel 28,093 26,355 25,340 Europe 3,594 5,348 3,825 Latin America 3,994 5,248 4,221 Asia 3,336 4,979 3,028 Others 121 490 495 $ 114,469 $ 102,825 $ 77,494 c. Cost of goods sold Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Cost of materials 54,888 41,179 36,154 Salary and related expenses 14,867 13,137 10,596 Depreciation and amortization 2,859 2,504 2,443 Energy 1,426 1,202 959 Subcontractors 3,633 3,995 2,833 Other manufacturing expenses 989 1,572 1,057 78,662 63,589 54,042 Decrease (increase) in inventories (5,665 ) 7,148 2,092 $ 72,997 $ 70,737 $ 56,134 d. Research and development Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Salary and related expenses $ 5,823 $ 6,413 $ 5,237 Subcontractors 2,275 3,392 8,318 Materials and allocation of facility costs 1,131 1,101 1,907 Others 518 1,067 783 $ 9,747 $ 11,973 $ 16,245 e. Selling and marketing Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Salary and related expenses $ 1,647 1,470 1,272 Marketing support 121 95 79 Packing, shipping and delivery 477 607 494 Marketing and advertising 424 627 337 Registration and marketing fees 470 1,162 796 Others 491 437 265 $ 3,630 $ 4,398 $ 3,243 f. General and administrative Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Salary and related expenses $ 3,085 $ 3,138 3,029 Employees welfare 1,151 2,182 1,465 Professional fees and public company expense 2,012 *1,549 *1,416 Depreciation, amortization and impairment 686 649 712 Communication and software services 675 *554 *362 Others 916 *201 *369 $ 8,525 $ 8,273 $ 7,353 * Reclassified g. Financial income/expense Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Financial incomes Interest income and gains from marketable securities $ 820 $ 500 $ 469 Financial expenses Fees and interest paid to financial institutions $ 340 $ 162 $ 126 |
INCOME (LOSS) PER SHARE
INCOME (LOSS) PER SHARE | 12 Months Ended |
Dec. 31, 2018 | |
Income (loss) per share attributable to equity holders of the Company: | |
INCOME (LOSS) PER SHARE | Note 23: - Income (Loss) per Share a. Details of the number of shares and income (loss) used in the computation of income (loss) per share Year Ended December 31 2018 2017 2016 Weighted Number of Shares Income Attributed to equity holders of the Company Weighted Number of Shares Income Attributed to equity holders of the Company Weighted Number of Shares Loss Attributed to equity holders of the Company U.S. Dollars in thousands U.S. Dollars in thousands U.S. Dollars in thousands For the computation of basic income (loss) 40,275,374 $ 22,296 37,970,697 $ 6,901 36,418,833 $ (6,733 ) Effect of potential dilutive ordinary shares 170,043 - 74,400 - - - For the computation of diluted income (loss) 40,445,417 $ 22,296 38,045,097 $ 6,901 36,418,833 $ (6,733 ) b. The computation of the diluted income per share in 2018 and 2017 took into account the options and RSs due to their dilutive effect. |
OPERATING SEGMENTS
OPERATING SEGMENTS | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of operating segments [abstract] | |
OPERATING SEGMENTS | Note 24: - Operating Segments a. General The operating segments are identified on the basis of information that is reviewed by the chief operating decision makers ("CODM") to make decisions about resources to be allocated and assess its performance. Accordingly, for management purposes, the Group is organized into operating segments based on the products and services of the business units and has two operating segments as follows: Proprietary Products Develop and manufacture plasma-derived therapeutics and market them in more than 15 countries. Distribution Distribute imported drugs in Israel which are manufactured by third parties. Segment performance is evaluated based on revenues and gross profit in the financial statements. The segment results reported to the CODM include items that are allocated directly to the segments and items that can be allocated on a reasonable basis. Items that were not allocated, mainly the Group's headquarter assets, research and development costs, sales and marketing costs, general and administrative costs and financial costs (consisting of finance expenses and finance income and including fair value adjustments of financial instruments), are managed on a group basis. The segment liabilities do not include loans and financial liabilities as these liabilities are managed on a group basis. b. Reporting on operating segments Proprietary Products Distribution Total U.S. Dollars in thousands Year Ended December 31, 2018 Revenues $ 90,784 $ 23,685 $ 114,469 Gross profit $ 37,988 $ 3,484 $ 41,472 Unallocated corporate expenses (22,213 ) Finance income, net 1,082 Income before taxes on income $ 20,341 Proprietary Products Distribution Total U.S Dollars in thousands Year Ended December 31, 2017 Revenues $ 79,559 $ 23,266 $ 102,825 Gross profit $ 28,224 $ 3,864 $ 32,088 Unallocated corporate expenses (24,644 ) Finance expense, net (274 ) Income before taxes on income $ 7,170 Proprietary Products Distribution Total U.S. Dollars in thousands Year Ended December 31, 2016 Revenues $ 55,958 $ 21,536 $ 77,494 Gross profit $ 18,235 $ 3,125 $ 21,360 Unallocated corporate expenses (26,841 ) Finance expense, net 470 Loss before taxes on income $ (5,011 ) |
BALANCES AND TRANSACTIONS WITH
BALANCES AND TRANSACTIONS WITH RELATED PARTIES | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of transactions between related parties [abstract] | |
BALANCES AND TRANSACTIONS WITH RELATED PARTIES | Note 25: - Balances and Transactions with Related Parties a. Balances with related parties December 31, December 31, 2018 2017 U.S. Dollars in thousands Other accounts payables $ 336 $ 292 Employee benefit liabilities, net $ 80 $ 92 Trade receivable $ 1,135 $ 2,382 b. Transactions with employed/directors that accounts as related parties Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Salary and related expenses to those employed by the Company or on its behalf $ 352 $ 460 $ 473 Remuneration of directors not employed by the Company or on its behalf $ 366 $ 107 $ 122 Number of People to whom the Salary and remuneration Related and related parties employed by the Company or on its behalf 2 2 2 Directors not employed by the Company 8 2 3 10 4 5 c. Transactions with key executive personnel (including non-related parties) Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Short-term benefits $ 2,766 $ 2,959 $ 2,654 Share-based payment 285 310 460 Other long-term benefits - 6 28 $ 3,051 $ 3,275 $ 3,142 d. Transactions with related parties Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Sales $ 3,529 $ 3,455 $ 2,230 Selling and marketing expenses $ 313 $ 121 $ 101 General and administrative expenses $ 408 $ 446 $ 503 e. Revenues and Expenses from Related and Interested Parties Terms of Transactions with Related Parties 1. Sales to related parties are conducted at market prices. Open account that have yet to be repaid by the end of the year by a related party bear no interest and their settlement will be in cash and certain balances are guaranteed by letter of credit. For the years ended December 31, 2018, 2017 and 2016, the Company recorded no allowance for doubtful accounts for trade receivable from related parties. On May 26, 2011, the Company announced its engagement in an amended agreement regarding the distribution of GLASSIA , that revises and replaces the distribution agreement signed in 2001 between the Company and Tuteur SACIFIA ("Tuteur"), a company registered in Argentina, currently under the control of the Hahn family. The amendment to the agreement was made as an arm’s length transaction. Pursuant to the distribution agreement, Tuteur serves as the exclusive distributor of GLASSIA and KamRho(D), in Argentina, Paraguay and Bolivia. During 2019, a third amendment to the agreement was executed, which was effective as of July 1, 2018, pursuant to which the Company extended a per vial discount on the price of GLASSIA in exchange for obtaining a bank guarantee from Tuteur to cover any future supply of products to Tuteur. 2. On July 29, 2015 the Company’s Board of Directors approved the entering into a distribution agreement with Khairi S.A. (“Khairi”), a company held, inter alia, by Mr. Leon Recanati, the Chairman of the Company's f. Chief executive officer employment terms On June 30, 2015 the Company’s shareholders approved the employment terms of Mr. Amir London in his position as the Company’s Chief Executive Officer (“CEO”), effective as of July 1, 2015. Under the employment agreement, Mr. Amir London is entitled to a monthly gross salary of NIS 65,000 (or $16,658). On August 30, 2016 the general meeting of the shareholders approved the update of Mr. London’s monthly gross salary to NIS 71,500 (or $18,430), effective as of July, 1 2016. On December 20, 2018 the general meeting of the shareholders approved the update of Mr. London’s monthly gross salary to NIS 82,500 (or $22,627), effective as of July, 1 2018. During 2018 the Company recorded approximately $139 thousands, as a bonus to Mr. London. As for the grant of options and restricted shares to Mr. London, refer to Note 20b. |
EVENTS SUBSEQUENTS TO THE REPOR
EVENTS SUBSEQUENTS TO THE REPORTING PERIOD | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of non-adjusting events after reporting period [abstract] | |
EVENTS SUBSEQUENTS TO THE REPORTING PERIOD | Note 26: - EVENTS SUBSEQUENTS TO THE REPORTING PERIOD a. On February 4, 2019 a wholly owned subsidiary of the Company named Kamada Ireland limited was established in Ireland. b. As for the 3 rd |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of significant accounting policies [Abstract] | |
Basis of presentation of financial statements | a. Basis of presentation of financial statements 1. These financial statements have been prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standard Board. 2. Measurement basis: The Company's consolidated Financial Statements are prepared on a cost basis, except for financial instruments (including derivatives) at fair value through profit or loss and other comprehensive income such as marketable securities financial assets, employee benefit assets and employee benefit liabilities. The Company has elected to present profit or loss items using the "function of expense" method. b . The Company's operating cycle is one year. c. The consolidated financial statements comprise the financial statements of companies that are controlled by the Company (subsidiaries). Control is achieved when the Company is exposed, or has rights, to variable returns from its involvement with the investee and has the ability to affect those returns through its power over the investee. The consolidation of the financial statements commences on the date on which control is obtained and ends when such control ceases. The financial statements of the Company and of the subsidiaries are prepared as of the same dates and periods. The consolidated financial statements are prepared using uniform accounting policies by all companies in the Group. Significant intercompany balances and transactions and gains or losses resulting from intercompany transactions are eliminated in full in the consolidated financial statements. |
Functional currency, presentation currency and foreign currency | d. Functional currency, presentation currency and foreign currency 1. Functional currency and presentation currency The consolidated financial statements are presented in U.S. dollars, which is the Company's functional and presentation currency. 2. Transactions, assets and liabilities in foreign currency Transactions denominated in foreign currency are recorded on initial recognition at the exchange rate at the date of the transaction. After initial recognition, monetary assets and liabilities denominated in foreign currency are translated at the end of each reporting period into the functional currency at the exchange rate at that date. Exchange differences are recognized in profit or loss. Non-monetary assets and liabilities measured at cost in a foreign currency are translated at the exchange rate at the date of the transaction. |
Cash and cash equivalents | e. Cash and cash equivalents Cash comprise of cash at banks and on hand. Cash equivalents are considered as highly liquid investments, including unrestricted short-term bank deposits with an original maturity of three months or less from the date of purchase, which are subject to an insignificant risk of changes in value. |
Short-term investments | f. Short-term investments: Short-term bank deposits with a maturity of more than three months from the deposit date but less than one year and securities measured at fair value through other comprehensive income. |
Allowance for doubtful accounts | g. Allowance for doubtful accounts The allowance for doubtful accounts is determined in respect of specific debts whose collection, in the opinion of the Company's management, is doubtful. Impaired debts are derecognized when they are assessed as uncollectible. As of December 31, 2018 and December 31, 2017 there was no allowance for doubtful accounts. |
Inventories | h. Inventories Inventories are measured at the lower of cost and net realizable value. The cost of inventories comprises costs of purchase of raw and other materials and costs incurred in bringing the inventories to their present location and condition. Net realizable value is the estimated selling price in the ordinary course of business. Cost of inventories is determined as follows: Raw materials - At cost using the first-in, first-out method. Fair value of raw material received at no charge is not included in the inventory value. Work in process - Direct and indirect costs including materials, labor and other direct and indirect manufacturing costs calculated at average costs for the quarter and allocated to the manufactured batches during that quarter based on predetermined allocation factors. Finished products - Direct and indirect costs including materials, labor and other direct and indirect manufacturing costs calculated at average costs and allocated to the manufactured finished products during that quarter based on predetermined allocation factors. Purchased products - At cost using the first-in, first-out method. The Company periodically evaluates the condition and age of inventories and accounts for impairment of inventories with a lower market value or which are slow moving. |
Research and development costs | i . Research and development costs Research expenditures are recognized in profit or loss when incurred and include preclinical and clinical costs (as well as cost of materials associated with the development of new products or existing products for new therapeutic indications). In addition, these costs include additional product development activities with respect to approved and distributed products as well as Post Marketing Commitment research and development activities. An intangible asset arising from a development project or from the development phase of an internal project is recognized if the Company can demonstrate the technical feasibility of completing the intangible asset so that it will be available for use or sale; the Company's intention to complete the intangible asset and use or sell it; the Company's ability to use or sell the intangible asset; how the intangible asset will generate future economic benefits; the availability of adequate technical, financial and other resources to complete the intangible asset; and the Company's ability to measure reliably the expenditure attributable to the intangible asset during its development. Since the Company development projects are often subject to regulatory approval procedures and other uncertainties, the conditions for the capitalization of costs incurred before receipt of approvals are not normally satisfied and therefore, development expenditures are recognized in profit or loss when incurred . |
Revenue recognition | j. Revenue recognition Regarding the initial adoption of IFRS 15, "Revenue from Contracts with Customers" ("the Standard"), the Company elected to adopt the provisions of the Standard using the modified retrospective method with the application of certain practical expedients and without restatement of comparative data. Revenues are recognized in profit or loss when the revenues can be measured reliably, it is probable that the economic benefits associated with the transaction will flow to the Company and the costs incurred or to be incurred in respect of the transaction can be measured reliably. Revenues are recognized at an amount that reflects the consideration to which an entity expects to be entitled in exchange for transferring goods or services to a customer. Agreements with strategic partner that include upfront and milestone payments contain a performance obligation that is satisfied over time given that the customer simultaneously receives and consumes the benefits provided by the Company. The Company recognizes revenue for upfront payments over time rather than at a point of time. The Company identified the existence of a significant financing component resulting from an upfront payment and recorded revenue against finance expense in the financial statements of 2018. In the tables below is the impact of IFRS 15 on the financial statements: As of January 01, 2018 before implementation of IFRS 15 Difference As of January ,01 2018 according to IFRS 15 U.S. Dollars in thousands Accumulated deficit $ (104,563 ) $ (757 ) $ (105,320 ) According to the previous accounting policy Difference As presented in the financial statements U.S. Dollars in thousands As of December 31, 2018 Current Liabilities Deferred revenues $ 1,129 - $ 1,129 Accumulated deficit (83,024 ) - (83,024 ) According to the previous accounting policy Difference As presented in the financial statements U.S. Dollars in thousands For the Year ended on December 31, 2018 Total revenues $ 113,652 $ 817 $ 114,469 Financial expenses (280 ) (60 ) (340 ) Net income 21,539 757 22,296 In cases where the Company operates as a principal supplier and it exposed to the risks and rewards associated with the transaction, revenues are presented on a gross basis. In events when the Company receives at no charge raw material, that is required for manufacturing one of the Company's products, the Company recorded the fair value of the raw material used and sold as revenue and charged the same fair value to cost of revenue. Deferred revenues Deferred revenues include unearned amounts received from customers not yet recognized as revenues. |
Taxes on income | k. Taxes on income Taxes on income in profit or loss comprise of current and deferred taxes. Current or deferred taxes are recognized in profit or loss, except to the extent that the tax arises from items which are recognized directly in other comprehensive income or in equity. 1. Current taxes: The current tax liability is measured using the tax rates and tax laws that have been enacted or substantively enacted by the end of reporting period as well as adjustments required in connection with the tax liability in respect of previous years. 2. Deferred taxes: Deferred taxes are computed in respect of temporary differences between the carrying amounts in the financial statements and the amounts attributed for tax purposes. Deferred taxes are measured at the tax rates that are expected to apply when the asset is realized or the liability is settled, based on tax laws that have been enacted or substantively enacted by the end of the reporting period. Deferred taxes are offset in the statement of financial position if there is a legally enforceable right to offset a current tax asset against a current tax liability and the deferred taxes relate to the same taxpayer and the same taxation authority. |
Leases | l. Leases The criteria for classifying leases as finance or operating leases depend on the substance of the agreements and are made at the inception of the lease in accordance with the following principles as set out in IAS 17. The Group as lessee: 1. Finance lease Finance leases transfer to the Company substantially all the risks and benefits incidental to ownership of the leased asset. At the commencement of the lease term, the leased assets are measured at the fair value of the leased asset or, if lower, at the present value of the minimum lease payments. The leased asset is depreciated over the shorter of the lease term and the expected life of the leased asset. 2. Operating lease Lease agreements are classified as an operating lease if they do not transfer substantially all the risks and benefits incidental to ownership of the leased asset. Lease payments are recognized as an expense in profit or loss on a straight-line basis over the lease term. |
Property, plant and equipment | m. Property, plant and equipment Property, plant and equipment are measured at cost, including directly attributable costs and financing costs, less accumulated depreciation, accumulated impairment losses and any related investment grants and excluding day-to-day servicing expenses. Cost includes spare parts and auxiliary equipment that can be used only in connection with the plant and equipment. The Company's assets include computer systems comprising hardware and software. Software forming an integral part of the hardware to the extent that the hardware cannot function without the software installed on it is classified as property, plant and equipment. In contrast, software that adds functionality to the hardware is classified as an intangible asset. The cost of assets includes the cost of materials, direct labor costs, as well as any costs directly attributable to bringing the asset to the location and condition necessary for it to operate in the manner intended by management. Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows: % Mainly Buildings 2.5-4 4 Machinery and equipment 10-20 15 Vehicles 15 15 Computers, software, equipment and office furniture 6-33 33 Leasehold improvements ( * ) 10 (*) Leasehold improvements are depreciated on a straight-line basis over the shorter of the lease term (including the extension option held by the Company and intended to be exercised) and the expected life of the improvement. The useful life, depreciation method and residual value of an asset are reviewed at the year-end and any changes are accounted for prospectively as a change in accounting estimate. Depreciation of an asset ceases at the earlier of the date that the asset is classified as held for sale and the date that the asset is derecognized. |
Impairment of non-financial assets | n. Impairment of non-financial assets The Company evaluates the need to record an impairment of the carrying amount of non-financial assets whenever events or changes in circumstances indicate that the carrying amount is not recoverable. If the carrying amount of non-financial assets exceeds their recoverable amount, the assets are reduced to their recoverable amount. The recoverable amount is the higher of fair value less costs of sale and value in use. In measuring value in use, the expected future cash flows are discounted using a pre-tax discount rate that reflects the risks specific to the asset. The recoverable amount of an asset that does not generate independent cash flows is determined for the cash-generating unit to which the asset belongs. An impairment loss of an asset, is reversed only if there have been changes in the estimates used to determine the asset's recoverable amount since the last impairment loss was recognized. Reversal of an impairment loss, as above, shall not be increased above the lower of the carrying amount that would have been determined (net of depreciation or amortization) had no impairment loss been recognized for the asset in prior years and its recoverable amount. |
Financial instruments | o. Financial instruments Regarding the initial adoption of IFRS 9, "Financial Instruments" ("the Standard"), the Company elected to adopt the provisions of the Standard retrospectively without restatement of comparative data. 1. Financial assets Financial After initial recognition, the accounting treatment of financial assets is based on their classification as follows: Debt financial instruments are subsequently measured at fair value through profit or loss (FVPL), amortized cost, or fair value through other comprehensive income (FVOCI). The classification is based on two criteria: the Company’s business model for managing the assets; and whether the instruments’ contractual cash flows represent ‘solely payments of principal and interest’ on the principal amount outstanding (the ‘SPPI criterion’). The classification and measurement of the Company’s debt financial assets are as follows: • Debt instruments at amortized cost for financial assets that are held within a business model with the objective to hold the financial assets in order to collect contractual cash flows that meet the SPPI criterion. This category includes the Company’s Trade and other receivables. • Debt instruments at FVOCI, with gains or losses recycled to profit or loss on derecognition. Financial assets in this category are the Company’s quoted debt instruments that meet the SPPI criterion and are held within a business model both to collect cash flows and to sell. Interest earned whilst holding AFS financial investments is reported as interest income using the effective interest rate method. Financial assets at FVPL comprise derivative a. Impairment of financial assets The Company assesses at the end of each reporting period whether there is any objective evidence of impairment of a financial asset or group of financial assets. The Company records an allowance for expected credit loss ("ECL") for all debt financial assets not held at FVPL. ECLs are based on the difference between the contractual cash flows due in accordance with the contract and all the cash flows that the Company expects to receive. For other debt financial assets (i.e., debt securities at FVOCI), the ECL is based on the 12-month ECL. The 12-month ECL is the portion of lifetime ECLs that results from default events on a financial instrument that are possible within 12 months after the reporting date. As of December 31, 2018 there is no ECL allowance. 2. Financial liabilities Financial liabilities within the scope of IFRS 9 are initially measured at fair value. After initial recognition, the accounting treatment of financial liabilities is based on their classification as follows: a. Financial liabilities measured at amortized cost Loans, including capital leases, are measured based on their terms at amortized cost using the effective interest method taking into account directly attributable transaction costs. b. Financial liabilities measured at fair value Derivatives are classified as fair value through profit and loss unless they are designated as effective hedging instruments. Transaction costs are recognized in profit or loss. 3. Fair value measurement Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurement is based on the assumption that the transaction will take place in the asset's or the liability's principal market, or in the absence of a principal market, in the most advantageous market. The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest. A fair value measurement of a non-financial asset takes into account a market participant's ability to generate economic benefits by using the asset in its highest and best use or by selling it to another market participant that would use the asset in its highest and best use. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities for which fair value is measured or disclosed in the financial statements are categorized within the fair value hierarchy, described as follows, based on the lowest level input that is significant to the fair value measurement as a whole: - Level 1 - quoted prices (unadjusted) in active markets for identical assets or liabilities. - Level 2 - inputs other than quoted prices included within Level 1 that are observable either directly or indirectly. - Level 3 - inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data). 4. Offsetting financial instruments Financial assets and financial liabilities are offset and the net amount is presented in the statement of financial position if there is a legally enforceable right to set off the recognized amounts and there is an intention either to settle on a net basis or to realize the asset and settle the liability simultaneously. The right of set-off must be legally enforceable not only during the ordinary course of business of the parties to the contract but also in the event of bankruptcy or insolvency of one of the parties. In order for the right of set-off to be currently available, it must not be contingent on a future event, there may not be periods during which the right is not available, or there may not be any events that will cause the right to expire. 5. De-recognition of financial instruments a. Financial assets Financial assets are derecognized when the contractual rights to the cash flows from the financial asset expire or the Company has transferred its contractual rights to receive cash flows from the financial asset or assumes an obligation to pay the cash flows in full without material delay to a third party and has transferred substantially all the risks and rewards of the asset, or has neither transferred nor retained substantially all the risks and rewards of the asset, but has transferred control of the asset. b. Financial liabilities A financial liability is derecognized when it is extinguished, that is when the obligation is discharged or cancelled or expires. A financial liability is extinguished when the debtor (the Company) discharges the liability by paying in cash, other financial assets, goods or services or is legally released from the liability. |
Derivative financial instruments designated as hedges | p. Derivative financial instruments designated as hedges The Company enters into contracts for derivative financial instruments such as forward currency contracts and cylinder strategy in respect of foreign currency to hedge risks associated with foreign exchange rates fluctuations. Such derivative financial instruments are carried as financial assets when the fair value is positive and as financial liabilities when the fair value is negative. At the inception of a hedge relationship, the Company formally designates and documents the hedge relationship to which the Company wishes to apply hedge accounting and the risk management objective and strategy for undertaking the hedge. The hedge effectiveness is assessed at the end of each reporting period. Any gains or losses arising from changes in the fair value of derivatives that do not qualify for hedge accounting are recorded immediately in profit or loss. Cash flow hedges The effective portion of the gain or loss on the hedging instrument is recognized as other comprehensive income (loss), while any ineffective portion is recognized immediately in profit or loss. Amounts recognized as other comprehensive income (loss) are reclassified to profit or loss when the hedged transaction affects profit or loss, such as when the hedged income or expense is recognized or when a forecast payment occurs. If the forecast transaction or firm commitment is no longer expected to occur, amounts previously recognized in other comprehensive income are reclassified to profit or loss. If the hedging instrument expires or is sold, terminated or exercised, or if its designation as a hedge is revoked, amounts previously recognized in other comprehensive income remain in other comprehensive income until the forecast transaction or firm commitment occurs. |
Accrued expenses | q. Accrued expenses A provision in accordance with IAS 37 is recognized when the Group has a present (legal or constructive) obligation as a result of a past event, it is expected to require the use of economic resources to clear the obligation and a reliable estimate can be made of it. |
Employee benefit liabilities | r. Employee benefit liabilities The Company has several employee benefit plans: 1. Short-term employee benefits Short-term employee benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions and are recognized as expenses as the services are rendered. A liability in respect of a cash bonus is recognized when the Company has a legal or constructive obligation to make such payment as a result of past service rendered by an employee and a reliable estimate of the amount can be made. 2. Post-employment benefits The post-employment benefits plans are normally financed by contributions to insurance companies and classified as defined contribution plans or as defined benefit plans. The Company has defined contribution plans pursuant to Section 14 to the Israeli Severance Pay Law under which the Company pays fixed contributions to certain employees under section 14 and will have no legal or constructive obligation to pay further contributions. Contributions to the defined contribution plan in respect of severance or retirement pay are recognized as an expense when contributed concurrently with performance of the employee's services. In addition the Company operates a defined benefit plan in respect of severance pay pursuant to the Israeli Severance Pay Law. According to the Law, employees are entitled to severance pay upon dismissal or retirement. The liability for termination of employment is measured using the projected unit credit method. The actuarial assumptions include expected salary increases and rates of employee's turnover based on the estimated timing of payment. The amounts are presented based on discounted expected future cash flows using a discount rate determined by reference to market yields at the reporting date on high quality corporate bonds that are linked to the Consumer Price Index with a term that is consistent with the estimated term of the severance pay obligation. In respect of its severance pay obligation to certain of its employees, the Company makes current deposits in pension funds and insurance companies ("the plan assets"). Plan assets comprise assets held by a long-term employee benefit fund or qualifying insurance policies. Plan assets are not available to the Company's own creditors and cannot be returned directly to the Company. The liability for employee benefits shown in the statement of financial position reflects the present value of the defined benefit obligation less the fair value of the plan assets. Re-measurements of the net liability are recognized in other comprehensive income in the period in which they occur. |
Share-based payment transactions | s. Share-based payment transactions The Company's employees and Board of Directors members are entitled to remuneration in the form of equity-settled share-based payment transactions. Equity-settled transactions The cost of equity-settled transactions (options and restricted shares) with employees and Board of Directors members is measured at the fair value of the equity instruments granted at grant date. The fair value of options is determined using a standard option pricing model. The fair value of restricted shares is determined using the share price at the grant date. The cost of equity-settled transactions is recognized in profit or loss together with a corresponding increase in shareholder's equity during the period which the performance and/or service conditions are to be satisfied ending on the date on which the relevant employees become entitled to the award ("the vesting period"). The cumulative expense recognized for equity-settled transactions at the end of each reporting period until the vesting date reflects the extent to which the vesting period has expired and the Company’s best estimate of the number of equity instruments that will ultimately vest. No expense is recognized for awards that do not ultimately vest. In the event that the Company modifies the conditions on which equity-instruments were granted, an additional expense is calculated and recognized |
Earnings (loss) per Share | t. Earnings (loss) per Share Earnings (loss) per share are calculated by dividing the net income (loss) attributable to Company shareholders by the weighted number of ordinary shares outstanding during the period. Ordinary shares underlying shares options or restricted shares are only included in the calculation of diluted income (loss) per share when their impact dilutes the income (loss) per share. Furthermore, potential ordinary shares converted during the period are included under diluted income (loss) per share only until the conversion date, and from that date on are included under basic income (loss) per share. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of significant accounting policies [Abstract] | |
Schedule of Impact of IFRS 15 | In the tables below is the impact of IFRS 15 on the financial statements: As of January 01, 2018 before implementation of IFRS 15 Difference As of January ,01 2018 according to IFRS 15 U.S. Dollars in thousands Accumulated deficit $ (104,563 ) $ (757 ) $ (105,320 ) According to the previous accounting policy Difference As presented in the financial statements U.S. Dollars in thousands As of December 31, 2018 Current Liabilities Deferred revenues $ 1,129 - $ 1,129 Accumulated deficit (83,024 ) - (83,024 ) According to the previous accounting policy Difference As presented in the financial statements U.S. Dollars in thousands For the Year ended on December 31, 2018 Total revenues $ 113,652 $ 817 $ 114,469 Financial expenses (280 ) (60 ) (340 ) Net income 21,539 757 22,296 |
Schedule of Useful Lives for Property, Plant and Equipment | Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows: % Mainly Buildings 2.5-4 4 Machinery and equipment 10-20 15 Vehicles 15 15 Computers, software, equipment and office furniture 6-33 33 Leasehold improvements ( * ) 10 (*) Leasehold improvements are depreciated on a straight-line basis over the shorter of the lease term (including the extension option held by the Company and intended to be exercised) and the expected life of the improvement. |
DISCLUSURE OF NEW STANDARDS I_2
DISCLUSURE OF NEW STANDARDS IN THE PERIOD PRIOR TO THEIR ADOPTION (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of new ifrs in the period [Abstract] | |
Schedule of Impact on Statement of Financial Position | During 2018, the Company has performed a detailed impact assessment of IFRS 16. Impact on the statement of financial position (increase/(decrease)) as at January 1, 2019: Assets U.S. Dollars in thousands Property, plant and equipment (right-of-use assets) 4,138 Lease liabilities 4,622 Net impact on equity (484 ) |
CASH AND CASH EQUIVALENTS (Tabl
CASH AND CASH EQUIVALENTS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Cash and cash equivalents [abstract] | |
Schedule of Cash and Cash Equivalents | December 31, 2018 2017 U.S. Dollars in thousands Cash and deposits for immediate withdrawal $ 18,018 $ 8,539 Cash equivalents in USD deposits (1) - 4,001 Cash equivalents in NIS deposits (2) 75 141 $ 18,093 $ 12,681 (1) The deposits bear interest of 1.53% per year, as of December 31, 2017 . (2) The deposits bear interest of 0.16% per year, as of December 31, 2018 and 0.01% per year, as of December 31, 2017. |
SHORT-TERM INVESTMENTS (Tables)
SHORT-TERM INVESTMENTS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of short-term investments [Abstract] | |
Schedule of Short-term Investments | December 31, 2018 2017 U.S. Dollars in thousands Fair value through other comprehensive income $ 10,325 $ 8,597 Marketable securities (equity and debt) at fair value through profit or loss (2) - 1,663 Bank deposits in USD (1) 22,174 20,078 $ 32,499 $ 30,338 (1) The deposits bear interest of 2.6%-3.5% and 1.7%-2.3% per year, as of December 31, 2018 and 2017, respectively. (2) Following implementation of IFRS 9 all the investment portfolio is measured as fair value through other comprehensive income. As a result the Company reclassified from FVTPL to FVOCI as of January 1, 2018. |
TRADE RECEIVABLES, NET (Tables)
TRADE RECEIVABLES, NET (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Trade and other current receivables [abstract] | |
Schedule of Trade Receivables, Net | December 31, 2018 2017 U.S. Dollars in thousands Open accounts: In NIS $ 6,780 $ 8,263 In USD 20,814 22,284 $ 27,594 $ 30,547 Checks receivable 80 115 $ 27,674 $ 30,662 Less allowance for doubtful accounts - - Trade receivables, net $ 27,674 $ 30,662 |
Schedule of Analysis of Past Due but Not Impaired Trade Receivables | An analysis of past due but not impaired trade receivables with reference to reporting date: Past due trade receivables with aging of Neither past due Up to 30 Days 30-60 60-90 90-120 Over 120 days Total U.S. Dollars in thousands December 31, 2018 $ 27,215 $ 337 $ 15 $ 15 $ 6 $ 6 $ 27,594 December 31, 2017 $ 29,692 $ 680 $ 21 $ 152 $ 2 - $ 30,547 |
OTHER ACCOUNTS RECEIVABLES (Tab
OTHER ACCOUNTS RECEIVABLES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of other accounts receivables [Abstract] | |
Schedule of Other Accounts Receivables | December 31, 2018 2017 U.S. Dollars in thousands Materials for clinical trials and inventory designated for R&D activities $ 399 $ 635 Prepaid expenses 1,086 822 Government authorities 1,552 563 Accrued interest 66 66 Accrued income 193 33 Other 12 13 $ 3,308 $ 2,132 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Classes of current inventories [abstract] | |
Schedule of Inventories | December 31, 2018 2017 U.S. Dollars in thousands Finished products $ 7,023 $ 5,168 Purchased products 4,813 2,695 Work in progress 4,792 6,159 Raw materials 12,688 7,048 $ 29,316 $ 21,070 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of detailed information about property, plant and equipment [abstract] | |
Schedule of Composition and Movement of Property, Plant and Equipment | Composition and movement: 2018 Land and Buildings(1) Machinery and Equipment Vehicles Computers, Software, Equipment and Office Furniture Leasehold Improvements Total U.S. Dollars in thousands Cost ` Balance at January 1, 2018 $ 28,399 $ 29,602 $ 66 $ 6,522 $ 1,273 $ 65,862 Additions 806 2,331 19 590 (132 ) 3,614 Sale and write-off (38 ) (1,547 ) - (619 ) - (2,204 ) Balance as of December 31, 2018 29,167 30,386 85 6,493 1,141 67,272 Accumulated Depreciation Balance as of January 1, 2018 13,916 21,430 59 5,194 85 40,684 Depreciation and impairment 1,198 1,711 4 672 118 3,703 Sale and write-off (38 ) (1,462 ) - (619 ) - (2,119 ) Balance as of December 31, 2018 15,076 21,679 63 5,247 203 42,268 Depreciated cost as of December 31, 2018 $ 14,091 $ 8,707 $ 22 $ 1,246 $ 938 $ 25,004 2017 Land and Buildings(1) Machinery and Equipment (1) (2) Vehicles Computers, Software, Equipment and Office Furniture Leasehold Improvements Total U.S. Dollars in thousands Cost Balance at January 1, 2017 $ 27,618 $ 26,485 $ 94 $ 5,520 $ 1,052 $ 60,769 Additions 781 3,151 - 1,002 1,196 6,130 Sale and write-off - (34 ) (28 ) - (975 ) (1,037 ) Balance as of December 31, 2017 28,399 29,602 66 6,522 1,273 65,862 Accumulated Depreciation Balance as of January 1, 2017 12,606 19,972 86 4,559 967 38,190 Depreciation and impairment 1,310 1,492 1 635 85 3,523 Sale and write-off - (34 ) (28 ) - (967 ) (1,029 ) Balance as of December 31, 2017 13,916 21,430 59 5,194 85 40,684 Depreciated cost as of December 31, 2017 $ 14,483 $ 8,172 $ 7 1,328 $ 1,188 $ 25,178 (1) Including labor costs charged in 2018 and 2017 to the cost of facilities, machinery and equipment in the amount of $514 thousands and $431 thousands, respectively. (2) Including financing costs of $44 thousands capitalized in 2017 to the cost of machinery and equipment. During 2018 no financing costs were capitalized. |
Schedule of Capitalized Leasing Rights of Land from Israel Land Administration | Capitalized leasing rights of land from the Israel land administration. December 31, 2018 2017 U.S. Dollars in thousands Under finance lease $ 1,004 $ 1,016 |
OTHER LONG TERM ASSETS (Tables)
OTHER LONG TERM ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Miscellaneous non-current assets [abstract] | |
Schedule of Other Long Term Assets | December 31, 2018 2017 U.S. Dollars in thousands Distribution right (1) 123 - Long term pre-paid expenses 51 49 $ 174 $ 49 (1) During 2018 the Company entered into agreement to obtain the distribution right of a certain therapeutic product to be distributed in Israel, subject to Israeli Ministry of Health (“IL MOH") marking approval. Pursuant to the agreement, the Company was required to make certain upfront and milestone payments. These payments are accounted for as long term assets through obtaining IL MOH marketing authorization, and it will be amortized during the product's economic useful life. |
TRADE PAYABLES (Tables)
TRADE PAYABLES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Trade and other current payables [abstract] | |
Schedule of Trade Payables | December 31, 2018 2017 U.S. Dollars in thousands Open debts mainly in USD $ 11,408 $ 11,246 Open debts in NIS 5,876 6,789 Sub-Total 17,284 18,035 Notes payable 1 1 $ 17,285 $ 18,036 |
OTHER ACCOUNTS PAYABLES (Tables
OTHER ACCOUNTS PAYABLES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of other accounts payable [Abstract] | |
Schedule of Other Accounts Payables | December 31, 2018 2017 U.S. Dollars in thousands Employees and payroll accruals $ 4,708 $ 4,735 Derivatives financial instruments 64 8 Accrued Expenses and Others 489 1,077 $ 5,261 $ 5,820 |
LOANS AND CAPITAL LEASES (Table
LOANS AND CAPITAL LEASES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of loans and capital leases [abstract] | |
Schedule of Loans and Capital Leases | December 31, 2018 2017 U.S. Dollars in thousands Total loans and capital leases (1) 1,278 1,984 Less current maturities 562 614 Long term loans and capital leases $ 716 $ 1,370 (1) Capital leases balance was $138 thousands and $274 thousands, as of December 31, 2018 and 2017, respectively. Bank loans The loans are |
FINANCIAL INSTRUMENTS (Tables)
FINANCIAL INSTRUMENTS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of detailed information about financial instruments [abstract] | |
Schedule of Classification of Financial Assets and Liabilities | The financial assets and financial liabilities in the balance sheet are classified by groups of financial instruments pursuant to IFRS 9: December 31, 2018 2017 U.S. Dollars in thousands Financial assets Financial assets at fair value: Marketable securities (equity and debt) – through profit or loss - $ 1,663 Financial assets at fair value through other comprehensive income: Financial assets at fair value through other comprehensive income 10,324 8,597 Financial assets at cost: Cash and cash equivalent 18,093 * 12,681 Short term bank deposits 22,175 *20,078 $ 50,592 $ 43,019 Financial liabilities Derivatives instruments mainly measured at fair value through other comprehensive income $ 64 $ 8 Financial liabilities measured at amortized cost: Bank loans and capital leases 1,278 1,984 $ 1,342 $ 1,992 *Reclassified |
Schedule of Maturity Profile of Company's Financial Liabilities based on Contractual Undiscounted Payments | The table below summarizes the maturity profile of the Company's financial liabilities based on contractual undiscounted payments: December 31, 2018 Less than one year 1 to 2 2 to 3 3 to 5 Total U.S. Dollars in thousands Trade payables $ 17,285 - - - $ 17,285 Other accounts payables 5,261 - - - 5,261 Long term loans and capital leases (including interest) $ 595 $ 495 $ 209 $ 32 $ 1,331 $ 23,141 $ 495 $ 209 $ 32 $ 23,877 December 31, 2017 Less than one year 1 to 2 2 to 3 3 to 5 Total U.S. Dollars in thousands Trade payables $ 18,036 - - - $ 18,036 Other accounts payables 5,820 - - - 5,820 Long term loans and capital leases (including interest) 669 634 532 260 2,095 $ 24,525 $ 634 $ 532 $ 260 $ 25,951 |
Schedule of Changes in Liabilities Arising From Financing Activities | Changes in liabilities arising from financing activities January 1, 2018 Payments Foreign exchange movement Cash from new loans New leases December 31, 2018 U.S. Dollars in thousands Bank loans $ 1,710 (460 ) (110 ) - - 1,140 Capital leases 274 (136 ) - - - 138 Total $ 1,984 $ (596 ) $ (110 ) - - $ 1,278 |
Schedule of Carrying Amount and Fair Value of Financial Instruments | The following table demonstrates the carrying amount and fair value of the financial instruments presented in the financial statements not at fair value: Carrying Amount Fair Value December 31, December 31, 2018 2017 2018 2017 U.S. Dollars in thousands Financial liabilities Bank loans and capital Leases $ 1,278 $ 1,984 $ 1,275 $ 1,984 |
Schedule of Financial Assets Measured at Fair Value | Financial assets (liabilities) measured at fair value: Financial assets (liabilities) measured at fair value: Level 1 Level 2 thousands December 31, 2018 Debt securities (corporate and government) $ 1,588 - Derivatives instruments - (64 ) Fair value through other comprehensive income $ 8,736 $ 1,588 $ 8,672 Level 1 Level 2 thousands December 31, 2017 Marketable securities at fair value through profit or loss: Equity shares $ 77 Mutual funds 456 Debt securities (corporate and government) 1,130 Derivatives instruments (8 ) Available for sale debt securities (corporate and government) $ 8,597 $ 1,663 $ 8,589 |
Schedule of Sensitivity Analysis for Market Risks | December 31, 2018 2017 U.S. Dollars in thousands Sensitivity test to changes in market price of listed Securities Gain (loss) from change: 5% increase in market price $ 519 $ 513 5% decrease in market price $ (519 ) $ (513 ) Sensitivity test to changes in foreign currency: Gain (loss) from change: 5% increase in NIS $ (21 ) $ (143 ) 5% decrease in NIS $ 21 $ 143 5% increase in Euro $ (197 ) $ (135 ) 5% decrease in Euro $ 197 $ 135 |
Schedule of Linkage Terms of Financial Liabilities by Groups of Financial Instruments | December 31, 2018 2017 U.S. Dollars in thousands In NIS: Bank loans measured at amortized cost $ 1,140 $ 1,710 In USD: Capital leases measured at amortized cost $ 138 $ 274 |
EMPLOYEE BENEFIT LIABILITIES,_2
EMPLOYEE BENEFIT LIABILITIES, NET (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of defined benefit plans [abstract] | |
Schedule of Expenses Recognized in Comprehensive Income (Loss) | Expenses recognized in comprehensive income (loss): Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Current service cost $ 292 $ 356 $ 359 Interest expenses, net 25 23 20 Current service cost (income) due to the transfer of real yield from the compensation component to the royalties' component in executive insurance policies before 2004 3 (7 ) 5 Total employee benefit expenses 320 372 384 Actual return on plan assets $ 171 $ 119 $ 22 |
Schedule of Expenses Presented in Statement of Comprehensive Income (Loss) | The expenses are presented in the Statement of Comprehensive income (loss) as follows Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Cost of revenues $ 175 $ 211 $ 228 Research and development 50 57 62 Selling and marketing 75 *73 *67 General and administrative 20 *31 *27 $ 320 $ 372 $ 384 * Reclassified |
Schedule of Plan Liabilities, Net | The plan liabilities, net: December 31, 2018 2017 U.S. Dollars in thousands Defined benefit obligation $ 4,987 $ 5,907 Fair value of plan assets (4,200 ) (4,763 ) Total liabilities, net $ 787 $ 1,144 |
Schedule of Changes in Present Value of Defined Benefit Obligation | Changes in the present value of defined benefit obligation 2018 2017 U.S. Dollars in thousands Balance at January 1, $ 5,907 $ 5,235 Interest costs 110 151 Current service cost 292 356 Benefits paid (645 ) (641 ) Demographic assumptions (29 ) (28 ) Financial assumptions (223 ) 254 Past Experience (2 ) 6 Currency Exchange (423 ) 574 Balance at December 31, $ 4,987 $ 5,907 |
Schedule of Changes in Fair Value of Plan Assets | Changes in the fair value of plan assets 2018 2017 U.S. Dollars in thousands Balance at January 1, $ 4,763 $ 4,513 Expected return 85 127 Contributions by employer 182 227 Benefits paid (564 ) (586 ) Demographic assumptions 5 1 Financial assumptions (2 ) 1 Past Experience 83 (11 ) Current service cost due to the transfer of real yield from the compensation component to the royalties component in executive insurance policies before 2004 (3 ) 7 Currency exchange (349 ) 484 Balance at December 31, $ 4,200 $ 4,763 |
Schedule of Principal Assumptions Underlying Defined Benefit Plan | The principal assumptions underlying the defined benefit plan 2018 2017 2016 % Discount rate of the plan liability 2.02 2.27 3.72 Future salary increases 3.6 4 4 |
CONTINGENT LIABILITIES AND CO_2
CONTINGENT LIABILITIES AND COMMITMENTS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of contingent liabilities and commitments [Abstract] | |
Schedule of Minimum Future Lease Fees for Office and Storage Spaces | Minimum future lease fees for the office and storage spaces as of December 31, 2018 are as follows: U.S. Dollars in thousands Year 1 $ 577 Year 2 to 5 2,365 Year 6 and thereafter 1,848 $ 4,790 |
Schedule of Minimum Future Lease Fees for Existing Vehicles | Minimum U.S Dollars in thousands Year 1 $ 406 Year 2 209 Year 3 29 $ 644 |
EQUITY (Tables)
EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of classes of share capital [abstract] | |
Schedule of Share Capital | share capital December 31, 2018 December 31, 2017 Authorized Outstanding Authorized Outstanding ordinary shares of NIS 1 par value 70,000,000 40,295,078 70,000,000 40,262,819 |
SHARE-BASED PAYMENT (Tables)
SHARE-BASED PAYMENT (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of terms and conditions of share-based payment arrangement [abstract] | |
Schedule of Expense Recognized in Financial Statements | The share based compensation expense that was recognized for services received from employees and Board of Directors members is presented in the following table: For the Year Ended December 31 2018 2017 2016 U.S. Dollar in thousands Cost of revenues $ 401 $ 179 $ 332 Research and development 224 138 134 Selling and marketing 51 48 71 General and administrative 272 118 534 Total share-based compensation $ 948 $ 483 $ 1,071 |
Schedule of Change of Awards | The following table lists the number of share options, the weighted average exercise prices of share options and changes in share options grants during the year: 2018 2017 2016 Number of Options Weighted Average Exercise Price Number of Options Weighted Average Exercise Price Number of Options Weighted Average Exercise Price In NIS In NIS In NIS Outstanding at beginning of year 2,572,372 32.47 2,487,236 35.20 2,281,493 38.96 Granted 617,825 19.02 458,950 21.10 401,275 15.17 Exercised (53,584 ) 15.77 (10,659 ) 18.19 (8,398 ) 18.47 Forfeited (691,016 ) 30.51 (363,155 ) 35.70 (187,134 ) 39.22 Outstanding at end of year 2,445,597 29.99 2,572,372 32.47 2,487,236 35.20 Exercisable at end of year 1,406,048 38.02 1,755,253 38.69 1,543,358 40.44 The weighted average remaining contractual life for the share options 3.63 3.22 3.62 |
Schedule of Number of RSs and Modification in Employee RSs | The following table lists the number of RSs and changes in RSs grants during the year: Number of RSs 2018 2017 2016 U.S. Dollars in thousands Outstanding at beginning of year 76,512 27,333 - Granted 96,308 58,835 29,333 End of restriction period (23,572 ) (7,656 ) - Forfeited (9,542 ) (2,000 ) (2,000 ) Outstanding at end of year 139,706 76,512 27,333 The weighted average remaining contractual life for the restricted share 5.79 5.92 6.20 |
Schedule of Inputs to Binomial Model Used for Fair Value Measurement | The following table lists the inputs to the binomial model used for the fair value measurement of equity-settled share options for the above plan: 2018 2017 2016 Dividend yield (%) - - - Expected volatility of the share prices (%) 25-39 37-45 32-51 Risk-free interest rate (%) 0.2 – 2.0 0.1 – 1.83 0.13 – 1.83 Contractual term of up to (years) 6.5 6.5 6.5 Exercise multiple 2 2 2 Weighted average share prices (NIS) 18.49-21.17 16.05-16.44 15.17 Expected average forfeiture rate (%) 1-5 1-5 0-5 |
TAXES ON INCOME (Tables)
TAXES ON INCOME (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Taxes On Income Schedule Of Theoretical Tax | |
Schedule of Weighted Combination of Applicable Rates | Percent of Reduced Tax Period Tax Exemption Period Foreign Ownership Rate of Reduced Tax 0-25% 25% 5/0 years 2/10 years 25-49% 25% 8/0 years 2/10 years 49-74% 20% 8/0 years 2/10 years 74-90% 15% 8/0 years 2/10 years 90-100% 10% 8/0 years 2/10 years |
Schedule of Deferred Taxes | The Company initially recorded deferred tax assets for carry forward losses and other temporary differences, as their utilization in the foreseeable future is estimated to be probable. Below is the roll forward for deferred taxes: Total U.S Dollars in thousands Balance at January 1, 2018 $ - Amount carried to profit and loss 1,944 Amount carried to other comprehensive income (8 ) Amount carried to other capital reserve 112 Balance as of December 31, 2018 $ 2,048 |
Schedule of Current Taxes on Income | Taxes on income Year ended December 31, 2018 2017 2016 U.S. Dollars in thousands Current taxes $ - $ 129 $ 362 Deferred tax income (1,944 ) - - Taxes in respect of prior years (11 ) 140 1,360 Taxes on income $ (1,955 ) $ 269 $ 1,722 |
Schedule of Reconciliation of Taxes on Profit Loss | The table below represent the reconciliation between the statutory tax rate and the effective tax rate as recorded in profit or loss Year ended December 31, 2018 U.S. Dollars in thousands Gain before taxes on income $ 20,341 Statutory tax rate 23 % Tax calculated using the statutory tax rate 4,678 Carry-forward tax losses utilization for which no deferred taxes were provided, net (4,678 ) Temporary differences for which deferred taxes are initially recognized (1,944 ) Prior year taxes (11 ) Tax on income $ (1,955 ) Effective tax rate 9.6 % |
SUPPLEMENTARY INFORMATION TO _2
SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF PROFIT AND LOSS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of supplementary information to the statements of comprehensive loss [Abstract] | |
Schedule of Additional Information about Revenues | Additional information about revenues Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Revenues from major customers each of whom amount to 10% or more, of total revenues Customer A $ 63,788 $ 60,383 $ 40,451 Customer B - - 10,225 Customer C 11,779 - - $ 75,567 $ 60,383 $ 50,676 |
Schedule of Revenues Based on Location of Customers | Revenues based on the location of the customers, are as follows: Year Ended December 31, 2018 2017 2016 U.S. Dollars in U.S.A $ 75,331 $ 60,405 $ 40,585 Israel 28,093 26,355 25,340 Europe 3,594 5,348 3,825 Latin America 3,994 5,248 4,221 Asia 3,336 4,979 3,028 Others 121 490 495 $ 114,469 $ 102,825 $ 77,494 |
Schedule of Income and Expenses | c. Cost of goods sold Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Cost of materials 54,888 41,179 36,154 Salary and related expenses 14,867 13,137 10,596 Depreciation and amortization 2,859 2,504 2,443 Energy 1,426 1,202 959 Subcontractors 3,633 3,995 2,833 Other manufacturing expenses 989 1,572 1,057 78,662 63,589 54,042 Decrease (increase) in inventories (5,665 ) 7,148 2,092 $ 72,997 $ 70,737 $ 56,134 d. Research and development Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Salary and related expenses $ 5,823 $ 6,413 $ 5,237 Subcontractors 2,275 3,392 8,318 Materials and allocation of facility costs 1,131 1,101 1,907 Others 518 1,067 783 $ 9,747 $ 11,973 $ 16,245 e. Selling and marketing Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Salary and related expenses $ 1,647 1,470 1,272 Marketing support 121 95 79 Packing, shipping and delivery 477 607 494 Marketing and advertising 424 627 337 Registration and marketing fees 470 1,162 796 Others 491 437 265 $ 3,630 $ 4,398 $ 3,243 f. General and administrative Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Salary and related expenses $ 3,085 $ 3,138 3,029 Employees welfare 1,151 2,182 1,465 Professional fees and public company expense 2,012 *1,549 *1,416 Depreciation, amortization and impairment 686 649 712 Communication and software services 675 *554 *362 Others 916 *201 *369 $ 8,525 $ 8,273 $ 7,353 * Reclassified g. Financial income/expense Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Financial incomes Interest income and gains from marketable securities $ 820 $ 500 $ 469 Financial expenses Fees and interest paid to financial institutions $ 340 $ 162 $ 126 |
INCOME (LOSS) PER SHARE (Tables
INCOME (LOSS) PER SHARE (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income (loss) per share attributable to equity holders of the Company: | |
Schedule of Details of Number of Shares and Income (Loss) | Details of the number of shares and income (loss) used in the computation of income (loss) per share Year Ended December 31 2018 2017 2016 Weighted Number of Shares Income Attributed to equity holders of the Company Weighted Number of Shares Income Attributed to equity holders of the Company Weighted Number of Shares Loss Attributed to equity holders of the Company U.S. Dollars in thousands U.S. Dollars in thousands U.S. Dollars in thousands For the computation of basic income (loss) 40,275,374 $ 22,296 37,970,697 $ 6,901 36,418,833 $ (6,733 ) Effect of potential dilutive ordinary shares 170,043 - 74,400 - - - For the computation of diluted income (loss) 40,445,417 $ 22,296 38,045,097 $ 6,901 36,418,833 $ (6,733 ) |
OPERATING SEGMENTS (Tables)
OPERATING SEGMENTS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of operating segments [abstract] | |
Schedule of Reporting on Operating Segments | Reporting on operating segments Proprietary Products Distribution Total U.S. Dollars in thousands Year Ended December 31, 2018 Revenues $ 90,784 $ 23,685 $ 114,469 Gross profit $ 37,988 $ 3,484 $ 41,472 Unallocated corporate expenses (22,213 ) Finance income, net 1,082 Income before taxes on income $ 20,341 Proprietary Products Distribution Total U.S Dollars in thousands Year Ended December 31, 2017 Revenues $ 79,559 $ 23,266 $ 102,825 Gross profit $ 28,224 $ 3,864 $ 32,088 Unallocated corporate expenses (24,644 ) Finance expense, net (274 ) Income before taxes on income $ 7,170 Proprietary Products Distribution Total U.S. Dollars in thousands Year Ended December 31, 2016 Revenues $ 55,958 $ 21,536 $ 77,494 Gross profit $ 18,235 $ 3,125 $ 21,360 Unallocated corporate expenses (26,841 ) Finance expense, net 470 Loss before taxes on income $ (5,011 ) |
BALANCES AND TRANSACTIONS WIT_2
BALANCES AND TRANSACTIONS WITH RELATED PARTIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of transactions between related parties [abstract] | |
Schedule of Balances with Related Parties | Balances with related parties December 31, December 31, 2018 2017 U.S. Dollars in thousands Other accounts payables $ 336 $ 292 Employee benefit liabilities, net $ 80 $ 92 Trade receivable $ 1,135 $ 2,382 |
Schedule of Transactions with Employed/Directors that Accounts as Related Parties | Transactions with employed/directors that accounts as related parties Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Salary and related expenses to those employed by the Company or on its behalf $ 352 $ 460 $ 473 Remuneration of directors not employed by the Company or on its behalf $ 366 $ 107 $ 122 Number of People to whom the Salary and remuneration Related and related parties employed by the Company or on its behalf 2 2 2 Directors not employed by the Company 8 2 3 10 4 5 |
Schedule of Transactions with Key Executive Personnel | Transactions with key executive personnel (including non-related parties) Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Short-term benefits $ 2,766 $ 2,959 $ 2,654 Share-based payment 285 310 460 Other long-term benefits - 6 28 $ 3,051 $ 3,275 $ 3,142 |
Schedule of Transactions with Related Parties | Transactions with related parties Year Ended December 31, 2018 2017 2016 U.S. Dollars in thousands Sales $ 3,529 $ 3,455 $ 2,230 Selling and marketing expenses $ 313 $ 121 $ 101 General and administrative expenses $ 408 $ 446 $ 503 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Narrative) (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of significant accounting policies [Abstract] | ||
Allowance for doubtful accounts |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES (Schedule of Impact of IFRS 15) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement Line Items [Line Items] | |||
Accumulated deficit | $ (83,024) | $ (104,563) | |
Current Liabilities | |||
Deferred revenues | 461 | 4,927 | |
Total revenues | 90,784 | 79,559 | $ 55,958 |
Financial expenses | (340) | (162) | (126) |
Net income | $ 22,296 | 6,901 | $ (6,733) |
Before implementation of IFRS 15 [Member] | |||
Statement Line Items [Line Items] | |||
Accumulated deficit | (104,563) | ||
Current Liabilities | |||
Deferred revenues | 1,129 | ||
Total revenues | 113,652 | ||
Financial expenses | (280) | ||
Net income | 21,539 | ||
Difference [Member] | |||
Statement Line Items [Line Items] | |||
Accumulated deficit | (757) | ||
Current Liabilities | |||
Deferred revenues | |||
Total revenues | 817 | ||
Financial expenses | (60) | ||
Net income | 757 | ||
According to IFRS 15 [Member] | |||
Statement Line Items [Line Items] | |||
Accumulated deficit | (105,320) | ||
Current Liabilities | |||
Deferred revenues | 1,129 | ||
Total revenues | 114,469 | ||
Financial expenses | (340) | ||
Net income | $ 22,296 |
SIGNIFICANT ACCOUNTING POLICI_6
SIGNIFICANT ACCOUNTING POLICIES (Schedule of Useful Lives for Property, Plant and Equipment) (Details) | 12 Months Ended | |
Dec. 31, 2018 | ||
Building [Member] | ||
Disclosure of detailed information about property, plant and equipment [line items] | ||
Depreciation percentage on straight-line basis over the useful life of the assets (in %) | 2.5-4 | |
Mainly % | 4 | |
Machinery and equipment [Member] | ||
Disclosure of detailed information about property, plant and equipment [line items] | ||
Depreciation percentage on straight-line basis over the useful life of the assets (in %) | 10-20 | |
Mainly % | 15 | |
Vehicles [Member] | ||
Disclosure of detailed information about property, plant and equipment [line items] | ||
Depreciation percentage on straight-line basis over the useful life of the assets (in %) | 15 | |
Mainly % | 15 | |
Computers, software, equipment and office furniture [Member] | ||
Disclosure of detailed information about property, plant and equipment [line items] | ||
Depreciation percentage on straight-line basis over the useful life of the assets (in %) | 6-33 | |
Mainly % | 33 | |
Leasehold improvements [Member] | ||
Disclosure of detailed information about property, plant and equipment [line items] | ||
Depreciation percentage on straight-line basis over the useful life of the assets (in %) | - | [1] |
Mainly % | 10 | |
[1] | Leasehold improvements are depreciated on a straight-line basis over the shorter of the lease term (including the extension option held by the Company and intended to be exercised) and the expected life of the improvement. |
DISCLUSURE OF NEW STANDARDS I_3
DISCLUSURE OF NEW STANDARDS IN THE PERIOD PRIOR TO THEIR ADOPTION (Narrative) (Details) - Adoption of IFRS 16 [Member] $ in Thousands | Dec. 31, 2018USD ($) |
Disclosure of expected impact of initial application of new standards or interpretations [line items] | |
Expected decrease in lease expense from adoption of IFRS 16 | $ 967 |
Expected increase in depreciation expense from adoption of IFRS 16 | 804 |
Expected increase in finance expense from adoption of IFRS 16 | 185 |
Total expected increase in operating income from adoption of IFRS 16 | 163 |
Total expected decrease in financial expense from adoption of IFRS 16 in income before taxes | $ 22 |
DISCLUSURE OF NEW STANDARDS I_4
DISCLUSURE OF NEW STANDARDS IN THE PERIOD PRIOR TO THEIR ADOPTION (Schedule of Impact on Financial Position) (Details) | Dec. 31, 2018USD ($) |
Assets | |
Property, plant and equipment (right-of-use assets) | $ 4,138 |
Lease liabilities | 4,622 |
Net impact on equity | $ (484) |
CASH AND CASH EQUIVALENTS (Narr
CASH AND CASH EQUIVALENTS (Narrative) (Details) - Fixed interest rate [Member] | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of financial assets [line items] | ||
Interest rate on deposits | 1.53% | |
NIS [Member] | ||
Disclosure of financial assets [line items] | ||
Interest rate on deposits | 0.16% | 0.01% |
CASH AND CASH EQUIVALENTS (Sche
CASH AND CASH EQUIVALENTS (Schedule of Cash and Cash Equivalents) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Cash and cash equivalents [abstract] | |||||
Cash and deposits for immediate withdrawal | $ 18,018 | $ 8,539 | |||
Cash equivalents in USD deposits | [1] | 4,001 | |||
Cash equivalents in NIS deposits | [2] | 75 | 141 | ||
Cash and cash equivalents | $ 18,093 | $ 12,681 | $ 9,968 | $ 5,047 | |
[1] | The deposits bear interest of 1.53% per year, as of December 31, 2017 . | ||||
[2] | The deposits bear interest of 0.16% per year, as of December 31, 2018 and 0.01% per year, as of December 31, 2017. |
SHORT-TERM INVESTMENTS (Narrati
SHORT-TERM INVESTMENTS (Narrative) (Details) - Fixed interest rate [Member] | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of financial assets [line items] | ||
Interest rate on deposits | 1.53% | |
Bottom of range [Member] | ||
Disclosure of financial assets [line items] | ||
Interest rate on deposits | 2.60% | 1.70% |
Top of range [Member] | ||
Disclosure of financial assets [line items] | ||
Interest rate on deposits | 3.50% | 2.30% |
SHORT-TERM INVESTMENTS (Schedul
SHORT-TERM INVESTMENTS (Schedule of Short-term Investments) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of short-term investments [Abstract] | |||
Fair value through other comprehensive income | $ 10,325 | $ 8,597 | |
Marketable securities (equity and debt) at fair value through profit or loss | [1] | 1,663 | |
Bank deposits in USD | [2] | 22,174 | 20,078 |
Short-term investments | $ 32,499 | $ 30,338 | |
[1] | Following implementation of IFRS 9 all the investment portfolio is measured as fair value through other comprehensive income. As a result the Company reclassified from FVTPL to FVOCI as of January 1, 2018. | ||
[2] | The deposits bear interest of 2.6%-3.5% and 1.7%-2.3% per year, as of December 31, 2018 and 2017, respectively. |
TRADE RECEIVABLES, NET (Schedul
TRADE RECEIVABLES, NET (Schedule of Trade Receivables, Net) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Open accounts: | ||
In NIS | $ 6,780 | $ 8,263 |
In USD | 20,814 | 22,284 |
Total open accounts | 27,594 | 30,547 |
Checks receivable | 80 | 115 |
Trade receivables, gross | 27,674 | 30,662 |
Less allowance for doubtful accounts | ||
Trade receivables, net | $ 27,674 | $ 30,662 |
TRADE RECEIVABLES, NET (Sched_2
TRADE RECEIVABLES, NET (Schedule of Analysis of Past Due but Not Impaired Trade Receivables) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of provision matrix [line items] | ||
Trade receivables | $ 27,594 | $ 30,547 |
Neither past due nor impaired [Member] | ||
Disclosure of provision matrix [line items] | ||
Trade receivables | 27,215 | 29,692 |
Past due trade receivables with aging of Up to 30 Days [Member] | ||
Disclosure of provision matrix [line items] | ||
Trade receivables | 337 | 680 |
Past due trade receivables with aging of 30-60 Days [Member] | ||
Disclosure of provision matrix [line items] | ||
Trade receivables | 15 | 21 |
Past due trade receivables with aging of 60-90 Days [Member] | ||
Disclosure of provision matrix [line items] | ||
Trade receivables | 15 | 152 |
Past due trade receivables with aging of 90-120 Days [Member] | ||
Disclosure of provision matrix [line items] | ||
Trade receivables | 6 | 2 |
Past due trade receivables with aging of Over 120 days [Member] | ||
Disclosure of provision matrix [line items] | ||
Trade receivables | $ 6 |
OTHER ACCOUNTS RECEIVABLES (Sch
OTHER ACCOUNTS RECEIVABLES (Schedule of Other Accounts Receivables) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of other accounts receivables [Abstract] | ||
Materials for clinical trials and inventory designated for R&D activities | $ 399 | $ 635 |
Prepaid expenses | 1,086 | 822 |
Government authorities | 1,552 | 563 |
Accrued interest | 66 | 66 |
Accrued income | 193 | 33 |
Other | 12 | 13 |
Other accounts receivables | $ 3,308 | $ 2,132 |
INVENTORIES (Narrative) (Detail
INVENTORIES (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Classes of current inventories [abstract] | |||
Cost of inventories recognised as expense during period | $ 61 | $ 460 | $ 544 |
INVENTORIES (Schedule of Invent
INVENTORIES (Schedule of Inventories) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Classes of current inventories [abstract] | ||
Finished products | $ 7,023 | $ 5,168 |
Purchased products | 4,813 | 2,695 |
Work in progress | 4,792 | 6,159 |
Raw materials | 12,688 | 7,048 |
Inventories | $ 29,316 | $ 21,070 |
PROPERTY, PLANT AND EQUIPMENT_2
PROPERTY, PLANT AND EQUIPMENT (Narrative) (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018USD ($)m² | Dec. 31, 2017USD ($) | |
Disclosure of detailed information about property, plant and equipment [line items] | ||
Area of capitalized leasing rights from Israel Land Administration | m² | 16,880 | |
Lease period with Israel Land Administration | 2,058 | |
Extension option for lease with with Israel Land Administration (in years) | 49 years | |
Cost [Member] | ||
Disclosure of detailed information about property, plant and equipment [line items] | ||
Cost of facilities, machinery and equipment | $ 514 | $ 431 |
Cost [Member] | Machinery and equipment [Member] | ||
Disclosure of detailed information about property, plant and equipment [line items] | ||
Borrowing costs of machinery and equipment | $ 44 |
PROPERTY, PLANT AND EQUIPMENT_3
PROPERTY, PLANT AND EQUIPMENT (Schedule of Composition and Movement of Property, Plant and Equipment) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | ||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance | $ 25,178 | ||
Balance | 25,004 | $ 25,178 | |
Cost [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance | 65,862 | 60,769 | |
Adjustments of opening balance | (132) | ||
Balance at January 1, 2018 | 65,730 | ||
Additions | 3,614 | 6,130 | |
Sale and write-off | (2,204) | (1,037) | |
Balance | 67,272 | 65,862 | |
Accumulated Depreciation [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance | 40,684 | 38,190 | |
Depreciation and impairment | 3,703 | 3,523 | |
Sale and write-off | (2,119) | (1,029) | |
Balance | 42,268 | 40,684 | |
Depreciated cost as of December 31, 2018 | 25,004 | 25,178 | |
Land and Buildings [Member] | Cost [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance | [1] | 28,399 | 27,618 |
Balance at January 1, 2018 | [1] | 28,399 | |
Additions | [1] | 806 | 781 |
Sale and write-off | [1] | (38) | |
Balance | [1] | 29,167 | 28,399 |
Land and Buildings [Member] | Accumulated Depreciation [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance | [1] | 13,916 | 12,606 |
Depreciation and impairment | [1] | 1,198 | 1,310 |
Sale and write-off | [1] | (38) | |
Balance | [1] | 15,076 | 13,916 |
Depreciated cost as of December 31, 2018 | [1] | 14,091 | 14,483 |
Machinery and equipment [Member] | Cost [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance | [1],[2] | 29,602 | 26,485 |
Balance at January 1, 2018 | [1],[2] | 29,602 | |
Additions | [1],[2] | 2,331 | 3,151 |
Sale and write-off | [1],[2] | (1,547) | (34) |
Balance | [1],[2] | 30,386 | 29,602 |
Machinery and equipment [Member] | Accumulated Depreciation [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance | [1],[2] | 21,430 | 19,972 |
Depreciation and impairment | [1],[2] | 1,711 | 1,492 |
Sale and write-off | [1],[2] | (1,462) | (34) |
Balance | [1],[2] | 21,679 | 21,430 |
Depreciated cost as of December 31, 2018 | [1],[2] | 8,707 | 8,172 |
Vehicles [Member] | Cost [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance | 66 | 94 | |
Balance at January 1, 2018 | 66 | ||
Additions | 19 | ||
Sale and write-off | (28) | ||
Balance | 85 | 66 | |
Vehicles [Member] | Accumulated Depreciation [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance | 59 | 86 | |
Depreciation and impairment | 4 | 1 | |
Sale and write-off | (28) | ||
Balance | 63 | 59 | |
Depreciated cost as of December 31, 2018 | 22 | 7 | |
Computers, software, equipment and office furniture [Member] | Cost [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance | 6,522 | 5,520 | |
Balance at January 1, 2018 | 6,522 | ||
Additions | 590 | 1,002 | |
Sale and write-off | (619) | ||
Balance | 6,493 | 6,522 | |
Computers, software, equipment and office furniture [Member] | Accumulated Depreciation [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance | 5,194 | 4,559 | |
Depreciation and impairment | 672 | 635 | |
Sale and write-off | (619) | ||
Balance | 5,247 | 5,194 | |
Depreciated cost as of December 31, 2018 | 1,246 | 1,328 | |
Leasehold improvements [Member] | Cost [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance | 1,273 | 1,052 | |
Adjustments of opening balance | (132) | ||
Balance at January 1, 2018 | 1,141 | ||
Additions | 1,196 | ||
Sale and write-off | (975) | ||
Balance | 1,141 | 1,273 | |
Leasehold improvements [Member] | Accumulated Depreciation [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance | 85 | 967 | |
Depreciation and impairment | 118 | 85 | |
Sale and write-off | 0 | (967) | |
Balance | 203 | 85 | |
Depreciated cost as of December 31, 2018 | $ 938 | $ 1,188 | |
[1] | Including labor costs charged in 2018 and 2017 to the cost of facilities, machinery and equipment in the amount of $514 thousands and $431 thousands, respectively. | ||
[2] | Including financing costs of $44 thousands capitalized in 2017 to the cost of machinery and equipment. During 2018 no financing costs were capitalized. |
PROPERTY, PLANT AND EQUIPMENT_4
PROPERTY, PLANT AND EQUIPMENT (Schedule of Capitalized Leasing Rights of Land from Israel Land Administration) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of detailed information about property, plant and equipment [abstract] | ||
Under finance lease | $ 1,004 | $ 1,016 |
OTHER LONG TERM ASSETS (Schedul
OTHER LONG TERM ASSETS (Schedule of Other Long Term Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | |
Miscellaneous non-current assets [abstract] | |||
Distribution right | [1] | $ 123 | |
Long term pre-paid expenses | 51 | 49 | |
Total long term pre-paid expenses | $ 174 | $ 49 | |
[1] | During 2018 the Company entered into agreement to obtain the distribution right of a certain therapeutic product to be distributed in Israel, subject to Israeli Ministry of Health ("IL MOH") marketing approval. Pursuant to the agreement, the Company was required to make certain upfront and milestone payments. These payments are accounted for as long term assets through obtaining IL MOH marketing authorization, and it will be amortized during the product's economic useful life. |
TRADE PAYABLES (Schedule of Tra
TRADE PAYABLES (Schedule of Trade Payables) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Trade and other current payables [abstract] | ||
Open debts mainly in USD | $ 11,408 | $ 11,246 |
Open debts in NIS | 5,876 | 6,789 |
Sub-Total | 17,284 | 18,035 |
Notes payable | 1 | 1 |
Trade payables | $ 17,285 | $ 18,036 |
OTHER ACCOUNTS PAYABLES (Schedu
OTHER ACCOUNTS PAYABLES (Schedule of Other Accounts Payables) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of other accounts payable [Abstract] | ||
Employees and payroll accruals | $ 4,708 | $ 4,735 |
Derivatives financial instruments | 64 | 8 |
Accrued Expenses and Others | 489 | 1,077 |
Other accounts payables | $ 5,261 | $ 5,820 |
LOANS AND CAPITAL LEASES (Narra
LOANS AND CAPITAL LEASES (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of detailed information about borrowings [line items] | |||
Capital lease balance | $ 138 | $ 274 | |
Proceeds from long-term loans | $ 279 | $ 1,701 | |
Bottom of range [Member] | |||
Disclosure of detailed information about borrowings [line items] | |||
Interest rate | 3.15% | ||
Top of range [Member] | |||
Disclosure of detailed information about borrowings [line items] | |||
Interest rate | 3.55% |
LOANS AND CAPITAL LEASES (Sched
LOANS AND CAPITAL LEASES (Schedule of Loans and Capital Leases) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of loans and capital leases [abstract] | |||
Total loans and capital leases | [1] | $ 1,278 | $ 1,984 |
Less current maturities | 562 | 614 | |
Long term loans and capital leases | $ 716 | $ 1,370 | |
[1] | Capital leases balance was $138 thousands and $274 thousands, as of December 31, 2018 and 2017, respectively. |
FINANCIAL INSTRUMENTS (Narrativ
FINANCIAL INSTRUMENTS (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of detailed information about hedges [line items] | |||
Net unrecognized loss recorded in other comprehensive loss | $ (176) | $ 329 | $ 47 |
Cash flow hedges [Member] | |||
Disclosure of detailed information about hedges [line items] | |||
Fair value of derivative instrument designated as hedging instrument | 58 | ||
Open transactions for derivative instruments designated as hedging | 1,169 | ||
Net unrecognized loss recorded in other comprehensive loss | 99 | ||
Derivatives instruments not designated as hedging [Member] | |||
Disclosure of detailed information about hedges [line items] | |||
Fair value of the derivative instruments | 6 | ||
Open transactions for derivative instruments not designated as hedging | $ 5,009 |
FINANCIAL INSTRUMENTS (Schedule
FINANCIAL INSTRUMENTS (Schedule of Classification of Financial Assets and Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | ||
Disclosure of detailed information about financial instruments [line items] | ||||
Financial assets | $ 50,592 | $ 43,019 | ||
Financial liabilities | 1,342 | 1,992 | ||
Financial liabilities at fair value through other comprehensive income: Derivatives instruments [Member] | ||||
Disclosure of detailed information about financial instruments [line items] | ||||
Financial liabilities | 64 | 8 | ||
Financial liabilities measured at amortized cost: Bank loans and capital leases [Member] | ||||
Disclosure of detailed information about financial instruments [line items] | ||||
Financial liabilities | 1,278 | 1,984 | ||
Financial assets at fair value: Marketable securities (equity and debt) - through profit or loss [Member] | ||||
Disclosure of detailed information about financial instruments [line items] | ||||
Financial assets | 1,663 | |||
Financial assets at fair value through other comprehensive income [Member] | ||||
Disclosure of detailed information about financial instruments [line items] | ||||
Financial assets | 10,324 | 8,597 | ||
Available for sale debt securities [Member] | ||||
Disclosure of detailed information about financial instruments [line items] | ||||
Financial assets | ||||
Financial assets at cost - Cash and cash equivalent [Member] | ||||
Disclosure of detailed information about financial instruments [line items] | ||||
Financial assets | [1] | 18,093 | 12,681 | |
Financial assets at cost - Short term bank deposits [Member] | ||||
Disclosure of detailed information about financial instruments [line items] | ||||
Financial assets | $ 22,175 | $ 20,078 | [1] | |
[1] | Reclassified |
FINANCIAL INSTRUMENTS (Schedu_2
FINANCIAL INSTRUMENTS (Schedule of Financial Liabilities based on Contractual Undiscounted Payments) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of maturity analysis for derivative financial liabilities [line items] | ||
Trade payables | $ 17,285 | $ 18,036 |
Other accounts payables | 5,261 | 5,820 |
Long term loans and capital leases (including interest) | 1,331 | 2,095 |
Financial liabilities | 23,877 | 25,951 |
Less than one year [Member] | ||
Disclosure of maturity analysis for derivative financial liabilities [line items] | ||
Trade payables | 17,285 | 18,036 |
Other accounts payables | 5,261 | 5,820 |
Long term loans and capital leases (including interest) | 595 | 669 |
Financial liabilities | 23,141 | 24,525 |
1 to 2 [Member] | ||
Disclosure of maturity analysis for derivative financial liabilities [line items] | ||
Trade payables | ||
Other accounts payables | ||
Long term loans and capital leases (including interest) | 495 | 634 |
Financial liabilities | 495 | 634 |
2 to 3 [Member] | ||
Disclosure of maturity analysis for derivative financial liabilities [line items] | ||
Trade payables | ||
Other accounts payables | ||
Long term loans and capital leases (including interest) | 209 | 532 |
Financial liabilities | 209 | 532 |
3 to 5 [Member] | ||
Disclosure of maturity analysis for derivative financial liabilities [line items] | ||
Trade payables | ||
Other accounts payables | ||
Long term loans and capital leases (including interest) | 32 | 260 |
Financial liabilities | $ 32 | $ 260 |
FINANCIAL INSTRUMENTS (Schedu_3
FINANCIAL INSTRUMENTS (Schedule of Changes in Liabilities Arising From Financing Activities) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Disclosure of reconciliation of liabilities arising from financing activities [line items] | |
Beginning | $ 1,984 |
Payments | (596) |
Foreign exchange movement | (110) |
Cash from new loans | |
New leases | |
Ending | 1,278 |
Bank loans [Member] | |
Disclosure of reconciliation of liabilities arising from financing activities [line items] | |
Beginning | 1,710 |
Payments | (460) |
Foreign exchange movement | (110) |
Cash from new loans | |
New leases | |
Ending | 1,140 |
Capital lease [Member] | |
Disclosure of reconciliation of liabilities arising from financing activities [line items] | |
Beginning | 274 |
Payments | (136) |
Foreign exchange movement | |
Cash from new loans | |
New leases | |
Ending | $ 138 |
FINANCIAL INSTRUMENTS (Schedu_4
FINANCIAL INSTRUMENTS (Schedule of Carrying Amount and Fair Value of Financial Instruments) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of financial liabilities [line items] | ||
Financial liabilities Carrying Amount | $ 1,342 | $ 1,992 |
Bank loans and capital leases [Member] | ||
Disclosure of financial liabilities [line items] | ||
Financial liabilities Carrying Amount | 1,278 | 1,984 |
Financial liabilities Fair Value | $ 1,275 | $ 1,984 |
FINANCIAL INSTRUMENTS (Schedu_5
FINANCIAL INSTRUMENTS (Schedule of Classification of Financial Instruments by Fair Value Hierarchy) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Level 1 [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | $ 1,588 | $ 1,663 |
Level 1 [Member] | Debt securities (corporate and government) [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | 1,588 | |
Level 1 [Member] | Marketable securities at fair value through profit or loss [Member] | Equity shares [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | 77 | |
Level 1 [Member] | Marketable securities at fair value through profit or loss [Member] | Mutual funds [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | 456 | |
Level 1 [Member] | Marketable securities at fair value through profit or loss [Member] | Debt securities (corporate and government) [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | 1,130 | |
Level 1 [Member] | Derivatives instruments [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | ||
Level 1 [Member] | Financial assets at fair value through other comprehensive income | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | ||
Level 2 [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | 8,672 | 8,589 |
Level 2 [Member] | Debt securities (corporate and government) [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | ||
Level 2 [Member] | Derivatives instruments [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | (64) | (8) |
Level 2 [Member] | Financial assets at fair value through other comprehensive income [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | $ 8,597 | |
Level 2 [Member] | Financial assets at fair value through other comprehensive income | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | $ 8,736 |
FINANCIAL INSTRUMENTS (Schedu_6
FINANCIAL INSTRUMENTS (Schedule of Sensitivity Test) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
5% increase in market price [Member] | ||
Sensitivity test to changes in market price of listed Securities | ||
Gain (loss) from sensitivity test to changes in market price of listed Securities | $ 519 | $ 513 |
5% decrease in market price [Member] | ||
Sensitivity test to changes in market price of listed Securities | ||
Gain (loss) from sensitivity test to changes in market price of listed Securities | (519) | (513) |
5% increase in NIS [Member] | ||
Sensitivity test to changes in foreign currency: | ||
Gain (loss) from sensitivity test to changes in foreign currency | (21) | (143) |
5% decrease in NIS [Member] | ||
Sensitivity test to changes in foreign currency: | ||
Gain (loss) from sensitivity test to changes in foreign currency | 21 | 143 |
5% increase in Euro [Member] | ||
Sensitivity test to changes in foreign currency: | ||
Gain (loss) from sensitivity test to changes in foreign currency | (197) | (135) |
5% decrease in Euro [Member] | ||
Sensitivity test to changes in foreign currency: | ||
Gain (loss) from sensitivity test to changes in foreign currency | $ 197 | $ 135 |
FINANCIAL INSTRUMENTS (Schedu_7
FINANCIAL INSTRUMENTS (Schedule of Linkage Terms of Financial Liabilities by Groups of Financial Instruments) (Details) ₪ in Thousands, $ in Thousands | Dec. 31, 2018USD ($) | Dec. 31, 2018ILS (₪) | Dec. 31, 2017USD ($) | Dec. 31, 2017ILS (₪) |
Bank loans measured at amortized cost [Member] | NIS [Member] | ||||
In NIS and USD: | ||||
Linkage terms of financial liabilities by groups of financial instruments pursuant to IFRS 9 | ₪ | ₪ 1,140 | ₪ 1,710 | ||
Capital leases measured at amortized cost [Member] | ||||
In NIS and USD: | ||||
Linkage terms of financial liabilities by groups of financial instruments pursuant to IFRS 9 | $ | $ 138 | $ 274 |
EMPLOYEE BENEFIT LIABILITIES,_3
EMPLOYEE BENEFIT LIABILITIES, NET (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of sensitivity analysis for actuarial assumptions [line items] | |||
Expenses for defined benefit deposit | $ 992 | $ 884 | $ 669 |
Discount rates [Member] | |||
Disclosure of sensitivity analysis for actuarial assumptions [line items] | |||
Reasonably possible increase in actuarial assumption | 1.00% | ||
Reasonably possible decrease in actuarial assumption | 1.00% | ||
Increase (decrease) in defined benefit obligation from a 1% increase in actuarial assumption | $ 241 | ||
Increase (decrease) in defined benefit obligation from a 1% decrease in actuarial assumption | $ 189 | ||
Expected salary growth [Member] | |||
Disclosure of sensitivity analysis for actuarial assumptions [line items] | |||
Reasonably possible increase in actuarial assumption | 1.00% | ||
Increase (decrease) in defined benefit obligation from a 1% increase in actuarial assumption | $ 229 | ||
Increase (decrease) in defined benefit obligation from a 1% decrease in actuarial assumption | $ 182 |
EMPLOYEE BENEFIT LIABILITIES,_4
EMPLOYEE BENEFIT LIABILITIES, NET (Schedule of Expenses Recognized in Comprehensive Income (Loss)) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of defined benefit plans [abstract] | |||
Current service cost | $ 292 | $ 356 | $ 359 |
Interest expenses, net | 25 | 23 | 20 |
Current service cost (income) due to the transfer of real yield from the compensation component to the royalties' component in executive insurance policies before 2004. | 3 | (7) | 5 |
Total employee benefit expenses | 320 | 372 | 384 |
Actual (negative) return on plan assets | $ 171 | $ 119 | $ 22 |
EMPLOYEE BENEFIT LIABILITIES,_5
EMPLOYEE BENEFIT LIABILITIES, NET (Schedule of Expenses are Presented in Statement of Comprehensive Income (Loss)) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |||
Disclosure of defined benefit plans [line items] | |||||
Total employee benefit expenses | $ 320 | $ 372 | $ 384 | ||
Cost of revenues [Member] | |||||
Disclosure of defined benefit plans [line items] | |||||
Total employee benefit expenses | 175 | 211 | 228 | ||
Research and development [Member] | |||||
Disclosure of defined benefit plans [line items] | |||||
Total employee benefit expenses | 50 | 57 | 62 | ||
Selling and marketing [Member] | |||||
Disclosure of defined benefit plans [line items] | |||||
Total employee benefit expenses | 75 | 73 | [1] | 67 | [1] |
General and administrative [Member] | |||||
Disclosure of defined benefit plans [line items] | |||||
Total employee benefit expenses | $ 20 | $ 31 | [1] | $ 27 | [1] |
[1] | Reclassified |
EMPLOYEE BENEFIT LIABILITIES,_6
EMPLOYEE BENEFIT LIABILITIES, NET (Schedule of Plan Assets (Liabilities), Net) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of defined benefit plans [abstract] | ||
Defined benefit obligation | $ 4,987 | $ 5,907 |
Fair value of plan assets | (4,200) | (4,763) |
Total liabilities, net | $ 787 | $ 1,144 |
EMPLOYEE BENEFIT LIABILITIES,_7
EMPLOYEE BENEFIT LIABILITIES, NET (Schedule of Changes in Present Value of Defined Benefit Obligation) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of net defined benefit liability (asset) [line items] | |||
Interest costs | $ 25 | $ 23 | $ 20 |
Current service cost | 292 | 356 | 359 |
Defined Benefit Obligation [Member] | |||
Disclosure of net defined benefit liability (asset) [line items] | |||
Balance at January 1, | 5,907 | 5,235 | |
Interest costs | 110 | 151 | |
Current service cost | 292 | 356 | |
Benefits paid | (645) | (641) | |
Demographic assumptions | (29) | (28) | |
Financial assumptions | (223) | 254 | |
Past Experience | (2) | 6 | |
Currency Exchange | (423) | 574 | |
Balance at December 31, | $ 4,987 | $ 5,907 | $ 5,235 |
EMPLOYEE BENEFIT LIABILITIES,_8
EMPLOYEE BENEFIT LIABILITIES, NET (Schedule of Changes in Fair Value of Plan Assets) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of net defined benefit liability (asset) [line items] | |||
Balance at January 1, | $ 4,763 | ||
Expected return | 171 | $ 119 | $ 22 |
Current service cost due to the transfer of real yield from the compensation component to the royalties component in executive insurance policies before 2004. | 3 | (7) | 5 |
Balance at December 31, | 4,200 | 4,763 | |
Plan assets [Member] | |||
Disclosure of net defined benefit liability (asset) [line items] | |||
Balance at January 1, | 4,763 | 4,513 | |
Expected return | 85 | 127 | |
Contributions by employer | 182 | 227 | |
Benefits paid | (564) | (586) | |
Demographic assumptions | 5 | 1 | |
Financial assumptions | (2) | 1 | |
Past Experience | 83 | (11) | |
Current service cost due to the transfer of real yield from the compensation component to the royalties component in executive insurance policies before 2004. | (3) | 7 | |
Currency exchange | (349) | 484 | |
Balance at December 31, | $ 4,200 | $ 4,763 | $ 4,513 |
EMPLOYEE BENEFIT LIABILITIES,_9
EMPLOYEE BENEFIT LIABILITIES, NET (Schedule of Principal Assumptions Underlying Defined Benefit Plan) (Details) | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Disclosure of defined benefit plans [abstract] | |||
Discount rate of the plan liability | 2.02% | 2.27% | 3.72% |
Future salary increases | 3.60% | 4.00% | 4.00% |
CONTINGENT LIABILITIES AND CO_3
CONTINGENT LIABILITIES AND COMMITMENTS (Narrative) (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended |
Aug. 23, 2010 | Dec. 31, 2018 | |
Baxter Healthcare Corporation [Member] | ||
Disclosure of contingent liabilities [line items] | ||
Agreement term | 30 years | |
Agreement payment amount | $ 45 | |
Minimum amount purchased by third party from Kamada through five years from signing the agreement | 60 | |
Minimum yearly royalties to be paid by shire starting from the beginning of the sale of Glassia produced by Shire in accordance with the License Agreement | $ 5 | |
Amount received from Distribution Agreement | $ 39.5 | |
Maximum cost of experiment with Glassia | $ 10 | |
Operating lease agreements [Member] | ||
Disclosure of contingent liabilities [line items] | ||
Agreements expiration date | 2,026 | |
Vehicles [Member] | ||
Disclosure of contingent liabilities [line items] | ||
Agreements expiration date | 2019-2021 | |
Patents [Member] | ||
Disclosure of contingent liabilities [line items] | ||
Agreements expiration date | 15 years |
CONTINGENT LIABILITIES AND CO_4
CONTINGENT LIABILITIES AND COMMITMENTS (Schedule of Minimum Future Lease Fees for Office and Storage Spaces) (Details) - Building [Member] $ in Thousands | Dec. 31, 2018USD ($) |
Disclosure of finance lease and operating lease by lessee [line items] | |
Minimum future lease fees for the office and storage spaces | $ 4,790 |
Year 1 [Member] | |
Disclosure of finance lease and operating lease by lessee [line items] | |
Minimum future lease fees for the office and storage spaces | 577 |
Year 2 to 5 [Member] | |
Disclosure of finance lease and operating lease by lessee [line items] | |
Minimum future lease fees for the office and storage spaces | 2,365 |
Year 6 and thereafter [Member] | |
Disclosure of finance lease and operating lease by lessee [line items] | |
Minimum future lease fees for the office and storage spaces | $ 1,848 |
CONTINGENT LIABILITIES AND CO_5
CONTINGENT LIABILITIES AND COMMITMENTS (Schedule of Minimum Future Lease Fees for Existing Vehicles) (Details) - Vehicles [Member] $ in Thousands | Dec. 31, 2018USD ($) |
Disclosure of finance lease and operating lease by lessee [line items] | |
Minimum future lease fees for the existing vehicles | $ 644 |
Year 1 [Member] | |
Disclosure of finance lease and operating lease by lessee [line items] | |
Minimum future lease fees for the existing vehicles | 406 |
Year 2 [Member] | |
Disclosure of finance lease and operating lease by lessee [line items] | |
Minimum future lease fees for the existing vehicles | 209 |
Year 3 [Member] | |
Disclosure of finance lease and operating lease by lessee [line items] | |
Minimum future lease fees for the existing vehicles | $ 29 |
GUARANTEES AND CHARGES (Details
GUARANTEES AND CHARGES (Details) - Dec. 31, 2018 ₪ in Thousands, $ in Thousands | USD ($) | ILS (₪) |
Disclosure of contingent liabilities [line items] | ||
Value of loans for which collateral has been pledged | ₪ | ₪ 8,355 | |
Contingent liability for guarantees [member] | ||
Disclosure of contingent liabilities [line items] | ||
Contingent liability | $ | $ 208 |
EQUITY (Narrative) (Details)
EQUITY (Narrative) (Details) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($)shares | Dec. 31, 2016shares | Dec. 31, 2018₪ / shares | Dec. 31, 2017₪ / shares | |
Disclosure of classes of share capital [abstract] | |||||
Share options, exercised | 53,584 | 10,659 | 8,398 | ||
Ordinary shares issued from share options exercised | 8,686 | 1,988 | |||
Ordinary shares par value | ₪ / shares | ₪ 1 | ₪ 1 | |||
Proceeds from share options exercised | $ | $ 9 | $ 3 | |||
Option vested | 23,572 | 7,656 |
EQUITY (Schedule of Share Capit
EQUITY (Schedule of Share Capital) (Details) - ₪ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of classes of share capital [abstract] | ||
Ordinary shares of NIS 1 par value, Authorized | 70,000,000 | 70,000,000 |
Ordinary shares of NIS 1 par value, Outstanding | 40,295,078 | 40,262,819 |
Ordinary shares par value | ₪ 1 | ₪ 1 |
SHARE-BASED PAYMENT (Narrative)
SHARE-BASED PAYMENT (Narrative) (Details) | 1 Months Ended | 12 Months Ended | ||||||
Dec. 20, 2018USD ($)shares | Sep. 30, 2016 | Dec. 31, 2018USD ($)shares | Dec. 31, 2017ILS (₪)shares | Dec. 31, 2016ILS (₪)shares | Dec. 31, 2018ILS (₪)shares | Dec. 20, 2018ILS (₪) | Dec. 31, 2015ILS (₪) | |
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||||
Option granted | 617,825 | 458,950 | 401,275 | |||||
Exercisable shares | 1,406,048 | 1,755,253 | 1,543,358 | 1,406,048 | ||||
Exercise price of options | ₪ | ₪ 32.47 | ₪ 35.2 | ₪ 29.99 | ₪ 38.96 | ||||
Dividend yield | ||||||||
Bottom of range [Member] | ||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||||
Exercise price of options | ₪ | ₪ 15 | 15 | ||||||
Expected volatility | 25.00% | 37.00% | 32.00% | |||||
Risk-free interest rate | 0.20% | 0.10% | 0.13% | |||||
Expected average forfeiture rate | 1.00% | 1.00% | 0.00% | |||||
Top of range [Member] | ||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||||
Exercise price of options | ₪ | ₪ 57 | ₪ 57 | ||||||
Expected volatility | 39.00% | 45.00% | 51.00% | |||||
Risk-free interest rate | 2.00% | 1.83% | 1.83% | |||||
Expected average forfeiture rate | 5.00% | 5.00% | 5.00% | |||||
Number of RSs [Member] | ||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||||
Option granted | 96,308 | 58,835 | 29,333 | |||||
2011 Option Plan [Member] | ||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||||
Vesting description of options | Pursuant to the 2011 Plan, granted share options and RS generally vest over a four-year period following the date of the grant in 13 installments: 25% of the options vest on the first anniversary of the grant date and 6.25% options vest at the end of each quarter thereafter. | |||||||
Chief Executive Officer [Member] | ||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||||
Option granted | 90,000 | |||||||
Exercise price of options | ₪ | ₪ 18.93 | |||||||
Fair value of options | $ | $ 156,000 | |||||||
Chief Executive Officer [Member] | Number of RSs [Member] | ||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||||
Option granted | 30,000 | |||||||
Fair value of options | $ | $ 148,000 | |||||||
Employees options [Member] | ||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||||
Option granted | 417,825 | |||||||
Fair value of options | $ | $ 795,000 | |||||||
Employees options [Member] | Number of RSs [Member] | ||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||||
Option granted | 66,308 | |||||||
Fair value of options | $ | $ 344,000 | |||||||
Directors options [Member] | ||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||||
Option granted | 110,000 | |||||||
Fair value of options | $ | $ 170,000 | |||||||
Directors options [Member] | Bottom of range [Member] | ||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||||
Exercise price of options | ₪ | 18.93 | |||||||
Directors options [Member] | Top of range [Member] | ||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||||
Exercise price of options | ₪ | ₪ 22.54 |
SHARE-BASED PAYMENT (Schedule o
SHARE-BASED PAYMENT (Schedule of Expense Recognized in Financial Statements) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Total share-based compensation | $ 948 | $ 483 | $ 1,071 |
Cost of revenues [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Total share-based compensation | 401 | 179 | 332 |
Research and development [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Total share-based compensation | 224 | 138 | 134 |
Selling and marketing [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Total share-based compensation | 51 | 48 | 71 |
General and administrative [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Total share-based compensation | $ 272 | $ 118 | $ 534 |
SHARE-BASED PAYMENT (Schedule_2
SHARE-BASED PAYMENT (Schedule of Change of Awards) (Details) | 12 Months Ended | ||
Dec. 31, 2018ILS (₪)sharesyr | Dec. 31, 2017ILS (₪)sharesyr | Dec. 31, 2016ILS (₪)sharesyr | |
Number of Options | |||
Outstanding at beginning of year | shares | 2,572,372 | 2,487,236 | 2,281,493 |
Granted | shares | 617,825 | 458,950 | 401,275 |
Exercised | shares | (53,584) | (10,659) | (8,398) |
Forfeited | shares | (691,016) | (363,155) | (187,134) |
Outstanding at end of year | shares | 2,445,597 | 2,572,372 | 2,487,236 |
Exercisable at end of year | shares | 1,406,048 | 1,755,253 | 1,543,358 |
Weighted Average Exercise Price | |||
Outstanding at beginning of year | ₪ | ₪ 32.47 | ₪ 35.2 | ₪ 38.96 |
Granted | ₪ | 19.02 | 21.1 | 15.17 |
Exercised | ₪ | 15.77 | 18.19 | 18.47 |
Forfeited | ₪ | 30.51 | 35.7 | 39.22 |
Outstanding at end of year | ₪ | 29.99 | 32.47 | 35.2 |
Exercisable at end of year | ₪ | ₪ 38.02 | ₪ 38.69 | ₪ 40.44 |
The weighted average remaining contractual life for the share options | yr | 3.63 | 3.22 | 3.62 |
SHARE-BASED PAYMENT (Schedule_3
SHARE-BASED PAYMENT (Schedule of Number of RSs and Modification in Employee RSs) (Details) | 12 Months Ended | ||
Dec. 31, 2018sharesyr | Dec. 31, 2017sharesyr | Dec. 31, 2016sharesyr | |
Disclosure of classes of share capital [line items] | |||
Outstanding at beginning of year | 2,572,372 | 2,487,236 | 2,281,493 |
Granted | 617,825 | 458,950 | 401,275 |
Forfeited | (691,016) | (363,155) | (187,134) |
Outstanding at end of year | 2,445,597 | 2,572,372 | 2,487,236 |
The weighted average remaining contractual life for the restricted share | yr | 3.63 | 3.22 | 3.62 |
Number of RSs [Member] | |||
Disclosure of classes of share capital [line items] | |||
Outstanding at beginning of year | 76,512 | 27,333 | |
Granted | 96,308 | 58,835 | 29,333 |
End of restriction period | (23,572) | (7,656) | |
Forfeited | (9,542) | (2,000) | (2,000) |
Outstanding at end of year | 139,706 | 76,512 | 27,333 |
The weighted average remaining contractual life for the restricted share | yr | 5.79 | 5.92 | 6.20 |
SHARE-BASED PAYMENT (Schedule_4
SHARE-BASED PAYMENT (Schedule of Inputs to Binomial Model Used for Fair Value Measurement) (Details) | 12 Months Ended | |||||
Dec. 31, 2018USD ($)yr | Dec. 31, 2018ILS (₪)yr | Dec. 31, 2017USD ($)yr | Dec. 31, 2017ILS (₪)yr | Dec. 31, 2016USD ($)yr | Dec. 31, 2016ILS (₪)yr | |
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Dividend yield (%) | ||||||
Contractual term of up to (years) | yr | 6.5 | 6.5 | 6.5 | 6.5 | 6.5 | 6.5 |
Exercise multiple | $ | $ 2 | $ 2 | $ 2 | |||
Weighted average share prices (NIS) | ₪ 15.17 | |||||
Bottom of range [Member] | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Expected volatility of the share prices (%) | 25.00% | 25.00% | 37.00% | 37.00% | 32.00% | 32.00% |
Risk-free interest rate (%) | 0.20% | 0.20% | 0.10% | 0.10% | 0.13% | 0.13% |
Weighted average share prices (NIS) | ₪ 18.49 | ₪ 16.05 | ||||
Expected average forfeiture rate (%) | 1.00% | 1.00% | 1.00% | 1.00% | 0.00% | 0.00% |
Top of range [Member] | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Expected volatility of the share prices (%) | 39.00% | 39.00% | 45.00% | 45.00% | 51.00% | 51.00% |
Risk-free interest rate (%) | 2.00% | 2.00% | 1.83% | 1.83% | 1.83% | 1.83% |
Weighted average share prices (NIS) | ₪ 21.17 | ₪ 16.44 | ||||
Expected average forfeiture rate (%) | 5.00% | 5.00% | 5.00% | 5.00% | 5.00% | 5.00% |
TAXES ON INCOME (Narrative) (De
TAXES ON INCOME (Narrative) (Details) - USD ($) $ in Thousands | Jul. 10, 2016 | Dec. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Useful life of intangible assets | five years | |||
Tax rate | 23.00% | |||
Reduced corporate tax | In 2017 from 25% to 24%, and in 2018 from 24% to 23% | 25% to 24% | ||
Agreement settlement amount | $ 1,300 | |||
Carry forward losses | $ 65,177 | |||
Deferred tax asset | 2,048 | |||
Carry forward losses foreseeable future | $ 37,224 | |||
NIS [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Agreement settlement amount | $ 5,000 | |||
Law for the Encouragement of Industry (Taxes), 1969 [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Percentage of income that is generated from industrial enterprise | 90.00% | |||
Period of right to deduct expenses related to public offerings | Three years | |||
Law for the Encouragement of Industry (Taxes), 1969 [Member] | patents, know-how and certain other intangible [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Useful life of intangible assets | Eight years | |||
Law for the Encouragement of Capital Investments, 1959 [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Reduced corporate tax | 10% to 25% during the remaining five to eight years | |||
Tax benefit description | The benefits period is limited to 12 years from completion of the investment or commencement of production ("Year of Operation"), or 14 years from the year in which the certificate of approval was obtained. | |||
Law for the Encouragement of Capital Investments, 1959 [Member] | Development Zone A [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Tax rate | 24.00% | |||
Law for the Encouragement of Capital Investments, 1959 [Member] | Development Zone B [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Tax rate | 10.00% | |||
Law for the Encouragement of Capital Investments, 1959 [Member] | Alternative Track [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Reduced corporate tax | 10% to 25% for the following five to eight years | |||
Tax benefit description | The benefits period is limited to 12 years from the Year of Operation, or 14 years from the year in which the certificate of approval was obtained. | |||
Tax benefits under Amendment 60 [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Tax rate | 15.00% | |||
Tax benefit description | The duration of tax benefits is subject to a limitation of the earlier of 7 to 10 years (depending on the extent of foreign investment in the company) from the first year in which the company generated taxable income (at, or after, the Year of Election) , or 12 years from the first day of the Year of Election. | |||
Dividend distributed during benefits period | Dividend is distributed during the benefits period or within the following 12 years (the limitation does not apply to a Foreign Investors Company, which is a company that more than 25% of its shares owned by non-Israeli residents). | |||
Preferred Enterprise [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Tax rate | 16.00% | |||
Percentage of minimum threshold export | 25.00% | |||
Preferred Enterprise [Member] | Development Zone A [Member] | Bottom of range [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Tax rate | 7.50% | |||
Preferred Enterprise [Member] | Development Zone A [Member] | Top of range [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Tax rate | 9.00% | |||
2011 Amendment [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Tax rate | 12.50% | |||
2011 Amendment [Member] | Development Zone A [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Tax rate | 7.00% | |||
Preferred technology enterprise [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Tax rate | 12.00% | |||
Preferred technology enterprise [Member] | Development Zone A [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Tax rate | 7.50% | |||
Special preferred technology enterprise [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Tax rate | 6.00% | |||
Dividends distributed from technology enterprise earnings [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Tax rate | 4.00% |
TAXES ON INCOME (Schedule of We
TAXES ON INCOME (Schedule of Weighted Combination of Applicable Rates) (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Rate of Reduced Tax | In 2017 from 25% to 24%, and in 2018 from 24% to 23% | 25% to 24% |
Percent of Foreign Ownership One [Member] | ||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Percent of Foreign Ownership | 0-25% | |
Rate of Reduced Tax | 25% | |
Reduced Tax Period | 5/0 years | |
Tax Exemption Period | 2/10 years | |
Percent of Foreign Ownership Two [Member] | ||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Percent of Foreign Ownership | 25-49% | |
Rate of Reduced Tax | 25% | |
Reduced Tax Period | 8/0 years | |
Tax Exemption Period | 2/10 years | |
Percent of Foreign Ownership Three [Member] | ||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Percent of Foreign Ownership | 49-74% | |
Rate of Reduced Tax | 20% | |
Reduced Tax Period | 8/0 years | |
Tax Exemption Period | 2/10 years | |
Percent of Foreign Ownership Four [Member] | ||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Percent of Foreign Ownership | 74-90% | |
Rate of Reduced Tax | 15% | |
Reduced Tax Period | 8/0 years | |
Tax Exemption Period | 2/10 years | |
Percent of Foreign Ownership Five [Member] | ||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Percent of Foreign Ownership | 90-100% | |
Rate of Reduced Tax | 10% | |
Reduced Tax Period | 8/0 years | |
Tax Exemption Period | 2/10 years |
TAXES ON INCOME (Schedule of De
TAXES ON INCOME (Schedule of Deferred Taxes) (Details) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |
Balance at January 1, 2018 | |
Amount carried to profit and loss | 1,944 |
Amount carried to other comprehensive income | (8) |
Amount carried to other capital reserve | 112 |
Balance as of December 31, 2018 | $ 2,048 |
TAXES ON INCOME (Schedule of Cu
TAXES ON INCOME (Schedule of Current Taxes on Income) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Taxes On Income Schedule Of Theoretical Tax | |||
Current taxes | $ 129 | $ 362 | |
Deferred tax income | (1,944) | ||
Taxes in respect of prior years | (11) | 140 | 1,360 |
Tax income | $ (1,955) | $ 269 | $ 1,722 |
TAXES ON INCOME (Schedule of Th
TAXES ON INCOME (Schedule of Theoretical tax) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Taxes On Income Schedule Of Theoretical Tax | |||
Gain before taxes on income | $ 20,341 | ||
Statutory tax rate | 23.00% | ||
Tax calculated using the statutory tax rate | $ 4,678 | ||
Carry-forward tax losses utilization for which no deferred taxes were provided, net | (4,678) | ||
Temporary differences for which deferred taxes are initially recognized | (1,944) | ||
Prior year taxes | (11) | 140 | 1,360 |
Tax on income | $ (1,955) | $ 269 | $ 1,722 |
Effective tax rate | 9.60% |
SUPPLEMENTARY INFORMATION TO _3
SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF PROFIT AND LOSS (Schedule of Additional Information about Revenues) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of major customers [line items] | |||
Additional information about revenues | $ 114,469 | $ 102,825 | $ 77,494 |
Revenues from major customers each of whom amount to 10% or more, of total revenues [Member] | |||
Disclosure of major customers [line items] | |||
Additional information about revenues | 75,567 | 60,383 | 50,676 |
Customer A [Member] | |||
Disclosure of major customers [line items] | |||
Additional information about revenues | 63,788 | 60,383 | 40,451 |
Customer B [Member] | |||
Disclosure of major customers [line items] | |||
Additional information about revenues | 10,225 | ||
Customer C [Member] | |||
Disclosure of major customers [line items] | |||
Additional information about revenues | $ 11,779 |
SUPPLEMENTARY INFORMATION TO _4
SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF PROFIT AND LOSS (Schedule of Revenues Based of Customers) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of geographical areas [line items] | |||
Revenue | $ 114,469 | $ 102,825 | $ 77,494 |
U.S.A. [Member] | |||
Disclosure of geographical areas [line items] | |||
Revenue | 75,331 | 60,405 | 40,585 |
Israel [Member] | |||
Disclosure of geographical areas [line items] | |||
Revenue | 28,093 | 26,355 | 25,340 |
Europe [Member] | |||
Disclosure of geographical areas [line items] | |||
Revenue | 3,594 | 5,348 | 3,825 |
Latin America [Member] | |||
Disclosure of geographical areas [line items] | |||
Revenue | 3,994 | 5,248 | 4,221 |
Asia [Member] | |||
Disclosure of geographical areas [line items] | |||
Revenue | 3,336 | 4,979 | 3,028 |
Others [Member] | |||
Disclosure of geographical areas [line items] | |||
Revenue | $ 121 | $ 490 | $ 495 |
SUPPLEMENTARY INFORMATION TO _5
SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF PROFIT AND LOSS (Schedule of Income and Expenses) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |||
Cost of goods sold | |||||
Cost of materials | $ 54,888 | $ 41,179 | $ 36,154 | ||
Salary and related expenses | 14,867 | 13,137 | 10,596 | ||
Depreciation and amortization | 2,859 | 2,504 | 2,443 | ||
Energy | 1,426 | 1,202 | 959 | ||
Subcontractors | 3,633 | 3,995 | 2,833 | ||
Other manufacturing expenses | 989 | 1,572 | 1,057 | ||
Total expenses | 78,662 | 63,589 | 54,042 | ||
Decrease (increase) in inventories | (5,665) | 7,148 | 2,092 | ||
Total cost of revenues | 72,997 | 70,737 | 56,134 | ||
Research and development | |||||
Salary and related expenses | 5,823 | 6,413 | 5,237 | ||
Subcontractors | 2,275 | 3,392 | 8,318 | ||
Materials and allocation of facility costs | 1,131 | 1,101 | 1,907 | ||
Others | 518 | 1,067 | 783 | ||
Research and development expenses | 9,747 | 11,973 | 16,245 | ||
Selling and marketing | |||||
Salary and related expenses | 1,647 | 1,470 | 1,272 | ||
Marketing support | 121 | 95 | 79 | ||
Packing, shipping and delivery | 477 | 607 | 494 | ||
Marketing and advertising | 424 | 627 | 337 | ||
Registration and marketing fees | 470 | 1,162 | 796 | ||
Others | 491 | 437 | 265 | ||
Selling and marketing expenses | 3,630 | 4,398 | 3,243 | ||
General and administrative | |||||
Salary and related expenses | 3,085 | 3,138 | 3,029 | ||
Employees welfare | 1,151 | 2,182 | 1,465 | ||
Professional fees and public company expense | 2,012 | 1,549 | [1] | 1,416 | [1] |
Depreciation, amortization and impairment | 686 | 649 | 712 | ||
Communication and software services | 675 | 554 | [1] | 362 | [1] |
Others | 916 | 201 | [1] | 369 | [1] |
General and administrative expenses | 8,525 | 8,273 | 7,353 | ||
Financial incomes | |||||
Interest income and gains from marketable securities | 820 | 500 | 469 | ||
Financial expenses | |||||
Fees and interest paid to financial institutions | $ 340 | $ 162 | $ 126 | ||
[1] | Reclassified |
INCOME (LOSS) PER SHARE (Schedu
INCOME (LOSS) PER SHARE (Schedule of Details of Number of Shares and Income (Loss)) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income (loss) per share attributable to equity holders of the Company: | |||
Weighted Number of Shares For the computation of basic income (loss) | 40,275,374 | 37,970,697 | 36,418,833 |
Weighted Number of Shares Effect of potential dilutive ordinary shares | 170,043 | 74,400 | |
Weighted Number of Shares For the computation of diluted income (loss) | 40,445,417 | 38,045,097 | 36,418,833 |
Loss Attributed to equity holders of the Company For the computation of basic income (loss) | $ 22,296,000 | $ 6,901,000 | $ (6,733,000) |
Loss Attributed to equity holders of the Company Effect of potential dilutive ordinary shares | |||
Loss Attributed to equity holders of the Company For the computation of diluted income (loss) | $ 22,296,000 | $ 6,901,000 | $ (6,733,000) |
OPERATING SEGMENTS (Schedule of
OPERATING SEGMENTS (Schedule of Reporting on Operating Segments) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of operating segments [line items] | |||
Revenues | $ 114,469 | $ 102,825 | $ 77,494 |
Gross profit | 41,472 | 32,088 | 21,360 |
Unallocated corporate expenses | (22,213) | (24,644) | (26,841) |
Finance income, net | 1,082 | (274) | 470 |
Income (loss) before taxes on income | 20,341 | 7,170 | (5,011) |
Proprietary Products [Member] | |||
Disclosure of operating segments [line items] | |||
Revenues | 90,784 | 79,559 | 55,958 |
Gross profit | 37,988 | 28,224 | 18,235 |
Distribution [Member] | |||
Disclosure of operating segments [line items] | |||
Revenues | 23,685 | 23,266 | 21,536 |
Gross profit | $ 3,484 | $ 3,864 | $ 3,125 |
BALANCES AND TRANSACTIONS WIT_3
BALANCES AND TRANSACTIONS WITH RELATED PARTIES (Narrative) (Details) | 1 Months Ended | 12 Months Ended | ||||||
Dec. 20, 2018USD ($) | Aug. 30, 2016USD ($) | Aug. 30, 2016ILS (₪) | Jun. 30, 2015USD ($) | Jun. 30, 2015ILS (₪) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Disclosure of transactions between related parties [line items] | ||||||||
Allowance for doubtful accounts for sums receivable from related parties | ||||||||
Chief Executive Officer [Member] | ||||||||
Disclosure of transactions between related parties [line items] | ||||||||
Monthly gross salary | $ 22,627 | $ 18,430 | ||||||
Chief Executive Officer [Member] | ||||||||
Disclosure of transactions between related parties [line items] | ||||||||
Monthly gross salary | $ 16,658 | |||||||
Annual bonus | $ 139 | |||||||
Chief Executive Officer [Member] | NIS [Member] | ||||||||
Disclosure of transactions between related parties [line items] | ||||||||
Monthly gross salary | $ 82,500 | ₪ 71,500 | ₪ 65,000 |
BALANCES AND TRANSACTIONS WIT_4
BALANCES AND TRANSACTIONS WITH RELATED PARTIES (Schedule of Balances with Related Parties) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of transactions between related parties [abstract] | ||
Other accounts payables | $ 336 | $ 292 |
Employee benefit liabilities, net | 80 | 92 |
Trade receivable | $ 1,135 | $ 2,382 |
BALANCES AND TRANSACTIONS WIT_5
BALANCES AND TRANSACTIONS WITH RELATED PARTIES (Schedule of Benefits to Related Parties) (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Disclosure of transactions between related parties [abstract] | |||
Salary and related expenses to those employed by the Company or on its behalf | $ 352 | $ 460 | $ 473 |
Remuneration of directors not employed by the Company or on its behalf | $ 366 | $ 107 | $ 122 |
Related and related parties employed by the Company or on its behalf | 2 | 2 | 2 |
Directors not employed by the Company | 8 | 2 | 3 |
Number of People to whom the Salary and Benefits Refer | 10 | 4 | 5 |
BALANCES AND TRANSACTIONS WIT_6
BALANCES AND TRANSACTIONS WITH RELATED PARTIES (Schedule of Transactions with Key Executive Personnel) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of transactions between related parties [abstract] | |||
Short-term benefits | $ 2,766 | $ 2,959 | $ 2,654 |
Share-based payment | 285 | 310 | 460 |
Other long-term benefits | 6 | 28 | |
Benefits to key executive personnel | $ 3,051 | $ 3,275 | $ 3,142 |
BALANCES AND TRANSACTIONS WIT_7
BALANCES AND TRANSACTIONS WITH RELATED PARTIES (Schedule of Transactions with Related Parties) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of transactions between related parties [abstract] | |||
Sales | $ 3,529 | $ 3,455 | $ 2,230 |
Selling and marketing expenses | 313 | 121 | 101 |
General and administrative expenses | $ 408 | $ 446 | $ 503 |