Document and Entity Information
Document and Entity Information | 12 Months Ended |
Dec. 31, 2019shares | |
Document and Entity Information [Abstract] | |
Entity Registrant Name | KAMADA LTD |
Entity Central Index Key | 0001567529 |
Document Type | 20-F |
Document Period End Date | Dec. 31, 2019 |
Amendment Flag | false |
Current Fiscal Year End Date | --12-31 |
Entity a Well-known Seasoned Issuer | No |
Entity a Voluntary Filer | No |
Entity Current Reporting Status | Yes |
Entity Filer Category | Accelerated Filer |
Entity Shell Company | false |
Entity Emerging Growth Company | false |
Document Fiscal Period Focus | FY |
Document Fiscal Year Focus | 2019 |
Entity File Number | 001-35948 |
Entity Interactive Data Current | Yes |
Entity Incorporation State Country Code | L3 |
Document Annual Report | true |
Document Transition Report | false |
Document Shell Company Report | false |
Entity Common Stock, Shares Outstanding | 4,035,310 |
Consolidated Statements of Fina
Consolidated Statements of Financial Position - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current Assets | ||
Cash and cash equivalents | $ 42,662 | $ 18,093 |
Short-term investments | 31,245 | 32,499 |
Trade receivables, net | 23,210 | 27,674 |
Other accounts receivables | 3,272 | 3,308 |
Inventories | 43,173 | 29,316 |
Total Current Assets | 143,562 | 110,890 |
Non-Current Assets | ||
Property, plant and equipment, net | 24,550 | 25,004 |
Right-of-use assets | 4,022 | |
Other long term assets | 352 | 174 |
Deferred taxes | 1,311 | 2,048 |
Total Non-Current Assets | 30,235 | 27,226 |
Total Assets | 173,797 | 138,116 |
Current Liabilities | ||
Current maturities of bank loans | 489 | 452 |
Current maturities of lease liabilities | 1,020 | 110 |
Trade payables | 24,830 | 17,285 |
Other accounts payables | 5,811 | 5,261 |
Deferred revenues | 589 | 461 |
Total Current Liabilities | 32,739 | 23,569 |
Non-Current Liabilities | ||
Bank loans | 257 | 688 |
Lease liabilities | 3,981 | 28 |
Deferred revenues | 232 | 668 |
Employee benefit liabilities, net | 1,269 | 787 |
Total Non-Current Liabilities | 5,739 | 2,171 |
Shareholder's Equity | ||
Ordinary shares | 10,425 | 10,409 |
Additional paid in capital net | 180,819 | 179,147 |
Capital reserve due to translation to presentation currency | (3,490) | (3,490) |
Capital reserve from hedges | 8 | (57) |
Capital reserve from financial assets measured at fair value through other comprehensive income | 145 | 34 |
Capital reserve from share-based payments | 8,844 | 9,353 |
Capital reserve from employee benefits | (359) | 4 |
Accumulated deficit | (61,073) | (83,024) |
Total Shareholder's Equity | 135,319 | 112,376 |
Total Liabilities and Shareholder's Equity | $ 173,797 | $ 138,116 |
Consolidated Statements of Prof
Consolidated Statements of Profit or Loss and Other Comprehensive Income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Profit or loss [abstract] | |||
Revenues from proprietary products | $ 97,696 | $ 90,784 | $ 79,559 |
Revenues from distribution | 29,491 | 23,685 | 23,266 |
Total revenues | 127,187 | 114,469 | 102,825 |
Cost of revenues from proprietary products | 52,425 | 52,796 | 51,335 |
Cost of revenues from distribution | 25,025 | 20,201 | 19,402 |
Total cost of revenues | 77,450 | 72,997 | 70,737 |
Gross profit | 49,737 | 41,472 | 32,088 |
Research and development expenses | 13,059 | 9,747 | 11,973 |
Selling and marketing expenses | 4,370 | 3,630 | 4,398 |
General and administrative expenses | 9,194 | 8,525 | 8,273 |
Other expense | 330 | 311 | |
Operating income | 22,784 | 19,259 | 7,444 |
Financial income | 1,146 | 830 | 500 |
Expense in respect of securities measured at fair value, net | (5) | (178) | (80) |
Income (expenses) in respect of currency exchange differences and derivatives instruments, net | (651) | 602 | (612) |
Financial expense | (293) | (172) | (82) |
Income before tax on income | 22,981 | 20,341 | 7,170 |
Taxes on income | 730 | (1,955) | 269 |
Net Income | 22,251 | 22,296 | 6,901 |
Amounts that will be or that have been reclassified to profit or loss when specific conditions are met | |||
Gain (loss) from securities measured at fair value through other comprehensive income | 143 | 51 | (23) |
Gain (loss) on cash flow hedges | 92 | (176) | 329 |
Net amounts transferred to the statement of profit or loss for cash flow hedges | (23) | 70 | (256) |
Items that will not be reclassified to profit or loss in subsequent periods: | |||
Remeasurement gain (loss) from defined benefit plan | (388) | 340 | (256) |
Tax effect | (11) | (9) | |
Total comprehensive income | $ 22,064 | $ 22,572 | $ 6,695 |
Earnings per share attributable to equity holders of the Company: | |||
Basic net earnings per share | $ 0.55 | $ 0.55 | $ 0.18 |
Diluted net earnings per share | $ 0.55 | $ 0.55 | $ 0.18 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Equity - USD ($) $ in Thousands | Share capital | Additional paid in capital | Capital reserve From securities measured at fair value through other Comprehensive income | Capital reserve due to translation to presentation currency | Capital reserve from hedges | Capital reserve from share based payments | Capital reserve from employee benefits | Accumulated deficit | Total |
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) | (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 Initial application of IFRS 15 | (757) | (757) | |||||||
Balance as at January 1, 2018 (after initially application of IFRS 15) | 10,400 | 177,874 | (4) | (3,490) | 46 | 9,566 | (337) | (105,320) | 88,735 |
Net income | 22,296 | 22,296 | |||||||
Other comprehensive income (loss) | 50 | (106) | 340 | 284 | |||||
Tax effect | (12) | 3 | 1 | (8) | |||||
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 | |||||||
Tax effect | 112 | 112 | |||||||
Balance at Dec. 31, 2018 | 10,409 | 179,147 | 34 | (3,490) | (57) | 9,353 | 4 | (83,024) | 112,376 |
Cumulative effect of initially application of IFRS 16 | (300) | (300) | |||||||
Balance as at January 1, 2019 (after Initial application of IFRS 16) | 10,409 | 179,147 | 34 | (3,490) | (57) | 9,353 | 4 | (83,324) | 112,076 |
Net income | 22,251 | 22,251 | |||||||
Other comprehensive income (loss) | 143 | 69 | (388) | (176) | |||||
Tax effect | (32) | (4) | 25 | (11) | |||||
Total comprehensive income (loss) | 111 | 65 | (363) | 22,251 | 22,064 | ||||
Exercise and forfeiture of share-based payment into shares | 16 | 1,672 | (1,672) | 16 | |||||
Cost of share-based payment | 1,163 | 1,163 | |||||||
Balance at Dec. 31, 2019 | $ 10,425 | $ 180,819 | $ 145 | $ (3,490) | $ 8 | $ 8,844 | $ (359) | $ (61,073) | $ 135,319 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash Flows from Operating Activities | |||
Net income | $ 22,251 | $ 22,296 | $ 6,901 |
Adjustments to the profit or loss items: | |||
Depreciation and amortization | 4,519 | 3,703 | 3,523 |
Financial expense (income), net | (197) | (1,082) | 274 |
Cost of share-based payment | 1,163 | 948 | 483 |
Taxes on income | 730 | (1,955) | 269 |
Loss (gain) from sale of property and equipment | (2) | 55 | (52) |
Change in employee benefit liabilities, net | 94 | (16) | 166 |
Adjustments to the profit or loss items | 6,307 | 1,653 | 4,663 |
Changes in asset and liability items: | |||
Decrease (increase) in trade receivables, net | 5,117 | 2,311 | (9,967) |
Decrease (increase) in other accounts receivables | (214) | (1,336) | 328 |
Decrease (increase) in inventories | (13,857) | (8,246) | 4,524 |
Decrease in deferred expenses | 399 | 235 | 594 |
Increase (decrease) in trade payables | 6,259 | (1,116) | (838) |
Increase (decrease) in other accounts payables | 863 | (658) | 71 |
Decrease in deferred revenues | (283) | (5,256) | (2,930) |
Total Changes in asset and liability | (1,716) | (14,066) | (8,218) |
Cash paid during the year for: | |||
Interest paid | (243) | (54) | (21) |
Interest received | 1,106 | 739 | 399 |
Taxes paid | (134) | (22) | (116) |
Cash received (paid) during the year | 729 | 663 | 262 |
Net cash provided by operating activities | 27,571 | 10,546 | 3,608 |
Cash Flows from Investing Activities | |||
Investment in short term investments, net | 1,727 | (2,322) | (11,501) |
Purchase of property and equipment and intangible assets | (2,300) | (2,884) | (4,167) |
Proceeds from sale of property and equipment | 9 | 30 | 60 |
Net cash used in investing activities | (564) | (5,176) | (15,608) |
Cash Flows from Financing Activities | |||
Proceeds from exercise of share base payments | 16 | 9 | 3 |
Receipt of long-term loans | 279 | ||
Repayment of lease liabilities | (1,070) | (136) | (111) |
Repayment of long-term loans | (476) | (460) | (419) |
Proceeds from issuance of ordinary shares, net | 15,568 | ||
Net cash provided by (used in) financing activities | (1,530) | (587) | 15,320 |
Exchange differences on balances of cash and cash equivalent | (908) | 629 | (607) |
Increase in cash and cash equivalents | 24,569 | 5,412 | 2,713 |
Cash and cash equivalents at the beginning of the year | 18,093 | 12,681 | 9,968 |
Cash and cash equivalents at the end of the year | 42,662 | 18,093 | 12,681 |
Significant non-cash transactions | |||
Right-of-use asset recognized with corresponding lease liability | 5,035 | 282 | |
Purchase of property and equipment | $ 992 | $ 720 | $ 1,681 |
GENERAL
GENERAL | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of general [abstract] | |
GENERAL | Note 1: - General a. General description of the Company and its activity Kamada Ltd. (“the Company”) is a plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed 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 highly-purified, liquid form, as well as other plasma-derived immune globulins. The Company’s flagship product is Glassia ® ® Pursuant to the agreement with Takeda (as detailed on Note 17) the Company will continue to produce Glassia for Takeda through 2021. Takeda is planning to complete the technology transfer of Glassia, and pending FDA approval, will initiate its own production of Glassia for the U.S. market in 2021. Accordingly, following the transition of manufacturing to Takeda, the Company will terminate the manufacturing and sale of Glassia to Takeda resulting in a significant reduction in revenues. Pursuant to the agreement, upon initiation of sales of Glassia manufactured by Takeda, Takeda will pay royalties to the Company at a rate of 12% on net sales through August 2025, and at a rate of 6% thereafter until 2040, with a minimum of $5 million annually, for each of the years from 2022 to 2040. The Company’s activity is divided into two operating segments: Proprietary Products Development, manufacturing, sales and distribution of plasma-derived protein therapeutics. Distribution Distribute imported drug products in Israel, which are manufactured by third parties. b. The Company’s securities are listed for trading on the Tel Aviv stock exchange and on the NASDAQ. The Company has three wholly-owned subsidiaries – Kamada Inc. and Kamada Ireland limited which are not active and Kamada Biopharma Limited. In addition the Company owns 74% of Kamada Assets Ltd (“Kamada Assets”). c. Definitions In these Financial Statements – The Company - Kamada Ltd. The Group - The Company and its subsidiaries. Subsidiary - A company which the Company has a control over (as defined in IFRS 10) and whose financial statements are consolidated with the Company’s Financial Statements. Related parties - As defined in International Accounting Standard (“IAS”) 24. USD/$ - U.S. dollar. NIS - New Israeli Shekel EUR - Euro |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2019 | |
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. 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, 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. Non-monetary assets and liabilities denominated in foreign currency and measured at fair value are translated into the functional currency using the exchange rate prevailing at the date when the fair value was determined. 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 deposits 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. The deposits are presented according to their terms of deposit. 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, 2019 the Company recognized an allowance for doubtful accounts at an amount of $67 thousands. The Company did not recognize an allowance in respect of groups of customers that are collectively assessed for impairment since it did not identify any groups of customers which bear similar credit risks. Impaired receivables are derecognized when they are assessed as uncollectible. 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 Costs of raw materials, direct and indirect costs including labor, other materials and other indirect manufacturing costs allocated to the in process manufactured batches through the end of the reporting period. The allocation of indirect costs is accounted for on a quarterly basis by dividing the total quarterly indirect manufacturing cost to the batches manufactured during that quarter based on predetermined allocation factors. Finished products Costs of raw materials, direct and indirect costs including labor, other materials and other indirect manufacturing costs allocated to the manufactured finished products through completion of manufacturing process. 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 On January 1, 2018, the Company initially adopted IFRS 15, "Revenue from Contracts with Customers" ("the Standard"). The Company elected to apply the provisions of the Standard using the modified retrospective method with the application of certain practical expedients and without restatement of comparative data. The accounting policy for revenue recognition applied from January 1, 2018, is as follows: The Company recognizes revenue when the customer obtains control over the promised goods or services. 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. The Company includes variable consideration, such as milestone payments or volume rebates, in the transaction price only when it is highly probable that its inclusion will not result in a significant revenue reversal in the future when the uncertainty has been subsequently resolved In determining the amount of revenue from contracts with customers, the Company evaluates whether it is a principal or an agent in the arrangement. The Company is a principal when the Company controls the promised goods or services before transferring them to the customer. In these circumstances, the Company recognizes revenue for the gross amount of the consideration. Identifying the contract The Company account for a contract with a customer only when all of the following criteria are met: a) The parties to the contract have approved the contract (in writing, orally or in accordance with other customary business practices) and are committed to perform their respective obligations; b) The Company can identify each party's rights regarding the goods or services to be transferred; c) The Company can identify the payment terms for the goods or services to be transferred; d) The contract has commercial substance (i.e. the risk, timing or amount of the entity's future cash flows is expected to change as a result of the contract); and e) It is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer For the purpose of paragraph (e) the Company examines, inter alia, the percentage of the advance payments received and the spread of the contractual payments, past experience with the customer and the status and existence of sufficient collateral. Combination of contracts The Company accounts for multiple contracts as a single contract when all the contracts are signed at or near the same time with the same customer or with related parties of the customer, and when one of the following criteria is met: a) The contracts are negotiated as a package with a single commercial objective. b) The amount of consideration to be paid in one contract depends on the consideration of another contract. c) The goods or services that the Company will provide according to the contracts represent a single performance obligation for the Company. Identifying performance obligations On the contract's inception date the Company assesses the goods or services promised in the contract with the customer and identifies the performance obligations in it. The Company identifies the performance obligations when the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and the Company promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. Determining the transaction price The transaction price is the amount of the consideration that is expected to be received based on the contract terms. The Company takes into account the effects of all the following elements when determining the transaction price: a) Variable consideration – The Company determines the transaction price separately for each contract with a customer. When exercising this judgment, the Company evaluates the effect of each variable amount in the contract, taking into consideration discounts, penalties, variations, claims, and non-cash consideration. The Company includes the estimated variable consideration in the transaction price only to the extent it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty is resolved. The Company updates the estimated transaction price to represent faithfully the circumstances present at the end of the reporting period and the changes in circumstances during the reporting period. b) Existence of a significant financing component – the Company adjusts the amount of the promised consideration in respect of the effects of the time value of money when certain advance payments provide the Company with a significant financing benefit. The financing component is recognized as interest expenses over the period, which are calculated according to the effective interest method. c) Non-cash consideration - Non-cash consideration is measured at the fair value for goods receivable on a contract's inception. d) Consideration payable to customers- The Company accounts for payments made to a customer as a reduction of the revenues from the customer when the Company recognizes revenue from the transfer of goods or services to the customer or the Company pays the consideration or promises to pay the consideration in accordance with the Company's customary business practices. When the consideration payable to a customer is a payment for a distinct good or service from the customer, then the Company accounts for the purchase of the good or service in the same way it accounts for other purchases from suppliers. Allocating the transaction price For contracts that consist of more than one performance obligation, at contract inception the Company allocates the contract transaction price to each performance obligation identified in the contract on a relative stand-alone selling price basis. The stand-alone selling price is the price at which the Company would sell the promised goods or services separately to a customer. When the stand-alone selling price is not directly observable by reference to similar transactions with similar customers, the Company applies suitable methods for estimating the stand-alone selling price including: the adjusted market assessment approach, the expected cost plus a margin approach and the residual approach. The Company may also use a combination of these approaches to allocate the transaction price in the contract. Satisfaction of performance obligations The Company recognizes revenue from contracts with customers when the control over the goods or services is transferred to the customer. For most contracts, revenue recognition occurs at a point in time when control of the asset is transferred to the customer, generally on delivery of the goods. For agreements with a strategic partner, performance obligations are generally satisfied over time, given that the customer both simultaneously receives and consumes the benefits provided by the Company, or receives assets with no alternative use, for which the Company has an enforceable right to payment for performance completed to date. The method for measuring the progress of performance obligations that are satisfied over time usually based upon the deliverables forming part of performance obligations. Contract modifications A contract modification is a change in the scope or price (or both) of a contract that was approved by the parties to the contract. A contract modification can be approved in writing, orally or be implied by customary business practices. A contract modification can take place also when the parties to the contract have a disagreement regarding the scope or price (or both) of the modification or when the parties have approved the modification in scope of the contract but have not yet agreed on the corresponding price modification. When a contract modification has not yet been approved by the parties, the Company continues to recognize revenues according to the existing contract, while disregarding the contract modification, until the date the contract modification is approved or the contract modification is legally enforceable. The Company accounts for a contract modification as an adjustment of the existing contract since the remaining goods or services after the contract modification are not distinct and therefore constitute a part of one performance obligation that is partially satisfied on the date of the contract modification. The effect of the modification on the transaction price and on the rate of progress towards full satisfaction of the performance obligation is recognized as an adjustment to revenues (increase or decrease) on the date of the contract modification, meaning on a catch-up basis. When a contract modification increases the scope of the contract as a result of adding distinct goods or services and the contract price changes by an amount reflecting the stand-alone selling prices of the additional goods or services, the Company accounts for the contract modification as a separate contract. The Company generate revenue mainly from sale of products to strategic partners and distributors as well as from the licensing of our technology and distribution rights. The Company identifies the goods and services it promises in its contracts with customers and analyzes whether each good or service promised is distinct. The Company further groups a series of distinct goods or services to a single performance obligation. The Company's conclusion depends on the specific facts and circumstances pertaining to a contract. In the majority of contracts, revenue recognition occurs at a point in time when control of our product is transferred to the customer, generally on delivery of the goods. With regards to certain contract with our strategic partner the Company analyzed the following: The Company identified few performance obligations which include: a. Grant of a license for distribution one of the Company's products in certain territories and the supply of predetermined minimum quantities. b. The supply of a predetermined quantity of the Company's product for the purpose of clinical trials performed conducted by strategic partner. c. Grant of a license for the use of the Company's knowledge and patents, and the provision of consulting services with respect to the transfer of technology. Subsequently, the Company determines the transaction price. The transaction price is the amount of the consideration that is expected to be received based on the contract terms. The Company takes into account the effects of all the following elements when determining the transaction price a. Variable consideration – certain amounts of the promised consideration such as milestone payments and volume rebates. The Company includes the estimated variable consideration in the transaction price only to the extent it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty is resolved. b. Significant financing component – Advance payments received provide with the benefit of financing. Accordingly the Company adjusted the transaction price for the effects of the time value of money. c. Non-cash consideration – Raw materials provided as non-cash consideration. This consideration is measured at fair value. d. Consideration payable to customers- The Company accounts for payments made to a customer as a reduction of the revenues from the customer when the Company recognizes revenue from the transfer of goods or services to the customer or the Company pays the consideration or promises to pay the consideration in accordance with the Company's customary business practices. The Company allocates the transaction price to the different performance obligation identified. This allocation is based on relative stand-alone selling price. For certain amounts of variable consideration the Company allocated to a certain performance obligation or to a distinct goods or services within it. For each performance obligation identified, the Company recognizes revenue when (or as) it satisfies the performance obligation. The performance obligations are satisfied over time, as the customer both simultaneously receives and consumes the benefits provided by the Company, or receives assets with no alternative use, for which the Company has an enforceable right to payment for performance completed to date. The method for measuring the progress in performance obligations that are satisfied over time usually based upon the deliverables forming part of those performance obligations. Deferred revenues Deferred revenues include unearned amounts received from customers not yet recognized as revenues. The accounting policy for revenue recognition applied until December 31, 2017 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. 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. Revenues are measured at the fair value of the consideration received less any trade discounts, volume rebates and returns. The specific criteria for revenue recognition for the following types of revenues are: - Revenues from the sale of goods are recognized when all the significant risks and rewards of ownership of the goods have passed to the buyer and the seller no longer retains continuing managerial involvement. The delivery date is usually the date on which ownership passes. - Agreements with multiple elements provide for varying consideration terms, such as upfront payments and milestone payments. Revenues from such agreements that do not contain a general right of return and that are composed of multiple elements such as distribution exclusivity, license and services are allocated to the different elements and are recognized in respect of each element separately. An element constitutes a separate accounting unit if and only if it has a separate value to the customer. Revenue from the different element is recognized when the criteria for revenue recognition have been met and only to the extent of the consideration that is not contingent upon completion or performance of future services in the contract. 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 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 carryforward losses and 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 tax assets are reviewed at the end of each reporting period and reduced to the extent that it is not probable that they will be utilized. Deductible carryforward losses and temporary differences for which deferred tax assets had not been recognized are reviewed at the end of each reporting period and a respective deferred tax asset is recognized to the extent that their utilization is probable. 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. 3. IFRIC 23, "Uncertainty over Income Tax Treatments": In June 2017, the IASB issued IFRIC 23, "Uncertainty over Income Tax Treatments" ("the Interpretation"). The Interpretation clarifies the accounting for recognition and measurement of assets or liabilities in accordance with the provisions of IAS 12, "Income Taxes", in situations of uncertainty involving income taxes. The Interpretation provides guidance on (i) considering whether some tax treatments should be considered collectively, (ii) measurement of the effects of uncertainty involving income taxes on the financial statements and (iii) accounting for changes in facts and circumstances in respect of the uncertainty. As of December 31, 2019 and 2018, the application of IFRIC 23 did not have a material effect on the financial statements. l. Leases As of January 1, 2019 the Company initially applied IFRS 16, "Leases" ("the Standard"). The Company chose to apply the provisions of the Standard using the modified retrospective approach without restatement of comparative data. The accounting policy for leases applied effective from January 1, 2019, is as follows: The Company accounts for a contract as a lease when the contract terms convey the right to control the use of an identified asset for a period of time in exchange for consideration. On the inception date of the lease, the Company determines whether the arrangement is a lease or contains a lease, while examining if it conveys the right to control the use of an identified asset for a period of time in exchange for consideration. In its assessment of whether an arrangement conveys the right to control the use of an identified asset, the Company assesses whether it has the following two rights throughout the lease term: a) The right to obtain substantially all the economic benefits from use of the identified asset; and b) The right to direct the identified asset's use. The Company as a lessee: For leases in which the Company is the lessee, the Company recognizes on the commencement date of the lease a right-of-use asset and a lease liability, excluding leases whose term is up to 12 months and leases for which the underlying asset is of low value. For these excluded leases, the Company has elected to recognize the lease payments as an expense in profit or loss on a straight-line basis over the lease term. In measuring the lease liability, the Company has elected to apply the practical expedient in the Standard and does not separate the lease components from the non-lease components (such as management and maintenance services, etc.) included in a single contract. On the commencement date, the lease liability includes all unpaid lease payments discounted at the interest rate implicit in the lease, if that rate can be readily determined, or otherwise using the Company's incremental borrowing rate. After the commencement date, the Company measures the lease liability using the effective interest rate method. On the commencement date, the right-of-use asset is recognized in an amount equal to the lease liability plus lease payments already made on or before the commencement date and initial direct costs incurred less any lease incentives received. The right-of-use asset is measured applying the cost model and depreciated over the shorter of its useful life or the lease term. The Company tests for impairment of the right-of-use asset whenever there are indications of impairment pursuant to the provisions of IAS 36. Depreciation of right-of-use asset After lease commencement, a right-of-use asset is measured on a cost basis less accumulated depreciation and accumulated impairment losses and is adjusted for re-measurements of the lease liability. Depreciation is calculated on a straight-line basis over the useful life or contractual lease period, whichever earlier, as follows: % Mainly % Land and Buildings 10 10 Vehicles 20-33 3 office equipment (i.e. printing and photocopying machines) 20 20 Lease extension and termination options: A non-cancellable lease term includes both the periods covered by an option to extend the lease when it is reasonably certain that the extension option will be exercised and the periods covered by a lease termination option when it is reasonably certain that the termination option will not be exercised. In the event of any change in the expected exercise of the lease extension option or in the expected non-exercise of the lease termination option, the Company re-measures the lease liability based on the revised lease term using a revised discount rate as of the date of the change in expectations. The total change is recognized in the carrying amount of the right-of-use asset until it is reduced to zero, and any further reductions are recognized in profit or loss. Subleases: In a transaction in which the Company is a lessee of an underlying asset (head lease) and the asset is subleased to a third party, the Company assesses whether the risks and rewards incidental to ownership of the right-of-use asset have been transferred to the sub-lessee, among others, by evaluating the sublease term with reference to the useful life of the right-of-use asset arising from the head lease. When substantially all the risks and rewards incidental to ownership of the right-of-use asset have been transferred to the sub- lessee, the Company accounts for the sublease as a finance lease, otherwise it is accounted for as an operating lease. If the sublease is classified as a finance lease, the leased asset is derecognized on the commencement date and a new asset, "finance lease receivable" is recognized at an amount equivalent to the present value of the lease payments, discounted at the interest rate implicit in the lease. Any difference between the carrying amount of the leased asset before the derecognition and the carrying amount of the finance lease receivable is recognized in profit or loss. Lease modification: If a lease modification does not reduce the scope of the lease and does not result in a separate lease, the Company re-measures the lease liability based on the modified lease terms using a revised discount rate as of the modification date and records the change in the lease liability as an adjustment to the right-of-use asset. If a lease modification reduces the scope of the lease, the Company recognizes a gain or loss arising from the partial or full reduction of the carrying amount of the right-of-use asset and the lease liability. The Company subsequently remeasures the carrying amount of the lease liability according to the revised lease terms, at the revised discount rate as of the modification date and records the change in the lease liability as an adjustment to the right-of-use asset. For additional information regarding right-of-use assets and lease liabilities and refer to Note 14. The accounting policy for leases applied until December 31, 2018, is as follows: 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 Company 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, less accumulated depreciation 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. |
SIGNIFICANT ACCOUNTING JUDGMENT
SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUMPTIONS USED IN THE PREPARATION OF THE FINANCIAL STATEMENTS | 12 Months Ended |
Dec. 31, 2019 | |
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 Determining the fair value of share-based payment transactions The fair value of share-based payment transactions is determined upon initial recognition by an acceptable option pricing model. The inputs to the model include share price, exercise price and assumptions regarding expected volatility, expected life of share option and expected dividend yield. Discount rate for a lease liability When the Company is unable to readily determine the discount rate implicit in a lease in order to measure the lease liability, the Company uses an incremental borrowing rate. That rate represents the rate of interest that the Company would have to pay to borrow over a similar term and with similar security, the funds necessary to obtain an asset of similar value to the right-of-use asset in a similar economic environment. When there are no financing transactions that can serve as a basis, the Company determines the incremental borrowing rate based on its credit risk, the lease term and other economic variables deriving from the lease contract's conditions and restrictions. In certain situations, the Company is assisted by an external valuation expert in determining the incremental borrowing rate. 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. Inventory Work in process and Finished Good including direct and indirect costs. The allocation of indirect costs is accounted for on a quarterly basis by dividing the total quarterly indirect manufacturing cost to the batches manufactured during that quarter based on predetermined allocation factors. The criteria for allocation of indirect manufacturing expense to manufactured batches which eventually effect our inventory value is subject to Company judgment. 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. - 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. - Lease extension and/or termination options In evaluating whether it is reasonably certain that the Company will exercise an option to extend a lease or not exercise an option to terminate a lease, the Company considers all relevant facts and circumstances that create an economic incentive for the Company to exercise the option to extend or not exercise the option to terminate such as: significant amounts invested in leasehold improvements, the significance of the underlying asset to the Company's operation and whether it is a specialized asset, the Company's past experience with similar leases, etc. After the commencement date, the Company reassesses the term of the lease upon the occurrence of a significant event or a significant change in circumstances that affects whether the Company is reasonably certain to exercise an option or not exercise an option previously included in the determination of the lease term, such as significant leasehold improvements that had not been anticipated on the lease commencement date, sublease of the underlying asset for a period that exceeds the end of the previously determined lease period, etc. - 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. - Impairment of inventories with realizable value lower than cost or which are slow moving 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, net of selling expenses. The estimation of realizable value can effect on the inventory value at the period end. - Recognition of deferred tax asset in respect of carry forward tax losses Deferred tax assets are recognized for unused carryforward tax losses and deductible temporary differences to the extent that it is probable that taxable profit will be available against which the losses can be utilized. Significant management judgment is required to determine the amount of deferred tax assets that can be recognized, based upon the timing and level of future taxable profits, its source and the tax planning strategy. For information regarding deferred taxes recognition, please refer to note 21. - Impairment test for the production facility The Company performed an impairment test of its production facility. 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 Discount Cash Flow ("DCF") model using the Company's long term forecast. As of December 31, 2019 no impairment was recorded as the recoverable amount exceeded the book value. - 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. |
DISCLUSURE OF NEW STANDARDS IN
DISCLUSURE OF NEW STANDARDS IN THE PERIOD PRIOR TO THEIR ADOPTION | 12 Months Ended |
Dec. 31, 2019 | |
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 Amendments to IFRS 9, IFRS 7 and IAS 39: In September 2019, the IASB published an amendment to IFRS 9, "Financial Instruments", IFRS 7, "Financial Instruments: Disclosures" and IAS 39," Financial Instruments: Recognition and Measurement" ("the Amendment"). In view of global regulatory changes, numerous countries have considered introducing a reform in the benchmark Interbank Offered Rates ("IBORs") (LIBOR, the London Interbank Offered Rate, being one of the most common examples) and switching to a risk-free interest rate alternative ("RFRs") which extensively rely on data of specific transactions. The IBOR reform leads to uncertainty regarding the dates and amounts to be attributed to future cash flows relating to both hedging instruments and hedged items that rely on existing IBORs. According to the existing accounting guidance of IFRS 9 and IAS 39, entities that have entered into the above hedges are facing uncertainty as a result of the IBOR reform which is likely to affect their ability to continue meeting the effective hedging requirements underlying existing transactions as well as the hedging requirements of future transactions. In order to resolve this uncertainty, the IASB issued the Amendment to offer transitional reliefs for entities that apply IBOR-based hedge accounting. The Amendment represents phase one in the reform that will include additional amendments in the future. The Amendment also permits certain reliefs in applying the hedge accounting effectiveness tests during the period of transition from IBORs to RFRs. These reliefs assume that the benchmark interest underlying the hedge will not change as a result of the expected interest reform. The reliefs will be effective indefinitely, until the occurrence of one of the events specified in the Amendment. The Amendment also requires entities to provide specific disclosures of the application of any reliefs. The Amendment is to be applied retrospectively for annual periods beginning on or after January 1, 2020. Early adoption is permitted. The Company believes that the adoption of the Amendment will not have an effect on its financial statements since it does not currently enter into substantial IBOR-based hedges. |
CASH AND CASH EQUIVALENTS
CASH AND CASH EQUIVALENTS | 12 Months Ended |
Dec. 31, 2019 | |
Cash and cash equivalents [abstract] | |
CASH AND CASH EQUIVALENTS | Note 5: - Cash and Cash Equivalents December 31, 2019 2018 U.S. Dollars in thousands Cash and deposits for immediate withdrawal $ 25,559 $ 18,018 Cash equivalents in USD deposits (1) 17,017 - Cash equivalents in NIS deposits (2) 86 75 Total Cash and Cash Equivalents $ 42,662 $ 18,093 (1) The deposits bear interest of 2.0%-2.4% per year, as of December 31, 2019. (2) The deposits bear interest of 0.02% per year, as of December 31, 2019 and 0.16% per year, as of December 31, 2018. |
SHORT-TERM INVESTMENTS
SHORT-TERM INVESTMENTS | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of short-term investments [abstract] | |
SHORT-TERM INVESTMENTS | Note 6: Short-Term Investments December 31, 2019 2018 U.S. Dollars in thousands Fair value through other comprehensive income $ 12,832 $ 10,325 Bank deposits in USD (1) 18,413 22,174 Total Short-Term Investments $ 31,245 $ 32,499 (1) The deposits bear interest of 2.5%-3.3% and 2.6%-3.5% per year, as of December 31, 2019 and 2018, respectively. |
TRADE RECEIVABLES, NET
TRADE RECEIVABLES, NET | 12 Months Ended |
Dec. 31, 2019 | |
Trade and other current receivables [abstract] | |
TRADE RECEIVABLES, NET | Note 7: Trade Receivables, Net December 31, 2019 2018 U.S. Dollars in thousands Open accounts: In NIS $ 8,357 $ 6,780 In USD 14,920 20,814 $ 23,277 $ 27,594 Checks receivable - 80 $ 23,277 $ 27,674 Less allowance for doubtful accounts(1) (67 ) - Total Trade receivables, net $ 23,210 $ 27,674 (1) Allowance for doubtful accounts: December 31, 2018 - Provision for the year (67 ) December 31, 2019 (67 ) 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 nor impaired Up to 30 Days 31-60 Days 61-90 Days 91-120 Days Over 121 days Total December 31, 2019 $ 22,617 $ 469 $ 25 $ 33 $ 65 $ 68 (1) $ 23,277 December 31, 2018 $ 27,215 $ 337 $ 15 $ 15 $ 6 $ 6 $ 27,594 (1) $67 thousands of the over 121 days balance is provided for as allowance for doubtful accounts. |
OTHER ACCOUNTS RECEIVABLES
OTHER ACCOUNTS RECEIVABLES | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of other accounts receivables [abstract] | |
OTHER ACCOUNTS RECEIVABLES | Note 8: - Other Accounts Receivables December 31, 2019 2018 U.S. Dollars in thousands Government authorities $ 1,838 $ 1,552 Prepaid expenses 1,240 1,086 Accrued interest 70 66 Accrued income 101 193 Materials for clinical trials and inventory designated for R&D activities - 399 Other 8 12 Derivatives financial instruments mainly measured at fair value through other comprehensive income 15 - Total Other Accounts Receivables $ 3,272 $ 3,308 |
INVENTORIES
INVENTORIES | 12 Months Ended |
Dec. 31, 2019 | |
Classes of current inventories [abstract] | |
INVENTORIES | Note 9: - Inventories December 31, 2019 2018 U.S. Dollars in thousands Finished products $ 12,016 $ 7,023 Purchased products 10,412 4,813 Work in progress 9,043 4,792 Raw materials 11,702 12,688 Total Inventories $ 43,173 $ 29,316 (1) The inventories balance as of December 31, 2019 and December 31, 2018 is presented net of impairment of inventories in the amount of $334 thousands and $61 thousands, respectively. |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of detailed information about property, plant and equipment [abstract] | |
PROPERTY, PLANT AND EQUIPMENT | Note 10: - Property, Plant And Equipment a. Composition and movement: 2019 Land and Buildings Machinery and Equipment Vehicles Computers, Software, Equipment and Office Furniture Leasehold Improvements Total U.S. Dollars in thousands Cost Balance at January 1, 2019 $ 29,167 $ 30,386 $ 85 $ 6,493 $ 1,141 $ 67,272 Additions 1,101 1,302 - 699 14 3,116 Sale and write-off - (148 ) - (391 ) - (539 ) Balance as of December 31, 2019 30,268 31,540 85 6,801 1,155 69,849 Accumulated Depreciation Balance as of January 1, 2019 15,076 21,679 63 5,247 203 42,268 Depreciation 1,232 1,575 5 636 115 3,563 Sale and write-off - (142 ) - (390 ) - (532 ) Balance as of December 31, 2019 16,308 23,112 68 5,493 318 45,299 Depreciated cost as of December 31, 2019 $ 13,960 $ 8,428 $ 17 $ 1,308 $ 837 $ 24,550 (1) Including labor costs charged in 2019 to the cost of facilities, machinery and equipment in the amount of $493 thousands. 2018 Land and Buildings 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 (1) Including labor costs charged in 2018 to the cost of facilities, machinery and equipment in the amount of $514 thousands. b. As for liens, refer to Note 18. c. Leasing rights of land from the Israel land administration. December 31, 2019 2018 U.S. Dollars in thousands Under finance lease $ 992 $ 1,004 A Company’s subsidiary 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, 2019 | |
Miscellaneous non-current assets [abstract] | |
OTHER LONG TERM ASSETS | Note 11: - Other Long Term Assets December 31, 2019 2018 U.S. Dollars in thousands Distribution right (1) 298 123 Long term pre-paid expenses 54 51 Total Other Long Term Assets $ 352 $ 174 (1) During 2018 and 2019 the Company entered into agreements for the distribution right of certain therapeutic products to be distributed in Israel, subject to Israeli Ministry of Health (“IL MOH”) marketing approval. Pursuant to the agreements, 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. As of December 31, 2019 no amortization was recorded. |
TRADE PAYABLES
TRADE PAYABLES | 12 Months Ended |
Dec. 31, 2019 | |
Trade and other current payables [abstract] | |
TRADE PAYABLES | Note 12: - Trade Payables December 31, 2019 2018 U.S. Dollars in thousands Open debts mainly in USD $ 7,847 $ 7,256 Open debts in EUR 11,426 4,206 Open debts in NIS 5,557 5,822 Sub-Total 24,830 17,284 Notes payable - 1 Total Trade Payables $ 24,830 $ 17,285 |
OTHER ACCOUNTS PAYABLES
OTHER ACCOUNTS PAYABLES | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of other accounts payable [Abstract] | |
OTHER ACCOUNTS PAYABLES | Note 13: - Other Accounts Payables December 31, 2019 2018 U.S. Dollars in thousands Employees and payroll accruals $ 5,669 $ 4,708 Derivatives financial instruments mainly measured at fair value through other comprehensive income - 64 Accrued Expenses and Others 142 489 Total Other Accounts Payables $ 5,811 $ 5,261 |
LOANS AND LEASES
LOANS AND LEASES | 12 Months Ended |
Dec. 31, 2019 | |
Loans and leases [abstract] | |
LOANS AND CAPITAL LEASES | Note 14: - Loans and Leases a. Bank loans December 31, 2019 2018 U.S. Dollars in thousands Bank loans 746 688 Less current maturities of bank loans 257 452 Total Long term bank loans $ 489 $ 1,140 Bank loans The bank loans are payable over 60 equal monthly installments. The loans bear fixed interest rate in the range of 3.15% -3.55%. No new bank loans received in 2019. See Note 18 regarding pledge information related to the bank loans. b. Leases The Company applies IFRS 16, Leases, as from January 1, 2019. The Company has lease agreements with respect to the following items: 1. Office and storage spaces: The Company has engaged in lease agreements for office and storage spaces for total of 10 years which includes lease extension for three year that will expire in 2026. 2. Vehicles: The Company leases vehicles for mainly for three-year periods from several different leasing companies. 3. Office equipment (i.e. printing and photocopying machines): The Company leases office equipment (i.e. printing and photocopying machines) for five year periods. Right-of-use assets composition and Changes in leas liabilities Right-of-use-assets Rented Offices Vehicles Computers, Software, Equipment and Office Furniture Total Lease (2) U.S Dollars in thousands As of January 1, 2019 (1) $ 3,466 $ 663 $ 32 $ 4,161 $ 4,855 Additions to right -of -use assets - 874 874 870 Write-off - (57 ) (57 ) (60 ) Depreciation expense (433 ) (517 ) (6 ) (956 ) - Exchange rate differences - - - 406 Repayment of lease liabilities - - - (1,070 ) As of December 31, 2019 $ 3,033 $ 989 $ 26 $ 4,022 $ 5,001 (1) Following the initial application of IFRS 16, on January 1, 2019 , the Company recorded operating lease commitment classified as a lease liability at the amount of $4,717 thousands with respect to office and storage spaces, vehicles and certain office equipment (i.e. printing and photocopying machines) at the amount of $4,022, $663 and $32 thousands, respectively. Also refer to Note 2ii. (2) The weighted average incremental borrowing rate used to discount future lease payments in the calculation of the lease liability was in the range of 3.06%-4.6% evaluated based on credit risk, terms of the leases and other economic variables. Below is the Consolidated Statements of Profit or Loss and Other Comprehensive Income impact for the year ended December 31, 2019 Expense decrease For the year ended on U.S Dollars in thousands Operating lease expense $ 1,182 Depreciation of right of use assets (956 ) Operating income 226 Finance expense (212 ) Net Income (loss) $ 14 Below is the Consolidated Statements of cash flow impact for the year ended December 31, 2019 According to the previous accounting policy Difference According to the current accounting policy U.S Dollars in thousands For the year ended on December 31, 2019 Cash flows from operating activities $ 26,501 $ 1,070 $ 27,571 Cash flows from financing activities $ (460 ) $ (1,070 ) $ (1,530 ) Maturity analysis of the Company’s lease liabilities (including interest) Less than one 1 to 2 2 to 3 3 to 5 6 and Total Lease liabilities (including interest) $ 1,198 $ 1,000 $ 797 $ 1,352 1,364 $ 5,711 Lease extension The Company has leases that include extension options. These options provide flexibility in managing the leased assets and align with the Company’s business needs. The Company exercises significant judgement in deciding whether it is reasonably certain that the extension options will be exercised. Office and storage spaces leases have extension options for additional three years. The Company have reasonably certain that the extension option will be exercised in order to avoid a significant adverse impact to its operating activities. |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of detailed information about financial instruments [abstract] | |
FINANCIAL INSTRUMENTS | Note 15: - Financial Instruments a. Classification of financial assets and liabilities The financial assets liabilities in the balance sheet are classified by groups of financial instruments pursuant to IFRS 9: December 31, 2019 2018 U.S. Dollars in thousands Financial assets Financial assets at fair value through profit or loss: Foreign exchange forward contracts $ 2 $ - Financial assets at fair value through other comprehensive income: Cash flow hedges 13 Marketable debt securities 12,832 10,324 Financial assets at cost: Cash and cash equivalent 42,662 18,093 Short term bank deposits 18,413 22,175 Total assets measured at fair value through other comprehensive income $ 73,920 $ 50,592 Total financial assets $ 73,920 $ 50,592 Financial liabilities Financial assets at fair value through profit or loss: Foreign exchange forward contracts $ - $ 6 Financial liabilities at fair value through other comprehensive income: Cash flow hedges $ - $ 58 Financial liabilities measured at amortized cost: Bank loans 746 1,140 Leases 5,001 138 Total Financial liabilities measured at amortized cost: $ 5,747 $ 1,278 Total financial and lease liabilities $ 5,747 $ 1,342 b. Financial risk factors The Company’s activities expose it to various financial risks, such as market risk (foreign currency risk, interest rate risk and price risk), credit risk and liquidity risk. The Company’s investment policy focuses on activities that will preserve the Company’s capital. The Company utilized derivatives to hedge certain exposures to risk. Risk management is the responsibility of the Company Chief Executive Officer (CEO) and Company Chief Financial Officer (CFO), in accordance with the policy 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, 2019 and 2018, the Company has a position in financial derivatives intended to hedge changes in the exchange rate of the USD vs. the NIS and the EUR (see also Note 15f. below). b) Price risk As of December 31, 2019 and 2018, the Company has financial instruments, classified as financial 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) Cash, cash equivalent and short term investments: The Company holds cash, cash equivalents, short term deposits and other financial instruments at major financial institutions in Israel. In accordance with Company policy, evaluations of the relative strength of credit of the various financial institutions are made on an ongoing basis. Short-term investments 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. b) 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 the debt such as letters of creditor and down payments. In addition, the Company partially insures its overseas sales with foreign trade risk insurance. Refer to Note 7 for additional information. 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, 2019 and 2018 is the carrying amount of trade receivables. c) Foreign currency derivative contracts: The Company is exposed to foreign currency exchange movements, primarily in USD vs. NIS and EUR. Consequently, it enters into various foreign currency exchange contracts with major financial institutions (see also Note 15f. below). 3. Liquidity risk The table below summarizes the maturity profile of the Company’s financial liabilities based on contractual undiscounted payments: December 31, 2019 Less than one 1 to 2 2 to 3 3 to 5 6 and Total Trade payables $ 24,830 - - - - $ 24,830 Other accounts payables 5,811 - - - - 5,811 bank loans (including interest) 506 227 34 - - 767 Lease liabilities (including interest) 1,198 1,000 797 1,352 1,364 5,711 $ 32,345 $ 1,227 $ 831 $ 1,352 $ 1,364 $ 37,119 December 31, 2018 Less than one 1 to 2 2 to 3 3 to 5 Total Trade payables $ 17,285 - - - $ 17,285 Other accounts payables 5,261 - - - 5,261 Long term bank loans and leases (including interest) 595 495 209 32 1,331 $ 23,141 $ 495 $ 209 $ 32 $ 23,877 Changes in liabilities arising from financing activities January 1, Cumulative effect of initially applying IFRS 16 (1) Payments Foreign exchange movement New loans and leases Write off December 31, U.S. Dollars in thousands Bank loans $ 1,140 - (475 ) 81 - - $ 746 Leases 138 4,717 (1,070 ) 406 870 (60 ) 5,001 Total $ 1,278 $ 4,717 $ (1,545 ) $ 487 $ 870 $ (60 ) $ 5,747 (1) Following the initial application of IFRS 16, on January 1, 2019 , the Company recorded discounted operating lease commitment classified as a lease at the amount of $4,717 thousands with respect to office and storage spaces, vehicles and certain office equipment (i.e. printing and photocopying machines) at the amount of $4,023, $663 and $31 thousands, respectively. c. Fair value The following table demonstrates the carrying amount and fair value of the financial assets and liabilities presented in the financial statements not at fair value: Carrying Amount Fair Value December 31, December 31, 2019 2018 2019 2018 U.S. Dollars in thousands Financial liabilities Bank loans 746 1,140 754 1,139 Leases 5,001 138 5,583 136 Total Financial liabilities $ 5,747 $ 1,278 $ 6,337 $ 1,275 The fair value of the bank loans and 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 December 31, 2019 Debt securities (corporate and government) measured at fair value through other comprehensive income $ 4,289 8,543 Derivatives instruments - 15 $ 4,289 $ 8,558 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 During 2019 and 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, 2019 2018 U.S. Dollars in thousands Sensitivity test to changes in market price of listed Securities Gain (loss) from change: 5% increase in market price $ 642 $ 519 5% decrease in market price $ (642 ) $ (519 ) Sensitivity test to changes in foreign currency: Gain (loss) from change: 5% increase in NIS $ (24 ) $ (21 ) 5% decrease in NIS $ 24 $ 21 5% increase in Euro $ (552 ) $ (197 ) 5% decrease in Euro $ 552 $ 197 e. Linkage terms of financial liabilities by groups of financial instruments pursuant to IFRS 9: December 31, 2019 2018 U.S. Dollars in thousands In NIS: Bank loans measured at amortized cost $ 746 $ 1,140 Leases measured at amortized cost 4,973 - $ 5,719 $ 1,140 In USD: Leases measured at amortized cost $ 28 $ 138 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, 2019 the fair value of the derivative instruments not designated as hedging was an asset of $2 thousands. The open transactions for those derivatives were in an amount of $6,316 thousands. Cash flow hedges As of December 31, 2019, 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, 2019 the fair value of the derivative instruments designated as hedge accounting was an asset of $13 thousands. The open transactions for those derivatives were in an amount of $371 thousands. Cash flow hedges of the expected salaries expenses in December 31, 2019 was estimated as highly effective and accordingly a net unrecognized income was recorded in other comprehensive income in the amount of $65 thousands net. |
EMPLOYEE BENEFIT LIABILITIES, N
EMPLOYEE BENEFIT LIABILITIES, NET | 12 Months Ended |
Dec. 31, 2019 | |
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. 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 bargaining 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 2019, 2018 and 2017 were $1,102 thousands, $992 thousands and $884 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, 2019 2018 2017 U.S. Dollars in thousands Current service cost $ 282 $ 292 $ 356 Interest expenses, net 24 25 23 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 (1 ) 3 (7 ) Total employee benefit expenses 305 320 372 Actual return on plan assets $ 158 $ 171 $ 119 The expenses are presented in the Statement of Comprehensive income (loss) as follows Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Cost of revenues $ 201 $ 175 $ 211 Research and development 62 50 57 Selling and marketing 16 75 73 General and administrative 26 20 31 $ 305 $ 320 $ 372 4. The plan liabilities, net: December 31, 2019 2018 U.S. Dollars in thousands Defined benefit obligation $ 5,058 $ 4,987 Fair value of plan assets (3,789 ) (4,200 ) Total liabilities, net $ 1,269 $ 787 5 Changes in the present value of defined benefit obligation 2019 2018 U.S. Dollars in thousands Balance at January 1, $ 4,987 $ 5,907 Interest costs 133 110 Current service cost 282 292 Benefits paid (1,180 ) (645 ) Demographic assumptions 40 (29 ) Financial assumptions 292 (223 ) Past Experience 108 (2 ) Currency Exchange 396 (423 ) Balance at December 31, $ 5,058 $ 4,987 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 2019 2018 U.S. Dollars in thousands Balance at January 1, $ 4,200 $ 4,763 Expected return 108 85 Contributions by employer 179 182 Benefits paid (1,081 ) (564 ) Demographic assumptions (4 ) 5 Financial assumptions (2 ) (2 ) Past Experience 58 82 Current service cost due to the transfer of real yield from the compensation component to the royalties component in executive insurance policies before 2004 1 (3 ) Currency exchange 330 (348 ) Balance at December 31, $ 3,789 $ 4,200 7. The principal assumptions underlying the defined benefit plan 2019 2018 2017 % Discount rate of the plan liability 2.79 2.02 2.27 Future salary increases 3.1 3.6 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 $288 thousands or increase by $343 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 $326 thousands or decrease by $276 thousands, respectively. |
CONTINGENT LIABILITIES AND COMM
CONTINGENT LIABILITIES AND COMMITMENTS | 12 Months Ended |
Dec. 31, 2019 | |
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 for 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 (“Shire”), 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 plasma derived fraction IV-1 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 over the first five years of the term of the Distribution Agreement. In addition, upon initiation of sales of Glassia manufactured by Takeda the Company will be entitled to royalty payments at a rate of 12% on net sales of Glassia through August 2025, and at a rate of 6% thereafter until 2040, with a minimum of $5 million annually (the “Royalty Payments”). As of December 31, 2019, 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 October 2016 amendment of the Distribution Agreement, the net proceeds on account of the upfront the milestone payments received were recorded as deferred revenues and were recognized as revenues based on the actual sales of Glassia on a pro-rata basis. Following October 2016, the balance of the deferred revenues was 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. The Company is entitled to the remaining unpaid balance of the millstone payments totaling $5.5 million which will be paid upon the achievement of such milestones. Between 2013 and 2019, 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. Pursuant to the recent amendment of the Distribution Agreement entered into during August 2019, the maximum commitment by the Company to manufacture and sale Glassia to Takeda and the minimum commitment of Takeda to acquire Glassia manufactured by the Company is currently extended through the end of 2021. The Company projects that total revenues from sales of Glassia to Takeda for the year 2020 will be approximately $65 million and for the year 2021 between $25 million to $50 million. See note 22a for information regarding 2019 revenues from sales to Takeda. Takeda is planning to complete the technology transfer of Glassia, and pending FDA approval, will initiate, during 2021 its own production of Glassia for distribution in the U.S. market. Accordingly, following the transition of manufacturing to Takeda, the Company will terminate the manufacturing and sale of Glassia to Takeda resulting in a significant reduction in revenues. Upon initiation of sales of Glassia manufactured by Takeda, Takeda will pay the Company the Royalty Payments as defined above. 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 plasma derived fraction IV-1 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 plasma derived fraction IV-1 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 plasma derived fraction IV-1 for its continued development and for the production, sale and distribution of Glassia by the Company outside the Territory. b. In November 2006, the Company entered into an agreement with PARI GmbH in connection with a supply by the third party of a certain medical devise required for the development of a Company’s Inhaled AAT 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 certain quantities of devices for carrying out 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 device patents expiration period or 15 years from the first commercial sale of the Company’s the Inhaled AAT 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 device exceeding a certain amount, through the later of the device patents expiration period or 15 years from the first commercial sale of the Company’s Inhaled AAT 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. In May 2019, the Company signed a Clinical Study Supply Agreement (“CSSA”) with such third party for the supply of the required quantities of controller kits and the web portal associated with the third party’s device required for Company’s continued clinical trials with respect the its Inhaled AAT product. The CSSA is a supplement agreement to the agreement and will expire upon the expiration or termination of the agreement. c. In July 2011, the Company entered into a strategic collaboration agreement with Kedrion Biopharma for clinical development, marketing, distribution and sales in the United States of KedRab, the Company’s rabies immune globulin (Human). The product, KedRab, is manufactured and marketed by the Company in other countries. The Company obtained U.S marketing approval from the FDA for KedRab in August 2017. Launch of the product in the US was initiated in the beginning of 2018. In October 2016 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 planned to finalize in 2020. The cost of the study is equally shared between the parties. d. In July 2019, the Company entered into a 7-year Master Clinical Services Agreement with a third party for the provision of certain clinical research services and other tasks to be performed by such third party, in connection with the Company’s Phase III clinical study for its inhaled AAT product. e. In December 2019, the Company entered into a binding term sheet for a 12-year contract manufacturing agreement with a third party to manufacture an FDA-approved and commercialized specialty hyper-immune globulin product. Following the execution of the required technology transfer from the current manufacturer, and pending obtaining all required FDA approvals, the Company is expected to commence commercial manufacturing of the product in early 2023. f. In December 2019, the Company entered into an agreement with Alvotech , a global biopharmaceutical company, to commercialize Alvotech’s portfolio of six biosimilar product candidates in Israel, upon receipt of regulatory approval from the Israeli Ministry of Health (“IMOH”). Pursuant to the agreement the Company is obligated to pay Alvotech certain milestone payments to Alvotech, in advance of the launch of the six biosimilar in Israel. |
GUARANTEES AND CHARGES
GUARANTEES AND CHARGES | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of guarantees and charges [abstract] | |
GUARANTEES AND CHARGES | Note 18: - Guarantees and Charges a. The Company provided a bank guarantees in the amount of $ 255 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. b. The Company pledged specific purchased assets as collateral against loans, in the original amount of NIS 8,355 thousands ($ 2,176 thousands) received to fund the purchase of such assets. |
EQUITY
EQUITY | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of classes of share capital [abstract] | |
EQUITY | Note 19: - Equity a. share capital December 31, 2019 December 31, 2018 Authorized Outstanding Authorized Outstanding Ordinary shares of NIS 1 par value 70,000,000 40,353,101 70,000,000 40,295,078 b. Movement in share capital: Issued and outstanding share capital: Number of shares Balance as of January 1, 2018 40,262,819 Issue of shares - Exercise of options into shares 8,686 Exercise of restricted shares 23,573 Balance as of December 31, 2018 40,295,078 Issue of shares Exercise of options into shares 13,133 Exercise of restricted shares 44,890 Balance as of December 31, 2019 40,353,101 Ordinary shares of NIS 1 par value c. Rights attached to Shares Voting rights at the shareholders general meeting, rights to dividend, rights in case of liquidation of the Company and rights to nominate directors. d. Share options and restricted shares During 2019 and 2018, 67,470 and 53,584 share options, respectively, were exercised, on a cash-less basis, into 13,133 and 8,686 ordinary shares of NIS 1 par value each and 44,892 and 23,572 restricted shares were vested for total consideration of $16 thousand and $9 thousands, respectively. For additional information regarding options and restricted shares granted to employees and management in 2019, refer to Note 20 below. e. 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. f. Issuance of ordinary shares by the Company Refer to Note 25 e 3 for information regarding the issuance of ordinary shares as of February 10, 2020 |
SHARE-BASED PAYMENT
SHARE-BASED PAYMENT | 12 Months Ended |
Dec. 31, 2019 | |
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 an 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 2019 2018 2017 U.S. Dollar in thousands Cost of revenues $ 364 $ 401 $ 179 Research and development 254 224 138 Selling and marketing 63 51 48 General and administrative 482 272 118 Total share-based compensation $ 1,163 $ 948 $ 483 b. Share options granted to the Company’s Chief Executive Officer (“CEO”) On June 20, 2019 the Company’s Board of Directors approved the grant of options to purchase 90,000 Ordinary Shares of the Company at an exercise price of NIS 21.34 per share and 30,000 RS to the Company’s CEO. The initial fair value of the options and of the RSs estimated based on the Binomial Model was $154 thousands and $165 thousands, respectively. The grant of the equity instruments to the Company’s CEO is subject to the approval of the General Meeting of Shareholders of the Company that is expected to take place during March 2020 c. Share options and Restricted shares granted to Employees and Management 1. During 2019 the Company’s Board of Directors approved the grant of 443,000 options to employees and members of the Company’s management. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $778 thousands. 2. During 2019, the Company’s Board of Directors approved the grant of 69,725 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 $381 thousands. d. Share options granted to members of the Board of Directors On January 20, 2020, the Company’s Board of Directors approved the grant of 212,800 options to Board of Directors. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $391 thousands. The grant of the options to the Board of Directors is subject to the approval of the General Meeting of Shareholders of the Company that is expected to take place by March 2020. e. 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: 2019 2018 2017 Number of Weighted Number of Weighted Number of Weighted In NIS In NIS In NIS Outstanding at beginning of year 2,445,597 29.99 2,572,372 32.47 2,487,236 35.20 Granted 443,800 20.64 617,825 19.02 458,950 21.10 Exercised (67,470 ) 32.30 (53,584 ) 15.77 (10,659 ) 18.19 Forfeited (485,373 ) 16.98 (691,016 ) 30.51 (363,155 ) 35.70 Outstanding at end of year 2,336,554 27.87 2,445,597 29.99 2,572,372 32.47 Exercisable at end of year 1,412,023 33.17 1,406,048 38.02 1,755,253 38.69 The weighted average remaining contractual life for the share options 3.39 3.63 3.22 The range of exercise prices for share options outstanding as of December 31, 2018 and 2019 were NIS 15- NIS 57. Exercise is by cashless method. f. The following table lists the number of RSs and changes in RSs grants during the year: Number of RSs 2019 2018 2017 Outstanding at beginning of year 139,706 76,512 27,333 Granted 69,725 96,308 58,835 End of restriction period (18,643 ) (23,572 ) (7,656 ) Forfeited (44,892 ) (9,542 ) (2,000 ) Outstanding at end of year 145,896 139,706 76,512 The weighted average remaining contractual life for the restricted share 2.78 3.21 3.54 g. 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: 2019 2018 2017 Dividend yield (%) - - - Expected volatility of the share prices (%) 23-41 25-39 37-45 Risk-free interest rate (%) 0.3 – 1.7 0.2-2.0 0.1-1.83 Contractual term of up to (years) 6.5 6.5 6.5 Exercise multiple 2 2 2 Weighted average share prices (NIS) 19.17-19.65 18.49-21.17 16.05-16.44 Expected average forfeiture rate (%) 2-6 1-5 1-5 |
TAXES ON INCOME
TAXES ON INCOME | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of taxes on income [Abstract] | |
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 Law”), provides several tax benefits for “Industrial Companies.” Pursuant to the Encouragement of Industry Law, a company qualifies as an Industrial Company if it is a resident of Israel and at least 90% of its income in any tax year (exclusive of income from certain defense loans) is generated from an “Industrial Enterprise” that it owns. An Industrial Enterprise is defined as an enterprise whose principal activity, in a given tax year, is industrial activity. 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. The Company believes that it currently qualifies as an industrial company within the definition of the Industry Encouragement Law. The Company cannot confirm that the Israeli tax authorities will agree that the Company qualifies, or, if qualified, that it will continue to qualify as an industrial company or that the benefits described above will be available to the Company in the future. 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. Tax Exemption Period Reduced Tax Period Rate of Reduced Tax Percent of Foreign Ownership 2/10 years 5/0 years 25 % 0-25% 2/10 years 8/0 years 25 % 25-49% 2/10 years 8/0 years 20 % 49-74% 2/10 years 8/0 years 15 % 74-90% 2/10 years 8/0 years 10 % 90-100% 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%. The Israeli corporate income tax rate was 23% in 2019 and 2018 and 24% in 2017. c. Tax assessments The Company has finalized tax assessments through the end of tax year 2013. d. Carry forward losses for tax purposes and other temporary differences As of December 31, 2019, the Company has carry forward losses and other temporary differences in the amount of $ 47,400 thousands. Final tax assessments for the years 2015 onwards could have an impact on the balance of carry forward tax losses for which deferred tax asset was not recognized. During 2019, the Company recorded deferred tax asset at an amount of $ 1,311 thousands representing utilization of $ 20,484 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. Uncertain tax positions The Company analyzed uncertainty involving income taxes on its financial statements and whether it has any potential impact on the financial statements. As of December 31, 2019 and 2018, the application of IFRIC 23 did not have a material effect on the financial statements. f. 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 Balance at January 1, 2019 $ 2,048 Amount carried to profit and loss (726 ) Amount carried to other comprehensive income (11 ) Balance as of December 31, 2019 $ 1,311 Deferred tax liabilities have not been recognized for the immaterial temporary differences associated with investments in subsidiaries because the disposal of these subsidiaries in the foreseeable future is not probable and because distributions of dividends by these companies are not subject to tax. g. Composition: Statements of financial position Statements of profit or loss December 31, Year ended December 31, 2019 2018 2019 2018 2017 U.S Dollars in thousands Deferred tax liabilities: Financial assets measured at fair value through other comprehensive income (32 ) (12 ) Revaluation of derivatives (4 ) Deferred tax assets: Carryforward tax losses 1,330 2,056 (726 ) (1,944 ) - Employee benefits 25 1 Issuance of sheers Revaluation of derivatives 3 Deferred tax income (expenses) (726 ) (1,944 ) Deferred tax assets, net $ 1,311 $ 2,048 The deferred taxes are reflected in the statement of financial position as follows: December 31, 2019 2018 NIS in thousands Non-current assets $ 1,311 $ 2,048 h. Taxes on income Year ended December 31, 2019 2018 2017 U.S. Dollars in thousands Current taxes $ - $ - $ 129 Deferred tax expenses (income) 726 (1,944 ) - Taxes in respect of prior years 4 (11 ) 140 Taxes on income $ 730 $ (1,955 ) $ 269 i. 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, 2019 U.S. Dollars in thousands Gain before taxes on income $ 22,981 Statutory tax rate 23 % Tax calculated using the statutory tax rate 5,286 Increase (decrease) in taxes resulting from permanent differences - the tax effect: Adjustment of deferred tax balances following a change in tax rates (356 ) Taxable income with preferred income tax rates by virtue of the Encouragement Law (3,747 ) Tax exempt income, income subject to special tax rates and nondeductible expenses and other (105 ) Increase in unrecognized tax losses in the year (352 ) Prior year taxes 4 Tax on income $ 730 Effective tax rate 3.2 % 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, 2019 | |
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, 2019 2018 2017 U.S. Dollars in thousands Revenues from major customers each of whom amount to 10% or more, of total revenues Customer A (1) $ 68,138 $ 63,788 $ 60,383 Customer B 16,369 11,779 - Customer C 14,454 - - $ 98,961 $ 75,567 $ 60,383 (1) For additional information regarding the aggregate amount of the transaction price allocated to the performance obligations that are unsatisfied, refer to note 17a. b. Revenues based on the location of the customers, are as follows: Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands U.S.A $ 84,572 $ 75,331 $ 60,405 Israel 31,959 28,093 26,355 Europe 4,701 3,594 5,348 Latin America 3,792 3,994 5,248 Asia 2,067 3,336 4,979 Others 96 121 490 Total Revenue $ 127,187 $ 114,469 $ 102,825 c. Cost of goods sold Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Cost of materials $ 69,766 $ 56,156 $ 41,179 Salary and related expenses 16,941 15,290 13,755 Subcontractors 4,451 3,633 3,995 Depreciation and amortization 2,991 2,859 2,504 Energy 1,551 1,426 1,202 Other manufacturing expenses 712 566 954 96,412 79,930 63,589 Decrease (increase) in inventories (18,962 ) (6,933 ) 7,148 Total Cost of goods sold $ 77,450 $ 72,997 $ 70,737 d. Research and development Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Salary and related expenses $ 5,897 $ 5,925 $ 6,537 Subcontractors 5,196 2,275 3,392 Materials and allocation of facility costs 966 1,131 1,597 Depreciation and amortization 663 159 120 Others 337 257 327 Total Research and development $ 13,059 $ 9,747 $ 11,973 e. Selling and marketing Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Salary and related expenses $ 1,467 1,647 1,470 Marketing support 103 121 95 Packing, shipping and delivery 504 477 607 Marketing and advertising 788 424 627 Registration and marketing fees 917 470 1,162 Others 591 491 437 Total Selling and marketing $ 4,370 $ 3,630 $ 4,398 f. General and administrative Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Salary and related expenses $ 3,475 $ 3,085 3,138 Employees welfare 1,296 1,151 2,182 Professional fees and public company expense 2,162 2,012 1,549 Depreciation, amortization and impairment 717 686 649 Communication and software services 799 675 554 Others 745 916 201 Total General and administrative $ 9,194 $ 8,525 $ 8,273 g. Financial expense(income) Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Financial income Interest income and gains from marketable securities $ 1,146 $ 830 $ 500 Financial expense Fees and interest paid to financial institutions 293 172 82 Financial income and (expense) Derivatives instruments measured at fair value (512 ) 504 (511 ) Translation differences of financial assets and liabilities (139 ) 98 (101 ) Bond securities measured at fair value (5 ) (178 ) (80 ) Total Financial expense(income) $ 197 $ 1,082 $ (274 ) |
INCOME (LOSS) PER SHARE
INCOME (LOSS) PER SHARE | 12 Months Ended |
Dec. 31, 2019 | |
Income (Loss) Per Share [abstract] | |
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, 2019 2018 2017 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 U.S. Dollars U.S. Dollars For the computation of basic income (loss) 40,320,888 $ 22,251 40,275,374 $ 22,296 37,970,697 $ 6,901 Effect of potential dilutive ordinary shares 260,739 - 170,043 - 74,400 - For the computation of diluted income (loss) 40,581,627 $ 22,251 40,445,417 $ 22,296 38,045,097 $ 6,901 b. The computation of the diluted income per share for the years ending December 31, 2019, 2018 and 2017 took into account the options and RSs due to their dilutive effect. |
OPERATING SEGMENTS
OPERATING SEGMENTS | 12 Months Ended |
Dec. 31, 2019 | |
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 Company is organized into operating segments based on the products and services of the business units and has two operating segments as follows: Proprietary Products Development, manufacturing, sales and distribution of plasma-derived protein therapeutics. Distribution Distribute imported drug products 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 Company’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 Company 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, 2019 Revenues $ 97,696 $ 29,491 $ 127,187 Gross profit $ 45,271 $ 4,466 $ 49,737 Unallocated corporate expenses (26,953 ) Finance income, net 197 Income before taxes on income $ 22,981 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 thousand Year Ended December 31, 2017 Revenues $ 79,559 $ 23,266 $ 102,825 Gross profit $ 28,224 $ 3,864 $ 32,088 Unallocated corporate expenses (26,644 ) Finance expense, net (274 ) Loss before taxes on income $ 7,170 |
BALANCES AND TRANSACTIONS WITH
BALANCES AND TRANSACTIONS WITH RELATED PARTIES | 12 Months Ended |
Dec. 31, 2019 | |
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, U.S. Dollars in thousands Other accounts payables $ 151 $ 336 Employee benefit liabilities, net $ - $ 80 Trade receivable $ - $ 1,135 b. Transactions with employed/directors that accounts as related parties Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Salary and related expenses to those employed by the Company or on its behalf $ 311 $ 352 $ 460 Remuneration of directors not employed by the Company or on its behalf $ 363 $ 366 $ 107 Number of People to whom the Salary and remuneration Refer: Related and related parties employed by the Company or on its behalf 2 2 2 Directors not employed by the Company 7 8 2 Total Directors employed and not employed by the Company 9 10 4 c. Transactions with key executive personnel (including non-related parties) Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Short-term benefits $ 3,157 $ 2,766 $ 2,959 Share-based payment 188 285 310 Other long-term benefits - - 6 Total $ 3,345 $ 3,051 $ 3,275 d. Transactions with related parties Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Revenues $ 2,566 $ 3,529 $ 3,455 Cost of Goods Sold $ 13 $ - $ - Selling and marketing expenses $ 257 $ 313 $ 121 General and administrative expenses $ 447 $ 408 $ 446 e. Terms of Transactions with Related Parties 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, 2019, 2018 and 2017, the Company recorded no allowance for doubtful accounts for trade receivable from related parties. 1. On May 26, 2011, the Company entered into an amended agreement with Tuteur SACIFIA (“Tuteur”), a company registered in Argentina, currently under the control of the Hahn family. Such amended agreement revises and replaces the distribution agreement signed in 2001 between the Company and Tuteur in connection with the distribution of Glassia in Argentina and Paraguay. The amended agreement was made as an arm’s length transaction. On August 19, 2014 the Company entered into a subsequent amendment to the agreement, pursuant to which, the Company granted Tuteur distribution right in Argentina for its KamRho(D) product. In addition the distribution territory and expanded to include Bolivia. Pursuant to the distribution agreement, Tuteur serves as the exclusive distributor of Glassia and KamRho(D), in Argentina, Paraguay and Bolivia. In 2016 the Board of Directors approved a marketing contribution funding to Tuteur for reimbursement of costs associated with marketing activities aimed to locating new AATD patients and increasing the overall number of AATD patients treated with Glassia in Argentina. Such funding was paid by the Company in each of 2016 and 2017. In addition, in 2016 and in 2017 the Board of Directors approved extending a price discount for KamRho(D) to Tuteur. During 2018, a third amendment to the agreement was executed, which was effective as of July 1, 2018, pursuant to which the Company extended a price discount for Glassia. Pursuant to the third amendment Tuteur was obligated to issue bank guarantees to cover any future outstanding debt due to supply of products by the Company to Tuteur. 2. On July 29, 2015 the Company entered into a distribution agreement with Khairi S.A. (“Khairi”), a company held, inter alia, by Mr. Leon Recanati, the Chairman of the Company’s Board of Directors, and Mr. Jonathan Hahn, a director of the Company and his siblings, for the distribution of Glassia and KamRho(D) in Uruguay. This distribution agreement with Khairi is an arm’s length transaction For the years ending December 31, 2019, 2018 and 2017 there were no sales of Glassi and KamRho(D) by the Company to Khairi 3. FIMI Opportunity Fund 6, L.P. and FIMI Israel Opportunity Fund 6, Limited Partnership (the “FIMI Funds”) purchased on November 21, 2019 5,240,956 ordinary shares at a price of $6.00, representing 12.99%. On February 10, 2020, the Company closed a private placement with FIMI Opportunity Fund 6, L.P. and FIMI Israel Opportunity Fund 6, Limited Partnership (the “FIMI Funds”), a then 12.99% stockholder of the Company. Pursuant to the private placement the Company issued 4,166,667 ordinary shares at a price of $6.00 per share, for an aggregate gross proceeds of $25,000 thousands. Upon closing of the private placement, the FIMI Funds ownership represents approximately 21% of the Company’s outstanding shares. Concurrently, the Company entered into a registration rights agreement with the FIMI Funds, pursuant to which the FIMI Funds are entitled to customary demand registration rights (effective six months following the closing of the transaction) and piggyback registration rights with respect to all shares held by FIMI Funds. Mr. Ishay Davidi, Ms. Lilach Asher Topilsky and Mr. Amiram Boehm, members of our board of directors, are executives of the FIMI Funds. The following Israeli entities: Amnir recycling industries Ltd., Grafity office equipment marketing, G-one security solutions, Carmel Frenkel IND, and Oxygen & Argon works Ltd who are controlled by the FIMI Funds, are currently engaged by the Company for the provision of certain services relating to its continuous operations in non-material amounts and in market prices. f. CEO employment terms On December 20, 2018 the Company’s shareholders approved an amendment to the employment terms of the Company’s CEO. Pursuant to the amendment the CEO monthly gross salary increased to NIS 82,500 (or $22,627), effective as of July, 1 2018. On June 20, 2019 the Company’s Board of Directors approved a subsequent amendment to the employment terms of the Company’s CEO, pursuant to which, the monthly gross salary will increased to NIS 88,000 (or $25,462), effective as July 1, 2019. The updated employment terms are subject to the approval of the General Meeting of Shareholders which is expected to take place during March 2020. During 2019 the Company accounted for a bonus accrual to the CEO in the amount of $189 thousands. As for a grant of options and restricted shares to the CEO, refer to Note 20b. |
EVENTS SUBSEQUENTS TO THE REPOR
EVENTS SUBSEQUENTS TO THE REPORTING PERIOD | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of non-adjusting events after reporting period [abstract] | |
EVENTS SUBSEQUENTS TO THE REPORTING PERIOD | Note 26: - Events Subsequents to the Reporting Period a. As for grant of options to the members of the Board of Directors approved by the Board of Directors on January 20, 2020, refer to Note 20d. b. As for the private placement closed with the FIMI funds on February 10, 2020 refer to note 25e3. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
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. 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, 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. Non-monetary assets and liabilities denominated in foreign currency and measured at fair value are translated into the functional currency using the exchange rate prevailing at the date when the fair value was determined. |
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 deposits 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. The deposits are presented according to their terms of deposit. |
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, 2019 the Company recognized an allowance for doubtful accounts at an amount of $67 thousands. The Company did not recognize an allowance in respect of groups of customers that are collectively assessed for impairment since it did not identify any groups of customers which bear similar credit risks. Impaired receivables are derecognized when they are assessed as uncollectible. |
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 Costs of raw materials, direct and indirect costs including labor, other materials and other indirect manufacturing costs allocated to the in process manufactured batches through the end of the reporting period. The allocation of indirect costs is accounted for on a quarterly basis by dividing the total quarterly indirect manufacturing cost to the batches manufactured during that quarter based on predetermined allocation factors. Finished products Costs of raw materials, direct and indirect costs including labor, other materials and other indirect manufacturing costs allocated to the manufactured finished products through completion of manufacturing process. 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 On January 1, 2018, the Company initially adopted IFRS 15, “Revenue from Contracts with Customers” (“the Standard”). The Company elected to apply the provisions of the Standard using the modified retrospective method with the application of certain practical expedients and without restatement of comparative data. The accounting policy for revenue recognition applied from January 1, 2018, is as follows: The Company recognizes revenue when the customer obtains control over the promised goods or services. 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. The Company includes variable consideration, such as milestone payments or volume rebates, in the transaction price only when it is highly probable that its inclusion will not result in a significant revenue reversal in the future when the uncertainty has been subsequently resolved In determining the amount of revenue from contracts with customers, the Company evaluates whether it is a principal or an agent in the arrangement. The Company is a principal when the Company controls the promised goods or services before transferring them to the customer. In these circumstances, the Company recognizes revenue for the gross amount of the consideration. Identifying the contract The Company account for a contract with a customer only when all of the following criteria are met: a) The parties to the contract have approved the contract (in writing, orally or in accordance with other customary business practices) and are committed to perform their respective obligations; b) The Company can identify each party’s rights regarding the goods or services to be transferred; c) The Company can identify the payment terms for the goods or services to be transferred; d) The contract has commercial substance (i.e. the risk, timing or amount of the entity’s future cash flows is expected to change as a result of the contract); and e) It is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer For the purpose of paragraph (e) the Company examines, inter alia, the percentage of the advance payments received and the spread of the contractual payments, past experience with the customer and the status and existence of sufficient collateral. Combination of contracts The Company accounts for multiple contracts as a single contract when all the contracts are signed at or near the same time with the same customer or with related parties of the customer, and when one of the following criteria is met: a) The contracts are negotiated as a package with a single commercial objective. b) The amount of consideration to be paid in one contract depends on the consideration of another contract. c) The goods or services that the Company will provide according to the contracts represent a single performance obligation for the Company. Identifying performance obligations On the contract’s inception date the Company assesses the goods or services promised in the contract with the customer and identifies the performance obligations in it. The Company identifies the performance obligations when the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and the Company promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. Determining the transaction price The transaction price is the amount of the consideration that is expected to be received based on the contract terms. The Company takes into account the effects of all the following elements when determining the transaction price: a) Variable consideration – The Company determines the transaction price separately for each contract with a customer. When exercising this judgment, the Company evaluates the effect of each variable amount in the contract, taking into consideration discounts, penalties, variations, claims, and non-cash consideration. The Company includes the estimated variable consideration in the transaction price only to the extent it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty is resolved. The Company updates the estimated transaction price to represent faithfully the circumstances present at the end of the reporting period and the changes in circumstances during the reporting period. b) Existence of a significant financing component – the Company adjusts the amount of the promised consideration in respect of the effects of the time value of money when certain advance payments provide the Company with a significant financing benefit. The financing component is recognized as interest expenses over the period, which are calculated according to the effective interest method. c) Non-cash consideration - Non-cash consideration is measured at the fair value for goods receivable on a contract’s inception. d) Consideration payable to customers- The Company accounts for payments made to a customer as a reduction of the revenues from the customer when the Company recognizes revenue from the transfer of goods or services to the customer or the Company pays the consideration or promises to pay the consideration in accordance with the Company’s customary business practices. When the consideration payable to a customer is a payment for a distinct good or service from the customer, then the Company accounts for the purchase of the good or service in the same way it accounts for other purchases from suppliers. Allocating the transaction price For contracts that consist of more than one performance obligation, at contract inception the Company allocates the contract transaction price to each performance obligation identified in the contract on a relative stand-alone selling price basis. The stand-alone selling price is the price at which the Company would sell the promised goods or services separately to a customer. When the stand-alone selling price is not directly observable by reference to similar transactions with similar customers, the Company applies suitable methods for estimating the stand-alone selling price including: the adjusted market assessment approach, the expected cost plus a margin approach and the residual approach. The Company may also use a combination of these approaches to allocate the transaction price in the contract. Satisfaction of performance obligations The Company recognizes revenue from contracts with customers when the control over the goods or services is transferred to the customer. For most contracts, revenue recognition occurs at a point in time when control of the asset is transferred to the customer, generally on delivery of the goods. For agreements with a strategic partner, performance obligations are generally satisfied over time, given that the customer both simultaneously receives and consumes the benefits provided by the Company, or receives assets with no alternative use, for which the Company has an enforceable right to payment for performance completed to date. The method for measuring the progress of performance obligations that are satisfied over time usually based upon the deliverables forming part of performance obligations. Contract modifications A contract modification is a change in the scope or price (or both) of a contract that was approved by the parties to the contract. A contract modification can be approved in writing, orally or be implied by customary business practices. A contract modification can take place also when the parties to the contract have a disagreement regarding the scope or price (or both) of the modification or when the parties have approved the modification in scope of the contract but have not yet agreed on the corresponding price modification. When a contract modification has not yet been approved by the parties, the Company continues to recognize revenues according to the existing contract, while disregarding the contract modification, until the date the contract modification is approved or the contract modification is legally enforceable. The Company accounts for a contract modification as an adjustment of the existing contract since the remaining goods or services after the contract modification are not distinct and therefore constitute a part of one performance obligation that is partially satisfied on the date of the contract modification. The effect of the modification on the transaction price and on the rate of progress towards full satisfaction of the performance obligation is recognized as an adjustment to revenues (increase or decrease) on the date of the contract modification, meaning on a catch-up basis. When a contract modification increases the scope of the contract as a result of adding distinct goods or services and the contract price changes by an amount reflecting the stand-alone selling prices of the additional goods or services, the Company accounts for the contract modification as a separate contract. The Company generate revenue mainly from sale of products to strategic partners and distributors as well as from the licensing of our technology and distribution rights. The Company identifies the goods and services it promises in its contracts with customers and analyzes whether each good or service promised is distinct. The Company further groups a series of distinct goods or services to a single performance obligation. The Company’s conclusion depends on the specific facts and circumstances pertaining to a contract. In the majority of contracts, revenue recognition occurs at a point in time when control of our product is transferred to the customer, generally on delivery of the goods. With regards to certain contract with our strategic partner the Company analyzed the following: The Company identified few performance obligations which include: a. Grant of a license for distribution one of the Company’s products in certain territories and the supply of predetermined minimum quantities. b. The supply of a predetermined quantity of the Company’s product for the purpose of clinical trials performed conducted by strategic partner. c. Grant of a license for the use of the Company’s knowledge and patents, and the provision of consulting services with respect to the transfer of technology. Subsequently, the Company determines the transaction price. The transaction price is the amount of the consideration that is expected to be received based on the contract terms. The Company takes into account the effects of all the following elements when determining the transaction price a. Variable consideration – certain amounts of the promised consideration such as milestone payments and volume rebates. The Company includes the estimated variable consideration in the transaction price only to the extent it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty is resolved. b. Significant financing component – Advance payments received provide with the benefit of financing. Accordingly the Company adjusted the transaction price for the effects of the time value of money. c. Non-cash consideration – Raw materials provided as non-cash consideration. This consideration is measured at fair value. d. Consideration payable to customers- The Company accounts for payments made to a customer as a reduction of the revenues from the customer when the Company recognizes revenue from the transfer of goods or services to the customer or the Company pays the consideration or promises to pay the consideration in accordance with the Company’s customary business practices. The Company allocates the transaction price to the different performance obligation identified. This allocation is based on relative stand-alone selling price. For certain amounts of variable consideration the Company allocated to a certain performance obligation or to a distinct goods or services within it. For each performance obligation identified, the Company recognizes revenue when (or as) it satisfies the performance obligation. The performance obligations are satisfied over time, as the customer both simultaneously receives and consumes the benefits provided by the Company, or receives assets with no alternative use, for which the Company has an enforceable right to payment for performance completed to date. The method for measuring the progress in performance obligations that are satisfied over time usually based upon the deliverables forming part of those performance obligations. Deferred revenues Deferred revenues include unearned amounts received from customers not yet recognized as revenues. The accounting policy for revenue recognition applied until December 31, 2017 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. 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. Revenues are measured at the fair value of the consideration received less any trade discounts, volume rebates and returns. The specific criteria for revenue recognition for the following types of revenues are: - Revenues from the sale of goods are recognized when all the significant risks and rewards of ownership of the goods have passed to the buyer and the seller no longer retains continuing managerial involvement. The delivery date is usually the date on which ownership passes. - Agreements with multiple elements provide for varying consideration terms, such as upfront payments and milestone payments. Revenues from such agreements that do not contain a general right of return and that are composed of multiple elements such as distribution exclusivity, license and services are allocated to the different elements and are recognized in respect of each element separately. An element constitutes a separate accounting unit if and only if it has a separate value to the customer. Revenue from the different element is recognized when the criteria for revenue recognition have been met and only to the extent of the consideration that is not contingent upon completion or performance of future services in the contract. |
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 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 carryforward losses and 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 tax assets are reviewed at the end of each reporting period and reduced to the extent that it is not probable that they will be utilized. Deductible carryforward losses and temporary differences for which deferred tax assets had not been recognized are reviewed at the end of each reporting period and a respective deferred tax asset is recognized to the extent that their utilization is probable. 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. 3. IFRIC 23, "Uncertainty over Income Tax Treatments": In June 2017, the IASB issued IFRIC 23, "Uncertainty over Income Tax Treatments" ("the Interpretation"). The Interpretation clarifies the accounting for recognition and measurement of assets or liabilities in accordance with the provisions of IAS 12, "Income Taxes", in situations of uncertainty involving income taxes. The Interpretation provides guidance on (i) considering whether some tax treatments should be considered collectively, (ii) measurement of the effects of uncertainty involving income taxes on the financial statements and (iii) accounting for changes in facts and circumstances in respect of the uncertainty. As of December 31, 2019 and 2018, the application of IFRIC 23 did not have a material effect on the financial statements. |
Leases | l. Leases As of January 1, 2019 the Company initially applied IFRS 16, "Leases" ("the Standard"). The Company chose to apply the provisions of the Standard using the modified retrospective approach without restatement of comparative data. The accounting policy for leases applied effective from January 1, 2019, is as follows: The Company accounts for a contract as a lease when the contract terms convey the right to control the use of an identified asset for a period of time in exchange for consideration. On the inception date of the lease, the Company determines whether the arrangement is a lease or contains a lease, while examining if it conveys the right to control the use of an identified asset for a period of time in exchange for consideration. In its assessment of whether an arrangement conveys the right to control the use of an identified asset, the Company assesses whether it has the following two rights throughout the lease term: a) The right to obtain substantially all the economic benefits from use of the identified asset; and b) The right to direct the identified asset's use. The Company as a lessee: For leases in which the Company is the lessee, the Company recognizes on the commencement date of the lease a right-of-use asset and a lease liability, excluding leases whose term is up to 12 months and leases for which the underlying asset is of low value. For these excluded leases, the Company has elected to recognize the lease payments as an expense in profit or loss on a straight-line basis over the lease term. In measuring the lease liability, the Company has elected to apply the practical expedient in the Standard and does not separate the lease components from the non-lease components (such as management and maintenance services, etc.) included in a single contract. On the commencement date, the lease liability includes all unpaid lease payments discounted at the interest rate implicit in the lease, if that rate can be readily determined, or otherwise using the Company's incremental borrowing rate. After the commencement date, the Company measures the lease liability using the effective interest rate method. On the commencement date, the right-of-use asset is recognized in an amount equal to the lease liability plus lease payments already made on or before the commencement date and initial direct costs incurred less any lease incentives received. The right-of-use asset is measured applying the cost model and depreciated over the shorter of its useful life or the lease term. The Company tests for impairment of the right-of-use asset whenever there are indications of impairment pursuant to the provisions of IAS 36. Depreciation of right-of-use asset After lease commencement, a right-of-use asset is measured on a cost basis less accumulated depreciation and accumulated impairment losses and is adjusted for re-measurements of the lease liability. Depreciation is calculated on a straight-line basis over the useful life or contractual lease period, whichever earlier, as follows: % Mainly % Land and Buildings 10 10 Vehicles 20-33 3 office equipment (i.e. printing and photocopying machines) 20 20 Lease extension and termination options: A non-cancellable lease term includes both the periods covered by an option to extend the lease when it is reasonably certain that the extension option will be exercised and the periods covered by a lease termination option when it is reasonably certain that the termination option will not be exercised. In the event of any change in the expected exercise of the lease extension option or in the expected non-exercise of the lease termination option, the Company re-measures the lease liability based on the revised lease term using a revised discount rate as of the date of the change in expectations. The total change is recognized in the carrying amount of the right-of-use asset until it is reduced to zero, and any further reductions are recognized in profit or loss. Subleases: In a transaction in which the Company is a lessee of an underlying asset (head lease) and the asset is subleased to a third party, the Company assesses whether the risks and rewards incidental to ownership of the right-of-use asset have been transferred to the sub-lessee, among others, by evaluating the sublease term with reference to the useful life of the right-of-use asset arising from the head lease. When substantially all the risks and rewards incidental to ownership of the right-of-use asset have been transferred to the sub- lessee, the Company accounts for the sublease as a finance lease, otherwise it is accounted for as an operating lease. If the sublease is classified as a finance lease, the leased asset is derecognized on the commencement date and a new asset, "finance lease receivable" is recognized at an amount equivalent to the present value of the lease payments, discounted at the interest rate implicit in the lease. Any difference between the carrying amount of the leased asset before the derecognition and the carrying amount of the finance lease receivable is recognized in profit or loss. Lease modification: If a lease modification does not reduce the scope of the lease and does not result in a separate lease, the Company re-measures the lease liability based on the modified lease terms using a revised discount rate as of the modification date and records the change in the lease liability as an adjustment to the right-of-use asset. If a lease modification reduces the scope of the lease, the Company recognizes a gain or loss arising from the partial or full reduction of the carrying amount of the right-of-use asset and the lease liability. The Company subsequently remeasures the carrying amount of the lease liability according to the revised lease terms, at the revised discount rate as of the modification date and records the change in the lease liability as an adjustment to the right-of-use asset. For additional information regarding right-of-use assets and lease liabilities and refer to Note 14. The accounting policy for leases applied until December 31, 2018, is as follows: 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 Company 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, less accumulated depreciation 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. The reversal of impairment loss of an asset presented at cost is recognized in profit or loss. |
Financial instruments | o. Financial instruments On January 1, 2018, the Company initially adopted IFRS 9, "Financial Instruments" ("the Standard"). The Company elected to apply the provisions of the Standard retrospectively without restatement of comparative data. The accounting policy for financial instruments applied commencing from January 1, 2018, is as follows: 1. Financial assets Financial assets are classified at initial recognition, and subsequently measured at amortized cost, fair value through other comprehensive income (OCI), and fair value through profit or loss. The classification of financial assets at initial recognition depends on the financial asset's contractual cash flow characteristics and the Company's business model for managing them. With the exception of trade receivables that do not contain a significant financing component or for which the Company has applied the practical expedient, the Company initially measures a financial asset at its fair value plus, in the case of a financial asset not at fair value through profit or loss, transaction costs. 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: a) 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. b) 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 Available For Sale (AFS) financial investments is reported as interest income using the effective interest rate method. Financial assets at FVPL comprise derivative instruments unless they are designated as effective hedging instruments. Impairment of financial assets The Company evaluates at the end of each reporting period the loss allowance for financial debt instruments which are not measured at fair value through profit or loss. The Company distinguishes between two types of loss allowances: a) Debt instruments whose credit risk has not increased significantly since initial recognition, or whose credit risk is low - the loss allowance recognized in respect of this debt instrument is measured at an amount equal to the expected credit losses within 12 months from the reporting date (12-month ECLs); or b) Debt instruments whose credit risk has increased significantly since initial recognition, and whose credit risk is not low - the loss allowance recognized is measured at an amount equal to the expected credit losses over the instrument's remaining term (lifetime ECLs). The Company has short-term financial assets such as trade receivables in respect of which the Company applies a simplified approach and measures the loss allowance in an amount equal to the lifetime expected credit losses. An impairment loss on debt instruments measured at amortized cost is recognized in profit or loss with a corresponding loss allowance that is offset from the carrying amount of the financial asset, whereas the impairment loss on debt instruments measured at fair value through other comprehensive income is recognized in profit or loss with a corresponding loss allowance that is recorded in other comprehensive income and not as a reduction of the carrying amount of the financial asset in the statement of financial position. The Company applies the low credit risk simplification in the Standard, according to which the Company assumes the debt instrument's credit risk has not increased significantly since initial recognition if on the reporting date it is determined that the instrument has a low credit risk, for example when the instrument has an external rating of "investment grade". In addition, the Company considers that when contractual payments in respect of a debt instrument are more than 30 days past due, there has been a significant increase in credit risk, unless there is reasonable and supportable information that demonstrates that the credit risk has not increased significantly. The Company considers a financial asset in default when contractual payments are more than 90 days past due. However, in certain cases, the Company considers a financial asset to be in default when external or internal information indicates that the Company is unlikely to receive the outstanding contractual amounts in full. The Company considers a financial asset that is not measured at fair value through profit or loss as credit-impaired when one or more events that have a detrimental impact on the estimated future cash flows of that financial asset have occurred. The Company takes into consideration the following events as evidence that a financial asset is credit impaired: a) significant financial difficulty of the issuer or borrower; b) a breach of contract, such as a default or past due event; c) a concession granted to the borrower due to the borrower's financial difficulties that would otherwise not be granted; d) it is probable that the borrower will enter bankruptcy or financial reorganization; e) the disappearance of an active market for that financial asset because of financial difficulties; or f) the purchase or origination of a financial asset at a deep discount that reflects the incurred credit losses. 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, 2019 there is no ECL allowance. 2. Financial liabilities Financial liabilities within the scope of IFRS 9 are initially measured at fair value less transaction costs that are directly attributable to the issue of the financial liability. 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 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. After initial recognition, changes in fair value are recognized either in profit or loss for non-hedge accounting derivatives or in other comprehensive income for hedge accounting derivatives. |
Fair value measurement | p. 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. 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). 1 . 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. 2 . 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 | q . 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 and cash flows risk. 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. |
Provisions | r . Provisions A provision in accordance with IAS 37 is recognized when the Company 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. The expense is recognized in the statement of profit or loss net of any reimbursement. |
Employee benefit liabilities | s . 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 | t. 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 over the remaining vesting period for any modification that increases the total fair value of the share-based payment arrangement or is otherwise beneficial to the employee or director at the modification date. |
Earnings (loss) per Share | u. 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. |
Reclassification of prior years' amounts | v . Reclassification of prior years’ amounts Certain amounts in prior years’ financial statements have been reclassified to conform to the current year’s presentation. The reclassification had no effect on previously reported net loss or shareholders’ equity. |
Initial application of IFRS 16, Leases | w. Changes in accounting policies - initial application of new financial reporting and accounting standards and amendments to existing financial reporting and accounting standards: Initial application of IFRS 16, “Leases” In January 2016, the IASB issued IFRS 16, “Leases” (“the Standard”), which provides guidance on the recognition, measurement, presentation and disclosure of leases and supersedes IAS 17, “Leases” (“the old Standard”), IFRIC 4, “Determining Whether an Arrangement Contains a Lease”, and SIC-15, “Operating Leases - Incentives”. According to the Standard, a lease is a contract, or part of a contract, that conveys the right to use an asset for a period of time in exchange for consideration. The Standard has been applied for the first time in these financial statements. As permitted by the Standard, the Company elected to apply the provisions of the Standard using the modified retrospective method. The Company recognized lease liabilities on the initial application date of the Standard in respect of leases previously classified as operating leases according to IAS 17. The amount of the liability as of the date of initial application of the Standard was measured using the Company’s incremental borrowing rate of interest on the date of initial application of the Standard. Certain right-of-use assets were measured as if the Standard has been applied from the commencement date of the lease but for the purpose of calculation, the lessee’s incremental borrowing rate on the date of initial adoption was used, while the carrying amount of other right-of-use assets are identical to the carrying amount of the lease liability. For details of the accounting policy applied from the date of initial application of the Standard, see Note 14b. The main effect of the initial application of the Standard relates to existing leases in which the Company is the lessee. According to the Standard, as explained in Note 14b, the Company recognizes a lease liability and a corresponding right-of-use asset for each lease in which it is the lessee, excluding certain exceptions. This accounting treatment is different than the accounting treatment applied under the old Standard according to which the lease payments in respect of leases for which substantially all the risks and rewards incidental to ownership of the leased asset were not transferred to the lessee were recognized as an expense in profit or loss on a straight-line basis over the lease term. Following are data relating to the initial application of the Standard as of January 1, 2019, in respect of leases existing as of that date: According to the previous accounting policy Difference According to the current accounting policy U.S Dollars in thousands As of January 1, 2019 Non-current assets: Right-of-use assets $ - $ 4,161 $ 4,161 Liabilities Current maturities of leases 110 810 920 Leases 28 3,907 3,935 Other accounts payables $ 5,261 $ (255 ) $ 5,006 Shareholder’s Equity Accumulated deficit $ 112,376 $ (300 ) $ 112,076 The lease liabilities as at January 1, 2019 can be reconciled to the operating lease commitments as of December 31, 2018 as follows: U.S Dollars In thousands Future minimum payments for non-cancellable leases as per IAS 17 according to the financial statements as of December 31, 2018 $ 5,434 Weighted average incremental borrowing rate as at January 1, 2019 (1) 3.06%-4.6% Discounted operating lease commitment at January 1, 2019 4,685 Add: Leases of other equipment 32 Leases that were previously identified as leases under IAS 17 138 Lease liabilities as at January 1, 2019 $ 4,855 (1) The weighted average incremental borrowing rate was evaluated based on credit risk, terms of the leases and other economic variables. The weighted average incremental borrowing rate was used to discount future lease payments in the calculation of the lease liability on the date of initial adoption of the Standard. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of significant accounting policies [abstract] | |
Schedule of Impact of IFRS 15 | % Mainly % Land and Buildings 10 10 Vehicles 20-33 3 office equipment (i.e. printing and photocopying machines) 20 20 |
Schedule of Useful Lives for Property, Plant and Equipment | % 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. |
Schedule of initial adoption of the Standard | According to the previous accounting policy Difference According to the current accounting policy U.S Dollars in thousands As of January 1, 2019 Non-current assets: Right-of-use assets $ - $ 4,161 $ 4,161 Liabilities Current maturities of leases 110 810 920 Leases 28 3,907 3,935 Other accounts payables 5,261 (255 ) 5,006 Shareholder's Equity Accumulated deficit $ 112,376 $ (300 ) $ 112,076 |
Schedule of lease liabilities | U.S Dollars In thousands Future minimum payments for non-cancellable leases as per IAS 17 according to the financial statements as of December 31, 2018 $ 5,434 Weighted average incremental borrowing rate as at January 1, 2019 (1) 3.06%-4.6% Discounted operating lease commitment at January 1, 2019 4,685 Add: Leases of other equipment 32 Leases that were previously identified as leases under IAS 17 138 Lease liabilities as at January 1, 2019 $ 4,855 |
CASH AND CASH EQUIVALENTS (Tabl
CASH AND CASH EQUIVALENTS (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Cash and cash equivalents [abstract] | |
Schedule of Cash and Cash Equivalents | December 31, 2019 2018 U.S. Dollars in thousands Cash and deposits for immediate withdrawal $ 25,559 $ 18,018 Cash equivalents in USD deposits (1) 17,017 - Cash equivalents in NIS deposits (2) 86 75 Total Cash and Cash Equivalents $ 42,662 $ 18,093 (1) The deposits bear interest of 2.0%-2.4% per year, as of December 31, 2019. (2) The deposits bear interest of 0.02% per year, as of December 31, 2019 and 0.16% per year, as of December 31, 2018. |
SHORT-TERM INVESTMENTS (Tables)
SHORT-TERM INVESTMENTS (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of short-term investments [abstract] | |
Schedule of Short-term Investments | December 31, 2019 2018 U.S. Dollars in thousands Fair value through other comprehensive income $ 12,832 $ 10,325 Bank deposits in USD (1) 18,413 22,174 Total Short-Term Investments $ 31,245 $ 32,499 (1) The deposits bear interest of 2.5%-3.3% and 2.6%-3.5% per year, as of December 31, 2019 and 2018, respectively. |
TRADE RECEIVABLES, NET (Tables)
TRADE RECEIVABLES, NET (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Trade and other current receivables [abstract] | |
Schedule of Trade Receivables, Net | December 31, 2019 2018 U.S. Dollars in thousands Open accounts: In NIS $ 8,357 $ 6,780 In USD 14,920 20,814 $ 23,277 $ 27,594 Checks receivable - 80 $ 23,277 $ 27,674 Less allowance for doubtful accounts(1) (67 ) - Total Trade receivables, net $ 23,210 $ 27,674 (1) Allowance for doubtful accounts: December 31, 2018 - Provision for the year (67 ) December 31, 2019 (67 ) (1) $67 thousands of the over 121 days balance is provided for as allowance for doubtful accounts. |
Schedule of Analysis of Past Due but Not Impaired Trade Receivables | Past due trade receivables with aging of Neither past due nor impaired Up to 30 Days 31-60 Days 61-90 Days 91-120 Days Over 121 days Total December 31, 2019 $ 22,617 $ 469 $ 25 $ 33 $ 65 $ 68 (1) $ 23,277 December 31, 2018 $ 27,215 $ 337 $ 15 $ 15 $ 6 $ 6 $ 27,594 (1) $67 thousands of the over 121 days balance is provided for as allowance for doubtful accounts. |
OTHER ACCOUNTS RECEIVABLES (Tab
OTHER ACCOUNTS RECEIVABLES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of other accounts receivables [abstract] | |
Schedule of Other Accounts Receivables | December 31, 2019 2018 U.S. Dollars in thousands Government authorities $ 1,838 $ 1,552 Prepaid expenses 1,240 1,086 Accrued interest 70 66 Accrued income 101 193 Materials for clinical trials and inventory designated for R&D activities - 399 Other 8 12 Derivatives financial instruments mainly measured at fair value through other comprehensive income 15 - Total Other Accounts Receivables $ 3,272 $ 3,308 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Classes of current inventories [abstract] | |
Schedule of Inventories | December 31, 2019 2018 U.S. Dollars in thousands Finished products $ 12,016 $ 7,023 Purchased products 10,412 4,813 Work in progress 9,043 4,792 Raw materials 11,702 12,688 Total Inventories $ 43,173 $ 29,316 (1) The inventories balance as of December 31, 2019 and December 31, 2018 is presented net of impairment of inventories in the amount of $334 thousands and $61 thousands, respectively. |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of detailed information about property, plant and equipment [abstract] | |
Schedule of Composition and Movement of Property, Plant and Equipment | 2019 Land and Buildings Machinery and Equipment Vehicles Computers, Software, Equipment and Office Furniture Leasehold Improvements Total U.S. Dollars in thousands Cost Balance at January 1, 2019 $ 29,167 $ 30,386 $ 85 $ 6,493 $ 1,141 $ 67,272 Additions 1,101 1,302 - 699 14 3,116 Sale and write-off - (148 ) - (391 ) - (539 ) Balance as of December 31, 2019 30,268 31,540 85 6,801 1,155 69,849 Accumulated Depreciation Balance as of January 1, 2019 15,076 21,679 63 5,247 203 42,268 Depreciation 1,232 1,575 5 636 115 3,563 Sale and write-off - (142 ) - (390 ) - (532 ) Balance as of December 31, 2019 16,308 23,112 68 5,493 318 45,299 Depreciated cost as of December 31, 2019 $ 13,960 $ 8,428 $ 17 $ 1,308 $ 837 $ 24,550 (1) Including labor costs charged in 2019 to the cost of facilities, machinery and equipment in the amount of $493 thousands. 2018 Land and Buildings 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 (1) Including labor costs charged in 2018 to the cost of facilities, machinery and equipment in the amount of $514 thousands. |
Schedule of Leasing Rights of Land from Israel Land Administration | December 31, 2019 2018 U.S. Dollars in thousands Under finance lease $ 992 $ 1,004 |
OTHER LONG TERM ASSETS (Tables)
OTHER LONG TERM ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Miscellaneous non-current assets [abstract] | |
Schedule of Other Long Term Assets | December 31, 2019 2018 U.S. Dollars in thousands Distribution right (1) 298 123 Long term pre-paid expenses 54 51 Total Other Long Term Assets $ 352 $ 174 (1) During 2018 and 2019 the Company entered into agreements for the distribution right of certain therapeutic products to be distributed in Israel, subject to Israeli Ministry of Health (“IL MOH”) marketing approval. Pursuant to the agreements, 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. As of December 31, 2019 no amortization was recorded. |
TRADE PAYABLES (Tables)
TRADE PAYABLES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Trade and other current payables [abstract] | |
Schedule of Trade Payables | December 31, 2019 2018 U.S. Dollars in thousands Open debts mainly in USD $ 7,847 $ 7,256 Open debts in EUR 11,426 4,206 Open debts in NIS 5,557 5,822 Sub-Total 24,830 17,284 Notes payable - 1 Total Trade Payables $ 24,830 $ 17,285 |
OTHER ACCOUNTS PAYABLES (Tables
OTHER ACCOUNTS PAYABLES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of other accounts payable [Abstract] | |
Schedule of Other Accounts Payables | Note 13: - Other Accounts Payables December 31, 2019 2018 U.S. Dollars in thousands Employees and payroll accruals $ 5,669 $ 4,708 Derivatives financial instruments mainly measured at fair value through other comprehensive income - 64 Accrued Expenses and Others 142 489 Total Other Accounts Payables $ 5,811 $ 5,261 |
LOANS AND LEASES (Tables)
LOANS AND LEASES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of loans and capital leases [abstract] | |
Schedule of Loans and Capital Leases | December 31, 2019 2018 U.S. Dollars in thousands Bank loans 746 688 Less current maturities of bank loans 257 452 Total Long term bank loans $ 489 $ 1,140 |
Schedule of right-of-use assets composition and changes in lease liabilities | Right-of-use-assets Rented Offices Vehicles Computers, Software, Equipment and Office Furniture Total Lease U.S Dollars in thousands As of January 1, 2019 (1) $ 3,466 $ 663 $ 32 $ 4,161 $ 4,855 Additions to right -of -use assets - 874 874 870 Write-off - (57 ) (57 ) (60 ) Depreciation expense (433 ) (517 ) (6 ) (956 ) - Exchange rate differences - - - 406 Repayment of lease liabilities - - - (1,070 ) As of December 31, 2019 $ 3,033 $ 989 $ 26 $ 4,022 $ 5,001 (1) Following the initial application of IFRS 16, on January 1, 2019 , the Company recorded operating lease commitment classified as a lease liability at the amount of $4,717 thousands with respect to office and storage spaces, vehicles and certain office equipment (i.e. printing and photocopying machines) at the amount of $4,022, $663 and $32 thousands, respectively. Also refer to Note 2ii. The weighted average incremental borrowing rate used to discount future lease payments in the calculation of the lease liability was in the range of 3.06%-4.6% evaluated based on credit risk, terms of the leases and other economic variables. |
Schedule of Consolidated statements | Below is the Consolidated Statements of Profit or Loss and Other Comprehensive Income impact for the year ended December 31, 2019 Expense decrease For the year ended on U.S Dollars in thousands Operating lease expense $ 1,182 Depreciation of right of use assets (956 ) Operating income 226 Finance expense (212 ) Net Income (loss) $ 14 Below is the Consolidated Statements of cash flow impact for the year ended December 31, 2019 According to the previous accounting policy Difference According to the current accounting policy U.S Dollars in thousands For the year ended on December 31, 2019 Cash flows from operating activities $ 26,501 $ 1,070 $ 27,571 Cash flows from financing activities $ (460 ) $ (1,070 ) $ (1,530 ) |
Schedule of maturity analysis of lease liabilities | Maturity analysis of the Company's lease liabilities (including interest) Less than one 1 to 2 2 to 3 3 to 5 6 and Total Lease liabilities (including interest) $ 1,198 $ 1,000 $ 797 $ 1,352 1,364 $ 5,711 |
FINANCIAL INSTRUMENTS (Tables)
FINANCIAL INSTRUMENTS (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of detailed information about financial instruments [abstract] | |
Schedule of Classification of Financial Assets and Liabilities | December 31, 2019 2018 U.S. Dollars in thousands Financial assets Financial assets at fair value through profit or loss: Foreign exchange forward contracts $ 2 $ - Financial assets at fair value through other comprehensive income: Cash flow hedges 13 Marketable debt securities 12,832 10,324 Financial assets at cost: Cash and cash equivalent 42,662 18,093 Short term bank deposits 18,413 22,175 Total assets measured at fair value through other comprehensive income $ 73,920 $ 50,592 Total financial assets $ 73,920 $ 50,592 Financial liabilities Financial assets at fair value through profit or loss: Foreign exchange forward contracts $ - $ 6 Financial liabilities at fair value through other comprehensive income: Cash flow hedges $ - $ 58 Financial liabilities measured at amortized cost: Bank loans 746 1,140 Leases 5,001 138 Total Financial liabilities measured at amortized cost: $ 5,747 $ 1,278 Total financial and lease liabilities $ 5,747 $ 1,342 |
Schedule of Maturity Profile of Company's Financial Liabilities based on Contractual Undiscounted Payments | December 31, 2019 Less than one 1 to 2 2 to 3 3 to 5 6 and Total Trade payables $ 24,830 - - - - $ 24,830 Other accounts payables 5,811 - - - - 5,811 bank loans (including interest) 506 227 34 - - 767 Lease liabilities (including interest) 1,198 1,000 797 1,352 1,364 5,711 $ 32,345 $ 1,227 $ 831 $ 1,352 $ 1,364 $ 37,119 December 31, 2018 Less than one 1 to 2 2 to 3 3 to 5 Total Trade payables $ 17,285 - - - $ 17,285 Other accounts payables 5,261 - - - 5,261 Long term bank loans and leases (including interest) 595 495 209 32 1,331 $ 23,141 $ 495 $ 209 $ 32 $ 23,877 |
Schedule of Changes in Liabilities Arising From Financing Activities | Changes in liabilities arising from financing activities January 1, Cumulative effect of initially applying IFRS 16 (1) Payments Foreign exchange movement New loans and leases Write off December 31, U.S. Dollars in thousands Bank loans $ 1,140 - (475 ) 81 - - $ 746 Leases 138 4,717 (1,070 ) 406 870 (60 ) 5,001 Total $ 1,278 $ 4,717 $ (1,545 ) $ 487 $ 870 $ (60 ) $ 5,747 (1) Following the initial application of IFRS 16, on January 1, 2019 , the Company recorded discounted operating lease commitment classified as a lease at the amount of $4,717 thousands with respect to office and storage spaces, vehicles and certain office equipment (i.e. printing and photocopying machines) at the amount of $4,023, $663 and $31 thousands, respectively. |
Schedule of Carrying Amount and Fair Value of Financial Instruments | Carrying Amount Fair Value December 31, December 31, 2019 2018 2019 2018 U.S. Dollars in thousands Financial liabilities Bank loans 746 1,140 754 1,139 Leases 5,001 138 5,583 136 Total Financial liabilities $ 5,747 $ 1,278 $ 6,337 $ 1,275 |
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 U.S. Dollars in December 31, 2019 Debt securities (corporate and government) measured at fair value through other comprehensive income $ 4,289 8,543 Derivatives instruments - 15 $ 4,289 $ 8,558 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 |
Schedule of Sensitivity Analysis for Market Risks | December 31, 2019 2018 U.S. Dollars in thousands Sensitivity test to changes in market price of listed Securities Gain (loss) from change: 5% increase in market price $ 642 $ 519 5% decrease in market price $ (642 ) $ (519 ) Sensitivity test to changes in foreign currency: Gain (loss) from change: 5% increase in NIS $ (24 ) $ (21 ) 5% decrease in NIS $ 24 $ 21 5% increase in Euro $ (552 ) $ (197 ) 5% decrease in Euro $ 552 $ 197 |
Schedule of Linkage Terms of Financial Liabilities by Groups of Financial Instruments | December 31, 2019 2018 U.S. Dollars in thousands In NIS: Bank loans measured at amortized cost $ 746 $ 1,140 Leases measured at amortized cost 4,973 - $ 5,719 $ 1,140 In USD: Leases measured at amortized cost $ 28 $ 138 |
EMPLOYEE BENEFIT LIABILITIES,_2
EMPLOYEE BENEFIT LIABILITIES, NET (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of defined benefit plans [abstract] | |
Schedule of Expenses Recognized in Comprehensive Income (Loss) | Expenses recognized in comprehensive income (loss): Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Current service cost $ 282 $ 292 $ 356 Interest expenses, net 24 25 23 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 (1 ) 3 (7 ) Total employee benefit expenses 305 320 372 Actual return on plan assets $ 158 $ 171 $ 119 |
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, 2019 2018 2017 U.S. Dollars in thousands Cost of revenues $ 201 $ 175 $ 211 Research and development 62 50 57 Selling and marketing 16 75 73 General and administrative 26 20 31 $ 305 $ 320 $ 372 |
Schedule of Plan Liabilities, Net | The plan liabilities, net: December 31, 2019 2018 U.S. Dollars in thousands Defined benefit obligation $ 5,058 $ 4,987 Fair value of plan assets (3,789 ) (4,200 ) Total liabilities, net $ 1,269 $ 787 |
Schedule of Changes in Present Value of Defined Benefit Obligation | Changes in the present value of defined benefit obligation 2019 2018 U.S. Dollars in thousands Balance at January 1, $ 4,987 $ 5,907 Interest costs 133 110 Current service cost 282 292 Benefits paid (1,180 ) (645 ) Demographic assumptions 40 (29 ) Financial assumptions 292 (223 ) Past Experience 108 (2 ) Currency Exchange 396 (423 ) Balance at December 31, $ 5,058 $ 4,987 |
Schedule of Changes in Fair Value of Plan Assets | 2019 2018 U.S. Dollars in thousands Balance at January 1, $ 4,200 $ 4,763 Expected return 108 85 Contributions by employer 179 182 Benefits paid (1,081 ) (564 ) Demographic assumptions (4 ) 5 Financial assumptions (2 ) (2 ) Past Experience 58 82 Current service cost due to the transfer of real yield from the compensation component to the royalties component in executive insurance policies before 2004 1 (3 ) Currency exchange 330 (348 ) Balance at December 31, $ 3,789 $ 4,200 |
Schedule of Principal Assumptions Underlying Defined Benefit Plan | The principal assumptions underlying the defined benefit plan 2019 2018 2017 % Discount rate of the plan liability 2.79 2.02 2.27 Future salary increases 3.1 3.6 4 |
EQUITY (Tables)
EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of classes of share capital [abstract] | |
Schedule of Share Capital | December 31, 2019 December 31, 2018 Authorized Outstanding Authorized Outstanding Ordinary shares of NIS 1 par value 70,000,000 40,353,101 70,000,000 40,295,078 Number of shares Balance as of January 1, 2018 40,262,819 Issue of shares - Exercise of options into shares 8,686 Exercise of restricted shares 23,573 Balance as of December 31, 2018 40,295,078 Issue of shares Exercise of options into shares 13,133 Exercise of restricted shares 44,890 Balance as of December 31, 2019 40,353,101 |
SHARE-BASED PAYMENT (Tables)
SHARE-BASED PAYMENT (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
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 2019 2018 2017 U.S. Dollar in thousands Cost of revenues $ 364 $ 401 $ 179 Research and development 254 224 138 Selling and marketing 63 51 48 General and administrative 482 272 118 Total share-based compensation $ 1,163 $ 948 $ 483 |
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: 2019 2018 2017 Number of Weighted Number of Weighted Number of Weighted In NIS In NIS In NIS Outstanding at beginning of year 2,445,597 29.99 2,572,372 32.47 2,487,236 35.20 Granted 443,800 20.64 617,825 19.02 458,950 21.10 Exercised (67,470 ) 32.30 (53,584 ) 15.77 (10,659 ) 18.19 Forfeited (485,373 ) 16.98 (691,016 ) 30.51 (363,155 ) 35.70 Outstanding at end of year 2,336,554 27.87 2,445,597 29.99 2,572,372 32.47 Exercisable at end of year 1,412,023 33.17 1,406,048 38.02 1,755,253 38.69 The weighted average remaining contractual life for the share options 3.39 3.63 3.22 |
Schedule of Number of RSs and Modification in Employee RSs | Number of RSs 2019 2018 2017 Outstanding at beginning of year 139,706 76,512 27,333 Granted 69,725 96,308 58,835 End of restriction period (18,643 ) (23,572 ) (7,656 ) Forfeited (44,892 ) (9,542 ) (2,000 ) Outstanding at end of year 145,896 139,706 76,512 The weighted average remaining contractual life for the restricted share 2.78 3.21 3.54 |
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: 2019 2018 2017 Dividend yield (%) - - - Expected volatility of the share prices (%) 23-41 25-39 37-45 Risk-free interest rate (%) 0.3 – 1.7 0.2-0.2.0 0.1-1.83 Contractual term of up to (years) 6.5 6.5 6.5 Exercise multiple 2 2 2 Weighted average share prices (NIS) 19.17-19.65 18.49-21.17 16.05-16.44 Expected average forfeiture rate (%) 2-6 1-5 1-5 |
TAXES ON INCOME (Tables)
TAXES ON INCOME (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of taxes on income [Abstract] | |
Schedule of Weighted Combination of Applicable Rates | Tax Exemption Period Reduced Tax Period Rate of Reduced Tax Percent of Foreign Ownership 2/10 years 5/0 years 25 % 0-25% 2/10 years 8/0 years 25 % 25-49% 2/10 years 8/0 years 20 % 49-74% 2/10 years 8/0 years 15 % 74-90% 2/10 years 8/0 years 10 % 90-100% |
Schedule of Deferred Taxes | Total U.S Dollars Balance at January 1, 2019 $ 2,048 Amount carried to profit and loss (726 ) Amount carried to other comprehensive income (11 ) Balance as of December 31, 2019 $ 1,311 |
Schedule of deferred tax liabilities and assets | Statements of financial position Statements of profit or loss December 31, Year ended December 31, 2019 2018 2019 2018 2017 U.S Dollars in thousands Deferred tax liabilities: Financial assets measured at fair value through other comprehensive income (32 ) (12 ) Revaluation of derivatives (4 ) Deferred tax assets: Carryforward tax losses 1,330 2,056 (726 ) (1,944 ) - Employee benefits 25 1 Issuance of sheers Revaluation of derivatives 3 Deferred tax income (expenses) (726 ) (1,944 ) Deferred tax assets, net $ 1,311 $ 2,048 |
Shedule of deferred taxes are reflected in the statement of financial position | December 31, 2019 2018 NIS in thousands Non-current assets $ 1,311 $ 2,048 |
Schedule of Current Taxes on Income | Year ended December 31, 2019 2018 2017 U.S. Dollars in thousands Current taxes $ - $ - $ 129 Deferred tax expenses (income) 726 (1,944 ) - Taxes in respect of prior years 4 (11 ) 140 Taxes on income $ 730 $ (1,955 ) $ 269 |
Schedule of Reconciliation of Taxes on Profit Loss | Year ended December 31, 2019 U.S. Dollars in thousands Gain before taxes on income $ 22,981 Statutory tax rate 23 % Tax calculated using the statutory tax rate 5,285 Tax benefit arising from preferred income tax rates by virtue of the Encouragement Law [ ] Temporary differences for which deferred taxes are initially recognized Prior year taxes 4 Tax on income $ 730 Effective tax rate 3.2 % 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, 2019 | |
Disclosure of supplementary information to the statements of comprehensive loss [abstract] | |
Schedule of Additional Information about Revenues | Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Revenues from major customers each of whom amount to 10% or more, of total revenues Customer A (1) $ 68,138 $ 63,788 $ 60,383 Customer B 16,369 11,779 - Customer C 14,454 - - $ 98,961 $ 75,567 $ 60,383 (1) For additional information regarding the aggregate amount of the transaction price allocated to the performance obligations that are unsatisfied, refer to note 17a. |
Schedule of Revenues Based on Location of Customers | Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands U.S.A $ 84,572 $ 75,331 $ 60,405 Israel 31,959 28,093 26,355 Europe 4,701 3,594 5,348 Latin America 3,792 3,994 5,248 Asia 2,067 3,336 4,979 Others 96 121 490 Total Revenue $ 127,187 $ 114,469 $ 102,825 |
Schedule of Income and Expenses | Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Cost of materials $ 69,766 $ 56,156 $ 41,179 Salary and related expenses 16,941 15,290 13,755 Subcontractors 4,451 3,633 3,995 Depreciation and amortization 2,991 2,859 2,504 Energy 1,551 1,426 1,202 Other manufacturing expenses 712 566 954 96,412 79,930 63,589 Decrease (increase) in inventories (18,962 ) (6,933 ) 7,148 Total Cost of goods sold $ 77,450 $ 72,997 $ 70,737 d. Research and development Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Salary and related expenses $ 5,897 $ 5,925 $ 6,537 Subcontractors 5,196 2,275 3,392 Materials and allocation of facility costs 966 1,131 1,597 Depreciation and amortization 663 159 120 Others 337 257 327 Total Research and development $ 13,059 $ 9,747 $ 11,973 e. Selling and marketing Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Salary and related expenses $ 1,467 1,647 1,470 Marketing support 103 121 95 Packing, shipping and delivery 504 477 607 Marketing and advertising 788 424 627 Registration and marketing fees 917 470 1,162 Others 591 491 437 Total Selling and marketing $ 4,370 $ 3,630 $ 4,398 f. General and administrative Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Salary and related expenses $ 3,475 $ 3,085 3,138 Employees welfare 1,296 1,151 2,182 Professional fees and public company expense 2,162 2,012 1,549 Depreciation, amortization and impairment 717 686 649 Communication and software services 799 675 554 Others 745 916 201 Total General and administrative $ 9,194 $ 8,525 $ 8,273 g. Financial expense(income) Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Financial income Interest income and gains from marketable securities $ 1,146 $ 830 $ 500 Financial expense Fees and interest paid to financial institutions 293 172 82 Financial income and (expense) Derivatives instruments measured at fair value (512 ) 504 (511 ) Translation differences of financial assets and liabilities (139 ) 98 (101 ) Bond securities measured at fair value (5 ) (178 ) (80 ) Total Financial expense(income) $ 197 $ 1,082 $ (274 ) |
INCOME (LOSS) PER SHARE (Tables
INCOME (LOSS) PER SHARE (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income (Loss) Per Share [abstract] | |
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, 2019 2018 2017 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 U.S. Dollars U.S. Dollars For the computation of basic income (loss) 40,320,888 $ 22,251 40,275,374 $ 22,296 37,970,697 $ 6,901 Effect of potential dilutive ordinary shares 260,739 - 170,043 - 74,400 - For the computation of diluted income (loss) 40,581,627 $ 22,251 40,445,417 $ 22,296 38,045,097 $ 6,901 |
OPERATING SEGMENTS (Tables)
OPERATING SEGMENTS (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of operating segments [abstract] | |
Schedule of Reporting on Operating Segments | Proprietary Products Distribution Total U.S. Dollars in thousands Year Ended December 31, 2019 Revenues $ 97,696 $ 29,491 $ 127,187 Gross profit $ 45,271 $ 4,466 $ 49,737 Unallocated corporate expenses (26,953 ) Finance income, net 197 Income before taxes on income $ 22,981 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 thousand Year Ended December 31, 2017 Revenues $ 79,559 $ 23,266 $ 102,825 Gross profit $ 28,224 $ 3,864 $ 32,088 Unallocated corporate expenses (26,644 ) Finance expense, net (274 ) Loss before taxes on income $ 7,170 |
BALANCES AND TRANSACTIONS WIT_2
BALANCES AND TRANSACTIONS WITH RELATED PARTIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of transactions between related parties [abstract] | |
Schedule of balances with related parties | Balances with related parties December 31, December 31, U.S. Dollars in thousands Other accounts payables $ 151 $ 336 Employee benefit liabilities, net $ - $ 80 Trade receivable $ - $ 1,135 |
Schedule of transactions with employed/directors that accounts as related parties | Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Salary and related expenses to those employed by the Company or on its behalf $ 311 $ 352 $ 460 Remuneration of directors not employed by the Company or on its behalf $ 363 $ 366 $ 107 Number of People to whom the Salary and remuneration Refer: Related and related parties employed by the Company or on its behalf 2 2 2 Directors not employed by the Company 7 8 2 Total Directors employed and not employed by the Company 9 10 4 |
Schedule of transactions with key executive personnel | Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Short-term benefits $ 3,157 $ 2,766 $ 2,959 Share-based payment 188 285 310 Other long-term benefits - - 6 Total $ 3,345 $ 3,051 $ 3,275 |
Schedule of transactions with related parties | Year Ended December 31, 2019 2018 2017 U.S. Dollars in thousands Revenues $ 2,566 $ 3,529 $ 3,455 Cost of Goods Sold $ 13 $ - $ - Selling and marketing expenses $ 257 $ 313 $ 121 General and administrative expenses $ 447 $ 408 $ 446 |
GENERAL (Narrative) (Details)
GENERAL (Narrative) (Details) - Glassia [Member] | 12 Months Ended |
Dec. 31, 2019 | |
Statement Line Items [Line Items] | |
Agreement on initiation of sales, description | The agreement, upon initiation of sales of Glassia manufactured by Takeda, Takeda will pay royalties to the Company at a rate of 12% on net sales through August 2025, and at a rate of 6% thereafter until 2040, with a minimum of $5 million annually, for each of the years from 2022 to 2040. |
Subsidiary ownership interest, percent | 74.00% |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Narrative) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Disclosure of significant accounting policies [abstract] | ||
Allowance for doubtful accounts | $ 67 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES (Schedule of Depreciation of right-of-use asset) (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Land and Buildings [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 |
Mainly % | 10 |
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 %) | 20-33 |
Mainly % | 33 |
Office equipment (i.e. printing and photocopying machines) [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 %) | 20 |
Mainly % | 20 |
SIGNIFICANT ACCOUNTING POLICI_6
SIGNIFICANT ACCOUNTING POLICIES (Schedule of Useful Lives for Property, Plant and Equipment) (Details) | 12 Months Ended | |
Dec. 31, 2019 | ||
Buildings [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. |
SIGNIFICANT ACCOUNTING POLICI_7
SIGNIFICANT ACCOUNTING POLICIES (Schedule of initial adoption of the Standard) (Details 2) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | |
Non-current assets: | |||
Right-of-use assets | $ 4,022 | [1] | |
Shareholder's Equity | |||
Accumulated deficit | $ (61,073) | (83,024) | |
According to the previous accounting policy [Member] | |||
Non-current assets: | |||
Right-of-use assets | |||
Liabilities | |||
Current maturities of leases | 110 | ||
Leases | 28 | ||
Other accounts payables | 5,261 | ||
Shareholder's Equity | |||
Accumulated deficit | 112,376 | ||
Difference [Member] | |||
Non-current assets: | |||
Right-of-use assets | 4,161 | ||
Liabilities | |||
Current maturities of leases | 810 | ||
Leases | 3,907 | ||
Other accounts payables | (255) | ||
Shareholder's Equity | |||
Accumulated deficit | (300) | ||
According to the current accounting policy [Member] | |||
Non-current assets: | |||
Right-of-use assets | 4,161 | ||
Liabilities | |||
Current maturities of leases | 920 | ||
Leases | 3,935 | ||
Other accounts payables | 5,006 | ||
Shareholder's Equity | |||
Accumulated deficit | $ 112,076 | ||
[1] | Following the initial application of IFRS 16, on January 1, 2019 , the Company recorded operating lease commitment classified as a lease liability at the amount of $4,717 thousands with respect to office and storage spaces, vehicles and certain office equipment (i.e. printing and photocopying machines) at the amount of $4,022, $663 and $32 thousands, respectively. Also refer to Note 2ii |
SIGNIFICANT ACCOUNTING POLICI_8
SIGNIFICANT ACCOUNTING POLICIES (Schedule of lease liabilities) (Details 2) - USD ($) $ in Thousands | Dec. 31, 2018 | Jan. 31, 2018 | |
Disclosure of detailed information about property, plant and equipment [line items] | |||
Future minimum payments for non-cancellable leases as per IAS 17 according to the financial statements as of December 31, 2018 | $ 5,434 | ||
Discounted operating lease commitment at January 1, 2019 | 4,685 | ||
Add: Leases of other equipment | 32 | ||
Leases that were previously identified as leases under IAS 17 | 138 | ||
Lease liabilities as at January 1, 2019 | $ 4,855 | ||
Top of range [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Weighted average incremental borrowing rate as at January 1, 2019 (1) | [1] | 3.06% | |
Bottom of range [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Weighted average incremental borrowing rate as at January 1, 2019 (1) | [1] | 4.60% | |
[1] | The weighted average incremental borrowing rate was evaluated based on credit risk, terms of the leases and other economic variables. The weighted average incremental borrowing rate was used to discount future lease payments in the calculation of the lease liability on the date of initial adoption of the Standard. |
CASH AND CASH EQUIVALENTS (Narr
CASH AND CASH EQUIVALENTS (Narrative) (Details) - Fixed interest rate [Member] | Dec. 31, 2019 | Dec. 31, 2018 |
Bottom of range [Member] | ||
Disclosure of financial assets [line items] | ||
Interest rate on deposits | 2.00% | |
Top of range [Member] | ||
Disclosure of financial assets [line items] | ||
Interest rate on deposits | 2.40% | |
NIS [Member] | ||
Disclosure of financial assets [line items] | ||
Interest rate on deposits | 0.02% | 0.16% |
CASH AND CASH EQUIVALENTS (Sche
CASH AND CASH EQUIVALENTS (Schedule of Cash and Cash Equivalents) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash and cash equivalents [abstract] | |||||
Cash and deposits for immediate withdrawal | $ 25,559 | $ 18,018 | |||
Cash equivalents in USD deposits | [1] | 17,017 | |||
Cash equivalents in NIS deposits | [2] | 86 | 75 | ||
Total Cash and Cash Equivalents | $ 42,662 | $ 18,093 | $ 12,681 | $ 9,968 | |
[1] | The deposits bear interest of 2.0%-2.4% per year, as of December 31, 2019. | ||||
[2] | The deposits bear interest of 0.02% per year, as of December 31, 2019 and 0.16% per year, as of December 31, 2018. |
SHORT-TERM INVESTMENTS (Narrati
SHORT-TERM INVESTMENTS (Narrative) (Details) - Fixed interest rate [Member] | Dec. 31, 2019 | Dec. 31, 2018 |
Bottom of range [Member] | ||
Disclosure of financial assets [line items] | ||
Interest rate on deposits | 2.50% | 2.60% |
Top of range [Member] | ||
Disclosure of financial assets [line items] | ||
Interest rate on deposits | 3.30% | 3.50% |
SHORT-TERM INVESTMENTS (Schedul
SHORT-TERM INVESTMENTS (Schedule of Short-term Investments) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure of short-term investments [abstract] | |||
Fair value through other comprehensive income | $ 12,832 | $ 10,325 | |
Bank deposits in USD | [1] | 18,413 | 22,174 |
Total Short-Term Investments | $ 31,245 | $ 32,499 | |
[1] | The deposits bear interest of 2.5%-3.3% and 2.6%-3.5% per year, as of December 31, 2019 and 2018, respectively. |
TRADE RECEIVABLES, NET (Schedul
TRADE RECEIVABLES, NET (Schedule of Trade Receivables, Net) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Open accounts: | ||
In NIS | $ 8,357 | $ 6,780 |
In USD | 14,920 | 20,814 |
Total open accounts | 23,277 | 27,594 |
Checks receivable | 80 | |
Trade receivables, gross | 23,277 | 27,674 |
Less allowance for doubtful accounts | (67) | |
Total Trade receivables, net | $ 23,210 | $ 27,674 |
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, 2019 | Dec. 31, 2018 | |
Disclosure of provision matrix [line items] | |||
Trade receivables | $ 23,277 | $ 27,594 | |
Past due trade receivables with aging of 91-120 Days [Member] | |||
Disclosure of provision matrix [line items] | |||
Trade receivables | 65 | 6 | |
Past due trade receivables with aging of 61-90 Days [Member] | |||
Disclosure of provision matrix [line items] | |||
Trade receivables | 33 | 15 | |
Past due trade receivables with aging of 31-60 Days [Member] | |||
Disclosure of provision matrix [line items] | |||
Trade receivables | 25 | 15 | |
Past due trade receivables with aging of Up to 30 Days [Member] | |||
Disclosure of provision matrix [line items] | |||
Trade receivables | 469 | 337 | |
Neither past due nor impaired [Member] | |||
Disclosure of provision matrix [line items] | |||
Trade receivables | 22,617 | 27,215 | |
Past due trade receivables with aging of Over 121 days [Member] | |||
Disclosure of provision matrix [line items] | |||
Trade receivables | $ 68 | [1] | $ 6 |
[1] | $67 thousands of the over 121 days balance is provided for as allowance for doubtful accounts. |
TRADE RECEIVABLES, NET (Narrati
TRADE RECEIVABLES, NET (Narrative) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Trade and other current receivables [abstract] | ||
Allowance for doubtful accounts | $ 67 |
OTHER ACCOUNTS RECEIVABLES (Sch
OTHER ACCOUNTS RECEIVABLES (Schedule of Other Accounts Receivables) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Disclosure of other accounts receivables [abstract] | ||
Government authorities | $ 1,838 | $ 1,552 |
Prepaid expenses | 1,240 | 1,086 |
Accrued interest | 70 | 66 |
Accrued income | 101 | 193 |
Materials for clinical trials and inventory designated for R&D activities | 399 | |
Other | 8 | 12 |
Derivatives financial instruments mainly measured at fair value through other comprehensive income | 15 | |
Total Other Accounts Receivables | $ 3,272 | $ 3,308 |
INVENTORIES (Narrative) (Detail
INVENTORIES (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Classes of current inventories [abstract] | ||
Impairment of inventories | $ 334 | $ 61 |
INVENTORIES (Schedule of Invent
INVENTORIES (Schedule of Inventories) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Classes of current inventories [abstract] | ||
Finished products | $ 12,016 | $ 7,023 |
Purchased products | 10,412 | 4,813 |
Work in progress | 9,043 | 4,792 |
Raw materials | 11,702 | 12,688 |
Total Inventories | $ 43,173 | $ 29,316 |
PROPERTY, PLANT AND EQUIPMENT_2
PROPERTY, PLANT AND EQUIPMENT (Narrative) (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019USD ($)m² | Dec. 31, 2018USD ($) | |
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 | 2058 | |
Extension option for lease 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 | $ | $ 493 | $ 514 |
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, 2019 | Dec. 31, 2018 | ||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Balance | $ 25,004 | ||||
Depreciation of right-of-use assets | 956 | ||||
Balance | 24,550 | $ 25,004 | |||
Cost [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Balance | 67,272 | 65,862 | |||
Additions | 3,116 | 3,614 | |||
Sale and write-off | (539) | (2,204) | |||
Balance | 69,849 | 67,272 | |||
Accumulated Depreciation [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Balance | 42,268 | 40,684 | |||
Depreciation and impairment | 3,703 | ||||
Depreciation | 3,563 | ||||
Depreciation of right-of-use assets | 956 | ||||
Sale and write-off | (531) | (2,119) | |||
Balance | 45,299 | 42,268 | |||
Depreciated cost as of December 31, 2019 | 24,550 | 25,004 | |||
Land and Buildings [Member] | Cost [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Balance | 29,167 | [1] | 28,399 | [2] | |
Additions | 1,101 | [1] | 806 | [2] | |
Sale and write-off | [1] | (38) | [2] | ||
Balance | [1] | 30,268 | 29,167 | ||
Land and Buildings [Member] | Accumulated Depreciation [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Balance | 15,076 | [1] | 13,916 | [2] | |
Depreciation and impairment | [2] | 1,198 | |||
Depreciation | [1] | 1,232 | |||
Sale and write-off | [1] | (38) | [2] | ||
Balance | [1] | 16,308 | 15,076 | ||
Depreciated cost as of December 31, 2019 | 13,960 | [1] | 14,091 | [2] | |
Machinery and equipment [Member] | Cost [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Balance | 30,386 | [1] | 29,602 | [2] | |
Additions | 1,302 | [1] | 2,331 | [2] | |
Sale and write-off | (148) | [1] | (1,547) | [2] | |
Balance | [1] | 31,540 | 30,386 | ||
Machinery and equipment [Member] | Accumulated Depreciation [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Balance | 21,679 | [1] | 21,430 | [2] | |
Depreciation and impairment | [2] | 1,711 | |||
Depreciation | [1] | 1,575 | |||
Sale and write-off | (142) | [1] | (1,462) | [2] | |
Balance | [1] | 23,112 | 21,679 | ||
Depreciated cost as of December 31, 2019 | 8,428 | [1] | 8,707 | [2] | |
Vehicles [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Depreciation of right-of-use assets | 517 | ||||
Vehicles [Member] | Cost [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Balance | 85 | 66 | |||
Additions | 19 | ||||
Sale and write-off | |||||
Balance | 85 | 85 | |||
Vehicles [Member] | Accumulated Depreciation [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Balance | 63 | 59 | |||
Depreciation and impairment | 4 | ||||
Depreciation | 5 | ||||
Depreciation of right-of-use assets | 516 | ||||
Sale and write-off | |||||
Balance | 68 | 63 | |||
Depreciated cost as of December 31, 2019 | 17 | 22 | |||
Computers, software, equipment and office furniture [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Depreciation of right-of-use assets | 6 | ||||
Computers, software, equipment and office furniture [Member] | Cost [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Balance | 6,493 | 6,522 | |||
Additions | 699 | 590 | |||
Sale and write-off | (391) | (619) | |||
Balance | 6,801 | 6,493 | |||
Computers, software, equipment and office furniture [Member] | Accumulated Depreciation [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Balance | 5,247 | 5,194 | |||
Depreciation and impairment | 672 | ||||
Depreciation | 636 | ||||
Depreciation of right-of-use assets | 6 | ||||
Sale and write-off | (390) | (619) | |||
Balance | 5,493 | 5,247 | |||
Depreciated cost as of December 31, 2019 | 1,308 | 1,246 | |||
Leasehold improvements [Member] | Cost [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Balance | 1,141 | 1,273 | |||
Additions | 14 | (132) | |||
Sale and write-off | |||||
Balance | 1,155 | 1,141 | |||
Leasehold improvements [Member] | Accumulated Depreciation [Member] | |||||
Disclosure of detailed information about property, plant and equipment [line items] | |||||
Balance | 203 | 85 | |||
Depreciation and impairment | 118 | ||||
Depreciation | 115 | ||||
Depreciation of right-of-use assets | |||||
Sale and write-off | |||||
Balance | 318 | 203 | |||
Depreciated cost as of December 31, 2019 | $ 837 | $ 938 | |||
[1] | Including labor costs charged in 2019 to the cost of facilities, machinery and equipment in the amount of $493 thousands. | ||||
[2] | Including labor costs charged in 2018 to the cost of facilities, machinery and equipment in the amount of $514 thousands. |
PROPERTY, PLANT AND EQUIPMENT_4
PROPERTY, PLANT AND EQUIPMENT (Schedule of Capitalized Leasing Rights of Land from Israel Land Administration) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Disclosure of detailed information about property, plant and equipment [abstract] | ||
Under finance lease | $ 992 | $ 1,004 |
OTHER LONG TERM ASSETS (Schedul
OTHER LONG TERM ASSETS (Schedule of Other Long Term Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | |
Miscellaneous non-current assets [abstract] | |||
Distribution right | [1] | $ 298 | $ 123 |
Long term pre-paid expenses | 54 | 51 | |
Total Other Long Term Assets | $ 352 | $ 174 | |
[1] | During 2018 and 2019 the Company entered into agreements for the distribution right of certain therapeutic products to be distributed in Israel, subject to Israeli Ministry of Health ("IL MOH") marketing approval. Pursuant to the agreements, 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. As of December 31, 2019 no amortization was recorded. |
TRADE PAYABLES (Schedule of Tra
TRADE PAYABLES (Schedule of Trade Payables) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Trade and other current payables [abstract] | ||
Open debts mainly in USD | $ 7,847 | $ 7,256 |
Open debts in EUR | 11,426 | 4,206 |
Open debts in NIS | 5,557 | 5,822 |
Sub-Total | 24,830 | 17,284 |
Notes payable | 1 | |
Total Trade Payables | $ 24,830 | $ 17,285 |
OTHER ACCOUNTS PAYABLES (Schedu
OTHER ACCOUNTS PAYABLES (Schedule of Other Accounts Payables) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Disclosure of other accounts payable [Abstract] | ||
Employees and payroll accruals | $ 5,669 | $ 4,708 |
Derivatives financial instruments mainly measured at fair value through other comprehensive income | 64 | |
Accrued Expenses and Others | 142 | 489 |
Total Other Accounts Payables | $ 5,811 | $ 5,261 |
LOANS AND LEASES (Narrative) (D
LOANS AND LEASES (Narrative) (Details) | Dec. 31, 2019 |
Bottom of range [Member] | |
Disclosure of detailed information about borrowings [line items] | |
Interest rate | 3.15% |
Weighted average rate | 3.06% |
Top of range [Member] | |
Disclosure of detailed information about borrowings [line items] | |
Interest rate | 3.55% |
Weighted average rate | 4.60% |
LOANS AND LEASES (Schedule of L
LOANS AND LEASES (Schedule of Loans and Leases) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Disclosure of loans and capital leases [abstract] | ||
Bank loans | $ 746 | $ 688 |
Less current maturities of bank loans | 257 | 452 |
Total Long term bank loans | $ 257 | $ 688 |
LOANS AND LEASES (Schedule of R
LOANS AND LEASES (Schedule of Right-of-use assets composition and Changes in leas liabilities) (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019USD ($) | ||
Statement Line Items [Line Items] | ||
Beginning balance | [1] | |
Additions to right -of -use assets | 874 | |
Write-off | (57) | |
Depreciation expense | (956) | |
Exchange rate differences | ||
Repayment of lease liabilities | ||
Ending balance | 4,022 | |
Rented Offices [Member] | ||
Statement Line Items [Line Items] | ||
Beginning balance | 3,466 | [1] |
Additions to right -of -use assets | ||
Write-off | ||
Depreciation expense | (433) | |
Exchange rate differences | ||
Repayment of lease liabilities | ||
Ending balance | 3,033 | |
Vehicles [Member] | ||
Statement Line Items [Line Items] | ||
Beginning balance | 663 | [1] |
Additions to right -of -use assets | 874 | |
Write-off | (57) | |
Depreciation expense | (517) | |
Exchange rate differences | ||
Repayment of lease liabilities | ||
Ending balance | 989 | |
Computer Equipment [Member] | ||
Statement Line Items [Line Items] | ||
Beginning balance | 32 | [1] |
Additions to right -of -use assets | ||
Write-off | ||
Depreciation expense | (6) | |
Exchange rate differences | ||
Repayment of lease liabilities | ||
Ending balance | 26 | |
Lease liabilities [member] | ||
Statement Line Items [Line Items] | ||
Beginning balance | 4,855 | [1],[2] |
Additions to right -of -use assets | 870 | [2] |
Write-off | (60) | [2] |
Depreciation expense | [2] | |
Exchange rate differences | 406 | [2] |
Repayment of lease liabilities | (1,070) | [2] |
Ending balance | $ 5,001 | [2] |
[1] | Following the initial application of IFRS 16, on January 1, 2019 , the Company recorded operating lease commitment classified as a lease liability at the amount of $4,717 thousands with respect to office and storage spaces, vehicles and certain office equipment (i.e. printing and photocopying machines) at the amount of $4,022, $663 and $32 thousands, respectively. Also refer to Note 2ii | |
[2] | In 2019, interest expenses of lease liability amounted in $212 thousands. |
LOANS AND LEASES (Schedule of P
LOANS AND LEASES (Schedule of Profit or Loss and Other Comprehensive Income) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Disclosure of loans and capital leases [abstract] | |
Operating lease expense | $ 1,182 |
Depreciation of right of use assets | 956 |
Operating income | 226 |
Finance expense | (212) |
Net Income (loss) | $ 14 |
LOANS AND LEASES (Schedule of c
LOANS AND LEASES (Schedule of cash flow impact) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Statement Line Items [Line Items] | |||
Cash flows from operating activities | $ 27,571 | $ 10,546 | $ 3,608 |
Cash flows from financing activities | (1,530) | $ (587) | $ 15,320 |
Previously stated [member] | |||
Statement Line Items [Line Items] | |||
Cash flows from operating activities | 26,501 | ||
Cash flows from financing activities | (460) | ||
Difference [Member] | |||
Statement Line Items [Line Items] | |||
Cash flows from operating activities | 1,070 | ||
Cash flows from financing activities | $ (1,070) |
LOANS AND LEASES (Schedule of M
LOANS AND LEASES (Schedule of Maturity analysis of the Company’s lease liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Statement Line Items [Line Items] | ||
Lease liabilities (including interest) | $ 5,711 | $ 1,331 |
Less than one year [Member] | ||
Statement Line Items [Line Items] | ||
Lease liabilities (including interest) | 1,198 | 595 |
1 to 2 [Member] | ||
Statement Line Items [Line Items] | ||
Lease liabilities (including interest) | 1,000 | 495 |
2 to 3 [Member] | ||
Statement Line Items [Line Items] | ||
Lease liabilities (including interest) | 797 | 209 |
3 to 5 [Member] | ||
Statement Line Items [Line Items] | ||
Lease liabilities (including interest) | 1,352 | $ 32 |
6 and thereafter [Member] | ||
Statement Line Items [Line Items] | ||
Lease liabilities (including interest) | $ 1,364 |
FINANCIAL INSTRUMENTS (Narrativ
FINANCIAL INSTRUMENTS (Narrative) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Disclosure of detailed information about hedges [line items] | |
Discounted operating lease | $ 4,717 |
Office and storage spaces [Member] | |
Disclosure of detailed information about hedges [line items] | |
Discounted operating lease | 4,023 |
Vehicles [Member] | |
Disclosure of detailed information about hedges [line items] | |
Discounted operating lease | 663 |
Office equipment [Member] | |
Disclosure of detailed information about hedges [line items] | |
Discounted operating lease | 31 |
Cash flow hedges [Member] | |
Disclosure of detailed information about hedges [line items] | |
Fair value of derivative instrument designated as hedging instrument | 13 |
Open transactions for derivative instruments designated as hedging | 371 |
Net unrecognized loss recorded in other comprehensive loss | 65 |
Derivatives instruments not designated as hedging [Member] | |
Disclosure of detailed information about hedges [line items] | |
Fair value of the derivative instruments | 2 |
Open transactions for derivative instruments not designated as hedging | $ 6,316 |
FINANCIAL INSTRUMENTS (Schedule
FINANCIAL INSTRUMENTS (Schedule of Classification of Financial Assets and Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Disclosure of detailed information about financial instruments [line items] | ||
Financial assets | $ 73,920 | $ 50,592 |
Financial liabilities | 5,747 | 1,342 |
Financial assets at fair value through profit or loss: Foreign exchange forward contracts [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Financial liabilities | 6 | |
Financial liabilities at fair value through other comprehensive income: Cash flow hedges [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Financial liabilities | 58 | |
Financial liabilities measured at amortized cost: Bank loans [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Financial liabilities | 746 | 1,140 |
Financial liabilities measured at amortized cost: Leases [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Financial liabilities | 5,001 | 138 |
Financial liabilities at amortised cost, class [member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Financial liabilities | 5,747 | 1,278 |
Financial assets at fair value through profit or loss: Foreign exchange forward contracts [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Financial assets | 2 | |
Financial assets at fair value through other comprehensive income: Cash flow hedges [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Financial assets | 13 | |
Financial assets at fair value through other comprehensive income: Marketable debt securities [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Financial assets | 12,832 | 10,324 |
Financial assets at cost: Cash and cash equivalent [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Financial assets | 42,662 | 18,093 |
Financial assets at cost: Short term bank deposits [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Financial assets | 18,413 | 22,175 |
Total assets measured at fair value through other comprehensive income [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Financial assets | $ 73,920 | $ 50,592 |
FINANCIAL INSTRUMENTS (Schedu_2
FINANCIAL INSTRUMENTS (Schedule of Financial Liabilities based on Contractual Undiscounted Payments) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Disclosure of maturity analysis for derivative financial liabilities [line items] | ||
Trade payables | $ 24,830 | $ 17,285 |
Other accounts payables | 5,811 | 5,261 |
bank loans (including interest) | 767 | |
Long term bank loans and leases (including interest) | 5,711 | 1,331 |
Financial liabilities | 37,119 | 23,877 |
Less than one year [Member] | ||
Disclosure of maturity analysis for derivative financial liabilities [line items] | ||
Trade payables | 24,830 | 17,285 |
Other accounts payables | 5,811 | 5,261 |
bank loans (including interest) | 506 | |
Long term bank loans and leases (including interest) | 1,198 | 595 |
Financial liabilities | 32,345 | 23,141 |
1 to 2 [Member] | ||
Disclosure of maturity analysis for derivative financial liabilities [line items] | ||
Trade payables | ||
Other accounts payables | ||
bank loans (including interest) | 227 | |
Long term bank loans and leases (including interest) | 1,000 | 495 |
Financial liabilities | 1,227 | 495 |
2 to 3 [Member] | ||
Disclosure of maturity analysis for derivative financial liabilities [line items] | ||
Trade payables | ||
Other accounts payables | ||
bank loans (including interest) | 34 | |
Long term bank loans and leases (including interest) | 797 | 209 |
Financial liabilities | 831 | 209 |
3 to 5 [Member] | ||
Disclosure of maturity analysis for derivative financial liabilities [line items] | ||
Trade payables | ||
Other accounts payables | ||
bank loans (including interest) | ||
Long term bank loans and leases (including interest) | 1,352 | 32 |
Financial liabilities | 1,352 | $ 32 |
6 and thereafter [Member] | ||
Disclosure of maturity analysis for derivative financial liabilities [line items] | ||
Trade payables | ||
Other accounts payables | ||
bank loans (including interest) | ||
Long term bank loans and leases (including interest) | 1,364 | |
Financial liabilities | $ 1,364 |
FINANCIAL INSTRUMENTS (Schedu_3
FINANCIAL INSTRUMENTS (Schedule of Changes in Liabilities Arising From Financing Activities) (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019USD ($) | ||
Disclosure of reconciliation of liabilities arising from financing activities [line items] | ||
Beginning | $ 1,278 | |
Cumulative effect of initially applying IFRS 16 | 4,717 | [1] |
Payments | (1,545) | |
Foreign exchange movement | 487 | |
New loans and leases | 870 | |
Write off | (60) | |
Ending | 5,747 | |
Bank loans [Member] | ||
Disclosure of reconciliation of liabilities arising from financing activities [line items] | ||
Beginning | 1,140 | |
Cumulative effect of initially applying IFRS 16 | [1] | |
Payments | (475) | |
Foreign exchange movement | 81 | |
New loans and leases | ||
Write off | ||
Ending | 746 | |
Leases [Member] | ||
Disclosure of reconciliation of liabilities arising from financing activities [line items] | ||
Beginning | 138 | |
Cumulative effect of initially applying IFRS 16 | 4,717 | [1] |
Payments | (1,070) | |
Foreign exchange movement | 406 | |
New loans and leases | 870 | |
Write off | (60) | |
Ending | $ 5,001 | |
[1] | Following the initial application of IFRS 16, on January 1, 2019 , the Company recorded discounted operating lease commitment classified as a lease at the amount of $4,717 thousands with respect to office and storage spaces, vehicles and certain office equipment (i.e. printing and photocopying machines) at the amount of $4,023, $663 and $31 thousands, respectively. |
FINANCIAL INSTRUMENTS (Schedu_4
FINANCIAL INSTRUMENTS (Schedule of Carrying Amount and Fair Value of Financial Instruments) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Financial liabilities | ||
Financial liabilities Carrying Amount | $ 5,747 | $ 1,342 |
Financial liabilities Fair Value | 6,337 | 1,275 |
Leases [Member] | ||
Financial liabilities | ||
Financial liabilities Carrying Amount | 5,001 | 138 |
Financial liabilities Fair Value | 5,583 | 136 |
Bank loans [Member] | ||
Financial liabilities | ||
Financial liabilities Carrying Amount | 746 | 1,140 |
Financial liabilities Fair Value | $ 754 | $ 1,139 |
FINANCIAL INSTRUMENTS (Schedu_5
FINANCIAL INSTRUMENTS (Schedule of Classification of Financial Instruments by Fair Value Hierarchy) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Disclosure of financial assets [line items] | ||
Financial liabilities measured at fair value | $ 6,337 | $ 1,275 |
Level 1 [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | 4,289 | 1,588 |
Level 1 [Member] | Derivatives instruments [Member] | ||
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 | 8,558 | 8,672 |
Level 2 [Member] | Derivatives instruments [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | 15 | (64) |
Debt securities (corporate and government) [Member] | Level 1 [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | 4,289 | 1,588 |
Debt securities (corporate and government) [Member] | Level 2 [Member] | ||
Disclosure of financial assets [line items] | ||
Financial assets measured at fair value | $ 8,543 | $ 8,736 |
FINANCIAL INSTRUMENTS (Schedu_6
FINANCIAL INSTRUMENTS (Schedule of Sensitivity Test) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
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 | $ 642 | $ 519 |
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 | (642) | (519) |
5% increase in NIS [Member] | ||
Sensitivity test to changes in foreign currency: | ||
Gain (loss) from sensitivity test to changes in foreign currency | (24) | (21) |
5% decrease in NIS [Member] | ||
Sensitivity test to changes in foreign currency: | ||
Gain (loss) from sensitivity test to changes in foreign currency | 24 | 21 |
5% increase in Euro [Member] | ||
Sensitivity test to changes in foreign currency: | ||
Gain (loss) from sensitivity test to changes in foreign currency | (552) | (197) |
5% decrease in Euro [Member] | ||
Sensitivity test to changes in foreign currency: | ||
Gain (loss) from sensitivity test to changes in foreign currency | $ 552 | $ 197 |
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, 2019USD ($) | Dec. 31, 2019ILS (₪) | Dec. 31, 2018USD ($) | Dec. 31, 2018ILS (₪) |
NIS [Member] | ||||
In NIS and USD: | ||||
Linkage terms of financial liabilities by groups of financial instruments pursuant to IFRS 9 | ₪ 5,719 | ₪ 1,140 | ||
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 | 746 | 1,140 | ||
Leases measured at amortized cost [Member] | ||||
In NIS and USD: | ||||
Linkage terms of financial liabilities by groups of financial instruments pursuant to IFRS 9 | $ | $ 28 | $ 138 | ||
Leases 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 | ₪ 4,973 |
EMPLOYEE BENEFIT LIABILITIES,_3
EMPLOYEE BENEFIT LIABILITIES, NET (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of sensitivity analysis for actuarial assumptions [line items] | |||
Expenses for defined benefit deposit | $ 1,102 | $ 992 | $ 884 |
Expected salary growth [Member] | |||
Disclosure of sensitivity analysis for actuarial assumptions [line items] | |||
Increase (decrease) in defined benefit obligation from a 1% increase in actuarial assumption | 326 | ||
Increase (decrease) in defined benefit obligation from a 1% decrease in actuarial assumption | 276 | ||
Discount rates [Member] | |||
Disclosure of sensitivity analysis for actuarial assumptions [line items] | |||
Increase (decrease) in defined benefit obligation from a 1% increase in actuarial assumption | 288 | ||
Increase (decrease) in defined benefit obligation from a 1% decrease in actuarial assumption | $ 343 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of defined benefit plans [abstract] | |||
Current service cost | $ 282 | $ 292 | $ 356 |
Interest expenses, net | 24 | 25 | 23 |
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 | (1) | 3 | (7) |
Total employee benefit expenses | 305 | 320 | 372 |
Actual return on plan assets | $ 158 | $ 171 | $ 119 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of defined benefit plans [line items] | |||
Total employee benefit expenses | $ 305 | $ 320 | $ 372 |
Cost of revenues [Member] | |||
Disclosure of defined benefit plans [line items] | |||
Total employee benefit expenses | 201 | 175 | 211 |
Research and development [Member] | |||
Disclosure of defined benefit plans [line items] | |||
Total employee benefit expenses | 62 | 50 | 57 |
Selling and marketing [Member] | |||
Disclosure of defined benefit plans [line items] | |||
Total employee benefit expenses | 16 | 75 | 73 |
General and administrative [Member] | |||
Disclosure of defined benefit plans [line items] | |||
Total employee benefit expenses | $ 26 | $ 20 | $ 31 |
EMPLOYEE BENEFIT LIABILITIES,_6
EMPLOYEE BENEFIT LIABILITIES, NET (Schedule of Plan Liabilities, Net) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Disclosure of defined benefit plans [abstract] | ||
Defined benefit obligation | $ 5,058 | $ 4,987 |
Fair value of plan assets | (3,789) | (4,200) |
Total liabilities, net | $ 1,269 | $ 787 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of net defined benefit liability (asset) [line items] | |||
Interest costs | $ 24 | $ 25 | $ 23 |
Current service cost | 282 | 292 | 356 |
Defined Benefit Obligation [Member] | |||
Disclosure of net defined benefit liability (asset) [line items] | |||
Balance at January 1, | 4,987 | 5,907 | |
Interest costs | 133 | 110 | |
Current service cost | 282 | 292 | |
Benefits paid | (1,180) | (645) | |
Demographic assumptions | 40 | (29) | |
Financial assumptions | 292 | (223) | |
Past Experience | 108 | (2) | |
Currency Exchange | 396 | (423) | |
Balance at December 31, | $ 5,058 | $ 4,987 | $ 5,907 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of net defined benefit liability (asset) [line items] | |||
Balance at January 1, | $ 4,200 | ||
Expected return | 158 | $ 171 | $ 119 |
Current service cost due to the transfer of real yield from the compensation component to the royalties component in executive insurance policies before 2004 | (1) | 3 | (7) |
Balance at December 31, | 3,789 | 4,200 | |
Plan assets [Member] | |||
Disclosure of net defined benefit liability (asset) [line items] | |||
Balance at January 1, | 4,200 | 4,763 | |
Expected return | 108 | 85 | |
Contributions by employer | 179 | 182 | |
Benefits paid | (1,081) | (564) | |
Demographic assumptions | (4) | 5 | |
Financial assumptions | (2) | (2) | |
Past Experience | 58 | 82 | |
Current service cost due to the transfer of real yield from the compensation component to the royalties component in executive insurance policies before 2004 | 1 | (3) | |
Currency Exchange | 330 | (248) | |
Balance at December 31, | $ 3,789 | $ 4,200 | $ 4,763 |
EMPLOYEE BENEFIT LIABILITIES,_9
EMPLOYEE BENEFIT LIABILITIES, NET (Schedule of Principal Assumptions Underlying Defined Benefit Plan) (Details) | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Disclosure of defined benefit plans [abstract] | |||
Discount rate of the plan liability | 2.79% | 2.02% | 2.27% |
Future salary increases | 3.10% | 3.60% | 4.00% |
CONTINGENT LIABILITIES AND CO_2
CONTINGENT LIABILITIES AND COMMITMENTS (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Jul. 31, 2019 | Aug. 23, 2010 | Dec. 31, 2019 | |
Disclosure of contingent liabilities [line items] | |||
Distribution agreement, description | The Company projects that total revenues from sales of Glassia to Takeda for the year 2020 will be approximately $65 million and for the year 2021 between $25 million to $50 million. See note 22a for information regarding 2019 revenues from sales to Takeda. | ||
Unpaid balance of millstone payments | $ 5,500 | ||
Baxter Healthcare Corporation [Member] | |||
Disclosure of contingent liabilities [line items] | |||
Agreement term | 30 years | ||
Agreement payment amount | $ 45,000 | ||
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 | $ 5,000 | ||
Amount received from Distribution Agreement | 39,500 | ||
Maximum cost of experiment with Glassia | $ 10,000 | ||
Operating lease agreements [Member] | |||
Disclosure of contingent liabilities [line items] | |||
License agreement, description | The Company will be entitled to royalty payments in a rate of 12% on net sales of Glassia through August 2025, and at a rate of 6% thereafter until 2040, with a minimum of $5 million annually. | ||
Patents [Member] | |||
Disclosure of contingent liabilities [line items] | |||
Agreements expiration date | 15 years | ||
Master Clinical Services Agreement [Member] | |||
Disclosure of contingent liabilities [line items] | |||
Agreements expiration date | 7 years | ||
Manufacturing Agreement [Member] | |||
Disclosure of contingent liabilities [line items] | |||
Agreements expiration date | 12 years |
GUARANTEES AND CHARGES (Details
GUARANTEES AND CHARGES (Details) - Dec. 31, 2019 ₪ in Thousands, $ in Thousands | USD ($) | ILS (₪) |
Disclosure of contingent liabilities [line items] | ||
Value of loans for which collateral has been pledged | $ 2,176 | |
NIS [Member] | ||
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 | $ 255 |
EQUITY (Narrative) (Details)
EQUITY (Narrative) (Details) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($)shares | Dec. 31, 2019₪ / shares | Dec. 31, 2018₪ / shares | |
Disclosure of classes of share capital [abstract] | ||||
Share options, exercised | 67,470 | 53,584 | ||
Ordinary shares issued from share options exercised | 13,133 | 8,686 | ||
Ordinary shares par value | ₪ / shares | ₪ 1 | ₪ 1 | ||
Proceeds from share options exercised | $ | $ 16 | $ 9 | ||
Option vested | 44,892 | 23,572 |
EQUITY (Schedule of Share Capit
EQUITY (Schedule of Share Capital) (Details) - shares | Dec. 31, 2019 | Dec. 31, 2018 |
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 | 40,353,101 | 40,295,078 |
EQUITY (Schedule of Issued and
EQUITY (Schedule of Issued and Outstanding Share Capital) (Details) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure of classes of share capital [abstract] | ||
Begginning balance | 40,295,078 | 40,262,819 |
Issue of shares | ||
Exercise of options into shares | 13,133 | 8,686 |
Exercise of restricted shares | 44,890 | 23,573 |
Ending balance | 40,353,101 | 40,295,078 |
SHARE-BASED PAYMENT (Narrative)
SHARE-BASED PAYMENT (Narrative) (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Jun. 20, 2019USD ($)shares | Sep. 30, 2016 | Dec. 31, 2019USD ($)shares | Dec. 31, 2018₪ / sharesshares | Dec. 31, 2017shares | Dec. 31, 2019₪ / shares | Jun. 20, 2019₪ / shares | |
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||
Option granted | 443,800 | 617,825 | 458,950 | ||||
Number of RSs [Member] | |||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||
Option granted | 69,725 | 96,308 | 58,835 | ||||
Top of range [Member] | |||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||
Exercise price of options | ₪ / shares | ₪ 57 | ₪ 57 | |||||
Bottom of range [Member] | |||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||
Exercise price of options | ₪ / shares | ₪ 15 | ₪ 15 | |||||
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 | ₪ / shares | ₪ 21.34 | ||||||
Fair value of options | $ | $ 154 | ||||||
Chief Executive Officer [Member] | Number of RSs [Member] | |||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||
Option granted | 30,000 | ||||||
Exercise price of options | ₪ / shares | ₪ 21.34 | ||||||
Fair value of options | $ | $ 165 | ||||||
Employees options [Member] | |||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||
Option granted | 443,800 | ||||||
Fair value of options | $ | $ 778 | ||||||
Employees options [Member] | Number of RSs [Member] | |||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||
Option granted | 69,725 | ||||||
Fair value of options | $ | $ 381 | ||||||
Directors options [Member] | |||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||
Vesting description of options | On January 20, 2020, the Company's Board of Directors approved the grant of 212,800 options to Board of Directors. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $391 thousands. The grant of the options to the Board of Directors is subject to the approval of the General Meeting of Shareholders of the Company that is expected to take place by March 2020. |
SHARE-BASED PAYMENT (Schedule o
SHARE-BASED PAYMENT (Schedule of Expense Recognized in Financial Statements) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Total share-based compensation | $ 1,163 | $ 948 | $ 483 |
Cost of revenues [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Total share-based compensation | 364 | 401 | 179 |
Research and development [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Total share-based compensation | 254 | 224 | 138 |
Selling and marketing [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Total share-based compensation | 63 | 51 | 48 |
General and administrative [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Total share-based compensation | $ 482 | $ 272 | $ 118 |
SHARE-BASED PAYMENT (Schedule_2
SHARE-BASED PAYMENT (Schedule of Change of Awards) (Details) - ₪ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Number of Options | |||
Outstanding at beginning of year | 2,445,597 | 2,572,372 | 2,487,236 |
Granted | 443,800 | 617,825 | 458,950 |
Exercised | (67,470) | (53,584) | (10,659) |
Forfeited | (485,373) | (691,016) | (363,155) |
Outstanding at end of year | 2,336,554 | 2,445,597 | 2,572,372 |
Exercisable at end of year | 1,412,023 | 1,406,048 | 1,755,253 |
Weighted Average Exercise Price | |||
Outstanding at beginning of year | ₪ 29.99 | ₪ 32.47 | ₪ 35.2 |
Granted | 20.64 | 19.02 | 21.10 |
Exercised | 32.30 | 15.77 | 18.19 |
Forfeited | 16.98 | 30.51 | 35.70 |
Outstanding at end of year | 27.87 | 29.99 | 32.47 |
Exercisable at end of year | ₪ 33.17 | ₪ 38.02 | ₪ 38.69 |
The weighted average remaining contractual life for the share options | 3 years 4 months 20 days | 3 years 7 months 17 days | 3 years 2 months 19 days |
SHARE-BASED PAYMENT (Schedule_3
SHARE-BASED PAYMENT (Schedule of Number of RSs and Modification in Employee RSs) (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of classes of share capital [line items] | |||
Outstanding at beginning of year | 2,445,597 | 2,572,372 | 2,487,236 |
Granted | 443,800 | 617,825 | 458,950 |
Forfeited | (485,373) | (691,016) | (363,155) |
Outstanding at end of year | 2,336,554 | 2,445,597 | 2,572,372 |
The weighted average remaining contractual life for the restricted share | 3 years 4 months 20 days | 3 years 7 months 17 days | 3 years 2 months 19 days |
Number of RSs [Member] | |||
Disclosure of classes of share capital [line items] | |||
Outstanding at beginning of year | 139,706 | 76,512 | 27,333 |
Granted | 69,725 | 96,308 | 58,835 |
End of restriction period | (18,643) | (23,572) | |
Forfeited | (44,892) | (9,542) | (7,656) |
Outstanding at end of year | 145,896 | 139,706 | 76,512 |
The weighted average remaining contractual life for the restricted share | 2 years 9 months 11 days | 3 years 2 months 16 days | 3 years 6 months 14 days |
SHARE-BASED PAYMENT (Schedule_4
SHARE-BASED PAYMENT (Schedule of Inputs to Binomial Model Used for Fair Value Measurement) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Dividend yield (%) | |||
Contractual term of up to (years) | 6 years 6 months | 6 years 6 months | 6 years 6 months |
Exercise multiple | $ 2 | $ 2 | $ 2 |
Bottom of range [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Expected volatility of the share prices (%) | 23.00% | 25.00% | 37.00% |
Risk-free interest rate (%) | 0.30% | 0.20% | 0.10% |
Weighted average share prices (NIS) | $ 19.17 | $ 18.49 | $ 16.05 |
Expected average forfeiture rate (%) | 2.00% | 1.00% | 1.00% |
Top of range [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Expected volatility of the share prices (%) | 41.00% | 39.00% | 45.00% |
Risk-free interest rate (%) | 1.70% | 0.20% | 1.83% |
Weighted average share prices (NIS) | $ 19.65 | $ 21.17 | $ 16.44 |
Expected average forfeiture rate (%) | 6.00% | 5.00% | 5.00% |
TAXES ON INCOME (Narrative) (De
TAXES ON INCOME (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2019 | 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% | 23.00% | ||
Carry forward losses | $ 47,289 | |||
Deferred tax asset | 1,311 | $ 2,048 | ||
Carry forward losses foreseeable future | $ 20,484 | |||
Dividends distributed from technology enterprise earnings [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Tax rate | 4.00% | |||
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% | |||
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% | |||
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 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. | |||
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). | |||
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% | |||
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 | |||
Legislative Amendments [Member] | ||||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||||
Reduced corporate tax | In 2017 from 25% to 24%, and in 2018 from 24% to 23% | 24% to 23% | 25% to 24% | |
Corporate income tax rate | 23.00% | 23.00% | 24.00% |
TAXES ON INCOME (Schedule of We
TAXES ON INCOME (Schedule of Weighted Combination of Applicable Rates) (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Percent of Foreign Ownership One [Member] | |
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |
Tax Exemption Period | 2/10 years |
Reduced Tax Period | 5/0 years |
Rate of Reduced Tax | 25% |
Percent of Foreign Ownership | 0-25% |
Percent of Foreign Ownership Two [Member] | |
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |
Tax Exemption Period | 2/10 years |
Reduced Tax Period | 8/0 years |
Rate of Reduced Tax | 25% |
Percent of Foreign Ownership | 25-49% |
Percent of Foreign Ownership Three [Member] | |
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |
Tax Exemption Period | 2/10 years |
Reduced Tax Period | 8/0 years |
Rate of Reduced Tax | 20% |
Percent of Foreign Ownership | 49-74% |
Percent of Foreign Ownership Four [Member] | |
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |
Tax Exemption Period | 2/10 years |
Reduced Tax Period | 8/0 years |
Rate of Reduced Tax | 15% |
Percent of Foreign Ownership | 74-90% |
Percent of Foreign Ownership Five [Member] | |
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |
Tax Exemption Period | 2/10 years |
Reduced Tax Period | 8/0 years |
Rate of Reduced Tax | 10% |
Percent of Foreign Ownership | 90-100% |
TAXES ON INCOME (Schedule of De
TAXES ON INCOME (Schedule of Deferred Taxes) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Disclosure of taxes on income [Abstract] | |
Balance at January 1, 2018 | $ 2,048 |
Amount carried to profit and loss | (726) |
Amount carried to other comprehensive income | (11) |
Balance as of December 31, 2018 | $ 1,311 |
TAXES ON INCOME (Schedule of _2
TAXES ON INCOME (Schedule of deferred tax liabilities and assets) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of taxes on income [Abstract] | |||
Financial assets measured at fair value through other comprehensive income | $ (32) | $ (12) | |
Revaluation of derivatives | (4) | ||
Carryforward tax losses | 1,330 | 2,056 | |
Carryforward tax losses 1 | 726 | 1,944 | |
Employee benefits | 25 | 1 | |
Issuance of sheers | |||
Revaluation of derivatives | 3 | ||
Deferred tax income (expenses) | 11 | 9 | |
Deferred tax assets, net | $ 1,311 | $ 2,048 |
TAXES ON INCOME (Shedule of def
TAXES ON INCOME (Shedule of deferred taxes are reflected in the statement of financial position) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Non-current assets | $ 30,235 | $ 27,226 |
NIS [Member] | ||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Non-current assets | $ 2,048 | $ 1,311 |
TAXES ON INCOME (Schedule of Cu
TAXES ON INCOME (Schedule of Current Taxes on Income) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of taxes on income [Abstract] | |||
Current taxes | $ 129 | ||
Deferred tax income | 726 | (1,944) | |
Taxes in respect of prior years | 4 | (11) | 140 |
Taxes on income | $ 730 | $ (1,955) | $ 269 |
TAXES ON INCOME (Schedule of Th
TAXES ON INCOME (Schedule of Theoretical tax) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of taxes on income [Abstract] | |||
Gain before taxes on income | $ 22,981 | $ 20,341 | |
Statutory tax rate | 23.00% | 23.00% | |
Tax calculated using the statutory tax rate | $ 5,285 | $ 4,678 | |
Adjustment of deferred tax balances following a change in tax rates | (356) | ||
Taxable income with preferred income tax rates by virtue of the Encouragement Law | (3,747) | ||
Tax exempt income, income subject to special tax rates and nondeductible expenses and other | (105) | ||
Carry-forward tax losses utilization for which no deferred taxes were provided, net | (4,678) | ||
Temporary differences for which deferred taxes are initially recognized | 726 | (1,944) | |
Increase in unrecognized tax losses in the year | (352) | ||
Prior year taxes | 4 | (11) | 140 |
Tax on income | $ 730 | $ (1,955) | $ 269 |
Effective tax rate | 3.20% | 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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | ||
Disclosure of major customers [line items] | ||||
Revenues from major customers | $ 98,961 | $ 75,567 | $ 60,383 | |
Customer A [Member] | ||||
Disclosure of major customers [line items] | ||||
Revenues from major customers | [1] | 68,138 | 63,788 | 60,383 |
Customer B [Member] | ||||
Disclosure of major customers [line items] | ||||
Revenues from major customers | 16,369 | 11,779 | ||
Customer C [Member] | ||||
Disclosure of major customers [line items] | ||||
Revenues from major customers | $ 14,454 | |||
[1] | For additional information regarding the aggregate amount of the transaction price allocated to the performance obligations that are unsatisfied, refer to note 17a. |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of geographical areas [line items] | |||
Total Revenue | $ 127,187 | $ 114,469 | $ 102,825 |
US [Member] | |||
Disclosure of geographical areas [line items] | |||
Total Revenue | 84,572 | 75,331 | 60,405 |
Israel [Member] | |||
Disclosure of geographical areas [line items] | |||
Total Revenue | 31,959 | 28,093 | 26,355 |
Europe [Member] | |||
Disclosure of geographical areas [line items] | |||
Total Revenue | 4,701 | 3,594 | 5,348 |
Latin America [Member] | |||
Disclosure of geographical areas [line items] | |||
Total Revenue | 3,792 | 3,994 | 5,248 |
Asia [Member] | |||
Disclosure of geographical areas [line items] | |||
Total Revenue | 2,067 | 3,336 | 4,979 |
Others [Member] | |||
Disclosure of geographical areas [line items] | |||
Total Revenue | $ 96 | $ 121 | $ 490 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cost of goods sold | |||
Cost of materials | $ 69,766 | $ 56,156 | $ 41,179 |
Salary and related expenses | 16,941 | 15,290 | 13,755 |
Subcontractors | 4,451 | 3,633 | 3,995 |
Depreciation and amortization | 2,991 | 2,859 | 2,504 |
Energy | 1,551 | 1,426 | 1,202 |
Other manufacturing expenses | 712 | 566 | 954 |
Total expenses | 96,412 | 79,930 | 63,589 |
Decrease (increase) in inventories | (18,962) | (6,933) | 7,148 |
Total Cost of goods sold | 77,450 | 72,997 | 70,737 |
Research and development | |||
Salary and related expenses | 5,897 | 5,925 | 6,537 |
Subcontractors | 5,196 | 2,275 | 3,392 |
Materials and allocation of facility costs | 966 | 1,131 | 1,597 |
Depreciation and amortization | 663 | 159 | 120 |
Others | 337 | 257 | 327 |
Total Research and development | 13,059 | 9,747 | 11,973 |
Selling and marketing | |||
Salary and related expenses | 1,467 | 1,647 | 1,470 |
Marketing support | 103 | 121 | 95 |
Packing, shipping and delivery | 504 | 477 | 607 |
Marketing and advertising | 788 | 424 | 627 |
Registration and marketing fees | 917 | 470 | 1,162 |
Others | 591 | 491 | 437 |
Total Selling and marketing | 4,370 | 3,630 | 4,398 |
General and administrative | |||
Salary and related expenses | 3,475 | 3,085 | 3,138 |
Employees welfare | 1,296 | 1,151 | 2,182 |
Professional fees and public company expense | 2,162 | 2,012 | 1,549 |
Depreciation, amortization and impairment | 717 | 686 | 649 |
Communication and software services | 799 | 675 | 554 |
Others | 745 | 916 | 201 |
Total General and administrative | 9,194 | 8,525 | 8,273 |
Financial incomes | |||
Interest income and gains from marketable securities | 1,146 | 830 | 500 |
Financial expenses | |||
Fees and interest paid to financial institutions | 293 | 172 | 82 |
Financial income and (expense) | |||
Derivatives instruments measured at fair value | (512) | 504 | (511) |
Translation differences of financial assets and liabilities | (139) | 98 | (101) |
Bond securities measured at fair value | (5) | (178) | (80) |
Total Financial expense(income) | $ 197 | $ 1,082 | $ (274) |
INCOME (LOSS) PER SHARE (Schedu
INCOME (LOSS) PER SHARE (Schedule of Details of Number of Shares and Income (Loss)) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income (Loss) Per Share [abstract] | |||
Weighted Number of Shares For the computation of basic income (loss) | 40,320,888 | 40,275,374 | 37,970,697 |
Weighted Number of Shares Effect of potential dilutive ordinary shares | 260,739 | 170,043 | 74,400 |
Weighted Number of Shares For the computation of diluted income (loss) | 40,581,627 | 40,445,417 | 38,045,097 |
Loss Attributed to equity holders of the Company For the computation of basic income (loss) | $ 22,251 | $ 22,296 | $ 6,901 |
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) | $ 22,251 | $ 22,296 | $ 6,901 |
OPERATING SEGMENTS (Schedule of
OPERATING SEGMENTS (Schedule of Reporting on Operating Segments) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of operating segments [line items] | |||
Revenues | $ 127,187 | $ 114,469 | $ 102,825 |
Gross profit | 49,737 | 41,472 | 32,088 |
Unallocated corporate expenses | (26,953) | (22,213) | (26,644) |
Finance income, net | 197 | 1,082 | (274) |
Income before taxes on income | 22,981 | 20,341 | 7,170 |
Proprietary Products [Member] | |||
Disclosure of operating segments [line items] | |||
Revenues | 97,696 | 90,784 | 79,559 |
Gross profit | 45,271 | 37,988 | 28,224 |
Distribution [Member] | |||
Disclosure of operating segments [line items] | |||
Revenues | 29,491 | 23,685 | 23,266 |
Gross profit | $ 4,466 | $ 3,484 | $ 3,864 |
BALANCES AND TRANSACTIONS WIT_3
BALANCES AND TRANSACTIONS WITH RELATED PARTIES (Narrative) (Details) $ / shares in Units, ₪ in Thousands, $ in Thousands | Feb. 10, 2020USD ($)$ / sharesshares | Nov. 21, 2019$ / sharesshares | Jun. 20, 2019USD ($) | Jun. 20, 2019ILS (₪) | Dec. 20, 2018USD ($) | Dec. 20, 2018ILS (₪) | Dec. 31, 2019USD ($) |
FIMI Funds [Member] | |||||||
Disclosure of transactions between related parties [line items] | |||||||
Shares purchased | shares | 5,240,956 | ||||||
Share price | $ / shares | $ 6 | ||||||
Interest rate, percentage | 0.1299 | ||||||
FIMI Funds [Member] | Non-adjusting events after reporting period [member] | |||||||
Disclosure of transactions between related parties [line items] | |||||||
Shares purchased | shares | 4,166,667 | ||||||
Share price | $ / shares | $ 6 | ||||||
Interest rate, percentage | 0.1299 | ||||||
Gross proceeds | $ 25,000 | ||||||
Funds ownership percentage | 0.21 | ||||||
Chief Executive Officer [Member] | |||||||
Disclosure of transactions between related parties [line items] | |||||||
Monthly gross salary | $ 22,627 | ||||||
Chief Executive Officer [Member] | |||||||
Disclosure of transactions between related parties [line items] | |||||||
Monthly gross salary | $ 25,462 | ||||||
Annual bonus | $ 189 | ||||||
Chief Executive Officer [Member] | NIS [Member] | |||||||
Disclosure of transactions between related parties [line items] | |||||||
Monthly gross salary | ₪ | ₪ 88,000 | ₪ 82,500 |
BALANCES AND TRANSACTIONS WIT_4
BALANCES AND TRANSACTIONS WITH RELATED PARTIES (Schedule of Balances with Related Parties) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Disclosure of transactions between related parties [abstract] | ||
Other accounts payables | $ 151 | $ 336 |
Employee benefit liabilities, net | 80 | |
Trade receivable | $ 1,135 |
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, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Disclosure of transactions between related parties [abstract] | |||
Salary and related expenses to those employed by the Company or on its behalf | $ 311 | $ 352 | $ 460 |
Remuneration of directors not employed by the Company or on its behalf | $ 363 | $ 366 | $ 107 |
Related and related parties employed by the Company or on its behalf | 2 | 2 | 2 |
Directors not employed by the Company | 7 | 8 | 2 |
Total Directors employed and not employed by the Company | 9 | 10 | 4 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of transactions between related parties [abstract] | |||
Short-term benefits | $ 3,157 | $ 2,766 | $ 2,959 |
Share-based payment | 188 | 285 | 310 |
Other long-term benefits | 6 | ||
Total | $ 3,345 | $ 3,051 | $ 3,275 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of transactions between related parties [abstract] | |||
Revenues | $ 2,566 | $ 3,529 | $ 3,455 |
Cost of Goods Sold | 13 | ||
Selling and marketing expenses | 257 | 313 | 121 |
General and administrative expenses | $ 447 | $ 408 | $ 446 |